Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. https://clinicaltrials.gov Unique identifier NCT02879448.

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© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

Déclaration de conflit d'intérêts

Conflict of interest: D.L. has received research and educational grants to the institution from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific. He has also received speaker’s honorarium from Abbott, Medtronic, Biotronik, and Boston Scientific. J.E.N.-K. has received institutional research grants from Abbott and Boston Scientific. S.W. reports research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc. Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. He also served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments. He is also a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. D.T. has received consulting fees from Abbott and Occlutech and institutional research grants for clinical trials from Abbott and the NIH. M.J.P. has received honoraria from Abbott Vascular, ACIST Medical, Boston Scientific, Biotronik, Biosense Webster, Medtronic, Philips, and WL Gore. A.G. has received consulting fees from Abbott, Biosense Webster, and Boston Scientific and speaker honorarium from Boston Scientific. N.G. has received institutional research grants from Medtronic Inc., Boston Scientific Inc., Abbott, and CVRx Inc. K.K. has received speakers honorarium from Abbott and consulting fees from Edwards Lifesciences. L.M. is a member of cardiovascular core laboratory that has contracts with Abbott, Edwards Lifesciences, and Medtronic, for which he receives no direct compensation. A.M. serves as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, for which he receives no direct compensation. J.A.A. and R.G. are employees of Abbott. C.R.E. has received institutional research grants from Boehringer-Ingelheim Inc., Medtronic Inc., Boston Scientific Inc., Consulting/Advisory-Medtronic Inc., Abbott Medical Inc., Boston Scientific Inc., and AtriCure Inc.