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 a long 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.