Safety and efficacy of the CELT ACD femoral arteriotomy closure device in the office-based laboratory.

OBJECTIVE

Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bedrest and 20 to 30 minutes or more of compression for hemostasis. Current arterial closure devices have emerged in recent years, but patients still require prolonged bedrest and time to ambulation and discharge, and these devices are associated with significant access device complications, including hematoma, retroperitoneal bleeding, transfusion requirement, pseudoaneurysm, arteriovenous fistula, and arterial thrombosis. A novel femoral access closure device, the CELT ACD (Vasorum Ltd, Dublin, Ireland), has been previously shown to reduce these complication rates and allow rapid hemostasis, require little or no bedrest, and shortened time to ambulation and discharge. This is especially advantageous in the outpatient setting. We report our initial experience with this device.

METHODS

A prospective single-center single-arm study was performed in an office-based laboratory setting to assess the safety and efficacy of the CELT ACD closure device. Patients underwent diagnostic and therapeutic peripheral arterial procedures from retrograde or antegrade common femoral artery access. Primary endpoints include device deployment success, time to hemostasis, and major or minor complications. Secondary endpoints include time to ambulation and time to discharge. Major complications were defined as bleeding requiring hospitalization or blood transfusion, device embolization, pseudoaneurysm formation, and limb ischemia. Minor complications were defined as bleeding not requiring hospitalization/blood transfusion, device malfunction, and access site infection.

RESULTS

A total of 442 patients were enrolled with common femoral access only. Median age was 78 years (range, 48-91 years), and 64% were male. Heparin was given in all cases, with median heparin dose of 6000 units (range, 3000-10,000 units). Protamine reversal was used in 10 cases due to minor soft tissue bleeding. Average time to hemostasis was 12.1 seconds (±13.2 seconds), time to ambulation was 17.1 minutes (±5.2 minutes), and time to discharge was 31.7 minutes (±8.9 minutes). All devices (100%) were deployed successfully. No major complications occurred (0%). Ten minor complications (2.3%) occurred; all were minor soft tissue bleeding from the access site that resolved with protamine reversal of heparin and manual compression.

CONCLUSIONS

The CELT ACD closure device is safe and easily deployed with a very low complication rate, and significantly reduces time to hemostasis, ambulation, and discharge in patients undergoing peripheral arterial intervention from a common femoral artery approach in the office-based laboratory setting. This is a promising device that deserves further evaluation.