Ferrarotto Hospital, University of Catania, Catania, Italy.
McGill University Health Center, Montreal, Québec, Canada.
JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.
This study is the first report of 2 cases of HighLife (HighLife, Paris, France) implantation in humans.
Transcatheter mitral valve implantation represents a promising approach to treating mitral regurgitation in patients at increased risk of perioperative mortality. The HighLife transcatheter mitral valve is a 2-component system. The valve is implanted in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant.
The procedures were successfully performed in a 69-year-old man and a 65-year-old woman with severe functional mitral regurgitation. Both patients were in New York Heart Association functional class IV heart failure with depressed left ventricular ejection fraction and additional comorbidities.
The valve was implanted uneventfully in both patients. General anesthesia was used. The subannular implant was deployed through the transfemoral access, whereas the transcatheter mitral valve was released using the transapical access. Patients maintained hemodynamically stable. There were no intraoperative complications. Acutely, post-procedural echocardiograms demonstrated excellent prosthetic valve function with a low transvalvular gradient and no paravalvular leak and left ventricular outflow tract obstruction. Both patients had mild intraprosthetic regurgitation. Patient #1 survived at 5-months follow-up in New York Heart Association functional class II with excellent prosthesis performance. Patient #2 expired 4 days after a technically successful procedure, because the left ventricle did not tolerate the reduction of mitral regurgitation and despite a high dose of inotropic agents the left ventricular function rapidly deteriorated.
Transcatheter mitral valve implantation using the 2-component HighLife system is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent.
本研究首次报道了 2 例 HighLife（HighLife，巴黎，法国）在人体中的植入病例。
经导管二尖瓣置换术代表了一种有前途的治疗方法，可用于因围手术期死亡率增加而处于高危状态的二尖瓣反流患者。HighLife 经导管二尖瓣瓣膜为两部分系统。瓣膜植入二尖瓣位置，并通过相互作用并达到与先前定位的瓣环下植入物的平衡位置来固定。
该程序在两名患有严重功能性二尖瓣反流的 69 岁男性和 65 岁女性中成功进行。两名患者均处于纽约心脏协会心功能 IV 级心力衰竭状态，左心室射血分数降低，并伴有其他合并症。
两名患者的瓣膜均成功植入。均使用全身麻醉。瓣环下植入物通过经股动脉入路部署，而经导管二尖瓣瓣膜通过经心尖入路释放。患者血流动力学稳定。术中无并发症。术后即刻超声心动图显示，人工瓣膜功能良好，跨瓣压差低，无瓣周漏和左心室流出道梗阻。两名患者均有轻度瓣周反流。患者 #1 在 5 个月的随访中，纽约心脏协会心功能 II 级，生存，人工瓣膜功能良好。患者 #2 在技术上成功的手术后 4 天死亡，因为左心室无法耐受二尖瓣反流的减少，尽管使用了高剂量的正性肌力药物，但左心室功能迅速恶化。
使用两部分 HighLife 系统进行经导管二尖瓣置换术在技术上是可行的，并且可以安全进行。假体的早期血流动力学性能良好。
