Doss Mirko, Sirat Sami, Kiessling Arndt H, Jaenicke Stephanie, Moritz Anton
Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.
J Heart Valve Dis. 2012 Nov;21(6):753-7.
The BioPhysio bioprosthesis (Edwards Lifesciences LLC, Irvine, CA, USA) was designed to further improve the hemodynamic performance currently achieved by stented valves. A flexible Nitinol stent that preserves aortic root dynamics, thus maximizing the effective orifice area (EOA), is a key innovation of this prosthesis. The study aim was to provide a clinical evaluation of this new device.
Between December 2004 and August 2005, a total of 50 patients (27 males, 23 females; mean age 75.8 +/- 5.1 years; range: 55-84 years) received a BioPhysio aortic bioprosthesis. Clinical outcomes, EOAs, mean gradients and regression of left ventricular hypertrophy were evaluated echocardiographically at discharge, and at six, 12, 24, 36, 48, and 60 months after surgery.
The 60-month follow up was complete for all patients. No patients died within 30 days of surgery, but the late mortality was 14% (n = 6). There was one sudden unexplained death. One patient developed endocarditis at two years after surgery and underwent reoperation. There were no cases of stroke or renal failure. The BioPhysio prosthesis showed a good hemodynamic performance, with a significant fall in mean gradient to 15.1 +/- 8.3 mmHg, a mean EOA of 1.5 +/- 0.7 cm2, and a mean ejection fraction of 61 +/- 7.2%. There were no cases of aortic regurgitation. The NYHA functional class was improved in all patients, and there was a significant reduction in the left ventricular mass index to 185.7 +/- 49.6 g/m2 at 24 months.
The clinical performance of the BioPhysio aortic bioprosthesis is comparable to that of regular stentless aortic valves. However, clinical approval for the widespread use of this bioprosthesis was not obtained.
BioPhysio生物瓣膜（美国加利福尼亚州尔湾市爱德华兹生命科学公司）旨在进一步改善目前带支架瓣膜所实现的血流动力学性能。一种能保留主动脉根部动力学从而使有效瓣口面积（EOA）最大化的柔性镍钛诺支架是该瓣膜的一项关键创新。本研究的目的是对这种新装置进行临床评估。
在2004年12月至2005年8月期间，共有50例患者（27例男性，23例女性；平均年龄75.8±5.1岁；范围：55 - 84岁）接受了BioPhysio主动脉生物瓣膜植入。在出院时以及术后6个月、12个月、24个月、36个月、48个月和60个月时，通过超声心动图评估临床结局、EOA、平均压差以及左心室肥厚的消退情况。
所有患者均完成了60个月的随访。术后30天内无患者死亡，但晚期死亡率为14%（n = 6）。有1例原因不明的猝死。1例患者在术后两年发生心内膜炎并接受了再次手术。无中风或肾衰竭病例。BioPhysio瓣膜显示出良好的血流动力学性能，平均压差显著降至15.1±8.3 mmHg，平均EOA为1.5±0.7 cm²，平均射血分数为61±7.2%。无主动脉瓣反流病例。所有患者的纽约心脏协会（NYHA）心功能分级均得到改善，左心室质量指数在24个月时显著降至185.7±49.6 g/m²。
BioPhysio主动脉生物瓣膜的临床性能与常规无支架主动脉瓣膜相当。然而，该生物瓣膜尚未获得广泛应用的临床批准。
