title: 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).
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: mbarbanti83@gmail.com.
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Gulino
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immè
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Sgroi
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, University of Tokai, School of Medicine, Isehara, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; The Valve & Structural Heart Disease Intervention Center, Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Patanè
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Sicuso
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Gerlando
authors.initials: G
authors.lastname: Pilato
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Alessio
authors.initials: A
authors.lastname: Di Landro
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Denise
authors.initials: D
authors.lastname: Todaro
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Di Simone
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Picci
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Giannetto
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Costa
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Wanda
authors.initials: W
authors.lastname: Deste
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Giannazzo
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Grasso
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D003287:Contrast Media / Q000009:adverse effects*; D004231:Diuresis / Q000187:drug effects*; D004232:Diuretics / Q000627:therapeutic use*; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D005665:Furosemide / Q000627:therapeutic use*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007262:Infusions, Intravenous; D007558:Italy; D008297:Male; D011446:Prospective Studies; D011859:Radiography; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
chemical_list: D003287:Contrast Media; D004232:Diuretics; D014283:Triiodobenzoic Acids; D005665:Furosemide; C044834:iodixanol
keywords: AKI; RenalGuard; TAVR