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Multicenter Study
. 2022 Aug 22;15(16):1639-1648.
doi: 10.1016/j.jcin.2022.05.036. Epub 2022 Jul 27.

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI

Sarah Mauler-Wittwer  1 , Horst Sievert  2 , Anna-Maria Ioppolo  1 , Felix Mahfoud  3 , Didier Carrié  4 , Janusz Lipiecki  5 , Georg Nickenig  6 , Jean Fajadet  7 , Siegfried Eckert  8 , Marie-Claude Morice  9 , Philippe Garot  10
Affiliations
Free article
Multicenter Study

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI

Sarah Mauler-Wittwer et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials.

Objectives: The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures.

Methods: STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines.

Results: The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups.

Conclusions: In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

Keywords: PCI; TAVR; cardiovascular intervention; contrast media; contrast-induced nephropathy; renal failure.

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Conflict of interest statement

Funding Support and Author Disclosures The STRENGTH study was funded by RenalGuard Solutions Inc. Dr Sievert has received study honoraria to institution, travel expenses, consulting fees <25.000 €: 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Contego, Coramaze, Croivalve, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Lifetech, Magenta, Maquet Getinge Group, Medtronic, Metavention, Mitralix, Mokita, NXT Biomedical, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and Whiteswell. Dr Mahfoud has received grants from RenalGuard Solutions Inc during the conduct of the study; has received grants from Deutsche Gesellschaft für Kardiologie; has received grants from Deutsche Forschungsgemeinschaft (SFB TRR219); has received grants and personal fees from Bayer; grants and personal fees from Boehringer Ingelheim; has received grants and personal fees from Medtronic; and has received grants and personal fees from ReCor Medical outside the submitted work. Dr Morice is the CEO and a shareholder of CERC; the CRO in charge of the trial; and a minor shareholder of Electroducer. Dr Garot is a medical director and a shareholder of CERC; and has received minor speaker’s fees from Abbott, Biosensors, Boston, and Edwards outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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