Preliminary experience with the Xtrak debulking device in the treatment of peripheral occlusions.

PURPOSE: To report our initial experience with a new rotary debulking device designed for treating long, diffusely diseased arterial segments.

METHODS: Ten symptomatic patients (8 men; mean age 63 years, range 34-76) with occluded superficial femoral (n = 6) or popliteal (n = 4) arteries were enrolled into a study to evaluate the debulking capabilities of a rotational atherectomy device. Occlusion length ranged from 4.0 to 16.1 cm (mean 11.1 +/- 4.10). The occlusions were treated with a low-speed, over-the-wire rotary device featuring a flexible, spiral "corkscrew" that embeds itself in the obstructive material while a rotary cutting catheter simultaneously cuts and captures the obstruction in a single pass.

RESULTS: The device cut and retrieved material in a single pass from all segments without device-related complications. The captured material consisted of a mixture of atherosclerotic plaque and thrombus. Minimum lumen diameters (MLD) increased from 0.0 to 2.2 +/- 1.09 mm (p<0.05) after Xtrak treatment and to 4.09 +/- 1.20 mm (p<0.05) after adjunctive balloon dilation, which was used in 8 of 10 segments. All patients improved clinically after the procedure, with an increased the mean ankle-brachial index sustained at 6 months (0.69 +/- 0.32, p<0.05 compared to baseline and 1-month measurements). Six months after the procedure, 7 patients remained free of clinical symptoms, while 3 patients required a subsequent intervention.

CONCLUSIONS: These initial results demonstrate that the Xtrak device can safely debulk long segments of diffusely diseased arteries in a single pass while simultaneously retrieving the occluding material. Supplementary angioplasty may be required in the majority of cases. Larger studies are required to determine whether debulking followed by balloon dilation improves the long-term prognosis in patients with chronic lower limb occlusions.