ArticleClinical research in cardiology : official journal of the German Cardiac Society2019
One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Temporal trends in TAVI outcomes: experience from an Irish tertiary referral centre.Irish journal of medical science · 2025Article
- Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months.Journal of patient-reported outcomes · 2025Observational
- Multiparametric Outcome Assessment After Transcatheter Aortic Valve Implantation-A Systematic Review.Journal of clinical medicine · 2025Review
- Adaptation of Aortic Bioprosthetic Valves for Pulmonary Position: Comparative Analysis of Transcatheter and Surgical Valves.Journal of cardiovascular translational research · 2024Article
- Determinants and treatments of heart failure after transcatheter aortic valve implantation: moving up a notch.ESC heart failure · 2023Review
- Left ventricular stroke volume index following transcatheter aortic valve replacement is an early predictor of 1-year survival.Clinical cardiology · 2023Article
- Post-Transcatheter Aortic Valve Replacement (TAVR) Vascular Complications: Femoral Artery Minimal Surgical Access Versus Percutaneous Approach.Journal of the Saudi Heart Association · 2022Article
- A novel endovascular treatment for transcatheter aortic valve embolization.Journal of vascular surgery cases and innovative techniques · 2021Article
- Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Article
- Review
- Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography.Interactive cardiovascular and thoracic surgery · 2021Article
- Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Article
- Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Article
- Kidney injury as post-interventional complication of TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Review
- Periprocedural embolisation of a Sapien 3 TAVI prosthesis: failure and success.Clinical research in cardiology : official journal of the German Cardiac Society · 2020Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
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%).
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