WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.
“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.
The finding was based on data derived from the SENTINEL IDE and SENTINEL H studies, which were conducted to evaluate whether capture of debris by the Sentinel Cerebral Protection System (CPS) during TAVR procedures reduces risk of stroke and other embolic events. Of the 526 patients participating in these studies, Dr. Schmidt presented histopathological and histomorphological data from 246 patients at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center. The primary results of the SENTINEL studies were presented previously.Of the 246 patients, 145 (59%) received a Sapien 3 device, 40 (16%) received an Evolut R, 36 (14%) received a Lotus, and 25 (10%) received a Sapien XT. Particle features based on histopathological and histomorphological analyses were compared. A multivariate analysis was conducted to test for interaction with the amount of debris according to patient demographics and procedural characteristics, which differed for the devices evaluated.