La strategia delle indicazioni AHAACC per la gestione dellinsufficiencia cardiaca nel mondo reale

1
La strategia delle indicazioni AHA/ACC per la
gestione dellinsufficiencia cardiaca nel mondo
reale

• Sharon A. Hunt, M.D.
• Stanford University
• HEART FAILURE PREVENTION AND MANAGEMENT FROM
  DRUGS TO DEVICES
• GENOVA, Aprile 1-2, 2005

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AHA/ACC Guidelines Strategies for Heart
Failure Management in the Real World

• Sharon A. Hunt, M.D.
• Professor, Cardiovascular Medicine
• Stanford University
• HEART FAILURE PREVENTION AND MANAGEMENT FROM
  DRUGS TO DEVICES
• Genova, 1-2 Abrile 2005

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BACKGROUND

• Move to create clinical guidelines over past 10
  years with purpose of (a) codifying and
• (b) promoting implementation of evidence-based
  advances in diagnosis and therapy

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Since HF is widely perceived as a growing
epidemic

• Guidelines have been written to guide clinicians
  re state-of-the art evidence-based practice
• ACC/AHA First in 1995, then 2001 (update in
  progress)
• HFSA work-in-progress
• ESC - 2001

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The one currently published guideline in US

• ACC/AHA Update of the 1995 Guidelines for t he
  Evaluation and Management of Chronic Heart
  Failure in the Adult
• JACC and Circ 2001

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What were the old guidelines anyway?

• First ones published in 1995
• Circulation 1995922764-2784.

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What were the old guidelines?

• 1. Greatly emphasized evaluation
• and management of acute HF
• 2. Discussed only HF with
• systolic dysfunction
• 3. Excluded pediatric population

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The New 2001 Guidelines

• Full text (all 168 pages) at both
• www.acc.org
• www.americanheart.org
• Executive summary
• JACC 2001382101-13.

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WRITING COMMITTEE MEMBERS

• Sharon A. Hunt, MD, FACC, Chair
• David W. Baker, MD, MPH, FACP
• Marshall H Chin, MD, MPH, FACP
• Michael Pl Cinquegrani, MD, PhD, FACC
• Arthur M. Feldman, MD, PhD, FACC
• Gary S. Francis, MD, FACC
• Theodore G. Ganiats, MD,
• Sidney Goldstein, MD, FACC
• Gabriel Gregoratos, MD, FACC
• Mariell L. Jessup, MD, FACC
• R. Joseph Noble, MD, FACC
• Milton Packer, MD, FACC
• Marc A. Silver, MD, FACC, FACP, FCCP
• Lynne Warner Stevenson, MD, FACC

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The New 2001 GuidelinesWhat was new?

• One deletion
• Several additions
• Several updates
• One major/new proposal

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The New 2001 Guidelines

• Unchanged
• Pediatric population excluded

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Pediatric population excluded because

• No clinical HF trials include children
• Causes of HF overall quite different in children

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The New 2001 Guidelines

• Deletion
• Excludes discussion of acute heart failure

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Exclude acute HF

• The types of therapy involved have become very
  different from those involved in chronic HF,
  might well merit a separate set of guidelines

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Thus, new guidelines address only

• Chronic heart failure
• Heart failure in the adult

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The New 2001 Guidelines

• Additions
• Section on HF associated with diastolic
  dysfunction
• Discussion of promising new modalities

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Section on HF associated with diastolic
dysfunction

• Recognition of the entity
• Recognition of the absence of clinical trials
• Set of therapeutic principles

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Section on promising new therapeutic modalities

• Most no longer are so promising in 2005!
• eg. Endothelin inhibitors
• Cytokine antagonists

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The New 2001 Guidelines

• Updates
• Recommendations for therapy for symptomatic HF
• ACE inhibitors
• Beta Blockers
• Digitalis glycosides

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The New 2001 Guidelines

• One major/new proposal
• New staging system for heart failure

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PROPOSED STAGES

• Designed to emphasize preventability of HF
• Designed to recognize the progressive nature of
  LV dysfunction

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PROPOSED STAGES

• Analogy to strategies used in oncology ie
• Identifying high risk population,
• Using effective measures of prevention and early
  detection
• Using therapy appropriate to stage

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PROPOSED STAGES OF HF

• STAGE A High risk for developing HF
• STAGE B ASx LV dysfunction
• STAGE C Past or current Sx HF
• STAGE D End-stage HF

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PROPOSED STAGES OF HF

• STAGES A and B
• Do not signify clinical heart failure for
  diagnostic or coding purposesare really
  pre-heart failure

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PROPOSED STAGES

• COMPLEMENT, DO NOT REPLACE NYHA CLASSES
• NYHA Classes - shift back/forth in individual
  patient (in response to Rx and/or progression of
  disease)
• Stages - progress in one direction

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GUIDELINE PROCESS

• Most have no idea how these
• guidelines documents come to be
• or how complicated, but ultimately democratic
  the process to
• create them actually is.

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GUIDELINE PROCESS

• ACC/AHA Mother Committee
• ACC/AHA Task Force on Practice Guidelines
• 1. Determines need for new or updated
• guideline
• 2. Selects/invites writing committee (WC)
• members
• 3. Selects/invites other organizations to
• participate when appropriate (HFSA,
• ESC, etc.)

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GUIDELINE PROCESS

• ACC/AHA Mother Committee
• ACC/AHA Task Force on Practice Guidelines
• WC selection
• Need those with expertise
• Need to avoid conflict of interest
• How to balance these requirements??

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GUIDELINE PROCESS

• WRITING COMMITTEE
• Meets (2-3 face-to-face meetings, many conference
  calls)
• Creates outline
• Makes writing assignments

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GUIDELINE PROCESS

• WRITING COMMITTEE
• Writes the document
• (Sounds simple, no?)
• Writing and communication facilitated by
  introduction of web-based document system for
  authors

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GUIDELINE PROCESS

• WRITING COMMITTEE
• Writes the document
• (Sounds simple, no?)
• IN WRITING AND DISCUSSING MANY POINTS, THERE IS
  OFTEN A FINE LINE BETWEEN EXPERTISE AND CONFLICT
  OF INTEREST.
• NEW RULES THREATEN TO DUMB DOWN THE PROCESS
  (Personal opinion)

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GUIDELINE PROCESS

• DOCUMENT SENT FOR PEER REVIEW
• Official reviewers from each involved
  organization
• Random non-official reviewers with expertise in
  the field
• (Approximately 20 reviewers in all)

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GUIDELINE PROCESS

• DOCUMENT RE-THOUGHT AND REVISED IN RESPONSE TO
  REVIEWER COMMENTS
• SPECIFIC RESPONSES MADE TO EVERY POINT MADE BY
  OFFICIAL REVIEWERS

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GUIDELINE PROCESS

• REVISED DOCUMENT
• Approved by consensus of WC, then
• Sent to governing boards of ACC and AHA (and
  other involved organizations) for approval
• Sometimes further revised in response to comments
  from these Boards

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GUIDELINE PROCESS

• FINAL DOCUMENT
• Published online
• www.acc.org and www.americanheart.org
• Executive summary published in print (JACC and
  Circulation)
• Printed pocket guideline available

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GUIDELINE PROCESS

• Mother Committee reviews documents every two
  years to determine need to update or revise
• If the answer is yesthe process
• begins all over again

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GUIDELINE PROCESS

• For updated or revised guidelines
• The chair serves two consecutive terms and then
  is replaced
• One third of the WC is replaced each time

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2005 Guidelines Update

• Will consider
• Interchangeability of ACEI and
• ARB
• Role of aldosterone antagonists
• Role of CRT
• Role of ICDs
• More prominent mention of HF
• with preserved LVEF

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THERAPY - STAGE C(Patients with LV Dysfunction
and Current or Prior Sx)

• DRUGS RECOMMENDED FOR ROUTINE USE
• DIURETICS (for Sx)
• ACE INHIBITORS
• BETA BLOCKERS
• DIGITALIS

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THERAPY - STAGE C(Patients with LV Dysfunction
and Current or Prior Sx)

• ACE Inhibitors and Beta Blockers
• RECOMMENDATIONS
• USE THE AGENTS PROVEN IN CLINICAL TRIALS
• AIM FOR THE DOSES PROVEN IN CLINICAL TRIALS

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Beta Blockers Proven in Clinical Trials

• There are three
• BISOPROLOL (CIBIS study)
• METOPROLOL SUCCINATE
• sustained release (MERIT-HF)
• CARVEDILOL (US Carvedilol, others)

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Beta Blockers Proven in Clinical Trials

• BISOPROLOL
• CIBIS-II study drug vs. placebo
• N 2647 patients
• Target dose 10 mg daily
• All cause mortality RR 0.66
• Lancet 19993539

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Beta Blockers Proven in Clinical Trials

• METOPROLOL SUCCINATE
• (sustained release)
• MERIT-HF trial drug vs. placebo
• N 3991 patients
• Target dose 200 mg daily
• All cause mortality RR 0.66
• Lancet 19993532001

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Beta Blockers Proven in Clinical Trials

• CARVEDILOL
• U.S. Carvedilol study drug vs. placebo
• N 1094 patients
• Target dose 25 mg twice daily
• All cause mortality RR 0.35
• NEJM 19963341349

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Kaplan-Meier Analysis of Survival among Patients
with Chronic Heart Failure in the Placebo and
Carvedilol Groups
Packer, M. et al. N Engl J Med 19963341349-1355
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Kaplan-Meier Analysis of Survival without
Hospitalization for Cardiovascular Reasons
(Event-free Survival) in the Placebo and
Carvedilol Groups
Packer, M. et al. N Engl J Med 19963341349-1355
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Indications for use of beta blockers

• STAGE A For BP control
• STAGE B All patients (unless contraindicated)
• STAGE C All patients (unless contraindicated)
• STAGE D All patients (if tolerated)