Safety and performance of targeted renal therapy: the Be-RITe! Registry.
OBJECTIVE
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<0.0001). Only 4 (1.4%) patients required dialysis (versus the 2.6% predicted rate, p = NS).


CONCLUSIONS
The Benephit system and TRT during coronary and endovascular procedures in patients at high risk for renal failure is simple to use and safe. With the infusion of intrarenal fenoldopam, the incidence of CIN was significantly lower than predicted by risk score calculations.
Weisz
Giora
G
Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, NY 10032, USA. gweisz@crf.org
Filby
Steven J
SJ
Cohen
Mauricio G
MG
Allie
David E
DE
Weinstock
Barry S
BS
Kyriazis
Dimitris
D
Walker
Craig M
CM
Moses
Jeffrey W
JW
Danna
Paolo
P
Fearon
William F
WF
Sachdev
Naveen
N
Wiechmann
Bret N
BN
Vora
Kishor
K
Findeiss
Laura
L
Price
Matthew J
MJ
Mehran
Roxana
R
Leon
Martin B
MB
Teirstein
Paul S
PS
D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000008:administration & dosage; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation; D003287:Contrast Media / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000295:instrumentation; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D018818:Fenoldopam / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000008:administration & dosage; D010818:Practice Patterns, Physicians'; D020011:Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011859:Radiography; D012042:Registries; D012077:Renal Artery / Q000000981:diagnostic imaging; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000139:chemically induced / Q000517:prevention & control* / Q000628:therapy; D012189:Retrospective Studies; D017693:Sodium Bicarbonate / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D003287:Contrast Media; D020011:Protective Agents; D020097:Natriuretic Peptide, Brain; D017693:Sodium Bicarbonate; D003404:Creatinine; D000527:Alprostadil; D018818:Fenoldopam