经股动脉经导管主动脉瓣植入术患者的脑血管事件：一项汇总患者水平的研究。
Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study.
机构信息
Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.
Hospital Regional Universitario de Málaga Malaga Spain.
出版信息
J Am Heart Assoc. 2024 Sep 3;13(17):e032901. doi: 10.1161/JAHA.123.032901. Epub 2024 Aug 27.
BACKGROUND
Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real-world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI.
METHODS AND RESULTS
The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient-level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%-8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007-2010: 2.1%, 2011-2014: 2.5%, 2015-2018: 2.1%, 2019-2022: 2.1%; =0.28). Moreover, 30-day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low-risk, 2.6% in intermediate-risk, and 2.5% in high-risk patients (=0.21). Mortality was higher in patients with 30-day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1-6.5]; <0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0-4.2]; <0.001). One-year mortality rates for stroke did not decline over time (2007-2010: 46.9%, 2011-2014: 46.0%, 2015-2018: 43.0%, 2019-2022: 39.1%; =0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke.
CONCLUSIONS
In 24 305 patients who underwent transfemoral TAVI, 30-day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty-day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.
背景
经导管主动脉瓣置换术（TAVI）后，脑血管事件仍然是最具破坏性的并发症之一。关于经股 TAVI 后纵向趋势和结局的真实世界当代队列数据仍然有限。本研究旨在评估经股 TAVI 后脑血管事件的发生率、时间趋势、预测因素和结局。
方法和结果
CENTER2（球囊扩张瓣膜与自扩张瓣膜行经导管主动脉瓣置换术患者的脑血管事件 2）研究纳入了 2007 年至 2022 年期间接受 TAVI 的患者。该数据库包含来自 10 项临床研究的汇总患者水平数据。共有 24305 名患者接受了经股 TAVI（平均年龄 81.5±6.7 岁，56%为女性，中位胸外科医生协会预测死亡率为 4.9%[3.1%-8.5%]）。其中，2.2%（n=534）的患者在 TAVI 后 30 天内发生卒中，40 例（0.4%）发生短暂性脑缺血发作。在治疗期间，卒中发生率保持稳定（2007-2010 年：2.1%，2011-2014 年：2.5%，2015-2018 年：2.1%，2019-2022 年：2.1%；=0.28）。此外，30 天脑血管事件发生率在胸外科医生协会预测死亡率风险类别中相似：低危患者为 2.1%，中危患者为 2.6%，高危患者为 2.5%（=0.21）。30 天卒中患者的 30 天死亡率高于无卒中患者（20.3%比 4.7%；优势比，5.1[95%CI，4.1-6.5]；<0.001）和 1 年死亡率（44.1%比 15.0%；风险比，3.5[95%CI，3.0-4.2]；<0.001）。1 年卒中死亡率并未随时间下降（2007-2010 年：46.9%，2011-2014 年：46.0%，2015-2018 年：43.0%，2019-2022 年：39.1%；=0.32）。1 年后，7.0%接受 TAVI 的患者发生卒中。
结论
在 24305 名接受经股 TAVI 的患者中，2007 年至 2022 年期间 30 天脑血管事件发生率仍保持在≈2.2%。胸外科医生协会预测死亡率风险类别中 30 天卒中发生率相似。卒中后死亡率仍然很高。
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