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Medical device's risky off-label use under question

Not every person needs such a procedure, but if your doctor suggests you get a left atrial appendage exclusion using the Lariat snare device, think twice about it.

According to a report published in JAMA Internal Medicine, there's reason to believe it could increase the risk of adverse events such as a need for urgent cardiac surgery or even death. At the very least, the authors of the study suggest that the device's use for LAA exclusion be tested by the Food and Drug Administration to determine whether it's safe and effective for the job.

The FDA approved the Lariat device in 2006 for the placement of sutures in certain operations. That was granted on the basis of the manufacturer's statement that it is substantially equivalent to devices like it. The problem is that researchers have found that doctors have started to put the device to use for the LAA exclusion, for which it is not approved.

Off-label use of a drug or device is not uncommon, and the study's authors acknowledge that the Lariat's design seems to be applicable for the exclusion procedure. But after reviewing a lot of data from hundreds of cases in which it was used that way, the doctors say they found too many patients suffered harm. One patient died.

For purposes of background, a doctor might call for an LAA exclusion if a patient is older and suffers from abnormal heart rhythm because of atrial fibrillation. It's believed certain patients face a risk that clots from the sac-like appendage could escape and cause a stroke. Doctors seek to block it off by cinching the sac closed and tying it off with the Lariat.

Another device that blocks the sac with an implant won FDA approval for that specific purpose in March.

Use of the Lariat is not illegal and its application for LAA exclusion might not be considered clearly negligent, amounting to medical malpractice. But its use might be worth questioning.

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