Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF)
Abstract 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 ca...
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| Format: | Article |
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Wiley
2025-06-01
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| Series: | ESC Heart Failure |
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| Online Access: | https://doi.org/10.1002/ehf2.15192 |
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| author | Jan Biegus JoAnn Lindenfeld G. Michael Felker George Bakris Michael Jonas Anuradha Lala Zviad Kereselidze George Khabeishvili Irakli Gogorishvili Julio Núñez Antoni Bayés‐Genís Piotr Ponikowski William T. Abraham |
| author_facet | Jan Biegus JoAnn Lindenfeld G. Michael Felker George Bakris Michael Jonas Anuradha Lala Zviad Kereselidze George Khabeishvili Irakli Gogorishvili Julio Núñez Antoni Bayés‐Genís Piotr Ponikowski William T. Abraham |
| author_sort | Jan Biegus |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-7ff46efa62b84b68883a799d9b437e98 |
| institution | DOAJ |
| issn | 2055-5822 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj-art-7ff46efa62b84b68883a799d9b437e982025-08-20T03:11:21ZengWileyESC Heart Failure2055-58222025-06-011231719172610.1002/ehf2.15192Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF)Jan Biegus0JoAnn Lindenfeld1G. Michael Felker2George Bakris3Michael Jonas4Anuradha Lala5Zviad Kereselidze6George Khabeishvili7Irakli Gogorishvili8Julio Núñez9Antoni Bayés‐Genís10Piotr Ponikowski11William T. Abraham12Institute of Heart Diseases Wroclaw Medical University Wrocław PolandVanderbilt Heart and Vascular Institute Vanderbilt University Medical Center Nashville Tennessee USADuke Clinical Research Institute Duke University Durham North Carolina USADepartment of Medicine University of Chicago Medicine Chicago Illinois USADepartment of Cardiology, Kaplan Medical Center Hebrew University School of Medicine Rehovot IsraelZena and Michael A. Wiener Cardiovascular Institute, Department of Population Health Science and Policy Icahn School of Medicine at Mount Sinai New York New York USATbilisi Heart Center Tbilisi GeorgiaTbilisi Heart and Vascular Clinic Ilia State University Tbilisi GeorgiaIsraeli–Georgian Multiprofile Medical Center Healthycore Tbilisi Tbilisi GeorgiaCardiology Department Hospital Clínico Universitario de Valencia Valencia SpainHeart Institute Hospital Universitari Germans Trias i Pujol, CIBERCV Badalona SpainInstitute of Heart Diseases Wroclaw Medical University Wrocław PolandDivision of Cardiovascular Medicine Ohio State University Columbus Ohio USAAbstract 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.https://doi.org/10.1002/ehf2.15192acute heart failuredecongestionlymphatic system |
| spellingShingle | Jan Biegus JoAnn Lindenfeld G. Michael Felker George Bakris Michael Jonas Anuradha Lala Zviad Kereselidze George Khabeishvili Irakli Gogorishvili Julio Núñez Antoni Bayés‐Genís Piotr Ponikowski William T. Abraham Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) ESC Heart Failure acute heart failure decongestion lymphatic system |
| title | Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) |
| title_full | Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) |
| title_fullStr | Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) |
| title_full_unstemmed | Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) |
| title_short | Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA‐HF) |
| title_sort | design and rationale of the elym™ system for decompensation of excess lymphatic fluid via the thoracic duct in acute heart failure delta hf |
| topic | acute heart failure decongestion lymphatic system |
| url | https://doi.org/10.1002/ehf2.15192 |
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