TY - JOUR
T1 - Safety and procedural success of left atrial appendage exclusion with the lariat device
T2 - A systematic review of published reports and analytic review of the FDAMAUDE database
AU - Chatterjee, Saurav
AU - Herrmann, Howard C.
AU - Wilensky, Robert L.
AU - Hirshfeld, John
AU - McCormick, Daniel
AU - Frankel, David S.
AU - Yeh, Robert W.
AU - Armstrong, Ehrin J.
AU - Kumbhani, Dharam J.
AU - Giri, Jay
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2015/7/1
Y1 - 2015/7/1
N2 - IMPORTANCE The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. OBJECTIVES To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device.We performed a formal analytic review of the FDAMAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. DATA SOURCES For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. DATA EXTRACTIONS AND SYNTHESIS Datawere abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDAMAUDE data set. MAIN OUTCOMES AND MEASURES Procedural adverse events and procedural success. RESULTS In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3%(279 of 309 procedures). In the FDAMAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. CONCLUSIONS AND RELEVANCE This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.
AB - IMPORTANCE The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. OBJECTIVES To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device.We performed a formal analytic review of the FDAMAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. DATA SOURCES For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. DATA EXTRACTIONS AND SYNTHESIS Datawere abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDAMAUDE data set. MAIN OUTCOMES AND MEASURES Procedural adverse events and procedural success. RESULTS In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3%(279 of 309 procedures). In the FDAMAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. CONCLUSIONS AND RELEVANCE This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.
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U2 - 10.1001/jamainternmed.2015.1513
DO - 10.1001/jamainternmed.2015.1513
M3 - Article
C2 - 25938303
AN - SCOPUS:84937437433
SN - 2168-6106
VL - 175
SP - 1104
EP - 1109
JO - JAMA Internal Medicine
JF - JAMA Internal Medicine
IS - 7
ER -