Efficacy and Complications of Angio-Seal(r) Device in Patients Undergoing Coronary Angiography and Angioplasty

ABSTRACT

BACKGROUND AND OBJECTIVES: The Angio-Seal(r) (a St. Jude Medical Co., USA) hemostatic puncture closure device produces direct femoral arterial hemostasis, by anchoring a collagen plug to the anterior vascular wall, through a sheath delivery system. The rapid and effective hemostasis leads to earlier ambulation, minimized hospital stay, patient discomfort and vascular complications. This study was performed to evaluate the efficacy and complications of an Angio-Seal in patients undergoing coronary angiography and angioplasty. SUBJECTS AND MEHTODS A total 228 consecutive patients, admitted to our hospital for percutaneous coronary intervention, between October 2001 and May 2002, were enrolled and randomized into 2 groups. 116 patients were treated with an Angio-Seal and the other 112 with manual compression only (control group). The clinical characteristics, procedure related factors, time to ambulation, times to outpatient discharge and complications were analyzed in each patient. All the clinical and procedure-related factors, leading to oozing and delayed bleeding, were also analyzed in the 113 patients who had a successfully completed Angio-Seal deployment. RESULTS: The times to ambulation (7.96+/-5.81 hours vs. 23.32+/-3.35 hours) and times to outpatient discharge (2.00+/-0.94 days vs. 3.47+/-3.61 days) were significantly shorter in the Angio-Seal compared to the control group (p=0.001 & p=0.001, respectively). There was oozing in 20 patients (17.7%) and delayed bleeding in 6 (5.3%) of the successful Angio-Seal deployment group. The occurrence of oozing was significantly higher in the heparin infusion cases (40%. 18.3%, p=0.034), and was correlated with a later hematoma formation rate and the size of the hematoma (30% vs. 9.7%, 0.68+/-1.26 cm vs. 0.17+/-0.70 cm, p=0.015 & p=0.001, respectively). Delayed bleeding was correlated to the hematoma occurrence rate (50% vs. 11.2%, p=0.006). CONCLUSION: The Angio-Seal resulted in earlier ambulation and shorten the patients' hospital stay. Oozing, delayed bleeding, hematomas were noted as complications. Oozing and delayed bleeding were correlated with a high hematoma occurrence rate. Careful inspection of the puncture sites, following an Angio-Seal deployment, should be performed.