E B Diethrich1, K Papazoglou. 1. Department of Cardiovascular Surgery, Arizona Heart Institute & Foundation, Phoenix 85006, USA.
Abstract
PURPOSE: To examine whether endoluminal grafts (ELGs) of radically expandable polytetrafluoroethylene (PTFE) can successfully form durable internal conduits to revascularize lengthy occlusive disease and exclude aneurysms in the femoropopliteal (FP) arteries. METHODS: Under protocol, implantation of an unpredilated PTFE tube ELG anchored with Palmaz stents using a low-profile percutaneous delivery system was attempted in 50 symptomatic patients for a variety of pathologies: (1) restenosis; (2) complex lesions unlikely to be treated successfully with other endoluminal therapies; (3) acute angioplasty failure; and (4) aneurysms. There were 37 occlusions, 14 stenoses, and 2 long, combined stenotic-aneurysmal lesions in 47 native arteries, 5 FP grafts, and 1 femorotibial (FT) vein graft. Thirty-two percent of the patients had < or = vessel runoff. The average lesion length was 20.4 +/- 11.4 cm (range 1.5 to 40), and the mean preoperative ankle-brachial index (ABI) at rest was 0.53 +/- 0.14. RESULTS: In a 20-month period through April 1995, 50 patients (34 males, 16 females; mean age 69.5 years, range 45 to 87) underwent 54 procedures in 53 limbs; 55 ELGs were successfully deployed in 51 limbs; 2 patients were converted to FP bypass owing to technical problems (96% procedural success). There were 18 inhospital complications: 1 distal wire dissection repaired with an additional ELG; 2 hematomas requiring surgical repair; 1 graft collapse; 1 pseudoaneurysm at the site of a mid-ELG leak; 7 minor access sequelae; and 6 acute ELG thromboses, 4 treated with lytic therapy and balloon dilation, 1 with open thrombectomy, and 1 with bypass grafting. The mean postoperative ABI was 1.01 +/- 0.10. During the 30-day postprocedure period, 2 ELGs rethrombosed and 2 other limbs (3 ELGs) occluded; 1 thrombosis and 1 rethrombosis were lysed successfully, but the other 2 patients had an FP bypass. Over the mean 8.3 +/- 5.5 month follow-up, 6 additional ELGs occluded and 1 reoccluded; 4 were successfully treated by endovascular techniques for a primary patency of 72% and secondary patency of 84% by life-table analysis. CONCLUSIONS: Endovascular grafting is a conceptually attractive technique that has the potential to expand the current boundaries of interventional treatment. This preliminary experience attests to the feasibility and safety of ELG deployment in the superficial femoral arteries. Whether such a device can match the durability of classical revascularization techniques remains to be determined in clinical trials when device configurations and deployment techniques have been standardized.
PURPOSE: To examine whether endoluminal grafts (ELGs) of radically expandable polytetrafluoroethylene (PTFE) can successfully form durable internal conduits to revascularize lengthy occlusive disease and exclude aneurysms in the femoropopliteal (FP) arteries. METHODS: Under protocol, implantation of an unpredilated PTFE tube ELG anchored with Palmaz stents using a low-profile percutaneous delivery system was attempted in 50 symptomatic patients for a variety of pathologies: (1) restenosis; (2) complex lesions unlikely to be treated successfully with other endoluminal therapies; (3) acute angioplasty failure; and (4) aneurysms. There were 37 occlusions, 14 stenoses, and 2 long, combined stenotic-aneurysmal lesions in 47 native arteries, 5 FP grafts, and 1 femorotibial (FT) vein graft. Thirty-two percent of the patients had < or = vessel runoff. The average lesion length was 20.4 +/- 11.4 cm (range 1.5 to 40), and the mean preoperative ankle-brachial index (ABI) at rest was 0.53 +/- 0.14. RESULTS: In a 20-month period through April 1995, 50 patients (34 males, 16 females; mean age 69.5 years, range 45 to 87) underwent 54 procedures in 53 limbs; 55 ELGs were successfully deployed in 51 limbs; 2 patients were converted to FP bypass owing to technical problems (96% procedural success). There were 18 inhospital complications: 1 distal wire dissection repaired with an additional ELG; 2 hematomas requiring surgical repair; 1 graft collapse; 1 pseudoaneurysm at the site of a mid-ELG leak; 7 minor access sequelae; and 6 acute ELG thromboses, 4 treated with lytic therapy and balloon dilation, 1 with open thrombectomy, and 1 with bypass grafting. The mean postoperative ABI was 1.01 +/- 0.10. During the 30-day postprocedure period, 2 ELGs rethrombosed and 2 other limbs (3 ELGs) occluded; 1 thrombosis and 1 rethrombosis were lysed successfully, but the other 2 patients had an FP bypass. Over the mean 8.3 +/- 5.5 month follow-up, 6 additional ELGs occluded and 1 reoccluded; 4 were successfully treated by endovascular techniques for a primary patency of 72% and secondary patency of 84% by life-table analysis. CONCLUSIONS: Endovascular grafting is a conceptually attractive technique that has the potential to expand the current boundaries of interventional treatment. This preliminary experience attests to the feasibility and safety of ELG deployment in the superficial femoral arteries. Whether such a device can match the durability of classical revascularization techniques remains to be determined in clinical trials when device configurations and deployment techniques have been standardized.