Gennaro Giustino1, Roxana Mehran1, Roland Veltkamp2, Michela Faggioni1, Usman Baber1, George D Dangas3. 1. Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Department of Stroke Medicine, Division of Brain Sciences, Imperial College, London, United Kingdom. 3. Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: george.dangas@mountsinai.org.
Abstract
OBJECTIVES: The aim of this study was to investigate the efficacy and safety of intraprocedural embolic protection (EP) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Randomized controlled trials (RCTs) investigating the efficacy of EP devices during TAVR were relatively underpowered. METHODS: A systematic review and study-level meta-analysis was performed of randomized controlled trials that tested the efficacy and safety of EP during TAVR. Trials using any type of EP and TAVR vascular access were included. Primary imaging efficacy endpoints were total lesion volume and number of new ischemic lesions. Primary clinical efficacy endpoints were any deterioration in National Institutes of Health Stroke Scale and Montreal Cognitive Assessment scores at hospital discharge. Primary analyses were performed using the intention-to-treat approach. RESULTS: Four randomized clinical trials (total n = 252) were included. Use of EP was associated with lower total lesion volume (standardized mean difference -0.65; 95% confidence interval [CI]: -1.06 to -0.25; p = 0.002) and smaller number of new ischemic lesions (standardized mean difference -1.27; 95% CI: -2.45 to -0.09; p = 0.03). EP was associated with a trend toward lower risk for deterioration in National Institutes of Health Stroke Scale score at discharge (risk ratio: 0.55; 95% CI: 0.27 to 1.09; p = 0.09) and higher Montreal Cognitive Assessment score (standardized mean difference 0.40; 95% CI: 0.04 to 0.76; p = 0.03). Risk for overt stroke and all-cause mortality were nonsignificantly lower in the EP group. CONCLUSIONS: Use of EP seems to be associated with reductions in imaging markers of cerebral infarction and early clinical neurological effectiveness in patients undergoing TAVR.
OBJECTIVES: The aim of this study was to investigate the efficacy and safety of intraprocedural embolic protection (EP) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Randomized controlled trials (RCTs) investigating the efficacy of EP devices during TAVR were relatively underpowered. METHODS: A systematic review and study-level meta-analysis was performed of randomized controlled trials that tested the efficacy and safety of EP during TAVR. Trials using any type of EP and TAVR vascular access were included. Primary imaging efficacy endpoints were total lesion volume and number of new ischemic lesions. Primary clinical efficacy endpoints were any deterioration in National Institutes of Health Stroke Scale and Montreal Cognitive Assessment scores at hospital discharge. Primary analyses were performed using the intention-to-treat approach. RESULTS: Four randomized clinical trials (total n = 252) were included. Use of EP was associated with lower total lesion volume (standardized mean difference -0.65; 95% confidence interval [CI]: -1.06 to -0.25; p = 0.002) and smaller number of new ischemic lesions (standardized mean difference -1.27; 95% CI: -2.45 to -0.09; p = 0.03). EP was associated with a trend toward lower risk for deterioration in National Institutes of Health Stroke Scale score at discharge (risk ratio: 0.55; 95% CI: 0.27 to 1.09; p = 0.09) and higher Montreal Cognitive Assessment score (standardized mean difference 0.40; 95% CI: 0.04 to 0.76; p = 0.03). Risk for overt stroke and all-cause mortality were nonsignificantly lower in the EP group. CONCLUSIONS: Use of EP seems to be associated with reductions in imaging markers of cerebral infarction and early clinical neurological effectiveness in patients undergoing TAVR.
Authors: Alexander C Fanaroff; Pratik Manandhar; David R Holmes; David J Cohen; J Kevin Harrison; G Chad Hughes; Vinod H Thourani; Michael J Mack; Matthew W Sherwood; W Schuyler Jones; Sreekanth Vemulapalli Journal: Circ Cardiovasc Interv Date: 2017-10 Impact factor: 6.546
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: Ozan M Demir; Gianmarco Iannopollo; Antonio Mangieri; Marco B Ancona; Damiano Regazzoli; Satoru Mitomo; Antonio Colombo; Giora Weisz; Azeem Latib Journal: Front Cardiovasc Med Date: 2018-10-23