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.
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).
Dobutamine > 10 ug/kg/min x 15 minutes or
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
Single group
Protek Solo Transseptal Cannula
DeviceThe Protek Solo Transseptal Cannula ECMO cannula will be placed from the right femoral vein and the drainage cannula will be placed from either the left femoral vein or the right internal jugular vein.
Survival until transplant
Number of subjects to survive between placement of cannula and lung transplant.
Number of subjects to experience adverse events
Adverse events are defined as: death, major bleeding, failure to achieve left atrium access, device migration and stroke.
Extra-corporeal membrane oxygenation (ECMO) support
Number of days after transplant on ECMO support
Dialysis
Number of subjects who need dialysis after transplant
Hospital Discharge
Number of patients that are successfully discharged from the hospital
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