In this study, most of the debris was found to come from the vascular bed, but foreign body debris and debris from myocardium was also identified. One hypothesis for the greater debris from the Lotus and Evolut R devices is that these are positionable, raising the possibility that manipulation of the devices was the source of the debris, according to Dr. Schmidt. However, this hypothesis needs verification.
One message from this study is that “capture of debris is universal across different transcatheter valve types,” Dr. Schmidt said, adding that this “supports the benefit of using a CPS device in all TAVR procedures.”
Several commentators, including Jeffrey Popma, MD, director of the Interventional Cardiology Clinical Service at Beth Israel Deaconess Hospital, Boston, observed that it would be inappropriate to conclude that the greater debris observed in this study would necessarily translate into a difference in risk of embolic events for the devices evaluated with or without a CPS device. He and others emphasized no relationship to clinical risk was demonstrated in this study.
Dr. Schmidt reports no potential conflicts of interest.
SOURCE: Schmidt T et al. CROI 2018.