Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry

Vivian Vij; Kerstin Piayda; Dominik Nelles; Steffen Gloekler; Roberto Galea; Monika Fürholz; Bernhard Meier; Marco Valgimigli; Gilles O’Hara; Dabit Arzamendi; Victor Agudelo; Lluis Asmarats; Xavier Freixa; Eduardo Flores-Umanzor; Ole De Backer; Lars Sondergaard; Luis Nombela-Franco; Angela McInerney; Kasper Korsholm; Jens Erik Nielsen-Kudsk; Shazia Afzal; Tobias Zeus; Felix Operhalski; Boris Schmidt; Gilles Montalescot; Paul Guedeney; Xavier Iriart; Noelie Miton; Jacqueline Saw; Thomas Gilhofer; Laurent Fauchier; Egzon Veliqi; Felix Meincke; Nils Petri; Peter Nordbeck; Dmitrii Ognerubov; Evgeny Merkulov; Ignacio Cruz-González; Rocío Gonzalez-Ferreiro; Deepak L. Bhatt; Alessandra Laricchia; Antonio Mangieri; Heyder Omran; Jan Wilko Schrickel; Josep Rodes-Cabau; Horst Sievert; Georg Nickenig; Alexander Sedaghat

doi:10.1007/s00392-022-02065-4

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry

Vivian Vij, Kerstin Piayda, Dominik Nelles, Steffen Gloekler, Roberto Galea, Monika Fürholz, Bernhard Meier, Marco Valgimigli, Gilles O’Hara, Dabit Arzamendi, Victor Agudelo, Lluis Asmarats, Xavier Freixa, Eduardo Flores-Umanzor, Ole De Backer, Lars Sondergaard, Luis Nombela-Franco, Angela McInerney, Kasper Korsholm, Jens Erik Nielsen-KudskShazia Afzal, Tobias Zeus, Felix Operhalski, Boris Schmidt, Gilles Montalescot, Paul Guedeney, Xavier Iriart, Noelie Miton, Jacqueline Saw, Thomas Gilhofer, Laurent Fauchier, Egzon Veliqi, Felix Meincke, Nils Petri, Peter Nordbeck, Dmitrii Ognerubov, Evgeny Merkulov, Ignacio Cruz-González, Rocío Gonzalez-Ferreiro, Deepak L. Bhatt, Alessandra Laricchia, Antonio Mangieri, Heyder Omran, Jan Wilko Schrickel, Josep Rodes-Cabau, Horst Sievert, Georg Nickenig, Alexander Sedaghat^*

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

21 Citationer (Scopus)

Abstract

Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88–9.49], p < 0.01). Conclusions: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position. Graphical abstract: [Figure not available: see fulltext.].

Originalsprog	Engelsk
Tidsskrift	Clinical Research in Cardiology
Vol/bind	111
Udgave nummer	11
Sider (fra-til)	1276-1285
ISSN	1861-0684
DOI	https://doi.org/10.1007/s00392-022-02065-4
Status	Udgivet - 2022

Bibliografisk note

Funding Information:
Alexander Sedaghat has received travel grants from Abbott and Boston Scientific and is a proctor for Lifetech. Lars Sondergaard has received consultant fees and institutional research grants from Abbott and Boston Scientific, and is shareholder in Eclipse Medical. Dr Cruz-Gonzalez is a proctor for Abbott, Boston Scientific and Lifetech and was funded by ISCIII (PI19/00658) and co-funded by ERDF, "A way to make Europe". Jens Erik Nielsen-Kudsk is a proctor and consultant for Abbott and Boston Scientific. Dabit Arzamendi is a proctor for Abbott and Boston Scientific. Xavier Freixa is a proctor for Abbott, Boston Scientific and Lifetech. Antonio Mangieri is part of the advisory board of Boston Scientific and received an institutional grant from Boston Scientific. Dr. Nombela-Franco has served as a proctor of Abbott Vascular and received speaker honoraria from Boston Scientific and Abbott Vascular. Dr. Meier has received consultant fees from Abbott. Xavier Iriart is a proctor for Abbott and Boston Scientific. Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Consultant: Broadview Ventures; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent.) Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda.

Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Adgang til dokumentet

10.1007/s00392-022-02065-4

Citationsformater

Vij, V., Piayda, K., Nelles, D., Gloekler, S., Galea, R., Fürholz, M., Meier, B., Valgimigli, M., O’Hara, G., Arzamendi, D., Agudelo, V., Asmarats, L., Freixa, X., Flores-Umanzor, E., De Backer, O., Sondergaard, L., Nombela-Franco, L., McInerney, A., Korsholm, K., ... Sedaghat, A. (2022). Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry. Clinical Research in Cardiology, 111(11), 1276-1285. https://doi.org/10.1007/s00392-022-02065-4

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry. / Vij, Vivian; Piayda, Kerstin; Nelles, Dominik et al.
I: Clinical Research in Cardiology, Bind 111, Nr. 11, 2022, s. 1276-1285.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Vij, V, Piayda, K, Nelles, D, Gloekler, S, Galea, R, Fürholz, M, Meier, B, Valgimigli, M, O’Hara, G, Arzamendi, D, Agudelo, V, Asmarats, L, Freixa, X, Flores-Umanzor, E, De Backer, O , Sondergaard, L, Nombela-Franco, L, McInerney, A, Korsholm, K, Nielsen-Kudsk, JE, Afzal, S, Zeus, T, Operhalski, F, Schmidt, B, Montalescot, G, Guedeney, P, Iriart, X, Miton, N, Saw, J, Gilhofer, T, Fauchier, L, Veliqi, E, Meincke, F, Petri, N, Nordbeck, P, Ognerubov, D, Merkulov, E, Cruz-González, I, Gonzalez-Ferreiro, R, Bhatt, DL, Laricchia, A, Mangieri, A, Omran, H, Schrickel, JW, Rodes-Cabau, J, Sievert, H, Nickenig, G & Sedaghat, A 2022, 'Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry', Clinical Research in Cardiology, bind 111, nr. 11, s. 1276-1285. https://doi.org/10.1007/s00392-022-02065-4

@article{e7770359be1c4c12ad1c0a4c422d5850,

title = "Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry",

abstract = "Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88–9.49], p < 0.01). Conclusions: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position. Graphical abstract: [Figure not available: see fulltext.].",

keywords = "Atrial fibrillation, Device-related thrombus, Left atrial appendage closure, Stroke",

author = "Vivian Vij and Kerstin Piayda and Dominik Nelles and Steffen Gloekler and Roberto Galea and Monika F{\"u}rholz and Bernhard Meier and Marco Valgimigli and Gilles O{\textquoteright}Hara and Dabit Arzamendi and Victor Agudelo and Lluis Asmarats and Xavier Freixa and Eduardo Flores-Umanzor and {De Backer}, Ole and Lars Sondergaard and Luis Nombela-Franco and Angela McInerney and Kasper Korsholm and Nielsen-Kudsk, {Jens Erik} and Shazia Afzal and Tobias Zeus and Felix Operhalski and Boris Schmidt and Gilles Montalescot and Paul Guedeney and Xavier Iriart and Noelie Miton and Jacqueline Saw and Thomas Gilhofer and Laurent Fauchier and Egzon Veliqi and Felix Meincke and Nils Petri and Peter Nordbeck and Dmitrii Ognerubov and Evgeny Merkulov and Ignacio Cruz-Gonz{\'a}lez and Roc{\'i}o Gonzalez-Ferreiro and Bhatt, {Deepak L.} and Alessandra Laricchia and Antonio Mangieri and Heyder Omran and Schrickel, {Jan Wilko} and Josep Rodes-Cabau and Horst Sievert and Georg Nickenig and Alexander Sedaghat",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.",

year = "2022",

doi = "10.1007/s00392-022-02065-4",

language = "English",

volume = "111",

pages = "1276--1285",

journal = "Clinical Research in Cardiology",

issn = "1861-0684",

publisher = "Springer Medizin",

number = "11",

}

TY - JOUR

T1 - Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure

T2 - an analysis from the multicenter EUROC-DRT registry

AU - Vij, Vivian

AU - Piayda, Kerstin

AU - Nelles, Dominik

AU - Gloekler, Steffen

AU - Galea, Roberto

AU - Fürholz, Monika

AU - Meier, Bernhard

AU - Valgimigli, Marco

AU - O’Hara, Gilles

AU - Arzamendi, Dabit

AU - Agudelo, Victor

AU - Asmarats, Lluis

AU - Freixa, Xavier

AU - Flores-Umanzor, Eduardo

AU - De Backer, Ole

AU - Sondergaard, Lars

AU - Nombela-Franco, Luis

AU - McInerney, Angela

AU - Korsholm, Kasper

AU - Nielsen-Kudsk, Jens Erik

AU - Afzal, Shazia

AU - Zeus, Tobias

AU - Operhalski, Felix

AU - Schmidt, Boris

AU - Montalescot, Gilles

AU - Guedeney, Paul

AU - Iriart, Xavier

AU - Miton, Noelie

AU - Saw, Jacqueline

AU - Gilhofer, Thomas

AU - Fauchier, Laurent

AU - Veliqi, Egzon

AU - Meincke, Felix

AU - Petri, Nils

AU - Nordbeck, Peter

AU - Ognerubov, Dmitrii

AU - Merkulov, Evgeny

AU - Cruz-González, Ignacio

AU - Gonzalez-Ferreiro, Rocío

AU - Bhatt, Deepak L.

AU - Laricchia, Alessandra

AU - Mangieri, Antonio

AU - Omran, Heyder

AU - Schrickel, Jan Wilko

AU - Rodes-Cabau, Josep

AU - Sievert, Horst

AU - Nickenig, Georg

AU - Sedaghat, Alexander

PY - 2022

Y1 - 2022

N2 - Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88–9.49], p < 0.01). Conclusions: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position. Graphical abstract: [Figure not available: see fulltext.].

AB - Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88–9.49], p < 0.01). Conclusions: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position. Graphical abstract: [Figure not available: see fulltext.].

KW - Atrial fibrillation

KW - Device-related thrombus

KW - Left atrial appendage closure

KW - Stroke

U2 - 10.1007/s00392-022-02065-4

DO - 10.1007/s00392-022-02065-4

M3 - Journal article

C2 - 35849156

AN - SCOPUS:85134489269

SN - 1861-0684

VL - 111

SP - 1276

EP - 1285

JO - Clinical Research in Cardiology

JF - Clinical Research in Cardiology

IS - 11

ER -