Hypotension Clinical Trial
Official title:
Vasoplegia During VA-ECMO for Refractory Cardiogenic Shock : Descriptive Analysis of a Retrospective Cohort
The cardiogenic shock is characterized by an alteration of organs function following a
decrease in cardiac output linked to an impairment of cardiac performance. The prognosis
remains poor with mortality between 40 and 50%. Nowadays, Extracorporeal Life Support (ECLS
or VA-ECMO) is the referent therapy to restore blood flow in the body when medical treatment
is not sufficient. Despite a good blood flow provided by the ECLS, many patients develop a
severe hypotension (so called vasoplegia) due to a loss of vascular resistance mainly
explained by the inflammatory response to shock and extracorporeal circulation. The treatment
of this reaction includes vasopressors (Norepinephrine in usual care) and serum surrogate
perfusion to achieve a mean arterial pressure (MAP) above 65 mmHg.
The purpose of this study is to describe the patients with vasoplegia among a retrospective
cohort of patients treated with an ECLS in our university center, over the 4 last years, to
determine major complication rate (including death, kidney failure and arrythmias) and their
outcome. This study will provide consistent data useful for further trials about targets of
pressure and treatments to increase blood pressure during ECLS.
Cardiogenic shock is characterized by global tissue hypoperfusion following a decrease in
cardiac output by impairing myocardial performance in the absence of hypovolemia. This
life-threatening hypoperfusion quickly leads to multiple organs dysfunction with a high risk
of cardiac arrest. The main cause is ischemic. The prognosis remains poor with mortality
between 40 and 50% and depends on the speed of care by a specialized team. Early etiologic
treatment is essential, but initial symptomatic management is based on catecholamines, mainly
norepinephrine and dobutamine. The intra-aortic balloon pump showed no improvement in
survival in large randomized studies. Refractory cardiogenic shock is defined by the
inefficiency or intolerance of catecholamines and the indication of temporary circulatory
support should be considered as soon as possible in the absence of contraindications
(comorbidities, advanced age, therapeutic limitation). The veno-arterial extracorporeal
membrane oxygenation (VA-ECMO or ECLS) is the preferred circulatory assistance in this
indication because it provides an overall circulatory support up to 100% of the theoretical
cardiac output, with oxygenation, and is quickly implanted peripherally (surgical or
percutaneous cannulation of the femoral vein and the femoral artery). However, this
extracorporeal circulation also has disadvantages by opposing a major afterload to the
failing left ventricle and reducing or even abolishing the pulmonary circulation and blood
flow in the heart chambers. In addition, the interaction with the artificial surfaces and the
oxygenation membrane of the extracorporeal circuit contributes to the inflammatory response
already initiated as a result of low cardiac output, tissue hypoperfusion, mesenteric
ischemia and possibly myocardial infarction in case of acute coronary syndrome. This systemic
inflammatory response syndrome (SIRS) is similar to sepsis and its main clinical presentation
is a vascular dysfunction resulting in vasoplegia and capillary leak syndrome responsible for
relative hypovolemia and interstitial inflation.
Since the flow provided by the centrifugal pump is continuous, the blood pressure under
VA-ECMO presents low or no pulsatile waves and is better represented by the mean arterial
pressure (MAP). The ideal targets of MAP under VA-ECMO are controversial but it is widely
accepted that the MAP should not be less than 65mmHg as recommended in septic shock to
maintain an acceptable perfusion pressure and should not exceed 95mmHg to limit afterload.
Between these limits, the MAP must be individualized according to each situation
(hypertensive patient for example). In France, Norepinephrine is the first-line drug to
achieve this goal of MAP after correction of volemia, without dose limitation in the absence
of currently validated alternative, while resistance mechanisms can be activated, and its
efficiency may be limited in case of acidosis. Potential side effects are the occurrence of
atrial or ventricular arrhythmias, tachycardia, pro-inflammatory cytokine release,
immunosuppression, renal dysfunction.
Management of MAP and vasopressors under VA-ECMO is poorly described in the literature (5),
although Norepinephrine is widely used in routine practice. In particular, the investigators
do not know the frequency of use and Norepinephrine doses during ECMO-VA, as well as their
prognostic involvement. Vasoplegia during VA-ECMO is defined by a Norepinephrine dose greater
than 0.1µg/kg/min after a 500ml fluid challenge despite overall blood flow (ECMO + native
heart) greater than 2l/min/m2 or allowing to achieve 65% of ScvO2.
This cohort study aims to describe the vasoplegia observed during VA-ECMO, the Norepinephrine
treatment characteristics, complications and outcome. The primary end-point is the incidence
of a composite criteria of major complications including death, acute kidney injury and
arrythmias.
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