A technology designed to prevent contrast-induced acute kidney injury demonstrated an ability to manage fluids during diuretic therapy in patients with congestive HF, according to findings presented at the Device Therapies for Heart Failure congress.
Researchers conducted a first-in-humans study of the technology (RenalGuard System, RenalGuard Solutions) in 10 patients with congestive HF. According to a press release from the company, the technology measures a patient’s urine output and infuses a specific volume of saline to maintain fluid balance, and clinicians can set a rate beyond which the system will not allow the patient’s fluid balance to drop.
“There is a clear unmet need for alternative methods of fluid removal with superior efficacy in patients with heart failure,” Felix Mahfoud, MD, from Saarland University Hospital in Homburg, Germany, who made one of two presentations on the technology, said in the release. “This first-in-man study demonstrated that RenalGuard can safely be used in these patients while maintaining the proper conditions to both prevent diuretic resistance and increase the removal of excess fluid from the patient. Our initial experience with the RenalGuard System in heart failure patients is very promising, and we look forward to advancing our understanding of the benefits of this therapy to patients at risk.”
The fluid removal rate cannot be tightly controlled with diuretics, and although ultrafiltration systems solve that problem, they require extracorporeal blood flow and a filter, Mahfoud said during the presentation.
“It would be ideal to have a volume removal therapy that was controllable and allowed continuation and optimization of pharmacological therapy for HF, including improving the patient’s response to diuretics, with low invasiveness,” he said.
In the second presentation, Piotr Ponikowski, MD, PhD, from Wroclaw Medical University, Poland, reported than none of the 10 patients had a fluid loss rate greater than that set in the RenalGuard System by clinicians.
“RenalGuard therapy is remarkably simple and safe, and works automatically to carefully achieve and control the desired fluid balance,” Ponikowski said in the release.
Jim Dillon, CEO of RenalGuard Solutions, told Cardiology Today that the findings show that use of the technology is feasible in the setting of congestive HF and “suggest it is possible to give controlled fluid back to overloaded patients safely,” even if that may seem counterintuitive.
The data also “suggest that RenalGuard has the potential to induce high urine output rates in [congestive] HF patients,” Dillon said. “It has been clearly established that RenalGuard can induce and maintain high urine output rates in cath lab patients with chronic kidney disease, but it was unknown if this benefit would carry over to these patients, and it seems to.”
He said more research must be done on who best benefits from the therapy, how it compares with standard therapy and whether it affects longer-term outcomes.
The technology has a CE mark for fluid balance in Europe. It is not yet approved for any indication in the United States. – by Erik Swain
Ponikowski P. RenalGuard for Heart Failure Treatment. Both presented at: Device Therapies for Heart Failure; Dec. 15-16, 2017; Berlin.
Dillon is an employee of RenalGuard Solutions. Mahfoud reports he has received grants and personal fees from Medtronic and St. Jude Medical. Ponikowski reports he has financial ties with multiple pharmaceutical and device companies.