Jens Erik Nielsen-Kudsk, Boris Schmidt, Stephan Windecker, Neeraj Shah, William Gray, Christopher R Ellis, Konstantinos Koulogiannis, Jordan A Anderson, Ryan Gage, Dhanunjaya Lakkireddy
{"title":"Amulet IDE试验中高危器械相关血栓的特征和临床结果","authors":"Jens Erik Nielsen-Kudsk, Boris Schmidt, Stephan Windecker, Neeraj Shah, William Gray, Christopher R Ellis, Konstantinos Koulogiannis, Jordan A Anderson, Ryan Gage, Dhanunjaya Lakkireddy","doi":"10.1016/j.jacep.2025.02.016","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Characteristics of device-related thrombus (DRT) may differ between types of left atrial appendage occlusion devices, and the association of different DRT characteristics to clinical outcomes is largely unknown.</p><p><strong>Objectives: </strong>The incidence, characteristics, and clinical outcomes through 5 years of high- and low-risk DRTs were assessed in the Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial).</p><p><strong>Methods: </strong>An independent core laboratory analyzed all available images at the required 45-day and 12-month visits, and clinical events were reported through 5 years' post-left atrial appendage occlusion.</p><p><strong>Results: </strong>Of the 1,788 patients with a successful device implant, DRT was observed in 3.3% (30 of 903) and 4.5% (40 of 885) of Amulet and Watchman 2.5 device patients throughout 12 months, respectively (P = 0.192). DRTs were successfully classified as high risk if pedunculated, mobile, >3 mm in thickness, or without continuation onto the left atrial wall. A significantly higher incidence of high-risk DRTs was observed on the Watchman 2.5 device (4.0% [35 of 885]) compared with the Amulet occluder (2.2% [20 of 903]) (P = 0.030). Most low-risk DRTs resolved (12 of 15), whereas high-risk DRTs remained mostly unresolved (34 of 55). Through 5 years, all clinical outcome rates were numerically higher in the high-risk DRT group compared with the low-risk DRT or no-DRT group; significance was observed in the composite of stroke, systemic embolism, or cardiovascular death (30.4% vs 19.9%; HR: 1.74; 95% CI: 1.03-2.92; P = 0.037) and cardiovascular death (26.4% vs 14.5%, HR: 2.09; 95% CI: 1.20-3.66; P = 0.009).</p><p><strong>Conclusions: </strong>High-risk DRTs were observed in a higher number of Watchman 2.5 device patients compared with Amulet occluder patients. The composite of stroke, systemic embolism, or cardiovascular death occurred more often in patients with high-risk DRTs compared with those with low-risk DRTs or no DRTs. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [Amulet IDE Trial]; NCT02879448).</p>","PeriodicalId":14573,"journal":{"name":"JACC. 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DRTs were successfully classified as high risk if pedunculated, mobile, >3 mm in thickness, or without continuation onto the left atrial wall. A significantly higher incidence of high-risk DRTs was observed on the Watchman 2.5 device (4.0% [35 of 885]) compared with the Amulet occluder (2.2% [20 of 903]) (P = 0.030). Most low-risk DRTs resolved (12 of 15), whereas high-risk DRTs remained mostly unresolved (34 of 55). Through 5 years, all clinical outcome rates were numerically higher in the high-risk DRT group compared with the low-risk DRT or no-DRT group; significance was observed in the composite of stroke, systemic embolism, or cardiovascular death (30.4% vs 19.9%; HR: 1.74; 95% CI: 1.03-2.92; P = 0.037) and cardiovascular death (26.4% vs 14.5%, HR: 2.09; 95% CI: 1.20-3.66; P = 0.009).</p><p><strong>Conclusions: </strong>High-risk DRTs were observed in a higher number of Watchman 2.5 device patients compared with Amulet occluder patients. The composite of stroke, systemic embolism, or cardiovascular death occurred more often in patients with high-risk DRTs compared with those with low-risk DRTs or no DRTs. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [Amulet IDE Trial]; NCT02879448).</p>\",\"PeriodicalId\":14573,\"journal\":{\"name\":\"JACC. Clinical electrophysiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.0000,\"publicationDate\":\"2025-03-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JACC. 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Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial.
Background: Characteristics of device-related thrombus (DRT) may differ between types of left atrial appendage occlusion devices, and the association of different DRT characteristics to clinical outcomes is largely unknown.
Objectives: The incidence, characteristics, and clinical outcomes through 5 years of high- and low-risk DRTs were assessed in the Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial).
Methods: An independent core laboratory analyzed all available images at the required 45-day and 12-month visits, and clinical events were reported through 5 years' post-left atrial appendage occlusion.
Results: Of the 1,788 patients with a successful device implant, DRT was observed in 3.3% (30 of 903) and 4.5% (40 of 885) of Amulet and Watchman 2.5 device patients throughout 12 months, respectively (P = 0.192). DRTs were successfully classified as high risk if pedunculated, mobile, >3 mm in thickness, or without continuation onto the left atrial wall. A significantly higher incidence of high-risk DRTs was observed on the Watchman 2.5 device (4.0% [35 of 885]) compared with the Amulet occluder (2.2% [20 of 903]) (P = 0.030). Most low-risk DRTs resolved (12 of 15), whereas high-risk DRTs remained mostly unresolved (34 of 55). Through 5 years, all clinical outcome rates were numerically higher in the high-risk DRT group compared with the low-risk DRT or no-DRT group; significance was observed in the composite of stroke, systemic embolism, or cardiovascular death (30.4% vs 19.9%; HR: 1.74; 95% CI: 1.03-2.92; P = 0.037) and cardiovascular death (26.4% vs 14.5%, HR: 2.09; 95% CI: 1.20-3.66; P = 0.009).
Conclusions: High-risk DRTs were observed in a higher number of Watchman 2.5 device patients compared with Amulet occluder patients. The composite of stroke, systemic embolism, or cardiovascular death occurred more often in patients with high-risk DRTs compared with those with low-risk DRTs or no DRTs. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [Amulet IDE Trial]; NCT02879448).
期刊介绍：
JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.
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