Houston-based Procyrion evaluated Aortix percutaneous mechanical circulatory support (pMCS) pump in patients with acute decompensated heart failure (ADHF) and worsening renal function. This is known as cardiorenal syndrome (CRS).
The pump patients — unresponsive to available medical therapy — demonstrated significant improvements across a range of functions. These include kidney function, cardiac function and patient-reported assessment of shortness of breath at 30 days.
Procyrion presented results today at the Technology and Heart Failure Therapeutics (THT) conference in Boston.
Dr. Jennifer A. Cowger, section head of heart transplantation and mechanical circulatory support, Henry Ford Hospital in Detroit, said patients with CRS often end up the most difficult to treat. Often, they present persistent congestion even after intravenous diuretic therapy. This leads to “very poor outcomes” with high rates of mortality, as well as rehospitalization.
“After being unresponsive to available medical therapy for more than a week, patients who were treated with the Aortix pump showed a significant increase in urine output resulting in a large loss of excess fluid and improvements in kidney function present at 30 days, indicating the potential of the Aortix therapy to disrupt the harmful cycle of CRS,” Cowger said.
About the Procyrion Aortix device’s study results
The CRS pilot study treated 18 patients across 10 centers in the U.S. and Australia.
Findings included rapid decongestion as patients shed, on average, 10.7 liters of excess fluid. Filling pressures (central venous pressure and pulmonary capillary wedge pressure) decreased by more than 33%.
Kidney function (measured by eGFR) improved by a median of 29% at 30 days. Cardiac function (measured by the NT-proBNP biomarker) improved by a median of 34% at 30 days. Procyrion reported a 46% reduction in shortness of breath symptoms at 30 days.
The company designed Aortix for placement in the descending thoracic aorta via a percutaneous catheter procedure. It treated patients for a mean of 4.6 days to simultaneously unload and rest the heart and increase perfusion of the kidneys. With its intra-aortic placement and the harnessing of fluid entrainment, Aortix pumps blood without the need for a valve. Procyrion said the device provides a physiologically natural delivery of therapy.
Implantation takes approximately 45 minutes and retrieval takes approximately 15 minutes at the completion of therapy. The device requires no fluid purges or expensive consoles to operate the device. Procyrion said this allows it to easily integrate into practices.
“The consistent results from the pilot study indicate that Aortix therapy has the potential to be a major therapeutic advancement for CRS patients who have exhausted other treatment options,” said Dr. Eric Fain president and CEO of Procyrion. “After years of development, it is very exciting to see how well the Aortix platform performs clinically and we look forward to further demonstrating the effectiveness of the system in our upcoming DRAIN-HF pivotal trial, which the company plans to initiate later this year.”