Safety and feasibility of the eLym™ system for interstitial decongestion in acute decompensated heart failure: primary results of the DELTA-HF trial

作者：Jorge Nuche, María Dolores García‐Cosío Carmena, Jan Biegus, Zviad Kereselidze, Archil Chukhrukidze, George Khabeishvili, Nikoloz Shaburishvili, J N Julio Nunez, Gema Miñana, Ignacio J. Amat‐Santos, J Sáinz López, Dan Haberman, Scott McKane, Sergio Shkurovich, Jill Amstutz, George Bakris, G Michael Felker, Michael Jonas, A Lala, JoAnn Lindenfeld, P P Piotr Ponikowski, Xavier Carillo Suarez, Antoni Bayés‐Genís, William T. Abraham · 发表于：European Journal of Heart Failure · 年份：2026 · DOI：10.1093/ejhf/xuag157 · 被引用次数：3 · 研究领域：Lymphatic System and Diseases、Lymphatic Disorders and Treatments、Pleural and Pulmonary Diseases

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 cau...