From King's Health Partners, London, UK (O.W.); Municipal Hospital, Karlsruhe, Germany (G.S.); University Heart Centre, Hamburg, Germany (H.T.); Department of Cardiovascular Medicine, University Hospital Muenster, Germany (H.B.); Clinique Pasteur, Toulouse, France (N.D.); University Central Hospital, Helsinki, Finland (L.I.); University Heart Centre, Bad Krozingen, Germany (F.-J.N.); University Padua, Department of Cardiac, Thoracic and Vascular Sciences, Italy (G.T.); University Hospital Ramon y Cajal, Madrid, Spain (J.L.Z.); and Hopital Bichat, Paris, France (A.V.).
Circulation. 2017 Mar 21;135(12):1123-1132. doi: 10.1161/CIRCULATIONAHA.116.025103. Epub 2017 Jan 19.
The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given.
Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee.
A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients.
Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used.
SOURCE 3 注册研究（SAPIEN 主动脉生物瓣欧洲结果）是一项欧洲多中心、观察性注册研究，研究对象为新一代经导管心脏瓣膜 SAPIEN 3（爱德华兹生命科学公司，尔湾，加利福尼亚州）。其目的是在获得欧洲批准后，记录临床安全性和性能的结果。
在这里，我们报告了 SOURCE 3 注册研究的 30 天结果。所有数据均为自我报告，所有参与中心都承诺在研究开始前，根据患者的同意，支持他们连续使用 SAPIEN 3 经导管心脏瓣膜。不良事件采用 Valve Academic Research Consortium 2 标准定义，并由独立的临床事件委员会裁决。
2014 年 7 月至 2015 年 10 月，来自 10 个国家的 80 个中心共纳入 1950 例患者。其中，1947 例患者接受了 SAPIEN 3 经导管主动脉瓣植入术（TAVI）（平均年龄 81.6±6.6 岁，48.1%为女性）。主要合并症包括冠状动脉疾病（51.5%）、肾功能不全（27.4%）、糖尿病（29.5%）、慢性阻塞性肺疾病（16.0%）和平均 logistic EuroSCORE 为 18.3±13.2。经股动脉入路占 87.1%（n=1695），非经股动脉入路占 252 例。股动脉入路中 59.9%采用了镇静，50%的患者 TAVI 未行主动脉球囊扩张术。植入成功率（1 个瓣膜位于预期位置）为 98.3%。转为常规手术（0.6%）和使用体外循环（0.7%）的情况很少见。不良事件发生率较低，报告的 30 天全因死亡率为 2.2%，心血管死亡率为 1.1%，中风为 1.4%，主要血管并发症为 4.1%，危及生命的出血为 5%，TAVI 后起搏器植入为 12%。3.1%的报告患者存在中度或重度瓣周漏。
SOURCE 3 注册研究的结果表明，当使用第三代 TAVI 装置时，该研究显示了欧洲当前的趋势和 TAVI 在日常实践中的良好结果。
