The Safety and Feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid Via the Thoracic Duct in Acute Decompensated Heart Failure
The goal of this feasibility study is to evaluated the safety and performance of the WhiteSwell eLym System in the treatment of fluid overload or congestion in adult patients with Acute Decompensated Heart Failure (ADHF). The main question\[s\] it aims to answer are: * Acute device safety (30 days) * Chronic device safety (31-180 days) * Primary performance Outcomes (Technical success and patient treatment outcomes) Participants who are hospitalized for ADHF will be screened for treatment with the eLym System. The System, placed in a heart catheterization laboratory, will be temporarily placed for up to 72 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 90- and 180-days.
• Age ≥ 18 years
• Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
• Subjects receiving intravenous (IV) diuretic for decompensated heart failure and demonstrating fluid overload. This includes peripheral edema ≥2+ (on a 0 to 4+ scale) and a minimum of 1 of the following:
‣ Jugular venous distension ≥10 cm H20;
⁃ Pulmonary edema as determined by auscultation or imaging;
⁃ Hepatojugular reflux;
⁃ Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea;
⁃ Dyspnea at rest with respiration rate ≥20 per minute.
• Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent
• Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2
• Subject must meet on one of the following criteria:
‣ Subject has had a heart failure hospitalization or worsening of heart failure event requiring IV diuretic therapy (in hospital, emergency room, urgent care, or HF clinic) within the previous 6 months;
⁃ Renal function as measured by eGFR ≥20 and ≤45 ml/min/1.73m2;
⁃ At initial HF admission, \<600 ml of urine output within 6 hours of initial IV bolus or urine sodium of \<50 mmol/L at 1-2 hours after initial IV diuretic dose.
• Elevated N-Terminal (NT) Pro B-type Natriuretic Peptide (BNP) or BNP:
‣ NT Pro BNP \>1000 pg/ml (\>1500 for subjects with atrial fibrillation);
⁃ BNP \>250 pg/ml (\>375 for subjects with atrial fibrillation).
• Albumin \>2.5 g/dL
• Subject must be able to have device placement procedure within 96 hours of presentation to the hospital and still be demonstrating fluid overload at the time of device placement
⁃ Subject willing and able to complete study assessments and agrees to comply with all follow-up evaluations
⁃ Subject has provided written informed consent