Department of Cardiothoracic Surgery, King's College Hospital/King's Health Partners, London, UK.
Eur J Cardiothorac Surg. 2013 Feb;43(2):371-7. doi: 10.1093/ejcts/ezs203. Epub 2012 Apr 20.
The feasibility of transcatheter aortic valve implantation is limited by the diameter of the aortic annulus. Patients with an annulus of >25 mm were previously unsuitable for transcatheter valve implantation using the Edwards SAPIEN™ bioprosthesis. The 29-mm Edwards SAPIEN XT™ bioprosthesis is a new device suitable for transapical aortic valve implantation in patients with a large aortic annulus. We report the worldwide experience in using this device.
A total of 120 patients (age 80.3 ± 5.7 years, 2.5% female) underwent transapical aortic valve implantation using a 29-mm Edwards SAPIEN XT™ bioprosthesis between the period of December 2009 and February 2011. The mean values of the logistic EuroSCORE and the STS score were 23.4 ± 7.7 and 6.8 ± 4.0, respectively. A total of 20 centres participated in this study and all patients gave written informed consent.
There were two conversions to open heart surgery (1.7%) and four patients (3.3%) required a temporary cardiopulmonary bypass support. A mean of 131 ± 68.0-ml contrast dye was used. The procedural success, defined as one valve implanted, no aortic regurgitation (AR) >2+ and a transcatheter valve in the appropriate position, was achieved in 95.8% of patients. Early postoperative complications at ≤ 30 days included renal failure requiring temporary dialysis (n = 7, 5.8%), reopening for bleeding (n = 5, 4.2%), stroke (n = 2, 1.7%), respiratory complications requiring prolonged mechanical ventilation (n = 11, 9.2%) and postoperative pacemaker implantation (n = 15/12.5%). The Kaplan-Meier survival estimates were 95.8% at 30-day, 88.9% at 6-month and 79.8% at the 1-year follow-up. The controlled echocardiography data at 30 days (n = 95) revealed no/trivial AR in 79 (84.1%), mild AR in 12 (12.8%) and moderate in two (2.2%) patients. The univariable analysis of baseline characteristics revealed no predictor for 30-day mortality.
The 29-mm Edwards SAPIEN XT™ bioprosthesis provides an excellent outcome in patients with a large aortic annulus undergoing transapical aortic valve implantation. Using this larger transcatheter heart valve, a broader population of high-risk elderly patients with aortic stenosis can be treated by minimally invasive transapical implantation techniques.
经导管主动脉瓣植入术的可行性受到主动脉瓣环直径的限制。以前，主动脉瓣环直径>25 毫米的患者不适合使用爱德华兹 SAPIEN™ 生物瓣进行经导管瓣膜植入。29 毫米爱德华兹 SAPIEN XT™ 生物瓣是一种新的装置，适用于主动脉瓣环较大的经心尖主动脉瓣植入术患者。我们报告了使用该装置的全球经验。
2009 年 12 月至 2011 年 2 月期间，共有 120 名（年龄 80.3±5.7 岁，2.5%为女性）患者接受了经心尖 29 毫米爱德华兹 SAPIEN XT™ 生物瓣主动脉瓣植入术。逻辑 EuroSCORE 和 STS 评分的平均值分别为 23.4±7.7 和 6.8±4.0。共有 20 个中心参与了这项研究，所有患者均签署了知情同意书。
有 2 例（1.7%）转为开胸手术，4 例（3.3%）需要临时体外循环支持。平均使用 131±68.0-ml 造影剂。95.8%的患者达到了手术成功的标准，即一个瓣膜植入、无主动脉瓣反流（AR）>2+和经导管瓣膜位于适当位置。术后 30 天内的早期并发症包括需要临时透析的肾功能衰竭（n=7，5.8%）、因出血再次打开（n=5，4.2%）、中风（n=2，1.7%）、需要长时间机械通气的呼吸并发症（n=11，9.2%）和术后起搏器植入（n=15/12.5%）。30 天的 Kaplan-Meier 生存估计分别为 95.8%、88.9%和 79.8%。术后 30 天（n=95）的超声心动图数据显示，无/轻微 AR 为 79 例（84.1%）、轻度 AR 为 12 例（12.8%）和中度 AR 为 2 例（2.2%）。单变量基线特征分析未发现 30 天死亡率的预测因素。
29 毫米爱德华兹 SAPIEN XT™ 生物瓣在主动脉瓣环较大的经心尖主动脉瓣植入术患者中提供了极好的结果。使用这种较大的经导管心脏瓣膜，更多的高危老年主动脉瓣狭窄患者可以通过微创的经心尖植入技术进行治疗。
