ABSTRACT
BACKGROUND: The most frequent complications from percutaneous electrophysiology procedures relate to vascular access. We sought to perform the first randomised controlled trial for femoral venous haemostasis utilising a simple and novel purse string suture (PSS) technique. METHODS: We randomised 200 consecutive patients who were referred for electrophysiology procedures at two different hospitals to either 10minutes of manual pressure or a PSS over the femoral vein and determined the incidence of vascular access site complications. RESULTS: The mean age was 61.8±12.1years and 138 (69%) were male. Bleeding requiring addition pressure or a FemStop (Abbott Laboratories, Abbott Park, IL, USA) for complete haemostasis occurred in 17/99 (17%) patients in the PSS arm and 19/101 (19%) patients in the manual pressure arm (p=0.72). There were no cases of haematoma prolonging hospital stay, arterio-venous fistula, pseudoaneurysm or retroperitoneal bleeding. The mean duration to achieve haemostasis was 45seconds in the PSS arm and 10minutes 44seconds in the manual pressure arm (p<0.001). Pain/discomfort associated with haemostasis occurred in 15/99 (15%) patients in the PSS arm and in 29/101 (29%) patients receiving manual pressure (p=0.03). CONCLUSIONS: In this randomised trial we demonstrate that an easy to perform PSS is as effective at achieving haemostasis as 10minutes of manual pressure for catheter ablation procedures. The PSS is considerably faster to perform and is more comfortable for patients than manual pressure.
