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Outcomes of Transcatheter Aortic Valve Replacement in Patients with Bicuspid Aortic Valve Disease: A Report from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
Circulation ( IF 35.5 ) Pub Date : 2020-02-26 , DOI: 10.1161/circulationaha.119.040333
Sharif A Halim 1, 2 , Fred H Edwards 3 , David Dai 1 , Zhuokai Li 1 , Michael J Mack 4 , David R Holmes 5 , E Murat Tuzcu 6 , Vinod H Thourani 7 , J Kevin Harrison 1 , J Matthew Brennan 8
Affiliation  

Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis compared with those with tricuspid AV. Methods: We used data from the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011-November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid vs. tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). Results: After exclusions, there were 170,959 eligible procedures at 593 sites during the specified interval. Of these, 5,412 TAVR procedures (3.2%) were performed in bicuspid AV patients, including 3,705 with current generation devices. Compared to patients with tricuspid valves, bicuspid AV patients were younger and had a lower STS Predicted Risk of Operative Mortality (PROM) score. When current generation devices were used to treat bicuspid AV patients, device success increased (93.5 vs. 96.3, p=0.001) and the incidence of 2+ aortic insufficiency declined (14.0 vs. 2.7%, p<0.001) compared with older generation devices. With current generation devices, device success was slightly lower in the bicuspid (vs. tricuspid) AV group (96.3% in bicuspid vs. 97.4% in tricuspid, p=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among bicuspid AV patients (2.7% vs. 2.1%, p<0.001). A lower 1-year adjusted risk of mortality (hazard ratio 0.88, 95% confidence interval 0.78-0.99) was observed for bicuspid vs. tricuspid AV patients in the Medicare-linked cohort, while no difference was observed in the 1-year adjusted risk of stroke (hazard ratio 1.14, confidence interval 0.94-1.39). Conclusions: Using current generation devices, procedural, post-procedural, and 1-year outcomes were comparable following TAVR for bicuspid AV vs. tricuspid AV disease. With newer generation devices, TAVR is a viable treatment option for bicuspid AV patients.

中文翻译:

二尖瓣主动脉瓣膜病变患者经导管主动脉瓣置换的结果:胸外科医师协会/美国心脏病学会经导管导管瓣膜治疗注册中心的报告。

背景:经导管AV替换(TAVR)装置的关键评估不包括双尖瓣主动脉瓣(AV)狭窄的患者。我们试图评估三尖瓣狭窄与三尖瓣狭窄相比TAVR的结果。方法:我们使用了来自胸外科医师协会(STS)/美国心脏病学会经导管瓣膜治疗注册中心(2011年11月至2018年11月)的数据来确定器械成功率,手术结果,TAVR后瓣膜性能以及医院内临床结果(死亡率,中风和大出血),取决于瓣膜的形态(二尖瓣对三尖瓣)。结果按旧的和当前的(Sapien 3和Evolut R)世代瓣膜假体进行分层。在符合条件的个人(≥65岁)中,使用Medicare行政索赔评估了1年的死亡率和中风。结果:排除后,在指定的时间间隔内,在593个地点进行了170959项合格手术。其中,在二尖瓣性AV患者中进行了5,412例TAVR手术(占3.2%),其中包括3,705例采用了当前世代设备。与三尖瓣患者相比,双尖瓣AV患者年轻,STS预测的手术死亡风险(PROM)评分较低。当使用现代设备治疗二尖瓣型房颤患者时,与较老一代设备相比,设备成功率提高了(93.5 vs. 96.3,p = 0.001),主动脉瓣关闭不全的发生率降低了(14.0 vs. 2.7%,p <0.001)。 。对于当前的设备,双尖牙的设备成功率略低(vs. 三尖瓣)AV组(双尖瓣96.3%,三尖瓣97.4%,p = 0.07),双尖瓣AV患者中度或严重主动脉瓣关闭不全的发生率略高(2.7%vs. 2.1%,p <0.001)。在与Medicare相关的队列中,二尖瓣和三尖瓣AV患者的1年调整后死亡风险较低(危险比0.88,95%置信区间0.78-0.99),而1年调整后风险未观察到差异中风风险比(危险比1.14,置信区间0.94-1.39)。结论:使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,术后和1年结果相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。在二尖瓣型AV患者中残留中度或严重主动脉瓣关闭不全的发生率略高(2.7%对2.1%,p <0.001)。在与Medicare相关的队列中,二尖瓣和三尖瓣AV患者的1年调整后死亡风险较低(危险比0.88,95%置信区间0.78-0.99),而1年调整后风险未观察到差异中风风险比(危险比1.14,置信区间0.94-1.39)。结论:使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,术后和1年结果相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。在二尖瓣型AV患者中残留中度或严重主动脉瓣关闭不全的发生率略高(2.7%对2.1%,p <0.001)。在与Medicare相关的队列中,二尖瓣和三尖瓣AV患者的1年调整后死亡风险较低(危险比0.88,95%置信区间0.78-0.99),而1年调整后风险未观察到差异中风风险比(危险比1.14,置信区间0.94-1.39)。结论:使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,术后和1年结果相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。在与Medicare相关的队列中,二尖瓣和三尖瓣AV患者的1年调整后死亡风险较低(危险比0.88,95%置信区间0.78-0.99),而1年调整后风险未观察到差异中风风险比(危险比1.14,置信区间0.94-1.39)。结论:使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,术后和1年结果相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。在与Medicare相关的队列中,二尖瓣和三尖瓣AV患者的1年调整后死亡风险较低(危险比0.88,95%置信区间0.78-0.99),而1年调整后风险未观察到差异中风风险比(危险比1.14,置信区间0.94-1.39)。结论:使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,术后和1年结果相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,手术后和1年结局相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。使用现代设备,TAVR后的二尖瓣AV与三尖瓣AV疾病的手术,手术后和1年结局相当。对于新一代的设备,TAVR是二尖瓣性AV患者的可行治疗选择。
更新日期:2020-03-30
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