Börgermann Jochen, Holzhey David M, Thielmann Matthias, Girdauskas Evaldas, Schroefel Holger, Hofmann Steffen, Treede Hendrik, Matschke Klaus, Hilker Michael, Strauch Justus T, Carrel Thierry, Wahlers Thorsten, Diegeler Anno, Kempfert Jörg, Walther Thomas
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Department of Cardiac Surgery, Heart Center Leipzig University, Leipzig, Germany.
Eur J Cardiothorac Surg. 2017 May 1;51(5):936-942. doi: 10.1093/ejcts/ezw423.
The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine.
From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2.
Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up.
The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.
ACURATE TA TM系统是一种经心尖入路的自膨胀经导管心脏瓣膜系统，在临床试验的可控环境中已被证明是安全有效的。SAVI-1和SAVI-2注册研究旨在评估这些有前景的结果能否转化为针对所有患者的临床常规治疗。
从2011年11月至2012年（SAVI-1），以及2013年11月至2014年（SAVI-2），共有500例患者被纳入前瞻性、针对所有患者的多中心、跨国SAVI注册研究。患者在各自医院按照护理标准接受治疗。我们报告并比较SAVI-1和SAVI-2之间30天和1年的临床结果。
患者年龄为80.8±6.1岁，平均逻辑EuroSCORE-I为23.4±14.3%。在SAVI-1中，71.3%的手术在快速起搏下植入瓣膜，而在SAVI-2中为3.6%。SAVI-1和SAVI-2之间的临床和超声心动图结果无显著差异。30天和1年时的总体死亡率分别为6.8%和19.9%，卒中发生率分别为2.2%和3.7%；10.2%的患者接受了永久起搏器植入，出院后未观察到经导管瓣膜相关并发症。早期随访时，1.9%的患者报告有≥2+的瓣周漏，1年随访时为2.6%。
SAVI注册研究证实，使用ACURATE TA TM装置经心尖植入在针对所有患者的情况下是安全有效的，并发症发生率低，短期和1年时性能结果稳定；SAVI-1和SAVI-2的结果相似。
