VER 2.1 by RadcliffeVascular

Vascular & Endovascular Review Volume 2 • Issue 1 • Spring 2019

Volume 2 • Issue 1 • Spring 2019

www.VERjournal.com

Acute Type B Dissection Andre Ramdon and R Clement Darling III

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives Grigorios Korosoglou, Sorin Giusca, Martin Andrassy and Michael Lichtenberg

Insights and Clinical Implications from the pELVIS Registry for the Treatment of Aneurysms Involving the Iliac Bifurcation Gergana T Taneva, Giovanni Torsello and Konstantinos P Donas

Endovascular Aneurysm Repair Using Anaconda Repositionable Aortic Stent Graft Assisted Exclusively by Intravascular Ultrasound Imaging Gaetano La Barbera, Giuliana La Rosa, Fabrizio Valentino, Gabriele Ferro, Dario Parsaei, Rosario Lipari, Davide Petrucelli and Francesco Talarico

ISSN: 2516–3299

Carotid artery stenosis on CT angiography in a patient after stroke

Left renal artery as the lowest renal artery on intravascular ultrasound scan

Calcifications affecting arteries

Vascular

Lifelong Learning for Vascular Professionals

VER 2.1 COVER.indd All Pages

02/04/2019 18:48

S AV E T H E

DATE Wynn Las Vegas Las Vegas, Nevada, USA

Registration opening May 2019 www.vivaphysicians.org

Venous Endovascular INterventional Strategies

NEW HANDS-ON ULTRASOUND AND IMAGING SESSIONS

NOVEMBER 2-4, 2019

Vascular InterVentional Advances

• PIVOTAL LATE-BREAKING CLINICAL TRIALS • GLOBAL LIVE CASES • NEW DIALYSIS COURSE • EXPANDED HANDS-ON INNOVATION LAB • DYNAMIC FELLOWS PROGRAM

N O V E M B E R 4 - 7, 2 0 1 9

Untitled-7 1

28/03/2019 23:23

Volume 2 • Issue 1 • Spring 2019

www.VERjournal.com

Editor-in-Chief Stephen Black

Guy's and St Thomas’ Hospital, London

Section Editor – Aortic

Section Editor – Venous

Andrew Choong

Rick de Graaf

National University of Singapore, Singapore

Maastricht University Medical Centre, the Netherlands

Section Editor – Peripheral Artery Disease

Section Editor - Complex Endovascular Procedures

Michael Lichtenberg

Konstantinos P Donas

Klinikum Arnsberg, Karolinen Hospital, Germany

St Franziskus Hospital, Münster, Germany

Section Editor – Case Reports Ash Patel King´s College London, UK

Cover images © Adobe Stock

Editorial Board Elias Brountzos

Ross Milner

Attikon University General Hospital, Greece

University of Chicago Medical Center, Chicago, US

Andrew Bullen

Abdullah Omari

Wollongong Hospital, Australia

St Vincent’s Clinic, New South Wales, Australia

Patrick Chong

Gerry O’Sullivan

Frimley Health NHS Foundation Trust, Surrey, UK

University College Hospital, Ireland

Brian G DeRubertis

Prakash Saha

David Gefffen School of Medicine at UCLA, US

King’s College Hospital, London, UK

Fernando Gallardo

Morad Sallam

University Hospital Complex of Santiago de Compostela, Spain

Guy’s and St Thomas’ NHS Foundation Trust, London, UK

Andrew Holden

Michael C Stoner

Auckland City Hospital, New Zealand

University of Rochester Medical Center, New York, US

Emad Hussein

Sherif Sultan

Ain Shams University Hospital, Cairo, Egypt

National University of Ireland, Ireland

Houman Jalaie

Gustaf Tegler

University Hospital RWTH, Aachen, Belgium

Uppsala University, Sweden

Narayan Karunanithy

Gergana Todorova Taneva

Guy’s and St Thomas’ NHS Foundation Trust, London, UK

University Ramón y Cajal, Madrid, Spain

Martin Maresch

Ramon Varcoe

BDF Hospital, Bahrain

Prince of Wales Hospital, Sydney, Australia

Editorial

Accounts

Managing Editor Rosie Scott | Production Editor Aashni Shah Publishing Director Leiah Norcott | Senior Designer Tatiana Losinska Contact rosie.scott@radcliffe-group.com

Key Account Directors Rob Barclay, David Bradbury, Gary Swanston Accounts Team William Cadden, Bradley Wilson Contact rob.barclay@radcliffe-group.com

Partnerships

Leadership

Marketing Manager Anne-Marie Benoy Contact anne-marie.benoy@radcliffe-group.com

Chief Executive Officer David Ramsey Chief Operations Officer Liam O’Neill

Published by Radcliffe Vascular. All information by Radcliffe Vascular and each of the contributors from various sources is as current and accurate as possible. However, due to human or mechanical errors, Radcliffe Vascular and the contributors cannot guarantee the accuracy, adequacy or completeness of any information, and cannot be held responsible for any errors or omissions, or for the results obtained from the use thereof. Published content is for information purposes only and is not a substitute for professional medical advice. Where views and opinions are expressed, they are those of the author(s) and do not necessarily reflect or represent the views and opinions of Radcliffe Vascular. Radcliffe Vascular, Unit F, First Floor, Bourne End Business Park, Cores End Road, Bourne End, Buckinghamshire SL8 5AS, UK.

ISSN: 2516–3299 eISSN: 2516–3302

VER_masthead_2019.indd 1

02/04/2019 18:53

Established: September 2018 | Frequency: Bi-annual | Current issue: Spring 2019

Aims and Scope

Submissions and Instructions to Authors

• Vascular & Endovascular Review aims to assist time-pressured physicians to stay abreast of key advances and opinion in vascular and endovascular practice. • Vascular & Endovascular Review comprises balanced and comprehensive articles written by leading authorities, addressing the most pertinent developments in the field. • Vascular & Endovascular Review provides comprehensive updates on a range of salient issues to support physicians in continuously developing their knowledge and effectiveness in day-to-day clinical practice.

• Contributors are identified by the Editor-in-Chief with the support of the Section Editors and Managing Editor, and guidance from the Editorial Board. • Following acceptance of an invitation, the author(s) and Managing Editor, in conjunction with the Editor-in-Chief and Section Editors, formalise the working title and scope of the article. • The ‘Instructions to Authors’ document and additional submission details are available at www.VERjournal.com • Leading authorities wishing to discuss potential submissions should contact the Managing Editor, Rosie Scott rosie.scott@radcliffe-group.com

Structure and Format • Vascular & Endovascular Review is a bi-annual journal comprising review articles, expert opinion articles and guest editorials. • The structure and degree of coverage assigned to each category of the journal is the decision of the Editor-in-Chief, with the support of the Section Editors and Editorial Board. • Articles are fully referenced, providing a comprehensive review of existing knowledge and opinion. • Each edition of Vascular & Endovascular Review is available in full online at www.VERjournal.com

Reprints All articles published in Vascular & Endovascular Review are available as reprints. Please contact the Publishing Director, Leiah Norcott leiah.norcott@radcliffe-group.com

Distribution and Readership Vascular and Endovascular Review is distributed bi-annually through controlled circulation to senior healthcare professionals in the field in Europe.

Open Access, Copyright and Permissions

Editorial Expertise Vascular & Endovascular Review is supported by various levels of expertise: • Overall direction from an Editor-in-Chief, supported by Section Editors and an Editorial Board comprising leading authorities from a variety of related disciplines. • Invited contributors who are recognised authorities in their respective fields. • Peer review – conducted by experts appointed for their experience and knowledge of a specific topic. • An experienced team of Editors and Technical Editors.

Peer Review • On submission, all articles are assessed by the Editor-in-Chief to determine their suitability for inclusion. • The Managing Editor, following consultation with the Editor-in-Chief, Section Editors and/or a member of the Editorial Board, sends the manuscript to reviewers who are selected on the basis of their specialist knowledge in the relevant area. All peer review is conducted double-blind. • Following review, manuscripts are accepted without modification, accepted pending modification (in which case the manuscripts are returned to the author(s) to incorporate required changes), or rejected outright. The Editor-in-Chief reserves the right to accept or reject any proposed amendments. • Once the authors have amended a manuscript in accordance with the reviewers’ comments, the manuscript is assessed to ensure the revised version meets quality expectations. The manuscript is sent to the Editor-in-Chief for final approval prior to publication.

Articles published within this journal are open access, which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly. The author retains all non-commercial rights for articles published herein under the CC-BY-NC 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/ legalcode). Radcliffe Vascular retain all commercial rights for articles published herein unless otherwise stated. Permission to reproduce an article for commercial purposes, either in full or in part, should be sought from the publication’s Managing Editor.

Online All manuscripts published in Vascular & Endovascular Review are available free-to-view at www.VERjournal.com. Also available at www.radcliffecardiology.com are articles from our other journals – including Arrhythmia & Electrophysiology Review, Interventional Cardiology Review, Cardiac Failure Review, European Cardiology Review and US Cardiology Review.

Vascular

Lifelong Learning for Vascular Professionals

VER_A+S 2019.indd 2

07/04/2019 15:30

Contents

Foreword Stephen Black

DOI: https://doi.org/10.15420/ver.2019.6.1

Peripheral Artery Disease Below-the-ankle Angioplasty: Current Evidence and Future Perspectives

Stavros Spiliopoulos, Lazaros Reppas, Konstantinos Palialexis and Elias Brountzos DOI: https://doi.org/10.15420/ver.2018.19.2

Insights and Clinical Implications from the pELVIS Registry for the Treatment of Aneurysms Involving the Iliac Bifurcation

Gergana T Taneva, Giovanni Torsello and Konstantinos P Donas, on behalf of the pELVIS Registry collaborators DOI: https://doi.org/10.15420/ver.2018.22.2

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives

Grigorios Korosoglou, Sorin Giusca, Martin Andrassy and Michael Lichtenberg DOI: https://doi.org/10.15420/ver.2018.16.2

Historical Overview of Vascular Allograft Transplantation

Kerbi Alejandro Guevara-Noriega, Albert Martinez Toiran, Bruno Alvarez-Concejo and Jose Luis Pomar DOI: https://doi.org/10.15420/ver.2018.15.1

Aortic Alternative Access for Transcatheter Aortic Valve Implantation: Current Evidence and Future Directions

JJ Coughlan, Thomas J Kiernan and Samer Arnous DOI: https://doi.org/10.15420/ver.2019.4.2

Acute Type B Dissection

Andre Ramdon and R Clement Darling III DOI: https://doi.org/10.15420/ver.2018.21.1

Endovascular Aneurysm Repair Using Anaconda Repositionable Aortic Stent Graft Assisted Exclusively by Intravascular Ultrasound Imaging

Gaetano La Barbera, Giuliana La Rosa, Fabrizio Valentino, Gabriele Ferro, Dario Parsaei, Rosario Lipari, Davide Petrucelli and Francesco Talarico DOI: https://doi.org/10.15420/ver.2019.3.1

The Fate of the Superior Mesenteric Artery in Fenestrated Endovascular Repair of Complex Abdominal Aortic Aneurysms

Yongcheng Xu and Yukun Li DOI: https://doi.org/10.15420/ver.2019.1.1

Carotid Carotid Artery Stenosis

Edward Y Woo and Joshua Dearing DOI: https://doi.org/10.15420/ver.2018.14.2

Case Reports Combined Less-invasive Surgical and Endovascular Technique to Minimise Operative Trauma and Treat Excessive Aortoiliac Thrombotic Obliteration with Popliteo-crural Involvement and Acute Limb Ischaemia

Gergana T Taneva, Georgios Karaolanis, Marco Pipitone, Giovanni Torsello and Konstantinos P Donas DOI: https://doi.org/10.15420/ver.2018.18.1

Bilateral Lower Limb Disabling Claudication in a Young Man: A Case of Mönckeberg’s Arteriosclerosis

Khalid Abdelaziz Mowafy, Mosaad Soliman, Ahmed Magdy Hammoda and Reem Mosaad Soliman DOI: https://doi.org/10.15420/ver.2018.20.3

Importance of Follow-up Imaging in the Detection of Delayed Type 2 Endoleaks Despite Complete Aneurysmal Sac Shrinkage

Gergana T Taneva, Omid Shafe, Giovanni B Torsello, Arne Schwindt, Jamal Moosavi and Parham Sadeghipour DOI: http://doi.org/10.15420/ver.2019.2.2

VERR_ Contents 2.1.indd 3

02/04/2019 19:09

Supporting life-long learning for vascular professionals Led by Editor-in-Chief Stephen Black and underpinned by an editorial board of worldrenowned physicians, Vascular & Endovascular Review is a peer-reviewed journal that publishes reviews, case reports and guest editorials. Available in print and online, Vascular & Endovascular Reviewâ&#x20AC;&#x2122;s articles are free-to-access, and aim to support continuous learning for physicians within the field.

Call for Submissions Vascular & Endovascular Review publishes invited contributions from prominent experts, but also welcomes speculative submissions of a superior quality. For further information on submitting an article, or for free access to the journal, please visit: www.VERjournal.com

Vascular

Lifelong Learning for Vascular Professionals

Vascular & Endovascular Review is part of the Radcliffe Group. For further information, including access to thousands of educational reviews, visit: www.radcliffe-group.com or www.radcliffecardiology.com

VER_CallForSubmission 2019.indd 77

02/04/2019 19:10

Foreword

Stephen Black Guy's and St Thomas’ Hospital, London

t is with great pleasure that we introduce to you, our readers, to the first issue of Vascular & Endovascular Review for 2019. VER was launched last year, with the aim of providing vascular interventionists with a resource to keep their practice up to date and to continuously develop their knowledge and effectiveness in day-to-day clinical practice through education and informative material. This issue features a range of articles on major areas of peripheral artery disease, aortic and carotid, as well as case reports, from renowned experts. In our peripheral artery disease section, Spiliopoulos et al. discuss the currently available data and the future perspectives on below-the-ankle and pedal arch endovascular treatment, and Korosoglou et al. discuss the current evidence and future perspectives of the role of atherectomy in peripheral artery disease. In their article, Guevara-Noriega et al. provide a historical overview of vascular allograft transplantation through a literature review on its evolution and its use and acceptance by vascular surgeons, exposing three stages: preliminary experimentation; a decline in use due to long-term complications; and its current use in special indications subject to a thorough analysis. The last article in this section by Taneva et al. looks at the pELVIS Registry for the treatment of aneurysms involving the iliac bifurcation. They discuss the feasibility of the technique with good short- and mid-term results, and state that the most common anatomical challenge for iliac branch device use is the presence of aneurysmal deterioration of the internal iliac arteries, concluding that the relatively low procedure-related complications and repeat interventions show broad applicability of the technique. In the aortic section, Coughlan et al. discuss transcatheter aortic valve implantation, and provide an overview of options for alternative vascular access in TAVI, the clinical rationale for using them, current evidence and areas for clinical investigation. Ramdon and Darling III look at acute type B dissections and discuss that, even though early treatment for uncomplicated type B dissections still remains controversial, certain characteristics may benefit from early intervention. In their study, La Barbera et al. discuss endovascular aneurysm repair (EVAR) using anaconda repositionable aortic stent graft assisted exclusively by intravascular ultrasound imaging, and conclude that a full EVAR procedure is feasible using only intravascular ultrasound navigation and repositionable aortic stent graft without contrast medium injection in anatomically selected cases. Xu and Li discuss the superior mesenteric artery (SMA) in fenestrated endovascular repair of complex abdominal aortic aneurysms and review current literature to improve understanding of the nature course of the SMA in fenestrated technology. In the carotid section, Woo and Dearing outline the current guidelines for carotid artery stenosis and review current studies and analyses. Future studies and emerging technologies are outlined in an attempt to provide an evaluation of the current data and management of this complex problem. Finally, we present three case reports. Mowafy et al. present a case of Mönckeberg’s arteriosclerosis in a young man with bilateral lower limb disabling claudication; Taneva et al. look at the combined less-invasive surgical and endovascular technique to minimise operative trauma and to treat excessive aortoiliac thrombotic obliteration with popliteo-crural involvement and acute limb ischaemia in a 51-year-old man; and Taneva et al. discuss the importance of follow-up imaging in the detection of delayed type 2 endoleaks despite complete aneurysmal sac shrinkage in two cases. We hope you enjoy the reading this latest issue of Vascular & Endovascular Review.

DOI: https://doi.org/10.15420/ver.2019.6.1

VER2-1-Foreword.indd 5

Access at: www.VERjournal.com

02/04/2019 19:12

Peripheral Artery Disease

Below-the-ankle Angioplasty: Current Evidence and Future Perspectives Stavros Spiliopoulos, Lazaros Reppas, Konstantinos Palialexis and Elias Brountzos 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens, Greece

Abstract Over 20 million adults in Europe suffer from peripheral arterial disease (PAD). The annual incidence of PAD is approximately 2.4%, while the annual incidence of critical limb ischaemia (CLI), the last and most severe stage of PAD, has been reported to be 0.4%. Endovascular angioplasty and/or stenting of infrapopliteal disease is, today, an established treatment for critical limb ischaemia. The main technical advantages of endovascular treatment over open bypass surgery include the possibility to revascularise more than one infrapopliteal vessels and, most importantly, to treat outflow pedal vessel disease or even reconstitute the pedal arch. Data of below-the-ankle angioplasty are beginning to sum up and the contribution of pedal arch angioplasty in limb salvage and wound healing are currently under investigation. In this review, currently available data and the future perspectives on below-the-ankle and pedal arch endovascular treatment will be presented.

Keywords Critical limb ischaemia, balloon angioplasty, wound healing, amputation, endovascular treatment, pedal arch angioplasty. Disclosure: The authors have no conflicts of interest to declare. Received: 19 November 2018 Accepted: 17 January 2019 Citation: Vascular & Endovascular Review 2019:2(1):6–8. DOI: https://doi.org/10.15420/ver.2018.19.2 Correspondence: Stavros Spiliopoulos, 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens, Greece. Email: stavspiliop@med.uoa.gr Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

More than 20 million adults in Europe have peripheral arterial disease (PAD) and the worldwide prevalence of the disease increases to 20% for patients over 70 years of age.1 The annual incidence of PAD is approximately 2.4%, while the annual incidence of critical limb ischaemia (CLI), the last and most severe stage of PAD, has been reported to be 0.4%.2 CLI is a limb-threatening pathology that has been correlated with exceedingly high amputation rates when prompt revascularisation is not offered. A mortality rate of over 50% at 5 years after the diagnosis has been reported.3,4 The goal of revascularisation is the establishment of adequate reperfusion of the foot tissue to relieve ischaemic symptoms and enable wound healing, which is usually achieved by creating a straight line of blood flow to the distal foot. Patients with CLI usually present with multilevel vascular disease involving the iliac, femoropopliteal and infrapopliteal vessels. However, in CLI patients with comorbidities, such as diabetes or end-stage renal disease (or both), the involvement of infrapopliteal and pedal arch disease is characteristic and frequent.5 Endovascular angioplasty and/or stenting of infrapopliteal disease is an established treatment for CLI. The main reasons why distal bypass surgery is either not recommended or frequently not feasible include high surgical risk of the patient, unavailability of an autologous venous conduit, poor-quality arterial runoff and extensive pedal arch disease.6,7 In contrast, minimally invasive infrapopliteal angioplasty and stenting does not necessitate general anaesthesia, requires less procedural time than open bypass surgery, results in low complication rates and can be easily repeated. Furthermore, the main technical advantages of

Access at: www.VERjournal.com

VER_Spiliopoulos_FINAL.indd 6

endovascular treatment over open bypass surgery include the option to revascularise more than one infrapopliteal vessel and, most importantly, to treat outflow pedal vessel disease or even reconstitute the pedal arch. It was nearly 20 years ago when endovascular pioneers published the first data on infrapopliteal balloon angioplasty and stenting, paving the way towards more effective endovascular treatment of CLI.8–10 With the advent of novel, improved, dedicated infrapopliteal endovascular devices such as 0.014-inch guidewires and supporting catheters, as well as tapered, low-profile, angioplasty balloon catheters, the possibility of safe and feasible below-the-ankle and pedal arch vessel angioplasty has arisen. Moreover, the development of retrograde pedal arterial access using dedicated low-profile sheaths and novel revascularisation techniques including the subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) dual access technique, have broadened the indications and further improved the success rates of previously technically impossible endovascular procedures.11

Data So Far The first study to compare below-the-knee angioplasty with or without pedal arch angioplasty was published in 2009 by Manzi et al.11 This study employed the pedal-plantar loop technique first described in a case report by Fusaro et al. in 2007.12 Manzi et al. investigated 135 consecutive CLI patients treated with the pedal-plantar loop technique in a prospectively maintained registry. These patients were compared with a retrospectively analysed cohort of 1,331 CLI patients who

28/03/2019 21:55

Below-the-ankle Angioplasty underwent below-the-knee angioplasty only. Acute technical success in the pedal-plantar loop group was 85%, compared with 100% in the below-the-knee angioplasty group. The 1-year limb salvage rate was similar between the two groups. However, at the 15-day follow-up, a significant improvement in transcutaneous oxygen tension (TcPO2) was noted in the group of patients with successful revascularisation of the foot arteries, compared with patients with two below-the-knee vessels at the ankle level with partial foot outflow (p<0.001).11 In 2010, Abdelhamid et al. reported longer-term outcomes following angioplasty of pedal and plantar arteries in 42 CLI cases. Technical success was 88.0% – similar to that reported by Manzi et al., while limb salvage was 81.9% at 2-year follow-up.13 Transdorsal-to-plantar or transplantar-to-dorsal balloon angioplasty for limb salvage in eight CLI patients with diabetes was also reported by Zhu et al. The authors managed to recanalise five out of eight patients (62.5%). Rest pain improved in all cases, wound healing or improvement was noted in two patients and no major amputation was necessary.14 A year later, Alexandrescu et al. published the first results of angiosome-guided infrapopliteal angioplasty with the aim of improving wound healing. In the majority of the patients, additional pedal and plantar artery angioplasty was performed resulting in excellent limb salvage rates.15 The same year, Kawarada et al. published the first study of below-the-ankle stenting. In this retrospective analysis of 40 critical ischaemic limbs (31 patients), balloon-expandable, baremetal stents were deployed following significant recoil, flow-limiting dissection, abrupt closure or repeat early reocclusion. Technical success was 93.0% and limb salvage was 82.1% at 2-year follow-up. However, the majority of the stents were deformed and two cases of acute or subacute stent occlusion were noted, while reinterventionfree rates were disappointing (39.6%, 39.6%, and 35.2%, at 6, 12, and 24 months, respectively).16 Following the unacceptably high clinically significant restenosis rates with bare-metal stents, Katsanos et al. reported outcomes of belowthe-ankle angioplasty and bail-out drug-eluting or self-expanding Nitinol stents in a series of 40 limbs in 37 CLI patients. Provisional stenting was used as a bail-out option following suboptimal angioplasty in 45.2% of the cases. Coronary drug-eluting stents (DES) were implanted in 57.9% of the cases, and self-expanding Nitinol stents were implanted in the remaining 42.1%. Despite the fact that half of the DES implanted were deformed or fractured during follow-up, self-expanding stents were associated with significantly higher restenosis and lower primary patency rates compared with balloon angioplasty or DES. The overall binary restenosis rate was 64.1% and repeat intervention-free survival was 93.6% at 1-year follow-up.17 Stent deformation and fracture is common in this specific anatomical area, which can be described as ‘stent non-friendly’.18 Stents (preferably DES) should be reserved for real bail-out cases, such as when the patient is facing amputation. Palena et al. retrospectively analysed 38 CLI patients who had undergone transmetatarsal arterial access and retrograde recanalisation of the foot and the tibial vessels, resulting in a satisfactory amputation-free survival rate of 81.5% at 1-year follow-up.19 In 2016, in another retrospective single-centre study, Nakama et al. investigated the clinical utility of additional pedal angioplasty in 29 CLI patients and, for the first time, an angiographic criterion for pedal angioplasty was described.20 Specifically, pedal arch angioplasty

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Spiliopoulos_FINAL.indd 7

was performed only if no sufficient wound blush around the target wounds was noted following above-the-ankle, tibial revascularisation. The authors compared outcomes of 14 limbs with additional pedal arch angioplasty and 18 limbs without pedal arch angioplasty as a result of sufficient wound blush. Technical success rate was 93% (13 of 14 patients), and following successful pedal arch angioplasty sufficient wound blush was achieved. Interestingly, despite the fact that limb salvage, amputation-free survival and freedom from reintervention were similar between the two study groups, wound healing (93.0% versus 60.0%; p=0.05) and time to wound healing (86.0 ± 18.7 versus 152.0 ± 60.2 days; p=0.05) were significantly improved in patients who underwent pedal arch angioplasty. In 2017, the same group published the outcomes of the first large scale multicentre registry. 21 The Retrospective Analysis for the Clinical Impact of Pedal Artery Revascularization Versus Non-Revascularization Strategy for Patients With Critical Limb Ischemia (RENDEZVOUS) retrospective registry investigated a total of 257 CLI patients divided into two groups based on the performance of additional pedal angioplasty (n=140) or not (n=117). Again, wound healing and time to wound healing were significantly improved in the pedal angioplasty group compared with the no pedal angioplasty group (57.5% versus 37.3%; p=0.003 and 211 days versus 365 days; p=0.008, respectively). However, after patient stratification into low-, medium- and high-risk groups according to a delayed wound healing score, adjunctive pedal arch angioplasty was found to improve the rate of wound healing only in the medium-risk population. In the high-risk population, additional pedal arch angioplasty did not contribute to an improvement in wound healing. Finally, in 2018 Teymen et al. published the results of a retrospective, single-centre study comparing patients who underwent additional below-the-ankle angioplasty (n=20) or below-the-knee angioplasty only (n=25), using drug-coated balloons.22 Mean lesion length was similar in the two groups (36.40 ± 8.14 mm versus 33.40 ± 7.25 mm in the belowthe-ankle and below-the-knee only groups, respectively). Interestingly, the 1-year restenosis rate was low in the below-the-ankle group, marginally missing the level of statistical significance (15.8% versus 47.8%; p=0.059). However, amputation and survival rates were similar between the two groups. All available studies are summarised in Table 1.

Future Perspectives Below-the-ankle angioplasty is part of everyday clinical practice in experienced vascular centres. Despite the initial positive clinical outcomes for CLI patients with small-vessel outflow disease and poor limb salvage prognosis, data for inframalleolar angioplasty remain limited to single-centre, mainly retrospective case series’ with a small number of patients and only one large, retrospective, multicentre registry. There is no solid evidence demonstrating that additional pedal angioplasty improves limb salvage rates, although there are strong indications that wound healing and time to wound healing are significantly improved in medium-risk patients. Several issues remain to be determined, such as clear indications for pedal angioplasty and the extent of pedal arch reconstruction, as well as the feasibility and effectiveness of various novel endovascular devices, such as drug-coated balloons, druginfusion catheters, lithoplasty, balloons that minimise dissections and atherectomy devices in the specific anatomical area. It should be highlighted that although limb salvage remains a clear clinical endpoint, wound healing and, more specifically, time to wound healing, should also be evaluated. Non-healing or slowly-healing ulcers

28/03/2019 21:55

Peripheral Artery Disease Table 1: Summary of Studies Investigating Below-the-ankle Endovascular Treatment Author Manzi et al. 2009

Design

Patients

Follow up

Outcome

Prospective registry with

135

15 days

Significantly improved TcPO2 in the plantar

retrospective control Abdelhamid et al. 2010

angioplasty group

Retrospective, single arm

Kawarada et al. 201116

Retrospective, single arm

Katsanos et al.2013

Zhu et al. 201014

Palena et al. 201419 Nakama et al. 2016

2 years

Limb salvage 81.9%

9 months

Limb salvage 100.0%

2 years

Limb salvage 82.1%

Retrospective, single arm

3 years

Limb salvage 85.0%

Retrospective, single arm

1 year

Limb salvage 81.5%

Retrospective controlled

1 year

Wound healing and time to wound healing significantly improved in the pedal artery angioplasty group

Nakama et al. 2016721

Multicenter, prospective, controlled

257

1 year

Wound healing and time to wound healing significantly improved in the pedal artery angioplasty group

Teymen et al. 201822

Retrospective, controlled

1 year

Similar limb salvage rates after additional pedal angioplasty

TcPO2 = transcutaneous oxygen tension.

directly affect the patient’s quality of life, creating major economic and social consequences. Novel technologies currently under investigation have enabled assessment of the metabolic activity of the revascularised tissue as well as real-time tissue perfusion imaging to accurately

orgren L, Hiatt WR, Dormandy JA, et al. Inter-society N consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45:S5–67. https://doi.org/10.1016/j. jvs.2006.12.037; PMID: 17223489. Dua A, Lee CJ. Epidemiology of peripheral arterial disease and critical limb ischemia. Tech Vasc Interv Radiol 2016;19:91–5. https://doi.org/10.1053/j.tvir.2016.04.001; PMID: 27423989. Spiliopoulos S, Kitrou P, Katsanos K, Karnabatidis D. Current phase II drugs under investigation for the treatment of limb ischemia. Expert Opin Investig Drugs 2015;24:1447–58. https://doi.org/10.1517/13543784.2015.1081894; PMID: 26296189. Uccioli L, Meloni M, Izzo V, et al. Critical limb ischemia: current challenges and future prospects. Vasc Health Risk Manag 2018;14:63–74. https://doi.org/10.2147/VHRM.S125065; PMID: 29731636. Diehm N, Rohrer S, Baumgartner I, et al. Distribution pattern of infrageniculate arterial obstructions in patients with diabetes mellitus and renal insufficiency – implications for revascularization. Vasa 2008;37:265–73. https://doi. org/10.1024/0301-1526.37.3.265; PMID: 18690594. Rashid H, Slim H, Zayed H, et al. The impact of arterial pedal arch quality and angiosome revascularization on foot tissue loss healing and infrapopliteal bypass outcome. J Vasc Surg 2013;57:1219–26. https://doi.org/10.1016/j.jvs.2012.10.129; PMID: 23523278. Toursarkissian B, D’Ayala M, Stefanidis D, et al. Angiographic scoring of vascular occlusive disease in the diabetic foot: relevance to bypass graft patency and limb salvage. J Vasc Surg 2002;35:494–500. https://doi.org/10.1067/mva.2002.120046; PMID: 11877697. Soder HK, Manninen HI, Jaakkola P, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol 2000;11:1021–31. https://doi.org/10.1016/S10510443(07)61332-3; PMID: 10997465.

VER_Spiliopoulos_FINAL.indd 8

10.

11.

12.

13.

14.

15.

16.

quantify outcomes of tissue reperfusion following revascularisation.23 To address these issues, large, prospective, controlled studies designed to quantify tissue perfusion and wound healing following endovascular treatment are awaited.

chillinger M, Exner M, Mlekusch W, et al. Endovascular S revascularization below the knee: 6-month results and predictive value of C-reactive protein level. Radiology 2003;227:419–25. https://doi.org/10.1148/radiol.2272020137; PMID: 12649419. Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol 2009;20:1141–50. https:// doi.org/10.1016/j.jvir.2009.05.031; PMID: 19620014. Manzi M, Fusaro M, Ceccacci T, et al. Clinical results of belowthe knee intervention using pedal-plantar loop technique for the revascularization of foot arteries. J Cardiovasc Surg (Torino) 2009;50:331–7. PMID: 19543193. Fusaro M, Dalla Paola L, Biondi-Zoccai G. Pedal-plantar loop technique for a challenging below-the-knee chronic total occlusion: a novel approach to percutaneous revascularization in critical lower limb ischemia. J Invasive Cardiol 2007;19:E34–7. PMID: 17268048. Abdelhamid MF, Davies RS, Rai S, et al. Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia. Eur J Vasc Endovasc Surg 2010;39:762–8. https:// doi.org/10.1016/j.ejvs.2010.01.027; PMID: 20206557. Zhu YQ, Zhao JG, Li MH, et al. Retrograde transdorsalto-plantar or transplantar-to-dorsal intraluminal re-entry following unsuccessful subintimal angioplasty for belowthe-ankle arterial occlusion. J Endovasc Ther 2010;17:712–21. https://doi.org/10.1583/10-3207.1; PMID: 21142478. Alexandrescu V, Vincent G, Azdad K, et al. A reliable approach to diabetic neuroischemic foot wounds: below-the-knee angiosome-oriented angioplasty. J Endovasc Ther 2011;18:376–87. https://doi.org/10.1583/10-3260.1; PMID: 21679080. Kawarada O, Yokoi Y, Higashimori A, et al. Stent assisted below-the-ankle angioplasty for limb salvage. J Endovasc Ther 2011;18:32–42. https://doi.org/10.1583/10-3214.1; PMID: 21314346.

17. K atsanos K, Diamantopoulos A, Spiliopoulos S, et al. Below- the-ankle angioplasty and stenting for limb salvage: anatomical considerations and long-term outcomes. Cardiovasc Intervent Radiol 2013;36:926–35. https://doi.org/10.1007/s00270012-0514-x; PMID: 23152042. 18. Karnabatidis D, Katsanos K, Spiliopoulos S, et al. Incidence, anatomical location, and clinical significance of compressions and fractures in infrapopliteal balloon-expandable metal stents. J Endovasc Ther 2009;16:15–22. https://doi. org/10.1583/08-2530.1; PMID: 19281287. 19. Palena LM, Brocco E, Manzi M. The clinical utility of below-the-ankle angioplasty using “transmetatarsal artery access” in complex cases of CLI. Catheter Cardiovasc Interv 2014;83:123–9. https://doi.org/10.1002/ccd.24992; PMID: 23696069. 20. Nakama T, Watanabe N, Kimura T, et al. Clinical implications of additional pedal artery angioplasty in critical limb ischemia patients with infrapopliteal and pedal artery disease. J Endovasc Ther 2016;23:83–91. https://doi. org/10.1177/1526602815610119; PMID: 26442951. 21. Nakama T, Watanabe N, Haraguchi T, et al. Clinical outcomes of pedal artery angioplasty for patients with ischemic wounds: results from the multicenter RENDEZVOUS Registry. JACC Cardiovasc Interv 2017;10:79–90. https://doi.org/10.1016/j. jcin.2016.10.025; PMID: 28057289. 22. Teymen B, Akturk S. Comparison of drug eluting balloon angioplasty to infrapopliteal artery critical lesions with or without additional pedal artery angioplasty in patients with diabetes mellitus and critical limb ischemia. J Interv Cardiol 2018;31:400–6. https://doi.org/10.1111/joic.12475; PMID: 29250834. 23. Reekers JA, Koelemay MJ, Marquering HA, van Bavel ET. Functional imaging of the foot with perfusion angiography in critical limb ischemia. Cardiovasc Intervent Radiol 2016;39:183–9. https://doi.org/10.1007/s00270-015-1253-6; PMID: 26627485.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 21:55

Peripheral Artery Disease

Insights and Clinical Implications from the pELVIS Registry for the Treatment of Aneurysms Involving the Iliac Bifurcation Gergana T Taneva, Giovanni Torsello and Konstantinos P Donas, on behalf of the pELVIS Registry collaborators Department of Vascular Surgery, St Franziskus Hospital Münster, Münster, Germany

Abstract The pErformance of iLiac branch deVIces for aneurysmS (pELVIS) Registry is the largest retrospective analysis of prospectively collected data on the use of iliac branch devices (IBD) for the treatment of iliac and aortoiliac aneurysms. It shows the feasibility of the technique with good short- and mid-term results. The most common anatomical challenge for IBD use is the presence of aneurysmal deterioration of the internal iliac arteries (IIA). Experience acquired in the registry treating concomitant aneurysmal lesions of the IIA provides significant information on the performance of IBDs for this specific clinical presentation. Treatment of isolated aneurysms in the common iliac artery without extension to the infrarenal aorta showed favourable results with lower costs, and lower use of irradiation and contrast media. Overall, the relatively low procedure-related complications and repeat interventions show broad applicability of the technique. Further analysis is required to evaluate the longstanding performance of IBD.

Keywords pELVIS Registry, iliac branch, iliac aneurysm, aoroiliac aneurysm, isolated iliac aneurysm, hypogastric aneurysm Disclosure: The authors have no conflicts of interest to declare. Received: 18 December 2018 Accepted: 16 January 2019 Citation: Vascular & Endovascular Review 2019;2(1):9–11. DOI: https://doi.org/10.15420/ver.2018.22.2 Correspondence: Gergana Todorova Taneva, Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, 28040 Madrid, Spain. E: dr.gtaneva@gmail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Preservation of internal iliac artery (IIA) flow has been previously evaluated in the literature.1 In that sense, placement of iliac branch devices (IBDs) represents one of the most popular endovascular options when anatomically feasible.2,3 The first paper reporting the results of The pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation (pELVIS) Registry included 575 patients undergoing 650 IBD implantations with ZBIS (Cook Medical) or Gore (WL Gore & Associates ) IBDs. This retrospective analysis of prospectively collected data by prearranged protocols of the first six European vascular centres (Münster, Florence, Rome, Thessaloniki and Perugia) was published in 2017 and it showed good mid-term patency (at 32.6±9.9 months clinical follow-up) with a low reintervention rate (7.3%).4 In this same year, universities in Lille, Hamburg and Leipzig joined the registry. The aim of this report is to provide the latest longterm evidence and to evaluate the performance of IBDs in challenging conditions outside their normal usage.

Instructions for Use for Iliac Branch Device The recommendations for IBDs refer to the length and diameter of the external iliac artery (EIA), the IIA and the common iliac artery (CIA). Generally, uniform artery length of the EIA, IIA and CIA should be more than 20 mm, 10 mm and 50 mm, respectively, while the IIA diameter should not exceed 11 mm to be acceptable for proper sealing (4–11 mm for ZBIS IBDs from Cook Medical; 6.5–13.5 mm for Gore IBD). In 2010, Karthikesalingam et al. published an overview of the morphological suitability of patients with aortoiliac aneurysms for the

VER_Donas_FINAL.indd 9

use of commercially available IBDs.5 The majority of the people in this patient group were not fully compliant with selection criteria for IBD deployment according to the published guidelines by expert vascular surgeons nor the device manufacturer noting that the most common single anatomical challenge for IBD use was an aneurysmal IIA (AIIA). Other common limitations for IBD use are the presence of short (<50 mm) or narrow CIA, or the presence of ostial IIA disease.

Co-existing Internal Iliac Artery Aneurysm There are several difficulties to ensuring an adequate sealing zone when there is a co-existing AIIA. If the IBD branch diameter is 8 mm, an 8-mm balloon-expandable covered stent which varies in length between 22–59 mm needs to be employed. Consequently, an IIA diameter of more than 12 mm would be associated with an inadequate distal seal. Therefore, in case of a coexisting AIIA, sealing into the posterior trunk or one of the main IIA branches is needed to guarantee adequate sealing. However, this would create a diameter discrepancy between the IBD branch (posterior trunk) and the IIA branch used for distal landing. Hence, more than one bridging device should be used to seal the device and achieve better docking. The presence of AIIA can be associated with a higher incidence of type I endoleak, stenosis or thrombosis of the branch. In addition, the available stent grafts have different features and performance, especially in angulated IIAs. To our knowledge, there are only two published series with fewer than 20 patients each that describe the use of IBD in co-existing AIIAs. The Münster group described a

Access at: www.VERjournal.com

02/04/2019 20:38

Peripheral Artery Disease technique for a sufficient peripheral sealing zone in concomitant AIIAs.6 The use of a proximal balloon-expandable covered stent was preferred to stabilise the bridging device in the internal branch of the IBD. Additionally, a self-expandable covered stent was deployed distally in the posterior trunk of the IIA to improve the transition in mainly kinked IIA arteries, creating a landing zone of at least 2 cm in a healthy segment. Finally, a bare metal self-expanding stent was used to reline the transition between the bridging devices. This technique seemed to be successful for this small sample size providing good mid-term patency. Later, Noel-Lamy et al. reported outcomes in 15 patients with AIIAs treated with IBDs.7 The Canadian group used self-expandable covered stents as bridging device and extended into the superior gluteal artery without relining the stents. The preliminary results were encouraging. However, due to the limited number of inpatients (n=15; n=16), no robust conclusions can be drawn from these series. The pELVIS Registry covers 12 years of experience of IBDs in nine European vascular centres. The recently published findings from treating 264 patients with coexisting IIA aneurysms provides significant information about the performance of IBDs for this specific clinical presentation.8

Isolated Common Iliac Aneurysm Recommendations from manufacturers state that a proximal aortic endograft placement in the infrarenal aorta is mandatory to guarantee proper proximal sealing of IBDs. However, when an adequate neck that is at least 10 mm is present in the CIA, implantation of isolated IBD can be effective and will reduce costs and avoid covering the healthy aorta. Up to now, only single-centre experiences with a small number of isolated IBD implants have been reported.9 The next topic for evaluation by the pELVIS Registry is the safety and evaluation of freedom of reinterventions in case of isolated placement of an IBD for common iliac aneurysms with a proximal seal of more than 10 mm compared with the manufacturer’s recommendations to extend the seal in the infrarenal aorta. Subgroup analysis from the pELVIS Registry has shown that an adjunctive procedure with complementary devices in the proximal CIA was necessary in more than 60% of the cases.10 The goal of these procedures was to achieve complete coverage of the CIA extending the sealing zone for at least 10 mm.10 There were no statistically significant differences when comparing extension to the infrarenal aorta and non-extension in terms of early or long-term type IA endoleaks. Occlusion and high-grade stenosis were the cause for onethird of the reinterventions of the branched device (n=13/40; 32.5%), which increases concerns about the adaptability of the Z-stents on elongated iliac arteries and tight aortic or iliac bifurcations. The number of devices per implant was lower in the group without extension to the infrarenal aorta suggesting that a certain degree of cost savings would exist when compared with more extensive procedures. In fact, the duration of the procedures, the fluoroscopy time and the amount of iodine contrast medium were significantly reduced in patients undergoing isolated IBD. Even if a cost analysis was not possible due

L in PH, Chen AY, Vij A. Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important? Semin Vasc Surg 2009;22:193–200. https://doi.org/10.1053/ j.semvascsurg.2009.07.012; PMID: 19765531. Bekdache K, Dietzek AM, Cha ANV. Endovascular hypogastric artery preservation during endovascular aneurysm repair: a review of current techniques and devices. Ann Vasc Surg

VER_Donas_FINAL.indd 10

to different regulatory laws and device costs, the isolated use of IBD showed several economic advantages with an equivalent efficacy and should be considered in selected cases.

Secondary Procedures An overview of the secondary procedures in the pELVIS Registry was published in 2017 by our group.4 The low 30-day mortality and high technical success confirmed the safety and feasibility of IBDs. The mean clinical and radiological follow-up were 32.6 ± 9.9 months and 29.8 ± 21.1 months, respectively. Out of 650 successfully deployed ZBIS and Gore IBDs, nine (1.6%) reinterventions for occlusion or endoleak were performed within the first 30 days. The overall postoperative reintervention rate was 8.9%. Procedure-related secondary procedures were mainly performed in case of occlusion of the EIA/CIA segment of the IBD and type I/III endoleak. It seemed that the relatively rigid limb of the ZBIS device implies its poor conformability in elongated EIA. Therefore, the use of flexible nitinol stents was suggested to improve the transition in kinked EIAs. The fact that most of the type I endoleaks and occlusions appeared during the follow-up period highlighted the importance of radiological surveillance with annual CT angiographies and restricting the use of duplex scanning, especially in obese patients.11 Within the pELVIS Registry, all cases with occluded IIA (11/650 IBDs [1.6%]) were asymptomatic with patent contralateral IIA. Therefore, no reinterventions were required to recanalise the occluded IIA. A metaanalysis comparing IBD with coiling or plugging the IIA and extension to the EIA showed higher risk for gluteal claudication for the patients who had coiling and plugging.12 This stresses that IBD had better results, especially in young patients.

Conclusion The pELVIS Registry is the largest multicentre, retrospective analysis of the use of IBD to treat iliac and aortoiliac aneurysms. The results are promising with good outcomes in terms of safety, feasibility and midterm patency. The most common single anatomical challenge for IBD use is the presence of aneurysmal IIA. The registry’s findings about the treatment of concomitant aneurysmal lesion of the IIA artery will provide significant information about the performance of IBDs for this specific clinical presentation. The treatment of isolated CIA aneurysms without extension to the infrarenal aorta when feasible has shown similar results with lower costs, lower use of irradiation and contrast medium. Overall, the relatively low procedure-related complications and reinterventions show the broad applicability of this technique. However, further analysis of the long-term results is required to further evaluate the longstanding performance of this technique. Additional pELVIS Registry collaborators Münster, Germany: Martin Austermann. Florence, Italy: Walter Dorigo; San Camillo Forlanini. Rome, Italy: Piergiorgio Cao, Ciro Ferrer, Tor Vergata, Arnaldo Ippoliti, Matteo Barbante. Thessaloniki, Greece: Georgios A Pitoulias. Perugia, Italy: Fabio Verzini, Gianbattista Parlani, Gioele Simonte. Hamburg, Germany: Tilo Kölbel, Nikolaos Tsilimparis. Lille, France: Stephan Haulon. Leipzig, Germany: Daniela Branzan, Andrej Schmidt.

2015;29:367–76. https://doi.org/10.1016/j.avsg.2014.10.019; PMID: 25433280. Oderich GS, Greenberg RK. Endovascular iliac branch devices for iliac aneurysms. Perspect Vasc Surg Endovasc Ther 2011;23:166–72. https://doi.org/10.1177/1531003511408344; PMID: 21810808. Donas KP, Inchingolo M, Cao P, et al. Secondary procedures

following iliac branch device treatment of aneurysms involving the iliac bifurcation: the pELVIS registry. J Endovasc Ther 2017;24:405–10. https://doi.10.1177/1526602817705134; PMID: 28511617. Karthikesalingam A, Hinchliffe RJ, Holt PJE, et al. Endovascular aneurysm repair with preservation of the internal iliac artery using the iliac branch graft device. Eur J Vasc Endovasc Surg

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:38

pELVIS Registry Insights

2010;39:285–94. https://doi.org/10.1016/j.ejvs.2009.11.018; PMID: 19962329. Austermann M, Bisdas T, Torsello G, Bosiers MJ. Outcomes of a novel technique of endovascular repair of aneurysmal internal iliac arteries using iliac branch devices. J Vasc Surg 2017;58:1186–91. https://doi.org/10.1016/j.jvs.2013.04.054; PMID: 23810296. Jaskolka J, Lindsay TF, Oreopoulos GD, Tan KT. Internal iliac aneurysm repair outcomes using a modification of the iliac branch graft. Eur J Vasc Endovasc Surg 2015;50: 474–9. https://doi.org/10.1016/j.ejvs.2015.05.021; PMID: 26188719.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Donas_FINAL.indd 11

onas KP, Taneva GT, Pitoulias GA. Coexisting hypogastric D aneurysms worsen the outcomes of endovascular treatment by the iliac branch devices within the pELVIS Registry J Vasc Surg 2018;10:pii:S0741–5214 https://doi.org/10.1016/ j.jvs.2018.07.036; PMID: 30545704. 9. Dorigo W, Pulli R, Troisi N, et al. The treatment of isolated iliac artery aneurysm in patients with non-aneurysmal aorta. Eur J Vasc Endovasc Surg 2008;35:585–9. https://doi.org/10.1016/ j.ejvs.2007.11.017; PMID: 18226565. 10. Fargion AT, Masciello F, Pratesi C, Pratesi G. Results of the multicenter pELVIS Registry for isolated common iliac aneurysms treated by the iliac branch device. J Vasc Surg

2018;16:1367–73. https://doi.org/10.1016/j.jvs.2018.02.032; PMID: 30072046. 11. D evaraj S, Dodds SR. Ultrasound surveillance of ectatic abdominal aortas. Ann R Coll Surg Engl 2008;90:477–82. https://doi.org/10.1308/003588408X301064; PMID: 18765027. 12. Kontopodis N, Tavlas E, Papadopoulos G, Galanakis N, Tsetis D, Ioannou CV. Embolization or simple coverage to exclude the internal iliac artery during endovascular repair of aortoiliac aneurysms? Systematic review and meta-analysis of comparative studies. J Endovasc Ther 2017;24(1):47–56. https:// doi.org/10.1177/1526602816677962; PMID: 27864457.

02/04/2019 20:38

Peripheral Artery Disease

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives Grigorios Korosoglou, 1 Sorin Giusca, 1 Martin Andrassy 2 and Michael Lichtenberg 3 1. Department of Cardiology, Vascular Medicine and Pneumology, GRN Hospital Weinheim, Weinheim, Germany; 2. Department of Cardiology, Vascular Medicine and Diabetology, Fuerst-Stirum Hospital Bruchsal, Bruchsal, Germany; 3. Vascular Center Klinikum Arnsberg, Arnsberg, Germany

Abstract An ageing population and the increasing prevalence of cardiovascular risk factors have aggravated the burden of peripheral artery disease (PAD). Despite advances in the pharmacological treatment of atherosclerosis, many patients with symptomatic PAD require invasive procedures to reduce the symptoms of claudication, salvage tissue and prevent amputation and subsequent disability in those with critical limb ischaemia. After significant advances in endovascular treatment over the past two decades, these techniques are widely accepted as first-choice treatment in the majority of patients with PAD. However, in patients with severely calcified lesions, standard endovascular treatment such as plain or drug-coated balloon (DCB) angioplasty may fail due to vessel recoil or severe dissection in the acute setting, and intimal hyperplasia in the long term. With the use of percutaneous plaque modification and debulking techniques based on atherectomy, such calcified lesions can be tackled more easily after removal or fragmentation of atherosclerotic plaque. More homogeneous balloon expansion at lower pressures can be achieved after atherectomy, which reduces barotrauma while allowing better drug delivery to the vessel wall during DCB angioplasty avoids the need for stent placement. There are four principal methods of direct atherectomy available at the present time: directional atherectomy, rotational atherectomy, orbital atherectomy and hybrid atherectomy. In this article, we provide a short overview of these techniques and the current evidence from clinical trials to support their use.

Keywords Peripheral artery disease, atherectomy, rotational, directional, hybrid, infrainguinal disease, drug-coated balloon, stent placement Disclosure: The authors have no conflicts of interest to declare. Received: 1 October 2018 Accepted: 22 January 2019 Citation: Vascular & Endovascular Review 2019:2(1):12–8. DOI: https://doi.org/10.15420/ver.2018.16.2 Correspondence: Grigorios Korosoglou, GRN Academic Teaching Hospital Weinheim, Department of Cardiology and Vascular Medicine, Roentgenstrasse 1, D-69469, Weinheim, Germany. E: gkorosoglou@hotmail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

The prevalence of peripheral artery disease (PAD) has been rising consistently over the past few decades, along with increasing rates of type 2 diabetes. More than 200 million people are estimated to be affected by PAD worldwide.1 Despite aggressive modifications of lifestyle and risk factors, and advances in the pharmacological management of patients with PAD using antiplatelet agents, statins, cilostazol, angiotensin-converting enzyme inhibitors, angiotensinreceptor blockers and low-dose anticoagulation with rivaroxaban, patients with PAD frequently require invasive procedures to improve the symptoms of claudication and prevent tissue damage or loss in those with critical limb ischaemia (CLI).2 Due to recent technological advances in materials and devices for the endovascular treatment of PAD, a minimally invasive percutaneous approach is considered a first-choice strategy for the treatment of symptomatic patients and is given preference over older surgical options. According to current guidelines, endovascular therapy is the most favoured option for infrainguinal stenotic or occlusive lesions <25 cm, whereas open surgery may be associated with better longterm patency, especially when using saphenous vein grafts in patients with long occlusive lesions (>25 cm) that cross the knee.3 Commonly used techniques include plain balloon angioplasty, drug-coated balloon

Access at: www.VERjournal.com

VER_Korosoglou_FINAL.indd 12

(DCB) angioplasty, bare metal stents, drug-eluting stents and stent grafts for vessel perforation. Such endovascular approaches have been successfully used to alleviate symptoms in patients with claudication and have been associated with limb salvage in patients with CLI.4–6 In many cases, such ‘basic’ approaches may be compromised by severe calcification. Calcification may be the reason for a poor primary outcome due to early recoil or extensive flow-limiting dissections after high-pressure angioplasty, culminating in the need for bailout stent placement.7 Despite the most recent self-expandable nitinol stent technology, rates of re-stenosis may be high, resulting in primary patency rates of <50% for bare metal stents and <70% for drug-eluting stents at 5-year follow-up.8 Even with dedicated stent devices, stent fractures may occur at sites of extensive movement and flexion as in the popliteal artery, resulting in stent thrombosis and subsequent occlusion.9 With conventional open surgery, 5-year patency rates of more than 80% have been reported with saphenous vein grafts compared with 67% when using prosthetic conduits.10 Although no randomised trials are currently available for a head-to-head comparison of endovascular versus surgical treatment for long and calcified femoropopliteal lesions,

02/04/2019 20:43

Atherectomy in Peripheral Artery Disease it may be assumed that alternative treatment strategies will be needed to improve long-term patency rates with endovascular treatment. We need more advanced plaque modification techniques which would permit lesion preparation by endovascular debulking of calcified and fibrotic tissue. After performing adequate lesion preparation by atherectomy devices, the application of local pharmacological treatment with DCB and without stent placement would be desirable. Over the past few years, this approach had proved beneficial for the treatment of complex femoropopliteal lesions.11 Modalities of atherectomy can result in the removal of plaque and calcified tissue equivalent to that achieved by surgical techniques as well as minimally invasive percutaneous treatment. Atherectomy permits removal of calcified and fibrotic tissue rather than pressing it against the arterial wall. This provides luminal gain without barotrauma, reduces the risk of dissection in the acute setting and neointimal hyperplasia in the long term. Atherectomy is subsequently combined with low-pressure balloon angioplasty, minimising the likelihood of dissection and the need for stent placement. This approach concurs with the notion of ‘leaving no metal behind’, especially when treating mobile peripheral vessel segments. Avoiding stents in such vessel segments may improve long-term patency and facilitate future reinterventions, while still permitting the option of future surgical procedures. Even in densely calcified vessels that require stent placement, incomplete or eccentric stent expansion will be avoided because the lesions will have been adequately prepared beforehand. Despite the use of atherectomy devices, spotted stent implantation may be required with persistent recoil after atherectomy and balloon angioplasty, or persistent flow-limiting dissection. In addition, the placement of a coated stent may be necessary as a bailout option after vessel perforation due to the atherectomy device. A schematic illustration of each step of atherectomy and DCB angioplasty is shown in Figure 1. Four methods of atherectomy have been used for the treatment of infrainguinal disease: • • • •

Directional atherectomy. Rotational atherectomy. Orbital atherectomy. Hybrid atherectomy.

Each of these devices has unique features, with advantages and disadvantages with respect to lesion characteristics. The safety profile and efficacy of these devices has not yet been compared. Generally, atherectomy can be used for a broad spectrum of lesion characteristics although relative contraindications are subintimal crossing of the lesion and a vessel diameter smaller than that indicated for the respective device in the instructions for use. It should be noted that devices primarily designed for thrombectomy, such as Angiojet™ (Boston Scientific), Penumbra™ (Penumbra) or photoablation, such as excimer laser using the Turbo-Elite and Turbo-Power system (Spectranetics), are not discussed in the present article as the procedures do not involve atherectomy in the traditional sense of cutting or removing tissue.

Directional Atherectomy Carbide rotating cutter blades are used to cut and remove atherosclerotic tissue. Plaque is removed by the cutter device, which can be directly guided to the target lesion and rotated in the preferred direction. Directional atherectomy can tackle eccentric lesions more effectively than concentric ones. However, several passages are

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Korosoglou_FINAL.indd 13

Figure 1: Atherectomy and Drug-Coated Balloon Angioplasty Lesion preparation (debulking) using atherectomy techniques

2. Lesion preparation is 1. Atherectomy removes followed by low-pressure atherosclerotic/calcific tissue, balloon angioplasty, similar to open surgical decreasing the chance of techniques, resulting in dissection and obviating the lumen gain without need for stent placement barotrauma

3. Simultaneously, drug delivery to the vessel wall is increased, lowering the chance of restenosis due to neointimal tissue hyperplasia in the long term

The process includes initial debulking by the atherectomy device followed by low-pressure drug-coated balloon angioplasty. This is associated with a low probability of dissection, thus obviating the need for stent placement. It also facilitates drug delivery to the vessel wall.

needed to achieve sufficient removal of atherosclerotic tissue. The resected tissue is collected in a nose cone, which must be emptied after only a few passages. As no aspiration mechanism is involved when using these devices, plaque embolisation is a concern. The use of a distal protection filter is advisable, especially when addressing heavily calcified lesions. To date, three devices are available for directional atherectomy: the SilverHawk™, TurboHawk™ and the more recent HawkOne™ (all Medtronic), which can be used to treat peripheral lesions in vessels with a diameter of 1.5–7.0 mm.12 SilverHawk has one inner cutting blade and the TurboHawk has four. The four blades allow the device to remove a larger quantity of tissue per passage. This is an advantage when there is strongly calcified lesions. The HawkOne device has a single inner blade, which provides a better crossing profile and it has a distal flushing tool to simplify the cleaning process and allow more efficient excision. The safety and efficacy of directional atherectomy devices have been investigated in several prospective multicentre studies. 13–18 The first independently adjudicated prospective multicentre trial investigating the safety and efficacy of directional atherectomy was the Determination of Effectiveness of SilverHawk Peripheral Plaque Excision for the Treatment of Infrainguinal Vessels (DEFINITIVE LE). It involved 800 patients with claudication symptoms or CLI who were enrolled at 50 sites in the US and Europe.14 The device was associated with a success rate of 89% and bailout stenting rates of 3.2%. However, rates of distal embolisation, dissection, perforation and acute vessel occlusion were 3.8%, 2.3%, 5.3% and 2.0%, respectively. The mean lesion length was relatively low (7.5 cm in patients with claudication and 7.2 cm in patients with CLI), and only 40% of the lesions were calcified. In addition, the bailout stent rate was 3.2%, which was lower than that registered in preceding smaller studies.13 At the 2-month follow-up, the primary patency rate was 78% in patents with claudication, whereas 95% of patients with CLI were free of unplanned major amputation. Further outcome data for patient subgroups with popliteal and infrapopliteal lesions from the DEFINITIVE LE study have been reported recently.15,16,19 The safety and efficacy of the SilverHawk and TurboHawk

02/04/2019 20:43

Peripheral Artery Disease Figure 2: Flush Total Occlusion of a Heavily Calcified Proximal Right Superficial Femoral Artery A A

B B

A: Flush total occlusion of a heavily calcified proximal right superficial femoral artery (blue arrow). B: This occlusion could be successfully treated after intraluminal retrograde passage of the lesion. C: This used the 7 Fr HawkOne device. D: After several passages with the device, preparation of the lesion was achieved with <50% stenosis. E: Treatment was further optimised after drug-coated balloon angioplasty and without stent placement. F: The final angiographic result.

devices with the use of distal filter protection was reported in the DEFINITIVE Ca trial, in which 168 lesions with moderate to severe calcification were treated.17 The primary endpoint of effectiveness, defined as ≤50% residual stenosis, was achieved in 92% of the lesions, whereas the filter devices prevented embolic events in 97.5% (n=119) of 122 cases where excised tissue was captured. More recently, the DEFINITIVE AR trial sought to compare upfront directional atherectomy combined with DCB versus a DCB-only strategy in a randomised manner in patients with femoropopliteal disease.18 Combined treatment with atherectomy and DCB was effective and safe, but no added value was observed in comparison with a DCB-only strategy at 1-year follow-up. The authors concluded that larger prospective studies will be needed to address this question. More recently, directional atherectomy in combination with DCB was used in 30 consecutive patients with common femoral artery stenosis or occlusion.20 In this single-centre study, the procedural success was 100%. The authors noted a low rate of stenting (10%) and a very high patency rate of 97% at the follow-up investigation after 1 year. The DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions (REALITY) study is a prospective, single-arm multicentre study that will enrol 150 patients to evaluate the adjunctive use of atherectomy using the TurboHawk and HawkOne devices and DCB treatment in long and moderateto-heavily calcified femoropopliteal lesions. In addition, the current Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions (ADCAT) trial compares the performance of directional atherectomy and DCB versus a DCB-only treatment strategy in long de novo infrapopliteal lesions in a prospective randomised setting. The Pantheris system combines optical coherence tomography (OCT) with peripheral atherectomy. OCT is used in this context to facilitate intraluminal recanalisation of the occluded peripheral arteries.21 The safety and effectiveness of this device was recently demonstrated in the Evaluation of the Pantheris Atherectomy System (VISION) trial where a technical success rate of 97% was achieved with a diameter stenosis reduction from 78.7% at baseline to 30.3% after atherectomy alone and with a low rate of peri-procedural complications, such as perforation (0%), catheter-related dissection (0.5%) and embolisation (2%).21 Figure 2 illustrates a flush total occlusion of the heavily calcified proximal right superficial femoral artery (SFA), which was successfully tackled after intraluminal retrograde passage of the lesion.

VER_Korosoglou_FINAL.indd 14

Rotational Atherectomy Atherosclerotic tissue is concentrically excised using specially designed rotating tips or burrs. The luminal gain matches the size of the tip. Some of the devices are equipped with additional cutting blades to maximise debulking. The systems currently available for rotational atherectomy are the Rotarex®S system (Straub Medical), the Jetstream Atherectomy device (Boston Scientific) and the peripheral Rotablator system (Boston Scientific). The Rotarex S is a purely mechanical thrombectomy and atherectomy device, consisting of an external drive system which is connected to the Rotarex S catheter system by a magnetic clutch. A helix inside the catheter transmits the rotation from the drive system to the catheter head, which can rotate up to 10,000 rpm, creating a powerful negative suction force, facilitating the collection of fragmented thrombi and tissue material into an external bag following the Archimedes’ principle. It is available in 6 Fr, 8 Fr and 10 Fr sizes and is inserted over a dedicated guidewire. The device can be safely used in vessels of 3–8-mm diameter. Jetstream employs a 7 Fr platform and is available with two types of catheters, one equipped with a single set of front cutting blades and one with a second set of larger blades to increase the capability of upfront debulking. Continuous aspiration and active removal of the excised tissue and thrombus is ensured. This device could be especially useful in partly thrombotic lesions with subacute arterial occlusions. Data concerning the use of the Rotablator in peripheral arteries is limited. However, Jetstream was tested in a multicentre single-arm study involving 172 patients with infrainguinal lesions, yielding a device success rate of 99% and a 74% rate of freedom from target vessel revascularisation at 1-year follow-up.22,23 Using the Jetstream device, stent placement was performed in 7% of the lesions, whereas the primary and secondary duplex-documented patency rates were 61.8% and 81.3%, respectively.22 More recently, a relatively large retrospective study reported on long-term outcomes after atherectomy combined with angioplasty and provisional stenting versus angioplasty-only in 167 patients with common femoral artery disease.24 Patients in the combined atherectomy and angioplasty group had a significantly higher patency rate compared with the angioplasty group, implying the added value of atherectomy in these patients. In another study on the safety and efficacy of the Jetstream device in a real-world setting in 241 patients with femoropopliteal disease, the Jetstream achieved a high procedural success of 98.3% with low procedural complication rates (1% distal embolisation), and a relatively high rate of freedom from target lesion revascularisation (82%) after 1 year.25 However, higher rates of distal embolisation (8%) were reported in another similar study, which could be reduced to 2% using a distal protection filter.26 Figure 3 shows a chronic long occlusive lesion beginning at the level of the proximal SFA with scarce filling of the distal SFA. Figure 4 shows a chronic long occlusive lesion beginning at the proximal SFA due to occlusion of a long self-expanding nitinol stent.

Orbital Atherectomy An eccentrically mounted diamond-coated crown that orbits 360 degrees within the vessel is used for circumferential plaque removal. This allows calcified tissue to be removed without causing vessel wall trauma. In contrast to rotational atherectomy, which is limited by the size of the catheter tip or burr size, the debulked area can be increased by raising the rotational speed of the eccentrically mounted crown. Orbital atherectomy does not permit aspiration. Like

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:43

Atherectomy in Peripheral Artery Disease Figure 4: Chronic Long Occlusive Lesion of Almost the Whole Superficial Femoral Artery

Figure 3: Long Occlusive Lesion A

F A

A: A long occlusive lesion was seen on digital subtraction angiography images, beginning at the origin of the superficial femoral artery (blue arrow). B: Blue arrow shows scarce filling of the distal vessel. C: After antegrade passage of the lesion, the Jetstream atherectomy device achieved debulking of the occlusive lesion. D, E: A good angiographic result after subsequent drug-coated balloon angioplasty. F: A good two-vessel outflow to the foot without peripheral embolisation.

A, B: Chronic long occlusive lesion of almost the whole superficial femoral artery (SFA) due to occlusion of a long self-expanding nitinol stent (B), with scarce filling of the distal SFA and of the popliteal artery (blue arrows in C). D: The lesion was successfully treated using the 6 Fr Rotarex S catheter system combined with drug-coated balloon angioplasty. E–G: A good final angiographic result.

Figure 5: Focal Heavily Calcified Popliteal Lesion A

rotablation, distal embolisation due to the small particles produced by rapid crown rotation cannot be ruled out. The use of a distal protection device is advisable. Currently available orbital atherectomy devices include the CSI Stealth 360 and Diamondback 360 Orbital atherectomy systems (both from Cardiovascular Systems). Several clinical studies have confirmed that orbital atherectomy permits lowpressure balloon angioplasty after successful debulking, which was verified by intravascular imaging.27 Orbital atherectomy has been evaluated in several single-arm clinical trials including Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis (OASIS), the COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM) and COMPLIANCE 360°, which together included more than 4,000 patients.28–31 In the OASIS trial, 124 patients with 201 infrapopliteal lesions were treated with orbital atherectomy and the results were entered in a single-arm multicentre registry; 111 (55%) lesions were considered heavily calcified.28 Procedural success was achieved in 90% of the treated lesions, whereas procedural complications were noted in five patients (4%). At followup at 6 months, no patient required bypass surgery or unplanned amputation. An improvement on the Rutherford classification was observed in 78% of patients.28 In the CONFIRM registry trial, 4,766 lesions were treated with orbital atherectomy in 3,135 patients.29 In this large registry, orbital atherectomy combined with balloon angioplasty effectively reduced the degree of lesion lumen narrowing from 88% to 10%. Despite the relatively high rate of either moderately or severely calcified lesions (81%), the rate of stenting was relatively low (5.7%). In a more recent subsection analysis of the CONFIRM registries, the safety and efficacy of the technique was confirmed for the treatment of common femoral, iliac and even deep femoral artery lesions.32–34 The smaller COMPLIANCE 360° trial comprised 50 patients with heavily calcified femoropopliteal lesions who underwent orbital atherectomy plus angioplasty versus angioplasty alone.31 At 1-year follow-up, patency rates were similar (~80%) in both patient groups, despite significantly higher rates of bailout stenting in patients undergoing angioplasty alone (5.3% versus 77.8%; p<0.001). In another similar single-centre trial, the value of orbital atherectomy combined with DCB angioplasty

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Korosoglou_FINAL.indd 15

A: A focal heavily calcified popliteal lesion (blue arrow) in the popliteal artery of a patient with claudication symptoms (Rutherford Class 3). B, C: The lesion was treated with a 2.4-mm Phoenix device, resulting in effective debulking after several passages first without (B) and then with half and full (C) deflection. D. The outcome of atherectomy without angioplasty. E: Final angiographic outcome with drug-coated balloon.

was evaluated for the treatment of calcified femoropopliteal lesions in 89 patients.35 Despite the higher degree of calcification in patients who underwent atherectomy and DCB compared with those who underwent DCB alone (83% versus 42%; p<0.001), the rate of bailout stenting was lower in the combined therapy group (18% versus 39%; p=0.01). Furthermore, despite more complex lesions in the combined therapy group, patency rates were similar in both.

Hybrid Atherectomy Hybrid atherectomy combines features of directional and rotational atherectomy. The advantage is that the cutter device can be directly guided to the target lesions, while the high rotational speed of the cutter device enables continuous aspiration of the excised tissue. This modality was introduced with the Phoenix device (Philips Volcano), which was given Food and Drug Administration (FDA) approval for peripheral use in the US. The device is available in 1.8-mm, 2.2-mm and 2.4-mm sizes (which are compatible with 5 Fr, 6 Fr and 7 Fr sheaths, respectively), and with a 0.014-inch guidewire for the treatment of femoropopliteal and below-the-knee lesions. While the 1.8-mm and 2.2-mm catheter sizes serve as regular rotational atherectomy devices, the 2.4-mm catheter possesses a deflecting tip, thus facilitating a hybrid atherectomy modus. The Phoenix device consists of two main components: a long, double lumen catheter with a metallic front cutter at its distal tip, and the battery-powered handle device for atherectomy. The handle device

02/04/2019 20:43

Peripheral Artery Disease Table 1: Advantages and Disadvantages of Current Options for Endovascular Atherectomy Type of

Devices

Advantages

Disadvantages

Need for Capital

Directional

SilverHawk TurboHawk HawkOne

Directional cutting and plaque removal

Time consuming, requires several passes No aspiration function Associated with a high risk of distal embolisation

Rotational

Rotablator Jetstream Rotarex S

Effective in severely calcified lesions Active plaque removal with continuous aspiration (using the Jetstream device) Fast and effective (with the Jetstream device) even in partly thrombotic lesions

The depth of atherectomy cannot be changed once the burr has been selected

Yes

Orbital

CSI Stealth 360 Diamondback 360

Effective in severely calcified lesions The range of atherectomy can be modified with speed Minimises vessel trauma

Doubtful efficacy in in-stent restenosis Does not permit plaque removal

Yes

Hybrid

Phoenix

Effective in severely calcified lesions Active plaque removal with continuous aspiration Fast and effective due to single insertion. Cutter device can be directly guided to the target lesions (with the 2.4 mm catheter)

Doubtful efficacy in In-stent restenosis

Atherectomy

Equipment

Table 2: Guidewires Used with the Different Atherectomy Devices Type of

Devices

Guidewires and Distal Protection Devices (Filters)

Option to Use a

Atherectomy

Filter Device ™

Directional

SilverHawk TurboHawk HawkOne

The SpiderFX Embolic Protection Device is recommended for use as a 0.014-inch guidewire in conjunction with all three directional atherectomy devices.

Yes

Rotational

Rotablator

Rotawire floppy or Rotawire extra support, consisting of a 0.009-inch stainless steel core and a 0.014 inch distal platinum coil

Jetstream

Thruway™ 0.014-inch (Boston Scientific), Jetwire 0.014-inch (Boston Scientific), Spartacore™ Yes 0.014-inch (Abbott Vascular) or Iron Man™ 0.014-inch (Abbott Vascular). A Nav-6 distal protection filter system can be used in conjunction with a BareWire (Abbott Vascular)

Rotarex S

Rotarex S catheter 0.018-inch dedicated guidewire.

Orbital

CSI Stealth 360 Diamondback 360

ViperWire™ and ViperWire™ Advance guidewire 0.014 inch (Cardiovascular Systems) or with the Nav-6 distal protection filter system (Abbott Vascular)

Yes

Hybrid

Phoenix

Ev3 Nitrex Guidewire 0.014-inch (Medtronic) or Spartacore™ 0.014-inch (Abbott Vascular)

is disposable and does not require capital equipment. The cutter is rotated at high speed (10,000–12,000 rpm) which, in accordance with Archimedes’ principle, creates a strong suction force and allows continuous aspiration of the fragmented excised tissue into an external bag. Atherectomy can be performed with this device in vessel diameters of 2.5–7.0 mm. The recent prospective multicentre Endovascular Atherectomy Safety and Effectiveness (EASE) trial comprised 128 patients with 149 infrainguinal lesions, which were treated with the Phoenix hybrid atherectomy device.36 A technical success rate of 95.1% was achieved, resulting in an improvement of ≥1 Rutherford class in 80% of the patients after 6 months. Major adverse events occurred in 5.7% of patients at 30 days, whereas a patency rate of 86.1% was achieved at 6-month follow-up. Currently, the Prestige Pilot study (NCT03744572) is currently recruiting and will assess the value of Phoenix atherectomy in conjunction with intravascular ultrasound for the treatment of calcified infrapopliteal lesions. Figure 5 shows a heavily calcified popliteal lesion which was treated with the 2.4-mm Phoenix device.

VER_Korosoglou_FINAL.indd 16

The advantages and disadvantages of the atherectomy devices discussed in this article are summarised in Table 1. Information on the guidewires and distal protection systems that can be used with these devices is provided in Table 2.

Common Femoral Artery Disease For patients with common femoral artery lesions, endarterectomy and patch angioplasty is an established method of treatment with good long-term results.37,38 However, more recent studies have pointed to non-negligible complication and infection rates with this procedure, and a registry including 1,843 patients who underwent surgical endarterectomy demonstrated a high rate of 30-day mortality (3.4%), wound infections (8%) and need for further operations (10.2%).39–41 Therefore, in patients with common femoral artery disease, surgical endarterectomy may be considered the method of choice especially in young patients with calcified, de novo lesions if they are at low risk for surgery. Endovascular techniques may be a useful alternative option in patients with comorbidities, those who are unfit for surgery and in patients prone to develop wound infections after surgery,

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:43

Atherectomy in Peripheral Artery Disease including patients with obesity, diabetes or a compromised immune response. In addition, hybrid procedures, including common femoral endarterectomy and patch angioplasty followed by endovascular atherectomy of the superficial femoral artery, may be useful in patients with combined common and superficial femoral artery occlusive disease.

Figure 6: An Algorithm to Help Clinicians Decide the Use of Atherectomy with Endovascular Procedures

Evaluate patient characteristics and lesion anatomy, complexity and calcification

Future Perspectives A large number of FDA-approved atherectomy devices are currently available. However, published reports concerning their comparative safety and efficacy do not exist. Due to additional procedural costs, and capital equipment costs with some devices, randomised multicentre studies are necessary to determine the added value of this modality. Considering the safety and long-term effectiveness of most atherectomy devices, it is conceivable that the use of atherectomy will be increase in the next few years, especially in anatomical no-stent zones in the common femoral and popliteal arteries, in younger patients and in complex, long and calcified Trans-Atlantic Inter-Society Consensus C/D lesions. An algorithm designed to help clinicians to decide whether to use atherectomy with endovascular procedures is provided in Figure 6. Atherectomy promises to be a procedure that leaves no metal behind, especially in the presence of mobile arterial segments, and retains the possibility of future surgical options, particularly in younger patients without cardiopulmonary comorbidities. From the practical point of view, atherectomy devices will probably be readily accepted by interventional cardiologists familiar with coronary rotablation and by interventionalists who have performed rotational thrombectomy procedures. Considering the availability of diverse atherectomy devices, it would be advisable to first gain expertise in the use of a single device, with due attention to patient selection and lesion characteristics.

allino A, Aboyans V, Diehm C, et al. Non-coronary G atherosclerosis. Eur Heart J 2014;35:1112–9. https://doi. org/10.1093/eurheartj/ehu071; PMID: 24595865. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45:S5–67. https://doi.org/10.1016/j. jvs.2006.12.037; PMID: 17223489. Aboyans V, Ricco J-B, Bartelink M-LEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018;39:763–816. https://doi.org/10.1093/eurheartj/ehx095; PMID: 28886620. Greenhalgh RM, Belch JJF, Brown LC, et al. The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. Eur J Vasc Endovasc Surg 2008;36:680–8. https://doi.org/10.1016/j. ejvs.2008.10.007; PMID: 19022184. Fakhry F, Spronk S, van der Laan L, et al. Endovascular revascularization and supervised exercise for peripheral artery disease and intermittent claudication: a randomized clinical trial. JAMA 2015;314:1936–44. https://doi.org/10.1001/ jama.2015.14851; PMID: 26547465. Agarwal S, Sud K, Shishehbor MH. Nationwide trends of hospital admission and outcomes among critical limb ischemia patients: from 2003–2011. J Am Coll Cardiol 2016; 67:1901–13. https://doi.org/10.1016/j.jacc.2016.02.040; PMID: 27012780. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation 1992;86:64–70. https://doi.org/10.1161/01.CIR.86.1.64; PMID: 1617791.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Korosoglou_FINAL.indd 17

10.

11.

12.

13.

14.

15.

16.

Less complex lesions with low or no calcification grade

Younger patients – follow the “leave nothing behind” concept and preserve bypass landing zones

Occlusive lesions that cannot be passed by an intraluminal approach

Complex TASC C/D, strongly calcified non-occlusive lesions (PACSS score ≥3) Long diffuse non-occlusive disease

Lesions, where stent placement is allowed or perforation may be difficult to handle (iliac arteries)

Occlusive lesions that can be passed by an intraluminal approach (antegrade or retrograde) No-stent zones (common femoral and popliteal artery)

Consider atherectomy PACSS = peripheral artery calcification scoring system; TASC = Trans-Atlantic Inter-Society Consensus.

Conclusion Endovascular atherectomy has emerged as a novel technique for plaque removal in PAD, offering the benefits of tissue removal equivalent to that of traditional surgical endarterectomy as well as the advantages of minimally invasive percutaneous treatment. Plaque is actively excised and simultaneously aspirated or fragmented rather than pressed against the arterial wall. This provides luminal gain without vessel wall trauma and enhances the chances of homogeneous balloon expansion during subsequent angioplasty at low pressures. The risk of dissection is reduced, possibly obviating the need for stent placement and reducing the risk of neointimal hyperplasia in the long term.

ake MD, Ansel GM, Jaff MR, et al. Durable clinical D effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 2016;133:1472–83; https://doi. org/10.1161/CIRCULATIONAHA.115.016900; PMID: 26969758. Cambiaghi T, Spertino A, Bertoglio L, Chiesa R. Fracture of a Supera interwoven Nitinol stent after treatment of popliteal artery stenosis. J Endovasc Ther 2017;24:447–9. https://doi. org/10.1177/1526602817698655; PMID: 28351226. Klinkert P, Post PN, Breslau PJ, van Bockel JH. Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature. Eur J Vasc Endovasc Surg 2004;27: 357–62. https://doi.org/10.1016/j.ejvs.2003.12.027; PMID: 15015183. Korosoglou G, Lichtenberg M, Celik S, et al. The evolving role of drug-coated balloons for the treatment of complex femoropopliteal lesions. J Cardiovasc Surg (Torino) 2018;59:51–9. https://doi.org/10.23736/S0021-9509.17.10245-4; PMID: 28975777. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices Auckl 2014;8:1–10. https://doi.org/2147/MDER.S50594; PMID: 25565904. Shammas NW, Coiner D, Shammas GA, et al. Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial. J Vasc Interv Radiol JVIR 2011;22:1223–8. https://doi.org/10.1016/j.jvir.2011.05.013; PMID: 21757372. McKinsey JF, Zeller T, Rocha-Singh KJ, et al. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv 2014;7:923–33. https://doi.org/10.1016/j. jcin.2014.05.006; PMID: 25147039. Garcia LA, Jaff MR, Rocha-Singh KJ, et al. A comparison of clinical outcomes for diabetic and nondiabetic patients following directional atherectomy in the DEFINITIVE LE claudicant cohort. J Endovasc Ther 2015;22:701–11. https://doi. org/10.1177/1526602815599550; PMID: 26250748. Rastan A, McKinsey JF, Garcia LA, et al. One-year outcomes following directional atherectomy of infrapopliteal artery lesions: subgroup results of the prospective, multicenter DEFINITIVE LE trial. J Endovasc Ther 2015;22:839–46.

https://doi.org/10.1177/1526602815608610; PMID: 26445814. 17. R oberts D, Niazi K, Miller W, et al. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca++ trial. Catheter Cardiovasc Interv 2014;84:236–44. https://doi.org/10.1002/ccd.25384; PMID: 24402764. 18. Zeller T, Langhoff R, Rocha-Singh KJ, et al. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelvemonth results of the DEFINITIVE AR study. Circ Cardiovasc Interv 2017;10:pii: e004848.https://doi.org/10.1161/ CIRCINTERVENTIONS.116.004848; PMID: 28916599. 19. Rastan A, McKinsey JF, Garcia LA, et al. One-year outcomes following directional atherectomy of popliteal artery lesions: subgroup analysis of the prospective, multicenter DEFINITIVE LE trial. J Endovasc Ther 2018;25:100–8. https://doi. org/10.1177/1526602817740133; PMID: 29117818. 20. Cioppa A, Stabile E, Salemme L, et al. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes. Eurointervention 2017;12:1789–94. https://doi.org 10.4244/EIJ-D-15-00187; PMID: 28216476. 21. Schwindt AG, Bennett JG, Crowder WH, et al. Lower extremity revascularization using optical coherence tomography-guided directional atherectomy: final results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther 2017;24:355–66. https://doi. org/10.1177/1526602817701720; PMID: 28393673. 22. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther 2009;16:653–62. https://doi.org/10.1583/09-2826.1; PMID: 19995118. 23. Sixt S, Rastan A, Scheinert D, et al. The 1-year clinical impact of rotational aspiration atherectomy of infrainguinal lesions. Angiology 2011;62:645–56. https://doi. org/10.1177/0003319711403300; PMID: 21555314. 24. Mehta M, Zhou Y, Paty PSK, et al. Percutaneous common femoral artery interventions using angioplasty, atherectomy, and stenting. J Vasc Surg 2016;64:369–79.

02/04/2019 20:43

Peripheral Artery Disease https://doi.org/10.1016/j.jvs.2016.03.418; PMID: 27763265. 25. G ray WA, Garcia LA, Amin A, et al. Jetstream atherectomy system treatment of femoropopliteal arteries: results of the post-market JET registry. Cardiovasc Revasc Med 2018;19:506–11. https://doi.org/10.1016/j.carrev.2017.12.015; PMID: 29331436. 26. Banerjee A, Sarode K, Mohammad A, et al. Safety and effectiveness of the Nav-6 filter in preventing distal embolization during jetstream atherectomy of infrainguinal peripheral artery lesions. J Invasive Cardiol 2016;28:330–3. PMID: 27187983. 27. Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther 2012;19:480–8. https://doi.org/10.1583/JEVT-12-3815MR.1; PMID: 22891826. 28. Safian RD, Niazi K, Runyon JP, et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv 2009;73:406–12. https://doi.org/10.1002/ccd.21898; PMID: 19213094. 29. Das T, Mustapha J, Indes J, et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv 2014;83:115–22. https://doi.org/10.1002/ccd.25046; PMID: 23737432. 30. Adams GL, Das T, Lee MS, et al. Subanalysis of the CONFIRM registries: acute procedural outcomes in claudicant and

VER_Korosoglou_FINAL.indd 18

31.

32.

33.

34.

35.

critical limb ischemia patients with varying levels of calcification treated for peripheral arterial disease with orbital atherectomy. J Invasive Cardiol 2015;27:516–20. PMID: 26524206. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol 2014;26:355–60. PMID: 25091093. Lee MS, Heikali D, Mustapha J, et al. Acute procedural outcomes of orbital atherectomy for the treatment of common femoral artery disease: Sub-analysis of the CONFIRM Registries. Vasc Med Lond Engl 2017;22:301–6. https:// doi.org/10.1177/1358863X17708254; PMID: 28548625. Lee MS, Martinsen BJ, Hollowed J, et al. Acute procedural outcomes of orbital atherectomy for the treatment of iliac artery disease: Sub-analysis of the CONFIRM registries. Cardiovasc Revasc Med 2018;19:503–5. https://doi.org/10.1016/j. carrev.2017.10.016; PMID: 29174822. Lee MS, Srivastava PK, Al Yaseen S, et al. Acute procedural outcomes of orbital atherectomy for the treatment of profunda femoris artery disease: subanalysis of the CONFIRM registries. J Invasive Cardiol 2018;30:177–81. PMID: 29245154. Foley TR, Cotter RP, Kokkinidis DG, et al. Mid-term outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of femoropopliteal disease. Catheter Cardiovasc Interv 2017;89:1078–85. https://doi.org/10.1002/

ccd.26984; PMID: 28295971. 36. D avis T, Ramaiah V, Niazi K, et al. Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: early and midterm outcomes from the prospective multicenter EASE study. Vascular 2017;25: 563–75. https://doi.org/10.1177/1708538117712383; PMID: 28950783. 37. Radoux JM, Maïza D, Coffin O. Long-term outcome of 121 iliofemoral endarterectomy procedures. Ann Vasc Surg 2001;15:163–70. https://doi.org/10.1007/s100160010053; PMID: 11265079. 38. Mellière D, Blancas AE, Desgranges P, Becquemin JP. The underestimated advantages of iliofemoral endarterectomy. Ann Vasc Surg 2000;14:343–9. https://doi.org/10.1007/ s100169910068; PMID: 10943785. 39. Kang JL, Patel VI, Conrad MF, et al. Common femoral artery occlusive disease: contemporary results following surgical endarterectomy. J Vasc Surg 2008;48: 872–7.e1. https://doi.org/10.1016/j.jvs.2008.05.025; PMID: 18639427. 40. Kechagias A, Ylönen K, Biancari F. Long-term outcome after isolated endarterectomy of the femoral bifurcation. World J Surg 2008;32:51–4. https://doi.org/10.1007/s00268-007-9309-7; PMID: 18027016. 41. Nguyen B-N, Amdur RL, Abugideiri M, et al. Postoperative complications after common femoral endarterectomy. J Vasc Surg 2015;61:1489–1494.e1. https://doi.org/10.1016/j. jvs.2015.01.024; PMID: 257029176/j.jvs.2015.01.024.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:43

Peripheral Artery Disease

Historical Overview of Vascular Allograft Transplantation Kerbi Alejandro Guevara-Noriega, 1,2 Albert Martinez Toiran, 2 Bruno Alvarez-Concejo 3 and Jose Luis Pomar 4 1. Vascular Surgery Department, Clínica Teknon Barcelona, Barcelona, Spain; 2. Vascular Surgery Department, Parc Tauli University Hospital, Sabadell, Barcelona, Spain; 3. Internal Medicine Residency Programme, University of Texas Southwestern Hospital, Dallas, Texas, US; 4. Cardiovascular Surgery Department. Hospital Clinic i Provincial de Barcelona, Barcelona, Spain

Abstract There is a mix of therapeutic options for revascularisation in vascular surgery. The authors performed a literature review on the evolution of vascular allograft transplantation and its use and acceptance by vascular surgeons. This review exposed three stages: the first stage involved preliminary experimentation; the second stage was a decline in use due to long-term complications, and the third stage is its current use in special indications subject to a thorough analysis. There are few indications for the use of vascular allografts in clinical guidelines. However, there are publications of long series of case studies with variable results reflecting international use of the procedure. There is a current trend that favours its use with limited and individualised indications.

Keywords Vascular allografts, vascular transplant, grafts Disclosure: The authors have no conflicts of interest to declare. Received: 14 October 2018 Accepted: 7 January 2019 Citation: Vascular & Endovascular Review 2019:2(1):19–22. DOI: https://doi.org/10.15420/ver.2018.15.1 Correspondence: Kerbi Alejandro Guevara-Noriega, Parc Tauli 1, Floor 5, Vascular Surgery Department, Sabadell, Spain, 08208. E: kerbiguevara@hotmail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

The donation and transplantation of organs, tissues and cells is now an attractive and widely proven therapeutic option, which involves practices, that are accepted as commonplace, such as kidney and liver donation; but it also involves less striking practices such as tissue transplantation. A literature review was conducted to know the history of this practice. Three different stages were stablished according to the authors’ perspective. Eligible English- and Spanish-language articles published were identified through searches of PubMed (no time limits). With more and more indications, the transplantation of vascular tissue is an emergent practice, which began in the early 20th century and has gone through several stages. Since the publication of preliminary experiences, its use was abandoned due to possible long-term complications and it has been taken up at the end of the 20th century for special indications and has been subject to in-depth analysis.1.2

Stage 1 Although Hopfner described the possibility of performing the technique in 1903, the history of vascular tissue transplantation began in the hands of Alexis Carrel. This French biologist, physician and researcher is considered a pioneer in vascular surgery. Carrel described surgical techniques used on animals by 1905. These techniques involved transplant of venous segments in arterial territories in mice and he described the process of arterialisation and exposition of the conservation of blood vessels for transplant with the intention of avoiding the need to find possible donors.2–5

first described a femoro-popliteal shunt with a femoral vein and the second was a resection of a popliteal syphilitic aneurysm and its subsequent replacement by a popliteal vein.6 A year later, Lexer described the transplantation of an 8-cm vein segment after resection of a left subclavian artery aneurysm caused by dislocation of the humerus. These initial steps saw the beginnings of vascular tissue transplantation with autologous grafts.7 Other isolated publications included the case described by Pirovano in 1910 of the first transplant of vascular allografts, which was not successful, and a case series reported by Moure in 1914, who described 17 transplants of venous allografts with good results.2,6 In 1908, Carrel made a significant breakthrough by creating the first experimental blood vessel bank, leading to the Nobel Prize for Medicine in 1912 in recognition of his work on vasculature and the transplantation of blood vessels and organs.2 In the same year, he also published an article in which he demonstrated that an artery portion can be preserved and kept ‘alive’ in a chamber for several days or even weeks before transplantation. He found that blood vessels from dogs kept in a cold room can be transplanted successfully into cats and concluded that these methods could be applied to humans and there should be no delay to exploring this, but it was not until 1951 that Fontaine and Leriche founded the first bank of blood vessels for clinical use.2,6

Stage 2 In 1906, there was an important publication describing the first two successful human cases of bypass using autonomous vessels.6 The

VER_Noriega_FINAL.indd 19

The second stage of vascular tissue transplantation is characterised by a significant decline in its use due to unsatisfactory long-term

Access at: www.VERjournal.com

02/04/2019 20:45

Peripheral Artery Disease results. The poor results were possibly related to deficient preparation and preservation techniques. In this stage, there were cases of degenerative alterations with subsequent aneurysmal dilatation related to immunological responses. This led to an exploration of the use of synthetic prostheses.6 In 1952, Voorhees et al. performed animal studies that demonstrated the patency of synthetic derivatives in vascular territory and translated its application into clinical practice.7 This technique had a rapid evolution. Among the materials used were Ivalon, Orlon, nylon, Teflon and Dacron. In 1969, prostheses that are still in use today were developed by Gore, which developed the Teflon graft.6,8 Prostheses were developed with the ideal aim being described in 1953 as: “biologically inert, with stable physicochemical properties, guaranteed sterilisation, easy handling, non-carcinogenic and nonthrombogenic surface”. These criteria were later modified by Moneta and Porter in 1995 when they described the ideal prosthesis as “strong, inexpensive and possible to be used throughout the patient’s life, with easy and permanent insertion, biocompatible with the host, resistant to infection, with appropriate gauges, that remains permeable due to the visco-elastic properties resembling a natural artery without allowing blood or serum to escape, that does not degenerate or elicit an abnormal proliferative response of the vessel or tissue, non-thrombogenic or emboligenic, the one that does not occlude by flexing and does not damage the components of the blood”.9 These criteria revealed large defects in the vascular allografts; however, no synthetic arterial substitute has ever been able to comply with all these conditions. There were important achievements in this second stage, such as that of Gross in 1948, who replaced a segment of homologous aorta in a case of coarctation, establishing the technique as the first choice until the development of the prostheses. Similarly, Oudot in 1950 was the first to replace the aortic bifurcation and Dubost in 1951 the first to use a homograft after resection of an abdominal aneurysm.6,8 During this stage, some groups, including the one led by DeBakey, published series of cases that have not been possible to match.6,8 At present, thanks to advances in techniques of collection, processing and storage of the grafts, now called vascular allografts, and the progress in organ donation and transplantation, cryobiology, immunobiology, histocompatibility determinations and immunosuppressive therapy, these grafts are being reconsidered for use in a greater number of indications, thus starting the third stage of vascular tissue transplantation. All this is in the context of the development of commercial prostheses as the first indication in almost all cases of vascular segment replacement. 6

In this third stage, immunology was the objective of research. In 1989, Koene described the role of adaptation in the acceptance of allografts. He concluded that the long-term survival of the allograft depends on these immune responses.12 Previously Prendergast et al. observed immunological sensitivity and concluded that allografts generated immunological responses.13 More recently, the role that innate immunity and antibodies play in the rejection of grafts has been explored. So-called ‘allograft vasculopathy’ has been linked to a chronic inflammatory response mediated by natural killer cells, but carried out directly by donor-specific antibodies. Donor antibodies ultimately induce intracellular cascades that facilitate recruitment of monocytes and neutrophils, damaging the transplanted tissue. This area is still being researched.14 This gave rise to the experimental application of tissue transplantation and to the development of animal models. In 1983, Chow et al. performed the replacement of femoral arteries with cryopreserved tissues and compared the results with the replacement of autologous tissues, concluding that both techniques were similar.15 In 1997, Neves et al. published their findings on mechanisms of degeneration of cryopreserved grafts, analysing them in sheep. They concluded that there is partial loss of the endothelium and lymphocytic invasion in the entire graft, despite which the grafts maintain their integrity and cellular viability after transplantation. They showed evidence of re-epithelialisation of the graft and after a short period of neural degeneration, a reinnervation occurred. No statistically significant differences were found between transplants of fresh vascular tissue versus those that were cryopreserved.16 Among the alternative studies in the translational field is the model on venous grafts treated with glutharaldehyde performed by Moura in 2009. He performed experiments in rabbits whose grafts were assessed macroscopically and microscopically at 24 hours, 14 and 28 days. In his conclusions, he suggested the need to expand studies in the field of autologous tissue transplantation, since he showed that there were no clear differences in the technique he proposed. He also explained that this technique could provide an important tool for human use.17 Perhaps the three most recent translational works are those published by Sun et al. in 2010, Hwang et al. in 2011 and Olmos-Zúñiga et al. in 2016.18–20 Sun et al. explained an improved technique for performing aortic transplants in a murine model and demonstrates pathognomonic changes of chronic rejection but with longer-term tissue survival rather than usual techniques.18 Hwang et al. designed an experimental platform for the development of biocompatible microvasculature in rats and he showed that its model is potentially translatable and effective for future tissue engineering studies of small vessels.19

Stage 3 Vascular transplantation began being used again with prudence and with limited indications. Among these indications was the replacement of complex arterial segments, complex vascular lesions, replacement of infected arterial prostheses and, although it is little studied, the use in vascular access for patients on haemodialysis. Mestres summarised the use of these grafts in three indications and confirmed long-term results. He described some benefits regarding the reduction of hospital mortality, a high patency rate and a minimal rate of reinfection and rupture up to 10 years’ post-intervention.2,6,10,11

VER_Noriega_FINAL.indd 20

Olmos-Zuñiga et al. published the haemodynamic, gasometric and imaging results, as well as macroscopic and microscopic findings of the reconstruction of pulmonary arteries of dogs with lyophilised grafts (those not treated with glutaraldehyde) and cryopreserved arterial grafts. They suggested that the lyophilisation techniques may play in favour of less antigenicity, as well as preventing thrombosis and calcification of the grafts. Finally, they concluded that the lyophilisation without treatment with glutaraldehyde represents a feasible alternative with promising clinical results.20

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:45

Historical Overview of Vascular Allograft Transplantation Among the described clinical cases is the correction of coarctation of the thoraco-abdominal aorta with autologous cryopreserved arterial graft performed in a 7-year-old boy with a correct postoperative ultrasound, doppler ultrasonography with no significant changes with respect to a healthy subject, correct clinical values and good quality of life after the procedure.21 In 1998, an extensive study was published by Chiesa et al. that assessed differences between cryopreserved and fresh vascular tissues and concluded that there were no statistically significant differences between them.22 They described a 12-month tissue survival of 73% and reported the possibility of assessing ABO blood group compatibility among donors. This possible incompatibility has been dismissed in 2015 by Della Schiava et al., who considered that the immunological response may be related mainly to incompatibility of the major histocompatibility system. In this way, the clinical variables associated with the donor and recipient allografts become important.23 The use classically associated with this type of graft is the replacement of infected prosthetic segments. This was described in 2004, where the replacement of infected grafts in the infrarenal aorta by vascular allografts was presented in a series conducted over 14 years.24 Kieffer et al. concluded that vascular allografts, in the short as well as longterm are at least similar in behaviour to other replacement techniques in terms of the management of infra-renal prosthesis infections. They also found that most of the complications associated with this type of grafts are avoidable with an adequate cryopreservation process. Previously in 2001, Leseche et al. had commented on the usefulness of the use of vascular allografts in prosthetic infections, and in 1996, Koskas et al. documented 6 years of experience replacing infected prostheses from 83 cases with several postoperative complications, but with a limb survival rate of 100%.25,26 In 2009, Brown et al. published their mid-term results for arterial reconstruction with cryopreserved vascular tissue in cases of prosthesis infections.27 They presented a series of 52 patients followed up over 10 years that showed that the replacement of infected vascular prostheses by vascular allografts was a viable alternative. They stated that with adequate cryopreservation, allografts are resistant to reinfection, thrombosis and aneurysmal dilatation and recommended a long-term study to evaluate whether this technique is the most successful, effective and safe. More recently, in Greece, Locati et al. published a short series of 18 patients where 25 infected prostheses were replaced in different areas

4. 5.

6. 7.

errer A, Socarrás N, Del Risco T, et al. [Vascular allografts. F History and clinical use]. Revista Cubana de Angiología y Cirugía Vascular 2003:4 [in Spanish]. Ferrer A, Socarrás N, Del Risco T, et al. [Vascular tissue transplant. Historical account and clinical use]. Archivo Médico de Camagüey 2005;9 [in Spanish]. García Herrera A L, Moliner Cartaya M. [Some notes on the history of vascular surgery] Algunos apuntes en la historia de la cirugía vascular. Revista Médica Electrónica 2010;32 [in Spanish]. Carrel A, Guthrie CC. The transplantation of veins and organs. American Medicine 1905;10:1101–2. Carrel A. The preservation of tissues and its applications in surgery. JAMA 1912;59:523–27. https://doi.org/10.1001/ jama.1912.04270080205010. Vaquero Morillo F, Clará Velasco A, eds. Tratado de las Enfermedades Vasculares. Barcelona: Viguera; 2006. Voorhees AB Jr, Jaretzki A 3rd, Blakemore AH. The use of tubes constructed from vinyon “N” cloth in bridging arterial defects. Ann Surg 1952;135(3):332–6. PMID: 14903863. Herreros JM, Mastrobuoni S, Ubilla M, et al. [Cardiac and vascular homograft valves transplant]. Anales del Sistema

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Noriega_FINAL.indd 21

10.

11. 12. 13.

14.

15.

such as femoro-popliteal, aorto-iliac, and subclavian, concluding that these techniques are very useful in this indication since these grafts seem to have a greater resistance to infection.28 In 2010, a German team published an 8-year follow-up of patients treated with cryopreserved arterial homografts using exposure to C-reactive protein and leukocytes as analytical parameters to monitor during the immediate postoperative period.29 They also proposed that platelets and body temperature were important clinical parameters in the postoperative period. The team reported an 81% survival of transplanted tissue and free of re-interventions at 3 years. In the remaining 19% of patients, there were occlusions, stenosis, aneurysmal degenerations and graft-duodenal fistulas. It was concluded that the vascular allografts were a useful alternative. A more unusual use as pulmonary artery augmentation in a lung transplant has been described by Pablo Rueda et al. in 2005.30 They performed enlargement of the pulmonary artery in a case of inadequate organ extraction using an aortic artery allograft and concluded that the technique was useful to avoid the loss of the organ. The use of a graft in vascular access construction for hemodialysis was described in 2016 by Ha et al. as an alternative for immediate dialysis and with a survival rate comparable with other types of grafts.31 However, not all published results are so positive. In Italy in 2011, Ravenni et al. reported a case of total calcification of a homologous vascular graft used in the replacement of the aortic root in a 66-year-old man.32 Similarly, Minga Lowampa et al. published a series of 103 patients with replacement of prostheses infected by allografts whose short-term results were unfavourable with a high rate (29%) of postoperative complications, such as graft thrombosis, anastomotic pseudoaneurysm, aneurysmal degeneration and graft rupture.33 However, the authors comment on methods that could improve these results.

Conclusion There are limited data on the long-term evolution of vascular allografts. The research continues with a focus on advances in cryopreservation, immunology and alternative tissue preparation. At present, only one indication of vascular allografts have been established in clinical guidelines (replacement of infected grafts). Despite the wide use around the world, each case, indication, patient and territory should be assessed individually, with more data and studies needed to clarify the most appropriate indications.

Sanitario de Navarra 2011;29(Suppl 2) [in Spanish]. oneta GL, Porter JM. Arterial substitutes in peripheral M vascular surgery: a review. J Long Term Eff Med Implants 1995;5(1):47-67. PMID: 10163508. Ferrer A, Fernández R, Valerón A, et al. [Arterial homograft for haemodialysis]. Anales de Cirugía Cardiaca y Cirugía Vascular 2004;10:341–4 [in Spanish]. Mestres LC. Homoinjertos vasculares. In: Revuelta JM, ed. Avances en Cirugía de la Aorta. Barcelona: Ediciones Uriach, 2004;136–51. Koene RA. The role of adaptation in allograft acceptance. Kidney Int 1989;35:1073–86. PMID: 2651768. Prendergast FJ, McGeachie JK, Storrie EA. Vein to artery allografts: experimental evidence of immunological sensitivity in rats. Aust NZ J Surg 1987;57:249–52. https://doi. org/10.1111/j.1445-2197.1987.tb01349.x; PMID: 3498476. Merola J, Jane-Wit DD, Pober JS. Recent advances in allograft vasculopathy. Curr Opin Organ Transplant 2017;22:1–7. https://doi. org/ 10.1097/MOT.0000000000000370; PMID: 27898462. Chow SP, So YC, Chan CW. Experimental microarterial grafts: freeze-dried allografts versus autografts. Br J Plast Surg 1983;36:345–7. https://doi.org/10.1016/S0007-1226(83)90058-9; PMID: 6860865.

16. N eves JP, Gulbenkian S, Ramos T, et al. Mechanisms underlying degeneration of cryopreserved vascular homografts. J Thorac Cardiovasc Surg 1997;113:1014–21. https:// doi.org/10.1016/S0022-5223(97)70286-1; PMID: 9202681. 17. Moura R, Maffei FH, Mattar L, et al. Glutaraldehyde-treated homologous vein graft as a vein substitute: experimental study in rabbits. Int Angiol 2009;28:113–9. PMID: 19242400. 18. Sun H, Valdivia LA, Subbotin V, et al. Improved surgical technique for the establishment of a murine model of aortic transplantation. Microsurgery 1998;18:368–71. https:// doi.org/10.1002/(SICI)1098-2752(1998)18:6<368::AIDMICR5>3.0.CO;2-F; PMID: 9846999. 19. Hwang SJ, Kim SW, Choo SJ, et al. The decellularized vascular allograft as an experimental platform for developing a biocompatible small-diameter graft conduit in a rat surgical model. Yonsei Med J 2011;52:227–33. https://doi.org/10.3349/ ymj.2011.52.2.227; PMID: 21319339. 20. Olmos-Zuñiga JR, Jasso-Victoria R, Díaz-Martínez NE, et al. Lyophilized allografts without pre-treatment with glutaraldehyde are more suitable than cryopreserved allografts for pulmonary artery reconstruction. Braz J Med Biol Res 2016;49:e5001. https://doi.org/10.1590/1414-

02/04/2019 20:45

Peripheral Artery Disease 431X20155001; PMID: 26648092. 21. W ozniak G, Bauer J, Bohle RM, Dapper F. Coarctation of the thoraco-abdominal aorta: operative treatment with a cryopreserved arterial homograft in a seven-year-old boy. J Cardiovasc Surg 1998;39:483–8. PMID: 9788797. 22. Chiesa R, Astore D, Piccolo G, et al. Fresh and cryopreserved arterial homografts in the treatment of prosthetic graft infections: experience of the Italian Collaborative Vascular Homograft Group. Ann Vasc Surg 1998;12:457–62. https://doi. org/10.1007/s100169900184; PMID: 9732424. 23. Della Schiava N, Mathevet J, Boudjelit T, et al. Cryopreserved arterial allografts and ABO and rhesus compatibility, Ann Vasc Surg 2016;33:173–80. https://doi.org/10.1016/j. avsg.2015.11.014; PMID: 26916349. 24. Kieffer E, Gomes D, Chiche L, et al. Allograft replacement for infrarenal aortic graft infection: early and late results in 179 patients. J Vasc Surg 2004;39:1009–17. https://doi.org/10.1016/ j.jvs.2003.12.040; PMID: 15111853. 25. Leseche G, Castier Y, Petit MD, et al. Long-term results of

VER_Noriega_FINAL.indd 22

26.

27.

28.

29.

cryopreserved arterial allograft reconstruction in infected prosthetic grafts and mycotic aneurysms of the abdominal aorta. J Vasc Surg 2001;34:616–22. https://doi.org/10.1067/ mva.2001.116107; PMID: 11668314. Koskas F, Plissonnier D, Bahnini A, et al. In situ arterial allografting for aortoiliac graft infection: a 6-year experience. Cardiovascular Surg 1996;4:495–9. https://doi.org/10.1016/09672109(95)00126-3; PMID: 8866088. Brown KE, Heyer K, Rodriguez H, et al. Arterial reconstruction with cryopreserved human allografts in the setting of infection: A single-center experience with midterm followup. J Vasc Surg 2009 49:660–6. https://doi.org/10.1016/j. jvs.2008.10.026; PMID:19268771. Locati PM, Gallo E, Constantin E, et al. [The use of allografts in the surgical treatment of patients with infected vascular prostheses]. Vestn Khir Im I I Grek 1998;157:103–6. PMID: 9751993 [in Russian]. Bisdas T, Bredt M, Pichlmaier M, et al. Eight-year experience with cryopreserved arterial homografts for the in-situ

30.

31.

32.

33.

reconstruction of abdominal aortic infections. J Vasc Surg 2010;52:323–30. https://doi.org/10.1016/j.jvs.2010.02.277; PMID: 20570473. Rueda P, Morales J, Guzman E, et al. Aortic homograft for pulmonary artery augmentation in single lung transplantation. Ann Thorac Surg 2005;9:2161–2. https://doi.org/10.1016/j. athoracsur.2004.01.040; PMID: 15919340. Ha TY, Kim YH, Chang JW, et al. Clinical outcomes of cryopreserved arterial allograft used as a vascular conduit for hemodialysis. J Korean Med Sci. 2016;31:1266–72. https://doi. org/10.3346/jkms.2016.31.8.1266; PMID: 27478338. Ravenni G, Pratali S, Scioti G, Bortolotti U. Total calcification of an aortic homograft used as aortic root replacement. J Cardiovasc Med (Hagerstown) 201;12:191–2. https://doi. org/10.2459/JCM.0b013e3283356639; PMID: 20104179. Minga E, Holemans C, Stiennon L, et al. Late fate of cryopreserved arterial allograft. Eur J Vasc Endovasc Surg 2016;52:696–702. https://doi.org/10.1016/j.ejvs.2016.08.005; PMID: 27614553.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

02/04/2019 20:45

Aortic

Alternative Access for Transcatheter Aortic Valve Implantation: Current Evidence and Future Directions JJ Coughlan, Thomas J Kiernan and Samer Arnous Department of Cardiology, University Hospital Limerick, Dooradoyle, Ireland

Abstract Transcatheter aortic valve implantation (TAVI) is the usual technique for patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement. The transfemoral (TF) route is the most commonly used access type, and significant progress in this procedure has greatly increased the proportion of patients who can undergo it. Not all patients are suitable for TF TAVI, however, so other routes, including transapical, transaortic, subclavian, trans-subclavian/transaxillary, transcarotid and transcaval, may need to be used. Evidence on these routes shows promising results but the majority of this is registry data rather than randomised controlled trials, so TF TAVI remains the safest access route and should be considered for most patients. However, in patients who are unsuitable for TF TAVI, alternative access routes are safe and feasible. The challenges concern choosing the best route, the valve to use and skill of the specialist centre. This article provides a overview of options for alternative vascular access in TAVI, the clinical rationale for using them, current evidence and areas for clinical investigation.

Keywords Transcatheter aortic valve implantation, aortic valve, vascular access, aortic stenosis, transapical, transaortic, subclavian, trans-subclavian/ transaxillary, transcarotid, transcaval Disclosure: The authors have no conflicts of interest to declare. Received: 31 January 2019 Accepted: 26 February 2019 Citation: Vascular & Endovascular Review 2019;2(1):23–7. DOI: https://doi.org/10.15420/ver.2019.4.2 Correspondence: JJ Coughlan, Department of Cardiology, University Hospital Limerick, St Nessan’s Rd, Dooradoyle, Limerick, Ireland. E: jjcoughl@gmail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Transcatheter aortic valve implantation (TAVI) has emerged as the treatment of choice for patients with severe aortic stenosis (AS) deemed to be at high risk for surgical aortic valve replacement.1 Recent trials have suggested equipoise with regard to outcomes in patients with an intermediate risk, and clinical trials are underway in low-risk patients.2–8

undergoing a transapical (17.2%) or transaortic approach (6.2%). In this trial, the transthoracic approach was not found to be superior to surgical aortic valve replacement. In the transthoracic cohort, TAVI did not result in a lower rate of death from any cause or disabling stroke than surgery. This confirmed the primacy of the transfemoral approach for TAVI where it is possible in these patients.

The first TAVI procedure was performed by Alain Cribier in 2002 via an anterograde transeptal approach.9 Subsequently, the Placement of AoRTic TraNscathetER Valve (PARTNER) trial was published.10 This was the first randomised control trial of transfemoral TAVI, and compared it to the standard approach in patients with severe AS who were at high risk and inoperable. It demonstrated that TAVI reduced the risk of death (30.7% versus 49.7% at 1 year, p<0.001) and repeat hospitalisation (22.3% versus 44.1%, p<0.001) compared to standard therapy, despite a higher incidence of vascular complications (30.7% versus 5% at 30 days, p<0.001) and major stroke (5% versus 1.1% at 30 days, p=0.06).

This article provides a comprehensive overview of the current options for alternative vascular access in TAVI. We will also touch on the clinical rationale for using the various access routes and, where possible, discuss the best available current evidence and suggest areas in need of further clinical investigation.

Based on the results of PARTNER 1, the transfemoral route became the default access site for TAVI. Initially, this was achieved via surgical cutdown, which led to a correspondingly higher rate of vascular complications. The PARTNER 2 trial subsequently confirmed the utility of TAVI in intermediate-risk patients with AS, randomised to either TAVI or surgery.11 Of the 1,011 patients randomised to TAVI in this trial, the majority (76.6%) underwent transfemoral TAVI, with the remainder

VER_Coughlan_FINAL.indd 23

Current Practice in Transcatheter Aortic Valve Implantation The transfemoral route (TF TAVI) is the most commonly used access type for TAVI.12–14 The first-generation devices in 2005 required a femoral cutdown and the use of up to 24 Fr sheaths. Sheath sizes have decreased considerably since and current devices use 14–16 Fr sheaths. This has negated the need for surgical cutdown in the majority of cases, reduced vascular complications and increased the proportion of patients eligible for TF TAVI. There has been much progress with regard to simplification of the TF TAVI in recent years. This includes a move toward conscious sedation rather than general anaesthesia, percutaneous femoral access rather

Access at: www.VERjournal.com

28/03/2019 22:23

Aortic Figure 1: Algorithm for Deciding if Patient is a Candidate for Alternative Access Transcatheter Aortic Valve Implantation Transcatheter aortic valve versus aortic valve replacement

Heart team discussion

Decision made for TAVI MDCT of iliofemoral vasculature

Yes Suitable for TF TAVI? Iliofemoral anatomy Severe tortuosity Unsuitable angulation Severe calcification Atherosclerotic disease Unsuitable luminal diameter

TF TAVI?

Surgical option?

than surgical cut down, temporary pacing through the left ventricular guidewire instead of inserting a right ventricular temporary pacing wire through a femoral vein sheath, dedicated vascular closure devices, operating without transoesophageal echo guidance and post-procedure care plans designed to promote early ambulation and discharge.15–20 This modern, ‘minimalist’ TAVI approach is fast becoming the standard of care for straightforward cases. However, because of severe atherosclerotic disease, tortuosity, calcification or angulation, transfemoral access may not be feasible in around 10–15% of cases.14 A luminal diameter >6 mm is usually required. Severe calcification of the peripheral vasculature and coarctation of the aorta are also considered contraindications to the transfemoral route. Similarly, previous surgery or stenting in the aorta, iliac or femoral arteries may represent a relative contraindication. In such cases, several alternative access options are now available to the operator (Figure 1).

Alternative Access Options Rationale Percutaneous transfemoral access is considered the safest approach for TAVI and has become standard care for the majority of cases, as discussed above. Other vascular access sites (direct aortic, axillary, carotid and subclavian) also use the retrograde approach, but most require a surgical cutdown. Some of these approaches can now be performed percutaneously, but this method is still in its relative infancy in the majority of centres (Figure 2). Recently, transcaval TAVI has been described, using femoral vein access. A novel suprasternal approach has also been proposed although data on this is currently limited.21 Each access route is discussed below in more detail.

Transapical and Transaortic Access Initially, transapical (TA) TAVI was the preferred alternative access route for TAVI in patients with unsuitable femoral access. It is the only anterograde approach for TAVI. It requires general anaesthesia,

VER_Coughlan_FINAL.indd 24

In the transthoracic cohort of the PARTNER 2 trial, the majority of whom had TA TAVI, outcomes were not superior to surgical aortic valve replacement.11 However, the trial was not powered for this subgroup analysis. The majority of experience in TA TAVI is in balloon expandable valves. The use of TA TAVI has reduced over time. This is mainly for two reasons. First, smaller sheath sizes for TF access and greater operator experience have increased the proportion of patients suitable for TF TAVI. Second, the development of multiple other, less invasive access routes has expanded the modern operators’ armamentarium and concern over the higher complication rate associated with TA TAVI has led operators to prefer alternative access routes.22

Alternative access?

MDCT = multiple detector CT; SAVR = surgical aortic valve replacement; TAVI = transcatheter aortic valve implantation; TF = transfemoral.

a mini-thoracotomy and direct puncture of the left ventricular apex. This allows for easy valve crossing and excellent control of the valve position during implantation. The direct puncture of the apex may result in reduced left ventricular function, myocardial necrosis or myocardial stunning.

The transaortic (TAo) approach was also used in the PARTNER 2 trial, although in a smaller number of patients (n=65, 6.4% of total).11 Access is gained via a mini-thoracotomy or partial sternotomy. The procedure is performed under general anaesthesia. Cardiopulmonary bypass is generally not required. Once aortic access is gained, the valve can be deployed via a retrograde approach. Bapat et al. described their experience of TAo TAVI using a partial upper sternotomy in 17 patients using the balloon-expandable SAPIEN (Edwards Lifesciences) valve in 2012. They reported 30-day mortality of 4.3% versus 7.7% in the corresponding TA cohort and no significant differences in procedural complications.23 TAo TAVI is contraindicated in patients with a heavily calcified or atheromatous ascending aorta, vein grafts with high origin, or anatomical variations that might prevent good coaxial prosthesis deployment (i.e. pectus excavatum). It is preferred to TA TAVI in patients with severe pulmonary disease compromising the pleural space, severe systolic dysfunction, a small left ventricular cavity and a thin left ventricular wall. Amrane et al. performed a meta-analysis on TAo TAVI. They included 16 studies, all of which were observational and single arm. They reported a major vascular complication rate of 31%, pacemaker implantation rate of 11.7%, a 9.9% 30-day mortality rate and a 3.7% stroke rate.24

Trans-subclavian/Transaxillary The subclavian approach was initially performed after a surgical cutdown with isolation and preparation of the artery by a vascular or cardiothoracic surgeon. More recently, a true percutaneous subclavian approach has been discussed. Petronio et al. described their initial multicentre experience of 54 cases, all of which used the selfexpanding CoreValve (Medtronic) prosthesis.25 Pre-procedural CT scanning and angiography were performed to assess the diameters, tortuosity and calcification of the left axillary and subclavian arteries. The presence of a left internal mammary artery graft was not considered a contraindication as long as the subclavian artery was larger than 7 mm and free from atherosclerotic disease. Patients were considered ineligible for the procedure if

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:23

Alternative Access for Transcatheter Aortic Valve Implantation the vessel diameter was <6 mm, if the vessel was heavily calcified or tortuous, or if there was tight subclavian stenosis that was not amenable to balloon angioplasty. After surgical isolation of the artery, arterial access was obtained using the Seldinger technique. Initially a 6 Fr sheath and subsequently an 18 Fr sheath were inserted into the artery, then TAVI was performed using the standard technique. Procedural success was achieved in 100% of subclavian cases, compared with 98.4% of transfemoral TAVI cases (p=0.62). Procedural duration was longer in the surgical subclavian access group (120 minutes versus 70 minutes; p<0.0001). Intra-procedural mortality was 0% in the subclavian group and no specific complications were reported related to subclavian access. General anaesthesia was used for the majority of cases but, in centres with more experience of the procedure, local anaesthesia was also used. The left subclavian artery was used preferably as it allows for a more favourable orientation of the CoreValve delivery system through the aortic annulus. Right subclavian access requires that the 18 Fr sheath remains distal to the origin of the right internal carotid artery to avoid hypoperfusion of the brain. Valve implantation can also be more difficult due to the wider angle between the delivery catheter and the axis of the ascending aorta. Petronio et al. reported that subclavian access is feasible in patients with a pacemaker in situ as the surgical cutdown does not interfere with the pacemaker system.25 The US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry reported on 627 patients undergoing trans-subclavian and transaxillary TAVI using the SAPIEN 3 (Edwards Lifesciences) prosthesis.26 Procedural success was achieved in 97.9% of cases with a 30-day all-cause mortality of 4.4% and a major vascular complication rate of 3.1%. The stroke rate was 5.4%. The STS/ACC TVT registry did not differentiate between the trans-subclavian (supraclavicular) and transaxillary (infraclavicular) approaches. A fully percutaneous technique was used in 95 cases (15.2%). In the Nordic Aortic Valve Intervention (NOTION) trial, transsubclavian access was used in only 3.5% of cases (n=5).2 Transaxillary TAVI was also initially performed via surgical cutdown. However, as with trans-subclavian access, fully percutaneous transaxillary TAVI can also be performed. One study of 100 consecutive patients in two centres demonstrated a device success rate of 95% with 0% major and 11% minor access site complications.27 Mortality rates were 6% at 30 days and 14.8% at 1 year. Smaller published series have demonstrated similar results.28,29

Transcarotid Mylotte et al. described a large series of transcarotid TAVI, with 96 patients undergoing the procedure in three high-volume TAVI centres in France over 4 years (2009–2013).30 The patients included in this registry had small-calibre, heavily calcified, tortuous or stenotic iliofemoral anatomy or significant descending aortic pathology. Exclusion criteria in this study, which indicated patient was not suitable for a transcarotid approach, included significant (50%) common or internal carotid stenosis and congenital variants of the aortic arch. This series primarily used the CoreValve (92.7%); the Sapien valve was used in the remaining 7.3% of cases. Cardiac tamponade occurred in 4% of cases and there were no conversions to surgical aortic valve replacement. No major bleeding or vascular complications related

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Coughlan_FINAL.indd 25

Figure 2: Access Options in Modern Transcatheter Aortic Valve Implantation

Transcarotid

Transaxillary/subclavian

Transaortic Transcaval

Transapical

Transiliac

Transfemoral

to the access site occurred. Mortality at 30 days was 6.3% (n=6) with half of these being procedural deaths (n=3). There were no in-hospital strokes but there were three transient ischaemic attacks (3.1%). One of the most noticeable advantages of the transcarotid approach is that it does not require a thoracotomy or mini-sternotomy. As such, it may be preferable in patients with significant respiratory comorbidities or those who have had a prior sternotomy. In this cohort, the carotid artery was exposed via a small supraclavicular incision. The artery was dissected and clamped proximally and distally. The artery was then accessed percutaneously, allowing the transcatheter heart valve to be implanted. The arterial access site was repaired surgically after the delivery sheath had been removed. In this study, multislice CT was used to determine the dimensions of the carotid, subclavian and vertebral arteries with a minimal luminal diameter of 7 mm and above considered appropriate for trans-carotid access. Performing magnetic resonance angiography of the circle of Willis before the procedure is essential to determine if adequate collateral cerebral blood flow is present for potential transcarotid access. This was carried out in all cases in this series. The left common carotid artery is usually preferred as it provides superior coaxial alignment and was used in 88.5% of patients in this series. TAVI via the carotid route is certainly a viable option. However, recent meta-analyses and systematic reviews have suggested that the available data limit formal meta-analysis and, as such, they draw no firm conclusions regarding the safety and efficacy of this method.31,32

Transcaval The transcaval approach is the most novel alternative access route for TAVI. It involves femoral vein access with crossover to the abdominal aorta from the inferior vena cava. This is achieved by electrifying a caval guidewire and advancing it into an aortic snare. Importantly, like transcarotid TAVI, it avoids the morbidity of transthoracic approaches. Periprocedural CT scanning is paramount to ensure there is a suitable non-calcified area of abdominal aorta to allow wire crossover from the inferior vena cava. This area of aorta should also be free of any important arterial branches, such as

28/03/2019 22:23

Aortic Figure 3: Proposed Algorithm for Decision-making Regarding Alternative Access Transcatheter Aortic Valve Implantation

Deciding on an Alternative Access Route

Decision made for alternative access TAVI

Heart team discussion

MDCT imaging Carotids Thoracic aorta Subclavian/axillary artery Abdominal aorta

Patient factors Previous CABG Depressed LV function Carotid artery disease Respiratory disease

Other factors Relevant local expertise Functional circle of Willis Patient preference

Decision made regarding most appropriate alternative access route based on all factors Transcarotid

Transaxillary/subclavian

Transaortic/apical

Transcaval

CABG = coronary artery bypass graft; LV = left ventricular; MDCT = multiple detector CT; TAVI = transcatheter aortic valve implantation.

the renal artery, renal vein and aorto-iliac bifurcation, as a covered stent may be required as a bailout strategy if there are bleeding complications during the procedure. A microcatheter is delivered into the descending aorta and a stiff guidewire is introduced. Once crossover is achieved, the TAVI introducer sheath can be introduced in the usual manner and the valve implanted using a retrograde approach. A nitinol cardiac occluder device is used to close the iatrogenic aortocaval fistula after valve implantation. The largest cohort, described in the literature by Greenbaum et al., consists of 100 patients who were ineligible for femoral artery access and had a high or prohibitive risk from transthoracic access.33 Device implantation was successful in 99 patients. They reported a 30-day survival of 92%, a life-threatening bleeding rate of 7% and a major vascular complication rate of 13%. While this technique has certainly been demonstrated to be feasible, it is probably best reserved for use in experienced, high-volume specialist centres at present, but may become more commonplace

iontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic S valve implantation vs surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J 2016;37:3503–12. https://doi. org/10.1093/eurheartj/ehw225; PMID: 27389906. Thyregod HG, Søndergaard L, Ihlemann N, et al. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial. J Am Coll Cardiol 2015;65:2184–94. https://doi.org/10.1016/j.jacc.2015.03.014; PMID: 25787196. Natarajan D, Makkar R, MacCarthy P, et al. Placement of Aortic Transcatheter Valves (PARTNER) 2 Cohort A trial – transcatheter or surgical aortic-valve replacement in intermediate-risk patients. EuroIntervention 2016;12:805–8. https://doi.org/10.4244/EIJV12I6A131; PMID: 27542796. Barker CM, Reardon MJ. The CoreValve US pivotal trial. Semin Thorac Cardiovasc Surg 2014;26:179–86. https://doi.org/10.1053/ j.semtcvs.2014.10.001; PMID: 25527011.

VER_Coughlan_FINAL.indd 26

in future. A recent meta-analysis concluded that the initial evidence is encouraging but further prospective studies are probably required before any firm conclusions can be made.34

Multi-detector CT scanning plays a vital role in determining the most appropriate access route. It can give information on luminal diameter, calcific vessel load and tortuosity of the relevant vasculature. For TF TAVI, it allows practitioners to assess the iliofemoral vessels bilaterally to determine if a patient is suitable. If transcaval access is being considered, CT scanning can identify a suitable area on the right aortic wall for passage of the transcatheter aortic valve replacement sheath from the inferior vena cava to the abdominal aorta. For transcarotid TAVI, it provides valuable information on the subclavian, carotid and vertebral arteries. Imaging experts play an important role in the heart team discussion and can help guide operators toward the most appropriate access route. In general, vascular access site complications are a common cause of significant morbidity and mortality after a TAVI procedure. A key role of the heart team should be to identify the access route that will minimise this risk. If alternative access is considered, a vascular surgeon should be part of the heart team to identify potential risks associated with the access routes and assist in the decision-making (Figure 3).

Conclusion Since its inception, TAVI has undoubtedly revolutionised the treatment of aortic stenosis. Enormous strides have been made with regard to patient and device selection, pre-procedural planning and procedural simplification. This has resulted in improvements in patient outcomes and increased operator confidence with regards to taking on more complex cases. Unsuitable iliofemoral anatomy no longer precludes patients from undergoing TAVI and physicians have become more comfortable with alternative access routes. Without intervention, these patients have a poor prognosis with a mortality rate of around 50% at 2 years.35 While much of the published data on alternative access TAVI shows promising results, the majority of this is registry data rather than randomised controlled trials. TF TAVI remains the safest access route and should be considered in the majority of cases. However, in unsuitable patients, different access routes have been shown to be safe and feasible. The challenge is to choose the best alternative access route for the individual patient based on their vascular anatomy and comorbidities, choice of valve and the local institutional skill set.

eardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or R transcatheter aortic-valve replacement in intermediaterisk patients. N Engl J Med 2017;376:1321–31. https://doi. org/10.1056/NEJMoa1700456; PMID: 28304219. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients (NCT02701283). Available at: https://clinicaltrials. gov/ct2/show/NCT02701283 (accessed 27 February 2019). Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis (NOTION–2) (NCT02825134). Available at: https://clinicaltrials.gov/ct2/show/record/NCT02825134 (accessed 27 February 2019). The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3) (NCT02675114). Available at: https:// clinicaltrials.gov/ct2/show/NCT02675114 (accessed 27 February 2019). Cribier A, Eltchaninoff H, Bash A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis

10.

11.

12.

13.

for calcific aortic stenosis: first human case description. Circulation 2002;106:3006–8. https://doi.org/10.1161/01. CIR.0000047200.36165.B8; PMID: 12473543. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363:1597–607. https://doi. org/10.1056/NEJMoa1008232; PMID: 20961243. Leon MB, Smith CR, Mack M, Makkar R et al. Transcatheter or surgical aortic-valve replacement in intermediaterisk patients. N Engl J Med 2016; 374:1609–20. https://doi. org/10.1056/NEJMoa1514616; PMID: 27040324. Petronio AS, Capranzano P, Barbato E, et al. Current status of transcatheter valve therapy in Europe: results from an EAPCI survey. EuroIntervention 2016;12:890–5. https://doi.org/10.4244/ EIJY16M06_01; PMID: 27283408. Ludman PF, Moat N, de Belder MA, et al. Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6–year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry,

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:23

Alternative Access for Transcatheter Aortic Valve Implantation

14.

15.

16.

17.

18.

19.

20.

2007 to 2012. Circulation 2015;131(13):1181–90. https://doi. org/10.1161/CIRCULATIONAHA.114.013947; PMID: 25637628. Auffret V, Lefevre T, Van Belle E, et al. Temporal trends in transcatheter aortic valve replacement in France: FRANCE 2 to FRANCE TAVI. J Am Coll Cardiol 2017;70:42–55. https://doi. org/10.1016/j.jacc.2017.04.053; PMID: 28662806. Bajrangee A, Coughlan JJ, Sullivan V, et al. 11 Conscious sedation as the default anaesthetic approach for transcatheter aortic valve insertion (TAVI). Heart 2016;102:A7. Bajrangee A, Coughlan JJ, Teehan S, et al. Early and midterm outcomes after transcatheter aortic valve implantation (TAVI) in Ireland. Int J Cardiol Heart Vasc 2017;16:1–3. https://doi. org/10.1016/j.ijcha.2017.06.001; PMID: 28785604. Faurie B, Abdellaoui M, Wautot F, Staat P et al. Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures. Catheter Cardiovasc Interv 2016;88:988–93. https://doi.org/10.1002/ccd.26666; PMID: 27510946. Barbanti M, Capranzano P, Ohno Y, et al. Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation. EuroIntervention. 2015;11:690–7. https://doi.org/10.4244/EIJV11I6A137; PMID: 26499222. Vendrik J, van Mourik M, Vlastra W, Delewi R et al. TCT–222 safety and feasibility of an early ambulation protocol after transfemoral transcatheter aortic valve implantation: results of the early mobilisation after TF-TAVI (MobiTAVI) trial. J Am Coll Cardiol 2018;72(13 Supplement):B92–3. https://doi. org/10.1016/j.jacc.2018.08.1345. Barbanti M, Baan J, Spence MS, et al. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation – rationale and design of the FAST-TAVI registry. BMC Cardiovasc Disord 2017;17:259. https://doi.org/10.1186/ s12872-017-0693-0; PMID: 29017461.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Coughlan_FINAL.indd 27

21. C odner P, Pugliese D, Kouz R, et al. Transcatheter aortic valve replacement by a novel suprasternal approach. Ann Thorac Surg 2018;105:1215–22. https://doi.org/10.1016/j. athoracsur.2017.10.055; PMID: 29397928. 22. Grover FL, Vemulapalli S, Carroll JD, et al. 2016 annual report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol 2017;69:1215–30. https://doi.org/10.1016/j. jacc.2016.11.033; PMID: 27956264. 23. Bapat V, Khawaja MZ, Attia R, Narayana A et al. Transaortic transcatheter aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv 2012;79:733–40. https://doi.org/10.1002/ccd.23276; PMID: 21805602. 24. Amrane H, Porta F, Van Boven AV, et al. A meta-analysis on clinical outcomes after transaortic transcatheter aortic valve implantation by the heart team. EuroIntervention 2017;13:e168– 76. https://doi.org/10.4244/EIJ-D-16-00103; PMID: 28374676. 25. Petronio AS, De Carlo M, Giannini C, et al. Subclavian TAVI: more than an alternative access route. EuroIntervention 2013;9(Suppl):S33–7. https://doi.org/10.4244/EIJV9SSA7; PMID: 24025955. 26. Dahle T, Kaneko T, McCabe J. TCT–594 Trans-subclavian and axillary access for transcatheter aortic valve replacement using Sapien 3 THV from the US STS/ACC TVT Registry. J Am Coll Cardiol 2017;70(18 Suppl):B245–6. https://doi.org/10.1016/j. jacc.2017.09.781. 27. Schäfer U, Deuschl F, Schofer N, et al. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol 2017;232:247–54. https:// doi.org/10.1016/j.ijcard.2017.01.010; PMID: 28118931. 28. Ciuca C, Tarantini G, Latib A, et al. Trans-subclavian versus transapical access for transcatheter aortic valve

29.

30.

31.

32.

33.

34.

35.

implantation: a multicenter study. Catheter Cardiovasc Interv 2016;87:332–8. https://doi.org/10.1002/ccd.26012; PMID: 26010724. Amat-Santos IJ, Rojas P, Gutiérrez H, Vera S et al. Transubclavian approach: a competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv 2018;92:935–44. https://doi.org/10.1002/ccd.27485; PMID: 29314570. Mylotte D, Sudre A, Teiger E, Obadia JF. Transcarotid transcatheter aortic valve replacement. JACC: Cardiovasc Interv 2016;9:472–80. https://doi.org/10.1016/j.jcin.2015.11.045; PMID: 26965937. Stonier T, Harrison M, Choong AM. A systematic review of transcatheter aortic valve implantation via carotid artery access. Int J Cardiol 2016;219:41–55. https://doi.org/10.1016/j. ijcard.2016.05.049; PMID: 27281576. Wee IJ, Stonier T, Harrison M, Choong AM. Transcarotid transcatheter aortic valve implantation: a systematic review. J Cardiol 2018;71:525–33. https://doi.org/10.1016/j. jjcc.2018.01.010; PMID: 29499894. Greenbaum AB, Babaliaros VC, CHen MY, Stine AM. Transcaval access and closure for transcatheter aortic valve replacement: a prospective investigation. J Am Coll Cardiol 2017;69:511–21. https://doi.org/10.1016/j.jacc.2016.10.024; PMID: 27989885. Wee IJY, Syn N, Choong AM. Transcaval approach for endovascular aortic interventions: a systematic review. J Cardiol 2018;72:369–76. https://doi.org/10.1016/j. jjcc.2018.04.009; PMID: 29804907. Kelly TA, Rothbart RM, Cooper CM, et al. Comparison of outcome of asymptomatic to symptomatic patients older than 20 years of age with valvular aortic stenosis. Am J Cardiol 1988;61:123–30. https://doi.org/10.1016/00029149(88)91317-3; PMID: 3337000.

28/03/2019 22:23

Aortic

Acute Type B Dissection Andre Ramdon 1 and R Clement Darling III 2,3,4 1. Albany Medical College/Albany Medical Center Hospital, Albany, NY, US; 2. Albany Medical College; 3. Division of Vascular Surgery, Albany Medical Center Hospital, Albany, NY, US; 4. Institute for Vascular Health and Disease, Albany Medical Center Hospital, Albany, NY, US

Abstract Aortic dissections are catastrophic vascular emergencies, and early recognition and appropriate interventions can be crucial to survival. Research has changed the way aortic dissections are managed over the past two decades and will continue to contribute to the evolution of treatment modalities. Early treatment for uncomplicated type B dissections still remains controversial but certain characteristics may benefit from early intervention.

Keywords Aortic dissection, complicated dissection, TEVAR, thoracic endovascular aortic repair, type B aortic dissection, uncomplicated dissection Disclosure: The authors have no conflicts of interest to declare. Received: 2 October 2018 Accepted: 3 January 2019 Citation: Vascular & Endovascular Review 2019;2(1):28–31. DOI: https://doi.org/10.15420/ver.2018.21.1 Correspondence: R Clement Darling III, The Vascular Group, 391 Myrtle Avenue, Suite 5, Albany, NY 12208, US. E: darlinr@amc.edu Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

The first classification of aortic dissection was made by Debakey et al. in 1965.1 The widely accepted Stanford classification was coined by Daily et al. 5 years later; in this classification type B signifies that the intimal tear is distal to the left subclavian artery (similar to Debakey type 3).2 The basis of these classifications was predicated on the vastly different outcomes and treatment modalities for the different presentations. Additionally, the timeline from onset of symptoms can divide presentation into acute (<2 weeks), subacute (2 weeks to 3 months) and chronic (>3 months). It was recognised early on that medical management of type B aortic dissection (TBAD) resulted in good initial results with a review of published literature suggesting a 5-year mortality of 75–88%.3,4 TBAD can quickly become catastrophic – in-hospital mortality is as high as 10–14%.5,6

Presentation and Diagnosis The classic presentation of TBAD is an abrupt onset of severe sharp tearing or ripping pain in the chest or back. Pain is the presentation in 70–72.4% of cases of TBAD, with people most often experiencing pain in the back or occasionally the abdomen. Hypertension is the second most common presentation according to the International Registry of Aortic Dissection (IRAD) for TBAD, occurring in 66–70.1% of cases.5,7 Hypertension is also a predictor for complications, with blood pressure control representing an important goal for management. Early high inpatient mortality represents a subset of TBAD due to malperfusion and/or rupture.7 However, this may only represent the tip of the iceberg because estimates from autopsies suggest that 20–30% cases of TBAD do not make it to hospital.8 Malperfusion may be the presenting feature and occurs in up to 10% of TBAD cases.4 End organ dysfunction must be recognised early and is indicative of impending organ failure. This may be static or dynamic for flow, which can be corroborated by laboratory findings

Access at: www.VERjournal.com

VER_Darling_FINAL.indd 28

and imaging. Compromised spinal, visceral, renal or iliac blood flow may result in paralysis, paraplegia, lower limb ischaemia, abdominal pain or diarrhoea with raised liver function, amylase, lactate, urea, creatinine and coupled with absence (thrombosis) or delay in contrast enhancement in the target organ. The role of contrast enhanced imaging cannot be overemphasised as it gives useful information about the predictors of failure, malperfusion, pre-treatment sizing and – most importantly – aortic rupture. The diagnosis of impending rupture as defined as haemorrhagic pleural effusion or expanding peri-aortic haematoma can only be made with imaging.9 Historically, retrograde aortography was considered the gold standard for diagnosis; fortunately, this is only used during interventions. CT angiography (CTA) has become widely available with rapid image acquisition. CTA has a 93.8% sensitivity and a specificity of 87.1% which compares well with other modalities such as MRI or transoesophageal echocardiogram for acute aortic emergencies.10 MRI has sensitivity rates of 95–100% but is limited by its long examination time and availability.11 Transoesophageal echocardiogram for TBAD is limited by the need for general anaesthesia and it loses sensitivity in the aortic arch which is in the vicinity of the proximal tear. Intravascular ultrasound is now considered the standard intervention for TBAD.

Natural History and Aortic Remodelling In 80% of TBAD cases, the intimal tear is in a posterior-lateral aspect to the aorta, a few centimetres distal to the left subclavian artery with the trajectory of the false lumen taking various configurations but most commonly involving the left renal artery.12 Debakey et al. first reported that up to 40% of TBAD will degenerate over time.13 Since the founding of IRAD in 1995, there is a better understanding of the longterm outcomes. Five-year analysis suggests a better long-term survival in thoracic endovascular repair versus best medical management for

28/03/2019 22:27

Acute Type B Dissection TBAD shown by the IRAD registry.14 The ideology behind this is that aortic-related pathology will develop with time and the patients will eventually succumb to it. Only 41% of TBAD remain interventionfree at 6 years follow-up with 65% of the aortic-related interventions related to aneurysmal degeneration. Note that this is highly predicated on time, as these benefits were not realised at the 2-year follow-up. A significant reduction in all-cause mortality and aortic-specific mortality at 5 years was shown by the first randomised trial for uncomplicated TBAD with thoracic endovascular repair of the aorta (TEVAR) versus best medical management.15,16 There is a correlation with false lumen patency and progression to aneurysmal progression in TBAD.17 Tsai et al. showed mortality post-discharge based on thrombosis of false lumen was 13.7% in complete thrombosis, 31.6% in partial thrombosis and 22.6% in complete thrombosis.18 The concept of aortic remodelling with inducing false lumen thrombosis by sealing the aortic tear with TEVAR and redirecting flow to the true lumen has the potential to reduce complications. Additionally, Tolennar et al. showed patients with fully patent false lumen at presentation and branch vessel involvement are less likely to develop thrombosis and may benefit from TEVAR.19 This was corroborated in the INvestigation of Stent Grafts in Aortic Dissection (INSTEAD) trial with positive remodelling showing expansion of the true lumen from a mean of 19.4 mm to 32.4 mm at 2 years and shrunken false lumen from a mean of 29.3–8.6 mm at 2 years in subacute to early chronic, uncomplicated TBAD. This was maintained at 5 years and was reproducible at different levels of the aorta.15,16 The real-world experience from the VIRTUE Registry – a prospective, nonrandomised, multicentre European registry – shows promisingly similar results for complicated TBAD.20 The true lumen increased across all levels of aorta involved with reduction in the false lumen after TEVAR but interestingly, this reduction was more marked in the acute and subacute groups. This adds insight into the plasticity of the intermembrane, suggesting the more acute the dissection, the more likely it is that aortic remodelling will be successful. The majority of the changes in the lumen size occurs by 6 months.

Management Medical management guidelines recommend a target systolic blood pressure of 100–120 mmHg with heart rate <60 BPM.21 Beta-blockers should be the first-line treatment and should be used in preference to vasodilators unless contraindicated. It is not unusual for patients to need multiple medications for blood pressure control. Continuous monitoring in an intensive setting is preferred because up to 10–12% of these patients will have complications that occur during the initial encounter.

Acute Complicated Type B Dissection Details of stent grafting for a complicated TBAD was first published in 1999.22,23 This was the start of endovascular treatment of TBAD, which resulted in TEVAR and it was initially only used in cases that were not amenable for open surgery. The definition of complicated was standardised by the interdisciplinary expert group to include malperfusion, persistent or uncontrolled hypertension despite full medical therapy, and rupture or impending rupture.4 Open repair has traditionally offered the best chance of survival in complicated TBAD with the necessity for thoracotomy and left heart bypass adding to its risk of mortality. A high 30-day mortality of 19% and combined neurological complication of 9.8% in a meta-analysis by Moulakakis

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Darling_FINAL.indd 29

et al. made this a daunting procedure.24 This is compared to mortality in TEVAR of 10.2% and combined neurological complications at 9.1%.4 There are now several measures to improve neurological outcomes. 25 Long-term outcomes of TEVAR now include 5-year freedom from aortic-related interventions of 45–77% and survival ranging from 62 to 100%.4 This changing landscape of treatment has led an expert consensus to recommend TEVAR as the first-line treatment for complicated TBAD. Other modalities for treatment, such as fenestrations, have fallen out of favour. Interventions may be multiple; in addition to TEVAR, it may be necessary to ensure flow to the renal, visceral, iliac and left subclavian artery with stenting, fenestration or open surgical adjuncts. Complicated TBAD may also include increasing size, progression of dissection or refractory pain. Trimarchi et al. reviewed the IRAD data and found that recurrent pain or refractory hypertension appeared to be clinical features associated with increased inpatient mortality when managed medically (35.6% versus 1.5%).26 The real-world data from IRAD is encouraging. TEVAR confers a similar mortality benefit compared with medical management despite TEVAR being more suitable for the treatment of complicated TBAD.14 This led to a few TEVAR trials that were specific for acute complicated TBAD. The GORE TAG 08-01 study used the new conformable design placed in 50 patients, resulting in an 8% mortality, 18% stroke rate and 6% paraplegia rate at 30 days, and 88% survival at 1 year; there was a reduced mean false lumen area and increased true lumen diameter up to 3 years post-implantation.27 The Zenith TX2 was a ‘pathologyspecific’ graft with a combination of proximal covered stent and distal uncovered bare metal stent. It was implanted in 86 patients with acute and subacute complicated TBAD. There was stability or an increase in the true lumen size and a reduction of the false lumen in the thoracic aorta with a 30-day mortality of 4.7%, 7% stroke rate and 88.3% freedom from all-cause mortality at 1 year.28 However, the false lumen of the abdominal aorta continued to expand. The Valiant Captiva was implanted in 50 patients for acute complicated TBAD with 8% mortality, 6% stroke rate and 6% spinal ischaemia at 30 days; however, 47% of the patients had serious adverse events by 1 year. The true lumen was stable or increased in 93.1%, the false lumen was stable or decreased in 44% with partial or complete thrombosis in 91%.29 Overall, this represents the past two decades of a new alignment of treatment of stent graft treatment for complicated TBAD, with trials still ongoing. Continued efforts are needed to lower mortality and neurological complications in this catastrophic disease that would otherwise be fatal. Fenestrated/branched devices may have a role for the future. Open repair is super selective and only reserved for a minority of cases without proximal seal with rupture or impending rupture at the intimal tear in a patient who can tolerate an open procedure. Short segment proximal descending aortic replacement with left ventricular bypass would be the most appropriate procedure.

Acute Uncomplicated Type B Dissection There is mounting evidence that uncomplicated TBAD will become aneurysmal even with best medical therapy and will be responsible for up to 30% of late mortality combined with up to 66% of late aortic interventions.13,30 Controversy exists over the decision to intervene or to watch and wait. It is without question that those who develop aneurysmal disease and require intervention have a much higher mortality.

28/03/2019 22:27

Aortic The INSTEAD and Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) trials are the first and only two randomised trials for uncomplicated TBAD.15,31 The INSTEAD trial was a randomised study comparing 68 patients with optimal medical management versus 72 patients with TEVAR in addition to optimal medical management treated >14 days after onset of symptoms. This provided evidence of aortic remodelling at 2 years but without any impact on either allcause or aortic-specific mortality. Early complications included one paraplegia in both study groups, with the intervention group having one transient paraplegia and one stroke. True lumen recovery and false lumen thrombosis occurred in 91.3% of the intervention group compared with 19.4% of the optimal medical management group at 2 years.15 It was not until 2013 that data emerged to show that TEVAR with optimal medical management reduced aortic-specific mortality (6.9% versus 19.3%) and reduced disease progression (27.0% versus 46.1%) on an intention-to-treat basis.16 This study has been critiqued for not including acute TBAD and extending its inclusion criterion to early chronic phase (2–52 weeks) when it is thought the inter-membrane plasticity is lost and remodelling is less than ideal. The ADSORB trial was also randomised to similar comparative groups to include only acute, uncomplicated TBAD. It attempted to accrue 30 patients in the best medical therapy and 31 in the TEVAR plus best medical therapy group. ADSORB used 10 cm increments from the left subclavian artery to interrogate the lumens of sections of the dissection. A unique analysis dividing groups into false lumen growth versus no false lumen growth showed number of branch vessels and longer dissection lengths predicted growth of the false lumen. Additionally, TEVAR plus best medical therapy showed changes from partial to complete or patent to partial thrombosis in 90.3% compared with 31.0% in the best medical therapy group analysing the proximal 20 cm of the descending thoracic aorta.31 The trial was limited by being underpowered, there was a lack of long-term follow-up, and recruitment was restricted to 21 versus 16 (best medical versus TEVAR with best medical therapy) with a 9.6% crossover to the TEVAR group. With these trials and other encouraging data, the Food and Drug Administration first approved a thoracic device for dissection in 2013. There are now two approved devices in the US. The same year as the use of the first TEVAR was documented for use in complicated TBAD, Marui et al. suggested that patients with acute uncomplicated TBAD who show a maximum aortic diameter

ebakey ME, Henly WS, Cooley DA, et al. Surgical D management of dissecting aneurysms of the aorta. J Thorac Cardiovasc Surg 1965;49:130–49. PMID: 14261867. Daily PO, Trueblood HW, Stinson EB, et al. Management of acute aortic dissections. Ann Thorac Surg 1970;10:237–47. https://doi.org/10.1016/S0003-4975(10)65594-4; PMID: 5458238. Wheat MW Jr, Palmer RF, Bartley TD, Seelman RC. Treatment of dissecting aneurysms of the aorta without surgery. J Thorac Cardiovasc Surg 1965;50:364–73. PMID: 14346544. Fattori R, Cao P, De Rango P, et al. Interdisciplinary expert consensus document on management of type B aortic dissection. J Am Coll Cardiol 2013;61:1661–78. https://doi.org/10.1016/j.jacc.2012.11.072; PMID: 23500232. Pape LA, Awais M, Woznicki EM, et al. Presentation, diagnosis, and outcomes of acute aortic dissection: 17-year trends from the International Registry of Acute Aortic Dissection. J Am Coll Cardiol 2015;66:350–8. https://doi.org/10.1016/ j.jacc.2015.05.029; PMID: 26205591. Suzuki T, Mehta RH, Ince H, et al. Clinical profiles and outcomes of acute type B aortic dissection in the current era: lessons from the International Registry of Aortic Dissection (IRAD). Circulation 2003;108:II312–7. https://doi.org/10.1161/01. cir.0000087386.07204.09; PMID: 12970252. Hagan PG, Nienaber CA, Isselbacher EM, et al. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA 2000;283:897–903.

VER_Darling_FINAL.indd 30

10.

11.

12.

13.

14.

of ≥40 mm and a patent false lumen should undergo surgery earlier before aneurysmal enlargement occurs.32 Promising results from retrospective studies predict unique characteristics that will allow for treatment of a subset of uncomplicated TBAD that will progress to aneurysmal dilation, preventing its long-term sequelae. Grommes et al. noted that mortality in TBAD was more associated with total aortic diameter ≥41 mm and age >66 years with a 2-year cumulative survival of 68.5%, versus 95.7% for patients without these risk factors.33 Kudo et al. echoed these results, with their cohort showing aortic diameter >40 mm and ulcer-like projection from the false lumen were associated with late aortic events.34 Evangelista et al. noted that the larger the intimal tear, the greater likelihood of complications.35 Bogerijen et al. corroborated all these features, among others, after a systemic review and analysis in 2014.36 In 2016, Ray et al. carried out a retrospective review of 156 patients from a single institution with stratified analysis that suggested that an aortic diameter of >44 mm and false lumen diameter of >22 mm were both associated with a decrease in intervention-free survival. Additionally, age over 60 was a predictor of mortality.37 Schwartz et al. also carried out a retrospective review of a single centre with a larger cohort of 254 patients of whom 38% required intervention. Predictors of late aortic intervention at presentation included total aortic diameter of >40 mm, false lumen of >20 mm, entry tear of >10 mm and an increase in >5 mm between imaging studies. Thrombosis of the false lumen was deemed protective.38 These studies have put forward convincing data that best medical therapy may not be adequate in all cases and there is a role for TEVAR where the risk of procedure outweighs the risk of aortic-specific mortality.

Conclusion TBADs are a complex physiological and anatomical pathology. Early recognition, blood pressure control and appropriate interventions can minimise mortality and morbidity. Poor outcomes have driven the evolution of treatment for acute complicated TBAD, and TEVAR is now the standard of care. It is evident that there are predictors of tendency towards long-term consequences for acute uncomplicated TBAD. Continued research with randomised trials with precise and objective data to produce firm consensus guidelines is required. Nevertheless, the practice of TEVAR to allow aortic remodelling and prevent longterm sequalae will continue to be individualised in patients with uncomplicated TBAD.

https://doi.org/10.1001/jama.283.7.897; PMID: 10685714. Tsai TT, Fattori R, Trimarchi S, et al. Long-term survival in patients presenting with type B acute aortic dissection: insights from the International Registry of Acute Aortic Dissection. Circulation 2006;114:2226–31. https://doi. org/10.1161/CIRCULATIONAHA.106.622340; PMID: 17101856. Scott AJ, Bicknell CD. Contemporary management of acute type B dissection. Eur J Vasc Endovasc Surg 2016;51(3):452–9. https://doi.org/10.1016/j.ejvs.2015.10.026; PMID: 26684594. Nienaber CA, von Kodolitsch Y, Nicolas V, et al. The diagnosis of thoracic aortic dissection by noninvasive imaging procedures. N Engl J Med 1993;328:1–9. https://doi.org/10.1056/ NEJM199301073280101; PMID: 8416265. Moore AG, Eagle KA, Bruckman D, et al. Choice of computed tomography, transesophageal echocardiography, magnetic resonance imaging, and aortography in acute aortic dissection: International Registry of Acute Aortic Dissection (IRAD). Am J Cardiol 2002;89:1235–8. https://doi.org/10.1016/ S0002-9149(02)02316-0; PMID: 12008187. Crawford ES. The diagnosis and management of aortic dissection. JAMA 1990;264:2537–41. https://doi.org/10.1001/ jama.1990.03450190069031; PMID: 2232021. DeBakey ME, McCollum CH, Crawford ES, et al. Dissection and dissecting aneurysms of the aorta: twenty-year follow-up of five hundred twenty-seven patients treated surgically. Surgery 1982;92:1118–34. PMID: 7147190. Fattori R, Montgomery D, Lovato L, et al. Survival after

15.

16.

17.

18.

19.

endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv 2013;6:876–82. https://doi.org/10.1016/j.jcin.2013.05.003; PMID: 23968705. Nienaber CA, Rousseau H, Eggebrecht H, et al. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation 2009;120:2519–28. https://doi.org/10.1161/ CIRCULATIONAHA.109.886408; PMID: 19996018. Nienaber CA, Kische S, Rousseau H, et al. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv 2013;6:407–16. https://doi. org/10.1161/CIRCINTERVENTIONS.113.000463; PMID: 23922146. Sueyoshi E, Sakamoto I, Hayashi K, et al. Growth rate of aortic diameter in patients with type B aortic dissection during the chronic phase. Circulation 2004;110:II256–61. https://doi. org/10.1161/01.CIR.0000138386.48852.b6; PMID: 15364872. Tsai TT, Evangelista A, Nienaber CA, et al. Partial thrombosis of the false lumen in patients with acute type B aortic dissection. N Engl J Med 2007;357:349–59. https://doi. org/10.1056/NEJMoa063232; PMID: 17652650. Tolenaar JL, Kern JA, Jonker FH, et al. Predictors of false lumen thrombosis in type B aortic dissection treated with TEVAR. Ann Cardiothorac Surg 2014;3:255–63. doi: 10.3978/ j.issn.2225-319X.2014.05.17; PMID: 24967164.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:27

Acute Type B Dissection 20. I nvestigators VR. Mid-term outcomes and aortic remodelling after thoracic endovascular repair for acute, subacute, and chronic aortic dissection: the VIRTUE Registry. Eur J Vasc Endovasc Surg 2014;48:363–71. https://doi.org/10.1016/ j.ejvs.2014.05.007; PMID: 24952999. 21. Estrera AL, Miller CC, Safi HJ, et al. Outcomes of medical management of acute type B aortic dissection. Circulation 2006;114:I384–9. https://doi.org/10.1161/ CIRCULATIONAHA.105.001479; PMID: 16820605. 22. Dake MD, Kato N, Mitchell RS, et al. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med 1999;340:1546–52. https://doi.org/10.1056/ NEJM199905203402004; PMID: 10332016. 23. Nienaber CA, Fattori R, Lund G, et al. Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement. N Engl J Med 1999;340:1539–45. https://doi. org/10.1056/NEJM199905203402003. PMID: 10332015. 24. Moulakakis KG, Mylonas SN, Dalainas I, et al. Management of complicated and uncomplicated acute type B dissection. A systematic review and meta-analysis. Ann Cardiothorac Surg 2014;3:234–46. doi: 10.3978/j.issn.2225-319X.2014.05.08; PMID: 24967162. 25. Hnath JC, Mehta M, Taggert JB, et al. Strategies to improve spinal cord ischemia in endovascular thoracic aortic repair: Outcomes of a prospective cerebrospinal fluid drainage protocol. Journal of vascular surgery. 2008;48:836–40. https:// doi.org/10.1016/j.jvs.2008.05.073; PMID: 18723308. 26. Trimarchi S, Eagle KA, Nienaber CA, et al. Importance of refractory pain and hypertension in acute type B aortic

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Darling_FINAL.indd 31

27.

28.

29.

30.

31.

dissection: insights from the International Registry of Acute Aortic Dissection (IRAD). Circulation 2010;122:1283–9. https:// doi.org/10.1161/CIRCULATIONAHA.109.929422; PMID: 20837896. Cambria RP, Conrad MF, Matsumoto AH, et al. Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. J Vasc Surg 2015;62:271–8. https://doi.org/10.1016/j.jvs.2015.03.026; PMID: 26211376. Lombardi JV, Cambria RP, Nienaber CA, et al. Aortic remodeling after endovascular treatment of complicated type B aortic dissection with the use of a composite device design. J Vasc Surg 2014;59:1544–54. https://doi.org/10.1016/ j.jvs.2013.12.038; PMID: 24560244. Bavaria JE, Brinkman WT, Hughes GC, et al. Outcomes of thoracic endovascular aortic repair in acute type b aortic dissection: results from the Valiant United States Investigational Device Exemption Study. Ann Thorac Surg 2015;100:802–8; discussion:8–9. https://doi.org/10.1016/ j.athoracsur.2015.03.108; PMID: 26209487. Durham CA, Cambria RP, Wang LJ, et al. The natural history of medically managed acute type B aortic dissection. J Vasc Surg 2015;61:1192–8. https://doi.org/10.1016/j.jvs.2014.12.038; PMID: 25659458. Kamman AV, Brunkwall J, Verhoeven EL, et al. Predictors of aortic growth in uncomplicated type B aortic dissection from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) database. J Vasc Surg 2017;65:964–71e3. https://doi. org/10.1016/j.jvs.2016.09.033; PMID: 27876516.

32. M arui A, Mochizuki T, Mitsui N, et al. Toward the best treatment for uncomplicated patients with type B acute aortic dissection: A consideration for sound surgical indication. Circulation 1999;100:II275-80. https://doi.org/10.1161/01. CIR.100.suppl_2.II-275; PMID: 10567316. 33. Grommes J, Greiner A, Bendermacher B, et al. Risk factors for mortality and failure of conservative treatment after aortic type B dissection. J Thorac Cardiovasc Surg 2014;148:2155–60. https://doi.org/10.1016/j.jtcvs.2014.03.053; PMID: 24793648. 34. Kudo T, Mikamo A, Kurazumi H, et al. Predictors of late aortic events after Stanford type B acute aortic dissection. J Thorac Cardiovasc Surg 2014;148:98–104. https://doi.org/10.1016/ j.jtcvs.2013.07.047; PMID: 24029294. 35. Evangelista A, Galuppo V, Gruosso D, et al. Role of entry tear size in type B aortic dissection. Ann Cardiothorac Surg 2014;3:403–5. https://doi.org/10.3978/j.issn.2225319X.2014.07.03. PMID: 25133104. 36. van Bogerijen GH, Tolenaar JL, Rampoldi V, et al. Predictors of aortic growth in uncomplicated type B aortic dissection. J Vasc Surg 2014;59:1134–43. https://doi.org/10.1016/ j.jvs.2014.01.042; PMID: 24661897. 37. Ray HM, Durham CA, Ocazionez D, et al. Predictors of intervention and mortality in patients with uncomplicated acute type B aortic dissection. J Vasc Surg 2016;64:1560–8. https://doi.org/10.1016/j.jvs.2016.07.111; PMID: 27707621. 38. Schwartz SI, Durham C, Clouse WD, et al. Predictors of late aortic intervention in patients with medically treated type B aortic dissection. J Vasc Surg 2018;67:78–84. https://doi. org/10.1016/j.jvs.2017.05.128; PMID: 28912006.

28/03/2019 22:27

Aortic

Abstract Arteriography with contrast medium (CM) injection is normally employed to visualise the lowest renal artery during endovascular aneurysm repair (EVAR). Intravascular ultrasound (IVUS) has been proposed as an alternative, real-time imaging diagnostic technique to arteriography. In this study, we evaluated the feasibility of EVAR using Anaconda repositionable aortic stent graft (Vascutek) assisted by IVUS (Volcano Visions, Philips) during intraluminal navigation without CM. From January 2016 to December 2017, 25 patients with infrarenal abdominal aortic aneurysms, identified through anatomical inclusion criteria, underwent EVAR. All of the patients had an arteriogram at the end of the EVAR procedure to confirm aortic stent graft patency and to exclude type 1 endoleaks. The primary objective was the technical and clinical success of this CM-free aortic stent graft delivery procedure. At the end of the period, 150 target vessels were evaluated. IVUS versus angio-CT sensitivity and specificity rate were 97.3% and 100%, respectively. The primary technical success was obtained in 88% of the cases. Three patients (12%) needed CM injection to complete the procedure and there were no cases of type 1 endoleak. Primary clinical success was 100%. During follow-up at a mean of 20 months, none of the patients died or had complications. We conclude that a full EVAR procedure is feasible using only IVUS navigation and repositionable aortic stent graft without CM injection in anatomically selected cases.

Keywords Intravascular ultrasound, abdominal aortic aneurysm, iodinated contrast medium, endovascular aneurysm repair Disclosure: The authors have no conflicts of interest to declare. Received: 28 January 2019 Accepted: 13 February 2019 Citation: Vascular & Endovascular Review 2019;2(1):32–7. DOI: https://doi.org/10.15420/ver.2019.3.1 Correspondence: Gaetano La Barbera, Vascular Surgery Unit, Ospedale Civico Di Cristina Benfratelli, 4 Piazza N Leotta, 90127, Palermo, Italy. E: gaetano.labarbera@yahoo.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Endovascular aneurysm repair (EVAR) has been employed in nearly 70% of aneurysm treatments over the past decade because of its low invasiveness.1 During EVAR, the precise visualisation of the lowest renal artery (LoRA) and the hypogastric artery (HA) is fundamental for the correct delivery of both the aortic stent graft (ASG) body and Iliac limbs. The visualisation of the LoRA and HA are normally obtained by the injection of a contrast medium (CM), which can cause renal function impairment, acute adverse reactions and requires X-ray exposition.2 In this study, we evaluated the feasibility of EVAR using only intravascular ultrasound (IVUS) imaging navigation. Since this was a new technique, we decided to employ a repositionable ASG to ensure LoRA patency at the end of the procedure.3 IVUS has been proposed as an imaging diagnostic technique that can provide useful information during endovascular stent graft repair.4,5 Unlike traditional arteriography, IVUS provides the real-time visualisation of the vascular findings.6 However, a clear indication of what information can be obtained by IVUS during EVAR procedures is still missing.7,8

Materials and Methods From January 2016 to December 2017, 130 patients with infrarenal atherosclerotic abdominal aortic aneurysm (AAA) were treated by

Access at: www.VERjournal.com

VER_LaBarbera_FINAL.indd 32

EVAR in our tertiary vascular referral hospital. Of these, 25 patients (22 men and three women) were enrolled in a registry for a monocentric, non-randomised, open label study. The protocol was approved by the hospital’s institutional review board and every patient gave informed consent for the procedure. The patient data were gathered prospectively and analysed retrospectively. We used the Anaconda repositionable ASG (Vascutek). Intraluminal arterial navigation was assisted with IVUS using the Volcano Visions PV 0.035 catheter-based system (Philips).

Study Design We considered eligible patients with infrarenal AAA. The anatomy of the aneurysm was defined according to Eurostar classification.9 Preoperative assessment consisted of a clinical examination including the Society of Vascular Surgery/International Society of Cardiovascular Surgery risk scores and the American Society of Anaesthesiologists classification.10,11 The inclusion and exclusion criteria are listed in Table 1. Iliac axis tortuosity was considered according to the definition of Taudorf et al.12 CT angiography (CTA) was the standard preoperative imaging modality to assess for endograft sizing and aneurysm repair. All CTA sequences were processed using a 3D centre-line reconstruction by 3Surgery™ 4.0 platform (3mension Medical Imaging).

28/03/2019 22:39

Endovascular Aneurysm Repair Using Anaconda Graft Study Hypothesis The aim of this study was to evaluate the technical feasibility and clinical success according to Chaikof’s definition of EVAR.13 IVUS was used for vascular navigation and replaced intraprocedural angiography for target artery visualisation for the coeliac trunk, superior mesenteric, renal arteries and HA, as well as ASG delivery. We considered a target artery correctly visualised if, at its origin, the hyperechoic image of the aortic wall and the target artery wall were both clearly visualised, separated by the hypoechoic blood appearance at its lumen. We did not perform an arteriogram to aid positioning of the ASG except when IVUS was associated with no clear imaging of the ostium of the target arteries and at the end of the EVAR to check both the patency and the sealing of the ASG. The technical and clinical success defined as ASG delivery assisted only by IVUS were considered the primary endpoints. The technical success is represented by: the delivery of the ASG just below the inferior edge of the LoRA allowing its patency; the correct patency of the ASG with adequate distal perfusion; the patency of the HA origin after the limbs deployment; and absence of any type 1 endoleak. The clinical success was defined by the absence of adverse events and a 30-day survival rate. We considered the amount of CM and the procedure duration for each patient as secondary endpoints.

Table 1: Inclusion and Exclusion Criteria Inclusion criteria

Exclusion criteria

• • • • • •

• • • •

Aged 18–85 years Available to complete follow-up Life expectancy >2 years Candidate for open surgery AAA >50 mm in diameter Infrarenal proximal neck diameter 18–31.5 mm Infrarenal proximal neck length ≥15 mm Distal iliac fixation site diameter <16 mm Distal iliac fixation site length >30 mm Access vessel >7.5 mm in diameter

• • • • • • • •

Ruptured or symptomatic AAA Juxta-, para- or suprarenal AAA ASA grade IV or V Known allergy to CM, nitinol or polyester Impossibility to preserve at least one hypogastric artery Presence of VVAA or RRAA atherosclerotic disease Alpha angle ≥60° Beta angle ≥60° >50% continuous aortic neck calcification >50% continuous aortic neck thrombus Reverse conical infrarenal aortic neck External iliac stenosis >30%

AAA = abdominal aortic aneurysm; Alpha angle = angle between the longitudinal axis of the suprarenal aorta and the infrarenal aortic neck; ASA = American Society of Anaesthesiologists; Beta angle = angle between the longitudinal axis of the infrarenal aortic neck and the anevrismal sac; CM = contrast medium; RRAA = renal arteries; VVAA = visceral arteries.

Figure 1: Lowest Renal Artery Level Origin

Aortic Stent Graft The Anaconda ASG is a three-piece endovascular system. The stents are made of multiple-element nitinol stents internally covered with woven polyester fabric. The top of the ASG consists of a dual-ring stent that looks like an anaconda’s mouth. The configuration we used has anterior and posterior peaks and two valleys on the right and left side.3 The proximal stent is anchored in an infrarenal position by four pairs of nitinol hooks. The iliac legs are supported with independent nitinol ring stents, preventing kinks and providing flexibility for fixation in femoroiliac anatomy. The Anaconda ASG system can be repositioned by the control collar of the delivery system handle. Engagement of the contralateral gate is facilitated by a preloaded magnet wire to assist in the cannulation of the contralateral limb.

Intravascular Ultrasound The Volcano Visions PV 0.035 IVUS catheter-based system is an overthe-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. It acquires axial images of the vessel from inside the artery, providing detailed and accurate measurements of the lumen, arterial segment length, plaque area, and the location of key anatomical landmarks. There are 25 radiopaque markers on the distal end of the catheter starting 1 cm from the imaging plane. A lubricious hydrophilic coating is applied externally to the catheter.

Operative Procedure All surgeries were performed with a radiolucent table under fluoroscopic guidance. The ASG size was selected according to the AAA anatomy, with 20–30% oversizing of the prosthetic body in relation to the infrarenal neck diameter. All patients had a percutaneous procedure with local anaesthesia and intraprocedural anticoagulation. After placing a 10 Fr Avanti+® introducer (Cordis) on both sides, a stiff Lunderqvist 0.035 guidewire (Cook Medical) was advanced to the aortic arch. Then the IVUS catheter was moved over the left guidewire up to the coeliac trunk. Recording the scan, the coeliac trunk, the superior mesenteric and the renal arteries (RRAA) were identified. We then focused on the RRAA. The IVUS tip was positioned at the LoRA origin

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_LaBarbera_FINAL.indd 33

A: Clear visualisation of the left renal artery as the lowest renal artery (white arrow) on intravascular ultrasound scan. B: On X-ray, the intravascular ultrasound tip corresponds to the lowest renal artery level origin and proximal landmark of the aortic stent graft body delivery (black arrow).

and we marked this point as the proximal landmark of ASG delivery on the X-ray (Figure 1). Watching the ostium of the LoRA on the IVUS screen in real-time and the corresponding level of the IVUS tip on the X-ray screen, the ASG device was moved up from the right groin and it was then delivered, checking its position on the X-ray screen and taking care not to overcome the IVUS tip. Then we cannulated the contralateral gate of the body. Once we positioned the stiff guidewire inside the ASG body from the left groin, the IVUS catheter was advanced to check the patency of the LoRA. If IVUS did not visualise the LoRA, this meant that the ASG body covered it. In this case, the X-ray showed that the proximal ring of the ASG was over the tip mark of the IVUS catheter (Figure 2). We then collapsed the ASG body, moving it down and releasing it, to keep the LoRA origin clear. We checked with IVUS again that the LoRA was clearly visualised (Figure 3). Then we moved down the IVUS catheter until we visualised the hypogastric ostium. We marked the distal

28/03/2019 22:39

Aortic Figure 2: Proximal Aortic Stent Graft Body Delivery

Figure 3: Intravascular Ultrasound-directed Aortic Stent Graft Body Repositioning

A: Lowest renal artery (LoRA) before aortic stent graft (ASG) delivery (white arrow). B: LoRA disappearance after ASG delivery (white arrow). C: ASG collapse aimed at body repositioning (white arrow). D: LoRA reappearance after ASG repositioning (white arrow).

Figure 4: Marking the Distal Landing Zone

Image on the X-ray screen showing the proximal aortic stent graft stent overcoming the intravascular ultrasound tip (white arrow).

landing zone by placing the IVUS tip above this level (Figure 4). We then measured the length of the corresponding limb and released it using the CM-marked IVUS catheter segment. We repeated the last step for the right limb.

Follow-up Each patient underwent postoperative CTA at discharge. An abdominal instrumental follow-up was performed using CTA, duplex scan or contrast-enhanced ultrasonography (CEUS) at 6, 12 and 24 months. We registered overall survival, death as a result of aneurysmrelated treatment, open repair conversion, endoleaks, reintervention, aneurysm sac expansion or rupture, renal artery occlusion, stent-graft and arterial thrombosis, ASG integrity and migration.

Statistical Analysis The 2 × 2 table method analysis was employed to characterise the IVUS versus CTA accuracy, to clearly visualise target vessel location. Statistical significance of correlations was tested with the Pearson correlation coefficient.

Results Patient characteristics are listed in Table 2. The mean age of the participants was 74.1 years (range 58–85). We analysed 150 target

VER_LaBarbera_FINAL.indd 34

A: Intravascular ultrasound screen shows clear visualisation of the hypogastric artery origin (white arow). B: On X-ray screen, the intravascular ultrasound tip corresponds to the distal landmark of Iliac limb delivery (black arrow).

vessels. IVUS and preoperative CTA findings for the visualisation of visceral arteries (VVAA) matched in 100% of patients.

Postoperative Technical and Clinical Success In terms of RRAA visualisation, IVUS and preoperative CTA findings, matched in 84% of patients. In four patients (16%), IVUS was not able to clearly visualise the left renal artery (LRA), so we needed to use arteriography by injecting 30 ml of CM for each patient. In two cases the beta angle (the angle between the longitudinal axis of the infrarenal aortic neck and the anevrismal sac) was >40° and the LRA was the LoRA. In the other two cases, the controlateral guidewire competed with ultrasound beam; one of them had a beta angle >40° and the LRA was the LoRA. Therefore, because only three patients required CM for LoRA visualisation for ASG delivery, we obtained 88% technical success.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:39

Endovascular Aneurysm Repair Using Anaconda Graft Table 2: Patient Characteristics Demographic

Figure 5: Amount of Contrast Medium Received and Beta Angle Mean or

Range or

occurrence

percentage

100

(n=25) 74.1 years

58–94 years

Male

n=22

88%

Female

n=3

12%

n=0

n=18

72%

III

n=7

28%

Diabetes

n=2

Smoking

n=2

Hypertension

n=23

92%

Hyperlipidaemia

n=11

44%

Ischaemic cardiac disease

n=8

32%

Pulmonary disease

n=9

36%

n=22

88%

n=3

12%

Fusiform

n=23

92%

Saccular

n=2

Top

23 mm

18–30 mm

Middle

24.5 mm

20– 28 mm

Bottom

26 mm

25–29 mm

n=22

88%

n=1

n=2

n=0

20 mm

15–35 mm

≤40°

n=21

84%

>40°

n=4

16%

5.8 mm

50–75 mm

Left

12 mm

7–18 mm

Right

13 mm

7–18 mm

Length of common iliac

45 mm

30–55 mm

Pelvic artery index of tortuosity

1.4

1.1–1.5

Sex

ASA score

Risk factors

Eurostar type of AAA

Shape of AAA

Diameter infrarenal neck

Shape of neck

Length of neck Angulation of neck

Diameter of AAA Diameter of common iliac

At the end of the EVAR procedure, we always made an arteriography by injecting 15 ml of CM, confirming the patients had the correct ASG patency and no type 1 endoleak. In a single patient, one of the HA origins was not clearly visualised because of ostium calcification. We did not perform a control arteriogram on this patient. The 2 × 2 table analysis for evaluating the accuracy of IVUS to clearly visualise VVAA, RRAA, and HA showed a sensitivity of 97.3% and a specificity of 100%. The final control arteriogram confirmed the effectiveness of the ASG delivery with the correct patency of ASG, VVAA, HA and LoRA, as well as arterial outflow. The postoperative course was uneventful and all the patients were discharged. The average postoperative hospital stay was 2 days (range 1–3 days).

Contrast Medium Amount and Procedure Duration The average CM employed for the population study was 19.8 ml (range: 15–45 ml). Concerning the visualisation of the LoRA, we compared the

VER_LaBarbera_FINAL.indd 35

<40°

>40° Beta angle (°)

AAA = abdominal aortic aneurysm; ASA = American Society of Anaesthesiologists.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

CM >30 ml

Patients (%)

Age

CM <30 ml

Istogram showing the percentage of patients who received contrast medium <30 ml (blue) or contrast medium >30 ml (violet) with a beta angle <40° or >40° Patients with a more regular aortic neck angle (<40°), received significantly less contrast medium (p<0.01). CM = contrast medium.

amount of CM employed with the aortic neck angle. Three patients with a beta angle >40° received 30 ml of CM. Conversely, 21 of the 22 patients with a beta angle ≤40° received less than 30 ml of CM. Therefore the amount of CM employed was significantly correlated with the beta angle (p<0.01; Figure 5). In 68% of the patients, the ASG body was repositioned after the first delivery because the proximal ring of the ASG body competed with the LoRA. There was no type 1 endoleak, and one patient had a type 2 endoleak due to two understated lumbar arteries. The average EVAR time was 137 minutes (range 95–170 minutes, standard deviation 25.5 minutes).

Short- and Mid-term Clinical Success The follow-up range was an average of 20 months with a range of 1–24 months, during which none of the patients had died. The patient discharged with type 2 endoleak was asymptomatic, and the scheduled ultrasound controls showed a stable aneurismal diameter. During the follow-up, none of the patients had open repair conversion, new endoleaks, AAA sac expansion or rupture, renal artery occlusion, reintervention, thrombosis, loss of ASG integrity or ASG migration.

Discussion Until recently, IVUS has been used to support imaging techniques in peripheral arterial revascularisation, mostly in the coronary and carotid areas.4–8,14–18 IVUS is usually used as an ancillary intraprocedural technique during EVAR to visualise the target vessel compared with the more standard use of CM arteriography.14,19 It has not been clear whether IVUS can efficiently replace arteriography. Our study, with a mean follow-up of 20 months has proved the technical feasibility of a complete EVAR performed with Anaconda repositionable ASG and vascular navigation assisted only by IVUS. A study by Knowles et al. found that IVUS accuracy for target vessel location had a sensitivity of 100% in juxtarenal AAA for the location of both VVAA and RRAA.14 Our study focused on infrarenal AAA and we found 97.3% sensitivity and 100% specificity for VVAA and RRAA

28/03/2019 22:39

Aortic visualisation. Some authors emphasise the importance of the aortic neck angle related to the accuracy of IVUS imaging. It has been found that the placement of the IVUS probe within the lumen of an angulated aortic neck can result in an increased echogenic signal in the wall closest to the array, an attenuation of the signal on the opposite wall, and an overestimation of vessel size.6 Our 88% postoperative technical success rate suggests that the more regular the AAA anatomy, the more accurate the IVUS imaging. We found that IVUS did not visualise the LoRA in cases where the beta angle was >40°. We can conclude from this that IVUS correctly visualises the LoRA if the beta angle is not critical and if the echogenic tip is in the appropriate position for ultrasonic irradiation. As already found in previous studies, the endoluminal, centre-lined position of the IVUS is the best condition for the most accurate imaging.6,20 If the IVUS catheter tip is excessively dislocated toward one side of the aortic wall, the stiff guidewire support can be improved with a 30 cm, 9 Fr sheath advanced to the level of the left renal vein, as reported by Arko et al.21 Some studies completed EVAR without any final arteriographic information about the correct AAA exclusion. At the end of the procedure, IVUS is employed to confirm the effective ASG delivery and target artery patency, but without using repositionable ASG there is not a possibility to correct the implantation. Using this approach, Segesser et al., in a study involving 80 patients, reported a 5% rate of conversion to open surgery, a 16% rate of endoleak at the discharge and a 2.5% rate of late conversions.22 Marty et al. reported a 22% rate of major

proximal ASG anchoring. We had to reposition the ASG in 68% of patients in our study because of unclear LoRA visualisation. In all these cases it was evident on the X-ray screen that the proximal ASG stent had overcome the IVUS tip (Figure 2), indicating a competion with the LoRA. We had to reposition the ASG most frequently during the initial phases of our research, suggesting there is a learning curve with the technique that may affect success. ASG repositioning was needed when there was an upward dislocation of the IVUS tip due to its friction with the ASG device shaft during its advancement, or when there was a misalignment of the proximal edge of the ASG during its delivery. These drawbacks were successfully fixed by repositioning the ASG in a downward fashion. HA visualisation is the distal landmark. In our experience, IVUS always clearly visualised the origin of the HA, except in one patient because of arterial wall calcifications. Preoperative sizing identifies the HA origin, the calcifications, the percentage of stenosis, the haemodynamic relevance of the hypogastric blood flow and the distance between the aortic bifurcation and the HA origin necessary for measuring the length of the Iliac limb. The intraoperative positioning of the tip of the CM-marked IVUS catheter at the level of the aortic bifurcation allows the level of the HA origin to be measured. If we deliver the Iliac limb a few millimetres above this level, we can ensure that there is no competition with the HA ostium. Operator dependency is the recognised drawback of using ultrasound as a diagnostic technique.23 The same holds for IVUS imaging, with the additional caveat that this type of vascular visualisation is not commonly used by vascular surgeons.

morbidity in a 30-day follow-up period.7 Thanks to the use of a repositionable device, our procedure guaranteed the correct placement of the ASG without injection CM and none of the participants had a type 1 endoleak. Concerning the amount of CM used, Hoshina et al. and Knowles et al. always used an arteriogram to confirm the target vessel location and the effectiveness of EVAR.14,19 In these cases, IVUS imaging reduced the amount of CM injected (67 ± 34 ml versus 123 ± 50 ml; p<0.01). In our experience, the average CM employed for each patient was significantly lower (19.8 ± 9.3 ml), because in cases with favourable anatomical characteristics we used CM only for the final arteriogram after the EVAR procedure was complete. ASG body delivery is the pivotal step in EVAR, and IVUS is usually employed passively. Some authors identify the proximal landmark level by IVUS and then marked the level of IVUS tip on X-ray screen.7,14,22 Then they delivered the ASG under fluoroscopic control. Unlike our technique, they do not have the real-time visualisation of the LoRA and therefore the correct level of the IVUS tip. In our study, the synchronised use of IVUS and repositionable ASG, checks LoRA patency during ASG delivery in an ‘active’ way, ensuring correct

ani K, Lees T, Beiles B, et al. Treatment of abdominal aortic M aneurysm in nine countries 2005–2009: a vascunet report. Eur J Vasc Endovasc Surg 2011;42:598–607. https://doi.org/10.1016/ j.ejvs.2011.06.043; PMID: 21775173. Nguyen BN, Neville RF, Rahbar R, et al. Comparison of outcomes for open abdominal aortic aneurysm repair and endovascular repair in patients with chronic renal insufficiency. Ann Surg 2013;258:3949. https://doi.org/10.1097/ SLA.0b013e3182a15ada; PMID: 24022432. Rödel SGJ, Geelkerken RH, Prescott RJ, et al. The Anaconda AAA stent graft: 2-year clinical and technical results of

VER_LaBarbera_FINAL.indd 36

Our mean procedure time was 137 minutes, which is comparable to infrarenal standard EVAR, showing that using IVUS imaging does not increase the time of the procedure.24 This is a feasibility study and if these preliminary results are confirmed by other studies, IVUS technology development could improve vascular navigation by coupling better imaging with accurate haemodynamic information about the aorta and its branches.

Conclusion In this preliminary study we performed EVAR using active IVUS in real-time, allowing continuous imaging of the interactions between ASG and LoRA. We showed that CM-free, precise ASG delivery can be performed by using a repositionable ASG. We always performed a completion arteriogram at the end of the EVAR to check the patency of the ASG, excluding any type 1 endoleak and ensuring the effectiveness of the whole procedure. Our results indicate that well-defined inclusion criteria allow the best IVUS target vessel visualisation for CM-free ASG delivery. IVUS imaging is an operator-dependent technique and operator capability increased with experience. This study shows that Intravascular ultrasound technology can make EVAR a less invasive and safer procedure.

a multicentre clinical evaluation. Eur J Vasc Endovasc Surg 2009;38:732–40. https://doi.org/10.1016/j.ejvs.2009.08.007; PMID: 19775918. Ohki T. Pros and cons of IVUS imaging for endovascular procedures. Endovascular Today 2008;3:80–2. Available at: https://evtoday.com/2008/03/EVT0308_12.php (accessed 15 February 2019). Clark DJ, Lessio S, O’Donoghue M, et al. Safety and utility of intravascular ultrasound-guided carotid artery stenting. Cathet Cardiovasc Interv 2004;63:355–62. https://doi.org/10.1002/ ccd.20188; PMID: 15505835.

earce BJ, Jordan Jr WD. Using IVUS during EVAR and TEVAR: P improving patient outcomes. Semin Vasc Surg 2009;22:172–80. https://doi.org/10.1053/j.semvascsurg.2009.07.009; PMID: 19765528. Marty B, Tozzi P, Ruchat P, et al. Systematic and exclusive use of intravascular ultrasound for endovascular aneurysm repair – the Lausanne experience. Interact Cardiovasc Thoracic Surg 2005;4:275–79. https://doi.org/10.1510/icvts.2004.094193; PMID: 17670408. Phade SV, Toca MG, Kibbe MR. Techniques in endovascular aneurysm repair. Inter J Vasc Med 2011:964250. https://doi.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:39

Endovascular Aneurysm Repair Using Anaconda Graft

10.

11.

12.

13.

14.

org/10.1155/2011/964250; PMID: 22121487; PMID: 22121487. Harris PL, Buth J, Mialhe C, et al. The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair: the EUROSTAR project: EUROpean collaborators on Stent-graft Techniques for Abdominal aortic aneurysm Repair. J Endovasc Surg 1997;4:72–7. https://doi.org/10.1583/10746218(1997)004<0072:TNFCTO>2.0.CO;2; PMID: 9034923. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997;26:517–38. https://doi. org/10.1016/S0741-5214(97)70045-4; PMID: 9308598. Wolters U, Wolf T, Stutzer H, Schroder T. ASA classification and perioperative variables as predictors of postoperative outcome. Br J Anaest 1996;77:217–22. https://doi.org/10.1093/ bja/77.2.217; PMID: 8881629. Taudorf M, Jensen LP, Vogt KC, et al. Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA. Eur J Vasc Endovasc Surg 2014;48:527–33. https://doi.org/10.1016/j.ejvs.2014.04.018; PMID: 24878235. Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002;35:1048–60. https://doi.org/10.1067/mva.2002.123763; PMID: 12021727. Knowles M, Stanley GA, Baig MS, et al. Accuracy and utility of intravascular ultrasound for fenestrated endovascular

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_LaBarbera_FINAL.indd 37

15.

16.

17.

18.

19.

aortic aneurysm repair. J Vasc Surg 2013;58:1157. https://doi. org/10.1016/j.jvs.2013.07.076. Guo BL, Shi ZY, Guo DQ, et al. Effect of intravascular ultrasound-assisted thoracic endovascular aortic repair for ‘complicated’ type B aortic dissection. Chin Med J (Engl) 2015;128:2322–9. https://doi.org/10.4103/0366-6999.163386; PMID: 26315080. Kang SJ, Minitz GS. Outcomes with intravascular ultrasoundguided stent implantation: a metaanalysis of randomized trials in the era of drug-eluting stents. J Thorac Dis 2016;8: E841–3. https://doi.org/10.21037/jtd.2016.07.72; PMID: 27619165. Partovi S, Ghoshhajra BB, Walker TG. Beyond stenotic degree assessment in carotid atherosclerotic lesions: single catheter near-infrared spectroscopy and intravascular ultrasound. Int J Cardiovasc Imag 2016;32:201–3. https://doi.org/10.1007/s10554015-0729-4; PMID: 26245472. Karacsonyi J, Alaswad K, Jaffer FA, et al. Use of intravascular imaging during chronic total occlusion percutaneous coronary intervention: insights from a contemporary multicenter registry. J Am Heart Assoc 2016;5:e003890 https://doi.org/10.1161/JAHA.116.003890; PMID: 27543800. Hoshina K, Kato M, Miyahara T, et al. A retrospective study of intravascular ultrasound use in patients undergoing endovascular aneurysm repair: its usefulness and a description

20.

21.

22.

23.

24.

of the procedure. Eur J Vasc Endovasc Surg 2010;40:559–63. https://doi.org/10.1016/j.ejvs.2010.07.018; PMID: 20739201. Geselschap JH, Heilbron MJ, Hussain FM, et al. The effect of angulation on intravascular ultrasound imaging observed in vascular phantoms. J Endovasc Surg 1998;5:126–33. https://doi. org/10.1583/1074-6218(1998)005<0126:TEOAOI>2.0.CO;2; PMID: 9633956. Arko FR, Murphy EH, Davis CM 3rd, et al. Dynamic geometry and wall thickness of the aortic neck of abdominal aortic aneurysms with intravascular ultrasonography. J Vasc Surg 2007;46:891–7. https://doi.org/10.1016/j.jvs.2007.06.030; PMID: 17980275. Segesser LK, Marty B, Ruchat P, et al. Routine use of intravascular ultrasound for endovascular aneurysm repair: angiography is not necessary. Eur J Vasc Endovasc Surg 2002;23:537–42. https://doi.org/10.1053/ejvs.2002.1657; PMID: 12093071. Mansour A. Physician qualification in the clinical diagnostic vascular laboratory. In: AbuRhama AF, Bandick DF (eds). Noninvasive Vascular Diagnosis: A Practical Guide to the Therapy. New York: Springer, 2013;11–5. Lee CH, Chang CJ, Huang JK, Yang TF. Clinical outcomes of infrarenal abdominal aortic aneurysm that underwent endovascular repair in a district general hospital. J Thorac Dis 2016;8:1571–6. https://doi.org/10.21037/jtd.2016.06.30; PMID: 27499945.

28/03/2019 22:39

Aortic

The Fate of the Superior Mesenteric Artery in Fenestrated Endovascular Repair of Complex Abdominal Aortic Aneurysms Yongcheng Xu 1 and Yukun Li 2 1. Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai, China; 2. Heilongjiang University of Chinese Medicine First Affiliated Hospital, Harbin, China

Abstract Issues related to the superior mesenteric artery (SMA) in fenestrated endovascular aortic aneurysm repair (f-EVAR), such as misalignment of the endograft and bridging devices-associated complications, are rarely reported. Moreover, the absence of autopsies in the majority of patients who died in the published series makes a possible correlation with occlusion of the SMA unknown. Current studies that reported on f-EVAR were reviewed accordingly, aiming to improve our understanding of the natural course of the SMA in fenestrated technology and to explore the associated clinical complications.

Keywords Fenestrated endografting, superior mesenteric artery, aortic aneurysm, endovascular aneurysm repair, juxtarenal aortic aneurysm. Disclosure: The authors have no conflicts of interest to declare. Received: 20 January 2019 Accepted: 13 February 2019 Citation: Vascular & Endovascular Review 2019;2(1):38–9. DOI: https://doi.org/10.15420/ver.2019.1.1 Correspondence: Yukun Li, 51, an den Loddenbueschen, Muenster 48155, Germany. E: liyukun888@gmail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Since its introduction in 1996, fenestrated endovascular aortic aneurysm repair (f-EVAR) has made the endovascular treatment of pararenal aortic aneurysms possible. The devices are individually customised to the patient’s vascular anatomy, and especially to the morphology of the visceral vessels. In the typical fenestrated endovascular device design, the superior mesenteric artery (SMA) is involved, either having a large non-strut fenestration or a single-wide scallop (10 mm in diameter). According to the instructions for use, stenting for vessels accommodated by a scallop is optional and not recommended for large fenestrations. Involvement of the SMA improves the fixation and sealing zone of the fenestrated endograft; however, any deterioration of its perfusion can be associated with life-threatening complications. Despite the existence of a plethora of reports on f-EVAR, limited information is available about the outcome of the SMA with this therapeutic approach. The aim of this article was to carry out a review analysis to improve our understanding of the natural course of the SMA in fenestrated technology, and to explore the associated clinical complications.

Methods The MEDLINE, EMBASE and Cochrane databases were searched to identify all studies published in English between January 1996 and May 2017 that reported on f-EVAR. The included review studies reported on SMA-related events.

Results The research revealed two pathological mechanisms that seem to be related to the deterioration of the perfusion of the SMA. One of the

Access at: www.VERjournal.com

VER_Li_FINAL.indd 38

mechanisms is associated with the fenestrated endograft, and the other mechanism with the bridging devices that were used. Lala et al. reported the phenomenon of misalignment of the SMA scallop.1 In the case of demanding anatomical conditions, such as angulations of the iliac arteries or the neck, the scallop of the SMA can partially cover the orifice of the vessel. Nine of 21 patients (43%) of that group had some degree of misalignment of the SMA (range 9–71%). Among those patients, four (44%) developed complications, such as three high-grade SMA stenoses, and one occlusion. Overall, patients with unstented SMAs had significantly more adverse events directly attributable to SMA misalignment than the stented group (44% versus 5%, respectively; p<0.05). The median follow-up period for this group of patients was 7.7 months. The next issue, which was observed in relation to the SMA, implies different modes of failure of the bridging device used. Mastracci et al. suggested three different modes of failure.3 Two of the modes of failure relate to the branch–main body or branch–branch interface, which can be inadequate, and the third described pattern relates to material fatigue in the branch stent graft. The consequence is SMA stent graft occlusion. Mastracci et al. also demonstrated the cause for reintervention with SMA stents was stenosis or thrombosis of the bridging device in 50% of the overall occluded bridging devices.3 Three of these patients died.

Discussion Profound evaluation and reporting of the current literature on the fate of the patency of the SMA in f-EVAR is lacking. This issue is relevant due to the inevitable forces over time in the deployment of fenestrated bridging devices. These conditions can lead to separation, fracture

02/04/2019 20:48

Superior Mesenteric Artery in Fenestrated Endovascular Repair and occlusion of the bridging devices. These events can be accurately detected by CT angiography, but the majority of the patients treated by F-EVAR underwent duplex ultrasound.2 In the case of fenestrated endografting, the SMA is always involved either as a scallop or as triple fenestration and stenting. This article shows for the first time the published experience of SMA outcomes in f-EVAR in the literature. There are two major complications that are mainly reported: SMA occlusions and SMA coverage due to misalignment of the fenestrations, respectively. Even if the patency rate in the SMA deployed bridging devices is high, any relevant stenosis or occlusion of the SMA stent/stent graft is associated with life-threatening complications. Often the stenosis and intimal hyperplasia are located at the distal edge of the device in the transition to the vessel, and this makes the detection of lesions more demanding. The reported occlusion rate is low if we consider that a dedicated bridging device for this technology is still not available. Issues, such as the performance of the devices after flaring with the balloons and the pullout forces, still remain and have not been evaluated, making the high percentage of almost 95% patency incongruous. One possible explanation may be the poor quality of the radiological follow-up and the inappropriateness of duplex ultrasound for pararenal aortic aneurysms treated by f-EVAR. Mastracci et al. demonstrated reintervention for SMA stents in 26 patients, with half involving stenosis or thrombosis.3 Three of these patients died. Consequently, routine stenting with bridging devices not dedicated to this indication is not without risk. The next limitation is the fact that there is a plethora of different types of bridging devices available. These devices have different designs, and all of them attempt to address the features required for use in visceral vessels. These characteristics include advanced trackability, high radial force and adaption in angulated visceral

L ala S, Knowles M, Timaran D, et al. Superior mesenteric artery outcomes after fenestrated endovascular aortic aneurysm repair. J Vasc Surg 2016;64:692–7. https://doi. org/10.1016/j.jvs.2016.02.031; PMID: 27288103.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Li_FINAL.indd 39

vessels. The plethora of existing devices can also lead to different types of complications based on their design and characteristics. For example, single-layer coverage of the bare metal stent with expanded polytetrafluoroethylene can lead to separation of the expanded polytetrafluoroethylene with the creation of endoleaks, which requires reintervention and lining with additional placement of covered stents. The use of stainless steel devices can provide high radial force; however, the distal edge can provoke a stenosis in angulated visceral vessels due to its rigidity. Other devices with increased flexibility due to their design (cobalt chromium) can have poorer radial force, showing that the existing body of stent/stent grafts does not cover all needs for this indication for use. Lala et al. highlighted the phenomenon of SMA misalignment in up to half of the patients treated with stent-free SMA.1 This condition represents the critical threshold required to produce symptoms and mesenteric life-threatening complications. Moreover, the observed cases that occurred at 6 or 12 months indicated that there are dynamic changes of the graft over time that potentiate the misalignment. This makes the need for CT follow-up evaluation mandatory, and shows the significant limitation in the published literature in this context as, for example, one of the largest series published by Grimme et al. reported only 52% of patients had a 1-year CT follow-up, and 11% of patients had a 4-year CT follow-up.2 In summary, the reported SMA patency rates are high. In contrast, profound evaluation of the SMA outcomes in the fenestrated technology is lacking. There is very scant information about issues, such as misalignment of the device in the SMA and radiological CT angiography-based evidence about the SMA bridging device in order to exclude the failure modes, as reported by Mastracci et al.3 Issues, such as fractures or kinking of the SMA devices, are underreported in the literature, highlighting the need for a dedicated bridging device for this indication, which is still lacking.

rimme FA, Zeebregts CJ, Verhoeven EL, et al. Visceral G stent patency in fenestated stent grafting for abdominal aortic aneurysm. J Vasc Surg 2014;59:298–306. https://doi. org/10.1016/j.jvs.2013.08.005; PMID: 24080136.

astracci T, Eagleton MJ, Kuramochi Y, et al. Twelve-year M results of fenestrated endovascular repair for juxtarenal and thoracoabdominal aneurysms. J Vasc Surg 2015;61:355–64. https://doi.org/10.1016/j.jvs.2014.09.068; PMID: 25619574.

02/04/2019 20:48

Carotid

Carotid Artery Stenosis Edward Y Woo and Joshua Dearing Medstar Washington Hopsital Center, Washington DC, US

Abstract Stroke is one of the leading causes of death in the world and carotid artery stenosis is a major cause of ischaemic strokes. Symptomatic patients are often treated with either carotid endarterectomy (CEA) or carotid artery stenting (CAS). Asymptomatic patients can be treated with best medical therapy, CEA or CAS. While guidelines exist for the management of carotid artery stenosis, the results of recent studies are controversial regarding the safety of CAS compared with CEA. This review aims to outline the current guidelines while reviewing up-todate studies and analyses. Future studies and emerging technologies are outlined in an attempt to provide an evaluation of the current data and management of this complex problem.

Keywords Carotid artery stenosis, carotid endarterectomy, carotid artery stenting, guidelines, review Disclosure: The authors have no conflicts of interest to declare. Received: 3 October 2018 Accepted: 15 January 2019 Citation: Vascular & Endovascular Review 2019;2(1):40–4. DOI: https://doi.org/10.15420/ver.2018.14.2 Correspondence: Joshua Dearing, Medstar Washington Hopsital Center, 106 Irving Street Northwest, Physician Office Building North Tower, Suite 3150 Washington, DC 20010, US. E: Joshua.A.Dearing@medstar.net Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Even with advancements in risk factor modification and improvements in care, stroke is the fifth leading cause of death in the US. Cerebrovascular disease kills 140,000 Americans each year, 795,000 people have a stroke each year and 87% of these strokes are ischaemic.1 The incidence of stroke in Europe varies from 101.1 per 100,000 to 239.3 per 100,000, with a higher incidence in eastern Europe and a lower incidence in southern Europe.2 About 1.4 million strokes occur each year in Europe, in a population of about 715 million. In Europe, stroke is the second leading cause of death after heart disease, causing 1.1 million deaths each year.3 Stroke incidence increases with age; the median age for stroke is 73 in Europe and 69 in the US. As the population continues to age, it is likely that stroke will become an issue vascular surgeons and specialists will need to address with increased frequency.

reduce the risk of stroke in both the surgical and medical arms.6 Evidence suggests the greatest benefit when LDL is aggressively lowered to 1.81 mmol/l or a greater than 50% reduction using highdose statins.5 Smoking worsens all vascular disease and carotid artery disease is no different; even passive exposure to smoking can increase a person’s risk of stroke risk.7 Aspirin is recommended as antiplatelet therapy for all patients with carotid stenosis. Dual antiplatelet therapy has been shown to decrease the risk of recurrent stroke and should be considered in symptomatic patients.8 It has not been shown to increase the risk of moderate to severe bleeding, nor does it increase the risk of bleeding in patients undergoing carotid endarterectomy (CEA).9

Imaging Risk Factors There are a handful of risk factors for developing significant carotid artery disease: hypertension, diabetes, hyperlipidaemia and smoking. The Society for Vascular Surgery in the US and the European Society for Vascular Surgery recommend treating these risk factors medically and urge smoking cessation.4,5 Hypertension is an independent risk factor for stroke and it is compounded in the presence of diabetes. Recommendations are for long-term control of blood pressure with goals below 140/90 mmHg. Diabetes does lead to vessel wall changes, but strict glycaemic control has not shown to reduce the risk of stroke. However, it has been shown to reduce the risk of cardiovascular death, and so in patients with carotid artery disease, it remains a Grade 1C recommendation for people with diabetes who have a high-risk of coronary artery disease. In the Asymptomatic Carotid Surgery Trial (ACST), lipid-lowering therapy was shown to

Access at: www.VERjournal.com

VER_Dearing_FINAL.indd 40

Carotid duplex remains the first-line imaging modality for identifying the presence and severity of carotid disease. As a low-cost, noninvasive test, it is easily accessible to most patients and physicians. Doppler flow velocities remain the mainstay for defining the extent of carotid artery stenosis. Using criteria established in the North American Symptomatic Carotid Endarterectomy Trial (NASCET), a peak systolic velocity (PSV) of ≥125 cm/s corresponds to a ≥50% stenosis and a PSV of ≥230 cm/s corresponds to a ≥70% stenosis.10 These measurements have been verified in subsequent studies and are used by both the Society for Vascular Surgery and European Society of Vascular Surgery. Comparing internal carotid artery/common carotid artery diameter ratios and elevated end diastolic velocities allows providers to stratify 70-–79% and 80–89% stenoses but do little to aid in the sensitivity or specificity of detecting ≥50% and ≥70% stenosis.11

28/03/2019 22:49

Carotid Artery Stenosis Table 1: Comparison of Meta-analyses and Studies on the use of CEA and CAS Name

Type

Paraskevas et al. 201619 Database review

No of Studies/ Patients

Periprocedural Results

Long-term Results

21/1,500,000

Significantly higher risk of S/D with CAS

Not included

Meta-analysis

8/7091

Higher risk of S/D for CAS

Risk of S/D was higher at 2–10 years with CAS

Zhang et al. 201521

Meta-analysis

35/27,525

Higher risk of S/D for CAS

Significantly higher risk for CAS at 4 years and 10 years, but equal with CEA at 1 year

Lokuge et al. 201822

Meta-analysis

51/223,313

Higher risk of stroke with CAS

After 2005, risk of stroke decreased with CEA but not CAS

Kakkos et al. 201723

Meta-analysis

9/3,709

Higher risk of S/D with CAS, higher risk of MI with CEA

Not included

Moresoli et al. 201724

Meta-analysis

5/3,019

Higher risk of S/D with CAS

Risks the same in long term (>3 years)

Hicks et al. 2018

Database review

53,337

Higher risk of S/D with CAS

Increased risk at 2 years with CAS no matter the degree of stenosis

Vincent et al. 2015

CAS = carotid artery stenting; CEA = carotid endarterectomy; S/D = stroke/death.

Computed tomography angiography (CTA) and magnetic resonance arteriography (MRA) can provide adjunctive information about plaque morphology and extra information obtained from carotid duplex. MRA is prone to overestimating the degree of carotid artery stenosis but does not require ionising radiation. This can make it difficult to use MRA results to determine whether a carotid stenosis is moderate or severe.12 It can provide information regarding plaque morphology such as the presence of a lipid-rich necrotic core and a fibrous capsule with high sensitivity and specificity.13 CTA does not fall prey to the same overestimation as MRA and can provide information about the characteristics and extent of the carotid plaque. It is less capable of elucidating the composition of the plaque, save for its detection of calcifications in the plaque and arteries. Both allow imaging of the aortic arch and common carotid arteries. Carotid angiography uses contrast agents and carries the risk of stroke. As the most invasive testing method for carotid artery stenting (CAS), it is used the least. Current guidelines suggest only using it when other imaging modalities produce conflicting degrees of stenosis within the carotid artery. It may also be an appropriate imaging choice in patients with renal insufficiency, obesity or ferromagnetic devices precluding MRA or CTA.

Randomised Trials of Carotid Endarterectomy Versus Carotid Artery Stenting Early studies were mixed in their procedural protocols and enrolment. The Endarectomy versus Angioplasty in patients with symptomatic severe carotid stenosis trial (EVA-3S) was a French trial in 527 patients.14 This study was terminated early because of an increased rate of death and stroke in the stenting arm, which tracked to 5-year follow-up but not to 10 years.14 The Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial was a randomised trial that favoured CEA over CAS.15 It was terminated early secondary to enrolment issues. In the International Carotid Stenting Study (ICSS), 1,713 symptomatic patients with stenosis >50% were randomised between the two modalities.16 The 120-day incidence of stroke, MI or death was higher in the stenting group with the risks becoming similar at 5 years.16 Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) randomised 334 high-risk patients to CAS with embolic protection device (EPD) versus CEA. The study’s short-term results favoured CAS, while long-term results showed no difference between the two modalities.17

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Dearing_FINAL.indd 41

All the trials except SAPPHIRE found CAS to be inferior, with higher rates of stroke and/or death when compared with CEA. Despite this, conclusions on the inferiority of CAS could not be drawn. Protocols among the studies were not uniform. Dual antiplatelet therapy, which is now standard treatment for CAS, was not mandated in EVA-3S or ICSS.14,16 Proximal occlusion or EPDs are also now standard treatment, but EPDs were not required in any of the studies.18 The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) was responsible for demonstrating the necessity of these while following specific protocols during CAS.18 CREST was a large, multicentre study that initially randomised symptomatic patients, but then included asymptomatic patients, to either CAS or CEA. It mandated stricter and more uniform procedural protocols (such as using an EPD) and closely trained and monitored clinicians involved in the trial. It found that while periprocedural stroke was higher with CAS, periprocedural MI was higher with CEA. It also found no difference in the rates of their primary endpoint and declared that CAS was not inferior to CEA. While this study has been criticised since its completion, the results have been used to construct guidelines recommending CAS even in asymptomatic patients.18

Meta-analyses of Randomised Controlled Trials and Reviews of Carotid Stenosis Data Since the publication of the CREST results and the increased use of CAS in symptomatic and asymptomatic patients, more randomised trials and comparison studies have been performed. Meta-analyses of these studies have shown the superiority of CEA in the short term, especially in the periprocedural period. CAS is associated with higher rates of stroke and death within 30 days while CEA showed only higher rates of MI and cranial nerve injury in the periprocedural period. However, when the long-term data (more than 2 years) from these studies is compared, some studies show the two treatment modalities appear to have similar outcomes when looking at stroke and death rates.19–24 Some newer data show a persistent higher rate of adverse events in CAS compared with CEA in asymptomatic patients when comparing these events in both a severe stenosis group (60–79%) and a very severe stenosis group (≥80%).25 A more recent meta-analysis shows that, despite heterogeneity of the studies, there has been a decrease in rates of complications from CEA over time.22 Since 2005, there has been a fall in rates of periprocedural complications from CEA while the rates of death and stroke from CAS remain largely unchanged. This has been seen in

28/03/2019 22:49

Carotid both symptomatic patients undergoing CEA (a decrease from 5.11% to 2.68% after 2005) and asymptomatic patients (3.17% to 1.50% after 2005).22 Readmission rates have found to be lower in those patients undergoing CAS; however, when those patients are readmitted, they can have stent complications that lead to stroke and death.26 Table 1 shows a comparison of the meta-analyses and data studies.

Current Trials of Asymptomatic Carotid Artery Stenosis Given the lack of conclusive data on the use of CAS in asymptomatic patients, and given the advancements in both medical therapies and endovascular technologies, the debate over the use of CAS continues. Multiple trials are currently recruiting to determine the value of carotid revascularisation in the era of new medical therapies, as well as elucidating the updated risks of stroke and death with each method. ACST-2 is an ongoing trial that plans to enrol 5,000 patients with asymptomatic carotid artery stenosis and randomise them to CAS and CEA. It has enrolled more than 2,000 patients and plans to release results in 2021. Early results show only a 1% rate of stroke, MI and death in all participants at 1 month.27,28 SPACE-2 began in 2008 as a three-arm trial randomising patients to BMT, CAS + BMT or CEA + BMT.29 In 2013, the trial was divided into two parallel trials of CEA + BMT versus BMT, and CAS + BMT versus BMT after initial enrolment goals were not met. It was halted after enrolling 513 patients over 5 years. It found no incidence of stroke or death in the BMT group at 30 days though this was the smallest group with the least significant stenoses. As a result, it is hard to fully interpret this study and apply it to current treatment guidelines. The rate of stroke in those undergoing CEA was 1.97% and 2.54% in those undergoing CAS.29 CREST-2 is a multicentre, randomised trial designed as two parallel trials. In one, BMT is being compared with CEA + BMT. In the other, BMT is being compared with CAS + BMT. The study began in 2014 and recruited asymptomatic patients. It plans to look at the incidence of stroke and death at 44 days post procedure with a 4-year follow-up. The goal is to enrol 2,480 patients with plans to release data in 2020. Interim results have not been released.30 European Carotid Surgery Trial-2 (ECST-2) is a large, randomised trial that plans to look at symptomatic and asymptomatic carotid artery stenosis >50% in patients with a 5-year risk of stroke <15%. It will randomise patients to optimal medical therapy (OMT) versus CEA + OMT and CAS versus OMT. In this, OMT is BMT with the addition of antiplatelet or anticoagulation. The trial began in 2012 with a goal to enrol 2,000 patients. As of May 2017, only 247 patients had been enrolled.31

Future Technologies Silk Road Medical has designed a device for transcarotid artery revascularisation (TCAR) – the Enroute Neuroprotection and Stent System. The device uses the pressure gradient between the carotid circulation and the femoral vein to reverse the flow of blood during carotid artery stenting. Stenting and balloon angioplasty of the carotid artery stenosis is performed during reversal of blood flow. This reversal of flow is to prevent any distal embolisation while a filter catches any particulates before returning the blood to the venous circulation. Direct access to the common carotid artery is required via a cutdown while the venous aspect is placed percutaneously. Direct access to the

VER_Dearing_FINAL.indd 42

common carotid artery avoids any potential embolic events from aortic arch manipulation. A prospective, multicentre trial of the device named the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) trial had a 99% technical success rate with a 1.4% stroke rate.32 Stroke and death cumulative rates were 2.8% and there were no cranial nerve injuries. This initial study looked at 141 patients and a study is currently enrolling to examine results of the Enroute system in 1,000 patients.32 In the US in 2016, the Food and Drug Administration and the Centers for Medicare and Medicaid Services created the TCAR Surveillance Project to follow patients undergoing TCAR at hospitals participating in the Vascular Quality Initiative. The project includes information about the patient’s disease, the procedure and 1-year follow-up. A recent retrospective cohort analysed and compared 638 TCAR cases to 10,136 transfemoral carotid artery stenting (TFCAS) cases.33 In-hospital mortality was no different between the two groups, but in-hospital transient ischaemic attack (TIA)/stroke and the composite endpoint of TIA/stroke/death was higher in the TFCAS group compared with the TCAR group (3.3% versus 1.9% and 3.8% versus 2.2%, respectively). After multivariate comparison, the odds ratio for both in-hospital neurologic event and TIA/stroke/death in follow-up was 2.10 (95% CI [1.08–4.08]; p=0.3) in the TFCAS group regardless of whether the patient had symptomatic or asymptomatic disease. These preliminary findings in a real-world setting help reinforce the safety of TCAR. The completion of this study will help to further identify the role of this new technology.

Current Guidelines The Society for Vascular Surgery’s guidelines for management of carotid disease was updated in 2011 and recommends the following.4 CEA should be the first-line treatment for most symptomatic patients with stenosis of 50–99% and asymptomatic patients with stenosis of 60–99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. Patients should also have a life expectancy of 3–5 years. CAS should be reserved for symptomatic patients with stenosis of 50–99% at high risk for CEA for anatomic or medical reasons. These risks include uncorrectable and severe chronic obstructive pulmonary disease, congestive heart failure and/or uncorrectable coronary artery disease. Anatomic limitations include previous ipsilateral operation, tracheal stoma, external beam radiation to the area resulting in fibrosis or lesions proximal to the clavicle or beyond the vertebral body of C2. CAS is not recommended for asymptomatic patients. While CREST demonstrates the equivalence of CAS in properly selected patients in the hands of experienced interventionalists, the widespread use of CAS in asymptomatic patients is not supported at this time. Asymptomatic patients at high risk for intervention or with <3 years life expectancy should be considered for medical management as the first-line therapy.4 The European Society for Vascular Surgery updated its guidelines for carotid artery disease in 2017 and recommends the following.5 CEA should be considered in patients reporting carotid territory symptoms within the preceding 6 months and who have a 50–69%

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:49

Carotid Artery Stenosis Table 2: Risk Factors to Consider When Choosing Procedures High Risk for CEA

High Risk for CAS

Surgical Anatomy

Comorbidities

Vessel Anatomy

Plaque Characteristics

Previous CEA or neck surgery Presence of tracheostomy Previous radiation Contralateral occlusion Laryngeal nerve palsy Lesion extending above C2 vertebra

Severe CHF Severe CAD Severe pulmonary disease Renal Failure

Type II or III aortic arch Aortic arch disease Tortuosity of ICA or CCA Occlusive disease of access vessels

Lipid rich plaque Intraplaque haemorrhage Calcified plaque Thin fibrous cap Lesion located at a curve Extensive plaque

CAD = coronary artery disease; CAS = carotid artery stenting; CCA = common carotid artery; CEA = carotid endarterectomy; CHF = coronary heart failure; ICA = internal carotid artery.

carotid stenosis, provided the documented procedural death/stroke rate is <6%. In patients with average surgical risk and an asymptomatic 60–99% stenosis, CEA should be considered in the presence of one or more imaging characteristics that may be associated with an increased risk of late ipsilateral stroke, provided documented perioperative stroke/ death rates are <3% and the patient’s life expectancy exceeds 5 years. In average surgical risk patients with an asymptomatic 60–99% stenosis in the presence of one or more imaging characteristics that may be associated with an increased risk of late ipsilateral stroke, a CAS may be an alternative to CEA, provided documented perioperative stroke/ death rates are <3% and the patient’s life expectancy exceeds 5 years. CAS may be considered in selected asymptomatic patients who have been deemed by the multidisciplinary team to be high risk for surgery and who have an asymptomatic 60–99% stenosis in the presence of one or more imaging characteristics that may be associated with an increased risk of late ipsilateral stroke, and provided documented procedural risks are <3% and the patient’s life expectancy exceeds 5 years. Those criteria include silent infarction on CT, stenosis progression, large plaque area, plaque echolucency, intraplaque haemorrhage on MRI, spontaneous embolisation on transcranial Doppler and history of contralateral TIA.5

less of a high-risk factor for CEA, suggesting that care for this group has improved.34 Renal failure with a estimated glomerular filtration rate <60 puts patients at risk of MI after CEA, even in recent data.35 Soft plaque and intraplaque haemorrhage have been shown to increase the risk of stroke during CAS. Early studies suggest that MRI analysis of the plaque before the intervention can allow better stratification of stroke risk during CAS.36,37 This knowledge can be used to be better stratify patients for the proper intervention. For asymptomatic carotid stenosis, current evidence would suggest that CEA is preferable to CAS. While the advent of statins has improved the effect of BMT on asymptomatic carotid artery stenosis, the risk of stroke during observation of high-grade stenoses is still significant.38,39 There are also high-risk features for asymptomatic carotid artery stenosis that place patients at higher risk of having a stroke. These include progression of stenosis, unfavourable plaque appearance on ultrasound, silent infarcts on CT and reduced cerebrovascular reserve. Using these characteristics to stratify patients’ risk may further improve results of CEA.40,41 At present, CEA appears safer than CAS in the periprocedural period for asymptomatic carotid artery stenosis while results appear similar in the long term. Given the advent of new technologies and the lack of uniformity of previous studies, this difference in risk associated with each procedure may change.

Conclusion Deciding on a Treatment Modality When evaluating a symptomatic patient, the route to determining the appropriate treatment is more straightforward. As long as the patient has an acceptable life expectancy, their anatomic and medical considerations are evaluated to decide whether a CEA or a CAS is the best option for the patient using previous guidelines. Each approach has specific circumstances where a complication is more likely to occur (Table 2). For CEA, the two main considerations are medical comorbidities and vessel anatomy, while plaque morphology and vessel anatomy play the largest roles for CAS. Earlier studies showed that age and renal failure placed the patient at higher risk of having complications after CEA. Recent studies, while small, show that age is

3. 4.

enters for Disease Control and Prevention. Stroke Facts. C 2017. Available at: www.cdc.gov/stroke/facts.htm (accessed 19 January 2019). Shah R, Wilkins E, Nichols M, et al. Epidemiology report: trends in sex-specific cerebrovascular disease mortality in Europe based on WHO mortality. Eur Heart J 2018 https://doi. org/10.1093/eurheartj/ehy378; PMID: 30124820; epub ahead of press. World Health Organization. The World Health Report 2002 – Reducing Risks, Promoting Healthy Life. Geneva: WHO, 2002. Ricotta JJ, Aburahma A, Ascher E, et al. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg 2011;54:832–6. https://doi. org/10.1016/j.jvs.2011.07.004; PMID: 21889705.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Dearing_FINAL.indd 43

Even with advancements in medical therapies and technologies, the management of carotid artery stenosis remains complicated. The optimal management for many patients is still not clear. It is likely that the focus will be on patient-specific therapies in the future. Current evidence advocates CEA for both symptomatic and asymptomatic carotid artery stenosis given the low incidence of periprocedural issues while CAS has a narrower range of indications. Ongoing studies have the potential to better clarify the risks associated with BMT, CEA and CAS while aiding the creation of new guidelines for the treatment of carotid artery stenosis. Despite the many published studies, more information is still needed regarding the best way to approach this complex problem.

aylor AR, Ricco JB, de Borst GJ, et al. Editor’s choice – N management of atherosclerotic carotid and vertebral artery disease: 2017 clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2018;55:3–81. https://doi.org/10.1016/j.ejvs.2017.06.021; PMID: 28851594. Halliday A, Harrison M, Hayter E, et al 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet 2010;376:1074–84. https://doi.org/10.1016/S01406736(10)61197-X; PMID: 20870099. You RX, Thrift AG, McNeil JJ, et al. Ischemic stroke risk and passive exposure to spouses’ cigarette smoking. Melbourne Stroke Risk Factor Study (MERFS) Group. Am J Public Health

1999;89:572–5. https://doi.org/10.2105/AJPH.89.4.572; PMID: 10191806. 8. Jing J, Meng X, Zhao X, et al. Dual antiplatelet therapy in transient ischemic attack and minor stroke with different infarction patterns subgroup analysis of the CHANCE randomized clinical trial. JAMA Neurol 2018;75:711–9. https:// doi:10.1001/jamaneurol.2018.0247; PMID: 29582084. 9. Illuminati G, Schneider F, Pizzardi G, et al. Dual antiplatelet therapy does not increase the risk of bleeding after carotid endarterectomy: results of a prospective study. Ann Vasc Surg 2017;40:39–43. https://doi.org/10.1016/j.avsg.2016.09.012; PMID: 28161565. 10. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy

28/03/2019 22:49

Carotid

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

in symptomatic patients high with grade stenosis. N Engl J Med 1991;325:445–53. https://doi.org/10.1056/ NEJM199108153250701; PMID: 1852179. AbuRahma AF, Srivastava M, Stone PA, et al. Critical appraisal of the carotid duplex consensus criteria in the diagnosis of carotid artery stenosis. J Vasc Surg 2011;53:53–60. https://doi. org/10.1016/j.jvs.2010.07.045; PMID: 20951536. Nederkoom PJ, van der Graaf Y, Hunink, MG. Duplex ultrasound and magnetic resonance angiography compared with digital subtraction angiography in carotid artery stenosis: a systematic review. Stroke 2003;34:1324–32. https://doi. org/10.1161/01.STR.0000068367.08991.A2; PMID: 12690221. Yuan C, Mitsumori LM, Ferguson MS, et al. In vivo accuracy of multispectral magnetic resonance imaging for identifying lipid-rich necrotic cores and intraplaque hemorrhage in advanced human carotid plaques. Circulation 2001;104:2051–6 https://doi.org/10.1161/hc4201.097839; PMID: 11673345. Mas JL, Trinquart L, Leys D, et al. Endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol 2008;7:885–92. https://doi.org/10.1016/S1474-4422(08)70195-9; PMID: 18774745. SPACE Collaborative Group, Ringleb PA, Allenberg J, et al. 30 day results from the SPACE trial of stentprotected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet 2006;368:1239–47. https://doi.org/10.1016/S01406736(06)69122-8; PMID: 17027729. International Carotid Stenting Study Investigators, Ederle J, Dobson J, et al. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010;375: 985–97. https://doi.org/10.1016/S0140-6736(10)60239-5; PMID: 20189239. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotidartery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493–1501. https://doi.org/10.1056/ NEJMoa040127; PMID: 15470212. Silver FL, Mackey A, Clark WM, et al. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Stroke 2011;42:675–680. https://doi.org/10.1161/ STROKEAHA.110.610212; PMID:21307169. Paraskevas KI, Kalmykov EL, Naylor AR. Stroke/death rates following carotid artery stenting and carotid endarterectomy in contemporary administrative dataset registries: a systematic review. Eur J Vasc Endovasc Surg 2016;51:3–12. https://doi.org/10.1016/j.ejvs.2015.07.032; PMID: 26346006. Vincent S, Eberg M, Eisenberg MJ. Meta-analysis of

VER_Dearing_FINAL.indd 44

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

randomized controlled trials comparing the long-term outcomes of carotid artery stenting versus endarterectomy. Circ Cardiovasc Qual Outcomes 2015;8:S99–108. https://doi. org/10.1161/CIRCOUTCOMES.115.001933; PMID: 26515216. Zhang L, Zhao Z, Ouyang Y, et al. Systematic review and metaanalysis of carotid artery stenting versus endarterectomy for carotid stenosis: a chronological and worldwide study. Medicine (Baltimore) 2015;94:e1060. https://doi.org/10.1097/ MD.0000000000001060; PMID: 26131824. Lokuge K, de Waard DD, Halliday A, et al. Meta‐analysis of the procedural risks of carotid endarterectomy and carotid artery stenting over time. Br J Surg 2018;105:26-36. https://doi. org/10.1002/bjs.10717; PMID: 29205297. Kakkos SK, Kakisis I, Tsolakis IA, Geroulakos G. Endarterectomy achieves lower stroke and death rates compared with stenting in patients with asymptomatic carotid stenosis. J Vasc Surg 2017;66:607–17. https://doi. org/10.1016/j.jvs.2017.04.053; PMID: 28735954. Moresoli P, Habib B, Reynier P, et al. Carotid stenting versus endarterectomy for asymptomatic carotid artery stenosis a systematic review and meta-analysis. Stroke 2017;48:2150–7. https://doi.org/10.1161/STROKEAHA.117.016824; PMID: 28679848. Hicks CW, Nejim B, Aridi HD, et al. Transfemoral carotid artery stents should be used with caution in patients with asymptomatic carotid artery stenosis. Ann Vasc Surg 2019;54:1–11. https://doi.org/10.1016/j.avsg.2018.10.001; PMID: 30339900. Dakour Aridi, H Locham S, Nejim B, Malas MB. Comparison of 30-day readmission rates and risk factors between carotid artery stenting and endarterectomy. J Vasc Surg 2017;66:1432–44.e7. https://doi.org/10.1016/j.jvs.2017.05.097; PMID: 28865979. ACST-2 Collaborative Group, Halliday A, Bulbulia R, et al. Status update and interim results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2). Eur J Vasc Endovasc Surg 2013;46:510–8. https://doi.org/10.1016/j.ejvs.2013.07.020; PMID: 24051108. Bulbulia R, Halliday A. The Asymptomatic Carotid Surgery Trial-2 (ACST-2): an ongoing randomised controlled trial comparing carotid endarterectomy with carotid artery stenting to prevent stroke. Health Technol Assess 2017;21:1–40. https://doi.org/10.3310/hta21570; PMID: 29019319. Eckstein HH, Reiff T, Ringleb P, et al. SPACE-2: A missed opportunity to compare carotid endarterectomy, carotid stenting, and best medical treatment in patients with asymptomatic carotid stenoses. Eur J Vasc Endovasc Surg 2016;51:761–5. https://doi.org/10.1016/j.ejvs.2016.02.005; PMID: 27085660. Lal BK, Meschia JF, Brott TG. Clinical need, design, and goals for the Carotid Revascularization and Medical

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

Management for Asymptomatic Carotid Stenosis trial. Semin Vasc Surg 2017;30:2–7. https://doi.org/10.1053/ j.semvascsurg.2017.04.004; PMID: 28818255. European Carotid Surgery Trial-2. Protocol Summary. 2015. Available at: http://s489637516.websitehome.co.uk/ECST2/ protocolsummary.htm (accessed 19 January 2019). Kwolek CJ, Jaff MR, Leal JI et al. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg 2015;62:1227–34. https://doi.org/10.1016/ j.jvs.2015.04.460; PMID: 26506270. Malas MB, Dakour-Aridi H, Wang GJ, et al. Transcarotid artery revascularization versus transfemoral carotid artery stenting in the society for vascular surgery vascular quality initiative. J Vasc Surg 2019;69:92–103.e2. https://doi.org/10.1016/ j.jvs.2018.05.011; PMID: 29941316. Ballotta E, Toniato A, Farina F, et al. The perioperative outcomes of eversion carotid endarterectomy in diabetic patients aged 80 years or older. J Vasc Surg 2016;64:348–53. https://doi.org/10.1016/j.jvs.2016.01.052; PMID: 26993375. Avgerinos ED, Go C, Ling J, et al. Survival and long-term cardiovascular outcomes after carotid endarterectomy in patients with chronic renal insufficiency. Ann Vasc Surg 2015;29:15–21. https://doi.org/10.1016/j.avsg.2014.07.029; PMID: 25194551. Lindsay AC, Biasiolli L, Lee JM, et al. Plaque features associated with increased cerebral infarction after minor stroke and TIA: a prospective, case-control, 3-T carotid artery MR imaging study. JACC Cardiovasc Imaging 2012;5:388–96. https://doi.org/10.1016/j.jcmg.2011; PMID: 22498328. Yoshimura S, Yamada K, Kawasaki M, et al. High intensity signal on time-of-flight magnetic resonance angiography indicates carotid plaques at high risk for cerebral embolism. Stroke 2011;42:3132–7. https://doi.org/10.1161/STROKEAHA. 111.615708; PMID: 21868725. Paraskevas KI, Veith FJ, Ricco JB. Best medical treatment alone may not be adequate for all patients with asymptomatic carotid artery stenosis. J Vasc Surg 2018; 68:572–5. https://doi.org/10.1016/j.jvs.2018.02.046; PMID: 29773432. Park YJ, Kim DI, Kim GM, et al. Natural history of asymptomatic moderate carotid artery stenosis in the era of medical therapy. World Neurosurgery 2016;91:247–53. https://doi.org/10.1016/ j.wneu.2016.04.037; PMID: 27108032. Bogiatzi C, Cocker MS, Beanlands R, et al. Identifying highrisk asymptomatic carotid stenosis. Expert Opin Med Diagn 2012;6:139–51. https://doi.org/10.1517/17530059.2012. 662954; PMID: 23480656. Singh TD, Kramer CL, Mandrekar J, et al. Asymptomatic carotid stenosis: risk of progression and development of symptoms. Cerebrovasc Dis 2015;40:236–43. https://doi. org/10.1159/000439179; PMID: 26484542.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

28/03/2019 22:49

Case Reports

Combined Less-invasive Surgical and Endovascular Technique to Minimise Operative Trauma and Treat Excessive Aortoiliac Thrombotic Obliteration with Popliteo-crural Involvement and Acute Limb Ischaemia Gergana T Taneva 1,2 , Georgios Karaolanis 1 , Marco Pipitone 1 , Giovanni Torsello 1 and Konstantinos P Donas 1 1. Department of Vascular Surgery, St. Franziskus Hospital Münster, Germany; 2. University Hospital Ramon y Cajal, Madrid, Spain

Abstract This article demonstrates a less-invasive combined surgical and endovascular alternative approach in a case in which an excessive thrombotic formation in the infrarenal aorta caused occlusion of the iliac artery and the ipsilateral crural arteries. A 51-year-old man was admitted to the authors’ hospital with symptomatology of acute lower limb ischaemia. He had undergone endovascular treatment with placement of kissing stents in the common iliac arteries 2 years previously. A CT angiography scan revealed an extensive thrombus formation in the entire infrarenal aorta occluding the distal infrarenal aorta, the iliac artery and the crural arteries. He underwent a hybrid approach, with exposure of only the right common femoral artery and over-the-wire embolectomy of the infrarenal aorta and the iliac artery, and after the restoration of the inflow, an embolectomy of the peripheral vessels was carried out. To cover the residual aortic thrombus and to restore the severe in-stent restenosis of the previously deployed bare stents, three covered balloon-expandable stents were deployed in kissing technique. The patient was discharged on the fourth postoperative day with palpable peripheral pulses. Combined surgical and endovascular techniques minimise the operative trauma and length of hospital stay for the patient, successfully restoring the perfusion in a physiological manner.

Keywords Covered stents, embolectomy, hybrid approach, infrarenal thrombus, kissing technique Disclosure: The authors have no conflicts of interest to declare. Received: 16 October 2018 Accepted: 22 January 2019 Citation: Vascular & Endovascular Review 2019;2(1):45–7. DOI: https://doi.org/10.15420/ver.2018.18.1 Correspondence: Konstantinos P. Donas, Department of Vascular Surgery, St Franziskus Hospital, Hohenzollernring 72, 48145 Münster, Germany. E: konstantinos.donas@googlemail.com Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Excessive partial or total thrombotic obliteration of the aortoiliac segment represents a challenging clinical entity. In cases of surgical repair, infrarenal cross clamping of the aorta is associated with risk of thrombus embolisation in the renovisceral aorta.1 An alternative approach with extra-anatomic bypass from the axillary artery to the common femoral artery (CFA) also carries a risk of infection as a result of the subcutaneous cannulation and poorer patency.2 In cases of additional popliteo-crural involvement with severe clinical symptoms, such as rest pain, paraesthesia and paralysis, the treatment is demanding. The aim of this article is to demonstrate a less-invasive combined surgical and endovascular alternative approach for a patient who presented with an excessive thrombotic formation in the infrarenal aorta, occlusion in the entire iliac artery and additional ipsilateral involvement of the crural arteries.

Case Report A 51-year-old man was admitted to our hospital complaining of rest pain in his right leg and paraesthesia. Physical examination revealed symptoms of acute artery occlusion, including lack of pulses, paraesthesia, rest pain and paralysis of the right foot. The patient was a heavy smoker and reported a history of chronic misuse of drugs and analgesics. He had undergone deployment of a balloon-expandable

VER_Donas_Case report_FINAL.indd 45

bare-metal stent into the common iliac arteries 2 years previously. CT angiography showed an excessive thrombus formation in the entire infrarenal aorta with occlusion of the distal infrarenal aorta, the entire iliac artery and the crural arteries. The deployed bare-metal stents showed a bilateral compression with in-stent restenosis and subtotal occlusion, especially in the right side. Informed consent for publication of this case report was obtained.

Endovascular Procedure After administration of general anaesthesia and cut down to the right groin, exposure of the CFA was obtained. On the contralateral site, puncture of the CFA was performed and a 5 Fr sheath was placed. The right common iliac artery (rCIA) occlusion was cannulated with a 0.018-inch angled Glidewire® (Terumo). After advance of a Quick CrossTM Support Catheter (Spectranetics), the 0.018-inch wire was exchanged with a 0.035 inch stiff wire. Figure 1 shows the stenosed infrarenal aorta as a result of excessive thrombus formation and the complete occlusion of the right iliac artery and crural vessels. After heparinisation with 5,000 units, an over-the-wire embolectomy was performed with a Fogarty balloon from the infrarenal aorta to the iliac artery through the occluded right common iliac stent. Simultaneously, a balloon 10 mm in diameter (ev3, Medtronic) was advanced and

Access at: www.VERjournal.com

07/04/2019 15:10

Case Reports Figure 1: Intraoperative Digital Subtraction Angiography

Figure 3: Deployment of Balloon-expandable Stents

The intraoperative digital subtraction angiography illustrates the stenosis of the infrarenal aorta and the obstruction of the right common iliac artery and crural vessels caused by thrombotic embolisation.

Figure 2: Over-the-wire Embolectomy Two kissing covered balloon expandable stents (Advanta V12) were deployed across the aortic bifurcation.

Figure 4: Revascularisation of the Infrapopliteal Vessels

Over-the-wire embolectomy of the entire infrarenal and iliac axis with protection of the left common iliac artery with a 10-mm balloon

inflated in the orifice of the left common iliac artery to protect the left limb for peripheral embolisation during the embolectomy (Figure 2). A blood flow restoration on the right limb was immediately achieved. Angiography revealed a severe in-stent restenosis of the right side. To cover the residual thrombus formation of the infrarenal aorta and to treat the in-stent restenosis – especially of the right bare-metal stent in the common iliac artery – three covered balloon-expandable stents were deployed, 8 mm × 59 mm (Advanta V12, Getinge) in the kissing technique and 38 mm long in the distal rCIA (Figure 3). Angiography showed complete exclusion of the thrombus formation with restoration of the in-stent stenosis of the previously deployed iliac bare-metal stents. The pulses in the groin were palpable. The next step was to restore the peripheral perfusion of the right lower extremity. We changed the destination of the short sheath and cannulated the occluded crural arteries with a 0.014-inch wire (ChoICE PT, Boston Scientific). Additionally, we performed an overthe-wire embolectomy with the Fogarty catheter. This was repeated four times. The completion angiography showed two patent crural vessels with peripheral spasm in the peroneal artery (Figure 4). For this reason, we administered 0.5 ml recombinant tissue plasminogen activator (Actilyse®,Boehringer Ingelheim) superselectively. We closed

VER_Donas_Case report_FINAL.indd 46

Angiography showed two patent crural vessels with peripheral spasm in the peroneal artery.

the arteriotomy of the CFA with 5-0 Prolene® (Ethicon) sutures and, at the end, the fascia of the groin. By the end of the operation, the patient had palpable peripheral pulses. The operation was performed in a hybrid angiosuite room (Siemens Artis Zee). Meticulous clinical examination and estimation of creatinine kinase values were performed without evidence of limb-threatening compartment syndrome. The patient had an uneventful postoperative course and was discharged on the fourth day after the operation. The anticoagulation regime – because of the excessive thrombus formation – was warfarin and 75 mg clopidogrel daily for 6 months, and lifelong monotherapy with clopidogrel.

Discussion Acute lower limb ischaemia caused by aortoiliac and infrapopliteal thrombotic occlusive disease represents a challenging clinical entity requiring urgent and invasive treatment. Traditionally, the treatment option was open surgical repair including aortofemoral or axillofemoral

VA S C U L A R & E N D O VA S C U L A R R E V I E W

07/04/2019 15:10

Excessive Aortoiliac Thrombotic Obliteration bypass, which are associated with relatively high perioperative morbidity and mortality.3–4 Moreover, the invasiveness and risk of possible thrombotic embolisation in other vascular territories as a result of clamping of the aorta and manipulations during vessel exposure remain remarkable limitations.1 In particular, in cases of axillofemoral bypass placement, additional issues such as infection and poorer patency reflect significant drawbacks especially for a young patient without adherence, as in our case.2

The peripheral perfusion was restored by use of hybrid techniques, such as an over-the-wire embolectomy, to have the option of additional use of endovascular means, including balloons or stents in case of dissection and/or residual stenosis. The performance of the operation in a hybrid angiosuite room enabled additional angiographic evaluation of the revascularisation. The administration of local lysis decreased the peripheral spasms of the vessels and angiography showed all three crural vessels were patent.6

The preferred approach represents an alternative modality combining less invasive means. The excessive thrombotic formation in the entire infrarenal and iliac axis with concomitant popliteo-crural occlusion highlights the challenge of this pathology. After protection of the left iliac-femoral artery with a 10 mm balloon catheter we performed a successful over-the-wire open thrombectomy of the entire right iliac artery, restoring the perfusion to the occluded iliac segment. Figure 3 shows the patent iliac axis with a severe residual stenosis of the right common iliac stent. Additionally, we restored the severe in-stent stenosis – especially of the right stent – with placement of balloon-expandable covered stents such as the Advanta V12 in kissing technique. The use of covered devices was preferred because of the risk of peripheral embolisation of the thrombus formation. The inflow was significantly improved. The literature describes promising performance of balloon-expandable covered stents in similar conditions with optional additional placement of a 16 mm Advanta device in the infrarenal aorta, also known as the Covered Endovascular Reconstruction of Aortic Bifurcation technique.5

To the best of our knowledge, this is the first report referring to the treatment of such an excessive acute thrombotic lesion of the entire infrarenal arterial system of the right side by common femoral cut down and use of hybrid techniques. We have demonstrated that successful endovascular repair is possible in these critical situations and may be safer and associated with fewer complications than the open approach.

araolanis G, Moris D, Bakoyiannis C, et al. A critical K reappraisal of the treatment modalities of normal appearing thoracic aorta mural thrombi. Ann Transl Med 2017;5:306. https://doi.org/10.21037/atm.2017.05.15; PMID: 28856146. Diener H, Hellwinklel O, Carpenter S, et al. Homografts and extra-anatomical reconstructions for infected vascular grafts. J Cardiovasc Surg (Torino) 2014;55:217–23. PMID: 24796916. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Donas_Case report_FINAL.indd 47

Conclusion Combined surgical and endovascular techniques minimise operative trauma, duration of the operation and length of hospital stay for the patient. A surgical repair such as placement of an aortofemoral bypass in case of stent-graft occlusions and failed repeat endovascular recanalisation is still available, the restoration of the blood flow has a more physiological manner compared with an extra-anatomic axillofemoral bypass placement. Performance of these techniques in a hybrid angiosuite reflects the modern character of the vascular surgeon offering both options as complementary modalities.

arterial disease (lower extremity, renal, mesenteric, and abdominal aortic). Circulation 2006;11:e463–654. https://doi. org/10.1161/CIRCULATIONAHA.106.174526; PMID: 16549646. Onder H, Oguzkurt L, Tekbas G, et al. Successful treatment of delayed aortobifemoral graft thrombosis with manual aspiration thrombectomy. Diagn Interv Radiol 2012;1:142–5. https://doi.org/10.4261/1305-3825.DIR.4302-11.1; PMID: 22042730. Grimme FA, Goverde PC, Verbruggen PJ, et al. Editor’s

Choice – First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique for aortoiliac occlusive disease. Eur J Vasc Endovasc Surg 2015;5:638–47. https://doi.org/10.1016/j.ejvs.2015.06.112; PMID: 26343310. Berridge DC, Kessel DO, Robertson I. Surgery versus thrombolysis for initial management of acute limb ischaemia. Cochrane Database Syst Rev 2013;6:CD002784. https://doi. org/10.1002/14651858.CD002784.pub2; PMID: 23744596.

07/04/2019 15:10

Case Reports

Bilateral Lower Limb Disabling Claudication in a Young Man: A Case of Mönckeberg’s Arteriosclerosis Khalid Abdelaziz Mowafy, Mosaad Soliman, Ahmed Magdy Hammoda and Reem Mosaad Soliman Vascular and Endovascular Surgery Department, Mansoura College of Medicine, Mansoura University, Egypt

Abstract Mönckeberg’s arteriosclerosis, also called medial calcific sclerosis or Mönckeberg’s sclerosis, is a form of vessel hardening due to increased calcium deposits in the tunica media layer. There is disagreement over its clinical significance and aetiology and its relation to atherosclerosis and vascular calcification. Its clinical presentations and treatment are still debated. More effort should be directed on attempting to distinguish between atherosclerotic lesions and Mönckeberg’s lesions on the basis of age, location and the pattern of calcifications where there is considerable overlap between intimal or medial and involvement of the internal elastic lamina border between those planes. In-depth research is still needed to create consensus guidelines for the diagnosis and management of this condition. This article includes a review of the literature and a case report of a 22-year-old man with the condition.

Keywords Mönckeberg’s arteriosclerosis, medial calcification, claudication, atherosclerosis. Disclosure: The authors have no conflicts of interest to declare. Received: 10 December 2018 Accepted: 26 February 2019 Citation: Vascular & Endovascular Review 2019;2(1):48–52. DOI: https://doi.org/10.15420/ver.2018.20.3 Correspondence: Khalid Mowafy, Vascular and Endovascular Surgery Department, Mansoura College of Medicine, Mansoura University, 35515 Egypt. E: khalid_mowaphy@mans.edu.eg Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Mönckeberg’s arteriosclerosis (MA) is a pathological process involving dystrophic calcification of the tunica media layer of the arterial wall due to deposition of calcium hydroxyapatite crystals, or metastatic and metabolic calcification due to osteoblastic transformation of vascular smooth muscle cells, enhancing deposition of calcium hydroxyapatite crystals. It involves many factors including phosphorus activation of the PiT1 receptor, bone morphogenetic proteins 2 and 4, endogenous 1,25 dihydroxyvitamin D and vascular calcification activating factors. MA is possibly an expression of dysregulated osteogenic commitment of vascular progenitors, and so can lead to cardiovascular morbidity in young people who do not have known risk factors. Active calciﬁcation with bone formation results from osteogenic differentiation of resident or circulating calcifying vascular cells. Ectopic osteogenesis involves the deposition of matrix vesicles, which are cell products that act as sites for calcium hydroxyapatite crystal precipitation. The vesicles may originate from distant sites that reach the vascular matrix as substrate circulating nucleation complexes. The content of the vesicle and the composition of the microenvironment influence whether matrix vesicles are involved with calcium deposition. Another theory points to ineffective efferocytosis, where defective phagocytic clearance of apoptotic bodies by macrophages leads to accumulation of necrotic debris promoting calcium precipitation on the debris.1 Vascular calcification is accelerated in certain chronic inflammatory conditions, such as diabetes, chronic kidney disease and Paget’s

Access at: www.VERjournal.com

VER_Mowafy_FINAL.indd 48

disease, and in people who are taking vitamin K antagonists such as warfarin. It is now accepted that vascular calcification is not a passive phenomenon, but it is regulated by complex, active mechanisms.2,3 It has been found that vitamin K plays a crucial role in the regulation of ectopic calcifications by reversing vascular calcification. Vitamin K is an essential co-factor for the gamma-glutamyl-carboxylase enzyme, which is responsible for activation of 17 vitamin K-dependent proteins that have the ability to bind calcium.4,5 Chronic kidney disease is a cardiovascular risk factor because it causes pathological changes in the vasculature and bone and mineral disorders; these are manifested by abnormalities of calcium, phosphorus, parathyroid hormone and vitamin D, renal osteodystrophy and extra-osseous calcification of soft tissues and blood vessels.6,7 MA is diagnosed radiographically, as areas of linear calcifications in soft tissue. The linear calcifications are referred to as ‘rail tracking’, or ‘tramlines’ when the affected vessel is viewed longitudinally. In most cases, MA shows the clinical criteria of calciphylaxis (calcification of the tunica media, small vessel mural calcification with endovascular fibrosis, extravascular calcification, and vascular thrombosis, leading to tissue ischaemia). The term ‘Mönckeberg’s calcification’ has also been used to describe vascular calcinosis not related to chronic kidney disease in rare conditions, such as pseudoxanthoma elasticum (PXE) and the

07/04/2019 15:15

Bilateral Lower Limb Disabling Claudication Table 1: Arteries Affected in Case Reports of Mönckeberg’s Atherosclerosis Author

Figure 1: Extensive Diffuse Calcification

Arteries affected

Amillo Garayoa et al. 197727 Top et al. 2002

Popliteal

Shabat et al. 200428 Couri et al. 2005

Aorta, iliac and femoral

Sorensen et al. 200729 Son et al. 2009

Penile Superficial femoral arteries

Barr et al. 2010

Hand vessels Temporal and femoral

Superficial femoral arteries

MacDonald et al. 201232

External carotid arteries

Lucksom et al. 2014

Uterine vessels

Prasad et al. 20157

Superficial femoral and popliteal arteries

Omami 2017

Facial vasculature

Frazier et al. 201818

Infraorbital arteries

Pisani et al. 201835

Vertebral, renal, ovarian, hepatic, splenic, visceral and peripheral arteries of the upper and lower limbs

generalised arterial calcification of infancy (Keutel syndrome). In the majority of cases, MA is clinically asymptomatic, but it has been described as an independent risk factor for cardiovascular diseases and it commonly affects peripheral and coronary arteries.8 In a patient presenting with peripheral vascular disease of undefined aetiology and without any known risk factors, Mönckeberg’s calcification, although rare, could be the cause of peripheral vasculopathy. In a study to determine population-based estimates of peripheral artery disease (PAD), critical limb ischaemia and MA, ankle–brachial pressure index (ABPI) was measured, with an ABPI <0.9 indicating PAD.9 MA prevalence was calculated for two ABPI measurements >1.3 and >1.5. Using ABPI >1.5, MA was present in 1.1% and 0.5% of men and women, respectively, but at ABPI >1.5, prevalence was 13.3% for men and 6.9% for women. However, its aetiology remains unknown.10 MA affects diverse arterial areas that have been documented in case reports (Table 1). Most of the reported cases show the clinical criteria of calciphylaxis – calcification of the tunica media, small vessel mural calcification with endovascular fibrosis, extravascular calcification and vascular thrombosis, leading to tissue ischaemia. In the following case report, we focus on a pure medial calcification as a separate pathological entity, which represents a rare case of ischaemia that can give rise to symptoms in early life and could be limb and life-threatening.

Case Report The patient was a 22-year-old man with an average build. He had repeated muscle cramps and fatigue with heavy exercise that was relieved by rest. After initial reports, the condition progressed and he developed bilateral claudication pain with increased intensity and duration with regular exercise, in addition to early muscle atrophy. The patient had no history of trauma, diabetes or hypertension. He was a non-smoker and had never taken vitamin K antagonist therapy. His only reported treatment was regular use of non-steroidal antiinflammatory drugs for pain.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Mowafy_FINAL.indd 49

Plain X-ray showed extensive diffuse calcification, with some dilatation and tortuosity involving most of the arterial vascular tree of both lower limbs.

On physical examination, there were no symptoms or signs of lumbar disc prolapse and an MRI scan of the lumbosacral vertebrae was normal. He had palpable bilateral femoral pulses, non-palpable popliteal and distal pulsations. His ankle–brachial index could not be assessed and a picture of progressive muscle wasting was evident, but there was no tissue necrosis or impending ischaemic gangrene. Laboratory investigations showed a normal full blood count. Haemoglobin was 13.5 g/dl, total white cell count was 7,600/μl, with neutrophils 60%, lymphocytes 25%, monocytes 10% and normal platelet count. Serum creatinine was 0.8 mg/dl. His lipid profile showed triglycerides 4.15 mmol/l, LDL 3.2 mmol/l, total cholesterol 4.4 mmol/l and HDL 0.9 mmol/l. Rheumatoid and antinuclear factors were non-reagent. Cardiolipin antibodies immunoglobulin (Ig) M and IgG were negative. Cryoglobulins, hepatitis B and C were also negative. ESR and C-reactive protein were slightly elevated (60 mm/h and 95.7 mg/l). Protein C was 56% and protein S was 75%. Calcium in urine over 24 hours was 431.42 mg/dl, outside the normal range of 100–300 mg/dl. Parathyroid hormone was 98 pg/ml, slightly higher than the normal range of 16–87 pg/ml. ECG, echocardiogram and neurology were normal. A parathyroid scan was negative for adenoma or hyperplasia. An X-ray showed extensive diffuse calcification, with some dilatation and tortuosity involving most of the arterial vascular tree of both lower limbs, indicating Mönckeberg’s medial calcific sclerosis (Figure 1).

07/04/2019 15:15

Case Reports Figure 2: Follow-up CT Angiography

Figure 3: Follow-up CT Angiography

Multiple large plaques of calcifications are seen affecting the middle and distal superficial femoral artery (SFA) as well as the popliteal and deep femoral artery on both sides with 90% stenosis of the lumen at the distal third of SFA on both sides.

The infra-genicular region of both sides showed multiple large plaques of calcification affecting the tibioperoneal trunk and proximal anterior tibial arteries and total occlusion of the distal part of anterior tibial arteries on both sides, severely tortuous and dilated lower posterior tibial arteries. Those findings were bilateral in a mirror image picture.

A duplex ultrasound detected biphasic flow over both common femoral arteries and could not detect any flow from the deep femoral arteries down to the pedal arteries. This is suggestive of medial calcification.

sevelamer hydrochloride, a non-calcium containing phosphate binder â&#x20AC;&#x201C; the standard therapy for this condition.

CT angiography was performed to exclude thromboembolic events or popliteal artery diseases. It revealed patent distal abdominal aorta and both common iliacs, and common femoral arteries bilaterally. Multiple large plaques of calcifications were seen, affecting the middle and distal superficial femoral artery (SFA) as well as the popliteal and deep femoral artery on both sides, with 90% stenosis of the lumen at the distal third of the SFA on both sides.

Follow-up CT angiography 12 months later showed a mirror-image picture with no major changes from the previously noted heavy calcification. There was more dilatation, kinking of the lumens and early affection of CFA and proximal SFA (Figures 2 and 3). As there had been no improvement since initial presentation, open surgical revascularisation or angioplasty were considered. Because his condition is deteriorating, revascularisation is mandatory.

The infra-genicular region on both sides showed multiple large plaques of calcification affecting the tibioperoneal trunk and proximal anterior tibial arteries and total occlusion of the distal part of the anterior tibial arteries on both sides, with severely tortuous and dilated lower posterior tibial arteries. These findings were bilateral with a mirror image. A diagnosis of MA as a variant presentation of PXE was made at this point. He was started on cilostazol 100 mg twice daily and

Discussion

VER_Mowafy_FINAL.indd 50

The main cause of lower limb chronic ischaemia is atherosclerosis, caused by the formation of atheromatous plaques in the arteries. Known risk factors for atherosclerosis include family history, being male, old age, smoking, diabetes, dyslipidaemia and hypertension.11 If claudication pain occurs in patients who have none of these risk factors, other, less common aetiologies should be considered.12

VA S C U L A R & E N D O VA S C U L A R R E V I E W

07/04/2019 15:15

Bilateral Lower Limb Disabling Claudication Non-atherosclerotic peripheral artery diseases are a diverse group of disorders with different pathophysiologies, clinical manifestations and treatments. They include popliteal artery entrapment syndrome, cystic adventitial disease, iliac artery endofibrosis, fibromuscular dysplasia, Buerger’s disease, chronic exertional compartment syndrome, and medium and large vessel vasculitis, including Takayasu’s arteritis, giant cell arteritis and Behcet’s disease. The diagnostic approach to patients presenting with intermittent claudication must consider atherosclerotic as well as non-atherosclerotic causes of peripheral artery disease (PAD).13

in some peripheral arteries, the lack of validation and the semiquantitative nature of the measurements.20

The debate concerning the pathological process of MC and its association with intimal calcification in atherosclerosis goes back to 1903, when Johann Georg Mönckeberg first described medial calcification in the arteries of older people. He described stages of disease progression which could be concluded to be stages of atherosclerotic plaque formation.14

In 2014, Leftheriotis et al. studied the impact of calcification on arterial wall stiffness in PXE.21 PXE is an autosomal recessive disease caused by mutations in the ABCC6 gene and is characterised by progressive calcification of the elastic fibres in the skin, retinal Bruch’s membrane and the medial layers of large and medium-sized peripheral arteries. People with PXE develop cardiovascular events and complications, including PAD, at a younger age than the normal population, but they do not have obvious cardiovascular risk factors. Our patient could have a variant presentation of PXE.

The histopathology of PAD and the accompanying calcification are poorly defined, and it is not known whether this varies according to different risk factors. The majority of arteries in patients with PAD have a vascular lesion that is distinct from atherosclerosis, suggesting a different pathogenesis, and the main bulk of vascular calcification in the lower extremities is medial rather than intimal.15 Michelle et al. reviewed the literature on medial calcification and found reports of internal elastic lamina calcification.2 This was a good demonstration of the variability of atherosclerotic calcification in the involved layers of the arterial wall which has been misinterpreted as Mönckeberg’s sclerosis in the literature.

In our case, plain radiography was more consistent with criteria mentioned in the literature for the diagnosis of Mönckeberg’s arteriosclerosis (Figure 1). Our patient had no risk factors for atherosclerosis. He was thoroughly examined and investigated for all possible causes of hyperkalemia, dyslipidaemia or for other possible causes. The inherited condition PXE was a more appropriate aetiology to consider.

The absence of an accepted vascular calcium grading scale hampers the clinical assessment of the safety of endovascular devices in the treatment of calcified vessels.22 Flore et al. quantified non-coronary vascular calcification in asymptomatic patients at low to intermediate cardiovascular risk using a colour Doppler ultrasound-based score – the carotid, aortic, lower limbs calcium score (CALCS).23 They found that the CALCS correlated with other validated markers of subclinical atherosclerosis, such as carotid intima-media thickness and arterial stiffness. They concluded that CALCS may be a reliable alternative to the traditional coronary artery calcification score in the evaluation of peripheral calcium load and it allows a better stratification of patients. Hendriks recommends different methods of assessing calcification other than Agatston scoring because arterial calcification is an actively regulated process with associated detrimental effects, and the risk factor profile associated with MA differs from that of intimal arterial calcification.24

In articles that attempt to distinguish between atherosclerotic lesions and pure medial calcinosis on the basis of location and the pattern of calcifications, there was an overlap between intimal or medial which involved the internal elastic lamina border between those planes. When appropriately stained, lipid material was present, confirming atherosclerosis in some of the most densely calcified medial arteries. The histomorphology results were consistent for both atherosclerosis and MA. The calcific process included expression of osteoprotegerin, TNF-related apoptosis and mRNA expression patterns which were similar for both atherosclerosis and MA. Thus, MA seems to be a variant of advanced, calcified atherosclerosis with little inflammation and no clear evidence of an independent, non-atherogenic process.6,16

The presence of MA does not necessarily mean revascularisation cannot be performed. In some cases, revascularisation is possible, and will involve anastomosis and avoidance of clamping the artery, but in other situations, revascularisation is impossible due to intense calcification.25

Zhang et al. studied the distribution of atherosclerotic plaques in the arterial beds of the common femoral artery bifurcation. Plaque tends to be located in areas opposite the carina in SFAs. Normal arteries were more common in profunda femoris arteries than in common femoral arteries and SFAs.17

In 2015, Castling et al. reported their experience of using vessels affected by MA with medial calcification in an osseocutaneous radial forearm free flap reconstruction.26 They found that the anastomosis of affected arteries had no impact on flap viability. This suggests that there is the possibility of open revascularisation in these patients.

In our patient’s angiography, the profunda femoris arteries were heavily loaded with calcification and the common femoral artery was spared, which does not support atherosclerotic pathology.

Conclusion

Radiographically, medial calcinosis presents as areas of linear calcifications in soft tissue.18 Goebel and Füessl identified medial calcification in the legs using X-ray without histological confirmation.19 However, attempts to distinguish and quantify medial calcification using radiological patterns or by examining peripheral arteries are problematic because of poor specificity, the existence of atherosclerosis

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Mowafy_FINAL.indd 51

Although rare, Mönckeberg’s calcification should be considered as a potential cause of peripheral vasculopathy in a patient presenting with peripheral vascular disease with undefined aetiology in the absence of known risk factors. There is great diversity regarding arterial affection. Further studies are needed for clinicians to have a better understanding of the disease as a separate pathological entity. It would be useful to differentiate between the response of medial calcification to angioplasty, or even open revascularisation and that of predominant intimal calcification to create a treatment strategy for this condition.

07/04/2019 15:15

Case Reports 1.

Z azzeroni L, Faggioli G, Pasquinelli G. Mechanisms of arterial calciﬁcation: the role of matrix vesicles. Eur J Vasc Endovasc Surg 2018;55:425–32. https://doi.org/10.1016/j.ejvs.2017.12.009; PMID: 29371036. 2. Micheletti RG, Fishbein GA, Currier JS, et al. Calcification of the internal elastic lamina of coronary arteries. Mod Pathol 2008;21:1019–28 https://doi:10.1038/modpathol.2008.89; PMID: 18536656. 3. Leopold JA. Vascular calcification: mechanisms of vascular smooth muscle cell calcification. Trends Cardiovasc Med 2015;25:267–74. https://doi.org/10.1016/j.tcm.2014.10.021; PMID: 25435520. 4. Luo G, Ducy P, McKee MD, et al. Spontaneous calcification of arteries and cartilage in mice lacking matrix GLA protein. Nature 1997;386:78–81. https://doi.org/10.1038/386078a0; PMID: 9052783. 5. Michaux A, Matagrin B, Debaux JV, et al. Missense mutation of VKORC1 leads to medial arterial calcification in rats. 2018;8:13733. https://doi.org.10.1038/s41598-018-31788-6; PMID: 30214074. 6. McCullough PA, Agrawa V, Danielewicz E, Abela GS. Accelerated atherosclerotic calcification and Monckeberg’s sclerosis: a continuum of advanced vascular pathology in chronic kidney disease. Clin J Am Soc Nephrol 2008;3:1585–98. https://doi.org/10.2215/CJN.01930408; PMID: 18667741. 7. Prasad R, Devasia T, Kareem H, Kumar A. Non-healing ulcer of right foot due to Monckeberg’s arteriosclerosis. BMJ Case Rep 2015;2015:bcr2014208047; https://doi.org/10.1136/bcr-2014208047; PMID: 25630335. 8. Couri CE, da Silva GA, Martinez JA, et al. Mönckeberg’s sclerosis – is the artery the only target of calcification? BMC Cardiovasc Disord 2005;5:34. https://doi.org/10.1186/1471-22615-34; PMID: 16343348. 9. Kröger K, Stang A, Kondratieva J, et al. Prevalence of peripheral arterial disease – results of the Heinz Nixdorf recall study. Eur J Epidemiol 2006;21:279–85. https://doi.org/10.1007/ s10654-006-0015-9; PMID: 16685578. 10. Top C, Canker Z, Silit E, et al. Mönckeberg’s sclerosis: an unusual presentation – a case report. Angiology 2002;53:483–6. https://doi.org/10.1177/000331970205300418; PMID: 12143958. 11. Lacey B, Herrington WG, Preiss P, et al. Role of emerging risk factors in cardiovascular outcomes. Curr Atheroscler Rep 2017;19:28; PMID: 28477314. 12. Schoen FJ, Cotran RS. Blood vessels. In: Cotran RS, Kumar V, Collins T (eds). Robbins Pathologic Basis of Disease. 6th ed. Philadelphia: WB Saunders, 1999;493–542.

VER_Mowafy_FINAL.indd 52

13. M intz AJ, Weinberg I. Nonatherosclerotic PAD: approach to exertional pain in the lower extremities. Curr Cardiol Rep 2015;17:66. https://doi.org/10.1007/s11886-015-0622-8; PMID: 26162862. 14. Mönckeberg JG. On the calcification of the extremity arteries and their atherosclerotic behaviour. Virchows Arch Pathol Anat 1903;171:141–67 [in German]. https://doi.org/10.1007/ BF01926946. 15. O’Neill WC, Han KH, Schneider TM, Hennigar RA. Prevalence of nonatheromatous lesions in peripheral arterial disease, Arterioscler Thromb Vasc Biol 2014;35:439–47. https://doi. org.10.1161/ATVBAHA.114.304764; PMID: 25477344. 16. Schoppet M, Al-Fakhri N, Franke FE, et al. Localization of osteoprotegerin, tumor necrosis factor related apoptosisinducing ligand, and receptor activator of nuclear factorkappaB ligand in Mönckeberg’s sclerosis and atherosclerosis. J Clin Endocrinol Metab 2004;89:4104–12. https://doi.org/10.1210/ jc.2003-031432; PMID: 15292354. 17. Zhang B, Yang M, Zou Y. Plaque distribution in common femoral artery bifurcations, based on multi-slice computed tomography assessment. Clin Invest Med 2018;41:E228–34. https://doi.org/10.25011/cim.v40i6.29123; PMID: 29256388. 18. Frazier JJ, Casian R, Benson BW. Mönckeberg medial calcinosis of the infraorbital arteries: a first case report. Oral Surg Oral Med Oral Pathol Oral Radiol 2018;125:e31–5. https:// doi.org/10.1016/j.oooo.2017.11.014; PMID: 29248421. 19. Goebel FD, Füessl HS. Mönckeberg’s sclerosis after sympathetic denervation in diabetic and non-diabetic subjects. Diabetologia 1983;24:347–50. https://doi.org/10.1007/ BF00251822; PMID: 6873514. 20. Adragao A, Pires C, Lucas C, et al. A simple vascular calcification score predicts cardiovascular risk in hemodialysis patients. Nephrol Dial Transplant 2004;19:1480–8. https://doi.org/10.1093/ndt/gfh217; PMID: 15034154. 21. Leftheriotis G, Kauffenstein G, Hamel JF, et al. The contribution of arterial calcification to peripheral arterial disease in pseudoxanthoma elasticum. PLoS ONE 2014;9:e96003. https:// doi.org/10.1371/journal.pone.0096003; PMID: 24800819. 22. Rocha-Singh KJ, Zeller T, Jaff MR, et al. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv 2014;83:E212–20. https:// doi.org.10.1002/ccd.25387; PMID: 24402839. 23. Flore R, Zocco MA, Ainora ME, et al. A novel ultrasound-based vascular calcification score (CALCS) to detect subclinical atherosclerosis. Eur Rev Med Pharmacol Sci 2018;22:736–42. https://doi.org.10.26355/eurrev_201802_14304; PMID: 29461604.

24. Hendriks EJE. Thesis. Medial Arterial Calcification: Novel Insights into its Determinants and Cardiovascular Implications. Utrecht University, 2016. Available at: https://dspace.library.uu.nl/bitstream/ handle/1874/347904/Hendriks.pdf (accessed 5 March 2019). 25. Lichtenfels E, Frankini AD, Becker AS, Pires VC. Monckeberg’s arteriosclerosis as a cause of lower limb critical ischemia: case report. Jornal Vascular Brasileiro 2007;6:97–100 [in Portuguese]. https://doi.org/10.1590/S167754492007000100015. 26. Castling B, Bhatia S, Ahsan F. Monckeberg’s arteriosclerosis: vascular calcification complicating microvascular surgery. Int J Oral Maxillofac Surg 2015;44:34–6. https://doi.org/10.1016/j. ijom.2014.10.011; PMID: 25457834. 27. Amillo Garayoa S, Leyes Vence M, Arriola Guenaga FJ. Transfer of the second toe to the hand in a patient with Monckeberg’s sclerosis. Scand J Plast Reconstr Surg Hand Surg 1997;31:181–3. https://doi.org/10.3109/02844319709085487; PMID: 9232705. 28. Shabat S, Mann G, Stern A, et al. Popliteal artery rupture during total knee replacement in a patient with Mönckeberg’s sclerosis: a case report. J Knee Surg 2004;17:117–9. https://doi. org/10.1055/s-0030-1248208; PMID: 15124665. 29. Sorensen MD, Long LO, Wessells H, Kuan JK. Monckeberg’s calciphylaxis with necrosis of the glans penis: a case presentation. Hemodial Int 2007;11:300–2. https://doi. org/10.1111/j.1542-4758.2007.00183.x; PMID: 17576293. 30. Son CN, Jung KH, Song SY, Jun JB. Monckeberg’s sclerosis in a patient with systemic sclerosis. Rheumatol Int 2009;30:105–7. https://doi.org/10.1007/s00296-009-0896-5; PMID: 19322568. 31. Barr L, Lyer US, Sardesai A, Chitnavis J. Tourniquet failure during total knee replacement due to arterial calcification: case report and review of the literature. J Periop Pract 2010;20:55–8. https://doi.org/10.1177/175045891002000202; PMID: 20192092. 32. MacDonald DS, Zhang L, Gu Y. Calcification of the external carotid arteries and their branches. Dentomaxillofac Radiol 2012;41:615–8. https://doi.org/10.1259/dmfr/88771381; PMID: 22241884. 33. Lucksom P, Kharka L, Sebastian N, Gupta A. Monckeberg’s arteriosclerosis in uterine vessels: an unusual presentation. J Obstet Gynaecol India 2014;64:436–7. https://doi.org.10.1007/ s13224-012-0306-x; PMID: 25489150. 34. Omami G. Monckeberg arteriosclerosis: a telltale sign. J Oral Maxillofac Surg 2017;75:2383–4. https://doi.org.10.1016/j. joms.2017.04.007; PMID: 28499804. 35. Pisani P, De Troia A, Allegri L, et al. Malignant Mönckeberg medial calcific sclerosis. Intern Emerg Med 2018;13:615–7. https://doi.org.s10.1007/s11739-018-1794-1; PMID: 29363009.

VA S C U L A R & E N D O VA S C U L A R R E V I E W

07/04/2019 15:15

Case Reports

Importance of Follow-up Imaging in the Detection of Delayed Type 2 Endoleaks Despite Complete Aneurysmal Sac Shrinkage Gergana T Taneva, 1 Omid Shafe, 2 Giovanni B Torsello, 3 Arne Schwindt, 3 Jamal Moosavi 2 , Parham Sadeghipour 2 and Konstantinos P Donas 3 1. University Hospital Ramón y Cajal, Madrid, Spain; 2. Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran; 3. Department of Vascular Surgery, St Franziskus Hospital, Münster, Germany;

Abstract Type 2 endoleaks usually constitute a benign and self-limited phenomenon, which rarely leads to aneurysmal sac expansion. However, in a small subset of patients, a persistent type 2 endoleak might pressurise the aneurysmal sac causing expansion. The authors present two cases with delayed new-onset type 2 endoleak. One occurred after standard endovascular aortic repair and the other after chimney endovascular aortic repair, causing expansion of the aneurysmal sac after a period of complete aneurysmal sac shrinkage. Accordingly, there is a risk of sac re-expansion due to delayed onset endoleaks, independent of the technique, justifying the need for a continuous follow-up despite long-term aneurysmal sac shrinkage.

Keywords Aneurysm sack growth, type 2 endoleaks, delayed endoleaks, aneurysm follow-up, Onyx embolization Disclosure: The authors have no conflicts of interest to declare. Received: 21 January 2019 Accepted: 12 March 2019 Citation: Vascular & Endovascular Review 2019;2(1):53–5. DOI: http://doi.org/10.15420/ver.2019.2.2 Correspondence: Gergana T Taneva, Ramón y Cajal University Hospital, Ctra Colmenar Viejo, km. 9, 100, 28034, Madrid, Spain. E: dr.gtaneva@gmail.com. Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Although type 2 endoleaks are considered a benign finding after endovascular aortic repair (EVAR), they may cause expansion and pressurisation of the aneurysmal sac. 1 Thus, type 2 endoleaks are usually followed via imaging: annually for non-expanding aneurysmal sacs and every 6 months in the case of sac enlargement, recommending treatment when sac enlargement is noted.2 Potential risk factors such as persistent type 2 endoleaks, large inferior mesenteric artery (IMA), and the use of antiplatelet drugs have been related to sac growth in that setting.3 We have encountered two abdominal aortic aneurysms treated with EVAR and chimney EVAR (ch-EVAR) in which delayed aneurysmal sac re-expansion was observed in control CT angiography (CTA).

(Figure 1). The 6-month CTA showed stable aneurysm sac diameter without any further increase.

Case 1

The type 2 endoleaks had not been noted in previous imaging studies and were considered responsible for the aneurysmal sac enlargement (Figure 2). In this case, IMA was used to access the aneurysmal sac and then embolise (retrograde approach) with coils and Onyx. A follow-up CTA after 6 months showed stable sac size without further growth.

A 68-year-old man experienced sac re-expansion in post-ch-EVAR follow-up. He had undergone ch-EVAR 7 years previously and follow-up imaging over the years after the procedure had shown complete shrinkage of the aneurysmal sac without any endoleak. After 6 years, the CTA showed a type 2 endoleak originating from the inferior mesenteric artery (IMA), causing the sac re-expansion (Figure 1). The positions of the stent graft and the chimney grafts were stable, and there was no evidence of aortic stent graft migration or type 1A/1B endoleak. The expansion rate was about 1 mm within 6 months, so inferior mesenteric artery (IMA) embolisation was performed over an 0.014-inch wire through a retrograde approach via the Riolan arch. A microcatheter was inserted into the ostium of the IMA, and Onyx (Medtronic) was injected to induce thrombosis

VER_Taneva_FINAL.indd 53

Case 2 A 70-year-old man was found to have aneurysmal sac re-expansion in post-EVAR follow-up imaging. The aneurysm had been excluded successfully with an Endurant II stent graft (Medtronic Endovascular). There was no endoleak post procedurally or during the first 4 years of follow-up, and there was a significant reduction in the size of the aneurysmal sac. However, his latest CTA showed sac re-expansion, along with a type 2 endoleak from a lumbar artery and IMA in delayedphase images.

Discussion The two cases of new onset type 2 endoleak after successful chEVAR and EVAR described here did not seem to relate to the employed therapeutic approach. The endoleak-free period with complete sac shrinkage was 6 years in the first case and 4 years in the second. There were no signs of systemic infection in laboratory evaluations and in both cases the IMA was the feeding vessel. The reason for the

Access at: www.VERjournal.com

07/04/2019 15:40

Case Reports Figure 1: Case 1

Figure 2: Case 2

Aneurysmal sac size is illustrated before and after the procedure, during a mid-term followup. A: Pre-EVAR, the aneurysm sac reached 7 cm in diameter. B: Sac size shrunk up to 4.6 cm after 3 years follow-up (2016) C: Two years later (2018), the sac showed an expansion of more than 2 cm (6.5 cm diameter), along with a new onset type 2 endoleak.

Aneurysmal sac re-expansion after 6-year significant sac shrinkage. A: Sac size had reached 36 mm by the time we found a type 2 endoleak. B and C: Rapid sac size enlargement occurred within 6 months. D: Microcatheter was placed in the collateral vessels originating from the hepatic artery. E: Onyx was injected into the ostium of the endoleak via the inferior mesenteric artery approach.

reperfusion of the IMA that led to the new delayed endoleak onset of the two presented cases was unknown. Both cases were successfully treated with retrograde use of Onyx and ostial embolisation. However, Onyx material causes CTA artefacts which preclude further endoleak visualisation. Thus, after Onyx embolisation, follow-up is limited to aneurysm sac diameter trace. EVAR is now the dominant mode of treatment for abdominal aortic aneurysms. Although multiple observational and randomised clinical studies have reported consistent early survival benefits for the endovascular strategy, the late survival benefit is less promising.5,6 Aneurysmal sac expansion is one of the most important factors influencing late survival.7 Endoleaks are the main causes of sac expansion.8 Compared to type 1 and type 3 endoleaks, type 2 endoleaks are usually regarded as a benign finding and are mostly managed conservatively.8,9 Three clinical courses of the aneurysmal sac have been described in the presence of a type 2 endoleak: shrinkage, stability or expansion, and it is the third scenario which needs re-intervention.8 The rate of type 2 endoleaks during 1-year follow-up has been estimated to be 10 to 20% in various clinical reports.7 Only 1% of patients with type 2 endoleaks experienced aortic rupture; sac expansion is an important predictor of this.10 The Society of Vascular Surgery recommends control CTA at 1 and 12 months after EVAR. An additional imaging follow-up is necessary

VER_Taneva_FINAL.indd 54

if there are abnormal findings on the first CTA or during the EVAR procedure.10 Thereafter, annual CTA is recommended if no sac expansion, endoleaks or device malposition are observed. CTA can be replaced by Doppler ultrasound after the first year if there have been no complications.10 Although recent guidelines may restrain the number of post-EVAR CTAs, the surveillance adherence rate is still poor, with Garg et al. finding that only 43% of patients received complete follow-up, and of those with incomplete surveillance, 64% had long gaps in imaging. 11 Patients experiencing sac expansion, late endoleaks, and re-intervention had a higher rate of poor adherence. 11 Inaccessible CTA, cost, contrast nephropathy and radiation exposure are among the most notable factors contributing to poor adherence.12 These two cases demonstrate the likelihood of late sac growth despite significant shrinkage during follow-up. Consequently, even though there is a tendency to reduce imaging after adequate sealing and aneurysmal sac shrinkage is observed, post-EVAR surveillance cannot be completely halted. CTA is a highly sensitive and specific method, which is widely accepted and employed for control after endovascular treatment. However, it entails the use of contrast medium and radiation, which have the potential side-effects of contrastinduced nephrotoxicity and malignancies from cumulative radiation exposure. These risks can be avoided by using magnetic resonance angiography and contrast-enhanced duplex ultrasound, but these methods require expertise for interpretation.13 Sac expansion can be diagnosed by Doppler ultrasound, while more advanced imaging can be used in cases with a complicated course (such as sac enlargement). 14 This modification in imaging surveillance has been suggested in recent literature, and offers the additional benefit of cost reduction. 12,15

VA S C U L A R & E N D O VA S C U L A R R E V I E W

07/04/2019 15:40

Detection of Delayed Type 2 Endoleaks Conclusion Aneurysmal sac re-expansion after long-term shrinkage can be detected during follow-up, independent of the treatment

ilverberg D, Baril DT, Ellozy SH, et al. An 8-year experience S with type II endoleaks: natural history suggests selective intervention is a safe approach. J Vasc Surg 2006;44:453–9. https://doi.org/10.1016/j.jvs.2006.04.058; PMID: 16950415. Cassagnes L, Perignon R, Amokrane F, et al. Aortic stentgrafts: Endoleak surveillance. Diagn Interv Imaging 2016;97:19–27. https://doi.org/10.1016/j.diii.2014.12.014l PMID: 26254711. Timaran CH, Ohki T, Rhee SJ, et al. Predicting aneurysm enlargement in patients with persistent type II endoleaks. J Vasc Surg 2004; 9:1157–62. https://doi.org/10.1016/j. jvs.2003.12.033; PMID: 15192552. Chikazawa G, Hiraoka A, Totsugawa T, et al. Influencing factors for abdominal aortic aneurysm sac shrinkage and enlargement after EVAR: clinical reviews before introduction of preoperative coil embolization. Ann Vasc Dis 2014;7:280–5. https://doi.org/10.3400/avd.oa.14-00050; PMID: 25298830. Dua A, Kuy S, Lee CJ, et al. Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010. J Vasc Surg 2014; 59:1512–7. https://doi.org/10.1016/j.jvs.2014.01.007; PMID: 24560865. Schermerhorn ML, Buck DB, O’Malley AJ, et al. Long-term outcomes of abdominal aortic aneurysm in the Medicare

VA S C U L A R & E N D O VA S C U L A R R E V I E W

VER_Taneva_FINAL.indd 55

approach for abdominal aortic aneurysm. The cases we have presented here highlight the importance of ongoing surveillance after EVAR.

population. N Engl J Med 2015;373:328–38. https://doi. org/10.1056/NEJMoa1405778; PMID: 26200979. 7. Deery SE, Ergul EA, Schermerhorn ML, et al. Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair. J Vasc Surg 2018;67:157–64. https://doi.org/10.1016/j.jvs.2017.06.075; PMID: 28865980. 8. Candell L, Tucker LY, Goodney P, et al. Early and delayed rupture after endovascular abdominal aortic aneurysm repair in a 10-year multicenter registry. J Vasc Surg 2014;60:1146–53. https://doi.org/10.1016/j.jvs.2014.05.046; PMID: 24957409. 9. Lo RC, Buck DB, Herrmann J, et al. Risk factors and consequences of persistent type II endoleaks. J Vasc Surg 2016;63:895–901. https://doi.org/10.1016/j.jvs.2015.10.088; PMID: 26796291. 10. Chaikof EL, Brewster DC, Dalman RL, et al. SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary. J Vasc Surg 2009; 50:880–96. https://doi.org/10.1016/j.jvs.2009.07.001; PMID: 19786241. 11. Garg T, Baker LC, Mell MW. Adherence to postoperative surveillance guidelines after endovascular aortic aneurysm

12.

13.

14.

15.

repair among Medicare beneficiaries. J Vasc Surg 2015;61:23–7. https://doi.org/10.1016/j.jvs.2014.07.003; PMID: 25088738. AbuRahma AF, Yacoub M, Hass SM, et al. Compliance of postendovascular aortic aneurysm repair imaging surveillance. J Vasc Surg 2016;63:589–95. https://doi. org/10.1016/j.jvs.2015.09.021; PMID: 26781078. Cantisani V, Ricci P, Grazhdani H, et al. Prospective comparative analysis of colour-Doppler ultrasound, contrastenhanced ultrasound, computed tomography and magnetic resonance in detecting endoleak after endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg 2011;41:186–92. https://doi.org/10.1016/j.ejvs.2010.10.003; PMID: 21095141. Bargellini I, Cioni R, Napoli V, et al. Ultrasonographic surveillance with selective CTA after endovascular repair of abdominal aortic aneurysm. J Endovasc Ther 2009;16:93–104. https://doi.org/10.1583/08-2508.1; PMID: 19281282. Nordon IM, Karthikesalingam A, Hinchliffe RJ, et al. Secondary interventions following endovascular aneurysm repair (EVAR) and the enduring value of graft surveillance. Eur J Vasc Endovasc Surg 2010;39:547–54. https://doi.org/10.1016/j. ejvs.2009.11.002; PMID: 19939711.

07/04/2019 15:40

Cardiology

Lifelong Learning for Cardiovascular Professionals

Vascular

Lifelong Learning for Vascular Professionals

DID YOU KNOW THAT RADCLIFFE GROUP PUBLISHES SIX REVIEW JOURNALS? PubMed indexed

PubMed indexed

Radcliff

REGISTER ONLINE FOR FREE ACCESS TO ALL JOURNALS, OPINION LEADER INTERVIEWS AND WEBINARS! Get in touch if you would like to: • Submit a review article • Be a peer reviewer • Host a webinar

Lifelong Learnin

CONTACT: Leiah Norcott Editorial and Publishing Director T: +44 (0)20 7193 0989 E: leiah.norcott@radcliffe-group.com

A4 Ad 2.indd 1

www.radcliffecardiology.com www.radcliffevascular.com

28/03/2019 23:22

Radcli

Lifelong Lea

WEBINARS ROUNDTABLES EXPERT INTERVIEWS JOURNAL PUBLICATIONS @radcliffeCARDIO

@RadcliffeVascu1

Radcliffe Cardiology

Radcliffe Vascular

Radcliffe Cardiology

radcliffe_cardiology

Radcliffe Cardiology

Lifelong Learning for Cardiovascular Professionals

A4 Ad 1.indd 1

ARTICLE PUBLICATIONS INDUSTRY NEWS CLINICAL TRIAL REVIEWS AND MORE...

Vascular

Lifelong Learning for Vascular Professionals

28/03/2019 23:17

Video

Education Streaming

CME Marketing

Vascular

Media

Radcliffe

Cardiology Online

Research

Courses

Medical

Digital

Publishing

Articles

Webinars

Healthcare Round Tables Surgeons

Journals Learning

Academic

www.radcliffecardiology.com A4 RadcliffeCardioAd 2018 op4.indd 1

06/05/2018 13:51