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AHRQ’s Effective Health Care Program: Applying Existing Evidence to Cardiac Care

Slide Presentation in Text Format

 

Monday, December 6, 2010

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  • On the top of the slide are the logos for the Department of Health and Human Services and the Agency for Healthcare Research and Quality (AHRQ).

 

Slide 2

Questions

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CALL-IN NUMBER: (888)-632-5065  ACCESS CODE:77787674#


Slide 3

Agenda

  • Brief Overview of Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program - Katherine Griffith, Moderator
  • Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation- Ann Garlitski M.D.
  • Q&A from Audience

 

CALL-IN NUMBER: (888)-632-5065 ACCESS CODE:777876784#

 

 

Slide 4

Questions

To submit a question:

  • Press the “Ask Question” button located at the bottom of the screen. 
  • When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. 
  • Once you have completed your question, press the “Submit” button.


Slide 5

Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program

Katherine Griffith, M.H.S.
AHRQ’s Office of Communications and Knowledge Transfer


Slide 6

Patient-Centered Outcomes Research

  • Also known as comparative effectiveness research

 

  • Unbiased and practical, evidence-based information
  • Compares drugs, devices, tests and surgeries, and approaches to health care
    • Benefits and harms
    • What is known and what isn’t

 

  • Descriptive, not prescriptive


Slide 7

A Framework for Patient-Centered Outcomes Research

This framework outlines the step-by-step process for how the development and implementation of patient-centered outcomes research leads to improvement in health care. Once a topic is nominated, a horizon scan and synthesis of the evidence is completed, followed by evidence generation. Then the research is translated, disseminated, and implemented.

 

 

Slide 8 

Research Focus: 14 Priority Conditions

  • Arthritis and nontraumatic joint disorders
  • Cancer
  • Cardiovascular disease, including stroke and hypertension
  • Dementia, including Alzheimer’s disease
  • Depression and other mental health disorders
  • Developmental delays, ADHD and autism
  • Diabetes mellitus
  • Functional limitations and disability
  • Infectious disease including HIV/AIDS
  • Obesity
  • Peptic ulcer disease and dyspepsia
  • Pregnancy including preterm birth
  • Pulmonary disease/asthma
  • Substance abuse

 

Slide 9

Effective Health Care Program Translation Products

Multiple images of different products that the Effective Health Care Program creates from the systematic review reports.  These products include: CE Modules, Interactive Case Study, faculty slides, patient decision aid, policymaker summary, consumer guide, clinician guide, Web site, and executive summary.


Slide 10

Heart and Blood Vessel Resources

Two images of consumer guides titled, “ACE Inhibitors” and “ARBs” To Protect Your Heart?  A Guide for Patients Being Treated for Stable Coronary Heart Disease, and Treating High Cholesterol: A Guide for Adults.


Slide 11

Public Involvement

A diagram of the multiple points in the development and dissemination process where stakeholders can get involved. The process includes: Topic Generation, Topic Development, Topic Refinement, Research Review, and Research Needs and Development.  The multiple ways that information is disseminated includes: Web Links, Newsletter Blurbs, Articles or Comment, Web conferences, and Continuing Education.


Slide 12

Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation

Ann C. Garlitski, M.D.
Assistant Professor of Medicine
Tufts University School of Medicine
Tufts Medical Center, Boston, MA

 

Slide 13

Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation

Stanley Ip, Teruhiko Terasawa, Ethan M. Balk, Mei Chung, Alawi A. Alsheikh-Ali, Ann C. Garlitski, Joseph Lau

Tufts Medical Center Evidence-based Practice Center

 

I am a clinical cardiac electrophysiologist, and I perform catheter ablation of atrial fibrillation. I have no other conflicts of interest.

 

Slide 14

Atrial Fibrillation (AF) Background

Prevalence of AF

  • Increases with age, from 0.1% in people <55 years to more than 9% by 80 years of age
  • AF is the most common sustained arrhythmia

Risk factors for AF

  • Hypertension
  • Diabetes mellitus
  • Structural heart disease
  • Myocardial infarction
  • Cardiothoracic surgery

Consequences of AF

  • Congestive heart failure
  • Cardiac ischemia
  • Tachycardia-mediated cardiomyopathy
  • Increased stroke risk 5X
  • Increased mortality 2X
  • Impact on quality of life
  • Significant burden to health care system

 

Slide 15

Management of AF

  • Rate control
  • AV node ablation and pacemaker implant
  • Rhythm control
  • Surgery- Maze procedure
  • Radiofrequency Ablation (RFA)

 

Slide 16

Initial clinical use of RF energy 1987
Initial clinical use of RFA to treat AF 1998

The New England Journal of Medicine

Spontaneous Initiation of Atrial Fibrillation By Ectopic Beats Orginating in the Pulmonary Veins

Michel Haissaguerre, M.D., Pierre Jais, M.D., Dipen C. Shah, M.D., Atsushi Takahashi, M.D., Méléze Hocini, M.D., Gilles Quiniou, M.D., Stephanie Garrigue, M.D., Alain Le Mouroux, M.D., Philippe Le Metayer, M.D., and Jacques Clementy, M.D.

On the bottom of this slide there are images of the right and left atrium.


Slide 17

Key Questions

  1. What is the effect of RFA compared to surgical or medical treatment on short (6-12 months) and long (>12 months) term clinical outcomes such as rhythm control?
  2. What are the patient- and intervention-level characteristics associated with the effect of RFA on rhythm control?
  3. How does the effect of RFA on rhythm control differ among the techniques?
  4. What are the harms and complications associated with RFA?

 

 

Slide 18

Study Selection in the Systematic Review of RFA

 

Rejection Reasons (Number of articles)
*Cohort studies for adverse events with <100 patients (55)
*Studies used conventional 4 mm tip catheter only (40)
*Cohort studies with No comparison with Less than 50 Patients (79)
*<80% patients with AF (6)
*Intraoperative RFA (10)
*No outcomes including adverse events (25)
*Not RFA (6)
*Other reasons (49)**


Slide 19

Methods

Study selection

  • Randomized controlled trials of any sample size
  • Prospective cohort studies >50 subjects
  • Retrospective cohort studies >100 subjects

Rating the strength of evidence of each key question

  • Number and quality of primary studies
  • Duration of followup
  • Consistency across studies
  • Rating based on the confidence that the evidence reflects the true effect
    • HIGH
    • MODERATE
    • LOW
    • INSUFFICIENT – evidence is either unavailable or does not permit an estimation of an effect

 

Slide 20

RFA vs. Surgery

  • No study

 

Slide 21

Q1. RFA vs. Medical Therapy Outcome – Rhythm Control

  • Moderate level of evidence that 2nd line therapy is effective at 12 months

 

    • Meta-analysis of 3 RCTs - 364 patients
  • RR 3.46 (95% CI 1.97, 6.01)
  • Insufficient evidence that 1st line therapy is effective at 12 months

 

    • 1 randomized controlled trial - 67 patients
  • 88% vs. 37%, P<0.001

 

Slide 22

RFA vs. Medical Therapy
CHF 1 obs study (n=1,171) @ 30 months f/u
RR=0.56 (95%CI 0.37-0.84)
Volume Changes 1 RCT (53 vs. 59 patients) @ 12 months
- LAD  38.7 vs. 38.9 mm
- EF 65.4 vs. 65.4%

 

Strength of Evidence: Insufficient


Slide 23

Stroke

  • Meta-analysis of 6 RCTs (n=689)
  • Low
    • stroke event rate not systematically assessed
  • Avoiding Anticoagulation
  • 1 RCT (52 vs. 53 patients) @ 12 months 60 vs. 34% (P=0.02)
  • Low
    • single study with small N

 

Slide 24

Q2. Patient & Intervention Characteristics

  • Male vs. female – High level of evidence that there is no association with sex and AF recurrence
  • Age – High level of evidence that there is no association between age (approx 40-70 years) and AF recurrence
  • Operator experience/setting - Insufficient evidence (no study directly addressed this question)

 

Slide 25

Paroxysmal vs. Non-paroxysmal AF

  • Low level of evidence
    • mostly univariable analyses
    • 17 studies
      • 11 found no statistically significant association between AF type and recurrence
      • 6 found nonparoxysmal AF predicted higher recurrence

 

Slide 26

Left Atrial Diameter (LAD)/Ejection Fraction (EF)

      • Moderate level of evidence among patients with normal or mildly abnormal LAD or EF

 

    • 4/20 studies found an association between larger LAD and increase AF recurrence
    • 8/17 studies found an association between low EF and increase AF recurrence


Slide 27

Q3. Different Techniques Catheters: 8 mm vs. Irrigated Tip

      • Moderate level of evidence
    • 4 RCTs found no significant difference in rhythm control
    • 6-12 month followup

 

On the right side of the slide is a x-ray image of a heart with a catheter present in the x ray.

 

Slide 28

Q4. Harms and Complications of RFA

      • Low level of evidence
      • Nonuniform definitions and assessments

 

    • No data on time of occurrence
    • Except for pulmonary vein (PV) stenosis at 3 months
    • 83 studies reported ≥1 event


Slide 29

Major Adverse Events

      • PV stenosis (0-19%)
      • Cardiac tamponade (0-5%)
      • Stroke or TIA (0-7%)
      • Atrioesophageal fistula (0.07 to 1.2%)
      • Deaths (5 deaths in 63 studies*)

            *possible duplicate studies


Slide 30

Summary

  • Effective as a second-line therapy but short follow-up (≤12 months)
  • Insufficient data on first-line therapy
  • Major clinical complications <5%, but quality of data is poor
  • Need more data on the elderly, patients with multiple comorbidities, long-term (years) rates of AF recurrence, effects from radiation exposure, QOL, and mortality

 

Slide 31

Maintenance of Sinus Rhythm

This slide contains a flow chart that was taken from the ACC HRS guidelines on the management of atrial fibrillation.  The catheter ablation is in aqua and is depicted as an appropriate second-line therapy.  First there are recommendations to use antiarrhythmic agents and then the possibility of catheter ablation as a tool to maintain sinus rhythm.


Slide 32

Questions

  • To submit a question:
    • Press the “Ask Question” button located at the bottom of the screen. 
    • When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. 
    • Once you have completed your question, press the “Submit” button.


Slide 33

For more information about …

 

Slide 34

Upcoming Web conferences 

  • Monday, December 13 at 11 a.m. ET.

Evidence-Based Medicine for Pharmacists
in the Patient-Centered Medical Home

  • Tuesday, December 14 at 12 p.m. ET.

Applying Existing Evidence to Diabetes Care


Slide 35

Thank you!

  • Thank you for joining us today!
  • Please take a moment to provide us feedback at the end of this event.
  • A recording and transcript for today’s event will be available on the AHRQ Web site.