Michael Barbella, Managing Editor12.08.23
WhiteSwell is sharing positive initial results from its ongoing DELTA-HF trial evaluating the safety and performance of the WhiteSwell eLym System in treating fluid overload or congestion in patients with acute decompensated heart failure (ADHF).
In DELTA-HF, a minimally invasive catheter-based system is introduced to remove excess fluid from the body’s tissues and organs concurrent with diuretic removal of excess vascular fluid. The eLym System targets the body’s largest lymphatic vessel and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.
Nine hospitalized patients received eLym therapy in conjunction with diuretic therapy, while six patients received standard of care treatment with loop diuretics alone.
Summary of key findings:
The eLym System is a minimally invasive catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system’s ability to actively drain fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system’s major highway, the thoracic duct, connects. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.
“This is a new approach, and we are excited to investigate WhiteSwell’s catheter-based system,” said Zviad Kereselidze, M.D., head of the ICCU at Tbilisi Heart Center. “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.”
WhiteSwell continues to evaluate this unique approach to treating ADHF patients with continued enrollment and follow-up in 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) Trial. The company looks forward to sharing additional data in the future.
ADHF is an episode of worsening heart failure symptoms that results in millions of hospitalizations worldwide each year, including 3 million in the U.S. alone.1 Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires hospital-based treatment to remove excess fluid in a process called decongestion. Complete decongestion is the goal of ADHF treatment since residual congestion at hospital discharge is the strongest predictor of rehospitalization and death.2 As many as half of ADHF patients are discharged from the hospital not fully decongested, and one out of four ADHF patients is readmitted to the hospital within one month.3,4,5
In healthy individuals, the lymphatic system continuously captures fluid from tissues throughout the body and pumps it back into the vascular system to maintain homeostasis. In ADHF, excess fluid collects in the tissues of the body (the interstitial compartment), causing edema and an increase in venous blood pressure. Excess tissue fluid and high venous blood pressure interfere with the lymphatic system’s ability to move fluid back to the vascular system, which can further exacerbate congestion.
WhiteSwell is a patient-focused company focused on treatments for ADHF, a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland.
References
1 Hollenberg et al., J Am Coll Cardiol 2019;74:1966–2011. (1M annual hospital discharges with HF as primary diagnosis and 2M hospital discharges with HF as secondary contributing diagnosis.)
2 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-473
3 Girerd et al, Integrative Assessment of Congestion in Heart Failure Throughout the Patient Journey, J Am Coll Cardiol HF 2018;6:273–85
4 Arrigo et al, Nature Reviews Disease Primers volume 6, Article number: 16 (2020)
5 Rubio-Gracia, J. et al. (2018). International Journal of Cardiology, 258, pp. 185-191.
In DELTA-HF, a minimally invasive catheter-based system is introduced to remove excess fluid from the body’s tissues and organs concurrent with diuretic removal of excess vascular fluid. The eLym System targets the body’s largest lymphatic vessel and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.
Nine hospitalized patients received eLym therapy in conjunction with diuretic therapy, while six patients received standard of care treatment with loop diuretics alone.
Summary of key findings:
- Treatment with the eLym System was performed safely and successfully.
- Deployed and activated in nine patients with a mean 24-hour treatment time.
- No patient experienced a serious procedure-, device-, or therapy-related adverse event.
- Early clinical results are promising and support further clinical investigation.
- Patients who underwent therapy with the eLym System plus loop diuretic lost a mean of 6.0±4.6 kg from baseline to hospital discharge while maintaining kidney function, as measured by a stable or improved creatinine (mean Δ -0.10±0.12 mg/dL).
- The loop diuretic-only group lost a mean 3.3±3.7 kg.
- One treated patient (1/9, 11%) was hospitalized within 30 days of discharge.
The eLym System is a minimally invasive catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system’s ability to actively drain fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system’s major highway, the thoracic duct, connects. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.
“This is a new approach, and we are excited to investigate WhiteSwell’s catheter-based system,” said Zviad Kereselidze, M.D., head of the ICCU at Tbilisi Heart Center. “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.”
WhiteSwell continues to evaluate this unique approach to treating ADHF patients with continued enrollment and follow-up in 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) Trial. The company looks forward to sharing additional data in the future.
ADHF is an episode of worsening heart failure symptoms that results in millions of hospitalizations worldwide each year, including 3 million in the U.S. alone.1 Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires hospital-based treatment to remove excess fluid in a process called decongestion. Complete decongestion is the goal of ADHF treatment since residual congestion at hospital discharge is the strongest predictor of rehospitalization and death.2 As many as half of ADHF patients are discharged from the hospital not fully decongested, and one out of four ADHF patients is readmitted to the hospital within one month.3,4,5
In healthy individuals, the lymphatic system continuously captures fluid from tissues throughout the body and pumps it back into the vascular system to maintain homeostasis. In ADHF, excess fluid collects in the tissues of the body (the interstitial compartment), causing edema and an increase in venous blood pressure. Excess tissue fluid and high venous blood pressure interfere with the lymphatic system’s ability to move fluid back to the vascular system, which can further exacerbate congestion.
WhiteSwell is a patient-focused company focused on treatments for ADHF, a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland.
References
1 Hollenberg et al., J Am Coll Cardiol 2019;74:1966–2011. (1M annual hospital discharges with HF as primary diagnosis and 2M hospital discharges with HF as secondary contributing diagnosis.)
2 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-473
3 Girerd et al, Integrative Assessment of Congestion in Heart Failure Throughout the Patient Journey, J Am Coll Cardiol HF 2018;6:273–85
4 Arrigo et al, Nature Reviews Disease Primers volume 6, Article number: 16 (2020)
5 Rubio-Gracia, J. et al. (2018). International Journal of Cardiology, 258, pp. 185-191.