Surgery using a St. Jude Medical Inc. device to close openings in the heart after a stroke drew mixed results in a company-funded study.
When all participants were included in the data, the usual standard in research used for U.S. regulatory approval, there was no benefit from the Amplatzer PFO Occluder compared with non-surgical drug treatment in reducing the risk of a second stroke in patients who have an opening between the two upper chambers of their hearts. A reanalysis of the data in selected participants found a slight gain.
The $20,000 procedure, in which the device is threaded into the heart via a vein in the leg and clamped like a cuff-link through the hole, is performed about 9,000 times a year in the U.S. The findings, presented at the Transcatheter Cardiovascular Therapeutics conference in Miami, suggest it isn’t a panacea for young people who inexplicably suffer a stroke and now rely on lifelong blood thinners to avoid another one.
“I don’t think it will change practice a whole lot,” said Ajay Kirtane, director of the interventional cardiology fellowship program at Columbia University Medical Center/New York-Presbyterian Hospital in New York. “I would like as a physician to have the option to discuss it with the patient and be able to use it if the patient elects to do so. That would be the ideal scenario. To use it in everybody, I don’t think you can do that on the basis of this data.”
About 40,000 people would be potential candidates if the results were positive, said Larry Biegelsen, an analyst at Wells Fargo Securities in New York.
The Amplatzer plug, made up of two wire-mesh discs filled with a polyester fabric, generates less than $100 million a year. The potential market for the heart closure device to prevent strokes is about $400 million, wrote Biegelsen in a Sept. 24 note to investors.
The trial, dubbed Respect, tracked 980 patients ages 18 to 60. It started in 2003 and ran until there were 25 strokes recorded. There were no deaths or fatal strokes, with non-fatal strokes occurring in 9 patients assigned to the Amplatzer plug and 16 patients slated to get medicine.