Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Circulation: Cardiovascular Interventions Pub Date : 2024-11-01 Epub Date: 2024-10-18 DOI:10.1161/CIRCINTERVENTIONS.124.014018

Thomas Modine, Didier Tchétché, Nicolas M Van Mieghem, G Michael Deeb, Stanley J Chetcuti, Steven J Yakubov, Paul Sorajja, Hemal Gada, Mubashir Mumtaz, Basel Ramlawi, Tanvir Bajwa, John Crouch, Paul S Teirstein, Neal S Kleiman, Ayman Iskander, Rodrigo Bagur, Michael W A Chu, Pierre Berthoumieu, Arnaud Sudre, Rik Adrichem, Saki Ito, Jian Huang, Jeffrey J Popma, John K Forrest, Michael J Reardon

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Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.

Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.

Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.

Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

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年轻（小于 75 岁）低手术风险重度主动脉瓣狭窄患者 TAVR 术后三年的疗效。

背景：经导管主动脉瓣置换术（TAVR经导管主动脉瓣置换术（TAVR）是严重主动脉瓣狭窄患者手术的替代方案，但有关年轻、低风险患者的数据有限。本分析比较了低手术风险患者的疗效：Evolut 低风险试验将 1414 名低风险患者随机分为接受环上自扩张 TAVR 或手术治疗。我们比较了 TAVR 和手术患者 3 年后的全因死亡率或致残中风率、相关临床结果和生物人工瓣膜性能：P=0.241）。虽然TAVR和手术在全因死亡率方面没有差异，但TAVR（0.6%）的致残性中风发生率低于手术（2.9%；P=0.019），而手术的起搏器植入发生率（7.1%）低于TAVR（21.0%；PP=0.962）。TAVR的瓣膜性能明显优于手术，平均主动脉梯度更低（PPConclusions：低风险患者注册：URL：https://clinicaltrials.gov；唯一标识符：NCT02701283。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.