Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2023 Dec;112(12):1790-1799.
doi: 10.1007/s00392-023-02237-w. Epub 2023 Jun 9.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry

Vivian Vij #  1 , Ignacio Cruz-González #  2 , Roberto Galea  3 , Kerstin Piayda  4 , Dominik Nelles  1 , Lara Vogt  1 , Steffen Gloekler  3 , Monika Fürholz  3 , Bernhard Meier  3 , Lorenz Räber  3 , Gilles O'Hara  5 , Dabit Arzamendi  6 , Victor Agudelo  6 , Lluis Asmarats  5   6 , Xavier Freixa  7 , Eduardo Flores-Umanzor  7 , Ole De Backer  8 , Lars Sondergaard  8 , Luis Nombela-Franco  9 , Angela McInerney  9 , Pablo Salinas  9 , Kasper Korsholm  10 , Jens Erik Nielsen-Kudsk  10 , Shazia Afzal  11 , Tobias Zeus  11 , Felix Operhalski  12 , Boris Schmidt  12 , Gilles Montalescot  13 , Paul Guedeney  13 , Xavier Iriart  14 , Noelie Miton  14 , Jacqueline Saw  15 , Thomas Gilhofer  16 , Laurent Fauchier  17 , Egzon Veliqi  18 , Felix Meincke  18 , Nils Petri  19 , Peter Nordbeck  19 , Rocio Gonzalez-Ferreiro  2 , Deepak L Bhatt  20 , Alessandra Laricchia  21   22 , Antonio Mangieri  21   22 , Heyder Omran  23 , Jan Wilko Schrickel  1 , Josep Rodes-Cabau  5 , Georg Nickenig  1 , Horst Sievert  4 , Alexander Sedaghat  24   25
Affiliations
Multicenter Study

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry

Vivian Vij et al. Clin Res Cardiol. 2023 Dec.

Abstract

Background: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited.

Aims: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed.

Methods: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared.

Results: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%).

Conclusion: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Keywords: Atrial fibrillation; Device-related thrombus; Left atrial appendage closure; Stroke.

PubMed Disclaimer

Conflict of interest statement

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 a 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. 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, Hims; 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; 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, CinCor, Cleerly, 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, Youngene, 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. Georg Nickenig has received honoraria for lectures or advisory boards from Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Cardiovalve, Daiichi Sankyo, Edwards, Medtronic, Novartis, Pfizer, Sanofi Aventis and is a shareholder of Beren, and Cardiovalve. Georg Nickenig has also participated in clinical trials for Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Cardiovalve, Daiichi Sankyo, Edwards, Medtronic, Novartis, Pfizer, Sanofi Aventis. Georg Nickenig has received research fundings from DFG, BMBF, EU, Abbott, Bayer, BMS, Boehringer Ingelheim, Edwards, Medtronic, Novartis, Pfizer. DOI G. Montalescot: research funds for the Institution or fees from Abbott, Amgen, AstraZeneca, Axis, Bayer, BMS, Boehringer-Ingelheim, Boston-Scientific, Cell Prothera, CSL Behring, Idorsia, Leo-Pharma, Lilly, Medtronic, Novartis, Pfizer, Quantum Genomics, Sanofi, Terumo.

Figures

Fig. 1
Fig. 1
Timing of stroke/SE from DRT diagnosis in each reported case of symptomatic DRT
Fig. 2
Fig. 2
Position of DRT on LAAC occluder, a valvular DRT position; b DRT in a central occluder position, a.e. attached to screw, c DRT located on the ridge side of occluder in a “cul-de-sac” between LUPV and occluder
Fig. 3
Fig. 3
Evidence of DRT in different LAA occluder types. a DRT on a Watchman occluder (non-pacifier occuder), b DRT on an Amplatzer Amulet (pacifier occluder)
See this image and copyright information in PMC

References

    1. Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa MA, Ibrahim R, Schillinger W, Meier B, Park J-W. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: Multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016;11:1170–1179. doi: 10.4244/EIJY15M01_06. - DOI - PubMed
    1. Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the watchman left atrial appendage system for embolic protection in patients with AF (PROTECT AF) clinical trial and the continued access registry. Circulation. 2011;123:417–424. doi: 10.1161/CIRCULATIONAHA.110.976449. - DOI - PubMed
    1. Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation. J Am Coll Cardiol. 2018;71:1528–1536. doi: 10.1016/j.jacc.2018.01.076. - DOI - PubMed
    1. Sedaghat A, Nickenig G, Schrickel JW, Ince H, Schmidt B, Protopopov AV, Betts TR, Gori T, Sievert H, Mazzone P, Grygier M, Wald C, Vireca E, Allocco D, Boersma LVA. Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry. Catheter Cardiovasc Interv. 2021 doi: 10.1002/ccd.29458. - DOI - PubMed
    1. Dukkipati SR, Kar S, Holmes DR, Doshi SK, Swarup V, Gibson DN, Maini B, Gordon NT, Main ML, Reddy VY. Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. 2018;138:874–885. doi: 10.1161/CIRCULATIONAHA.118.035090. - DOI - PubMed

Publication types