Lazkani Mohamad, Singh Nirmal, Howe Carol, Patel Nachiket, Colón Modesto J, Tasset Mark, Amabile Orazio, Morris Michael, Fang H Kenith, Pershad Ashish
University of Arizona, Banner University Medical Center - Phoenix, United States.
University of Arizona, Banner University Medical Center, Tuscon, United States.
Cardiovasc Revasc Med. 2019 Jan;20(1):57-69. doi: 10.1016/j.carrev.2018.04.001. Epub 2018 Apr 20.
Transcatheter aortic valve replacement (TAVR) has been approved for use in patients with severe aortic stenosis at intermediate, high and extreme surgical risk. This meta-analysis was performed to assess the safety and efficacy of TAVR compared to surgical aortic valve replacement (SAVR) in intermediate risk patients.
We searched PubMed, EMBASE, Web of science, and the Cochrane Central Register of Controlled Trials databases for studies comparing TAVR versus SAVR in patients at intermediate surgical risk, with a mean Society of Thoracic Surgeon score of 3-8% or a mean logistic European risk score of 10-20%. The primary endpoint was to assess the efficacy of TAVR compared to SAVR, defined as all-cause and cardiovascular mortality at 30-days, 1-year, and ≥2 years of follow-up. Secondary endpoints were the safety profile, comprising of cerebrovascular events, myocardial infarctions, permanent pacemaker placement, new onset atrial fibrillation, aortic regurgitation, vascular complications, major bleeding and acute kidney injury.
This is the largest and most contemporary meta-analysis of 5647 intermediate risk patients in eleven studies published to date. There were no statistically significant differences in all-cause and cardiac mortality at 30 days, 1- year and >2-years of follow up. Acute kidney injury and atrial fibrillation occurred more frequently in patients treated with SAVR and permanent pacemaker implantation and aortic insufficiency were more frequent in patients treated with TAVR.
This meta-analysis suggests that for intermediate risk patients with severe aortic stenosis, TAVR has similar efficacy as SAVR but with a different adverse event profile.
经导管主动脉瓣置换术（TAVR）已被批准用于手术风险为中、高和极高的严重主动脉瓣狭窄患者。本荟萃分析旨在评估在中危患者中，TAVR与外科主动脉瓣置换术（SAVR）相比的安全性和有效性。
我们检索了PubMed、EMBASE、科学网和Cochrane对照试验中央注册数据库，以查找比较中危手术患者TAVR与SAVR的研究，这些患者的胸外科医师协会平均评分在3%-8%或欧洲心脏手术风险评估系统（EuroSCORE）平均逻辑风险评分为10%-20%。主要终点是评估TAVR与SAVR相比的有效性，定义为随访30天、1年和≥2年时的全因死亡率和心血管死亡率。次要终点是安全性指标，包括脑血管事件、心肌梗死、永久性起搏器植入、新发房颤、主动脉瓣反流、血管并发症、大出血和急性肾损伤。
这是对迄今为止发表的11项研究中5647例中危患者进行的最大规模且最新的荟萃分析。在随访30天、1年和>2年时，全因死亡率和心脏死亡率无统计学显著差异。急性肾损伤和房颤在接受SAVR治疗的患者中更频繁发生，永久性起搏器植入和主动脉瓣关闭不全在接受TAVR治疗的患者中更频繁发生。
本荟萃分析表明，对于中危严重主动脉瓣狭窄患者，TAVR与SAVR疗效相似，但不良事件谱不同。
