Purse-string suture and 3-way stopcock for effective venous hemostasis in structural heart procedures: the SUTURE-3 study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: 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.
Authors: Santiago Jesús Camacho Freire, Miguel Ángel Montilla Garrido, Elena Izaga Torralba, Javier León Jiménez, Prudencia Gómez Fernández, Irene Sánchez Fernández, Jessica Roa Garrido, Francisco Javier Landero García, Óscar Lagos de Grande, María Eugenia Gracia Hiraldo, Carmen Lluch Requerey, José Francisco Díaz Fernández, Francisco Navarro Roldán, and, Antonio Enrique Gómez Menchero
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4412037182