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Minerva Cardiology and Angiology 2021 Jun 17

DOI: 10.23736/S2724-5683.21.05718-5


language: English

Percutaneous suture-mediated Patent Fossa Ovalis (PFO) closure: two-year clinical follow-up

Achille GASPARDONE 1 , Alessandra CINQUE 1, Elisa BEGGIO 1, Antonella DE SANTIS 1, Emanuela D'ASCOLI 1, Fabiana PICCIONI 1, Maria IAMELE 1, Gregory A. SGUEGLIA 1, Carlo GASPARDONE 2, Antonio DI MATTEO 3, Francesco VERSACI 3

1 Division of Cardiology, Sant’Eugenio Hospital, Rome, Italy; 2 Vita-Salute San Raffaele University, Milan, Italy; 3 Santa Maria Goretti Hospital, Latina, Italy


BACKGROUND: Percutaneous suture-mediated patent fossa ovalis (PFO) closure has been recently introduced in clinical practice showing a favorable efficacy and safety profile in most PFO cases. The aim of this study was to assess the long-term outcomes of PFO closure by direct suture in a large consecutive series of patients.
METHODS: We extracted all consecutive patients who underwent percutaneous closure of the PFO by suture technique (HeartStitch, Fountain Valley, CA, USA) from June 2016 with a follow up of at least 2 years. After PFO closure, patients were followed-up clinically at 1, 6 and up to 12 months and microbubble transthoracic echocardiography (TTE) scheduled between 3 and 6 months, and at 12-month followup. After 12 months, patients were clinically checked every 6 months.
RESULTS: As of September 1, 2020, 187 patients had undergone PFO closure with suture for at least two years and, of these, 181 (121 women and 60 men, mean age 45±13 years, range 15-75 years) had complete clinical and instrumental follow-up (97%). There were no peri-procedural complications. Mean follow up was 1076±251 days (range 727-1574). At 12-month TTE, a significant residual atrial shunt was found in 39 patients (21%). At follow-up no recurrent thromboembolic or cerebral event occurred, no instrumental evidence of suture dehiscence detected and, 18 months after the procedure, one patient had an episode of transient atrial fibrillation lasting less than 24 hours and resolved spontaneously.
CONCLUSIONS: Long-term follow-up data indicate that PFO closure by direct suturing is safe and effective. Two years after the procedure, there were no significant complications, no permanent arrhythmic complications and evidence of suture dehiscence.

KEY WORDS: Patent fossa ovalis; Suture; Safety; Efficacy; Follow up

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