Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table
Por:
Windecker, S, Gilard, M, Achenbach, S, Cribier, A, Delgado, V, Deych, N, Drossart, I, Eltchaninoff, H, Fraser, AG, Goncalves, A, Hindricks, G, Holborow, R, Kappetein, AP, Kilmartin, J, Kurucova, J, Lüscher, TF, Mehran, R, O'Connor, DB, Perkins, M, Samset, E, von Bardeleben, RS and Weidinger, F
Publicada:
1 abr 2024
Ahead of Print:
1 feb 2024
Resumen:
Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.
Graphical Abstract European investigators have had a pioneering role in the history of cardiovascular device innovation and will continue to do so. AF, atrial fibrillation; AS, aortic stenosis; BAV, balloon aortic valvuloplasty.
Filiaciones:
Windecker, S:
Univ Bern, Bern Univ Hosp, Inselspital, Dept Cardiol, Freiburgstr, CH-3010 Bern, Switzerland
Gilard, M:
Hosp La Cavale Blanche, Dept Cardiol, La Cavale Blanche Hosp Blvd Tanguy Prigent, F-29200 Brest, France
Achenbach, S:
Friedrich Alexander Univ Erlangen Nurnberg FAU, Dept Cardiol, Erlangen, Germany
Cribier, A:
Univ Rouen Normandie, Dept Cardiol, Inserm U1096, F-76000 Rouen, France
:
Univ Hosp Germans Trias & Pujol, Dept Cardiol, Badalona, Spain
Deych, N:
Edwards Lifesci, Edwards Lifesciences, Nyon, Switzerland
Drossart, I:
ESC Patient Forum, Sophia Antipolis, France
Eltchaninoff, H:
Univ Hosp Charles Nicolle, Dept Cardiol, Rouen, France
Fraser, AG:
Univ Hosp Wales, Dept Cardiol, Cardiff, Wales
Goncalves, A:
Precis Diagnost, Philips, Cambridge, MA USA
Univ Porto, Fac Med, Med Sch, Dept Surg & Physiol, Porto, Portugal
Hindricks, G:
German Heart Ctr Berlin, Dept Cardiol, Berlin, Germany
Holborow, R:
British Stand Inst, Global Compliance, Whitchurch, England
Kappetein, AP:
Medtron Bakken Res Ctr, Maastricht, Netherlands
Kilmartin, J:
Medtronic, Medtron, Galway, Ireland
Kurucova, J:
Edwards Lifesci, Edwards Lifesciences, Nyon, Switzerland
Lüscher, TF:
Imperial Coll London, Royal Brompton Hosp, London, England
Harefield Hosp, London, England
Imperial Coll, London, England
Kings Coll London, London, England
Univ Zurich, Ctr Mol Cardiol, Zurich, Switzerland
Mehran, R:
Mt Sinai Hosp, Icahn Sch Med, New York, NY USA
O'Connor, DB:
Hlth Prod Regulatory Author HPRA, Dublin, Ireland
Perkins, M:
GE Healthcare Cardiol Solut, Harrogate, England
Samset, E:
GE Healthcare Cardiol Solut, Oslo, Norway
Univ Oslo, Dept Informat, Oslo, Norway
von Bardeleben, RS:
Univ Med Ctr, Heart Valve Ctr, Dept Cardiol, Mainz, Germany
Weidinger, F:
Klin Landstr, Med Dept Cardiol & Intens Care Med 2, Vienna, Austria
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