Results of laser-assisted balloon angioplasty for peripheral arterial obstruction using a lensed fiber-tip delivery catheter

Percutaneous transluminal balloon angioplasty of obstructed iliac and femoral arteries is the therapy of choice in the management of selected patients with peripheral vascular disease. The advantages of percutaneous balloon angioplasty include a reduction in the morbidity of the revascularization procedure, a shorter hospital stay, and comparable 5-year patency rates when compared with surgical revascularization in selected patients.^1,2 One of the limitations of balloon angioplasty is that a lesion must first be crossed with a guidewire. The inability to cross occlusions with a guidewire is the most common cause of failure of the procedure. Laser angioplasty may have a role as an adjunct to balloon angioplasty by recanalizing lesions that cannot be traversed with a guidewire. The laser can create a channel through the arterial occlusion allowing the balloon catheter to be advanced across the lesion to further reduce the arterial stenosis. Early clinical trials of laser angioplasty in the peripheral arteries have demonstrated the unsatisfactory results obtained with single bare optical fibers used to deliver the laser energy due to the small channels created,³ and the high incidence of arterial perforatior not only increase the size of the lumen created with the laser fiber but also reduce the risk of mechanical perforation, we have modified the distal end with a spherical lens that increases the spot size of the laser fiber and provides an atraumatic tip for the optical fiber. This report describes the first human clinical trials including 6-month follow-up of patients treated with a lensed fiber-tip laser delivery system designed for percutaneous revascularization of peripheral vascular obstructive lesions not amenable to conventional balloon angioplasty.