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

AHRQ’s Effective Health Care Program: Applying Existing Evidence to Cardiac Care. Monday, December 6, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 77787674#. Questions. To submit a question: Press the “Ask Question” button located at the bottom of the screen.

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

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  1. AHRQ’s Effective Health Care Program: Applying Existing Evidence to Cardiac Care Monday, December 6, 2010 CALL-IN TELEPHONE NUMBER: (888)-632-5065 ACCESS CODE: 77787674#

  2. 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. CALL-IN NUMBER: (888)-632-5065 ACCESS CODE: 77787674 # 2

  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: 77787674 # 3

  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. 4

  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 5

  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 Harms Benefits 6

  7. A Framework for Patient-Centered Outcomes Research Evidence Generation Strategies Interventions Conditions Populations Improvements in Health Care Horizon Scanning Evidence Need Identification Dissemination Translation Evidence Synthesis Research Platform Infrastructure – Methods Development – Training 7

  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 diseases, including HIV/AIDS Obesity Peptic ulcer disease and dyspepsia Pregnancy including preterm birth Pulmonary disease/asthma Substance abuse 8

  9. Effective Health Care Program Translation Products Patient Decision Aid (available soon) Executive Summary Web Site Systematic Review Report Clinician Guide Faculty Slides Consumer Guide Interactive Case Study Policymaker Summary 9 CE Modules

  10. Heart and Blood Vessel Resources 10

  11. Public Involvement Report Translation & Dissemination Topic Generation Topic Refinement Research Review Research Needs Development Topic Development During the Research Process Disseminating the Findings • Nominate topics using the online form • Participate in key question refinement • Comment via the web on draft key questions and reports Web links Newsletter blurbs Articles or commentaries Web conferences Continuing education 11

  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 12

  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. 13

  14. 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 Atrial Fibrillation (AF) Background • 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 healthcare system 14

  15. Management of AF Rate control AV node ablation and pacemaker implant Rhythm control Surgery - Maze procedure Radiofrequency Ablation (RFA) 15

  16. Initial clinical use of RF energy 1987 Initial clinical use of RFA to treat AF 1998 16 Haissaguerre, M et al. NEJM September 1998; 330:659-666.

  17. Key Questions 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? What are the patient- and intervention-level characteristics associated with the effect of RFA on rhythm control? How does the effect of RFA on rhythm control differ among the techniques? What are the harms and complications associated with RFA? 17

  18. Study Selection in the Systematic Review of RFA 18

  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 19

  20. RFA vs. Surgery No study 20

  21. Q1. RFA vs. Medical TherapyOutcome - 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 21

  22. RFA vs. Medical Therapy Strength of Evidence : Insufficient 22

  23. Stroke Avoiding Anticoagulation 23

  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) 24

  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 25

  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 26

  27. Moderate level of evidence 4 RCTs found no significant difference in rhythm control 6-12 month followup Q3. Different TechniquesCatheters: 8 mm vs. Irrigated Tip 27

  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 28

  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 29

  30. Summary Effective as a 2nd line therapy but short followup (≤12 months) Insufficient data on 1st line therapy Major clinical complications <5%, but quality of data is poor Need more data on the elderly, patients with multiple co-morbidities, long-term (years) rates of AF recurrence, effects from radiation exposure, QOL, and mortality 30

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  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. 32

  33. For more information about… • AHRQ’s Effective Health Care Program: www.effectivehealthcare.ahrq.gov. • Accessing these FREE resources through AHRQ’s Publications Clearinghouse: (800) 358-9295. • E-mail notices: http://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/. • If you have a question about utilizing AHRQ resources please e-mail us at: EHC_Clinicians@ahrq.hhs.gov. 33

  34. Upcoming Web Conferences • Monday, December 13th at 11 a.m. ET. Evidence-Based Medicine for Pharmacists in the Patient-Centered Medical Home • Tuesday, December 14th at 12 p.m. ET. Applying Existing Evidence to Diabetes Care 34

  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. 35

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