Open surgical versus minimally invasive in situ femorodistal bypass: Long-term results

Purpose: To compare long-term patency and limb survival rates for the classical in situ surgical bypass procedure versus a minimally invasive technique for femorodistal revascularization. Methods: From May 1992 to June 1994, a prospective multicenter study was undertaken at 4 centers to evaluate the open versus closed technique for femorodistal bypass grafting. Of 97 patients enrolled in the trial, 73 patients (49 men; mean age 71 years) were assigned to the long-term follow-up protocol and prospectively randomized to the open (n = 38) or closed (n = 35) procedure. The classical open technique is characterized by along incision over the length of the bypass graft, while the minimally invasive procedure involves only two short incisions over each anastomosis site (the side branches are closed with a coaxial embolization catheter system). Graft patency was evaluated with duplex imaging periodically throughout the 4-year observation period. Results: There was no statistically significant difference between the treatment groups with respect to age, sex, hypertension, ischemic heart disease, or smoking. However, the open group had a significantly greater incidence of diabetes (p = 0.037). Over a median 4.7-year follow-up (range 0.3-6.4), 9 (12%) patients (3 open and 6 closed) were lost to follow-up: 2 died and 7 refused the duplex examination. No significant differences in 4-year patency, limb salvage, or survival was demonstrated between the open versus closed treatment groups; 4-year secondary patency was 62% versus 64%, respectively, and limb salvage was 72% versus 86%. Conclusions: The closed technique for femorodistal in situ bypass procedures yields favorable long-term outcomes compared to the traditional open technique.