经导管主动脉瓣置换术治疗失败的外科生物瓣耐久性和临床结局。
Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses.
机构信息
University of Vermont Larner College of Medicine, Burlington (H.L.D.).
Department of Cardiac Surgery, University of Michigan, Ann Arbor (G.M.D.).
出版信息
Circ Cardiovasc Interv. 2019 Oct;12(10):e008155. doi: 10.1161/CIRCINTERVENTIONS.119.008155. Epub 2019 Oct 14.
BACKGROUND
Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR.
METHODS
The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch.
RESULTS
From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (=0.01).
CONCLUSIONS
Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.
背景
当外科瓣膜出现恶化和功能障碍时，经导管主动脉瓣置换术（TAVR）是一种选择。本研究报告了经导管主动脉瓣置换术（TAVR）后 3 年的结果。
方法
CoreValve US 扩展使用研究是一项前瞻性、非随机、单臂研究，评估了 TAVR 在极危手术生物瓣主动脉瓣失败患者中的安全性和有效性。研究终点包括 3 年内全因死亡率、需要再次瓣膜介入治疗、随时间变化的血流动力学变化和生活质量。根据是否存在先前的外科瓣膜假体-患者不匹配情况对患者进行分层。
结果
2013 年 3 月至 2015 年 5 月，226 名被认为极危的患者（STS-PROM [胸外科医生预测死亡率] 9.0±7%）接受了经导管主动脉瓣置换术。该队列中 47.2%的患者存在先前的外科瓣膜假体-患者不匹配。3 年时，全因死亡率或主要卒中发生率为 28.6%，93%的患者为纽约心脏协会（NYHA）心功能 I 或 II 级心力衰竭。3 年内瓣膜性能保持稳定，瓣膜再介入率低（4.4%），有效瓣口面积随时间逐渐增加，严重结构性瓣膜恶化率为 2.7%。先前存在严重的假体-患者不匹配与 3 年死亡率无关，但与 3 年随访时生活质量的改善明显较少相关（=0.01）。
结论
在外科生物瓣失败且手术风险极高的患者中，自膨式 TAVR 与持久的血流动力学和良好的临床结果相关。先前存在的外科瓣膜假体-患者不匹配与死亡率无关，但确实限制了患者在 3 年随访期间生活质量的改善。
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