Transcatheter closure of atrial septal defect and patent foramen ovale with the ASDOS device (a multi-institutional European trial)∗∗See Appendix for the list of participating institutions and investigators.

Sievert, Horst; Babic, Uros U.; Hausdorf, G.; Schneider, Martin; Höpp, Hans W.; Pfeiffer, Dietrich; Pfisterer, Matthias; Friedli, Béat; Urban, Philip

doi:10.1016/s0002-9149(98)00650-x

Cited by 155 publications

(103 citation statements)

References 22 publications

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“…31 Hung et al 20 reported the results of PFO transcatheter closure in 67 patients with a mean age of 46 years. An 86% effective occlusion rate and a risk of recurrent stroke or TIA of 3.2% per year were described at a mean follow-up of 2.6 years.…”

Section: Comparison With Previous Studies Of Percutaneous Transcathetmentioning

confidence: 99%

Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

et al. 2002

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Background-Percutaneous transcatheter closure of patent foramen ovale (PFO) is used as an alternative to surgery or long-term anticoagulation for the treatment of patients with paradoxical embolism and PFO. Methods and Results-We report the immediate and long-term clinical and echocardiographic outcome of 110 consecutive patients (58 males, mean age 47Ϯ14 years) who underwent transcatheter closure of PFO because of paradoxical embolism between 1995 and 2001. Procedural success, defined as successful deployment of the device and effective occlusion (no, or trivial, shunt after device placement), was achieved in all (100%) patients. There was no in-hospital mortality, 1 device migration requiring surgical intervention (0.9%), and 1 episode of cardiac tamponade (0.9%) requiring pericardiocentesis. A progressive increment in full occlusion was observed (44%, 51%, 66%, and 71% at 1 day, 6 months, and 1 and 2 years, respectively, after device placement). At a mean follow-up of 2.3 years, 2 patients experienced recurrent neurological events (1 fatal stroke and 1 transient ischemic attack), representing an annual risk of recurrence of 0.9%. In addition, 4 (3.6%) of the patients required reintervention for device malalignment or significant shunt. Kaplan-Meier analysis showed a freedom from recurrent embolic events and reintervention of 96% and 90% at 1 and 5 years, respectively. Conclusions-Transcatheter closure of PFO is a safe and effective therapy for patients with paradoxical embolism and PFO. It is associated with a high success rate, low incidence of hospital complications, and low frequency of recurrent systemic embolic events.

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Section: Comparison With Previous Studies Of Percutaneous Transcathetmentioning

confidence: 99%

Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

et al. 2002

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“…[5][6][7][8][9][10][11][12][13][14][15] However, which is the best device for closure of ASD remains controversial. [5][6][7][8][9][10][11][12][13][14][15][16][17] For central-located secundum ASD of small to medium size, closure with a device is strongly recommended. Sideris' button device had been reported to successfully close secundum ASD in some patients.…”

Section: Discussionmentioning

confidence: 99%

“…22,25) Although an atrial septal defect occlusion system (ASDOS, Sulzer Osypka, Rheinfelden, Germany) has been tried in many European countries, 16) it has a moderate / larger residual shunt in 2% and a small residual shunt in 26% of patients one year after the implantation, 16) Furthermore, complications included cerebral thrombosis, late atrial wall perforation, infections in 14%, and frame deformity in 4% of the patients during the 230 patients-years of followup study. 16) Transfemoral approach over both side femoral arteries is also a technical difficulty associated with this particular device. 13,16) The buttoned device of Sideris has been tried worldwide to close the ASD.…”

Section: Discussionmentioning

confidence: 99%

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Transcatheter Closure of Atrial Septal Defect with a CardioSEAL Device

Hwang

Lee

et al. 2000

Jpn Heart J

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SUMMARYTranscatheter closure of an interatrial septal defect (ASD) with a CardioSEAL device was successfully performed on 12 Taiwanese children. There were five boys and seven girls, aged from 3.6-13.9 (8.3 ± 3.2) years and with body weight of 15-57 (33.7 ± 14.7) kgs. After one year of follow-up studies, which included physical examination, ECG, chest X-ray and echocardiography, complete closure of ASD was achieved in nine (75%) patients. Two children with a trivial residual shunt were asymptomatic and without audible cardiac murmur. A girl had a small residual left to right atrial shunt by color Doppler echocardiography, but without audible cardiac murmur. There were no immediate or intermediate complications. Transcatheter implantation of the CardioSEAL device is a safe and proper treatment for children with non-complicated small to medium secundum ASD. (Jpn Heart J 2000; 41: 471-480)

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“…Buttoned device reprinted from [8] with permission from Elsevier. ASDOS Reprinted from [12] and [13] respectively with permission from Elsevier.Monodisk Reproduced from [14] with permission of Springer. AngelWing Reprinted from [15] with permission from Elsevier.…”

Section: Rashkind's Single Umbrellamentioning

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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Transcatheter closure of atrial septal defect and patent foramen ovale with the ASDOS device (a multi-institutional European trial)∗∗See Appendix for the list of participating institutions and investigators.

Cited by 155 publications

References 22 publications

Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

Transcatheter Closure of Atrial Septal Defect with a CardioSEAL Device

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

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