EurekaMag.com logo
+ Site Statistics
References:
53,869,633
Abstracts:
29,686,251
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on LinkedInFollow on LinkedIn

+ Translate

Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial



Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial



Catheterization and Cardiovascular Interventions 60(4): 524-528



Closure of patent foramen ovale (PFO) has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. We report the immediate and mid-term results of the phase 1 U.S. Multicenter Clinical Trial of patients who underwent transcatheter PFO closure for paradoxical embolism using the new Amplatzer PFO device. Fifty patients (28 male/22 female) underwent catheter closure of their PFOs at a mean age of 41 +/- 11 years. Thirty-six patients had ischemic stroke, 10 had transient ischemic attack, and 4 had peripheral embolism. Seventeen patients had atrial septal aneurysm. The implantation procedure was successful in 49/49 patients; one patient did not have a PFO. Complete closure was seen immediately after the procedure in 26/49 patients; 17 had minimal residual shunt, 4 had moderate and 2 had large residual shunts. The median fluoroscopy time was 10.5 min (2.8-43 min). There were no complications related to the device. One patient developed an arteriovenous fistula at the catheter site requiring surgical repair. At a mean follow-up interval of 16.5 +/- 7.2 months, there were no deaths or recurrent neurological or peripheral embolic events. Eight patients reported an episode of dizziness or palpitations (four of them within 18 days of the procedure). No episodes of atrial dysrhythmias were noted. Contrast bubble study at last follow-up documented complete closure in 45/48 patients; one patient had minimal, one had moderate residual shunt, and one had a large shunt. One patient was lost to follow-up. We conclude that catheter closure of PFO associated with stroke/transient ischemic attack or peripheral embolism using the new Amplatzer PFO device is a safe and effective method in preventing recurrence of such episodes. Randomized clinical trials comparing device closure versus continued medical therapy are underway.

(PDF emailed within 0-6 h: $19.90)

Accession: 050816199

Download citation: RISBibTeXText

PMID: 14624434

DOI: 10.1002/ccd.10674



Related references

Intermediate and long-term results of transcatheter closure of patent foramen ovale using the amplatzer patent foramen ovale occluder: one case of pulmonary embolism irrespective of patent foramen ovale closure. Korean Circulation Journal 41(7): 356-362, 2011

Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism: procedural and follow-up results after implantation of the Amplatzer®-occluder device. Journal of Interventional Cardiology 24(1): 85-91, 2011

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. European Heart Journal 25(5): 424-430, 2004

Percutaneous closure of patent foramen ovale in patients with paradoxical embolism using the Amplatzer PFO Occluder. Circulation 102(18 Supplement): II 564, October 31, 2000

Interventional closure with Amplatzer PFO occluder of patent foramen ovale in patients with paradoxical cerebral embolism. Journal of Interventional Cardiology 18(3): 173-179, 2005

Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the amplatzer PFO occluder without intraprocedural echocardiography: effect of device size. Jacc. Cardiovascular Interventions 2(2): 116-123, 2010

Results of US phase I clinical trial of closure of patent foramen ovale associated with stroke/transient ischemic attack of peripheral embolism using the Amplatzer patent foramen ovale device. Journal of the American College of Cardiology 41(6 Supplement A): 75A, March 19, 2003

Transcatheter closure of patent foramen ovale to prevent paradoxical embolism Acute results and longterm follow-up in 174 patients using the STARFlex septal occluder. Circulation 108(17 Supplement): IV-494, October 28, 2003

Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients. Journal of Interventional Cardiology 16(1): 43-50, 2003

Transcatheter closure of patent foramen ovale in patients with paradoxical embolism: intermediate-term risk of recurrent neurological events. Catheterization and Cardiovascular Interventions 55(2): 189-194, 2002

Midterm results after occlusion of an patent foramen ovale after presumed paradoxical embolism with the Amplatzer PFO occluder. European Heart Journal 21(Abstract Supplement): 126, August-September, 2000

Transcatheter closure of patent foramen ovale in patients with paradoxical embolism. Procedural and follow-up results after implantation of the Starflex occluder device with conjunctive intensified anticoagulation regimen. Journal of Interventional Cardiology 21(2): 183-189, 2008

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials 12(): 56-56, 2011

Transcatheter closure of patent foramen ovale in Chinese patients with paradoxical embolism. -Immediate results and long-term follow-up-. Circulation Journal 75(8): 1867-1871, 2011

Transcatheter Amplatzer device closure of atrial septal defect and patent foramen ovale in patients with presumed paradoxical embolism. Mayo Clinic Proceedings 79(1): 35-41, 2004