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Vascular closure device failure: frequency and implications: a propensity-matched analysis
Sripal Bangalore1, Nipun Arora, Frederic S Resnic
1Division of Cardiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
Insights
Vascular closure device (VCD) failure is rare, occurring in 2.7% of cases. However, VCD failure significantly increases the risk of vascular complications, necessitating close patient monitoring.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Vascular closure devices (VCDs) are widely used after cardiac catheterization to improve patient outcomes.
- The frequency and consequences of VCD failure remain incompletely understood.
Purpose of the Study:
- To define the incidence and clinical sequelae of VCD failure in a large patient cohort.
- To assess the association between VCD failure and vascular complications.
Main Methods:
- A prospective registry of 9823 patients undergoing cardiac catheterization using collagen plug-based (Angio-Seal) or suture-based (Perclose) VCDs was analyzed.
- VCD failure was defined as unsuccessful deployment or failure to achieve hemostasis.
- Vascular complications were categorized as major, minor, or any, and compared between successful and failed VCD deployments.
Main Results:
- VCD failure occurred in 2.7% of patients (268/9823), with a higher incidence in percutaneous coronary intervention (3.0%) versus diagnostic procedures (2.3%).
- Patients experiencing VCD failure had a significantly increased risk of any vascular complication (6.7% vs. 1.4%), major complication (1.9% vs. 0.6%), and minor complication (6.0% vs. 1.1%).
- This increased risk of vascular complications associated with VCD failure persisted even after propensity score matching.
Conclusions:
- Vascular closure device failure is an infrequent event in current clinical practice.
- Despite its rarity, VCD failure is strongly associated with a substantial rise in the risk of vascular complications.
- Close monitoring of patients experiencing VCD failure is crucial to manage potential complications effectively.
Background:
Vascular closure devices (VCDs) are effective in reducing the time to ambulation for patients undergoing cardiac catheterization procedures and in reducing the risk of vascular complications in selected patient cohorts. However, the frequency and consequence of failure of VCDs is not well defined.
Methods And Results:
From a prospective registry of consecutive patients undergoing cardiac catheterization at our center, 9823 patients who received either a collagen plug-based (Angio-Seal) or a suture-based (Perclose) VCD were selected for the study. VCD failure was defined as unsuccessful deployment or failure to achieve hemostasis. Major vascular complication was defined as any retroperitoneal hemorrhage, limb ischemia, or any surgical repair. Minor vascular complication was defined as any groin bleeding, hematoma (> or = 5 cm), pseudoaneurysm, or arteriovenous fistula. Any vascular complication was defined as either a major or minor vascular complication. Among the 9823 patients in the study, VCD failed in 268 patients (2.7%; 2.3% diagnostic versus 3.0% percutaneous coronary intervention; P=0.029). Patients with VCD failure had significantly increased risk of any (6.7% versus 1.4%; P<0.0001), major (1.9% versus 0.6%; P=0.006), or minor (6.0% versus 1.1%; P<0.0001) vascular complication compared with the group with successful deployment of VCD. The increased risk of vascular complication was unchanged in a propensity score-matched cohort.
Conclusions:
In contemporary practice, VCD failure is rare, but when it does fail, it is associated with a significant increase in the risk of vascular complications. Patients with VCD failure should be closely monitored.
