SPC365

Percutaneous suture-mediated patent foramen ovale closure: results from the largest national registry

Session: SESSÃO DE COMUNICAÇÕES ORAIS 09 - CARDIOLOGIA DE INTERVENÇÃO/ESTRUTURAL
Speaker: Inês Gomes Campos

Congress: CPC 2025
Topic: H. Interventional Cardiology and Cardiovascular Surgery
Theme: 25. Interventional Cardiology
Subtheme: 25.3 Non-coronary Cardiac Intervention
Session Type: Comunicações Orais
FP Number: ---
Authors: Inês Gomes Campos; Joel Monteiro; Bruno Bragança; Inês Oliveira; Mauro Moreira; José Luís Ferraro; Rafaela G. Lopes; Ana Rodrigo Costa; Marta Tavares Silva; João Carlos Silva; Rui André Rodrigues; Aurora Andrade

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Background</strong>: Percutaneous suture-mediated patent foramen ovale (PFO) closure with NobleStitch EL has demonstrated high<span style="color:black"> immediate success rates and absence of significant procedural complications</span>. However, data on long-term outcomes remain scarce.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Aim</strong>: To assess the efficacy and long-term safety profile of NobleStitch EL procedure.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Methods</strong>: Single-center retrospective observational registry of consecutive patients admitted for PFO closure with NobleStitch EL between January 2020 and September 2024. Patient and baseline PFO echocardiographic characteristics were collected. Patients were followed up to 2.5 years (mean 533 <span style="font-family:Symbol">&plusmn;</span> 398 days) and recurrence of cerebral events, incidence of atrial fibrillation, residual right-to-left shunt (RLS) and need for additional PFO intervention were recorded.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Results</strong>: Among 79 patients included (mean age 48.5<span style="font-family:Symbol">&plusmn;</span>12.6 years, 55.7% female), 95% were referred for PFO closure for cryptogenic stroke and transit ischemic attack (TIA), with high RoPE score (median 6). PFO was <em>tunnel-like</em> in 81.2%, with median length 10.0mm (IQR 8.3), width 3.0mm (IQR 2.0) and atrial septal aneurysm in 41.6%. Baseline spontaneous RLS was present in 87.8% patients.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:medium"><span style="color:#000000"><span style="font-family:Calibri,sans-serif">Two stitches were used in 7 patients and one of them had a device implanted due to significant residual RLS (grade</span><span style="font-family:Symbol">&gt;=</span><span style="font-family:Calibri,sans-serif">2) at the end of the procedure. Three procedural complications occurred: 1 groin hematoma, 1 TIA and 1 iatrogenic atrial septal defect that had a device implanted 2 days later. </span></span></span></p>

<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000">During follow-up, 30 patients (40.0%) had significant residual RLS and 28 (35.4%) were submitted to a new procedure: device implantation in 20 patients, additional suture in 2 patients, surgical closure in 1 patient and 5 patients were awaiting reintervention. The mechanisms of ineffective closure most frequently reported were partial detachment (60.9%) and atrial septal tear (21.7%).</span></span></span></p>

<p style="text-align:start"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000">There were 3 cases of late PFO reopening, one of them with recurrence of PFO-related stroke that had a device implanted 3 months later. No patient had atrial fibrillation.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Conclusion</strong>: This study represents the largest and longest national registry of patients submitted to PFO closure with NobleStitch EL. This suture-mediated technique was shown to be safe, though associated with a non-negligible rate of shunt patency or PFO reopening during follow-up, requiring re-intervention with another suture or device. This highlights the need for better patient selection and the importance of longer follow-up.</span></span></span></p>