Andreas Martin, Wallner Stephanie, Habertheuer Andreas, Rath Claus, Schauperl Martin, Binder Thomas, Beitzke Dietrich, Rosenhek Raphael, Loewe Christian, Wiedemann Dominik, Kocher Alfred, Laufer Guenther
Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Interact Cardiovasc Thorac Surg. 2016 Jun;22(6):799-805. doi: 10.1093/icvts/ivw052. Epub 2016 Mar 13.
Sutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types.
All patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included. Patients undergoing bypass surgery, an additional valve procedure, atrial ablation surgery or replacement of the ascending aorta were excluded. Preoperative characteristics, operative specifications, survival, valve-related adverse events and transvalvulvar gradients were compared.
One hundred sixteen patients underwent rapid-deployment aortic valve replacement [mean age 75 years (SD: 8); 62% female] and 132 patients underwent conventional aortic valve replacement [70 years (SD: 9); 31% female; P < 0.001]. Conventional valve patients were taller and heavier. The mean EuroSCORE II was 3.1% (SD: 2.7) and 4.4% (SD: 6.0) for rapid-deployment and conventional valve patients, respectively (P = 0.085). The mean implanted valve size was higher in the conventional group [23.2 mm (SD: 2.0) vs 22.5 mm (SD: 2.2); P = 0.007], but postoperative transvalvular mean gradients were comparable [15 mmHg (SD: 6) vs 14 mmHg (SD: 5); P = 0.457]. A subgroup analysis of the most common valve sizes (21 and 23 mm; implanted in 63% of patients) revealed significantly reduced mean postoperative transvalvular gradients in the rapid-deployment group [14 mmHg (SD: 4) vs 16 mmHg (SD: 5); P = 0.025]. A significantly higher percentage received minimally invasive procedures in the rapid-deployment group (59 vs 39%; P < 0.001). The 1- and 3-year survival rate was 96 and 90% in the rapid-deployment group and 95 and 89% in the conventional group (P = 0.521), respectively. Valve-related pacemaker implantations were more common in the rapid-deployment group (9 vs 2%; P = 0.014) and postoperative stroke was more common in the conventional group (1.6 vs 0% per patient year; P = 0.044).
We conclude that this rapid-deployment valve probably facilitates minimally invasive surgery. Furthermore, a subgroup analysis showed reduced transvalvular gradients in smaller valve sizes compared with the conventionally implanted valve of the same type. The favourable haemodynamic profile and the potentially different spectrum of valve-related adverse events should be addressed in further clinical trials.
无缝合且快速植入的瓣膜最近已应用于临床实践。爱德华兹INTUITY瓣膜系统是爱德华兹麦格纳心包瓣膜与瓣下支架框架的组合，以实现快速植入。我们进行了一项平行队列研究，比较这两种瓣膜类型。
纳入2010年5月至2014年7月因主动脉狭窄接受爱德华兹麦格纳易瓣膜或爱德华兹INTUITY瓣膜系统的所有患者。排除接受旁路手术、额外瓣膜手术、心房消融手术或升主动脉置换的患者。比较术前特征、手术规格、生存率、瓣膜相关不良事件和跨瓣压差。
116例患者接受了快速植入主动脉瓣置换术[平均年龄75岁（标准差：8）；62%为女性]，132例患者接受了传统主动脉瓣置换术[70岁（标准差：9）；31%为女性；P<0.001]。传统瓣膜患者更高更重。快速植入瓣膜组和传统瓣膜组的平均欧洲心脏手术风险评估系统II分别为3.1%（标准差：2.7）和4.4%（标准差：6.0）（P=0.085）。传统组植入瓣膜的平均尺寸更高[23.2mm（标准差：2.0）对22.5mm（标准差：2.2）；P=0.007]，但术后跨瓣平均压差相当[15mmHg（标准差：6）对14mmHg（标准差：5）；P=0.457]。对最常见瓣膜尺寸（21和23mm；63%的患者植入）进行的亚组分析显示，快速植入瓣膜组术后平均跨瓣压差显著降低[14mmHg（标准差：4）对16mmHg（标准差：5）；P=0.025]。快速植入瓣膜组接受微创操作的比例显著更高（59%对39%；P<0.001）。快速植入瓣膜组1年和3年生存率分别为96%和90%，传统组分别为95%和89%（P=0.521）。瓣膜相关起搏器植入在快速植入瓣膜组更常见（9%对2%；P=0.014），术后中风在传统组更常见（每位患者每年1.6%对0%；P=0.044）。
我们得出结论，这种快速植入瓣膜可能有助于微创手术。此外，亚组分析显示，与相同类型的传统植入瓣膜相比，较小瓣膜尺寸的跨瓣压差降低。在进一步的临床试验中应探讨其有利的血流动力学特征以及瓣膜相关不良事件可能不同的范围。
