Clinical outcomes and quality of life assessment of patients with diabetes mellitus undergoing surgical ablation of atrial fibrillation

Abstract

Background: Vascular access site complications can follow diagnostic coronary and peripheral angiography and can be associated with significant morbidity. Vascular closure devices improve hemostasis at the access site and potentially reduce complications rates. We compared the complication rates of the Boomerang closure device, which closes the arteriotomy site using vascular elastic recoil and thrombosis, with the complication rates after manual compression in patients undergoing diagnostic angiographic procedures. Methods and results: We studied 710 predominantly male patients undergoing diagnostic coronary and peripheral angiography at a Veterans' Administration Medical Center. The mean age was 63.6 years. Boomerang closure devices were used in 203 (28.6%) patients, and manual compression was used in 507 (71.4%) patients. Significant groin complications such as arteriovenous fistula, pseudoaneurysm or hematoma greater than 5 cm occurred in 3 (1.5%) patients who had a Boomerang closure device and in 12 (2.4%) patients who had manual compression used for hemostasis [odds ratio (OR) 0.62, 95% confidence interval (CI) 0.17–2.22, P=.44]. Other complications such as minor bleeding complications requiring additional manual compression, bruising, pain and swelling occurred in 24 (11.8%) patients who had a Boomerang closure device and 30 (5.9%) patients who had manual compression (OR 2.10, 95% CI 1.19–3.74, P=.0126). After adjustment for other comorbid factors such as age, gender, peripheral vascular disease and chronic kidney disease, the association of significant complications with the use of the Boomerang closure device remained not significant (OR 0.63, 95% CI 0.19–2.20, P=.48), while the association of minor complications with the use of the Boomerang device remained significant (OR 2.28, 95% CI 1.24–4.69, P=.0048). Conclusion: In this cohort of predominantly male patients, the use of the Boomerang closure device was not associated with a decreased risk of major groin complications and was associated with an increased risk of minor complications compared to manual compression.