In older patients with atrial fibrillation, cardiologists increasingly are using a snare-like device to close off a small sac in the heart thought to be the source of clots that can cause stroke in those with the abnormal heart rhythm.
But the U.S. Food and Drug Administration did not approve the Lariat device for that specific purpose, and now a new University of Pennsylvania-led study says this approach, though legal, too often leads to urgent surgery and even death.
Several area hospitals have used the device, including one that is part of Penn’s own health system – Pennsylvania Hospital – though physicians there have stopped. Others that have tried it include Deborah Heart & Lung Center in Browns Mills and Cooper University Health Care in Camden, where physicians say it is a reasonable choice for stroke-prone patients with limited options.
In the study, published Monday in JAMA Internal Medicine, authors found that the procedure was reported to be successful in 90.3 percent of the 309 cases they identified in the medical literature. Success meant physicians were able to close off the left atrial appendage, a sac in the wall of the heart’s left atrium – not that there was any reduction in the rate of strokes.
But urgent follow-up surgery was needed in seven patients, or 2.3 percent of reported cases, and one patient died.
The study authors also searched an FDA database of adverse events associated with medical devices, finding reports of five patients who died after undergoing a Lariat heart procedure and an additional 23 who required urgent follow-up surgery.
Senior author Jay Giri, an assistant professor at Penn’s Perelman School of Medicine, urged a formal study of the device before further use.
“The Lariat is an absolutely ingenious piece of engineering,” said Giri, an interventional cardiologist. “However, ingenuity doesn’t guarantee its safety and efficacy.”
Meanwhile, the device, made by SentreHEART Inc. of Redwood City, Calif., is facing competition from a product specifically approved by the FDA to deal with this heart sac. Rather than cinching the sac shut, the Watchman device is implanted in the sac to block clots from emerging.
The Watchman, made by Boston Scientific of Marlborough, Mass., was cleared by the FDA in March after rigorous clinical trials.
The FDA approved the Lariat in 2006 without such trials because its manufacturer told the agency that the product was substantially equivalent to other suturing devices on the market.