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Abstract
Objective Stroke may occur during transcatheter aortic valve replacement (TAVR) due to debris dislodgement into intracranial arteries. Sentinel Cerebral Protection System is a filter device designed to capture the debris in the brachiocephalic and left common carotid arteries. However, clinical studies have not shown reductions in cerebral infarction with the Sentinel, possibly due to incomplete coverage and large pore size (140 µm). The EnCompass F2, a self-expanding nitinol stent with filter membrane made of electrospun polyurethane and smaller pore size (average 28 µm), provides coverage to all three great vessels of the aortic arch by using a simple unsheath deployment technique. This in vitro study aimed to compare the efficacy of the EnCompass F2 device against the Sentinel device and unprotected controls.
Methods A silicone model of the human aorta with cervical arteries was connected to a peristaltic pump to simulate physiological flow patterns (5L/min). A mixture of polyethylene microspheres with variable sizes (small 45-53 µm, medium 106-125 µm, and large 250-300 µm) was injected into the origin of the ascending aorta without a device, or with cerebral protection using either the Sentinel or Encompass F2 devices. Particles were collected from the right vertebral artery (RVA), right common carotid artery (RCCA), left common carotid artery (LCCA), and left vertebral artery (LVA), and counted using a Multisizer Coulter Counter. The experiment was repeated nine times per group.
Results The EnCompass F2 device demonstrated significantly lower counts of small, medium, and large particles in all four vessels compared to unprotected controls. The Sentinel reduced large particles in three vessels but not in the LVA and did not reduce small or medium-sized particles in any vessels. The protection efficacy (η) of EnCompass F2 and Sentinel was 91.1% and 11.7% for small, 96.8% and 6.5% for medium, and 99.3% and 64.7% for large particles, respectively. The protection effect of EnCompass F2 was significantly better than that of the Sentinel for all particle sizes.
Conclusions In our in vitro model, the EnCompass F2 filter stent demonstrated superior efficacy in providing full cerebral protection with smaller pores compared to the partial protection offered by the Sentinel device, potentially contributing to improved cerebral protection.
Disclosures M. Ghovvati: None. T. Imahori: None. N. Fukui: None. A. Gajjar: None. M. Nakayama: None. L. Guo: None. S. Tateshima: None. G. Duckwiler: 2; C; EnCompass. N. Kaneko: 2; C; EnCompass.