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 (P=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.

中文翻译：

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手术生物假体失败的经导管主动脉瓣置换术的耐用性和临床结果。

背景：当外科手术瓣膜表现出恶化和功能障碍时，可以选择瓣膜内经导管主动脉瓣置换术（TAVR）。该研究报告了自扩张式TAVR瓣膜瓣膜置换术后的3年结果。方法：CoreValve美国扩展使用研究是一项前瞻性，非随机，单臂研究，旨在评估TAVR在有症状的极高风险患者中的安全性和有效性。外科生物主动脉瓣失败。研究终点包括全因死亡率，需要进行瓣膜再介入，血液动力学随时间的变化以及3年的生活质量。结果：从2013年3月至2015年5月，有226例患者被视为极度危险（STS-PROM [胸外科医师学会预测的死亡风险] 9。0±7％）曾尝试过气门瓣TAVR。队列中有47.2％的患者存在手术瓣膜假体-患者不匹配的情况。在3年时，全因死亡率或严重中风率为28.6％，其中93％的患者患有纽约心脏协会I或II型心力衰竭。阀门性能保持了3年以上，阀门再干预率低（4.4％），有效节流孔面积随时间的推移得到了改善，阀门的严重结构劣化率达到了2.7％。先前存在的严重的假体-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显着相关（93％的患者患有纽约心脏协会I或II型心力衰竭。阀门性能保持了3年以上，阀门再干预率低（4.4％），有效节流孔面积随时间的推移得到了改善，阀门的严重结构劣化率达到了2.7％。先前存在的严重的假体-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显着相关（93％的患者患有纽约心脏协会I或II型心力衰竭。阀门性能保持了3年以上，阀门再干预率低（4.4％），有效节流孔面积随时间的推移得到了改善，阀门的严重结构劣化率达到了2.7％。先前存在的严重的假体-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显着相关（P = 0.01）。结论：手术生物假体失败且具有极高的手术风险的患者，自扩张TAVR与持久的血流动力学和出色的临床疗效相关。预先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年的随访中生活质量的改善。临床试验注册：URL：http://www.clinicaltrials.gov。唯一标识符：NCT01675440。