Key result
The WATCHMAN device was associated with a higher cumulative incidence of stroke/TIA, pericardiocentesis, cardiac surgery, and death compared to the LARIAT device (1.93% vs. 1.15%; P=0.001).
Why the study?
Does the WATCHMAN device compared to the LARIAT device affect the incidence of safety events in AF patients undergoing left atrial appendage closure?
Observational (n=10,738)
Does the WATCHMAN device compared to the LARIAT device affect the incidence of safety events in AF patients undergoing left atrial appendage closure?
Absolute Event Rate: 1.93% vs 1.15%
p-value: p=0.001
Post-approval adoption of new LAAC technology is associated with increased complications, highlighting the need for improved postmarket training and monitoring.
Observational LAAC device comparisons warrant cautious interpretation and should not change practice; leaves open need for randomized safety trials.
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.
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Jazayeri et al. (2017) conducted an observational in Atrial fibrillation unable to tolerate long-term oral anticoagulation (n=10,738). WATCHMAN device vs. LARIAT device was evaluated on Composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death (p=0.001). The WATCHMAN device was associated with a higher cumulative incidence of stroke/TIA, pericardiocentesis, cardiac surgery, and death compared to the LARIAT device (1.93% vs. 1.15%; P=0.001).
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