Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort I: Veno-arterial Extracorporeal Membrane Oxygenation (PLUTO-I)

Study Overview
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Brief Summary
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Invasive pressure-volume (PV) loop measurements have the potential to confirm or refute earlier computer simulations and animal studies regarding changes in cardiovascular physiology induced by (veno-arterial) ECMO. PV loop analysis could create a framework for the (ICU-) clinician for VA-ECMO weaning guidance, based on a patient's individual hemodynamic profile. PV loop measurements may, in future, serve as a guide for which patient would benefit most from (prolonged) VA-ECMO support or which patient would require additional LV unloading. Within the context of PLUTO-I, patients on VA-ECMO support who are eligible for weaning from VA-ECMO will undergo biventricular PV loop measurements on different intensities of extracorporeal support.

Detailed Description
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Using VA-ECMO support, physiological stability can be maintained in patients with refractory hemodynamic failure as bridge to recovery, definitive therapy or decision making. Previous animal studies and computer simulations hypothesize increased LV afterload as well as RV distention during VA-ECMO. Decision making concerning VA-ECMO weaning is largely based on bedside hemodynamic (including echocardiographic) parameters. Profound details of the effects of VA-ECMO on elemental cardiac physiology, including myocardial metabolic efficiency and ventricular-arterial coupling, are limited. We hypothesize biventricular pressure-volume loop (PVL) measurement will enhance understanding of elemental cardiovascular physiology including ventricular interdependence during different levels of VA-ECMO support. PVL measurement will hypothetically provide opportunities in discovering novel predictors for successful weaning from VA-ECMO support. For the purpose of PLUTO-I, patients on VA-ECMO who are eligible to wean will undergo invasive PV-loop measurements on different intensities of extracorporeal flow.

Official Title
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Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort I: Veno-arterial Extracorporeal Membrane Oxygenation (PLUTO-I)

Conditions
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Extracorporeal Membrane Oxygenation, Cardio/Pulm: Heart Failure

Intervention / Treatment
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* Other: Pressure-volume loop measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - On VA-ECMO support for any indication Exclusion Criteria: Age < 18 years Re-initiation of VA-ECMO during the same ICU admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational arm<br>Patients on VA-ECMO, eligible for weaning | Other: Pressure-volume loop measurements<br>* Pressure-volume loop measurements using a conductance catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Work in mmHg/mL | The energy necessary for the myocardium to propel blood in the ventricle. Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Potential Energy in mmHg/mL | The (unused) energy stored in the myocardium following systole. Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Pressure-Volume Area in mmHg/mL | The net metabolic demand of the myocardium throughout the cardiac cycle. Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Volume in mL | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Cardiac Output | By thermodilution, using pulmonary artery catheterization | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Preload recruitable stroke work in mmHg/mL | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Tau in ms | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Systolic and diastolic intraventricular dyssynchrony in % | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Minimal and maximal dP/dt in mmHg/s | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Arterial elastance (Ea) and end-systolic elastance (Ees) in mmHg/mL | Expressed by PV-loop reconstructions based on conductance catheter measurements (following application of concerning single-beat algorithms) | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| End-diastolic and end-systolic pressure in mmHg | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| End-diastolic and end-systolic volume in mL | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| Starling Contractile Index in mmHg/mL | Expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| V0, V15, V30 and V100 in mL | I.e. ventricular volume at 0, 15, 30 and 100 mmHg, expressed by PV-loop reconstructions based on conductance catheter measurements. | Perprocedural (i.e. when ECMO flow is decreased from maximal to minimal L/min) | 
| All-cause mortality | Mortality, irrespective of etiology | Within 30 days after study measurements | 
| Successful weaning from VA-ECMO | A state of persistent hemodynamic stability without the necessity for re-initiation of VA-ECMO support within 48 hours after termination of VA-ECMO support as well as survival at least 48 hours after decannulation | 48 hours after study measurements | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure-volume loop, Cardiac mechanoenergetics