Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
Int J Cardiol. 2017 Oct 15;245:83-89. doi: 10.1016/j.ijcard.2017.07.083. Epub 2017 Jul 25.
The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices.
A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses.
A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3).
Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.
本研究旨在进行加权荟萃分析，以确定第二代经导管主动脉瓣置换术（TAVR）后急性（≤30 天）主要结局的发生率。
从 2011 年 1 月至 2017 年 5 月，使用预设标准对多个电子数据库进行了全面检索。新一代 TAVR 装置的定义为任何获得 CE 标志批准或在 CoreValve 和 SAPIEN XT 假体后仍在接受 CE 标志评估的装置。
共有 37 项研究纳入了 10822 名患者，符合纳入标准并纳入分析。研究中使用的装置如下：SAPIEN 3（n=5423，45.9%）、Lotus Valve（n=3007，%）、Portico（n=130，1.1%）、JenaValve（n=345，2.9%）、Symetis Acurate（n=1314，11.1%）和 Evolut R（n=1603，13.6%）。30 天全因死亡率和心血管 30 天死亡率分别为 2.2%（95%CI：1.6%至 2.8%）和 1.6%（95%CI：0.9%至 2.3%）；任何卒中及主要/致残性卒中的发生率分别为 2.6%（95%CI：2.0%至 3.3%）和 0.9%（95%CI：0.2%至 1.6%）；威胁生命的出血率为 3.9%（95%CI：2.9%至 5.0%）；主要血管并发症发生率为 4.5%（95%CI：3.7%至 5.4%）；起搏器植入率为 16.2%（95%CI：12.7%至 19.6%）；中度以上主动脉瓣反流发生率为 1.6%（95%CI：0.9%至 2.3%）。
第二代 TAVR 装置在 30 天时具有极低的死亡率和主要并发症发生率，并且具有更好的假体性能，仅有不到 2%的患者出现中度以上的术后主动脉瓣反流。另一方面，起搏器植入的需求似乎仍然是一个未解决的问题，需要进一步研究。
