RenalGuard System Research Articles

Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation.

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a serious complication which is associated with increased mortality. The RenalGuard system was developed to reduce the risk of AKI after contrast media exposition by furosemide-induced diuresis with matched isotonic intravenous hydration. The aim of this study was to examine the effect of the RenalGuard system on the occurrence of AKI after TAVI in patients with chronic kidney disease. The present study is a single-center randomized trial including patients with severe aortic valve stenosis undergoing TAVI. Overall, a total of 100 patients treated by TAVI between January 2017 and August 2018 were randomly assigned to a periprocedural treatment with the RenalGuard system or standard treatment by pre- and postprocedural intravenous hydration. Primary endpoint was the occurrence of AKI after TAVI, and secondary endpoints were assessed according to valve academic research consortium 2 criteria. Overall, the prevalence of AKI was 18.4% (n = 18). The majority of these patients developed mild AKI according to stage 1. Comparing RenalGuard to standard therapy, no significant differences were observed in the occurrence of AKI (RenalGuard: 21.3%; control group: 15.7%; p = 0.651). In addition, there were no differences between the groups with regard to 30-day and 12-month mortality and procedure-associated complication rates. In this randomized trial, we did not detect a reduction in AKI after TAVI by using the RenalGuard system. A substantial number of patients with chronic kidney disease developed AKI after TAVI, whereas the majority presented with mild AKI according to stage 1 (ClinicalTrials.gov number NCT04537325).

Future insights of pharmacological prevention for AKI post cardiopulmonary bypass surgery (based on PK/PD approach).

The incidence of acute kidney injury (AKI) post-cardiopulmonary bypass (CPB) can cause an increase in the rate of renal replacement therapy (RRT) and mortality rate. Compared to brain and liver damage post-CPB, AKI has the highest incidence of 83%. Based on this phenomenon, various efforts have been made to reduce the incidence of AKI post-CPB, both pharmacologically and non-pharmacologically interventions. The purpose of this review is to emphasize several renal protector agents which under optimal conditions can provide significant benefits in reducing the incidence of AKI post-CPB. This article was obtained by conducting a study on several kinds of literature, including the original article, RCT study, systematic review and meta-analysis, and other review articles. There are five renal protector agents that are the focus of this article, those are fenoldopam which effectively works to prevent the incidence of AKI post-CPB, while furosemide has shown satisfactory results in patients with decreased renal function when administered in the Renal Guard (RG) system, mannitol, and nitric oxide, both of these can also effectively reduce the incidence of AKI post‐CPB by controlling its blood concentration and timing of administration, and another form of N-Acetylcysteine, namely N‐Acetylcysteine amide has better activity as a renoprotective agent than N‐Acetylcysteine itself. The benefits of these agents can be obtained by developing devices that can control drug levels in the blood and create optimal conditions for drugs during the use of a CPB machine.

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

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 withdiuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials. 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. 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 filtration15-40mL/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. 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. 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 12months compared with conventional intravenous hydration.

Forced Diuresis with Matched Isotonic Intravenous Hydration Prevents Renal Contrast Media Accumulation.

The accumulation of contrast media in the kidneys might lead to contrast-induced acute kidney injury. In this prospective, controlled observational study, we aimed to evaluate whether forced diuresis with matched isotonic intravenous hydration prevents the accumulation of contrast media in the kidneys of patients undergoing cardiac interventional procedures. We compared the intensity of contrast media accumulation as observed in nephrograms following these procedures, with and without peri-procedural controlled renal flushing. The study group consisted of 25 patients with impaired renal function treated with the RenalGuard system. The two control groups included 25 patients with normal kidney function and 8 patients with impaired renal function undergoing similar procedures with routine pre-procedural hydration, but without controlled renal flushing. Renal contrast media accumulation at the end of each procedure was scored by blinded cardiologists. The renal contrast accumulation score (CAS) in the study group was significantly lower, with a median score of 0 (IQR (0–0)) compared with 1.5 (IQR (1–2)) in the normal renal function control group and 1 (IQR (0.38–1.62)) in the impaired renal function control group (p < 0.001 and 0.003, respectively). In a multivariate analysis of CAS, RenalGuard treatment was independently associated with lower CAS compared to both control groups. In conclusion, RenalGuard use prevents renal contrast accumulation in patients with impaired renal function undergoing cardiac procedures with intra-arterial contrast media injection.

PP162 Use Of The RenalGuard® System To Prevent Contrast-Induced Nephropathy

IntroductionContrast-induced nephropathy (CIN) is a common cause of hospital-acquired acute kidney injury (AKI) following the administration of contrast media for coronary interventions or procedures such as diagnostic coronary angiography. The optimal way of preventing CIN remains uncertain. However, preliminary intravenous hydration, minimizing the volume of contrast media, and avoiding the use of nephrotoxic drugs are recommended in current management guidelines. The aim of this analysis was to compare the RenalGuard® system with standard care.MethodsA comprehensive literature search was conducted in PubMed and Google Scholar to identify evidence on the clinical and economic effectiveness of forced diuresis with matched hydration using the RenalGuard system for preventing CIN. Multiple criteria decision analysis (MCDA) was used to assess the performance of the method in hospital settings, compared with alternative options.ResultsSeveral systematic reviews with meta-analyses demonstrated that forced diuresis with matched hydration using the RenalGuard system was associated with a significantly lower relative risk of CIN among high-risk patients with chronic kidney disease. However, the evidence supporting the advantage of the proposed method over current forced diuresis techniques with manual calculation of the volumes for matched hydration in the hospital setting was limited.ConclusionsAlthough the effectiveness of the RenalGuard system has been demonstrated in meta-analyses, its clinical advantage over forced diuresis with manual hydration calculation is uncertain. It is also worth noting the lack of evidence to date on this technology, the fact that it is still at the research stage in some countries, and that it is not included in CIN management guidelines.

RenalGuard system and conventional hydration for preventing contrast-associated acute kidney injury in patients undergoing cardiac interventional procedures: A systematic review and meta-analysis

BackgroundContrast-associated acute kidney injury (CA-AKI) can increase the mortality of patients undergoing transcatheter aortic valve replacement (TAVR) or percutaneous coronary intervention (PCI). The purpose of this paper was to compare the efficacy of the RenalGuard System and conventional hydration regimen in preventing CA-AKI in patients with TAVR or PCI. MethodsWe searched PubMed, Embase, Web of Science, and the Cochrane Central Register of Clinical Trials (last updated July 11, 2020) for suitable reports. The primary outcome was the occurrence of CA-AKI. The secondary outcomes were renal replacement therapy (RRT), major cardiovascular events (MACEs), and other adverse complications. ResultsThe search strategy yielded 270 studies (with data for 2067 participants). In the subgroup of PCI, low incidence of CA-AKI (6.7% vs 15.7%; 95%CI: 0.27 to 0.54; I2 = 8%; P < 0.00001) associate with RenalGuard group (RG) rather than control group (CG). Similarly, in the subgroup of TAVR, a low incidence of CA-AKI (15.6% vs 26.9%; 95%CI: 0.35 to 0.82; I2 = 88%; P = 0.004) relates to RG. However, this result is highly heterogeneous. Compare with conventional hydration, RenalGuard significantly reduce the incidence of pulmonary edema (1.5%vs4.1%; 95%CI: 0.18 to 0.72; I2 = 0%; P = 0.004). ConclusionsRenalGuard System can lessen the risk of CA-AKI and RRT in patients undergoing PCI. But for patients experiencing TAVR, due to unique hemodynamic effects, the role of RenalGuard remains questionable. RenalGuard is more secure than conventional hydration. Future work should elucidate the feasibility and safety of this prophylactic intervention in cardiac interventional therapy.

NGAL in trans-catheter aortic valve implantation on and off RenalGuard

Introduction: Acute kidney injury (AKI) is a well-known complication post invasive cardiac procedures. RenalGuard system has been shown to reduce the risk of AKI in high-risk patients by evacuating iodine-based contrast material rapidly. Neutrophil gelatinase-associated lipocalin (NGAL) is a glycoprotein stored in granules of mature neutrophils and is released to the blood stream due to acute tubular damage. This report examined the biomarker as a sub study of the randomized sham control study REDUCE-AKI in the setting of Trans-Aortic Valve Implantation (TAVI). Methods: Venous blood was drawn from 27 patients. Blood was drawn at designated time intervals: before the procedure, after 12 hours and after 24 hours. Patients were randomly allocated to active versus sham RenalGuard activity. Results: There was no difference between baseline and 24 hours levels in NGAL values (ng/mL) in the sham group (median 70.3 IQ 21.5, 176.6) versus the active group (median 46.9, IQR 1.3, 127.7) (P = 0.259). There was also no association between NGAL and clinical complications. Conclusion: Forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI and measuring NGAL correlates with these findings.

Results of the multicenter, prospective, randomised STRENGTH (Study To evaluate the use of RENalGuard to proTect patients at High risk of acute kidney injury) study

Abstract Aim Radio-contrast agents are widely used in coronary, peripheral and structural interventions. Use of these iodine-containing agents can be associated with contrast-induced acute kidney injury (CI-AKI) that can cause substantial morbidity and mortality. The RenalGuard system induces a forced diuresis with a matched hydration and has been shown beneficial in patients requiring coronary angiogram and PCI. Methods STRENGTH is a prospective, randomised (1:1), open-labeled, parallel-group, multicenter (10 centers in Germany and France) study where patients at high risk of CI-AKI were randomly assigned to RenalGuard® therapy or conventional strategy including preventive hydration before complex percutaneous cardiovascular intervention (PCI, peripheral and structural). In the RenalGuard arm, matched fluid replacement was started 60 minutes pre-procedure and maintained for up to 4 hours afterwards. Patients were given an initial i.v. bolus of up to 250 ml of normal saline over 30 minutes and then an i.v. bolus of furosemide (0.5 mg/kg). To be enrolled, patients had to have moderate to severe renal failure (defined as 15≤eGFR≤40 mL/min/m2) and a high-volume contrast requiring cardiovascular procedure (estimated contrast volume&amp;gt;3 times eGFR value). The main exclusion criterion was administration of iodine contrast media within 5 days before index procedure. The primary endpoint was CI-AKI defined as an increase in sCr ≥0.3 mg/dL or an increase of 25% of basal value or requiring dialysis within 5 days after procedure. The primary analysis for efficacy is performed in a modified intention-to-treat basis. The trial was designed and monitored by an independent CRO (Cardiovascular European Research Center, CERC, Massy, France). Results A total of 259 patients aged 79.1±8.8 yrs were included in the study. Among them, 129 were assigned to RenalGuard therapy and 130 to preventive saline hydration. Their mean baseline eGFR was 32 (25; 37) vs. 33 (25; 39) mL/min/m2, respectively (p=0.88). Total fluid intake volume within 24hrs before the procedure was 2383±1146 vs. 1386±842mL, respectively (p&amp;lt;0.0001). Procedure type was complex PCI (48%), TAVI (25%), peripheral intervention (18%), other structural intervention (9%) with no difference between groups (p=0.56). The total amount of contrast used for the procedure was 116.3±68.2mL in the RenalGuard arm vs. 104.1±56.7 mL in the conventional arm (p=0.26). A staged procedure was performed in 24 patients, including 16 in the RenalGuard and 8 in the control arm with a mean interval from the first intervention of 43±29 days and 24±19 days, respectively. For this second procedure, the total amount of contrast was 80±59 vs. 87±73mL. Conclusion The primary and secondary endpoints of the Study To evaluate the use of RENalGuard to proTect patients at High risk of CI-AKI comparing RenalGuard therapy to conventional hydration in 259 patients requiring complex percutaneous cardiovascular intervention will be presented. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): CERC

Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate–Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury

ObjectivesThis study compared left ventricular end-diastolic pressure (LVEDP)–guided and urine flow rate (UFR)-guided hydration. BackgroundTailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI). MethodsBetween July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed. ResultsThe primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030). ConclusionsThe study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.

Hydration Strategies for Preventing Contrast-Induced Acute Kidney Injury: A Systematic Review and Bayesian Network Meta-Analysis.

Aims Many previous studies have examined the effect of different hydration strategies on prevention of contrast-induced acute kidney injury (CI-AKI), but the optimal strategy is unknown. We performed a network meta-analysis (NWM) of these previous studies to identify the optimal strategy. Methods and Results Web of Science, PubMed, OVID Medline, and Cochrane Library were searched from their inception dates to September 30, 2018. Randomized controlled trials (RCTs) were selected based on strict inclusion criteria, and a Bayesian NWM was performed using WinBUGS V.1.4.3. We finally analyzed 60 eligible RCTs, which examined 21,293 patients and 2232 CI-AKI events. Compared to intravenous 0.9% sodium chloride (reference), intravenous sodium bicarbonate (OR [95% CI]: 0.74 [0.57, 0.93]), hemodynamic guided hydration (0.41 [0.18, 0.93]), and RenalGuard guided hydration (0.32 [0.14, 0.70]) significantly reduced the occurrence of CI-AKI. Oral hydration and intravenous 0.9% sodium chloride were each noninferior to no hydration in preventing CI-AKI. Intravenous 0.9% sodium chloride, sodium bicarbonate, and hemodynamic guided hydration were each noninferior to oral hydration in preventing CI-AKI. Based on surface under the cumulative ranking curve values, the RenalGuard system was best (0.974) and hemodynamic guided hydration was second best (0.849). Conclusion There was substantial evidence to support the use of RenalGuard or hemodynamic guided hydration for preventing CI-AKI in high-risk patients, especially those with chronic kidney disease or cardiac dysfunction.

Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial

IntroductionPercutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention...

RenalGuard system to prevent contrast-induced acute kidney injury in Japanese patients with renal dysfunction; RESPECT KIDNEY study.

Increasing the urine flow rate (UFR) reduces the toxic effect of contrast media. Use of the RenalGuard system enables the achievement of a high UFR by maintaining intravascular volume and prevents the development of contrast-induced acute kidney injury (CI-AKI). However, the efficacy and safety of RenalGuard system have not yet been evaluated in Japan. This multicenter prospective study evaluated the efficacy and safety of the RenalGuard therapy in preventing CI-AKI development in 60 Japanese patients with renal dysfunction [estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2] undergoing catheter procedures. Baseline eGFR and Mehran's CIN (contrast-induced nephropathy) risk score were 35.1 ± 8.5mL/min/1.73m2 and 11.7 ± 4.3, respectively. Regardless of this high-risk profile, the incidence of CI-AKI was 8.6% (5/58) compared with the 26.1% incidence estimated by the CIN risk score. Moreover, two-sided 95% (Fisher's) exact confidence interval was 2.9-19.0 and its upper limit (i.e., 19.0) was less than the prespecified threshold incidence of 25.0. Univariate logistic regression analysis demonstrated that the UFR during catheter procedure was one of the most important factor associated with CI-AKI (odds ratio 0.99, confidence interval 0.98-1.00, p = 0.03). In conclusion, RenalGuard therapy may prevent CI-AKI development in Japanese patients with renal dysfunction. Further large-scale prospective multicenter studies are necessary to confirm our findings.

High-volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast-induced nephropathy: A meta-analysis of randomized trials.

Contrast-induced nephropathy (CIN) is a well-recognized complication of coronary angiography that is associated with poor outcomes. Several small randomized controlled trials (RCTs) have recently shown that in patients with chronic kidney disease (CKD), furosemide-induced forced diuresis with matched hydration using the RenalGuard system can prevent its occurrence. However, individual studies have been underpowered and thus cannot show significant differences in major clinical endpoints. Forced diuresis with matched hydration using the RenalGuard system improves clinical outcomes in patients undergoing coronary angiography. Scientific databases and websites were searched for relevant RCTs. The pooled risk ratios were calculated using random-effects models. The primary endpoint was CIN, and the secondary endpoints were major adverse clinical events (MACEs) and the need for renal replacement therapy. Data from 3 trials including 586 patients were analyzed. High-volume forced diuresis with matched hydration using the RenalGuard system decreased risk of CIN by 60% (risk ratio: 0.40, 95% confidence interval: 0.25 to 0.65, P < 0.001), MACE rate by 59%, and the need for renal replacement therapy by 78%, compared with the standard of care. In patients with CKD undergoing coronary angiography, high-volume forced diuresis with matched hydration using the RenalGuard system significantly reduces the risk of CIN, MACE rate, and the need for renal replacement therapy. Larger RCTs with sufficient power are needed to confirm these findings.

The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study

ObjectivesAs proof of concept, this prospective, observational study assessed the feasibility and early clinical outcomes of performing on-pump cardiac surgery with the RenalGuard system.BackgroundAcute kidney injury (AKI) is reported in...

Use of the RenalGuard system to prevent contrast-induced AKI: A meta-analysis.

Contrast-induced kidney injury (CI-AKI) following cardiovascular interventions results in increased morbidity and mortality. RenalGuard (RG) is a novel, closed loop system which balances volume administration with forced diuresis to maintain a high urine output. We performed a meta-analysis of the existing data comparing use of RG to conventional volume expansion. Ten studies were found eligible, of which four were randomized controlled trials. Of an aggregate sample size (N) of 1585 patients, 698 were enrolled in the four RCTs and 887 belonged to the remaining registries included in this meta-analysis. Primary outcomes included CI-AKI incidence and relative risk. Mortality, dialysis, and major adverse cardiovascular events (MACCE) were secondary outcomes. A random effects model was used and data were evaluated for publication bias. RG was associated with significant risk reduction in CI-AKI compared to control (RR: 0.30, 95%CI: 0.18-0.50, P < 0.01). CI-AKI in RG was found to be 7.7% versus 23.6% in the control group (P < 0.01). Use of RG was associated with decreased mortality (RR: 0.43, 95%CI: 0.18-0.99, P = 0.05), dialysis (RR: 0.20, 95%CI: 0.06-0.61, P = 0.01), and MACCE (RR: 0.42, 95%CI: 0.27-0.65, P < 0.01) compared to control. RG significantly reduces rates of CI-AKI compared to standard volume expansion and is also associated with decreased rates of death, dialysis, and MACCE.

Prevention of Contrast-Induced Acute Kidney Injury by Furosemide With Matched Hydration in Patients Undergoing Interventional Procedures: A Systematic Review and Meta-Analysis of Randomized Trials

ObjectivesThe objective of this meta-analysis of randomized trials was to evaluate if the administration of furosemide with matched hydration using the RenalGuard System reduces contrast-induced acute kidney injury (CI-AKI) in patients undergoing interventional procedures. BackgroundCI-AKI is a serious complication following angiographic procedures and a powerful predictor of unfavorable early and long-term outcomes. MethodsOnline databases were searched up to October 1, 2016, for randomized controlled trials. The primary outcome was the incidence of CI-AKI, and the secondary outcomes were need for renal replacement therapy, mortality, stroke, and adverse events. ResultsA total of four trials (n = 698) published between 2011 and 2016 were included in the analysis and included patients undergoing percutaneous coronary procedures and transcatheter aortic valve replacement. RenalGuard therapy was associated with a lower incidence of CI-AKI compared with control treatment (27 of 348 [7.76%] patients vs. 75 of 350 [21.43%] patients; odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.19 to 0.50; I2 = 4%; p < 0.00001) and with a lower need for renal replacement therapy (2 of 346 [0.58%] patients vs. 12 of 348 [3.45%] patients; OR: 0.19; 95% CI: 0.05 to 0.76; I2 = 0%; p = 0.02). No major adverse events occurred in patients undergoing RenalGuard therapy. ConclusionsThe main finding of this meta-analysis is that furosemide with matched hydration by the RenalGuard System may reduce the incidence of CI-AKI in high-risk patients undergoing percutaneous coronary intervention or transcatheter aortic valve replacement. However, further independent high-quality randomized trials should elucidate the effectiveness and safety of this prophylactic intervention in interventional cardiology.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI. This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

Renal guard system in high-risk patients for contrast-induced acute kidney injure

Renal guard system in high-risk patients for contrast-induced acute kidney injure

RenalGuard system in high-risk patients for contrast-induced acute kidney injury

High urine flow rate (UFR) has been suggested as a target for effective prevention of contrast-induced acute kidney injury (CI-AKI). The RenalGuard therapy (saline infusion plus furosemide controlled by the RenalGuard system) facilitates the achievement of this target. Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m(2) and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score >7%) treated by the RenalGuard therapy were analyzed. The primary end points were (1) the relationship between CI-AKI and UFR during preprocedural, intraprocedural, and postprocedural phases of the RenalGuard therapy and (2) the rate of acute pulmonary edema and impairment in electrolytes balance. Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P < .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CI-AKI prevention was a mean intraprocedural phase UFR ≥450 mL/h (area under curve 0.62, P = .009, sensitivity 80%, specificity 46%). Performance of percutaneous coronary intervention (hazard ratio [HR] 4.13, 95% CI 1.81-9.10, P < .001), the intraprocedural phase UFR <450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose >0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P < .001) were independent predictors of CI-AKI. Pulmonary edema occurred in 4 patients (1%). Potassium replacement was required in 16 patients (4%). No patients developed severe hypomagnesemia, hyponatremia, or hypernatremia. RenalGuard therapy is safe and effective in reaching high UFR. Mean intraprocedural UFR ≥450 mL/h should be the target for optimal CI-AKI prevention.

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).

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.