Talanas Giuseppe, Laconi Angelo, Kereiakes Dean J, Merella Pierluigi, Reardon Michael J, Spano Andrea, Petretto Gerardo, Lauriola Francesco, Casula Marta, Micheluzzi Valentina, Isgender Mehriban, Chatzizisis Yiannis, Farkouh Michael E, Lansky Alexandra J, Piazza Nicolo, Portoghese Michele, Casu Gavino, Navarese Eliano Pio
Clinical Experimental Cardiology, Clinical and Interventional Cardiology, University of Sassari, Sassari, Italy.
SIRIO MEDICINE Research Network, Sassari, Italy.
J Soc Cardiovasc Angiogr Interv. 2024 May 15;3(7):102143. doi: 10.1016/j.jscai.2024.102143. eCollection 2024 Jul.
We aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear.
We included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up. The primary end point was death or disabling stroke. Secondary end points were all-cause mortality, cardiac mortality, stroke, pacemaker implantation, valve thrombosis, valve gradients, and moderate-to-severe paravalvular leaks. The study is registered with PROSPERO (CRD42023481856).
Seven trials (N = 7785 patients) were included. Weighted mean trial follow-up was 5.76 ± 0.073 years. Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; = .70). Mortality risks were similar. TAVR resulted in higher pacemaker implantation and moderate-to-severe paravalvular leaks compared to SAVR. Results were consistent across different surgical risk profiles. As compared to SAVR, self-expanding TAVR had lower death or stroke risk ( interaction = .06), valve thrombosis ( interaction = .06), and valve gradients ( interaction < .01) but higher pacemaker implantation rates than balloon-expandable TAVR ( interaction < .01).
In severe aortic stenosis, the long-term mortality or disabling stroke risk of TAVR is similar to SAVR, but with higher risk of pacemaker implantation, especially with self-expanding valves. As compared with SAVR, the relative reduction in death or stroke risk and valve thrombosis was greater with self-expanding than with balloon-expandable valves.
我们旨在对比较经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）治疗严重主动脉瓣狭窄患者长期预后的随机试验进行荟萃分析。TAVR的短期疗效和安全性已得到证实，但长期预后尚不清楚。
我们纳入了在最长可用随访期比较TAVR与SAVR的随机对照试验。主要终点是死亡或致残性卒中。次要终点包括全因死亡率、心脏死亡率、卒中、起搏器植入、瓣膜血栓形成、瓣膜压差以及中至重度瓣周漏。该研究已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42023481856）。
纳入了7项试验（N = 7785例患者）。试验加权平均随访时间为5.76±0.073年。总体而言，TAVR与SAVR相比，在死亡或致残性卒中方面未观察到显著差异（风险比[HR]，1.02；95%置信区间[CI]，0.93 - 1.11；P = 0.70）。死亡风险相似。与SAVR相比，TAVR导致更高的起搏器植入率和中至重度瓣周漏。在不同手术风险特征的患者中结果一致。与SAVR相比，自膨式TAVR的死亡或卒中风险（交互作用P = 0.06）、瓣膜血栓形成（交互作用P = 0.06）和瓣膜压差（交互作用P < 0.01）更低，但起搏器植入率高于球囊扩张式TAVR（交互作用P < 0.01）。
在严重主动脉瓣狭窄患者中，TAVR的长期死亡或致残性卒中风险与SAVR相似，但起搏器植入风险更高，尤其是使用自膨式瓣膜时。与SAVR相比，自膨式瓣膜在降低死亡或卒中风险以及瓣膜血栓形成方面的相对降幅大于球囊扩张式瓣膜。
