Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series

Haas, Nikolaus A.; Soetemann, Dagmar B.; Ateş, İsmail; Başpınar, Osman; Ditkivskyy, Igor; Duke, Chris; Godart, François; Lorber, Avraham; Oliveira, Edmundo Clarindo; Onorato, Eustaquio; Paç, Feyza Ayşenur; Promphan, Worakan; Riede, Frank-Thomas; Roymanee, Supaporn; Sabiniewicz, Robert; Shebani, Suhair O.; Sievert, Horst; Tin, Do; Happel, Christoph M.

doi:10.1002/ccd.26497

Cited by 60 publications

(57 citation statements)

References 39 publications

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“…The closure rate increased to 83.1% at discharge from the hospital. Complete closure rate at 2‐year‐follow‐up was 97% [15,17].…”

Section: Discussionmentioning

confidence: 94%

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Recent review of transcatheter closure of atrial septal defect

Yang

2018

The Kaohsiung J of Med Scie

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Atrial septal defect (ASD) is one of the two most common congenital heart diseases in children and adult. After the application of catheter intervention for ASD, this became an alternative treatment other than surgery from late 1990. In 2001, the procedure was further approved by the US Food and Drug Administration (FDA), and become the first choice for most cases of secundum type of ASD worldwide. The success rate is more than 98% in literature reviews, with low complication rates in percutaneous ASD closure. Major complications are around 1%, including device embolization, cardiac erosions, new-onset atrial arrhythmia, and other comorbidities. We reviewed indications for percutaneous secundum type ASD closure, technique, successful rate and major complications in this article. To complete the catheter intervention with difficult ASD conditions, various procedural techniques have been developed recently. We also report a challenging case by a current balloon-assisted technique for huge ASD closure.

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“…The closure rate increased to 83.1% at discharge from the hospital. Complete closure rate at 2‐year‐follow‐up was 97% [15,17].…”

Section: Discussionmentioning

confidence: 94%

“…Successful device implantation rate of ASD closure was 97.9–98.7% [14–16]. Residual shunt might not be uncommon after device implantation, but it is rare at long‐term follow‐up.…”

Section: Discussionmentioning

confidence: 95%

Recent review of transcatheter closure of atrial septal defect

Yang

2018

The Kaohsiung J of Med Scie

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“…The IRFACODE registry reported a 0.3% embolisation rate in 1333 patients who underwent ASD closure with an Occlutech device . In our series transcatheter device retrieval was successful in 92% (11/12) of cases and 88% (7/8) of cases where the device had embolized.…”

Section: Discussionmentioning

confidence: 99%

Techniques for transcatheter retrieval of the occlutech ASD device United Kingdom–European multicenter report

Shebani

Rehman

Taliotis³

et al. 2016

Cathet Cardio Intervent

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To gather current experience in Occlutech ASD device retrieval, to determine whether snaring is an effective technique and to highlight alternative retrieval techniques; METHODS AND RESULTS: United Kingdom and European Occlutech ASD device implanters reported their experience in dealing with device embolization and retrieval. Six operators reported 12 retrieval cases. Retrieval was successful in 92% (11/12), although in most cases it was not straightforward and required multiple attempts using different techniques and equipment. When each different technique or equipment combination was considered separately, there were a total of 23 retrieval attempts. Fifteen attempts involved snaring the ball on the right atrial disc of the device ("the RA pin"). In 12/15 of these attempts the snare slipped off the RA pin. In 8/15 attempts snaring eventually failed. In two cases retrieval was facilitated by elongating the device in a blood vessel. In three cases retrieval was achieved by grasping the RA pin with the jaws of the Occlutech Flex II delivery cable; CONCLUSIONS: Snares do not grip the RA pin sufficiently to reliably retrieve the device. Funnelling the device into a blood vessel or grasping the RA pin with the jaws of the delivery cable may be successful alternatives. © 2016 Wiley Periodicals, Inc.

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“…Transcatheter closure of the atrial septal defect (ASD) has taken the place of surgical closure of the ASD since Amplatzer Septal Occluder (ASO) was on the market in the late 1990s . More recently, Occlutech Figulla ASD Occluder (FSO) has been innovated to provide better structural flexibility and was introduced in Japan in 2016. While critical complication of cardiac erosion associated with ASO has happened in up to 0.3% of the patients, a case report of cardiac trauma related to the FSO has not been published yet.…”

Section: Introductionmentioning

confidence: 99%

Case report: Atrioventricular block after transcatheter atrial septal closure using the Figulla® Flex II ASD occluder

Sato

Kato

Takeda

et al. 2019

Cathet Cardio Intervent

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We report a 7‐year‐old male patient who developed severe atrioventricular block after transcatheter closure of the atrial septal defect with an Occlutech Figulla® Flex II ASD occluder (FSO). He had a small aortic rim and the defect measuring 22.3 mm by balloon sizing. When a 24 mm FSO was deployed, he developed Wenckebach second‐degree heart block; however, it recovered to sinus rhythm. Hence, the device was implanted. The rhythm deteriorated to a fixed 2:1 heart block within 7 hr. He underwent surgical retrieval of the device and closure of the defect. Intraoperative findings demonstrated the right atrium disk compressing the triangle of Koch, resulting in a small hematoma. The rhythm recovered completely by 7 days after the surgery. Care must be taken when a relatively large device is deployed in a patient with small rims as even “soft and flexible” device like the FSO can injure the endocardium.

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Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series

Abstract: ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc.

Cited by 60 publications

References 39 publications

Recent review of transcatheter closure of atrial septal defect

Recent review of transcatheter closure of atrial septal defect

Techniques for transcatheter retrieval of the occlutech ASD device United Kingdom–European multicenter report

Case report: Atrioventricular block after transcatheter atrial septal closure using the Figulla® Flex II ASD occluder

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