Of the 28 patients, 17 (61%) had pre-existing CKD. Some patients suffered AKI as a result of coronary artery bypass surgery and abdominal aorta aneurysm repair. Comorbid conditions were common in the study group, with 16 patients (57%) suffering respiratory distress.
Overall mortality at 28 days was 11%. “Although this is not a controlled trial, the mortality rate is unusually low in our experience,” Dr. Tumlin said. “Frankly, we would have expected 40%-50% of these patients to die within the 28 days we followed them. We would have thought that two of the three patients who had to go to dialysis would have died. But they all survived through at least 28 days.”
In the study, Dr. Tumlin employed the FlowMedica Benephit Intra-Renal Drug Delivery System, a unique catheter that bifurcates when deployed, allowing catheterization of both renal arteries almost simultaneously. “We could get two catheters in there to accomplish the same thing,” he said, “but the FlowMedica device really simplifies this procedure and could make feasible bedside [use] in the intensive care unit.”
“The FlowMedica catheter system appears to be a safe and effective means for doing intrarenal fenoldopam infusion,” Dr. Tumlin said. The Benephit Infusion Systems are FDA-approved and indicated for the “infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries.” FlowMedica is now part of AngioDynamics.
In a related study involving the prevention of contrast-induced nephropathy (CIN), Dr. Tumlin found that patients treated intrarenally with fenoldopam and the antioxidant mesna did not perform better than those treated with fenoldopam alone.
Dr. Tumlin disclosed possible financial conflicts of interest with GE Healthcare; FlowMedica, Inc.; and Hospira Pharmaceuticals.
Commenting on the new findings, James F. Benenati, MD, medical director of the noninvasive vascular laboratory at Baptist Cardiac & Vascular Institute in Miami, observed: “The use of the bifurcated catheter to infuse fenoldopam into the renal arteries is very promising. We are excited about this use because we really have little with which to treat patients who suffer acute kidney injury.”
Deployment of the catheter makes it possible to deliver more medication into the kidneys, he said, adding that he was confident enough to use the catheter in a live demonstration during the ISET meeting.