Author + information
- Received August 12, 2011
- Revision received April 12, 2012
- Accepted May 12, 2012
- Published online August 1, 2012.
- Venkatesan D. Vidi, MD, MPH⁎,
- Michael E. Matheny, MD, MS, MPH†,‡,
- Usha S. Govindarajulu, PhD⁎,
- Sharon-Lise T. Normand, PhD§∥,
- Susan L. Robbins, BS⁎,
- Vikram V. Agarwal, MD, MPH¶,
- Sripal Bangalore, MD, MHA# and
- Frederic S. Resnic, MD, MSc⁎,⁎ ()
- ↵⁎Reprint requests and correspondence
: Dr. Frederic Resnic, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115
Objectives The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs.
Background VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.
Methods From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug–based (n = 18,533), a nitinol clip–based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.
Results Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug–based, 6.1% of suture-based, 9.5% of nitinol clip–based VCDs). Patients with VCD failure had an excess risk of “any” (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score–adjusted analysis, when compared with collagen plug–based VCD (reference odds ratio [OR] = 1.0), nitinol clip–based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug–based VCD and nitinol clip–based VCD, but not for suture-based VCD.
Conclusions VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.
This study was funded, in part, by grants from the National Institutes of Health (NIH R01-LM008142) and the Veteran's Administration Health Services Research and Development Service (CDA 2-2008-020).
Dr. Bangalore is on the advisory board of Daiicho Sankyo. Dr. Resnic is a consultant of Medtronic Inc., St. Jude Medical, and Agfa Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. This paper was presented in part at the 2011 Annual Scientific Session of the American College of Cardiology, New Orleans, Louisiana, on April 5, 2011.
- Received August 12, 2011.
- Revision received April 12, 2012.
- Accepted May 12, 2012.
- American College of Cardiology Foundation