First-of-its-kind drainage device helps limit heart failure rehospitalizations
An investigational, first-of-its-kind catheter-based device for lymphatic drainage in acute decompensated heart failure (ADHF) was deployed successfully in 40 patients, and 98% of them saw decreases in thoracic duct pressure that led to improved symptoms. That's according to the DELTA-HF trial, which was presented as a late-breaking study session at the Heart Failure 2026 Congress in Barcelona. The study was simultaneously published in the European Journal of Heart Failure.[1]
All 40 patients treated with the WhiteSwell eLym system demonstrated decongestion at discharge. The mean weight loss was nearly 15 pounds, kidney function was stable and the six-month rate of freedom from heart failure hospitalization and death was 82.5%.
“Patients enrolled in DELTA-HF had multiple comorbidities with many poor responders to the current standard of care, diuretic therapy. In diuretic nonresponders, we would expect to see six-month event rates as high as 50%,” study principal investigator William T. Abraham, MD, a professor at The Ohio State University, said in a statement. “Thus, the 82.5% freedom from heart failure hospitalization and death at six months is particularly noteworthy. I look forward to continuing clinical evaluation of this paradigm-shifting approach and its potential to more effectively decongest patients with difficult-to-treat ADHF.”
The multicenter, single-arm study evaluated the safety and effectiveness of the minimally invasive eLym device, which is deployed in the left internal jugular and innominate veins near the thoracic duct outflow. It creates a localized lower-pressure zone to facilitate the removal of excess fluid from tissue using an endovenous micro-axial impeller pump. The trial enrolled hospitalized patients who did not respond to high home diuretic dose with multiple comorbidities. Patients were treated with the eLym system for an average of 23.1 hours along with standard IV diuretic therapy. Patients were then followed for six months.
The modified EVEREST congestion score is commonly used assessment in ADHF to quantify volume overload and assess the level of decongestion at discharge. This trial showed the median modified EVEREST congestion score at baseline at 5.0, but with treatment it dropped to 0 by discharge and remained stable to six months.
The eLym device previously earned the FDA's breakthrough device designation, according to WhiteSwell. Study investigators believe it could help address persistent heart failure congestion, which has been a major driver for rehospitalization and mortality.
Two patients did have serious procedure-related adverse events. This included one death and one hypotensive event that later resolved.
"After approximately 24 hours of therapy, patients showed clear signs of decongestion and symptomatic improvement, with diuresis continuing following bedside device removal," Jorge Nuche, MD, PhD, explained in a statement. Nuche, an interventional cardiologist at Hospital Universitario 12 de Octubre in Madrid and presented the study data at the conference.
According to Nuche, the favorable safety and feasibility profile of this device, along with the clear clinical improvements, support further investigations of the eLym device. WhiteSwell is already planning the LYMPH-HF randomized pivotal clinical trial for later in 2026, with participating sites in the U.S., Canada, Europe and Israel. It will compare the safety and performance of the eLym system plus optimal diuretic therapy to optimal diuretic therapy alone.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]