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经导管主动脉瓣置换术住院死亡率的学习曲线:来自巴西国家注册中心的见解。

Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry.

机构信息

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP - Brasil.

Hospital Sírio-Libanês, São Paulo, SP - Brasil.

出版信息

Arq Bras Cardiol. 2024 Jun;121(7):e20230622. doi: 10.36660/abc.20230622.

DOI:10.36660/abc.20230622
PMID:39082574
Abstract

BACKGROUND

Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries.

OBJECTIVE

To assess TAVR's LC in Brazil over time.

METHODS

We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05.

RESULTS

A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10.

CONCLUSION

A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

摘要

背景

发展中国家缺乏关于经导管主动脉瓣置换术(TAVR)学习曲线(LC)的可靠数据。

目的

评估巴西 TAVR 随时间推移的 LC。

方法

我们分析了 2008 年至 2023 年巴西 TAVR 注册中心的数据。每个中心的患者按照病例序列号(CSN)的顺序编号。LC 使用调整后的 EuroSCORE-II 和新一代假体进行限制立方样条分析。此外,根据 CSN 基于经验水平将患者分为不同组:第 1 至 40 名(初始经验)、第 41 至 80 名(早期经验)、第 81 至 120 名(中级经验)和超过 121 名(高级经验)。还根据 2014 年之前治疗的病例数(>40 例和≤40 例)对医院进行分组,进行了额外的分析。采用的显著性水平为<0.05。

结果

共纳入 25 个中心的 3194 名患者。平均年龄和 EuroSCORE II 分别为 80.7±8.1 岁和 7±7.1。LC 分析表明,在治疗 40 名患者后,调整后的住院死亡率有所下降。在第 118 例病例后,曲线趋于平稳。各组的住院死亡率分别为初始经验组 8.6%、早期经验组 7.7%、中级经验组 5.9%和高级经验组 3.7%(p<0.001)。高级经验独立预测死亡率降低(OR 0.57,p=0.013 与初始经验相比)。2014 年之前低容量中心的死亡风险没有随着经验的增加而显著降低,而高容量中心在第 10 例之后则持续改善。

结论

巴西观察到 TAVR 住院死亡率的 LC 现象。这种影响在 2014 年之前治疗前 40 例病例的中心比在 2014 年之后达到这一里程碑的中心更为明显。

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