CLINICAL STUDY
Transcatheter closure of patent foramen ovale in patients with cerebral ischemia
Martin U. Braun, MD*,
Dieter Fassbender, MD ,
Steffen P. Schoen, MD* ,
Markus Haass, MD,
Rainer Schraeder, MD ,
Werner Scholtz, MD and
Ruth H. Strasser, MD, FESC*,*
* Department of Cardiology, University of Dresden, Dresden, Germany
Department of Cardiology, University of Heidelberg, Heidelberg, Germany
Heart and Diabetes Center, Bad Oeynhausen, University of Bochum, Bochum, Germany
Bethanien Hospital-CCB Frankfurt/Main, Frankfurt, Germany
Manuscript received September 17, 2001;
revised manuscript received March 13, 2002,
accepted April 3, 2002.
* Reprint requests and correspondence: Prof. Dr. med. Ruth H. Strasser, Department of Cardiology, University of Dresden, Fetscherstr. 76, P.O. Box 95, 01307 Dresden, Germany.
Ruth.Strasser{at}mailbox.tu-dresden.de
OBJECTIVES: The present study was conducted to determine the safety of the transcatheter closure of a patent foramen ovale (PFO) in patients with cryptogenic cerebral ischemia and the midterm follow-up of recurrent thromboembolic events after interventional PFO closure.
BACKGROUND: Current therapeutic options for stroke prevention in patients with PFO and a history of thromboembolic events include chronic antithrombotics and more invasive treatments such as surgical closure or minor invasive transcatheter permanent closure of the PFO. Promising preliminary and pilot data with the Amplatzer Septal Occluder or the PFO-Star Occluder have been reported. Systematic and long-term data are still missing.
METHODS: A total of 276 consecutive patients with a PFO and a history of at least one thromboembolic event were recruited in four medical centers and underwent percutaneous PFO closure with the PFO-Star device. Follow-up data were analyzed over an average of 15.1 months, equivalent to 345 patient-years.
RESULTS: The implantation was successful in all 276 patients. Peri-interventional reversible complications included transient ST-segment elevations (1.8%) and transient ischemic attack (TIA) (0.8%). Two devices have been removed surgically. During follow-up the annual recurrence rate of thromboembolic events was 1.7% for TIA, 0% for stroke and 0% for peripheral emboli.
CONCLUSIONS: Interventional PFO closure with the PFO-Star device appears to be a reliable and promising technique resulting in a low recurrence rate of thromboembolic events, especially stroke in patients with a history of cryptogenic ischemia presumably due to paradoxical embolization. To our knowledge, this is the largest coherent and prospective study for interventional PFO closure.
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Abbreviations and Acronyms
| | ASA | | atrial septal aneurysm | | CT | | computer tomography | | ECG | | electrocardiogram | | IV | | intravenous/intravenously | | MRI | | magnetic resonance imaging | | PFO | | patent foramen ovale | | TEE | | transesophageal echocardiography | | TIA | | transient ischemic attack |
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