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)

• Published in: JACC. Cardiovascular interventions Vol. 8; no. 12; p. 1595
• Main Authors: Barbanti, Marco, Gulino, Simona, Capranzano, Piera, Immè, Sebastiano, Sgroi, Carmelo, Tamburino, Claudia, Ohno, Yohei, Attizzani, Guilherme F, Patanè, Martina, Sicuso, Rita, Pilato, Gerlando, Di Landro, Alessio, Todaro, Denise, Di Simone, Emanuela, Picci, Andrea, Giannetto, Giuliana, Costa, Giuliano, Deste, Wanda, Giannazzo, Daniela, Grasso, Carmelo, Capodanno, Davide, Tamburino, Corrado
• Format: Journal Article
• Language: English
• Published: United States 01.10.2015
• Subjects: Acute Kidney Injury - chemically induced; Acute Kidney Injury - diagnosis; Acute Kidney Injury - physiopathology; Acute Kidney Injury - prevention & control; Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - methods; Contrast Media - adverse effects; Diuresis - drug effects; Diuretics - therapeutic use; Female; Fluid Therapy - adverse effects; Fluid Therapy - instrumentation; Fluid Therapy - methods; Furosemide - therapeutic use; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - methods; Humans; Infusions, Intravenous; Italy; Male; Prospective Studies; Radiography; Registries; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Triiodobenzoic Acids - adverse effects; RenalGuard; TAVR; AKI
• ISSN: 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2015.07.012

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). 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. 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. 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. 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.