CC BY 4.0 · TH Open 2023; 07(02): e117-e127
DOI: 10.1055/a-2068-5783
Original Article

Combination of Primary Hemostatic Disorders and Atrial Fibrillation Increases Bleeding Events Following Transcatheter Aortic Valve Replacement

1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
2   UMR1260 INSERM, Nanomédecine Régénérative, Université de Strasbourg, Strasbourg, France
,
Benjamin Marchandot
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Marion Kibler
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Adrien Carmona
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Truong Dinh Phi
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Joe Heger
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Antonin Trimaille
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Sébastien Hess
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Laurent Sattler
3   Department of Haemostasis, Centre Hospitalier Universitaire, Strasbourg, France
,
Mickael Ohana
4   Department of Radiology, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Antje Reydel
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Laurence Jesel
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
2   UMR1260 INSERM, Nanomédecine Régénérative, Université de Strasbourg, Strasbourg, France
,
Patrick Ohlmann
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
,
Olivier Morel
1   Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
2   UMR1260 INSERM, Nanomédecine Régénérative, Université de Strasbourg, Strasbourg, France
› Author Affiliations
Funding This study was supported by Groupe pour l'Enseignement, la prévention et la Recherche Cardiologique en Alsace.

Abstract

Background Patients with atrial fibrillation (AF) are likely to have a poor prognosis including bleedings following transcatheter aortic valve replacement (TAVR). Closure time of adenosine diphosphate (CT-ADP) is a primary hemostasis point-of-care test and is a predictor of bleeding events following TAVR. We aimed to evaluate the impact of ongoing primary hemostatic disorders on bleeding events in TAVR patients with AF.

Methods We enrolled 878 patients from our prospective registry. The primary endpoint was VARC-2 major/life-threatening bleeding complications (MLBCs) at 1 year after TAVR and secondary endpoint was major adverse cardiac and cerebrovascular events (MACCEs) at 1 year, defined as a composite of all-cause death, myocardial infarction, stroke, and heart failure hospitalization. Ongoing primary hemostatic disorder was defined by a postprocedural CT-ADP >180 seconds.

Results Patients with AF had a higher incidence of MLBCs (20 vs. 12%, p = 0.002), MACCE (29 vs. 20%, p = 0.002), and all-cause mortality (15 vs. 8%, p = 0.002) within 1 year compared to non-AF patients. When the cohort was split into four subgroups according to AF and CT-ADP >180 seconds, patients with AF and CT-ADP >180 seconds had the highest risk of MLBCs and MACCE. Multivariate Cox regression analysis confirmed that the patients with AF and CT-ADP >180 seconds had 3.9-fold higher risk of MLBCs, whereas those patients were no longer associated with MACCE after the adjustment.

Conclusion In TAVR patients, AF with postprocedural CT-ADP >180 seconds was strongly associated with MLBCs following TAVR. Our study suggests that persistent primary hemostatic disorders contribute to a higher risk of bleeding events particularly in AF patients.

Supplementary Material



Publication History

Received: 29 August 2022

Accepted: 27 March 2023

Accepted Manuscript online:
04 April 2023

Article published online:
11 May 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Søndergaard L, Ihlemann N, Capodanno D. et al. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol 2019; 73 (05) 546-553
  • 2 Smith CR, Leon MB, Mack MJ. et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364 (23) 2187-2198
  • 3 Thyregod HG, Steinbrüchel DA, Ihlemann N. et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers notion randomized clinical trial. J Am Coll Cardiol 2015; 65 (20) 2184-2194
  • 4 Mack MJ, Leon MB, Thourani VH. et al; PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019; 380 (18) 1695-1705
  • 5 Lother A, Kaier K, Ahrens I. et al. Bleeding complications drive in-hospital mortality of patients with atrial fibrillation after transcatheter aortic valve replacement. Thromb Haemost 2020; 120 (11) 1580-1586
  • 6 Tarantini G, Mojoli M, Urena M, Vahanian A. Atrial fibrillation in patients undergoing transcatheter aortic valve implantation: epidemiology, timing, predictors, and outcome. Eur Heart J 2017; 38 (17) 1285-1293
  • 7 Kibler M, Marchandot B, Messas N. et al. Ct-adp point-of-care assay predicts 30-day paravalvular aortic regurgitation and bleeding events following transcatheter aortic valve replacement. Thromb Haemost 2018; 118 (05) 893-905
  • 8 Kibler M, Marchandot B, Messas N. et al. Primary hemostatic disorders and late major bleeding after transcatheter aortic valve replacement. J Am Coll Cardiol 2018; 72 (18) 2139-2148
  • 9 Van Belle E, Rauch A, Vincent F. et al. Von willebrand factor multimers during transcatheter aortic-valve replacement. N Engl J Med 2016; 375 (04) 335-344
  • 10 Matsushita K, Marchandot B, Trimaille A. et al. Paradoxical increase of stroke in patients with defect of high molecular weight multimers of the von willebrand factors following transcatheter aortic valve replacement. Thromb Haemost 2020; 120 (09) 1330-1338
  • 11 Mincu RI, Rassaf T, Totzeck M. Red blood cell transfusion in patients with ST-elevation myocardial infarction-a meta-analysis of more than 21,000 patients. Neth Heart J 2018; 26 (09) 454-460
  • 12 Bahrainwala ZS, Grega MA, Hogue CW. et al. Intraoperative hemoglobin levels and transfusion independently predict stroke after cardiac operations. Ann Thorac Surg 2011; 91 (04) 1113-1118
  • 13 Vahanian A, Beyersdorf F, Praz F. et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2022; 43 (07) 561-632
  • 14 Hindricks G, Potpara T, Dagres N. et al; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 2021; 42 (05) 373-498
  • 15 Brugada J, Katritsis DG, Arbelo E. et al; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J 2020; 41 (05) 655-720
  • 16 Morel O, El Ghannudi S, Jesel L. et al. Cardiovascular mortality in chronic kidney disease patients undergoing percutaneous coronary intervention is mainly related to impaired P2Y12 inhibition by clopidogrel. J Am Coll Cardiol 2011; 57 (04) 399-408
  • 17 Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010; 138 (05) 1093-1100
  • 18 Okuno T, Hagemeyer D, Brugger N. et al. Valvular and nonvalvular atrial fibrillation in patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv 2020; 13 (18) 2124-2133
  • 19 Mentias A, Saad M, Girotra S. et al. Impact of pre-existing and new-onset atrial fibrillation on outcomes after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019; 12 (21) 2119-2129
  • 20 Nijenhuis VJ, Brouwer J, Delewi R. et al. Anticoagulation with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med 2020; 382 (18) 1696-1707
  • 21 Mammen EF, Alshameeri RS, Comp PC. Preliminary data from a field trial of the PFA-100 system. Semin Thromb Hemost 1995; 21 (Suppl. 02) 113-121
  • 22 Fressinaud E, Veyradier A, Truchaud F. et al. Screening for von Willebrand disease with a new analyzer using high shear stress: a study of 60 cases. Blood 1998; 91 (04) 1325-1331
  • 23 Van Belle E, Vincent F, Rauch A. et al. Von willebrand factor and management of heart valve disease: JACC review topic of the week. J Am Coll Cardiol 2019; 73 (09) 1078-1088
  • 24 Matsushita K, Marchandot B, Kibler M. et al. Predictive impact of paravalvular leak assessments on clinical outcomes following transcatheter aortic valve replacement. Am J Cardiol 2020; 135: 181-182
  • 25 Matsushita K, Marchandot B, Kibler M. et al. Discrepancy in von willebrand abnormalities between degenerative and functional mitral regurgitation. Am J Cardiol 2021; 149: 157-159
  • 26 Dangas GD, Tijssen JGP, Wöhrle J. et al; GALILEO Investigators. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020; 382 (02) 120-129
  • 27 Ten Berg J, Sibbing D, Rocca B. et al. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J 2021; 42 (23) 2265-2269
  • 28 Matsushita K, Marchandot B, Kibler M. et al. P2y12 inhibition by clopidogrel increases periprocedural bleeds in patients undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 2019; 74 (21) 2707-2708
  • 29 Van Mieghem NM, Unverdorben M, Hengstenberg C. et al; ENVISAGE-TAVI AF Investigators. Edoxaban versus vitamin k antagonist for atrial fibrillation after tavr. N Engl J Med 2021; 385 (23) 2150-2160
  • 30 Navarese EP, Zhang Z, Kubica J. et al; a Joint Effort of the Italian and Polish Cardiac Interventional Societies. Development and validation of a practical model to identify patients at risk of bleeding after tavr. JACC Cardiovasc Interv 2021; 14 (11) 1196-1206
  • 31 Collas VM, Paelinck BP, Rodrigus IE, Vrints CJ, Van Craenenbroeck EM, Bosmans JM. Red cell distribution width improves the prediction of prognosis after transcatheter aortic valve implantation. Eur J Cardiothorac Surg 2016; 49 (02) 471-477
  • 32 Matsushita K, Trimaille A, Marchandot B, Ohlmann P, Morel O. Oral anticoagulant dose adjustment after tavr: the role of closure time with adenosine diphosphate. JACC Cardiovasc Interv 2022; 15 (24) 2575