The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.
Implantation of LVADs (Left Ventricular Assist Device) is a medium to long-term therapeutic option for patients with end-stage heart failure and isolated left ventricular dysfunction. Nevertheless, LVADs use remain limited by the frequency of their adverse effects, most of which being unpredictable. In the literature, loss of pulsatility seems to be associated with CF-LVADs complications, including bleeding. Accordingly, the primary objective of this study is to determine whether patient's preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor (VWF), a blood glycoprotein involved in hemostasis. This deficiency, characterized by a decrease or absence of VWF High Molecular Weight Multimers (HMWMs), is present to varying degrees in almost all patients with LVADs and is a major risk factor for bleeding complications in these patients. Pulsatility is estimated by the patient's blood pressure differential, measured 1) at discharge from the operating room (=transfer to care), 2) at discharge from care (=transfer to his or her room), 3) at discharge from the hospital (=transfer to rehabilitation), and then at each follow-up visit up to 6 months post-implantation. The primary endpoint is to determine whether a preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor ratio of High Molecular Weight Multimers (HMWMs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
For 10 visits (out of the 12 of the protocol), \~40 ml of blood is sampled for research purposes in addition to care sampling.
Groupement Hospitalier pitié Salpêtrière
Paris, France
Von Willebrand factor high molecular weight multimers (HMWM) ratio
Comparison of Von Willebrand factor high molecular weight multimers (HMWM) ratio at LVAD pre-implantation and at day 30. Measure of an correlation between preserved pulsatility and the HMWM ratio evolution during the first month after implantation.
Time frame: 30 days after LVAD IMPLANTATION
Severe postoperative gastrointestinal bleeding
Track record of patients undergoing gastrointestinal bleeding, identified by a decreased hemoglobin level associated with chronic iron deficiency anemia of unexplained cause and melena or bleeding demonstrated by exploration of the gastrointestinal tract by esophageal endoscopy, colonoscopy, or endoscopic videoscopy and resulting in any of the following: * Death * Re-operation * Hospitalization * An erythrocyte transfusion defined as: * Within 7 days of implantation : * Patients weighing 50 kg or more: ≥ 4U of packed red blood cells in a 24-hour period. * Patients weighing less than 50 kg: ≥ 20 mL/kg of packed red blood cells over a 24-hour period * After 7 days post-implantation : any transfusion of packed red blood cells.
Time frame: 6 months
Post-operative right ventricular failure
Track record of patients undergoing right ventricular failure, identified by: * Elevation of central venous pressure (CVP) \>16 mmHg by direct or echocardiographic measurement (inferior vena cava diameter \>20 mm and respiratory variations \<50%) for more than 48 hours * and at least one of the following signs of hemodynamic failure persisting for more than 48 hours: * Increased inotropic score * Hyperlactatemia \>3 mmol/l * Hepatic cytolysis: increase in AST and/or ALT by a factor of 3 or more after implantation * Degradation of renal function (AKIN grade 2: creatinine elevation \> 50% compared with before explantation and diuresis \< 0.5 ml/kg/24h for 12 hours) * Implantation of right temporary circulatory support (ECMO)
Time frame: 6 months
Platelet dysfunction
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Platelet dysfunction defined by a significant increase in circulating levels of p-selectin and glycocalicin between pre- and post-implantation
Time frame: 6 months
Post-operative transient or permanent ischemic attack
Track record of patients undergoing ischemic attack (between 24 hours and 6 months post-operative) as assessed per INTERMACS definition
Time frame: 6 months
Vascular endothelium dysfunction
Vascular endothelial dysfunction defined by a significant increase in circulating levels of syndecan, thrombomodulin, TFPI and PAI-1 between pre- and post-implantation
Time frame: 6 months
Prolonged systemic inflammatory reaction syndrome
Monthly measures of following circulating inflammatory factors : TNFα et β, NF kappab, TGF α /β1/β2,IFNγ et β, IL-1β, IL-1RA, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p40, IL12-P70, IL-17, IL17A et F,CX3CL1 (fractalkine),MCP-1(CCL2), MIP-1 (CCL3), MIP-1β(CCL4), MIP-3-beta (CCL19), 6Ckine(CCL21), MCD (CCL22) Myostatin, calveolin-1.
Time frame: 6 months
Evolution of immune responses
Monthly phenotyping of monocytes and T cells
Time frame: 6 months
Aortic valve fusion
Monthly echographic evaluation
Time frame: 6 months
Aortic valve insufficiency
Monthly echographic evaluation
Time frame: 6 months
Evaluation of cardiac recovery
Monthly exercise stress test evaluation (starting 2 months post-operative)
Time frame: 6 months