Purse-string suture and 3-way stopcock for effective venous hemostasis in structural heart procedures: the SUTURE-3 study

ABSTRACT Introduction and objectives: Complete and secure venous access closure is essential at the end of large-bore catheter-based procedures. The aim of this study is to evaluate the safety and efficacy profile of a new simplified purse-string suture with 3-way stopcock to improve venous hemostasis in structural heart procedures (the SUTURE-3 study). Methods: We conducted a multicenter, non-randomized and prospective study including all consecutive patients undergoing any interventional procedures with a ≥ 10-Fr femoral venous access in whom a simplified purse-string suture with 3-way stopcock for venous hemostasis was used. Exclusion criteria were < 10-Fr diameters or ipsilateral artery access. We evaluate the safety profile according to the Valve Academic Research Consortium-3 criteria, efficacy (correct hemostasis), a pain-score (visual analog scale [VAS]) and a clinical 1 month-follow up. Results: A total 222 patients were included. Mean age was 73.6 ± 9.7 years (58%, men; 85%, hypertensive; 44%, diabetics; 91%, had a past medical history of atrial fibrillation). We found significantly high CHA2DS2-VA (4.1 ± 1.8) and HAS-BLED (3.5 ± 1.6) scores with a higher proportion of previous major bleeding (62%). A total of 54% of patients were on oral anticoagulation and 25%/6% on single/dual antiplatelet therapy, respectively. The most common procedure was left atrial appendage closure (n = 154, 69%) and mitral valve transcatheter edge-to-edge repair (n = 41, 18%). Mean diameter access was 15.6 ± 5-Fr; 91%, echo-guided; compression time, 4 ± 1.7 h; pain in VAS, 0.6 ± 1.5. Hemostasis was instantaneous with a 100% success rate, and only 2 minor bleeding events being reported (0.9%). No access complications (including infections) were recorded after discharge at the 1-month follow-up. Conclusions: The simplified purse string suture with 3-way stopcock to improve venous hemostasis in structural heart procedures is a simple, inexpensive, safe and effective procedure.