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Device innovation in cardiovascular medicine

Location: Royaumont Abbey, Asnières-sur-Oise (Paris, France)

22/11/2022 09:00 22/11/2022 16:00 Europe/Paris Device innovation in cardiovascular medicine

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A plenary meeting chaired by Prof. Stephan Windecker, Prof. Martine Gilard, Dr. Marta Santiuste (Bayer), Dr. Pieter Kappetein (Medtronic), Dr. Jana Kurucova (Edwards LifeSciences), and Mr Mark Perkins (GE Healthcare).

Session 1

Session 2

Session 3

Session 4

Session 5

Session 6



Background and objectives of the meeting

The growing elderly population worldwide represents a major challenge for care-givers, healthcare providers and politicians.

The Autumn 2022 edition of the ESC Cardiovascular Round Table centers around the topic “Device Innovation in Cardiovascular Medicine”. In addition to major advances in the pharmacological treatment of cardiovascular diseases, implantable devices play a pivotal role and have contributed immensely to address unmet needs and improve outcomes of deadly cardiovascular disease manifestations.

The advent of primary percutaneous coronary intervention as default therapy in patients with acute myocardial infarction has significantly improved survival and reduced the risk of reinfarction. Temporary and permanent cardiac assist devices represent important therapeutic strategies, both in patients with acute and chronic end-stage heart failure. Transcatheter aortic valve implantation has been established as alternative to surgical aortic valve replacement across the entire spectrum of surgical risk providing similar or superior outcomes to conventional surgery while being associated with important patient-related outcome benefits such as a less invasive procedure resulting in shorter hospital stays and faster return to everyday activities. Similarly, transcatheter therapies of secondary mitral valve regurgitation provide important benefits beyond foundational drug therapy in heart failure patients. Implantable cardioverter defibrillators and resynchronization devices have been proven life-saving and important adjunct treatments in patients with heart failure. Ablation therapies for supraventricular and ventricular rhythm disturbances have become the dominant therapy in patients with arrhythmias due to limited drug therapy success.

While these examples serve to illustrate the benefit of modern cardiovascular device therapies, the purpose of the ESC CRT 2022 is to highlight recent opportunities, emerging fields and trends, preclinical and clinical evaluation of devices, changes in regulatory requirements and importantly patient’s perspective. As such we use the example of TAVI to illustrate how an intervention pioneered in Europe led to a paradigm shift in the treatment of patients with severe, symptomatic aortic stenosis. In parallel to device advances there have been important improvements in imaging, both in the coronary and valvular field, with growing importance of multimodality imaging as well as imaging guidance.
We will discuss the importance of novel imaging technology and the advent of artificial intelligence to guide device interventions and improve outcomes. Smart devices will be yet another topic to be discussed and will provide a look into the future of diagnostic and therapeutic device capabilities in cardiovascular medicine. The advances in device innovation are accompanied by thorough preclinical and clinical investigations, and we will discuss the value of meaningful clinical endpoints and the role of real world evidence. Similarly, device evaluation and oversight in analogy to pharmacological agents require regulatory oversight and guidance providing an opportunity to exchange between clinical investigators, regulators and industry. Finally, patient related outcomes and patient’s perspective will be addressed in the context of cardiovascular devices.

Innovation is central to the future advance of cardiovascular health care and in view of the dynamic milieu in Europe having been the cradle of percutaneous coronary intervention (first PCI in Zurich 1977) and TAVI (first TAVI in Rouen in 2002), we hope that this meeting will provide important inputs and discussion points.


22 November 2022 – 09:00 - 16:00

09:00 - 09:10

Welcome from the CRT chairpersons

Introduction and objectives of the meeting

Prof. Thomas Luescher (ESC President-Elect) and Prof. Alexandra Goncalves (Philips)

Prof. Martine Gilard and Prof. Stephan Windecker

09:10 - 09:40

Session I – Medical device innovation in Europe – 20 years of TAVI
A look backwards, a look forward


Prof. Alain Cribier, Rouen   

Prof. Hélène Eltchaninoff, Rouen

09:40 - 09:55


09:55 - 10:10

Session II - Patient perspective

Inga Drossart (ESC Patient Forum)

10:10 - 10:25


10:25 - 11:15

Session III – Innovation in imaging in medical devices

10:25 - 10:40

Imaging overview and introduction

Dr. Victoria Delgado (Barcelona)

10:40 - 10:55

Imaging fusion and ICE

Prof. Ralph Stephan von Bardeleben (Mainz)

10:55 - 11:10

Artificial Intelligence and imaging

Prof.  Eigil Samset (GE Healthcare)

11:00 - 11:25


11:25 - 11:40

Coffee Break

11:40 - 11:55

Session IV – Smart devices

Prof. Gerhard Hindricks (Leipzig)

11:55 - 12:10


12:10 - 12:55


12:55 - 13:30


13:30 - 13:45

Session V – The changing regulatory environment and impact on innovation in Europe

13:30 - 13:45

An industry perspective

John Kilmartin (Medtronic) and Nataliya Deych (Edwards)

13:45 - 14:00

A perspective from a Notified Body                                                       

Dr Richard Holborow (UK)

14:00 - 14:15

Regulatory challenges and tools

Dr Donal O'Connor (Ireland)

14:15 - 14:30


14:30 - 15:45

Session VI – Regulatory – Future of device innovation in Europe

14:30 - 14:45

Device evaluation in Europe to date

Prof. Alan Fraser (Cardiff)

14:45 - 15:00

Meaningful clinical endpoints and QoL-RWE and RCTs

Dr. Roxana Mehran (New York, via Zoom)

15:00 - 15:45

General discussion

15:45 - 16:00

Concluding remarks - Next steps – A publication