Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial).
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.
Pedersen
Wes R
WR
Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota 55407, USA. wpedersen@mplsheart.com
Van Tassel
Robert A
RA
Pierce
Talia A
TA
Pence
David M
DM
Monyak
David J
DJ
Kim
Tae H
TH
Harris
Kevin M
KM
Knickelbine
Thomas
T
Lesser
John R
JR
Madison
James D
JD
Mooney
Michael R
MR
Goldenberg
Irvin F
IF
Longe
Terrence F
TF
Poulose
Anil K
AK
Graham
Kevin J
KJ
Nelson
Richard R
RR
Pritzker
Marc R
MR
Pagan-Carlo
Luis A
LA
Boisjolie
Charlene R
CR
Zenovich
Andrey G
AG
Schwartz
Robert S
RS
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