The BioSTAR device versus the CardioSEAL device in patent foramen ovale closure: comparison of mid-term efficacy and safety

Aims: To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR device with the nonbioabsorbable CardioSEAL device for percutaneous patent foramen ovale (PFO) closure. Methods and results: All 81 consecutive patients who underwent PFO closure with the CardioSEAL or BioSTAR device between June 2003 and July 2008 were included. The presence of a residual shunt (minimal, moderate or large) was measured in both groups at six months follow-up, using contrast transthoracic echocardiography. Forty-four patients (48.4±11.4 years) received the CardioSEAL device and 37 patients the BioSTAR device (47.9±10.7 years). There were no significant differences in shortterm complications. Two patients who received the BioSTAR device developed a recurrent transient cerebral ischaemic event. Overall, atrial arrhythmias occurred in 19%, with no difference between both groups. At six months, a residual shunt was present in 29% (27% minimal, 2% moderate) using the CardioSEAL device compared to 28% (17% minimal, 11% moderate) using the BioSTAR device (p=0.18). A predictor for residual shunt could not be found. Conclusions: There is no difference in safety and efficacy at six months between the CardioSEAL and BioSTAR device used for PFO closure. However, using the BioSTAR device tends to be associated with a higher percentage of moderate shunting.

[1]  J. T. ten Berg,et al.  New bioabsorbable septal repair implant for percutaneous closure of a patent foramen ovale: Short‐term results of a single‐centre experience , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[2]  M. Post,et al.  Grading of pulmonary right-to-left shunt with transthoracic contrast echocardiography: does it predict the indication for embolotherapy? , 2009, Chest.

[3]  J. M. Berg,et al.  Complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke , 2008, Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation.

[4]  B. Meier,et al.  Patent foramen ovale and ventricular septal defect closure , 2008, Heart.

[5]  S. Kutty,et al.  Causes of recurrent focal neurologic events after transcatheter closure of patent foramen ovale with the CardioSEAL septal occluder. , 2008, The American journal of cardiology.

[6]  W. Budts,et al.  Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study. , 2008, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[7]  N. Wunderlich,et al.  Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). , 2008, The American journal of cardiology.

[8]  M. Schwerzmann,et al.  Long-term results after fluoroscopy-guided closure of patent foramen ovale for secondary prevention of paradoxical embolism , 2007, Heart.

[9]  J. V. Olsen,et al.  Outcomes after transcatheter closure of patent foramen ovale in patients with paradoxical embolism. , 2007, The American journal of cardiology.

[10]  J. Tobis,et al.  Five-year experience with percutaneous closure of patent foramen ovale. , 2007, The American journal of cardiology.

[11]  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.

[12]  C. White,et al.  Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. , 2006, The Journal of invasive cardiology.

[13]  P. Wohlsein,et al.  Interventional atrial septal defect closure using a totally bioresorbable occluder matrix: development and preclinical evaluation of the BioSTAR device. , 2006, Journal of the American College of Cardiology.

[14]  W. Budts,et al.  Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome , 2005, Acta cardiologica.

[15]  A. Divekar,et al.  Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder. , 2005, Journal of the American College of Cardiology.

[16]  B. Meier.  Closure of patent foramen ovale: technique, pitfalls, complications, and follow up , 2005, Heart.

[17]  M. Schwerzmann,et al.  Transcatheter treatment of atrial septal aneurysm associated with patent foramen ovale for prevention of recurrent paradoxical embolism in high-risk patients. , 2005, Journal of the American College of Cardiology.

[18]  J. Cheatham,et al.  Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[19]  J. De Sutter,et al.  Second harmonic transthoracic echocardiography: the new reference screening method for the detection of patent foramen ovale. , 2004, European journal of echocardiography : the journal of the Working Group on Echocardiography of the European Society of Cardiology.

[20]  P. Block,et al.  Transcatheter patent foramen ovale closure for secondary prevention of paradoxical embolic events: Acute results from the FORECAST registry , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[21]  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.

[22]  J. Tobis,et al.  Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices. , 2004, The American journal of cardiology.

[23]  Paul Khairy,et al.  Transcatheter Closure versus Medical Therapy of Patent Foramen Ovale and Presumed Paradoxical Thromboemboli , 2003, Annals of Internal Medicine.

[24]  P. Wohlsein,et al.  A new biological matrix for septal occlusion. , 2003, Journal of interventional cardiology.

[25]  R. Erbel,et al.  Intracardiac Echocardiography Is Superior to Conventional Monitoring for Guiding Device Closure of Interatrial Communications , 2003, Circulation.

[26]  R. Sacco,et al.  Effect of Medical Treatment in Stroke Patients With Patent Foramen Ovale: Patent Foramen Ovale in Cryptogenic Stroke Study , 2002, Circulation.

[27]  J. Coste,et al.  Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. , 2001, The New England journal of medicine.

[28]  Q. Cao,et al.  Transcatheter closure of atrial septal defects and patent foramen ovale under intracardiac echocardiographic guidance: Feasibility and comparison with transesophageal echocardiography , 2001, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[29]  I. Bone,et al.  Interatrial septal abnormalities and stroke , 2000, Neurology.

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

[31]  J. Bogousslavsky,et al.  Stroke recurrence in patients with patent foramen ovale , 1996, Neurology.

[32]  M. Zuber,et al.  Recurrent cerebrovascular events in patients with patent foramen ovale, atrial septal aneurysm, or both and cryptogenic stroke or transient ischemic attack. French Study Group on Patent Foramen Ovale and Atrial Septal Aneurysm. , 1995, American heart journal.

[33]  F. Chédru,et al.  Atrial Septal Aneurysm and Patent Foramen Ovale as Risk Factors for Cryptogenic Stroke in Patients Less Than 55 Years of Age: A Study Using Transesophageal Echocardiography , 1993, Stroke.

[34]  J. Newburger,et al.  Transcatheter Closure of Patent Foramen Ovale After Presumed Paradoxical Embolism , 1992, Circulation.

[35]  H. J. Smith,et al.  PATENT FORAMEN OVALE IN YOUNG STROKE PATIENTS , 1988, The Lancet.

[36]  P. Lechat,et al.  Prevalence of patent foramen ovale in patients with stroke. , 1988, The New England journal of medicine.