The U.S. Food & Drug Administration (FDA) is warning about patient deaths and other adverse events linked to the LARIAT Suture Delivery Device, a medical tool that has been used “off-label” to close the left atrial appendage (LAA) in patients with atrial fibrillation, or a-fib, to prevent stroke.
FDA Warns of “Off-Label” use of LAA Closure Device
July 13, 2015 – The LARIAT Suture Delivery Device is approved to deliver sutures for soft tissue closure; however, surgeons have been using it “off-label” to close the left atrial appendage (LAA) to prevent stroke in patients with atrial fibrillation.
The problem was first reported on in JAMA Internal Medicine in May. SentreHeart, the company that markets the LARIAT, said it planned to conduct a trial for a a-fib indication.
FDA is aware of at least 45 adverse events through June 30, 2015 in patients undergoing LAA closure with the Lariat Suture Delivery Device and/or its associated products. These reports 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).
Of the 45 adverse events linked to the LARIAT LAA closure device, 34 (about 75%) required emergency heart surgery to treat.
In June, SentreHeart announced that FDA had cleared it to initiate the so-called “AMAZE trial” of LARIAT for LAA closure in patients with persistent or long-standing atrial fibrillation. The procedure is intended to reduce the incidence of stroke caused by a blood clot in the left atrial appendage detaching and traveling through the bloodstream to the brain.
AMAZE is a 2-stage trial slated to enroll up to 600 patients, with up to 175 million at 15 centers during the first stage alone. The procedure will be done on a-fib patients who qualify for pulmonary vein isolation (PVI) catheter ablation. The trial is intended to compare the use of PVI ablation plus LARIAT to the use of PVI alone.
“The left atrial appendage has been accurately termed our most lethal human attachment,” Said Dr. James Cox, a surgeon who developed the first ablation treatment for a-fib. “The Lariat is the only percutaneous device that can provide the electromechanical isolation of the myocardium of the LAA by devascularization and, when combined with PVI ablation, would seem to be the one most likely to improve catheter ablation outcomes for afib.”
The LARIAT isn’t the only LAA closure device on the market. After years of rejections, Boston Scientific in March secured approval for its Watchman device, which prevents LAA blood clots from entering the bloodstr