Purpose: The aim of this prospective randomized study was to evaluate the relative risks and advantages of using the Hemobahn graft for popliteal artery aneurysm (PAA) treatment compared with open repair (OR). The primary end point was patency rate; secondary end points were hospital stay and length of surgical procedure.
Methods: The study was a prospective, randomized clinical trial carried out at a single center from January 1999 to December 2003. Inclusion criteria were an aneurysmal lesion in the popliteal artery with a diameter > or = 2 cm at the angio-computed tomography (CT) scan, and proximal and distal neck of the aneurysm with a length of > 1 cm to offer a secure site of fixation of the stent graft. Exclusion criteria were age < 50 years old, poor distal runoff, contraindication to antiplatelet, anticoagulant, or thrombolytic therapy, and symptoms of nerve and vein compression. The enrolled patients were thereafter prospectively randomized in a 1-to-1 ratio between OR (group A) or endovascular therapy (ET) (group B). The follow-up protocol consisted of duplex ultrasound scan and ankle-brachial index (ABI) measured during a force leg flexion at 1, 3, and 6 months. Group B patients underwent an angio-CT scan and plain radiography of the knee with leg flexion (> 120 degrees) at 6 and 12 months, and then yearly.
Results: Between January 1999 and December 2003, 30 PAAs were performed: 15 OR (group A) and 15 ET (group B). Bypass and exclusion of the PAA was the preferred method of OR; no perioperative graft failure was observed. Twenty stent grafts were placed in 15 PAAs. Endograft thrombosis occurred in one patient (6.7%) in the postoperative period. The mean follow-up period was 46.1 months (range, 12 to 72 months) for group A and 45.9 months (range, 12 to 65 months) for group B. Kaplan-Meier analysis showed a primary patency rate of 100% at 12 months for OR and 86.7% at 12 months with a secondary patency rate of 100% at 12 and 36 months for ET. No statistical differences were observed at the log-rank test. The mean operation time (OR, 155.3 minutes; ET, 75.4 minutes) and hospital stay (OR, 7.7 days; ET, 4.3 days) were statistically longer for OR compared with ET (P < .01).
Conclusion: We can conclude, with the power limitation of the study, that PAA treatment can be safely performed by using either OR or ET. ET has several advantages, such as quicker recovery and shorter hospital stay.