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 ... -  《-》

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 ... -  《-》

Residual Shunt after Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke: Serial Bubble Contrast Transesophageal Echocardiography Data.

Percutaneous closure of patent foramen ovale (PFO) is an alternative option to medical treatment for secondary prevention for cryptogenic stroke (CS). Despite technical success of procedure, residual shunt (RS) which is a presumable cause for recurrent stroke is observed in some patients. We evaluated the RS with serial follow-up bubble contrast transesophageal echocardiography (BCTEE) after PFO closure. Among consecutive 47 CS patients who underwent PFO closure, a serial follow-up BCTEE at 3 and 9 months after the index procedure was completed in 38 patients (81%, 46 ± 10 years, 19 men). To evaluate the efficacy of PFO closure, the incidence of any and significant RS (≥ moderate) was assessed. All PFO closure procedures were successful. The Amplatzer PFO Occluder (n = 19) or the Gore Septal Occluder (n = 19) were used. Any RS was observed in 13 (34%) and 10 patients (26%) at 3 and 9 months after the procedure. Significant RS was observed in 6 (16%) and 4 (11%) patients at 3- and 9-month follow-up BCTEE. Patients who were treated with the Gore Septal Occluder have a less incidence of any RS in 3 months, and any/significant RS in 3- and 9-month follow-up BCTEE without statistical significance. RS grade keeps decreasing after PFO closure, but it remains even after 9 months in some patients. Incomplete sealing of PFO should be taken into consideration in management of CS patients even after technically successful PFO closure.

Moon J ，Kim M ，Oh PC ，Shin DH ，Park HM ，Jo YY ，Lee JS ，Kang WC ... -  《-》

Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial.

Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates. This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography. Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up. From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction-defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1). PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).

Lee PH ，Song JK ，Kim JS ，Heo R ，Lee S ，Kim DH ，Song JM ，Kang DH ，Kwon SU ，Kang DW ，Lee D ，Kwon HS ，Yun SC ，Sun BJ ，Park JH ，Lee JH ，Jeong HS ，Song HJ ，Kim J ，Park SJ ... -  《-》