Abstract 3674: Late Results of Amplatzer Device Percutaneous Closure of Patent Foramen Ovale Without Echocardiographic Guidance
Background: Patent foramen ovale (PFO) has been associated with cryptogenic stroke. Percutaneous PFO closure has been shown safe and feasible using a wide variety of devices, and its clinical efficacy appeared favorable compared with medical treatment. Based on our experience, the Amplatzer PFO Occluder was associated with the lowest risk for complications and the highest rates of complete closure.
Methods: 420 consecutive patients (age 51±12 years; 57% male) with both PFO and at least one cryptogenic ischemic stroke, transient ischemic attack (TIA), or peripheral embolic event underwent percutaneous PFO closure without echocardiographic guidance, using the Amplatzer PFO Occluder. An 18 mm device was used in 48 patients, a 25 mm device in 312 patients, and a 35 mm device in 60 patients. The mean number of clinically apparent embolic events prior to the intervention was 1.6, and 140 patients (33%) had more than one event. An atrial septal aneurysm was present in addition to the PFO in 137 patients (33%). All patients were followed prospectively for up to 6 years.
Results: The implantation procedure was successful in all patients (100%). There were only 2 procedural complications (0.5%; 2 arteriovenous fistulae requiring elective surgical correction), without any long-term sequelae. Contrast transesophageal echocardiography after Val-salva maneuver at 6 months showed complete abolition of right-to-left shunt via PFO in 89% of patients, whereas a minimal, moderate, or large residual shunt persisted in 7%, 3%, and 1%, respectively. During a mean follow-up period of 2.1±1.4 years (median 2.0 years; total 881 patient-years), 2 deaths (1 road traffic accident, 1 cancer), 3 ischemic strokes, 4 TIAs, and no peripheral emboli were reported. Freedom from recurrent ischemic stroke, TIA, or peripheral embolism was 99% at 1 year, 99% at 2 years, and 97% at 5 years.
Conclusions: The present study documents excellent safety and long-term efficacy of percutaneous PFO closure guided by fluoroscopy only using the Amplatzer PFO Occluder in a large cohort of patients.