Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Distal perfusion catheter insertion.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure, Myocarditis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Distal perfusion catheter insertion
Distal perfusion catheter insertion under fluoroscopy or ultrasouond guidance in ipsilateral femoral artery to prevent limb ischemia.
Primary outcome measures
- Major limb ischemia requiring intervention [Time frame: within 30 days from randomization]
Secondary outcome measures (10)
- All-cause mortality [Time frame: within 90 days from randomization]
- Cardiovascular mortality [Time frame: within 90 days from randomization]
- Successful weaning of mechanical circulatory device [Time frame: within 90 days from randomization]
- Bleeding [Time frame: within 90 days from randomization]
- Systemic thromboembolism other than stroke during MCS [Time frame: within 90 days from randomization]
- Cerebrovascular accidents [Time frame: within 90 days from randomization]
- Rates of renal replacement therapy during index hospitalization [Time frame: within 30 days from randomization]
- Duration of MCS during index hospitalization [Time frame: within 30 days from randomization]
- Duration of hospital stay during index hospitalization [Time frame: within 30 days from randomization]
- Duration of mechanical ventilation during index hospitalization [Time frame: within 30 days from randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 6 centers
- Gyeongsang National University Changwon Hospital — Changwon
- Samsung Medical Center Changwon Hospital — Changwon
- Kwandong University Intl. ST. Mary's Hospital — Incheon
- Samsung Medical Center — Seoul
- Eunpyeong St. Mary's Hospital — Seoul
- Korea University Anam Hospital — Seoul
Identifiers
NCT: NCT07482865 · SMC0108884119023