Source: Braun MU, et al. J Am Coll Cardiol. 2002; 39:2019-2025.
In 276 patients with pfo and at least 1 cerebral thromboembolic event, percutaneous closure with the Star Occluder was performed and the patients were followed for an average of 15 months or 345 patient years. Although device deployment success was 100%, there was a 4% peri-interventional complication rate. Most were minor and reversible such as TIA in 2 and atrial fibrillation in 2. Only 2 patients had device dislodgement requiring surgical removal; one from the heart and one from the abdominal aorta. Post-procedure patients were on heparin for 3 days, clopridogrel for 6 weeks, and aspirin for one year. The subsequent annual TIA rate was 1.7%, but there were no strokes or peripheral emboli observed. Of interest, device adherent thrombus was detected in 8 patients. They were put on oral anticoagulation and none had embolic events. Braun and colleagues concluded that percutaneous PFO closure in cryptogenic stroke patient’s results in a low recurrence rate of subsequent thromboembolic events.
Comment by Michael H. Crawford, MD
There are 4 approaches to the treatment of cryptogenic stroke associated with PFO: surgical closure, percutaneous closure, warfarin, or antiplatelet drugs such as aspirin. Given the recent reported successes with newer generation percutaneous devices, it would appear that the role of surgery is in decline. If the results of this large device trial are compared to the large medical trial above it would appear that the device has the edge since there were no subsequent strokes reported, whereas there were in the medical therapy study. However, one needs to consider the complications of device implantation, which were low, but included surgical removal of the device in 2 patients. Also, the most frequent complication was transient ECG ST elevation presumably due to air embolism (2%). Although no myocardial infarctions were reported, this is a concern. On the other hand, Braun et al point out that the device world is a moving target and improvements were made during the trial that confined some of these complications to the early years. Further refinements will undoubtedly reduce complications more, but I doubt they will ever be zero. Another consideration is that the 2 studies are not truly comparable because of the different methods of patient selection and different study designs. Thus, a randomized trial would be valuable to confirm the superiority of device closure vs. prevention of clot formation. When the choice was between surgery or clot prevention medical therapy, I usually recommended the latter unless I thought clot prevention would not be successful. Now with improved percutaneous devices the choice is more difficult, especially in the patient with a large PFO or with an atrial septal aneurysm where stroke rates are known to be higher.
Dr. Crawford is Professor of Medicine, Mayo Medical School; Consultant in Cardiovascular Diseases, and Director of Research, Mayo Clinic, Scottsdale, AZ.
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