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

Introduction: In patients with cryptogenic stroke, one of the most frequently found abnor-malities 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. Objectives: To present procedural details of the technique and baseline characteristics of patients who underwent the procedure in our center.Methods: A single-center prospective observational registry was established between Febru-ary 2020 and February 2021, to assess the safety, efficacy and possible advantages of a novel percutaneous PFO closure system (NobleStitch (R) EL). Patient and PFO characteristics as well as technical features were collected for analysis.Results: Twenty-three patients were considered suitable for this technique after trans-esophageal 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 (R) sys-tem 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.

Automated summary

In this observational study, we presented a novel percutaneous PFO closure system that showed favorable safety and efficacy outcomes. The technique involved surgical suture-mediated closure and had clear advantages.