Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia (M.C.H., H.C.H., S.A., T.K., J.G.).
Cardiovascular Quality, Outcomes, and Evaluative Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia (M.C.H., P.A.P., T.K., N.D.D., F.H.M., J.G.).
Circulation. 2017 Nov 28;136(22):2132-2140. doi: 10.1161/CIRCULATIONAHA.116.026656. Epub 2017 Sep 1.
Conscious sedation is used during transcatheter aortic valve replacement (TAVR) with limited evidence as to the safety and efficacy of this practice.
The National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to characterize the anesthesia choice and clinical outcomes of all US patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014, and June 30, 2015. Raw and inverse probability of treatment-weighted analyses were performed to compare patients undergoing TAVR with general anesthesia with patients undergoing TAVR with conscious sedation on an intention-to-treat basis for the primary outcome of in-hospital mortality, and secondary outcomes including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, intensive care unit and hospital length-of-stay, and rates of discharge to home. Post hoc falsification end point analyses were performed to evaluate for residual confounding.
Conscious sedation was used in 1737/10 997 (15.8%) cases with a significant trend of increasing usage over the time period studied ( for trend<0.001). In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% versus 98.5%, =0.31). The conscious sedation group was less likely to experience in-hospital (1.6% versus 2.5%, =0.03) and 30-day death (2.9% versus 4.1%, =0.03). Conversion from conscious sedation to general anesthesia was noted in 102 of 1737 (5.9%) of conscious sedation cases. After inverse probability of treatment-weighted adjustment for 51 covariates, conscious sedation was associated with lower procedural success (97.9% versus 98.6%, <0.001) and a reduced rate of mortality at the in-hospital (1.5% versus 2.4%, <0.001) and 30-day (2.3% versus 4.0%, <0.001) time points. Conscious sedation was associated with reductions in procedural inotrope requirement, intensive care unit and hospital length of stay (6.0 versus 6.5 days, <0.001), and combined 30-day death/stroke rates (4.8% versus 6.4%, <0.001). Falsification end point analyses of vascular complications, bleeding, and new pacemaker/defibrillator implantation demonstrated no significant differences between groups after adjustment.
In US practice, conscious sedation is associated with briefer length of stay and lower in-hospital and 30-day mortality in comparison with TAVR with general anesthesia in both unadjusted and adjusted analyses. These results suggest the safety of conscious sedation in this population, although comparative effectiveness analyses using observational data cannot definitively establish the superiority of one technique over another.
在经导管主动脉瓣置换术（TAVR）中使用镇静，其安全性和疗效的证据有限。
使用全国心血管数据注册协会胸外科医师学会/美国心脏病学会经导管瓣膜治疗注册数据库，对 2014 年 4 月 1 日至 2015 年 6 月 30 日期间所有接受择期经皮经股 TAVR 的美国患者的麻醉选择和临床结局进行特征描述。对接受全身麻醉和接受镇静的 TAVR 患者进行原始和逆概率治疗加权分析，主要结局为住院死亡率，次要结局包括 30 天死亡率、住院和 30 天死亡/卒中、手术成功率、重症监护病房和住院时间、出院回家率。进行事后虚假终点分析以评估残留混杂。
10997 例患者中有 1737 例（15.8%）采用镇静，研究期间镇静使用率呈显著上升趋势（趋势<0.001）。在原始分析中，清醒镇静和全身麻醉的术中成功率相似（98.2%与 98.5%，=0.31）。镇静组住院（1.6%比 2.5%，=0.03）和 30 天死亡率（2.9%比 4.1%，=0.03）较低。在 1737 例清醒镇静患者中，有 102 例（5.9%）从清醒镇静转为全身麻醉。经过对 51 个混杂因素进行逆概率治疗加权调整后，清醒镇静与较低的手术成功率（97.9%与 98.6%，<0.001）和住院（1.5%与 2.4%，<0.001）和 30 天（2.3%与 4.0%，<0.001）死亡率相关。清醒镇静可降低术中儿茶酚胺需求、重症监护病房和住院时间（6.0 天与 6.5 天，<0.001）以及 30 天死亡/卒中发生率（4.8%与 6.4%，<0.001）。在调整后，血管并发症、出血和新植入起搏器/除颤器的虚假终点分析显示两组之间无显著差异。
在美国，与全身麻醉的 TAVR 相比，镇静可缩短住院时间，并降低住院和 30 天死亡率，无论在未调整分析还是调整分析中均如此。这些结果表明，在该人群中镇静是安全的，尽管使用观察性数据进行的比较有效性分析不能确定一种技术比另一种技术更优越。
