Vemulapalli Sreekanth, Holmes David R, Dai David, Matsouaka Roland, Mack Michael J, Grover Fred L, Makkar Raj R, Thourani Vinod H, Douglas Pamela S
Duke Clinical Research Institute, Durham, NC.
Division of Cardiology, Mayo Clinic, Rochester, MN.
Am Heart J. 2018 Jan;195:1-13. doi: 10.1016/j.ahj.2017.09.005. Epub 2017 Sep 9.
BACKGROUND: Recent reports of leaflet abnormalities (detected using advanced imaging) have raised questions regarding transcatheter aortic valve replacement (TAVR) durability. We sought to determine the incidence of valve hemodynamic deterioration (VHD) and its association with cardiovascular outcomes. METHODS AND RESULTS: Consecutive cases with paired postimplant and follow-up echocardiograms from November 2011 to March 2015 in the STS/ACC TVT Registry were allocated into 2 overlapping cohorts: early (paired echocardiograms at 0 and 30 days) and late (paired echocardiograms at 30 days and 1 year). VHD was defined as an increase in mean aortic valve gradient ≥10 mm Hg. Eighteen-month cardiovascular outcomes were determined via linkage with Centers for Medicare & Medicaid Services claims. Backwards selection logistic regression was performed to determine predictors of VHD. Among 10,099 TAVRs with paired echocardiograms, the median age was 84 years and 48.7% were female, with Society of Thoracic Surgeons score distributions of <8% (61.7%), 8%-15% (28.8%), and >15% (9.5%). The incidence of VHD was 2.1% in the early cohort and 2.5% in the late cohort. There was no significant difference between those with and without VHD in either cohort in the combined end point of death/stroke/aortic valve reintervention or heart failure hospitalization or myocardial infarction. Independent predictors of VHD included chronic lung disease, valve-in-valve procedure, 23-mm TAVR valve, severe patient-prosthesis mismatch, increasing body mass index, and increasing baseline aortic valve gradient. CONCLUSIONS: The incidence of VHD in US clinical practice is low, and VHD is not associated with increased cardiovascular events at 18 months. Patient and procedural predictors may help to identify patients at risk for VHD in whom surveillance or preventive strategies may be considered.
背景:近期有关瓣叶异常(通过先进成像技术检测到)的报道引发了关于经导管主动脉瓣置换术(TAVR)耐久性的疑问。我们试图确定瓣膜血流动力学恶化(VHD)的发生率及其与心血管结局的关联。 方法与结果:在STS/ACC TVT注册研究中,选取2011年11月至2015年3月期间有植入后和随访超声心动图配对资料的连续病例,分为2个重叠队列:早期(0天和30天的超声心动图配对)和晚期(30天和1年的超声心动图配对)。VHD定义为平均主动脉瓣压差增加≥10 mmHg。通过与医疗保险和医疗补助服务中心的索赔数据进行关联,确定18个月的心血管结局。采用向后选择逻辑回归分析确定VHD的预测因素。在10,099例有超声心动图配对的TAVR病例中,中位年龄为84岁,48.7%为女性,胸外科医师协会评分分布为<8%(61.7%)、8%-15%(28.8%)和>15%(9.5%)。早期队列中VHD的发生率为2.1%,晚期队列中为2.5%。在死亡/中风/主动脉瓣再次干预、心力衰竭住院或心肌梗死的联合终点方面,有VHD和无VHD的患者在两个队列中均无显著差异。VHD的独立预测因素包括慢性肺病、瓣中瓣手术、23-mm TAVR瓣膜、严重的患者-假体不匹配、体重指数增加以及基线主动脉瓣压差增加。 结论:在美国临床实践中,VHD的发生率较低,且VHD与18个月时心血管事件增加无关。患者和手术相关的预测因素可能有助于识别有VHD风险的患者,对于这些患者可考虑进行监测或采取预防策略。
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