Peripheral artery recanalization in humans using balloon and laser angioplasty.

The treatment of patients with complex peripheral arterial disease and those who have had previous unsuccessful attempted revascularization procedures can be clinically challenging. Initial treatment was begun using therapy by percutaneous balloon and laser angioplasty, then proceeding to bypass surgery if severe ischemia persisted. Both percutaneous and cut-down approaches were used to access totally occluded arteries. An attempt was made to cross the occlusion mechanically with either a guide wire or an activated laser probe. If laser recanalization was not successful, the patient underwent bypass surgery or was managed with medication unless an amputation was necessary. Following initial screening of 381 patients, 115 procedures were performed on 103 patients. In 31 procedures (28 patients), only balloon angioplasty was performed. In 84 procedures (75 patients), laser recanalization was attempted: 55 percutaneously and 29 by cut-down. Overall technical success (crossing the obstruction without perforation) was 86/115 (75%). Technically successful procedures were characterized by shorter arterial occlusions than were technical failures (8.4 +/- 1 cm vs. 14.3 +/- 1.9 cm; p < 0.004). Clinical success (residual stenosis < 50%, symptom relief, improved ankle brachial index > or = 0.15, and no complications) was achieved in 22/31 (71%) of balloon angioplasty procedures alone. The stenoses decreased from 98 +/- 4% to 31 +/- 24%, p < 0.00001. Combined percutaneous laser and balloon angioplasty had a technical success of 36/55 (65%). Stenoses were reduced from 99 +/- 2% to 56 +/- 14% after laser angioplasty, to 30 +/- 15% after balloon angioplasty, p < 0.0001. Laser angioplasty performed via a cut-down had a clinical success of 9/29 (31%). However, major complications were rare. Device staging for treatment of peripheral vascular disease provides additional options for patients who are at high surgical risk and/or in whom standard therapy has failed.