Biegus Jan, Lindenfeld JoAnn, Felker G Michael, Bakris George, Jonas Michael, Lala Anuradha, Kereselidze Zviad, Khabeishvili George, Gogorishvili Irakli, Núñez Julio, Bayés-Genís Antoni, Ponikowski Piotr, Abraham William T
Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland.
Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
ESC Heart Fail. 2025 Jun;12(3):1719-1726. doi: 10.1002/ehf2.15192. Epub 2024 Dec 24.
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.
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).
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.
组织间隙是多余液体积聚的主要腔隙，在急性失代偿性心力衰竭（ADHF）中形成外周充血。淋巴系统负责该腔隙的持续引流。在ADHF中，该系统功能不足会导致血管外液体积聚，这突出了淋巴系统功能衰竭在ADHF病理生理学中的关键作用。eLym™系统是一种经皮装置，旨在通过在胸导管区域创建一个低压区来促进淋巴引流，理论上可使淋巴系统更有效地减压。
急性失代偿性心力衰竭经胸导管使用eLym™系统消除多余淋巴液的安全性和可行性：DELTA-HF研究是一项前瞻性、多中心、单臂研究，旨在评估WhiteSwell eLym™系统治疗ADHF液体超负荷的安全性和可行性。最多可招募50名受试者并接受治疗。纳入标准包括存在充血、家庭利尿剂剂量≥80mg呋塞米（或等效药物）和利钠肽升高。关键排除标准包括解剖学异常和无法进行全身抗凝。研究终点包括该操作的安全性（短期和长期）和可行性。将前瞻性评估几个充血指数。描述性统计将总结研究结果。该研究已在clinicaltrial.gov（NCT05747196）注册。
DELTA-HF研究的结果将提供有关eLym™系统安全性和可行性的信息，并将提供其在ADHF患者中应用的首例人体临床信号。
