Safety and performance of targeted renal therapy

The Be-RITe! registry

Giora Weisz, Steven J. Filby, Mauricio G. Cohen, David E. Allie, Barry S. Weinstock, Dimitris Kyriazis, Craig M. Walker, Jeffrey W. Moses, Paolo Danna, William F. Fearon, Naveen Sachdev, Bret N. Wiechmann, Kishor Vora, Laura Findeiss, Matthew J. Price, Roxana Mehran, Martin B. Leon, Paul S. Teirstein

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

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<0.0001). Only 4 (1.4%) patients required dialysis (versus the 2.6% predicted rate, p=NS). Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)1-12
Number of pages12
JournalJournal of Endovascular Therapy
Volume16
Issue number1
DOIs
StatePublished - Feb 1 2009

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Registries
Kidney
Safety
Fenoldopam
Therapeutics
Catheterization
Incidence
Endovascular Procedures
Sodium Bicarbonate
Alprostadil
Brain Natriuretic Peptide
Renal Artery
Renal Insufficiency
Dialysis
Creatinine
Angiography

All Science Journal Classification (ASJC) codes

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Weisz, G., Filby, S. J., Cohen, M. G., Allie, D. E., Weinstock, B. S., Kyriazis, D., ... Teirstein, P. S. (2009). Safety and performance of targeted renal therapy: The Be-RITe! registry. Journal of Endovascular Therapy, 16(1), 1-12. https://doi.org/10.1583/08-2515.1

Safety and performance of targeted renal therapy : The Be-RITe! registry. / 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.

In: Journal of Endovascular Therapy, Vol. 16, No. 1, 01.02.2009, p. 1-12.

Research output: Contribution to journalArticle

Weisz, G, Filby, SJ, Cohen, MG, Allie, DE, Weinstock, BS, Kyriazis, D, Walker, CM, Moses, JW, Danna, P, Fearon, WF, Sachdev, N, Wiechmann, BN, Vora, K, Findeiss, L, Price, MJ, Mehran, R, Leon, MB & Teirstein, PS 2009, 'Safety and performance of targeted renal therapy: The Be-RITe! registry', Journal of Endovascular Therapy, vol. 16, no. 1, pp. 1-12. https://doi.org/10.1583/08-2515.1
Weisz G, Filby SJ, Cohen MG, Allie DE, Weinstock BS, Kyriazis D et al. Safety and performance of targeted renal therapy: The Be-RITe! registry. Journal of Endovascular Therapy. 2009 Feb 1;16(1):1-12. https://doi.org/10.1583/08-2515.1
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. / Safety and performance of targeted renal therapy : The Be-RITe! registry. In: Journal of Endovascular Therapy. 2009 ; Vol. 16, No. 1. pp. 1-12.
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abstract = "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<0.0001). Only 4 (1.4{\%}) patients required dialysis (versus the 2.6{\%} predicted rate, p=NS). Conclusion: 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.",
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AU - Weisz, Giora

AU - Filby, Steven J.

AU - Cohen, Mauricio G.

AU - Allie, David E.

AU - Weinstock, Barry S.

AU - Kyriazis, Dimitris

AU - Walker, Craig M.

AU - Moses, Jeffrey W.

AU - Danna, Paolo

AU - Fearon, William F.

AU - Sachdev, Naveen

AU - Wiechmann, Bret N.

AU - Vora, Kishor

AU - Findeiss, Laura

AU - Price, Matthew J.

AU - Mehran, Roxana

AU - Leon, Martin B.

AU - Teirstein, Paul S.

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N2 - 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<0.0001). Only 4 (1.4%) patients required dialysis (versus the 2.6% predicted rate, p=NS). Conclusion: 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.

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