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

Gaspardone, Achille; Marco, Federico De; Sgueglia, Gregory A.; Santis, Antonella De; Iamele, Maria; D'Ascoli, Emanuela; Tusa, Maurizio; Corciu, Anca Irina; Mullen, Michael; Nobles, Anthony; Carminati, Mário; Bedogni, Francesco

doi:10.4244/eij-d-18-00023

Cited by 49 publications

(56 citation statements)

References 20 publications

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“…The NobleStitch™ EL system has had a CE mark in Europe for PFO closure for more than 8 years, typically used with the method described by Gaspardon, et al 13 The system has had a 510(k) clearance in the United States for intravascular and intracardiac shunting for over 3 years.…”

Section: Methodsmentioning

confidence: 99%

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Use of the NobleStitch™ EL for the treatment of patients with residual right‐to‐left shunt following device closure of PFO

Chaudhry-Waterman

Shapiro

Thompson

2021

Clinical Case Reports

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Section: Methodsmentioning

confidence: 99%

“…The suture ends are then loaded through the cylindrical KwiKnot, which is advanced via the third catheter to approximate the atrial septum, where the sutures are tightened to oppose the secundum and primum septa. The KwiKnot is locked in place, and the excess suture is cut and removed 13 …”

Section: Methodsmentioning

confidence: 99%

Use of the NobleStitch™ EL for the treatment of patients with residual right‐to‐left shunt following device closure of PFO

Chaudhry-Waterman

Shapiro

Thompson

2021

Clinical Case Reports

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“…Although this device is not approved in the United States for PFO closure, it is now being used off label for this procedure. The first reported series of cases with this device were reported in a prospective study from 12 centers in Italy[79]. This study enrolled 192 patients who were considered acceptable candidates for suture-mediated PFO closure.…”

Section: Non-implant Defect Closurementioning

confidence: 99%

State-of-the-Art Atrial Septal Defect Closure Devices for Congenital Heart

O’Byrne

Levi

2019

Interventional Cardiology Clinics

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The purpose of this review is to describe the current state of the art in terms of available devices and indications for the transcatheter device closure of atrial septal defects (ASD) and patent foramen ovale (PFO) in children and young adults. Techniques for transcatheter device closure of ASD (TC-ASD) are well established and TC-ASD has a proven track record of efficacy and safety. Device erosion, a rare but potentially catastrophic adverse event of TC-ASD has raised questions about the relative safety of TC-ASD versus operative open heart surgical ASD closure (O-ASD). Despite a concerted effort to study the issue, there are no solutions that avoid the risk of erosions definitively when using the Amplatzer device. There is evidence that concern about erosions has changed practice in the United States, specifically that more patients are referred for O-ASD than in the past. Efforts to study these changes have also revealed more variation in TC-ASD practice than previously appreciated. New devices for ASD closure with properties that may reduce the risk of erosion are being developed and brought to market, but, in the meantime, cardiologists must continue to balance the risks and benefits of TC- and O-ASD closure. Recent studies demonstrating the superiority of PFO device closure over medical therapy for cryptogenic stroke is likely to lead to changes in practice for structural/interventional cardiologists. Previously, the overwhelming majority of ASD closure procedures were performed for right heart volume overload due to left to right shunt, but stroke prophylaxis may become a more significant part of the volume in pediatric/congenital catheterization laboratories. Care should be taken in extrapolating this data to children and younger adults, and important questions about patient selection remain unresolved.

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“…This kind of procedure does not require TEE or ICE guidance: the role of echocardiography is limited to the screening phase and the pre‐operative assessment of PFO anatomical features. However, there are currently few data available on the efficacy and safety of suture‐based devices positioning 63 and further experience is needed. Although limited data available, PFO closure with suture‐based devices is usually considered more difficult in presence of larger PFO, with or without ASA.…”

Section: Introductionmentioning

confidence: 99%

The evolving role of echocardiography in the assessment of patent foramen ovale in patients with left‐side thromboembolism

et al. 2021

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Patent foramen ovale (PFO) is the most common congenital cardiac abnormality found approximately in 25% of the adult population. 1,2 PFO has been associated with several pathological conditions but the most significant one is ischemic stroke due to paradoxical embolization. 3 Although only ~4%-5.5% of strokes are due to paradoxical embolism, 4 PFO-associated stroke accounts for 10% of ischemic stroke occurring in young-and middle-aged adults. 5 On the other hand, PFO is an incidental bystander in a significant part of patients with ischemic stroke. In last years, several studies have been conducted to determine the role of PFO closure in secondary prevention of ischemic stroke. Aim of this review is to underline the important role of ultrasound in PFO assessment, indication to treatment, intraprocedural guidance, and follow-up. | Embryology of interatrial septumPatent foramen ovale is a normal communication of the fetal heart between the right and the left atria, shunting the oxygenated blood, coming from the inferior vena cava (IVC), from the right atrium (RA) to the left atrium (LA). During the first and second months of intrauterine development, the primordial single atrium is divided in two halves by formation and fusion of two septa: the septum primum and the septum secundum. 6 At the antero-superior edge of the fossa

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

Abstract: The early results of this first Italian registry indicate that the suture-mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, and provides an effective closure of PFO comparable to traditional devices with a good safety profile at medium-term follow-up.

Cited by 49 publications

References 20 publications

Use of the NobleStitch™ EL for the treatment of patients with residual right‐to‐left shunt following device closure of PFO

Use of the NobleStitch™ EL for the treatment of patients with residual right‐to‐left shunt following device closure of PFO

State-of-the-Art Atrial Septal Defect Closure Devices for Congenital Heart

The evolving role of echocardiography in the assessment of patent foramen ovale in patients with left‐side thromboembolism

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