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Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

AbstractOBJECTIVES:
The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR).
BACKGROUND:
TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored.
METHODS:
The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure.
RESULTS:
The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days.
CONCLUSIONS:
Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.
AuthorsMarco Barbanti, Simona Gulino, Piera Capranzano, Sebastiano Immè, Carmelo Sgroi, Claudia Tamburino, Yohei Ohno, Guilherme F Attizzani, Martina Patanè, Rita Sicuso, Gerlando Pilato, Alessio Di Landro, Denise Todaro, Emanuela Di Simone, Andrea Picci, Giuliana Giannetto, Giuliano Costa, Wanda Deste, Daniela Giannazzo, Carmelo Grasso, Davide Capodanno, Corrado Tamburino
JournalJACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 8 Issue 12 Pg. 1595-604 (Oct 2015) ISSN: 1876-7605 [Electronic] United States
PMID26386766 (Publication Type: Journal Article, Randomized Controlled Trial)
CopyrightCopyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Contrast Media
  • Diuretics
  • Triiodobenzoic Acids
  • Furosemide
  • iodixanol
Topics
  • Acute Kidney Injury (chemically induced, diagnosis, physiopathology, prevention & control)
  • Aged
  • Aged, 80 and over
  • Aortic Valve (diagnostic imaging)
  • Aortic Valve Stenosis (diagnostic imaging, therapy)
  • Cardiac Catheterization (adverse effects, methods)
  • Contrast Media (adverse effects)
  • Diuresis (drug effects)
  • Diuretics (therapeutic use)
  • Female
  • Fluid Therapy (adverse effects, instrumentation, methods)
  • Furosemide (therapeutic use)
  • Heart Valve Prosthesis Implantation (adverse effects, methods)
  • Humans
  • Infusions, Intravenous
  • Italy
  • Male
  • Prospective Studies
  • Radiography
  • Registries
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Triiodobenzoic Acids (adverse effects)

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