A new era in patent foramen ovale closure – a percutaneous suture-based ‘deviceless’ technique (NobleStitch®): Experience of a Portuguese center

Abstract

IntroductionIn patients with cryptogenic stroke, one of the most frequently found abnormalities is patent foramen ovale (PFO). Percutaneous ‘deviceless’ systems based on surgical suture-mediated PFO closure have recently been introduced and show a favorable efficacy and safety profile with clear advantages. ObjectivesTo present procedural details of the technique and baseline characteristics of patients who underwent the procedure in our center. MethodsA single-center prospective observational registry was established between February 2020 and February 2021, to assess the safety, efficacy and possible advantages of a novel percutaneous PFO closure system (NobleStitch® EL). Patient and PFO characteristics as well as technical features were collected for analysis. ResultsTwenty-three patients were considered suitable for this technique after transesophageal echocardiography. Their mean age was 51 years and 69.5% were women. Most patients (91.3%) had a history of cryptogenic stroke. PFO closure with the NobleStitch® system was successfully performed in all patients. All procedures were performed under local anesthesia and fluoroscopic monitoring. The mean duration of the procedure was 52 min and median contrast dose used was 187 ml. Median radiation dose absorbed per patient was 61.5 Gy cm2. All patients were discharged asymptomatic 24 hours after the procedure with no peri- or postprocedural complications recorded. ConclusionSuture-mediated PFO closure represents a valid and safe alternative to traditional umbrella-like devices, and is feasible in the majority of PFO anatomies. Follow-up information, results of larger series and clinical trials may possibly validate this technique as the first choice for PFO closure.