Department of Cardiovascular Medicine, Heart Vascular and Thoracic Institute, Cleveland Clinic Cleveland OH USA.
J Am Heart Assoc. 2024 Aug 6;13(15):e034298. doi: 10.1161/JAHA.124.034298. Epub 2024 Aug 5.
Studies have shown inconclusive results on the effectiveness of cerebral protection devices (CPDs) with transcatheter aortic valve replacement. We aimed to analyze the national statistics on stroke and other outcomes with CPD use.
The Nationwide Readmissions Database (2017-2020) was queried to obtain data on patients undergoing transcatheter aortic valve replacement. Outcomes were compared between patients with a CPD and patients without a CPD. Of 271 804 patients undergoing transcatheter aortic valve replacement, CPD was used in 7.3% of patients. In a multivariable logistic regression analysis, CPD use was not associated with lower overall stroke rates (1.6% versus 1.9% without CPD; odds ratio, 0.95 [95% CI, 0.84-1.07]; =0.364), but it was significantly associated with lower major stroke rates (1.2% versus 1.5% without CPD; odds ratio, 0.85 [95% CI, 0.74-0.98]; =0.02). Patients with a CPD also had a shorter length of stay, higher routine discharges to home/self-care (74.9% versus 70.6%), and lower mortality rates (0.7% versus 1.3%). The 30-day (9.6% versus 11.7%) and 180-day (24.6% versus 28.2%) readmission rates were significantly lower in the CPD cohort. Among patients who developed stroke, patients with a CPD had more frequent routine discharges. Prior valve surgery was associated with the highest risk of overall and major stroke.
CPD use during transcatheter aortic valve replacement was not independently associated with a lower risk of overall stroke but was associated with a lower risk of major stroke in a multivariable model. Data from future randomized trials that may offset any potential confounders in our study are required to help identify patients who would benefit from the use of these devices.
研究表明，经导管主动脉瓣置换术中使用脑保护装置（CPD）的效果尚无定论。我们旨在分析 CPD 使用与中风和其他结局的全国统计数据。
从全国再入院数据库（2017-2020 年）中检索接受经导管主动脉瓣置换术的患者数据。将使用 CPD 的患者与未使用 CPD 的患者的结局进行比较。在 271804 例接受经导管主动脉瓣置换术的患者中，7.3%的患者使用了 CPD。在多变量逻辑回归分析中，CPD 的使用与较低的总体中风发生率无关（CPD 组为 1.6%，无 CPD 组为 1.9%；优势比，0.95[95%CI，0.84-1.07]；=0.364），但与较低的主要中风发生率显著相关（CPD 组为 1.2%，无 CPD 组为 1.5%；优势比，0.85[95%CI，0.74-0.98]；=0.02）。使用 CPD 的患者的住院时间更短，常规出院回家/自我护理的比例更高（74.9%比 70.6%），死亡率更低（0.7%比 1.3%）。CPD 组的 30 天（9.6%比 11.7%）和 180 天（24.6%比 28.2%）再入院率显著降低。在发生中风的患者中，使用 CPD 的患者常规出院的比例更高。既往瓣膜手术与总体和主要中风的风险最高相关。
在经导管主动脉瓣置换术中使用 CPD 与总体中风风险降低无关，但与多变量模型中的主要中风风险降低相关。需要来自未来随机试验的数据来帮助确定哪些患者将从这些设备的使用中获益，这些数据可能会抵消我们研究中的任何潜在混杂因素。
