60岁缺血性脑卒中患者PFO装置闭合

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-05-26 DOI:10.1016/j.jcin.2025.03.034

Ruby Satpathy MD , Josep Rodés-Cabau MD, PhD , David E. Thaler MD, PhD , David M. Kent MD, MS , Samuel Turner MD , Srinivasa Potluri MD , Kranthi K. Kolli PhD , Nils Peter Borgstrom PhD , Julie B. Prillinger PhD , Jeffrey L. Saver MD

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引用次数: 0

摘要

经导管闭合卵圆孔未闭（PFO）是≤60岁隐源性缺血性卒中患者减少卒中的推荐选择，但关于60岁患者闭合卵圆孔未闭后临床结果的数据很少。目的：本真实世界证据研究的目的是评估美国60岁患者PFO关闭的临床结果。方法使用2016年至2022年的医疗保险服务收费数据，识别60岁以上因缺血性卒中住院并诊断为PFO或房间隔缺损且既往服务收费覆盖≥6个月的患者。植入Amplatzer或Talisman PFO闭塞器的患者（器械组）通过与制造商器械跟踪数据库的链接进行识别，并与未植入器械的患者（对照组）进行倾向评分匹配（1:4）。评估30天内的急性安全事件和3年内的复发性缺血性卒中。结果医疗保险受益人20999人(器械组，n = 1132人；对照组（n = 19,867）符合纳入标准。匹配队列包括5508名医疗保险受益人(器械组，n = 1132；对照组，n = 4,376)，女性占45%，中位年龄71岁（Q1-Q3: 67-75岁），中位随访时间2.58年（Q1-Q3: 1.17-3.97年）。器械组缺血性卒中复发风险（1.65 [95% CI: 1.18-2.13]事件/ 100患者-年）显著低于对照组（2.66 [95% CI: 2.33-3.00]事件/ 100患者-年）(HR: 0.62；95% ci: 0.44-0.88；P = 0.007)。死亡的30天安全事件发生率无差异，但静脉血栓栓塞(1.86% vs 0.37%；P & lt;0.001)和心房颤动或扑动(1.41% vs 0.64%；P = 0.01)。结论：在一项真实的美国60岁患者队列中，与单纯药物治疗相比，PFO关闭与缺血性卒中复发风险降低相关，同时保持临床可接受的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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PFO Device Closure in Patients >60 Years of Age With Ischemic Stroke

Background

Transcatheter closure of patent foramen ovale (PFO) is a recommended stroke reduction option in patients ≤60 years of age with cryptogenic ischemic stroke, but data on clinical outcomes following PFO closure in patients >60 years of age are scarce.

Objectives

The aim of this real-world evidence study was to evaluate the clinical outcomes of PFO closure in patients >60 years of age in the United States.

Methods

Medicare fee-for-service data from 2016 to 2022 were used to identify patients >60 years of age who were hospitalized with ischemic stroke and diagnosed with PFO or atrial septal defect and also had ≥6 months of prior fee-for-service coverage. Patients who were implanted with the Amplatzer or Talisman PFO occluder (device group) were identified by linkage to a manufacturer device-tracking database and were propensity score matched (1:4) to those who did not undergo device implantation (control group). Acute safety events through 30 days and recurrent ischemic stroke through 3 years were evaluated.

Results

A total of 20,999 Medicare beneficiaries (device group, n = 1,132; control group, n = 19,867) met the inclusion criteria. The matched cohort included 5,508 Medicare beneficiaries (device group, n = 1,132; control group, n = 4,376), with 45% women, a median age of 71 years (Q1-Q3: 67-75 years), and median follow-up of 2.58 years (Q1-Q3: 1.17-3.97 years). The risk for recurrent ischemic stroke was significantly lower in the device group (1.65 [95% CI: 1.18-2.13] events per 100 patient-years) than the control group (2.66 [95% CI: 2.33-3.00] events per 100 patient-years) (HR: 0.62; 95% CI: 0.44-0.88; P = 0.007). Rates of 30-day safety events were not different for death, but venous thromboembolism (1.86% vs 0.37%; P < 0.001) and atrial fibrillation or flutter (1.41% vs 0.64%; P = 0.01) were more common in the device group.

Conclusions

In a real-world U.S. cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical therapy alone, while maintaining a clinically acceptable safety profile.

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.