Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

医学 狭窄 二尖瓣 心脏病学 内科学 气球 临床终点 心脏骨骼 反流(循环) 主动脉瓣狭窄 解剖(医学) 阀门更换 外科 主动脉瓣置换术 随机对照试验
作者
Ignacio J. Amat‐Santos,Mario García‐Gómez,Federico De Marco,Kim Won-Keun,João Brito,Jonathan Halim,John Jose,Gunasekaran Sengotuvelu,Ashok Seth,Christian Juhl Terkelsen,Marcin Protasiewicz,Nelson Bonilla,Bruno García,Juan Pablo Sánchez-Luna,Sara Blasco-Turrión,José Carlos González,Esther González-Bartol,Alexander Ijsselmuiden,Itzíar Gómez,Manuel Carrasco‐Moraleja
出处
期刊:Revista española de cardiología [Elsevier BV]
卷期号:76 (11): 872-880 被引量:18
标识
DOI:10.1016/j.rec.2023.03.002
摘要

No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis.Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days.A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation.In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.
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