SAFETY IN THE CATH LAB How to Minimise Contrast Toxicity

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1 SAFETY IN THE CATH LAB How to Minimise Contrast Toxicity Dr. Vijay Kunadian MBBS, MD, MRCP Senior Lecturer and Consultant Interventional Cardiologist Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University & Freeman Hospital, Newcastle upon Tyne

2 I DO NOT HAVE ANY CONFLICT OF INTEREST TO DECLARE

3 Contrast Media in Cath Lab In the UK 231, 510 coronary angiography procedures per year and 87, 676 PCI procedures per year are carried out.

4 Definition and Incidence Contrast- induced nephropathy (CIN): A rise in serum creatinine by either 0.5 mg/dl or by 25% from baseline within the first 2 3 days after contrast administration Incidence of CIN: Ranges from 0.6% to 2.3%. CIN rate may be as high as 50% in the presence chronic renal insufficiency and diabetes mellitus.

5 Mechanisms of CIN Ischemia/hypoxemia Contrast media reduces renal blood flow, particularly in the medulla of the kidney. Inhibition of NO synthesis Cell toxicity CM are taken up by renal tubule cells and interfere with mitochondria, leading to the release of stimuli for the cell to undergo apoptosis.

6 CIN The Problem CIN is the third most common cause of acute renal failure in hospitalized patients. Nearly all cases reflect mild transient impairment of renal function. 7% require temporary dialysis or progress to end- stage renal disease. 13%- 50% of patients will require permanent renal replacement therapy. In- hospital mortality is extremely high (37-39%) in patients requiring dialysis after PCI. Circulation. 2002;;105(19):

7 Risk Factors for CIN Patient- related Risk Factors Renal insufficiency Diabetes mellitus with renal insufficiency Age Volume depletion Hypotension Low cardiac output Class IV CHF Other nephrotoxins Renal transplant Hypoalbuminemia (<35 g/l) Procedure- related Risk Factors Multiple contrast media injection within 72 hrs High volume of contrast media High osmolality of contrast media

8 Contrast Volume Contrast volume (from 100 ml to 800 ml) may increase the risk of CIN, depending mainly on patient characteristics, clinical scenarios, and CIN definition. In one trial, the cutoff dose of contrast below which there were no cases of acute renal failure requiring dialysis after coronary intervention was 100 ml. However, in patients with both chronic renal insufficiency and diabetes mellitus, even less than 100 ml of contrast agent may cause CIN. Am J Med. 1997;;103(5): Am J Med. 1990;;89(5):

9 Scheme to Define CIN Risk Score Risk Factors Integer Score Hypotension 5 IABP 5 CHF 5 Age >75 years Anemia Diabetes Risk Score Risk of CIN Risk of Dialysis 5 7.5% 0.04% Contrast media volume 1 for each 100 cc 3 Calculate 6 to % 0.12% Serum creatinine > 1.5mg/dl 4 OR egfr <60ml/min/1.73 m 2 2 for for for < 20 egfr < 60ml/min/1.73 m 2 = 186 x (SCr) x (Age) X (0.742 if female) x (1.210 if African American) 11 to % 1.09% % 12.6% Mehran et al. JACC 2004;;44:

10 CIN Risk Score & 1- year Mortality 1-year mortality Red bars = development dataset Blue bars = validation dataset Risk Groups: Low Moderate High Very High Risk Score: 5 6 to to Prognostic significance of the proposed risk score for CIN extended to prediction of 1-year mortality. Mehran et al. JACC 2004;;44:

11 Tested Therapies so far. Pharmacologic strategies Hydration Beneficial Na bicarbonate May be beneficial Furosemide May be harmful Mannitol May be harmful N- acetylcysteine Inconsistent data Dopamine No benefit Fenoldopam No benefit Theophylline Inconsistent data Ca channel block Inconsistent data ACEI/ARB Inconsistent data ANP No benefit Prostaglandin E1 May be beneficial Statins May be beneficial Non- pharmacologic strategies Hemodialysis Inconsistent data Hemofiltration May be beneficial Benephit May be beneficial RenalGuard May be beneficial

12 N- Acetylcysteine- NAC 2,308 Patients undergoing an angiographic procedure with at least one of the following risk factors: Age > 70 years;; Chronic Renal Failure;; Diabetes Mellitus;; Heart Failure or LVEF <0.45;; Shock Concealed Randomization Acetylcysteine 1200mg Orally Twice Daily for 2 Doses Before and 2 Doses After Procedure ITT Matching Placebo ITT Primary Endpoint: Contrast-induced nephropathy (CIN) ( 25% elevation of serum creatinine above baseline 48h-96h after angiography) Secondary Endpoints: Total mortality, CV mortality, Need for dialysis, Doubling of serum creatinine, Side effects Circulation 2011 Sep 13;;124(11):

13 N- Acetylcysteine ACT- Results X Circulation 2011 Sep 13;;124(11):

14 N- Acetylcysteine ACT- Results X Circulation 2011 Sep 13;;124(11):

15 Hydration with 0.9% Saline Mueller, C. et al. Arch Intern Med 2002;;162:

16 Hydration with 0.9% Saline 1 ml/kg of body weight per hour for 24 hours Mueller, C. et al. Arch Intern Med 2002;;162:

17 Early Hydration with Sodium Bicarbonate Patients underwent primary PCI Maioli M et al. Circ Cardiovasc Interv 2011;;4:

18 Sodium Bicarbonate

19 RenalGuard System No inadvertant volume depletion. Loading dose of 250 ml saline IV fluids matched in real time to urine output. Low dose furosemide mg/kg

20 REMEDIA II Trial Sodium Bicardonate & Acetylcysteine RenalGuard group Hydration by sodium bicarbonate (3 ml/kg i.v. 1 h before and 1 ml/kg for 6 h after) & NAC 1200 mg BID x 2 & 1.5 g e.v. during the procedure Hydration with normal saline (urine flow 300 ml/h) & NAC (1.5 g/l) & limited (0.25 mg/kg) furosemide dose Circulation Sep 13;;124(11):1260-9

21 Clinical Characteristics Control Group (N=146) RenalGuard Group (N=146) Age, yrs (mean ± SD) 75 ± 9 76 ± Male, % 103 (70.5%) 88 (60.5%) BMI (kg/m 2 ) 29± 5 28 ± Blood pressure (mm Hg) Systolic Diastolic Mean 152±27 78±10 103±13 152±27 77±13 102±15 P LVEF, % (mean ± SD) 48 ± ± LVEDP (mm Hg) 14±7 14± Diabetes mellitus 104 (71%) 101 (69%) 0.51 Hypertension, % 144 (98%) 143 (98%) 0.95 Drugs: ACE inhibitor Calcium channel blocker Angiotensin II receptor inhibitor Diuretics b blocker Statins 67 (46%) 44 (30%) 45 (31%) 85 (58%) 88 (60%) 111 (76%) 70 (48%) 36 (25%) 42 (29%) 93 (64%) 92 (63%) 108 (74%) Circulation Sep 13;;124(11):1260-9

22 RenalGuard group Pre- procedure Procedure Post- procedure 600 Urine flow rate (ml/h) Foley Catheter RenalGuard system Prime ( 250 ml) Furosemide (0.25 mg/kg) Continuous real- time matched replacement fluid Biomarkers: Ä scr = baseline, 2, 6, 12, 24 and 48 hours Ä scyc = baseline, 2, 6, 12, 24 and 48 hours Ä NGAL = baseline, 2, 6, 12, 24 and 48 hours Patient ready forprocedure when urine flow rate is 300 ml/h Time (minutes) Circulation Sep 13;;124(11):1260-9

23 Urine Volume at 24 hours p < Control Group RenalGuard group Circulation Sep 13;;124(11):1260-9

24 Primary endpoint CI- AKI (%) Odds ratio = 0.47; 95% CI= , p = % 30/146 11% 16/ Control group RenalGuard group Circulation Sep 13;;124(11):1260-9

25 MYTHOS Consecutive CKD patients (egfr<60ml/min/1.73m 2 ) undergoing coronary angiography between September 1, 2008 and September 15, 2010 NSTEMI patients with CKD undergoing urgent coronary angiography (n=73) Stable CKD patients undergoing elective coronary angiography (n=101) Randomized (n=174) Intention-to-treat sample Allocated to control group (n=85) Allocated to FMH group (n=89) 2 patients excluded (withdrawal of elective coronary angiography and acute pulmonary edema during hydration) 2 patients excluded (failure to insert Foley catheter) analyzed (n=83) per-protocol sample analyzed (n=87) per-protocol sample Marenzi G. et al. JACC Interv 2012

26 MYTHOS CIN incidence (%) P= % RR = 0.29 (95% CI ) Control group 18% P=0.44 RR = 0.42 (95% CI ) 10% 4.6% 4% P=0.003 RR = 0.16 (95% CI ) N=83 N=87 N=52 N=48 N=31 N=39 Overall Elective angiography Urgent angiography 5% FMH group Marenzi G. et al. JACC Interv 2012

27 CARE Design DESIGN: Prospective, randomized, double-blind, parallel-group, multi-center clinical evaluation iopamidol-370 and iodixanol patients enrolled between July 2005 and June 2006 in 25 clinical site in North America 468 assigned to a treatment arm 14 patients withdrew consent OBJECTIVE: To compare the incidence of CIN between iopamidol-370 and iodixanol-320 PRIMARY ENDPOINT: Increase in SCr 0.5 mg/dl from baseline to 45 to 120 hours after administration 230 patients assigned to Iopamidol evaluable patient 26 excluded 236 patients assigned to Iodixanol excluded 210 evaluable patient Solomon, RJ et. al., Circulation 115, 3189 (2007)

28 CARE p = 0.39 p = 0.44 p = 0.15 Solomon, RJ et. al., Circulation 115, 3189 (2007)

29 Summary CIN is one of the most important independent predictors of poor outcome post PCI CIN remains a frequent source of acute renal failure and is associated with increased morbidity and mortality, and higher resource utilization Several factors predispose patients to CIN Preventive measures pre procedure, as well as careful post procedure management should be routine in all patients

30 How to minimise CIN 1. Matched Hydration 2. Discontinue nephrotoxic drugs (NSAIDS, antibiotics, etc) 3. Limit contrast agent volume 4. Low- osmolar/iso- osmolar agents preferable 5. RenalGuard appears promising...

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