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

Published online by Cambridge University Press:  21 May 2018

Stanimir Georgiev
Affiliation:
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the TU Munich, Munich, Germany
Daniel Tanase
Affiliation:
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the TU Munich, Munich, Germany
Thomas Genz
Affiliation:
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the TU Munich, Munich, Germany
Peter Ewert
Affiliation:
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the TU Munich, Munich, Germany
Susanne Naumann
Affiliation:
Experimental and Molecular Pediatric Cardiology, German Heart Center Munich at the TU Munich, Munich, Germany
Robert Dalla Pozza
Affiliation:
Department of Pediatric Cardiology and Pediatric Intensive Care, Ludwig-Maximilian-University, Munich, Germany
Andreas Eicken
Affiliation:
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the TU Munich, Munich, Germany
Corresponding
E-mail address:

Abstract

Objectives

This study aimed to develop a method for retrieval of the new meshed nitinol atrial septal defect occluders – Ceraflex and Occlutech.

Background

The newly developed atrial septal defect occluders have potential benefits considering implantation, but concerns regarding their removal in case of embolisation have been raised.

Methods

Over 21 years, 1449 patients underwent interventional atrial septal defect occlusion in our institution. We reviewed the cases of embolisation of the device, developed a strategy for device removal, and tested it on the benchside and in animal tests.

Results

In 11 patients (0.8%), the intended atrial septal defect occlusion was complicated by an embolisation of the device. In contrast to the Amplatzer septal occluders, retrieval of Occlutech devices larger than 16 mm with snare techniques was impossible. In benchside tests, this was confirmed and a new method for removal of large meshed devices was developed. This involved the commercially available Maslanka® biopsy forceps. The feasibility of this technique in vivo was tested in a pig model. During animal tests, using the Maslanka biopsy forceps it was possible to interventionally retrieve embolised Ceraflex and Occlutech devices of different sizes – 10, 16, 30, and 40 mm – into a 12-F sheath.

Conclusion

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.

Type
Original Articles
Copyright
© Cambridge University Press 2018 

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References

1. King, TD, Thompson, SL, Steiner, C, Mills, NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976; 235: 25062509.CrossRefGoogle ScholarPubMed
2. Fischer, G, Stieh, J, Uebing, A, Hoffmann, U, Morf, G, Kramer, HH. Experience with transcatheter closure of secundum atrial septal defects using the amplatzer septal occluder: a single centre study in 236 consecutive patients. Heart 2003; 89: 199204.CrossRefGoogle ScholarPubMed
3. Du, ZD, Hijazi, ZM, Kleinman, CS, Silverman, NH, Larntz, K, Amplatzer, I. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol 2002; 39: 18361844.CrossRefGoogle ScholarPubMed
4. Masura, J, Gavora, P, Podnar, T. Long-term outcome of transcatheter secundum-type atrial septal defect closure using amplatzer septal occluders. J Am Coll Cardiol 2005; 45: 505507.CrossRefGoogle ScholarPubMed
5. Eicken, A, Witsenburg, M, Sebening, W, et al. Interventional catheter occlusion of the atrial septal defect of the secundum type--experiences with “cardioseal” and “angel wings”. Z Kardiol 1999; 88: 10151022.CrossRefGoogle ScholarPubMed
6. Levi, DS, Moore, JW. Embolization and retrieval of the amplatzer septal occluder. Cathete Cardiovasc Interv 2004; 61: 543547.CrossRefGoogle ScholarPubMed
7. Majunke, N, Bialkowski, J, Wilson, N, et al. Closure of atrial septal defect with the amplatzer septal occluder in adults. Am J Cardiol 2009; 103: 550554.CrossRefGoogle ScholarPubMed
8. DiBardino, DJ, McElhinney, DB, Aditya, KK, Mayer, JE. Analysis of the us food and drug administration manufacturer and user facility device experience database for adverse events involving amplatzer septal occluder devices and comparison with the society of thoracic surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 2009; 137: 13341341.CrossRefGoogle ScholarPubMed
9. Haas, NA, Soetemann, DB, Ates, I, et al. Closure of secundum atrial septal defects by using the Occlutech occluder devices in more than 1300 patients: the IRFACODE project: a retrospective case series. Catheter Cardiovasc Interv 2016; 88: 571581.CrossRefGoogle ScholarPubMed
10. Shebani, SO, Rehman, R, Taliotis, D, et al. Techniques for transcatheter retrieval of the Occlutech ASD device united kingdom-European multicenter report. Catheter Cardiovasc Interv 2017; 89: 690698.CrossRefGoogle ScholarPubMed
11. Ewert, P, Berger, F, Daehnert, I, Krings, G, Dittrich, S, Lange, PE. Diagnostic catheterization and balloon sizing of atrial septal defects by echocardiographic guidance without fluoroscopy. Echocardiography. 2000; 17: 159163.CrossRefGoogle ScholarPubMed
12. Chessa, M, Carminati, M, Butera, G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002; 39: 10611065.CrossRefGoogle ScholarPubMed
13. Moore, J, Hegde, S, El-Said, H, et al. Transcatheter device closure of atrial septal defects a safety review. JACC Cardiovasc Interv 2013; 6: 433442.CrossRefGoogle ScholarPubMed
14. Goel, PK, Kapoor, A, Batra, A, Khanna, R. Transcatheter retrieval of embolized amplatzer septal occluder. Tex Heart Inst J 2012; 39: 653656.Google ScholarPubMed
15. Loh, JP, Satler, LF, Slack, MC. Management of a large atrial septal occluder embolized to the left ventricular outflow tract without the use of cardiac surgery. Catheter Cardiovasc Interv 2014; 84: 497502.CrossRefGoogle ScholarPubMed
16. Shirodkar, S, Patil, S, Pinto, R, Dalvi, B. Successful retrieval of migrated amplatzer septal occluder. Ann Pediatr Cardiol 2010; 3: 8386.Google ScholarPubMed
17. Katta, N, Gautam, S, Webel, R. Successful percutaneous retrieval of embolized septal occluder device from aortic arch and placement of a newer septal occluder device in combined procedure. Case Rep Cardiol 2016; 2016: 1032801.Google ScholarPubMed
18. Sadiq, M, Ur Rehman, A, Mehmood, A. Successful retrieval of a Figulla Occlutech septal occluder – embolized device stability and potential solutions. Ann Pediatr Cardiol 2016; 9: 161163.CrossRefGoogle ScholarPubMed
19. Pac, A, Polat, TB, Cetin, I, Oflaz, MB, Balli, S. Figulla ASD occluder versus amplatzer septal occluder: a comparative study on validation of a novel device for percutaneous closure of atrial septal defects. J Interv Cardiol 2009; 22: 489495.CrossRefGoogle ScholarPubMed
20. Haas, NA, Happel, CM, Soetemann, DB, et al. Optimal septum alignment of the Figulla (r) flex occluder to the atrial septum in patients with secundum atrial septal defects. Eurointervention 2016; 11: 11531160.CrossRefGoogle Scholar
21. Astarcioglu, MA, Kalcik, M, Sen, T, et al. Ceraflex versus amplatzer occluder for secundum atrial septal defect closure multicenter clinical experience. Herz 2015; 40: 146150.CrossRefGoogle ScholarPubMed
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Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept
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