A stroke is a condition that is much more common among seniors than younger individuals; however, when a young person suffers a stroke, it often deprives them of many potentially productive years. UCLA researchers have participated in multi-center study addressing stroke prevention among younger patients who have a defect in the upper chamber of their heart. The researchers’ evaluation of a new heart hole closure device was published on March 20 in The New England Journal of Medicine.
The investigators attempted to determine the best treatment to prevent further strokes--whether closing the hole with a button device, along with anti-clotting medicines, or just anti-clotting medicines alone. Although the results are encouraging, the authors caution that further investigation is needed before a complete determination of the benefits of the procedure can be made. UCLA was one of the 69 performance sites for the trial known as the Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT). Over an eight year period, the study enrolled 980 relatively young patients between 18 and 60 years of age (average age 46) who had had a cryptogenic ischemic stroke (a stroke of unknown origin) and a patent foramen ovaleor or PFO (hole in the wall of the heart); 49% of patients had suffered a major stroke. Up to 10% of all strokes in the United States occur in patients in whom a PFO is the only identified potential cause.
The patients were followed for an average of approximately 2.5 years. A comparison was made between patients who had received a button device to close the hole plus blood thinners to patients who only received blood thinners. The researchers found that the group that received the button device showed a trend toward having fewer recurrent strokes than those receiving standard care with anti-clotting medications (9 versus 16); however, the difference did not meet statistical tests for being definite. Further analyses conducted in the subset of patients who adhered to their assigned treatments provided additional evidence of device benefit.
One of the principal investigators, Dr. Jeffrey Saver, a UCLA professor of neurology, noted that both treatments benefited patients and reduced the risk of stroke in patients with PFOs. He noted that this was “good news for patients and doctors. It will be important to continue to follow the patients in this study and to combine the results of this trial with others, to confirm the indications of added benefit of device closure.” He added, “Closure device therapy may be a useful strategy for selected patients with a history of cryptogenic stroke and PFO. This population is generally younger than the average stroke patient, and otherwise are facing a lifetime of potentially riskier medications without this procedure.” .
“Results of the RESPECT trial together with results from another study called the PC-Trial, demonstrated that patients who received the device did show a benefit,” noted Dr. Jonathan Tobis, director of Interventional Cardiology and the RESPECT lead investigator at the UCLA site. He notes that closing this hole in the heart has also been studied as possibly helping with other health issues such as migraine. He explained, “We’re still learning about the impact when this hole in the heart does not naturally close like it is supposed to.”
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