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

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Agenda Brief Overview of Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program- Katherine Griffith, Moderator 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. Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation- Ann Garlitski, M.D. Q&A from Audience Q&A from Audience CALL-IN NUMBER: (888) ACCESS CODE: #

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Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program Katherine Griffith, M.H.S. AHRQ’s Office of Communications and Knowledge Transfer

Patient-Centered Outcomes Research Benefits Harms Also known as comparative effectiveness research Also known as comparative effectiveness research Unbiased and practical, evidence-based information Unbiased and practical, evidence-based information Compares drugs, devices, tests and surgeries, and approaches to health care Compares drugs, devices, tests and surgeries, and approaches to health care – Benefits and harms – What is known and what isn’t Descriptive, not prescriptive Descriptive, not prescriptive

HorizonScanning Evidence Need Need Identification Identification EvidenceSynthesis Evidence Generation GenerationStrategiesInterventionsConditionsPopulations DisseminationTranslation Improvements in in Health Care Health Care Research Platform Infrastructure – Methods Development – Training A Framework for Patient-Centered Outcomes Research

Research Focus: 14 Priority Conditions Arthritis and nontraumatic joint disorders Arthritis and nontraumatic joint disorders Cancer Cancer Cardiovascular disease, including stroke and hypertension Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer’s disease Dementia, including Alzheimer’s disease Depression and other mental health disorders Depression and other mental health disorders Developmental delays, ADHD and autism Developmental delays, ADHD and autism Diabetes mellitus Diabetes mellitus Functional limitations and disability Functional limitations and disability Infectious diseases, including HIV/AIDS Infectious diseases, including HIV/AIDS Obesity Obesity Peptic ulcer disease and dyspepsia Peptic ulcer disease and dyspepsia Pregnancy including preterm birth Pregnancy including preterm birth Pulmonary disease/asthma Pulmonary disease/asthma Substance abuse Substance abuse 8

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

Heart and Blood Vessel Resources 10

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

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

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

Prevalence of AF Increases with age, from 0.1% in people <55 years to more than 9% by 80 years of age 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 AF is the most common sustained arrhythmia Risk factors for AF Hypertension Hypertension Diabetes mellitus Diabetes mellitus Structural heart disease Structural heart disease Myocardial infarction Myocardial infarction Cardiothoracic surgery Cardiothoracic surgery Consequences of AF Congestive heart failure Congestive heart failure Cardiac ischemia Cardiac ischemia Tachycardia-mediated Tachycardia-mediated cardiomyopathy cardiomyopathy Increased stroke risk 5X Increased stroke risk 5X Increased mortality 2X Increased mortality 2X Impact on quality of life Impact on quality of life Significant burden to Significant burden to healthcare system healthcare system Atrial Fibrillation (AF) Background 14

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

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

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? 17

Study Selection in the Systematic Review of RFA 18

Study selection Randomized controlled trials of any sample size Randomized controlled trials of any sample size Prospective cohort studies >50 subjects Prospective cohort studies >50 subjects Retrospective cohort studies >100 subjects Retrospective cohort studies >100 subjects Rating the strength of evidence of each key question Number and quality of primary studies Number and quality of primary studies Duration of followup Duration of followup Consistency across studies Consistency across studies Rating based on the confidence that the evidence reflects the true effect 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 Methods 19

RFA vs. Surgery No study No study 20

Q1. RFA vs. Medical Therapy Outcome - Rhythm Control Moderate level of evidence that 2 nd line therapy is effective at 12 months Moderate level of evidence that 2 nd line therapy is effective at 12 months – Meta-analysis of 3 RCTs patients RR 3.46 (95% CI 1.97, 6.01) RR 3.46 (95% CI 1.97, 6.01) Insufficient evidence that 1 st line therapy is effective at 12 months Insufficient evidence that 1 st line therapy is effective at 12 months – 1 randomized controlled trial - 67 patients 88% vs. 37%, P< % vs. 37%, P<

RFA vs. Medical Therapy CHF 1 obs study 30 months f/u RR=0.56 (95%CI ) Volume Changes 1 RCT (53 vs months - LAD 38.7 vs mm - LAD 38.7 vs mm - EF 65.4 vs. 65.4% - EF 65.4 vs. 65.4% Strength of Evidence : Insufficient 22

Stroke Meta-analysis of 6 RCTs (n=689) low -stroke event rate not systematically assessed Avoiding Anticoagulation 1 RCT (52 vs months 60 vs. 34% (P=0.02) 60 vs. 34% (P=0.02)low -single study with small N 23

Q2. Patient & Intervention Characteristics Male vs. female – High level of evidence that there is no association with sex and AF recurrence 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 years) and AF recurrence Age – High level of evidence that there is no association between age (approx years) and AF recurrence Operator experience/setting - Insufficient evidence (no study directly addressed this question) Operator experience/setting - Insufficient evidence (no study directly addressed this question) 24

Paroxysmal vs. Non-paroxysmal AF Low level of evidence Low level of evidence – Mostly univariable analyses – 17 studies 11 found no statistically significant association between AF type and recurrence 11 found no statistically significant association between AF type and recurrence 6 found nonparoxysmal AF predicted higher recurrence 6 found nonparoxysmal AF predicted higher recurrence 25

Left Atrial Diameter (LAD)/Ejection Fraction (EF) Moderate level of evidence among patients with normal or mildly abnormal LAD or 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

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

Q4. Harms and Complications of RFA Low level of evidence Low level of evidence Nonuniform definitions and assessments Nonuniform definitions and assessments – No data on time of occurrence – Except for pulmonary vein(PV)stenosis at 3 months – Except for pulmonary vein (PV) stenosis at 3 months – 83 studies reported ≥1 event 28

Major Adverse Events PV stenosis (0-19%) PV stenosis (0-19%) Cardiac tamponade (0-5%) Cardiac tamponade (0-5%) Stroke or TIA (0-7%) Stroke or TIA (0-7%) Atrioesophageal fistula (0.07 to 1.2%) Atrioesophageal fistula (0.07 to 1.2%) Deaths (5 deaths in 63 studies  ) Deaths (5 deaths in 63 studies  )  possible duplicate studies 29

Summary Effective as a 2 nd line therapy but short followup (≤12 months) Effective as a 2 nd line therapy but short followup (≤12 months) Insufficient data on 1 st line therapy Insufficient data on 1 st line therapy Major clinical complications <5%, but quality of data is poor 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 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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Upcoming Web Conferences Monday, December 13 th at 11 a.m. ET. Monday, December 13 th at 11 a.m. ET. Evidence-Based Medicine for Pharmacists in the Patient-Centered Medical Home Tuesday, December 14 th at 12 p.m. ET. Tuesday, December 14 th at 12 p.m. ET. Applying Existing Evidence to Diabetes Care 34

Thank you! Thank you for joining us today! Thank you for joining us today! Please take a moment to provide us feedback at the end of this event. 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. A recording and transcript for today’s event will be available on the AHRQ Web site. 35