Doenst Torsten, Gregg Alexander C, Kirov Hristo, Di Franco Antonino, Caldonazo Tulio, Rahouma Mohamed, Krieger Katherine, Pisano Francesca, Gaudino Mario, Falk Volkmar
Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Jena, Germany.
Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
Eur J Cardiothorac Surg. 2025 Jul 1;67(7). doi: 10.1093/ejcts/ezaf215.
Transcatheter aortic valve implantation (TAVI) has shown similar short-term outcomes when compared to surgical aortic valve replacement (SAVR) in randomized controlled trials (RCTs). Longer-term outcomes for low-risk cohorts are now emerging. Here, we analyse all low-risk TAVI versus SAVR RCTs that completed 5-year follow-up.
A systematic MEDLINE database search was conducted through 6 May 2025, identifying all low-risk RCTs comparing TAVI with SAVR that had completed 5-year follow-up. The primary outcomes were all-cause mortality and the composite of all-cause mortality or disabling stroke. Secondary outcomes included stroke, cardiovascular death, aortic reintervention, myocardial infarction, paravalvular leak, need for permanent pacemaker and postprocedural atrial fibrillation.
Four RCTs, including 3557 patients (TAVI: 1829; SAVR: 1728), were analysed. There was no difference between cohorts in all-cause mortality [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI): 0.88-1.16, P = 0.88] or the composite of all-cause mortality or disabling stroke (IRR 1.03, 95% CI: 0.92-1.17, P = 0.59). TAVI was associated with increased risk of mild or greater paravalvular leak (IRR 7.63, 95% CI: 2.82-20.65, P < 0.001) and permanent pacemaker implantation (IRR 2.12, 95% CI: 1.5-2.98, P < 0.001) and a decreased risk of postprocedural atrial fibrillation (IRR 0.44, 95% CI: 0.28-0.71, P < 0.001).
In published RCTs of low-risk cohorts with completed 5-year follow-up, there was no significant difference between TAVI and SAVR neither in overall mortality nor in the composite of mortality and stroke. Valve-related events (paravalvular leaks and pacemaker need) were higher with TAVI, while atrial fibrillation was more common with SAVR.
在随机对照试验（RCT）中，经导管主动脉瓣植入术（TAVI）与外科主动脉瓣置换术（SAVR）相比，已显示出相似的短期疗效。低风险队列的长期疗效目前正在显现。在此，我们分析了所有完成5年随访的低风险TAVI与SAVR的RCT。
通过检索MEDLINE数据库，截至2025年5月6日，识别所有比较TAVI与SAVR且完成5年随访的低风险RCT。主要结局为全因死亡率以及全因死亡率或致残性卒中的复合结局。次要结局包括卒中、心血管死亡、主动脉再次干预、心肌梗死、瓣周漏、永久起搏器需求及术后房颤。
分析了4项RCT，共3557例患者（TAVI组1829例；SAVR组1728例）。两组在全因死亡率[发病率比（IRR）1.01，95%置信区间（CI）：0.88 - 1.16，P = 0.88]或全因死亡率或致残性卒中的复合结局（IRR 1.03，95% CI：0.92 - 1.17，P = 0.59）方面无差异。TAVI与轻度及以上瓣周漏风险增加（IRR 7.63，95% CI：2.82 - 20.65，P < 0.001）和永久起搏器植入风险增加（IRR 2.12，95% CI：1.5 - 2.98，P < 0.001）相关，且与术后房颤风险降低（IRR 0.44，95% CI：0.28 - 0.71，P < 0.001）相关。
在已发表的完成5年随访的低风险队列RCT中，TAVI与SAVR在总体死亡率以及死亡率和卒中的复合结局方面均无显著差异。TAVI相关的瓣膜事件（瓣周漏和起搏器需求）较高，而SAVR术后房颤更常见。
