ImportanceAlthough transcatheter aortic valve replacement (TAVR) outcomes in the US have improved substantially since 2011, it is unknown whether these trends have continued since 2019.ObjectiveTo examine changes in risk-adjusted TAVR outcomes from 2019 to 2022 and to examine any noteworthy trends over time.Design, Setting, and ParticipantsThis cohort study examined data from patients with severe aortic stenosis treated with TAVR at 786 US hospitals between January 1, 2019, and March 31, 2022, included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry.ExposurePatients who underwent TAVR.Main Outcomes and MeasuresThe primary outcome was 30-day mortality, and the secondary outcomes were in-hospital mortality and 30-day composite adverse events. To understand factors explaining these trends, a series of logistic regression models was constructed for each outcome, with time as the primary explanatory variable. After adjusting for changing patent characteristics and procedural factors, a series of exploratory analyses was performed to examine the extent to which these findings could be explained by several plausible hypotheses.ResultsThis study’s analytic cohort included a total of 210 495 patients. Median (IQR) patient age was 79 (73-85) years, and 91 313 patients (43.4%) were female. Median (IQR) STS predicted risk of mortality (PROM) was 3.3% (2.0%-5.3%). There were no significant changes in unadjusted 30-day mortality from quarter 1 of 2019 (2.4%) to the end of quarter 1 of 2022 (2.2%) (P for trend = .10), with an unadjusted odds ratio (OR) for time of 0.98 per year (95% CI, 0.94-1.01). After adjusting for patient characteristics, the OR increased to 1.05 per year (95% CI, 1.02-1.08), which increased further after adjusting for procedural characteristics to 1.09 per year (95% CI, 1.05-1.13). In exploratory analyses, there were no meaningful changes in the adjusted odds of death after excluding sites that entered the STS/ACC TVT Registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.11; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), or patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12).Conclusions and RelevanceIn this observational cohort study performing a national analysis of outcomes after TAVR, it was found that risk-adjusted 30-day mortality increased modestly from January 2019 to March 2022. However, no site-level, patient-related, or process-related factors were identified that could explain these findings. Although the absolute increase in risk-adjusted mortality during the study period was relatively small, these findings warrant continued surveillance.

中文翻译：

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经导管主动脉瓣置换术结局的趋势


重要性尽管自 2011 年以来美国经导管主动脉瓣置换术 （TAVR） 结局已大幅改善，但尚不清楚这些趋势自 2019 年以来是否持续尚不清楚。设计、设置和参与者该队列研究检查了 2019 年 1 月 1 日至 2022 年 3 月 31 日期间在美国 786 家医院接受 TAVR 治疗的严重主动脉瓣狭窄患者的数据，这些患者包含在胸外科医师协会 （STS）/美国心脏病学会 （ACC） 经导管瓣膜治疗 （TVT） 登记处。主要结局和措施主要结局是 30 天死亡率，次要结局是院内死亡率和 30 天复合不良事件。为了了解解释这些趋势的因素，为每个结果构建了一系列 logistic 回归模型，以时间作为主要解释变量。在调整了不断变化的专利特征和程序因素后，进行了一系列探索性分析，以检查这些发现在多大程度上可以用几个合理的假设来解释。结果本研究的分析队列共纳入 210 495 例患者。中位 （IQR） 患者年龄为 79 （73-85） 岁，其中 91 313 例患者 （43.4%） 为女性。中位 （IQR） STS 预测死亡风险 （PROM） 为 3.3% （2.0%-5.3%）。从 2019 年第 1 季度 （2.4%） 到 2022 年第 1 季度末 （2.2%） ，未经调整的 30 天死亡率没有显著变化 （P 代表趋势 = .10），未经调整的比值比 （OR） 为每年 0.98 （95% CI，0.94-1.01）。在调整患者特征后，OR 增加到每年 1.05 （95% CI，1.02-1.08），在调整程序特征后进一步增加至每年 1.09 （95% CI，1.05-1.13）。在探索性分析中，排除 2019 年或之后进入 STS/ACC TVT 登记处的部位（OR，1.09;95% CI，1.05-1.13）、低容量部位（OR，1.09;95% CI，1.06-1.13）、低风险患者（OR，1.11;95% CI，1.07-1.15）、二叶式主动脉瓣患者（OR，1.09;95% CI，1.06-1.13）、低风险患者（OR，1.11;95% CI，1.07-1.15）、二叶式主动脉瓣患者（OR，1.09;95% CI， 1.05-1.13）、院内死亡（OR，1.08;95% CI，1.03-1.14）或经历过主要血管并发症的患者（OR，1.09;95% CI，1.05-1.12）。结论和相关性在这项对 TAVR 后结果进行全国分析的观察性队列研究中，发现从 2019 年 1 月到 2022 年 3 月，风险调整后的 30 天死亡率略有增加。然而，没有确定可以解释这些发现的部位水平、患者相关或过程相关因素。尽管研究期间风险调整死亡率的绝对增加相对较小，但这些发现值得继续监测。