New Device Clears Fluid Buildup in Heart Failure Patients Better Than Diuretics Alone
A clinical trial shows an implantable pump that drains fluid through the lymphatic system reduced congestion symptoms in hospitalized heart failure patients—a stubborn problem that standard diuretics often fail to solve. The finding could reshape treatment protocols and reduce costly hospital readmissions, a major cost driver in cardiology.
Originaltitel: Safety and Feasibility of the eLymTM System for Interstitial Decongestion in Acute Decompensated Heart Failure: Primary results of the DELTA-HF trial
BACKGROUND: Persistent congestion at discharge is associated with worse outcomes in acute decompensated heart failure (ADHF), with impaired lymphatic function contributing to difficult-to-target tissue and organ congestion. METHODS: The safety and effectiveness of the eLym System in ADHF was evaluated in the multicenter, single-arm DELTA-HF trial. A localized reduced-pressure zone at the venous angle was created in 40 patients using an endovenous axial pump to support lymph drainage through the thoracic duct. RESULTS: Forty patients with ADHF (32.5% female, 71±11 years) received therapy. Patients had a median of 2 hospitalizations in the prior 6 months. All were on home daily loop diuretic dose equivalent to ≥80 mg furosemide. Device deployment was successful in all cases (therapy time: 23.1±7.3 hours). Weight decreased by 3.6±2.4 kg during eLym therapy and by 6.8±3.4 kg at discharge. Median modified EVEREST Clinical Congestion Score improved from 5.0 (4.0-6.0) to 2.0 (1.0-4.0) after eLym treatment and to 0 (0-1.0) by discharge, remaining stable through 6 months (change from baseline p-values <0.0001). Serum creatinine remained stable acutely and through 6-months. Freedom from device- or procedure-related serious adverse events was 95%. One patient had a vascular complication causing mediastinal hematoma and death; another required inotropes due to hypotension. At 6 months, two patients experienced three HF hospitalizations and five patients died: four from cardiovascular causes; one from urosepsis. CONCLUSIONS: eLym therapy in ADHF appeared to be safe, with early data suggesting effective, durable decongestion and a low 6-month rehospitalization rate. Randomized controlled trials evaluating eLym therapy are warranted.