Acute Limb Ischemia, Acute Myocardial Infarction of Inferior Wall, Cardiogenic Shock, Congestive Heart Failure, Myocarditis
Conditions
Keywords
Cardiogenic Shock, Distal perfusion catherter, Acute Myocardial Infarction, Congestive Heart Failure, Limb ischemia
Brief summary
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine distal perfusion catheter (DPC) insertion versus provisional distal perfusion catheter (DPC) insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing mechanical circulatory support (MCS) through femoral artery approach.
Detailed description
Acute limb ischemia is a well-recognized vascular complication following peripheral mechanical circulatory support (MCS) including veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or a percutaneous microaxial ventricular assist device (Impella) via femoral arterial cannulation, with reported incidence rates ranging up to 10-30% of patients. Distal perfusion catheter (DPC) has been introduced as a strategy to restore antegrade flow distal to the femoral arterial cannula, aiming to mitigate ischemic complications by augmenting perfusion through antegrade flow into the superficial femoral artery. Current practice guidance from the Extracorporeal Life Support Organization (ELSO) supports the use of ipsilateral DPC placement at the time of peripheral VA-ECMO cannulation to reduce the risk of limb ischemia and recommends monitoring for adequate flow using Doppler or near-infrared spectroscopy (NIRS). However, these recommendations are predominantly based on observational studies and expert consensus, and do not stem from randomized controlled trial evidence. Current expert consensus and related guidelines describe that routine prophylactic DPC insertion should be considered in patients undergoing VA-ECMO as Class IIa (Level of evidence B) recommendation. Several observational cohort studies have associated routine prophylactic DPC with reduced limb ischemia compared with no DPC placement, yet these are limited by confounding bias and variability in clinical practice patterns. Retrospective data suggested that delayed or rescue insertion after onset of limb ischemia may be less effective at preventing major ischemic sequelae than earlier DPC insertion strategies. Given the absence of robust evidence from randomized controlled trial, it remains uncertain whether a strategy of routine prophylactic DPC insertion would be superior over a provisional DPC insertion guided by clinical monitoring in terms of limb ischemia reduction, limb-related morbidity, duration of MCS, and other clinical outcomes including in-hospital mortality. In this regard, Routine versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support (PERFUSE-MCS) trial was designed to compare clinical outcomes between routine DPC insertion versus provisional DPC insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing MCS through femoral artery approach.
Interventions
PROCEDUREDistal perfusion catheter insertion
Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.
Sponsors
Samsung Medical Center
Korea University Anam Hospital
Gyeongsang National University Changwon Hospital
Samsung Changwon Hospital
Eunpyeong St. Mary's Hospital
Kwandong University Intl. ST. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Clinical events will be independently adjudicated by Clinical Event Adjudication Committee whose members are blinded to the assignmet groups.
Intervention model description
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine DPC insertion versus provisional DPC insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing MCS through femoral artery approach.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 years old * Cardiogenic shock requiring mechanical circulatory support through femoral artery approach * Subject who can verbally confirm understandings of risks and benefits of receiving distal perfusion catheter insertion and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Under the critically-ill clinical circumstance (unclear consciousness of patient), legally authorized representative can provide written informed consent prior to any study related procedure.
Exclusion criteria
* Apparent symptoms and sign of acute limb ischemia immediately after mechanical circulatory support insertion * Significant coagulopathy precluding invasive procedure due to high risk of bleeding * Pregnant women, women with potential childbearing, or lactating women * Irreversible limb ischemia requiring interventional procedures or surgery at the time of MCS insertion * Previous history if femoral-femoral bypass grafting or femoral-popliteal bypass grafting * Previous history of limb amputation * Unwilling or unable to obtain informed consent from the participant or legally authorized representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major limb ischemia requiring intervention | within 30 days from randomization | Major limb ischemia requiring intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | within 90 days from randomization | Time to all-cause mortality |
| Cardiovascular mortality | within 90 days from randomization | Time to cardiovascular mortality |
| Successful weaning of mechanical circulatory device | within 90 days from randomization | Successful weaning of mechanical circulatory device |
| Bleeding | within 90 days from randomization | Bleeding defined by BARC type 2,3, or 5 |
| Systemic thromboembolism other than stroke during MCS | within 90 days from randomization | Systemic thromboembolism other than stroke during MCS |
| Cerebrovascular accidents | within 90 days from randomization | Cerebrovascular accidents (ischemic stroke or hemorrhagic stroke) |
| Rates of renal replacement therapy during index hospitalization | within 30 days from randomization | Rates of renal replacement therapy during index hospitalization |
| Duration of MCS during index hospitalization | within 30 days from randomization | Duration of MCS during index hospitalization |
| Duration of hospital stay during index hospitalization | within 30 days from randomization | Duration of hospital stay during index hospitalization |
| Duration of mechanical ventilation during index hospitalization | within 30 days from randomization | Duration of mechanical ventilation during index hospitalization |
Countries
South Korea
Contacts
CONTACTJoo Myung Lee, MD, MPH, PhD
CONTACTJeong Hoon Yang, MD, PhD
PRINCIPAL_INVESTIGATORJeong Hoon Yang, MD, PhD
Samsung Medical Center
Outcome results
None listed