Safety and feasibility of the eLym™ 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