Abstract 4178: Complications of Femoral Angio-Seal-Closure Device After Coronary Angiography-Acute and Long-term Results
Objective: The Angio-Seal haemostatic puncture closure device is commonly used to minimize vascular complications at the puncture site after coronary angiography. The objective of this study was to analyze the safety and major complication rate of the device in our department.
Methods: We performed a retrospective analysis of 1823 patients (pts.) treated with Angio-Seal after coronary angiography. In 49 (2.7%, 38 male, 11 female) pts. a relevant complication (i.e. hematoma, pseudoaneurysm, AV-fistula or femoral artery stenosis due to the device) after Angio-Seal-application was diagnosed.
Results: Hematoma was diagnosed in 9 pts. (0.5%), all of them treated conservatively. Pseudoaneurysm occurred in 16 pts. (0.8%), in 9 pts. ultrasound guided compression was possible, in 6 pts. thrombine injection was performed and 1 pt. underwent surgery. In 6 pts. AV-fistula was diagnosed, 5 of them treated conservatively, 1 pt. surgically. In 18 pts. Angio-Seal-induced femoral artery stenosis was diagnosed, mean grade of stenosis was 81±18.6%. In 10 symptomatic pts. walking capacity (64±18.3m) and ankle-brachial-index (ABI) at rest (0.49±0.14) were significantly reduced in comparison to asymptomatic patients (139±47,1m, p<0.001, ABI 0.73±0.13). In symptomatic pts. a total number of 8 self-expandable nitinol stents (mean length 45.2±14.7mm) were implanted, 2 patients were treated only by single PTA, in 1 patient additional local thrombolysis was performed. Technical success without residual stenosis could be achieved in all pts.. Asymptomatic pts. were treated conservatively. After mean follow-up of 49.2 (range 28 to 60) months all asymptomatic pts. were stable and free of symptoms, walking capacity and mean ABI remained stable at 172±65.4m and 0.67±0.2. In pts. treated by PTA walking capacity and ABI had increased significantly (227±17.7m and 0.95±0.2 (p<0.001)). In 1 pt. restenosis could be successfully treated by repeat PTA leading to an assisted primary patency of 100%.
Conclusion: After Angio-Seal-Closure femoral complications regularly occur, mostly treatable conservatively. In some cases it can induce femoral artery stenosis that, if symptomatic, it can be treated interventionally with a sufficient long-term patency.