Purpose: To test the percutaneous introducibility of the expandable vascular sheath (EVS) system and the safety of percutaneous balloon-assisted thrombectomy.
Methods: The EVS was inserted directly (n= 9) or through a 9.5 Fr regular vascular introducer sheath (n= 9) into the femoral arteries and veins and carotid arteries in four dogs (18–21 kg). Balloon-assisted thrombectomies were simulated in iliac arteries. Histologic examinations were done at sites of funnel deployment immediately (n= 4) and 25 days (n= 8) after the intervention.
Results: The EVS was successfully introduced into six of nine vessels by a direct percutaneous approach. Balloon-assisted thrombectomy using the EVS device caused localized intimal denudation, disruption of the internal elastic lamina, and mild hemorrhages into the media; one arterial dissection at the site of funnel deployment was seen. All indirect insertions and funnel deployments were successful. Twenty-five days after the experiments, intimal hyperplasia was noted in all cases.
Conclusion: Percutaneous balloon-assisted thrombectomy may cause mild vascular injuries. Direct percutaneous introduction of the EVS device cannot be recommended yet.