Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial)

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.,...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2006-08, Vol.68 (2), p.183-192
Hauptverfasser: 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., Pagan-Carlo, Luis A., Boisjolie, Charlene R., Zenovich, Andrey G., Schwartz, Robert S.
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Sprache:eng
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Zusammenfassung: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.
ISSN:1522-1946
1522-726X
DOI:10.1002/ccd.20818