Suture-mediated PFO Closure: Long-Term Clinical Outcomes and Predictors of Technical Success (JACC: Advances August 2025)-Article: Suture-Mediated PFO Closure: Long-Term Clinical Outcomes and Predictors of Technical Success

Article: Suture-Mediated PFO Closure: Long-Term Clinical Outcomes and Predictors of Technical Success

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This large single-center study evaluated the long-term safety and efficacy of percutaneous suture-mediated patent fossa ovalis (PFO) closure using the NobleStitch EL system in 703 patients with PFO-associated ischemic stroke or transient ischemic attack from 2016 to 2023. With a median clinical follow-up of 4 years, no recurrent cerebrovascular events occurred and only one transient atrial fibrillation episode was documented, underscoring excellent safety and durable stroke prevention compared to traditional device-based closure.<br /><br />Technical success, defined as no or minimal residual right-to-left shunt (RLS ≤1 grade on a 0-3 scale) by transthoracic echocardiography with bubble testing, was initially achieved with a single suture in 82.4% of patients; success rose to 88.3% when additional sutures were placed as needed during the procedure. Residual significant shunt was found in 91 patients during follow-up; 22 of these underwent further closure with additional sutures or implanted devices, resulting in elimination of shunt without device-related complications.<br /><br />Multivariable analysis identified key predictors of residual shunt after closure: larger maximum PFO width, shorter minimum PFO length (septal overlap), presence of atrial septal aneurysm, and severe Valsalva-induced shunting. These factors informed development of the novel LASSO score (Length, Aneurysm, Severe Shunt, Opening), which stratifies patients into low, moderate, and high risk for residual shunting with good internal validation (AUC=0.73). Patients with low LASSO scores (0-1) had a 94% success rate, while those with high scores (4-6) had only 61%, guiding optimal patient selection.<br /><br />The suture-mediated technique offers advantages over device implantation by eliminating metallic implants, preserving atrial anatomy, reducing arrhythmia risk, and facilitating future left-heart interventions. Procedural safety was excellent, with minimal complications. Limitations include the single-center observational design, lack of centralized echocardiographic core lab, and absence of systematic arrhythmia monitoring. External validation of the LASSO score and multicenter studies are underway.<br /><br />In summary, suture-mediated PFO closure is a safe, effective, and durable alternative to device-based methods with very low stroke recurrence, minimal adverse events, and a validated echocardiographic scoring system that improves patient selection and procedural planning. These findings support broader adoption of this novel technique with potential to enhance outcomes in patients with PFO-related cryptogenic stroke.

Keywords

percutaneous suture-mediated PFO closure

NobleStitch EL system

ischemic stroke

transient ischemic attack

residual right-to-left shunt

LASSO score

atrial septal aneurysm

Valsalva-induced shunting

stroke prevention

patient selection