Department of Cardiovascular Medicine Harrington Heart and Vascular InstituteUniversity Hospitals Cleveland Medical Center Cleveland OH.
Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery) Yale University School of Medicine New Haven CT.
J Am Heart Assoc. 2021 Sep 21;10(18):e021871. doi: 10.1161/JAHA.121.021871. Epub 2021 Sep 13.
Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes were based on the Society of Thoracic Surgeons-American College of Cardiology-Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty-day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (=0.02). Clinical events were low at 30 days (Evolut PRO: for the all-cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all-cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all-cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all-cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self-expandable supra-annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.
在退行性外科主动脉瓣患者中，采用带瓣环上经导管主动脉瓣置换术（transcatheter aortic valve replacement with supra-annular transcatheter heart valves）。尚未在外科瓣失效患者中评估下一代自膨式 Evolut PRO 瓣膜。
在 2015 年 4 月至 2019 年 6 月期间，在美国胸外科医师学会（Society of Thoracic Surgeons）和美国心脏病学会经导管瓣膜治疗注册中心（American College of Cardiology Transcatheter Valve Therapy Registry）的退行性外科主动脉瓣手术中，使用 Evolut R 或 Evolut PRO 经导管心脏瓣膜的患者中评估了经导管主动脉瓣置换术的效果。由临床中心行经胸超声心动图评估经导管瓣膜性能。根据胸外科医师学会-美国心脏病学会-经导管瓣膜治疗注册中心的定义，评估住院期间、30 天和 1 年的临床结果。在 5897 例退行性外科主动脉瓣患者中进行了经导管主动脉瓣置换术（5061 例患者接受 Evolut R 瓣膜，836 例接受 Evolut PRO 瓣膜）。两组患者 30 天的经导管心脏瓣膜血流动力学性能均良好（平均梯度：Evolut PRO 组：13.8±7.5mmHg；Evolut R 组：14.5±8.1mmHg），但瓣周漏在瓣膜类型之间有显著差异（P=0.02）。30 天临床事件发生率较低（Evolut PRO 组：全因死亡率 2.8%，任何卒中 1.8%，新植入起搏器 3.0%；Evolut R 组：全因死亡率 2.5%，任何卒中 2.2%，新植入起搏器 5.3%），1 年时也较低（Evolut PRO 组：全因死亡率 9.2%，任何卒中 3.1%；Evolut R 组：全因死亡率 9.8%，任何卒中 2.9%）。
带瓣环上自膨式经导管心脏瓣膜的退行性外科主动脉瓣置换术与良好的临床结局和瓣膜血流动力学相关。新一代 Evolut PRO 可进一步减少残余瓣周漏。
