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

TY - JOUR

T1 - Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder

T2 - Results from a prospective European multicenter study

AU - Hardt, Stefan E

AU - Eicken, Andreas

AU - Berger, Felix

AU - Schubert, Stephan

AU - Carminati, Mario

AU - Butera, Gianfranco

AU - Grohmann, Jochen

AU - Höhn, Rene

AU - Nielsen-Kudsk, Jens Erik

AU - Hildick-Smith, David

AU - Settergren, Magnus

AU - Thomson, John D

AU - Geis, Nicolas

AU - Søndergaard, Lars

N1 - © 2017 Wiley Periodicals, Inc.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Aims: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. Methods and Results: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up. Conclusion: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up.

AB - Aims: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. Methods and Results: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up. Conclusion: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up.

U2 - 10.1002/ccd.26993

DO - 10.1002/ccd.26993

M3 - Journal article

C2 - 28296023

SN - 1522-1946

VL - 90

SP - 824

EP - 829

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

IS - 5

ER -