First pilot study with the TriGUARD 3 Cerebral Embolic Protection Device
DOI: 10.4244/EIJ-D-19-00741
Pedro G Magalhaes1, ; Nynke HM Kooistra2; Geert EH Leenders3; Pauliina M Margolis4; Alexandra J Lansky5; Adriaan O Kraaijeveld3; Michiel Voskuil3; Pieter Stella6, ;
1. Hospital de Vila Real, Cardiology, Vila Real, Portugal 2. Cardiology Department, Division Heart & Lungs, University Medical Center Utrecht (UMCU), Utrecht, Netherlands 3. Interventional Cardiology Department, Division Heart & Lungs, University Medical Center Utrecht (UMCU), Utrecht, Netherlands 4. Chief Medical Officer at Keystone Heart 5. Cardiovascular Medicine, Heart and Vascular Clinical Research Program, Yale University School of Medicine, Connecticut, US 6. Interventional Cardiology Department, Division Heart & Lungs, University Medical Center Utrecht (UMCU), Utrecht, Netherlands, NETHERLANDS
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A substantial proportion of patients submitted to transcatheter aortic valve replacement (TAVR) continues to be affected by procedure-related neurological events, with 30-day clinical stroke rates in the range of 4-7%. Also, routine neuroimaging studies reveal that ischemic cerebral infarction caused by showers of cerebral emboli during valve instrumentation and placement affect virtually all patients undergoing TAVR [1-3].
In order to prevent these embolic phenomena several cerebral embolic protection devices (CEPD) have been recently developed and their use during TAVR was associated with improved early imaging and clinical neurological outcomes [1].
The TriGUARD and TriGUARD HDH have previously shown reductions in new ischemic brain lesions and total lesion volume (TLV) per-patient in diffusion-weighted magnetic resonance imaging (DW-MRI) in the DEFLECT I and III trials [2,3].
The present study was a prospective, single center, single arm pilot study to evaluate the safety and performance of the newest TriGUARD 3 CEPD in patients undergoing TAVR.