Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices
Section snippets
Patient population
From February 2001 to June 2003, 66 consecutive adult patients underwent transcatheter closure of an interatrial communication using the CardioSEAL or the Amplatzer device. Indications for PFO closure included the presence of spontaneous or provokable (with Valsalva maneuver) right to left shunt confirmed by a contrast study using agitated saline during TEE, and (1) a history of ≥1 cryptogenic stroke or transient ischemic attack, or (2) the presence of systemic hypoxemia that was partially
Patient population
Sixty-six consecutive adult patients underwent transcatheter closure therapy of interatrial communications. The closure devices were successfully deployed in all 66 patients. Baseline demographics of the patients are shown in Table 1. Forty-four of the 66 patients (67%) were women; mean age was 47 ± 14 years (range 17 to 77). Most of the patients (n = 48) had a PFO alone (73%). There were morphologic variations of the ASD, including 5 fenestrated septums. An atrial septal aneurysm was found in
Discussion
Although results from recent reports are encouraging,12, 13, 14 there remain several possible complications related to transcatheter closure of interatrial communications. These include air embolism, device embolization, atrial perforation, device malposition, residual shunt, device arm fracture, arrhythmia, infection, and thrombus formation on the device. Although most of these complications are caused by technical problems and may be solved by refinements of the device and implantation
References (30)
- et al.
Atrial septal aneurysma new classification in two hundred five adults
J Am Soc Echocardiogr
(1997) - et al.
Early and late complications associated with transcatheter occlusion of secundum atrial septal defect
J Am Coll Cardiol
(2002) - et al.
Patent foramen ovale transcatheter closure device thrombosis
Mayo Clin Proc
(2001) - et al.
Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS device (a multi-institutional European trial)
Am J Cardiol
(1998) - et al.
Thrombus formation after transcatheter closure of atrial septal defect
Am J Cardiol
(1999) - et al.
A prospective, blinded determination of the natural history of aspirin resistance among stable patients with cardiovascular disease
J Am Coll Cardiol
(2003) - et al.
Transcatheter closure of patent foramen ovale in patients with cerebral ischemia
J Am Coll Cardiol
(2002) - et al.
Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned devicecomparison with first, second and third generation devices. International Buttoned Device Trial Group
J Am Coll Cardiol
(2000) - et al.
Transcatheter closure of patent foramen ovale in patients with cerebral ischemia
J Am Coll Cardiol
(2002) Summary and comparison of atrial septal defect closure devices
Curr Interv Cardiol Rep
(2000)
Massive thromboembolism due to transcatheter ASD closure with ASDOS device
J Invasive Cardiol
Surgical removal of atrial septal defect occlusion system-devices
Eur J Cardiothorac Surg
Closure of secundum atrial septal defects with the Amplatzer septal occluder devicetechniques and problems
Cathet Cardiovasc Intervent
The CardioSEAL devicehistory, techniques, results
J Interven Cardiol
Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices
J Interv Cardiol
Cited by (135)
PFO Device Closure Despite Thrombophilia: The Need for Good Observational Studies
2023, JACC: Cardiovascular InterventionsNobleStitch EL PFO Closure Guided by Transesophageal Echocardiography
2022, Journal of Cardiothoracic and Vascular AnesthesiaCongenital Heart Disease: A Clinical, Pathological, Embryological, and Segmental Analysis
2022, Congenital Heart Disease: A Clinical, Pathological, Embryological, and Segmental AnalysisNeurologic complications of implantable devices
2021, Handbook of Clinical NeurologyAmplatzer PFO Occluder Device may Prevent Recurrent Stroke in Patients with Patent Foramen Ovale and Cryptogenic Stroke: A Meta-Analysis of Randomised Trials
2014, Heart Lung and CirculationCitation Excerpt :The American Heart Association/American Stroke Association and the American College of Cardiology Foundation have stated that more evidence is needed to advise for or against closing the PFO in patients with cryptogenic stroke. [2]. Off label use of the closure device is only supported by small, observational, non-randomised trials and a meta-analysis of observational studies [3–9]. There are three randomised trials published so far in the literature, which compared the closure device against standard medical therapy in patients with cryptogenic stroke [10–12].