20 minute read
Aortic valve
FROM THE COVER DIVERSITY IN CARE
‘FROM BEING EXCLUSIVE TO MORE INCLUSIVE’ continued from page 1
the SVS in 2019. “At a time of unfortunate xenophobia in our culture, the SVS has always been an open international society, and this is no better reflected than in the backgrounds of so many of our past leaders,” he will tell attendees. The “unparalleled leadership of the SVS” in the field of vascular disease “reflects not only the wisdom of our past leaders,” but the organization’s commitment to evolution going forward, AbuRahma will say.
The chief of vascular and endovascular surgery at West Virginia University School of Medicine/Charleston Area Medical Center in Charleston, West Virginia, will spotlight how this evolution at the SVS has played out at the structural and committee levels.
“In the early SVS years, and during the first 50 years, there were very limited numbers of standing committees, including the membership, program, nominating [committees], and a committee on arrangements for VAM,” he plans to say.
AbuRahma will outline how the membership has expanded and become more inclusive, and how new dedicated membership sections for women, young surgeons and physician assistants, and for areas such as community practice and office-based labs, have broadened discussion and educational offerings.
He also will point out how changes at the SVS Nominating Committee level capture the essence of the Society’s evolution. “In the past, the SVS Nominating Committee consisted of three members appointed by the president one month before VAM, usually the three immediate past presidents, and its function was to compile a slate of officers to be presented to the Executive Council and members at the VAM,” AbuRahma will inform attendees. “Currently, it consists of seven members—the three most recent and surviving and available past presidents with the most senior as chair, one member that is elected annually from and by the 11 representatives of the regional and vascular societies serving on the Strategic Board, one member-at-large elected from the SVS membership who is not currently serving on the Executive Board, the vice-chair of the Community Practice Section, and the chair of Leadership and Diversity Committee.”
Looking ahead, AbuRahma will go on, the SVS must maintain focus on key areas, such as branding the specialty, continuing the fight for “fair and appropriate payment,” and continuing the support for those in community practice: “We must be united and have a common message across members and keep investing in embracing diversity and cultural change,” he will tell delegates.
“We should keep investing in our health and wellness and our early-career members which is critical for our future. We must continue to embrace quality in vascular patient care and finally we must work towards finding a common pathway in working with other non-vascular surgeon providers who practice endovascular therapy based on acceptable dedicated training in endovascular intervention.”
That harkens back to AbuRahma’s chosen topic for last year’s E. Stanley Crawford Critical Issues Forum in San Diego. The then incoming SVS president focused on the role of multispecialty care in vascular and endovascular surgery, hoping to get at least some answers to the question: Can the competing specialties of the vasculature work together?
AbuRahma assembled a panel of physicians covering every specialty involved in the treatment of vascular disease for the VAM 2021 event. During the Forum, AbuRahma himself declared: “Vascular providers must have defined, dedicated vascular and endovascular training during their formal residency or fellowship. Multispecialty practice, if feasible, will enhance and improve vascular care.”
At VAM 2022, AbuRahma is set to return to the topic, and will pose such questions as what strategy vascular surgery should deploy in order to ensure vascular procedures are carried out by appropriately trained specialists. “Many specialties are attracted to performing vascular procedures in light of workforce shortage, and mal-distribution creates access issues to vascular surgeons,” he will say. “Advances in treatment and device technology make therapy for an increasing number of vascular conditions within the perceived scope of other specialists, some of whom are without adequate training. The current policies and incentives are rewarding the wrong behavior with consequences of quality challenges, increased complications landing in vascular surgery practices, payment inefficiencies with overutilization and unnecessary procedures.”
He will once again raise the virtues of multispecialty practice, which traces its roots to his state—West Virginia—and the concept of a Vascular Center of Excellence model, such as the one developed at his institution: eight board-certified vascular surgeons, two board-certified cardiologists/vascular interventionists, one board-certified vascular medicine interventionist and one board-certified interventional radiologist.
AbuRahma conducted a survey of SVS members to assess the level of interest in multispecialty models of practice. Among the results, he found more than 50% of respondents saw cardiologists/interventional cardiologists and interventional radiologists as a threat among non-vascular surgeon providers performing procedures for vascular disease, while 58% said they did not form part of a multispecialty group that includes non-vascular surgeons.
What, then, should the strategy be? AbuRahma will ask: “How can the SVS best position itself to take the lead in shaping the future of vascular surgery care delivery, and optimizing patient outcomes? Can demonstrated competence and quality metrics be established and agreed upon across specialties? Who are the critical partners to engage in the dialogue?” And, he will add, “are there highly successful multispecialty models to be demonstrated? All of us know politics are local. Can we or should we influence and or impact training guidelines?”—Bryan Kay
ALI ABURAHMA
MULTIDISCIPLINARY CARE VASCULAR SURGEONS ‘HAVE A ROLE TO PLAY’ IN TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURES
VASCULAR SURGERY ASSISTANCE IN
transcatheter aortic valve replacement (TAVR) can facilitate safe and effective device introduction through cases involving challenging femoral or iliac access. This was the conclusion delivered by Enrico Gallitto, MD, from the University of Bologna, Bologna, Italy in a presentation looking at the role of the vascular surgeon in transcatheter aortic valve implantation.
During Thursday’s Plenary Session 3, Gallitto delivered the findings of an analysis of TAVR procedures assisted by vascular surgeons between 2016 and 2020—in what Gallitto describes as a “high-volume tertiary hospital.” Gallitto noted that TAVR has become the standard treatment for severe aortic valve stenosis among patients at both high and intermediate operative risk for surgical valve replacement.
Percutaneous transfemoral access is the preferred route for the procedure, he added, due to its low invasiveness and lower perioperative morbidity and mortality compared to transapical, transaxillary or transaortic approaches. However, Gallitto added that vascular access complications occurring from the transfemoral access are associated with prolonged hospitalization and 30-day mortality, and the presence of severe peripheral arterial diseases as well as aortic aneurysm or cerebrovascular insufficiency may necessitate concomitant endovascular management.
“A multidisciplinary team with interventional cardiologists and vascular surgeons may minimize the rate of vascular access complications in patients with challenging femoral/ iliac access and significant disease of other vascular districts,” he added, noting that this may be important to optimize the outcome of transfemoral TAVR. The study sought to evaluate the role of vascular surgeons in transfemoral TAVR.
Gallitto and colleagues looked at pre-, intra- and postoperative data for the given time period, which were clustered and retrospectively analyzed by a dedicated group of both interventional cardiologists and vascular surgeons.
Vascular access complications were defined according with the Valve Academic Research Consortium (VARC) 2 guidelines, and the outcomes of TAVR procedures with vascular surgeon involvement were assessed as the study’s endpoints.
Overall, Gallitto and colleagues assessed a total of 937 TAVR procedures performed with a transfemoral approach ranging between 78% (2016) and 98% (2020). Vascular surgeons were involved in 67 (7%) procedures.
Of these, three (4%) had indications for concomitant abdominal aortic aneurysm (endovascular aneurysm repair [EVAR]+TAVR), two (3%) with severe carotid stenosis (TAVR+CAS), and 62 (93%) had hostile femoral or iliac access or vascular access complications.
Balloon angioplasty of iliac artery pre-TAVR was performed in 51 cases (conventional percutaneous transluminal angioplasty [PTA]: 38/51‒75%; conventional PTA+intravascular lithotripsy [IVL]: 13/51–25%).
The TAVR procedure was successfully completed via the percutaneous transfemoral approach in all 62 cases with challenging femoral/iliac access, Gallitto reported. Vascular access complications necessitating interventions occurred in 18 out of the 937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (83%) and 15/18 (25%) cases, respectively. Fifteen/18 (83%) vascular access complications were treated during the index procedure, Gallitto reported, adding that there were no instances of procedure-related mortality or 30-day readmissions.
In his concluding remarks, Gallitto commented that the necessity of vascular surgeon assistance in TAVR procedures is “not infrequent”, and participation by vascular specialists allows safe and effective device introduction through challenging femoral/iliac access, for example.
“Similarly, the concomitant significant disease of other vascular districts can be safely addressed potentially reducing postoperative related mortality/morbidity,” he noted. “The organization of composite cardiological and vascular surgery teams should be encouraged wherever possible.”
Indications • The Valiant™ Thoracic Stent Graft with the Captivia™
Delivery System is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy, including: • iliac/femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; • nonaneurysmal aortic diameter in the range of 18 mm to 42mm (fusiform and saccular aneurysms/ penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and • nonaneurysmal aortic proximal and distal neck lengths ≥ 20mm (fusiform and saccular aneurysms/ penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.
Contraindications The Valiant Thoracic Stent Graft with the Captivia Delivery System is contraindicated in: • Patients who have a condition that threatens to infect the graft. • Patients with known sensitivities or allergies to the device materials. Warnings and Precautions The long-term safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm (>5mm), endoleaks, migration, inadequate seal zone, or continued flow into the false lumen in the case of a dissection) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant Thoracic Stent Graft with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. As cautioned in the Instructions for Use, a balloon should never be used when treating a dissection. The safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.
Heli-FX™ & Heli-FX™ Thoracic EndoAnchor™ Systems
Indications for Use The Heli-FX™ EndoAnchor™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX™ EndoAnchor™ system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor™ implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.
Contraindications Treatment with the Heli-FX™ EndoAnchor™ system is contraindicated for use in the following circumstances: • In patients with known allergies to the EndoAnchor™ implant material (MP35N-LT) • In conjunction with the Endologix Powerlink™* endograft
Warnings • The long-term performance of the EndoAnchor™ implant has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up visits to assess the patient’s health status and endograft performance. The EndoAnchor™ implant does not reduce this requirement. • The EndoAnchor™ implant and the Heli-FX™
EndoAnchor™ system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith™*, Cook Zenith™* TX2™*, Gore
Excluder™*, Gore TAG™*, Medtronic AneuRx™,
Medtronic Endurant™, Medtronic Talent™
AAA, Medtronic Talent™ TAA, Medtronic Valiant
Xcelerant™, Medtronic Valiant™ Captivia™, and
Medtronic Valiant Navion™ endografts. Use with endografts other than those listed above has not been evaluated. • The performance of the EndoAnchor™ implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor™ implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type
III endoleaks. • The performance of the EndoAnchor™ implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor™ implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures. • The performance of the EndoAnchor™ implant has not been evaluated for securing multiple anatomical structures together. Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events. MRI Safety and Compatibility • The EndoAnchor™ implants have been determined to be MR Conditional at 3T or less when the scanner is in
Normal Operating Mode with whole-body-averaged
SAR of 2 W/kg, or in First Level Controlled Mode with a maximum whole-body-averaged SAR of 4 W/kg. • Please refer to documentation provided by the endograft system manufacturer for MR safety status of the endograft system with which the EndoAnchor™ implants are being used.
Potential Adverse Events Possible adverse events that are associated with the Heli-FX™ EndoAnchor™ system, include, but are not limited to:
MRI Safety and Compatibility Non-clinical testing has demonstrated that the Valiant Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under specific conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.
Adverse Events Potential adverse events include, but are not limited to access failure, access site complications (e.g. spasm, trauma, bleeding, rupture, dissection), adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aortic expansion (e.g. aneurysm, false lumen), aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia/infarction, bowel necrosis, bowel obstruction, branch vessel occlusion, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA) / stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties / failures, dissection / perforation / rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion / erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortobronchial,
• Aneurysm rupture • Death • EndoAnchor™ implant embolization • Endoleaks (Type III) • Enteric fistula • Failure to correct/prevent Type I endoleak • Failure to prevent endograft migration • Infection • Renal complications (renal artery occlusion/dissection or contrast-induced acute kidney injury) • Stroke • Surgical conversion to open repair • Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula • Vessel damage, including dissection, perforation, and spasm Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the Instructions for Use provided with the endograft for additional potential adverse events.
Endurant™ II/Endurant™ IIs Stent Graft System
Indications The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX™ EndoAnchor™ system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks (see Neck length definition below). The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics: • Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories • Proximal neck length of ○ ≥ 10 mm; or ○ ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor system (bifurcated stent graft only)
Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.
• Infrarenal neck angulation of ≤ 60° • Aortic neck diameters with a range of 19 to 32 mm • Distal fixation length(s) of ≥ 15 mm • Iliac diameters with a range of 8 to 25 mm • Morphology suitable for aneurysm repair • patients with known sensitivities or allergies to the device materials. When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in:
• patients with known sensitivities to the EndoAnchor implant materials. For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device.
Warnings and Precautions • The long-term safety and effectiveness of the
Endurant II/Endurant IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or less than the recommended number of EndoAnchor system when used in short (≥ 4 mm and < 10 mm) proximal necks) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. • Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. • The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. • Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin. • Studies indicate that the danger of micro-embolization increases with increased duration of the procedure. The safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant II/Endurant IIs stent graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.
Adverse Events Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor system (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient aortoenteric, aortoesophageal, arteriovenous, and lymph), gastrointestinal bleeding /complications, genitourinary complications, hematoma, hemorrhage / bleeding, hypotension / hypertension, infection or fever, insertion or removal difficulties, intercostal pain, intramural hematoma, leg /foot edema, lymphocele, myocardial infarction, neuropathy, occlusion – venous or arterial, pain / reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, perfusion of the false lumen, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural / post-procedural bleeding, prosthesis dilatation / infection / rupture / thrombosis, pseudoaneurysm, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression / failure, sepsis, seroma, shock, spinal neurological deficit, stent graft material failure (including breakage of metal portion of device) / migration / misplacement / occlusion / twisting / kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, wound infection. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.
CAUTION: EndoAnchor™ implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zones. EndoAnchor™ implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2mm in thickness. Attempting to place EndoAnchor™ implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing.
fever and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis) Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Join us in booth #414
How can you optimize durability for your aortic patients?
Thursday, June 16 | 12:30 p.m. TEVAR in all DTA pathologies: 5-year insights from a real-world registry with Valiant™ Captivia™ Thoracic Stent Graft System
Frank R. Arko, III, M.D. | Jean M. Panneton, M.D.
Friday, June 17 | 9:30 a.m. EVAR in challenging AAA: 8-year insights from ENGAGE OUS registry with Endurant™ Stent Graft System
Marc Schermerhorn, M.D.
Thursday, June 16 | 3:00 p.m. Augmented Intelligence for endovascular care with Cydar EV Maps and Endurant™ Stent Graft System
Matt Waltham, M.D. | Ross Milner, M.D.
Friday, June 17 | 3:00 p.m. ESAR in wide necks: 3-year conclusions from ANCHOR registry with Heli-FX™ EndoAnchor™ System in reinforcing seal
Apostolos K. Tassiopoulos, M.D.
This seminar is restricted to physicians and teams trained in interventional vascular techniques treating patient populations described in the Instructions for Use for Medtronic endovascular therapies products. Medtronic product Instructions for Use and on-label product information can be found at http://manuals.medtronic.com/manuals/main/us/en_US/home. As a medical device manufacturer, Medtronic does not provide credentials or certify your professional medical skills and/or your ability to provide appropriate medical care to patients for whom you intend to use a Medtronic medical device. This content is not intended for attendees who practice in geographies where this product’s use has not been approved. Please see a Medtronic representative for additional information on product availability in your geography.
