Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany. Electronic address: https://twitter.com/feistritzerH_J.
University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany.
J Am Coll Cardiol. 2021 May 4;77(17):2204-2215. doi: 10.1016/j.jacc.2021.03.007.
The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days.
The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial.
Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites.
In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63).
In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150).
随机 SOLVE-TAVI（第二代自膨式瓣膜与球囊扩张式瓣膜以及全身麻醉与局部麻醉在经导管主动脉瓣置换术中的比较）试验比较了新一代自膨式瓣膜（SEV）和球囊扩张式瓣膜（BEV），以及全身麻醉联合镇静（CS）与全身麻醉（GA）在经股动脉经导管主动脉瓣置换术（TAVR）患者中的应用。两种策略在 30 天时均显示出相似的结果。
本研究旨在比较随机 SOLVE-TAVI 试验中 1 年随访时的临床结果。
采用 2×2 析因设计，447 例中高危、严重症状性主动脉瓣狭窄患者随机分为经股动脉 TAVR 组，分别使用 SEV（Evolut R，美敦力公司，明尼苏达州明尼阿波利斯市）或 BEV（Sapien 3，爱德华兹生命科学公司，加利福尼亚州欧文市）以及 CS 或 GA，在 7 个中心进行。
在瓣膜比较策略中，BEV 组和 SEV 组的全因死亡率、卒中和中重度瓣周漏及永久性起搏器植入的复合终点发生率相似（n=84，38.3% vs. n=87，40.4%；风险比：0.94；95%置信区间：0.70 至 1.26；p=0.66），1 年时。关于麻醉比较，GA 组和 CS 组的全因死亡率、卒中和心肌梗死以及急性肾损伤的复合终点发生率相似（n=61，25.7% vs. n=54，23.8%；风险比：1.09；95%置信区间：0.76 至 1.57；p=0.63）。
在经股动脉 TAVR 的中高危患者中，使用复合临床终点，新一代 SEV 和 BEV 以及 CS 和 GA 在 1 年时显示出相似的临床结果。（第二代自膨式瓣膜与球囊扩张式瓣膜以及全身麻醉与局部麻醉在 TAVI 中的比较[SOLVE-TAVI]；NCT02737150）。
