SPC365

Is real world patent foramen ovale closure a safe and effective strategy?

Session: Posters (Sessão 4 - Écran 7) - Intervenção Cardíaca Coronária e Estrutural 2 - Foco na Doença Estrutural Não Valvular
Speaker: Pedro Morais

Congress: CPC 2022
Topic: H. Interventional Cardiology and Cardiovascular Surgery
Theme: 25. Interventional Cardiology
Subtheme: 25.4 Interventional Cardiology - Other
Session Type: Pósters Electrónicos
FP Number: ---
Authors: Pedro s Morais; Miguel Nobre Menezes; Ana Rita Francisco; Eduardo Infante Oliveira; Claudia Jorge; Pedro p Cardoso; Fausto j Pinto
<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Introduction</span></span></strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">: </span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Patent foramen ovale (PFO) is a very common and benign finding in the adult population. However, it can enable paradoxical embolism and associates with stroke and systemic embolism (SE). Randomized clinical trials have shown that PFO closure (PFOC) in cryptogenic stroke (CS) patients (pts) associates with lower rates of recurrent stroke and real-world confirmation of this strategy safety and efficacy is lacking.</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Purpose</span></span></strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">:</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">To ascertain the real-world PFOC safety and effectiveness in different clinical settings, with a particular focus on CS.</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Methods</span></span></strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">:</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Single center registry of 142pts subjected to PFOC in the 2012-2020 period. </span></span></span></span><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Patient clinical profile, RoPE score and procedural aspects were gathered using the institution registry. Complications and clinical recurrence during follow-up (FU) were evaluated using the national health database. Procedural safety was evaluated in terms of vascular access complication, cardiac tamponade and infection. Long term safety was evaluated in terms of bleeding event requiring medical attention during FU. Efficacy was evaluated for the recurrence of transient ischemic attack or stroke (TIAS), systemic embolism (SE) and platypnea&ndash;orthodoxia (PO). TIAS recurrence was compared with the expected event rate calculated by the RoPE score.</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Results</span></span></strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">: PFOC was performed on 142 pts using Amplatzer PFO Ocluder<span style="color:black">&reg;</span><span style="color:black">, Hyperion PFOO&reg; and Amplatzer Cribiform Ocluder&reg;. The sizes used were 25(67%), 35(14%), 24(11%), 30(6%) and 18mm(2%). </span>Average procedure and fluoroscopy time was 52 and 12 minutes. 51,4% of pts were female. Mean age of 51&plusmn;13years. </span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:black">There were very few procedural complications, with only 1 case of cardiac tamponade treated with immediate pericardiocentesis. There were no cases of vascular complication or infection. During a mean follow-up period of 3,2&plusmn;2 years, only 2 pts had bleeding events requiring medical attention (1 epistaxis and 1 menorrhagia), both after the 6month period of dual anti-platelet therapy used in 86% of pts. </span></span></span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:black">Only 2 pts died during FU, both from metastasized cancer and with no cardiovascular event associated. From the 137pts treated for TIAS or SE, none had SE, 3 had TIA and 3 had CS from which, 1 was a lung cancer patient with Factor V Leiden thrombophilia recently vaccinated for COVID-19, 1 had a large aortic valve fibroelastoma and the last had a transesophageal echocardiogram failing to show agitated saline passage to the left circulation. From the 5pts treated for PO, none had further positional dyspnea episodes. </span></span></span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="background-color:white"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:black">Mean RoPE score was 5,4</span></span></span><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:black">&plusmn;</span></span></span><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif"><span style="color:black">1,4, predicting from 15,4 to 26,2 embolic events in the study follow-up period, contrasting with the 6 events registered after PFOC, that were in their most part non-PFO related.</span></span></span></span></span></span></p>

<p style="text-align:justify">&nbsp;</p>

<p><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">Conclusion</span></span></strong><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">:</span></span></span></span></p>

<p><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri Light&quot;,sans-serif">During a prolonged follow-up, PFOC proved to be a very safe procedure that allows for significant embolic risk reduction, as well as a valid treatment for platypnea&ndash;orthodoxia syndrome.</span></span></span></span></p>