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CLI onset rare after use of collagen plug-based vascular closure device
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Procedures involving use of a collagen plug-based vascular closure device rarely led to the onset of critical limb ischemia, according to results of a new study.
Researchers retrospectively interrogated a prospectively maintained single-center database to determine the frequency of critical limb ischemia (CLI) onset after use of the collagen plug-based vascular closure device (Angio-Seal, St. Jude Medical) in 13,595 PCI procedures between June 2006 and December 2013 (mean age, 72 years; 67% men).
According to the study background, the most serious known complication of the vascular closure device is limb ischemia caused by an intra-arterial deposition of collagen.
Omran Amer, MD, from the department of internal medicine ˗ cardiology, University of Leipzig Heart Center, Germany, and colleagues defined CLI as acute onset of rest pain after application of the vascular closure device that required endovascular or surgical treatment.
They determined that only 43 patients (0.3%) had onset of CLI attributable to use of the vascular closure device.
CLI was treated by endovascular intervention in 16 (37%) of those patients, and by surgery in 27 (63%), according to the researchers. Among those receiving endovascular treatment, 94% underwent balloon angioplasty, 56% had a stent implanted, 50% underwent thrombectomy and 19% had local fibrinolysis. Four patients requiring surgery and two requiring endovascular treatment died during their hospital stay.
Compared with those without CLI, those with CLI had lower BMI (P = .02), higher incidence of peripheral artery disease (P < .001), a higher rate of ACS (P = .03) and a higher rate of renal insufficiency (P = .002), according to Amer and colleagues.
When they conducted a multivariable logistic regression analysis, they determined that PAD (HR = 5.08; 95% CI, 2.54-10.17) and renal insufficiency (HR = 2.38; 95% CI, 1.26-4.51) were independent predictors of CLI onset after use of the vascular closure device.
“Interventional cardiologists should be aware of potential high-risk patients and complications after use of a [vascular closure device] to provide prompt and adequate therapy,” Amer and colleagues wrote. – by Erik Swain
Disclosure: The researchers report no relevant financial disclosures.
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