The Edwards EACTS Congress Hub

Opening the proceedings was Don Bobo (Edwards Lifesciences, USA), who explained that sustaining innovation in surgery relies on active interest and collaboration from surgeons, as well as balanced requirements from regulators. Partnership with physicians and policy makers is important to prioritize meaningful innovation, as is influencing payers to enact policies that support life-saving innovations. In addition to this, he added, industry commitment must continue to invest in development and clinical programs.

This sentiment was echoed by Hendrik Treede (Halle), who commented: “You can connect to startups, but at a certain point you need big players in the field to help that startup further develop. This has worked well in the past and will work again in the future.”

You can connect to startups, but at a certain point you need big players in the field to help that startup further develop.

Innovation today is tempered by a greater emphasis on quality outcome data, countered Volkmar Falk (Berlin): “It is on us – the scientists and surgeons in the room – that we properly do science and correctly inform our colleagues of what we are doing.”

Citing the INDURE registry (Inspiris Resilia Durability Registry), he continued: “I would encourage you all to participate. What is very important is the use of standardized definitions for reporting outcomes, and that we have an echo core lab in place. That is solid data…a very well-done registry.”

Dr Falk stressed the growing importance of clinical trials, longer-term data, post-market follow-up and device traceability, in accordance with new EU Medical Device Regulations (2020). “In Europe we will have increased governance and oversight.”

In Europe we will have increased governance and oversight.

In an increasingly technical environment, the development of 3D printing and simulations will improve preoperative planning training with mathematical precision, said Peyman Sardari Nia (Maastricht). “There is a need for a different concept of training. Advances make what we do on a daily basis so technical. We need to have proper training but also the correct way to select patients.”

There is a need for a different concept of training.

Noting the positive changes that the transcatheter era have brought, he added: “Two byproducts are preoperative planning, and the heart team – taking away the gatekeeper job from one specialist into the interdisciplinary position.”

The session concluded with a presentation from Heart Valve Voice Chairman Chris Young (London), on the theme of growing patient involvement in clinical choices. Crucially, while some patients realize the powers they have, others do not. “We are desperate to increase the number of people that have stethoscope checks…to pick up, earlier and earlier, heart valve disease,” said Dr Young. “We’ve done a lot of webinars, as a resource for GPs. We’ve also come up with guidelines, and we are now increasingly involved in research. We are raising the issue of heart valve disease and its earlier diagnosis.”

We are desperate to increase the number of people that have stethoscope checks.

In setting such as these, noted Nikolaos Bonaros (Innsbruck) during the session, “the heart team allows for the development of common strategies for uncommon cases,” by combining expertise and eliminating knowledge biases.

The heart team allows for the development of common strategies for uncommon cases.

In asymptomatic severe aortic stenosis, registry data suggest that watchful waiting poses a greater mortality risk compared to SAVR or TAVI. According to speaker Jan-Malte Sinning (Bonn), “If you have an asymptomatic patient, you have not asked them correctly about his or her symptoms.”

If you have an asymptomatic patient, you have not asked them correctly about his or her symptoms.

In low-flow, low-gradient severe aortic stenosis, dobutamine stress echo and calcium score via CT can be valuable tools in distinguishing subtypes, as part of an integrated diagnostic approach, said Christian Frerker (Hamburg), who referred to this issue as “not an unavoidable challenge…but it is unavoidable to look more in depth.”

Younger patients are presented with unique valve choice, explained Michael Borger (Leipzig), with longer term data becoming increasingly valuable. “Structural valve deterioration (SVD) is the Achilles’ heel of bioprosthetic valves,” he said, stressing however that freedom from SVD may be longer than commonly thought. The panel, siding in favour of biological valves in younger patients, noted that treatment planning should incorporate future redo procedures.

Evolutions in technology and data promise to bring more precision to the decision-making process between physicians and patients. To this end, the now-standardised definition of SVD will play a key role in future data comparisons, noted Thomas Sénage (Nantes). However, appropriate statistical models for SVD are crucial, following the tendency of models such as Kaplan-Meier to underestimate SVD complication.

SVD aetiology is multifactorial in nature, explained Bart Meuris (Leuven). Recently interest has regained in valve-related factors such as prosthesis mismatch, valve type and haemodynamic issues. “There is so much R&D to provide more durable tissues to our patients”, he commented.

There is so much R&D to provide more durable tissues to our patients.

One such development in tissue technology is RESILIA, clinical data for which takes shape in the COMMENCE trials in Europe and the US in both aortic and mitral positions. Alongside this, INDURE (the Inspiris Resilia Durability Registry) and INSPIRE (The Inspiris Surgical bioprosthesis Prospective International registry) will evaluate the safety and performance and risk of SVD associated with the novel valve.

Sixty years of Edwards innovation are marked at the 2018 EACTS Annual Meeting in Milan with a lunchtime symposium focused on pathways to breakthrough innovation in cardiac surgery, which seeks to highlight the continuing commitment of innovative surgeons, industry partners, health authorities and patients in bringing about the betterment of standards of care.

The symposium, ‘Pathways to Breakthrough Innovation in Cardiac Surgery’, takes place in Brown 3 between 12:45 and 14:00 on Saturday 20 October.

It comprises a rapid fire session during which selected stakeholders are represented, followed by a debate that forms that core of the proceedings. Central to the talks and debate is the notion of the changing face of innovation: the adoption of new therapies has in the past been principally propelled by experienced, pioneering physicians; today, guidelines and standards of patient safety and device efficacy hold a more prominent role. Nevertheless, early adopters of new technologies continue to be crucial players in assessing new technologies with a view to improving upon the shortcomings of existing therapies.

Early adopters of new technologies continue to be crucial players in assessing new technologies with a view to improving upon the shortcomings of existing therapies.

With unmet patient needs not fully captured by current therapies, clinical literature and guidelines, the adoption of innovative technologies and assessing their benefit is a prominent question. In order to resolve this, an ongoing synergy is demanded between key stakeholders involved in innovation to grant access to new therapies, to define quality standards and education needs in healthcare.

Representing the strategic role of industry during the symposium will be Donald Bobo, Corporate Vice President of Strategy and Corporate Development at Edwards. He will speak of the evolution of industry standards with respect to research and development, quality systems and clinical benchmark trials, as well as discussing the continuing role that the company plays in education and skills training in conjunction with healthcare providers. He will also discuss the role the company plays in balancing investment in innovation with other important factors: identifying patient and healthcare provider’s unmet needs, and ensuring that new technologies are safe, useable, and clinically- and cost-effective.

The Chair of the EACTS New Technology Task Force, Hendrik Treede (Director of the Department of Cardiac Surgery at the Mid-German Heart Center, University Hospital Halle, Saale), will then discuss the historical development of the partnership between industry and medicine, as well as looking to its future and the critical role that surgeons play in shaping this. The EACTS New Technology Task Force develops the programme of the Techno-College, the concept-driven venture presenting the latest technologies under development in the field of cardiovascular medicine.

In an interview ahead of the Annual Meeting, Dr Treede described the changing way in which new concepts are developed and brought into broad clinical use. “Industry plays a very important role,” he said. “If there is no industry partnership it is very hard to make a product out of an idea. If you look at the history of Edwards, this is a company that nicely depicts how this has been done.”

Indeed, the collaboration between engineer Miles Edwards and surgeon Albert Starr that commenced in 1958 led to the creation of the world’s first commercially-available artificial heart valve, the Starr-Edwards, providing the cornerstone of the company and marking a new era in the treatment of valvular heart disease. Since then a great evolution has continued, noted Dr Treede, with the development of Carpentier valve repair techniques, the PERIMOUNT valves, and more recently the promising INSPIRIS valve with the new RESILIA tissue. “These examples nicely prove how solid the cooperation between an industry partner and a developing surgeon can be, and what comes out of that.

“The standard products that we use in basic routine have been developed by surgeons who had great ideas and who got the support they needed from industry. When this happens at eye-to-eye level, then it really prioritises the patient. Edwards is a great example of this working well.”

If you look at the history of Edwards, this is a company that nicely depicts how industry partnership has been done.

Asked how the relationships between different stakeholders has changed, Dr Treede continued: “Today we are more patient- and outcome-driven. We can also offer more individualised medicine, putting the patient’s needs at the centre of our work because we have so many possibilities in treating the patient. This, again, has something to do with the work we have done in the past.

“A surgeon who is very innovative will often work with very small companies and start-up companies. And the cooperation, especially when it comes to practical research, between smaller or larger industry partners and developing physicians has been more intense in the last years than what I remember it being 20 years ago.”

In his concluding remarks, Dr Treede noted the changing role of the surgeon as a key theme of the symposium. “I will be looking into the future where this innovation may end up, and where surgeons can find their role in this whole field,” he said. “Of course hoping that this role is an important one.”

The cooperation between industry partners and developing physicians has been more intense in recent years than what I remember it being 20 years ago.

Following this presentation, Volkmar Falk (German Heart Centre Berlin, Germany) explores whether the CE mark alone is enough to justify adopting a new practice or device, as well as the fundamental role of physicians in the post-market clinical evaluation of new technologies. Cutting-edge technologies in artificial intelligence, robotics and 3D printing are then discussed by Peyman Sardari Nia (Maastricht University Medical Center, the Netherlands).

Christopher Young (Guy’s and St Thomas’ Hospital, and London Bridge Hospital, UK), who co-chairs the symposium alongside Michael Borger (Heart Center Leipzig, Germany), concludes the rapid fire segment with a presentation on the topic of patient power as a way of driving change. Dr Young is Chairman of the patients’ association Heart Valve Voice, which works to improve patient access to appropriate care, as well as driving research and policy in the right direction.

Much lies under the bracket of ‘the patient voice’, including ensured access to appropriate care, and ensuring that patients are both informed and supported. In addition, developing patient-centred outcomes in research and including patients’ priorities in policy formation, are contemporaneous issues.

In an interview ahead of the Annual Meeting, Dr Young explained the need for patient advocacy organisations, and what they achieve: “Heart Valve Voice is designed as a way for patients to voice their concerns about treatment, to maximise treatment benefits, to change the way that people will pay for treatment, and to get fair treatment.

“In the UK, some areas get a lot of treatment while others get very little. And although I am a cardiac surgeon, this has nothing to do with cardiac surgery or cardiology. It is really about improving what we do.”

Heart valve disease affects around 1.6 million people, he explained, an issue “largely unrecognised” in the UK. “Heart Valve Voice is about making sure that, when you get recognised, the system that you go into is the same system that delivers a fair outcome for everybody, not just for the privileged few or those with the right postal code.”

Heart Valve Voice has addressed these issues by a number of different approaches. The organisation has written parliamentary white papers, taken part in parliamentary events and presented at sports and other events, in order to publicise and educate about, for example, the importance of stethoscope checks and the need to raise awareness about of heart valve disease.

We want to stand up for the ones that don’t know as much, to highlight just how much power they have to dictate and change things.

Turning to the topic of his presentation, Dr Young explained how patient empowerment can not only raise standards, but can also drive change in innovation and practice: “Patients have powers they do not realise – certainly in the UK. They go to their doctor and get sent to the local hospital, but they can go anywhere they like in the country. Most of them don’t know that.

“The ones that do know that, get the better care. Some know about keyhole surgery, some know about TAVI. Patients know more and more. We want to stand up for the ones that don’t know as much, to highlight just how much power they have to dictate and change things.

“This symposium is an opportunity to meet and discuss, in an open forum, how we can shape the future.”

“The example I use all the time is this: when I say patients should have keyhole heart surgery, some surgeons will turn around to me and say that keyhole is no better. But, if a patient says to the surgeon that they want keyhole heart surgery and the surgeon says it’s no better, then the patient can ask, ‘Why are you going to make a big hole in me? Why don’t you make a little hole if it is just as good?’ Patients have much more power, because they can persuade doctors. Patients are now better educated, they do their research, they go on the internet. What I want to say is that some patients are very powerful, know an awful lot, and effect change.”

The session as a whole, concluded Dr Young, serves as an opportunity to discuss how patient safety can be maintained when new technology is introduced. Another important balancing act, he added, lies in ensuring the timely development of surgeon’s skills to meet new technologies. “Patient associations and charities, such as Heart Valve Voice, are increasingly powerful, and their role will no doubt feature in these conversations,” he noted. “This symposium is an opportunity to meet and discuss, in an open forum, how we can shape the future.”

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Reference:
EACTS Daily News, Issue 2 Friday 19 October 2018, page 6-7.

Dr Emiliano Rodríguez-Caulo (Malaga, Spain) and Dr. Manuel Carnero Alcázar (Madrid, Spain) presented the results of two studies comparing the long-term survival (10─15 year follow-up) and MACCE outcomes (30-day mortality, stroke, valve-related reoperation and major bleeding) of patients treated with bioprosthetic and mechanical valves.The use of bioprostheses is increasing in surgical aortic valve replacement (sAVR), due to innovation in bioprosthetic valve design to extend durability and improve long-term outcomes. However current ESC/EACTS guidelines recommend that mechanical prostheses are utilized in patients <60 years. In the past there has been conflicting evidence regarding the long-term patient survival following bioprosthetis sAVR. However, recent studies suggest that in younger patients (>55 years) survival is comparable among patients treated with bioprosthetic or mechanical valves.

Summary of abstracts^1,2

In a retrospective multicenter Andalusian study presented by Dr Emiliano Rodríguez-Caulo¹ 1443 patients with isolated sAVR from 2000─15.

• Propensity-score matching (PSM; 2:1) was used to compare outcomes in patients aged 50─65 years, treated with mechanical (n=506) and bioprosthetic valves (n=257).
• Patients were excluded with concomitant surgery, reinterventions, endocarditis or alternative residency.
• Following PSM, there were no significant differences between mechanical and bioprosthetic vales on the survival of patients particularly between 55 and 65 years old at 15-year follow-up.
• Patients treated with mechanical valves were more likely to experience major bleeding or bleeding/transfusion, whereas patients treated with bioprostheses were more likely to experience prosthesis reoperation (most commonly due to an ischemic event).
• No differences in early mortality, MACCE or component endpoints were found.

In a similar study, Dr. Manuel Carnero Alcázar² presented a study of patients following sAVR ± coronary artery bypass graft from 2005─17.

• Patients with prior surgery, endocarditis or a need for any other surgical procedure were excluded.
• Survival was compared over 10-years of follow-up according to prosthesis type (mechanical versus bioprosthesis), and age category (<55, 55─65, 65─75 and >75 years).
• Irrespective of age group, patient survival at 10-year follow-up was similar in patients treated with mechanical or bioprosthetic valves.
• Risk of mortality was increased in patients >65 years (versus < 55 years) and in those with (versus without) prior peripheral arterial disease, chronic obstructive pulmonary disease and NYHA class III and IV, chronic kidney disease, LVEF <50%, and pulmonary artery systolic pressure > 55 mmHg.

In summary, these studies provide further evidence to support the rationale that cardiologist/surgeons  should be given the choice of whether to opt for a bioprosthetic or a mechanical valve in patients <60 years old based on patient preference and co-morbidities. In doing so it also highlights a need for a review of the current ESC/EACTS recommendations.

More information and abstract available in the EACTs Scientific Programme.

References:

1. Rodriguez-Caulo E, Macías Rubio D, Adsuar A, Ferreiro-Marzal A, Arias Dachary F.J, Parody Cuerda G, Fernández-Sáenz F. Fifteen years outcomes following bioprosthetic versus mechanical isolated aortic valve replacement for aortic stenosis in patients aged 50 to 65 years: The Andalousian aortic valve multicentric study (ANDALVALVE). Presented at 32^nd EACTS Annual Meeting, Milan, Italy, 18─20 October 2018. Accessed on 21^st September, 2018.
2. Carnero Alcázar M, Villagran E, Cobiella J, Alswies A, Ramchandani B, Cristóbal Castañón J. L, Torres Maestro B, Maroto L. Long term survival after mechanical or tissue aortic valve replacement. Presented at 32^nd EACTS Annual Meeting, Milan, Italy, 18─20 October 2018. Accessed on 21^st September, 2018.

Several studies have suggested that patient survival is reduced if patient-prosthesis mismatch (PPM) occurs following surgical aortic valve replacement (sAVR). However, there is conflicting evidence and further investigations are warranted to determine the factors associated with poorer survival with PPM , e.g. preoperative risk factors or measures of PPM (effective orifice area [EOA] and geometric orifice area [GOA]). Dr Severin Semsroth (Innsbruck, Austria) and Dr Márcio Madeira (Lisbon, Portugal) presented the results of two studies designed to bridge this knowledge gap.

Summary of abstracts^1,2

Dr Severin Semsroth,¹ presented a study that utilized a cohort of 1284 patients following isolated sAVR (excluding those with endocarditis or subsequent surgery) from 2001─16.

• Patients were matched using a propensity-score analysis according to 10 preoperative risk factors.
• 238 matched pairs of patients with and without PPM were assessed at 10 year follow-up. Prior to propensity score matching (PSM) the preoperative risk factors of the patient cohorts were compared.
• The comparison illustrated that a higher proportion of patients with PPM versus no PPM were >75 years old, female, obese, with NYHA III/IV and aortic stenosis and without impaired creatinine clearance.
• Interestingly, patients with PPM had a significantly lower survival than those without.
• However this difference was absent following PSM. These findings suggested that in isolation, PPM does not impact long-term survival, however this cohort is at greater risk of poor survival due to a greater accumulation of preoperative risk factors.

Dr Márcio Madeira,² presented results from a single center retrospective study of PPM in 812 patients following isolated sAVR from 2007─2016.

• In this study the relation between indexed GOA (iGOA; calculated from the manufacturer orifice area and body surface area) and short and long-term survival, as well as predictors of poor outcome, were investigated in patients following isolated sAVR with 10-year follow-up data for all-cause mortality.
• This study focused on biological prostheses (n=812), excluding patients treated with mechanical prostheses and those with subsequent surgery, endocarditis, sutureless and stentless prostheses and those treated with a prosthesis larger than 25 mm (n=684).
• The results of the study showed that following sAVR with bioprostheses, patient survival at 10-year follow-up was significantly lower in those with moderate PPM.
• Early predictors of an increased likelihood of mortality or the composite MACCE endpoint (all-cause mortality, stroke and myocardial infarction) were extracardiac arteriopathy and pulmonary disease/heart failure, respectively.
• While iGOA did not predict early survival or MACCE, at 4.5 years a higher iGOA was associated with higher likelihood of survival.

Taken together, these recent studies support previous results that suggested that long-term survival is reduced in patients with PPM. Earlier identification of patients with PPM, and those at greatest risk of developing PPM, may help improve survival of patients following sAVR.

More information and abstract available in the EACTs Scientific Programme.

References:

1. Semsroth S, Dumfarth J, Kofler M, Sommerauer F, Matteucci-Gothe R and Grimm M. Prosthesis-patient mismatch does not effect long-term survival in surgical aortic valve replacement – a propensity score matched analysis. Presented at 32^nd EACTS Annual Meeting, Milan, Italy, 18─20 October 2018. Accessed on 21^st September, 2018.
2. Madeira M, Ranchordás S, Oliveira P, Nolasco T, Marques M, Sousa Uva M, Abecasis M, Neves J. Patient prosthesis mismatch in biologic aortic prosthesis: ten years results. Presented at 32^nd EACTS Annual Meeting, Milan, Italy, 18─20 October 2018. Accessed on 21^st September, 2018.