Commenting on the findings in The Annals of Thoracic Surgery, Hamilton writes: “We are a global community representing a broad scope of practice and a variety of careers. However, our current society members are mostly
Of note, the data paint a picture of an overwhelmingly male community, with a 93% male membership across the four societies. EACTS had the highest proportion of women (9%), with ASCVTS (3%) the lowest. For the STS and the EACTS, the median age of female members was 48 (IQR 41, 57), which was younger than males (median 58, IQR 48, 68). When stratified in five-year increments, female members were mostly in the younger categories (35‒39, 40‒44, 45‒49, and 50‒54). Among the 788 female members, the most common practice area was adult cardiac surgery (27%), and when stratified by academic rank, 21% identified as assistant, 29% as associate, and 50% as full professor. Of all full professors, 5% (n = 141/2,569) are female. Most females practiced academic medicine (60%), and 45% of females (n=160/358) were in their early career stage. Additionally, most members were in the late stage of their careers (64%), with the AATS (94%) having the highest proportion of late-stage career members, and the STS (38%), the lowest.
THIS COMES AFTER A HOST OF NEW data were presented at EuroPCR 2022 (17–20 May, Paris, France) highlighting the potential of renal denervation as an adjunctive hypertension therapy, complementing existing treatments such as lifestyle changes and antihypertensive medications, researchers say.
Hamilton and colleagues examined membership data from the directories of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), the European Association for CardioThoracic Surgery (EACTS), and the Asian Society for Cardiovascular and Thoracic Surgery (ASCVTS) to gain a better understanding of the global composition of the cardiothoracic surgery community. Previous attempts to map out the make-up of the specialism have relied on survey data, which are potentially biased or limited by low response rates, Hamilton noted. The analysis looked at variables including gender, age, academic rank and practice area, which were categorised to include adult cardiac, general thoracic, cardiac and thoracic, congenital and other. A total of 12,053 membership profiles were captured in the analysis, the bulk of which (6,365) belonged to STS, followed by EACTS (3,661), AATS (1,495), and ASCVTS (532). Most members were located in the USA andAgeEurope.datawere available for STS and EACTS, and reflected a median age in both societies of 57 (interquartile range [IQR] 45,61). When stratified by society, STS was older with a median age of 60 (IQRThe50,71).largest area of practice was found to be adult cardiac surgery (31%), while more members practiced a combination of cardiac and thoracic surgery (20%), and over a quarter (26%) of members practiced combinations including vascular surgery and critical care.
A new consensus statement—in development from the European Society of Cardiology (ESC) and the European Association of Cardiovascular Interventions (EAPCI)—will take into account latest evidence of the safety and efficacy of renal denervation as a devicebased treatment for hypertension from sham controlled trials.
“We know from large meta-analyses and prospective randomised clinical trials that reducing blood pressure is impactful for patients,” he added. “The problem is not that we do not know that blood pressure is a serious issue, the problem is that we have available drugs that work quite well but patients do not like them and do not take them. There is obviously an unmet need, and renal denervation represents a device-based treatment option to tackle that problem.”
Continued on page 4
Featured in this issue: August 2022 | Issue 66 www.cardiovascularnews.com
A new dawn for renal denervation? Latest data to feature in fresh guidelines
Speaking at the four-day EuroPCR meeting, Felix Mahfoud (Saarland University Hospital, Hamburg, Germany) commented that renal denervation represents a device-based treatment option to tackle a potentially unmet clinical need for some patients.
TR: New data at 2022EuroPCR page 18 Profile: pageNguyenTom14 8 CX ViennaAortic Preview Continued on page 2 It is crucial that we wake up to these issues and create action on both individual and leadership levels” Barbara Hamilton 31% surgeonscardiac 93% maleCardiothoracicsurgerycommunityinnumbers 12,053 membersprofiled EACTS has the highest proportion of female members 9% 64% in later stages of career
“Despite all advances in care we still have a significant proportion [of patients] that are either undiagnosed or not sufficiently controlled to target blood pressure, and that holds true for almost all regions and geographies around the world,” Mahfoud said.
The time for change is now: Call for action over age and gender profile of global cardiothoracic surgery community
The future of the specialty depends on its ability to evolve and grow and efforts must be made to attract trainees that represent a diverse patient population, the author of the analysis, Barbara Hamilton (University of California, San Francisco, San Francisco, USA), writes in The Annals of Thoracic Surgery this month.
In a hot-line session at EuroPCR, Mahfoud presented the three-year Global Symplicity Registry results, assessing blood pressure and CLASP
Analysis of the global make-up of the four largest global societies for cardiothoracic surgery suggest that the field is currently dominated by an older and predominantly male workforce.
The release of data from three clinical studies—the Global Symplicity Registry, SPYRAL HTN-ON MED and a pooled analysis of ultrasound renal denervation from the RADIANCE HTN SOLO and TRIO trial cohorts—add to renewed interest in renal denervation as a novel treatment modality for patients with hypertension, after a first generation of clinical trials showed mixed results following the procedure.
n A SHORTCUT TO CORONARY ACCESS: Attendees to both EuroPCR (17 20 May, Paris, France) and TVT 2020 (The Structural Heart Summit, 8 10 June, Chicago, USA) heard the latest insights into the use of a device intended to prevent coronary obstruction after transcatheter aortic valve implantation (TAVI), that investigators believe will be an increasing need as the procedure continues to develop in younger, lower risk patients.
“The take-home message of this study is clear: we must make our specialty more attractive to female surgeons, and take active steps to increase the presence of female surgeons in leadership positions within the associations,” J Rafael Sádaba (Hospital Universitario de Navarra, Pamplona, Spain), a co-author on the study and EACTS secretary general told Cardiovascular News “I was glad to see that EACTS leads the way, not only in the overall proportion of female surgeons among our members, but more importantly, in the percentage of female trainees. Nevertheless, there is plenty of room for improvement, and we continue to strive for a gender balance among membership and leadership positions, and in our daily activities as an association.”
the
n IN PROFILE: Cardiothoracic surgeon Tom Nguyen (San Francisco, USA) speaks to Cardiovascular News about the importance of taking a cross-disciplinary approach to cardiovascular care, and why he believes that training in both surgical and transcatheter approaches to treat heart disease have been an important driver in his development, as well as the future of robotic cardiac surgery.
For more on this story go to page 19.
DvirDanny
Continued from page 1
The time for change is now: Call for action over age and gender profile of global cardiothoracic surgery community male, of older age, in their later career stage, and of high academic rank.” The future of the specialty depends on the ability to evolve and grow, Hamilton comments, adding that to do so the field must be able to attract trainees that represent the patients that are served.
Printed by: Buxton Press Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2022. All rights reserved. Write to us! If you have comments on this issue or suggestions for upcoming editions write to will@bibamedical.com Make sure you get your copy of Next issue: October 2022 Publisher: Roger Greenhalgh Content Director: Urmila Kerslake Editor-in-chief: Simon Redwood Senior editor: Will will@bibamedical.comDate Editorial contribution: Jamie Bell, Jocelyn Hudson, Adam Pearce, Clare Tierney Design: Terry Hawes, Wes Mitchell and David Reekie Advertising: Labinot Sherifi labinot@bibamedical.com Subscriptions: Pleasesubscriptions@bibamedical.comcontactthe Cardiovascular News team with news or advertising queries Tel: +44 (0)20 7736 8788 We must make our specialty more attractive to female surgeons, and take active
to
n ANDCOVID-19STEMI: Emerging data set out the stark impact resulting from the disruption to care for patients with STelevation myocardial infarction (STEMI) during the early period of the COVID-19 pandemic in both Europe and the USA in 2020. This is among the new data that have lead experts to warn that cardiovascular care could be severely disrupted across the globe for years to come.
“We must work to balance our community, support, promote, and increase the visibility of female and other under-represented trainees and surgeons,” Hamilton adds.Although the results of the analysis point towards an overwhelmingly male community, Hamilton recognises that study gains have been made in female representation.“Wefoundthat EACTS had the highest proportion of female members (9%) and that 25% of EACTS trainees were female,” the author writes, noting that most females were in the early stages of their career and more likely to be cardiac surgeons.
Published by: BIBA Publishing, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 steps increase presence of Sádaba
female surgeons in leadership positions within the associations” J Rafael
“The representation of women in the active cardiothoracic surgery workforce has consistently increased from 4% in 2007 to 8% in 2020,” Hamilton continues. “However, this progress is offset in comparison with the medical world at large, which consists of 46% female trainees and 36% active physicians (across all specialties), and by the lack of female representation in senior and leadership positions.”Femalevisibility in leadership roles at national cardiothoracic surgery meetings has traditionally been poor, she adds, with 13% of session leaders between 2015 and 2019 being female, and most past sessions being led by all-male panels. Hamilton notes that the study does have limitations, including that the data do not represent the true practicing cardiothoracic surgery workforce. In particular, due to data protection regulations, the study team were unable to cross-check data and remove duplicate or overlapping memberships within
For more on this story go to page 14.
some societies, meaning some individuals may have been double counted.
2 August 2022 | Issue66 inNewsbrief The latest stories from the world of Cardiology facebook.com/cardiovascularnews linkedin.com/company/cardiovascular-news @cn_publishing www.cardiovascularnews.com Top Stories
“It is crucial that we wake up to these issues and create action on both individual and leadership levels. This action can include changing the narrative we have with students and trainees to highlight the need for and joy of our specialty, and by consciously promoting under-represented and female members of our societies, academic institutions, and communities. Actively supporting these minority members for visible and highranking positions can create change from top to bottom through not just action but inspiration. The time for change is now.”
“We are global with a diversity of careers but concerning factors that require immediate attention,” Hamilton writes in her concluding remarks. “We are ageing and unbalanced in terms of sex, and risk losing the ability of our specialty to achieve longevity and sustainability. We must attract young students and residents, as well as support and encourage talented female and other under-represented trainees and young faculty members. We have made some small strides in these areas, but plentiful opportunities exist for continued growth and development.
For more on this story go to page 7.
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“We need to work up to exclude different phenotypes, especially of secondary hypertension or with increased arterial stiffness, that should not be treated by renal denervation, focusing on what we know from the trials to select younger patients, difficult to control patients, those who are also willing to have renal denervation because they do not want to take any more medications or are completely nonadherent to treatment ,” comments Azizi. dawn for renal denervation?
Alongside Mahfoud and Kandzari, Ajay Kirtane (Columbia University Irving Medical Center/ NewYork Presbyterian Hospital, New York, USA) offered findings of a patient-level pooled analysis of ultrasound renal denervation in the RADIANCE HTN SOLO and TRIO trials. The analysis tracked the use of ultrasound renal denervation using the Paradise (Recor Medical) system in a drug-resistant population (three years or more of antihypertensive medications) taken from the RADIANCE-HTN TRIO study, and from RADIANCE-HTN SOLO, in a population with mild-to-moderate hypertension (controlled on 1-2 antihypertensive medications or uncontrolled on 0-2 medications). The results of the analysis showed that there was no heterogeneity in effect on blood pressure reduction and medication burden. Those results looking at a mixed population over a six-month period favoured ultrasound renal denervation over the sham population and the pooled analysis of the RADIANCE-HTN trials suggests “the response to ultrasound renal denervation is similar in the presence or absence of medications and consistent across the whole spectrum of “Wehypertension.”showedby combining these two trials that during six-month follow-up, the average drop in blood pressure, either evaluated by ambulatory blood pressure monitoring or home blood pressure monitoring, was around 5‒6mmHg systolic blood pressure difference, which is highly statistically significant,” Michel Azizi (Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France), the co-primary investigator in the trials, tells Cardiovascular News. “It is also highly clinically significant in terms of ambulatory blood pressure decrease which is larger than the office blood pressure decrease.
“Renal denervation therapy has travelled a very storied path over the past five, 10 or 15 years, with initial unbridled enthusiasm to disillusionment with the SYMPLICITY HTN 3 study, and now revitalised with five successive sham-controlled randomised trials with two different treatment methods showing, not only statistically significant, but clinically meaningful improvements in blood pressure,” Kandzari told Cardiovascular News, reflecting on the direction of travel for the treatment to date. In his presentation, Kandzari noted that although early results from the pilot study showed that patients who underwent renal denervation while on antihypertensive medications had lower blood pressure when compared to the sham control group, the effect of renal denervation on blood pressure burden over time had not been established.
Considering how the new data are likely to shape the future path, Kandzari told Cardiovascular News: “We are not quite at the point where renal denervation therapy is available commercially, but we are nearing that point through the completion of ongoing clinical trials and then we start to think—as has already been proposed by societal documents in both Europe and the USA—about patient indications and who might be the ideal patient population.”
During the same EuroPCR session, David Kandzari (Piedmont Heart Institute, Atlanta, USA) delivered three-year data from the SPYRAL HTN-ON MED trial, which is also investigating Medtronic’s Symplicity Spyral renal denervation system, and offers an overview of the impact of renal denervation on long-term time in target blood pressure range compared with sham control.
A new
August 2022 | Issue664
With this latest report, a time in target therapeutic range analysis was performed using data comparing the two groups over three years and showed that renal denervation was associated with significantly higher time in target therapeutic range, with more time in the blood pressure target range at two and through to three years as compared to the sham group, thus affirming the sustained efficacy of renal denervation over lateterm follow-up. The benefits were observed against the background of similar if not higher medication dose and number in the sham control group.
Latest data to feature in fresh guidelines Continued from page 1
“This occurred with less medication prescribed to the patients randomised to the renal denervation group by physicians kept blind to the randomisation for six months, [and] increases the evidence around the mid-term blood pressure lowering efficacy of renal denervation using an ultrasound catheter for six months. It also was extremely safe, [with] no major safety issues,” Azizi comments.
Renal therapydenervationhastravelled a very storied path over the past five, 10 or 15 years, with initial unbridled enthusiasm to disillusionment with the SYMPLICITY HTN 3 study, and now revitalised with five successive shamcontrolled trials” David Kandzari We need to work up to exclude different hypertensionsecondaryespeciallyphenotypes,of or with increased arterial stiffness, that should not be treated by denervation”renal Michel Azizi
Renal Denervation major adverse cardiovascular events (MACE) after renal denervation using Medtronic’s Symplicity system. The results showed that a 10% ‘time in target range’ increase in the first six months reduces the odds of MACE events in the following 24 months and led to the conclusion that sustained blood pressure reduction after renal denervation predicts a meaningful reduction in clinical events. In the large, global registry that involved 3,077 patients who underwent radiofrequency renal denervation, a greater amount of time in target blood pressure range was associated with fewer cardiovascular events including cardiovascular death, myocardial infarction, and stroke. Mahfoud commented that, though the data come with some limitations, they are “encouraging” and show for the first time patients with a higher time in target range following renal denervation have reduced events. “That should convince people that lowering blood pressure with renal denervation translates into improved outcomes,” he remarked.
Furthermore, he notes that at the European level, ESC and EAPCI are bringing a new position statement on renal denervation taking into account the latest evidence from the different clinical trials. The topic will feature in a focused session at the ESC Congress 2022 (26–29 August, Barcelona, Spain).
“The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move towards a consistent method of diagnosing kidney diseases that is independent of race.” Paul Palevsky Renal reckonscommunitywithremoval of race variable in kidney disease diagnosis
dialysis care on page
*Available for US and EU readers only **Available worldwide Visit renalinterventions.net and click ‘Subscriptions’ for complimentary print subscription* and e-newsletter subscription** AvailableSubscribetodayinprintanddigitalformatsandthroughoursocialchannelsOctober 2021 issue:thisIn Profile: Mallios page atTwelve-monthCIRSE2021 dialysisDialysis:care page inHealthcareTransplantation:disparitiesthespotlight page 20 news, insight and the American Society of Nephrology (ASN) have jointly released report outlining a new race-free approach to diagnosing kidney disease. In its report, the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease recommends the adoption of the new estimated glomerular ltration rate (eGFR) 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation that estimates kidney T move towards consistent method of diagnosing kidney diseases that independent of race. While the work of the task force is an important initial path forward, both of our organisations are committed to continuing to work to eliminate disparities in the diagnosis and treatment of kidney disease.” “As the largest organisations representing kidney patients and health professionals, NKF and ASN are committed to eliminating health disparities that harm kidney patients, and ensuring that racial bias does not ect the diagnosis and subsequent treatment of kidney diseases,” said ASN president Susan Quaggin. “By recommending the CKD-EPI creatinine equation re without the race variable, the task force has taken action and demonstrated how nephrology continues to lead the way in promoting healthcare justice. It time for other medical specialties to follow our lead, and NKF and ASN stand ready to help however we can.” In the USA, more than 37 million adults have kidney diseases and 90% are not aware they have diminished kidney function, the NKF-ASN statement adds, with disproportionate number of these patients being Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, and Native Hawaiian Bioarti cial device preclinicalafterKidneyXreceivesawardreachingtesting kidney device (iBAK) has moved closer to becoming reality after being awarded US$650,000 prize from KidneyX. The device’s creator, the Kidney Project, received this award following the rst ever demonstration of its functional prototype. The Kidney Project is a US-wide collaboration led by Shuvo Roy (University of California San Francisco [UCSF], San Francisco, USA) and William Fissell (Vanderbilt University Medical Center, Nashville, USA). In the past few years, it has successfully tested the two essential components that make up its arti cial kidney technology—a haemofilter, which removes waste products and toxins from blood, and bioreactor, which winning teams selected from eld of innovators across Canada, Israel, Japan, The Netherlands, Portugal, Singapore, South Korea, the UK, and the USA. Other recipient technologies included wearable, lightweight, dialysate-free arti cial kidney (US Kidney Research Corporation) and genetically engineered pig kidneys designed to increase supplies of transplantable organs (Makana Therapeutics).
A trusted provider of latest news, review of cutting-edge research, congress coverage and opinion from thought leaders A specialised news source in the field of renal managementdisease independentEditorially
Continued
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For the current, retrospective study, the researchers collected data on health claims from 2016 to 2018 for discharges from acute care hospitals across 11 states in the USA. Patients were aged over 18 and they were followed up for an average (median) of 1.7 years. The researchers adjusted their analyses to account for factors that could affect the results such as age, sex, race, insurance status, medical history and body mass index.
AF after surgery is linked to hospitalisationofincreasedanriskheartfailure
Among 76,536 patients undergoing heart surgery, 14,365 (18.8%) developed postoperative AF and the risk of hospitalisation for heart failure increased by a third compared to patients who did not develop AF. Among 2,929,854 patients with no history of heart disease who had surgery, 23,763 (0.8%) developed AF and the risk of hospitalisation for heart failure doubled. The first author of the study, Parag Goyal (Weill Cornell Medicine, New York, USA), said: “Our study, which to our knowledge is the largest study to date, shows that postoperative atrial fibrillation is associated with future heart failure hospitalisations. This could mean that atrial fibrillation is an important indicator of underlying but not yet detected heart failure; or it could mean that atrial fibrillation itself contributes to the future development of heart failure.
Issue65 | August 2022 7 Cardiovascular surgery
Post-operative AF occurs in up to 40% of patients undergoing heart surgery and 2% of patients undergoing non-cardiac surgery. Doctors have tended to view it as a benign event, triggered by the stress of the surgery. However, evidence is emerging that postoperative AF is linked to longer term problems such as stroke and death from any cause, although, until now, there has been limited evidence regarding its association with subsequent heart failure.
The patients’ survival rate was 90.2% at one year, 67.9% at five years, 31.1% at 10 years and 8.2% at 15 years, according to the study. The surgical mortality rate was 4%, but it declined significantly during the 26-year study period. Mortality in the last three years of the study period was 1.6%. Risk factors associated with reduced survival time included advanced age, diabetes mellitus, smoking history and chronic lung disease. Just over 56% of the surgeries were elective procedures, 40% were performed in urgent situations and 3.8% were
Researchers reviewed case histories for 1,283 patients who were older than age 80 and underwent primary isolated CABG at Mayo Clinic in Rochester between 1 January 1993 and 31 October 2019. Median survival time was 7.6 years, compared with six years for ageand sex-matched octogenarians in the general US population.
“Theemergencies.longermedian survival in octogenarians undergoing surgery and the relatively low rates of complications observed in our study imply that with tailored surgery candidacy and consideration of specific high-risk factors, CABG may be an important treatment strategy for those patients with multivessel coronary artery disease,” says Choi.
“Regardless of the mechanism, our study shows that postoperative atrial fibrillation is clearly an important entity that merits attention and incorporation into decisionmaking. Most importantly, patients and doctors need to be more vigilant about heart failure symptoms among patients who develop postoperative atrial fibrillation. Those who do develop the condition may require more aggressive treatments for other risk factors for heart failure, such as high blood pressure, diabetes and narrowing of the arteries.”
Regardless of the mechanism, our study shows that postoperative atrial fibrillation is clearly an important entity that merits attention and incorporation into decision-making”
People who develop an arrhythmia after surgery have an increased risk of subsequently being admitted to hospital with heart failure, according to a study of over three million patients published in the European Heart Journal. The study showed that the risk of hospitalisation for heart failure among patients who developed atrial fibrillation (AF) after surgery increased regardless of whether or not the surgery was for a heart condition.
While this study could not specifically address which of these mechanisms are at play, our hope is that this study will inspire future work into exploring the underlying mechanism seen in our important findings.
CABG “associated with favourable outcomes and increased long-term survival” octogenariansamong
The strength of this study is its large size, according to the researchers. Limitations include the fact that it is an observational study and, therefore, cannot prove that postoperative AF causes heart failure, only that it is associated withTheit.researchers hope to conduct further studies to understand the underlying mechanism and to investigate ways of preventing future hospitalizations for heart failure among patients who develop postoperative AF.
FURTHER RESEARCH IS NEEDED to identify patient groups that may benefit most from surgical revascularisation, according to Choi and co-authors of the study published in Mayo Clinic Proceedings
“Our results show that coronary artery bypass surgery can be beneficial for patients over age 80,” says Choi, a clinical fellow in cardiac surgery and the study’s first author. “The key is to carefully identify patients who can most benefit from the procedure. That is what future research can help with: to identify subgroups of patients who can most benefit.”
A retrospective study from Kubkin Choi and researchers from Mayo Clinic (Rochester, USA) has found that coronary artery bypass grafting (CABG) in patients over the age of 80 was associated with favourable outcomes and increased longterm survival, despite carrying a high surgical risk.
In the conclusion to the paper, the researchers write: “In the meantime, clinicians should be aware that POAF [postoperative AF] may be a harbinger of heart failure.”
In an editorial to accompany the paper, Melissa Middeldorp and Christine Albert (both Smidt Heart Institute at CedarsSinai, Los Angeles, USA), write: “These data add to a growing body of literature suggesting that POAF is not just a transient response to surgery but may be reflective of underlying atrial and myocardial structural changes that not only predispose to the acute AF event but to other potentially related adverse cardiovascular events, such as heart failure hospitalisation.”
CX Aortic Vienna: Cardiac and vascular surgeons collaborate at the vanguard of aortic care
Joseph Coselli
“I have had the honour and the privilege during my career to treat the aorta from the aortic valve all the way to the femoral arteries,” notes Joseph Coselli (Houston, USA), who has been among the expert speakers to have participated in previous editions of CX Aortic Vienna and is returning in 2022. “The entire history of aortic surgery, and vascular surgery to the same extent, has been one of technical and clinicalCosellievolution.”adds:“The Charing Cross meetings are among the best with regard to the broad spectrum of technology and clinical information and sharing among experts. I would invite everyone to take the opportunity to learn a lot about vascular and aortic surgery at CX Aortic Vienna.”
The programme encompasses discussion and debate spanning key talking points in the aortic space including aortic arch interventions, thoracic dissection, thoracic imaging, thoracoabdominal techniques, juxtarenal, abdominal aortic and iliac artery therapies.
Roger Greenhalgh
HAVING ATTRACTED A GLOBAL, ONLINE audience during its first two editions, CX Aortic Vienna will continue to reach out to the worldwide aortic surgery community. The 2022 edition features three days of high-quality digital programming, to be broadcast live from 24–26 October for the wider global audience, delivering a total of 15 hours of aortic education, which will also be available ondemand to registered attendees after the event. The format for the digital edition will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast. The programme includes open and endovascular aortic techniques and technologies, including edited aortic cases. For the first time, the meeting will also offer an in-person component from its home city, Vienna, Austria, where CX Aortic Vienna has been invited to provide two 90-minute primetime cutting-edge English-language sessions for attendees of the Dreiländertagung—the joint meeting of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG) and the German Society of Vascular Surgery (DGG)—on Thursday, 20 October. World-leading faculty
The entire history of aortic surgery has been one of technical and clinical evolution
Talking points
“This is not just the surgeons, but the physicians—we have radiologists, imaging experts, vascular scientists and vascular nurses. All who manage aortic patients are welcome to come and join us for the digital edition on 24, 25 and 26 October this year.”
“CX Aortic Vienna is the unique chance to get together with cardiac surgeons and all kinds of vascular specialists that are treating the aorta,” says Zimmermann, discussing the importance of the multidisciplinary focus at the heart of CX Aortic Vienna. “The problem is that we have a transition zone in the arch and we—as vascular surgeons— move further and further into the ascending aorta with our endovascular techniques. This can only be done with the support of the cardiac surgeons, and this is the reason why we really look forward to CX Aortic Vienna because everyone comes together addressing this complex field.“
CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The meeting will showcase the latest approaches—open and endovascular—for the treatment of complex aortic problems spanning the aortic valve to the iliac arteries.
Multidisciplinary approach The importance of multidisciplinary aortic approaches will be a key strand running through CX Aortic Vienna’s content and discussion, and the 2022 event will continue its mission to bring together specialists of all skills—be they cardiac, vascular or endovascular—to provide a comprehensive overview of cutting-edge aortic treatment.
We are focusing on both open andtechniquesendovascular
The full programme has been curated by a Vascular, Endovascular and Cardiothoracic Executive board comprised of leaders in the field of aortic care including CX Aortic Vienna founding chair Roger Greenhalgh (London, UK), alongside Tilo Kölbel (Hamburg, Germany) who will moderate the inperson session at Dreiländertagung, Afshin Assadian (Vienna, Austria), Roberto Chiesa (Milan, Italy), Martin Grabenwöger (Vienna, Austria), Stéphan Haulon (Paris, France), Gustavo Oderich (Houston, USA), Markus Steinbauer (Regensburg, Germany) and Alexander Zimmermann (Zürich, Switzerland).
Tilo Kölbel
C M Y CM MY CY CMY K 8 Cardiovascular surgery August 2022 | Issue65
“October is the time for aortic disease and to discuss newest trends, technologies and features in aortic therapy,” comments Kölbel. “We are focusing on both open and endovascular techniques and we are inviting the cardiovascular and vascular communities to come to CX Aortic Vienna, with a presence during the Dreiländertagung, and very much to the virtual event that happens a few days later.”
CX Aortic Vienna is for all of those who manage the aorta
From 2023 onwards, CX Aortic Vienna will be held annually in October as a hybrid meeting in-person in Vienna whilst simultaneously livestreaming globally.
“This is, as always, a focus upon the aorta as managed by cardiac aortic surgeons, open vascular surgeons and endovascular surgeons; from the aortic valve at one end, to the iliacs at the other end,” says Greenhalgh of the event’s 2022 edition. “CX Aortic Vienna, for those of you who have been to it before, is for all of those who manage the aorta,” he adds.
and
speciality
sessions on-demand CX Aortic Vienna
aortic approaches
our
AORTICVIENNA cxaortic.com CLASSICAL OPEN AND ENDOVASCULAR SOLUTIONS CARDIAC, VASCULAR AND ENDOVASCULAR AORTIC ADVANCES DIGITAL EDITION, LONDON 24–26 OCTOBER 2022 REGISTER NOW
in
All the speakers were excellent. It was a perfect overview, I was able to look back at the was a revolution in and updated knowledge the It was a great use of my time.learning!Intensive
Socioeconomic factors may guide choice of coronaryrevascularisationmyocardialoptionsforarterydisease
Though the choice of myocardial revascularisation strategy—either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)— among patients with coronary artery disease remains a topic of some debate among surgeons and interventional cardiologists, one study has found that socioeconomic factors may play an important role in determining treatment choices.
RESEARCH PUBLISHED IN The Annals of Thoracic Surgery suggests that high socioeconomic distress is associated with greater risk-adjusted odds of PCI relative to CABG among a US patient population. This is the conclusion put forward by Raymond J Strobel (University of Virginia, Charlottesville, USA) and colleagues following examination of data from the American College of Cardiology (ACC) CathPCI registry and the Society of Thoracic Surgeons (STS) database, taken between 2018–2021.Strobel et al write that
understandingtheandtrialsthecontroversyrecentregardinginterpretationofcomparingPCICABG“highlightimportanceofwhatmay influence the decision to offer PCI or CABG for the treatment of coronary artery disease”. The influence that socioeconomic status may have on such a treatment choice is unknown, the authors add, noting that recent work has demonstrated that patients undergoing both PCI and CABG are becoming more diverse and less affluent over time. In order to characterise the influence of socioeconomic determinants of health on the choice of PCI or CABG, the study team undertook a multicentre, retrospective cohort study of patients undergoing either of the two treatment strategies, logged as documented in either of the twoPatientsregistries.were assigned distressed communities index (DCI) scores, a socioeconomic ranking that uses factors including educational level, poverty, unemployment, housing vacancies, median income, and business growth, with patients ranked on a score between zero for no distress to 100 denoting a high level of distress. The most distressed quintile of patients, those with a DCI ≥80, were compared to all other patients. Strobel et al analysed data from a total of 23,223 patients who underwent either PCI (n=16,079) or CABG (n=7,144) for coronary artery disease across 28 centres during the study period. They note that prior to adjustment, high socioeconomic distress occurred more amongfrequentlyCABGpatients (DCI ≥80; 12.4%, p<0.001). However, after CABGreceivingwithdistresshighresearchersadjustment,multivariablethereportthatsocioeconomicwasassociatedgreateroddsofPCIrelativeto(oddsratio[OR] 1.26; 95%, confidence interval [CI] 1.07–1.49, p=0.007). Furthermore, the study team reports that high socioeconomic distress was significantly associated with postprocedural mortality (OR 1.52, CI 1.02–2.26,Discussingp=0.039).someof the underlying data and potential contributing factors to their findings, Strobel et al comment in their paper that patients in high DCI communities may not be able to financially tolerate the longer recovery time associated with surgery, leading them to preferentially pursue PCI. Alternatively, the authors add, it is possible that patients residing in communities with high DCI may be counselled against pursuing surgery due to perceived difficulties with post-surgical recovery due to a lack of financial or social support.
In June, INTEGRITTY group members Alessandro Parolari (University of Milan, Milan, Italy), Rui Almeida (Universidade Estadual do Oeste do Paraná, Cascavel, Brazil) and William E Boden (Boston University School of Medicine, Boston, USA) submitted a commentary article to European Heart Journal in response to an earlier viewpoint in the same publication from Mario Gaudino (Cornell Medicine, New York, USA), Michael E Farkouh (University of Toronto, Toronto, Canada) and Gregg Stone (Mount Sinai Medical Center, New York, USA). Gaudino, Farkouh and Stone had sought to reconcile evidence informing clinical decision-making relating to the choice between PCI or CABG for patients with left main disease and how this should guide treatment decisions. Parolari, Almeida and Boden write that they “strongly endorse” the creation of a new, transparent consensus document “that is rigorously and ethically configured by a meticulous and thorough revision of current guidelines on this topic and which is eventually endorsed by the vast majority of scientific cardiovascular, both cardiologic and surgical, societies”.
Our scope is to appraise and
interpretationdescriptionindependentandteamaevidenceevaluatethroughmultidisciplinaryofexperts,provideanandofit”
distressedsocioeconomicallyoddsRisk-adjustedofreceivingPCIvs.CABGforpatients1.26 OR
Cardiac surgeons from North America, Europe and Latin America are among the signatories to a multidisciplinary group seeking to address what it describes as a “widening gap” between evidence and guideline recommendations in cardiovascular medicine.
“The vision of INTEGRITTY is to promote and provide unbiased, critical and unconflicted evidence in cardiovascular medicine in order to aid healthcare professionals to make the best choice with patients, in compliance with the mission of academic institutions and scientific societies of pursuing consistency of knowledge and evidence-based decision-making,” the group’s statement notes. “Our scope is to appraise and evaluate evidence through a multidisciplinary team of experts, and provide an independent description and interpretation of Init.”the INTEGRITTY group’s crosshairs is the ongoing debate surrounding the interpretation of trial data comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for patients with left main disease, and how this should guide treatment decisions. This has been a topic of particular debate between sections of the cardiac surgery and interventional cardiology communities for some time. Of note, the European Association for Cardio-Thoracic Surgery (EACTS) withdrew support for 2018 guidelines for the treatment of patients with left main coronary artery disease and stable angina. This came after a BBC investigation cast doubt on the findings of the EXCEL clinical trial, which was among the evidence used to inform the drafting of the guidelines.
Divisions were once again in evidence when the American Association for Thoracic Surgery (AATS) and The Society of Thoracic Surgeons (STS) opted not to endorse new joint guidelines for coronary artery revascularisation, issued in late 2021.
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INTEGRITTY—International Evidence Grading Research Initiative Towards Transparency and Data Quality—is a response to the “increasing confrontations between groups with duality of interests, such as intellectual, political or financial”, founding members said in a statement published online. “This has reached an unacceptable level, and major randomised controlled trials and guidelines are questioned in their credibility,” the statement goes on to add. Twenty-three cardiac surgeons and cardiologists are listed as members of the group and they include Fabio Barilli (S Croce Hospital, Cuneo, Italy), Victor Dayan (Universidad de la República, Montevideo, Uruguay), Milan Milojevic (Dedinje Cardiovascular Institute, Belgrade, Serbia), J Rafael Sádaba (Hospital Universitario de Navarra, Pamplona, Spain) and John Mandrola (Baptist Health Louisville, Louisville, USA).
Cardiac surgeons among signatories to group seeking “critical appraisal” of evidence in cardiovascular medicine
implantassistleftsurvivalnotvolumeSurgeondoesimpactafterventriculardevice
Issue66 | August 2022 11
Chiang commented: “We used an adaptive trial design with a planned interim analysis to allow for early stopping of the trial for efficacy or futility and to allow for sample size re-estimation.”
Concurrent tricuspid valve surgery and left ventricular assist device implantation do not lower the incidence of right heart failure
There was no significant difference in the primary outcome of the two arms. At six months, 46.43% of the TVR group and 43.75% of the No TVR group had experienced moderate to severe RHF. The study also looked at the incidence of all-cause mortality, atrioventricular block, major bleeding, prolonged mechanical ventilation, and stroke, and found no statistically significant difference. Based on this analysis, the trial has been discontinued for futility. Chiang said that they plan to follow-up with these patients and perform another analysis at one year to evaluate whether there are long-term benefits.
In complex operations, surgeon volume may impact outcomes, the study’s authors note, adding that their research sought to understand if individual surgeon volume affects LVAD outcomes.
The study’s authors report that there were 315 patients who met inclusion criteria—45 in the low-volume group and 270 in the high-volume group. There was no difference in survival to hospital discharge between the low (91.9%) and high (83.3%) volume matched groups (p=0.22). Survival at one year was also similar (85.4% vs. 80.6%, p=0.55), Boudreaux et al report.
Study stratifies pacemaker rates associated with tricuspid repair after mitral valve surgery
The purpose of the TVVAD trial was to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients who present with moderate or severe TR. This study evaluated whether concurrent surgical correction of moderate or greater TR in patients undergoing LVAD implantation prevents postoperative RHF compared to LVAD implantation alone.
BishawiMuath
Muath Bishawi (Duke University, Durham, USA), co-principal investigator for the trial, added: “In our study, we focused on the primary endpoint, which was right heart dysfunction up to six months. Many other endpoints in the study, however, may be of interest to focus on for future trials. These may include late re-admissions beyond six months, quality-adjusted life years, and cost in hospital and long-term care.”
Concomitant tricuspid annuloplasty is the only independent risk factor for permanent pacemaker implantation in patients undergoing mitral valve surgery for degenerative mitral regurgitation, research presented at the American Association for Thoracic Surgery annual meeting (AATS 2022, 14–17 May, Boston, USA) by Gorav Ailawadi (University of Michigan, Ann Arbor, USA) has concluded.
T his was the conclusion of the TVVAD trial, findings of which were presented at the American Association for Thoracic Surgery annual meeting (AATS 2022, 14–17 May, Boston, USA). RHF continues to be a major source of morbidity and mortality following LVAD implantation, authors of the study note. Tricuspid regurgitation (TR) is frequently observed preoperatively in patients undergoing LVAD implantation; and the presence of moderate or severe TR prior to LVAD appears to be associated with a high incidence of RHF during the first six months after the Severalprocedure.retrospective studies have evaluated whether concurrent surgical correction of the tricuspid valve at the time of LVAD implantation can reduce postoperative RHF and improve outcomes. Most of these studies did not demonstrate a significant benefit for concomitant tricuspid surgery; however, these analyses are inherently limited by selection bias.
Sixty patients with moderate or severe TR on preoperative echocardiography were randomised to either LVAD implantation alone (No TVR, n=28) or LVAD implantation with concomitant tricuspid valve surgery (TVR, n=32). Randomisation was stratified by preoperative right ventricular (RV) dysfunction (none/mild vs moderate vs severe).
The study team reviewed primary LVAD implants at University of Nebraska Medical Center between 2013 and 2019. Cases were dichotomised into a high-volume group (surgeons averaging 11 or more LVAD cases per year), and a low-volume group (10 or less per year), and propensity score matching wasSurvivalperformed.todischarge, one-year survival, and incidence of major adverse events were compared between the low- and highvolume groups and predictors of survival were identified with multivariate analysis.
Concurrent tricuspid valve surgery and left ventricular assist device (LVAD) implantation did not lead to a lower incidence of right heart failure (RHF) when compared to LVAD implantation alone in select patients.
INVESTIGATORS REPORT that there was no difference in survival or adverse events between high- and low-volume surgeons performing left ventricular assist device (LVAD) implants, suggesting that, in an experienced multidisciplinary setting, low-volume LVAD surgeons can achieve similar outcomes to their high-volume colleagues. This is the conclusion of Joel Boudreaux (University of Nebraska, Omaha, USA) and colleagues, writing in the Journal of Cardiac Surgery. Their research was previously presented at the 2021 annual meeting of the International Society of Heart and Lung Transplantation (ISHLT 2021, 24–28 April, virtual).
“We felt that this question had not been definitively answered, so we decided to perform a randomised controlled study on this topic,” said presenter Yuting Chiang (New York Presbyterian/ Columbia University Medical Center, New York, USA).
IN A RECENT CARDIOTHORACIC Surgical Trials Network (CTSN) trial, the addition of tricuspid annuloplasty at the time of mitral valve surgery in patients with degenerative mitral regurgitation and moderate or less tricuspid regurgitation reduced the composite rate of death, reoperation for tricuspid regurgitation, or tricuspid regurgitation progression at two years, Ailawadi told AATS attendees. This outcome, however, was counterbalanced by an increased incidence of permanent pacemaker implantation, he said. Ailawadi and colleagues looked at the data for 399 of the 401 patients to analyse the timing, indications, and risk factors of permanent pacemaker implantation. Within two years of the initial study, 30 of the patients who had mitral valve surgery and tricuspid annuloplasty had received permanent pacemakers, and six of those had mitral valve surgery alone. The majority of those implants (29) occurred within 30 days of surgery. Potential risk factors (baseline characteristics, echocardiographic parameters, and operative details) were compared between patients with and without a permanent pacemaker. Univariate analysis identified age, history of atrial fibrillation, tricuspid annuloplasty and mitral valve procedures, concomitant maze, and tricuspid valve annulus dimension as potential risk factors for permanent pacemaker implantation within 30 days. None of these were statistically significant, AilawadiAmongreported.patients with degenerative mitral valve disease, 25‒30% have tricuspid regurgitation. For severe cases, concomitant mitral valve surgery and tricuspid valve is required. The debate is about the advisability and risks for moderate to less-than-moderated cases, Ailawadi commented in his AATS presentation, adding that “what is best for the patient is the first consideration”.
McNamara et al measured personal dose equivalents per case at head level recorded using real-time radiation dosimeters during 60 procedures—30 LAAO and 30 TEER—within their centre carried out from July 2016 to January 2018, and performed using fluoroscopy and transesophageal echocardiography (TEE) guidance. The cath lab teams wore traditional lead apparel, consisting of a lead skirt, apron and thyroid collar, and a mobile, height-adjustable accessory lead shield was placed between the patient and the interventional echocardiographer.Investigatorsreport that the median radiation dose per case was higher for interventional echocardiographers (10.6μSv; interquartile range [IQR] 4.2‒22.4μSv) than for interventional cardiologists (2.1μSv; IQR, 0.2‒8.3μSv; p<0.001).
“The primary results of this cross-sectional study of occupational radiation exposure indicate that interventional echocardiographers received significantly greater head-level radiation doses than interventional cardiologists during two commonly performed structural heart cases,” McNamara et al write. “In addition, in more than 25% of cases, the interventional echocardiographer received a dose that exceeded 20μSv, which is roughly 10-fold higher than the previously reported mean procedural dose equivalent received by interventional cardiologists across a variety of different procedures.”
The researchers note that the generalisability of the findings is limited due to the single-centre design of the study, as some centres may use different shielding techniques, but they note that additional research is needed to determine optimal approaches to radiation safety among interventional echocardiographers.
DISCO RADIAL finds comparable radial artery occlusion rate between two access strategies
“Everything in interventional cardiology starts with vascular access and finishes with vascular access,” commented Aminian, presenting his findings at EuroPCR 2022. “We know that the radial artery is becoming the first choice as standard access for coronary procedures, owing to increased safety. This recommendation is endorsed by the most recent European and US guidelines, so this is really the standard now in all cath labs.” Occlusion of the radial artery is by far the most common complication after the procedure and its occurrence precludes the use of the same radial artery for future procedures, or as a conduit for coronary artery bypass graft (CABG) surgery, Aminian explained, adding that decreasing the rate of occlusion is something that should be central in all radial“Theprogrammes.goalofthis trial was to assess the superiority of distal radial access as compared to conventional radial access with respect to forearm radial artery occlusion,” he explained. Through the trial, Aminian and colleagues randomised patients with an indication to PCI 1:1 to receive either distal radial access or conventional, transradial access, with both arms implementing a systemic implementation of best practices to reduce radial artery occlusion. Procedures were performed using the 6Fr Glidesheath SlenderAminian(Terumo).documented the best preventive measures for avoiding radial artery occlusion, describing these as: “… use of slender sheaths, adequate procedural anticoagulation, a short haemostasis time with a minimum pressure strategy, [and] patent haemostasis.”
The study team write that their data reveal a previously under-recognised occupational exposure risk, that should have “important ramifications” for the rapidly-expanding field of interventional echocardiography.“Giventherapidly increasing rates of LAAO and TEER procedures and progress in the field of interventional echocardiography, steps to quantify the occupational risk of interventional echocardiographers are warranted to help inform mitigation attempts,” the authors of the study note.
Adel Aminian
During TEER, interventional echocardiographers received a median radiation dose of 10.5μSv IQR 3.1‒20.5μSv), which was higher than the median radiation dose received by interventional cardiologists (0.9 μSv; IQR, 0.1‒12.2μSv; p<0.001). During LAAO procedures, the median radiation dose was 10.6 μSv (IQR, 5.8‒24.1μSv) among interventional echocardiographers and 3.5 (IQR, 1.3‒6.3μSv) among interventional cardiologists (p<0.001). Compared with interventional echocardiographers, sonographers exhibited low median radiation doses during both LAAO (0.2μSv; IQR, 0.0‒1.6μSv; p<0.001) and TEER (0.0μSv; IQR, 0.0‒0.1μSv; p<0.001).According to the researchers, the odds of interventional echocardiographers having a radiation dose greater than 20μSv were 7.5 times greater than interventional cardiologists. Furethermore, interventional echocardiographers were observed to have median head-level radiation doses that were three-fold greater during LAAO and 11.7-fold greater during TEER than for interventional cardiologists.
THESE WERE AMONG THE findings gleaned from the randomised, international, multicentre DISCO RADIAL trial, which compared the two approaches in more than 1,300 patients in 15 centres in Europe and Japan. Findings from DISCO RADIAL were presented by Adel Aminian (Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium) during a late-breaking trial session at EuroPCR 2022 (17–20 May, Paris, France).and published in JACC: Cardiovascular Interventions Aminian told EuroPCR attendees that both approaches yielded equally “very low” incidence of forearm radial artery occlusion, but conceded that distal radial access was not superior to conventional radial access with respect to forearm radial artery occlusion, which was the primary endpoint of the trial.
Echocardiographers face “under-recognised” radiation exposure risk in the cath lab Echocardiographers may be at significantly greater risk of exposure to harmful levels of radiation than interventional cardiologists when performing structural heart procedures in the cath lab, new research published in JAMA Network Open suggests.
Overall, 657 patients underwent conventional transradial access, and 650 patients distal radial access, Aminian detailed. Forearm radial artery occlusion did not differ between groups (0.91% vs. 0.31%; p=0.29), he revealed. “We ended up with a very low rate of radial artery occlusion in both groups, without a statistical difference,” he revealed. Of note, patent haemostasis could be achieved in as high as 94.4% of patients randomised to conventional radial access, reflecting investigators' strict adherence to preventive measures. Some differences were noted in terms of secondary endpoints. Importantly, crossover rates were higher with distal radial access (3.5% vs. 7.4%; p=0.002), and median haemostasis time was shorter (180 vs. 153 minutes; p<0.001). Radial artery spasm occurred more with distal radial access (2.7% vs. 5.4%; p=0.015). Commenting on these findings, Aminian said: “If you look at the key secondary endpoints, we see that distal radial access is associated with a more demanding access, [and] more crossover, which was significantly higher in the distal group, with an absolute difference of Looking3%.” at the procedure in terms of duration, radiation dose and contrast use, there was no impact, he commented, adding that once the access was gained there was no difference in the success of the procedure.
The use of distal radial artery access for percutaneous coronary intervention (PCI) comes at the expense of a higher crossover rate than conventional, transradial artery access, but may offer a simpler and shorter haemostasis process.
Everything accesswithcardiologyinterventionalinstartsvascularand finishes with vascular access”
The study’s primary endpoint, incidence of forearm radial artery occlusion, was assessed by vascular ultrasound at discharge, and the trial’s key secondary endpoints included crossover rates, haemostasis time, spasm and access related complications.
T his was the finding from David A McNamara (Frederik Meijer Heart & Vascular Institute, Grand Rapids, USA) and colleagues, who performed a single-centre, cross-sectional study looking at radiation dosage among interventional cardiologists, echocardiographers and sonographers carrying out a series of left atrial appendage occlusion (LAAO) and transcatheter edge-to-edge mitral valve repair (TEER) procedures.
August 2022 | Issue6612 Top Stories
The segmented regression showed 194 STEMI PCIs done monthly (95% confidence interval [CI] 182‒207, p<0.001) with a month-to-month increase of two cases (95% CI 1–2.8, p<0.001). After pandemic declaration, STEMI PCI decreased by 39 (95% CI -60‒-18, p<0.001) per month.
Researchers noted a need for continued analysis of other potential consequences and ramifications of untreated STEMI patients that may result in increased mortality, heart failure and morbidities in the aftermath of the COVID-19 pandemic. These studies are among the examples of research to have emerged detailing the stark impact of the pandemic on cardiac care across the globe—full effects of which may yet to be felt. In a paper published in the European Heart Journal in May, researchers from a global study warned that problems with heart health, caused by the “global collateral damage” of the pandemic, would “…continue to accrue unless mitigation strategies are speedily implemented”.
EURO PCR
THIS IS ACCORDING TO analysis presented at EuroPCR 2022 (17–20 May, Paris, France), which emerged from the We CARE initiative, a joint campaign launched by PCR and Stent‒Save a Life! aimed at maintaining access to cardiac care during the pandemic. The We CARE campaign has supported a series of national studies in Spain, Sweden, the UK and the USA, looking at the long-term health outcomes and cost for STEMIs occurring during the pandemic.
Data were abstracted from the NCDR CathPCI registry between March 2018 and June 2021, taken from 42 centres throughout the USA. Timing of the COVID-19 pandemic was assessed with county-level COVID prevalence.
STEMI PCI trends increased until pandemic declaration in March 2020, the researchers reported, with a rapid decrease which was most acutely seen in April 2020, during the first COVID-19 surge. Thereafter, STEMI PCIs rose consistently until December 2020, during the second COVID-19 surge, when a less severe drop occurred.
PatientsqualitycontributeddroptooflifelossinEnglandwithST-elevationmyocardialinfarction (STEMI) had an average loss of 1.86 years of survival during the first month of the COVID-19 lockdown in 2020, compared with before the lockdown, with a corresponding loss of quality of life.
Findings from the first of these analyses, focusing on the effect of the first COVID-19 lockdown in England in March‒April 2020, was presented at EuroPCR 2022 by Mamas Mamas (Keele University, Newcastle-UnderLyme, UK). This compared STEMI outcomes during the lockdown with an equivalent STEMI population prior to theMamaspandemic.had previously reported a significant decline in percutaneous coronary intervention (PCI) procedures in England due to the lockdown in the first wave of the COVID-19 pandemic in a paper published in Circulation: Cardiovascular Interventions PCR chairman William Wijns (Lambe Institute for Translational Medicine, Galway, Ireland) detailed the stark impact of the pandemic on STEMI care and noted that through the advocacy programme—We CARE—the interventional cardiology community had “spent a lot of time trying to convince authorities, [and] regulatory bodies, that if you implement new treatments there is going to be an impact on patient outcomes”.
The loss of care for many STEMI patients afforded the opportunity for the “unfortunate experiment” to chart the impact the removal of care is likely to have on outcomes and overall societal costs, Wijns said. To do this, researchers developed a model to analyse the societal impact of the lockdown for both outcomes and cost. “We did this because, as we all know, there has been a fear of catching COVID, therefore patients would not be admitted or did not want to be admitted,” Wijns explained. “Also, some authorities in many countries have issued stay at home messages, and of course the hospitals have redirected and reorganised completely their care pathways to give priority on COVID-19 and thereby cancer treatment, cardiovascular treatment was postponed, delayed or even did not take place. The most acute part of that was even the reduction in treatment of patients with STEMI.”
The findings were presented at the Society for Cardiovascular Angiography & Interventions 2022 Scientific Sessions (SCAI 2022; 19–22 May, Atlanta, USA) following an analysis of data from the Ascension Health System’s internal National Cardiovascular Data Registry (NCDR). Researchers looked at rates of PCI for STEMI in parallel with COVID-19 surges. Using data from the NCDR, researchers found that STEMI PCI cases dropped by nearly 30% following the beginning of the COVID-19 pandemic and have yet to recover to pre-pandemic levels.
majordespitetohesitationusprobablybaselinetoneverrising,STEMIDespiterateswehavegottenbackourpre-COVIDwhichtellsthereisstilltocomethehospitalhavingaheartattack”
“STEMI admissions did recover quickly, but we had a similar removal of care period for the second wave,” Wijns added, noting that the analysis will be extended to other countries.
The impact, Wijns said, is a larger pool of untreated patients, due to slower access to the interventions of reperfusion and poor patient outcomes. Analysing the data uncovered through the study, Wijns revealed that having a STEMI during the lockdown period caused, on average, a loss of nearly two years of life for each patient, compared to having a STEMI prior to the“Thislockdown.difference is driven primarily by the reduced hospitalisation rate at the start of the lockdown period, but also to a smaller extent over time, to a higher mortality rate, and that is because untreated patients suffer from more complications, they more often move into heart failure, they more often have severe arrhythmias, and the morbidity it has caused propagates over time,” Wijns said. Researchers also saw a significant increase in mortality during the lockdown period that propagates over the long term and this translates into massive costs, he added, on top of an estimated £26 million societal cost.
“Despite STEMI rates rising, we have never gotten back to our pre-COVID baseline which probably tells us there is still hesitation to come to the hospital despite having a major heart attack.”
Global admissions The study describes a “substantial global decline” in hospital admissions of people suffering from cardiovascular disease. As a result, the number of people dying at home or in the community from heart conditions increased, the researchers suggest. Although the problems identified by the researchers were seen across the world, they were exacerbated in low to middle income countries. The result has been an increased death rate among cardiovascular patients in hospitals in low to middle income countries, as well as more people dying at home from cardiovascular disease in the UK.
Though the figures from England showed a recovery in the number of admissions for STEMI, a separate analysis of data from a US-wide health system suggests that the volume of PCI procedures for STEMI has yet to return to pre-pandemic levels, having fallen “dramatically” following the onset of COVID-19.
Pandemic STEMI admission
STEMI PCI trends
“Our network of PCI centres across the country gives us unique access to data that independent centres may not have,” said Manoj Thangam (Ascension Texas Cardiovascular, Austin, USA) lead author of the study.
Deepak L Bhatt (Brigham and Women’s Hospital, Boston, USA) and a senior author in the paper, said: “This analysis really brings to light the substantial impact the COVID-19 pandemic has had and will continue to have in harming cardiovascular health globally.”
Issue66 | August 2022 13COVID-19
William Wijns
A segmented regression analysis with a monthly interrupted time series utilising a linear regression model to quantify expected STEMI PCIs before and after COVID-19 onset was performed. The predicted number of PCIs for STEMI was compared to predictions if COVID-19 had not occurred to evaluate differences in STEMI volumes.
The backbone of my development has been my father. He has the classic immigrant story: we came to the USA at the end of the Vietnam War with next to nothing. I had a very strong taste of what hunger and poverty felt like. What my father taught us was how to be disciplined, the value of hard work, and also how anything is achievable if you dream big and have a clear map to chase after those dreams. He was a big dreamer, and he did a lot during a short time. The second mentor was Denton Cooley, a real pioneer in the field of cardiothoracic surgery. I respected him for constantly thinking outside the box, and for being fearless in a calculated sort of way. In medicine, it takes a little bit of bravery to go out and do something for the first time where the risks are unknown. I applaud him for that. You have an interest in both transcatheter and surgical techniques. Why do you see this multidisciplinary approach as being important? I often refer to Simon Sinek's YouTube talk, which says that it is not what you do and how you do it, it is why you do it. For me, the 'why' is so important. The 'what' is that I use my knife to cut things. The 'why' is that someone has a disease in the coronary artery or in the heart valve. I wanted to step back and to be someone who is treating the 'why'. To do that, you really need to wear different hats. You cannot be a surgeon only, and you cannot be an interventional cardiologist only. I really try to shape my experience to focus on the disease process. The reality is that patients could not care less about what we do, they just want to feel better. They want their ailment to be addressed effectively so that they can get back to their normal life. I have always kept that in mind.
During your career, has there been any one particular development to have pushed the field forward significantly? Transcatheter technologies have definitely been a transformative technology and have taken the medical world by storm. It is crazy that in the past, to replace a person's aortic valve, you would have to stop the heart, cut the valve out, put it back in, and so on. Now we can do it through a tiny incision in the groin for patients who are at higher risk, and they go home the next day.
There is nothing that I would want to be more than a cardiothoracic surgeon and I have spent the past 20‒25 years of my life trying to be the best I can be.
PROFILE alisonlang.com
You cannot be a surgeon only, and you cannot be an cardiologistinterventionalonly”
Tom Nguyen
14 Interview August 2022 | Issue66
Nowadays there is a strong emphasis on shared decision-making through the heart team principle. What do you see as the important role of the cardiothoracic surgeon in such a team? The surgeon is very important because they bring a very unique perspective to the table. The surgeon can often bring a three-dimensional perspective to the disease process. So for example, cardiologists see things in two dimensions, using an angiogram or a catheter. But for us, every day we are opening up the chest and looking at the heart in three dimensions. I think there is definitely appreciation of the relative structures and the anatomy of things in three dimensions. It is also important because, up to now, a lot of the backup options when things do not go well will always fall back on surgery. Why did you choose to become a doctor, and then what brought you to cardiac surgery? Medicine is such a unique privilege. A doctor has a very intimate relationship with their patient, who might share information that they really do not tell anyone, even sometimes their significant other. The beautiful thing about that is that you get a chance to use science to make people feel better. A lot of the patients I operate on are elderly, and that means treating a heart that has been beating for the past 80 years or more. It is such an honour and a testament to science, though it is technically very demanding.
Who have been the biggest influences and mentors to have shaped your career?
As a proponent of minimally invasive cardiac surgery and transcatheter techniques, Tom Nguyen (University of California San Francisco, San Francisco, USA) is a cardiothoracic surgeon with an eye to the future, who believes that embracing new ways of working are fundamental to improving outcomes for heart surgery patients. He discusses how his upbringing has shaped his approach to medicine.
What is even more crazy is that we are doing this with patients who are partially awake. It has also been an educational experience, because with a lot of technologies you have to be careful about tempering enthusiasm and not letting it run wild without having solid data and research. It has been very exciting to be involved with well-done research trials looking at these technologies and comparing them to whatever the status quo is, and trying to figure out what is best for every patient.
What are your current research interests? My interest is in anything that provides a less invasive way to approach disease of the heart. Those include transcatheter technologies, whether it be transcatheter aortic valve implantation (TAVI) or mitral clip, minimally invasive aortic and mitral valve repair, and also robotic surgery. I also think there are a lot of technologies out there that are under-utilised in medicine. Think about when you are using Amazon, how easy it is to do a one-click purchase. Compare that to how hard it is for you to schedule an appointment with your physician. It should be just like that one-click purchase, and it should be centred around the patient to make them jump through as few hoops as possible. You recently performed the first robotic cardiac surgery procedure at your centre. How big is the potential for robotic technology to impact the field? It is important to have as many tools in your toolbox as possible. The unique thing about the robot is that, when I wear loupes, the magnification is often around four times as big. With the robot you can magnify up to 10 times and you are actually seeing things at a different angle and with a different perspective than when you look through your eyes. The degrees of articulation with the robot are almost limitless. With our hands, we have joints on our wrists and our fingers, so we can only do so much. But with the robot you can put as many kinds of joints as there are possible. Like all things with technology, we are excited about it, but we want to make sure that the data are there and that we are cautious about it, that we are not doing anything that is too cavalier when trying to bring this technology in.
I think the one thing that is kind of basic that the field can be better at is recruiting a more diverse group of cardiothoracic surgeons. The number of women and minorities in the field are not representative of the population and the patients being treated, and I think we could definitely do that better. As far as recruiting people into the field, I think it is important to recruit surgeons who are hungry and looking forward to the future, who are innovative and creative and not willing to stagnate. I think that is super important. For future generations of cardiothoracic surgeons, how important will it be to master transcatheter techniques?
15InterviewIssue66 | August 2022 Current appointments Chief of Cardiothoracic Surgery, University of California, San Francisco Helen and Charles Schwab Distinguished Professor of Surgery Co-director, Heart and Vascular Center Education & training Doctor of Medicine, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, USA Post-doctoral Research Fellow, Stanford Department of Cardiothoracic Surgery, Stanford, University, Stanford, USA Fellowship, Cardiothoracic Surgery, Columbia Presbyterian Hospital, Columba University, New York, USA Research interests Minimally invasive valve surgery Surgical simulation & education Transcatheter aortic valve implantation (TAVI) Awards & honours
What do you think cardiothoracic surgery can do to attract more young physicians into the field?
It is imperative to avoid extinction. I think it is important for surgeons to understand transcatheter skills, and in some ways, we need to know the data behind it, as well as the techniques, more so than others. That is the only way that we can effectively articulate what we are going to do and why we are doing it.
Looking back over your career, are there any cases that really stand out to you? At a basic level, if you want to do anything, whether it is to be a professional basketball player or a cardiothoracic surgeon, you do not know you can do it until you do it. That lightbulb moment came for me when I did an aortic valve replacement case during training, after many years of study. What was very special was that my mentor reached over and said ‘today you became a cardiothoracic surgeon’. I remember that vividly and it was very special. Outside of medicine, what are your hobbies and interests? Family is very important. I am lucky to have a wife who is an interventional radiologist here at University of California San Francisco. We have a three and a half year old daughter who keeps us on our toes. I enjoy sports—particularly basketball— and music, which I think are so important. They help to teach you the concept of teamwork, the concept of discipline, the concept of failing and getting back on your feet. I am also a bit of a techie. There are many different technologies that can really change medicine, not only medical technologies, but information technology as well.
Fact file
University of Texas Houston Benjy F Brooks Outstanding Clinical Faculty Award, University of Texas Houston, Houston, USA International Society for Minimally Award(ISMICS)CardiothoracicInvasiveSurgeryBestManuscriptfor2016 Top 40 under 40, JournalBusinessHouston
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A RETROSPECTIVE REVIEW of more than 24,000 patients who underwent an electrocardiogram (ECG) has found that nearly one-quarter had mitral annulus calcification. Researchers from Mayo Clinic (Rochester, USA), who carried out the study, reported that mitral valve dysfunction was more than twice as prevalent for those patients, who also were at higher risk of all-cause mortality. The research suggests that mitral annulus calcification is a predictor of mortality, as well as a marker of valvular and cardiovascular disease. The findings are outlined in an article published in Mayo Clinic
Proceedings Among the key findings from the study, researchers found that a moderate or greater degrees of mitral valve dysfunction was more than twice as common in patients with mitral annulus calcification thanFurthermore,without. they report that, after adjustment for comorbidities, mitral annulus calcification was associated with higher mortality, as well as noting that mortality was highest in patients with mitral annulus calcification and mitral valve“Thedysfunction.association between mitral annulus calcification and mitral valve dysfunction is important to understand because it affects treatment considerations for valve dysfunction,” says Patricia Pellikka, the study’s corresponding author. Of 24,414 patients evaluated with an ECG, 5,502, or 23%, had mitral annulus calcification, according to theMitralstudy.valve disease was observed in 16% of those patients. Among patients with mitral annulus calcification, 54% of those with mitral valve dysfunction were female, and frailty was common. The presence of mitral annulus calcification was associated with higher mortality, after statistical adjustment. Mitral valve dysfunction increased mortality, regardless of the presence of mitral annulus calcification. But patients with both conditions had the highest mortality, the study finds.
The study met its primary endpoint with a three-fold reduction in more-than-mild PAR with the Acurate neo2 valve (11.2% for Acurate neo vs. 3.5% for Acurate neo2).
“These late-breaking data debunk traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid TEER therapy,” Nickenig was later quoted as saying in a press release circulated by Abbott following the presentation of the findings. “The findings continue to demonstrate TriClip’s ability to reduce TR and improve quality of life in a broad range of anatomies.”
The analysis presented by Scotti at TVT 2022 follows closely behind the release of further data looking at Acurate neo2 at EuroPCR 2022 (17–20 May, Paris, France), where Christopher Meduri (Karolinska Institut, Stockholm, Sweden) presented findings from the Neo-Align study, a single-centre study of 170 patients who underwent TAVI with the Acurate neo2 valve using a novel implant technique to attempt commissural alignment of the prosthetic and native valves. The study demonstrated that commissural alignment can be achieved safely, effectively and quickly, with data demonstrating that 97% of patients had no significant misalignment (80% non; 17% mild; 1.2% moderate; 1.8% severe).
The study used retrospective registry data from 2,026 patients from 34 European centres comparing outcomes with the previousgeneration Acurate neo valve from the NEOPRO Registry (1,263 patients from 18 centres) with the Acurate neo2 valve from the NEOPRO2 Registry (763 patients from 16 centres).
Eight patients from the TRILUMINATE study and 41 patients from bRIGHT were included within the analysis. Nickenig reported that in patients with TR and a pacemaker lead across the tricuspid valve, 30-day results of the TriClip and TriClip G4 TEER systems from the two studies demonstrated a high rate of implant success (98%) alongside a high rate of acute procedural success (91%), as well as at least a two-grade TR reduction in 64% of patients. Investigators also reported significant clinical improvements among the patient population including 69% of patients achieving New York Heart Assocation (NYHA) functional class I/II, an improvement by 57% from baseline of 12%, with a 19-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score. The data point to the fact that patients with leads in varying positions and with varying levels of leaflet interaction have successfully undergone TEER using the TriClip and TriClip G4 devices.
NickenigGeorg
TRANSCATHETER AORTIC VALVE implantation (TAVI) with the Acurate neo2 (Boston Scientific) device was associated with a lower prevalence of moderate or severe paravalvular aortic regurgitation (AR) and more patients with no or trace paravalvular AR compared with an earlier-generation device—a difference that was particularly evident in patients with heavy aortic valve calcification. This was the conclusion of Andrea Scotti (Montefiore Medical Center, New York, USA), who delivered analysis of data from the NEOPRO and NEOPRO-2 registries during a late-breaking trial session at TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA). The analysis looked at haemodynamic performance and clinical outcomes of TAVI with the latest-generation Acurate neo2 device.
These late-breaking data debunk traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid TEER therapy”
Structural Heart Interventions 17Structural Heart InterventionsIssue66 | August
Patients2022with
Also at EuroPCR, Andrea Buono (Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy) reported findings from the ITAL-neo registry, a two-arm, retrospective registry of 900 patients from 13 centres, which it was reported, demonstrated superior performance of Acurate neo2 compared with the previous-generation device in minimising paravalvular leak (PVL).
mitral annulus calcification at higher risk of mitral valve dysfunction
Findings included a reduction in moderate or severe paravalvular aortic regurgitation (PAR) for the Acurate neo2 valve (2% vs. 5% with Acurate neo; p<0.001). Investigators also found a significant reduction in mild PAR with patients receiving the Acurate neo2 valve, demonstrating a greater proportion of none/trace PAR (38% vs. 59% with Acurate neo, p<0.001).
New data “debunk idea that patients with pacemakers may not be eligible for transcatheter edge-to-edge repair”
Data from the first report on patients with a pacemaker lead across the tricuspid valve have shown that implant of the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems (Abbott) significantly reduce tricuspid regurgitation (TR) and improve quality of life.
T hese were among the conclusions presented by Georg Nickenig (University Hospital Bonn, Bonn, Germany) during a late-breaking trial session at TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA), where he delivered insights from the TRILUMINATE and bRIGHT studies looking at the TriClip device in TR patients with endocardial leads. Patients with TR who are candidates for transcatheter repair commonly have a pacemaker lead across the tricuspid valve, though this patient population has not specifically been studied. Combined outcomes from the TRILUMINATE and bRIGHT prospective, singlearm, multicentre trials examined whether TR patients previously implanted with a pacemaker lead can benefit from the TriClip device.
Late-breaking data point to favourable latest-generationperformancehaemodynamicof TAVI device
Dual antiplatelet therapy (DAPT) after left atrial appendage occlusion (LAAO) using the Watchman FLX (Boston Scientific) device was comparable in terms of rates of death, stroke, bleeding or device-related thrombus when compared to use of aspirin with an anticoagulant, warfarin or direct oral anticoagulant (DOAC), analysis of registry data has shown.
Summing up the findings, Coylewright remarked that the DAPT FLX study shows no difference in death, stroke, bleeding or device-related thrombus between a post-procedure medication regimen of DAPT versus DOAC or warfarin plus aspirin at 45 days with Watchman FLX.
Sustained reduction in tricuspid regurgitation seen at one-year in CLASP TR study
“We also know that outcomes with both medical and surgical therapies are suboptimal,” she added, explaining the rationale for the trial. The study sought to investigate the efficacy and safety of the Pascal tricuspid valve repair system, described by Hahn as having independent clasps that allow staged leaflet capture and optimisation. Two iterations of the Pascal device were used in the study, the Pascal and Pascal Ace, which was introduced after the study began enrolling. Hahn noted that the Pascal Ace is a narrower profile device with a smaller central spacer designed to complement the Pascal device, and towards the end of the study was the primary device being implanted.
“A sustained TR reduction was seen in this study,” Hahn said, detailing the results of the study. “You can see at baseline [that] severe, massive and torrential [regurgitation] in nearly all patients, was reduced at 30 days to moderate or less in 75% of patients. “Importantly, at that 30-day mark, looking at the first 34 patients versus the second 31 patients, the TR reduction to moderate or less was only 70% in the first cohort, and 86% in the second cohort.”Atone year, 100% of patients improved by at least one TR grade, 75% by at least two TR grades, and 86% reached moderate or less tricuspid regurgitation, Hahn reported. In that setting there was sustained functional and quality of life improvements, she added, noting that 92% of patients achieved New York Heart Association (NYHA) class I or II, while Kansas City Cardiomyopathy Questionnaire (KCCQ) scores showed a change of 18 points at 30 days and this was sustained out to oneSurvivalyear. out to one year was 88%, while the freedom from heart failure hospitalisation rate was 79%, Hahn reported. “This meant that the annualised heart failure rehospitalisation rate was reduced by 56% in this cohort,” sheGreatersaid. TR reductions and shorter procedure times were achieved in the second half of the study, Hahn detailed, later ascribing this to the introduction of the newer-generation device, and improvements in patient selection. Considering the implications of the findings, Hahn described the Pascal device as an “…important option for treatment of patients with severe TR.”
In order to be enrolled in the study, patients had to be deemed to have symptomatic tricuspid regurgitation despite medical therapy and to be appropriate for receipt of the device. The primary endpoint was a composite of major adverse events (MAE) at 30 days. The trial has enrolled 65 patients in total, Hahn explained, noting that oneyear follow-up is available in 46. Describing the baseline characteristics, Hahn noted that 97% of the patients had severe tricuspid regurgitation, with just one patient deemed to have moderate-to-severe regurgitation. Successful implant was achieved in 91% of patients. Procedural success, defined as a reduction of TR of at least one grade with no further intervention, was found to have occurred in 88% of patients, while clinical success, defined as procedural success without MAE at 30 days was 77%.
Dual WatchmantherapyantiplateletafterFLXis comparable to approvedcurrentlyregimens
Rebecca Hahn
HEADLINE FINDINGS OF THE prospective single-arm study from 14 sites in the USA were reported by Rebecca Hahn (Columbia University Medical Center, New York, USA) on behalf of the CLASP TR study investigators during a late-breaking trial session at EuroPCR 2022 (17–20 May, Paris,“WeFrance).nowknow that mortality increases with TR severity,” Hahn told EuroPCR 2022 attendees, pointing to data showing a “nearly linear” relationship between effective regurgitant orifice area as well as regurgitant volume.
One-year outcomes of the CLASP TR study, investigating the use of the Pascal (Edwards Lifesciences) transcatheter tricuspid repair system, reported a significant reduction in tricuspid regurgitation (TR) among patients receiving the device.
The current on-label, post-procedure regimen after Watchman FLX includes 45 days of aspirin with an anticoagulant, warfarin or DOAC, Coylewright detailed in her presentation, commenting: “We see barriers to referral for left atrial appendage occlusion for fear of the 45-day requirement of anticoagulation afterTheprocedure.”studypresented at TVT, which analysed patients from the National Cardiovascular Disease LAAO Registry (NCDR), sought to evaluate if DAPT is a safe alternative option.
18 Structural Heart Interventions August 2022 | Issue66
“If we are choosing not to use the FDA [US Food and Drug Administration]-approved regimen post-Watchman, then the patients are probably different,” Coylewright commented, noting that this was reflected in the baseline characteristics of the patients, with those who were discharged on DAPT typically being older, having more vascular or coronary disease, prior stroke, or major bleeding.
CoylewrightMegan
THESE WERE AMONG THE INSIGHTS presented by Megan Coylewright (Chattanooga, USA) during a late-breaking trial session at TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA), where she delivered findings of the DAPT FLX study, comparing effectiveness of post-procedural medications following LAAO. Patients with atrial fibrillation (AF) have a heightened risk of stroke, Coylewright told TVT attendees, noting that the most common source of clots is the left atrial appendage. Many patients, she said, have an “appropriate rationale” to avoid long-term anticoagulation. Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular AF who are at increased risk for stroke and systemic embolism.
Coylewright reported that adjusted outcomes from discharge to 45 days with regards to the differences between DAPT and DOAC plus aspirin, showed the composite endpoint of death, stroke and major bleeding occurred in 2.9% of DAPT patients and 3.3% in the DOAC plus aspirin group. There was no significant difference in the rate of device-related thrombus in each group, she noted. Comparing DAPT with warfarin plus aspirin, Coylewright again reported that there was no significant difference in the composite endpoint, which reached 2.8% for the DAPT group and 3% in the warfarin plus aspirin cohort. Additionally, there was no significant difference in device-related thrombus, which remained low in both groups. Noting some of the limitations of the study, Coylewright commented that the use of a variety of post-procedure medication regimens as seen in the registry data, indicates that physicians are already individualising their approach to the risks of devicerelated thrombus and stroke and bleeding risks, despite the currently approved indications. “Propensity matching, thus, cannot adjust for all of the differences inherent in physicians already selecting patients for one therapy over another,” she remarked.
One technique that has been developed to avoid this complication is BASILICA, a transcatheter electrosurgical procedure performed before TAVI in which catheters and guidewires are used to traverse and lacerate the aortic leaflet in front of the threatened coronary artery to preserve perfusion.
9.2%
Investigational device offers hope of a ‘shortcut’ to prevent coronary obstruction after TAVI
Dvir was presenting insights from the first-in-human use of the dedicated transcatheter leaflet splitting device—the ShortCut catheter (Pi-Cardia)—a tool designed for potential uses including leaflet splitting to enable valve-in-valve procedures, splitting of native leaflets to avoid coronary impairment, or “tricuspidisation” of bicuspid valves prior to TAVI.
Five years have passed since we performed the first BASILICA cases, Dvir noted in his presentation at TVT, but the technique is far from widespread, he added, possibly due to its complexity. Having a dedicated tool that replicates the outcome of the BASILICA technique, albeit via a much simpler method, may offer a more accessible option for retaining coronary flow that can be compromised postTAVI or in some native valves. At TVT, Dvir described the design and use of the ShortCut device, as well as detailing outcomes in the first eight patients to have undergone leaflet splitting with ShortCut on a compassionate-use basis. ShortCut is delivered transfemorally using a 16Fr sheath over a routine left ventricular wire, Dvir explained in his presentation, where he walked through the steps of the procedure. Once the device is delivered to the target area at the base of the leaflet, a small blade is advanced into the leaflet which, once manually pulled through, creates a split in the leaflet.
Kendra
1day 0% 78% implantationPacemaker mortality30-day traceNone/PVLhospitallengthMedianofstay severeModerate/PVL DvirDanny
THIS IS ACCORDING TO THE findings of an analysis of the use of an optimised pre- and post-procedural TAVI care pathway among 400 patients treated in the USA and Canada from the main cohort of the Optimize PRO clinical study, a study of the Evolut (Medtronic) TAVI valve.
Use of the cusp overlap technique for the deployment of devices in transcatheter aortic valve implantation (TAVI), alongside an optimised care pathway, yields low pacemaker rates, expedited discharge and low rates of residual aortic regurgitation.
19Structural Heart InterventionsIssue66 | August 2022
“WITH VALVE-IN-VALVE PROCEDURES AND as we go to a younger population and are treating [more] failed transcatheter heart valve devices, we may see the risk of having coronary obstruction increasing dramatically. We need to find tools to prevent coronary obstruction,” Danny Dvir (Shaare Zedek Medical Center, Jerusalem, Israel) told attendees of TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA). “We know how to identify cases at risk for coronary obstruction and we just need a safe, simple and effective leaflet splitting tool that will enable TAVI expansion into the younger population.”
Preventing coronary obstruction after transcatheter aortic valve implantation (TAVI) becomes increasingly important as the procedure moves into a lower-risk patient population. According to researchers in Europe and Israel, a new device may offer a simple solution to preventing this complication in TAVI patients.
The Optimize PRO study utilises a TAVI care pathway to evaluate common practices and shared experiences such as conscious sedation and early mobilisation. A conduction disturbance pathway evaluates efficiencies and heart team considerations for monitoring and managing patients with conduction disturbance who might be considered for a pacemaker post-TAVI.
Single-digit pacemaker rates seen in TAVI with cusp overlap technique
“It is quite straightforward,” Dvir commented, noting that the procedure can be completed in around 20 minutes, significantly shorter than the time needed to perform a BASILICA laceration and does not require electrification.
The cusp overlap technique, which was a part of the optimised care pathway, is designed to help implanters assess and achieve the target implant depth to reduce interaction with the conduction system. Results of the analysis were presented by Kendra Grubb (Emory University, Atlanta, USA) during a late-breaking trial session at EuroPCR 2022 (17–20 May, Paris, France) and show that the cusp overlap technique led to more “predictability and control”. This resulted in a single-digit pacemaker implantation rate (9.2%), a low 30-day mortality rate (0.8%), median length of hospital stay of one day, and upon discharge, no cases of moderate/ severe paravalvular leak (PVL) (0%) and 78% of patients had none/ trace PVL. The lowest pacemaker implantation rates were observed when all steps of the cusp overlap technique were“Thefollowed.results demonstrate significant improvement for TAVI with the Evolut valve, some of the best results in an Evolut trial we have ever seen,” Grubb was quoted in a Medtronic press release as saying. “Adopting the cusp overlap technique and clinical pathways resulted in single-digit pacemaker rates out to 30 days, nextday discharge in the majority of the patients, and remarkably low rates of paravalvular leak.”
ShortCut was among the headline innovations to emerge from two of the summer’s major conferences covering the structural heart and interventional cardiology, TVT and EuroPCR 2022 (17–20 May, Paris, France). At EuroPCR, Didier Tchétché (Clinique Pasteur, Toulouse, France) also delivered early insights into the use of the device. Coronary artery obstruction occurs in around 0.7% of TAVI cases, and is thought to carry around 50% mortality, a previous study has suggested.
Of the eight patients to have undergone the procedure at the time of the presentation, Dvir noted that there had been no incidences of coronary We need to find tools to prevent coronary obstruction” Grubb 0.8%
The post-market, prospective, multicentre study is evaluating outcomes associated with procedurerelated techniques and post-procedure TAVI when using the self-expanding, supra-annular Evolut PRO and PRO+ TAVI systems in patients with symptomatic severe aortic stenosis. The current interim analysis includes 400 main cohort patients and 104 roll-in patients at up to 46 sites in the USA and Canada. The primary endpoint includes the rate of all-cause mortality or all-stroke at 30 days with secondary endpoints of discharge time, percentage of patients with more than moderate aortic regurgitation, and the rate of pacemaker implant for new-onset or worsening conduction disturbance at 30 days. The study will also evaluate rehospitalisation rates and discharge time at 30 days and one year.
Conducted at 34 centres across the UK, the UK TAVI trial enrolled patients between April 2014 and April 2018. Patients were randomised to either TAVI using a CE mark-approved device (n=458) or SAVR (n=455), with a
Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort Matti Adam
UK-wide randomised trial reports noninferiority of TAVI to surgery for all-cause mortality at one year
TAVI system reported in both aortic stenosis and aortic regurgitation patients
T he study, a randomised clinical trial, found that among 913 patients at moderately increased operative risk due to age or comorbidity, all-cause mortality at one year was 4.6% with TAVI versus 6.6% with surgery.
Transcatheter aortic valve implantation (TAVI) was found to be non-inferior to surgery for all-cause mortality at one year among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk according to findings of the UK TAVI trial, published in the Journal of the American Medical Association (JAMA)
20 Structural Heart Interventions August 2022 | Issue66
Promising results for Trilogy
Later, Alexander R Tamm (Johannes Gutenberg-Universität, Mainz, Germany) presented data on 45 AR patients from the same six German heart centres. In this series, all patients presented with moderate-severe or severe AR. At baseline, 71% of the patients presented with NYHA III/IV, and 58% had an LVEF less than or equal to 50%. The outcomes of the AR series were also positive, with technical success achieved in all patients. There were no conversions to open surgery, stroke, or death. Postoperatively, 92% of the patients had none or trace PVL and nine patients required a new pacemaker. Of the patients requiring a pacemaker, at least 33% of them had pre-existing conduction system abnormalities.“BeforeTrilogy’s CE mark approval, TAVI for AR was performed off-label using devices designed for aortic stenosis—which posed procedural challenges with poorer outcomes,” said Tamm. “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the haemodynamics are the best in class.” The Trilogy valve received CE mark for the treatment of severe symptomatic AR and AS in May 2021, becoming the first transfemoral TAVI device of its kind to receive approval across both indications.
One-year mortality: TAVI Surgery 4.6% 6.6% Bleeding events: TAVI Surgery 7.2% 20.2% Vascular complications: TAVI Surgery 10.3% 2.4% AdamMatti
MATTI ADAM (UNIVERSITY HOSPITAL Cologne, Cologne, Germany) reported the first 28 commercial implants of the Trilogy system for AS across six high-volume German centres. In Adam’s series, all patients presented with severe AS. At baseline, 61% of the patients presented with New York Heart Association class III or IV heart failure (NYHA III/IV), and 29% had a left ventricular ejection fraction (LVEF) of less than or equal to 50%. The outcomes were positive, achieving 100% technical success, zero conversions to open surgery, zero new permanent pacemakers, and one patient death, which was non-device related, Adam reported. Post-operatively, 86% of the patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.
The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial tissue valve.
Previous studies have shown that TAVI is a safe and effective treatment for people who are not eligible for surgical aortic valve replacement (SAVR) or among those at high operative risk.
“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” said Adam. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”
primary endpoint of all-cause mortality at one Investigatorsyear. reported that among 913 patients randomised to either TAVI or SAVR, 912 (99.9%) completed follow-up and were included in the non-inferiority analysis. At one year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, the investigators report. Of 30 prespecified secondary outcomes reported, 24 showed no significant difference at one year, the investigators add.TAVI was associated with significantly shorter post-procedural hospitalisation (a median of three days versus eight days, while there were also significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs. 20.2%). However, the TAVI group did see significantly more vascular complications (10.3% vs 2.4%), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic“Theseregurgitation.areextremely encouraging results after one year,” adds Toff. “However, we shall continue to monitor the participants for at least five years to ensure no late differences in the groups emerge and to assess the durability of the TAVI valves. We hope to publish the five-year results by the end of next year. In the meantime, patient-specific treatment recommendations should continue to be made by a multidisciplinary heart team.”
Results from the first commercial implants of the Trilogy transcatheter aortic valve implantation (TAVI) system (Jenavalve) for high-surgical risk patients with severe, symptomatic aortic stenosis (AS) or aortic regurgitation (AR) were reported at EuroPCR 2022 (17–20 May, Paris, France).
However, UK TAVI included patients who were at lower risk and suitable for eitherLeadprocedure.authorof the study, William Toff (University of Leicester, Leicester, UK), said: “It is great news for patients that TAVI is just as safe and effective as surgery even in patients at lower operative risk. This procedure is much less invasive than conventional approaches. People who would otherwise require open-heart surgery can have this procedure, and as it has a faster recovery time, it means a shorter stay in hospital for patients.”
Register your place today www.eacts.org
Endpoints of the trial were net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACCE), and major or clinically relevant nonmajor bleeding events.
In his concluding remarks, Vranckx told EuroPCR attendees that in patients at high-bleeding risk who had undergone implantation of the Ultimaster sirolimuseluting stent, regardless of the PCI complexity, the discontinuation of DAPT at a median of 34 days compared with continuation of treatment for a median of 193 days was associated with similar rates of NACE and MACCE, as well as a lower rate of major or clinically relevant non-major bleeding.
Patients identified by nuclear stress testing as having severe stress-induced myocardial ischaemia are likely to benefit from early coronary revascularisation through either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), while those with mild or no ischaemia are not, according to a new study published in the Journal of the American College of Cardiology (JACC)
“These results confirm the benefits of stress testing for clinical management. What you want from any test when considering coronary revascularisation procedures is that the test will identify a large percentage of patients who are at low clinical risk and do so correctly, while identifying only a small percentage of patients who are at high clinical risk and do so correctly. That is what we found with nuclear stress testing in this study,” adds Rozanski.
Patients undergoing PCI with more advanced coronary artery disease will require more complex procedures”
For the analysis, high-bleeding risk patients were selected one month after the index procedure. If they were free from ischaemic and bleeding events they were allowed to enter the trial and were treated either with an abbreviated, one-month, DAPT regimen followed by single antiplatelet therapy at the discretion of the operator, versus a more prolonged, “standard” DAPT treatment, lasting at least three months after the index procedure for patients on oral anticoagulation.
Shorter antiplatelet regime shows benefit for high bleeding risk patients regardless of PCI complexity
T he findings of the analysis were presented by Pascal Vranckx (Hasselt University, Hasselt, Belgium) and simultaneously published in the European Heart Journal. In his presentation, Vranckx summarised the findings of MASTER DAPT, which were originally presented by Marco Valgimigli (Cardiocentro Ticino Foundation, Lugano, Switzerland) at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual). The trial found that in high-bleeding risk patients, after intervention using the Ultimaster stent, one month of DAPT was shown to be non-inferior when compared with more than two months of DAPT for the net and major adverse clinical events, and was superior for reducing major and clinically relevant non-major bleeding.“Weall know that patients undergoing PCI with more advanced coronary artery disease will require more complex procedures and remain at increased risk of short and long-term adverse ischaemic events,” commented Vranckx. “For that reason and against that background, we wanted to assess the consistency of the treatment effects of one-month of DAPT, versus more prolonged DAPT, based on PCI and patient complexity.”
“[These are] very consistent findings in this trial, reassuring and mimicking the major trial,” he said. However, the findings are couched by some limitations, including that it was an open-label study and randomisation was not stratified based on PCI complexity. He also noted the absence of a universally accepted definition for complex PCI, and said the results may not apply to patients treated using other stent platforms.
The researchers analysed records of more than 43,000 patients who underwent nuclear stress testing with suspected CAD between 1998 and 2017 at Cedars Sinai Medical Center in Los Angeles with a median 11-year followup for mortality/survival. Investigators grouped patients according to their level of myocardial ischaemia as well as left ventricular ejection fraction (LVEF).
“Importantly, the presence of severe ischaemia does not necessarily mean that coronary revascularisation should be applied. New data from a large clinical trial suggests that when medical therapy is optimised it may be as effective as coronary revascularisation in such patients. But regardless, the presence of severe ischaemia indicates high clinical risk, which then requires aggressive management to reduce clinical risk.”
“There is keen interest in assessing how measurement of myocardial ischaemia during stress testing can help shape physicians’ decision to refer patients for coronary numberevaluated“Ourheartpatientsnotprocedures,revascularisationbutthisissuehasbeenwellstudiedamongwhohaveunderlyingdamage,”saidRozanski.study,whichalargeofpatients
Stress testing can guide patient selection for coronary revascularisation
The study provides two important insights, according to the research team. First, it showed that the frequency of myocardial ischaemia during stress testing varies according to patients’ heart function. Of the 39,883 patients with normal heart function (LVEF >55%), fewer than 8% had ischaemia. However, among the 3,560 patients with reduced heart function (LVEF <45%, which indicates prior heart damage), more than 40% had myocardial
Complex PCI was classified according to criteria including the treatment of three or more vessels, implantation of three or more stents, treatment of three or more lesions, bifurcation with two stents implanted, a total stent length of >60mm, or chronic total occlusion as target lesion. In addition, the investigators also did a sensitivity analysis on a more comprehensive complex PCI definition, including left main stenting and graft stenting. Baseline, angiographic and procedural characteristics stratified by PCI complexity were well balanced between the two antiplatelet regimens.Turning to the results, Vranckx detailed that the rate of NACE saw no statistical difference for both complex and non-complex lesions, with a similar picture for MACCE. In terms of major or clinically-relevant non-major bleeding, he detailed that the same Kaplan Maier curves appear as were seen in the primary trial, with a difference between abbreviated versus non-abbreviated DAPT between complex and non-complex PCI arms.
Alan Rozanski
The study also showed that the presence of myocardial ischaemia increases the risk of death in patients with normal and reduced heart function. Among both groups of patients, performing CABG or PCI procedures was not associated with improved survival among those with either no or only mild ischaemia during the stress test. Among patients with severe ischaemia, coronary procedures were associated with more than 30% higher survival rates compared to those managed with medication only. This was the case for patients with and without heart damage.
with pre-existing heart damage who underwent cardiac stress testing, finally addresses this clinical void.”
August 2022 | Issue6622 Coronary Revascularisation
FOR PATIENTS WITH SEVERE ischaemia, early revascularisation was associated with a more than 30% reduction in mortality compared to patients with severe ischaemia treated with medication, but no benefit was shown for the other groups, investigator Alan Rozanski (Icahn School of Medicine at Mount Sinai, New York, USA) and colleagues reported. This new study can help guide physicians on how to manage patients with suspected heart disease, the study’s authors suggest. Physicians order stress tests when they suspect that a patient’s chest pain or other clinical symptoms are from coronary artery disease (CAD), or plaque build-up inside the coronary arteries. These help determine if a patient has obstructive CAD, which leads to significant ischaemia. If the ischaemia due to obstructive CAD is severe, physicians can restore adequate blood flow through either CABG or PCI. Nuclear stress testing is the most common stress test used to detect myocardial ischaemia.
Pascal Vranckx
Analysis of the MASTER DAPT trial, presented as a late-breaking trial at EuroPCR 2022 (17–20 May, Paris, France), found that patients undergoing complex percutaneous coronary intervention (PCI) using the Ultimaster (Terumo) biodegradable-polymer, sirolimus-eluting stent saw a lower rate of bleeding after one month of dual antiplatelet therapy (DAPT), compared to those who had a longer course of DAPT.
The presentation follows the recent publication of SCAI’s “Expert Consensus Statement on SexSpecific Consideration in Myocardial Revascularization” in JSCAI, which referenced the role of IVL in female patients. The SCAI statement concluded, “while additional evidence is needed, these results taken in the context of outcomes with atherectomy devices suggest that IVL may emerge as a first-line therapy for plaque modification of calcified lesions in women specifically.”
“Given the established safety profile of IVL and the high rates of acute and long-term adverse events in women undergoing PCI, with or without atheroablation of calcified lesions, coronary IVL is an attractive treatment option for optimising outcomes in our female patients,” said Alexandra Lansky (Yale University School of Medicine, New Haven, USA). “While this is the first one-year analysis of its kind for coronary IVL, the sustained benefit in MACE at one year suggests that IVL should be considered first-line therapy for plaque modification in women with calcified lesions.”
“As someone who is dedicating her career to addressing the needs of the most complex patients, I find these results very encouraging,” said Katherine Kunkel (Piedmont Heart Institute, Atlanta, USA), one of the sites that participated in Disrupt CAD III. “Thanks to an increasing focus on the challenges of female patients, which often include atypical symptoms, later presentation with smaller and more tortuous vessels, and possibly an unconscious bias that may be associated with under-treatment, I am confident that we are heading in the right direction to improve outcomes in female patients. Additionally, tools like IVL are helping level the playing field for safely and effectively treating all types of patients with calcified disease.”
Alexandra Lansky
12.7MACE% Women 13.3% Men Target10.4failurelesion% Women 11.2% Men Target vessel MI 8.5% Women 9.7% Men Target revascularisationlesion2.9% Women 4.2% Men thrombosisStent0% Women 1.2% Men Sunil Rao
In a press release, SCAI detailed that Rao graduated summa cum laude from Miami University (Oxford, USA), and laude from The Ohio State University College of Medicine (Columbus, USA) where he won the David Saylor Memorial Award for cardiology research. He completed a residency in internal medicine and fellowships in cardiology and interventional cardiology at Duke University Medical Center (Durham, USA). He then served as chief fellow at the Duke Clinical Research Institute After his training, he joined the faculty at Duke University Medical Center as an assistant professor of medicine and rose to become professor of medicine in 2017. In 2005, he became the director of the Catheterization Laboratories at the Durham VA Medical Center (Durham, USA) and in 2014, he was appointed chief of cardiology at the same institution.Asthechief of cardiology, SCAI’s press release adds, Rao has overseen the expansion of the faculty at the VA to increase patient access, start new clinical programmes, and leverage VA research funding. New clinical programmes include a structural heart disease service, a same-day discharge after percutaneous coronary intervention (PCI) programme, and a transradial PCI programme. In September, Rao begins a new role as director of interventional cardiology for the NYU Langone Health System (New York, USA). Rao has published over 400 peer-reviewed manuscripts. His main research interests are pharmacological and interventional therapies for acute coronary syndromes, as well as bleeding and blood transfusion complications among patients with ischemic heart disease. At the national level, Rao serves as editor-in-chief of Circulation: Cardiovascular Interventions and is a former chair of the SCAI Quality Improvement Committee.
A POOLED ANALYSIS OF THE Disrupt CAD III & IV studies showed that IVL was equally safe and effective in men (n=342) and women (n=106). Despite the smaller vessel size in women (2.8mm vs. 3.1mm, p=<0.001), the primary effectiveness endpoint of procedural success for women and men was similar (90.6% vs. 93%, p=0.47), Shockwave Medical reported in a press release. The primary safety endpoint of 30-day major adverse cardiovascular events (MACE) for women and men was also similar (9.4% vs. 7%, p=0.55). Notably, there were also consistently low rates of post-IVL serious angiographic complications in women and men (2.2% vs. 2.6%, p=0.85), which differs from similar analyses in an atherectomy population.
“It is a tremendous honour to lead SCAI during the next year as we continue to make meaningful progress towards the organisation’s priorities outlined in our strategic plan, as well as empower and educate our members who are the leaders of interventional cardiology,” Rao stated. “I look forward to working with our members in the year ahead to improve patient outcomes.” I look forward to working with our members in the year ahead to improve patient outcomes”
Analysis looks at coronary womenoutcomeslithotripsyinandmen
Issue66 | August 2022 23Conference Coverage
SCAI names Sunil Rao as SunilpresidentincomingRao(DukeUniversityHealth System, Durham, USA) has assumed the office of president of the Society for Cardiovascular Angiography & Interventions (SCAI). His term as president began during the 2022 Scientific Sessions (SCAI 2022; 19–22 May, Atlanta, USA).
New data confirming one-year outcomes with coronary intravascular lithotripsy (IVL, Shockwave Medical) in both women and men were presented at the 2022 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions (SCAI 2022; 19–22 May, Atlanta, USA).
Women and men had similar rates of MACE (12.7% vs. 13.3%, p=0.83) and target lesion failure (TLF, 10.4% vs. 11.2%, p=0.85), respectively. The components of target lesion revascularisation (TLF) were low in both women and men and numerically favoured females, including target vessel-myocardial infarction (MI, 8.5% vs. 9.7%), target lesion revascularisation (2.9% vs. 4.2%) and stent thrombosis (0% vs. 1.2%).
“I am deeply impressed by the accuracy and quick learning curve of R-One. Not only can it complete the positioning of the balloon and stent catheter precisely, it also enables manipulation of two guidewires, one of them being parked in a stand-by path, facilitating complex PCI presenting tortuous and/or calcified lesions. This could reduce the risk of intraoperative and post-operative complications, which would benefit both patients and operators,” said Yundai Chen, director of the cardiology department at 301 “TheHospital.simpleand intuitive design of R-One is very convenient for doctors to operate with. We can get started after only short-term training. Additionally, we can complete the intervention whilst being totally protected by sitting in front of the X-Ray-proof console and manipulating the devices using only the joysticks. We look forward to working with R-One on a daily basis to benefit more patients and doctors,” commented Jian An, department of cardiovascular medicine, dean of the Shanxi Cardiovascular Hospital. “R-One drastically improves our working conditions. First, we can operate while fully protected from radiation; compared to manual interventions where we need to stand for long hours, only a few centimeters from the X-Ray tube, which can induce serious diseases, like cancer, and orthopaedic injuries. Second, it offers a high level of precision, which directly benefits the patient,” added Zhixiong Zhong, dean of the Meizhou Peoples’ Hospital.
The registry has primary endpoints of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularisation (CD-TLR). Secondary endpoints include target vessel failure (TVF), major adverse cardiovascular events (MACE) and stent thrombosis.
All patients in the newly approved arm will receive a Reducer device per protocol. The two imaging sub-studies, utilising computed tomography (CT) and positron emission tomography (PET), aim to provide further support for the Reducer’s safety profile and mechanism of action.
OCT clinical study of Firehawk stent meets primary endpoint at six months MicroPort has shared results from the TARGET STEMI OCT China clinical study for its Firehawk rapamycin target-eluting coronary stent system. Led by Ling Tao of Xijing Hospital (Shaanxi, China) the study was conducted in a population of patients with high-risk ST-elevation myocardial infarctionTARGET(STEMI).STEMI OCT China, a prospective, multicentre, randomised controlled study included a total of 44 patients enrolled from three hospitals in China. The results of the six-month optical coherence tomography (OCT) follow-up showed that the study achieved its primary endpoint of stent strut neointimal thickness. The stent strut neointimal thicknesses at 12-months were 73.03±33.30µm and 78.96±33.29µm for Firehawk and Xience (Abbott) treatment groups, respectively (P for non-inferiority <0.001), demonstrating that the neointimal thickness on Firehawk at six months was non-inferior to that on the Xience stent. Angiographic and OCT data at the six-month follow-up of secondary endpoints also showed that the Firehawk stent that was used in the experimental group was comparable to the Xience group in terms of the percentage of complete strut coverage, percentage of malapposed struts, in-stent late loss, and in-segment late loss. Additionally, no cardiac death, target vessel infarction events, or stent thrombosis occurred in either group at the 12-month clinical follow-up. The manuscripts of the study have been accepted by the Journal of Frontiers in Cardiovascular Medicine Tao said: “There is a lack of similar OCT studies due to the difficulty of conducting OCT investigations in patients with high-risk STEMI, as individuals must be enrolled within 12 hours of the onset of symptoms. Data from this trial are very promising for the safety and efficacy of Firehawk stents. We are pleased to see the excellent OCT data in this study, which provides compelling evidence for vessel rapid healing in high-risk STEMI patients.”
Angiolite R-One robotic PCI platform
(University Hospital of León, León,Non-selectedSpain). patients who underwent percutaneous coronary intervention (PCI) with at least one Angiolite stent were enrolled in the registry and are currently being followed out to five years. The objective of the study is to evaluate the efficacy and safety of Angiolite and confirm the outcomes of previous pre-clinical and clinical studies.
Cathbot enrolmentcompletesinclinical study of robotic-assisted PCI in China Cathbot—a joint venture between Robocath and MicroPort—has enrolled the last patient in its clinical study in China. This is the first step towards obtaining approval from China’s National Medical Products Administration (NMPA) for the commercialisation of R-One, the robotic percutaneous coronary intervention (PCI) platform, in the Chinese market. The multicentre clinical study began in November 2021 and has enrolled 149 patients over six months. Four centres participated in the trial: 301 Hospital (Beijing, China), Shanxi Cardiovascular Hospital (Shanxi, China), Meizhou Peoples’ Hospital (Meizhou, China), and the People’s Hospital of Xinjiang Uygur Autonomous Region (Ürümqi, China).
The three-year follow-up results from RANGO, an observational, prospective, multicentre registry were presented at EuroPCR 2022 (17–20 May, Paris, France) by Armando Pérez de Prado
Mano Thubrikar, inventor of the Optimum TAV and the company’s founder and president, stated: “We are grateful to Drs Trebacz and Williams and the entire team, for the success in the first two patients. Optimum TAV has unparalleled pre-clinical durability, and we plan to bring this technology to more patients soon.”
Neovasc gains approval for protocol supplement to COSIRA-II trial Neovasc has announced that the US Food and Drug Administration (FDA) has approved a protocol supplement to the COSIRA-II investigational device exemption (IDE) trial. The approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer. The timing of the approval is ahead of the company’s internal target and will allow for additional patients to beThetreated.supplement adds a single, non-randomised arm to the existing protocol that allows enrolment of patients who are believed to benefit from Reducer implantation to reduce their angina symptoms, but who do not otherwise qualify for the randomised arm. These patients are well defined within the protocol and include patients with non-obstructive coronary artery disease who were previously ineligible for treatment. In addition, the expansion allows patients with predominantly right-sided ischaemia, and those unable to perform a treadmill test due to amputation, to be included.
Clinical News
24 Market Watch August 2022 | Issue66
Williams and Susheel Kodali (New York-Presbyterian/Columbia University Medical Center, New York, USA) have been the company’s medical advisors since its founding. Three-year results of RANGO registry presented at EuroPCR 2022 iVascular has announced the release of three-year observational data concerning its Angiolite cobaltchromium sirolimus-eluting stent.
“Positive” 30-day outcomes for patients receiving Optimum transcatheter aortic valve Thubrikar Aortic Valve has announced successful 30-day outcomes in the first two patients receiving the Optimum transcatheter aortic valve (Optimum TAV). The implantations were performed by the principal investigator, Jaroslaw Trebacz, at the Specialty Hospital Jana Pawla II, Krakow, Poland. The study was approved by the Competent Authority of Poland and conducted in accordance with European Union (EU) Medical Device Regulations (MDR). Mathew Williams (NYU Langone Health, New York, USA) proctored the implant team of an interventional cardiologist and a cardiac surgeon. Three more patients are expected to receive the Optimum TAV in the coming weeks. The procedures were conducted using the minimalist transcatheter aortic valve implantation (TAVI) approach. Both patients showed significant clinical improvement as evidenced by quantitative improvements in valvular pressure gradients and effective orifice areas (EOAs). The patients met all primary outcome measures and were free from all-cause mortality, stroke, major bleeding, pacemaker implantation, moderate to severe regurgitation, and vascular complications three months following implantation. Their quality of life has also improved significantly.
The three-year follow-up results from 646 patients presented by Pérez de Prado showed that patients presented with high-complexity coronary disease (prevalence of previous MI (18.4%), previous coronary revascularisation (23.4%), clinical presentation as STsegment elevation MI (STEMI, 23.1%), and multivessel disease (47.8%)) and 58.4% of the treated lesions were classified as B2/C showing high complexity.Three-year all-cause death, cardiac death and MI rates showed very low values: 4.2%, 1.6% and 2.3%, respectively. Also, definite or probable device thrombosis occurred in only 0.7% of patients. TLF, TVF and MACE rates at three-year follow-up were also low 3.1%, 3.1% and 8%, respectively supporting the outstanding clinical performance and safety of Angiolite stent, iVascular said in a press release.
Teleflex has announced the first patient enrolment in a clinical study that is intended to demonstrate the safety of the Manta vascular closure device using ultrasound guidance, without dependence on preprocedural depth locator measurements. The study will enrol patients undergoing elective transcatheter aortic valve implantation (TAVI) procedures with planned percutaneous femoral arterial access. Enrolling up to 150 patients in up to 15 investigational sites across the USA and Canada, the MANTA Ultra study is a prospective, multicentre, single-arm trial employing the primary safety endpoint of any large bore access site-related Valve Academic Research Consortium-2 (VARC-2) major vascular complication within 30 days (adapted from VARC-2 Criteria). The occurrence of access site complications is known to be associated with higher rates of morbidity and mortality and increased costs associated with prolonged length of stay. The practice of ultrasound-guided access has been associated with a reduced risk of major and minor access site vascular complications, as well as reduced risk of life-threatening, major, and minor access site bleed complications.
Cordella meets safety and efficacy endpoints in SIRONA 2 clinical trial Endotronix has announced data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure patients. The prospective, multicentre trial met all primary safety and efficacy endpoints and resulted in low rates of HF hospitalisation, further validating pulmonary artery (PA) pressure-guided HF management as standard of care for NYHA class III heart failure patients.
Clinical News Captis
PA pressure measurements from a seated position,” stated Wilfried Mullens (Hospital Oost-Limburg, University Hasselt, Genk, Belgium).
“The daily measurements provided a comprehensive clinical picture of the patient’s health over time, which supported guideline-directed medical therapy (GDMT) resulting in excellent clinical outcomes with low heart failure hospitalisation (HFH) rates.”
deployment, the company said in a pressTherelease.principal investigators of the study include David A Wood (University of British Columbia Centre for Cardiovascular Innovation, Vancouver, Canada) and Vijay S Iyer (University of Buffalo, Buffalo, USA).
Teleflex is committed to exploring whether the known benefits of ultrasound-guided access will translate to ultrasound-guided closure, resulting in safe Manta device
First-in-human results of SavvyWire TAVI guidewire support safety Results of the 20-patient, first-inhuman clinical study supporting the safety and efficacy of the SavvyWire (OpSens) guidewire for transcatheter aortic valve implantation (TAVI) were presented at EuroPCR 2022 (17–20 May, Paris, France) and simultaneously published in EuroIntervention
Data from the SIRONA 2 trial was presented in a late-breaking session at European Society of Cardiology’s (ESC) Heart Failure Association (HFA) 2022 annual conference (22 May, Madrid, Spain).
“We are excited to embark on the Teleflex MANTA Ultra study,” said Wood. “We expect the study results to show that the use of ultrasound further aids in avoiding Manta device deployment complications attributed to anchor malpositioning by providing direct visualisation of the closure process.”Withvisualisation of the access site during Manta device deployment, the study intends to demonstrate that ultrasound allows for precise deployment and positive positioning of the Manta device anchor within the vessel. This approach, if proven effective, will allow the Manta device to be used in clinical scenarios where the baseline arterial depth is not measured, or may have changed intraoperatively or postoperatively.
First-in-human results of Captis embolic protection device presented at EuroPCR 2022 Filterlex Medical has announced results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the Captis device, a full-body embolic protection device that reduces risk of stroke and other complications during left-heart procedures.Studydata by presented at EuroPCR 2022 (17–20 May, Paris, France) by Ran Kornowski (Rabin Medical Center, Tel Aviv, Israel). The trial was a prospective, single-arm study involving 20 patients who underwent a successful transcatheter aortic valve implantation (TAVI) procedure while using the Captis embolic protection device. Key outcomes from the trial included 100% technical device performance success, with the Captis device having been successfully deployed and retrieved in all patients, and the TAVI procedure performed with no interference.Kornowski also reported that there were no device-related complications, and no patients positionedcerebrovascularexperiencedevents.TheCaptisdeviceissecurelyintheaorta,protecting its surface, while facilitating a seamless TAVI procedure, without additional arterial access, Filterlex Medical detailed in a press release.
The open-label, single-arm SIRONA 2 trial included 70 patients who were successfully implanted with the Cordella Sensor at seven European sites across Ireland, Belgium and Germany. The results confirmed a strong safety profile with no PA sensor failures, only one device/system related complication (DSRC=1.3%) and 0% mortality at 90 days. The primary efficacy endpoint of accuracy, comparing Cordella Sensor with the gold standard fluid-filled reference catheter accuracy at 90 days, was also met. In addition, the study demonstrated a low six-month HFH event rate (0.16) with the majority of patients improving their NYHA classification (67.5%). Compliance with daily readings of PA pressure, weight, blood pressure, heart rate and blood oxygen were consistently above 93% over six months. Moreover, patients overwhelmingly found the system easy to use (94%) and were knowledgeable about their normal range of daily measurements (67%).
First patients enrolled in MANTA Ultra vascular closure device study
Digital drainage system for cardiac surgery “safe and effective” Centese has announced the publication of the first peer-reviewed clinical study of its Thoraguard digital drainage system for cardiac surgery in the Journal of Thoracic and Cardiovascular Surgery Open Thoraguard is a digital chest tube management system that provides automated clog clearance without human intervention while continuously and precisely monitoring critical physiological parameters to inform clinical decision-making and optimise outcomes.Thestudy found that Thoraguard is safe and effective compared to conventional analogue chest tubes when used following cardiac surgery (the study’s primary endpoints). The authors noted that the Thoraguard occlusion (clog) rate (2%) and reintervention rate were exceptionally low. In addition, the automated clog clearance function enabled cardiac surgeons to use smaller chest tubes than conventional tubes for enhanced patient comfort.“Thisstudy shows that the future of cardiac surgery and chest drainage is upon us. Our surgical tools must be digitally enabled to keep pace with technological advances in the field,” commented Jack Boyd (Stanford University Medical Center, Stanford, USA), the principal investigator of the study.
“In addition to achieving the primary safety and accuracy endpoints, the SIRONA 2 trial demonstrated a consistently high level of patient compliance with daily readings of PA pressure and physiologic data with a strong preference for performing
Haim Danenberg (Wolfson Medical Center, Holon, Israel) and the study’s principal investigator, said: “Safe and effective brain protection in percutaneous heart procedures is a true unmet need—I am very impressed with the promising Captis technology. Filterlex has developed an innovative solution that protects TAVI a patient’s brain and Kornowskikidneys.”added: “I am excited about the successful results in the FIH study and look forward to being part of future Captis research.”
The new clinical data presented by Josep Rodés-Cabau (Quebec Heart and Lung Institute, Quebec City, Canada) support the safety and efficacy of the SavvyWire for TAVI procedures, OpSens said in a press release. A total of 12 patients received an Evolut PRO+ (Medtronic) valve and eight patients received a Sapien 3/Ultra valve (Edwards Lifesciences). Patient enrolment was performed at Quebec Heart and Lung Institute by Rodés-Cabau and at the Montreal Heart Institute (Montreal, Canada) by RedaInvestigatorsIbrahim. reported that appropriate left ventricular rapid pacing was achieved in all patients, resulting in an adequate reduction of aortic pressure. No procedural mortality, stroke, cardiac perforation, or guidewire malfunction were reported. Continuous and accurate recording of pressure measurements during the TAVI procedures was achieved in all patients, with an excellent correlation between systolic and left ventricular end-diastolic pressure obtained using traditional pigtail catheters and the new SavvyWire, OpSens’ press release adds. The SavvyWire is a third-generation, intelligent and pre-shaped structural guidewire, with integrated pressure monitoring and the capacity to perform left ventricular pacing. This device aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange, in line with the minimalist approach.
25Market WatchIssue66 | August 2022
The VenusP-Valve (Venus Medtech) transcatheter pulmonic valve replacement (TPVR) system has been approved by China’s National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation in patients who have undergone a congenital heart defect (CHD) procedure with native right ventricular outflow tract (RVOT).
In light of the 2021 guidelines from the American Heart Association (AHA), American College of Cardiology (ACC), American Society of Echocardiography (ASE), American College of Chest Physicians (CHEST), Society for Academic Emergency Medicine (SAEM), Society of Cardiovascular Computed Tomography (SCCT), and Society for Cardiovascular Magnetic Resonance (SCMR) for the evaluation and diagnosis of chest pain and in consultation with its clinical advisors, HeartBeam elected to include the full dataset for clinical validation studying in support of the 510(k) submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the US Food and Drug Administration (FDA).
VenusP-Valve gains approval from China’s NMPA
For the registration application, the NMPA has accepted trial data submitted to support the device’s CE mark approval, which was received in April 2022. The device was approved by the US Food and Drug Administration (FDA) for compassionate use in two cases in the USA in May 2022 and the first compassionate case was completed successfully in June 2022. Following its first clinical implantation in 2013, VenusP-Valve has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America, Venus Medtech said in a pressAccordingrelease. to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusPValve is 100% in 64 patients (some patients have not been included due to the ongoing pandemic), the company adds. All-cause mortality and surgical reintervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. Meanwhile, fiveyear follow-up data of the Chinese trial reported a 3.64% postoperative fiveyear all-cause mortality rate. Commenting on the approval, Ge Junbo (Zhongshan Hospital, Shanghai, China), principal investigator of the Chinese clinical trial of VenusP-Valve, said: “The first clinical application of VenusP-Valve dated to May 2013, and we were all impressed by its excellent immediate outcomes. The overall clinical results of the multicentre study testified to effective and steady improvements it brought to patients’ cardiac function, making me extremely proud of this Chinese-developed valve product. Moreover, its recent launch in Europe and compassionate use in the USA demonstrated the recognition it received from the international medical community. That is how a truly meaningful innovative medical device is defined.”
In a press release, Medtronic adds that design changes incorporated in the Onyx Frontier include increased catheter flexibility, a dual-layer balloon technology and a lower crossing profile.
Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the Accucinch system is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
“The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently,” said Azeem Latib (Montefiore Medical Center, New York, USA). “Delivering safe and effective outcomes to our patients is our number one priority. It is important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes.”
Product News Calendar of events C M Y CM MY CY CMY K Accucinch Onyx Frontier
Medtronic gains FDA approval for Onyx Frontier drug-eluting stent Medtronic has received US Food and Drug Administration (FDA) approval for the Onyx Frontier drug-eluting stent (DES), the latest generation in its Resolute range of devices. According to Medtronic, the new device features an enhanced delivery system designed to improve deliverability and increase acute performance in challenging cases.
“It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischaemia without definitive injury to the cardiac tissue,” said Russell Jones (Phoebe Putney Health System, Albany, USA). “Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention.”HeartBeam’s platform is anticipated
26 August 2022 | Issue66Market Watch 27–30 August European Society of Cardiology (ESC) Congress 2022 Barcelona, Spain escardio.org 16–20 September TCT 2022 Boston, USA crf.org 5–8 October European Association for Cardio-Thoracic Surgery (EACTS) 2022 Annual Meeting Milan, Italy eacts.org/annual-meeting 24–26 October CX Aortic Vienna 2022 Digital Edition Digital cxaortic.com 27–29 November PCR London Valves London, UK pcronline.com 14–15 December GulfPCR-GIM Dubai, UAE pcronline.com 21–232023 January Society of Thoracic Surgeons (STS) Annual Meeting San Diego, USA sts.org/meetings 25–28 February Cardiovascular Research Technologies (CRT) 23 Washington DC, USA crtmeeting.org 4–6 March American College of Cardiology (ACC) 2023 Scientific Session New Orleans, USA expo.acc.org
“In addition to the delivery system enhancements, Onyx Frontier offers a broad size matrix to treat more patients and is the only 2mm DES available in the USA (similar to Resolute Onyx),” Medtronic’s press release adds. Onyx Frontier is available in 4.5–5mm sizes that can be expanded to 6 mm, and shares the same clinical indications as Resolute Onyx, including the most recent approval for patients that are at high risk of bleeding who may benefit from a dual antiplatelet therapy (DAPT) duration as short as one month. The Onyx Frontier DES is now approved in the USA and is pending CE mark.
“The chronic and progressive nature of heart failure leaves many patients to face an increasingly challenging future as existing treatments, including medications and pacemaker devices, are not able to keep the disease at bay,” said Ulrich P Jorde (Montefiore Health System, New York, USA), global co-principal investigator of the CORCINCH-HF study.
HeartBeam expands software platform to cover unstable angina HeartBeam is expanding the available patient population for its emergency department software technology solution. In evaluating the electrocardiogram (ECG) database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina.
to assist physicians in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatmentHeartBeam’sregimen.software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies. FDA grants breakthrough status for restorationventricularAccucinchsystem
Ancora Heart has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Accucinch ventricular restoration system.
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27Issue66 | August 2022
Precautions Only physicians who have received adequate training should perform implantation of the stent. Subsequent stent restenosis or occlusion may require repeat catheter-based treatments (including balloon dilatation) of the arterial segment containing the stent. The long-term outcome following repeat catheter-based treatments of previously implanted stents is not well characterized. The risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to contrast agents. Do not expose or wipe the product with organic solvents such as alcohol. The use of a drug-eluting stent (DES) outside of the labeled indications, including use in patients with more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction (MI), or death. Care should be taken to control the position of the guide catheter tip during stent delivery, stent deployment, and balloon withdrawal. Before withdrawing the stent delivery system, confirm complete balloon deflation using fluoroscopy to avoid arterial damage caused by guiding catheter movement into the vessel. Stent thrombosis is a low-frequency event that is frequently associated with MI or death. Data from the RESOLUTE clinical trials have been prospectively evaluated and adjudicated using the definition developed by the Academic Research Consortium (ARC). The safety and effectiveness of the stent have not yet been established in the following patient populations: Patients with target lesions that were treated with prior brachytherapy or the use of brachytherapy to treat in-stent restenosis of the stent Women who are pregnant or lactating Men intending to father children Pediatric patients below the age of 18 years Patients with coronary artery reference vessel diameters of <2.0 mm or >5.0 mm Patients with evidence of an acute ST-elevation MI within 72 hours of intended stent implantation Patients with vessel thrombus at the lesion site Patients with lesions located in a saphenous vein graft, in the left main coronary artery, ostial lesions, or bifurcation lesions Patients with diffuse disease or poor flow distal to identified lesions Patients with 3 vessel disease
2 Based on bench test data on file at Medtronic. May not be indicative of clinical performance. N = 5 DES of each tested: Onyx Frontier DES, Orsiro Mission DES, Resolute Onyx DES, XIENCE Skypoint DES, SYNERGY DES.
Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks (in alphabetical order) may include but are not limited to: Abrupt vessel closure Access site pain, hematoma, or hemorrhage Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating) Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF) Arrhythmias, including ventricular fibrillation Balloon rupture Bleeding Cardiac tamponade Coronary artery occlusion, perforation, rupture, or dissection Coronary artery spasm Death Embolism (air, tissue, device, or thrombus) Emergency surgery: peripheral vascular or coronary bypass Failure to deliver the stent Hemorrhage requiring transfusion Hypotension/ hypertensionIncompletestent apposition Infection or fever MI
Pericarditis Peripheral ischemia/peripheral nerve injury
Adverse events related to BioLinx polymer Although the type of risks of the BioLinx polymer coating are expected to be no different than those of other stent coatings, the potential for these risks are currently unknown as the coating has limited previous use in humans. These risks may include but are not limited to the following: Allergic reaction Focal inflammation at the site of stent implantation Restenosis of the stented artery Please reference appropriate product Instructions for Use for more information regarding indications, contraindications, warnings, precautions, and potential adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For further information, please call and/or consult Medtronic at the toll-free numbers or websites listed.
The Onyx Frontier system is contraindicated for use in: Patients with a known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative • Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy • Patients with a known hypersensitivity to the BioLinx™ polymer or its individual components. Coronary artery stenting is contraindicated for use in: Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. Warnings Ensure that the inner package has not been opened or damaged as this would indicate the sterile barrier has been breached. The use of this product carries the same risks associated with coronary artery stent implantation procedures, which include subacute and late vessel thrombosis, vascular complications, and bleeding events. This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
Dual antiplatelet therapy (DAPT) using a combination treatment of aspirin with a P2Y12 platelet inhibitor after percutaneous coronary intervention (PCI), reduces the risk of stent thrombosis and ischemic cardiac events, but increases the risk of bleeding complications. The optimal duration of DAPT (specifically a P2Y12 platelet inhibitor in addition to aspirin) following DES implantation is unknown, and DES thrombosis may still occur despite continued therapy. It is very important that the patient is compliant with the post-procedural antiplatelet recommendations.
Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, and patient preference. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of stent thrombosis, MI, or death. Before PCI, if premature discontinuation of antiplatelet therapy is anticipated, physicians should carefully evaluate with the patient whether a DES and its associated recommended DAPT regimen is the appropriate PCI choice. Following PCI, if elective noncardiac surgery requiring suspension of antiplatelet therapy is considered, the risks and benefits of the procedure should be weighed against the possible risk associated with interruption of antiplatelet therapy. Patients who require premature DAPT discontinuation should be carefully monitored for cardiac events. At the discretion of the patient’s treating physician(s), the antiplatelet therapy should be restarted as soon as possible. Potential adverse events
The Onyx Frontier zotarolimus-eluting coronary stent system is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.00 mm to 5.00 mm. In addition, the Onyx Frontier™ zotarolimus-eluting coronary stent system is indicated for treating de novo chronic total occlusions. Contraindications
References 1 Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2016.03.513. 2 Mauri L, Kereiakes DJ, Yeh RW, et al. Twelve or 30 Months of Dual Antiplatelet Therapy After Drug-Eluting Stents. N Engl J Med December 4, 2014;371:2155-2166. 3 Urban P, Mehran R, Colleran R, et al. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. May 22, 2019;140:240-261. 4 Windecker S, Latib A, Kedhi E, et al. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. March 26, 2020;382:1208-1218. Medtronic Tel: 707.525.0111 LifeLine Customer Support Tel: 877.526.7890 UC202211208 EN ©2022 Medtronic. Medtronic, other the 03/2022 Tel: 888.283.7868
Indications
Oral antiplatelet therapy
1 Based on bench test data on file at Medtronic. May not be indicative of clinical performance. N = 7 DES of each tested: Onyx Frontier DES, Resolute Onyx DES, Orsiro Mission DES, XIENCE Sierra DES, XIENCE Skypoint DES, SYNERGY DES, SYNERGY XD DES.
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Renal failure Restenosis of the stented artery Shock/pulmonary edema Stable or unstable angina Stent deformation, collapse, or fracture Stent migration or embolization Stent misplacement Stroke/transient ischemic attack
Thrombosis (acute, subacute, or late)
Adverse events related to Zotarolimus Patients’ exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/ complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include but are not limited to: Anemia Diarrhea Dry skin Headache Hematuria Infection Injection site reaction Pain (abdominal, arthralgia, injection site) Rash The potential adverse reactions in nursing infants from zotarolimus have not been determined. The pharmacokinetic and safety profiles of zotarolimus in infants are not known.
The safety and effectiveness of the stent have not been established in the cerebral, carotid, or peripheral vasculature. Additionally, the safety and effectiveness of using atherectomy devices with the stent have not been established. The effect of potential drug interactions on the safety or effectiveness of the Onyx Frontier stent has not been investigated. Potential interactions of the stent with other drug-eluting or coated stents have not been evaluated and should be avoided whenever possible. Clinical studies of the Resolute stent did not suggest any significant differences in safety and effectiveness for male and female patients and did not include sufficient numbers of patients to assess for differences in safety and effectiveness due to ethnicity.
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Per 2016 ACC/AHA guidelines,1 a daily aspirin dose of 81 mg is recommended indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at least 6 months in stable ischemic heart disease patients and for at least 12 months in patients with acute coronary syndrome (ACS). Consistent with the DAPT Study, 2 and the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in patients at higher ischemic risk with lower bleeding risk. The Academic Research Consortium (ARC) proposed a standardized definition for identifying patients at high bleeding risk (HBR) 3. Additionally, evidence from a dedicated study of Resolute Onyx in HBR patients and those who are unable to tolerate long term DAPT after PCI has been published4 Based on the Onyx ONE Clear Analysis, the Resolute Onyx stent is safe and effective in patients at high risk of bleeding treated with one month of DAPT. The patients evaluated in the Onyx ONE Clear Analysis met the pre-defined criteria for high bleeding risk and were those whom in the opinion of their physician, the potential benefit of 1-Month DAPT outweighed the potential risk. In addition to at least one HBR risk factor, enrollment included 48.6% ACS patients (unstable angina 22.8%, Non-STEMI 21.7% and STEMI 4.2%).
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betterjustGreatdeliverablegotAsthelatestmemberoftheMedtronic DES family, Onyx Frontier DES inherits the same stent platform, clinical data, and indications you’ve come to rely on with Resolute Onyx™ DES. What makes it even better is its delivery system resulting in best-in-class with a lower crossing profile.2 See more at medtronic.com/OnyxFrontier †Stent delivery system updates were implemented on the 2.0–4.0 mm Onyx Frontier DES diameters.
