Schulz Eberhard, Jabs Alexander, Gori Tommaso, von Bardeleben Stephan, Hink Ulrich, Kasper-König Walter, Vahl Christian Friedrich, Münzel Thomas
Center for Cardiology, Cardiology 1, Universitätsmedizin Mainz, Germany.
Department of Cardiology, Klinikum Frankfurt Höchst, Frankfurt am Main, Germany.
Int J Cardiol Heart Vasc. 2016 Jul 5;12:52-56. doi: 10.1016/j.ijcha.2016.06.002. eCollection 2016 Sep.
The Medtronic Evolut R (EVR) is a novel transcatheter heart valve designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of the new EVR with the established Medtronic CoreValve (CV) system.
Of 151 patients undergoing transfemoral transcatheter aortic valve implantation with a self-expanding valve at our institution between January 2013 and January 2016, 86 were treated with EVR and 65 with CV. Patients treated with EVR had a significantly lower rate of more-than-mild aortic regurgitation and a higher rate of device success. Recapture maneuvers to optimize valve deployment were performed in 22.1% of the EVR procedures. Transvalvular post-procedural gradients were slightly higher in the EVR group, while no differences were observed in the incidence of safety endpoints at 30 days, vascular complications, or need for permanent pacemaker implantation following asystole or complete atrioventricular block.
These initial single-center experience data on the short-term outcomes after EVR valve implantation show a substantially reduced rate of more-than-mild paravalvular regurgitation and higher device success, while 30-day safety outcomes were similar to the CV system. Clinical outcome data from long-term follow-up and larger scale multicenter experience are now necessary.
美敦力Evolut R（EVR）是一种新型经导管心脏瓣膜，旨在实现精确植入预定位置，并最大限度减少人工瓣膜功能障碍及手术并发症。我们的目的是比较新型EVR与已获认可的美敦力CoreValve（CV）系统的短期功能和临床结局。
2013年1月至2016年1月期间，在我们机构接受经股动脉自膨式瓣膜经导管主动脉瓣植入术的151例患者中，86例接受EVR治疗，65例接受CV治疗。接受EVR治疗的患者中、重度主动脉瓣反流发生率显著更低，器械成功率更高。22.1%的EVR手术进行了重新捕获操作以优化瓣膜展开。EVR组术后跨瓣压差略高，而在30天安全性终点事件发生率、血管并发症或因心脏停搏或完全性房室传导阻滞而需要植入永久性起搏器方面未观察到差异。
这些关于EVR瓣膜植入术后短期结局的初步单中心经验数据显示，中、重度瓣周反流发生率大幅降低，器械成功率更高，而30天安全性结局与CV系统相似。现在需要长期随访和更大规模多中心经验的临床结局数据。
