美国亚特兰大皮埃蒙特心脏研究所Vinod H. Thourani团队联合加州雪松-西奈医疗中心Raj R. Makkar团队研究了经导管主动脉瓣置换术治疗二、三尖瓣主动脉狭窄的低手术风险患者死亡率或卒中的相关性。2021年9月21日出版的《美国医学会杂志》发表了该成果。

对于手术风险低的患者，经导管主动脉瓣置换术（TAVR）治疗二尖瓣狭窄的疗效数据有限。

为了比较TAVR与球囊扩张瓣膜治疗二叶和三叶主动脉瓣狭窄的疗效，研究组对在684个美国中心接受TAVR患者进行了一项基于登记的队列研究。参与者于2015年6月至2020年10月在胸外科医师学会（STS）/美国心脏病学院经导管瓣膜治疗中心注册。159 661例患者（7058例二尖瓣狭窄，152 603例三尖瓣）中，37?660名患者（3243名二尖瓣，34 417例三尖瓣）的手术风险较低（定义为STS风险评分<3%），纳入分析。主要结局是30天和1年的死亡率和卒中风险。次要结局包括手术并发症和瓣膜血流动力学。

3168例具有低手术风险的二尖瓣和三尖瓣主动脉狭窄患者平均年龄为69岁，69.8%为男性，平均STS预测死亡率风险：二尖瓣组为1.7%，三尖瓣组为1.7%。二尖瓣组和三尖瓣组在30天时的死亡率分别为0.9%和0.8%，1年时的死亡率分别为4.6%和6.6%，30天中风发生率分别为1.4%和1.2%，1年中风发生率分别为2.0%和2.1%，组间差异不显著。二尖瓣组和三尖瓣组在手术并发症、瓣膜血流动力学、中度或重度瓣膜旁漏等方面均无显著差异。

结果表明，在这项以登记为基础的初步研究中，对因主动脉狭窄而接受TAVR治疗的低手术风险倾向匹配患者、接受二尖瓣和三尖瓣主动脉狭窄治疗的患者在30天或1年时的死亡率或卒中风险无显著差异。

附：英文原文

Title: Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk

Author: Raj R. Makkar, Sung-Han Yoon, Tarun Chakravarty, Samir R. Kapadia, Amar Krishnaswamy, Pinak B. Shah, Tsuyoshi Kaneko, Eric R. Skipper, Michael Rinaldi, Vasilis Babaliaros, Sreekanth Vemulapalli, Alfredo Trento, Wen Cheng, Susheel Kodali, Michael J. Mack, Martin B. Leon, Vinod H. Thourani

Issue&Volume: 2021/09/21

Abstract:

Importance  There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk.

Objective  To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk.

Design, Setting, and Participants  Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159661 patients (7058 bicuspid, 152603 tricuspid), 37660 patients (3243 bicuspid and 34417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis.

Exposures  TAVR for bicuspid vs tricuspid aortic stenosis.

Main Outcomes and Measures  Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics.

Results  Among 159661 patients (7058 bicuspid; 152603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups’ rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P=.55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P=.06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P=.55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P=.89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, 0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, 0.6% to 3.2%]).

Conclusions and Relevance  In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

DOI: 10.1001/jama.2021.13346

Source: https://jamanetwork.com/journals/jama/article-abstract/2784359