Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey...

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Transcript of Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey...

Page 1: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.
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Prakash Balan, MD, JD, FACC, FSCAIAssociate ProfessorInterventional CardiologyThe University of Texas Health Science CenterHouston, Texas

Best Practices for Screening Patients with Chronic Kidney Disease in the Catheterization Laboratory

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Financial Disclosures

Prakash Balan, MD, JD, FACC, FSCAI

• Consultant: Osprey Medical Pty, Ltd.

• Consultant/Speaker: Abiomed, Inc.

• Speaker: Chiesi, Inc.

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Learning Objectives

• Understand the definition of CKD and the clinical metrics used to screen for CKD

• Identify comorbidities that impact the outcomes of patients with CKD

• Establish appropriate contrast dose thresholds, and implement athreshold management system in the catheterization laboratory

CKD = chronic kidney disease.

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Heart and Kidneys Work Together

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Nephrons in the Kidney

• Tiny filters in the kidney that purify blood and remove waste products

• Each kidney contains ~1 million nephrons

• Nephrons do not regenerate NIH National Institute of Diabetes and Digestive and Kidney Diseases [website]. Your kidneys & how they work. https://www.niddk.nih.gov/health-information/kidney-disease/kidneys-how-they-work. Accessed September 17, 2018.

Tubules

Glomerulus (filter)

Tubules

Kidney

Blood with waste

Blood without waste

Ureter

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Did You Know?

• All of the blood in the body passes through the kidneys several times a day

• Kidneys remove ~2 quarts of toxins, wastes, and water from your body

• The kidneys filter 120-150 quarts of blood every day, enough to fill a large bathtub

NIH National Institute of Diabetes and Digestive and Kidney Diseases [website]. Your kidneys & how they work. https://www.niddk.nih.gov/health-information/kidney-disease/kidneys-how-they-work. Accessed September 17, 2018. KidneyChat.com [website]. Understanding the function of the kidney? https://www.kidneychat.com/function-of-the-kidney.html. Accessed September 17, 2018.

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The Heart and Kidneys Work Together

• 25% of the cardiac output goes to the kidneys• Without the heart, the kidneys would not have oxygenated

blood to perform their important functions – Waste removal

– Blood pressure maintenance

– Electrolyte balance

– Hormone production

• Without the kidneys, the hormone system regulating blood pressure goes into overdrive and the heart has to pump against higher arterial pressure

• The heart eventually experiences increased workload

NIH National Institute of Diabetes and Digestive and Kidney Diseases [website]. Heart disease & kidney disease. https://www.niddk.nih.

gov/health-information/kidney-disease/heart-disease. Accessed September 17, 2018. National Kidney Foundation [website]. The heart and kidney connection. https://www.kidney.org/atoz/content/heart-and-kidney-connection. Accessed September 17, 2018. Heart Matters

[website]. The heart-kidney link. https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/kidney-heart-link. Accessed September 17, 2018.

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What Is True for the Heart Is True for the Kidneys

NIH National Institute of Diabetes and Digestive and Kidney Diseases [website]. Heart disease & kidney disease. https://www.niddk.nih.

gov/health-information/kidney-disease/heart-disease. Accessed September 17, 2018. National Kidney Foundation [website]. The heart and kidney connection. https://www.kidney.org/atoz/content/heart-and-kidney-connection. Accessed September 17, 2018. Heart Matters

[website]. The heart-kidney link. https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/kidney-heart-link. Accessed September 17, 2018.

Decreased Blood Flow

Organ Injury

Ischemia

Necrosis

Loss of Function

Time is muscle. This applies to all tissue/organs. The heart is not unique!Kidneys need an environment rich in blood flow and oxygen to function properly

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Cardiorenal Syndrome

Ronco C, et al. J Am Coll Cardiol. 2008;52(19):1527-1539.

Hemodynamically Mediated Damage

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Chronic Kidney Disease

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Facts about CKD

• CKD is common among adults in the United States

– 30 million American adults have CKD

– Millions of others are at increased risk (1 in 3 adults)

• Heart disease is the most common cause of death among people with CKD

– If you have kidney disease, you are more likely to get heart disease

• 48% with severely reduced kidney function, not on dialysis, are not even

aware they have CKD

NIH National Institute of Diabetes and Digestive and Kidney Diseases [website]. Heart disease & kidney disease. https://www.niddk.nih.

gov/health-information/kidney-disease/heart-disease. Accessed September 17, 2018. National Kidney Foundation [website]. About chronic

kidney disease. https://www.kidney.org/atoz/content/about-chronic-kidney-disease. Accessed September 17, 2018. National Kidney

Foundation [website]. One in seven American adults estimated to have chronic kidney disease. https://www.kidney.org/news/one-seven-

american-adults-estimated-to-have-chronic-kidney-disease. Accessed September 17, 2018.

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Heart and Kidney Connection: Patients with CKD Have Higher Rates of Heart Disease

CVD = cardiovascular disease; ASHD = atherosclerotic heart disease; AMI = acute myocardial infarction; CHF = congestive heart failure; VHD = valvular heart disease; CVA/TIA = cerebrovascular accident/transient ischemic attack; PAD = peripheral artery disease; AFIB = atrial fibrillation; SCA/VA = sudden cardiac arrest/ventricular arrhythmia; VTE/PE = venous thromboembolism and pulmonary embolism. USRDS United States Renal Data System [website]. Chapter 4: Cardiovascular disease in patients with CKD. https://www.usrds.org/2016/view/v1_04.aspx. Accessed September 17, 2018.

70

0

40

Patie

nts

(%)

60

20

30

50

10

CVDAny CVD VHD AFIB VTE/PEPAD SCA/VAASHD CHFAMI CVA/TIA

With CKDWithout CKD

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How Do You Test for CKD?

• Urine test: Albumin-to-creatinine ratio (ACR)– Checks for protein in the urine, which can be a sign of CKD

– Typically part of a complete work-up of the urine to detect other possible signs of kidney damage or disease

• Blood test: Serum creatinine (SCr)– Measures level of SCr (waste product) in your blood

National Kidney Foundation [website]. About chronic kidney disease. https://www.kidney.org/atoz/content/about-chronic-kidney-disease. Accessed September 17, 2018.

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Helpful Measurements in Identifying CKD

• Serum creatinine (SCr)

– Waste product that comes from normal wear and tear on muscles in the body

– “Normal” creatinine depends on patient age, race, gender, and body size

• Estimated glomerular filtration rate (eGFR)

– eGFR is a better predictor of kidney disease stages than SCr alone

– eGFR takes multiple factors into account, such as SCr level, age, race, and gender

National Kidney Foundation [website]. About chronic kidney disease. https://www.kidney.org/atoz/content/about-chronic-kidney-disease. Accessed September 17, 2018.

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Stages of CKD

GFR = glomerular filtration rate.Fresenius Kidney Care [website]. Kidney disease stages. https://www.freseniuskidneycare.com/about-chronic-kidney-disease/stages/chronic-kidney-disease-ckd-stages. Accessed September 17, 2018.

STAGE 1 STAGE 2 STAGE 3 STAGE 4 STAGE 5CKD Risk Factors/Damage with Preserved GFR

MildReducedKidneyFunction

ModerateReducedKidneyFunction

SevereReducedKidneyFunction

KidneyFailure

eGFR (mL/min)90 1560 30

SCr88.41.0

265.23.0

132.61.5

176.82.00

397.84.5

μmol/dLmg/dL

Low Risk High Risk

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CKD: Patients at Risk for AKI

AKI = acute kidney injury; CIN = contrast-induced nephropathy.

Fresenius Kidney Care [website]. Kidney disease stages. https://www.freseniuskidneycare.com/about-chronic-kidney-disease/stages/chronic-kidney-disease-ckd-stages. Accessed September 17, 2018.

STAGE 1 STAGE 2 STAGE 3 STAGE 4 STAGE 5

CKD Risk Factors/Damage with Preserved GFR

MildReducedKidneyFunction

ModerateReducedKidneyFunction

SevereReducedKidneyFunction

KidneyFailure

eGFR (mL/min)

90 1560 30

SCr

88.4

1.0

265.2

3.0

132.6

1.5

176.8

2.00

397.8

4.5

μmol/dL

mg/dL

Low Risk High Risk

Patients at High Risk for CIN

25% of Patients

Patients with pre-existing CKD (eGFR <60)

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Stages of CKD GFR* % of Kidney Function

Stage 1 Kidney damage with normal kidney function 90 or higher

Stage 2 Kidney damage with mild loss of kidney function 89 to 60

Stage 3a Mild to moderate loss of kidney function 59 to 45

Stage 3b Moderate to severe loss of kidney function 44 to 30

Stage 4 Severe loss of kidney function 29 to 15

Stage 5 Kidney failure <15

Stages of CKD and GFR

*Your GFR number tells you how much kidney function you have. As kidney disease gets worse, the GFR number goes down.National Kidney Foundation [website]. Glomerular filtration rate (GFR). https://www.kidney.org/atoz/content/gfr. Accessed September 17, 2018.

eGFR Value Is Approximately Equal to the Percentage of Remaining Kidney Function

90%-100%

89%-60%

59%-45%

44%-30%

29%-15%

<15%

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National Kidney Foundation eGFR Calculator

National Kidney Foundation [website]. EGFR Calculator. https://www.kidney.org/apps/professionals/egfr-calculator.

Accessed September 17, 2018.

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Several Methods for Calculating eGFR

CC = creatinine clearance; CKD-EPI = chronic kidney disease epidemiology collaboration; MDRD = modification of diet in renal disease; IDMS = isotope dilution mass spectrometry.National Kidney Foundation [website]. EGFR Calculator. https://www.kidney.org/apps/professionals/egfr-calculator.Accessed September 17, 2018.

Method Description

CKD-EPI Creatinine 2009 Equation• Recommended by the National Kidney Foundation

• Estimates GFR from SCr, age, sex, and race

• More accurate than MDRD, particularly in people with higher levels of GFR

MDRD Study Equation• Adjusted for body surface area

• More accurate than CC measured from 24-hour urine collection or estimated by Cockcroft-Gault formula

CKD-EPI Cystatin and Creatinine 2012 Equation

• Designed for use with standardized creatinine values that are calibrated to IDMS traceable and standardized cystatin C values

• Creatinine-cystatin C equation performs better than equations based on either of these markers alone

• May provide more accurate estimates in patients with differences in diet, extreme muscle mass, or chronic illness

Cockcroft-Gault Formula

• Estimates CCs using age, weight, and gender. It is not adjusted for body surface area

• Less accurate than CKD-EPI and MDRD Study equations, especially in older and obese people

Revised Bedside Schwartz Formula • For ages 1-17 years

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eGFR: A Better Index of Kidney Function

National Kidney Foundation [website]. Cystatin C. What is its role in estimating GFR? https://www.kidney.org/sites/default/files/02-10-

0204_GAJ_CystatinC.pdf.

All Have Same SCr (1.2 mg/dL), but Patient on Right Has Stage 3 CKD

The Same SCr: Very Different eGFR

22-Year-Old

Black Man

58-Year-Old

White Man

80-Year-Old

White Woman

SCr 1.2 mg/dL 1.2 mg/dL 1.2 mg/dL

GFR as estimated by

the MDRD equation98 mL/min/1.73 m2 66 mL/min/1.73 m2 46 mL/min/1.73 m2

Kidney function

Normal GFR orstage 1 CKD if kidney

damage is also present

Stage 2 CKD if kidney damage is also present Stage 3 CKD

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AKI

Rahman M, et al. Am Fam Physician. 2012;86(7):631-639.

POST-RENAL

Obstructionurine unable to

drain adequately –system ‘backed up’

PRE-RENAL

Inadequate Perfusionnot enough blood at

sufficient pressureto allow filtering

RENAL

Cellular Damage/Intrinsicdamage to the cells thatmake filtering mechanismpossible

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Differences between CKD and AKI

• CKD– Usually caused by long-term diseases such as diabetes mellitus and hypertension

– Slowly damages the kidneys and reduces their function over time

– Progressive; can get worse over time

– Damage to kidneys causes scars and is permanent

• AKI (also called acute renal failure)

– Usually caused by an event such as dehydration, blood loss from surgery or injury,or medications, including contrast media, nonsteroidal anti-inflammatory drugs, and anti-hypertensives

NIH National Institute of Diabetes and Digestive and Kidney Disease [website]. Chronic kidney disease (CKD). https://www.niddk.nih.gov/health-information/kidney-disease/chronic-kidney-disease-ckd. Accessed September 17, 2018. WebMD [website]. What is acute kidney failure. https://www.webmd.com/a-to-z-guides/what-is-acute-kidney-failure#1. Accessed September 17, 2018.

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How Is Contrast Nephrotoxic?

• Decreased blood flow due to increased blood viscosity – Reduced tubular flow

– Tubular obstruction/injury

– Increased intra-renal tissue pressure

• Direct cytotoxic effect– Damage to endothelium and tubular epithelium

– Oxidative stress

– Cellular injury and death

• Vasoconstriction– Impairs blood flow by decreasing volume

Persson PB, et al. Kidney Int. 2005;68:14.

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RIFLE and AKIN Criteria for Diagnosis and Classification of AKI

RIFLE AKIN

Class SCra Urine Output(common to both) Stage SCrb

Risk Increased SCr to >1.5 x baseline Urine output <0.5 mg/kg/hfor >6 hours 1 Increase in SCr ≥0.3 mg/dL or

increase in SCr to ≥150%-200% of baseline

Injury Increased SCr to >2 x baseline Urine output <0.5 mg/kg/hfor >12 hours 2 Increase in SCr to >200%-300%

of baseline

FailureIncreased SCr to >3 x baseline;

or an increase of ≥0.5 mg/dLto a value of ≥4 mg/dL

Urine output <0.3 mg/kg/hfor >12 hours or

anuria for >12 hours3

Increase in SCr to >300% of baseline;or to ≥4 mg/dL with an acute increase

of ≥0.5 mg/dL; or on RRT

Loss Need for RRT for >4 weeks

End Stage Need for RRT for >3 months

KDIGO = Kidney Disease: Improving Global OutcomesIncrease in SCr of 0.3 mg/dL over 48 Hours or >50% over 7 Days

KDIGO definition harmonized prior RIFLE and AKIN definitions of AKI

Definitions of AKI

aFor RIFLE, the increase in SCr should be both abrupt (within 1-7 days) and sustained (24 hours).bFor AKIN, the increase in SCr must occur in less than 48 hours.RIFLE = risk, injury, failure, loss end-stage disease; AKIN = Acute Kidney Injury Network; RRT = renal replacement therapy.Palevsky PM, et al. Am J Kidney Dis. 2013;61(5):649-672.

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0.5

9.7

1.4

6.4

2.1

3.8

CI-AKI Is a Growing Problem That Contributes

to Poor Patient Outcomes

Note: Incidence of AKI: Population incidence of acute kidney injury among cardiac catheterization and PCI patients in the United States from 2001 to 2011.CI-AKI = contrast-induced acute kidney injury; NCDR = National Cardiovascular Data Registry; PCI = percutaneous coronary intervention.Brown J, et al. J Am Heart Assoc. 2016;5:e002739. Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

Nearly 20-foldincrease indeath for patientswith AKI post-PCI

• NCDR CathPCI Registry®

– 985,737 consecutive patients undergoing PCI

– 1253 US hospitals

– Real-world dataset

Perc

ent R

isk

(%)

Death MI

10.0

0

8.0

6.0

2.0

4.0

Bleeding

Patients with AKIPatients without AKI

90,000

150,000

60,000

Popu

latio

n In

cide

nce

of A

KI

120,000

Year

30,0002008 20112003 20102006 20092004 200720052001 2002

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Negative Effects of CIN

• Impact of CIN

– Increased risk of heart disease

– Long-term dialysis

– Longer hospitalization (average, 4 days longer)

– Increased hospital 30-day readmissions

– High risk of death

Lindsay J, et al. Catheter Cardiovasc Interv. 2003;59(3):338-343. Rihal CS, et al. Circulation. 2002;105:2259-2264. Dangas G, et al. Am J Cardiol. 2005;95:13-19. Subramanian S, et al. J Med Econ. 2007;10:119-134. James MT, et al. Circulation. 2011;123:409-416. Koulouridis I, et al. Am J Kidney Dis. 2014.

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How Is AKI Tracked in the Hospital?

• NCDR CathPCI Registry

– Owned and operated by the American College of Cardiology (ACC)

– First and oldest registry (1997)

– Voluntary with >1730 hospitals participating

• Established to improve hospital quality performance

– Hospitals can compare their quality performance metrics to the national average in a US national registry

– Used to identify and implement hospital quality improvement initiatives

American College of Cardiology. Quality Improvement for Institutions. NCDR. CathPCI Registry®. https://cvquality.acc.org/NCDR-Home/registries/hospital-registries/cathpci-registry. Accessed September 17, 2018.

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Analysis of NCDR Data

Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

Total Procedures(N=1,254,089)

Analytic Cohort(N=954,729)

EX1: Multiple PCI(N=32,999)

EX2: Missing Creatinine(N=239,025)

EX3: Currently Dialysis(N=24,517)

EX4: Missing Contrast(N=2,819)

Population Selection Flow Diagram

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Predictors of AKI

NSTEMI/UA = non-ST-segment elevation myocardial/unstable angina; ACS = acute coronary syndrome; IABP = intra-aortic balloon pump; STEMI = ST-segment elevation myocardial infarction.Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

5.2

0.07

8.0

0.3

12.9

0.7

26.6

4.3

1Normal

GFR ≥60

45

2Mild

GFR 45-60

3ModerateGFR 30-45

4Severe

GFR <30

0

20

40

Prop

ortio

n A

KIN

(%)

30

10

15

35

25

5

0

4

7

Proportion Dialysis (%

)

6

2

3

8

5

1

GFR Level

Contrast 75 U 1.14 (1.13, 1.15)Age 10 years 1.15 (1.14, 1.16)Mild GFR vs Normal 1.21 (1.19, 1.24)Prior CVD 1.27 (1.24, 1.30)Prior HF 1.32 (1.29, 1.35)NSTEMI/UA vs Non-ACS 1.51 (1.48, 1.54)Diabetes mellitus 1.61 (1.59, 1.64)Prior Card Arrest 1.72 (1.65, 1.81)Mod GFR vs Normal 1.75 (1.71, 1.80)Anemia 1.92 (1.87, 1.98)2 Weeks HF 2.04 (1.99, 2.08)IABP before Procedure 2.13 (1.92, 2.35)STEMI vs Non-ACS 2.60 (2.53, 2.67)Prior Card Shock 2.92 (2.80, 3.04)Severe GFR vs Normal 3.59 (3.47, 3.71)

40.5 1 2More Likely AKINLess Likely AKIN

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AKI Is Tracked as a Quality Metric

CV = contrast volume.American College of Cardiology. NCDR. National Cardiovascular Data Registry. CathPCI Registry, version 4.4. Institutional Outcomes Report 2014Q3. National Outcomes Report 999997. 2010. https://cvquality.acc.org/docs/default-source/ncdr/reports/cathpci_registry_2014q3_sample_report.pdf?sfvrsn=dfe08fbf_2. Accessed September 17, 2018.

NCDR Tracks CV and Kidney Health (AKI) as a Key Quality Indicator

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Society Guidelines for the Prevention of CI-AKI

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What Are Cardiology Guidelines?

• Definition

– “Rules of the road” for evidence-based standard of care in the catheterization laboratory

– Summarize published literature and provide recommendations for diagnostics and interventional procedures

• Purpose

– Improve quality of care

– Optimize patient outcomes

– Reduce healthcare costs by focusing resources on most effective strategies (appropriate use)

American College of Cardiology. Guidelines and clinical documents. https://www.acc.org/guidelines. American Heart Association. Guidelines & Statements. https://professional.heart.org/professional/GuidelinesStatements/UCM_316885_Guidelines-Statements.jsp. Society of Cardiovascular and Angiography and Interventions. Society for Cardiovascular Angiography and Interventions. Guidelines. https://www.guidelinecentral.com/shop/society/society-for-cardiovascular-angiography-and-interventions/. Accessed September 17, 2018.

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Cardiology Guidelines

• Who develops the guidelines?

– American College of Cardiology (ACC)

– American Heart Association (AHA)

– Society of Cardiovascular and Angiography and Interventions (SCAI)

American College of Cardiology. Guidelines and clinical documents. https://www.acc.org/guidelines. American Heart Association. Guidelines & Statements. https://professional.heart.org/professional/GuidelinesStatements/UCM_316885_Guidelines-Statements.jsp. Society of Cardiovascular and Angiography and Interventions. Society for Cardiovascular Angiography and Interventions. Guidelines. https://www.guidelinecentral.com/shop/society/society-for-cardiovascular-angiography-and-interventions/. Accessed September 17, 2018.

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2011 Society Guidelines for Prevention of CI-AKI:Class I Recommendations

Levine GN, et al. Circulation. 2011;124(23):e574-651.

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2016 SCAI Guidelines Update:Real-Time Monitoring

Naidu SS, et al. Catheter Cardiovasc Interv. Published online April 2016. doi:10.1002/ccd.26551. Wiley Periodicals, Inc.

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AKI Prevention Strategies

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Age 10 years 1.15 (1.14, 1.16)Mild CKD vs Normal 1.21 (1.19, 1.24)Prior CVD 1.27 (1.24, 1.31)Prior HF 1.33 (1.29, 1.36)NSTEMI/UA vs Non-ACS 1.50 (1.47, 1.54)Diabetes mellitus 1.61 (1.58, 1.64)Moderate CKD vs Normal 1.65 (1.60, 1.70)Cardiac Arrest on Presentation 1.78 (1.69, 1.88)Anemia 1.90 (1.83, 1.97)HF on Presentation 2.04 (1.99, 2.10)IABP Prior to Procedure 2.19 (1.95, 2.47)STEMI vs Non-ACS 2.59 (2.51, 2.67)Cardiogenic Shock 2.83 (2.70, 2.98)Severe CKD vs Normal 3.10 (2.98, 3.22)

40.5 1 2More Likely AKINLess Likely AKIN

Prevention of AKI: Screen for RiskRisk Score Models for CI-AKI

HF = heart failure.Mehran R, et al. J Am Coll Cardiol. 2004;44(7):1393-1399. Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

• American College of Cardiology (ACC)• National Cardiovascular Data Registry (NCDR)

EmergingMost Well-Known

NCDR Risk Score(Tsai 2015)

Mehran Risk Score(Mehran 2004)

Risk Factors

eGFR (mL/min/1.73 m2) – 186 x (SCr)-1.154 x (Age)-0.304 x (0.742 if female) x (1.210 if black)

Hypotension

IABP

CHF

Age >75 years

Anemia

Diabetes mellitus

Contrast media volume

SCr >1.5 mg/dL

eGFR < 60 mL/min/1.73 m2

Integer Score

5

5

5

4

3

3

1 for each 100 CC2

4

2 for 40-604 for 20-406 for <20

OR

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Prevention of AKI:Hydration Therapy

• Guidelines recommend adequate preparatory hydration for patients at risk for CI-AKI

– Clinical guidelines recommend IV hydration as preferable to oral hydration and that hydration 4 hours before and after exposure to dye is preferable to a bolus administration

• Open to interpretation

– No well-defined protocols exist to guide fluid administration

• Optimal hydration for patients undergoing contrast media exposure remains under debate

IV = intravenous.Levine GN, et al. Circulation. 2011;124(23):e574-e651.

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Prevention of AKI:Hydration Clinical Update

Key Points

• Primary endpoint: Major adverse kidney eventsand death

• Secondary endpoint: AKI

• Trial stopped early due to lack of interaction between sodium bicarbonate and acetylcysteine with respect to primary endpoint

• In coronary angiography, for at-risk renal patients

– No benefit for using IV sodium bicarbonate over IV sodium chloride

– No benefit for oral administration of acetylcysteine over placebo

Weisbord SD, et al. N Engl J Med. 2018;378(7):603-614.

PRESERVE Trial Group Double-blind, placebo, comparatordrug-controlled, randomized trial

Patients Hospitals Countries

5177 53 US, Australia, New Zealand, Malaysia

Publication Date: February 15, 2018

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T h e n e w e ngl a nd j o u r na l o f m e dic i n e

n engl j med 378;9 nejm.org March 1, 2018 829

From the Department of Medicine, Divi-sion of Allergy, Pulmonary, and Critical Care Medicine (M.W.S., J.D.C., G.R.B., T.W.R.), the Departments of Emergency Medicine (W.H.S.), Anesthesiology (J.P.W., J.M.E., A.B.K., C.G.H., A.H., L. Weavind, A.D.S.), Biomedical Informatics ( J.P.W., J.M.E.), Surgery ( J.M.E., O.D.G., A.K.M.), Health Policy ( J.M.E.), Biostatistics (L. Wang, D.W.B.), and Pharmaceutical Services (J.L.S.), and the Division of Ne-phrology and Hypertension, Vanderbilt Center for Kidney Disease and Integrated Program for Acute Kidney Disease (E.D.S.) — all at Vanderbilt University Medical Center, Nashville. Address reprint requests to Dr. Rice at the Department of Medi-cine, Vanderbilt University Medical Center, T-1218 MCN, 1161 21st Ave. S., Nashville, TN 37232, or at todd . rice@ vanderbilt . edu.

* A complete list of the SMART Investiga-tors is provided in the Supplementary Appendix, available at NEJM.org.

N Engl J Med 2018;378:829-39.DOI: 10.1056/NEJMoa1711584Copyright © 2018 Massachusetts Medical Society.

BACKGROUNDBoth balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes.

METHODSIn a pragmatic, cluster-randomized, multiple-crossover trial conducted in five inten-sive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause, new renal-replacement therapy, or persis-tent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) — all censored at hospital discharge or 30 days, whichever occurred first.

RESULTSAmong the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P = 0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P = 0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P = 0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P = 0.60).

CONCLUSIONSAmong critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779.)

A BS TR AC T

Balanced Crystalloids versus Saline in Critically Ill Adults

Matthew W. Semler, M.D., Wesley H. Self, M.D., M.P.H., Jonathan P. Wanderer, M.D., Jesse M. Ehrenfeld, M.D., M.P.H.,

Li Wang, M.S., Daniel W. Byrne, M.S., Joanna L. Stollings, Pharm.D., Avinash B. Kumar, M.D., Christopher G. Hughes, M.D.,

Antonio Hernandez, M.D., Oscar D. Guillamondegui, M.D., M.P.H., Addison K. May, M.D., Liza Weavind, M.B., B.Ch., Jonathan D. Casey, M.D.,

Edward D. Siew, M.D., Andrew D. Shaw, M.B., Gordon R. Bernard, M.D., and Todd W. Rice, M.D., for the SMART Investigators

and the Pragmatic Critical Care Research Group*

Original Article

The New England Journal of Medicine Downloaded from nejm.org by JAIRAJ PATIL on August 22, 2018. For personal use only. No other uses without permission.

Copyright © 2018 Massachusetts Medical Society. All rights reserved.

n engl j med 378;9 nejm.org March 1, 2018836

T h e n e w e ngl a nd j o u r na l o f m e dic i n e

OutcomeBalanced Crystalloids

(N = 7942)Saline

(N = 7860)Adjusted Odds Ratio

(95% CI)† P Value†

Primary outcome

Major adverse kidney event within 30 days — no. (%)‡ 1139 (14.3) 1211 (15.4) 0.90 (0.82 to 0.99) 0.04

Components of primary outcome

In-hospital death before 30 days — no. (%) 818 (10.3) 875 (11.1) 0.90 (0.80 to 1.01) 0.06

Receipt of new renal-replacement therapy — no./total no. (%)§

189/7558 (2.5) 220/7458 (2.9) 0.84 (0.68 to 1.02) 0.08

Among survivors 106/6787 (1.6) 117/6657 (1.8)

Final creatinine level ≥200% of baseline — no./total no. (%)§

487/7558 (6.4) 494/7458 (6.6) 0.96 (0.84 to 1.11) 0.60

Among survivors 259/6787 (3.8) 273/6657 (4.1)

Among survivors without new renal-replacement therapy

215/6681 (3.2) 219/6540 (3.3)

Secondary outcomes

In-hospital death — no. (%)

Before ICU discharge 528 (6.6) 572 (7.3) 0.89 (0.78 to 1.02) 0.08

Before 60 days 928 (11.7) 975 (12.4) 0.92 (0.83 to 1.02) 0.13

ICU-free days¶ 0.94

Median 25.3 25.3 1.00 (0.89 to 1.13)

Interquartile range 22.1 to 26.6 22.2 to 26.6

Mean 21.8±8.3 21.7±8.6

Ventilator-free days¶ 1.06 (0.97 to 1.16) 0.22

Median 28.0 28.0

Interquartile range 26.0 to 28.0 26.0 to 28.0

Mean 24.2±8.6 23.9±8.9

Vasopressor-free days¶ 1.05 (0.97 to 1.14) 0.26

Median 28.0 28.0

Interquartile range 27.0 to 28.0 27.0 to 28.0

Mean 24.7±8.5 24.4±8.8

Renal-replacement therapy–free days¶ 1.11 (1.02 to 1.20) 0.01

Median 28.0 28.0

Interquartile range 28.0 to 28.0 28.0 to 28.0

Mean 25.0±8.6 24.8±8.9

Secondary renal outcomes§

Stage 2 or higher AKI developing after enrollment — no./total no. (%)∥

807/7558 (10.7) 858/7458 (11.5) 0.91 (0.82 to 1.01) 0.09

Creatinine — mg/dl**

Highest before discharge or day 30 1.01 (0.97 to 1.05) 0.58

Median 0.99 0.99

Interquartile range 0.78 to 1.53 0.78 to 1.52

Change from baseline to highest value 0.98 (0.94 to 1.02) 0.35

Median 0.04 0.04

Interquartile range −0.08 to 0.31 −0.08 to 0.32

Table 2. Clinical Outcomes.*

The New England Journal of Medicine Downloaded from nejm.org by JAIRAJ PATIL on August 22, 2018. For personal use only. No other uses without permission.

Copyright © 2018 Massachusetts Medical Society. All rights reserved.

Prevention of AKI:Hydration Clinical Update

Semler MW, et al. N Engl J Med. 2018;378: 829-839.

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Prevention of AKI:Hydration Protocol Examples

ACCF/AHA/SCAI = American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions; LVEDP = left ventricular end-diastolic pressure.Qian G, et al. J Am Coll Cardiol Intv. 2016;9:89-96.

Hemodynamic-Guided Fluid Administration Clinical Practice Guidelines

Name POSEIDON Trial Hydration ProtocolACCF/AHA/SCAI PracticeGuidelines for PCI

Type Sliding scale hydration based on intracardiac pressure measurements (LVEDP)

Normal saline (isotonic crystalloid)

Pre-procedure Bolus infusion at 3 mL/kg for 1 hourIV administration:1-1.5 mL/kg/h for 3-12 hours

Intra- andpost-procedure

• 5 mL/kg/h for LVEDP <13 mm Hg• 3 mL/kg/h for LVEDP 13-18 mm Hg• 1.5 mL/kg/h for LVEDP >18 mm Hg

*continued 4 hours post-procedure

IV administration:1-1.5 mL/kg/h for 6-24 hours

Reference Brar, et al. The Lancet. 2014;383:1814-1823

Levine GN, et al. JACC. 2011;58(24):e44-e122

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Prevention of AKI:Contrast-Reduction Clinical Update

Key Points

• AKI rates and CVs vary greatly among

physicians

• Every incremental 75 mL of contrast used

increased the risk of AKI by 42%

• Opportunity to reduce use of CV and

variation among operators

• No correlation observed between patient’s

risk of AKI and CV used

Amin A, et al. JAMA Cardiol. 2017;2(9):1007-1012.

Cross Sectional Study DataPatients Physicians Hospitals

1.3 million 5,973 1,338

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Study Shows a Clinical Need forAdvanced Contrast-Reduction Strategies

Amin A, et al. JAMA Cardiol. 2017;2(9):1007-1012.

250

0

Mea

n C

V (

mL

)

200

100

150

50

AKI Risk (Decile)

1 5 8 107 92 43 6

No correlation observed between patient’s AKI risk and CV used

Physician’s Mean CV by Deciles of AKI Risk

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Prevention of AKI: Reduce Contrast

• Operator-controlled injections through standard manifolds

– Slow down injection rate

• Streaming may occur

– Leads to poor visualization

– Use smaller syringe

• Insufficient volume forsustained injection

– 50-50 mixed shot of saline and contrast

• Poor visualization may occur

Gurm HS, et al. J Invasive Cardiol. 2016;28(4):142-146.

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Prevention of AKI: Reduce Contrast

• Limit injections

• Manifold handling

• Avoid LV gram, peripheral runoff

• Avoid side-hole guides

• Intravascular ultrasound

• Use landmarks

• Avoid excessive puffing

Nayak KR, et al. Catheter Cardiovasc Interv. 2010;75(7):1076-1083.

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Prevention of AKI: Reduce Contrast

• Biplane imaging

– Images from two different simultaneous points of view

– Can be challenging to use

Sadick V, et al. Br J Radiol. 2010;83(939):379-394.

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Prevention of AKI: Reduce Contrast

• Automated injectors (eg, ACIST CVi® Contrast Delivery System)

– Tracks contrast electronically

– Contrast reduction benefits have been shown to be inconclusive and contradictory in published studies

Gurm HS, et al. JACC: Cardiovasc Interv. 2013;6(4):399-405.

Disposable hand controller

Touch screen provides forset-up, adjustable injectionvolume and flow rate limits,

and contrast tracking

5-patient contrast reservoir

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Prevention of AKI: Reduce Contrast

Reduce contrast dye; decrease AKI risk

• Contrast reduction during catheterization laboratory procedures is linked to a decreased risk of AKI

• BMC2 model shows a reduction of AKI by 16% when contrast delivery was reduced by 40%

BMC2 = Blue Cross Blue Shield of Michigan Cardiovascular Consortium.Gurm HS, et al. J Invasive Cardiol. 2016;28(4):142-146.

0 100

10

25

20

5

Exp

ecte

d R

educ

tion

in A

KI (

%)

20 4030 50

15

Reduction in CV (%)

Model-Predicted Reduction in Total AKI Casesby Percent Reduction in CV

Contrast-sparing intervention used in all patients

30%-45%Contrast Reduction

13%-18% Reduction in AKI

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CI-AKI Outcomes and Economics

Meersch M, et al. Intensive Care Med. Open access online 2017. Hobson CE, et al. Circulation. 2009;119:2444-2453. Dasta JF, et al. Nephrol Dial Transplant. 2008;23:1970-1974. Hobson C, et al. Ann Surg. 2014;00:1-8. Mehta RL, et al. The Lancet. 2015;385(9987):2616-2643. Brown JR, et al. Ann Thorac Surg. 2014;97:111-117.

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Additional hospitalization costs $10,000-$12,000

for each patient with AKI

AKI Events Increase Patient Length of Stay

Subramanian S, et al. J Med Econ. 2007;10(2):119-134. Pfuntner A, et al. Agency for Healthcare Research and Quality Statistical Brief #168. December 2013. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb168-Hospital-Costs-United-States-2011.pdf. Amin A, et al. JAMA Cardiol. 2017;2(9):1007-1012.

Patients with AKI Are 15 Times More Likely To Be Hospitalized over 4 Days

The length ofhospital stay increases,on average,3.75 days forpatients with AKI

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AKI 30-Day Readmissions Are Costly to Hospitals

CMS Centers for Medicare & Medicaid Services30-day readmission penalty

FY 2015

Unplanned 30-day readmission for conditions including:

– AMI

– HF

– Pneumonia

– Chronic obstructive pulmonary disease

– Total hip and knee arthroplasty

Hospital payment penalty:

– Up to 3% applied to all Medicare dischargesKoulouridis I, et al. Am J Kidney Dis. 2015;65(2):275-282.

37% Increase in 30-Day Readmissions for Patients with Development of AKI

25

0

Hos

pita

l Rea

dmis

sion

Rat

e (%

)

20

No AKI

11

AKI

15

5

15

10

30-day readmissionswith and without AKI

Readmissions primarily forAMI and HF

30-Day

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AKI Events Increase Bundled Payment Risk

• There is an increasing shift to alternative payment models

• CI-AKI provides significant economic risk under these new payment models

Koulouridis I, et al. Am J Kidney Dis. 2015;65(2):275-282.

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Summary

• The costs of AKI are high for the hospital and the patient

• There is no treatment for AKI

• Contrast reduction is an important part of an overall kidney care protocol

Educate staffabout the risks of AKI

Advocate for theat-risk patient in the

catheterization laboratory

Advocate for protocolsfor the at-risk patient

(screen, hydrate, reduce contrast)

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Hitinder S. Gurm, MDAssociate Chief Clinical OfficerFrankel Cardiovascular Center University of MichiganAnn Arbor, Michigan

Best Practices for Screening Patients with Chronic Kidney Disease in the Catheterization Laboratory

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Financial Disclosures

Hitinder S Gurm, MD

• Consultant: Osprey Medical

• Research Funding: NIH, Blue Cross Blue Shield of Michigan

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Learning Objectives

• Understand the definition of CKD and the clinical metrics used toscreen for CKD

• Identify comorbidities that impact the outcomes of patients with CKD

• Establish appropriate contrast dose thresholds, and implement a threshold management system in the catheterization laboratory

CKD = chronic kidney disease.

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AKI in the Catheterization Laboratory:The Why

• AKI– Common– Expensive– Associated with high morbidity and mortality rates

Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

0.5

9.7

34.3

1.4

6.4

15.8

2.13.8

7.9

40

0

20

Ris

k (%

)

10

15

30

5

Death MIBleeding

35

25

No AKIN

AKIN

Dialysis

7.1

6.0

0.5 0.3 0.3

Any AKINor

Dialysis

AKIN1

AKIN3

Dialysis0

4

8

Inci

den

ce (

%) 6

2

3

7

5

1

AKIN2

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Underlying Hypothesis

• Contrast-media-induced injury appears to be directly related to the concentration of contrast media in the glomerular filtrate and eventually in the renal tubules

– Less glomeruli (CKD) = higher contrast concentration in tubule

– Less glomerular filtrate (dehydration) = higher contrast concentration in tubule

– More contrast injected = higher contrast concentration in tubule

Rojkovskiy I, et al. Interv Cardiol Clin. 2014;3(3):393-404.

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Prevention of AKI: Two Modifiable Factors

1. Hydration

2. Minimization of CV

Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl. 2012;2:1-138.

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BMC2 Hydration Guidelines

Gurm H. Cath Lab Digest [website]. Contrast management: Contrast-induced nephropathy. 2017;25(11). https://www.cathlabdigest.com/article/Setting-Contrast-Thresholds-High-Risk-Patients. Accessed September 11, 2018. BMC2 PCI-VIC Best Practice Protocols. January 2014. https://bmc2.org/system/files/private/best-practice-protocols-5-20-14.pdf.

Oral hydration bythe patient

IV hydration bythe catheterization

laboratory

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BMC2 Hydration Guidelines

• Oral hydration

– Clear liquids to be encouraged for up to 2 hours before the procedure (at least 500 mL in 6 hours)

• Drink one glass of water/sodium-rich fluid every hour starting 4-6 hours before the procedure and continue until 2 hours before the procedure

– Modify NPO for catheterization

• No fatty food for 8 hours

• No other solid food or milk for 6 hours

• Nothing by mouth for 2 hours

NPO = nothing by mouth.Gurm H. Cath Lab Digest [website]. Contrast management: Contrast-induced nephropathy. 2017;25(11). https://www.cathlabdigest.com/article/Setting-Contrast-Thresholds-High-Risk-Patients. Accessed September 11, 2018. BMC2 PCI-VIC Best Practice Protocols. January 2014. https://bmc2.org/system/files/private/best-practice-protocols-5-20-14.pdf.

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IV Hydration Protocol

• Pre-hydration: 3 mL/kg over 1 hour (or 1 mL/kg for 1-3 hours)

– Hold for severe valve disease, current CHF

• During/Post-hydration

– LVEDP-based 1.5-5.0 mL/kg for 4 hours (assume maximum weight of 100 kg)

Gurm H. Cath Lab Digest [website]. Contrast management: Contrast-induced nephropathy. 2017;25(11). https://www.cathlabdigest.com/article/Setting-Contrast-Thresholds-High-Risk-Patients. Accessed September 11, 2018. BMC2 PCI-VIC Best Practice Protocols. January 2014. https://bmc2.org/system/files/private/best-practice-protocols-5-20-14.pdf.

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Contrast Dose Thresholds in theCatheterization Laboratory: The What

Lauver A, et al. PLOS One. 2014. doi: 10.1371/journal.pone.0113598.

CV and AKI in a Rabbit

10.0 g L/kg

7.5 g L/kg

5.0 g L/kg

2.5 g L/kg

Hyperosmotic NaCI(721 mOsm)

12

0

Cre

atin

ine

(mg/

dL)

Timepoint (hours)1 40 2 3

4

10

8

2

6

30 5020 40

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Renal Cortex Histologic Analysis

Lauver A, et al. PLOS One. 2014. doi: 10.1371/journal.pone.0113598.

10.0 g L/kg 2.5 g L/kgIoxilan injection

Proximal tubule

Glomerulus 20 μm

= heterophils

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Renal Function-Based Contrast Dosing

NRD = nephropathy requiring dialysis.Gurm HS, et al. J Am Coll Cardiol. 2011;58(9):907-914.

10

CINNRD

0

4

9

Patie

nts

with

CIN

(%)

6

2

3

7

5

1

0

0.4

1.2

Patients with N

RD

(%)

0.8

0.2

1.0

0.6

0.08-1.33 2.29-2.61 3.44-4.06 5.11-9.99

8

2.98-3.44 4.06-5.111.33-1.68 1.99-2.291.69-1.99 2.61-2.98

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3

1

Patie

nts

with

NR

D (%

)

Renal Function-Based Contrast Dosing:Key Subgroups

CCC = calculated creatinine clearance.Gurm HS, et al. J Am Coll Cardiol. 2011;58(9):907-914.

Primary PCI for STEMI(n=3965)

P (CIN)<.0001P (NRD)<.0001

CV/CCC≥3

14

8

0

2

Pati

en

ts w

ith

CIN

(%

)12

4

6

10

CV/CCC2-2.9

CV/CCC<2

2.5

1.0

0.0

2.0

0.5

1.5

Patients Undergoing Elective PCI(n=22,912)

P (CIN)=.008P (NRD)=.17

CV/CCC≥3

1.4

0.8

0

0.2

Pati

en

ts w

ith

CIN

(%

)

1.2

0.4

0.6

1.0

CV/CCC2-2.9

CV/CCC<2

0.045

0.03

0.0

0.005

0.04

0.015

0.02

0.035

NSTEMI (excluding shock)(n=9082)

P (CIN)<.001P (NRD)<.001

CV/CCC≥3

9

6

0

2

8

4

5

7

CV/CCC2-2.9

CV/CCC<2

0.8

0.5

0.0

0.2

Patie

nts

with

NR

D (%

)

0.7

0.3

0.4

0.6

Cardiogenic Shock(n=866)

P (CIN)=.0145P (NRD)=.0012

CV/CCC≥3

35

20

0

5

30

10

15

25

CV/CCC2-2.9

CV/CCC<2

9

5

0

1

8

2

3

6

0.025

0.01

7

4

0.1

Page 68: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

How to Reduce CV?The How

1. Use GFR-based dosing – Confirm GFR and contrast thresholds in the time out

2. Monitor CV in all cases– Routine feedback to the laboratory on CV used in each case

3. In intermediate- to high-risk patients– Use biplane

– Avoid LV gram/aortography if GFR low

– Consider using the DyeVert Contrast Reduction System

– Use intravascular ultrasound, dry cine, buddy wire for stent sizing in highest-risk patients

– Stage procedures when appropriate

Gurm HS, et al. J Am Coll Cardiol. 2011;58(9):907-914. US Food and Drug Administration [website].Medical Devices. DyeVert. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171217.pdf.

Page 69: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

Dedicated Devices: Do We Need Them?

1. Reduce contrast reflux without impacting procedural quality

2. Fit in seamlessly with the catheterization laboratory flow

3. No down side, reduce contrast dose, and prevent contrast waste without excessive radiation or increasing procedural complexity

4. Sensitize the catheterization laboratorystaff on the need to minimize CV with real-time feedback

US Food and Drug Administration [website].Medical Devices. DyeVert. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171217.pdf.

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DyeVert Randomized Controlled Trial

• 96 patients undergoing coronary angiography randomized to control angiography or use of the DyeVert Contrast Reduction System

• CV reduction and image quality

Desch S, et al. Int J Cardiol. 2018;257:50-53.

Primary Outcomes: CV Reduction and Image Quality

Control DyeVert

N CV (mL) N CV (mL) P Value Reduction (%)

As Treated 48 62.5±12.7 47 38.0±13.1 <.001 39.2

Per Protocol 48 62.5±12.7 46 36.9±10.9 <.001 40.9

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You Can Prevent AKI!

Gurm HS, et al. JACC: Cardiovas Interv. 2018;11(5):505-510.

35

Risk-Adjusted AKI Rate (%)

Mean CV/eGFR

0

30B

ars

–C

V ≥

3 x

GFR

(% o

f cas

es)

10

15

20

5

2010 2014

25

2011 20132012 20151.5

4.0 Lines –C

V/eG

FR and A

KI R

ate (%)

3.0

2.0

3.5

2.5

2016

Trends in risk-adjusted AKI rates in Michigan

40

Page 72: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

Is Even Lower CV Better?

Gurm HS, et al. Catheter Cardiovasc Interv. 2018 Aug 25. doi: 10.1002/ccd.27819 [Epub ahead of print].

Distribution of PCI procedures by ratio of CV to CC

Distribution of PCI Cases by CV Indexed to CC (CV/CC)

CV/CC0 82 64 10

3000

0

Freq

uenc

y

2500

1000

1500

500

2000

CV/CC ≤113.07%

of cases

CV/CC 1-368.42%

of cases

CV/CC >318.51%

of cases

Page 73: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

Incidence of AKI by CV/CC Ratio

Gurm HS, et al. Catheter Cardiovasc Interv. 2018 Aug 25. doi: 10.1002/ccd.27819 [Epub ahead of print].

Unadjusted AKI RateAdjusted AKI Rate

2.2

1.5

2.82.3

4.0

7.7

CV/CC <10

8

3

7In

cide

nce

of A

KI (

%)

CV/CC 1-3 CV/CC >3

5

1

2

6

4

Page 74: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

Risk-Adjusted AKI Rates by CV/CC Categoriesand Preprocedural Predicted Risk of AKI

Gurm HS, et al. Catheter Cardiovasc Interv. 2018 Aug 25. doi: 10.1002/ccd.27819 [Epub ahead of print].

10.03

13.53

20.12

1.65 2.14 3.010.5 0.44 0.85

40

0

20

Inci

denc

e of

AK

I (%

)

10

15

30

5

<1% >7%1%-7%

35

25CV/CC <1CV/CC 1-3CV/CC >3

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Use of Ultra-Low CV as a Proportion of All Cases

Gurm HS, et al. Catheter Cardiovasc Interv. 2018 Aug 25. doi: 10.1002/ccd.27819 [Epub ahead of print].

Use of ultra-low CV as a proportion of all cases performed by an operatoror at a participating institution in Michigan

Distribution of PCI Operators by Rate of Ultra-Low Contrast

Cases with CV/CC ≤1 (%)0 4020 860 100

30

0

Freq

uenc

y

25

10

15

5

20

30

0

Cas

es w

ith C

V/C

C ≤

1 (%

) 25

10

15

5

20

Hospital

Mean Rate of Ultra-Low Contrast by Hospital

Overall mean rate: 13.07%

Page 76: Best Practices for Screening in the Catheterization LaboratoryOsprey... · • Consultant: Osprey Medical Pty, Ltd. • Consultant/Speaker: Abiomed, Inc. • Speaker: Chiesi, Inc.

Implications of AKI

• Associated with increased mortality and morbidity rates

• Associated with significantly increased cost

• Medico-legal concern

• No specific treatment

• Prevention remains the key

Tsai TT, et al. J Am Coll Cardiol Intv. 2014;7:1-9.

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Cost Implications of CI-AKI

• Average cost of CI-AKI ~$8900

Parsh J, et al. J Am Coll Cardiol. 2016;67(13):279.

Comparison of Total Episode Cost between Patients withand without CI-AKI

Without CINWith CIN 0

Patie

nts

at o

r bel

ow C

ost (

%)

Adjusted Total Episode Cost ($1000s)10

5101520253035404550556065707580859095

100

$14,462

$16,511

$21,059

$17,480

$22,689

$34,746

20 30 40 60 80 110 160 230 330

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Why Does AKI Increase the Risk of Death?

• Increased risk of bleeding

• Increased risk of thrombosis

• Worsened myocardial healing and remodeling

• Altered metabolic milieu and increased risk of arrhythmia

• Inability to use angiotensin-converting enzyme inhibitor/angiotensin receptor blocker or aldosterone antagonists

Gurm HS, et al, eds. (2014). Renal Complications in the Catheterization Laboratory. An Issue of Interventional Cardiology Clinics, E-book. 2014;3(3):317-460. Philadelphia, PA: Elsevier Health Sciences.

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Clinical Impact of Preventing CI-AKI

Brar SS, et al. Lancet. 2014;383(9931):1814-1823.

Rate of major adverse events in each group. The graph shows the 6-month rate of major adverse events,defined as a composite of all-cause mortality, MI, or dialysis.

Prevention of Contrast Renal Injury with Different Hydration Strategies (POSEIDON)

Time (days)150

0

15

5

1800

LVEDPControl

10R

ate

ofM

ajor

Adv

erse

Eve

nts

(%)

194192

190187

LVEDPControlNo. at Risk 190

181191189

90 12030 60

196200

190188

190184

Log-rank P=.009

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Prevent AKI: It Is Good Medicine

• Clinically relevant

• Measurable with a persistent gap

• Actionable

• Results in improved downstream outcomes