SPC365

The NOBLE Protocol For Patients Undergoing Suture-mediated PFO Closure

Session: Sessão de Posters 33 - Cardiopatia congénita e hipertensão pulmonar: da evidência à ação
Speaker: Inês Gomes Campos

Congress: CPC 2026
Topic: F. Valvular, Myocardial, Pericardial, Pulmonary, Congenital Heart Disease
Theme: 20. Congenital Heart Disease and Pediatric Cardiology
Subtheme: 20.4 Congenital Heart Disease – Treatment
Session Type: Posters Eletrónicos
FP Number: ---
Authors: Inês Gomes Campos; Joel Monteiro; Diana Ribeiro; Ana Rodrigo Costa; José Luís Ferraro; Mauro Moreira; Marta Tavares Silva; João Carlos Silva; André Luz; Rui André Rodrigues; Aurora Andrade; Achilles Gaspardone

<p style="text-align:justify"><span style="font-size:medium"><span style="font-family:Calibri,sans-serif"><span style="color:#000000"><strong>Background</strong>: Suture-mediated patent foramen ovale (PFO) closure has emerged as a promising alternative to traditional device-based strategy. However, long-term data reveal rates of significant residual shunt (SRS) up to 25-40%, highlighting the importance of optimal patient selection. Additionally, sporadic cases of late PFO reopening reinforce the need for prolonged and structured follow-up.</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 develop the first systematic protocol for patients undergoing suture-mediated PFO closure.</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>Discussion</strong>: The protocol follows the acronym NOBLE.</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>N &ndash; Neurological events:</strong> Most patients are referred for PFO closure after cryptogenic stroke. Other indications considered in a case-by-case basis include platypnea-orthodeoxia syndrome, systemic thromboembolism, migraine and decompression sickness.</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>O &ndash; Optimal Anatomy:</strong> Detailed anatomical assessment is essential. SRS is strongly associated with specific septal features, and scoring systems are valuable tools for identifying suitable candidates. LASSO score (PFO length&lt;7mm: 1 point; atrial septal aneurysm: 1, severe Valsalva shunt: 2; PFO opening &gt;4mm: 2) was recently proposed by <em>Gaspardone et al</em> and externally validated in a large portuguese registry. Patients scoring 0-1 have a 94% success rate (effective PFO closure) vs 61% for scores 4-6. Although predictive capacicity is moderate, its use is strongly recommended.</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>B &ndash; Baseline Success:</strong> Suture-mediated closure allows immediate assessment of residual shunt. SRS at the end of the procedure should be addressed - by additional sutures or adding a device &ndash; according to patient&rsquo;s anatomy, ensuring optimal PFO closure.</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>L &ndash; Long follow-up:</strong> Clinical assessment and contrast echocardiography are crucial in the first 3 months, when most SRS are identified. Sporadic cases of late PFO reopening, up to 5 years post-procedure, have been reported. A repeated contrast echocardiographam at 3-year follow-up is therefore advised.</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>E &ndash; Event Analysis:</strong> A prospective clinical registry validating this protocol is recommended as it provides real-world, consecutive patient data with extended follow-up and detailed clinical variables. This enables robust identification of predictors of long-term SRS, particularly given the limited predictive performance of existing risk scores. </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 protocol offers the first structured approach for suture-mediated PFO closure, optimizing patient selection, procedural strategy and long-term follow-up, grounded in the experience of leading experts and supported by the largest multinational registries avaliable.</span></span></span></p>