Cardiology Depatment, Valladolid University Hospital, Valladolid, Castilla y León, Spain.
Cardiology Department, San Carlos University Hospital, Madrid, Spain.
Heart. 2022 May;108(9):725-732. doi: 10.1136/heartjnl-2021-319349. Epub 2021 Jul 20.
The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.
Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.
A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001).
The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.
与自膨式瓣膜相比，球囊扩张的 Sapien-3 瓣膜在残余主动脉瓣反流方面表现出更好的结果。我们旨在首次比较经导管心脏瓣膜（THV）Sapien-3 与球囊扩张型 Myval 装置的早期临床结果。
连续纳入 2018 年 6 月后在 9 个欧洲机构接受 Sapien-3 或 Myval THV 治疗的有症状重度主动脉瓣狭窄的患者。前瞻性收集早期临床结局数据，并对 30 天超声心动图进行盲法分析。进行以下变量的匹配：年龄、体表面积、胸外科医生协会风险评分、左心室功能、平均梯度、经股动脉入路、主动脉瓣钙质、主动脉瓣环平均直径、面积和偏心指数。
共纳入 416 例患者，分别接受 Sapien-3（n=286，68.7%）或 Myval THV（n=130，31.3%）治疗，匹配后比较了 103 对。基线特征相似。手术成功率（Sapien-3：94.2%；Myval：93.2%，p=0.219）、30 天死亡率（Sapien-3：2.9%；Myval：0.97%，p=0.625）、临床疗效（12.6% vs 4.9%，p=0.057）和早期安全性（12.6% vs 4.9%，p=0.096）相当。Myval 组需要新植入永久性起搏器的比例较低（15.5% vs 5.8%，p=0.020）。Sapien-3 组有≥中度主动脉瓣反流的比例为 1%，Myval 组为 0%，两组差异无统计学意义（p=0.314），但 Sapien-3 组的平均梯度高于 Myval 组（p<0.001）。
新型 Myval 球囊扩张式 THV 在安全性方面具有优势，永久性起搏器植入率低，经超声心动图盲法分析显示残余梯度和瓣周漏发生率良好。
