RenalGuard Studied for Prevention of Acute Kidney Injury in TAVR Patients

September 18, 2015—Marco Barbanti, MD, et al published findings from the PROTECT-TAVI study that was conducted to investigate the effect of the RenalGuard system (PLC Medical Systems) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). The study is available online ahead of print in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

According to the investigators, the RenalGuard system is a dedicated device designed for contrast-induced AKI prevention. The study seeks to explore whether this device is also effective in patients with severe aortic stenosis undergoing TAVR, which is associated with varying degrees of postprocedural AKI. 

As summarized in JACC: Cardiovascular Interventions, this investigator-driven, single-center, prospective, open-label, registry-based randomized study used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. In the study, 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 hours after the procedure.

The investigators found that the AKI rate was lower in the RenalGuard group than in the control group (5.4% vs 25%; P = .014). All but one of the AKIs was mild (stage 1). Severe damage (stage 3) occurred only in one patient, who was in the control group. 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 either group at 30 days.

The investigators concluded that 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.