Medical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Karlsruhe, Germany.
Institut Hospitalier Jacques Cartier, Massy, France.
JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.
OBJECTIVES: The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. BACKGROUND: Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. METHODS: The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. RESULTS: The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. CONCLUSIONS: The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).
目的：SOURCE XT 注册研究（Edwards SAPIEN XT 主动脉生物瓣多区域结局注册研究）评估了在真实世界环境中使用 SAPIEN XT（爱德华生命科学公司，加利福尼亚州欧文）瓣膜的情况和临床结局。
背景：经导管主动脉瓣置换术是一种已确立的治疗高危/不可手术的严重主动脉瓣狭窄的方法。SAPIEN XT 是一种球囊扩张瓣膜，具有增强的功能，可通过更小的输送鞘管进行输送。
方法：SOURCE XT 注册研究是一项前瞻性、多中心、上市后批准的研究。对 99 个地点的 2688 名患者的数据进行了分析。主要终点是全因死亡率、卒中和重大血管并发症、出血以及术后 30 天和 1 年的起搏器植入。
结果：平均年龄为 81.4±6.6 岁，42.3%为男性，平均欧洲心脏手术风险评估系统（EuroSCORE）为 20.4±12.4%。患者存在高冠状动脉疾病负担（44.2%）、糖尿病（29.4%）、肾功能不全（28.9%）、心房颤动（25.6%）和外周血管疾病（21.2%）。术后 30 天生存率为 93.7%，1 年生存率为 80.6%。术后 30 天随访时，卒中发生率为 3.6%，重大血管并发症发生率为 6.5%，危及生命的出血发生率为 5.5%，新植入起搏器发生率为 9.5%，中度/重度瓣周漏发生率为 5.5%。多变量分析确定非经股入路（风险比[HR]：1.84；p<0.0001）、肾功能不全（HR：1.53；p<0.0001）、肝脏疾病（HR：1.67；p=0.0453）、中度/重度三尖瓣反流（HR：1.47；p=0.0019）、瓷主动脉（HR：1.47；p=0.0352）和心房颤动（HR：1.41；p=0.0014）与 1 年死亡率的最高 HRs 相关。重大血管并发症和主要/危及生命的出血是与 1 年死亡率显著增加相关的最常见并发症。
结论：SOURCE XT 注册研究表明，在欧洲商业化后第一年，SAPIEN XT THV 的使用是合理的。安全性状况持续稳定，在真实世界环境中已确立了临床获益。（SOURCE XT 注册研究；NCT01238497）。
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