Transcatheter patch closure of an atrial septal defect of sinus venosus type using the immediate release patch

Franke, Jennifer; Bertog, Stefan; Sideris, Eleftherios B.; Hofmann, Ilona; Wunderlich, Nina; Hornung, Marius; Sievert, Horst

doi:10.1002/ccd.25165

Cited by 8 publications

(4 citation statements)

References 8 publications

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“…Abdullah et al [56] describe an approach that combines covered stent grafts and occlusion devices to correct sinus venosus defects successfully in four patients; of which two required re-intervention with an additional covered stent or PFO closure device, but all without significant complications at the 12-month follow-up point [56] . Others have reported success with the immediate release patch, which has been under investigation in translational animal studies as a potential alternative to metallic devices [57,58] .…”

Section: Surgical Vs Transcatheter Interventionmentioning

confidence: 99%

Atrial septal defect repair in the age of transcatheter devices

Zimmermann¹,

Hussain²,

Worku³

et al. 2019

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The aim of this review is to discuss the management of atrial septal defects (ASD) in the adult patient paying special attention to the elderly population and the most recent transcatheter advancements. ASDs are characterized by the following categories: ostium secundum, ostium primum, sinus venosus, and coronary sinus defects; though multiple defects may exist concurrently. Intervention for closure of ASDs are indicated with the development of right ventricular volume overload, or in the clinical context of paradoxical embolic stroke. Previously, there was significant disagreement regarding the timing of ASD closure in adult patients, but there is now general consensus that adult patients with clinical evidence of right ventricular overload should undergo closure of ASDs at the time of presentation. The present review describes the typical presentation of patients with symptomatic ASD's, medical management, and whether surgical or percutaneous approach should be pursued. We will also discuss other important considerations for patient selection and potential early and late complications of transcatheter ASD closure such as congestive heart failure, device embolization, and tissue erosion. At the time of this writing, there are currently three FDA-approved devices for percutaneous VSD closure including the Amplatzer TM Septal Occluder (ASO, St. Jude Medical, St. Paul, MN), Gore HELEX TM Septal Occluder (W.L. Gore and Associates, Newark, NJ), and Gore CARDIOFORM TM Septal occluder (GCSO, W.L. Gore and Associates, Newark, NJ) devices. Many premarket approvals were granted for devices that never went to market due to poor investigational study performance. Likewise, the HELEX device has since been discontinued upon bringing the GCSO device to market. We will focus primarily on the ASO device with a brief review of current investigations into the GCSO device, both of which carry an indication for closure small to medium sized ASDs in the ostium secundum position. Additionally, this review covers the safety of transcatheter closure of ASDs with currently available devices, review studies associated with devices available outside the United States, and perioperative considerations for transcatheter Page 2 of 18 Zimmermann et al. Vessel Plus 2019;3:31 I http://dx.intervention. Obstacles to device employment and countermeasures to overcome operational challenges will also be discussed. To this end, variations or similarities of currently approved devices will be emphasized throughout this discussion where possible. Lastly, we will offer insights into device evolution trends with the expectation of new device developments on the horizon. We will briefly discuss up and coming areas of active research, including the emerging fields of novel biomaterials and gene therapy. MORPHOLOGY AND CLINICAL FEATURES OF ASDS Location, Morphology, and suitability for surgery vs. transcatheter interventionIt is important to note that morphological variations of different types of ASDs, which determines whether a particular defect is amenabl...

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Section: Surgical Vs Transcatheter Interventionmentioning

confidence: 99%

Atrial septal defect repair in the age of transcatheter devices

Zimmermann¹,

Hussain²,

Worku³

et al. 2019

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“…The original Transcatheter Patch required 48 h of patient's immobilization for secure attachment of the device to the inter-atrial septum before a balloon catheter could be removed [80]. The Immediate Release Patch (IRP) is the most recent version and consists of a porous polyurethane sleeve-shaped patch with a surgical adhesive to allow immediate release and accelerate septal attachment (Figure 3).…”

Section: Immediate Release Patchmentioning

confidence: 99%

“…Improvements to previous device designs include the potential for closure of ASDs with insufficient rim and for preventing wire-related complications such as fractures and perforations [80,81]. Also, the IRP is applicable for defects up to 30 mm using only three sizes (3-13, 14-25, and 25-30 mm over 9, 12 resp., 13-F sheaths), which enables more efficient device storage and availability.…”

Section: Immediate Release Patchmentioning

confidence: 99%

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Historical developments of atrial septal defect closure devices: what we learn from the past

Nassif

Abdelghani

Bouma

et al. 2016

Expert Review of Medical Devices

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Introduction: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. Areas covered: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. Expert opinion: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given. ARTICLE HISTORY

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Transcatheter closure of atrial septal defect and a patent foramen ovale in adults

Holy

Nietlispach

Meier

2020

Emerging Technologies for Heart Diseases

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Transcatheter patch closure of an atrial septal defect of sinus venosus type using the immediate release patch

Abstract: Following promising preclinical studies, we report our first clinical experience with transcatheter closure of an atrial septal defect of sinus venosus type in a 65-year-old patient using the Immediate Release Patch.

Cited by 8 publications

References 8 publications

Atrial septal defect repair in the age of transcatheter devices

Atrial septal defect repair in the age of transcatheter devices

Historical developments of atrial septal defect closure devices: what we learn from the past

Transcatheter closure of atrial septal defect and a patent foramen ovale in adults

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