Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis

Abstract

Aims In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). Methods and results Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4–6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan–Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1–4.3%] and 1.6% (95% CI 0.6–3.9%), respectively, while late BVF was 2.5% (95% CI 1.2–5%). Conclusion While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

“…In terms of all-cause mortality, we found no significant differences between the IA and the SA group. This finding is consistent with previous publications reporting a survival after TAVR of 23.2% at 7 years ( 9 ), and 22–27% at 8 years ( 10 , 11 ). Our results extend the 5-year analysis of the CHOICE randomized trial ( 4 ), suggesting that long-term mortality is largely determined by advanced age and comorbid conditions rather than the TAVR leaflet design.…”

Durability of Transcatheter Heart Valves: Standardized Definitions and Available Data

“…Even though the definition on SVD seems to be a widely accepted part of the EAPCI definition of BVD, there are still some noticeable deviations. Some authors are using invalid definitions of SVD, since they extend the time of baseline measurement [ 22 ] and combine different entities to define SVD [ 22 , 24 ]. None of the studies commented on morphological changes although these are fundamental in the recognition of SVD [ 7 ].…”

Design Variation, Implantation, and Outcome of Transcatheter Mitral Valve Prosthesis: A Comprehensive Review

“…Durability is of concern, especially for transcatheter devices to be implanted in younger patients. Studies in aortic valves that examined the durability between transcatheter and surgical prosthetic valves suggest that the durability of both approaches is comparable ( 75 ). All of the TMVI devices in the review used bovine and porcine pericardial tissue leaflets.…”