Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease

Abstract

Objective: Arterial closure devices (ACDs) seem to be safe and effective to obtain hemostasis for cardiac interventions and diagnostic vascular procedures. However, only limited evidence is presented on therapeutic interventions in patients with peripheral atherosclerotic disease. We compared ischemic and hemorrhagic complications of an ACD vs manual compression (MC) after puncture of the femoral artery for endovascular lower extremity procedures.

Methods: The records of all subsequent endovascular interventions for peripheral artery disease performed in a large teaching hospital, from January 2012 to April 2014, were retrospectively reviewed. The primary outcome was an ischemic complication requiring reintervention. Secondary outcomes were hematoma (needing conservative or invasive intervention) and infection (needing intervention or antibiotics). Multivariate analysis was performed to identify predictors for any complication.

Results: The Angio-Seal (St. Jude Medical, Minnetonka, Minn) closure device was used in 244 of 463 endovascular interventions (54%). Five patients (2%) who received an ACD needed emergency surgery for ischemic complications vs none in the MC group (P = .06). Hematomas occurred in 22 patients (9%) after ACD vs in six (3%) after MC (adjusted odds ratio [OR], 3.4; 95% confidence interval [CI], 1.4-8.9; P = .015). There were no infections in either group. ACD (OR, 3.8; 95% CI, 1.5-9.7) and current smoking (OR, 2.6; 95% CI, 1.01-6.7) were independent predictors for any complication.

Conclusions: This study demonstrates that ACD use in patients with peripheral artery disease can lead to serious adverse events resulting in increased morbidity. Therefore, the potential benefits of an ACD over MC should be carefully weighed.