SPC365

Efficacy and safety of suture-based PFO closure using the NobleStitch EL system: insights from a multicentre real-world analysis

Session: Sessão de Comunicações Orais 06 – Fechar as lacunas: soluções percutâneas na cardiopatia congénita e estrutural
Speaker: Diana Alexandra Teixeira Azevedo Ribeiro

Congress: CPC 2026
Topic: F. Valvular, Myocardial, Pericardial, Pulmonary, Congenital Heart Disease
Theme: 25. Interventional Cardiology
Subtheme: 25.3 Non-coronary Cardiac Intervention
Session Type: Comunicações Orais
FP Number: ---
Authors: Diana Ribeiro; Inês Gomes Campos; Joel Monteiro; Bruno Bragança; Marta Tavares Silva; Gilles Sousa; Raquel Baggen Santos; Bruno Brochado; João Brum Silveira; João Carlos Silva; Rui André Rodrigues; André Luz

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><strong><span style="font-family:&quot;Times New Roman&quot;,serif">Introduction:</span></strong><span style="font-family:&quot;Times New Roman&quot;,serif"> Patent foramen ovale (PFO) affects up to 25% of the population and is associated with cryptogenic stroke. The NobleStitch&reg; system enables implant-free, suture-mediated PFO closure and, despite short follow-up, the first published data suggested good safety and efficacy profile. </span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><strong><span style="font-family:&quot;Times New Roman&quot;,serif">Aim:</span></strong><span style="font-family:&quot;Times New Roman&quot;,serif"> To assess the efficacy and long-term safety of the NobleStitch&reg; technique across multiple centres.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><strong><span style="font-family:&quot;Times New Roman&quot;,serif">Methods:</span></strong><span style="font-family:&quot;Times New Roman&quot;,serif"> Retrospective multicentre study of consecutive patients admitted for PFO closure with NobleStitch&reg; in two central hospitals from Portugal, between January 2020 and May 2025. Patient demographics, procedural characteristics, safety, and adverse events were analysed. </span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><strong><span style="font-family:&quot;Times New Roman&quot;,serif">Results</span></strong><span style="font-family:&quot;Times New Roman&quot;,serif">: Of the 101 patients included (mean age 45.5 &plusmn; 12.8 years, 50.5% female), 93% were referred for PFO closure due to cryptogenic stroke or transit ischemic attack (TIA) and had a high RoPE score (median 6). A tunnel-like PFO was identified in 84.6% of cases, with a mean length of 10.3 &plusmn; 5.0 mm, width 3.7 &plusmn; 2.6 mm, and atrial septal aneurysm present in 33.3%. Right-to-left shunt (RLS) at rest with bubble test was observed in 90.4% of patients. </span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><span style="font-family:&quot;Times New Roman&quot;,serif">One patient required double disc device implantation due to significant residual RLS (grade &ge;2) at the end of the procedure. Three complications occurred: a groin hematoma, a TIA, and an iatrogenic atrial septal defect later treated with double disc device implantation. </span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><span style="font-family:&quot;Times New Roman&quot;,serif">Mean follow-up was 666 &plusmn; 496 days. During follow-up, significant residual RLS (grade &ge;2 on post-procedural TTE and/or TEE) was observed in 34 of 92 patients (37,0%). Thirty patients (32.6%) required reintervention: double disc device implantation in 26, an additional suture in 2, surgical closure in 1, and 1 patient is still awaiting reintervention. The most common mechanisms of ineffective closure were partial detachment (63%) and atrial septal tear (18.5%).</span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><span style="font-family:&quot;Times New Roman&quot;,serif">Two ischemic strokes were reported during follow up: one in a patient with suspected thrombophilia, who remained event-free after starting anticoagulation and did not require PFO re-closure; the other patient underwent subsequent PFO re-closure. No patient had atrial fibrillation.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Aptos,sans-serif"><strong><span style="font-family:&quot;Times New Roman&quot;,serif">Conclusion:</span></strong><span style="font-family:&quot;Times New Roman&quot;,serif"> This multicentre study shows that NobleStitch&reg; PFO closure is feasible and generally safe. However, significant residual shunts were more common than with standard double disc devices, and one-third of patients required further interventions, highlighting the need for careful patient selection and follow-up.</span></span></span></p>