TY - JOUR
T1 - Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis
AU - Testa, Luca
AU - Latib, Azeem
AU - Brambilla, Nedy
AU - De Marco, Federico
AU - Fiorina, Claudia
AU - Adamo, Marianna
AU - Giannini, Cristina
AU - Angelillis, Marco
AU - Barbanti, Marco
AU - Sgroi, Carmelo
AU - Poli, Arnaldo
AU - Ferrara, Erica
AU - Bruschi, Giuseppe
AU - Russo, Claudio Francesco
AU - Matteo, Montorfano
AU - De Felice, Francesco
AU - Musto, Carmine
AU - Curello, Salvatore
AU - Colombo, Antonio
AU - Tamburino, Corrado
AU - Petronio, Anna Sonia
AU - Bedogni, Francesco
N1 - Publisher Copyright:
© 2020 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020.
PY - 2020/5/21
Y1 - 2020/5/21
N2 - 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 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. 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 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years 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 8 years, 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.
AB - 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 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. 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 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years 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 8 years, 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.
KW - Aortic stenosis
KW - Durability
KW - Transcatheter aortic valve replacement
KW - Valve deterioration
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U2 - 10.1093/eurheartj/ehz925
DO - 10.1093/eurheartj/ehz925
M3 - Article
C2 - 31904800
AN - SCOPUS:85085264267
SN - 0195-668X
VL - 41
SP - 1876
EP - 1886
JO - European heart journal
JF - European heart journal
IS - 20
ER -