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Creating a Safer System. 24-month national Campaign. For re-evaluation March 2007. To help teams develop skills/capacity to monitor their performance and make Quality Improvements (QI) Focus is harm reduction and improving care processes and outcomes for patients. - PowerPoint PPT Presentation

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Page 1: Creating a Safer System

Creating a Safer System

Page 2: Creating a Safer System

24-month national Campaign. 24-month national Campaign. For re-evaluation For re-evaluation March 2007. March 2007.

To help teams develop To help teams develop skills/capacity to monitor their skills/capacity to monitor their performance and make Quality performance and make Quality Improvements (QI)Improvements (QI)

Focus is harm reduction and Focus is harm reduction and improving care processes and improving care processes and outcomes for patientsoutcomes for patients

Page 3: Creating a Safer System

Canadian Adverse Events Canadian Adverse Events StudyStudy 7.5% of all hospital admissions are 7.5% of all hospital admissions are

associated with an adverse event (2000)associated with an adverse event (2000) 36.9% of which were deemed 36.9% of which were deemed

preventablepreventable IE: 70,000 preventable adverse events IE: 70,000 preventable adverse events

per yearper year Possibly contributing to 9,000 Possibly contributing to 9,000

preventable deaths in Canada (2000)preventable deaths in Canada (2000)

Adverse Events in Canadian Hospitals Adverse Events in Canadian Hospitals (Baker, R. & Norton, P. et al (2004))(Baker, R. & Norton, P. et al (2004))

Page 4: Creating a Safer System

The The Key focusKey focus of SHN: solving the of SHN: solving the implementation issues that stand implementation issues that stand between our knowledge of "what between our knowledge of "what works” and our ability to reliably works” and our ability to reliably provide this standard of care provide this standard of care

Safer Healthcare Now!Safer Healthcare Now! aims to aims to provide quality improvement ideas, provide quality improvement ideas, supports and resources to hospital supports and resources to hospital teams with the goal of providing safer teams with the goal of providing safer care.care.

Page 5: Creating a Safer System

160 healthcare organizations and 160 healthcare organizations and 470 teams enrolled nationwide 470 teams enrolled nationwide (68 teams in Atlantic Canada) (68 teams in Atlantic Canada)

Partners include CMA, CCHSA, DOH, Partners include CMA, CCHSA, DOH, Professional Colleges , Associations Professional Colleges , Associations of Health Organizationsof Health Organizations

Page 6: Creating a Safer System

Six Improvement Initiatives:Six Improvement Initiatives:

– Acute Myocardial Infarction (AMI)Acute Myocardial Infarction (AMI)– Medication ReconciliationMedication Reconciliation– Surgical Site Infection (SSI)Surgical Site Infection (SSI)– Rapid Response (RRT)Rapid Response (RRT)– Central Line InfectionCentral Line Infection– Ventilator Associated Pneumonia (VAP)Ventilator Associated Pneumonia (VAP)

Page 7: Creating a Safer System

7

Cumulative 6-month mortality from ischemic heart disease

0 1 2 3 4 5 6

5

10

0

15

20

25

Months after hospital admission

Dea

ths /

100

pts

/ m

onth

Acute MIUnstable anginaStable angina

Duke Cardiovascular Database

N = 21,761; 1985-1992Diagnosis on adm to hosp

Page 8: Creating a Safer System

Atherosclerosis TimelineAtherosclerosis TimelineFoamFoamCells Cells

FattyFattyStreak Streak

IntermediateIntermediateLesion Lesion AtheromaAtheroma

FibrousFibrousPlaquePlaque

ComplicatedComplicatedLesion/Lesion/RuptureRupture

Adapted from Pepine CJ. Am J Cardiol. 1998;82(suppl 104).

From FirstDecade

From ThirdDecade

From FourthDecade

Endothelial DysfunctionEndothelial Dysfunction

Page 9: Creating a Safer System

9

Plaque Rupture and Clot Formation

Page 10: Creating a Safer System

10

No ST ElevationNo ST Elevation ST ElevationST Elevation

Acute Coronary SyndromeAcute Coronary Syndrome

Unstable AnginaUnstable Angina NQMINQMI Qwave MIQwave MI

NSTEMINSTEMI

Myocardial InfarctionMyocardial Infarction

Dx: MIDx: MIPrognosisPrognosis

Selection of RxSelection of Rx

Dx: ReinfarctionDx: ReinfarctionPrognosisPrognosis

Assess ReperfusionAssess Reperfusion

Serum Cardiac MarkersSerum Cardiac Markers

Page 11: Creating a Safer System

STST--ElevationElevation--MIMI

Clinical FindingClinical Finding

ECGECG

Serum MarkersSerum Markers

Risk AssessmentRisk Assessment

NoncardiacChest Pain

StableAngina

UnstableAngina

Non-ST-Elev. MI

ThrombolysisPrimary PCI

ASA + GP IIb/IIIa Inhibitor + Heparin/LMWH + Anti-ischemic RxEarly Invasive Rx

Discharge

NegativePositive

Diagnostic Rule Out MI/ACS

Pathway

STST--TT--Wave Wave ChangesChanges

ST ST ElevationElevationNegative

Low Probability MediumMedium--High RiskHigh Risk STEMISTEMILow Risk

ASA, Heparin/LMWH +Anti-ischemic Rx

Early Conserv.

Rest Pain, PostRest Pain, Post--MI, MI, DM, Prior ASADM, Prior ASA

Exertional PainAtypical Pain Ongoing Ongoing

PainPain

Negative PositivePositive

Cannon in Braunwald et al. Cannon in Braunwald et al. Heart Disease.Heart Disease. 2001.2001.

Page 12: Creating a Safer System

12

0

5

10

15

20

25

1967 1970 1979 1986 1990 1993 1997 1999

% M

orta

lity

Early Mortality After AMI

Mortality at 25 - 30 DaysMortality at 25 - 30 Days

GISSI-1Pre-CCU CCU -Block GUSTOISIS-2 GUSTO-3 ASSENT-2SK SK+ASA tPA tPA &

rPAtPA &TNK

Page 13: Creating a Safer System

Definition of AMIDefinition of AMI Patients admitted through ER with Patients admitted through ER with

diagnosis of AMI confirmed by 2 of :diagnosis of AMI confirmed by 2 of :

documented symptoms compatible with documented symptoms compatible with AMIAMI

ST elevation in 2 contiguous leads or ST elevation in 2 contiguous leads or new LBBB new LBBB

documented enzyme elevation.documented enzyme elevation.

Page 14: Creating a Safer System

14

Ischemic chest pain 30 min

Page 15: Creating a Safer System

15

Ischemic chest pain 30 min

Acute Anterior Injury

Page 16: Creating a Safer System

16

Ischemic Chest Pain – 30 min

Page 17: Creating a Safer System

17

Ischemic Chest Pain – 30 min

Acute inferior injury

Page 18: Creating a Safer System

18

ST Elevation MI: Management ST Elevation MI: Management PrinciplesPrinciples

1.1. Achieve early and complete reperfusion of the infarct-Achieve early and complete reperfusion of the infarct-related vesselrelated vessela.a. Primary Percutaneous intervention (PCI)Primary Percutaneous intervention (PCI)b.b. Thrombolytic therapyThrombolytic therapy

2.2. Use evidence-based adjunctive medical therapyUse evidence-based adjunctive medical therapya.a. ASAASAb.b. Beta blockersBeta blockersc.c. Angiotensin converting enzyme(ACE) inhibitorsAngiotensin converting enzyme(ACE) inhibitorsd.d. StatinsStatinse.e. Antithrombotic therapy (when indicated)Antithrombotic therapy (when indicated)

Page 19: Creating a Safer System

19

Primary PCI vs. ThrombolysisPrimary PCI vs. Thrombolysis

53% event free survival

37 % event free survival

From www.uptodate.com . Accessed on July 29, 2003

PAMI TRIAL: 395 patients

Events:

Death, recurrent MI or ischemia requiring revascularization

Page 20: Creating a Safer System

20

Fibrinolytic TherapyIs It A Treatment of the Past?

• Meta-analysis of 23 randomized trials

• Primary PCI reduced

Death 7% vs 9% Reinfarction 2.5% vs 6.8% Stroke 1% vs 2%

Lancet 2003; 361:13-20

Page 21: Creating a Safer System

21

Fibrinolysis vs. Transport for PCI

• On-site (community hospital) fibrinolysis compared with immediate transport to a regional center for PCI for STEMI

• A consistent 40% reduction in AE

• Time delay for transport were 10, 30, 43 min (277 min for PCI vs 245 min for fibrinolysis)

Odds ratio and 95% confidence intervals for the composite end point of death, reinfarction, and stroke at 30 days

ACC Scientific Sessions; March 20, 2002: Atlanta, GaESC; September 1, 2002: Berlin, Germany

J Am Coll Cardiol. 2002; 39: 1713–1719

Page 22: Creating a Safer System

22

Fibrinolytic TherapyIs It A Treatment of the Past?

• Resistance to primary PCI– Not enough Primary PCI studies have

been performed– Results may not be reproducible in low

volume and less experienced centers– Withholding thrombolytic while awaiting

PCI may cause harm

Page 23: Creating a Safer System

Benefits of PCI vs Lysis: The Importance of Timing

Kent DM et al Eff Clin Pract 4: 214, 2001

Page 24: Creating a Safer System

24

Thrombolytic Therapy: Importance of Early Thrombolytic Therapy: Importance of Early TherapyTherapy

Data from Boersma,E et al. Lancet 1996;348: 771

Benefit falls by 1.6 lives per 1000 patients per hour of treatment delay after two hours

Benefit Greatest within Two hours of therapy

Page 25: Creating a Safer System

25

ST Elevation MI: Importance of Early ST Elevation MI: Importance of Early ReperfusionReperfusion

TIMI 0=Occlusion

TIMI 1= Penetration

TIMI 2= Slow Flow

TIMI 3= Normal Flow

Page 26: Creating a Safer System

26

Thrombolytic Therapy: Ineligible PatientsThrombolytic Therapy: Ineligible Patients

From www.uptodate.com. Accessed July 28, 2003

Page 27: Creating a Safer System

27

ST elevation MI

• Fibrinolysis – TNK (tPA, rPA, SK) then• Low molecular weight heparin (Enoxaparin)

- 30 mg bolus IV under age 75 and - 1 mg/kg sq bid - Age 75 and up – 0.75 mg/kg sq bid. or

• Unfractionated heparin for very obese over 145 kg, renal failure

Page 28: Creating a Safer System

28

Thrombolytic Therapy: Bottom LineThrombolytic Therapy: Bottom Line• Earlier (within two hours of symptoms) administration Earlier (within two hours of symptoms) administration

associated with better outcomes but benefit shown up to 12 associated with better outcomes but benefit shown up to 12 hourshours

• Overall efficacy in achieving TIMI 3 flow is 50-60%Overall efficacy in achieving TIMI 3 flow is 50-60%• Risk of Hemmorragic Stroke Low (0.49%-0.72%)Risk of Hemmorragic Stroke Low (0.49%-0.72%)

– Less with SK than with t-PA or TnKLess with SK than with t-PA or TnK• 40% of patients are INELIGIBLE for thrombolytic therapy40% of patients are INELIGIBLE for thrombolytic therapy• Current Agent of Choice: Tenecteplase (TnK)Current Agent of Choice: Tenecteplase (TnK)• Primary PCI better:Primary PCI better:

– Higher rate of TIMI 3 flow (>90%)Higher rate of TIMI 3 flow (>90%)– Negligible risk of Intracranial HemmorrhageNegligible risk of Intracranial Hemmorrhage– Associated with improved outcomesAssociated with improved outcomes

Page 29: Creating a Safer System

29

Summary - STEMI

• ST-segment elevation ACS should receive reperfusion therapy (PCI or fibrinolysis) as a medical emergency

• Early use of aspirin, b-blockers, ACE inhibitors (in LV dysfunction), antithrombin agents, antiplatelet therapies

• Center with invasive facilities have better outcomes

Page 30: Creating a Safer System

TIMI Risk Score for STEMITIMI Risk Score for STEMI

Age 65-7475

DM/HTN or angina

Weight < 67 kg

Time to rx > 4 hrsAnterior STE or LBBB

HR >100SBP < 100

Historical

Exam

Presentation

Killip II-IV

2 points3 points1 point

3 points

2 points1 point

1 point1 point

2 points

Risk Score = Total (0 -14)

012345678

>8

Risk Score Odds of death by 30D*

(FRONT) (BACK)

0.1 (0.1-0.2)

0.3 (0.2-0.3)

0.4 (0.3-0.5)

0.7 (0.6-0.9)

1.2 (1.0-1.5)

2.2 (1.9-2.6)

3.0 (2.5-3.6)

4.8 (3.8-6.1)

5.8 (4.2-7.8)

8.8 (6.3-12)

*referenced to average mortality(95% confidence intervals)

Figure 6

Page 31: Creating a Safer System

3131

TIMI Risk Score for TIMI Risk Score for STEMISTEMI

From www.uptodate.com. Accessed June 28, 2003

Palm Pilot application available at:

www.timi.org

Page 32: Creating a Safer System

WMH AMI CommitteeWMH AMI Committee

Julie SuttonJulie Sutton- - Team LeaderTeam Leader Dr. Jamie GrahamDr. Jamie Graham--Cardiac Physician Rep.Cardiac Physician Rep. Bonnie WalkerBonnie Walker--Patient Safety Rep.Patient Safety Rep. Dr. Peter CallahanDr. Peter Callahan- - ER Physician Rep.ER Physician Rep.

Maureen DoodyMaureen Doody- - Educator Rep.Educator Rep.

Brenda RexBrenda Rex- - ICU Rep. ICU Rep.

Suzanne JosephSuzanne Joseph - - 3A Manager Rep. 3A Manager Rep.

Rhonda SquiresRhonda Squires- - 3A PCC Rep 3A PCC Rep..

Page 33: Creating a Safer System

AMI StatisticsAMI Statistics

Prompt ASA reduces risk of death Prompt ASA reduces risk of death by 15% ; Beta-blockers reduce risk by 15% ; Beta-blockers reduce risk of death in first week by 13% and of death in first week by 13% and long term mortality by 23% long term mortality by 23%

RAND study (NEJM) showed only RAND study (NEJM) showed only 61% of AMI patients receive ASA 61% of AMI patients receive ASA and only 45% receive beta-blockersand only 45% receive beta-blockers

Page 34: Creating a Safer System

AMI Key ComponentsAMI Key Components

1. Early administration of aspirin 1. Early administration of aspirin (within 24 hours)(within 24 hours)

2. Timely thrombolytic (within 30 minutes)2. Timely thrombolytic (within 30 minutes) 3. Aspirin at discharge3. Aspirin at discharge 4. Beta-blocker at discharge4. Beta-blocker at discharge 5. ACE-inhibitor at discharge 5. ACE-inhibitor at discharge

(if systolic dysfunction) (if systolic dysfunction) 6. Smoking cessation counseling6. Smoking cessation counseling

Page 35: Creating a Safer System

35

Potential Cumulative Impact of 4 Simple Secondary Prevention Treatments

RRR Event rate

None 8%

ASA 25% 6%

-Blockers 25% 4.5%

Lipid lowering 30% 3.0%

ACE-inhibitors 25% 2.3%

CUMULATIVE BENEFITS ARE LIKELY TO BE IN EXCESS OF 75% RRR, WHICH IS SUBSTANTIAL

"Yusuf S., Unpublished data." 

Page 36: Creating a Safer System

AMI Baseline DataAMI Baseline Data

BASED on Retrospective Chart BASED on Retrospective Chart ReviewReview

March -September 2005March -September 200574 Charts Identified, 20 Excluded74 Charts Identified, 20 Excluded54 reviewed for compliance and 54 reviewed for compliance and

documentation with each of AMI documentation with each of AMI components and overall (Perfect components and overall (Perfect Care)Care)

Page 37: Creating a Safer System

AMI Baseline Data vs. Goals

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

% o

f Pat

ient

s R

ecei

ving

Inte

rven

tion

Baseline 91.0% 80.0% 92.5% 90.0% 70.0% 50% 41.0%

Goal 90% 85% 90% 90% 85% 100% 95%

Aspirin at Arrival Thrombolytic Admin < 30 min

Aspirin at Discharge

Beta Blocker at Discharge

ACE or ARB at Discharge

Smoking Cessation

"Perfect Care"

Page 38: Creating a Safer System

38

Acute MI: ASA benefit

23% mortality reduction 42%

mortality reduction

ISIS-2: 17, 187 patients: Acute MI

Page 39: Creating a Safer System

1.1. Early Administration of ASAEarly Administration of ASA

Goal: Goal: >>90% compliance90% complianceAspirin 24 hrs before or after hospitalizationAspirin 24 hrs before or after hospitalization

Exclusions:Exclusions: Documented contraindications: Documented contraindications:

(ASA allergy, active bleeding, warfarin (ASA allergy, active bleeding, warfarin before arrival) before arrival)

Transferred in from or out to another Transferred in from or out to another acute care facility acute care facility

Page 40: Creating a Safer System

4040

ASA on ArrivalASA on Arrival

50

60

70

80

90

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 41: Creating a Safer System

4141

Thrombolysis: Decay with Thrombolysis: Decay with DelayDelay

0

20

40

60

80

100

0 2 4 6 8 10 12Hours Delay

Percent Benefit

Page 42: Creating a Safer System

2. 2. Timely ThrombolysisTimely Thrombolysis

Goal: Goal: >>85% compliance85% complianceThrombolytic Agent within 30 minutes Thrombolytic Agent within 30 minutes

(door to needle)of arrival(door to needle)of arrival

Exclusions:Exclusions: Transferred in from another facilityTransferred in from another facility No ST elevation or new LBBB presentNo ST elevation or new LBBB present Did not receive a thrombolytic or received Did not receive a thrombolytic or received

thrombolytic more than 6 hrs after arrivalthrombolytic more than 6 hrs after arrival

Page 43: Creating a Safer System

4343

Thrombolytic within 30 Thrombolytic within 30 minmin

0102030405060708090

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 44: Creating a Safer System

4444

Aspirin Evidence: Secondary Aspirin Evidence: Secondary PreventionPrevention

Antithrombotic Trialist Collaboration. BMJ 2002;324:71–86.

Category % Odds ReductionAcute myocardial infarctionAcute stroke Prior myocardial infarction Prior stroke/transient ischemic attackOther high risk Coronary artery disease

(e.g. unstable angina, heart failure) Peripheral arterial disease

(e.g. intermittent claudication) High risk of embolism (e.g. atrial fibrillation) Other (e.g. diabetes mellitus)All trials

1.00.50.0 1.5 2.0 Control better Antiplatelet better

Effect of antiplatelet therapy* on vascular events**

*Aspirin was the predominant antiplatelet agent studied**Vascular events include MI, stroke, or death

Page 45: Creating a Safer System

4545

Aspirin Evidence: Dose and Aspirin Evidence: Dose and EfficacyEfficacy

0.5 1.0 1.5 2.0

500-1500 mg 34 19

160-325 mg 19 26

75-150 mg 12 32

<75 mg 3 13

Any aspirin 65 23

Antiplatelet Better Antiplatelet Worse

Aspirin Dose No. of Trials (%)Odds Ratio for

Vascular Events

0

P<.0001

Indirect Comparisons of Aspirin Doses on Vascular Events in High-Risk Patients

Antithrombotic Trialists Collaboration. BMJ. 2002;324:71-86

Page 46: Creating a Safer System

3. Discharged on ASA3. Discharged on ASA Goal: Goal: >>90% compliance90% complianceAspirin prescribed on dischargeAspirin prescribed on discharge

Exclusions:Exclusions: Documented contraindications: Documented contraindications:

(ASA allergy,active bleeding, (ASA allergy,active bleeding, warfarin before arrival) warfarin before arrival)

Transferred out to another acute Transferred out to another acute care facilitycare facility

Page 47: Creating a Safer System

4747

ASA at DischargeASA at Discharge

70

75

80

85

90

95

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 48: Creating a Safer System

48

Acute MI: Benefit of Beta Blockers

Data from Gottlieb, SS et al. NEJM 1998;339:489

201, 752 patients with MI

Mortality reduction:

14.4% vs. 23.9% at 2 years

Page 49: Creating a Safer System

4949

Phase of Treatment

Acute treatment

Secondaryprevention

Overall

Total #Patients

28,970

24,298

53,268

0.5 1.0 2.0RR of death

-blockerbetter

RR (95% CI)

Placebobetter

0.87 (0.77-0.98)

0.77 (0.70-0.84)

0.81 (0.75-0.87)

-blocker Evidence-blocker Evidence

Antman E, Braunwald E. Acute Myocardial Infarction. In: Braunwald E, Zipes DP, Libby P, eds. Heart Disease: A textbook of Cardiovascular Medicine, 6th ed., Philadelphia, PA: W.B. Sanders, 2001, 1168.

Summary of Secondary Prevention Trials of -blocker Therapy

CI=Confidence interval, RR=Relative risk

Page 50: Creating a Safer System

5050

6,644 patients with LVEF <0.40 after a MI with or without HF randomized to carvedilol or placebo for 24 months

The CAPRICORN Investigators. Lancet. 2001;357:1385–1390.

RR 0.77 P=.030.7

0.75

0.8

0.85

0.9

0.95

1

0 0.5 1 1.5 2 2.5

Carvedilol

Placebo

Years

Prop

ortio

n Ev

ent-f

ree

n=975

n=984

-blocker Evidence: Post MI with -blocker Evidence: Post MI with Left Ventricular DysfunctionLeft Ventricular Dysfunction

Carvedilol Post-Infarct Survival Control in LV Dysfunction (CAPRICORN)

Page 51: Creating a Safer System

4. Discharged on Beta Blocker4. Discharged on Beta Blocker

Goal: Goal: >>90% compliance90% complianceBeta Blocker prescribed on dischargeBeta Blocker prescribed on discharge

Exclusions:Exclusions: Documented contraindications: (allergy, Documented contraindications: (allergy,

bradycardia or BP < 90 systolic day of bradycardia or BP < 90 systolic day of or day prior to discharge when not on or day prior to discharge when not on beta blocker, 2nd/3rd degree HB beta blocker, 2nd/3rd degree HB without a pacemaker,)without a pacemaker,)

Transferred out to another acute care Transferred out to another acute care facilityfacility

Page 52: Creating a Safer System

5252

Beta Blocker at Beta Blocker at DischargeDischarge

70

75

80

85

90

95

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 53: Creating a Safer System

53

Acute MI: ACE Inhibitor Benefit

Data from Pfeffer, MA et al.NEJM 1992;327: 669

Page 54: Creating a Safer System

5454

Years

Prob

abilit

y of

Eve

nt

00.05

0.150.2

0.250.3

0 1 2 3

0.350.4

4

ACE-IPlacebo

OR: 0.74 (0.66–0.83)0.1

Flather MD, et al. Lancet. 2000;355:1575–1581

SAVERadionuclideEF 40%

AIREClinical and/or radiographic signs of HF

TRACEEchocardiogramEF 35%

ACE Inhibitor Evidence: Post MI ACE Inhibitor Evidence: Post MI with LVD or HFwith LVD or HF

ACE-I=Angiotensin converting enzyme inhibitors, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, OR=Odds ratio

Page 55: Creating a Safer System

55

0

0.05

0.1

0.15

0.2

0 500 1000 1500

Days of Follow-up

% D

eath

, MI,

or S

trok

e

Ramipril Placebo

HOPE Primary Results Benefits of ACE Inhibitors

p<0.001

Page 56: Creating a Safer System

5656

ACE Inhibitor Evidence: ACE Inhibitor Evidence: Secondary PreventionSecondary Prevention

Comparison between the HOPE and PEACE trials

Braunwald, E. et al., NEJM 2004;351:2058-68.

CHD=Coronary heart disease, MI=Myocardial infarction

*Reflects greater blood pressure control, revascularization, and use of other risk-reducing medications (i.e., antiplatelet therapy, -blocker, lipid-lowering medication)

0

5

10

15

20

0 1 2 3 4 5

HOPE, placebo

HOPE, active drug (ramipril)

PEACE, placebo

MI,

Car

diac

dea

th,

or S

troke

(%)

Years

Page 57: Creating a Safer System

5757

ARB Evidence: Heart FailureARB Evidence: Heart Failure

Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) Alternative Trial

Granger CB et al. Lancet. 2003;362:772-777

ACE-I=Angiotensin converting enzyme inhibitors, ARB=Angiotensin receptor blockers, EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction

0 1 2 3Years

50

HR 0.77 p=0.00040

40

30

2010

CandesartanPlacebo

CV

Dea

th o

f H

ospi

taliz

atio

n fo

r HF

2,028 patients with symptomatic HF, LVSD (EF <40%), and intolerance to ACE-I randomized to candesartan (32 mg) or

placebo over 34 months

Page 58: Creating a Safer System

5858

ARB Evidence: Post MI with LVD ARB Evidence: Post MI with LVD or HFor HF

Pfeffer M et al. NEJM 2003;349:1893-1906.

Valsartan in Acute Myocardial Infarction Trial (VALIANT)

0.0

0.1

0.2

0.3

0.4

0 6 12 18 24 30 36

ValsartanValsartan and Captopril

Captopril

All

Cau

se M

orta

lity

Months

Valsartan vs. Captopril: HR = 1.00; P = 0.982Valsartan + Captopril vs. Captopril: HR = 0.98; P = 0.726

EF=Ejection fraction, HR=Hazard ratio, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, RAS=Renin angiotensin system

14,703 patients with post-MI HF or LVSD (EF <0.40) randomized to captopril (50 mg three times daily), valsartan (160 mg twice

daily), or captopril (50 mg three times daily) plus valsartan (80 mg twice daily) over 2 years

Page 59: Creating a Safer System

5. Discharged on ACEI/ARB5. Discharged on ACEI/ARB

Goal: Goal: >>85% compliance85% complianceACE Inhibitor prescribed on dischargeACE Inhibitor prescribed on discharge

Exclusions: Exclusions: Documented contraindication: Documented contraindication:

(allergy/intolerance, moderate to (allergy/intolerance, moderate to severe aortic stenosis, renal severe aortic stenosis, renal dysfunction, systolic BP dysfunction, systolic BP <100mmHg, K+ > 4.5)<100mmHg, K+ > 4.5)

Transferred out to another acute Transferred out to another acute care facilitycare facility

Page 60: Creating a Safer System

6060

ACEIACEI/ARB at Discharge/ARB at Discharge

40

50

60

70

80

90

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 61: Creating a Safer System

6161

0.1 1.0 10Ceased smoking Continued smoking

RR (95% Cl)StudyAberg, et al. 1983 0.67 (0.53-0.84)

Herlitz, et al. 1995 0.99 (0.42-2.33)

Johansson, et al. 1985 0.79 (0.46-1.37)

Perkins, et al. 1985 3.87 (0.81-18.37)

Sato, et al. 1992 0.10 (0.00-1.95)

Sparrow, et al. 1978 0.76 (0.37-1.58)

Vlietstra, et al. 1986 0.63 (0.51-0.78)

Voors, et al. 1996 0.54 (0.29-1.01)

Cigarette Smoking Cessation: Risk Cigarette Smoking Cessation: Risk of Non-fatal MI*of Non-fatal MI*

Critchley JA et al. JAMA. 2003;290:86-97.

*Includes those with known coronary heart disease CI=Confidence interval, RR=Relative risk

Page 62: Creating a Safer System

6. 6. Smoking Cessation Counseling Smoking Cessation Counseling on Dischargeon Discharge

Goal: 100 % complianceGoal: 100 % complianceReceived smoking cessation Received smoking cessation

advice,counselling and/or advice,counselling and/or pharmocological therapy or referral to pharmocological therapy or referral to Cardiac Rehab during hospitalizationCardiac Rehab during hospitalization

Exclusions: Exclusions: No history of smoking cigarettes, cigars No history of smoking cigarettes, cigars

or pipe anytime in year prior to admission or pipe anytime in year prior to admission Transferred out to another acute care Transferred out to another acute care

facilityfacility

Page 63: Creating a Safer System

6363

Smoking Cessation Smoking Cessation AdviceAdvice

0102030405060708090

2005 Mar-06 Jun-06

WMRHAtlanticCanada

Page 64: Creating a Safer System

7. “Perfect Care” for AMI7. “Perfect Care” for AMI

Goal 95%complianceGoal 95%compliance

The percentage of AMI patients who The percentage of AMI patients who received all 6 evidence based elements. received all 6 evidence based elements.

documentation of all 6 elements of care documentation of all 6 elements of care in appropriate time frames,in appropriate time frames,

documentation of clearly defined documentation of clearly defined contraindications .contraindications .

Page 65: Creating a Safer System

6565

““Perfect Care”Perfect Care”

0102030405060708090

100

2005 Mar-06 Jun-06

WMRHAtlanticCanada

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66

Acute MI: Statin Benefit

Data from: Heart Protection Study. Lancet 2002;360:7

20, 536 patients in Heart Protection Study

Page 67: Creating a Safer System

6767LaRosa JC et al. NEJM. 2005;352:1425-1435

LDL-C=Low density lipoprotein cholesterol; TNT=Treating to New Targets; HPS=Heart Protection Study; CARE=Cholesterol and Recurrent Events Trial; LIPID=Long-term Intervention with Pravastatin in Ischaemic Disease; 4S=Scandinavian Simvastatin Survival Study.

30

25

20

15

10

5

00 70 90 110 130 150 170 190 210

LDL-C (mg/dL)

TNT (atorvastatin 80 mg/d)TNT (atorvastatin 10 mg/d)

HPSCARE

LIPIDLIPID

CAREHPS

Eve

nt (%

) 4S

4SStatinPlacebo

Relationship between LDL Levels and Event Rates in Secondary Prevention Trials of Patients with Stable CHD

HMG-CoA Reductase Inhibitor: HMG-CoA Reductase Inhibitor: Secondary PreventionSecondary Prevention

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6868

Statin at DischargeStatin at Discharge

40

50

60

70

80

90

100

Mar-May 06 June-July 06

WMRH

Page 69: Creating a Safer System

Improvement ModelImprovement ModelPDSAPDSA

What are we trying to accomplish?

How will we know that a change is an improvement?

What changes can we make that will result in improvement?

Act Plan

Study Do

Page 70: Creating a Safer System

Plan a testPlan a test Try itTry it Observe the Observe the

resultsresults Act on what Act on what

is learnedis learned

Act Plan

DoStudy

Page 71: Creating a Safer System

Test again

Test Smoking Rehab

make changes

make changes

Test again

make changes

ae changes

Page 72: Creating a Safer System

Improvements in ProgressImprovements in Progress

Combining 2 Routine MI order Combining 2 Routine MI order sheets STEMI / NSTEMI to onesheets STEMI / NSTEMI to one

Reviewing Thrombolytic Standing Reviewing Thrombolytic Standing Order sheetOrder sheet

Reviewing Nicotine Replacement Reviewing Nicotine Replacement addition to hospital formularyaddition to hospital formulary

Page 73: Creating a Safer System

Next Steps: Concurrent DataNext Steps: Concurrent Data

Uses tests of change that allow Uses tests of change that allow changes while patient still in hospitalchanges while patient still in hospital

Allows identification of missed Allows identification of missed interventions so they can be interventions so they can be corrected before the patient is corrected before the patient is dischargeddischarged

Results in improved AMI care for Results in improved AMI care for patientspatients

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7474

MI MI Work Work sheetsheet

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7575

Contraindications – p.2Contraindications – p.2

Page 76: Creating a Safer System

Frontline Staff Can Make a Frontline Staff Can Make a Difference!Difference! MD’s: please use MI order sheetMD’s: please use MI order sheet Checklist of interventions for Checklist of interventions for

improved care for AMI into care improved care for AMI into care processesprocesses

During hospitalization check for During hospitalization check for interventions and document each interventions and document each as completed or contraindicatedas completed or contraindicated

Page 77: Creating a Safer System

7777

Components of Secondary Components of Secondary PreventionPrevention

Cigarette smoking cessationCigarette smoking cessationBlood pressure controlBlood pressure controlLipid management to goalLipid management to goalPhysical activityPhysical activityWeight management to goalWeight management to goalDiabetes management to goalDiabetes management to goalAntiplatelet agents / anticoagulantsAntiplatelet agents / anticoagulantsRenin angiotensin aldosterone system blockersRenin angiotensin aldosterone system blockersBeta blockersBeta blockersInfluenza vaccinationInfluenza vaccination

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7878

Prospective Studies Collaboration. Lancet. 2002;360:1903-1913

Usual Diastolic BP (mm Hg)Usual Systolic BP (mm Hg)

Isch

emic

Hea

rt D

isea

se M

orta

lity

50-59

60-69

70-79

80-89Age at Risk (Y)

40-49

256

128

64

32

16

8

4

2

1

0120 140 160 180

50-59

60-69

70-79

80-89Age at Risk (Y)

40-49

256

128

64

32

16

8

4

2

1

080 90 100 11070

Blood Pressure: Lower is BetterBlood Pressure: Lower is Better

Isch

emic

Hea

rt D

isea

se M

orta

lity

Ischemic Heart Disease Mortality

BP=Blood pressure

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7979

Observational study of self-reported physical activity in 772 men with Observational study of self-reported physical activity in 772 men with established coronary heart disease established coronary heart disease

Light or moderate exercise is associated with lower riskLight or moderate exercise is associated with lower risk

Wannamethee SG et al. Circulation 2000;102:1358-1363

Exercise Evidence: Mortality RiskExercise Evidence: Mortality Risk

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8080

Mhurchu N et al. Int J Epidemiol 2004;33:751-758

0.5

1.0

2.0

4.0

16 20 24 28 32 36

Body Mass Index (kg/m2)*

Haz

ard

Rat

io

0.5

1.0

2.0

4.0

16 20 24 28 32 36

0.5

1.0

2.0

4.0

16 20 24 28 32 36

HemorrhagicStroke

IschemicStroke

Ischemic HeartDisease

CV Risk Increases with Body Mass CV Risk Increases with Body Mass IndexIndex

CV=Cardiovascular

Body mass index is calculated as the weight in kilograms divided by the body surface area in meters2.

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8181

Clopidogrel Evidence: ACS Clopidogrel Evidence: ACS (Non-STEMI and UA)(Non-STEMI and UA)Clopidogrel in Unstable Angina to Prevent Recurrent Events

(CURE) Trial

The CURE Trial Investigators. NEJM. 2001;345:494-502

NSTEMI-ACS=Non ST-segment elevation acute coronary syndrome

0.00

0.02

0.04

0.06

0.08

0.10

0.12

0.14

3 6 90 12

Rat

e of

dea

th,

myo

card

ial i

nfar

ctio

n,

or s

troke

P<0.001

Months of Follow Up

Aspirin + ClopidogrelAspirin + Placebo

12,562 patients with a NSTEMI-ACS randomized to daily aspirin (75-325 mg) or clopidogrel (300 mg load, 75 mg thereafter)

plus aspirin (75-325 mg) for 3-12 months (average 9 months)

Page 82: Creating a Safer System

8282Pitt B et al. NEJM 1999;341:709-717

Aldosterone Antagonist: Heart Aldosterone Antagonist: Heart FailureFailure

Randomized Aldactone Evaluation Study (RALES)

EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association

RR = 0.70, P<0.001

Months

Sur

viva

l (%

)

3633302724211815129630

1.00.90.80.70.60.50

0

SpironolactonePlacebo

1,663 patients with NYHA Class III or IV HF and LVSD (EF <0.35) randomized to spironolactone (25 mg)

or placebo (50 mg) for 24 months

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8383

Aldosterone Antagonist: Post MI HF Aldosterone Antagonist: Post MI HF and LVSDand LVSD

Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS)

RR = 0.85, P=0.008

6 12 18 24 30 360

5

10

15

20

25

0

All

Cau

se M

orta

lity

(%)

Month

EplerenonePlacebo

6,644 patients with evidence of heart failure and LVSD (EF <0.40) after a MI randomized to eplerenone (50 mg) or placebo for 16 months

Pitt B et al. NEJM 2003;348:1309-21

EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction

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8484

Impact of AHA Get With The Impact of AHA Get With The Guidelines-CAD Program on Guidelines-CAD Program on Quality of CareQuality of Care

93

79

64 6757

9583

65 70 70

9787

6573 76

9687

6775 75

9791

6874

82

0102030405060708090

100

Aspirin Beta Blocker ACE Inhibitor Lipid Rx SmokingCessation

Baseline Q1 Q2 Q3 Q4

* ***

* p< 0.05 compared to baseline* *

* ** * **

GWTG-CAD: 123 US Hospitals n=27,825Labresh, Fonarow et al. Circulation 2003;108:IV-722

* *

Page 85: Creating a Safer System

Questions ?Questions ?