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
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 Garcia,Juan Pablo Sánchez-Luna,Sara Blasco Turrión,Joaquín Miguel Alonso González,Esther González Barto,Alexander Ijsselmuiden,Itziar Gómez-Salvador,Manuel Carrasco-Moraleja,Alberto San Román
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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