AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

AIMS The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. METHODS AND RESULTS Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). CONCLUSIONS According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

[1]  J. Carroll,et al.  Device Closure of Patent Foramen Ovale After Stroke: Pooled Analysis of Completed Randomized Trials. , 2016, Journal of the American College of Cardiology.

[2]  C. Happel,et al.  Optimal septum alignment of the Figulla Flex occluder to the atrial septum in patients with secundum atrial septal defects. , 2016, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[3]  M. Mullen,et al.  The Flatstent versus the conventional umbrella devices in the percutaneous closure of patent foramen ovale , 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[4]  X. Freixa,et al.  A novel system for transcatheter closure of patent foramen ovale: clinical and echocardiographic outcome comparison with other contemporary devices. , 2014, The Canadian journal of cardiology.

[5]  G. Milazzo,et al.  Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies. , 2014, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[6]  G. Sgueglia,et al.  Effect of percutaneous closure of patent foramen ovale on post-procedural arrhythmias. , 2013, Journal of the American College of Cardiology.

[7]  F. Fiorilli,et al.  Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes. , 2013, Circulation journal : official journal of the Japanese Circulation Society.

[8]  S. Bertog,et al.  Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale. , 2013, European heart journal.

[9]  G. Anzola,et al.  PEDIATRIC AND CONGENITAL HEART DISEASE Original Studies Management of Patients with Patent Foramen Ovale and Cryptogenic Stroke: A Collaborative, Multidisciplinary, Position Paper , 2013 .

[10]  A. Oto,et al.  Early-mid term follow-up results of percutaneous closure of the interatrial septal defects with occlutech figulla devices: a single center experience. , 2012, Journal of interventional cardiology.

[11]  J. T. ten Berg,et al.  Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety. , 2011, Journal of interventional cardiology.

[12]  S. Cook,et al.  Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale , 2011, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[13]  F. Buonanno,et al.  Management of residual shunts after initial percutaneous patent foramen ovale closure: A single center experience with immediate and long‐term follow‐up , 2022 .

[14]  Şevket Ballı,et al.  Figulla ASD occluder versus Amplatzer Septal Occluder: a comparative study on validation of a novel device for percutaneous closure of atrial septal defects. , 2009, Journal of interventional cardiology.

[15]  H. Figulla,et al.  Transvenous Closure of Patent Foramen Ovale: Preliminary Results with a New Self-Expanding Nitinol Wire Mesh in a Swine Model , 2009, Cardiology research and practice.

[16]  F. Eberli,et al.  Percutaneous PFO closure with Amplatzer PFO occluder: predictors of residual shunts at 6 months follow-up. , 2009, Congenital heart disease.

[17]  H. Figulla,et al.  Clinical evaluation of a novel occluder device (Occlutech®) for percutaneous transcatheter closure of patent foramen ovale (PFO) , 2008, Clinical Research in Cardiology.

[18]  W. Hillis,et al.  BioSTAR Evaluation STudy (BEST): A Prospective, Multicenter, Phase I Clinical Trial to Evaluate the Feasibility, Efficacy, and Safety of the BioSTAR Bioabsorbable Septal Repair Implant for the Closure of Atrial-Level Shunts , 2006, Circulation.

[19]  C. Spies,et al.  Patent foramen ovale closure in patients with cryptogenic thrombo-embolic events using the Cardia PFO occluder. , 2006, European heart journal.

[20]  N. Wilson,et al.  Percutaneous closure of patent foramen ovale , 2005, Internal medicine journal.

[21]  M. Schwerzmann,et al.  Implantation of a second closure device in patients with residual shunt after percutaneous closure of patent foramen ovale , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[22]  H. Reichmann,et al.  Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems. , 2004, European heart journal.

[23]  G. Anzola,et al.  Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients. , 2003, Journal of interventional cardiology.

[24]  L. Bruch,et al.  Transcatheter Closure of Interatrial Communications for Secondary Prevention of Paradoxical Embolism: Single-Center Experience , 2002, Circulation.

[25]  S. Windecker,et al.  Prognosis after percutaneous closure of patent foramen ovale for paradoxical embolism , 2001, Neurology.

[26]  B Meier,et al.  Percutaneous closure of patent foramen ovale in patients with paradoxical embolism: long-term risk of recurrent thromboembolic events. , 2000, Circulation.

[27]  J. Le Heuzey,et al.  Significant association of atrial vulnerability with atrial septal abnormalities in young patients with ischemic stroke of unknown cause. , 2000, Stroke.

[28]  A. Keren,et al.  Atrial septal aneurysm in adult patients. A multicenter study using transthoracic and transesophageal echocardiography. , 1995, Circulation.