Purpose: Neointimal hyperplasia is one of the limiting factors in infrainguinal prosthetic vascular grafting. We conducted a pilot study to assess the possible role of radiotherapy for the prevention of this proliferating cellular process.
Methods and materials: Ten patients (7 men, 3 women; median age: 73 years) suffering from critical leg ischemia were treated by infrainguinal revascularization using 6-mm polytetrafluoroethylene. Postoperative radiation therapy of the anastomotic sites started within 24 h. A dose of 20.4 Gy was delivered in 12 fractions in 2.5 weeks by external beam radiation with electrons. The target volume was defined as the clip-marked anastomotic region plus a 1.5-cm safety margin in each direction.
Results: Radiation therapy was technically feasible in all cases without radiation-related side effects. In one patient, radiotherapy had to be terminated prematurely, because of a hematoma at the distal anastomotic site with consequent skin necrosis. One patient developed an occlusion of a suprainguinal graft without anastomotic stenosis after 9 months; 2 other grafts occluded at 12-month intervals. At a median follow-up of 16 months, the remaining 6 patients had no signs of restenosis.
Conclusions: The restenosis rate of peripheral vascular grafts after external beam radiation was lower than expected without additional treatment. The value of this approach will now be determined in a randomized prospective trial.