PERIPHERAL ARTERY RECANALIZATION IN HUMANS USING BALLOON AND LASER ANGIOPLASTY

The treatment of patients with complex peripher al arterial disease an d those who have had previous unsuccess ful attempted revascularizatio n procedures can be clinically challenging. Initial treatment was begu n using therapy by percutaneous balloon and laser angioplasty, then pr oceeding to bypass surgery if severe ischemia persisted. Both percutan eous and cut-down approaches were used to access totally occluded arte ries, An attempt was made to cross the occlusion mechanically with eit her a guide wire or an activated laser probe. If laser recanalization was not successful, the patient underwent bypass surgery or was manage d with medication unless an amputation was necessary. Following initia l screening of 381 patients, 115 procedures were performed on 103 pati ents. In 31 procedures (28 patients), only balloon angioplasty was per formed. In 84 procedures (75 patients), laser recanalization was attem pted: 55 percutaneously and 29 by cut-down. Overall technical success (crossing the obstruction without perforation) was 86/115 (75%). Techn ically successful procedures were characterized by shorter arterial oc clusions than were technical failures (8.4 +/- 1 cm vs. 14.3 +/- 1.9 c m; p < 0.004). Clinical success (residual stenosis < 50%, symptom reli ef, improved ankle brachial index greater than or equal to 0.15, and n o complications) was achieved in 22/31 (71%) of balloon angioplasty pr ocedures 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 an gioplasty, p < 0.0001. Laser angioplasty performed via a cut-down had a clinical success of 9/29 (31%). However, major complications were ra re. Device staging for treatment of peripheral vascular disease provid es additional options for patients who are at high surgical risk and/o r in whom standard therapy has failed.