SPC365

Patent Foramen Ovale Closure: Comparative Analysis of NobleStitch EL and Amplatzer PFO Ocluder in a Single-Centre Cohort

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; Carlos David; David Sá Couto; Mariana Pereira Santos; Tiago Peixoto; Pedro Monteiro; Gilles Sousa; Raquel Baggen Santos; Bruno Brochado; João Brum Silveira; 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) is a common congenital defect linked to cryptogenic stroke. Percutaneous closure reduces recurrent cerebrovascular events, with the Amplatzer PFO Ocluder&reg; widely used and well established, while suture-mediated devices like NobleStitch&reg; (NS) offer a device-free alternative. Comparative real-world data remain limited.</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 compare the safety and efficacy outcomes of NobleStitch&reg; and Amplatzer PFO Ocluder&reg; in a single-centre cohort. </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">: Single-centre retrospective, pragmatic, observational, registry of PFO closures from December 2022 to July 2025. Patient demographics, procedural details, safety outcomes, and adverse events were analysed, comparing NobleStitch&reg; (NS) with Amplatzer PFO Ocluder&reg;, trying to match for baseline features. </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"> Ninety-five patients were included (mean age 48.8 &plusmn; 13.6 years; 47.6% female, Amplazter = 73, NS = 22). Patient demographics did not differ between groups. </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 RoPE scores were 6.2 &plusmn; 1.9 vs 5.9 &plusmn; 1.8, p=0.504, in the NS group and Amplatzer group, respectively. The primary indication for PFO closure was a cerebrovascular event, including cryptogenic stroke or transient ischaemic attack (87.7% in the Amplatzer group vs. 86.6% in the NS group; p = 0,762). PFO was tunnel-like in 97.9% patients, with mean length 13.1 &plusmn; 4.2 mm (NS) vs 12.4 &plusmn; 4.1 mm (Amplatzer), p=0.467; width 5.2 &plusmn; 3.7 mm vs 5.25 &plusmn; 3.3 mm, p=0.954, respectively. Atrial septal aneurysm (ASA) was more frequent in Amplatzer patients (44.9% vs 4.5%; p&lt;0.001). </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">Baseline significant right-to-left shunt (grade &ge;2) was present in 55% patients in NS group and 72,3% in Amplatzer group, p &lt; 0,05, and 100% in both groups when Valsalva manoeuvre was performed. One complication occurred with the NS device: a <em>septum secundum</em> tear needing a Amplatzer device for bail-out closure, whereas two minor complications occurred in Amplatzer patients: one incorrect disc apposition with residual shunt requiring a smaller device and one new-onset atrial fibrillation. </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">Follow-up (mean 263 &plusmn; 230 days) transthoracic echocardiography revealed spontaneous residual right-to-left shunt in 8 (36,4%) patients in NS group, and 4 (8,8%) in Amplatzer group, p &lt; 0,01. No recurrent cerebrovascular events occurred in either group.</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"> Both NobleStitch&reg; and Amplatzer PFO Ocluder&reg; were safe for PFO closure. However, residual shunting was more frequent after NS, while minor procedure-related complications occurred in the Amplatzer group. Patient selection should guide the device choice. Our study is limited by the retrospective nature of the analysis, as the Amplazter was the chosen device in ASA-patients. At this point, a prospective randomized trial to study both devices should be considered. </span></span></span></p>