Grube Eberhard, Schuler Gerhard, Buellesfeld Lutz, Gerckens Ulrich, Linke Axel, Wenaweser Peter, Sauren Barthel, Mohr Friedrich-Wilhelm, Walther Thomas, Zickmann Bernfried, Iversen Stein, Felderhoff Thomas, Cartier Raymond, Bonan Raoul
HELIOS Heart Center Siegburg, Siegburg, Germany.
J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.
We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California).
Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis.
Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support.
A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%.
Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
我们试图确定第二代（21 法式 [F]）和第三代（18F）CoreValve 主动脉瓣假体（CoreValve 公司，加利福尼亚州欧文市）经皮植入的操作性能和安全性。
经皮主动脉瓣置换术是一种新兴的替代疗法，用于治疗有严重症状的主动脉瓣狭窄的高危和无法手术的患者。
纳入符合以下条件的患者：1）有症状的严重主动脉瓣狭窄（瓣口面积 <1 cm²）；2）年龄≥80 岁且逻辑 EuroSCORE≥20%（21F 组）或年龄≥75 岁且逻辑 EuroSCORE≥15%（18F 组）；或 3）年龄≥65 岁并伴有其他预先指定的危险因素。18F 装置的引入使得从涉及全身麻醉、手术切开和体外循环的多学科方法转变为在局部麻醉下无需血流动力学支持的真正经皮方法。
共招募了 86 例患者（21F 组，n = 50；18F 组，n = 36），平均瓣口面积分别为 0.66±0.19 cm²（21F 组）和 0.54±0.15 cm²（18F 组），平均年龄分别为 81.3±5.2 岁（21F 组）和 83.4±6.7 岁（18F 组），平均逻辑 EuroSCORE 分别为 23.4±13.5%（21F 组）和 19.1±11.1%（18F 组）。急性器械成功率为 88%。成功植入器械后主动脉跨瓣压差显著降低（术前平均 43.7 mmHg 与术后 9.0 mmHg，p < 0.001），主动脉反流分级保持不变。急性操作成功率为 74%（21F 组：78%；18F 组：69%）。操作死亡率为 6%。总体 30 天死亡率为 12%；死亡、中风和心肌梗死的综合发生率为 22%。
对于高危患者，经皮植入 CoreValve 假体治疗严重主动脉瓣狭窄是可行的，且死亡率低于风险算法预测值。
