Debate. Cerebral embolic protection systems in TAVI: there is some supportive evidence

Abstract

Answer: Former studies described that, during TAVI, loose debris like arterial wall fragments, thrombi, valve tissue, and foreign bodies often enters the circulation.1 These particles are the aftermath of the device making its way through the aorta towards the aortic annulus, the positioning and displacement of a calcified stenotic valve between the new valve stent and the aortic wall, and further manipulations to optimize results (postdilatation). To this date, numerous studies have been published on the safety and efficacy profile of these cerebral protection devices (CPD). Specifically, 4 randomized clinical trials have been published associated with the SENTINEL (Boston Scientific Corp., United States): MISTRAL-C,2 CLEAN TAVI,3 SENTINEL,4 and PROTECTED TAVR5 we can talk about later on. The MISTRAL-C trial used cerebral magnetic resonance imaging to demonstrate a significant reduction in the number of patients with multiple cerebral lesions (20% vs 0%; P = .03) and less cognitive impairment (4% vs 27%; P = .017). Similarly, the CLEAN TAVI trial also reported fewer novel lesions and of a smaller volume without any differences being reported in the number of clinical events in the group that used CPD. These studies demonstrated fragments being captured in almost in 100% of the cases. Several metanalyses6-13 also confirm these results regarding the number and volume of cerebral lesions described, and even some show lower rates of strokes in the DPC group.10,12,13 Therefore, we not only have the visual in situ demonstration of the particles being captured in the baskets following implantation, but also scientific evidence that CPD are effective capturing fragments released during TAVI that can land in cerebral circulation, thus lowering the number of cerebral lesions found on the magnetic resonance imaging during the procedure. However, whether capturing such particles with the device has a clear clinical benefit for its widespread use is still to be elucidated.