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PROTECT TAVI: RenalGuard Reduces Acute Kidney Injury
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Patients undergoing transcatheter aortic valve replacement who were treated with furosemide-induced diuresis with matched isotonic IV hydration using the RenalGuard system experienced less acute kidney injury compared with those who received with a saline solution.
The aim of the investigator-driven, single-center, prospective, open-label, registry-based randomized PROTECT TAVI trial was to assess the efficacy of the RenalGuard system (PLC Medical Systems) in patients with severe aortic stenosis undergoing TAVR.
The study included 56 patients assigned hydration with normal saline solution controlled by the RenalGuard system and furosemide and 56 controls assigned a saline solution.
Incidence of Valve Academic Research Consortium (VARC)-defined acute kidney injury within 72 hours of the procedure served as the primary endpoint.
The primary endpoint rate was 5.4% in the RenalGuard group vs. 25% in the control group (P = .014). Stage 1 acute kidney injury occurred in 5.4% of the RenalGuard group vs. 23.2% of the control group. No patients in the study group and one control patient (1.8%) experienced stage 3 kidney injury.
There was no in-hospital renal failure requiring dialysis.
The two groups had similar rates of mortality, cerebrovascular events, bleeding and hospitalization for HF at 30 days.
Other findings indicated increased serum creatinine levels among controls compared with study patients.
The researchers reported no significant hydration-associated complications. Asymptomatic hypokalemia occurred in 41.1% of the RenalGuard group vs. 32.1% of the control group (P = .432).
Patients in both groups had a similar length of hospital stay (P = .94).
“Furosemide-induced diuresis with matched isotonic [IV] hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of [acute kidney injury] in patients undergoing TAVR,” the researchers concluded. – by Rob Volansky
Disclosure: One researcher reports consulting and serving as a proctor to Edwards Lifesciences and Medtronic, and consulting for St. Jude Medical.
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