Publications
Clinical Data and Publications
Cardiac Surgery AKI
KIDNEY Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial (2021)
Abstract
Objectives: Our goal was to investigate the efficacy of balanced forced diuresis in reducing the rate of acute kidney injury (AKI) in cardiac surgical patients requiring cardiopulmonary bypass (CPB), using the RenalGuard® (RG) system.
Methods: Patients at risk of developing AKI (history of diabetes and/or anaemia; estimated glomerular filtration rate 20-60 ml/min/1.73 m2; anticipated CPB time >120 min; log EuroSCORE > 5) were randomized to the RG system group (n = 110) or managed according to current practice (control = 110). The primary end point was the development of AKI within the first 3 postoperative days as defined by the RIFLE (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease) criteria.
Results: There were no significant differences in preoperative and intraoperative characteristics between the 2 groups. Postoperative AKI rates were significantly lower in the RG system group compared to the control group [10% (11/110) vs 20.9% (23/110); P = 0.025]. This effect persisted even after controlling for a number of potential confounders (odds ratio 2.82, 95% confidence interval 1.20-6.60; P = 0.017) when assessed by binary logistic regression analysis. The mean volumes of urine produced during surgery and within the first 24 h postoperatively were significantly higher in the RG system group (P < 0.001). There were no significant differences in the incidence of blood transfusions, atrial fibrillation and infections and in the median duration of intensive care unit stays between the groups. The number needed to treat with the RG system to prevent AKI was 9 patients (95% confidence interval 6.0-19.2).
Conclusions: In patients at risk for AKI who had cardiac surgery with CPB, the RS RG system significantly reduced the incidence of AKI and can be used safely and reproducibly. Larger studies are required to confirm cost benefits.
Balanced forced‐diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes
Abstract
Objectives
Forced‐diuresis during cardiopulmonary bypass (CPB) can be associated with significant electrolyte shifts. This study reports on the serum electrolyte changes during balanced forced‐diuresis with the RenalGuard® system (RG) during CPB.
Methods
Patients at risk of acute kidney injury (AKI)—(history of diabetes &/or anaemia, e‐GFR 20–60 ml/min/1.73 m2, anticipated CPB time >120 min, Log EuroScore >5)—were randomized to either RG (study group) or managed as per current practice (control group).
Results
The use of RG reduced AKI rate (10% for RG and 20.9% in control, p = .03). Mean urine output was significantly higher in the RG group during surgery (2366 ± 877 ml vs. 765 ± 549 ml, p < .001). The serum potassium levels were maintained between 3.96 and 4.97 mmol/L for the RG group and 4.02 and 5.23 mmol/L for the controls. Median potassium supplemental dose was 60 (0–220) mmol (RG group) as compared to 30 (0–190) mmol for control group over first 24 h (p < .001). On Day 1 post‐op, there were no significant differences in the serum sodium, potassium, calcium, magnesium, phosphate, and chloride levels between the two groups. Otherwise, postoperative clinical recovery was also similar.
Conclusions
Balanced forced‐diuresis with the RG reduced AKI rates after on‐pump cardiac surgery compared to controls. Although the RG group required higher doses of IV potassium replacement in the postoperative period, normal serum levels of potassium were maintained by appropriate intravenous potassium supplementation and the clinical outcomes between groups were similar.
Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131.
NGAL Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels
Abstract
Background: Neutrophil gelatinase-associated lipocalin (NGAL) is a recognised biomarker for acute kidney injury (AKI).This study investigated the impact of balanced forced-diuresis using RenalGuard® system (RG), in reducing acute kidney injury (AKI) rates and the associated NGAL levels (6-h post-CPB plasma level) post adult cardiac surgery with cardiopulmonary bypass (CPB).
Methods: Patients included in the study were at high-risk for AKI post cardiac surgery, namely history of diabetes and/or anaemia, e-GFR 20-60 ml/min/1.73 m2, Logistic EuroScore > 5, anticipated CPB time > 120 min. Patients were randomized to either RG (n = 110) or managed as per current practice (control = 110). RIFLE-defined AKI rate (based on serum creatinine level increase) within first 3 days of surgery and 6-h post CPB NGAL levels were the primary and secondary end-points.
Results: Pre and intra-operative characteristics between the two groups were similar (p > 0.05) including the pre-op NGAL levels, the oxygen delivery (ecDO2i) and the carbon dioxide production (ecVCO2i) during CPB. Patients in the RG group had a significantly lower post-operative RIFLE-defined AKI rate compared to control (10% (11/110) v/s 20.9% (23/110), p = 0.03). Overall, median 6-h post CPB NGAL levels in patients with AKI were significantly higher than those who did not develop AKI (211 vs 150 ng/ml, p < 0.001). Patients managed by balanced forced-diuresis had lower post-operative NGAL levels (146 vs 178 ng/ml, p = 0.09). Using previously reported NGAL cut-off level for AKI (142 ng/ml), binary logistic regression analysis confirmed a beneficial effect of the RG system, with an increased risk of AKI of 2.2 times in the control group (OR 2.2, 95% CI 1.14-4.27, p = 0.02).
Conclusions: Overall, the 6-h post-CPB plasma NGAL levels were significantly higher in patients who developed AKI. Patients managed with the novel approach of balanced forced-diuresis, provided by the RenalGuard® system, had a lower AKI rate and lower NGAL levels indicating a lesser degree of renal tissue injury.
Luckraz et al. J Cardiothorac Surg (2021) 16:240 https://doi.org/10.1186/s13019-021-01620-w
A new approach for the prevention of acute kidney injury in on-pump cardiac surgery (2021)
Abstract
Purpose: Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) is linked to significant patient morbidity and mortality. We assessed the use of instantaneous balanced forced diuresis provided by the RenalGuard® (RG) system in the perioperative phase and its impact on CSA-AKI.
Description: From September 2015 to June 2019, the RG system was used in 120 patients at high risk of CSA-AKI. The first 10 patients were studied as part of a device evaluation exercise, followed by a randomized study comparing the use of RG (110 patients) versus standard practice (110 patients). The balanced forced diuresis was started at induction of anesthesia, continued throughout surgery, and up to six hours post-admission on the CICU.
Evaluation: The RG system reduced CSA-AKI rates significantly without impacting the post-operative rates of atrial fibrillation, blood transfusion, and infection. Patients on the RG system produced 3 liters-5 liters of urine intra-operatively and required a higher dose of potassium supplementation (median dose 60 mmol vs. 30 mmol)
Conclusions: CSA-AKI rate is lowered by the RG system. Further studies are required to assess cost-benefit.
Clinical Practice 2021
The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study (2017)
Abstract
Objectives: As proof of concept, this prospective, observational study assessed the feasibility and early clinical outcomes of performing on-pump cardiac surgery with the RenalGuard system.
Background: Acute kidney injury (AKI) is reported in up to 30% of patients undergoing cardiac surgery and is a recognised independent predictor of both morbidity and mortality. Forced diuresis with the RenalGuard system reduces the incidence of AKI during percutaneous coronary intervention procedures but its use in cardiac surgery has not been explored.
Methods: Ten consecutive patients who were at risk of developing AKI during cardiac surgery were selected. The RenalGuard system was used to facilitate forced diuresis using weight-adjusted intravenous furosemide while maintaining neutral fluid balance by matched intravenous fluid replacement. This regimen was initiated preoperatively in all patients and continued for 6-12 hours postoperatively. Serum creatinine, electrolytes and need for renal replacement were documented in all patients.
Results: The RenalGuard system functioned successfully in all patients and facilitated high perioperative urine outputs, even when patients were placed on cardiopulmonary bypass (CPB). There were no incidences of significant (A) electrolyte imbalance, (B) changes in haemoglobin levels or (C) pulmonary oedema. No patients developed AKI within 36 hours of surgery despite one patient developing cardiac tamponade 8 hours postoperatively and one patient developing paralytic ileus. One patient, however, was 'electively' haemofiltered on day 2 after developing acute right ventricular failure. The median intensive care stay was 1.5 (1, 5) days.
Conclusion: The RenalGuard system can be used successfully in patients undergoing cardiac surgery with CPB and may reduce the incidence of AKI in at-risk patients.
Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2)
Contrast Induced AKI
The treatment of coronary artery disease in patients with chronic kidney disease: gaps, challenges and solutions (2023)
Abstract
Background: Chronic kidney disease (CKD) is associated with a high burden of coronary artery disease (CAD), which remains the leading cause of death in CKD patients. Despite the high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularization.
Summary: The management of CAD is more challenging in patients with CKD than in the general population due to concerns regarding side effects and renal toxicity, as well as uncertainty regarding clinical benefit of guideline-based medical therapy and interventions. Patients with advanced CKD and especially those receiving dialysis have not traditionally been represented in randomized trials evaluating either medical or revascularization therapies. Thus, only scant data from small prospective studies or retrospective analyses are available. Recently published studies suggest that there are significant opportunities to substantially improve both cardiovascular and renal outcomes of patients with CAD and CKD, including new medications and interventions. Thus, the objective of this review is to summarize the current evidence regarding the management of CAD in CKD patients, in particular with respect to improvement of both cardiovascular and renal outcomes.
Key Messages: Adequate medical therapy and coronary interventions using evidence-based strategies can improve both cardiac and renal outcomes in patients with CAD and CKD.
Karger: Kidney Diseases Kidney DOI: 10.1159/000533970
REMEDIAL III REnal Insufficiency Following Contrast MEDIA Administration TriaL III (2017)
Contribution To Literature:
The REMEDIAL III trial showed that a UFR-guided strategy using the RenalGuard System is superior to a LVEDP-guided strategy based on IV hydration in reducing contrast-induced acute kidney injury among patients with CKD and at high risk for this endpoint.
Description:
The goal of the trial was to compare the safety and efficacy of left ventricular end-diastolic pressure (LVEDP)-guided vs. urine flow rate (UFR)-guided hydration to prevent contrast-induced nephropathy among patients with chronic kidney disease (CKD) undergoing angiography or percutaneous coronary intervention (PCI).
AKIGUARD (acute kidney injury guarding device) independent, randomized and controlled trial on contrast-induced acute kidney injury prevention in the cath lab: in-hospital and one year outcomes (2014)
Abstract
Aims: Contrast-induced acute kidney injury (CIAKI) in patients with chronic kidney disease undergoing coronary angiography or percutaneous coronary intervention is a common iatrogenic complication associated with increased morbidity and mortality. This study compares sodium bicarbonate/isotonic saline/N-acetylcysteine/vitamin C prophylaxis (BS-NAC) against high-volume forced diuresis with matched hydration in CIAKI prevention.
Methods: One-hundred and thirty-three consecutive patients undergoing coronary angiography or percutaneous coronary intervention with estimated glomerular filtration rate less than 60 mL/min/1.73m were randomized to the study group receiving matched hydration (MHG) or to the control group receiving BS-NAC. MHG received in vein (i.v.) 250 mL isotonic saline bolus, followed by a 0.5 mg/kg furosemide i.v. bolus to forced diuresis. A dedicated device automatically matched the isotonic saline i.v. infusion rate to the urinary output for 1 h before, during and 4 h after the procedure.
Results: MHG had the lowest incidence of CIAKI (7 vs. 25%, P = 0.01), major adverse cardiac and cerebrovascular events at 1 year (7 vs. 32%, P < 0.01) and readmissions to cardiology/nephrology departments (8 vs. 25%, P = 0.03; hospitalization days 1.0 ± 3.8 vs. 4.9 ± 12.5, P = 0.01). Three months after the procedure the decrease in the estimated glomerular filtration rate was 0.02% for MHG versus 15% for the control group.
Conclusion: Matched hydration was more effective than BS-NAC in CIAKI prevention. One-year follow-up showed that matched hydration was associated also with limited chronic kidney disease progression, major adverse cardiac and cerebrovascular events and hospitalizations.
European Heart Journal ( 2014 ) 35 ( Abstract Supplement ), 142
MYTHOS: Prevention of Contrast Nephropathy by Furosemide with Matched Hydration (2012)
Abstract
Objectives
This study investigated the effect of furosemide-forced diuresis and intravenous saline infusion matched with urine output, using a novel dedicated device designed for contrast-induced nephropathy (CIN) prevention.
Background
CIN is a frequent cause of acute kidney injury associated with increased morbidity and mortality.
Methods
A total of 170 consecutive patients with chronic kidney disease (CKD) undergoing coronary procedures were randomized to either furosemide with matched hydration (FMH group, n = 87) or to standard intravenous isotonic saline hydration (control group; n = 83). The FMH group received an initial 250-ml intravenous bolus of normal saline over 30 min followed by an intravenous bolus (0.5 mg/kg) of furosemide. Hydration infusion rate was automatically adjusted to precisely replace the patient's urine output. When a urine output rate >300 ml/h was obtained, patients underwent the coronary procedure. Matched fluid replacement was maintained during the procedure and for 4 h post-treatment. The definition of CIN was a ≥25% or ≥0.5 mg/dl rise in serum creatinine over baseline.
Results
In the FMH group, no device- or therapy-related complications were observed. Four (4.6%) patients in the FMH group developed CIN versus 15 (18%) controls (p = 0.005). A lower incidence of cumulative in-hospital clinical complications was also observed in FMH-treated patients than in controls (8% vs. 18%; p = 0.052).
Conclusions
In patients with CKD undergoing coronary procedures, furosemide-induced high urine output with matched hydration significantly reduces the risk of CIN and may be associated with improved in-hospital outcome.
JACC: Cardiovascular Interventions Volume 5, Issue 1, January 2012, Pages 90-97
REMEDIAL II: Renal Insufficiency After Contrast Media Administration (2011)
Abstract
Background: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury.
Methods and results: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2) and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2): odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus -0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group.
Conclusion: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.
Circulation Aug 2011; Online ISSN: 1524-4359
Optimization and simplification of transcatheter aortic valve implantation therapy. (2018)
Abstract
Transcatheter aortic valve implantation (TAVI) is now a widely adopted therapy for the treatment of elderly patients with severe aortic stenosis. Improved pre-procedural screening, increased operators' experience and technology advancement have made this technique highly reliable and standardized. Areas covered: The purpose of this review article is to provide an overview of the strategies that can be adopted to optimize the TAVI procedure (pre-interventional work-up and procedural simplification and early discharge). Expert commentary: Optimization of TAVI therapy is already a reality and has shown to be safe in most patients, but its penetration has to face with real-world practice. The adoption of a minimalistic and optimized approach requires integration of multidisciplinary competences and an extended, dynamic conception of heart team, which also includes patients' families, referring cardiologist and general practitioners.
2018 Mar 9:1-10. doi: 10.1080/14779072.2018.1449644
High Urine Output With Matched Hydration for CI-AKI Prevention “Salus Per Aquam” (Health Through Water) (2017)
"In conclusion, despite the limitations that are common to all meta-analyses and the small number of trials published, the authors must be complimented for this important study. The results of their meta-analysis, along with those of other multicenter randomized trials that are needed to corroborate the present findings, suggest that furosemide-induced high-volume diuresis and maintenance of euvolemia through matched fluid replacement (RenalGuard therapy) might become a standard of care strategy for the prevention of CI-AKI in high-risk patients."
JACC: Cardiovascular Interventions Volume 10, Issue 4, February 2017; 364-366
Prevention of Contrast-Induced Acute Kidney Injury by Furosemide With Matched Hydration in Patients Undergoing Interventional Procedures (2017)
Abstract
Objectives: The 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.
Background: CI-AKI is a serious complication following angiographic procedures and a powerful predictor of unfavorable early and long-term outcomes.
Methods: Online 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.
Results: A 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.
Conclusions: The 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.
JACC: Cardiovascular Interventions Volume 10, Issue 4, February 2017; 355-363
PROTECT-TAVI Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement (2015)
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.
JACC Cardiovascular Interventions 2015;8(12):1595-1604.
Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population (2017)
Abstract
Background: Radiologists and cardiologists have a remarkably different approach to the clinical importance and to the need for prophylactic treatment of contrast-induced acute kidney injury (CI-AKI).
Objectives: To evaluate the efficacy of forced diuresis with matched controlled hydration (FMH) in a real-world, high risk population.
Methods: This is an investigator-driven, single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with FMH were compared to a matched historical control cohort.
Results: In the FMH treated patients, eGFR improved following the procedure from 37ml/min per 1.73m2 at baseline to 39ml/min per 1.73m2 (p<0.001); the net creatinine decreased from 1.85mg/dl to 1.78mg/dl (p<0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7ml/min per 1.73m2 to 33.2ml/min per 1.73m2 post procedurally (p<0.001); the net creatinine increased from 1.88mg/dl to 2.14mg/dl (p<0.001). The incidence of post procedural AKI was substantially lower in the FMH treated group (2.7%) compared to the control group (26.7%). By multivariable analysis FMH treatment was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p<0.001). Contrast volume did not correlate with AKI in neither univariate nor multivariate analyses.
Conclusions: In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI.
International Journal of Cardiology 226 (2017) 42–47
CA AKI & TAVI RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation (2016)
Abstract
Aims: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI).
Methods and results: 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.
Conclusions: This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.
EuroIntervention 2016;11:e1658-e1661
RenalGuard system in high-risk patients for contrast-induced Acute Kidney Injury (2016)
Abstract
Background: 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.
Methods Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m2 and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score N7%) 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.
Results: Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P b .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CIAKI 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 b .001), the intraprocedural phase UFR b450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose N0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P b .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.
Conclusions: 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.
American Heart Journal 173; March 2016; 67-76
Comparison Of Renalguard System, Continuous Venovenous Hemofiltration And Hydration In High-Risk Patients For Contrast-Induced Nephropathy (2012)
Abstract
Background
Contrast Induced - Nephropathy (CIN) is a relatively frequent complication of percutaneous coronary and peripheral artery interventions and is associated with significant in–hospital and long term morbidity and mortality. We aim to compare the impact on major events of RenalGuard system (RG), continuous veno–venous Hemofiltration (CVVH) and hydration (Hy) with sodium bicarbonate plus N–acetylcysteine in patients with severe renal failure.
Methods
We assigned 100 consecutive not dialyzed patients with severe renal failure (eGFR ≤30 mL/min × 1.73m2 or with a baseline Serum Creatinine > 1.5 mg/dL, or with a CIN risk score ≥ 11) scheduled for an elective percutaneous coronary and/or peripheral interventions to a preventive strategy with RG (33 pts), CVVH (35 pts) or Hy (32 pts). Primary end points were In–Hospital and 1 month dialysis and MACEs, and CIN. Secondarily, 6–Month MACEs were recorded.
Results
In–H dialysis occurred in none of RG patients, 7 (20%) of CVVH patients vs 2 (6.3%) of Hy group (p=0.013). In–H MACEs were significantly less frequent in RG procedure [RG:2 (6.1%), CVVH: 13 (37.1%) and Hy: 4 (12,5%) p=0.003; OR RG vs CVVH: 0.12; CI:0.02–0.60, p=0.01]. Similar trends were seen at 1 and 6 month follow–up. In particular, none of RG patients died at 6 month FU, vs 9 (25,7%) CVVH patients and 2 (6,3%) Hydration protocol patients (p=0.002). Albeit not significant, CIN occurred less frequently in RG patients (15.2%) than CVVH (31.4%) and hydration protocol (25.0%) (p=0,288).
Conclusions
For the first time, RenalGuard(r) system, CVVH and hydration with sodium bicarbonate and N–Acetylcysteine were compared in a real–world population: RG demonstrated to be a safe procedure and to significantly reduce the risk of In–Hospital, 1 month and 6 month MACEs, compared to continuous veno–venous Hemofiltration and Hydration.
Journal of the American College of Cardiology Volume 59, Issue 13 Suppl S, March 27, 2012
Feasibility study of the RenalGuard™ balanced hydration system: A novel strategy for the prevention of contrast-induced nephropathy in high risk patients (2011)
Abstract
Background: Contrast-induced nephropathy (CIN) is a frequent complication following angiographic procedures with significant impact on healthcare costs, and long-term outcomes. Multiple reno-protective strategies have been studied but few have shown benefit in prospective randomized studies beyond limiting the exposure to iodinated contrast and adequate intravenous. We studied the performance and safety of a novel system designed to achieve precise real-time high volume fluid balance using a closed loop hydration monitoring and infusion system.
Methods: This prospective, multi-center, FDA approved phase II feasibility study was designed to evaluate the safety and the performance of the RenalGuard matched hydration system. Between October 2006 and November 2007, twenty-three subjects at high risk for CIN (with an estimated glomerular filtration rate (eGFR)<50ml/min/1.73m(2)) undergoing diagnostic or therapeutic catheterization were treated with the system. The primary endpoint of the study was defined as the ability of the system to effectively dynamically match fluid administration to urine output.
Results: The 23 subjects at high risk for CIN enrolled had a mean±SD eGFR of 39±9.3. Patients achieved an hourly urine flow rate of 620±400ml/h. The system had a mean effectiveness rate of 99.9% over the duration of therapy with an average saline volume infused of 3825ml closely matched, minute to minute, to urine output of 3579ml. There were no major device-related complications from the experimental therapy, though one patient developed hypokalemia requiring replacement. Two subjects (9.5%) developed CIN as defined by >0.5mg/dl or >25% rise in serum creatinine at 48-60h post contrast administration when compared with the baseline.
Conclusion: The study confirmed that the RenalGuard(TM) system is safe and dynamically balances volume hydration with urine production. Further randomized studies are needed to confirm the efficacy of the system in reducing the incidence of CIN.
International Journal of Cardiology Int J Cardiol (2011), 10.1016/j.ijcard.2011.11.035 December 29, 2011