Redo-Transcatheter Aortic Valve Implantation (Redo-TAVI)-Pilot Study from Multicentre Nationwide Registry

再次经导管主动脉瓣置换术(Redo-TAVI)——来自全国多中心注册研究的试点研究

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Abstract

Objectives: The aim of this study is to evaluate the safety and efficacy of repeat transcatheter aortic valve implantation (redo-TAVI) in the polish population. Methods: In this multicentre nationwide registry (ClinicalTrials.gov identifier, NCT03361046), we provide characteristics, periprocedural variables and long-term outcomes of high-risk patients who underwent redo-TAVI. Results: The mean age among 32 individuals who underwent redo-TAVI was 75 ± 13 years, and 62.5% were male. The mean time from index TAVI to redo-TAVI was 4.7 ± 3.5 years, with failed procedures (up to 1 year) occurring in 7 (21.9%) and failed transcatheter heart valve (THV, beyond 1 year) in the remaining majority of the 25 (78.1%) patients. Computed tomography-based native bicuspid aortic anatomy was found frequently in 37.5% of cases (58.3% in failed procedures and 41.7% in failed THV). The mean failed THV size was large (27.7 ± 3 mm) and predominantly presenting with pure regurgitation (59.4%). In more than two-thirds (68.7%), balloon-expandable or self-expandable THV was the most common strategy of redo-TAVI. None or mild regurgitation was found in 90.6%, and the mean transvalvular gradient was 13.1 ± 5.5 mmHg, with only three cases with >20 mmHg of the residual gradient (9.4%). Peri-procedural and 30-day complications were low, and cardiovascular and all-cause mortality at 1 year was 9.4 and 15.6%, respectively. There was a relatively high incidence of non-procedural stroke after redo-TAVI (n = 5, 15.6%), with all cases observed after 30 days. Conclusions: Initial data of redo-TAVI in Poland suggest that the procedure is safe and characterized by favourable efficacy and low rates of short-term adverse outcomes. A high frequency of baseline native bicuspid anatomy and late stroke occurrence after the redo-procedure warrants further investigation in larger cohorts.

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