Decongestion via novel thoracic duct decompression device for worsening HF feasible
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Key takeaways:
- A minimally invasive catheter-based system could reduce congestion in patients hospitalized with acute decompensated HF.
- The researchers reported no device-related adverse events.
Early data show that thoracic duct decompression with a novel catheter-based system on top of IV loop diuretics safely lowered congestion in patients with acute decompensated HF compared with diuretics alone.
The results of the DELTA-HF trial were presented at the Heart Failure Society of America Annual Scientific Meeting.
“What caused the light bulb to go off for developing a tool like this was the recognition that in decompensated HF patients, most of the fluid volume excess resides in the interstitial space. Our standard of care treatment is to use a diuretic which removes fluid only from the intravascular space,” William T. Abraham, MD, professor of medicine, physiology and cell biology at The Ohio State University Wexner Medical Center, told Healio. “We hope that that interstitial fluid sort of passively follows it, but the problem is that most of the time it doesn't, and we discharge patients from the hospital with residual edema with residual interstitial fluid and that is associated with high rates of post-discharge mortality and rehospitalization. The goal here was to develop a way through which we could simultaneously decongest both the interstitial and the intervascular compartment.
“The way we're exploring decongesting the interstitial space is leveraging the thoracic duct, the point at which the interstitial fluid drained from the lymphatic system in about 75% of the body enters the venous circulation,” Abraham said. “We could exploit that system to try to better decongest the interstitial space. In the setting of HF, because the central venous pressure is elevated, it abolishes the pressure gradient between the thoracic duct and the central venous pressure, so that it impairs lymphatic flow back into the circulation.”
The novel system (eLym, WhiteSwell) works by creating a low-pressure zone at the thoracic duct outlet using a catheter-based device. Abraham and colleagues assessed whether the device — on top of IV loop diuretics — could support return of interstitial fluid to the vascular compartment and more completely decongest patients while preserving kidney function compared with standard care.
For the concurrent control, early feasibility DELTA-HF trial, the researchers enrolled 15 patients with acute decompensated HF with signs and symptoms of congestion and baseline oral diuretic dose of furosemide 80 mg or more. Nine patients (mean age, 66 years; 67% men) had their congestion treated with the device, and the other six (mean age, 78 years; 67% men) received standard care including IV loop diuretics.
Average treatment time with the device was 24 hours and there were no procedural, device or therapy-related adverse events, according to the presentation.
Patients assigned to the device plus loop diuretics lost on average 6 kg from baseline to discharge compared with 3.3 kg in the standard care arm and maintained a stable or improved average creatinine (mean change, 0.1 mg/dL).
One patient in the device group was readmitted within 30 days of hospital discharge.
In addition, patient-reported outcomes on the Patient Global Assessment and Likert scales indicated more improvement in the device arm compared with standard care that was sustained out to 30 days. Kansas City Cardiomyopathy Questionnaire and EQ-5D scores showed improvement in both arms out to 30 days, according to the study.
“We demonstrated that [thoracic duct decompression with this device] was feasible and preliminarily safe. We saw no major or serious adverse events, and in terms of looking for signals of effectiveness, we demonstrated substantial increases in fluid removal,” Abraham told Healio. “Importantly, we also saw preservation or improvement in kidney function. The reason why that's important is that standard of care treatment of acute decompensated HF with diuretics alone often results in worsening renal function. The ability to preserve renal function while taking more fluid out of the body, if confirmed as we enroll more patients in this study and subsequently do larger pilot and pivotal trials, would be an incredibly exciting development in the treatment of acute decompensated HF.”
Reference:
- WhiteSwell announces successful treatment of acute decompensated heart failure patients in its early feasibility DELTA-HF study. https://www.businesswire.com/news/home/20231007188660/en/WhiteSwell-Announces-Successful-Treatment-of-Acute-Decompensated-Heart-Failure-Patients-in-its-Early-Feasibility-DELTA-HF-Study. Published Oct. 7, 2023. Accessed Oct. 9, 2023.
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Abraham WT, et al. Rapid fire oral abstracts: Emerging heart failure therapies. Presented at: The Heart Failure Society of America Annual Scientific Meeting; Oct. 6-9, 2023; Cleveland.
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