Cardiovascular revascularization medicine : including molecular interventions · 2024
Transcatheter aortic valve replacement with corevalve self-expanding bioprosthesis: Clinical and durability data up to 12 years.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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История · было → стало
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Testa Luca, Giannini Cristina, Costa Giulia, Fiorina Claudia, Adamo Marianna, Massussi Mauro, Bruschi Giuseppe, Merlanti Bruno, Montorfano Matteo, Bellini Barbara, Poli Arnaldo, Ferrara Erica, Sisinni Antonio, Squillace Mattia, De Felice Francesco, Musto Carmine, Mazzapicchi Alessandro, Brambilla Nedy, Palmerini Tullio, De Carlo Marco, Bedogni Francesco
Аннотация
BACKGROUND AND AIMS: Transcatheter aortic valve replacement (TAVR) determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis but data on very long-term durability are lacking. We sought to evaluate the clinical and hemodynamic outcomes of the CoreValve porcine pericardial self-expanding bioprosthesis at 12-year follow-up.
METHODS: 882 inoperable or high-risk patients were treated with the CoreValve bioprosthesis in 8 Italian high-volume centers between 2007 and 2011. The endpoints were 12-year all-cause and cardiovascular mortality, and Cumulative Incidence Functions (CIFs) for severe Structural Valve Deterioration (SVD), Bioprosthetic Valve Dysfunction (BVD), Bioprosthetic Valve Failure (BVF), and severe Hemodynamic Valve Deterioration (HVD). VARC-3 definitions were applied.
RESULTS: Baseline characteristics included a mean age of 83 ± 6 years, and NYHA class III or IV in 76.3 % of patients. The actuarial risk of death at 12 years after TAVR was 95.5 % (CI 93.5 %- 97.1 %). The actual risk of cardiovascular death, weighted against the risk of non-cardiac death at 12 years was 23.9 % (21.0 %-26.8 %). The 12-year actual risk of BVD was 7.0 % (5.3 %-8.9 %), of SVD was 3.6 % (2.5 %-5.2 %), of BVF was 3.12 % (2.02 %-4.57 %), and of severe HVD was 1.7 % (0.9 %-2.9 %). Mean transaortic gradient significantly decreased after the procedure (52 ± 15 mmHg vs 9 ± 5 mmHg, p < 0.001), and remained stable up to 12 years (12 ± 4 mmHg, P = 0.08 vs. discharge).
CONCLUSIONS: The first-generation CoreValve bioprosthesis showed reassuring clinical and hemodynamic performance at 12-year follow-up.
METHODS: 882 inoperable or high-risk patients were treated with the CoreValve bioprosthesis in 8 Italian high-volume centers between 2007 and 2011. The endpoints were 12-year all-cause and cardiovascular mortality, and Cumulative Incidence Functions (CIFs) for severe Structural Valve Deterioration (SVD), Bioprosthetic Valve Dysfunction (BVD), Bioprosthetic Valve Failure (BVF), and severe Hemodynamic Valve Deterioration (HVD). VARC-3 definitions were applied.
RESULTS: Baseline characteristics included a mean age of 83 ± 6 years, and NYHA class III or IV in 76.3 % of patients. The actuarial risk of death at 12 years after TAVR was 95.5 % (CI 93.5 %- 97.1 %). The actual risk of cardiovascular death, weighted against the risk of non-cardiac death at 12 years was 23.9 % (21.0 %-26.8 %). The 12-year actual risk of BVD was 7.0 % (5.3 %-8.9 %), of SVD was 3.6 % (2.5 %-5.2 %), of BVF was 3.12 % (2.02 %-4.57 %), and of severe HVD was 1.7 % (0.9 %-2.9 %). Mean transaortic gradient significantly decreased after the procedure (52 ± 15 mmHg vs 9 ± 5 mmHg, p < 0.001), and remained stable up to 12 years (12 ± 4 mmHg, P = 0.08 vs. discharge).
CONCLUSIONS: The first-generation CoreValve bioprosthesis showed reassuring clinical and hemodynamic performance at 12-year follow-up.