CVD Critical Pathways Group 2006 Teleconferences

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CVD Critical Pathways Group 2006 Teleconferences

• April 19, 2006

This activity is supported by an educational
grant from the Bristol-Myers Squibb/Sanofi
Pharmaceuticals Partnership.
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Faculty
Gregg C. Fonarow, MDEliot Corday Professor of
Medicine and Cardiovascular ScienceDirector,
Ahmanson-UCLA Cardiomyopathy CenterUCLA Division
of CardiologyUCLA Medical CenterLos Angeles,
California
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Disclosure Statement

• The Network for Continuing Medical Education
  requires that CME faculty disclose, during the
  planning of an activity, the existence of any
  personal financial or other relationships they or
  their spouses/partners have with the commercial
  supporter of the activity or with the
  manufacturer of any commercial product or service
  discussed in the activity.

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Faculty Disclosure

• Gregg C. Fonarow, MD, has served as a consultant
  to and has received research support and
  honoraria from Bristol-Myers Squibb Company,
  GlaxoSmithKline, Merck Co., Inc., Pfizer Inc,
  sanofi-aventis, Schering-Plough Corporation, and
  Scios, Inc.
• The team from Presbyterian Hospital
  Cardiovascular Institute reports no such
  relationships.

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Polling Question 1

• Do you participate in the REACH registry?
• Yes
• No

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Preliminary Findings From the REACH Registry

• Gregg C. Fonarow, MD

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One-Year Cardiovascular Event Rates in a Global
Contemporary Registry of gt68,000 Outpatients
With Atherothrombosis the REduction of
Atherothrombosis for Continued Health (REACH)
Registry Results

• Ph.G Steg, DL. Bhatt, PWF. Wilson, EM. Ohman, J.
  Röther,CS. Liau, AT. Hirsch, JL. Mas, S.
  Goto,on behalf of the REACH Registry
  Investigators
• AP-HP, Hôpital Bichat-Claude Bernard, Paris,
  France

GROUPE HOSPITALIER BICHAT-CLAUDE
BERNARD
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Disclosures

• The REACH Registry is supported by sanofi-aventis
  and Bristol-Myers Squibb.

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Rationale

• In most cases, the information available from
  previous datasets regarding the characteristics,
  management, and outcomes of patients with, or at
  high risk of, atherothrombosis was limited
• to a single geographic locale (eg, North America,
  Europe)
• to a single subtype of patients (eg, post-MI,
  stroke)
• to inpatients, not outpatients or individuals in
  primary care

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The REACH Registry

• The REACH (REduction of Atherothrombosis for
  Continued Health) Registry has recruited
  outpatients who have had, or are at high risk of
  having, symptoms of atherothrombosis
• The Registry aims to study a contemporary stable
  patient population from various regions of the
  world in order to
• Describe the characteristics and management of
  these patients and of each subgroup
• Assess the long-term risk of atherothrombotic
  events in the global population and in each
  subgroup
• Assess the amount of cross-risk across
  subgroups
• Compare outcomes within different subject
  profiles
• Define predictors of risk for subsequent
  atherothrombotic events
• Follow-up planned at 12 and 21 months, extended
  to 3 and 4 years

Steg PG. Presented at 55th Annual Scientific
Session of the American Collegeof Cardiology
March 12, 2006 Atlanta, Ga.
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REACH Registry gt67,000 Patients From 5,473
Sites in 44 Countries
5,656
17,886
27,746
5,048
5,903
846
North America
1,931
Latin America
Western Europe
Eastern Europe
2,872
Middle East
Up to 15 patients/site (up to 20 in the US)
Asia (incl. Japan)
Australia
Bhatt DL, et al for the REACH Registry
Investigators. JAMA. 2006295180-189.
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A Broad Range of the At-Risk Population Is
Included
REACH Registry Inclusion Criteria
Must include Signed written informed consent Pat
ients aged 45 years or more

• Documented cerebrovascular diseaseischemic
  stroke ortransient ischemic attack
• Documentedcoronary disease,angina, MI,
  angioplasty/stent/bypass
• Documented historicalor current
  intermittentclaudication associatedwith ABI lt
  0.9

• Male ? 65 yearsor female ? 70 years
• Current smokinggt 15 cigarettes/day
• Type 1 or 2diabetes
• Hypercholesterolemia
• Diabetic nephropathy
• Hypertension
• Ankle brachial index(ABI) lt 0.9 in eitherleg at
  rest
• Asymptomatic carotidstenosis ? 70
• Presence of at leastone carotid plaque

At least 1of fourcriteria
At least 3 atherothrombotic risk factors
Bhatt DL, et al for the REACH Registry
Investigators. JAMA. 2006295180-189.
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Baseline Data

• Bhatt DL, et al for the REACH Registry
  Investigators. JAMA. 2006295180-189.

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Prevalence of Polyvascular Disease in the REACH
Registry
Bhatt DL, et al for the REACH Registry
Investigators. JAMA. 2006295180-189.
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Medication Use at Baseline
Bhatt DL, et al for the REACH Registry
Investigators. JAMA. 2006295180-189.
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Worldwide Patient Disposition
69,147 patients pre-enrolled (Database lock
December 15, 2005)

772 pts (1.1) Ineligible
68,375 patients enrolled

3,373 (5.0) Missed visits
139 pts (0.2) Withdrew consent
1,734 pts (2.5) Withdrew due to site
63,129 Worldwide one-year follow-up 92.3 of pts
enrolled (Data extraction January 16, 2006 )
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Statistics

• Events are reported as annualized event rates
• All event rates are reported after adjustment for
  age, and risk factors (smoking, diabetes,
  hypertension, hypercholesterolemia) except
  otherwise specified
• Adjustment was made by using a Cox model

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Patient Type
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Physician Profile
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1-Year Results

• Unless otherwise specified, event rates have been
  adjusted for age, hypertension, diabetes,
  smoking, and cholesterol

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Survival From CV Death/MI/StrokeTotal Population
100 90 80
0 2 4 6 8
10 12
Time to Event (months)
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Major Adverse Cardiovascular Event Rates at One
Year (Unadjusted)
TIA, unstable angina, other ischemic arterial
event including worsening of peripheral arterial
disease. RF risk factor.
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MACE Symptomatic Population
Rates adjusted for age and risk factors.
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Single vs Multiple and Overlapping
Atherothrombotic LocationsThe Example of CAD
Rates adjusted for age and risk factors.
TIA, unstable angina, other ischemic arterial
event including worsening of peripheral arterial
disease.
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Major End Points as a Function of Single vs
Multiple and Overlapping Locations
Polyvascular disease
Single arterial bed
CAD CVD PAD
CVD PAD
CAD PAD
CAD CVD
CAD alone
Overall
PAD alone
Overall
CVD alone
1.5
2.4
CV death
1.5
1.2
Nonfatal MI
3.1
1.5
Nonfatal stroke
6.0
3.4
CV death/MI/ stroke
22.0
12.8
CV death/MI/ stroke/ hospitalization
TIA, unstable angina, other ischemic arterial
event including worsening of peripheral arterial
disease.
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Major End Points as a Function of Single vs
Multiple and Overlapping Locations
1 Plt.05 2 Plt.01 3 Plt.001 (ref class CAD alone)
1 Plt.05 2 Plt.01 3 Plt.001 (ref class CAD CVD)
TIA, unstable angina, other ischemic arterial
event including worsening of peripheral arterial
disease.
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1-Year Cardiovascular Event Rates as Function of
Number of Symptomatic Disease Locations
All P values lt.001. Pts with ³3 risk factors but
no symptoms are counted as 0, even in the
presence of asymptomatic carotid plaque or
reduced ABI.
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Other Outcomes Leading to Hospitalization Since
Baseline
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Vascular Interventions Since Baseline
Multiple RF only (N11,444)
Total symptomatic (N51,685)
CVD (N17,451)
PAD (N7,674)
CAD (N37,542)
0.8
2.9
1.6
2.5
3.7
Coronary angioplasty/ stenting
0.4
1.0
0.7
1.3
1.1
CABG
0.2
0.5
0.4
0.3
0.3
Carotid angioplasty/ stenting
0.3
1.0
0.7
0.4
0.5
Carotid surgery
0.2
3.9
0.5
0.6
0.8
Peripheral bypass graft
0.3
5.1
0.8
1.0
1.1
Other method for PAD (angioplasty/stenting)
0.1
1.3
0.2
0.2
0.3
Amputation affecting lower limb
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Geographical Variation of 1-Year Cardiovascular
Event Rates
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Gender Comparison
Age and risk-factor adjusted
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Major Adverse Event Rates at 1 Year as a Function
of Age Total Population
Rates adjusted for risk factors
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CV Death/MI/Stroke vs Bleeding Symptomatic vs
RF Only (Unadjusted)
3.02
1.18
Requiring hospitalization or transfusion.
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Summary

• Despite contemporary therapy, stable outpatients
  with or at high risk of atherothrombosis
  experience high annual cardiovascular event rates
• 3.5 hard events (CV death/MI/stroke)
• One in 8 pts is hospitalized for CV reasons
• Hard event (CV death/MI/stroke) rates increase
  markedly with the number of symptomatic disease
  locations, ranging from 1.5 (risk factors only)
  to 7.1 (triple location)
• The magnitude of overlap between symptomatic
  arterial beds increases event rates

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Summary (cont.)

• The rate of bleeding leading to hospitalization
  or transfusion is in the range of lt1
• Rates of interventions are high
• 5 PCI/CABG in CAD pts
• 1.1 carotid stenting/surgery in CVD pts
• gt10 peripheral interventions in PAD pts
• 1.3 yearly amputation rate among PAD patients
• Among other factors, age, gender, and geographic
  variations appear to impact event rates

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Clinical Implications

• These results suggest the need to address
  atherothrombosis as a global disease rather
  than separately for each vascular bed
• All-out efforts are needed to reduce the high
  event rates experienced by atherothrombotic
  patients

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Featured Institution Presbyterian Hospital
Cardiovascular Institute Charlotte, North
Carolina
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Improving Vascular Care with CarePaths

• Cathy Rabb, RRT, RCP
• Manager, CV Outcomes
• L.B. Sossoman, MSN, ACNP
• CVI Nurse Practitioner
• CV Outcomes

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Presbyterian Hospital-Charlotte, N.C.
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Institute for Healthcare Improvement (IHI)
Model for Improvement
AIM What are we trying to accomplish?
Improvements What changes can we make
that will result in an improvement?
Measures How will we know if the change
resulted in an improvement?
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The Cycle of Improvement
Act Based on the knowledge gained in the study
stage, a decision is made. If the change
resulted in the desired level of improvement, the
change might be made permanent. If more work is
required, the team may begin a new cycle of
improvement, with revisions to the plan based on
the new information. This completes the cycle of
Continuous Quality Improvement or CQI.
Plan The team starts with the critical step of
planning for the change. The team must decide
What level of improvement is expected? Who must
be informed that a change will take place? Is
training required? What data should be
collected, by what method, and for how long? What
resources are required? Who is responsible to
communicate, educate, collect data, or provide
resources?
Do Baseline data may be collected. Training
and communication are done first. Then the change
is made and then comparison data is collected.
Observations are also made during this time such
as staff readiness for change, unforeseen
obstacles, or unexpected downstream effects of
the change.
Study or Check Data is analyzed to determine if
the change resulted in the expected level of
improvement, and if not, why not? The team also
examines What went well? What lessons were
learned? What can we do differently?
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Rapid Cycle Improvement
Rapid cycle improvement involves breaking down a
big project into smaller steps. Change is
difficult for everyone. Small changes are often
easier to implement and may be better tolerated
by the staff. The key to rapid cycle improvement
is to maintain momentum by keeping the team on
track.
Quality
Over time, the organization achieves a whole
new level of quality.
Time
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Best Practice Teams (BPTs)

• Multidisciplinary teams that meet monthly.
• Team members include physicians, nurses,
  respiratory therapy, physical therapy, rehab,
  pharmacy, anesthesia, OR/PACU staff, etc.
• Organized by major disease processes
• MI/Acute Coronary Syndrome
• PCI
• CHF
• Open Heart Surgery
• Vascular Surgery

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Functions of the BPT

• Lead by a physician champion
• Catalyst for positive change in the vascular
  service line
• Goals include standardization of care with the
  use of
• CarePaths
• Order Sets (pre-op and post-op)
• Standard discharge sheets
• Patient education materials
• Outcomes are tracked to drive more change!

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CarePath Development

• Procedure Focused
• Developed after intensive literature review.
• Incorporates published guidelines.

• Goal is to provide staff with a overview of the
  plan of care.
• 2nd Goal is to provide the patient and family a
  pictorial overview of the procedure.

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Process of Use

• Incorporated into the pre-op and post-op order
  sets to provide the patient/family a copy (in
  color)
• And to place a staff copy in the chart.
• A 2nd copy is placed with the documentation
  outside of the patients room.

• Staff uses the CarePath as a reference to chart
  by exception.
• Goals are discussed and the patient is On Path
  Day __.

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Current CarePaths

• Vascular
• Carotid Surgery
• Endovascular AAA
• Open AAA
• Amputation (under development)
• C/V Surgery
• CABG
• Valve Surgery

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Compliance with Use
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CarePaths and OutcomesEndo AAA Experience

• 60 of all AAA procedures.
• No mortality.
• 80 have no complications.
• Reported complications are minor and correctable.
  
• Reduction in PLOS from 2.5 days to 1.86 days.
• 54 discharged home on POD 1.
• 22 reduction in critical care use.
• () financial picture.

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Example of CarePath

• Endovascular AAA

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(No Transcript)
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Endovascular AAA Patient Guide
? This is a general guideline. Your personal
course may vary. ?
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Take Heart ? Play a Part
Teamwork is the fuel that allows ordinary
people to attain extraordinary results
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Polling Question 2
If you participated in a previous teleconference,
how much progress have you made since
then? (Please refer to the checklists on the
next 3 slides.)

• 1) We are currently on the same item
• 2) We have since moved to the next checkbox on
  the checklist
• 3) We have progressed by more than one item on
  the checklist
• 4) ACS pathways are up-to-date and regularly
  followed

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Progress ChecklistImmediate Goals
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Progress ChecklistShort-term Goals/Activities
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Progress ChecklistLong-term Goals/Activities
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Question-and-Answer Session
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Concluding RemarksGregg C. Fonarow, MD
Next program Wednesday, May 17, 2006 1200
Noon ET (900 AM PT)Topic Clinical
Implications of Recent ACS Clinical Trials
Faculty Christopher P. Cannon, MD