使用Evolut瓣膜评估新型Myval球囊扩张瓣膜：一项倾向匹配研究。
Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study.
作者信息
Halim Jonathan, Rooijakkers Maxim, den Heijer Peter, El Haddad Milad, van den Branden Ben, Vos Jeroen, Schölzel Bas, Meuwissen Martijn, van Gameren Menno, El Messaoudi Saloua, van Royen Niels, IJsselmuiden Sander
机构信息
Department of Cardiology, Amphia Hospital Breda, Molengracht 21, 4818 CK Breda, The Netherlands.
Department of Cardiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.
出版信息
J Clin Med. 2023 Jun 22;12(13):4213. doi: 10.3390/jcm12134213.
BACKGROUND
The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve.
METHODS
In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days.
RESULTS
Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, = 0.56), stroke (2% vs. 4%, = 0.41) and myocardial infarction (1% vs. 3%, = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, = 0.01). At 1 year, cardiac death (2% vs. 4%, = 0.41) and the stroke rate (7% vs. 5%, = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, = 0.17).
CONCLUSION
Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate-severe PVL in both groups.
背景
Myval球囊扩张式（BE）瓣膜在安全性和有效性方面已显示出令人鼓舞的早期临床数据。然而，与其他成熟的当代瓣膜的比较数据仍然很少。本研究旨在比较Myval BE瓣膜与Evolut自膨胀式（SE）瓣膜的性能。
方法
在这项回顾性单中心研究中，纳入223例有症状的重度主动脉瓣狭窄（AS）患者，并用Myval BE瓣膜（n = 120）或Evolut SE瓣膜（n = 103）进行治疗。然后，匹配后比较91对患者。在30天和1年时评估临床结局。在30天时进行超声心动图随访。
结果
两组的手术并发症均很少见。在30天随访时，未观察到心脏死亡（Myval组：1% vs. Evolut组：2%，P = 0.56）、中风（2% vs. 4%，P = 0.41）和心肌梗死（1% vs. 3%，P = 0.31）有显著差异。Myval组需要永久性起搏器植入（PPI）的情况明显更少（4% vs. 15%，P = 0.01）。在1年时，心脏死亡（2% vs. 4%，P = 0.41）和中风发生率（7% vs. 5%，P = 0.76）相似。两组中重度瓣周漏（PVL）也相当（1% vs. 4%，P = 0.17）。
结论
除了Evolut SE瓣膜的PPI率较高外，两种瓣膜的安全性和有效性结局相当。长达1年的随访中，两种瓣膜的中风和心脏死亡发生率均在可接受范围内。两组瓣膜血流动力学良好，中重度PVL发生率低。
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