Smidt心脏研究所Raj R. Makkar等研究人员对经导管主动脉瓣置换术治疗二尖瓣与三尖瓣主动脉瓣狭窄的死亡率或卒中进行比较。该项研究成果发表在2019年6月11日出版的《美国医学会杂志》上。

在这项以登记为基础的队列研究中，包括2691位倾向评分匹配的接受经导管主动脉瓣置换术（TAVR）治疗的二尖瓣和三尖瓣主动脉瓣狭窄患者，30天死亡率没有统计学上的显著差异(2.6%对2.5%)或1年死亡率(10.5%对12.0%)。 然而，在双主动脉瓣狭窄患者中，30天的中风风险明显更高(2.5%对1.6%)。TAVR治疗二尖瓣狭窄与三尖瓣狭窄患者死亡率无显著差异，但增加了30天的卒中风险;由于可能存在选择偏倚，需要进行随机试验来充分评估TAVR治疗双尖瓣主动脉狭窄的疗效和安全性。

研究人员表示，经导管主动脉瓣置换术(TAVR)适应证正在扩大，导致越来越多的双尖瓣狭窄患者接受TAVR治疗。

附：英文原文

Title: Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke

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

Issue&Volume:Vol 321, No. 22,2019

Abstract：

Importance Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy.

Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.

Design, Setting, and Participants Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018.

Exposures TAVR for bicuspid vs tricuspid aortic stenosis.

Main Outcomes and Measures Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment.

Results Of 81?822 consecutive patients with aortic stenosis (2726 bicuspid; 79?096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, −1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, −1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, −2.4 [95% CI, −5.1 to 0.3]; P = .08).

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

DOI: doi:10.1001/jama.2019.7108

Source: https://jamanetwork.com/journals/jama/article-abstract/2735503