Lower Limb Surveillance During VA-ECLS

Central Hospital, Nancy, France

Status: Completed

Conditions: Lower Limb Ischemia; Cardiogenic Shock; Cardiac Arrest

Treatments: Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03910062

PSS2018/MIRECMO-KOSZUTSKI/YB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

VA ECMO

Description:

Patients under VA-ECMO with a femoral reperfusion cannula.

Treatment:

Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring