The Lariat Suture Device is often used in “off-label” (unapproved) heart surgeries to prevent strokes, but the FDA is now warning that it can cause severe injuries and death.
Lariat Suture Device and “Off-Label” LAA Closure
SentreHEART Inc. manufactures the LARIAT® Suture Delivery Device, a snare-like device that is used to close soft-tissues with a pre-tied stitch (suture). It is commonly used for “off-label” heart surgeries to close the left atrial appendage (LAA), a pouch in the heart that is believed to be the source of blood clots that cause strokes in people with atrial fibrillation.
What is the problem?
The FDA has not approved the Lariat device for LAA closure. This use has never been studied for safety and effectiveness in clinical trials, and there is growing evidence of severe risks.
FDA Warning: Lariat Suture Device and LAA Closure Safety Risks
July 13, 2015 — In a Safety Communication, the FDA has reported receiving 45 adverse events involving LAA closure with the Lariat device, including six patient deaths. Of these events, 75% of patients had to have emergency open heart surgery to treat complications.
Lariat Device Side Effects
- Six patient deaths
- Laceration and/or perforation of the heart
- Complete LAA detachment from the heart
- Bleeding (hemorrhage)
- Low blood pressure (hypotension)
- Fluid collection around the heart (pericardial effusion)
- Fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade)
- Fluid collection around the lungs
Study Finds Risk of Emergency Heart Surgery
In May 2015, JAMA Internal Medicine published a study finding that 2.3% of patients treated with the Lariat device for LAA closure needed emergency open heart surgery.
FDA Approval Loophole?
The FDA 510(k) approval process has been criticized as a way for manufacturers to bring new devices to market without requiring new safety studies, so long as the device is similar to an existing device. Unfortunately, “similar” does not always mean “safe.”
According to Heartwire, the Lariat device was approved with a 510(k) application claiming it was similar to ordinary suture devices. However, it appears to have been specifically designed for off-label use in the heart:
“When you get into the weeds of it, the Lariat device appears to have been designed solely for the purpose of LAA exclusion. Upon 510(k) clearance, US and global patents were rapidly filed for closing the LAA with the device. The company even emphasizes ‘heart’ in its name.”
What is the alternative?
The FDA has approved Boston Scientific’s Watchman Device to close the LAA in patients with atrial fibrillation who are at risk of stroke.