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DELTA-HF trial: Device-based thoracic duct decompression with the eLym system could prove beneficial in acute decompensated heart failure patients.
Results of the DELTA-HF trial suggest device-based thoracic duct decompression could help reduce congestion in patients with acute decompensated heart failure.
A look at results from 14 hospitalized patients included in the ongoing DELTA-HF trial, results, which were presented at the Heart Failure Society of America (HFSA) 2023 Annual Scientific Meeting, suggest use of the eLym System was safe and well tolerated, with further analysis indicating notable improvements in both body weight and patient-reported outcomes.1
“It cannot be overemphasized how significant and challenging it is to fully decongest patients hospitalized with decompensated heart failure. Patients with persistent congestion at discharge are more likely to be rehospitalized, are less likely to be treated with optimal medical therapy and are at greater risk of poor outcomes. Most of the fluid accumulates in the tissues, and we have not previously had a way to actively target that fluid,” said William Abraham, MD, professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center.2 “WhiteSwell’s ingenious approach of reducing thoracic duct pressure to facilitate lymphatic drainage of the tissues enables us to actively address both interstitial tissue and intravascular decongestion simultaneously. I’m particularly encouraged by the amount of decongestion achieved with stable or improved creatinine, an indicator of kidney function.”
Developed and marketed by WhiteSwell, the eLym System is designed to create a low pressure zone at the thoracic duct outflow to support the drainage capabilities of the lymphatic system, which could help alleviate excess fluid in patients with acute decompensated heart failure who are using diuretic therapy. An open-label trial designed to test the safety and feasibility of the eLym System, DELTA-HF was designed to provide insight into acute device safety, chronic device safety, and primary performance outcomes.1,2
A total of 15 patients have been enrolled in the trial. This group had a mean age of 70 (Standard Deviation [SD], 10) years at baseline and 67% were men. When examining disease characteristics at baseline, the mean left ventricular ejection fruition was 34% (SD, 11), 47% had an ischemic etiology, the mean NT-proBNP level was 5184 (SD, 4782) pg/L, and the mean creatinine level was 1.1 (SD, 0.4) mg/dL.1
Among the 15 patients included, 9 had the device placed and activated. This cohort had a mean treatment time of 24 hours. Investigators highlighted there were no serious procedure-, device-, or therapy-related adverse events in this group.1
Further analysis revealed those who underwent device thruway with a loop diuretic lost a mean of 6.0 (SD, 4.6) kg from baseline to discharge, without a notable change in creatinine (mean Δ, -0.10 [SD, 0.12] mg/dL). In contrast, the loop diuretic-only group lost a mean of 3.3 (SD, 3.7) kg from baseline to discharge.1
Analysis of Patient Global and Likert Scale of Perceived Dyspnea responses indicated more 50% of patients treated with loop diuretics alone described their improvement as marked. Investigators pointed out 1 of the 9 patients was hospitalized for UTI and heart failure within 30 days of discharge.1
“This is a new approach, and we are excited to investigate WhiteSwell’s catheter-based system,” said Zviad Kereselidze, MD, head of the ICCU at Tbilisi Heart Center.2 “We have treated some of our most challenging patients who are frequently hospitalized with congestion, and we have been pleasantly surprised with how well they have decongested at the time of discharge and how the benefit was sustained at 30-day follow-up.”