Valve Durability (TAVI) Registry

Objectives

This registry will provide key information for clinicians, patients and regulators concerning the durability of different TAVI prostheses (including earlier iterations of contemporary devices).

• Primary objective: to determine the durability of TAVI devices (including detailed imaging evaluation) in patients whose valves were implanted ≥5 years ago.
• Secondary objective: to provide systematic follow-up of a large cohort of younger patients (<80years) following TAVI.

Join the registry

Important: The end of enrollment is planned on the 31 December 2020 so any new site needs to obtain the ethics approval before this date in order to enroll patients. 

Why do we need a valve durability registry in Europe?

TAVI (Transcatheter Aortic Valve Implantation) is now established as the preferred treatment option for patients with symptomatic severe aortic stenosis at prohibitive or high surgical risk. Its application is increasingly supported by an accumulating evidence base in patients at intermediate and low risk.  TAVI numbers already exceed those of surgical aortic valve replacement (SAVR) in many European nations.

As contemporary indications for TAVI shift to lower risk subjects (who are typically younger than those represented in early landmark trials), the issue of valve durability becomes increasingly important.

Lessons from surgical series suggest that structural valve deterioration (SVD) occurs more rapidly in younger patients. If SVD determines severe haemodynamic and/or morphological dysfunction, the important issue rises of how to handle bioprosthetic valve failure (BVF) in a TAVI patient with recurrent symptoms and worsening prognosis. Although implantation of a second valve is feasible, it is important to confirm that the durability of transcatheter heart valves is comparable to that of existing surgical bioprosthetic valves.

THV (transcatheter heart valve) durability is therefore a knowledge gap and a barrier to the further clinical application of TAVI. If the lifetime of a TAVI prosthesis is relatively long then the rationale for expanding application to younger and low risk patients is reasonable.

Since the first TAVI procedure performed in 2002, application has spread rapidly, to an extent that many European TAVI centres have now acquired more than five years experience. Since patients who were offered TAVI at the time of early inception were typically old and frail, their survival beyond five years is limited as a result of comorbidities (regardless of whether SVD occurred or not). This issue is a crucial limitation when long-term outcomes of TAVI are reported. Death exerts a competing risk against the reporting of SVD and many reports of TAVI durability are flawed, particularly with respect to the low number of patients at risk beyond five years.

Aims of the analysis

Valve performance at enrollment

• Rates of SVD, NSVD and BVF according to EAPCI/ESC/EACTS definitions
  (cumulative incidence of SVD, NSVD, thrombosis, endocarditis and BVF in patients who underwent TAVI in 2014 and beforehand).
• Morphological and hemodynamic valve performance at different time intervals (>5 years) following TAVI.

Valve durability in younger patients

• Actuarial freedom from SVD and BVF according to EAPCI/ESC/EACTS definitions.
• Actuarial freedom from definite endocarditis or thrombosis.
• Death and rehospitalisation.
• Morphological and hemodynamic valve performance at different time intervals (up to 10 years) following TAVI in patients aged <80 years.

Study Organisation

The study is centre-based, with an Executive Committee and Scientific Committee. 

The two chairpersons are Ana Sonia Petronio and Bernard Prendergast.

Executive Committee

Ana Sonia Petronio (Italy) – Registry Chairperson
Bernard Prendergast (UK) – Registry Chairperson
Michael Haude (Germany)
Stephan Windecker (Switzerland)
Andreas Baumbach (UK)
Helene Eltchaninoff (France)
Alec Vahanian (France)
Davide Capodanno (Italy)
Thomas Modine (France)
Jeroen Bax (The Netherlands)
Lars Sondergaard (Denmark)
Peter Ludman (UK)
Aldo Maggioni (Italy, EORP Scientific Coordinator)

Scientific Committee

Anna Sonia Petronio (Italy) - Chairperson
Bernard Prendergast (UK) - Chairperson
Davide Capodanno (Italy)
Cristina Giannini (Italy)
Gabor Toth (Austria)
Stefanie Shupke (Germany)
Aldo Maggioni (Italy)