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

Wes R. Pedersen, Robert A. Van Tassel, Talia A. Pierce, David M. Pence, David J. Monyak, Tae H. Kim, Kevin M. Harris, Thomas Knickelbine, John R. Lesser, James D. Madison, Michael R. Mooney, Irvin F. Goldenberg, Terrence F. Longe, Anil K. Poulose, Kevin J. Graham, Richard R. Nelson, Marc R. Pritzker, Luis A. Pagan-Carlo, Charlene R. Boisjolie, Andrey G. ZenovichRobert S. Schwartz

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)183-192
Number of pages10
JournalCatheterization and Cardiovascular Interventions
Volume68
Issue number2
DOIs
StatePublished - Aug 1 2006

Keywords

  • Aortic stenosis
  • Restenosis
  • Valvuloplasty

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