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)

OBJECTIVES 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 valvereplacement (TAVR).BACKGROUNDTAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicateddevice designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aorticstenosis undergoing TAVR is unexplored.METHODSThe present is an investigator-driven, single-center, prospective, open-label, registry-based randomizedstudy that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for random-ization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomlyassigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuardgroup) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic ResearchConsortium–defined AKI in thefirst 72 h after the procedure.RESULTSThe AKI rate was lower in the RenalGuard group than in the control group (n¼3 [5.4%] vs. n¼14 [25.0%],respectively, p¼0.014). 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 wasreported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heartfailure were noted in both groups at 30 days.CONCLUSIONSFurosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard sys-tem is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR. (J Am Coll Cardiol Intv2015;8:1595–604) © 2015 by the American College of Cardiology Foundation.From the *Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy;yDepartment of Cardiology, Universityof Tokai, School of Medicine, Isehara, Japan;zThe Valve & Structural Heart Disease Intervention Center, Harrington Heartand Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio; and thexETNA Foundation, Catania, Italy.JACC: CARDIOVASCULAR INTERVENTIONSVOL. 8, NO. 12, 2015ª2015 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATIONISSN 1936-8798/$36.00PUBLISHED BY ELSEVIER INC.http://dx.doi.org/10.1016/j.jcin.2015.07.012