A new rotational thrombectomy catheter: System design and first clinical experiences

Purpose: To describe a new catheter for the percutaneous mechanical removal of fresh and organized thrombi, and to assess its efficacy and safety in v itro and in vivo. Methods: The catheter consists of a coated stainless steel spiral that rota tes at 40,000 rpm over a guidewire inside the whole length of an 8 Fr, sing le-lumen, polyurethane catheter, driving a dual-blade cutting crown. Abrade d occlusion material is sucked into the catheter head through distal side h oles and transported by the spiral into a reservoir at the proximal end. Th e efficacy of the device was tested in arterial models and fresh bovine car otid arteries (n = 72). In a clinical pilot study 10 patients (8 women, 2 m en; mean age 70.6 +/- 10.1 years) with occlusions of the superficial femora l artery (2-12 cm, mean 5.8 cm), not older than 4 weeks, underwent thrombec tomy with the new catheter. Results: in arterial models and bovine cadaver arteries the catheter comple tely removed fresh thrombi. Occlusion material of higher consistency was cu t into particles of 100-500 Crm and transported outside. Thrombectomy was s uccessful and vessel patency restored in all 10 patients. The ankle/ brachi al pressure index significantly (p < 0.0005) increased from 0.41 +/- 0.18 b efore intervention to 0.88 +/- 0.15 after 48 hr and to 0.84 +/- 0.20 after 3 months. Two reocclusions occurred within 14 days after the intervention. Conclusion: Thrombectomy with the new device appears to be feasible and saf e in patients with acute and subacute occlusions of the femoropopliteal art ery.