高危患者自膨式经导管主动脉瓣置换术与外科主动脉瓣置换术的 5 年结果。
5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.
机构信息
Departments of Cardiothoracic Surgery and Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Departments of Cardiothoracic Surgery and Interventional Cardiology, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.
出版信息
J Am Coll Cardiol. 2018 Dec 4;72(22):2687-2696. doi: 10.1016/j.jacc.2018.08.2146. Epub 2018 Sep 21.
BACKGROUND
The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.
OBJECTIVES
The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
METHODS
Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
RESULTS
A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
CONCLUSIONS
This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
背景
CoreValve U.S. Pivotal High Risk 试验是第一项随机试验，结果显示在高手术风险患者中，经导管主动脉瓣置换术（TAVR）的 1 年死亡率优于主动脉瓣置换术（SAVR）。
目的
作者旨在比较 TAVR 与 SAVR 在中期 5 年的安全性、性能和耐用性方面的结果。
方法
高手术风险患者按 1:1 比例随机分为 TAVR 组（使用自膨式生物瓣）或 SAVR 组。采用 VARC-1（Valve Academic Research Consortium I）定义。严重血流动力学结构性瓣叶恶化定义为平均梯度≥40mmHg 或梯度变化≥20mmHg 或新发重度主动脉瓣反流。计划进行 5 年随访。
结果
共 797 例患者在 45 个美国中心被随机分为两组，其中 750 例尝试植入（TAVR=391 例，SAVR=359 例）。总体平均年龄为 83 岁，STS 评分为 7.4%。TAVR 和 SAVR 的 5 年全因死亡率分别为 55.3%和 55.4%。亚组分析显示死亡率无差异。TAVR 的主要卒中发生率为 12.3%，SAVR 为 13.2%。TAVR 的平均主动脉瓣梯度为 7.1±3.6mmHg，SAVR 为 10.9±5.7mmHg。未观察到有临床意义的瓣叶血栓。TAVR 的严重 SVD 无复发率为 99.2%，SAVR 为 98.3%（p=0.32），TAVR 的瓣膜再介入无复发率为 97.0%，SAVR 为 98.9%（p=0.04）。TAVR 组有 33.0%的患者和 SAVR 组有 19.8%的患者在 5 年内植入永久性起搏器。
结论
本研究显示 TAVR 或 SAVR 治疗高危患者的中期生存率和卒中率相似。严重结构性瓣叶恶化和瓣膜再介入并不常见。（经导管主动脉瓣置换治疗有症状的严重主动脉瓣狭窄高危和极高危患者的 Medtronic CoreValve 系统的安全性和疗效研究；NCT01240902）。
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