Background: At short-term follow-up, percutaneous suture-mediated patent fossa ovalis (PFO) closure appears as a safe and effective alternative to device-based methods. This study represents the largest cohort of patients undergoing suture-mediated patent fossa ovalis closure with the longest follow-up reported to date.
Objectives: To assess long-term clinical safety and efficacy of suture mediated patent fossa ovalis closure and identify predictors of technical success.
Methods: Between 2016 and 2023, 703 consecutive patients (47±12 years, 62% women) with PFO-associated stroke or transient ischemic attack (TIA) underwent suture-mediated PFO closure (Heartstitch, Fountain Valley, CA). All patients were followed-up using transthoracic echocardiography (TTE) with bubble test for 12 months to detect significant residual shunt (>1 grade on a 0-3 scale) and clinically for 4 years.
Results: At a median clinical follow-up of 4 years, no recurrent cerebrovascular events (stroke or TIA) were reported, and only one transient episode of atrial fibrillation occurred. Among the 703 patients, 91 showed residual shunt during follow-up (median TTE follow-up time of 11.5 months). Multivariable analysis identified independent predictors of significant residual shunt: patent fossa ovalis maximum width (OR per 1 mm increase: 1.34; 95% CI: 1.19-1.50; p<0.001), minimum patent fossa ovalis length (OR per 1 mm increase: 0.92; 95% CI: 0.86-0.98, p=0.015), atrial septal aneurysm (OR: 1.83; 95% CI: 1.14-2.91; p=0.011), and grade 3 Valsalva shunt (OR: 2.19; 95% CI: 1.25-3.90; p<0.007). A scoring system was developed based on the independent predictors of residual RLS ≥2, assigning points according to the magnitude of the logistic regression coefficients. Based on these variables, the LASSO score (Length, Aneurysm, Severe Shunt, Opening) was developed and internally validated (AUC 0.73; 95% CI: 0.68-0.78).
Conclusions: Suture-mediated patent fossa ovalis closure demonstrates long-term safety and efficacy. The LASSO score is a valuable tool for optimizing patient selection for this procedure.
JACC: Advances Editor-in-Chief
Candice K. Silversides, MD, FACC
JACC: Advances CME Editor
Kenneth A. Ellenbogen, MD
Author
Achille Gaspardone
Important Dates
Date of Release: August 25, 2025
Term of Approval/Date of CME/MOC Expiration: August 24, 2026