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 4.4years (interquartile range 1.4-6.7years). Longest FU reached 11years. 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 8years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (94mmHg at discharge, 95mmHg at 8years, P=0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU >= 5years 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 8years, 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.

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

Marco Barbanti;
2020-01-01

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 4.4years (interquartile range 1.4-6.7years). Longest FU reached 11years. 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 8years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (94mmHg at discharge, 95mmHg at 8years, P=0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU >= 5years 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 8years, 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11387/157347
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