Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept

Georgiev, Stanimir; Tanase, Daniel; Genz, T.; Ewert, Peter; Naumann, Susanne; Pozza, Robert Dalla; Eicken, Andreas

doi:10.1017/s1047951118000586

Cited by 4 publications

(4 citation statements)

References 21 publications

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“…Left ventricle, abdominal aorta and femoral vessels are familiar embolization locations if the device embolizes to the systemic circulation (30,31). An overall embolization rate of 2% is rather high although in concordance with other study reports, accounting an embolization rate of 0.2-2.2% (21,22,28,29,(32)(33)(34)(35). Undersized device and large defects with either deficient or floppy septal tissues are also associated with these complications (15,36,37).…”

Section: Device Embolizationsupporting

confidence: 79%

“…Both patients were described in detail above. Device embolization occurs at a rate of 0.6-2% and usually, as in our cases, device retrieval is successful (22,(27)(28)(29). Obviously in both patients the actual defect size was wrongly underestimated, although in both patients balloon sizing with the "stop flow" technique was employed.…”

Section: Device Embolizationmentioning

confidence: 61%

“…Removing large CeraFlex TM occluders with a snare may be difficult since it may slip of the right atrial hub. Georgiev et al reported on a viable method of interventional occluder removal using the Maslanka biopsy forceps assisting the snare (28). Left ventricle, abdominal aorta and femoral vessels are familiar embolization locations if the device embolizes to the systemic circulation (30,31).…”

Section: Device Embolizationmentioning

confidence: 99%

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A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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Background: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlex TM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU). Methods: Procedure specific data was collected on patients considered for ASD closure with the CeraFlex TM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU. Results: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlex TM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle. Conclusions: Catheter interventional closure of secundum ASDs with the CeraFlex TM ASD occluder was feasible, safe and effective in this study.

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Section: Device Embolizationsupporting

confidence: 79%

Section: Device Embolizationmentioning

confidence: 61%

Section: Device Embolizationmentioning

confidence: 99%

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A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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“…4 Alternative techniques include capturing the waist of the device (requires the use of a very large sheath), using a coronary wire to "harpoon" a device (can be technically challenging and requires very large sheaths), the double snare technique (not shown to be successful in FSO embolisation to the aorta) or even use commercially available modified bioptome forceps to recapture an embolised device (requires non-standard equipment). [5][6][7][8] To our knowledge, our patient is the smallest child to have had successful percutaneous retrieval of an embolised device within the aorta (Table 1). First described in 2004, the "mother and child" technique was devised for complex coronary interventions.…”

Section: Discussionmentioning

confidence: 94%

Successful retrieval of embolised Occlutech atrial septal defect occluder from descending aorta in a 4-year-old child using a “mother and child” technique: a case report and literature review

2022

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A 9 mm Occlutech septal occluder Flex II device was retrieved in a 4-year-old 22 kg child; A 6 Fr Cook® Flexor sheath (child) was inserted into a 9 Fr Occlutech® ASD Delivery Set (mother). Once the tip of the smaller sheath was close to the device, a 4 Fr right Judkins catheter was introduced with a snare. The right atrial hub was captured and withdrawn to the level of the 6 Fr sheath which was then withdrawn into the 9 Fr sheath before being removed completely. The “mother and child” technique offers a greater likelihood of slenderising and retrieving embolised devices.

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Transcatheter retrieval of atrial septal defect and patent ductus arteriosus occluder: a guidance for device retrieval based on comprehensive bench tests

et al. 2022

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Objectives: The aim of this study is to establish a guidance for device retrieval based on comprehensive bench tests. Background: Device embolisation remains a major complication in transcatheter closure of atrial septal defect and patent ductus arteriosus. Although percutaneous retrieval is feasible in the majority of cases, surgical retrieval may be required in complicated circumstances. However, the methods of transcatheter device retrieval have not been completely established. Methods: Bench tests of device retrieval were performed to verify the appropriate retrieval method according to device type/size. The devices used for testing were Amplatzer Septal Occluder (Abbott, Chicago, IL, United States of America), Figulla Flex II (Occlutech GmbH, Jena, Germany), Amplatzer Duct Occluder-I (Abbott), Amplatzer Duct Occluder-II (Abbott), and Amplatzer Vascular Plug-II (Abbott). The retrieval equipment constituted diagnostic catheters (multipurpose catheter and right Judkins catheter, 4-Fr or 5-Fr, Gadelius Medical, Tokyo, Japan), delivery sheath and cables for each device, Amplatz goose neck snares (Medtronic, Minneapolis, MN, United States of America), OSYPKA CATCHER (Osypka ag, Rheinfelden-Herten, Germany), and OSYPKA LASSOS (Osypka). We investigated the retrieval equipment and sheath sizes required for a successful retrieval procedure for variously sized devices. Results: For patent ductus arteriosus devices, the type of snare and the snaring position are considered important. For atrial septal defect devices, simple snare capture or a double-snare technique with a sufficiently large sheath is effective. Special care should be taken when using the OSYPKA CATCHER for device retrieval. Conclusions: The results of this study may assist in the selection of both capture devices and a retrieval sheath or a catheter for complete retrieval.

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Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept

Abstract: It was impossible to retrieve Occlutech and Ceraflex devices larger than 16 mm into a large sheath in vivo and during benchside tests. However, this was feasible on the bench and in vivo using the Maslanka biopsy forceps even with the largest available devices.

Cited by 4 publications

References 21 publications

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

Successful retrieval of embolised Occlutech atrial septal defect occluder from descending aorta in a 4-year-old child using a “mother and child” technique: a case report and literature review

Transcatheter retrieval of atrial septal defect and patent ductus arteriosus occluder: a guidance for device retrieval based on comprehensive bench tests

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