Aims: To test the safety of immediate mobilisation of patients undergoing coronary angiography and percutaneous coronary intervention (PCI) closed with Angio-Seal™ -a femoral vascular closure device.
Methods and results: First, a randomised controlled trial of immediate mobilisation vs. delayed ambulation was performed followed by a prospective validation registry to test the obtained results in a real-world situation. The randomised trial comprised 300 patients; the validation registry comprised 1,097 patients. Primary endpoints were complications defined as: small haematoma <5 cm and/or minor bleeding/oozing from the puncture site, haematomas ≥ 5 cm, bleeding needing transfusion, bleeding needing surgical attention, pseudoaneurysm and vasovagal reaction. In the randomised trial, overall complications were similar in both groups (16.0%vs.18.8%; p=0.53). Small haematomas/small bleedings/oozing were the most frequent (12.2% vs.15.3; p=0.44). There were no bleedings needing transfusion or surgical attention, and no pseudoaneurysms occurred. The prospective registry showed similar results. In the standard-care cohort, complications were similar to those in the implementation cohort (9.6% vs.11.3%; p=0.41), mainly consisting of small haematomas/minor bleedings/oozing (6.1% vs.7.3%; p=0.49). No bleedings needed transfusion or surgical attention. Pseudoaneurysms occurred in 1 (0.34%) vs. 3 (0.37%; p=0.94) and vasovagal reactions in three (1.0%) vs. four (0.5%; p=0.33) patients. It was possible to mobilise 87% of patients in the implementation cohort.
Conclusions: In patients undergoing coronary angiography or PCI, the use of immediate mobilisation after Angio-Seal™ deployment is safe. With routine use of a femoral vascular closure device, approximately 87% of patients are suitable for immediate mobilisation.