Lariat Suture Device Linked to Injuries, Deaths In Off-Label Uses
A new study warns that a popular heart suturing device may place patients at risk when surgeons employ it for uses not approved by federal health regulators.
In the latest issue of the medical journal JAMA Internal Medicine, researchers conducted a review of surgery cases involving off-label use of the Lariat device, highlighting several deaths and nearly two dozen injuries associated with the heart suturing product.
The Lariat device was approved by FDA as a simple suturing device; yet the study’s findings suggest it is being used off-label more often for left atrial appendage exclusion in patients with atrial fibrillation.
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Researchers conducted a review of studies published in PubMed, EMBASE, CINAHL and Cochrane Library from January 2007 to August 2014. They found 309 cases where the Lariat device was used on patients for off-label uses.
In seven cases, complications arose where the patients required urgent heart surgery after the device was used, a complication rate of approximately two percent.
Researchers identified at least one death resulting from the off-label use of the Lariat device, but the FDA’s MAUDE database revealed five deaths and 35 adverse event reports with use of the Lariat device. Another 23 reports of urgent cardiac surgery required after use of the device.
Overall, the success rate of the Lariat device is 90% , yet researchers still caution off-label use may be risky, especially for some patients.
Off-label Heart Surgery
Atrial fibrillation occurs when the heart beats irregularly. This can allow blood to pool and clot in the heart, causing the risk of stroke to increase by fivefold.
Doctors will often prescribe blood thinners, but some patients cannot use these medications due to other health problems. In this case doctors often turn to left atrial appendage exclusion surgery because the clots often form in the left atrial appendage.
Surgeons use the Lariat device to remove the appendage by lassoing the magnetic-tipped wires around the left atrial appendage. By drawing the lasso tight it seals it off from the rest of the heart, decreasing the risk of stroke.
Even thought the device is not approved for this use, researchers point out the Lariat seems designed for this exact purpose.
SentreHEART is now seeking FDA permission for clinical trials focused on off-label use of the Lariat device.
Researchers say the Lariat device needs to be assessed for safety and efficacy and are calling for a review of the device.
They also say people who have already been treated using the Lariat should not worry. The problems and adverse events identified by researchers occurred during placement of the lasso, not afterward.
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