Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke
Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke
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DOI：
10.1001/jama.2019.7108
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发表时间：
2019-06-11
影响因子：
120.7
通讯作者：
Kaneko, Tsuyoshi
中科院分区：
文献类型：
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作者：
Makkar, Raj R.;Yoon, Sung-Han;Kaneko, Tsuyoshi
重要性经导管主动脉瓣置换术（TAVR）的适应症正在扩大，导致越来越多的二尖瓣主动脉瓣狭窄患者接受TAVR。为获得美国食品和药物管理局的批准而进行的随机试验排除了二尖瓣解剖结构.OBJECTIVE比较球囊扩张瓣膜经导管主动脉瓣置换术治疗二尖瓣与三瓣主动脉瓣狭窄的结局.DESIGN，SETTING，AND PARTICIPANTS基于登记的前瞻性队列研究，在552家美国中心接受经导管主动脉瓣置换术的患者中进行。参与者于2015年6月至2018年11月入组胸外科医师协会（STS）/美国心脏病学会（ACC）经导管瓣膜治疗登记研究。暴露TAVR治疗二叶型与三叶型主动脉瓣狭窄。主要结局和指标主要结局为30天和1年死亡率和卒中。次要结果包括手术并发症、瓣膜血流动力学和生活质量评估。分析了2691对倾向评分匹配的二、三尖瓣主动脉瓣狭窄对（二尖瓣2726例，三尖瓣79096例（中位年龄，74岁[四分位距{IQR}，66-81岁]; 39.1%，女性;平均[SD] STS预测的死亡风险分别为4.9% [4.0%]和5.1% [4.2%]）。在30天（2.6% vs 2.5%;风险比[HR]，1.04，[95% CI，0.74-1.47]）和1年（10.5% vs 12.0%; HR，0.90 [95% CI，0.73-1.10]）时，二尖瓣和三尖瓣主动脉瓣狭窄患者的全因死亡率无显著差异。二叶型主动脉瓣狭窄的30天卒中率显著高于三叶型主动脉瓣狭窄（2.5% vs 1.6%; HR，1.57 [95% CI，1.06-2.33]）。在二尖瓣队列中，需要心内直视手术的手术并发症风险显著高于三尖瓣队列（分别为0.9% vs 0.4%;绝对风险差异[RD]，0.5%[95% CI，0%-0.9%]）。瓣膜血流动力学无显著差异。30天（2.0% vs 2.4%;绝对RD，0.3%[95% CI，-1.3%至0.7%]）和1年（3.2% vs 2.5%;绝对RD，0.7%[95% CI，-1.3%至2.7%]）时中度或重度瓣周漏无显著差异。在1年时，两组之间的生活质量改善没有显著差异（堪萨斯城心肌病问卷总体总分改善的差异，-2.4 [95% CI，-5.1至0.3]; P = .08）.结论和相关性在这一初步研究中，一项基于登记的研究，对因主动脉瓣狭窄接受经导管主动脉瓣置换术的倾向匹配患者进行，两瓣和三瓣主动脉瓣狭窄患者30天或1年死亡率无显著差异，但30天卒中风险增加。由于存在选择偏倚的可能性，并且缺乏手术治疗二尖瓣狭窄的对照组，因此需要进行随机试验以充分评估经导管主动脉瓣置换术治疗二尖瓣狭窄的有效性和安全性。
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.