When used “Off-label” for left atrial appendage (LAA) closure, the LARIAT Suture Delivery Device has been to adverse health complications and death.
What’s the Problem?
The LARIAT Suture Delivery Device is a snare-like medical tool approved to close soft tissues with a pre-tied stitch; however, many surgeons have used the device in “off-label” (unapproved) heart surgeries to close the left atrial appendage (LAA), a small sac in the muscle wall of the left atrium that may cause blood clots and stroke in patients with atrial fibrillation (a-fib).
“Off-Label” Use of LAA Closure Device Linked to Safety Risks: FDA Warning
On July 13, 2015, the FDA issued a Safety Alert warning that it had received at least 45 reports of adverse events linked to LAA closure with the LARIAT Suture Delivery Device. Of these, 34 (about 75%) required emergency heart surgery to treat complications.
LARIAT Suture Complications
According to the FDA warning, side effects of the LARIAT device have included:
- 6 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), and
- Fluid collection around the lung (pleural effusion).
FDA 510(k) Approval Loophole
The LARIAT Suture Delivery Device was approved through the FDA’s controversial 510(k) approval process, which requires little safety information and only some information concerning the products’ efficacy, so long as the device is similar to products already on the market.
According to Heartwire, LARIAT was approved via 510(k) because it was similar to ordinary suture devices. However, it appears to have been specifically designed for off-label use in heart surgery:
“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.”