Incidence, predictors, and treatment options of critical limb ischaemia after use of collagen plug-based vascular closure devices

Abstract

Aims: Limited data are available on the frequency and predictors of vascular closure device (VCD) failure with subsequent vascular complications. The aim of this study was to investigate the incidence, clinical characteristics, and treatment options in patients with critical limb ischaemia (CLI) after use of a collagen plug-based VCD. Methods and results: A high-volume, single-centre prospectively maintained database was retrospectively interrogated, 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 an Angio-Seal-related CLI. In a multivariable logistic regression analysis, peripheral artery disease and renal insufficiency were identified as independent predictors for CLI after Angio-Seal application. Treatment was performed in 27 patients (63%) by surgery and in 16 patients (37%) with endovascular angioplasty. Conclusions: CLI after use of a collagen plug-based VCD is rare. Peripheral artery disease was identified as an independent predictor of CLI. Interventional cardiologists should be aware of potentially high-risk patients and complications after use of a VCD to provide prompt and adequate therapy.