From the Department of Internal Medicine II, Cardiology, University of Ulm, Germany.
Circ Cardiovasc Interv. 2017 Jun;10(6). doi: 10.1161/CIRCINTERVENTIONS.116.004670.
New generation devices for transfemoral aortic valve replacement were optimized on valve positioning and reduction of residual aortic regurgitation. We compared 30-day, 12-month, and 24-month outcomes of the Boston Scientific Lotus valve (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) valve. Primary end point was all-cause mortality or disabling stroke within 12 months.
Between 2014 and 2016, 537 patients were enrolled at our center, and 202 patients received Lotus and 335 ES3. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation was lower with the repositionable and retrievable Lotus valve compared with the ES3. Rate of pacemaker implantation was significantly higher with the Lotus valve compared with the ES3 valve (36.1% versus 14.9%, <0.01). Valve Academic Research Consortium-2 early safety end point at 30 days was 7.4% with both devices with no difference in all-cause mortality (Lotus, 1.9%; ES3, 1.8%; =0.87), rate of disabling stroke (Lotus, 1.5%; ES3, 2.1%; =0.62), or major vascular complications (Lotus, 2.9%; ES3, 2.4%; =0.69). The primary end point at 12 months was similar between groups. In a propensity score-matched comparison, there was no difference in the primary end point within 12 months (Lotus, 15.5%; ES3, 18.6%; =0.69) and 24 months (Lotus, 21.9%; ES3, 26.4%; =0.49).
Transfemoral aortic valve replacement with the ES3 and the Lotus were associated with similar 30-day, 12-month, and 24-month clinical outcomes. Need for permanent pacemaker implantation was significantly higher with the repositionable Lotus device.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02162069.
新一代经股主动脉瓣置换术设备在瓣膜定位和减少残余主动脉瓣反流方面进行了优化。我们比较了 Boston Scientific Lotus 瓣膜（Lotus）和球囊扩张 Edwards Sapien 3 瓣膜（ES3）的 30 天、12 个月和 24 个月的结果。主要终点是 12 个月内全因死亡率或致残性卒中。
2014 年至 2016 年，我们中心共纳入 537 例患者，其中 202 例接受了 Lotus 治疗，335 例接受了 ES3 治疗。无中度或重度主动脉瓣反流残留。与 ES3 相比，可重新定位和可回收的 Lotus 瓣膜轻度主动脉瓣反流发生率较低。与 ES3 瓣膜相比，Lotus 瓣膜的起搏器植入率显著更高（36.1%比 14.9%，<0.01）。两种器械的 30 天 Valve Academic Research Consortium-2 早期安全性终点均为 7.4%，全因死亡率无差异（Lotus 为 1.9%，ES3 为 1.8%，=0.87），致残性卒中发生率（Lotus 为 1.5%，ES3 为 2.1%，=0.62）或主要血管并发症（Lotus 为 2.9%，ES3 为 2.4%，=0.69）。两组 12 个月的主要终点相似。在倾向评分匹配比较中，12 个月内主要终点无差异（Lotus 为 15.5%，ES3 为 18.6%，=0.69）和 24 个月（Lotus 为 21.9%，ES3 为 26.4%，=0.49）。
经股主动脉瓣置换术采用 ES3 和 Lotus 瓣膜的 30 天、12 个月和 24 个月临床结果相似。可重新定位的 Lotus 器械需要永久性起搏器植入的比例明显更高。
