Experimental atrial septal defect closure with a new, transcatheter, self-centering device.

Das, Gladwin S.; Voss, Greg; Jarvis, Gary A.; Wyche, Keith; Günther, Roland; Wilson, Robert F.

doi:10.1161/01.cir.88.4.1754

Cited by 172 publications

(69 citation statements)

References 18 publications

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“…Although several devices have become available since the first successful attempt at per-catheter ASD closure [21][22][23] , they have all been associated with occasional complications. 24 The Amplatzer Septal Occluder has recently been developed as a new device, 25 and although some favorable results compared with conventional surgical closure have been reported, 26 -28 limitations remain, including the need for patient selection in terms of age, body weight, and type of ASD, as well as a lower success rate than that of surgical closure.…”

Section: Discussionmentioning

confidence: 99%

Beating Atrial Septal Defect Closure Monitored by Epicardial Real-Time Three-Dimensional Echocardiography Without Cardiopulmonary Bypass

et al. 2003

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Background-We assessed the feasibility of beating atrial septal defect (ASD) closure monitored by real-time 3D echocardiography (RT3DE). Methods and Results-RT3DE was developed with prototype ultrasound equipment consisting of a high-speed 3D rendering unit with a frame rate of 5 to 10 frames/s. We also developed a prototype semiautomatic suture device and suture cutting system. In the experiment, 12 mongrel dogs were anesthetized, and after median sternotomy, the echo probe was applied directly to the surface of the right atrium. Three surgical maneuvers (balloon atrial septectomy, enlargement of the ASD, and ASD closure) were performed through the atrial port inserted into the right atrial appendage. The heart was then excised, and the area of the ASD measured by RT3DE was compared with its area measured directly. The ASD was successfully closed in all experimental animals except the first 2. Examination of the excised heart showed that none of the sutures were loose. The mean area of the ASD was 82.5Ϯ38.6 mm 2 when measured by RT3DE and 81.6Ϯ38.2 mm 2 when measured directly, and there was a significant correlation between the areas measured by RT3DE and those measured directly (echo measurementsϭ1.007ϫdirect measurementsϩ0.337; PϽ0.0001). A Bland-Altman analysis revealed close agreement between the results obtained by the 2 methods (7.807 mm 2 upper and Ϫ6.024 mm 2 lower limit of agreement). Conclusions-Introduction

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Section: Discussionmentioning

confidence: 99%

Beating Atrial Septal Defect Closure Monitored by Epicardial Real-Time Three-Dimensional Echocardiography Without Cardiopulmonary Bypass

et al. 2003

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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%

“…13,14,17) The implant procedure and technique of the CardioSEAL device is not more difficult than that of the ASDOS or Sideris device. The immediate and intermediate results of the CardioSEAL device were similar or better to those of other devices.…”

Section: Discussionmentioning

confidence: 99%

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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“…In 1993, Das and colleagues reported a new ASD device called AngelWing [31]. This device had two square disks with a Nitinol frame covered with Dacron to provide elastic stretch.…”

Section: Angelwingmentioning

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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Experimental atrial septal defect closure with a new, transcatheter, self-centering device.

Abstract: This feasibility study demonstrates that this new self-centering atrial septal defect closure device has a number of design features that permit effective and safe closures in a canine model. These results support the investigation of this device in human clinical trials.

Cited by 172 publications

References 18 publications

Beating Atrial Septal Defect Closure Monitored by Epicardial Real-Time Three-Dimensional Echocardiography Without Cardiopulmonary Bypass

Beating Atrial Septal Defect Closure Monitored by Epicardial Real-Time Three-Dimensional Echocardiography Without Cardiopulmonary Bypass

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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