Intermediate-term outcome of transcatheter secundum atrial septal defect closure using the Bard Clamshell Septal Umbrella

Prieto, Lourdes; Foreman, Cynthia; Cheatham, John P.; Latson, Larry

doi:10.1016/s0002-9149(96)00620-0

Cited by 71 publications

(31 citation statements)

References 7 publications

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“…1 Although a number of devices have undergone investigation, the ideal device does not exist. [2][3][4][5][6][7][8] Such a prosthesis would be simple to implant and easy to remove, provide 100% closure, maintain a low profile on the atrial septum, have an atraumatic contour, and be composed of materials with proven mechanical integrity and long-term biocompatibility. In 1995, we began to design an occlusion system that would incorporate these features.…”

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confidence: 99%

Development and Testing of the Helex Septal Occluder, a New Expanded Polytetrafluoroethylene Atrial Septal Defect Occlusion System

et al. 2001

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Background-A variety of transcatheter atrial septal defect (ASD) occluders are currently in use around the world.Although for the most part effective, all of these devices lack features that would be desirable in a "perfect" device. The Helex septal occluder is a new type of device designed to improve the results of transcatheter ASD closure. This study was designed to examine the effectiveness and safety of this occluder in an animal model. Methods and Results-The Helex was implanted into 24 dogs with surgically created ASDs. Procedural details focusing on deployment, removal, and early closure rates were examined. Follow-up consisted of sequential transesophageal echocardiography and fluoroscopy as well as epicardial contrast echocardiography and angiography at the time of death. Specimens were examined grossly and histologically, and devices were tested for metal fatigue. All animals had successful ASD closure. Implantation was uncomplicated (mean fluoroscopy time 11.7 minutes), and removal or repositioning was always possible. Closure rate as judged by transesophageal echocardiography was 88% initially and 100% at 2-week follow-up. Devices rapidly became infiltrated with connective tissue without inflammation and were endothelialized over time. There were no instances of thromboembolism. A single wire-frame fracture occurred secondary to a prototype delivery system malfunction. Conclusions-The

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confidence: 99%

Development and Testing of the Helex Septal Occluder, a New Expanded Polytetrafluoroethylene Atrial Septal Defect Occlusion System

et al. 2001

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“…One patient developed a transient second-degree AVB after deployment of the proximal disk in the right atrium, which was treated by injection of atropine sulphate (patient 14). No other complications, such as device embolization, thromboembolic events, pericardial effusion or endocarditis, occurred during the procedure or thereafter.…”

Section: Resultsmentioning

confidence: 99%

“…Two different approaches, venous and arterial, make the ASDOS in particular complex to use. The rate of residual shunt is high, ranging from 26.7% to 45.2%, [13][14][15][16] except for the AngelWings device (7.7%). 17 Furthermore, clinical trials of the Clamshell device were abandoned in Japan and the USA because of broken arms of the devise, 11 and subsequently a modified Clamshell device, CardioSeal, was developed.…”

Section: Discussionmentioning

confidence: 96%

Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal Occluder. A Japanese Clinical Trial.

Oho

Ishizawa

Akagi

et al. 2002

Circ J

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“…By then, 40-84% of the implanted devices were found to have early or late arm fractures which might have caused some of the reported residual shunts, embolization, new shunting, or stroke [22][23][24]. However, because of its proven superiority compared with older designs, the Lock Clamshell was modified and further studied as the CardioSEAL, which later became the STARFlex (see below).…”

Section: Lock Clamshell Occludermentioning

confidence: 99%

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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Intermediate-term outcome of transcatheter secundum atrial septal defect closure using the Bard Clamshell Septal Umbrella

Cited by 71 publications

References 7 publications

Development and Testing of the Helex Septal Occluder, a New Expanded Polytetrafluoroethylene Atrial Septal Defect Occlusion System

Development and Testing of the Helex Septal Occluder, a New Expanded Polytetrafluoroethylene Atrial Septal Defect Occlusion System

Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal Occluder. A Japanese Clinical Trial.

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

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