FDA Sounds Alarm Bells Over Use of Lariat Device for LAA Closure in A-fib Patients
The FDA has issued a safety communication warning against off-label use of the Lariat device for percutaneous closure of the left atrial appendage (LAA) for stroke prevention in A-fib patients. The announcement, released on July 13, 2015, comes several weeks after the agency granted Lariat’s manufacturer permission to study the device in a randomized clinical trial.
Lariat, made by SentreHEART (Redwood City, CA), is FDA-approved for delivery of a pre-tied stitch to aid in soft tissue closure during surgery. In late June, the company received an investigational device exemption to begin the AMAZE randomized trial, slated to enroll a maximum of 600 patients at up to 50 centers to evaluate the effect of LAA closure as an adjunctive treatment to pulmonary vein isolation ablation in persistent or longstanding persistent A-fib.
“While the company’s patent information for the device specifically says that their goal was for left atrial appendage occlusion, their FDA 510(k) approval was for soft tissue approximation,” Paul D. Varosy, MD, of the VA Eastern Colorado Health Care System (Denver, CO), told TCTMD in a telephone interview. “I think that it's good for patients that the FDA brought this discrepancy between how the device is being used and how it was actually approved to the public’s attention.”
According to the FDA, the communication is meant to alert healthcare providers and patients about reports of death and other serious adverse events associated with use of the Lariat device. The agency says it has identified 45 adverse events that occurred through June 30, 2015, in patients who underwent LAA closure with the Lariat and/or its associated devices.
Currently, Watchman (Boston Scientific) is the only FDA-approved device for percutaneous LAA closure aimed at stroke prevention in A-fib patients, but plenty of other technologies are in the pipeline.
“Some physicians are using the Lariat Suture Delivery Device along with 3 other cleared associated SentreHEART devices (the EndoCATH Occlusion Balloon catheter, the SofTIP Guide Cannula, and the FindrWIRZ System) to close the LAA,” reports the FDA statement. “The FDA has not evaluated the use of the Lariat Suture Delivery Device for LAA closure to reduce the risk of stroke in atrial fibrillation patients.”
Of the 45 adverse events that the agency found in a search of the Manufacturer and User Facility Device Experience (MAUDE) database, three-quarters resulted in emergency surgery and 6 in death.
The FDA recommends that healthcare providers:
- Be aware that the safety and effectiveness of Lariat to close the LAA and prevent stroke in patients with A-fib has not been established
- Consider treatment options for which safety and effectiveness have been established to reduce the risk of stroke in patients with A-fib
- Inform A-fib patients of the benefits and risks of the available treatment options to help prevent stroke prior to treatment
- Report any adverse events associated with the use of Lariat and/or its associated devices to the FDA and the manufacturer
‘No Need to Panic’
But in the meantime, Dhanunjaya Lakkireddy, MD, of the University of Kansas Medical Center (Kansas City, KS), who is serving as chair of the steering committee for the AMAZE study, told TCTMD in an email that the Lariat device “can be used outside the clinical trial.
“There is a huge unmet need for a device in high-risk, anticoagulation-ineligible patients, [for whom] no LAA exclusion options are available,” he continued. “Lariat provides a great solution to these unfortunate people who would otherwise continue to have life-threatening bleeds and those who failed anticoagulation and still continue to have strokes and other [systemic thromboembolism].”
Dr. Lakkireddy emphasized that the information in the FDA safety alert is nothing new. “It is interesting how this message is being interpreted by different people. This is not a recall,” he said. “What FDA has said is that people should pay attention to the potential complications in some published case series…. There is no need to panic.”
For optimal results, “operators should carefully choose the patients, conduct the procedures very meticulously, and make appropriate changes to their technique to ensure better safety,” he advised. “Every new device and field goes through the pains of early trials and tribulations.”
Approval Process Needs 1 Standard
But, Dr. Varosy countered, there is “a disconnect” between the “full premarket approval process requiring a demonstration of safety and efficacy for an entirely new class of devices,” which the FDA required for approval of the Watchman system, and what he perceives as lack of hard data gathered for the Lariat device.
Even without data, both the device and concept are “brilliant,” Dr. Varosy acknowledged. Yet clinicians and patients “should quite reasonably expect that there should be some demonstration of its safety and efficacy before we recommend this on a wholesale basis,” he emphasized, adding that this process need not require 10 years and multiple randomized trials.
“If [SentreHEART] can produce 1 randomized trial, we would be in a much better place in being able to advise patients,” Dr. Varosy said.
“For something like the Watchman, I feel like I can pretty well tell patients what the data are, what the risks are, what the benefits are. For the Lariat, we have an idea,” he continued. “We know that a lot of the strokes and nonvalvular A-fib come from the left atrial appendage, and it seems plausible for me that it may well be the case that if you ligate the left atrial appendage that it might prevent stroke, but we just don’t have data to prove that that is in fact the case at this point.”
Dr. Varosy concluded that “if we're going to expect one company's device to demonstrate safety and efficacy, we should have the same standard across different manufacturer's devices.”
Use of Lariat suture delivery device for left atrial appendage closure: FDA safety communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454501.htm. Published July 13, 2015. Accessed July 16, 2015.
- Dr. Varosy reports involvement with the National Cardiovascular Data Registry in the development of clinical registries, including one specifically for LAA closure.
- Dr. Lakkireddy reports serving as chair of the steering committee for the AMAZE study.
- Study Documents Complications of LAA Closure With the Lariat Device
- Study Indicates Snare Device for LAA Closure Should Only Be Used in Highest-Risk Patients
- Novel Device Shows Promise for Safe, Effective LAA Closure