Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial

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

Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial

Jens Erik Nielsen-Kudsk^*, Boris Schmidt, Stephan Windecker, Neeraj Shah, William Gray, Christopher R Ellis, Konstantinos Koulogiannis, Jordan A Anderson, Ryan Gage, Dhanunjaya Lakkireddy

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

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).

Originalsprog	Engelsk
Tidsskrift	JACC: Clinical Electrophysiology
ISSN	2405-500X
DOI	https://doi.org/10.1016/j.jacep.2025.02.016
Status	E-pub / Early view - 24 mar. 2025

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@article{e85f15b6776d4218a6b1f93665eed5a8,

title = "Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial",

abstract = "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).",

keywords = "Amulet, Watchman, atrial fibrillation, device-related thrombus, left atrial appendage occlusion, stroke",

author = "Nielsen-Kudsk, \{Jens Erik\} and Boris Schmidt and Stephan Windecker and Neeraj Shah and William Gray and Ellis, \{Christopher R\} and Konstantinos Koulogiannis and Anderson, \{Jordan A\} and Ryan Gage and Dhanunjaya Lakkireddy",

year = "2025",

month = mar,

day = "24",

doi = "10.1016/j.jacep.2025.02.016",

language = "English",

journal = "JACC: Clinical Electrophysiology",

issn = "2405-500X",

publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial

AU - Nielsen-Kudsk, Jens Erik

AU - Schmidt, Boris

AU - Windecker, Stephan

AU - Shah, Neeraj

AU - Gray, William

AU - Ellis, Christopher R

AU - Koulogiannis, Konstantinos

AU - Anderson, Jordan A

AU - Gage, Ryan

AU - Lakkireddy, Dhanunjaya

PY - 2025/3/24

Y1 - 2025/3/24

N2 - 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).

AB - 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).

KW - Amulet

KW - Watchman

KW - atrial fibrillation

KW - device-related thrombus

KW - left atrial appendage occlusion

KW - stroke

UR - http://www.scopus.com/inward/record.url?scp=105002315786&partnerID=8YFLogxK

U2 - 10.1016/j.jacep.2025.02.016

DO - 10.1016/j.jacep.2025.02.016

M3 - Journal article

C2 - 40208159

SN - 2405-500X

JO - JACC: Clinical Electrophysiology

JF - JACC: Clinical Electrophysiology

ER -

Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial

Abstract

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