Using the GORE® Septal Occluder (GSO) in Challenging Patent Foramen Ovale (PFO) Anatomies

Abstract

The Gore(®) Septal Occluder is an efficient device for patent foramen ovale closure in challenging anatomies, including long-tunnel PFOs and atrial septal aneurysms.

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study

“…Concerning mid‐term complications after PFO closure with the GSO device, some cases of new onset atrial arrhythmias—mostly atrial fibrillation —and palpitations due to ectopic supraventricular beats or without a documented arrhythmia have been described . This is in agreement with the results of our patient cohort.…”

“…Compared with implantation data from the RESPECT trial using the Amplatzer PFO Occluder (St. Jude Medical, Plymouth, MN) (procedure time 51.9 ± 28.6 min, fluoroscopy time 11.8 ± 8.9 min), implantation and radiation times in the present study are considerably shorter (procedure time 41 ± 25 min and fluoroscopy time: 5.6 ± 4.7 min) . The data of this multicenter trial are comparable to other studies applying the GSO device for PFO closure (range of mean procedure times 30 ± 20 min to 47 ± 12 min; range of mean fluoroscopy time 3.0 ± 1.7min to 6.9 ± 2.7 min) .…”

“…The data of the multicentric study presented here confirm the safety of the device and the ability for successful delivery that have been reported in other studies published so far employing the GSO device for PFO—and appropriately‐sized ASD—closure. Previous studies have consistently shown low periprocedural risk when implanting the GORE® CARDIOFORM Septal Occluder .…”

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

“…As the medical treatment therapy compared to PFO occlusion results in life long antiplatelet or oral anticoagulation therapy, interventional closure is considered reasonable by numerous physicians. Post interventional closure rates differ depending on the device used and have been described between 86 and 96 % [9–11, 13, 14]. The Amplatzer TM PFO Occluder (ST Jude Medical TM , Saint Paul, Minnesota, USA) is probable the most widely used occluder device and was recently studied in the two large multi-center RESPECT and PC trials.…”

“…The Amplatzer TM PFO Occluder (ST Jude Medical TM , Saint Paul, Minnesota, USA) is probable the most widely used occluder device and was recently studied in the two large multi-center RESPECT and PC trials. Other devices like the GORE ® HELEX ® (W. L. Gore & Associates, Inc, Newark, Delaware, USA), Nit-Occlud ® PFO (pfm medical ag, Cologne, Germany), Cardi-O-Fix PFO Occluder (Starway Medical Technology, Inc, Beijing, China) and CeraFlex TM PFO Occluder (Carlsbad, California, USA) are available [9, 11, 14–17]. Some devices such as the STARFlex ® (NMT Medical, Inc, Boston, Massachusetts, USA), studied in the CLOSURE I Trial have disappeared from the market [10, 12].…”