The first clinical experience with the new GORE® septal occluder (GSO)

TY - JOUR

T1 - The first clinical experience with the new GORE® septal occluder (GSO)

AU - Søndergaard, Lars

AU - Loh, Poay Huan

AU - Franzen, Olaf

AU - Ihlemann, Nikolaj

AU - Vejlstrup, Niels

PY - 2013/12

Y1 - 2013/12

N2 - Aims: A new GORE® septal occluder (GSO) was granted CE mark in Europe in June 2011 for the treatment of patent foramen ovale and atrial septal defect. Major changes have been made to the device and delivery system compared to the HELEX® device. The new delivery system has simplified the implantation procedure and the retrievability of the device after deployment if needed. The design of the GSO has improved the device apposition ability and tissue response whilst keeping its atraumatic design, low septal profile with minimal septal distortion and long-term biocompatibility. The first three clinical cases of GSO use in the world are briefly described and the immediate and short-term outcome of the first eleven patients who underwent PFO or ASD closure using GSO in our centre are reported. Methods and results: The mean age of the eleven patients was 539 years and six of them were women. Ten of these patients had patent foramen ovale and one had secundum atrial septal defect. In all the cases, the GSO devices were successfully deployed in the first attempt without any complication. Only one patient had a minor residual shunt detected immediately after the device deployment. All the patients were re-assessed 7033 days later and no residual shunt was detected in any of them. One of the patients had an episode of paroxysmal atrial fibrillation. There was no device fracture found in the six patients who also had a fluoroscopic examination during follow-up. Conclusions: Our initial experience with GSO shows promise in handling and occlusion rate. Larger-scale and longer-term outcome on the performance of GSO is required to ensure safety and efficacy.

AB - Aims: A new GORE® septal occluder (GSO) was granted CE mark in Europe in June 2011 for the treatment of patent foramen ovale and atrial septal defect. Major changes have been made to the device and delivery system compared to the HELEX® device. The new delivery system has simplified the implantation procedure and the retrievability of the device after deployment if needed. The design of the GSO has improved the device apposition ability and tissue response whilst keeping its atraumatic design, low septal profile with minimal septal distortion and long-term biocompatibility. The first three clinical cases of GSO use in the world are briefly described and the immediate and short-term outcome of the first eleven patients who underwent PFO or ASD closure using GSO in our centre are reported. Methods and results: The mean age of the eleven patients was 539 years and six of them were women. Ten of these patients had patent foramen ovale and one had secundum atrial septal defect. In all the cases, the GSO devices were successfully deployed in the first attempt without any complication. Only one patient had a minor residual shunt detected immediately after the device deployment. All the patients were re-assessed 7033 days later and no residual shunt was detected in any of them. One of the patients had an episode of paroxysmal atrial fibrillation. There was no device fracture found in the six patients who also had a fluoroscopic examination during follow-up. Conclusions: Our initial experience with GSO shows promise in handling and occlusion rate. Larger-scale and longer-term outcome on the performance of GSO is required to ensure safety and efficacy.

U2 - 10.4244/eijv9i8a160

DO - 10.4244/eijv9i8a160

M3 - Journal article

C2 - 23764807

SN - 1774-024X

VL - 9

SP - 959

EP - 963

JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

IS - 8

ER -