Suture-Mediated PFO Closure with the NobleStitch EL System: A Systematic Review and Single-Arm Meta-Analysis
Carlo Gaspardone, Giulio Falasconi, Gregory A Sgueglia, James A Thompson, Paolo Costa, Bryan W Kluck, Tommasa Siragusa, Cosmo Godino, Marco B Ancona, Marco Metra, Achille GaspardoneAbstract
Background
Transcatheter patent foramen ovale (PFO) closure is usually performed with device-based occluders, which leave a permanent implant and carry a risk of new-onset atrial fibrillation (AF). The NobleStitch EL system is a deviceless suture-mediated alternative, but no quantitative synthesis of its outcomes exists.
Objectives
To estimate pooled rates of significant residual shunt, post-procedural AF, and recurrent ischemic events after NobleStitch EL PFO closure.
Methods
We systematically searched five databases through May 2026 for observational studies of NobleStitch EL PFO closure. A single-arm random-effects meta-analysis of proportions (Freeman–Tukey transformation, DerSimonian–Laird model) was performed, with quality appraised using the Joanna Briggs Institute checklist. Pre-specified sensitivity analyses included leave-one-out, imaging-modality subgroups, targeted exclusions, and a logit–REML model. The review was registered with PROSPERO (CRD420261406437).
Results
Eight studies (1,082 patients) were included. Over a patient-weighted median imaging follow-up of 1.0 year (IQR, 0.9–1.0), pooled significant residual-shunt rate was 16.1% (95%CI: 11.6%–21.2%; I2 = 62.4%); heterogeneity was traced almost entirely to one small zero-event cohort, and leave-one-out omission of that study yielded a homogeneous 18.1% (95%CI: 15.9%–20.5%; I2 = 0.0%). Over a patient-weighted median clinical follow-up of 4.0 years (IQR, 0.9–4.0), pooled post-procedural AF was 0.3% (95%CI: 0.1%–0.7%) and recurrent ischemic stroke/TIA 0.1% (95%CI: 0.0%–0.5%), both with I2 = 0.0%.
Conclusions
Suture-mediated PFO closure with the NobleStitch EL system was associated with a significant residual-shunt rate of approximately 16%–18% and very low rates of post-procedural AF and recurrent ischemic events. These observational hypothesis-generating findings support the NobleStitch EL system as a deviceless alternative in selected patients.