Device to treat acute decompensated heart failure feasible, safe in first-in-human study
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Key takeaways:
- Device-based thoracic duct decompression reduced congestion safely in patients with acute decompensated heart failure.
- The device targets congestion from the interstitial space, which diuretics mostly do not.
Among patients with acute decompensated heart failure, device-based thoracic duct decompression demonstrated the ability to reduce congestion safely, according to results of a first-in-human study.
“We have made little or no progress over the past several decades, frankly since the advent of diuretic therapies, to treat acute decompensated heart failure (ADHF),” William T. Abraham, MD, FACP, FACC, FAHA, FESC, FRCPE, professor of medicine, physiology and cell biology and a College of Medicine Distinguished Professor in the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, told Healio. “We have seen many failed trials evaluating the pharmacological treatment of ADHF. This has created a large unmet need and set the stage for device development for the treatment of ADHF.”
Abraham presented 30-day, 90-day and 6-month results from the first nine patients of the DELTA-HF trial of thoracic duct decompression with a novel catheter-based system (eLym, WhiteSwell) on top of IV loop diuretics, as well as some early effectiveness data, at the Technology and Heart Failure Therapeutics (THT) annual meeting.
“When I first heard about the concept behind the development of this device, it was one of those ‘lightbulb going off’ moments,” Abraham told Healio. “This device targets the interstitial space for decongestion, resulting in simultaneous or concurrent emptying of the interstitial and intravascular spaces using the WhiteSwell eLym system along with diuretic therapy, with the goal of more adequately and efficiently decongesting the patient. The ‘lightbulb moment’ was appreciating that in decompensated heart failure, as in health, most of the fluid resides in the interstitial space. Very little of the volume expansion in heart failure is in the intravascular space. Yet diuretic therapy alone only passively addresses the interstitial fluid. The goal of the eLym system is to deliver a therapy called thoracic duct decompression for interstitial decongestion. That means lowering the local intravascular venous pressure around the region in which the thoracic duct empties into the venous circulation, and that’s at the left venous angle. In doing so, it restores a normal pressure gradient between the thoracic duct and the venous circulation and allows better emptying of lymphatic fluid into the venous circulation, where it then can be removed from the body via the kidneys using standard diuretic therapy.”
Among the first nine patients in the DELTA-HF trial, the mean age was 66 years and 67% were men. The technical success rate was 100% in terms of deployment, activation and removal of the eLym system.
In eight patients, there were no serious adverse events. The ninth “developed transient hypotension, which was treated with short-term use of dobutamine without any sequelae,” Abraham told Healio.
Mean weight loss between baseline and discharge was –5.9 kg, whereas level of daily diuretic use during the procedure was no different from outpatient levels (outpatient, 131 mg; procedure, 125 mg), Abraham said during the presentation.
Kidney function remained stable during and after the procedure, Abraham told Healio. At baseline, mean creatinine was 1.14 mg/dL, at the end of treatment and at discharge, it was 1.11 mg/dL, and at 30 days it was 1.13 mg/dL, he said.
Congestion was reduced based on peripheral edema-based assessment (peripheral edema scale score of more than 2 at baseline and 0 at 30 days) and orthopnea-based assessment (all patients with at least two-pillow orthopnea at baseline, but no orthopnea in any patient at discharge and 30 days), he said.
“And then using a congestion biomarker called Ca125, we demonstrated intermediate-term reductions in congestion that were sustained through 30 to 90 days, indicative of more complete decongestion,” Abraham told Healio.
In the 6 months before the procedure, the event rate of HF hospitalization or death was 1.4 per patient, whereas in the 6 months after the procedure, the rate was 0.3 per patient, a 77% reduction, demonstrating the potential of this approach for improving ADHF outcomes, Abraham said.
“The next steps here are to continue to enroll patients into this study, which is ongoing, and to gather additional initial feasibility, safety and effectiveness data,” Abraham told Healio. “Once that study is complete, if the additional enrollment confirms these current observations, we hope to move to the next big step, into a randomized trial.”
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Abraham WT, et al. Featured abstracts 3: FIM and EFS studies. Presented at: Technology and Heart Failure Therapeutics (THT); March 4-6, 2024; Boston.
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