Cardiovascular News 62–August 2021 (US) by BIBA Publishing

August 2021 | Issue 62

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August 2021 | Issue 62

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Sripal Bangalore Evidence-based practice in the cath lab

Profile Christoph Naber page 14

Divisive meta-analysis draws out debate over elective coronary revascularisation A meta-analysis reporting a significantly lower risk of cardiac death among patients randomised to elective coronary revascularisation plus medical therapy compared with medical therapy alone has attracted debate within the global cardiology community.

ome have welcomed the findings of the analysis, which points towards a longterm cardiovascular survival advantage achieved via revascularisation versus medical therapy alone in patients with stable ischaemic heart disease, but critics of the study have questioned the selection of trials for inclusion in the analysis as well as the primary and secondary endpoints used in reaching this conclusion. The findings were first presented by Eliano Navarese (Nicolaus Copernicus University, Toruń, Poland) during a late-breaking trial session at EuroPCR 2021 (18–20 May, virtual) and later published in the European Heart Journal (EHJ). Navarese told Cardiovascular News that the findings show a “significant and robust reduction of cardiac mortality in favour of elective coronary revascularisation compared with medical therapy alone”. To reach this conclusion, the study team pooled randomised trial data dating back to 1979 from 25 randomised trials sourced through MEDLINE, EMBASE, Google Scholar and other databases. Of the 19,806 patients included in the analysis, 10,023 were randomised to revascularisation using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) plus medical therapy, and 9,783 to medical therapy alone. The study’s primary endpoint was cardiac death, while secondary endpoints were all-cause death, spontaneous myocardial infarction (MI), any myocardial infarction, and stroke. The authors reported a statistically significant 21% relative risk reduction in cardiac death with revascularisation plus medical therapy (risk ratio [RR] 0.79, 95% confidence interval [CI] 0.67‒0.93, p<0.01), which they said was consistent in sensitivity analyses restricted to trials that did not include patients with prior acute coronary syndromes, chronic total occlusions or prevalent use of CABG in the invasive arm. According to Navarese and colleagues, the findings of the meta-analysis suggest that the benefits of revascularisation and optimised medical therapy are additive and their combination is required to achieve maximal and durable prevention of adverse events. Furthermore, the study’s authors suggest that the cardiac survival benefit of revascularisation plus medical therapy

Revascularisation + Medical therapy

increases progressively over time, with an incremental relative risk reduction of 19% for every four years of follow-up extension. The significance of the findings were highlighted in a press release by the Society for Cardiovascular Angiography & Interventions (SCAI), issued shortly after the presentation of the analysis at EuroPCR. In the statement, SCAI said that the meta-analysis indicates that coronary revascularisation with PCI or CABG provides a long-term cardiovascular survival advantage over an initial conservative approach in patients with stable ischaemic heart disease by lowering rates of spontaneous MI. SCAI welcomed this as “a new and exciting finding related to coronary revascularisation, including PCI”. “This comprehensive analysis clearly defines a risk reduction in cardiovascular mortality following coronary revascularisation in patients with stable coronary artery disease that is directly related to both duration of follow-up and magnitude of risk reduction in spontaneous myocardial infarction. This mechanistically plausible benefit of revascularisation is evident through multiple sensitivity analyses,” Dean Kereiakes, medical director of the Christ Hospital Research Institute in Cincinnati, USA, a co-author of the study, was quoted as saying in the SCAI statement. However, critics of the study have called into question the use of cardiac death as the primary endpoint for the meta-analysis. Among them were David L Brown

Medical therapy alone

The findings show a significant and robust reduction of cardiac mortality in favour of elective coronary revascularisation compared with medical therapy alone.” Eliano Navarese

page 18

Breaking point: Cardiovascular societies speak out as burnout puts strain on physician wellbeing Global action is needed to improve clinician wellbeing, according to four leading cardiovascular health organisations, who have called for steps to be taken to mitigate against the impact of clinician burnout within cardiology. THIS IS PART OF A JOINT CALL TO action from the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC) and the World Heart Federation (WHF), which has been issued in light of new evidence suggesting the COVID-19 pandemic has put increasing strain on cardiology professionals, with rates of burnout nearly doubling since the beginning of the pandemic. A joint opinion published simultaneously in the Journal of the American College of Cardiology, Circulation, European Heart Journal and Global Heart in July urges healthcare organisations and medical societies to implement strategies to prevent clinician burnout including the creation of structures that allow for confidential reporting of mistreatment, and the destigmatisation of clinician access to mental health resources. The paper defines clinician wellbeing as experiencing satisfaction and engagement with work, while also having a feeling of professional fulfilment and a sense of meaning in work. Conversely, burnout is defined as emotional exhaustion, depersonalisation and a sense of low personal accomplishments in a perceived stressful work environment. Athena Poppas, immediate past president of the ACC and co-author of the joint opinion, commented: “The COVID-19 pandemic has caused additional Laxmi strain on clinicians through Mehta increased patient mortality, personal and family safety concerns, fear of the unknown and increased work demands. The time is now to join with our global healthcare professionals to call for quick action to improve clinician wellbeing worldwide.” Continued on page 2

Continued on page 3

Conference Coverage: ACC.21

August 2021 | Issue 62

Top Stories

Breaking point: Cardiology societies speak out as burnout puts strain on physician wellbeing

of burnout among cardiovascular professionals nearly doubled when comparing pre- to peak COVID-19 levels,” said Mehta. “It clearly shows that there are lots of opportunities to improve the work environment; COVID-19 has really put a magnifying glass on the fact that things were bad and now have significantly worsened.” The survey revealed that some cardiovascular clinicians are thinking about leaving their jobs, in some cases, Continued from page 1 because of COVID-19. Plans to reduce clinical work hours Drivers associated with burnout among cardiologists in the next year, leave their current practice or retire early include lack of control over workload, a hectic work were reported by 23%, 13% and 13% of respondents, environment, misalignment of values and respectively, and rates were notably higher among insufficient documentation time. Women those who reported feeling burnt out. may have added stressors contributing For some, COVID-19 was the key to burnout such as lack of career influencer for these decisions, with 17% promotion, inequalities in income and of clinicians planning to reduce their disparities in mentorship, in addition clinical work hours, 12% planning to to working in environments that leave their current practice and 11% lack diversity, equity, inclusion and planning to retire due to COVID-19. belonging, the paper suggests. The survey also revealed financial “The rising rate of stress stressors exacerbated by COVID-19, with and burnout among health professionals 41% of respondents reporting that their rings an alarm bell. As well as serious salary had been reduced to some degree. consequences for the individual, it will Roughly the same percentage of clinicians impact patient care. The ESC joins other also reported inadequate health system professional societies today to raise a red Source: ACC’s 2020 Well Being Study support during the pandemic related to flag and to urge healthcare systems to create workers’ basic needs, such as food, lodging, healthy environments for all those providing patient care,” transportation, childcare and emotional support. said Stephan Achenbach, ESC president. “Health systems need to take steps to help Research presented at the American College of ensure basic safety, financial and personal needs Cardiology’s 70th Annual Scientific Session (ACC.21, 15– of cardiology clinicians, especially in the wake of 17 May, virtual) by Laxmi Mehta (Ohio State University Wexner Medical Center, Columbus, USA), who authored the joint paper, suggests that the COVID-19 pandemic has exacerbated the issue of burnout among cardiology professionals. During a late-breaking science session at ACC.21, Mehta presented results of the ACC’s 2020 Well Being study suggesting that reported levels of burnout had increased from 20% prior to the pandemic to 38% during the peak of the pandemic. Among all cardiovascular clinicians—cardiologists, physician assistants, nurse practitioners, nurses, pharmacists and imaging technologists—half provided direct care to patients with COVID-19, and yet one out COVID-19,” Mehta said. “There are also still many of five reported not having adequate personal protective unknowns with emerging variants and as our communities equipment (PPE). The rate of burnout was higher in this open more, some people are choosing not to get group. vaccinated, not to mention on top of the already taxed “We know from previous studies that burnout is health systems, there are additional burdens of caring for pervasive in cardiology and medicine in general, but patients with cardiovascular disease who delayed care we felt it was important to take the temperature of our and are now sicker than they would have been if they colleagues amid the COVID-19 pandemic. The prevalence presented earlier.”

Burnout on the rise

Prepandemic

Pandemic peak

20% 38%

Health systems need to take steps to help ensure basic safety, financial and personal needs of cardiology clinicians, especially in the wake of COVID-19.”

News in brief

The latest stories from the world of Cardiology

n IN-PERSON EDUCATION RETURNS: After a pause of more than 12 months, cardiovascular education has returned to an inperson setting. Among the first to return was TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA & virtual) which was held as a hybrid meeting for the first time ever. Course director Gregg W Stone (New York, USA) offers a review of the format, and considers the future of medical education, post-COVID-19.

For more on this story go to page 6. n SILENT ALARM: The pandemic has had a stark impact on the availability and delivery of care to patients seeking treatment for heart disease. Founders of the We CARE campaign tell Cardiovascular News how they aim to ensure that the interventional cardiology field is prepared to face future pandemics or public health emergencies.

For more on this story go to page 10. n REASSURING RESULTS FOR LOWRISK TAVI: Two-year data from the Evolut Low Risk trial, presented at EuroPCR 2021 (18–20 May, virtual), offer “reassuring” evidence on the outcomes of transcatheter aortic valve implantation (TAVI) in low-surgical risk patients, speakers at the virtual event commented.

For more on this story go to page 21.

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2021

Issue 62 | August 2021

Divisive metaanalysis draws out debate over elective coronary revascularisation

Coronary Revascularisation in the meta-analysis was also picked up as a talking point by Davide Capodanno (University of Catania and G RodolicoSan Marco, Catania, Italy) in a panel discussion following the presentation of the findings at EuroPCR. Capodanno pointed out that 12 of the studies

During the discussion, Rasha AlLamee (Imperial College London, London, UK) remarked that many within the interventional cardiology community would “breathe a sigh of relief” over the positive outcome in favour of revascularisation. However,

Continued from page 1

(Washington University School of Medicine, St Louis, USA) and William E Boden (Boston University School of Medicine, Boston, USA) who co-authored an editorial piece which was also published in EHJ. In the editorial, Brown and Boden suggest that Navarese et al appeared to downplay the neutral effects of revascularisation on all-cause mortality and non-fatal MI, and instead “cherrypicked” the primary and secondary outcomes of cardiac death and spontaneous MI that were reduced by revascularisation. Brown and Boden wrote: “By selecting outcomes that have not been primary endpoints in other meta-analyses on this topic, they recycle the well-worn narrative that routine revascularisation of CCS [chronic coronary syndrome] patients improves outcomes, yet seemingly ignore the contrary findings from contemporary landmark randomised controlled trials of almost 11,000 patients in the optimal medical therapy era from COURAGE [Clinical outcomes utilising revascularisation and aggressive drug evaluation] to ISCHEMIA [International study of comparative health effectiveness with medical and invasive approaches].” Furthermore, Brown and Boden suggest that if only the trials relevant to current practice published since the introduction of optimal medical therapy in 2007 are included in the analysis, there is no longer a reduction in cardiac death from revascularisation. The age of the studies selected for use

Eliano Navarese

Rasha AlLamee

included were conducted more than 10 years ago, which he described as being both potentially positive (due to the availability of long-term follow-up from these studies) and negative (due to these trials not accurately representing current practice). For the primary endpoint of cardiac mortality, Capodanno noted that there were five studies which carried “heavier weight” as drivers of the pooled result of the analysis. Of these, two older studies—ECSS (the European coronary surgery study) and MASS-2 (The medicine, angioplasty or surgery study)—contributed respectively to a 43% and a 40% relative risk reduction, whereas the other three heavily weighted studies did not show a significant difference in cardiac mortality.

Davide Capodanno she also questioned Navarese over the inclusion of trials dating back several decades, noting that medical therapy and revascularisation techniques have both improved over these time periods. Asked to consolidate these facts with the findings of the meta-analysis, Navarese remarked that medical therapy was administered in both arms of the study population, meaning that findings were “generally comparable” across both groups. Summing up, Naverese commented that it would be “almost unethical” not to offer revascularisation in stable patients with coronary artery disease, based upon these data. Further scrutiny of the paper’s findings came in the form of a discussion paper, also published in EHJ, this time in

Reporting a combined overall outcome is at serious risk of potentially masking the negative effect of a discrete procedure and does not provide clear evidence nor guidelines as to the best treatment for the individual patient.” Victor Dayan

late July, authored by cardiothoracic surgeon Victor Dayan (Universidad de la Republica, Montevideo, Uruguay) as well as colleagues from Italy, Switzerland and the UK. In their article, Dayan et al note that cardiac, as opposed to total mortality, is “notoriously susceptible to bias”, but added that the findings of the metaanalysis did not distinguish between revascularisation achieved using either PCI or CABG. “Considering that both strategies have different treatment objectives, it is not obviously intuitive to pool outcomes derived from both strategies when comparing with medical treatment,” the authors wrote. They go on to write that pooling CABG and PCI together can generate potential biases with regard to the different meaning and results of the procedures, pointing out that PCI and medical treatment have both made significant advances over the time period of the study, while CABG has “effectively not changed”. “We believe that given their profound differences in medium- to long-term outcomes, PCI and CABG revascularisation procedures should not be pooled during coronary revascularisation trials,” Dayan et al assert. “Furthermore, PCI and medical therapy procedures from 30 years ago have very limited relevance to current outcomes. While each revascularisation procedure has its inherent advantages and disadvantages, we are performing only one of them in our patients. Reporting a combined overall outcome is at serious risk of potentially masking the negative effect of a discrete procedure and does not provide clear evidence nor guidelines as to the best treatment for the individual patient.” The authors conclude that although meta-analyses can increase the precision of estimates of treatment effect; pooling studies with “questionable inclusion criteria” introduces systematic errors, which may lead to inappropriate conclusions.

Coronary revascularisation versus medical therapy:

What have randomised trial data shown? ECSS 1988

COURAGE 2007

MASS-2 2010

ISCHEMIA 2020

Trial: ECSS Year: 1988 Key finding: “At the projected five-year follow-up interval, we observed a significantly higher survival rate in the group that was assigned to surgical treatment than in the group assigned to medical treatment.”

Trial: COURAGE Year: 2007 Key finding: “As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.”

Trial: MASS-2 Year: 2010 Key finding: “Compared with CABG, medical therapy was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularisation, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events.”

Trial: ISCHEMIA Year: 2020 Key finding: “Among patients with stable coronary disease and moderate or severe ischaemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischaemic cardiovascular events or death from any cause over a median of 3.2 years.”

August 2021 | Issue 62

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Optimising TAVI device choice As transcatheter aortic valve implantation (TAVI) continues to expand into a younger, lower surgical risk patient population, several key factors become central to valve selection, Darren Mylotte (Galway University Hospitals, Galway, Ireland) tells Cardiovascular News. Most prominently among them are the durability of the prosthesis and sustained haemodynamic performance, as well as other important factors. Here, Mylotte discusses optimal TAVI device selection, considers the features and data behind the latest-generation Evolut PRO+ (Medtronic) device and outlines the cusp overlap technique—a TAVI technique designed to help implanters assess and achieve the target implant depth in order to reduce interaction with the conduction system. "THERE ARE SEVERAL FACTORS,” comments Mylotte, when explaining the important items to consider in the selection of a suitable TAVI device across all risk profiles. “There may be specific concerns you would have regarding the size of the patient's anatomy regarding calcification—be that in the left ventricular outflow tract (LVOT) or the leaflets— and whether there are specific concerns regarding the possibility of coronary artery occlusion, and of course vascular access,” he adds. For those in the lower risk bracket, there are additional factors to consider, according to Mylotte. “In low-risk patients you want to ensure that you have got the right valve in your hand to ensure that you get a good procedural outcome,” he says. “Beyond the procedure you of course want to make sure that you have the appropriate result for your patient in the long term, and that really comes down to a couple of different things: the absence of a permanent pacemaker, patient-prosthesis mismatch, or paravalvular leak, as well as good haemodynamics and access to the coronary arteries in due course, if it is required.” Haemodynamics are crucial, Mylotte comments, and this is one area that the Evolut system comes into its own. Results from the OPTIMIZE PRO clinical study, a postmarket, prospective multicentre study, covering 46 sites in the USA and Canada, and up to 15 sites in Europe, are the latest data available to document the use of the self-expanding, supra-annular Evolut PRO and PRO+ TAVI systems—with interim, 30-day results from 171 patients with symptomatic severe aortic stenosis,

EvolutTM PRO+ TAVI System

recently presented at the Society for Cardiovascular Angiography and Interventions 2021 scientific sessions (SCAI 2021, 28 April–1 May, virtual). Among the headline findings, the results paint a favourable picture for the Darren Mylotte haemodynamic performance of the latest-generation Evolut devices, which demonstrated low mean gradients (8.1mmHg) among the patients studied. “The device probably has best-inclass haemodynamics, which are absolutely relevant to avoid patient-prosthesis mismatch and hopefully to give us good durability of the system,” notes Mylotte.

The device probably has best-in-class haemodynamics, which are absolutely relevant to avoid patient-prosthesis mismatch and hopefully to give us good durability of the system.”

Evolut PRO+ comes in four valve sizes—23, 26, 29, and 34mm—with an external tissue wrap and an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations. The death or disabling stroke system uses an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range. pacemaker rate Evolut PRO+ also has a reduced delivery profile for 23–29mm valves, indicated to treat patients with vessels as small as 5mm. Alongside patients with no/trace favourable haemodynamics, aortic regurgitation the interim results from OPTIMIZE PRO also demonstrate excellent safety outcomes with 0% death or disabling stroke, a low pacemaker rate (8.8%), and low rates of residual total aortic regurgitation with the majority of subjects having none/trace (80.4%), and the rest mild (19.6%) at discharge. Patients also experienced an expedited discharge with a median hospital length of stay of one day. One of the important areas of study in OPTIMIZE PRO was the use of varied procedural approaches to assess their impact in improving patient care. Among them are the cusp overlap technique which has the potential to lower the risk of interference with the conduction system by providing a more accurate assessment of valve depth. “The cusp overlap technique allows us to implant more accurately where we want to implant, and as a consequence of that, end up with a lower rate of permanent pacemaker insertion using this system,” says Mylotte, explaining the merits of the cusp overlap technique. The technique has similarities to an RAO caudal approach, Mylotte notes, adding that this allows for greater certainty over implant depth, particularly on the non-coronary cusp, where the intrinsic conduction system tends to lie. “Compared to the traditional three-cusp implantation technique, the cusp overlap or the RAO-caudal technique allows you to understand your true depth of implant and therefore give you a more accurate deployment,” Mylotte adds. “Therefore, if you are 3mm in the cusp overlap technique, you are probably 3mm deep. On the other hand, with the traditional three-cusp technique when you look in the LAO-cranial view you tend to foreshorten the left ventricular outflow tract, and your depth of implant is much less certain.” Discussing the outcomes achieved with cusp overlap using the Evolut system, as demonstrated in OPTIMIZE PRO, Mylotte commented that there is a notable impact on pacemaker rates. However, he noted that this is predominantly seen in centres where the technique is well embedded, and cautioned that although the technique is simple to perform, a learning curve is to be anticipated. He says: “The thing that struck me is that in good centres, which have been using this technique for a while, they have universally very low pacemaker rates. On the other hand, there were two groups of newer centres: those that stuck rigorously to the new implantation technique and also reduced their pacemaker rates quite considerably, and others that found it difficult to transition and continued to experience higher pacemaker rates.” The technique comes with a learning curve, Mylotte explains, but once this is overcome, the benefit is tangible. “Once you get it, you will see your pacemaker rate drop quite considerably,” he concludes.

Optimize PRO: key findings

8.8%

80.4%

August 2021 | Issue 62

Interview

Back in the room: A welcome return to in-person education With the COVID-19 pandemic having switched virtually all of the major meetings in the cardiovascular calendar online, in-person events have begun to make a welcome return. TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA and virtual, organised by the Cardiovascular Research Foundation, New York, USA) was among the first to make a comeback, adopting the hybrid format for 2021. Course director Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA) spoke to Cardiovascular News about the format for the revamped meeting, the future for hybrid events, and how the TVT community responded to the new set-up.

How did it feel to be back in an in-person meeting?

It felt quite unusual at first. The meeting was held at the Fontainebleau Hotel in Miami Beach, and we limited the attendance to approximately 600 participants. That meeting will normally attract approximately 1,500 people, but we purposely limited it to 600 people, all of whom were vaccinated. For almost everybody that I spoke to TVT was their first major in-person meeting since the COVID-19 pandemic. Everyone was thrilled to be back together. It did feel a little bit unfamiliar at the beginning for most people, me included, and on the first day people were feeling their way around. In fact, many people were not even in the sessions on the first day, preferring to have more private meetings, reacquainting with people they had not seen in a long time. But by the second day the meeting rooms were packed again. It took some time to adapt and for people to reactivate and rediscover their “meeting legs” but it was highly successful and enjoyable.

Was there a noticeable change in the format of the meeting?

TVT 2021 was a hybrid meeting that had both a live and a virtual audience. We encouraged the faculty to be there (and most were live), however a sizeable proportion were virtual as it is still difficult for many international faculty and attendees to travel to the USA. In general, the hybrid transmission nature of the meeting worked well. The audio-visual capabilities could accept anywhere from zero to a maximum of four hybrid presences at once, and it was quite flexible, going from zero to four often in the same session. That worked relatively seamlessly. The transmission quality was high, there were no major broadcast delays, and we were able to communicate in real time effectively.

What measures were in place at the venue to keep attendees safe? We had a mandatory mask policy,

so when people were moving from session to session until they were seated and socially distanced, they did have to wear masks. We set the stage and audience seating so that the chairs were approximately six feet apart. That is a significant limitation because it does strikingly reduce the number of people that can occupy a large room. A venue that would normally hold, for example, 1,000 people might only be able to contain 250–300, depending on the seating arrangement. We also had hand sanitisers throughout the venue. Everyone had to provide a daily test, confirming that they were not having any symptoms of COVID-19 and did not have a recent positive COVID-19 test or COVID-19 illness. Otherwise, we asked people to use common sense. I would say for the most part people followed these guidelines. It was interesting because as I mentioned, this meeting was held in the Fontainebleau Hotel in Miami Beach, which is a very large property. Of the thousands of other (non-TVT) hotel guests, you would rarely see anybody with a mask. So, most of us were wearing jackets or suits and ties, in Miami in July and behaving appropriately at a serious medical meeting, whereas the rest of the hotel patrons were having a jolly good time, mostly maskless, and in swim attire.

How was the industry involvement adapted to the new format?

The event operated at a reduced capacity for in-person attendees

We did not have an exhibit hall which requires close quarters as people move from booth to booth. Rather, many of the participating companies reserved private rooms and held small meetings. Overall, we had extremely positive feedback from industry who were thrilled to once again meet physicians face to face.

Could this be scaled up to a larger meeting?

We are quite encouraged from TVT 2021 for the feasibility of scaling up to a larger meeting—and we will find out very soon, as we are holding a hybrid TCT meeting (4‒6 November, Orlando, USA and virtual). TCT will usually attract approximately 12,000 people live, but we are going to limit TCT 2021 to 5,000‒6,000 vaccinated attendees, again as a hybrid live and internet transmitted event, both for faculty and for attendees. TCT will be approximately 10 times as large as TVT and more complex given

There is nothing that can replace being with your colleagues for inspiration and the human experience. We were all enthused and even shocked at rediscovering how much we had missed the value of being together.” the breadth of the subjects that are covered but we are cautiously optimistic after the positive TVT experience that we will be able to scale up successfully.

How have the lessons from the pandemic shaped the meeting format? During the pandemic it became clear that Zoom-type meetings are feasible and do have an important role to play.

Gregg W Stone presenting during the in-person TVT 2021

Such meetings allow more frequent interactions with colleagues and at much lower cost and inconvenience compared with travel. Travelling half way around the world, or even across the country, for in-person meetings can be quite unproductive, although pre-pandemic that was the standard, and in retrospect many of us did that more frequently than was healthy. So, I expect that going forward there will remain an important role for Zoom-type meetings, whether for networking and brainstorming ideas, investigator meetings, or smaller educational events. That said, what almost all of us experienced at TVT is that there is nothing that can replace being together in person. The immediacy of interaction with colleagues and the transmission and retention of ideas and information is much more effective in person. I cannot explain exactly why, but it is undeniable. Whether it is because your concentration or attention span is greater, other cues you integrate from the environment, the ease of asking questions thus making the audience feel that they are a participant rather than an observer, or other factors, there is no doubt that the in-person learning experience is superior to being remote. There is also nothing that can replace being with your colleagues for inspiration and the human experience. We were all enthused and even shocked at rediscovering how much we had missed the value of being together.

Is there a future for hybrid meetings outside of the pandemic?

I do expect that there is going to be a very active and vibrant role for so-called hybrid educational events in the future, both for the faculty and for attendees, to allow broader representation and opportunities for people that cannot be there in person to participate in an event. But as TVT 2021 vividly exemplified—there is no substitute for being there. Gregg W Stone is director of cardiovascular research and education at the Center for Interventional Vascular Therapy, New York Presbyterian Hospital/Columbia University Medical Center, New York, USA.

Stroke is underdiagnosed. It can happen to any TAVR patient. No matter their age. No matter their background. Even minor cognitive events can represent life-changing effects for your patients and their families. It’s time to take another look at the effects of every stroke.

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SENTINEL™ Cerebral Protection System (CPS) - INDICATIONS FOR USE: The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9.0 – 15.0 mm for the brachiocephalic and 6.5 – 10.0 mm in the left common carotid. CONTRAINDICATIONS: • Do not use in patients for whom anticoagulant and antiplatelet therapy is contraindicated. • Do not use in patients with a known hypersensitivity to nickel-titanium. • Do not use in vessels with excessive tortuosity. • Do not use in patients with uncorrected bleeding disorders. • Do not use in patients with compromised blood flow to the right upper extremity. • Do not use in patients who have arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery. • Do not use in patients whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium. WARNINGS: • The appropriate antiplatelet/anticoagulation therapy should be administered pre- and post-procedure in accordance with standard medical practice. • It is recommended that the patency of the right radial or brachial artery be assessed prior to the introduction of the Sentinel System. • It is recommended that the patient be tested for occlusion of the radial or brachial artery prior to device introduction. • Do not use the device in left radial or left brachial access. • Do not use the Sentinel System to deliver any type of fluid to the patient e.g. contrast media, heparinized saline, etc. due to risk of air embolization and comprise to device performance. Excessive movement of filters may lead to embolization of debris, vessel and/or device damage. • Do not deploy the filters within a previously repaired artery, an artery that has been used for dialysis purposes, or an AV fistula. • Indwell time of the Sentinel System is not to exceed 90 minutes as occlusion could occur, resulting in slow or no flow. • Do not undersize or oversize the filters in relation to the selected vessel diameter. This may result in inadequate vessel wall apposition or incomplete deployment of the filters. (Refer to Sizing Guide, Table 1 in the DFU). PRECAUTIONS: • Do not forcefully bend or reshape the Articulating Sheath of the Sentinel System. • Use of TAVR delivery systems other than those designed to cross the aortic arch with a valve frame in a sheathed or crimped configuration may result in device interference or entanglement. ADVERSE EVENTS: • Possible adverse events associated with Sentinel System use and application procedure include, but are not limited to, the following: • Access site complications • Angina • Aortic dissection • Arrhythmia • Arteriovenous fistula • Atelectasis • Bleeding, operative or post-operative • Cardiac Tamponade • Cardiogenic Shock • Conduction system injury • Congestive Heart Failure (CHF) • Death • Endocarditis • Embolism, including air • Gastrointestinal (GI) bleed • Hematoma • Ischemia (coronary, limb, carotid) • Infection (local or systemic) • Myocardial Infarction (MI) • Nerve injury • Pericardial effusion • Pneumonia • Pulmonary edema • Pulmonary embolism • Respiratory failure • Respiratory insufficiency • Stroke • Vessel injury (e.g., dissection, rupture, perforation, pseudoaneurysm). CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings,Precautions, Adverse Events, and Operator’s Instructions. 92329606 B All cited trademarks are the property of their respective owners. All photographs taken by Boston Scientific. To order product or for more information, contact customer service at 1.888.272.1001.

August 2021 | Issue 62

Advertorial

THIS ADVERTORIAL IS SPONSORED BY PIE MEDICAL IMAGING

FAST II underscores vFFR as a “faster and easier” physiological lesion assessment tool Findings of the multicentre FAST II clinical trial, presented virtually at EuroPCR 2021 (18–21 May, virtual) underscore the potential of CAAS vessel fraction flow reserve (vFFR, PIE Medical Imaging) software—a non-invasive, angiography-based method for calculating fractional flow reserve (FFR) values—as a faster and easier physiological lesion assessment tool, compared to invasive, wire-based techniques.

his was among the take-home messages presented by Joost Daemen (Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands), principal investigator of the prospective, six-centre observational Fast Assessment of STenosis severity (FAST) II trial. Daemen presented the results during a late-breaking trial session at the EuroPCR meeting. Traditional FFR utilises a specialised guidewire to measure pressure differences across a coronary stenosis. CAAS vFFR is an alternative, angiographic method used to assess coronary physiology and calculate FFR values, indicating the significance of specific coronary lesions and showing where blood flow is limited. During his presentation, Daemen told EuroPCR attendees that while FFR-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI, the clinical uptake of this technique remains low. This is in part, he said, due to the perceived additional procedural time and cost with which it is associated, as well as a potential discomfort to patients due to the administration of hyperemic agents. “The problem with physiological lesion assessment is the fact that at present you are forced to use dedicated pressure wires or microcatheters that are not necessarily the best, most user-friendly wires,” Daemen told Cardiovascular News, discussing the presentation. “Moreover these devices come at a specific cost—and if you want to rely on hyperemic indices you are forced to use hyperemic agents which go along with specific patient discomfort.” vFFR—FFR derived from routine coronary angiography—eliminates these issues and could be a cost saving and easier approach, Daemen said. In his words, vFFR is a 3D, angiography-based FFR index, calculated based on the 3D reconstruction of the coronary anatomy. The technology requires two orthogonal angiographic projections that allow a 3D reconstruction of the vessel, combined with an input boundary condition for the pressure, which in this case is the aortic root pressure. Taken together these provide an instantaneous calculation of the vFFR over the specific segment of interest based on simplified computational fluid dynamics embedded in the algorithm. Studies have already validated the use of the vFFR algorithm in practice. Among them is FAST I, the initial validation study of the technique. This study was led by Daemen and Erasmus colleague Ken Masdjedi, and validated the software on 100 patients undergoing invasive pressure wire based FFR recordings. This showed that vFFR, as calculated using CAAS vFFR, had a high linear correlation to invasively measured FFR. “We were able to demonstrate a high diagnostic performance of the technology with an excellent correlation as compared to pressure wire based FFR in this series of 100 patients,” says Daemen. The study also showed that the diagnostic accuracy of vFFR in identifying lesions with an FFR ≤0.80, was higher when compared with 3D-quantitative coronary angiography (QCA).

Further to FAST I was the FAST EXTEND retrospective study, in which investigators assessed 296 patients using a similar approach to validate the use of vFFR in an extended cohort of patients. “We were able to confirm the diagnostic accuracy and correlation figures found in FAST I, and were also able to demonstrate a very low inference of variability,” comments Daemen, of the results. These studies led to FAST II, which sought to validate the 3D QCA-based CAAS vFFR software in a prospective multicentre setting as compared to invasively measured pressure wire-based FFR. The study included patients aged ≥18 years, presenting

out in the corelab and on-site. “The good thing is that we were able to confirm the findings of FAST I and FAST EXTEND, in the sense that we found a very good correlation between corelab vFFR and pressure Joost Daemen wire based FFR, as well as for sitecalculated vFFR and pressure wire FFR, with very promising sensitivity and specificity figures, very much in line with the initial study,” said Daemen, discussing the findings. “We were able to extend these findings to a population as encountered in different sites across the globe, where image acquisition might be different and where different image intensifiers were used.” Considering the case that these results make for the more widespread use of vFFR in clinical practice, Daemen said that ease of use of the system could aid its uptake. “The nice thing here is that the workflow is very easy,” he said. “The system automatically detects the optimal frame in both projections, which is quite convenient. The system has very accurate contour detection, there was a need to correct the contours in less than 9% of the vessel segments in the study. That

The nice thing here is that the workflow is very easy. The system automatically detects the optimal frame in both projections, which is quite convenient.” vFFR contour step

with stable angina or non-ST segment elevation myocardial infarction (NSTEMI), in whom pre-PCI FFR was performed in at least one coronary artery with intermediate stenosis. Daemen explained that key features of the FAST II trial included that the study tested a larger set of angiograms, as recorded at different institutions around the globe with the vFFRs calculated by both a blinded corelab as well as local operators. Patients with STelevation myocardial infarction (STEMI), cardiogenic shock or severe haemodynamic instability, adenosine intolerance or previous coronary artery bypass grafting (CABG) were excluded, as were those with ostial or left main lesions with an estimated diameter of stenosis >50%, a thrombus containing lesion, or excessive overlap or tortuosity precluding vFFR computation. Running from October 2018 to September 2020, the six-centre study identified 391 eligible patients. Of these, 337 were eligible for corelab vFFR, and 334 were available for final analysis. The final patient group was mainly male (73), with an average age of 66 years (±12 years). Predominantly, patients presented with stable angina (83%), and a smaller proportion with NSTEMI (12%) and unstable angina (5%). Results of FAST II appear to reinforce the FAST I and FAST EXTEND findings, Daemen commented, showing a high diagnostic performance of vFFR both when calculated on-site and by a blinded corelab. The data presented at EuroPCR show that vFFR achieved a mean value of 0.83±0.09 when calculated by a blinded corelab and 0.82±0.10 when calculated locally at the individual sites. Mean FFR, the reference standard was 0.83±0.08 . Analysis also showed a high degree of accuracy (90% vs. 83%), sensitivity (81% vs. 71%), and specificity (95% vs. 89%), in the analysis carried

is something that is specifically of interest because this has never been published by any of the alternative angio-based indices.” One important message Daemen highlighted is the need for good image quality—“People really need to make sure that they make good quality angiograms that allow the software to function properly,” he said. Turning to future areas for study, Daemen said that it is important to consider how the technology would perform in routine practice when used online. “In FAST II we assessed vFFR offline, either in the site or in the corelab, but that does not necessarily reflect the performance in a routine practice,” he commented, adding that there is a need for outcome data comparing the use of the technology to a standard reference like FFR or instantaneous wave-free ratio (iFR). This will be studied in FAST III—an international multicentre randomised outcome trial that is being carried out across 32 sites in Europe with the aim to enrol over 2,200 patients.

vFFR result step

Issue 62 | August 2021

Coronary Interventions

Revival of the bioresorbable scaffold? FUTURE-II hints at promise for Firesorb One-year results of the FUTURE-II study—a randomised trial comparing a thin-strut bioresorbable scaffold to an everolimuseluting cobalt-chromium stent—could reignite interest in the use of such devices, attendees at EuroPCR 2021 (18–20 May, virtual) heard. THIS WAS ACCORDING TO speaker Bo Xu (Fu Wai Hospital, Beijing, China), who presented findings from FUTURE-II in a late-breaking trial session at the virtual EuroPCR event. The study was simultaneously published online in JACC Cardiovascular Interventions. The FUTURE-II trial is a randomised trial comparing the thin-strut Firesorb (MicroPort) bioresorbable scaffold (BRS) to an everolimus-eluting cobaltchromium stent (EES, Xience, Abbott). The study enrolled 433 patients across 28 Chinese centres between 2017–2019. Xu said that the Firesorb device could be defined as a second-generation bioresorbable scaffold. The device is a 100‒125μm poly-L-lactic acid (PLLA)-based sirolimus-eluting scaffold, designed to decrease luminal protrusion and improve local haemodynamic profile. Earlier generations of BRS, according to Xu, were shown to have a high incidence of late adverse events. He put this down to the thickness of the strut

(typically 150μm), which he said can result in greater protrusion, delayed re-endothelialisation and unfavourable dismantling during resorption. FUTURE-II sought to demonstrate the non-inferiority of the Firesorb device versus the EES, with a primary surrogate endpoint of late lumen loss at one year. This is known to be associated with clinical event rates. The major secondary endpoint is one-year proportion of covered struts by optimal coherence tomography (OCT), which was evaluated in a subgroup of 80 patients. Patients aged between 18‒70 years old, with evidence of myocardial ischaemia and suitable for elective percutaneous coronary intervention (PCI), with a maximum of two de novo lesions in different epicardial coronary vessels and lesion lengths >25m, were deemed eligible for the trial. These patients were randomised in a 1:1 ratio to the Firesorb BRS group (n=215) or to the EES group (n=218).

Xu reported that the trial succeeded in showing the non-inferiority of Firesorb versus EES in terms of one-year angiographic late lumen loss (0.17±0.27 vs. 0.19±0.37 mm, p for non-inferiority <0.0001). Of note, implantation technique was almost perfect in both groups, with a high rate of pre-dilatation and post-dilatation, Xu told EuroPCR attendees. Non-inferiority was also shown in the secondary OCT endpoints, with a similar proportion of covered struts in both groups. Of note, a less incomplete strut apposition was found in the Firesorb group versus EES group at one year, Xu noted. No difference was found in terms of target lesion failure between groups with a very low rate of events (1.9% vs. 3.3%, p=0.37) and no definite or probable device thrombosis. “The present study proves the midterm safety and efficacy of the thinnerstrut Firesorb BRS and might give an

I hope this will be the revival of the BRS and we will be looking back to this session to say ‘this was the new beginning.”

Common cath lab practices under the microscope in AHA review The American Heart Association (AHA) has published a scientific statement challenging “traditionally held” cath lab practices, and instead offering evidence-based recommendations where these could be reconsidered.

ublished in Circulation, the review authored by Sripal Bangalore (New York University Grossman School of Medicine, New York, USA) and colleagues, highlights common pre-, intra-, and post-procedure cath lab practices where evidence has accumulated over time, and may point to a change in approach. Speaking to Cardiovascular News, Bangalore said: “The document outlines the evidence—or lack thereof— for certain practices in the cath lab. I think it is high time that we abandon age-old practice and move more towards evidence-based practice. We hope this scientific statement from the AHA will empower cath labs to change their practice.” In their review, Bangalore and colleagues consider the common practice of requiring patients to have nothing by mouth past midnight or for several hours before a cardiac catheterisation procedure, acknowledging that this is Sripal Bangalore

an “age-old” practice. However, the review suggests that evidence for this is “weak” and may not be necessary for patients who undergo procedures with only local anaesthesia and no sedation. Bangalore et al also address the practice of withholding medications prior to any catheterisation procedure, including the use of metformin, glucoselowering medications, renin-angiotensin blockers and oral anticoagulants. Turning to intraprocedure evidence-based practices, Bangalore and colleagues review sedation, anaesthesia and analgesia considerations, noting that most procedures performed in the cardiac cath lab are done using conscious sedation, with general anaesthesia reserved only for the most complex and critically ill patients. Considering the need for opiates, the authors write that, in most patients, opiates may not be needed to achieve optimal sedation, and the risk of opioid dependency is a concern. For this reason, they note that the use of opiates in non-elderly patients can be individualised based on the complexity of the procedure

opportunity to the comeback of PLLAbased BRS with improved physical and mechanical properties,” said Xu. After Xu’s presentation, discussants considered the results and their implication for clinical practice. Among them, Alexandra Lansky (Yale University School of Medicine, New Haven, USA), said: “After a long and protracted demise of the BRS programme, I do not think it is an easy task to be the first one out of the gate. “I hope this will be the revival of the BRS and we will be looking back to this session to say ‘this was the new beginning’.” The Firesorb BRS is in the process of being investigated in an ongoing series of studies enrolling 1,200 patients, which include FUTURE-I (first-in-man), FUTURE-II (randomised controlled trial), and FUTURE-III (objective performance criteria study). Commenting on the release of the results at EuroPCR, Qiyi Luo, MicroPort’s chief technology officer said: “The excitement about an implantable heart device that dissolves after doing its job will continue to increase with these positive results from a randomised, controlled trial showing comparable outcomes between Firesorb BRS and Xience. “These data represent a significant milestone for Firesorb BRS and highlight how this unique technology can potentially benefit patients with coronary heart disease.”

and the response to initial sedation with an anxiolytic agent alone. Looking at vascular access, the reviewers acknowledge that, since 2006, the adoption of radial access for coronary angiography and percutaneous coronary intervention (PCI) has steadily grown. They write that randomised trials and observational studies have shown that radial access reduces major bleeding and vascular complications, and in high-risk patients, including those with ST-segment elevation myocardial infarction (STEMI), may reduce mortality. “Despite this body of data, the use of the radial approach lags behind in some subgroups,” they add, before offering some considerations for specific groups including patients with prior mastectomy, with abnormal collateral hand circulation, or those needing coronary artery bypass graft (CABG) surgery. In terms of the postprocedure evidence considered, Bangalore and colleagues discuss the use of magnetic resonance imaging (MRI) in patients with a newly implanted coronary stent, noting that this is commonly avoided for around four-to-six weeks after stent implantation. However, the authors also state that current consensus maintains that recent coronary stent implantation is not a contraindication to MRI, writing that there are no published reports of adverse events associated with performing MRI in a patient following commercially available coronary stent implantation.

I think it is high time that we abandon age-old practice and move towards more evidencebased practice.”

August 2021 | Issue 62

10 Conference Coverage

Interventional cardiologists sound the alarm over silent impact of the pandemic Interventional cardiologists from across the globe have joined forces for a campaign reinforcing the crucial message that patients with heart disease should, by all means, continue seeking timely cardiac care and to prioritise the need for access to cardiovascular services that have been restricted due to the COVID-19 pandemic.

he campaign, titled We CARE, is a joint effort by PCR and Stent‒Save a Life!, a global initiative aimed at improving patient access to the lifesaving indication of primary percutaneous coronary intervention (p-PCI). Initiated by Christoph Naber (Wilhelmshaven, Germany) and William Wijns (Galway, Ireland), chairmen of Stent‒Save a Life! and PCR respectively, We CARE is seeking to establish itself as a grassroots campaign with messaging delivered globally via national or regional advocates. The initiative has a core aim to re-establish patient confidence in accessing cardiac healthcare services in the wake of the pandemic, as well as establishing a broader network of lobbying to politicians, healthcare stakeholders, and patient organisations on the importance of maintaining access to cardiovascular healthcare facilities in future. “We noticed, very early on in 2020, patients being afraid of seeking care when they had symptoms, out of fear of being contaminated. This has been a universal observation in almost every country, particularly during the first wave of the pandemic,” Wijns tells Cardiovascular News, discussing the impact that the pandemic has had on cardiovascular care. “Close to 50% of patients with acute cardiovascular disease who would have required treatment have been left behind and, in many patients coming late, severe complications were observed, which were rarely seen before,” he adds.

If you have a myocardial infarction and if you do not go to the hospital, or seek medical attention too late, your likelihood of a severe complication or death is high.” Recent research has highlighted the stark impact of the pandemic on the delivery of cardiovascular care. In particular the organisers of the We CARE campaign have pointed to research published in The Lancet detailing the number of admissions to hospitals in England for acute coronary syndrome, noting a decline from mid-February, 2020, falling from a 2019 baseline rate of 3,017 admissions per week to 1,813 per week by the end of March 2020, a reduction of 40%. The report by Marion Mafham (University of Oxford, Oxford, UK) et al states that reductions were recorded in numbers of admissions for acute myocardial infarction, ST-elevation myocardial infarction (STEMI), and non-STEMI

Image-guided PCI study demonstrates non-inferiority of ultra-thin stent Investigation of the use of an ultra-thin strut biopolymer sirolimuseluting (BP-SES; Orsiro, Biotronik) compared to a durable polymer everolimus-eluting stent (DP-EES; Xience, Abbott), yielded no statistically significant difference in 30-day outcomes between the two devices, according to findings of the CASTLE study presented during a late-breaking trial sessions at EuroPCR 2021 (18–20 May, virtual). THE CASTLE STUDY IS AN investigator-initiated, multicentre, single-blinded, randomised, noninferiority clinical trial carried out in 69 centres in Japan, investigator Masato Nakamura (Toho University, Tokyo, Japan) told EuroPCR attendees during his presentation of the interim results of the study. It has been anticipated that thinner stents have a potential to reduce vessel damage, inflammation, and thrombogenicity in patients undergoing percutaneous coronary intervention

(PCI), Nakamura said, setting out the background to the study. Previous trials, he noted, have shown that ultra-thin strut sirolimus-eluting stents reduce target lesion failure (TLF), although the “true mechanism” of this superiority remains unclear. Recent randomised trials have suggested that image-guided drug-eluting stent (DES) deployment reduces the risk of stent thrombosis and revascularisation rates, he added, noting that imageguided PCI is widely adopted in Japan. Therefore, Nakamura hypothesised that

(NSTEMI) from the average for 2019 to the end of March 2020. To address this, Naber says that the campaign’s message is twofold. First is the direct outreach to patients and primary care providers. “We need to tell them it is much safer to be treated than just to stay away,” he explains. “If you have a myocardial infarction and if you do not go to the hospital or seek medical attention too late, your likelihood of a severe complication or death is high. Much higher than the risk of becoming infected with COVID-19 in a controlled environment. We need our patients to understand that treatment for heart disease cannot wait.” Secondly, the campaign will seek to reach out on a political level to ensure that healthcare providers are adequately prepared to deal with any future pandemics or major crises that could impact the provision of or access to care as it did this time. “We need to tell them that in the future, if something like this comes, we need to be better prepared, the tolls for the individual, but also for the society are high” Naber comments. IN NUMBERS “We want to speak up and talk to the decision makers, healthcare providers, national ministers of health, and at an EU level,” says Wijns. “We are going to give them Deaths each year the numbers on the impact from cardiovascular of removing care that diseases. Even exists. And, of course, that during the pandemic, is another impetus to also cardiovascular encourage access in those diseases remain the areas.” leading cause of death Among the resources worldwide. available—and to be released—to participants are media kits containing posters and flyers, guidelines and tools to help healthcare professionals prevent Less heart attack procedure postponement, patients coming to ensure the preparedness hospital during the of healthcare systems, and COVID-19 outbreak. encourage them to accelerate the implementation of telemedicine.

COVID-19

17.9 mil ion

About 40%

image-guided deployment may cancel 69.1% in the BP-SES group and 68.6% the procedural factor and contribute to in the DP-EES group. the clarification of the true effect of the He relayed that there were no ultra-thin stent. significant differences between groups The trial enrolled patients with acute in terms of clinical and procedural and chronic coronary syndromes, characteristics. The trial included who were randomised in a 1:1 mainly chronic coronary ratio to image-guided PCI syndromes (85%), stent (intravascular ultrasound diameter ≤3mm (66%), and or optical coherence image-guidance was performed tomography) with BP-SES in at least 97.5% of the patients. (intervention group) or DP-EES At 30-day follow-up, there was (control group). Masato Nakamura no difference in TLF between The primary outcome was DP-SES vs DP-EES (5% vs target lesion failure (TLF), comprising 4.9%) or its components, Nakamura said. cardiovascular death, target vessel In the primary endpoint at the 12-month myocardial infarction, and clinicallyfollow-up, there was no difference in driven target lesion revascularisation at TLF between BP-SES vs DP-EES (HR a 12-month follow-up. An independent 0.59 [95%CI 0.26 to 1.36]). clinical event committee evaluated According to Nakamura, the data in angiographies and clinical events. The the interim analysis suggest that BP-SES prespecified margin for non-inferiority and DP-EES may have similar clinical was 3.3%. outcomes when PCI is performed Nakamura reported that between May under intracoronary imaging guidance. 2019 and March 2020, 1,440 patients However, conclusions should not be were randomised; 722 were allocated to drawn until the complete follow-up the BP-SES and 718 to the DP-EES. The is performed to assess any potential 12-month follow-up was completed in difference between the two devices.

Issue 62 | August 2021

Cardiovascular surgery Cardiothoracic surgery guidelines updated to optimise blood management among cardiac patients Clinical practice guidance released recently outline recommendations for reducing blood loss during cardiothoracic surgery and improving patient outcomes. The document, a multidisciplinary collaboration among The Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA), the American Society of ExtraCorporeal Technology (AmSECT), and the Society for the Advancement of Patient Blood Management (SABM), is available online in The Annals of Thoracic Surgery and two other journals.

“A

s medicine evolves and we learn more, Therefore, unless the proven benefit of blood transfusions it always is important to review past outweighs the known risks, it is better to treat patients assumptions, validate new information, and before, during, and after surgery in ways that decrease the concisely present the best current recommendations,” said risks of needing blood as much as possible for the best senior author Susan D Moffatt-Bruce, from the Royal outcomes,” he said. College of Physicians and Surgeons of Canada, Ottawa, Risks can be lessened through the use of PBM, to ensure Canada. “These recommendations are really centred on that a patient’s own blood is adequate and transfusions are the patient and how they would want to be treated during not needed. complex cardiothoracic procedures.” “Patient safety is well supported in this guideline, as it Since the last update of the guidance in 2011 there reduces the risks associated with blood transfusions,” adds has been a “remarkable increase” in minimally invasive Moffatt-Bruce. procedures that has contributed to a favourable shift in The guideline includes preoperative interventions blood product utilisation and management, according to corelated to identifying and managing anaemia. The most author Victor A Ferraris, from the University of Kentucky common cause of anaemia is iron deficiency, occurring in College of Medicine, Lexington, USA. As a result, the up to 50% of anaemic patients, according to the guideline. new practice guideline, which features 23 new or updated Historically, patients with preoperative anaemia are more recommendations, marks the third iteration and the first in likely to require transfusions, so treating iron-deficiency 10 years. “Blood management guidelines are a ‘moving anaemia should be done before surgery. If successful, this target’ that change with the advent of new or can dramatically reduce the need for a blood modified evidence,” he said. transfusion, the guidelines suggest. Unlike in the previous guideline, which The new guidelines also suggest that in used the term “blood conservation”; the cardiac operations with cardiopulmonary bypass new recommendations yield to the broader (CPB), the “well-established method” of red term “patient blood management” (PBM). cell salvage via centrifugation may be routinely PBM—developed in 2008—is a standard of used. In this process, blood that the patient loses care designed to optimise patient outcomes by during the operation is collected, filtered, and minimising blood loss, preventing anaemia, washed by a machine before being reinfused into and reducing the need for allogeneic blood Susan Moffatt-Bruce the patient. transfusions. This approach Another new addition also places patients at the to the guideline is the heart of the decision-making recommendation to administer process, ensuring that they human albumin after cardiac are fully informed of the surgery, which also has been risks and benefits of their shown to minimise the need treatments and incorporating for transfusion, the authors their values and choices into suggest. This medicine the treatment pathway. typically is used to treat or “This guideline provides prevent shock following clinicians with a detailed serious injury, bleeding, or assessment of patient surgery by increasing the blood management in the volume of blood plasma. cardiac surgical patient—what has been proven to work Also, priming of the CPB circuit with a patient’s own blood and what has not—as well as the ability to incorporate (known as “retrograde autologous priming”) should be used these techniques with the most up-to-date evidence,” said wherever possible, according to the guideline. This “simple, lead author Pierre R Tibi, from Yavapai Regional Medical safe, and effective process” has been shown to decrease Center, Prescott, USA. transfusion rates, especially for cardiac operations that Among the most important changes to the practice result in excessive blood loss. guideline is the adoption of PBM as a treatment of the “The guideline has been assembled by experts from whole patient, with blood considered a “liquid organ” or different specialties and backgrounds who have reviewed “vital entity” in taking care of the surgical patient, rather the most recent data,” said Moffatt-Bruce. “This guidance than focusing simply on when or when not to transfuse, says allows clinicians to standardise treatment with the Tibi. knowledge that they are utilising the best information while “Blood transfusions can be harmful to the body. considering all aspects of patient care.”

These recommendations are really centred on the patient and how they would want to be treated during complex cardiothoracic procedures.”

One in eight CABG patients readmitted within 30 days, meta-analysis finds Nearly one in eight coronary artery bypass graft (CABG) patients are readmitted within 30 days of their procedure, the majority of which are readmitted for non-cardiac causes. This is according to a systematic review and metaanalysis of readmission after CABG published in the Journal of Cardiothoracic Surgery. THE ANALYSIS, CONDUCTED BY Md Shajedur Rahman Shawon (Centre for Big Data Research in Health, University of New South Wales, Sydney, Australia) aimed to quantify rates of readmission within 30 days of CABG surgery, as well as exploring the causes of readmissions, and how patient- and hospital-level factors influence readmission. Shawon et al conducted systematic searches of the PubMed and Embase databases to retrieve observational studies investigating readmission after CABG. Random effect meta-analysis was used to estimate rates and predictors of 30day post-CABG readmission. The analysis drew data from 53 studies, which included data from 8,937,457 patients. The pooled 30-day readmission rate reported was 12.9% (95% CI: 11.3–14.4%). Shawon and colleagues found that the most frequently reported underlying causes of readmissions were infection and sepsis (range: 6.9–28.6%), cardiac arrhythmia (4.5–26.7%), congestive heart failure (5.8– 15.7%), respiratory complications (1–20%) and pleural effusion (0.4–22.5%). The study team did not observe any appreciable differences in readmission rates by year, despite significant changes over time in the risk profile and clinical presentation in patients undergoing CABG, and reductions in post-surgery length of stay. They write that collectively the majority of readmissions after CABG are due to non-cardiac causes, including but not limited to infections, pleural effusion, respiratory complications, gastrointestinal complications and bleeding. In conclusion, Shawon and colleagues write, “30-day readmission rates are strongly influenced by patients’ demographic and clinical characteristics, but not by broadly defined hospital characteristics. The findings of this study are valuable for benchmarking quality improvement in clinical care as well as informing hospital readmission reduction policies for CABG.”

August 2021 | Issue 62

Cardiovascular surgery Female aortic dissection patients presenting later, have higher mortality Women who experience acute aortic dissection are older, have more advanced disease than men when they seek medical care, and are also more likely to die, according to research published online in The Annals of Thoracic Surgery.

“D

ata over the course of the last few decades demonstrate differences in both presentation and outcomes between males and females who have acute aortic dissection, with greater mortality among females,” said Thomas G Gleason (Brigham and Women’s Hospital, Boston, USA). “This study underscores the need for further interrogatories into these sex differences that may help provoke refined sex-directed strategies to further improve outcomes.” Lauren Huckaby (University of Pittsburgh, Pennsylvania, USA) alongside Gleason and colleagues queried the Interventional Cohort (IVC) of the International Registry of Acute Aortic Dissection (IRAD) to explore sex-specific differences in presentation, operative approach, and outcomes in patients with type A acute aortic dissection (TAAD). IRAD is the largest consortium of centres worldwide (55 institutions in 12 countries) that collects and analyses data related to the clinical aspects of aortic dissection; the IVC was initiated to provide more detailed insight into surgical techniques and procedures for aortic dissection. The Stanford classification divides aortic dissections into two groups (A and B), depending on the location of the tear in the aorta. In type A dissection, the tear begins in the ascending aorta and frequently extends from the upper to lower sections of the aorta, compromising blood flow throughout the body. Type A aortic dissections have a high likelihood of migrating toward the heart, where they become deadly by rupturing into the pericardial sac that surrounds the organ. As many as 40% of people with aortic dissections die instantly, and the risk of death increases approximately 1% for every hour that the diagnosis and surgical repair are delayed, according to multisociety clinical practice guidelines. Within the IRAD-IVC database, the researchers identified 2,823 patients who experienced TAAD from 1996‒2018 and underwent operative repair or a surgical approach as part of a hybrid repair. Approximately 34% of the patients were female. Although less frequently affected by TAAD, female patients were significantly older than male patients (65.4 years vs. 58.6 years on average) and had different presenting symptoms, like hypotension and greater evidence of malperfusion, with a higher prevalence of shock (31.3% vs. 22.2%) and coma/ altered consciousness (11.5% vs. 7.5%). “The recognition that women present differently and later in the course suggests that they may be seeking emergency care in a more delayed fashion than men,” said Gleason. “Accordingly, clinicians should respond to these sometimes opaque signs and symptoms by considering aortic dissection early. These findings at presentation should raise suspicion among physicians into the possibility of aortic dissection, giving rise to immediate diagnosis to allow for more efficient surgical management. We should be hyper-vigilant in women to avoid any further delays in treatment.” The researchers noted that operative approaches were distinct between the sexes, with female patients being less likely than male patients to undergo aortic valve replacement, aortic root replacement, and/or complete arch replacement. In fact, the less frequent use of complete arch replacement in female patients (15.2% vs. 20.6%) was highlighted by the researchers because worse outcomes after the operation historically have been demonstrated. They deduced that this more aggressive approach may be avoided in the treatment of older, female patients due to concerns for worse outcomes. Overall, female patients had increased mortality, although in the last few years, mortality between the sexes was comparable, which suggests recent improvements in care. Thomas G Gleason

Delaying CABG after AMI may not improve outcomes A study looking at the timing of coronary artery bypass grafting (CABG) after the occurrence of acute myocardial infarction (AMI), suggests that although patients who undergo CABG within 24 hours of AMI more often present in cardiogenic shock, there is no significant outcome difference with those who undergo CABG after 24 hours. THE STUDY AUTHORED BY Valentino Bianco (University of Pittsburgh Medical Center, Pittsburgh, USA) and colleagues, published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS), assessed all patients who underwent CABG at the University of Pittsburgh Medical Center from 2011–2017 after an AMI. According to the authors, CABG is often delayed in the acute setting in an effort to limit associated operative morbidity and mortality. However, they add, delayed surgical revascularisation with the presumption of increasing patient stability and improving outcomes may not be applicable in all cases. Bianco and colleagues hypothesised that the timing of CABG after AMI may not be consistently associated with postoperative outcomes. In order to test this theory, they carried out a comparative analysis of 2,058 patients, after time from myocardial infarction presentation to the CABG procedure, including all-cause mortality and readmission. The study population was divided into two CABG timing cohorts, including those whose procedure was carried out less than 24 hours after AMI (n=292) and those whose procedure took place after 24 hours or more (n=1,766). Previous percutaneous coronary intervention (PCI), cardiogenic shock, and intra-aortic balloon pump were more prevalent in the less than 24 hours group, the study team wrote, as well as noting that operative mortality was significantly higher in the less than 24 hours cohort (7.19% vs 3.79%; p=0.01). Diabetes mellitus, peripheral vascular disease, serum creatinine, age, chronic obstructive pulmonary disease, and immunosuppression were significant

predictors (p<0.05) of mortality, they add. The study’s authors found that significantly more patients in the less than 24 hours time cohort presented with ST-elevation myocardial infarction (STEMI), required an intra-aortic balloon pump (IABP), and were in cardiogenic shock, but they concluded that CABG timing was not a significant independent predictor of time to death or major adverse cardiac and cerebrovascular events (MACCE)related readmission. The significantly higher incidence of acute haemodynamic compromise appeared to be the most relevant determinants of heightened short-term mortality risk in the less than 24 hours group, Bianco et al note, adding that, on risk-adjusted multivariable analysis, neither cardiogenic shock nor IABP placement were independent predictors of elevated operative mortality or readmission. Discussing the findings of their research, Bianco et al write that the lack of a significant association between time of CABG and patient outcomes “potentially has far-reaching implications and may be indicative of the need to consider foregoing delays in

Other recent data are encouraging and support that delaying CABG beyond one day did not affect mortality.” performing surgical revascularisation in the setting of AMI”. Bianco and colleagues add: “Other recent data are encouraging and support that delaying CABG beyond one day did not affect mortality. Our data are novel in that they show no significant difference in mortality or readmission, whether CABG is performed within 24 hours or after one day. Therefore, delaying surgical revascularisation with the presumption of increasing patient stability and improving outcomes may not be applicable in all cases, especially when the burden of associated comorbid disease is taken into consideration.” The study team concludes that the findings of their research indicate that in the presence of good clinical and surgical judgment, satisfactory outcomes can be achieved for patients with AMI undergoing CABG, for all time intervals.

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August 2021 | Issue 62

14 Interview

Profile

Christoph Naber Christoph Naber (Essen, Germany) talks to Cardiovascular News about his career in interventional cardiology. Known for his work in the Stent–Save a Life campaign, he has also served as a course director for AsiaPCR, and co-director for the EuroPCR and PCR London Valves events, and more recently has helped to found the We CARE campaign, in response to the COVID-19 pandemic.

Why did you choose to become a doctor and to specialise in interventional cardiology?

When I was 18 years old I carried out civil service in a local hospital, where they let me work virtually everywhere. I decided I wanted to become an intensive care nurse, but the head nurse of the ward strongly recommended I study medicine and I took his advice. One thing that really bothered me was the treatment of ST-elevation myocardial infarction (STEMI) patients. We resuscitated them if needed, and if they were lucky they left the hospital after six weeks. One of my closest friend’s fathers died from his second heart attack and there was virtually nothing we could do, as thrombolysis was only performed in trials in large academic centres and percutaneous coronary intervention (PCI) was not yet available for this indication in clinical practice.At the end of my time at Bochum University I had the chance to see my first “plain old” balloon angioplasty (POBA) in the cath lab. I still remember the sound of the indeflator and the electrocardiogram (ECG) showing STsegment elevations, which were gone after deflation of the balloon. This was unbelievable! I was immediately sold, and spent the rest of my internship reading about the BENESTENT trial, Antonio Colombo’s reasoning on high pressure stent-implantation, and the early trials on facilitated PCI in STEMI patients.

Who have been your career mentors?

I had the privilege to work with many impressive colleagues who helped me find my way. Many were heroes in my training, but may not be known to the international community. When I joined the team of Raimund Erbel in Essen, I was placed in the cath lab almost from day one. I met Michael Haude, who was head of the cath lab at that time. He was strict, but an outstanding interventionist and a systematic teacher. He forced us to assist and watch until we could anticipate his next step, and established the basis of all I know today. Years later, David Barrow, a British journalist who worked in the medical industry introduced me to Jean Fajadet. His natural, elegant, and effective approach is unique, but his attitude really changed my perspective. Whatever he does is always intended to meet his patients’ needs. The most impactful person I worked with was Jean Marco. I met him through Magali Breheret, an outstanding facilitator and mediator herself, who worked closely with him to introduce the principles of adult education into interventional courses. This impacted my understanding of interventional cardiology and changed the way I understand the needs of patients and colleagues.

What has been the most important development in interventional cardiology during your career?

Without doubt it is transcatheter aortic valve implantation (TAVI)—the very best elective indication we have today. I remember Martin Leon presenting the results of the PARTNER trial in 2010 with Alain Cribier sat in the front row. “Percutaneous valve implantation is the gold standard for patients with very high or prohibitive surgical risk,” he said—this was a moment of history!

As part of the team that carried out Germany’s first TAVI procedure in 2004 what is your view of the evolution of TAVI?

TAVI has come a long way since those early days. In 2004 it took the team, led by Stefan Sack and proctored by Alain Cribier, several hours to implant the valve. Now this is routine, and, if well prepared, can be done in around an hour. Complication rates have fallen and are competitive. We have excellent data for lower-risk patients and I believe the durability debate is now a rearguard battle. The future falls into access to care. Economic factors play a large role in the discussion, both in developing and industrialised countries.

What has been the biggest disappointment?

Unfortunately, absorbable scaffolds. The principle to “leave nothing behind” is intuitively right, and is the ultimate evolution of PCI. My clinical experiences were excellent and I still believe the method will be back before I retire. The basic principle of implanting absorbable devices as a kind of framework for the body to restore its natural structures is fascinating and can extend to many fields beyond coronary intervention.

What are your current research interests?

I am currently working in the field of access to care. Together with a team within the European Society of Cardiology (ESC), collecting data on cardiovascular interventions in more than 30 European countries. A key element is to understand how interventions are or can be implemented in our societies. The scary thing is that the databases in most countries are extremely poor or biased. My clinical research interest is also aimed in a similar direction—how do we propose the right treatment for the right patient? Alongside a consortium of scientists, physicians and payers, we initiated a trial to look at the indication for invasive diagnostics and PCI.

What led to the creation of the Stent– Save a Life! campaign? Stent–Save a Life! is the global successor of the

TAVI has come a long way since those early days… Now the procedure is routine and if well prepared, it can be done well in around an hour.” European Stent for Life campaign which was founded by the PCR family, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the ESC in 2009. It was a joint discussion between the chairmen of PCR, William Wijns and Jean Fajadet, the president and incoming president of EAPCI, Michael Haude and Andreas Baumbach, and myself

as chairman of Stent for Life to extend this project globally, in around 2016. Since then Stent–Save a Life! has become an incredible success with local initiatives on four continents, endorsed by the large interventional societies.

What success has the campaign had in improving patient access to primary PCI and where does it go next? From a European perspective, we had to change many perspectives. Instead of only promoting primary PCI for STEMI, we chose to aim at the building of local networks, as this is where the power of such initiatives comes from. We asked new countries to build local networks and to deliver the optimal available care to all STEMI patients in their respective regions. What the currently available optimal care is may vary from region to region and depends on the available resources. But, whatever it is, it is the best starting point and it will save

Issue 62 | August 2021

Interview 15

lives. The ultimate goal remains access to primary PCI for all STEMI patients around the globe.

We CARE is your most recent project. How is this addressing the challenges created by the pandemic?

We CARE is a platform built jointly by Stent–Save a Life! and PCR, supported by an unrestricted grant from Medtronic. At the outset of the COVID-19 crisis, many authorities postponed non-essential procedures until the outbreak could be better understood and contained. Societies were simply not prepared. Too many patients stayed away, even in life-threatening situations. We CARE is inviting thousands of interventional cardiologists and medical colleagues from around the world to take part in reversing this trend. To support them, the initiative is working on tools and guidelines to help prevent procedure postponement, encourage them to accelerate the implementation of telemedicine, and ensure the preparedness of healthcare systems.

Looking back over your career what has been your most memorable case?

The most memorable cases are not about techniques, but the trust and the relationship between physician and patient. One I will never forget was one of my first TAVI patients at the Contilia Heart and Vascular Centre in Essen—an 80-year-old lady who told me after TAVI that, despite feeling well, she did not feel the same person as before. Something had changed during the procedure. Using computed tomography (CT) of the brain we could show that she had multiple emboli, which we thought to be a consequence of the implantation. This was at the very time many publications targeted this problem, and was the reason I later engaged in stroke protection during TAVI. To finish her story, this lady remained my patient until she passed away, but her feeling of being someone else never went away. “First, do no harm” has many different aspects.

alisonlang.com

Outside of medicine, what are your hobbies and interests?

I love endurance training and do triathlons—there is something meditative about the training. I finish races in the last third, but as I race against myself, I always win! I also play golf, which is a great opportunity to play with friends from the interventional community all over the world. I love music, particularly classical, jazz and blues, and I played drums in my youth, although now it is mainly guitar. Travelling is something I never like to miss—in particular Greece, where my wife's family is from, and India, which always touches my heart in a special way.

Fact file Appointments (selected past and present)

Head of Cardiology and Intensive Care Medicine, Klinikum Wilhelmshaven, Wilhelmshaven, Germany Senior consultant at the West-German Heart Centre, University of Essen, Essen, Germany Interventional fellowship, Cardiology Cath Lab, Clinique Pasteur, Toulouse, France

Memberships (selected)

Past-chair of the Working Group on Interventional Cardiology, German Society for Cardiology (DGK) Executive board of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Fellow of the European Society of Cardiology (ESC) Fellow of the Asian Pacific Society of Interventional Cardiology (APSIC)

Education

First year resident, Department for Cardiology, Angiology und Pneumology, Heinrich-HeineUniversity, Duesseldorf, Germany Post-doctoral Fellow, Institute for Pharmacogenetics, University Hospital Essen, Essen, Germany Fellow, Department of Cardiology, West-German Heart Center, University Hospital Essen, Essen Germany

August 2021 | Issue 62

16 CX Aortic Vienna

Cardiac, vascular and endovascular leaders convene for CX Aortic Vienna Capturing the latest developments in the comprehensive treatment of aortic disease—from the aortic valve to the iliac arteries—CX Aortic Vienna returns for three days of CMEaccredited discussion and debate, bringing together the cardiac, vascular and endovascular worlds. With a live programme running from 5–7 October 2021, the meeting will showcase the latest approaches, open and endovascular, for the treatment of complex aortic problems.

X Aortic Vienna 2021 will be broadcast live online and available on-demand, with CX Aortic Vienna 2021 Vascular Endovascular and Cardiothoracic Executive Board members presenting from London, UK, and serving as expert moderators to generate exciting live audience discussion from around the world. Over five hours of CME content is available on each of the three days of broadcasting. “CX Aortic Vienna will begin at the top with the arch of the aorta. We ask ourselves: ‘What is the best way to treat aortic disease today?’” explains CX Aortic Vienna’s founding chair Roger Greenhalgh (London, UK). “In order to answer that we must involve cardiac surgeons, vascular surgeons and endovascular specialists, and then we shall work out how the patients should be best treated, debate it and discuss it. What we shall be considering at CX Aortic Vienna is every way in which the aorta can be managed—from the aortic valve to the iliac arteries.” The three days of education, innovation and evidence are brought to you with the participation of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG), the German Society of Vascular Surgery (DGG), the Italian Society of Vascular and Endovascular Surgery (SICVE), the French Society

for Vascular and Endovascular Surgery (SCVE), and Aortic Surgery “How To Do It” (HTDI). The format will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast, with five hours of CME programme on each day. The programme includes open and endovascular aortic techniques and technologies, including live and edited aortic cases, as well as industrial and networking satellite programmes spliced between CME sessions.

Day one:

Tuesday 5 October—features aortic arch challenges, with an opening session focusing on the frozen elephant trunk (FET) technique, asking whether the procedure continues to play an important role in the treatment of complex pathologies of the aortic arch. During the session, attendees will hear from expert speakers including Luca Bertoglio (Milan, Italy) who will discuss open or endovascular treatment of downstream thoracic or thoracoabdominal aortic pathology after FET, see edited cases from Gustavo Oderich (Houston, USA) and Tilo Kölbel (Hamburg, Germany), and learn about an optimised coagulation regime in contemporary FET surgery from Heinz Jakob (Essen, Germany). In a session dedicated to transcatheter aortic valve implantation (TAVI) and

paediatric cardiac aortic challenges, edited cases from David Holzhey (Leipzig, Germany) and Frank Arko (Charlotte, USA) document TAVI device deployment, and the benefits of thoracic stent grafts to see the positive remodeling of the aorta in patients with coarctation, respectively. Attendees will also gain insights from Michael Andrew Borger (Leipzig, Germany) on extraanatomic ascending-to-descending aortic bypass for patient with recurrent isthmus stenosis. Experts will also consider juxtarenal aortic neck challenges, with Giovanni Pratesi (Genoa, Italy) presenting an edited case detailing treatment of wide neck abdominal aortic aneurysms (AAAs) with enhanced proximal seal (ESAR) and Luca Bertoglio (Milan, Italy) discussing endovascular treatment of visceral aneurysm patch after previous thoracoabdominal aortic aneurysm (TAAA).

Day two:

Wednesday 6 October— the programme features a session on TAAA reconstruction and How To Do It (HTDI) from Roberto Chiesa (Milan, Italy) and his team. Among them, Daniel Mascia will detail TAAA standard open repair, Enrico Rinaldi will discuss recent advancements in TAAA open repair and organ protection, Andrea Kahlberg will offer tips and tricks in open conversion after thoracic endovascular aortic repair (TEVAR) or FET, and Luca Bertoglio will detail endovascular management of late complications of open TAAA repair,

CX Aortic Vienna will begin at the top with the arch of the aorta. We ask ourselves: What is the best way to treat aortic disease today?”

including intercostal and visceral patch aneurysm. Further focus on TAAA reconstruction on day two includes a podium first presentation from Dittmar Böckler (Heidelberg, Germany), a systematic review of migration in TEVAR, discussion of the durable long-term performance of a single TEVAR stent graft platform in multiple pathologies of the descending thoracic aorta from Joseph Bavaria (Philadelphia, USA), and outcomes of 3,677 TAAA open cases performed between 1986–2021, presented by Joseph Coselli (Houston, USA). Attendees will also hear the latest in radiation reduction challenges, including an edited case involving fenestrated EVAR using Fiber Optic RealShape (FORS) laser light guidance (Philips) from Kölbel, and discussion of dynamic computed tomography (CT) and magnetic resonance (MR) gold standards for aortic imaging from Alan Lumsden (Houston, USA). EVAR durability is also in the spotlight on day two of CX Aortic Vienna, with speakers touching on important current debates. Among them, Ian Loftus (London, UK) will detail 10year outcomes from aneurysm screening in South West London supporting an endovascular-first strategy, while Michael Stoner (Rochester Hills, USA) will consider the effect of aortic stent graft engineering on aortic sac regression after EVAR.

Final day:

Thursday 7 October—considers the importance of training and teamwork for optimal aortic patient outcomes. Eric Roselli (Cleveland, USA) will discuss the future training of aortic surgeons, while Bavaria lays out the importance of a multidisciplinary thoracic aortic team. Michael Jacobs (Maastricht, The Netherlands) will also set out the arguments and evidence to centralise complex open and endovascular aortic procedures. The three-day event will close with a series of best of abstract sessions, featuring abstracts from the Austrian, German and Swiss societies.

The speakers:

Left to right: Joseph Bavaria Dittmar Böckler Roberto Chiesa Joseph Coselli Gustavo Oderich

Issue 62 | August 2021

CX Aortic Vienna 17

Aortic Event

CX Aortic Vienna 2021 programme Bringing together the cardiac aortic, vascular and endovascular worlds, CX Aortic Vienna 2021, spanning the aortic valve to the iliac arteries. Broadcast globally, the CME-accredited meeting runs from 5 to 7 October. Register now at cxsymposium.com/cxaortic/cx-aortic-vienna/registration/. Day 1:

Day 2:

Day 3:

Tuesday 5th October

Wednesday 6th October

Thursday 7th October

Time: 11:00–18:00 London time (BST)

CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? Time: 11:00–12:00 London time (BST)

Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction & How To Do It (HTDI) Professor Roberto Chiesa and team Time: 11:00–12:00 London time (BST)

Training & Teamwork for Optimal Aortic Patient Outcomes Time: 11:00–12:00 London time (BST)

Best of CX and Prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? (continued) Time: 12:30–12:50 London time (BST) TAVI & CX Paediatric Cardiac Aortic Challenges Time: 12:50–13:30 London time (BST) Best of CX and Prize abstracts Time: 13:30–14:00 London time (BST) CX Juxtarenal Aortic Neck Challenges Time: 14:00–15:00 London time (BST) Industry Satellite: How to approach safely complex AAA with off-the-shelf solutions Time: 15:00–15:30 London time (BST) CX Arch Aortic Stroke from Thoracic Endovascular Procedures (STEP) Time: 15:30–16:20 London time (BST)

Industry satellite Time: 12:00–12:30 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 12:30–13:30 London time (BST) Industry Satellite: Five years of proven durability with Zenith Alpha thoracic Low-profile system Time: 13:30–14:00 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 14:00–14:40 London time (BST) Reduction of Radiation Challenges Time: 14:40–15:00 London time (BST) Key FORS moments discussed Time: 15:00–15:30 London time (BST) Reduction of Radiation Challenges (continued) Time: 15:30–15:50 London time (BST)

CX Aortic Dissection Challenges Time: 16:20–16:30 London time (BST)

CX EVAR Durability Questioned Time: 15:50–16:30 London time (BST)

Industry Satellite: Endovascular treatment of Type B aortic dissection Time: 16:30–17:00 London time (BST)

Best of CX and prize abstracts Time: 16:30–17:00 London time (BST)

CX Aortic Dissection Challenges (continued) Time: 17:00–18:00 London time (BST)

CX EVAR Durability Questioned (continued) Time: 17:00–17:10 London time (BST) Ruptured Abdominal Aortic Aneurysm (AAA) Time: 17:10–18:00 London time (BST)

Best of CX and prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques Time: 12:30–13:30 London time (BST) Best of CX and prize abstracts Time: 13:30–14:00 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques (continued) Time: 14:00–15:00 London time (BST) Best of CX and prize abstracts Time: 15:00–15:30 London time (BST) Best of Italian Society of Vascular and Endovascular Surgery (SICVE) Abstracts Time: 15:30–16:00 London time (BST) Best of Austrian Society of Vascular Surgery (OGG) Abstracts Time: 16:00–16:30 London time (BST) Best of CX and prize abstracts Time: 16:30–17:00 London time (BST) Best of German Society for Vascular Surgery and Vascular Medicine (DGG) Time: 17:00–17:30 London time (BST) Best of Swiss Society for Vascular Surgery (SGG) Time: 17:30–18:00 London time (BST)

August 2021 | Issue 62

18 Conference Coverage

ACC21

Clopidogrel monotherapy trumps aspirin for long-term maintenance after PCI Clopidogrel monotherapy produced better outcomes than aspirin for the long-term maintenance of patients who had undergone percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). This is according to findings of an investigator-initiated, randomised, openlabel, multicentre trial, which sought to examine the optimal choice of antiplatelet agent during the chronic maintenance period following PCI.

indings from the HOST-EXAM —Harmonizing optimal strategy for treatment of coronary artery diseases-extended antiplatelet monotherapy— trial were presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual) during a late-breaking trial session, and simultaneously published in The Lancet. Lead investigator Hyo-Soo Kim (Seoul National University Hospital, Seoul, Korea) told ACC.21 attendees that clopidogrel monotherapy significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction (MI), stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater, as compared to aspirin monotherapy. The beneficial effect of clopidogrel was also observed in thrombotic composite endpoints, as well as any bleeding endpoint. “These data confirm our working hypothesis that long-term maintenance antiplatelet monotherapy with clopidogrel produces better outcomes than aspirin in patients who are adverse event-free at one year after coronary stenting,” said Kim. The trial met its primary endpoint, which occurred in 5.7% of patients assigned to clopidogrel and 7.7% of

those assigned to aspirin. Current treatment guidelines recommend a dual antiplatelet therapy (DAPT) regimen of two antiplatelet drugs for six to 12 months after the insertion of a coronary stent to prevent blood clots. “However, the optimal single antiplatelet agent for long-term maintenance therapy beyond the duration of DAPT has been unclear,” Kim said. He added that in clinical practice, physicians may maintain patients on DAPT for as long as 18 months, depending on the patients’ level of risk for clotting. HOST-EXAM enrolled 5,436 patients from 37 centres in Korea who had received a coronary stent. Patients’ average age was 63 years; 75% were men, 34% had diabetes and 13% had chronic kidney disease. After completing between six and 18 months of DAPT without experiencing any adverse events, patients were randomly assigned to receive single-agent maintenance therapy with either clopidogrel or aspirin. Hyo-Soo Kim Researchers also assessed key secondary endpoints, including thrombotic composite endpoints of cardiac death, non-fatal myocardial infarction, ischaemic stroke, readmission due to acute coronary syndrome and stent thrombosis. They found that these secondary endpoints occurred in 3.8% of the patients who took clopidogrel compared with 5.6% of those who took aspirin; bleeding events were seen in 2.3% of patients in the clopidogrel group versus 3.3% of those in the aspirin group. All of the differences were statistically significant. “These results confirm that clopidogrel is superior to aspirin at reducing the incidence of bloodclotting events,” Kim said. “What is interesting is that clopidogrel also performed better than aspirin at reducing bleeding events. Such findings that one antiplatelet agent is better than the other in reducing both clotting and bleeding events have been observed in other studies comparing different antiplatelet regimens,

FLOWER-MI finds no benefit to FFR-guided PCI in STEMI patients with multi-vessel disease ST-elevation myocardial infarction (STEMI) patients with multivessel disease undergoing percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) did not experience improved outcomes compared to angiography-guided procedures, according to the findings of the FLOWER-MI trial, presented during a late-breaking trial session at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual). FLOWER-MI—FLOW evaluation to guide revascularisation in multi-vessel ST-elevation myocardial infarction—involved a head-to-head comparison of outcomes in STEMI patients with multi-vessel disease who underwent either FFR-guided stenting or stenting guided by angiography alone. FFR is performed during angiography to determine if the stenosis is significant and to guide the stenting procedure,

Etienne Puymirat (Georges Pompidou Hospital, Paris, France) and principal investigator of the study, told ACC.21 attendees. Previous studies have shown that STEMI patients treated with FFRguided stenting had better outcomes than those treated with medication alone, he added. The trial, conducted at 41 centres in France, enrolled 1,171 patients who had a stent inserted into a blocked coronary

suggesting that thrombotic and bleeding events are tightly associated with each other. For example, when patients experience bleeding, they stop the antiplatelet agents leading [them to experience] thrombotic events.” Kim said that the results apply only to patients who had completed between six and 18 months of DAPT without any adverse events. “It may be difficult to directly extrapolate our results to patients who received DAPT for a shorter period, such as one or three months,” he commented. “However, our results may be useful in helping physicians to select antiplatelet monotherapy for patients who are in the chronic stable phase after coronary stenting.” The two years of patient followup in the HOST-EXAM trial is longer than that of many previous trials comparing antiplatelet drug regimens in patients receiving a coronary stent, Kim added. He and his colleagues plan to continue their follow-up for a total of five years to gain insights into the longterm benefits and trade-offs of clopidogrel compared with aspirin. As the daily cost of clopidogrel is higher than that of aspirin, Kim said, he and his team are also planning a follow-up study that will examine the cost-effectiveness of the two medications. A limitation of the trial is that it was not blinded, meaning that both patients and their doctors knew which drug patients were receiving. Also, the total number of reported adverse events in both groups was lower than the investigators had expected when they designed the trial, which suggests that adverse events could have been under-reported. However, Kim said that the expected event rate was based on CAPRIE study 26 years ago and the GRAND-DES registry paper 10 years ago and thus he believes the main reason for the lower than expected rate of adverse events was not under-reporting, but the improved quality of care that has evolved over decades.

It may be difficult to directly extrapolate our results to patients who received DAPT for a shorter period, such as one or three months.”

artery after STEMI and who also had a second coronary artery that was at least 50% blocked. The patients’ average age was 62 years and 83% were men. Immediately after their first stenting procedure, patients were randomly assigned to undergo a second stenting procedure, guided either by FFR or by angiography alone. The second procedure was performed within five days during the same hospitalisation. After 12 months, 5.5% of patients in the FFR-guided group had died, had another non-fatal heart attack or had undergone an additional stenting procedure, compared with 4.2% of those in the angiography-guided group, a non-statistically significant difference. Moreover, the FFR-guided procedure was more expensive than the one guided by angiography alone. “The strategy of using FFR to guide the stenting procedure is not superior to the standard technique of using angiography to treat additional partially blocked arteries,” Puymirat told attendees at ACC.21. “In addition to having no benefit, we have also shown that, based on

costs in France, the FFR-guided strategy is more expensive.” The incidence of major adverse cardiovascular events in both groups of patients was considerably lower than the researchers expected, Puymirat said. “These patients were at high cardiovascular risk because of having multivessel disease,” he said. “Using data from previous trials and registries in this population, we estimated that about 15% of patients would have an adverse event within one year, but in our study the rate was 5% at one year.” The study failed to meet its primary endpoint, a composite of death from any cause, non-fatal heart attack, or urgent need for an additional stenting procedure within 12 months. A secondary endpoint looking at costeffectiveness favoured the use of angiography alone, Puymirat concluded. Etienne Puymirat

Issue 62 | August 2021

Conference Coverage 19

LAAO after heart surgery offers “new paradigm” for stroke prevention in AF patients Patients with an elevated risk of stroke due to arrhythmia or atrial fibrillation (AF) were much less likely to suffer a stroke after undergoing heart surgery if doctors concurrently performed left atrial appendage occlusion (LAAO), according to the results of a trial presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual). AF INCREASES THE RISK OF stroke or systemic embolism and it has been hypothesised that the blood clots that cause these conditions often originate in the left atrial appendage, a small sac on the upper left chamber of the heart. LAAO seals off this small sac, thus reducing the risk that a clot will form. In this trial, LAAO lowered the risk of stroke or systemic embolism, the primary endpoint, by 33% overall in patients with AF or atrial flutter. After the first 30 days following the procedure, patients who received LAAO were 42% less likely to suffer a stroke over longterm follow-up than those who did not

receive LAAO. The trial was stopped early due to the strength of the observed benefits from the procedure. “This study confirms a new paradigm for stroke prevention for patients with AF,” said Richard Whitlock, a cardiac surgeon at McMaster University, Ontario, Canada, and the study’s lead author. “The additive benefit of surgical LAAO on top of blood thinners has now been proven. There is no question that patients who are undergoing heart surgery and have elevated stroke risk and AF should have their atrial appendage occluded in their cardiac surgery.” Researchers in LAAOS III enrolled 4,811 patients undergoing heart surgery

DAPT deescalation may benefit AMI patients Switching from ticagrelor to clopidogrel dual antiplatelet therapy (DAPT) after 30 days was safer and more effective in preventing adverse events at one year than continuing on a high-potency DAPT regimen in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), according to data presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual).

“W

e have shown that, in patients who have had a heart attack and who have been treated with newer-generation stents and guideline-recommended medical therapy, de-escalation of DAPT by switching from ticagrelor to clopidogrel is completely safe and more effective than continuing to treat patients with ticagrelor,” said Kiyuk Chang (Catholic University of Korea, Seoul, South Korea), the lead author of the study, who presented the findings at ACC.21. The study’s primary endpoint, a composite of cardiovascular death, myocardial infarction (MI), stroke and Bleeding Academic Research Consortium (BARC) bleeding type 2,3 or 5 at any time from one– 12 months after the PCI procedure, was met.

at 105 centres in 27 geographic location, sex, countries. About two thirds age, type of AF, type of of the trial participants blood thinner used or other underwent valve surgery and variables. On average, the 20% underwent coronary procedure added less than 10 artery bypass graft (CABG) minutes to the heart surgery surgery. All the patients had and demonstrated safety documented AF or atrial both in the short and flutter and a CHA2DS2long term. VASc score of two or higher, “We were ecstatic to see indicating an elevated these results,” Whitlock risk of stroke. Half of the Richard Whitlock said. “This trial opens a participants were randomly new option for treatment of assigned to receive LAAO at the time of these patients by layering a mechanical their heart surgery. All patients received approach—occlusion—on top of a standard anticoagulant medications medical approach. Instead of a tension (blood thinners) to reduce the risk of between anticoagulation and occlusion, harmful clots after surgery. we need to start thinking about using After a median follow-up of 3.8 these as additive approaches when years, 4.8% of patients who received patients are at high risk for stroke. This LAAO and 7% of patients who did not is a procedure that is done once, and it receive LAAO had suffered a stroke, a keeps giving a benefit over time. This is difference that was highly significant going to prevent thousands of strokes.” in favour of LAAO. The difference Since LAAO procedures in the study was even more pronounced after the were performed through a standard first 30 days following surgery. Strokes surgical approach, it is unclear whether occurring soon after surgery typically catheter-based approaches for LAAO have causes beyond AF, such as calcium would bring the same benefits. from blood vessels; thus, the true impact This study was simultaneously of LAAO on the risk of stroke from published online in the New England AF is best seen after that early period, Journal of Medicine at the time of Whitlock said. presentation. The study’s main funding The results were consistent across sources were the Canadian Institutes all subgroups analysed, with LAAO of Health Research and the Heart and bringing the same benefits regardless of Stroke Foundation of Ontario.

Current treatment guidelines recommend that after the insertion of a cardiac stent patients should receive DAPT for six–12 months. Compared with clopidogrel, Ticagrelor is more potent, faster acting and has a more predictable antiplatelet effect, but also poses a higher risk of bleeding, Chang explained. Switching between P2Y12-inhibiting medications can escalate or deescalate the level of P2Y12 receptor inhibition. Previous studies have shown that patients are at the highest risk for a repeat event during the first 30 days after stent-insertion. Bleeding risk remains high during the maintenance phase of treatment (after the first 30 days). The trial—TALOS-AMI—is the largest study to date to test the safety and efficacy of a DAPT de-escalation strategy in minimising the risk of both another heart attack and a bleeding episode, Chang said. The trial enrolled 2,697 patients from East Asia (80% male, median age 60=years) 30 days after they had undergone stenting following AMI. During the month after their procedure, all patients had received DAPT with ticagrelor plus aspirin and had experienced no serious adverse events, such as another heart attack, stroke or major bleeding. Patients were randomly assigned either to continue taking ticagrelor plus aspirin daily for a year or to switch after 30 days to clopidogrel plus aspirin. At one year, the adverse events defined in the primary endpoint occurred in 59 patients in the clopidogrel group (4.6%) compared with 104 in the ticagrelor group (8.2%), a statistically significant difference. A total of 3% of patients in the clopidogrel group experienced bleeding that required medical intervention, compared with 5.6% in the ticagrelor group, also a statistically significant difference. Outcomes for ischaemia were similar in the two groups. “We found that the higher-potency DAPT regimen

with ticagrelor was needed only during the first 30 days after a heart attack, when the risks of another heart attack or arterial blockage are highest, and that this regimen may be harmful once this early phase has passed,” Chang said. “Many cardiologists are already using DAPT de-escalation in patient treatment, and the results of this study provide scientific evidence to justify this practice.” The study findings have limitations, Chang said, including that it was not blinded, and was conducted only in South Korea. Chang and colleagues are planning to conduct a follow-up study that will examine differences in outcomes between patients similar to those enrolled in the TALOS-AMI trial who are or are not treated with the DAPT de-escalation strategy in the “real world” outside of a clinical trial setting.

We found that the higher-potency DAPT regimen with ticagrelor was needed only during the first 30 days after a heart attack, when the risks of another heart attack or arterial blockage are highest, and that this regimen may be harmful once this early phase has passed.”

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Issue 62 | August 2021

Structural Heart Interventions Two-year results of Evolut Low Risk trial “reassuring” for TAVI in low-risk patients

Complete two-year follow-up data from the Evolut Low Risk trial, presented during a latebreaking trial session at EuroPCR 2021 (18–20 May, virtual), offer “reassuring” evidence on the outcomes of transcatheter aortic valve implantation (TAVI) in low-surgical risk patients, speakers at the virtual event commented. However, longer-term data are needed to better understand the merits of transcatheter or surgical interventions in low-risk aortic stenosis patients.

he Evolut Low Risk trial is a randomised, non-inferiority trial, in which TAVI with a selfexpanding supra-annular bioprosthesis (CoreValve, Evolut R, or Evolut PRO; Medtronic) was compared with surgical aortic-valve replacement (SAVR) in patients who had severe aortic stenosis and were at low surgical risk. Patients enrolled in the trial are due to be followed out to 10 years. One-year data from the trial, presented at the PCR e-course in 2020, demonstrated that TAVI is non-inferior to SAVR for all-cause mortality or disabling stroke. Presenting the complete two-year data on behalf of the Evolut Low Risk trial investigators at EuroPCR 2021, John Forrest (Yale School of Medicine, New Haven, USA) reported at the virtual meeting that, at two years, TAVI remained non-inferior to surgery with regard to these primary endpoints. Forrest told attendees that the as-treated cohort consisted of 1,414 patients, with TAVI attempted in 730 and surgery in 684 patients. Completed two-year followup was available for 97.3% in the TAVI group and 92.3% in the surgery group. At 12 months, the primary outcome occurred in 2.5% in the TAVI group vs. 4.3% in the surgical group (p=0.057), Forrest explained. At 24 months, the primary outcome occurred in 4.3% in the TAVI arm vs. 6.3% in the surgical group (p=0.084 for superiority, p<0.001 for noninferiority), he noted. The study group also examined the question of “catch-up” in outcomes between TAVI and surgery between 12 and 24 months. “In some of the recent low-risk TAVI studies, there has been a question of catch-up of the surgical arm between 12 and 24 months, as it relates to the initial benefit of TAVI,” said Forrest. “We know John Forrest with TAVI, because it is a less

invasive procedure, we do have this trend towards benefit of mortality early on with that early separation of the curves. To better evaluate this in this study, we performed a landmark analysis and reset at 12 months and followed from 12 to 24 months.” In this landmark analysis, the primary outcome occurred in 1.9% in the TAVI group vs. 2.1% in the surgical group (p=0.742); thereby indicating no late adverse catch-up phenomenon in the TAVI group between years one and two. Also additionally reported, at two years, TAVI with a self-expanding supraannular bioprosthesis was superior to surgery in regards to valve haemodynamics and prosthesispatient mismatch. However, surgery was superior to TAVI in regards to the incidence of pacemaker implantation and mild paravalvular leak. Following his presentation, Forrest was asked by session moderator Bernard Prendergast (St Thomas’ Hospital, London, UK), to comment on the implication of the results, and what reassurance they should provide to interventional cardiologists considering TAVI in lowrisk patients. “There was a lot of criticism that the interventional community was reacting to one-year data,” said Prendergast. “We now have two-year follow-up both from PARTNER 3 and the Evolut Low Risk trial— what does this mean for practice and for guidelines, and how long do we need to wait until we are comfortable and reassured that we can provide TAVI in younger and lower risk patients with a durable outcome?” Responding to these questions, Forrest said that the data should provide “reassurance” of the safety and efficacy of TAVI in low-risk patients. However, he also commented that longer-term data will be vital to provide a greater level of insight.

TAVI combined with mitral valve procedures may increase risk for patients Patients undergoing transcatheter aortic valve implantation (TAVI) alongside a mitral procedure—either transcatheter edge-to-edge repair (TEER) or transcatheter mitral valve replacement (TMVR)—during the same hospitalisation are at a higher risk for in-hospital mortality and morbidity compared to TAVI alone. THIS IS ACCORDING TO an analysis of data from the US National Readmissions Database (NDR) published in the JACC: Cardiovascular Interventions.

According to the study’s lead author Ayman Elbadawi (Houston Methodist Hospital, Houston, USA) available data on the outcomes of combined multivalvular transcatheter

interventions with TEER or TMVR during the index hospitalisation for TAVI are scarce.Assessing data from more than 210,000 TAVI admissions, the study’s authors identified 110 (0.05%) patients who underwent procedures that combined TAVI/ TEER, and a total of 98 (0.05%) patients who underwent combined TAVI/TMVR procedures. Detailing their findings, the study team documented that when compared with TAVI, combined TAVR/TEER was associated with higher in-hospital mortality (10.8% vs. 1.9%), as was combined TAVI/TMVR (13.3% vs. 1.9).There were no differences in other rates of in-hospital complications.

Two-year PINNACLE FLX results report low rate of ischaemic stroke for Watchman FLX Two-year results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) device for patients with non-valvular atrial fibrillation (NVAF) have shown that patients implanted with the device recorded a low rate of ischaemic stroke out to 24 months.

PRESENTED AS LATE-BREAKING CLINICAL science at TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA and virtual), the study evaluated the Watchman FLX device as an alternative to long-term oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), for stroke risk reduction in patients with NVAF. The prospective, non-randomised PINNACLE FLX trial included 400 patients in the USA with NVAF who were eligible for anticoagulation therapy to reduce the risk of stroke but had appropriate rationale to seek a non-pharmaceutical alternative. Following the 12-month results in which the trial met its primary safety and efficacy endpoints, the trial met its secondary effectiveness endpoint—defined as the occurrence of ischaemic stroke or systemic embolism over 24 months—with a rate of 3.4% compared to the performance goal of 8.7%. “These findings demonstrate sustained device performance over two years and reinforce the excellent safety and efficacy profile of the Watchman FLX technology,” said Saibal Kar, study co-principal investigator and interventional cardiologist at Los Robles Regional Medical Center and Bakersfield Heart Hospital, Oakland, USA. “Building upon the low complication rates and 100% rate of effective LAA closure seen at 12 months, the 3.4% rate of ischaemic stroke and systemic embolism at 24 months is very encouraging in this complex, elderly patient population.” In addition to the low rate of ischaemic stroke, the data through to 24 months also demonstrated that no patients experienced a device embolisation or pericardial effusion requiring cardiac surgery. “The final results of this pivotal study underscore how design advancements of the Watchman FLX device—which allow for improved anchoring, a faster, more effective LAA closure, and compatibility with more complex anatomies—have translated into a safe, effective and durable option for patients with NVAF at increased risk for stroke and systemic embolism and an appropriate rationale to seek a nonpharmaceutical alternative,” said Ian Meredith, global chief medical officer, Boston Scientific.

22 Structural Heart Interventions

August 2021 | Issue 62

Aborted TEER leads to poorer outcomes in mitral valve surgery Among patients undergoing mitral valve surgery after failed transcatheter edge-to-edge mitral valve repair (TEER), those whose initial TEER procedure was aborted faced poorer outcomes compared to patients who underwent successful TEER but required surgery for acute or delayed failures.

his was according to findings from the CUTTING-EDGE registry looking at the impact of timing of the surgery on mitral valve surgery outcomese after TEER, presented by Gilbert Tang (Mount Sinai Health System, New York, USA) during a latebreaking science session at TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA and virtual). “We know that over 100,000 TEER procedures have been done worldwide in patients with severe mitral regurgitation [MR], but multi-institutional longitudinal data on mitral valve surgery after TEER are not commonly reported. We created this registry in an attempt to look into this cohort of patients,” Tang said. Tang pointed to a recent Journal of the American College of Cardiology (JACC) paper, authored by Joanna Chikwe (Smidt Heart Institute at CedarsSinai, Los Angeles, USA) which looked at patients in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, and found that the majority of patients with failed TEER require replacement at the time of surgery, and the number of cases, including isolated and concomitant procedures, are rising.

Using data from the CUTTING-EDGE registry, Tang et al found that the rate of one-year mortality is around 31.3% in these patients. “We looked at a subgroup analysis and found that if you have moderate to severe tricuspid regurgitation (TR) pre-TEER, it is an independent predictor of mortality, however concomitant tricuspid valve surgery did not increase mortality in these patients,” Tang said. Tang and colleagues then sought to compare outcomes of mitral valve surgery after failed TEER, stratified by the timing from TEER to surgery in the CUTTING-EDGE registry. This included 332 patients from 34 centres worldwide from July 2009 to July 2020. Patients were stratified into three groups: aborted TEER, in which TEER was attempted but unsuccessful, leading to mitral valve surgery in the same or a different hospital admission; acute TEER failure, whereby mitral valve surgery after TEER was performed on the same index admission; or delayed TEER failure, where mitral valve surgery after TEER was performed on a separate admission. Mitral valve surgery was performed in 70 (21.2%) aborted, 58

(17.6%) acute and 202 (61.2%) delayed TEER failure patients. The study team evaluated Mitral Valve Academic Research Consortium (MVARC) outcomes at 30 days and one year, with a median follow-up of nine months (interquartile range [IQR] 1.2– 25.7 months) after mitral valve surgery. The overall cohort had an average age of 73.8 ±10.1 years. At the time of index TEER, the median STS Predicted Risk of Mortality (PROM) score for mitral valve repair was 4% (IQR=2.3–7.3%), with 51.3% deemed low or intermediate surgical risk by the heart team. A total of 59% had primary or mixed mitral regurgitation and 38.5% secondary MR. Tang noted that indications for mitral valve surgery included recurrent mitral regurgitation in 33.5% of patients, residual mitral regurgitation in 28.7%, single leaflet device attachment (SLDA) in 25.1%, partial leaflet detachment in 21.8% and mitral stenosis in 14.5%. At mitral valve surgery the median STS PROM score for mitral valve replacement was 4.8% (IQR=2.8–8.4%), and 42.2% had concomitant tricuspid valve surgery. Tang also charted the temporal trends of TEER cases by scenario, noting that, across time, the number of cases for aborted TEER remained constant. Summarising the key findings at index TEER, Tang said that there was more mixed mitral regurgitation, worse tricuspid regurgitation and right ventricular (RV) dysfunction in the aborted TEER group and lower left ventricular ejection fraction (LVEF) in the aborted and acute groups. Tang also reported that there was no difference in TEER locations or the number of devices used among the patient groups, but noted that more first-generation MitraClip

More experienced TAVI centres “less likely to use heart team approach” Assessment of patients by both interventional cardiologists and cardiac surgeons prior to transcatheter aortic valve intervention (TAVI)—known as the heart team approach— appears to be declining, particularly in centres with more mature TAVI programmes. This is according to a study of temporal trends of heart team utilisation in TAVI referrals and treatment allocation in Ontario, Canada from 2012–2019, findings from which were published online in the Journal of the American Heart Association (JAHA). STUDY AUTHORS GIL MARCUS, HARINDRA C Wijeysundera (Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada) et al speculate that the findings may suggest that more mature TAVI programmes have more comfort in determining patient eligibility for TAVI without requiring a full heart team approach on all patients. Marcus, Wijeysundera et al begin by noting that TAVI has evolved to become the standard of care, or a reasonable alternative, for patients with severe aortic stenosis (AS) across the entire spectrum of patient risk. Over the course of this evolution, the need for multidisciplinary care has gained recognition. The heart team concept—a collaborative approach to determine setting treatment strategies and to ensure multidisciplinary participation in procedures—has emerged as an important principal endorsed by a number of professional societies. Using data from the CorHealth Ontario registry, the study team looked at AS patients referred for consideration for TAVI at 11 tertiary cardiac hospitals

with onsite cardiac surgery, from the time of referral until they were off-listed. The heart team was defined as having a billing code for both a cardiologist and cardiac surgeon during the referral period, while the procedural team was defined as having a billing code during the TAVI procedure. Hierarchical logistical models were used to determine the drivers of heart team utilisation, and median odds ratios (ORs) were calculated to quantify the degree of variation among hospitals. According to the study’s authors, of 10,412 patients referred, 5,489 (52.7%) patients came via the heart team, with a substantial range between hospitals (median OR, 1.78). Further to this, Marcus, Wijeysundera et al found that utilisation of the heart team for TAVI referrals declined from 69.9% to 41.1% over the years of the study. Patient characteristics, such as older age, frailty and dementia, and hospital characteristics including TAVI programme size, were found to be associated with

(Abbott) devices were used in the delayed TEER group, compared to more MitraClip XTR/G4 in the aborted and acute groups. In terms of mitral valve surgery, Tang explained that worse LVEF, RV dysfunction, more residual MR, SLDA and partial leaflet detachment were observed in the aborted and acute groups, while worse TR was seen in the aborted group. More urgent and emergency surgeries were performed in the aborted and acute groups, Tang added, and there was a higher use of intra-aortic balloon pump (IABP) in the aborted TEER group, he said. Detailing the outcomes, Tang noted that there were no differences in rates of in-hospital mortality, stroke or intensive care unit (ICU) stay, although lower rates of LVEF and more RV dysfunction were recorded in the aborted TEER group. At 30 days, Tang reported that the highest mortality and worst TR was found in the aborted TEER group, while there were no differences in stroke and readmission rates in the other two groups. Turning to the one-year data, he noted that the highest mortality was again seen in the aborted TEER group, and detailed that there was no difference in stroke and echo parameters. Despite the differences in the three TEER failure scenarios, the aborted group had the highest 30-day and oneyear mortality. This was driven, Tang said, mostly by baseline risk factors, TR severity and RV dysfunction. In his concluding remarks, Tang said of the results: “The implication is that, whenever possible, an optimal procedural outcome during the initial TEER would be ideal to ending up in the aborted scenario requiring mitral valve surgery.”

lower heart team utilisation. However, despite a decline in heart team utilisation during referrals, the study team found that during the TAVI procedures the procedural team included both cardiologists and cardiac surgeons in 94.9% of cases, with minimal variation over time or between hospitals. Discussing the findings, the authors write that factors that seem to reflect programmatic maturity, such as higher volumes of TAVI completed, were associated with a lower heart team utilisation. They add: “Our findings may reflect that mature programmes have more comfort in determining patient eligibility for TAVI without requiring a full heart team approach on all patients, given their experience in understanding which patients are most appropriate for each procedure. Indeed, reassuringly, despite the observed decline in heart team utilisation in TAVI candidates, we did not find evidence that treatment allocation was influenced by this change.” The authors note that the study has several limitations, notably that the definition of a heart team was based on encounters with a cardiologist and a cardiac surgeon within a timeframe, not necessarily on the same day. Secondly, an important part of the data source, the billing done by the cardiologist and by the cardiac surgeon, is subject to under-reporting, they add. Furthermore, the dataset lacked granular information that precluded the calculation of risk scores such as the Euroscore or Society for Thoracic Surgeons (STS), while the analysis was done on a cohort of patients who were referred for TAVI consideration.

Structural Heart Interventions 23

Issue 62 | August 2021

MitraClip reduces hospitalisation in patients with secondary MR and heart failure An analysis of the rates of rehospitalisation and mortality in heart failure patients with secondary severe mitral regurgitation from the COAPT trial has found that transcatheter mitral valve repair (TMVr) with MitraClip (Abbott) reduced the total number of hospitalisations, including fatal rehospitalisation events. THIS WAS ACCORDING TO GENNARO Giustino (Mount Sinai Hospital, New York, USA), who presented the findings of the analysis during a latebreaking trial session at TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA and virtual). Giustino told delegates that though the use of MitraClip compared with medical therapy alone did reduce total hospitalisations, it did not modify the association between non-fatal hospitalisation events and subsequent death. In the opening to his presentation, Giustino remarked that the presence of secondary mitral regurgitation (MR) in patients with heart failure is associated with an increased risk of heart failure-related hospitalisation and death. “Among patients with heart failure, it has previously been shown that rehospitalisation events are associated with increased risk of morbidity, mortality and healthcare costs,” he commented. Giustino and colleagues aimed to test whether or not reducing the secondary MR with the MitraClip modulates the effect of rehospitalisation events on allcause mortality, by characterising the impact of all-case and cause-specific hospitalisation on mortality among patients with heart failure and secondary MR treated with MitraClip plus guideline-directed medical therapy versus guideline-directed medical therapy alone. COAPT (Cardiovascular outcomes assessment of the MitraClip percutaneous therapy for heart failure patients with functional mitral regurgitation) is an open-label, multicentre, randomised trial evaluating the outcomes of edge-to-edge TMVr using MitraClip in

symptomatic patients with heart failure and secondary MR. The trial found that TMVr with the MitraClip rapidly improved health status and reduced the long-term risks of death and heart failure hospitalisation in patients with heart failure and severe secondary MR who remained symptomatic Gennaro Giustino despite guideline-directed medical therapy. Eligible patients had ischaemic or non-ischaemic cardiomyopathy with left ventricular ejection fraction (LVEF) of 20–50% and left ventricular end-systolic diameter (LVESD) <7cm, moderate-to-severe (grade 3+) or severe (grade 4+ secondary MR, confirmed at an echocardiographic core laboratory before enrolment, and remained symptomatic (NYHA functional class II, III or ambulatory IV) despite maximally-tolerated guidelinedirected medical therapy and cardiac resynchronisation therapy if appropriate. Enrolled patients were randomly assigned in a 1:1 ratio to receive TMVr with the MitraClip, plus guideline-directed medical therapy or to medical therapy alone.

The use of MitraClip compared with medical therapy alone reduced the total number of hospitalisations, including fatal hospitalisation events and subsequent death.” For the present analysis, the endpoints of interest included: all-cause hospitalisation, cardiovascular-related hospitalisation, heart failurerelated hospitalisation, non-cardiovascular-related hospitalisation and all-cause mortality. Clinical followup was included out to two years. Giustino explained that heart failure related hospitalisation was defined as hospital admission, emergency department visit, or observation stay for >24 hours, including the presence of increased signs or symptoms of heart failure, and the administration or augmentation of intravenous heart failure therapy. Overnight stays at nursing home facilities, physical rehab or extended care facilities,

TRISCEND study demonstrates significant reduction in TR with Evoque tricuspid valve Early experience with the Evoque (Edwards Lifesciences) tricuspid valve replacement system demonstrated a significant reduction in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR. This is according to 30-day results of the TRISCEND study, presented during a late-breaking clinical trial session at EuroPCR 2021 (18–20 May, virtual) by Susheel Kodali (Columbia University Medical Center, New York, USA).

voque is a tricuspid valve replacement system, designed to be deployed via a transfemoral approach. The design of the valve features atraumatic anchors that are used to engage the native tricuspid valve leaflets, under echocardiographic guidance. TRISCEND is a prospective, single-arm, multicentre study, seeking to evaluate the safety and performance of

the device, in patients with symptomatic moderate TR. Endpoints studied include device and procedural success, TR reduction, and a composite of major adverse events (MAE) at 30 days. A total of 56 patients were enrolled in the study, with a mean age of 79±8 years, 77% of whom were female. Of these patients, Kodali detailed, 90% had severe or greater TR. Follow-up data after 30

including hospice, did not meet the protocol definition of hospitalisation. Analyses were performed in the intention to treat population at two years post-randomisation, and the association between hospitalisation events and allcause mortality was examined in time-varying Cox regression models including hospitalisation as a time-varying covariate. The study team evaluated the association of two-year all-cause mortality for each type of hospitalisation event, all hospitalisations and only non-fatal hospitalisations. The association between hospitalisations and mortality was evaluated separately in the MitraClip and medical therapy groups, with formal interaction testing to assess the heterogeneity of the effect of hospitalisation on mortality, according to the randomised assignment. Detailing the results, Giustino explained that, in the MitraClip group, most of the hospitalisations were non-cardiovascular related (46.37%), whereas in the guideline-directed medical therapy group they were mostly cardiovascular or heart failure-related (46.03%). In terms of timing, in both groups, most hospitalisations occurred between one month and one year, with most of the patients experiencing more than one hospitalisation event, Giustino added. Outlining the findings of the time to first event analysis, Giustino revealed that MitraClip significantly reduced all-cause cardiovascular hospitalisations related to heart failure, but did not reduce cardiovascular hospitalisations not related to heart failure. There were no significant differences in terms of noncardiovascular-related hospitalisation. Furthermore, Giustino noted that MitraClip resulted in significant reductions in all-cause fatal hospitalisation over two years, as well as heart failure-related fatal hospitalisation over the same timeframe. There were no significant differences in terms of the duration of hospitalisation, he added—a trend that was borne out across first, second and third hospitalisations in both groups. Limitations of the study included that associations between non-fatal hospitalisations and subsequent death is subject to residual confounding, and the relatively limited time of follow-up. Summing up the findings of the analysis, Giustino said that post-discharge hospitalisation events, particularly those that were heart failure and cardiovascular related, were associated with increased mortality. Furthermore, the use of MitraClip compared with medical therapy alone, reduced the total number of hospitalisations, including fatal rehospitalisation events, but did not modify the association between non-fatal hospitalisation events and subsequent death.

days were available for 47% of patients. Device success, which was defined as device deployment and delivery system retrieval as intended, was achieved in 98% of patients, Kodali said, while procedural success, which was defined as device success without significant paravalvular leak (PVL), was achieved in 94% of patients. Echo corelab analysis revealed that 90% had severe or greater TR at baseline, with 44% classed as ‘massive or torrential’. At 30-day followup, 98% had mild or non-traced TR, with all patients achieving at least a one-grade reduction in TR, and 95% improving by at least two grades. Two mortalities occurred within the 30-day follow-up, Kodali noted, while bleeding events occurred in 22.6% of patients. In total, 77.4% had no major adverse events at 30 days. “All patients achieved significant improvements in clinical, functional and quality of life outcomes at 30 days,” Kodali said, adding that baseline New

York Heart Assocation (NYHA) class improved “significantly” among the cohort, with 84% having been NYHA class 3 or 4 at baseline, and 77% class 1 or 2 at the 30-day follow-up. Concluding his presentation, Kodali commented that the Evoque system may be an important therapy for patients with severe tricuspid regurgitation. “This study showed favourable 30-day results, with high device and procedural success rates—98% and 94% respectively—a significant reduction in TR severity, with 98% mild or less TR at 30-day follow-up,” Kodali commented. He added: “The early experience with the Evoque transfemoral system demonstrated technical feasibility with an acceptable safety profile, along with significant TR reduction and symptomatic improvement at 30 days in patients with clinically significant TR.” A pivotal trial evaluating the use of the device has been initiated as a result of the study’s results, Kodali concluded.

24 Structural Heart Interventions

August 2021 | Issue 62

Case bias may colour view of TAVI outcomes on social media A preference for sharing only “ideal” cases by physicians on social media platforms including Twitter may create a false expectation of the outcomes of complex procedures, such as transcatheter aortic valve implantation (TAVI). This is according to a paper published in EuroIntervention authored by Sarah Gualano (University of Michigan, Ann Arbor, USA) and colleagues, which characterised the content and outcomes of tweets associated with the hashtag #TAVR, that were linked to real-world cases. “DESPITE ENTHUSIASM AND potential value of social media in sharing knowledge, concerns exist regarding selective reporting of experiences within this medium,” Gualano and colleagues write. “A bias toward communicating only ‘ideal‘ cases in tweets, for example, may imply better-than-expected outcomes for complex procedures like TAVI.” The authors of the study searched the Twitter database between June 2019 and May 2020 to identify tweets with patient cases linked to #TAVR. An interventional cardiologist or fellow then abstracted clinical and outcomes data from the cases using a standardised case report form, with TAVI success defined as documented implant of a valve in a functional position. They also counted whether the author of the post had received and communicated the patient’s consent for posting the case to their social media platform. According to the study team, over the

12-month investigation period, there were 499 #TAVR tweets eligible for the study, including 170 unique cases from 83 users. There was a 100% success rate with no deaths or strokes reported. However, the study team notes, there was substantial missing data. One myocardial infarction (MI) and three vascular complications were reported, but no permanent pacemaker (PPM) implant or paravalvular leak (PVL) worse than mild was reported. “Assuming missing data would be interpreted by the reader as not

Mild COVID-19 unlikely to lead to lasting heart damage Mild COVID-19 infection is unlikely to cause lasting damage to the structure or function of the heart, according to a study led by University College London (London, UK) researchers and funded by the British Heart Foundation (BHF) and Barts Charity. Researchers say the results, published in JACC Cardiovascular Imaging, should reassure the public, as they relate to the vast majority of people who had COVID-19 infections with mild or no symptoms.

his study of 149 healthcare workers recruited from Barts Health and Royal Free London NHS Trusts, London, UK is the largest study to date into mild COVID-19 infection and its longer-term impact on the heart. It follows concerns that because severe hospitalised COVID-19 infections are associated with blood clots, inflammation of the heart and heart damage, mild infections may cause similar complications. However, up until now, there has been little information specifically looking at this group of people and the effects on the heart later after infection. Researchers identified participants with mild COVID-19 from COVIDsortium, a study in three London hospitals where healthcare workers had undergone weekly samples of blood, saliva and nasal

occurring, overall rates of outcomes were much lower than reported in clinical trials or registries: death 0%, stroke 0%, MI 0.6%, PPM 0%, PVL 0%, 1.8% vascular complications,” Gualano et al report. Just two cases were posted with explicit patient consent. Despite growth in users of social media platforms across areas of medicine like interventional cardiology, there has been little written on, or formal scrutiny of, educational content in these settings, the authors of the paper suggest. Gualano and colleagues add that their findings point towards strong selection bias in both the types of cases being reported and also their outcomes. “This finding underscores the importance of registry data and institutional quality reviews to counterbalance the Pollyannaish view we may develop from social media. Avoiding over-optimism in Twitter users may be especially true for new or high-risk treatments like TAVI where innovation occurs regularly and evolving

swabs for 16 weeks. Six months after mild infection, they looked at the heart structure and function by analysing heart magnetic resonance imaging (MRI) scans of 74 healthcare workers with prior mild COVID-19 and compared them to the scans of 75 healthy age-, sex- and ethnicity-matched controls who had not previously been infected. They found no difference in the size or amount of muscle of the left ventricle, or its ability to pump blood out of the heart. The amount of inflammation and scarring in the heart, and the elasticity of the aorta, remained the same between the two groups. When the researchers analysed blood samples, they found no differences in the two markers of heart muscle damage—troponin and NT-proBNP—six months after mild COVID-19 infection. The team of researchers and cardiologists now suggest that there is little benefit from screening the hearts of people who have had mild

Disentangling the impact COVID-19 has on the heart has been a challenge. But we are now at the stage of the pandemic where we can really start to get a grip on the longer-term implications COVID-19 has on the health of our heart and blood vessels.”

practices may proliferate,” they write. Patient privacy has also been often overlooked with cases posted on Twitter, Gualano and colleagues add, noting that even if de-identified in the traditional sense, other content such as procedural date or its unique features may result in patient awareness of posting of their procedure. The authors describe this trend as “worrisome”.

A bias toward communicating only “ideal” cases in tweets may imply better-thanexpected outcomes for complex procedures like TAVI.”

infection, and research should focus on those who have suffered severe COVID-19, high-risk groups or those with ongoing symptoms. Thomas Treibel (UCL Institute of Cardiovascular Science and Barts Health NHS Trust, London, UK), said: “Disentangling the impact COVID-19 has on the heart has been a challenge. But we are now at the stage of the pandemic where we can really start to get a grip on the longer-term implications COVID-19 has on the health of our heart and blood vessels. “We have been able to capitalise on our incredible frontline staff who have been exposed to the virus this past year and we are pleased to show that the majority of people who have had COVID-19 seem to not be at increased risk of developing future heart complications. We now need to focus our attention on the long-term impact the virus has in those who have been hit hardest by the disease.” Sonya Babu-Narayan, associate medical director at BHF and consultant cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, UK, said: “These findings one year on from the start of the pandemic are welcome reassurance to the hundreds of thousands of people who have experienced COVID-19 with mild or no symptoms. “Throughout the pandemic, BHF researchers have made progress investigating the short and long-term effects of COVID-19 on the heart and circulatory system. There is still a lot more work to be done, but for now it seems the good news is that mild COVID-19 illness does not appear to be linked to lasting heart damage.” There were small abnormalities identified by MRI but these were not found more often in people who had mild COVID-19 than those that have never had it. The changes could have been caused by something other than coronavirus and they may not make any noticeable difference to the health of that person.

Issue 62 | August 2021

Market Watch 25

US and European launches for Abbott’s Ultreon AIbased coronary imaging platform

Product News

Xience stent

Xience stent receives US FDA approval for shortduration DAPT

Abbott has announced that its Xience family of stents has received US Food and Drug Administration (FDA) approval for one-month (as short as 28 days) dual antiplatelet therapy (DAPT) labelling for high bleeding risk (HBR) patients in the USA. This follows the receipt of CE mark in Europe for shorter duration DAPT in April 2021. In addition to the HBR indication, Abbott has also received FDA approval and European CE mark approval for its next-generation Xience Skypoint stent. Xience Skypoint is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively, Abbott said in a press release. “The new FDA approval for DAPT for the Xience family of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk. A short DAPT duration minimises risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance,” says Roxana Mehran, professor of Medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, New York, USA, and the global principal investigator for Abbott’s Short DAPT programme (XIENCE 28 and XIENCE 90).

MedAlliance launches Origin balloons for vessel preparation

MedAlliance has launched Origin SC and Origin NC, two high performance balloons for vessel preparation—which are complementary to Selution SLR its novel sirolimus-eluting balloon. Origin SC is a semi-compliant (SC) percutaneous transluminal coronary angioplasty (PTCA) balloon with a low crossing profile, making it an option for challenging lesions. Origin SC comes in a broad portfolio of sizes available for an SC balloon, including 1mm, 1.25mm, 1.5mm and 1.75mm balloon diameters. Origin NC is a non-compliant (NC) PTCA balloon, combining high pressure tolerance and controlled compliance with an optimal crossing profile for the

most challenging cases. Origin NC’s minimal balloon longitudinal growth ensures focused dilatation force on the target lesion, minimising the risk of damaging healthy tissue, MedAlliance said in a press release. Origin NC also offers one of the lowest crossing profiles among all categories of PTCA balloon catheter currently available, the company added, noting that this is particularly appropriate when facing tight stenoses in calcified, fibrotic lesions. “We are excited to be broadening our balloon portfolio with the Origin range which complements our flagship drugeluting balloon (DEB) Selution SLR”, said Jeffrey B Jump, chairman and CEO of MedAlliance. “This is just the start of our product expansion programme to vertically integrate high quality products for the benefit of patients around the world.”

Medtronic launches Prevail DCB in Europe

Medtronic has announced the launch of the Prevail drug-coated balloon (DCB) catheter in Europe following CE mark approval. The newest coronary DCB on the market, the Prevail DCB is used during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (CAD). During the catheter-based procedure, the balloon inflates within the artery, while the drug is delivered to the arterial tissue where it is absorbed. The Prevail DCB utilises a rapid absorption drug—paclitaxel—to enable treatment of de novo lesions, small vessel disease, and in-stent restenosis (ISR). DCB angioplasty does not require a permanent implant and is often used in cases where the implantation of a drugeluting stent (DES) is not desirable or is technically challenging. “As physicians treat more patients with complex lesions, it is critical to have a DCB that is highly deliverable across a variety of vasculatures, and also utilises a drug that absorbs quickly into the vessel,” said Azeem Latib, lead principal investigator of the PREVAIL study and section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center, New York, USA. “The excellent deliverability coupled with a strong safety profile that is backed by clinical evidence makes the Prevail DCB an ideal option for interventional cardiologists using DCB technology to treat their patients.” The Prevail DCB builds on the safety and efficacy demonstrated in the previous generation IN.PACT Falcon DCB clinical programme and was reaffirmed by the PREVAIL study presented at the 2020 PCR e-Course conference.

Abbott has announced that it has received US Food and Drug Administration (FDA) clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. This innovative imaging software combines OCT with artificial intelligence (AI) to provide physicians an enhanced, comprehensive view of coronary blood flow and blockages to assist physician decision-making and provide the best pathway for treatment. US clearance follows the recently attained CE mark in Europe, providing broader access to the latest OCT imaging platform for interventional cardiologists seeking to utilise the

The Ultreon platform in use

technology. Ultreon software integrates with Abbott’s new Dragonfly OpStar imaging catheter and PressureWire X guidewire to provide tools to assess coronary blood flow and blockages and improve treatment planning for patients, Abbott said in a press release. “Abbott’s new Ultreon software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making,” said Ziad Ali, director of the DeMatteis Cardiovascular Institute at St Francis Hospital and Heart Center, New York, USA. “Ultreon software guides stents to be placed with precision. These types of innovative technologies are instrumental in providing the best care for our patients.”

Shockwave’s coronary IVL device gains TPT payment approval

Shockwave Medical has announced that the Centers for Medicare & Medicaid Services (CMS) has granted approval for a transitional pass-through (TPT) payment for Shockwave C2 coronary intravascular lithotripsy (IVL) device, effective 1 July 2021. The TPT status provides incremental payment for Shockwave C2 devices used in the hospital outpatient settings. In the July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), CMS issued a new device transitional pass-through code (C1761) for use by hospitals to bill for Shockwave C2 Coronary IVL catheters. In addition, as part of the payment calculation, CMS announced that a customary deduction known as a device offset will not be applied to coronary stenting procedures involving coronary IVL. The Shockwave C2 coronary IVL device will be eligible for

Shockwave IVL

TPT payments for three years. This announcement comes less than two months after CMS recommended coronary IVL be eligible for incremental payment via a New Technology Addon Payment (NTAP) as part of the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. The intent of both the TPT and NTAP programs are to facilitate Medicare beneficiary access to the benefits of new and innovative devices while cost data is collected for eventual incorporation into the respective payment systems.

Edwards’ Konect Resilia and Mitris Resilia gain Health Canada approval

Edwards Lifesciences has announced that it has received regulatory approval from Health Canada for both the Konect Resilia aortic valved conduit and the Mitris Resilia mitral valve. Both feature the company’s novel Resilia tissue platform with anti-calcification properties currently used on the Inspiris Resilia aortic valve. “Innovation is paramount to the future of cardiac surgery,” said Michael Chu, chair/chief of Cardiac Surgery, London Health Sciences Centre and Western University, London, Canada. “Edwards continues to invest in new technology for surgeons and our patients. The addition of the Konect Resilia aortic valved conduit and the Mitris Resilia valve offers important new solutions for patients impacted by heart valve disease.” Resilia tissue is bovine pericardial tissue transformed by an advanced integrity preservation technology, and serves as the platform for Edwards’ new class of resilient valves. It has been studied in two clinical trials related to treatment of the aortic and mitral valves, which together represent outcomes on more than 900 patients and more than 3,500 patient years of follow-up. The patient follow-up period for the studies is, at this time, in the range of four to seven years. “Collaborating with surgeons from around the world, Edwards is dedicated to developing patient-centric innovations that improve long-term care and outcomes for cardiac surgery patients,” said Sharon Ryan, Edwards’ managing director, Canada. “Canada is the first country to have regulatory approval for all three Edwards Resilia tissue products. We are excited to bring these innovations to centres across the country and to continue to support best clinical outcomes.”

August 2021 | Issue 62

26 Market Watch

Product News Abbott’s Navitor TAVI system receives CE mark Abbott has announced it has received CE mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk. Using Abbott’s FlexNav delivery system, the Navitor TAVI system is the latest addition to the company’s structural heart transcatheter portfolio that offers physicians and patients less invasive options to treat heart diseases. Aortic stenosis restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure and, in certain cases, sudden cardiac death. For some people diagnosed with severe aortic stenosis, open-heart surgery is considered a high-risk procedure due to the potential complications stemming from age, frailty or having multiple other diseases or conditions. TAVI serves as a less

native valve) leaflets and large frame cells—features designed to help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD). The Navitor device is implanted with Abbott’s FlexNav delivery system, which received CE mark in 2020 and offers a slim design with the lowest TAVI delivery system profile, allowing treatment of people with vessels as small as 5mm. The slim catheter can accommodate different aortic anatomies for stable, predictable and accurate valve delivery and placement. “The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives,” said Michael Dale, senior vice president of Abbott’s structural heart business. “This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.”

Philips adds haemodynamic measurement to Azurion image-guided platform

The Navitor TAVI valve

invasive alternative to surgical aortic valve replacement and can reduce symptoms and improve the lives of patients with this debilitating condition. “With an ageing world population and with aortic stenosis cases projected to double in Europe and the USA in the next few decades, the need for innovative, minimally invasive solutions is critical,” said Lars Søndergaard, professor of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, who served as co-principal investigator for the global Navitor TAVI system clinical study. “While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications.” Navitor features a fabric cuff— NaviSeal—that works with the cardiac cycle to reduce or eliminate paravalvular leak (PVL), a common complication following TAVI procedures. The device also features intra-annular (within the

Royal Philips has announced the integration of its Interventional Hemodynamic system and portable patient monitor IntelliVue X3, providing advanced haemodynamic measurements at the tableside in the cath lab and continuous monitoring of key vital signs throughout the patient journey. In a press release, Philips says that the integration provides the opportunity for monitoring during image-guided procedures on its image-guided therapy system—Azurion—to improve workflow with comprehensive patient records that support timely clinical decision-making during interventional cardiology procedures. The solution was introduced at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21: 15–17 May, virtual). “Philips' Interventional Hemodynamic system with Patient Monitor IntelliVue X3 is a unique combination made possible by our strengths in patient monitoring and image-guided therapy,” said Ronald Tabaksblat, general manager image guided therapy systems at Philips. “Bringing advanced haemodynamic measurements to the tableside as an integrated part of our Azurion image-guided therapy system, it helps allow clinicians to assess the condition of the patient in real time during an intervention, without leaving the sterile field. It also streamlines workflows, providing continuous monitoring of the patient during every step of their care path, enhancing patient safety and confidence.” The IntelliVue X3 patient monitor

can be connected to the patient from anywhere in the hospital, after which it stays with them throughout the interventional procedure, providing continuous monitoring and registration of their vital signs in the IntelliVue IT solution. After connecting the IntelliVue X3 to its docking station at the tableside of the Azurion system, clinical staff can monitor all of the patient’s vital signs including pulse oximetry endtidal CO2, perform haemodynamic analyses and 12-lead ECG acquisitions, and relay results and waveforms from the lab’s control room to the Azurion tableside display. From the tableside the interventionalists can assess the data using the Azurion tableside Touch Screen Module, allowing them to remain focused on their patients. The system brings the latest physiological techniques to the interventional lab, including iFR (instant wave-Free Ratio) measurements, a hyperaemiafree technique unique to Philips that provides valuable functional information regarding the severity of lesions in the coronary arteries.

after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalisation, and result in death. Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD system, consistent with its commitment to prioritise patient safety. “The Medtronic Mission guides us to always do what is in the best interests of patients and that is exactly what we are doing and will do for those impacted by this decision. There is nothing more important than the safety and wellbeing of patients,” said Nnamdi Njoku, president of the Mechanical Circulatory Support business, which is part of the Cardiovascular Portfolio at Medtronic. “We recognise this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”

Medtronic stops sale of its HVAD system

Medtronic is stopping the distribution and sale of its HVAD system. The company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support. Medtronic also announced that it is developing a support programme for patients who have had an HVAD implanted and for caregivers and healthcare professionals who participate in their care. This programme is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. Though the company will stop

Azurion platform

distribution and sale of the HVAD system, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device, the company said in its announcement of the step. Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system as compared to other circulatory support devices available to patients. In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart

Tendyne valve

Tendyne receives breakthrough designation for MAC patients

Abbott has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its investigational Tendyne transcatheter mitral valve replacement (TMVR) system in a subset of patients with severe mitral annular calcification (MAC). MAC is a fibrous, degenerative calcification of the mitral valve support ring that is associated with mitral regurgitation (MR), stenosis, or a combination of these valvular lesions, and can pose challenges for surgical correction, limiting treatment options. Abbott’s Tendyne device is the first-to-world TMVR therapy that offers people with MAC who are not candidates for open-heart surgery a minimally invasive treatment option. Tendyne offers controllable repositioning and full retrievability of the TMVR device, Abbott said in a press release. In compassionate use and feasibility studies to date, operators have achieved 95% technical success in treating patients with severe MAC. Supported by last year’s CE mark, the Tendyne system offers a minimally invasive treatment option when a leaky valve needs to be replaced in this difficult to treat population.

Issue 62 | August 2021

Market Watch 27

Clinical News Biotronik touts two-year data from BIOSOLVE-IV registry

Long-term follow-up data from the BIOSOLVE-IV registry, presented at the EuroPCR 2021 meeting (18–20 May, virtual), strengthens the clinical evidence for Biotronik’s Magmaris resorbable magnesium scaffold (RMS) as a therapy option for patients with coronary artery disease, the company said. Jan Torzewski, head physician at the Cardiovascular Center OberallgaeuKempten (Kempten, Germany), presented the two-year results for the first cohort at the virtual EuroPCR meeting. BIOSOLVE-IV investigates the clinical performance and long-term safety of the Magmaris RMS in a real-world setting. In the first cohort of 1,075 patients, from more than 100 clinical sites in total, the target lesion failure (TLF) rate was 6.6% at 24 months. The outcomes demonstrated a very good safety profile, no increase in scaffold thrombosis between 12-month and 24-month follow-ups and a cardiac death rate of 0.5%, Biotronik said in its press release. “Our results confirm the low TLF rate of the Magmaris scaffold that we have seen in other long-term studies, such as BIOSOLVE-II and -III,” said Torzewski, one of the registry’s principal investigators. Pooled results from the BIOSOLVEII and BIOSOLVE-III trials (n=174) recently demonstrated TLF rates of 6.3% at 36 months and the BIOSOLVE-II trial alone demonstrated a TLF rate of 8% at 60 months for the Magmaris RMS. No definite or probable scaffold thrombosis was observed in these studies. “Furthermore, this bioresorbable scaffold is safe and comparable to various second-generation drug-eluting stents on the market,” commented Torzewski. Indeed, bioresorbable scaffolds aim to provide comparable performance to existing metallic drug-eluting stents, while delivering complete scaffold resorption within a certain time period to facilitate complete vessel healing. The magnesium backbone dissolves in the body approximately by 95% one year after implantation. “The data show that Biotronik’s Magmaris RMS is an innovative, bioresorbable scaffold that can provide a true therapy option for coronary artery disease,” commented Alexander Uhl, president vascular intervention at Biotronik. “We are excited to examine the benefits that our next generation magnesium scaffold, DREAMS 3G, will provide for both patients and physicians. Patient enrolment for the BIOMAG-I first-in-man study is ongoing.”

Sinomed announces presentation of PIONEER III

data at EuroPCR 2021

Sinomed has announced results from the HT Supreme healing-targeted drug-eluting stent (DES) in complex patients compared to the Xience (Abbott Cardiovascular) or Promus (Boston Scientific) family of DES. One-year results were presented at the 2021 EuroPCR annual congress (18–20 May, virtual), showing that the devices have similar clinical safety and effectiveness. The PIONEER III study enrolled 1,629 patients (randomised 2:1 experimental to control) from North America, Europe and Japan, where the complex patient subgroup showed similar rates of target lesion failure (TLF) at one-year. Patients were considered complex based on AHA/ ACC B2/C-criteria. HT Supreme had a target lesion failure (TLF) of 5.8% compared to 5.9% in the control arm, with no statistical difference. Additionally, long lesions, severe calcification and severe tortuosity showed no difference between the two arms. “The one-year target lesion failure rates of the HT Supreme are very low and compared favourably to current best-in-class devices,” said Andreas Baumbach from Queen Mary University of London, London, UK, and European co-primary investigator of the PIONEER III trial. “It is important for clinicians to understand how new devices perform in more complex lesions; as this is a reflection of the patients we treat day-to-day.” “As we progress our clinical programme and continue to see the same, safe and consistent data from trial to trial, we are convinced that our healing-targeted stent is the right approach,” said Jianhua Sun, chairman and chief executive officer of Sinomed. “Ensuing that all patient types have another safe option is a true benefit.”

analysis was a superior predictor of 10-year outcomes compared to the severity of a coronary stenosis shown on a coronary computed tomography angiogram (CTA). The 10-year results from the DISCOVER-FLOW trial were presented as a late-breaking trial during the virtual EuroPCR conference (18–20 May, virtual). “When diagnosing and managing patients with coronary artery disease, physicians want to understand the impact of treatment. We want to be able to provide immediate symptom relief and have confidence that the treatment we are selecting, specifically the possible benefits of revascularisation, will have a positive, long-lasting impact,” said Bon-Kwon Koo, professor of internal medicine, Seoul National University, and director of the Cardiovascular Center and chair of the Cardiology Division, Seoul National University Hospital, Seoul, Korea. “The 10-year outcomes indicate that FFRct is a more useful non-invasive test than coronary CT alone as the information provided helps physicians with longterm risk stratification and treatment selection for patients with coronary artery disease.” The DISCOVER-FLOW trial was the first-in-human trial evaluating the HeartFlow Analysis and enrolled 103 patients from four international hospitals. All patients received a HeartFlow Analysis following a coronary CT scan. “It is rare to have the opportunity to follow patients for 10 years in clinical trials and we were pleased to confirm the long-term prognostic value of FFRct through the DISCOVERFLOW trial,” said Campbell Rogers, chief medical officer, HeartFlow. “These new data are a reflection of the company’s commitment to providing comprehensive clinical evidence on the diagnostic accuracy, safety, efficacy and utility of the HeartFlow Analysis to help clinicians engage patients in the decision-making process and confidently diagnose and optimise treatment for patients with coronary artery disease.”

Cobra PzF stent demonstrates long-term safety at five years post-PCI

HeartFlow FFRCt

Ten-year DISCOVER-FLOW results back HeartFlow FFRct analysis HeartFlow has announced new data which indicate that the information provided by the HeartFlow FFRct

CeloNova BioSciences recently announced that its Cobra PzF nanocoated coronary stent (NCS) achieved exceptional long-term ischaemic safety of 0% definite and probable stent thrombosis (ST) and low ischaemia-driven target lesion revascularisation (ID-TLR) of 7.8% for its non-angiographic cohort at five years. Results conclude the company’s global, multicentre PzF SHIELD IDE clinical trial of highly complex patients undergoing percutaneous coronary intervention (PCI). The study met its primary and secondary endpoints at nine months, demonstrating an excellent safety profile with 0% ST and low, 4.6% ID-TLR with a minimum of one-month DAPT therapy and was the basis for the stent’s US Food and Drug Administration (FDA) approval in 2017.

“It is truly remarkable to have a stent achieve complete protection from ischaemic events with 0% definite and probable stent thrombosis at both the nine-month and five-year follow-up periods,” said Sigmund Silber, professor of medicine at the ISAR Heart Center, Munich, Germany. “The results are particularly noteworthy given the highly complex nature of the patients who were studied. It offers valuable insight into Cobra’s performance as coronary artery disease progresses over time.” A total of 296 patients with de novo coronary artery lesions from 35 centres across the USA and Europe received treatment with Cobra PzF NCS in the single-arm, non-randomised trial. The study’s population included elderly patients (66.5 average age) with comorbidities including diabetes (33.7%), atrial fibrillation (12.2%) and those with highly complex lesions (72% with type B2 or C lesions). “These results reinforce the unique thromboresistant, anti-inflammatory and rapid healing properties of Cobra's proprietary Polyzene-F coating, which has been consistently demonstrated in my pre-clinical research at CVPath since 2012,” stated Aloke Finn, medical director and chief scientific officer at CVPath and associate professor of medicine at the University of Maryland, College Park, USA. “The results of the SHIELD trial show that there is a unique advantage of the Polyzene-F coating in allowing a stent to heal quickly and in a functional way without the need for antiproliferative drug elution. I believe Cobra will continue to play an important role in delivering safety and efficacy in real-world clinical practice over time.” Over 25,000 patients worldwide have been treated to date with Cobra PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with exceptionally low ST, low TLR and with short DAPT regimens in a real-world patient population, CeloNova says in a press release. “We are extremely pleased that Cobra PzF NCS continues to strike the perfect balance between safety and efficacy and proud of its durable long-term clinical outcomes,” stated Carl St Bernard, president and chief executive officer of CeloNova. “We look forward to continuing to evaluate its performance with ultra-short DAPT in the highly underserved patient population at high risk for bleeding.” Cobra PzF NCS is currently being evaluated with 14-days DAPT in high bleeding risk patients in the COBRA REDUCE clinical trial, described by CeloNova as the world’s first and only randomised, global 14-day DAPT study. The study’s six-month results, which were announced at TCT Connect 2020 (14–18 October, virtual), demonstrated 0.6% definite and probable ST with 14 days of DAPT with Cobra PzF NCS. The company anticipates release of the study’s 12-month results later this year.

August 2021 | Issue 62

28 Market Watch

Industry News LivaNova completes initial divestiture of its heart valve business

LivaNova has successfully completed the initial closing of the divestiture of its heart valve business to Gyrus Capital, an investment firm dedicated to investments in the healthcare and sustainability sectors, for an enterprise value of €60 million (US$73 million). Corcym, an independent company recently launched and owned by entities funded and controlled by Gyrus, will manage the heart valve business. “The completion of the heart valve sale to Gyrus Capital allows LivaNova to optimise its portfolio and sharpen its focus on cardiovascular and neuromodulation, our two areas of excellence,” said Damien McDonald, chief executive officer of LivaNova. The heart valve business consists of a comprehensive portfolio of products, featuring Perceval, a sutureless aortic valve, and Memo 4D, a semi-rigid mitral annuloplasty ring. Approximately 850 employees will transition to Corcym as part of the global heart valve business, which has major operations in Saluggia, Italy and Vancouver, Canada. As of today, LivaNova and CORCYM completed the initial closing relating to Corcym's

acquisition of the LivaNova heart valve business. In the initial closing, Corcym acquired LivaNova manufacturing facilities in Saluggia and Vancouver and related assets in other geographies, representing most of the heart valve business. During the course of 2021, the parties expect to complete the transfer of the commercial operations in various local jurisdictions.

Abiomed acquires breakthrough device company PreCardia

Abiomed has acquired PreCardia, developer of a proprietary catheter and controller to expand options for patients with acute decompensated heart failure (ADHF). The PreCardia system is designed to rapidly treat ADHFrelated volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. PreCardia’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced rehospitalisations and improved quality of

life. The system is based on an invention by Navin Kapur and Richard Karas at the Molecular Cardiology Research Institute at Tufts Medical Center, Boston, USA. The design of the PreCardia system allows for straightforward placement by physicians and haemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the US Food and Drug Administration (FDA). “Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” said Lisa Wipperman Heine, president and chief executive officer at PreCardia.

MedAxiom announces industry partnership wiht Vector Remote Care

MedAxiom has announced an industry partnership with Vector Remote Care, a remote monitoring system for cardiac care teams to capture, manage, and analyse remote cardiac data. “Vector Remote goes beyond traditional implantable cardiac rhythm management monitoring by also offering physiologic monitoring for the management of heart failure and hypertension patients,” said Joe Sasson of MedAxiom Ventures. “The combination of these solutions can streamline member operations, drive new revenue, and reduce hospital readmissions, creating a positive impact on the patient and provider experience

and our members’ value metrics. We are excited to welcome them as a MedAxiom industry partner and bring their solutions to our membership community.” “Vector was founded with the goal of helping our clinical partners manage their patient load cost effectively,” said Kevin Hoffman, CEO and founder of Vector. “We look forward to working with MedAxiom and their members to create scalable cardiac programs that result in better patient outcomes, happier caregivers and improved financial results.” Vector’s Cardiac Intelligence platform helps cardiology practices stay connected to their patients while maximising the value of cardiac remote monitoring technology for arrhythmia management, heart failure and hypertension. Vector combines its Cardiac Intelligence platform and live patient support to influence patient behaviour through timely, multitouch communication and positive reinforcement. These strategies directly impact higher patient compliance and on-time transmission delivery. Vector's technology-enabled services allow providers to manage the entire cardiac remote data lifecycle. From patient set up to data transmission, analysis and electronic health record (EHR) integration, Vector provides tools and support to deliver care efficiently and support those practices overwhelmed by multiple systems, manual processes, or at risk of missing important alerts.

Calendar of events Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

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TAVI already about limiting they call for the provisiont have increasedand surgical aortic can say that procedures findings up equipmen TAVI think you Additionally, report on protective 72,991 of which includes worn The TVT te personal eter that can be (SAVR) trends,published in the Journal appropria The has how transcath replacement cath lab teams practice”, writing that 2019, was (JACC) and TAVI (PPE) for Data show implantation (TAVI) ising acute Cardiology to and including USA The report College of aortic valve “without comprom presenting with more year in the volume late 2020. the American of patients Surgery in and stroke grown year-ontreatment has been made PPE. 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An of compared TAVR of cardiolog and director of COMPLE and the risk ly forgotten in many TAVR, and Carroll, professor of Medicine n of the cath y of TAVR, WATCH School been complete on protectio of Colorado cardiology at the Universitof the TVT emphasis overdue.” enhanced chair future this apparent and interventional is the Denver, USA, the lead author on in team that lab Hospital, and al suggest after TAVI increasing Colorado Committee, Banning et opportunity for the on outcomes an e computer of care in Registry Steering ore, the data may provide or enhanced protectiv “Furtherm ent in quality the report. al improvem robotic of labs. substanti use es a cath document ies within of TAVI procedur they highlight years.” technolog in the article, the last nine that the number increase in the Elsewhere an data show patient follow-up of reflecting The TVT methods of in response changes to as the number each per site varies, sites performed procedures by many hospitalsthe use of . In 2019, volume of 2 instigated on page , including 161 total annual g TAVI has increased Continued to the pandemic average with nded sites performinTAVI procedures on e recomme 84 4 50 cases—th performed g TAVI by on page g fewer than performin Continued sites performin threshold for sites annual g minimum STS and ACC. undergoin of patients ers including e, as well stakehold median age show the TAVI experienc Data also from early decreased TAVI has

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Discrimination and harassment are a common experience among those working in cardiology According to the findings from a global survey carried out by the American College of Cardiology (ACC), which have been published in the Journal of the American College of Cardiology ( JACC). Responses suggest that as many as 44% of cardiologists report experiencing a hostile work environment (HWE) including being subject to emotional or sexual harassment, or discrimination. Authors concluded that a renewed focus on organisational structure, processes, and practices to mitigate these problems in cardiology across the globe is critical to ensuring workforce wellbeing and optimal patient care. The report is the culmination of a 50-item online survey conducted by the ACC in September to October 2019, reaching 5,931 cardiologists in Africa, Asia, the Caribbean, Europe, the Middle East, Oceana, and North,

Central, and South America. Questions covered demographic information, practice environment, academic rank, discrimination, and harassment, with a particular focus placed on the professional and personal challenges of cardiologists. Author Garima Sharma ( Johns Hopkins School of Medicine, Baltimore, USA) noted that the incidences of HWE were more commonly reported among female (68%), Black (53%) and North American (54%) respondents. Gender was the most frequent cause of discrimination (44%), the study found, followed by age (37%), race (24%), religion (15%), and sexual orientation (5%). Of the participants 77% were

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Balloon angioplasty in critical time window central to endovascular success for the slowto-mature AV fistula Discrimination and harassment are a common experience among those working in cardiology, according to the findings from a global survey carried out by the American College of Cardiology (ACC), which have been published in the Journal of the American College of Cardiology ( JACC). Responses suggest that as many as 44% of cardiologists report experiencing a hostile work environment (HWE) including being subject to emotional or sexual harassment, or discrimination.

uthors concluded that a renewed focus on organisational structure, processes, and practices to mitigate these problems in cardiology across the globe is critical to ensuring workforce wellbeing and optimal patient care. The report is the culmination of a 50-item online survey conducted by the ACC in September to October 2019, reaching 5,931 cardiologists in Africa, Asia, the Caribbean, Europe, the Middle East, Oceana, and North, Central, and South America. Questions covered demographic information, practice environment, academic rank, discrimination, and harassment, with a particular focus placed on the professional and personal challenges of cardiologists. Author Garima Sharma ( Johns Hopkins School of Medicine, Baltimore, USA) noted that the incidences of HWE were more commonly reported among female (68%), Black (53%) and North American (54%) respondents. Gender was the most frequent cause of discrimination (44%), the study found, followed by age (37%), race (24%), religion (15%), and sexual orientation (5%). Of the participants 77% were men (n=4,584), and 23% (n=1,347) were women. Survey participants predominantly identified as white (54%), followed by Asian (17%), Hispanic

(17%), and Black (3%); and 73% were ≤54 years of age. Most were married (75%); 12% were single, 7% were living with a partner, 3% were divorced, and 1% were separated. Cardiologists from the European Union represented the largest group of respondents (32%), followed by respondents from South America (18%), the Middle East, Eastern Europe and Asia (all 9%), Africa (8%), North America (7%), Central America (6%), and Oceana (2%). According to Sharma, the survey results indicate that . The report is the culmination of a 50-item online survey conducted by the ACC in September to October 2019, reaching 5,931 cardiologists in Africa, Asia, the Caribbean, Europe, the Middle East, Oceana, and North, Central, and South America. Questions covered demographic information, practice environment, academic rank, discrimination, and harassment, with a particular focus placed on the professional and personal challenges of cardiologists. Author Garima Sharma ( Johns Hopkins School of Medicine, Baltimore, USA) noted that the incidences of HWE were more commonly reported among female (68%), Black (53%) and North American (54%) respondents. Gender was the most frequent cause of discrimination (44%), the study found, followed by age (37%), race (24%), religion (15%), and sexual orientation (5%). Of the participants 77% were men (n=4,584), and 23% (n=1,347) were women. Survey participants predominantly identified as white (54%), followed by Asian (17%), Hispanic (17%), and Black (3%); and 73% were ≤54 years of age. Most were married (75%); 12% were single, 7% were living with a partner, 3% were divorced, and 1% were separated. Cardiologists from the European Union represented the largest group of respondents (32%), followed by respondents from South America (18%), the Middle East, Eastern Europe and Asia (all 9%), Africa (8%), North America (7%), Central America (6%), and Oceana (2%). According to Sharma, the survey results indicate that The

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Performance goal derived from contemporary 1-month DAPT trials, including ZEUS, LEADERS FREE, and SENIOR trials. Kandzari DE, Kirtane AJ, Windecker S, et al. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. November 2020;13(11):e009565. 2 Kandzari, et al. Complex PCI with 1-month DAPT in High Bleeding Risk Patients: Analysis from the Onyx ONE Clear Study. Presented at TCT Connect 2020. 3 Resolute Onyx DES IFU. The safety and effectiveness of the Resolute Onyx™ stent have not yet been Resolute Onyx™ Zotarolimus-eluting Coronary Stent System established in the following patient populations:  Patients with target lesions Indications ™ or the use of brachytherapy to treat The Resolute Onyx Zotarolimus-eluting Coronary Stent System is indicated that were treated with prior brachytherapy in-stent restenosis of a Resolute Onyx™ stent  Women who are pregnant or for improving coronary luminal diameters in patients, including those with lactating  Men intending to father children  Pediatric patients  Patients with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart coronary artery reference vessel diameters of < 2.0 mm or > 5.0 mm  Patients disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with evidence of an acute ST-elevation MI within 72 hours of intended stent with reference vessel diameters of 2.0 mm to 5.0 mm. In addition, the implantation  Patients with vessel thrombus at the lesion site  Patients with Resolute Onyx™ Zotarolimus-eluting Coronary Stent System is indicated for lesions located in a saphenous vein graft, in the left main coronary artery, ostial treating de novo chronic total occlusions. lesions, or bifurcation lesions  Patients with diffuse disease or poor flow distal Contraindications to identified lesions  Patients with three-vessel disease The Resolute Onyx™ Zotarolimus-eluting Coronary Stent System is ™ contraindicated for use in:  Patients with a known hypersensitivity or allergies The safety and effectiveness of the Resolute Onyx stent have not been established in the cerebral, carotid, or peripheral vasculature. to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, Oral Antiplatelet Therapy drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs Dual antiplatelet therapy (DAPT) using a combination treatment of aspirin or any other analogue or derivative  Patients with a known hypersensitivity with a P2Y12 platelet inhibitor after percutaneous coronary intervention to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy  Patients with a known hypersensitivity to the BioLinx™ (PCI), reduces the risk of stent thrombosis and ischemic cardiac events, but increases the risk of bleeding complications. The optimal duration of polymer or its individual components DAPT (specifically a P2Y12 platelet inhibitor in addition to aspirin) following Coronary artery stenting is contraindicated for use in:  Patients in whom DES implantation is unknown, and DES thrombosis may still occur despite antiplatelet and/or anticoagulation therapy is contraindicated  Patients who are judged to have a lesion that prevents complete inflation of an angioplasty continued therapy. It is very important that the patient is compliant with the post-procedural antiplatelet recommendations. balloon or proper placement of the stent or stent delivery system Per 2016 ACC/AHA guidelines,1 a daily aspirin dose of 81 mg is recommended Warnings indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at  Please ensure that the inner package has not been opened or damaged least 6 months in stable ischemic heart disease patients and for at least 12 as this would indicate the sterile barrier has been breached.  The use of months in patients with acute coronary syndrome (ACS). Consistent with the this product carries the same risks associated with coronary artery stent 2 implantation procedures, which include subacute and late vessel thrombosis, DAPT Study, and the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in patients at higher ischemic risk with lower bleeding risk. The vascular complications, and/or bleeding events.  This product should not Academic Research Consortium (ARC) proposed a standardized definition for be used in patients who are not likely to comply with the recommended identifying patients at high bleeding risk (HBR).3 Additionally, evidence from a antiplatelet therapy. dedicated study of Resolute Onyx in HBR patients and those who are unable Precautions to tolerate long term DAPT after PCI has been published.4  Only physicians who have received adequate training should perform Based on the Onyx ONE Clear Analysis, Resolute Onyx is safe and effective in implantation of the stent.  Subsequent stent restenosis or occlusion may patients at high risk of bleeding treated with one month of DAPT. The patients require repeat catheter-based treatments (including balloon dilatation) of evaluated in the Onyx ONE Clear Analysis met the pre-defined criteria for the arterial segment containing the stent. The long-term outcome following high bleeding risk and were those whom in the opinion of their physician, the repeat catheter-based treatments of previously implanted stents is not well potential benefit of 1-Month DAPT outweighed the potential risk. In addition characterized.  The risks and benefits of the stent implantation should be to at least one HBR risk factor, enrollment included 48.6% ACS patients assessed for patients with a history of severe reaction to contrast agents.  Do (unstable angina 22.8%, Non-STEMI 21.7% and STEMI 4.2%). not expose or wipe the product with organic solvents such as alcohol.  The Decisions about duration of DAPT are best made on an individual basis and use of a drug-eluting stent (DES) outside of the labeled indications, including should integrate clinical judgment, assessment of the benefit/risk ratio, and use in patients with more tortuous anatomy, may have an increased risk of patient preference. Premature discontinuation or interruption of prescribed adverse events, including stent thrombosis, stent embolization, MI, or death.  Care should be taken to control the position of the guide catheter tip during antiplatelet medication could result in a higher risk of stent thrombosis, MI, or death. Before PCI, if premature discontinuation of antiplatelet therapy is stent delivery, stent deployment, and balloon withdrawal. Before withdrawing anticipated, physicians should carefully evaluate with the patient whether a the stent delivery system, confirm complete balloon deflation using DES and its associated recommended DAPT regimen is the appropriate PCI fluoroscopy to avoid arterial damage caused by guiding catheter movement into the vessel.  Stent thrombosis is a low-frequency event that is frequently choice. associated with myocardial infarction (MI) or death. Data from the RESOLUTE Following PCI, if elective noncardiac surgery requiring suspension of antiplatelet therapy is considered, the risks and benefits of the procedure clinical trials have been prospectively evaluated and adjudicated using the should be weighed against the possible risk associated with interruption of definition developed by the Academic Research Consortium (ARC). *

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 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/hypertension  Incomplete stent apposition  Infection or fever  MI  Pericarditis  Peripheral ischemia/ peripheral nerve injury  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 Please reference appropriate product Instructions for Use for more information regarding indications, 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. 1 Levine GN, 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. For full text, please refer to the following website: http:// content.onlinejacc.org/articleaspx?doi=10.1016/j.jacc.2016.03.513 2 Mauri L, et al. Twelve or 30 months of dual antiplatelet therapy after drugeluting stents. N Engl J Med. 2014; 371:2155–66. 3 Urban P, Mehran R, Colleran R, et al. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019;140:240–6. 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. 2020:10.1056/NEJMoa1910021.

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Resolute Onyx™ DES

PROVEN SAFE AND EFFECTIVE WITH 1-MONTH DAPT IN HBR PATIENTS The Onyx ONE Clear Analysis Included the Most Complex High Bleeding Risk (HBR) Patients for Greater Confidence in Short DAPT Decisions1

Complex Patients

Complex Lesions

50%

Nearly

years average age

50%

ACS patients

39%

diabetes

moderate to severe calcified lesions

79%

B2/C lesions

Event Rates 1–12 months (%)

average stented length

patients with > 60 mm stented length2

Onyx ONE Clear Analysis p < 0.001

37 mm 225

n = 1,491/1,506

9.7

PERFORMANCE GOAL*

MONTH DAPT

7.0 2.6 Primary Endpoint Cardiac Cardiac Death/MI Death

4.8 MI

3.4

0.7

TLR

Def/Prob ST

DAPT duration decisions are best made on an individual basis. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of ST, MI, or death.

Resolute Onyx DES is indicated for HBR patients and labeled for 1-month DAPT.3