Bleeding and thrombotic events during micro-axial flow pump support: A European multicenter cohort study

Bleeding and thrombosis are major complications of micro-axial flow pump (mAFP) support in cardiogenic shock (CS), yet contemporary data on their incidence, temporal trends, and prognostic impact remain unclear. We retrospectively analyzed patients supported with mAFP between 2010 and 2023 across eleven high-volume European centers. Bleeding and thrombotic events during support were adjudicated and normalized to annual implant volumes. Kaplan–Meier analysis assessed 180-day survival, and multivariable logistic regression identified independent predictors of bleeding and thrombosis. Among 1,043 patients (61% acute myocardial infarction related CS), Impella CP was used in 72% and Impella 5 in 28%. Overall, 503 patients (48%) experienced ≥ 1 event: 252 bleeding only, 149 thrombosis only, and 102 both. Independent predictors of bleeding were post-cardiotomy CS (OR 2.64; 95% CI, 1.41–4.96; p = .003), Acute myocardial infarction related CS (AMICS) (OR 2.27; 95% CI, 1.38–3.74; p = .001), V-A ECMO unloading indication (OR 1.65; 95% CI, 1.14–2.39; p = .008) and renal replacement therapy at implantation (OR 1.56; 95% CI, 1.08–2.27; P = .019). Predictors of thrombosis were prior stroke (OR 2.51; 95% CI 1.40–4.51), AMI-CS (OR 2.06; 95% CI 1.42–3.00), and mAFP unloading with V-A ECMO (OR 2.03; 95% CI 1.38–2.98). Bleeding (OR 1.38; 95% CI 1.02–1.87) and thrombosis (OR 2.10; 95% CI 1.53–2.88) were independently associated with higher 180-day mortality. In this large European mAFP cohort, bleeding and thrombotic events were frequent and associated with mortality and adverse outcomes. Their distinct risk profiles support individualized prevention strategies and underscore the need for prospective randomized trials comparing anticoagulation regimens in risk-stratified patients.

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Journal
Critical Care
Published
2026-04-13
DOI
https://doi.org/10.1186/s13054-026-05984-0
Primary Topic
Mechanical Circulatory Support Devices
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article
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article

Bleeding and thrombotic events during micro-axial flow pump support: A European multicenter cohort study

Agnieszka Tycińska, Léo Lemarchand, Frédéric Bouisset, Wiktor Kuliczkowski et al.
Critical Care
Mechanical Circulatory Support Devices
article

Bleeding and thrombotic events during micro-axial flow pump support: A European multicenter cohort study

Agnieszka Tycińska, Léo Lemarchand, Frédéric Bouisset, Wiktor Kuliczkowski, Aneta Klotzka, Mikołaj Błaziak, Benedikt Schrage, Fanny Vardon, Monika Fürholz, Philippe Gaudard, Benedikt N. Beer, Laurent Bonello, Miloud Cherbi, Guillaume Leurent, Jonas Sundermeyer, Aurore Ughetto, Anna Konopka, Ana Magdalena Hurtado, The IMPACT Investigators, Matias Jacomet, Hadrien Pichené, Clément Delmas, Sara Gonzalez Lastra, Marie De Cuniac, Alexandre Ouattara, Marta Zaleska Kociecka, Julien Imbault, Chloe Tassain, Macarena Otero Escudero, Christophe Vandenbriele, Emma Chelvi Sendin, Antoine Beurton, Nicolas Nesseler, Dettling Angela, Arthur Chouaiki-perrois, François-Xavier Herion, Alexandre Mansour, Lukas Hunziker, Vasileios Panoulas, Flecher Erwan
article en

Abstract

Bleeding and thrombosis are major complications of micro-axial flow pump (mAFP) support in cardiogenic shock (CS), yet contemporary data on their incidence, temporal trends, and prognostic impact remain unclear. We retrospectively analyzed patients supported with mAFP between 2010 and 2023 across eleven high-volume European centers. Bleeding and thrombotic events during support were adjudicated and normalized to annual implant volumes. Kaplan–Meier analysis assessed 180-day survival, and multivariable logistic regression identified independent predictors of bleeding and thrombosis. Among 1,043 patients (61% acute myocardial infarction related CS), Impella CP was used in 72% and Impella 5 in 28%. Overall, 503 patients (48%) experienced ≥ 1 event: 252 bleeding only, 149 thrombosis only, and 102 both. Independent predictors of bleeding were post-cardiotomy CS (OR 2.64; 95% CI, 1.41–4.96; p = .003), Acute myocardial infarction related CS (AMICS) (OR 2.27; 95% CI, 1.38–3.74; p = .001), V-A ECMO unloading indication (OR 1.65; 95% CI, 1.14–2.39; p = .008) and renal replacement therapy at implantation (OR 1.56; 95% CI, 1.08–2.27; P = .019). Predictors of thrombosis were prior stroke (OR 2.51; 95% CI 1.40–4.51), AMI-CS (OR 2.06; 95% CI 1.42–3.00), and mAFP unloading with V-A ECMO (OR 2.03; 95% CI 1.38–2.98). Bleeding (OR 1.38; 95% CI 1.02–1.87) and thrombosis (OR 2.10; 95% CI 1.53–2.88) were independently associated with higher 180-day mortality. In this large European mAFP cohort, bleeding and thrombotic events were frequent and associated with mortality and adverse outcomes. Their distinct risk profiles support individualized prevention strategies and underscore the need for prospective randomized trials comparing anticoagulation regimens in risk-stratified patients.

Critical Care
Poznan University of Medical Sciences (PL), Centre National de la Recherche Scientifique (FR), Medical University of Białystok (PL), Université de Bordeaux (FR), Inserm (FR), Universität Hamburg (DE), Université de Montpellier (FR), Guy's and St Thomas' NHS Foundation Trust (GB), Royal Brompton & Harefield NHS Foundation Trust (GB), University Hospital of Bern (CH), Harefield Hospital (GB), Centre Hospitalier Universitaire de Bordeaux (FR), Wroclaw Medical University (PL), Physiologie et Médecine Expérimentale du Coeur et des Muscles (FR), Assistance Publique Hôpitaux de Marseille (FR), Centre Hospitalier Universitaire de Montpellier (FR), Laboratoire Traitement du Signal et de l'Image (FR), Institut de Recherche en Santé, Environnement et Travail (FR), University Medical Center Hamburg-Eppendorf (DE), Hôpital Nord (FR), Hôpital Rangueil (FR), Hôpital Pontchaillou (FR), German Centre for Cardiovascular Research (DE), Institute of Cardiology (PL), Hôpital Saint-Jacques (FR), Hôpital Arnaud de Villeneuve (FR), Centre Hospitalier Universitaire de Rennes (FR), Imperial College London (GB), Université de Rennes (FR)
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