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JACC Cardiovasc Interv. 2015 Oct;8(12):1595-604. doi: 10.1016/j.jcin.2015.07.012. Epub 2015 Sep 17.

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).

Author information

1
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: mbarbanti83@gmail.com.
2
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
3
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, University of Tokai, School of Medicine, Isehara, Japan.
4
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.
5
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.

Abstract

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 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.

KEYWORDS:

AKI; RenalGuard; TAVR

PMID:
26386766
DOI:
10.1016/j.jcin.2015.07.012
[Indexed for MEDLINE]
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