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Off-label use of LAA exclusion device associated with adverse events
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The Lariat device is frequently used off-label for left atrial appendage exclusion for stroke prevention in patients with atrial fibrillation, but reports of adverse events related to this use are not uncommon, according to a review published in JAMA Internal Medicine.
The Lariat device (SentreHeart) received 501(k) clearance from the FDA in 2006 for suture placement during surgical procedures, but has never been approved for left atrial appendage (LAA) exclusion in patients with AF, and clinical testing for that use was never performed, according to the study background.
Researchers conducted a systematic review of published literature to assess safety and procedural success of the device and a formal analytic review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database to compile real-world reports of adverse events associated with use of the device for LAA closure.
They found five reports of Lariat device use for LAA exclusion in 309 patients between January 2007 and August 2014.
According to those reports, procedural success, defined as successful LAA closure during the index procedure, occurred in 90.3% of cases. Pooled event rates using a generic inverse variance weighing with a random-effects model included 2.3% for urgent cardiac surgery and 0.3% for death.
In the FDA MAUDE database, researchers identified 35 unique reports of adverse events related to use of the Lariat device for LAA exclusion. These included five reports of pericardial effusion and death and 23 reports of urgent cardiac surgery without mention of death.
Jay Giri
“The Lariat is an ingenious piece of engineering for closing the [LAA], but ingenuity does not guarantee safety and efficacy,” Jay Giri, MD, MPH, assistant professor, cardiovascular medicine division, Perelman School of Medicine at the University of Pennsylvania, said in a press release. “The Lariat must be assessed as a device for [LAA] exclusion with randomized controlled trials before widespread use is adopted by the medical community. Our analysis raises broader issues with the FDA 510(k) clearance protocol for medical devices. We believe there needs to be a method for reassessing the safety of a device that has been cleared for one use but is being frequently used for a different purpose in real-world practice.”
In a related editorial, Paul D. Varosy, MD, wrote that “there appears to be more than intermediate risk associated with this device” and that it is concerning that the efficacy of the off-label use has not been evaluated in a randomized trial or clinical registry.
“Until we have such data, as well as approval of the Lariat by FDA specifically for this indication, its use in [LAA] occlusion in clinical practice should be questioned,” wrote Varosy, from the VA Eastern Colorado Health Care System, University of Colorado and Colorado Cardiovascular Outcomes Research Group, Denver. – by Erik Swain
Disclosures: Giri and Varosy report no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.
Perspective
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Matthew J. Price, MD
The paper does a good job of summarizing the current set of small studies of the Lariat procedure and their methodological limitations. Although the paper does not provide any novel findings, it does highlight the MAUDE database, the potential for significant adverse events with the device, and the FDA 510(k) regulatory process and how it applies specifically to the Lariat.
At this point, I think one must recognize the paucity of efficacy data and the lack of clarity regarding procedural safety and its potential for being high-risk and associated with substantial morbidity. LAA closure for stroke prevention is a prophylactic strategy, and ensuring that the benefits outweigh the risks is particularly important for a prophylactic procedure. There may be the occasional patient in whom the Lariat procedure might be considered on a humanitarian basis, but until there are robust data, I do not believe it is prudent to offer it broadly for stroke prevention in patients with AF.
I would like to see a prospective trial, preferably randomized, that is large enough to provide robust data regarding procedural safety with current techniques and long-term efficacy in reducing stroke (not only in providing anatomical closure).
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