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Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial)
Author(s) -
Pedersen Wes R.,
Van Tassel Robert A.,
Pierce Talia A.,
Pence David M.,
Monyak David J.,
Kim Tae H.,
Harris Kevin M.,
Knickelbine Thomas,
Lesser John R.,
Madison James D.,
Mooney Michael R.,
Goldenberg Irvin F.,
Longe Terrence F.,
Poulose Anil K.,
Graham Kevin J.,
Nelson Richard R.,
Pritzker Marc R.,
PaganCarlo Luis A.,
Boisjolie Charlene R.,
Zenovich Andrey G.,
Schwartz Robert S.
Publication year - 2006
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.20818
Subject(s) - medicine , restenosis , aortic valvuloplasty , percutaneous , balloon , aortic valve , cardiology , stenosis , surgery , aortic valve replacement , aortic valve stenosis , radiology , stent
Objectives: 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. © 2006 Wiley‐Liss, Inc.