Lower Limb Surveillance During VA-ECLS

Study Overview
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Brief Summary
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Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower limb surveillance.

Detailed Description
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VA ECLS is used as a temporary circulatory support during cardiogenic shock and refractory cardiac arrest. Complications of VA ECLS include hemorrhagic, infectious and ischemic events. VA ECLS requires arterial and venous canules which are frequently positioned in the femoral artery and vein, which carries the risk of lower limb ischemia due to retrograde flow and obstruction of the femoral artery lumen. VA ischemia during VA ECLS is frequent (11-52%) and requires the use of reperfusion canula in the femoral common artery on VA ECLS implantation in a primary prevention strategy, before lower limb ischemia occurs. Even with this strategy, lower limb ischemia can occur due to arterial thrombosis, arterial spasm or insufficient blood flow through the reperfusion canula. Lower limb complications are prevented by monitoring of regional oxygen saturation, control of the reperfusion canula position (ultrasound, angiography) and rapid management when lower limb ischemia is suspected. There are no clear recommendations regarding prevention of lower limb complications during VA ECLS and arterial angiography has been described to diagnose ischemic events and evaluate the effectiveness of an intervention such as injection of vasodilators. This study is a prospective evaluation of a strategy to prevent lower limb complications during VA ECLS with a systematic arterial angiography on VA ECLS implantation and when lower limb ischemia is suspected (regional oxygen tissue saturation <50% or a differential >15% between both lower limbs) in addition to continuous NIRS monitoring of lower limbs during VA ECLS.

Official Title
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Lower Limb Surveillance During VA-ECLS: Evaluation of Angiography Through the Reperfusion Cannula at VA-ECMO Implantation and of Near Infrared Spectroscopy (NIRS) Monitoring

Conditions
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Cardiogenic Shock, Cardiac Arrest, Lower Limb Ischemia

Intervention / Treatment
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* Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Temporary circulatory support with VA ECLS Age > 18 years Exclusion Criteria: Pregnancy History of iodinated contrast allergy History of lower limb amputation above the ankle Lower limb ischemia before starting of VA-ECLS Femoro-axillary VA-ECLS Absence of the lower limb reperfusion canula

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VA ECMO<br>Patients under VA-ECMO with a femoral reperfusion cannula. | Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring<br>* Data collection only (lower limb angiography, lower limbs NIRS values).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe limb ischemia | Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality rate | 28 days and 60 days | 
| Incidence of ischemia of the lower limb during ICU stay | StO2 < 50% during 4 consecutive minutes AND/OR StO2 differential > 15% during ICU stay | 2 months | 
| Incidence of renal replacement therapy during ICU stay | Number of patients who underwent renal replacement therapy | 2 months | 
| Duration of ICU stay | Number of days in the ICU | 60 days | 
| Duration of hospital stay | Number of days in the hospital | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VA-ECMO, VA-ECLS, Near-Infrared Spectroscopy (NIRS)