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

Summary

The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.

Eligibility

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.

Conditions3

Locations1 site

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