Long-term durability of transcatheter aortic valve replacement: outcomes from a contemporary cohort from a tertiary reference center at 5-years and beyond
Authors: Sa Mendes G , Lopes P , Campante Teles R , Araujo Goncalves P , Raposo L , Abecasis J , Brito J , Nolasco T , Madeira M , Felix Oliveira A , Goncalves M , Mendes M , Sousa Almeida M ,   UNICARV
Published: October 2021

Abstract

Background and aim
Long-term data on the durability of transcatheter heart valves is scarce. This is of particular interest as indications expand to younger and lower surgical risk patients. We sought to assess the incidence of long-term structural valve dysfunction (SVD) and bioprosthetic valve failure (BVF) in a cohort of patients with TAVR who reached at least 5-year follow-up, as compared to surgical aortic valve replacement (SAVR), performed within the same time-frame at the same institution.

Methods and results
Consecutive patients with at least 5-year available follow-up, who underwent TAVR between November 2008 to December 2015 in a tertiary single center, were included. From a group of 246 patients undergoing TAVR, 126 had available follow-up data (age at implantation: 83.0 [77.8–87.0] years; EuroScore II: 4.54 [2.60–6.29]%; follow-up: 5.94 [5.06–7.67] years). First generation Corevalve® and Sapien® prosthesis were implanted in 56% and 38% patients, respectively.
SVD and BVF were defined according to the new consensus statement from the EAPCI endorsed by the ESC and the EACTS. Mean transaortic pressure gradients decreased from 53.2±1.3 mmHg (pre-TAVR) to 10.4±0.4 mmHg (at discharge or up to one-year after TAVR, p&lt;0.001), and there was a small non-significant increase at the fifth-year and the last available follow-up (11.2±0.6 mmHg; 14.7±1.8 mmHg, respectively). Moderate and severe SVD were reported in 12 and 4 patients, respectively (8-year cumulative incidence function to SVD: 2.67%; 95% CI, 2.12–3.89). Of these 8 had BVF, 7 of them with hospitalization for acute heart failure. A total of 4 patients died and none required reintervention (redo TAVR or SAVR). BVF for non-SVD were observed in 4 patients (2 subclinic thrombosis successfully treated with anticoagulation and 2 paravalvular regurgitation due to endocarditis).
As comparator, from a cohort of 587 patients submitted to biological SAVR, 247 (age 75.0 [70.0–79.0] years; EuroScore II 1.43 [1.06–2.17]%) had available long-term follow-up (6.89 [6.08–8.19] years). Moderate and severe SVD were reported in 42 and 3 patients, respectively (8-year cumulative incidence function to SVD: 3.13%; 95% CI, 2.45–4.21). These events were clinically relevant (BVF) in 19 of them: 8 performed TAVR valve-in-valve procedures and 3 redo SAVR. At the fifth-year of follow-up the incidence of SVD was not statistically different between TAVR (8%) and SAVR (15%), with a p for comparison of 0.137.

Conclusions
In our population of patients with symptomatic severe aortic stenosis treated with first-generation percutaneous bioprostheses, TAVR was associated with a low incidence of BVF and SVD at the long-term follow-up. These outcomes seem indistinct from those occurring in patients submitted to conventional SAVR

Funding Acknowledgement
Type of funding sources: None. KM curve reporting probability of SVD