Abstract

Background Vascular access site complications can follow coronary and peripheral angioplasty procedures and be associated with significant morbidity. We compared the complication rates of the Angioseal closure device with complication rates after manual compression in patients undergoing coronary and peripheral interventional procedures. Methods and Results We studied 553 predominantly male patients undergoing percutaneous coronary, peripheral interventions, FFR or IVUS at a Veterans Administration Medical Center. The mean age was 64.6 years. Angioseal closure devices were used in 388 (70%) patients and manual compression was used in 165 (30%) patients. Major groin complications such as arteriovenous fistula, pseudoaneurysm or hematoma greater than 5 cm occurred in 16 (4.16%) patients who had an Angioseal closure device and 11 (6.67%) patients in whom manual compression was used for hemostasis (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.29-1.40; P=0.26). Other complications such as minor bleeding requiring additional manual compression, bruising, pain and swelling occurred in 32 (8.42%) patients who had an Angioseal closure device and 21 (12.4%) patients who had manual compression (OR 0.65, 95% CI 0.36-1.17; P=0.15). After adjustment for other comorbid factors such as age, type of anticoagulant used, peripheral vascular disease and chronic kidney disease, the association of major complications with the use of the Angioseal closure device remained similar to manual compression (OR 0.75, 95% CI 0.28-1.91; P=0.49). However, there was a trend for fewer minor complications with the closure device (OR 0.57, 95% CI 0.26-1.08; P=0.08). Conclusion In this cohort of predominantly male patients undergoing percutaneous coronary and peripheral intervention, the use of the Angioseal closure device was not associated with a decreased risk of major groin complications, but was associated with a trend for a decreased risk of minor complications compared to manual compression.

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