Transcatheter Heart Valve Interventions

Where Are We? Where Are We Going?

Bernard D. Prendergast; Helmut Baumgartner; Victoria Delgado; Olivier Gérard; Michael Haude; Anders Himmelmann; Bernard Iung; Matthew Leafstedt; Jasmine Lennartz; Francesco Maisano; Elena Andreassi Marinelli; Thomas Modine; Markus Mueller; Simon R. Redwood; Olaf Rörick; Cherif Sahyoun; Erika Saillant; Lars Søndergaard; Martin Thoenes; Karen Thomitzek; Marion Tschernich; Alec Vahanian; Olaf Wendler; Evelyn Julia Zemke; Jeroen J. Bax

Disclosures

Eur Heart J. 2019;40(5):422-440. 

In This Article

Abstract and Introduction

Abstract

Transcatheter heart valve interventions have transformed the outcomes of patients with valvular heart disease (VHD) who are unfavourable candidates for surgery. Technological advances have allowed extension of these interventions to younger or lower risk patients and those with other forms of VHD and may in the future permit earlier treatment of VHD in less symptomatic patients or those with moderate disease. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of transcatheter technology in these groups. As academic researchers, clinicians, industry, and patient stakeholders collaborate to research these broader indications for transcatheter valve interventions, it is essential to address (i) device durability and deliverability, (ii) specific anatomical needs (e.g. bicuspid aortic valves, aortic regurgitation, mitral and tricuspid valve disease), (iii) operator training, and (iv) the reinforced importance of the multidisciplinary Heart Team.

Introduction

Transcatheter valve interventions have transformed the management of valvular heart disease (VHD), especially for elderly patients at high surgical risk, and the European Society of Cardiology (ESC) and European Association of Cardiothoracic Surgery (EACTS) issued guidelines in 2017[1] for their application in clinical practice. The field has rapidly evolved since introduction of the first CE marked transcatheter aortic valve implantation (TAVI) devices in 2007[2] (Figure 1)[3,4] and ongoing studies are exploring extension of this technology to lower risk aortic stenosis (AS) patients and other forms of VHD.

Figure 1.

Overview of current transcatheter aortic valve implantation technology. (A) Edwards Lifesciences Sapien 3 Valve (Edwards Lifesciences, Irvine, CA, USA); (B) Medtronic CoreValve Evolut R (Medtronic, Minneapolis, MN, USA); (C) Symetis Acurate neo Valve [Symetis (now owned by Boston Scientific), Ecublens VD, Switzerland]; (D) JenaValve (JVT Research & Development Corporation, Irvine, CA, USA); (E) St. Jude Medical Portico Valve (St. Jude Medical, St. Paul, MN, USA); (F) Direct Flow Medical Valve (Direct Flow Medical, Inc., Santa Rosa, CA, USA); (G) Medtronic Engager Valve (Medtronic, Minneapolis, MN, USA); and (H) Boston Scientific Lotus Valve (Boston Scientific, Marlborough, MA, USA). F and G are no longer commercially available. Reprinted with permission from Vahl et al.4

Leaders in the field must consider unmet clinical needs, device safety, and optimal research approaches to address the desired outcomes of patients with VHD. Collaboration among researchers, clinicians, industry partners (including device, imaging, and pharmaceutical companies), regulators, payers, and patient organizations is critical. Accordingly, the ESC Cardiovascular Round Table (CRT) convened a dedicated workshop in October 2017 to (i) discuss the innovations and successes of transcatheter valve intervention, (ii) identify areas of unmet need and new indications, (iii) consider approaches to reinforce the importance of the Heart Team and expand patient access to Heart Valve Centres. Herein, we summarize the key outputs from this workshop.

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