Julia Seeger1, Birgid Gonska1, Markus Otto2, Wolfgang Rottbauer1, Jochen Wöhrle3. 1. Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany. 2. Department of Neurology, University of Ulm, Ulm, Germany. 3. Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany. Electronic address: jochen.woehrle@uniklinik-ulm.de.
Abstract
OBJECTIVES: The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions. METHODS: A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders. RESULTS: Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint. CONCLUSIONS: In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR.
OBJECTIVES: The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions. METHODS: A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders. RESULTS: Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint. CONCLUSIONS: In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR.
Authors: Paul Toon Lim Chiam; Nien Shen Chan; Yean Teng Lim; Choon Pin Lim; Dinesh Nair; Tai Tian Lim; Chao Yang Soon; Brian Chung Hoe Khoo; Jimmy Lim; Kok Soon Tan; Leslie Lam; Peter Yan; Yau Wei Ooi; Mei Sian Chong Journal: Singapore Med J Date: 2022-02-24 Impact factor: 3.331
Authors: Neel M Butala; Raj Makkar; Eric A Secemsky; Dianne Gallup; Guillaume Marquis-Gravel; Andrzej S Kosinski; Sreekanth Vemulapalli; Javier A Valle; Steven M Bradley; Tarun Chakravarty; Robert W Yeh; David J Cohen Journal: Circulation Date: 2021-02-23 Impact factor: 39.918