Initial experience with a transcatheter septal closure system for secondary stroke prevention in patients with interatrial septal defects.
ABSTRACT Percutaneous transcatheter closure of a patent foramen ovale (PFO) has been utilized over the last several years to prevent thromboembolic events in selected patients with a prior cryptogenic stroke. We describe our initial experience at Hartford Hospital with a transcatheter PFO closure system and our multidisciplinary approach.
From March to November 2002, we performed percutaneous transcatheter closure of a PFO in 16 patients with a prior history of cryptogenic stroke(s) and/or transient ischemic attack using the CardioSEAL Septal Occluder system. All 16 patients had a PFO visualized on their transesophageal echocardiogram (TEE) study, and 15 patients also had an atrial septal aneurysm. PFO closure was performed with a CardioSEAL Septal Occluder in the cardiac catheterization laboratory under general anesthesia with TEE guidance. Following device placement, all patients were discharged on a regimen of aspirin and clopidigrel, with follow-up in the Stroke Clinic.
Successful deployment of the septal occluder and effective PFO closure was achieved in all 16 patients with no major procedural or in-hospital complications. Short-term clinical follow-up has demonstrated no recurrent neurologic thromboembolic events, but one patient was rehospitalized for de novo atrial fibrillation. Follow-up transthoracic echocardiographic assessment at three to six months postprocedure, obtained in eight patients thus far, has demonstrated no residual interatrial shunting.
Our early results suggest that percutaneous PFO closure with the CardioSEAL Septal Occluder system is a safe option for secondary stroke prevention in carefully selected patients with interatrial septal defects and a history of cryptogenic stroke or TIA. Patient selection and the long-term effectiveness and safety of this approach require further assessment.
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ABSTRACT: We tested the feasibility of percutaneous patent foramen ovale (PFO) closure utilizing the Amplatzer multifenestrated Cribriform atrial septal occluder device. This device recently became available and may offer unique advantages for closure of PFO. Nineteen consecutive patients who underwent closure of PFO with the Cribriform device for a variety of indications under intracardiac echocardiographic and fluoroscopic guidance were studied. The degree of shunting was quantified pre- and postprocedure by echocardiography using both Doppler and agitated saline administration. The results with this device were compared to the prior 19 patients who underwent closure with a CardioSeal device. The mean age of patients was 52 years and 47% were female. Indications for closure were paradoxical embolism in 17 patients, and hypoxemia due to right to left shunt in 2 patients. The postprocedure bubble contrast study showed a marked improvement in right to left shunting with 13 patients (68%) demonstrating no shunt flow, 4 (21%) having trace shunting, and 2 (11%) mild shunting. There were no device-related complications. The mean procedure time was 28 +/- 10 min. In comparison to the CardioSeal device, a trend was apparent in terms of a greater percentage of patients with immediate closure with the Cribriform device, although a similar percentage of defect closure was seen at 6 months with both devices. Procedure time was shorter with the Cribriform device, related in part to the reduced need for balloon sizing. This initial experience suggests a number of favorable characteristics of the Amplatzer Cribriform device for PFO closure.Catheterization and Cardiovascular Interventions 03/2008; 71(3):383-7. · 2.51 Impact Factor