title: Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial).
abstract: OBJECTIVE
  We wished to determine the feasibility and early safety of external beam radiation therapy (EBRT) used following balloon aortic valvuloplasty (BAV) to prevent restenosis.
  
  
  BACKGROUND
  BAV for calcific aortic stenosis (AS) has been largely abandoned because of high restenosis rates, i.e., > 80% at 1 year. Radiation therapy is useful in preventing restenosis following vascular interventions and treating other benign noncardiovascular disorders.
  
  
  METHODS
  We conducted a 20-patient, pilot study evaluating EBRT to prevent restenosis following BAV in elderly patients with calcific AS. Total doses ranging from 12-18 Gy were delivered in fractions over a 3-5 day post-op period to the aortic valve. Echocardiography was performed pre and 2 days post-op, 1, 6, and 12 months following BAV.
  
  
  RESULTS
  One-year follow-up is completed (age 89 +/- 4). There were no complications related to EBRT. Eight patients died prior to 1 year; 5 of 10 (50%) in the low-dose (12 Gy) group and 3 of 10 (30%) in the high-dose (15-18 Gy) group. None of these 8 patients had restenosis, i.e., > 50% loss of the initial AVA gain, and only three deaths were cardiac in origin. One patient underwent aortic valve replacement and none repeated BAV. By 1 year, 3 of the initial 10 (30%) in the low-dose group and 1 of 9 (11%) in the high-dose group demonstrated restenosis (21% overall).
  
  
  CONCLUSIONS
  EBRT following BAV in elderly patients with AS is feasible, free of early complications, and holds promise in reducing the 1 year restenosis rate in a dose-dependent fashion.
authors.affiliation: Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota 55407, USA. wpedersen@mplsheart.com
authors.forename: Wes R
authors.initials: WR
authors.lastname: Pedersen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Van Tassel
authors.forename: Talia A
authors.initials: TA
authors.lastname: Pierce
authors.forename: David M
authors.initials: DM
authors.lastname: Pence
authors.forename: David J
authors.initials: DJ
authors.lastname: Monyak
authors.forename: Tae H
authors.initials: TH
authors.lastname: Kim
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Harris
authors.forename: Thomas
authors.initials: T
authors.lastname: Knickelbine
authors.forename: John R
authors.initials: JR
authors.lastname: Lesser
authors.forename: James D
authors.initials: JD
authors.lastname: Madison
authors.forename: Michael R
authors.initials: MR
authors.lastname: Mooney
authors.forename: Irvin F
authors.initials: IF
authors.lastname: Goldenberg
authors.forename: Terrence F
authors.initials: TF
authors.lastname: Longe
authors.forename: Anil K
authors.initials: AK
authors.lastname: Poulose
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Graham
authors.forename: Richard R
authors.initials: RR
authors.lastname: Nelson
authors.forename: Marc R
authors.initials: MR
authors.lastname: Pritzker
authors.forename: Luis A
authors.initials: LA
authors.lastname: Pagan-Carlo
authors.forename: Charlene R
authors.initials: CR
authors.lastname: Boisjolie
authors.forename: Andrey G
authors.initials: AG
authors.lastname: Zenovich
authors.forename: Robert S
authors.initials: RS
authors.lastname: Schwartz
mesh_terms: D000369:Aged, 80 and over; D001011:Aorta / Q000528:radiation effects; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000517:prevention & control* / Q000628:therapy; D001918:Brachytherapy; D002404:Catheterization; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011878:Radiotherapy / Q000379:methods; D011879:Radiotherapy Dosage; D012008:Recurrence