title: Benefits of external beam irradiation for peripheral arterial bypass: preliminary report on a phase I study.
abstract: OBJECTIVE
  To perform a Phase I study to determine the safety and feasibility of using external beam radiotherapy to prevent neointimal hyperplasia in patients after surgical bypass of occluded infrainguinal arteries.
  
  
  METHODS
  All patients undergoing operative infrainguinal bypass for chronic ischemia were eligible for enrollment, although those requiring a prosthetic graft were preferentially considered. Immediately after bypass, the distal anastomosis was marked with clips, and the baseline anatomy of the anastomosis was documented with an intraoperative angiogram. The distal anastomotic site and 2 cm of surrounding tissues were irradiated to a total dose of 30 Gy, delivered in 10 fractions. The first dose was given within 48 h of surgery.
  
  
  RESULTS
  Twenty-one patients were enrolled in this study. No anastomotic or wound problems or any other short-term complications of the treatment developed. However, at a mean follow-up of 10 months (range 3-18), 12 (57%) of the 21 grafts had occluded. Angiography was performed in 2 patients after successful thrombolysis and demonstrated normal anastomoses without residual stenosis. Evidence of stenosis at the irradiated anastomosis was seen in only 1 of the 21 patients by ongoing ultrasound surveillance.
  
  
  CONCLUSIONS
  Fractionated external irradiation to a total dose of 30 Gy delivered to the distal surgical anastomosis immediately after operative bypass has no short-term complications and was associated with an apparently low rate of intimal hyperplasia. However, any possible gains made by reducing the neointimal hyperplasia at the site of anastomosis were significantly diminished by the high frequency of thrombotic events.
authors.affiliation: Department of Radiation Oncology, University of Rochester Medical Center, 601 ElmwoodAvenue, Rochester, NY 14642, USA.
authors.forename: Arvind B
authors.initials: AB
authors.lastname: Soni
authors.forename: Karl A
authors.initials: KA
authors.lastname: Illig
authors.forename: Yaron
authors.initials: Y
authors.lastname: Sternbach
authors.forename: Paul
authors.initials: P
authors.lastname: Anthony
authors.forename: Phillip
authors.initials: P
authors.lastname: Jacob
authors.forename: Gopal
authors.initials: G
authors.lastname: Reddy
authors.forename: John
authors.initials: J
authors.lastname: Storey
authors.forename: Richard
authors.initials: R
authors.lastname: Gerety
authors.forename: Jacqueline P
authors.initials: JP
authors.lastname: Williams
authors.forename: Michael
authors.initials: M
authors.lastname: Schell
authors.forename: David
authors.initials: D
authors.lastname: Waldman
authors.forename: Philip
authors.initials: P
authors.lastname: Rubin
authors.forename: Richard
authors.initials: R
authors.lastname: Green
authors.forename: Paul
authors.initials: P
authors.lastname: Okunieff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D009131:Muscle, Smooth, Vascular / Q000502:physiology / Q000528:radiation effects*; D016491:Peripheral Vascular Diseases / Q000601:surgery*; D011836:Radiation Tolerance; D014656:Vascular Surgical Procedures