Author + information
- Received April 21, 2016
- Revision received June 27, 2016
- Accepted July 14, 2016
- Published online October 24, 2016.
- S1936879816311402-390c0c6b3303f7290da7267f3107c03fGennaro Giustino, MDa,
- S1936879816311402-954c0e442dda11ea9fe815a36852b4b3Roxana Mehran, MDa,
- S1936879816311402-68345a795bf62423f259775db3839e7cRoland Veltkamp, MDb,
- S1936879816311402-2c48752bf07f14ec90f35c84c9db62b0Michela Faggioni, MDa,
- S1936879816311402-5b7b375dab503053708852ae29b9fc39Usman Baber, MDa and
- S1936879816311402-1faeab01d76932a52311a433244b7451George D. Dangas, MD, PhDa,∗ ()
- aInterventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bDepartment of Stroke Medicine, Division of Brain Sciences, Imperial College, London, United Kingdom
- ↵∗Reprint requests and correspondence:
Dr. George D. Dangas, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
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.
Dr. Dangas is unpaid consultant to Bayer Daiichi-Sankyo and Medtronic and his spouse has received consulting fees (minor level) for Janssen and AstraZeneca and has stock options (minor level) of Claret Medical. Dr. Mehran has received consulting fees from Janssen and AstraZeneca and stock options (<1%) of Claret Medical. Dr. Veltkamp has received research support and consulting and speaking honoraria from Bayer, Boehringer, Bristol-Myers Squibb, Pfizer, Daiichi-Sankyo, Medtronic, Morphosys, St. Jude Medical, Apoplex Medical Technologies, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 21, 2016.
- Revision received June 27, 2016.
- Accepted July 14, 2016.
- American College of Cardiology Foundation