Study Evaluates CLI After Use of Collagen Plug-Based VCDs in Interventional Cardiology Procedures

December 18, 2015—Because limited data are available on the frequency and predictors of vascular closure device (VCD) failure with subsequent vascular complications, a study was conducted to investigate the incidence, clinical characteristics, and treatment options in patients with critical limb ischemia (CLI) after use of a collagen plug-based VCD. Omran Amer, MD, et al published the findings in EuroIntervention (2015;11:816–823).

The investigators retrospectively interrogated a high-volume, single-center prospectively maintained database, and cases of collagen plug-based VCD-related CLI were identified between June 2006 and December 2013. CLI was defined as acute onset of rest pain after VCD application requiring endovascular or surgical treatment.

Among 13,595 coronary procedures, 43 patients (0.3%) were identified with CLI related to Angio-Seal (St. Jude Medical, Inc.) closures. In a multivariable logistic regression analysis, peripheral artery disease and renal insufficiency were identified as independent predictors for CLI after Angio-Seal application. Twenty-seven patients (63%) received surgical treatment, and 16 patients (37%) were treated with endovascular angioplasty.

The investigators concluded that CLI after use of a collagen plug-based VCD is rare, and peripheral artery disease was identified as an independent predictor of CLI; therefore, interventional cardiologists should be aware of potentially high-risk patients and complications after use of a VCD to provide prompt and adequate therapy.