Safety and Performance of Targeted Renal Therapy: The Be-RITe! Registry

• Published in: Journal of endovascular therapy 2009-02, Vol.16 (1), p.1-12
• Main Authors: Weisz, Giora, Filby, Steven J., Cohen, Mauricio G., Allie, David E., Weinstock, Barry S., Kyriazis, Dimitris, Walker, Craig M., Moses, Jeffrey W., Danna, Paolo, Fearon, William F., Sachdev, Naveen, Wiechmann, Bret N., Vora, Kishor, Findeiss, Laura, Price, Matthew J., Mehran, Roxana, Leon, Martin B., Teirstein, Paul S.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Alprostadil - administration & dosage; Blood pressure; Catheterization - adverse effects; Catheterization - instrumentation; Contrast Media - adverse effects; Creatinine - blood; Drug Delivery Systems - adverse effects; Drug Delivery Systems - instrumentation; Equipment Design; Feasibility Studies; Female; Fenoldopam - administration & dosage; Humans; Incidence; Infusions, Intra-Arterial; Kidney diseases; Male; Medical imaging; Middle Aged; Mortality; Natriuretic Peptide, Brain - administration & dosage; Practice Patterns, Physicians; Protective Agents - administration & dosage; Protective Agents - adverse effects; Radiography; Registries; Renal Artery - diagnostic imaging; Renal Dialysis; Renal Insufficiency - chemically induced; Renal Insufficiency - prevention & control; Renal Insufficiency - therapy; Retrospective Studies; Risk factors; Sodium Bicarbonate - administration & dosage; Time Factors; Treatment Outcome; United States; Veins & arteries
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/08-2515.1

Purpose: To evaluate the safety and patterns of use of targeted renal therapy (TRT) with the Benephit system. TRT, the delivery of therapeutic agents directly to the kidneys by renal arterial infusion, has the advantage of providing a higher local effective dose with potentially greater renal effects, while limiting systemic adverse effects due to renal first-pass elimination. Methods: The Benephit System Renal Infusion Therapy (Be-RITe!) Multicenter Registry was a post-market registry following patients treated using the Benephit systems for TRT. The registry enrolled 501 patients (332 men; mean age 72.2±9.5 years) at high risk for contrast-induced nephropathy (CIN) during coronary or peripheral angiography/intervention or cardiovascular surgery. The Mehran score was used to compare the actual to predicted incidence of CIN within 48 hours post procedure. Results: Bilateral renal artery cannulation was successful in 94.2%, with a mean cannulation time of 2.0 minutes. Either fenoldopam mesylate, sodium bicarbonate, alprostadil, or B-type natriuretic peptide (BNP) was infused for 184±212 minutes. Mean creatinine levels did not change significantly (baseline, 24, and 48 hours post procedure: 1.95, 1.99, and 1.98 mg/dL, respectively; p=NS). In 285 patients who received TRT with fenoldopam and were followed for at least 48 hours, the incidence of CIN was 71% lower than predicted (8.1% actual CIN versus 28.0% predicted; p