Gore Cardioform Atrial Septal Occluder: Deployment Procedure and Techniques for Closing Challenging Secundum Atrial Septal Defects

2021 ◽  
pp. 1-25
Author(s):  
Varun Aggarwal ◽  
Arjun K Mohan ◽  
John Bass ◽  
Julia Steinberger ◽  
Sameh M Said ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
New Device ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
Fda Approval ◽  
Occluder Device ◽  
Key Features ◽  
Us Fda

Abstract Ostium secundum atrial septal defects are mostly closed in the cardiac catheterization laboratories using either Amplatzer® (Abbott Laboratories, IL) atrial septal occluder, Gore® Cardioform septal occluder and more recently using the recently approved (US FDA approval June 2019) Gore® Cardioform atrial septal defect occluder (W. L. Gore & Associates, AZ). Similar to any new device in the market, there is a learning curve to the deployment of this device. We therefore aim to report the key features about this new Gore Cardioform atrial septal defect occluder device with special emphasis on technical aspects that can be employed during transcatheter closure of challenging ostium secundum atrial septal defects using this device.

Transcatheter closure as standard treatment for most interatrial defects: experience in 200 patients treated with the Amplatzer ™ Septal Occluder

1999 ◽  
Vol 9 (5) ◽  
pp. 468-473 ◽  
Author(s):  
Felix Berger ◽  
Peter Ewert ◽  
Per G. Boöjrnstad ◽  
Ingo Dähnert ◽  
Gregor Krings ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
Paradoxical Embolism ◽  
Residual Shunt ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
Diagnostic Cardiac Catheterization ◽  
Long Term Follow Up

AbstractTo judge whether an Amplatzer™ Septal Occluder can be used as standard therapy instead of surgery for closure of atrial septal defects we report our experiences in 200 patients. Of these patients, 127 had an atrial septal defect with haemodynamically significant left-to-right shunt, 68 patients a persistent oval foramen after presumed paradoxical embolism, and 5 had a fenestration after Fontan-repair. Mean age was 29.8 years (0.8 to 77.7 years). Body weight ranged from 6.9 to 120.0 kg (mean 51.5 kg). After diagnostic cardiac catheterization, and balloon-sizing of the defect, we implanted Amplatzer™ Septal Occluders with stents of 4 to 28 mm diameter. Follow-up studies were obtained after 48hours, and one, six, and twelve months. Transcatheter closure of the atrial septal defect proved successful in all without any relevant residual shunts. In particular, complete closure was achieved in all patients after presumed paradoxical embolism. The mean period of follow-up is 9–5 months, with a range from 0.4 to 23.5 months, giving a total of 1898 patient months. The occlusion rate after three month was 98.1°. A trivial haemodynamically insignificant residual shunt remained in 1.9° of the patients. Fluoroscopy times ranged from 0 to 43.5 minutes, with a median of 8.7 minutes. The excellent results in the short and medium term in children and adults have resulted in using this device routinely at the present time for closure of central atrial septal defects up to a diameter of 28 mm. Final judgement, however, is only possible after long-term follow-up.

scholarly journals Transcatheter closure of secundum atrial septal defects with the atrial septal defect occlusion system (ASDOS): initial experience in children.

Heart ◽  
1996 ◽  
Vol 75 (1) ◽  
pp. 83-88 ◽  
Author(s):  
G. Hausdorf ◽  
M. Schneider ◽  
B. Franzbach ◽  
C. Kampmann ◽  
K. Kargus ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
Initial Experience ◽  
Septal Defects ◽  
Atrial Septal Defects

Device Size for Transcatheter Closure of Ovoid Interatrial Septal Defect

2013 ◽  
Vol 16 (4) ◽  
pp. 193
Author(s):  
Eun Hyun Cho ◽  
Jinyoung Song ◽  
Eun Young Choi ◽  
Sang Yoon Lee
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
Defect Group ◽  
Amplatzer Septal Occluder ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
The Mean ◽  
Computed Tomography Image ◽  
Device Size

<p><b>Background:</b> For successful transcatheter closure of an atrial septal defect with the Amplatzer septal occluder, the shape of the defect should be considered before selecting the device size. The purpose of this study was to evaluate the results of transcatheter closure of an ovoid atrial septal defect.</p><p><b>Methods:</b> Between January 2010 and February 2012, cardiac computer tomography examinations were performed in 78 patients who subsequently underwent transcatheter closure of an atrial septal defect. In this retrospective study, we reviewed these patients' medical records. We defined an ovoid atrial septal defect as a value of 0.75 for the ratio of the shortest diameter of the defect to the longest diameter, as measured in a computed tomography image. Transthoracic echocardiography examinations were made at 1 day and 6 months after the procedure.</p><p><b>Results:</b> Transcatheter closure of an atrial septal defect was successful in 26 patients in the ovoid-defect group and in 52 patients in the round-defect group. There were no serious complications in either group, and the rate of complete closure at 6 months was 92.3% in the ovoid-defect group and 93.1% in the round-defect group (<i>P ></i> .05). The mean (SD) difference between the device size and the defect's longest diameter, and the mean ratio of the device size to the longest diameter were significantly smaller in the ovoid-defect group (1.7 � 2.9 versus 3.8 � 2.5 and 1.1 � 0.1 versus 1.3 � 0.2, respectively).</p><p><b>Conclusions:</b> Transcatheter closure of an atrial septal defect is indicated even for an ovoid atrial septal defect. Ovoid atrial septal defects can be closed successfully with smaller sizes of the Amplatzer septal occluder than for round atrial septal defects.</p>

Infective endocarditis on an occluder closing an atrial septal defect

1999 ◽  
Vol 9 (1) ◽  
pp. 65-67 ◽  
Author(s):  
A. M. Bullock ◽  
S. Menahem ◽  
J. L. Wilkinson
Keyword(s):  
Infective Endocarditis ◽  
Atrial Septal Defect ◽  
Antibiotic Prophylaxis ◽  
Potential Risk ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
Surgical Closure ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
First Case

AbstractClosure of atrial septal defects be means of intravenous catheterisation has been undertaken using a variety of devices as an alternative to surgical closure.1–5 We describe the first case, to the best of our knowledge, of infective endocarditis complicating a successful transcatheter closure. This highlights the potential risk of this procedure, and emphasises the need for appropriate antibiotic prophylaxis until complete endothelialization of the device has occurred.

scholarly journals The role of three-dimensional transesophageal echocardiography in preoperative assessment of atrial septal defects

2015 ◽  
Vol 18 (1) ◽  
pp. 58 ◽  
Author(s):  
D. G. Tarasov ◽  
I. V. Tkachev ◽  
S. S. Kadrabulatova
Keyword(s):  
Atrial Septal Defect ◽  
Transesophageal Echocardiography ◽  
Septal Defect ◽  
Preoperative Evaluation ◽  
Three Dimensional ◽  
Maximum Diameter ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
Dimensional Echocardiography ◽  
Three Dimensional Echocardiography

An atrial septal defect is the most common congenital heart disease. Transcatheter defect closure has become widespread in recent times and the requirements for this procedure are rather strict. Two-dimensional echocardiography is limited in evaluating atrial septal defects because it provides planar images only. In order to preoperatively assess atrial septal defects, we applied three-dimensional transesophageal echocardiography and then compared the results with those of surgical operations. The maximum diameter, shape, area and localization of the atrial septal defect in 26 patients were estimated with three-dimensional echocardiography. It was found out that positive correlation existed between three-dimensional echocardiography findings and those measured during surgery. Three-dimensional echocardiography provides invaluable assistance in preoperative evaluation of atrial septal defects and in selection of treatment.

Pacemaker and conduction disturbances in patients with atrial septal defect

2020 ◽  
Vol 30 (7) ◽  
pp. 980-985 ◽  
Author(s):  
Diana H. R. Albæk ◽  
Sebastian Udholm ◽  
Anne-Sif L. Ovesen ◽  
Zarmiga Karunanithi ◽  
Camilla Nyboe ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Atrioventricular Block ◽  
Right Bundle Branch Block ◽  
Septal Defect ◽  
Pacemaker Implantation ◽  
Bundle Branch Block ◽  
Conduction Disturbances ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
Background Population

AbstractObjective:To determine the prevalence of pacemaker and conduction disturbances in patients with atrial septal defects.Design:All patients with an atrial septal defect born before 1994 were identified in the Danish National Patient Registry, and 297 patients were analysed for atrioventricular block, bradycardia, right bundle branch block, left anterior fascicular block, left posterior fascicular block, pacemaker, and mortality. Our results were compared with pre-existing data from a healthy background population. Further, outcomes were compared between patients with open atrial septal defects and atrial septal defects closed by surgery or transcatheter.Results:Most frequent findings were incomplete right bundle branch block (40.1%), left anterior fascicular block (3.7%), atrioventricular block (3.7%), and pacemaker (3.7%). Average age at pacemaker implantation was 32 years. Patients with defects closed surgically or by transcatheter had an increased prevalence of atrioventricular block (p < 0.01), incomplete right bundle branch block (p < 0.01), and left anterior fascicular block (p = 0.02) when compared to patients with unclosed atrial septal defects. At age above 25 years, there was a considerably higher prevalence of atrioventricular block (9.4% versus 0.1%) and complete right bundle branch block (1.9% versus 0.4%) when compared to the background cohorts.Conclusions:Patients with atrial septal defects have a considerably higher prevalence of conduction abnormalities when compared to the background population. Patients with surgically or transcatheter closed atrial septal defects demonstrated a higher demand for pacemaker and a higher prevalence of atrioventricular block, incomplete right bundle branch block, and left anterior fascicular block when compared to patients with unclosed atrial septal defects.

Comparative effects of surgical and percutaneous repair on P-wave and atrioventricular conduction in patients with atrial septal defect – ostium secundum type

2012 ◽  
Vol 23 (1) ◽  
pp. 132-137
Author(s):  
Hassan Javadzadegan ◽  
Mehrnoush Toufan ◽  
Ali Reza Sadighi ◽  
Joyce M. Chang ◽  
Nader D. Nader
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
P Wave ◽  
P Value ◽  
Device Closure ◽  
Wave Duration ◽  
Septal Defects ◽  
Atrial Septal Defects ◽  
P Wave Duration ◽  
Pr Interval

AbstractBoth surgical and percutaneous closures of atrial septal defects have been successful in reversal of atrial dilatation. We compared the effects of surgical and percutaneous transvenous device closure of atrial septal defect on post-operative changes of P-wave duration, PR segment, and PR interval. Electrocardiographic data were prospectively collected from 30 patients following either surgical (n equal to 16) or percutaneous (n equal to 16) repair of atrial septal defects between 2004 and 2010. A cardiologist blinded to the closure technique performed the electrocardiographic analyses. P-wave duration (98.5 plus or minus 15.4 to 86.4 plus or minus 13.2 milliseconds, p-value less than 0.05) and PR interval (162.9 plus or minus 18.5 to 140.6 plus or minus 15.2 milliseconds, p-value less than 0.05) were reduced after percutaneous transvenous device closure. P-wave duration (104.5 plus or minus 24.7 versus 83.2 plus or minus 13.3 milliseconds, p-value less than 0.05) and PR interval (173.2 plus or minus 38.7 versus 144.3 plus or minus 32.0 milliseconds, p-value less than 0.05) were also reduced after surgical closure. PR segment in the percutaneous group was significantly reduced (63.4 plus or minus 14.5 to 52.1 plus or minus 10.8 milliseconds, p-value less than 0.05), but not in the surgical group (68.6 plus or minus 18.7 versus 61.1 plus or minus 24.7 milliseconds). However, the difference in PR segment changes between the two groups was not significant (−11.3 plus or minus 15.0 versus −7.6 plus or minus 20.5 milliseconds, p-value equal to 0.18). Our analysis demonstrates that the changes between the two groups were not different and that both closure techniques reduce P-wave duration, PR segment, and PR interval within 6 months.

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