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Davide Capodanno, Anna S Petronio, Bernard Prendergast, Helene Eltchaninoff, Alec Vahanian, Thomas Modine, Patrizio Lancellotti, Lars Sondergaard, Peter F Ludman, Corrado Tamburino, Nicolò Piazza, Jane Hancock, Julinda Mehilli, Robert A Byrne, Andreas Baumbach, Arie Pieter Kappetein, Stephan Windecker, Jeroen Bax, Michael Haude, Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 38, Issue 45, 01 December 2017, Pages 3382–3390, https://doi.org/10.1093/eurheartj/ehx303
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Introduction
Despite continuing efforts during the last decades, there is no ‘ideal prosthetic valve substitute’. Every valve prosthesis invokes new pathophysiological processes, including the risks of thromboembolism, prosthetic endocarditis, and structural valve deterioration (SVD) or non-structural valve deterioration with consequent need for reintervention (Figure 1). Bioprostheses are now increasingly used in preference to mechanical valves in the aortic position but valve dysfunction may occur over time. The literature concerning surgical prostheses has taught us that bioprosthetic valve dysfunction is a complex phenomenon whose understanding requires more than the reporting of reintervention. Further research must encompass biological, pathological and haemodynamic mechanisms, use of contemporary non-invasive imaging, evaluation of the true incidence while avoiding methodological pitfalls, and identification of clinical, technical, and prosthesis-specific predictors.
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Since introduction in 2002 and broader clinical use in 2007, penetration of transcatheter aortic valve implantation (TAVI) has grown exponentially as a result of accruing evidence demonstrating safety and efficacy, and reduced invasiveness compared with surgery. TAVI is now the recommended therapy in elderly patients with aortic stenosis who are inoperable or at increased surgical risk1 and recent evidence has demonstrated at least its equivalence to surgery in intermediate and high-risk cohorts.2–4 However, our knowledge concerning the clinical outcomes of TAVI beyond 5 years is still limited. Although SVD is likely to be the main mechanism of bioprosthetic valve dysfunction in the longer term, definitions of SVD vary and follow-up studies are scarce. While it is possible to draw lessons from longer term experience with surgical bioprostheses, there are fundamental differences between TAVI and surgical aortic valve replacement (SAVR) (i.e. remaining valve calcification, mechanical stress, crimping of the valve tissue, valve leaflet geometry, balloon expansion or dilation, differences in haemodynamic profile, and patient-prosthesis mismatch), which may impact on the natural history of SVD (see Supplementary material online, Appendix). Critically, extended knowledge of the durability of TAVI is essential as we enter the time (>5 years after implantation) when SVD starts to occur in surgical bioprostheses. This knowledge assumes even greater importance as we consider expanding the indications for TAVI to lower risk and younger patients. As such, standardizing the definitions of valve- and patient-oriented durability outcomes is of paramount importance to enable objective evaluation of existing and novel TAVI prostheses, and their comparative efficacy vs. SAVR.
