Abstract
BACKGROUND: Vascular access and postprocedural access site management remain the leading causes for postprocedural complications following interventional electrophysiological (EP) procedures. METHOD: Patients were consecutively included in a prospective registry (TRUST, NCT05521451). Two vascular access and groin-site management protocols that changed as an institutional standard at a cut-off date (August 15, 2022) were compared. Group I used conventional access with an 8-h pressure bandage and bed rest. Group II utilized ultrasound-guided access, figure-of-8 suture, a 2-h pressure bandage, and 6 h total bed rest. Minor complications included hematoma, bleeding, AV fistula, or pseudoaneurysm not requiring intervention. Major complications involved any incident necessitating intervention (transfusion, surgery, interventional therapy) or retroperitoneal hematoma. RESULTS: A total of 1672 procedures in 1501 patients (median age 65 (IQR 56.74) years, 38% female) were analyzed. Clinical features were balanced with the exception of a higher body mass index (median 27 [24;31] vs. 26 [24;30], p = 0.011) and more frequent arterial hypertension (63% vs. 56%, p = 0.003) in Group I. Total vascular complication rate was 9% (69/780 procedures) for Group I, and 4% (40/892 procedures) for Group II (OR 0.48 [95% CI: 0.32-0.73], p < 0.001). Major complications occurred in 30/109 (28%) cases, of which 20/780 (3%) occurred in Group I and 10/892 (1%) in Group II (OR 0.43 [95% CI: 0.18-0.97], p = 0.042). Hematomata were most frequently observed in both groups (Group I: 46/69, 67%; Group II: 30/40, 75%). CONCLUSION: Vascular complication rates in EP-procedures were significantly reduced by implementing a novel institutional groin-site management standard including ultrasound-guided vascular access and modified post-interventional care.