Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia (N.D.D., J.E.B.).
Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, Leonard Davis Institute of Health Economics, Philadelphia, PA (N.D.D., J.E.B.).
Circulation. 2021 Jul 20;144(3):186-194. doi: 10.1161/CIRCULATIONAHA.120.051456. Epub 2021 May 5.
Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure.
We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected.
The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model.
There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.
经导管主动脉瓣置换术（TAVR）是治疗主动脉瓣狭窄的一种变革性疗法。尽管技术和技术迅速改进，但严重并发症仍然相对常见，并且单一结果测量无法很好地描述。本研究的目的是使用新的 30 天综合指标确定美国 TAVR 结果是否存在部位水平的差异。
我们使用胸外科医生协会/美国心脏病学会经导管瓣膜治疗登记处的数据进行了回顾性队列研究，以开发一种新的综合排名绩效指标，该指标包含死亡率和严重并发症。并发症综合排名的选择和排序顺序是根据它们与 1 年结果的调整关联确定的。根据 95%概率区间，风险调整后结果明显多于或少于全国平均水平的部位被归类为表现优于或差于预期。
发展队列包括 52561 名在 2015 年 1 月 1 日至 2017 年 12 月 31 日期间接受 TAVR 的患者。根据与 1 年风险调整死亡率和健康状况的关联，我们确定了 4 种围手术期并发症，除了死亡率之外，还包括在综合风险模型中。根据严重程度进行经验排名，这些并发症包括中风、大出血、危及生命或致残性出血、III 期急性肾损伤和中度或重度瓣周漏。根据这些排名结果，我们发现美国 TAVR 的护理质量存在显著的部位水平差异。总体而言，在 301 个（8%）部位观察到优于预期的部位表现，在 242 个（80%）部位观察到表现与预期相符，在 34 个（11%）部位观察到表现不如预期。与其他部位相比，30 天死亡率；中风；大出血、危及生命或致残性出血；和中度或重度瓣周漏在表现不佳的部位更为常见。该模型具有良好的综合可靠性。
美国 TAVR 护理质量存在很大差异，11%的部位被认为提供的护理低于平均水平。需要进一步研究以确定与高绩效和低绩效部位相关的结构、过程相关和技术因素。
