Abstract
AimsTo evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints “clinical efficacy after 30 days” and “time-related valve safety” proposed by the updated Valve Academic Research Consortium (VARC-2).Methods and resultsFour hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCORE I was 12% [8–19]. Device success was achieved in 93% (374/402) with moderate or severe paravalvular leakage (PVL) in 2%. At 1 year all-cause mortality was 8.9% [95% CI 6.4–12.2] and new permanent pacemaker implantation rate was 16% [95% CI 12.7–20.4]. The composite endpoint time-related valve safety occurred in 29% with structural valve deterioration, defined as elevated gradients or more than moderate PVL, occurring in 13%. The clinical efficacy endpoint after 30 days was observed in 37% of patients with the main contributor symptom worsening with New York Heart Association functional class III + in 17% of cases.ConclusionsFor the first time, VARC-2-defined composite endpoints at 1 year are reported and reveal a considerable proportion of patients experiencing the endpoint of time-related valve safety (29%) and clinical efficacy after 30 days (37%).
Highlights
Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic stenosis in patients at intermediate or high risk for conventional surgical aortic valve replacement [1, 2]
We report 1-year outcome of a large cohort of patients treated with the SAPIEN 3 (S3)-transcatheter heart valves (THV) at a single centre using VARC-2 criteria and for the first time report the composite endpoints at 1 year
Device success was achieved in 93% with paravalvular leakage (PVL) II + occurring in 2% (Table 2 depicts individual contributors of device success)
Summary
Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic stenosis in patients at intermediate or high risk for conventional surgical aortic valve replacement [1, 2]. With increasing operator experience, improved patient selection and continuous evolution of transcatheter heart valves (THV) and refinement of delivery systems a considerable improvement in outcome has been achieved with a reduction in 1-year mortality from 24% with older generation THV [3] to 12% with newer generations [2]. Clinical results of the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial have shown low 30-day mortality and low rates of stroke or paravalvular leakage (PVL) with the S3-THV [6]. The available 1-year data on this THV is limited by the fact that no study has evaluated outcomes according to the updated definitions proposed by the valvular academic research consortium (VARC-2) [9]. We report 1-year outcome of a large cohort of patients treated with the S3-THV at a single centre using VARC-2 criteria and for the first time report the composite endpoints at 1 year
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
