Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure
Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure
With this research the Investigators hope to learn if early aquapheresis in an outpatient
 setting will improve congestive heart failure symptoms in outpatients with decompensated
 heart failure who have been refractory to high dose diuretics. In previous trials in
 inpatient settings, aquapheresis has been demonstrated to improve quality of life and reduce
 hospital visits for those who have undergone the treatment. This study is one of the first to
 evaluate the effectiveness of aquapheresis in veterans with congestive heart failure in an
 outpatient setting.

 The aquapheresis device, Aquadex FlexFlow® System, manufactured by CHF Solutions™,
 Minneapolis, MN, has been approved by the Food and Drug Administration (FDA) for removing
 excess sodium and fluid from patients suffering from volume overload, like in congestive
 heart failure.
Congestive heart failure (CHF) affects nearly 2% of the U.S. population, with almost 1
 million hospital admissions for acute decompensated CHF annually. Congestive heart failure is
 the most frequent cause of hospitalization in patients over the age of 65. Patients admitted
 for acute decompensated heart failure (ADHF) have a high 6-month readmission rate for acute
 CHF, ranging from 23% to 40% in different studies. It is estimated that 25 to 30% of these
 patients are diuretic resistant with 50% of patients losing less than 5 lbs. from admission
 weight and 20% actually gaining weight during the hospitalization.

 Although loop diuretics have not been shown to improve survival in patients with CHF, they
 effectively alleviate symptoms of congestion. Diuretics have been part of standard CHF
 therapy in all recent survival trials of β-blockers, angiotensin converting enzyme
 inhibitors, and angiotensin II receptor blockers. Loop diuretics have been shown to be the
 most effective diuretics as single agents in moderate to severe heart failure. However, loop
 diuretics may be associated with increased morbidity and mortality attributable to
 deleterious effects on neurohormonal activation, electrolyte balance, and cardiac and renal
 function.

 Removal of excessive fluid in patients with CHF is usually achieved by a combination of fluid
 and salt restriction and loop diuretics, but in some cases volume overload persists. Diuretic
 resistance is common, especially after chronic exposure to loop diuretics; patients require
 escalating doses (PO or IV to bypass delayed absorption in gut due to bowel edema), addition
 of another diuretic that works on different part of renal tubules (i.e. Thiazides) +/-
 diuretic drip and, if still refractory, ultimately Aquapheresis (a form of ultrafiltration).

 Aquapheresis (AQ) compared to IV diuretics in the UNLOAD Trial (10), AQ safely produced
 greater weight loss, fluid removal, and reduction in 90-day readmission rate compared to IV
 diuretic. A meta-analysis of 10 randomized control trials (RCTs) showed AQ not only to be
 effective but safe. These observations suggest that a strategy of early ultrafiltration may
 improve responsiveness to diuretics, quicker weight loss, decrease hospitalization,
 readmission to hospital, ER or doctor visits with minimal risks. As result of these trials,
 American Hospital Association (AHA)/American College of Cardiology (ACC)/Heart Failure
 Society of American (HFSA) guidelines state it is reasonable to start Aquapheresis in
 patients with obvious volume overload or patients who are refractory to high dose diuretics
 (IIa, LOE B). Moreover, while this therapy is part of standard of care in an inpatient
 setting, many hospitals as a result of Affordable Care Act (ACA), have taken to AQ on an
 outpatient setting to further decrease the burden and attended cost associated with
 management of CHF. But the Investigators are unaware of any other prospective outpatient
 studies that have looked at the outcomes and cost effectiveness of aquapheresis.
Inclusion Criteria:

 Subjects must be 18 years of age or older already on standard of care therapy including
 Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin

 Receptor Blockers (ARBs), Sacubitril/Valsartan, beta-blocker, oral diuretic (80 mg Lasix/2
 mg Bumex/40 mg Torsemide+/-Thiazide diuretic), and meet the following inclusion criteria to
 be enrolled:

 Inclusion Criteria:

 1. CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide)

 2. Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the
 following:

 1. Elevated BNP (>100)

 2. Paroxysmal nocturnal dyspnea or orthopnea

 3. Elevated jugular venous distention (>/ 7 cm)

 4. X-ray findings consisted with CHF

 5. Presence of ascites or LE edema . -

 Exclusion Criteria:

 1. Acute Coronary Syndrome

 2. Hypertensive urgency or emergency

 3. Rapid atrial fibrillation difficult to control

 4. Contraindication to anticoagulation

 5. Pregnancy

 6. Requires hemodialysis (> CR > 3.0 mg/dl)

 7. Symptomatic hypotension

 8. Poor venous access

 9. Pressor dependent. -