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Vascular closure device failure in contemporary practice
Venkatesan D Vidi1, Michael E Matheny, Usha S Govindarajulu
1Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Insights
Vascular closure device (VCD) failure rates differ by device type and are linked to increased vascular complications. Nitinol clip-based VCDs showed the highest failure rates and risk of complications.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
Background:
- Vascular closure devices (VCDs) are widely used after percutaneous coronary interventions to improve patient outcomes.
- Limited data exist on VCD failure rates and their association with vascular complications.
Purpose of the Study:
- To determine the frequency and predictors of VCD deployment failure.
- To assess the association between VCD failure and vascular complications for three common VCD types.
Main Methods:
- Analysis of 23,813 interventional coronary procedures using collagen plug-based, nitinol clip-based, or suture-based VCDs.
- VCD failure defined as unsuccessful deployment or failure to achieve immediate hemostasis.
- Propensity score-adjusted analysis to compare VCD failure risks and complication rates.
Main Results:
- Overall VCD failure rate was 3.3%, with nitinol clip-based (9.5%) and suture-based (6.1%) devices having higher failure rates than collagen plug-based (2.1%).
- VCD failure significantly increased the risk of any, major, and minor vascular complications.
- Nitinol clip-based and suture-based VCDs showed increased odds of failure compared to collagen plug-based VCDs.
Conclusions:
- VCD failure rates vary significantly by device type.
- VCD failure is a strong predictor of vascular complications, emphasizing the importance of device selection and deployment success.
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.
