Valvular and Structural Heart Diseases
The use of vascular closure devices and impact on major bleeding and net adverse clinical events (NACEs) in balloon aortic valvuloplasty: A sub-analysis of the BRAVO study
Article first published online: 25 MAR 2013
Copyright © 2013 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 83, Issue 1, pages 148–153, 1 January 2014
How to Cite
O'Neill, B., Singh, V., Kini, A., Mehran, R., Jacobs, E., Knopf, D., Alfonso, C. E., Martinez, C. A., Martinezclark, P., O'Neill, W., Heldman, A. W., Yu, J., Baber, U., Kovacic, J. C., Dangas, G., Sharma, S., Sartori, S. and Cohen, M. G. (2014), The use of vascular closure devices and impact on major bleeding and net adverse clinical events (NACEs) in balloon aortic valvuloplasty: A sub-analysis of the BRAVO study. Cathet. Cardiovasc. Intervent., 83: 148–153. doi: 10.1002/ccd.24892
- Issue published online: 18 DEC 2013
- Article first published online: 25 MAR 2013
- Accepted manuscript online: 21 FEB 2013 11:10PM EST
- Manuscript Accepted: 17 FEB 2013
- Manuscript Revised: 16 JAN 2013
- Manuscript Received: 9 OCT 2012
- balloon aortic valvuloplasty;
- aortic stenosis;
- closure devices
To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV).
Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding.
The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10–13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use.
Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P < 0.001), a history of prior BAV (11.1% vs. 3.6%, P = 0.04) and peripheral vascular disease (30.7% vs. 19.7%, P = 0.01) was more common in those not undergoing preclosure (n = 159, 37%). Other clinical and demographic features were well balanced between groups. Vascular closure was associated with a significant reduction in NACE (24.5% vs. 10.0% P < 0.001). Results remained significant after adjusting for baseline differences and bivalirudin use (OR 0.38, 95% CI: 0.21–0.68; P = 0.001).
Our study suggests that suture-mediated vascular closure is associated with a substantial reduction in NACE after transfemoral BAV. Large randomized clinical trials should be conducted to confirm our results.© 2013 Wiley Periodicals, Inc.