Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension

Launched by MAYO CLINIC · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called trans-septal extra-corporeal membrane oxygenation (ECMO) to see if it can help patients with severe lung issues caused by pulmonary hypertension (high blood pressure in the lungs) and right heart failure. The main goal is to determine if this treatment can safely support patients while they wait for a lung transplant. The study is open to patients aged 18 and older who are on the lung transplant list and have specific types of pulmonary hypertension and right heart failure, which means their heart is struggling to pump effectively.

If you or a loved one qualify for this trial, you would receive ECMO, which is a machine that helps pump and oxygenate your blood, giving your heart and lungs a break while you prepare for a lung transplant. It's important to note that there are specific health criteria to be eligible, such as needing to show significant heart and lung challenges. Participants will be closely monitored throughout the trial to ensure their safety and well-being. If you have further questions about participation or the trial's details, talking with your healthcare team can provide more personalized information.

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Eligibility criteria

• • Inclusion Criteria
• Patients that are listed for lung transplantation and have:
• * PH defined as:
• • Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \< 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units
• • Group 3 PH is defined as the presence of chronic lung disease (CLD) and/or hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg.
• • Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).
• * Failing right ventricle function defined as:
• * a cardiac (CI) index \< 2.2 L/min/m\^2 despite continuous infusion of high dose inotropes defined as:
• * Inhaled nitric oxide \> 20 ppm and one of the following:
• • Dobutamine \> 10 ug/kg/min x 15 minutes or
• • Milrinone \> 0.5 ug/kg/min x 120 minutes or
• • Epinephrine \> 0.5 ug/kg/min x 15 minutes or
• * Norepinephrine \> 0.5 ug/kg/min x 15 minutes and have one of the following:
• • 1. central venous pressure (CVP) \> 15 mm Hg
• 2. global RV dysfunction on echocardiography defined as one of the following:
• • 1. a tricuspid annular plane systolic excursion score of \<14mm
• • 2. an RV diameter at base \>42mm
• • 3. RV short-axis or midcavity diameter \>35mm
• • Lactate greater than 3 mmol/L
• • Urine output \< 0.5 ml/kg/hour
• • Age \> 18 years old
• • BMI \<35
• • Informed consent signed by self or legally authorized representative.
• • Exclusion Criteria
• • INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
• • End organ failure defined as: hepatic total bilirubin \>5 mg/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine \>4 mg/dLbased on lab data within the 24 hours prior to transseptal ECMO initiation
• • Evidence of acute neurologic injury
• • Active infection defined as two of the following WBC \>12,500, positive blood culture, fever
• • RA thrombus
• • Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia
• • Right heart failure from isolated pulmonary embolism
• • Right heart failure from coronary artery disease or from left heart failure (WHO Type 2)
• • Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.