Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-11-28T02:46:42.138Z Has data issue: false hasContentIssue false
  • English
  • Français

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 ,
Daniel Tanase ,
Thomas Genz ,
Peter Ewert ,
Susanne Naumann ,
Robert Dalla Pozza  and
Andreas Eicken
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
*
Author for correspondence: S. Georgiev, Department for Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Lazarettstrasse 36, 80636 Munich, Germany. Tel: +49 89 1218 2740; Fax: +49 89 1218 4313; E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

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.

Keywords

ASD closuredevice embolisationdevice retrievalinterventional (stents, etc.)
Type
Original Articles
Information
Cardiology in the Young , Volume 28 , Issue 7 , July 2018 , pp. 955 - 960
Check for updates
Copyright
© Cambridge University Press 2018 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. King, TD, Thompson, SL, Steiner, C, Mills, NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976; 235: 2506–2509.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: 199–204.Google Scholar
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: 1836–1844.Google Scholar
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: 505–507.Google Scholar
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: 1015–1022.Google Scholar
6. Levi, DS, Moore, JW. Embolization and retrieval of the amplatzer septal occluder. Cathete Cardiovasc Interv 2004; 61: 543–547.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: 550–554.Google Scholar
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: 1334–1341.Google Scholar
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: 571–581.CrossRefGoogle Scholar
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: 690–698.Google Scholar
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: 159–163.Google Scholar
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: 1061–1065.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: 433–442.Google Scholar
14. Goel, PK, Kapoor, A, Batra, A, Khanna, R. Transcatheter retrieval of embolized amplatzer septal occluder. Tex Heart Inst J 2012; 39: 653–656.Google Scholar
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: 497–502.Google Scholar
16. Shirodkar, S, Patil, S, Pinto, R, Dalvi, B. Successful retrieval of migrated amplatzer septal occluder. Ann Pediatr Cardiol 2010; 3: 83–86.Google Scholar
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: 161–163.Google Scholar
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: 489–495.Google Scholar
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: 1153–1160.Google 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: 146–150.Google Scholar