Divyanshu Mohananey1, Kesavan Sankaramangalam1, Arnav Kumar2, Yash Jobanputra1, Pedro Villablanca3, Amar Krishnaswamy1, Stephanie Mick4, Lars G Svensson4, E Murat Tuzcu5, Samir R Kapadia6. 1. Department of Cardiovascular Medicine, Cleveland Clinic, OH, United States. 2. Department of Cardiovascular Medicine, Emory University, GA, United States. 3. Division of Cardiology, New York University, NY, United States. 4. Department of Cardiothoracic surgery, Cleveland Clinic, OH, United States. 5. Department of Cardiovascular Medicine, Cleveland Clinic, Abu Dhabi, United Arab Emirates. 6. Department of Cardiovascular Medicine, Cleveland Clinic, OH, United States. Electronic address: KAPADIS@ccf.org.
Abstract
BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) occurs with an incidence of 4-11% and is a particularly devastating adverse event associated with the procedure. Several cerebral protection devices (CPD) have been developed to prevent cerebrovascular events during TAVR. While most studies have shown CPD to be associated with decreased number and volume of lesions on diffusion weighted magnetic resonance imaging, the clinical benefit of these devices remains uncertain. METHODS: We aimed to use meta-analysis techniques to study the clinical safety and efficacy of these CPD in prospective randomized and non-randomized studies. Data was summarized as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI). We used the Higgins' I2 statistic to evaluate heterogeneity. RESULTS: We found no evidence of difference between patients with and without CPD [RR 0.70 (95% CI 0.40-1.21)] for the primary composite outcome of stroke and mortality at 30 days. The two groups were also comparable in peri-procedural strokes [RR 0.53 (95% CI 0.27-1.07)], stroke at 30 days [RR 0.69(95% CI 0.38-1.26)], mortality [RR 0.59 (95% CI 0.22-1.59) at 30 days, AKI [RR 0.68(95% CI 0.28-1.62)], major bleeding [RR 0.56 (95% CI 0.26-1.18)], life threating bleeding [0.54 (95% CI 0.19-1.53)] and major vascular complications [RR 0.80 (95% CI 0.52-1.24)]. The risk of strokes within the first week of TAVR was significantly lower in the CPD group [0.56(95% CI 0.33-0.96)]. CONCLUSION: CPD are associated with a decreased incidence of strokes within 1 week of follow-up without showing any evidence of increased risk of other peri-procedural adverse events.
BACKGROUND:Stroke after transcatheter aortic valve replacement (TAVR) occurs with an incidence of 4-11% and is a particularly devastating adverse event associated with the procedure. Several cerebral protection devices (CPD) have been developed to prevent cerebrovascular events during TAVR. While most studies have shown CPD to be associated with decreased number and volume of lesions on diffusion weighted magnetic resonance imaging, the clinical benefit of these devices remains uncertain. METHODS: We aimed to use meta-analysis techniques to study the clinical safety and efficacy of these CPD in prospective randomized and non-randomized studies. Data was summarized as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI). We used the Higgins' I2 statistic to evaluate heterogeneity. RESULTS: We found no evidence of difference between patients with and without CPD [RR 0.70 (95% CI 0.40-1.21)] for the primary composite outcome of stroke and mortality at 30 days. The two groups were also comparable in peri-procedural strokes [RR 0.53 (95% CI 0.27-1.07)], stroke at 30 days [RR 0.69(95% CI 0.38-1.26)], mortality [RR 0.59 (95% CI 0.22-1.59) at 30 days, AKI [RR 0.68(95% CI 0.28-1.62)], major bleeding [RR 0.56 (95% CI 0.26-1.18)], life threating bleeding [0.54 (95% CI 0.19-1.53)] and major vascular complications [RR 0.80 (95% CI 0.52-1.24)]. The risk of strokes within the first week of TAVR was significantly lower in the CPD group [0.56(95% CI 0.33-0.96)]. CONCLUSION:CPD are associated with a decreased incidence of strokes within 1 week of follow-up without showing any evidence of increased risk of other peri-procedural adverse events.