Abstract 7

Late Adverse Events After Amplatzer® Closure of Patent Foramen Ovale in 350 Patients With High Risk Stratification for Recurrent Stroke
CIRCULATION 2005; 112 (supplI ): 648

Sherman G. Sorensen, Peter J. Casterella, Utah Heart Clinic, LDS Hospital Cardiology, Salt Lake City, UT; Joseph B Muhlestein, LDS Hospital Cardiology, University of Utah, Salt Lake City, UT; Laurie Raleigh, Heather Aguilar, K Wes McKnight, Utah Heart Clinic, Salt Lake City, UT; Ali K Choucair, Brianna S Ronnow, LDS Hospital Cardiology, Salt Lake City, UT; Saurabh Gupta, University of Utah, Salt Lake City, UT; Donald L Lappé, LDS Hospital Cardiology, Utah Heart Clinic, Salt Lake City, UT

BACKGROUND: Patent foramen ovale is an accepted risk factor for cerebrovascular accident (CVA), especially in patients with additional high-risk features. Although percutaneous closure of PFO (PC-PFO) is now widely accepted as a safe procedure for CVA prevention, randomized clinical trial data are not available, and the long-term safety and efficacy of this procedure, especially in high risk patients, are not known. To address this question, we evaluated the late outcomes of all patients with at least one year follow-up after successful PC-PFO with the Amplatzer® PFO occluder device at a single center.

METHODS: Patients were evaluated either by direct phone contact or by system database query. Prior to PFO closure, risk stratification for recurrent CVA was performed assessing four established risk factors including severe shunt by transesophageal echo (TEE) or transcranial Doppler (TCD) criteria, multiple brain lesions on MRI (MMRI), interatrial septal aneurysm (IASA), and presence of migraine headache (MHA). Serious adverse events (SAE) were defined as: device related death (DRD), CVA with or without residual deficit, transient ischemic attack (TIA), device related failure (DRF) (embolization, dislodgement, need for device removal), pericardial effusion (PE) with or without tamponade, and other cardiac sequelae (OCS). The observed annualized incidence of recurrent CVA was then compared to a reported historical control incidence of 3.8% per year.

RESULTS: A total of 350 patients (age = 46±16 years, males = 36%, risk stratification: 1 risk = 100%, 2 risks = 89%, 3 risks = 49% and 4 risks = 12%) were followed for 24 months (range = 12-36). Follow-up TEE was performed in 30 patients (7.1%). Total SAE occurrence was as follows: DRD = 0, CVA = 4 (1.1% [residual deficit = 0], TIA = 5 [1.4%]), DRF with removal = 1 (0.3%), PE = 3 (0.9% [tamponade = 0]), and OCS = 3 (0.9% [atrial arrhythmias]). Annualized relative risk of CVA compared to historical controls = 0.15 (p<0.01)

CONCLUSION: In our population of 350 PFO patients at high risk for CVA, 1-3 year follow-up after catheter-based PFO revealed a remarkably low incidence of major adverse events including recurrent ischemic neurological events and device-related complications.