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

In 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. To present procedural details of the technique and baseline characteristics of patients who underwent the procedure in our center. A 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. Twenty-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. Suture-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.

Neto A ，Resende CX ，Tavares Silva M ，Silva JC ，Macedo F ... -  《-》

Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry.

Gaspardone A ，De Marco F ，Sgueglia GA ，De Santis A ，Iamele M ，D'Ascoli E ，Tusa M ，Corciu A ，Mullen M ，Nobles A ，Carminati M ，Bedogni F ... -  《-》

Anatomical predictors for suture-based closure of the patent foramen ovale: A multicenter experience.

NobleStitch EL is a novel suture-based technique used for patent foramen ovale (PFO) closure and an alternative to traditional double-disc devices without the need for antithrombotic therapy. However, successful closure rates are still unknown, and certain anatomies may be unfavorable for successful closure. We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure. We included 55 patients who underwent PFO closure with the NobleStitch EL in The Netherlands and Switzerland. Successful closure was defined as residual right-to-left shunt grade ≤1 with Valsalva maneuver at a cardiac ultrasound. Predefined possible anatomical determinants for effective closure included PFO length, atrial septal aneurysm, PFO entry- and exit diameter. Successful closure was achieved in 33 patients (60%). The PFO length was shorter in patients with successful closure compared to unsuccessful closure with a median length of 9.6 mm (IQR 8.0-15.0) versus 13.3 mm (IQR 11.4-18.6) on preprocedural ultrasound (p = 0.041) and 9.9 mm (IQR 8.0-13.1) versus 12.5 mm (IQR 9.7-15.4) on angiography (p = 0.049). Additionally, the PFO exit diameter and PFO volume were smaller in patients with successful closure than unsuccessful closure, with a mean diameter of 7.0 ± 3.1 mm versus 9.5 ± 3.8 mm (p = 0.015) and a median volume of 381 mm3 (IQR 286-894) versus 985 mm3 (IQR 572-1550) (p = 0.016). In our study cohort, the successful PFO closure rate using NobleStitch EL was relatively low (60%). With this alternative procedure, patients with a small PFO driven by a short PFO tunnel length and small exit diameter seem to be eligible for successful suture-based closure.

Witte LS ，Renkens MPL ，Gąsecka A ，El Bouziani A ，de Winter RJ ，Tijssen JGP ，Stella PR ，Leibundgut G ，Voskuil M ... -  《-》

Patent foramen ovale closure by using transesophageal echocardiography for cryptogenic stroke: single center experience in 132 consecutive patients.

Han Y ，Zhang X ，Zhang F 《Journal of Cardiothoracic Surgery》

Clinical Experience of Percutaneous Patent Foramen Ovale Closure Using the Amplatzer PFO Occluder in Japanese Patients to Prevent the Recurrence of Cryptogenic Stroke.

Takafuji H ，Obunai K ，Makihara Y ，Kato N ，Watanabe H ... -  《-》