Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA-HF)
Biegus, Jan (Wroclaw Medical University)
Lindenfeld, JoAnn (Vanderbilt University Medical Center)
Felker, G. Michael (Duke University)
Bakris, George (University of Chicago Medicine)
Jonas, Michael (Hebrew University School of Medicine)
Lala, Anuradha (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica))
Kereselidze, Zviad (Tbilisi Heart Center)
Khabeishvili, George (Ilia State University)
Gogorishvili, Irakli (Israeli-Georgian Multiprofile Medical Center Healthycore Tbilisi)
Núñez, Julio (Hospital Clínic Universitari (València))
Bayés-Genís, Antoni (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Abraham, William T. (Ohio State University)

Data:	2025
Resum:	Aims: The interstitial space is the major compartment in which the excess fluid is located, forming peripheral congestion in acute decompensated heart failure (ADHF). The lymphatic system is responsible for the constant drainage of the compartment. In ADHF, the inefficiency of this system causes extravascular fluid accumulation, underscoring the crucial role of lymphatic system failure in ADHF's pathophysiology. The eLym™ System is a transcutaneous device designed to facilitate lymph drainage by creating a low-pressure zone in the thoracic duct area, theoretically allowing more efficient decompression of the lymphatic system. Methods and Results: The safety and feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure: DELTA-HF Study is a prospective, multicentre, single-arm study designed to evaluate the safety and feasibility of the WhiteSwell eLym™ System in the treatment of fluid overload in ADHF. A maximum of 50 subjects may be enrolled and undergo the treatment. Inclusion criteria include the presence of congestion, a home diuretic dose ≥80 mg furosemide (or equivalent) and elevated natriuretic peptides. The key exclusion criteria include anatomical abnormalities and the inability to undergo systemic anticoagulation. The study endpoints include the safety (short- and long-term) and feasibility of the procedure. Several congestion indexes will be prospectively assessed. Descriptive statistics will summarize the study results. The study was registered in clinicaltrial. gov (NCT05747196). Conclusions: The results of the DELTA-HF study will provide information about the safety and feasibility of the eLym™ System and will provide first-in-human clinical signals of its use in ADHF patients.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Acute heart failure ; Decongestion ; Lymphatic system
Publicat a:	ESC Heart Failure, Vol. 12 Núm. 3 (June 2025) , p. 1719-1726, ISSN 2055-5822

DOI: 10.1002/ehf2.15192
PMID: 39716986

8 p, 589.9 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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