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

Monday, December 6, 2010Monday, December 6, 2010

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AgendaAgenda

Brief Overview of Patient-Centered Brief Overview of Patient-Centered Outcomes Research and AHRQ’s Outcomes Research and AHRQ’s Effective Health Care Program-Effective Health Care Program- Katherine Katherine Griffith, ModeratorGriffith, Moderator

Comparative Effectiveness of Comparative Effectiveness of Radiofrequency Catheter Ablation for Radiofrequency Catheter Ablation for Atrial FibrillationAtrial Fibrillation-- Ann Garlitski, M.D. Ann Garlitski, M.D.

Q&A from Audience Q&A from Audience

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Patient-Centered Outcomes Patient-Centered Outcomes Research and AHRQ’s Effective Research and AHRQ’s Effective

Health Care ProgramHealth Care Program

Katherine Griffith, M.H.S.Katherine Griffith, M.H.S.

AHRQ’s Office of Communications and AHRQ’s Office of Communications and Knowledge TransferKnowledge Transfer

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Patient-Centered Patient-Centered Outcomes ResearchOutcomes Research

Benefits

Harms

Also known as comparative effectiveness researchAlso known as comparative effectiveness research

Unbiased and practical, evidence-based Unbiased and practical, evidence-based information information

Compares drugs, devices, tests and surgeries, and Compares drugs, devices, tests and surgeries, and approaches to health care approaches to health care – Benefits and harms Benefits and harms – What is known and what isn’tWhat is known and what isn’t

Descriptive, not prescriptiveDescriptive, not prescriptive 66

Horizon Horizon ScanningScanning

EvidenceEvidence NeedNeed

IdentificationIdentification

Evidence Evidence SynthesisSynthesis

EvidenceEvidence GenerationGeneration

StrategiesStrategiesInterventionsInterventionsConditionsConditionsPopulationsPopulations

DisseminationDisseminationTranslationTranslation

ImprovementsImprovements inin

Health CareHealth Care

Research PlatformResearch PlatformInfrastructure – Methods Development – Training Infrastructure – Methods Development – Training

A Framework for A Framework for Patient-Centered Outcomes Patient-Centered Outcomes

ResearchResearch

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Research Focus: Research Focus: 14 Priority Conditions14 Priority Conditions

Arthritis and nontraumatic joint Arthritis and nontraumatic joint disordersdisorders

CancerCancer

Cardiovascular disease, Cardiovascular disease, including stroke and including stroke and hypertensionhypertension

Dementia, including Dementia, including Alzheimer’s diseaseAlzheimer’s disease

Depression and other mental Depression and other mental health disordershealth disorders

Developmental delays, ADHD Developmental delays, ADHD and autismand autism

Diabetes mellitusDiabetes mellitus

Functional limitations and Functional limitations and disabilitydisability

Infectious diseases, Infectious diseases, including HIV/AIDSincluding HIV/AIDS

ObesityObesity

Peptic ulcer disease and Peptic ulcer disease and dyspepsiadyspepsia

Pregnancy including Pregnancy including preterm birthpreterm birth

Pulmonary disease/asthmaPulmonary disease/asthma

Substance abuseSubstance abuse

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Effective Health Care Program Effective Health Care Program Translation ProductsTranslation Products

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Executive Summary

Web Site

ClinicianGuide

ConsumerGuide Policymaker

Summary

Interactive Case Study

CE Modules

Faculty Slides

Patient Decision Aid(available soon)

Systematic Review Report

Heart and Blood Vessel Heart and Blood Vessel ResourcesResources

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Public InvolvementPublic Involvement

Topic Topic GenerationGeneration

Topic Topic DevelopmentDevelopment

Topic Topic RefinementRefinement

Research Research ReviewReview

Research Research Needs Needs

DevelopmentDevelopment

Report Report Translation & Translation & DisseminationDissemination

During the Research ProcessDuring the Research Process

Web links

Newsletter blurbs

Articles or

commentaries

Web conferences

Continuing education

Disseminating the FindingsDisseminating the Findings

• Nominate topics using the online Nominate topics using the online formform• Participate in key question Participate in key question refinementrefinement• Comment via the web on draft key Comment via the web on draft key questions and reportsquestions and reports

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Comparative Effectiveness of Comparative Effectiveness of Radiofrequency Catheter Ablation for Radiofrequency Catheter Ablation for

Atrial FibrillationAtrial Fibrillation

Ann C. Garlitski, M.D.Ann C. Garlitski, M.D.Assistant Professor of MedicineAssistant Professor of Medicine

Tufts University School of MedicineTufts University School of MedicineTufts Medical Center, Boston, MATufts Medical Center, Boston, MA

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Comparative Effectiveness of Comparative Effectiveness of Radiofrequency Catheter Ablation for Radiofrequency Catheter Ablation for

Atrial FibrillationAtrial Fibrillation

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

Tufts Medical Center Evidence-based Practice CenterTufts Medical Center Evidence-based Practice Center

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

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Prevalence of AFPrevalence of AF Increases with age, from Increases with age, from

0.1% in people <55 years to 0.1% in people <55 years to more than 9% by 80 years of more than 9% by 80 years of ageage

AF is the AF is the most commonmost common sustained arrhythmiasustained arrhythmia

Risk factors for AFRisk factors for AF HypertensionHypertension Diabetes mellitusDiabetes mellitus Structural heart diseaseStructural heart disease Myocardial infarctionMyocardial infarction Cardiothoracic surgeryCardiothoracic surgery

Consequences of AFConsequences of AF Congestive heart failureCongestive heart failure Cardiac ischemiaCardiac ischemia Tachycardia-mediated Tachycardia-mediated cardiomyopathycardiomyopathy Increased stroke risk 5XIncreased stroke risk 5X Increased mortality 2XIncreased mortality 2X Impact on quality of lifeImpact on quality of life Significant burden to Significant burden to healthcare systemhealthcare system

Atrial Fibrillation (AF) Atrial Fibrillation (AF) BackgroundBackground

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Management of AFManagement of AF

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

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Haissaguerre, M et al. NEJM September 1998; 330:659-666.

Initial clinical use of RF energy 1987Initial clinical use of RF energy 1987

Initial clinical use of RFA to treat AF 1998Initial clinical use of RFA to treat AF 1998

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Key QuestionsKey Questions

1.1. What is the effect of RFA compared to surgical or What is the effect of RFA compared to surgical or medical treatment on short (6-12 months) and medical treatment on short (6-12 months) and long (>12 months) term clinical outcomes such as long (>12 months) term clinical outcomes such as rhythm control?rhythm control?

2.2. What are the patient- and intervention-level What are the patient- and intervention-level characteristics associated with the effect of RFA characteristics associated with the effect of RFA on rhythm control?on rhythm control?

3.3. How does the effect of RFA on rhythm control How does the effect of RFA on rhythm control differ among the techniques?differ among the techniques?

4.4. What are the harms and complications associated What are the harms and complications associated with RFA?with RFA?

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Citations identified in MEDLINE and CochraneCentral Trials Registry (n=2,169)

Articles retreived for full-text review (n=390)

Abstracts failed tomeet criteria

(n=2,562)

Articles reviewed (n=120)

Key Question 1: 8*

Key Question 2: 45*

Key Question 3: 43*

Key Question 4: 100*

Articles failed tomeet criteria

(n= 270)

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

Study Selection in the Study Selection in the Systematic Review of RFASystematic Review of RFA

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Study selectionStudy selection Randomized controlled trials of any sample sizeRandomized controlled trials of any sample size Prospective cohort studies >50 subjectsProspective cohort studies >50 subjects Retrospective cohort studies >100 subjectsRetrospective cohort studies >100 subjects

Rating the strength of evidence of each key questionRating the strength of evidence of each key question Number and quality of primary studiesNumber and quality of primary studies Duration of followupDuration of followup Consistency across studiesConsistency across studies Rating based on the confidence that the evidence reflects the true effectRating based on the confidence that the evidence reflects the true effect

– HIGH HIGH

– MODERATE MODERATE

– LOW LOW

– INSUFFICIENT – evidence is either unavailable or does not permit an INSUFFICIENT – evidence is either unavailable or does not permit an estimation of an effectestimation of an effect

MethodsMethods

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RFA vs. SurgeryRFA vs. Surgery

No studyNo study

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Q1. RFA vs. Medical TherapyQ1. RFA vs. Medical TherapyOutcome - Rhythm ControlOutcome - Rhythm Control

Moderate level of evidence that 2Moderate level of evidence that 2ndnd line therapy is line therapy is effective at 12 monthseffective at 12 months

– Meta-analysis of 3 RCTs - 364 patientsMeta-analysis of 3 RCTs - 364 patientsRR 3.46 (95% CI 1.97, 6.01)RR 3.46 (95% CI 1.97, 6.01)

Insufficient evidence that 1Insufficient evidence that 1stst line therapy is effective at line therapy is effective at 12 months12 months

– 1 randomized controlled trial - 67 patients1 randomized controlled trial - 67 patients88% vs. 37%, P<0.00188% vs. 37%, P<0.001

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RFA vs. Medical TherapyRFA vs. Medical Therapy

CHFCHF

1 obs study (n=1,171) @ 30 months 1 obs study (n=1,171) @ 30 months f/uf/u

RR=0.56 (95%CI 0.37-0.84)RR=0.56 (95%CI 0.37-0.84)

Volume Volume ChangesChanges

1 RCT (53 vs. 59 patients) @ 12 1 RCT (53 vs. 59 patients) @ 12 monthsmonths

- LAD 38.7 vs. 38.9 mm- LAD 38.7 vs. 38.9 mm

- EF 65.4 vs. 65.4%- EF 65.4 vs. 65.4%

Strength of Evidence : InsufficientStrength of Evidence : Insufficient 2222

StrokeStroke

Meta-analysis of 6 RCTs (n=689)Meta-analysis of 6 RCTs (n=689)

low low

-stroke event rate not systematically -stroke event rate not systematically assessedassessed

Avoiding AnticoagulationAvoiding Anticoagulation

1 RCT (52 vs. 53 patients) @ 12 months1 RCT (52 vs. 53 patients) @ 12 months

60 vs. 34% (P=0.02)60 vs. 34% (P=0.02)

lowlow

-single study with small N-single study with small N2323

Q2. Patient & Intervention Q2. Patient & Intervention CharacteristicsCharacteristics

Male vs. female – High level of evidence that Male vs. female – High level of evidence that there is no association with sex and AF there is no association with sex and AF recurrencerecurrence

Age – High level of evidence that there is no Age – High level of evidence that there is no association between age (approx 40-70 years) association between age (approx 40-70 years) and AF recurrenceand AF recurrence

Operator experience/setting - Insufficient Operator experience/setting - Insufficient evidence (no study directly addressed this evidence (no study directly addressed this question)question)

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Paroxysmal vs. Non-paroxysmal AFParoxysmal vs. Non-paroxysmal AF

Low level of evidence Low level of evidence – Mostly univariable analysesMostly univariable analyses

– 17 studies17 studies11 found no statistically significant association 11 found no statistically significant association

between AF type and recurrencebetween AF type and recurrence6 found nonparoxysmal AF predicted higher 6 found nonparoxysmal AF predicted higher

recurrencerecurrence

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

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

– 4/20 studies found an association between larger 4/20 studies found an association between larger LAD and increase AF recurrenceLAD and increase AF recurrence

– 8/17 studies found an association between low 8/17 studies found an association between low EF and increase AF recurrenceEF and increase AF recurrence

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Moderate level of evidence Moderate level of evidence

– 4 RCTs found no significant 4 RCTs found no significant difference in rhythm control difference in rhythm control

– 6-12 month followup6-12 month followup

Q3. Different TechniquesQ3. Different Techniques Catheters: 8 mm vs. Irrigated TipCatheters: 8 mm vs. Irrigated Tip

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Q4. Harms and Complications Q4. Harms and Complications of RFAof RFA

Low level of evidence Low level of evidence

Nonuniform definitions and assessmentsNonuniform definitions and assessments

– No data on time of occurrenceNo data on time of occurrence

– Except for pulmonary veinExcept for pulmonary vein (PV)(PV) stenosis at 3 stenosis at 3 monthsmonths

– 83 studies reported 83 studies reported ≥1 event≥1 event

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Major Adverse EventsMajor 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 studiesDeaths (5 deaths in 63 studies))

possible duplicate studiespossible duplicate studies

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SummarySummary

Effective as a 2Effective as a 2ndnd line therapy but short followup ( line therapy but short followup (≤12 ≤12 months)months)

Insufficient data on 1Insufficient data on 1stst line therapy line therapy

Major clinical complications <5%, but quality of data is Major clinical complications <5%, but quality of data is poorpoor

Need more data on the elderly, patients with multiple Need more data on the elderly, patients with multiple co-morbidities, long-term (years) rates of AF co-morbidities, long-term (years) rates of AF recurrence, effects from radiation exposure, QOL, and recurrence, effects from radiation exposure, QOL, and mortalitymortality 3030

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For more information about…For more information about…

AHRQ’s Effective Health Care Program: AHRQ’s Effective Health Care Program: www.effectivehealthcare.ahrq.gov..

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If you have a question about utilizing AHRQ If you have a question about utilizing AHRQ resources please e-mail us at: resources please e-mail us at: EHC_Clinicians@ahrq.hhs.gov.. 3333

Upcoming Web ConferencesUpcoming Web Conferences

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

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

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

Applying Existing Evidence to Diabetes CareApplying Existing Evidence to Diabetes Care

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