Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD

Inclusion criteria

• Age of 18 years and older.
• Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
• Primary hospitalization for acute decompensated chronic systolic heart failure.
• Potential LVAD candidate with:

a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan/sacubitril, aldosterone antagonist, SGLT2i, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days c) Known previous peak exercise oxygen consumption < 14 mL/Kg/min or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)

• Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
• At least one of the following two criteria:

• Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria -Central venous pressure > 16 mmHg

-Central venous pressure/Pulmonary wedge pressure >0.65

-Right ventricular stroke work index < 300 mmHg * ml/m2

-Pulmonary artery pulsatility index (PAPi) < 2,

• Worsening renal failure (WRF), defined for the purposes of this study as -Increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND

• eGFR** ≤ 30 ml/min/1.73 m2 based on serum creatinine at enrollment*** AND
• Cardiorenal syndrome is the most likely explanation for WRF AND
• Intolerant or inadequately responsive to standard of care diuretic therapy, defined as persistent signs and/or symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal net volume removal in a 24-hour period despite optimal medical therapy including intravenous diuretic therapy and an estimated need for >5kg fluid removal.

• Optimal intravenous diuretic therapy is defined as:

• Furosemide equivalent total daily dose of 240mg
• Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion
• A furosemide equivalent total daily dose <240mg if the dose has resulted in >3000 mL urine output/24 hours.
• PA catheter in place at the time of enrollment
• PCW ≥ 20 mmHg

• eGFR calculated using the CKD-EPI Creatinine Equation *** Recognizing that this is not a steady state creatinine

Exclusion criteria

• Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
• Prior sensitivity to dialysis device components
• Active bacteremia
• Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
• Metastatic malignancy requiring palliative chemo, biologic, or radiation
• Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine > 3 mcg/kg/min. (Note: use of vasodilating inotropes [i.e., dobutamine and milrinone] or dopamine at ≤ 3 mcg/kg/min will not preclude study inclusion)
• Patients requiring mechanical ventilatory support
• Patients requiring total parenteral nutrition during the treatment period
• Persistent SBP < 80 mmHg
• WBC < 4000 K/uL
• Platelets < 100,000K/uL
• Serum creatinine > 4 mg/dL or receiving dialysis / CRRT
• Acute coronary syndrome within the past month
• Women who are pregnant, breastfeeding a child, or trying to become pregnant
• Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
• Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and/or samples are taken (i.e., no test device or drug used) are allowed to participate.