A Food and Drug Administration (FDA) announcement and a study in JAMA Internal Medicine about use of the Lariat suture delivery device (SentreHeart) for left atrial appendage (LAA) closure have raised questions regarding using the device in this off-label indication.
On 13 July, the FDA announced 45 adverse events with the use of the Lariat device and its associated FDA-cleared devices (EndoCath Occlusion Balloon Catheter, the SofTip Guide Cannula and the FindrWirz system) for LAA occlusion. The agency states the events were recorded in the Manufacturer and User Facility Device Experience (MAUDE) database. The Lariat device is not FDA-cleared for the prevention of thromboembolic stroke in atrial fibrillation patients.
For atrial fibrillation patients who have difficulties taking anticoagulants, left atrial appendage closure has been proposed as an alternative treatment to reduce the risk of stroke. The only FDA-approved device to date for this indication is Watchman (Boston Scientific). It is also the only device, which has been evaluated in randomised controlled trials compared with the current standard of care.
The FDA’s safety communication details six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, haemorrhage, hypotension, pericardial effusion, cardiac tamponade and fluid pleural effusion. Of the 45 adverse events reported to the FDA, 34 resulted in the need to perform emergency surgery.
The agency said that it will continue to monitor this issue and keep the public informed if significant new information becomes available.
Review analysis of Lariat
The study published by Saurav Chatterjee (Division Cardiology, St Lukes-Roosevelt Hospital Center of the Mount Sinai Health System, New York, USA) and others in the July issue of JAMA Internal Medicine included data from the MAUDE database (the FDA announcement contains more up to date information). Due to the risk of adverse events found, the authors have questioned the off-label use of the Lariat device for LAA exclusion.
In the study, Chatterjee and colleagues highlight that this review represents “the most comprehensive analysis of acute procedural safety of the Lariat device to date.”
The study comprised two reviews; the first was a systematic review of all published literature on the Lariat device from PubMed, EMBASE, CINAHL and the Cochrane Library, including data from January 2007 through August 2014. The second analysis is a review of the FDA MAUDE database.
In the systematic review of five reports the authors found that the Lariat device was used in 309 participants with procedural success (defined as successful closure of the LAA during the index procedure) achieved in 90.3% of the cases. In the MAUDE database, Chatterjee et al found 35 unique reports of adverse events, five of those corresponded to pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death.
Despite the fact that the Lariat device has FDA clearance for the approximation of soft tissue, the authors note that all the cases found in the literature and the FDA MAUDE database report use of the Lariat device only for LAA closure. This device has been adopted for transcatheter LAA exclusion in patients with atrial fibrillation through a unique epicardial approach.
Chatterjee et al acknowledge that FDA 510(k) clearance did not require clinical testing of the Lariat device for the current specific indication and that clearance was predicted on demonstration of “substantial equivalence” with existing devices used for suture placement during other types of surgery.
In light of the adverse events found with the Lariat device, Chatterjee et al express concerns regarding the FDA new device application 510(k) protocol. They write: “The FDA needs a method for reassessing the safety of a device cleared for one purpose but used frequently for a different one, as is the case for the Lariat.”
The authors also highlight the need to undertake “high quality” randomised clinical trials examining the Lariat as a device for LAA exclusion “before its widespread use is adopted by the medical community,” they note.
In an accompanying commentary, Paul Varosi (VA Eastern Colorado Health Care System, University of Colorado, Denver, USA) writes: “On behalf of our patients, we should expect for Lariat the same rigorous evaluation by randomised trials and clinical device registries that are being undertaken for other left atrial appendage occlusion devices. Until we have such data, as well as approval of the Lariat by FDA specifically for this indication, its use for left atrial appendage occlusion in clinical practice should be questioned.”
Taking into consideration that in contrast to many technologies, percutaneous approaches to LAA have been developed simultaneously through multiple pathways, including the off-label use of FDA-approved devices, the most recent guidelines on left atrial appendage occlusion from the American College of Cardiology (ACC), the Heart Rhythm Society (HRS) and the Society for Cardiac Angiography and Interventions (SCAI) suggest the need to develop and implement new guidelines, expert consensus statements, requirements for training, operator credentialing and institutional policies to ensure optimisation of patient outcomes.
In June, SentreHeart announced the FDA approval of enrolment for an investigational device exemption randomised controlled trial (AMAZE), which will evaluate the use of the Lariat device for the ligation of the LAA as an adjunctive treatment to ablation in patients with persistent or long-standing persistent atrial fibrillation.