Stanimir Georgiev1, Daniel Tanase1, Thomas Genz1, Peter Ewert1, Susanne Naumann2, Robert Dalla Pozza3, Andreas Eicken1. 1. 1Department of Pediatric Cardiology and Congenital Heart Disease,German Heart Center Munich at the TU Munich,Munich,Germany. 2. 2Experimental and Molecular Pediatric Cardiology,German Heart Center Munich at the TU Munich,Munich,Germany. 3. 3Department of Pediatric Cardiology and Pediatric Intensive Care,Ludwig-Maximilian-University,Munich,Germany.
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.
OBJECTIVES: This study aimed to develop a method for retrieval of the new meshed nitinolatrial 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.
Authors: Raymond N Haddad; Diala Khraiche; Damien Bonnet; Mathilde Meot; Sophie Malekzadeh-Milani Journal: Front Pediatr Date: 2021-03-11 Impact factor: 3.418
Authors: Celina Fritz; Andrea Engelhardt; Jochen Grohmann; Ingo Dähnert; Johanna Hummel; Daniel Tanase; Peter Ewert; Andreas Eicken Journal: Cardiovasc Diagn Ther Date: 2022-08