Impact of Primary Hemostasis Disorders on Late Major Bleeding Events among Anticoagulated Atrial Fibrillation Patients Treated by TAVR

Laurent Dietrich; Marion Kibler; Kensuke Matsushita; Benjamin Marchandot; Antonin Trimaille; Antje Reydel; Bamba Diop; Phi Dinh Truong; Anh Mai Trung; Annie Trinh; Adrien Carmona; Sébastien Hess; Laurence Jesel; Patrick Ohlmann; Olivier Morel

doi:10.3390/jcm11010212

Impact of Primary Hemostasis Disorders on Late Major Bleeding Events among Anticoagulated Atrial Fibrillation Patients Treated by TAVR

J Clin Med. 2021 Dec 31;11(1):212. doi: 10.3390/jcm11010212.

Authors

Laurent Dietrich¹, Marion Kibler¹, Kensuke Matsushita^{1

2}, Benjamin Marchandot¹, Antonin Trimaille¹, Antje Reydel¹, Bamba Diop¹, Phi Dinh Truong³, Anh Mai Trung³, Annie Trinh¹, Adrien Carmona¹, Sébastien Hess¹, Laurence Jesel^{1

2}, Patrick Ohlmann¹, Olivier Morel^{1

2}

Affiliations

¹ Centre Hospitalier Universitaire, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France.
² Institut National de la Santé et de la Recherche Médicale (INSERM), Nano Médecine Régénérative, Unité Mixte de Recherche 1260, Faculté de Pharmacie, Université de Strasbourg, 67400 Illkirch, France.
³ Vietnam National Heart Institute, Bach Mai Hospital, Hanoi 100000, Vietnam.

Abstract

Background: Bleeding events are among the striking complications following transcatheter aortic valve replacement (TAVR), and bleeding prediction models are crucially warranted. Several studies have highlighted that primary hemostasis disorders secondary to persistent loss of high-molecular-weight (HMW) multimers of the von Willebrand factor (vWF) and assessed by adenosine diphosphate closure time (CT-ADP) may be a strong predictor of late major/life-threatening bleeding complications (MLBCs). Pre-existing atrial fibrillation (AF) is a frequent comorbidity in TAVR patients and potentially associated with increased bleeding events after the procedure.

Objectives: This study evaluated the impact of ongoing primary hemostasis disorders, as assessed by post-procedural CT-ADP > 180 s, on clinical events after TAVR among anticoagulated AF patients.

Methods: An ongoing primary hemostasis disorder was defined by post-procedure CT-ADP > 180 s. Bleeding complications were assessed according to the Valve Academic Research Consortium-2 (VARC-2) criteria. The primary endpoint was the occurrence of late MLBCs at one-year follow-up. The secondary endpoint was a composite of mortality, stroke, myocardial infarction, and rehospitalization for heart failure.

Results: In total, 384 TAVR patients were included in the analysis. Of these patients, 57 patients (14.8%) had a prolongated CT-ADP > 180 s. Increased MLBCs were observed in patients with CT-ADP > 180 s (35.1% versus 1.2%; p < 0.0001). Conversely, the occurrence of the composite endpoint did not differ between the groups. Multivariate analysis identified CT-ADP > 180 s (HR 28.93; 95% CI 9.74-85.95; p < 0.0001), bleeding history, paradoxical aortic stenosis (AS), and major vascular complications following TAVR as independent predictors of late MLBCs.

Conclusion: Among patients with anticoagulated AF, a post-procedural CT-ADP > 180 s was identified as a strong independent predictor of late MLBCs. These findings suggest that persistent primary hemostasis disorders contribute to a higher risk of late bleeding events and should be considered for a tailored, risk-adjusted antithrombotic therapy after TAVR.

Keywords: closure time with ADP; major life/threatening bleedings; primary hemostasis disorders; transcatheter aortic valve replacement.