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Bad medical outcome depends on definition of success

There are different ways to define success. For a child success might mean finally advancing out of diapers. For an aspiring driver success might mean finally passing the necessary tests — even if it takes two or three times to do it.

When someone in Texas goes into a hospital or a clinic for a medical procedure, chances are good that success in the patient’s mind means coming out of it better than he or she was before and anything less might prompt suspicions of medical malpractice. Seeking compensation then is a patient’s right. And it might be due if clear negligence can be shown. In some cases it might depend on how success is defined.

This may be an issue in connection with a device known as the Lariat. This is a tool that won Food and Drug Administration approval in 2006 as a general suturing device. It didn’t go through any testing to get the OK because the manufacturer claimed it to be substantially the same as other devices already on the market.

But since then, doctors have started to use the Lariat more and more for an off-label use — closing off the left atrial appendage in some older patients with atrial fibrillation. That’s because the sac is believed to be the source of blood clots. If those clots get out of the sac and into the blood stream they could cause a deadly stroke, so doctors look to shut the sac off.

The problem is that the Lariat was never approved for that. And according to a study by the University of Pennsylvania, there have been as many as 23 patients who required urgent cardiac surgery afterward and five deaths. Despite that, the records indicated an overall success rate of more than 90 percent for the procedure.

What that meant was that surgeons succeeded in performing the sac tie-off. It didn’t mean that there was any reduction in strokes — the reason the procedure was done in the first place.

As a result of the findings, authors of the study urged that a formal study be conducted before the device is used for this procedure on a widespread basis.

Source: Philly.com, “Penn study questions Lariat device to prevent stroke in heart patients,” Tom Avril, May 6, 2015