Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
J Thorac Cardiovasc Surg. 2015 Jan;149(1):163-73.e2. doi: 10.1016/j.jtcvs.2014.09.027. Epub 2014 Sep 18.
Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown.
Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437).
Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P < .001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm(2)/m(2), respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m(2), and was similar among groups (P = .262). There were no aortic valve reoperations.
Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.
在对三种当前代生物瓣的随机比较中，观察到小的早期术后血液动力学差异。这些差异是否持续存在并影响植入后 1 年的临床结果尚不清楚。
300 名患有严重主动脉瓣狭窄的成年人接受了瓣膜置换术，随机分为 Epic（St Jude，St Paul，Minn）（n=99）、Magna（Edwards LifeSciences Inc，Irvine，Calif）（n=100）和 Mitroflow（Sorin Biomedica Spa，Saluggio，Italy）（n=101）生物瓣。在植入后 1 年，通过超声心动图检查血液动力学瓣膜性能，在 241 名患者（Epic：79 名，Magna：77 名，Mitroflow：85 名；P=0.437）中评估临床结果。
平均年龄为 75±8 岁，164 名男性（68%）。在出院和 1 年之间，有 9 例死亡（3.7%）（Epic：3.7%，Magna：5.0%，Mitroflow：2.3%；P=0.654），6 例心力衰竭（2.5%）（Epic：1.3%，Magna：1.3%，Mitroflow：5.8%；P=0.265），27 例心房颤动/扑动（11.2%）（Epic：8.1%，Magna：11.0%，Mitroflow：7.9%；P=0.577）和无中风/短暂性脑缺血发作。1 年的超声心动图显示 Epic、Magna 和 Mitroflow 生物瓣之间在平均梯度（分别为 15.2±5.5、12.3±4.3 和 16.2±5.7mmHg；P<0.001）和指数主动脉瓣面积（分别为 0.93±0.28、1.04±0.28 和 0.96±-0.26cm2/m2；P=0.015）方面存在较小的血液动力学差异。当按超声心动图瓣环直径、通用瓣环大小和植入物大小对数据进行分层时，特别是当瓣环大小≥23mm 时，早期存在一些趋势。出院至 1 年之间的左心室质量指数回归平均为-16.5±28.1g/m2，各组之间相似（P=0.262）。没有主动脉瓣再次手术。
尽管当前代猪和心包生物瓣之间存在中期持续的小血液动力学差异，但我们的前瞻性随机比较显示，在 1 年时，设备的临床结果和质量回归是等效的。这些令人鼓舞的趋势必须在纵向随访中继续评估。
