Michael Barbella, Managing Editor04.29.24
WhiteSwell is hailing positive six-month follow-up data in its DELTA-HF study.
The trial is evaluating the company's WhiteSwell eLym System in nine hospitalized patients with acute decompensated heart failure (ADHF); the study subjects received eLym therapy in conjunction with diuretic therapy over a six-month period. Results showed:
“These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function,” said William Abraham, M.D., professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center. “We were especially encouraged by the dramatic reductions in heart failure related events, which were reduced despite no up-titration of guideline-directed medical therapy. I look forward to additional clinical data building upon these findings.”
Patients with acute decompensated heart failure who are discharged with persistent congestion tend to experience poor outcomes, including rehospitalization and death. In the DELTA-HF trial, patients are treated with the minimally invasive, catheter-based eLym System to facilitate fluid removal from the body’s tissues and organs, concurrent with diuretic removal of excess vascular fluid. The eLym System works by targeting the body’s largest lymphatic vessel, the thoracic duct, and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.
“We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat,” said George Khabeishvili, M.D., principal investigator, Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. “The treatment approach with the eLym System involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital.”
The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) trial is a non-randomized early feasibility trial evaluating the eLym System's safety and performance. 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.
WhiteSwell is a patient-focused company working to improve treatment of ADHF, a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland.
The trial is evaluating the company's WhiteSwell eLym System in nine hospitalized patients with acute decompensated heart failure (ADHF); the study subjects received eLym therapy in conjunction with diuretic therapy over a six-month period. Results showed:
- Reduced tissue congestion: A biomarker of tissue congestion, CA-125, decreased 77% from baseline to a median of 23 u/ml at 90 days.
- Reduced rehospitalizations: Comparing patients’ clinical course before and after eLym therapy, there were 13 heart failure-related rehospitalizations in the six months before eLym but two rehospitalizations and one heart failure-related death in the six months after eLym (a 77% reduction).
“These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function,” said William Abraham, M.D., professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center. “We were especially encouraged by the dramatic reductions in heart failure related events, which were reduced despite no up-titration of guideline-directed medical therapy. I look forward to additional clinical data building upon these findings.”
Patients with acute decompensated heart failure who are discharged with persistent congestion tend to experience poor outcomes, including rehospitalization and death. In the DELTA-HF trial, patients are treated with the minimally invasive, catheter-based eLym System to facilitate fluid removal from the body’s tissues and organs, concurrent with diuretic removal of excess vascular fluid. The eLym System works by targeting the body’s largest lymphatic vessel, the thoracic duct, and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.
“We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat,” said George Khabeishvili, M.D., principal investigator, Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. “The treatment approach with the eLym System involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital.”
The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) trial is a non-randomized early feasibility trial evaluating the eLym System's safety and performance. 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.
WhiteSwell is a patient-focused company working to improve treatment of ADHF, a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland.