Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).
Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.).
Circulation. 2020 Oct 13;142(15):1437-1447. doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21.
In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available.
The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.
The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; <0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; <0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]).
Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.
在临床实践中，大约有 50%接受经导管主动脉瓣置换术的患者接受局部麻醉加清醒镇静（CS）。然而，目前尚无比较 CS 与全身麻醉（GA）安全性和有效性的随机数据。
SOLVE-TAVI（第二代自扩张瓣膜与球囊扩张瓣膜以及经股动脉经导管主动脉瓣置换术 GA 与 CS 的比较）试验是一项多中心、开放标签、2×2 析因、随机试验，共纳入 447 例主动脉瓣狭窄患者，经股动脉行经导管主动脉瓣置换术，比较 CS 与 GA。主要疗效终点为等效性（等效性边界为 10%，显著性水平为 0.05），由全因死亡率、卒、心肌梗死、需要抗生素治疗的感染和 30 天急性肾损伤组成。
CS 组和 GA 组的主要复合终点发生率分别为 27.2%和 26.4%（差异率为 0.8[90%CI，-6.2 至 7.8]；=0.015）。各组成部分的事件发生率如下：全因死亡率分别为 3.2%和 2.3%（差异率为 1.0[90%CI，-2.9 至 4.8]；<0.001）；卒发生率分别为 2.4%和 2.8%（差异率为-0.4[90%CI，-3.8 至 3.8]；<0.001）；心肌梗死发生率分别为 0.5%和 0.0%（差异率为 0.5[90%CI，-3.0 至 3.9]；<0.001），需要抗生素治疗的感染发生率分别为 21.1%和 22.0%（差异率为-0.9[90%CI，-7.5 至 5.7]；=0.011）；急性肾损伤发生率分别为 9.0%和 9.2%（差异率为-0.2[90%CI，-5.2 至 4.8]；=0.0005）。CS 组（62.8%）与 GA 组（97.3%）相比，需要使用正性肌力药物或血管加压药的患者比例较低（差异率为 34.4[90%CI，-41.0 至-27.8]）。
在接受经股动脉经导管主动脉瓣置换术的主动脉瓣狭窄患者中，与 GA 相比，CS 的主要疗效终点无显著差异。这些发现表明 CS 可安全应用于经导管主动脉瓣置换术。
