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Catheter Ablation Procedures for Supraventricular Tachyarrhythmia Including Atrial Flutter & Atrial Fibrillation

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Catheter Ablation Procedures for Supraventricular Tachyarrhythmia Including Atrial Flutter & Atrial Fibrillation Health Technology Assessment Catheter Ablation Procedures For Supraventricular Tachyarrhythmia Including Atrial Flutter & Atrial Fibrillation Final Evidence Report April 17, 2013 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 hta.hca.wa.gov [email protected] Catheter ablation procedures for supraventricular tachyarrhythmia (SVTA) including atrial flutter and atrial fibrillation Provided by: Spectrum Research, Inc. Final Report Prepared by: Robin E. Hashimoto, PhD Annie Raich, MS, MPH Mark Junge, BS Andrea Skelly, PhD, MPH With assistance from: Emily Yoder, BA Daniel Hadidi Ellen M. Van Alstyne, MS Ann M. Derleth, PhD, MSPH Nora Henrikson, PhD, MPH April 15, 2013 This technology assessment report is based on research conducted by a contracted technology assessment center, with updates as contracted by the Washington State Health Care Authority. This report is an independent assessment of the technology question(s) described based on accepted methodological principles. The findings and conclusions contained herein are those of the investigators and authors who are responsible for the content. These findings and conclusions may not necessarily represent the views of the HCA/Agency and thus, no statement in this report shall be construed as an official position or policy of the HCA/Agency. The information in this assessment is intended to assist health care decision makers, clinicians, patients and policy makers in making sound evidence-based decisions that may improve the quality and cost-effectiveness of health care services. Information in this report is not a substitute for sound clinical judgment. Those making decisions regarding the provision of health care services should consider this report in a manner similar to any other medical reference, integrating the information with all other pertinent information to make decisions within the context of individual patient circumstances and resource availability. Health Technology Assessment April 17, 2013 TABLE OF CONTENTS EXECUTIVE SUMMARY 1 1. APPRAISAL 30 1.1. RATIONALE 30 1.2. KEY QUESTIONS 30 1.3. WASHINGTON STATE UTILIZATION AND COST DATA 33 2. BACKGROUND 43 2.1. EPIDEMIOLOGY AND BURDEN OF DISEASE 43 2.2. TREATMENT OPTIONS (SURGICAL AND NONSURGICAL) 45 2.3. TECHNOLOGY 45 2.4. COMPARATORS 46 2.5. INDICATIONS AND CONTRAINDICATIONS 48 2.6. POTENTIAL COMPLICATIONS/HARMS. 49 2.7. COSTS 50 2.8. CLINICAL GUIDELINES 51 2.9. PREVIOUS SYSTEMATIC REVIEWS/TECHNOLOGY ASSESSMENTS 67 2.10. MEDICARE AND REPRESENTATIVE PRIVATE INSURER COVERAGE POLICIES 115 3. THE EVIDENCE 123 3.1. METHODS OF THE SYSTEMATIC LITERATURE REVIEW 123 3.1.1. INCLUSION/EXCLUSION 123 3.1.2. DATA SOURCES AND SEARCH STRATEGY 126 3.1.3. DATA EXTRACTION 127 3.2. METHODS OF DATA ANALYSIS AND EVIDENCE SYNTHESIS 128 3.2.1. DATA ANALYSIS AND SYNTHESIS OF EVIDENCE 128 3.2.2. STUDY QUALITY ASSESSMENT: LEVEL OF EVIDENCE (LOE) EVALUATION 131 3.3. QUALITY OF LITERATURE AVAILABLE 131 4. RESULTS 134 4.1. KEY QUESTION 1: DOES CATHETER ABLATION IMPROVE PATIENT OUTCOMES IN PERSONS WITH SUPRAVENTRICULAR TACHYARRHYTHMIAS COMPARED WITH OTHER TREATMENT OPTIONS: WHAT IS THE EVIDENCE FOR COMPARATIVE EFFICACY AND EFFECTIVENESS OVER THE SHORT TERM AND LONGER TERM? 134 4.1.1. ATRIAL FIBRILLATION 134 4.1.2. ATRIAL FLUTTER 171 4.1.3. SUPRAVENTRICULAR TACHYCARDIAS (SVTS) 176 Catheter Ablation Procedures for SVTA - Final Evidence Report Page iv Health Technology Assessment April 17, 2013 4.1.3.1. ATRIOVENTRICULAR NODAL RECIPROCATING TACHYCARDIA (AVNRT) 176 4.1.3.2. AVRT, INCLUDING WOLFF-PARKINSON-WHITE (WPW) SYNDROME 182 4.1.3.3. MIXED POPULATIONS 187 4.1.3.4. SINUS TACHYCARDIA, ATRIAL TACHYCARDIA, AND FOCAL JUNCTIONAL ECTOPIC TACHYCARDIA AND NONPAROXYSMAL JUNCTIONAL TACHYCARDIA 191 4.2. KEY QUESTION 1A: IF CATHETER ABLATION IS EFFICACIOUS COMPARED WITH OTHER TREATMENT OPTIONS, IS THERE DIFFERENTIAL EFFICACY BETWEEN RADIOFREQUENCY ABLATION VERSUS CRYOABLATION? 191 4.2.1. ATRIAL FIBRILLATION 191 4.2.2. ATRIAL FLUTTER 192 4.2.3. SUPRAVENTRICULAR TACHYARRHYTHMIA 194 4.3 KEY QUESTION 2: WHAT IS THE EVIDENCE REGARDING THE COMPARATIVE EFFICACY OF VARIOUS APPROACHES TO RADIOFREQUENCY CATHETER ABLATION? 196 4.3.1. PVI VERSUS WACA 197 4.3.2. PVI VERSUS PVI WITH ADDITIONAL LEFT-SIDED ABLATION LINES 199 4.3.3. PVI VERSUS PVI WITH ADDITIONAL RIGHT-SIDED ABLATION LINES 202 4.3.4. PVI VERSUS COMPLEX FRACTIONATED ELECTROGRAM (CFE) ABLATION (± PVI): OUTCOMES 203 4.3.5. MISCELLANEOUS COMPARISONS 206 4.4 KEY QUESTION 3: WHAT IS THE EVIDENCE OF THE SAFETY OF CATHETER ABLATION? 211 4.4.1. ATRIAL FIBRILLATION 211 4.4.2. ATRIAL FLUTTER 229 4.4.3. SUPRAVENTRICULAR TACHYARRYTHMIAS (SVTS) 231 4.4.3.1 ATRIOVENTRICULAR NODAL RECIPROCATING TACHYCARDIA (AVNRT) 232 4.4.3.2 AVRT, INCLUDING WOLFF-PARKINSON-WHITE (WPW) SYNDROME 234 4.4.3.3. SINUS TACHYCARDIA, ATRIAL TACHYCARDIA, AND FOCAL JUNCTIONAL ECTOPIC TACHYCARDIA AND NONPAROXYSMAL JUNCTIONAL TACHYCARDIA 235 4.4.3.4. MIXED POPULATIONS 236 4.5 KEY QUESTION 4: DOES CATHETER ABLATION HAVE ANY DIFFERENTIAL EFFICACY OR SAFETY COMPARED WITH OTHER TREATMENT OPTIONS IN SUBPOPULATIONS? 238 Catheter Ablation Procedures for SVTA - Final Evidence Report Page v Health Technology Assessment April 17, 2013 4.5.1. ATRIAL FIBRILLATION 238 4.5.2 ATRIAL FLUTTER 243 4.5.3. SUPRAVENTRICULAR TACHYCARDIAS (SVT) 244 4.6. KEY QUESTION 5 : WHAT IS THE EVIDENCE OF COST-EFFECTIVENESS OF CATHETER ABLATION COMPARED WITH ALTERNATIVE TREATMENT OPTIONS IN THE SHORT- AND LONG-TERM? 245 4.6.1. ATRIAL FIBRILLATION 245 4.6.2. ATRIAL FLUTTER 256 4.6.3 SUPRAVENTRICULAR TACHYCARDIAS (SVTS) 256 5 . REFERENCES 280 TABLES TABLE 1. CLINICAL GUIDELINES ........................................................................................................................................... 57 TABLE 2. SUMMARY OF PREVIOUS SYSTEMATIC REVIEWS .......................................................................................................... 67 TABLE 3. SUMMARY OF PREVIOUS HEALTH TECHNOLOGY ASSESSMENTS. ................................................................................... 100 TABLE 4. PAYER POLICIES. ................................................................................................................................................ 116 TABLE 5. SUMMARY OF INCLUSION AND EXCLUSION CRITERIA (PICO): ..................................................................................... 124 TABLE 6. DESCRIPTION OF OUTCOMES INSTRUMENTS USED IN COMPARATIVE STUDIES EVALUATING CLINICAL HEALTH OUTCOMES. ....... 129 TABLE 7. STUDY POPULATION OVERVIEW: RCTS COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ............................................................................................................................................. 135 TABLE 8. TREATMENT OVERVIEW: RCTS COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ................................................................................................................................................ 139 TABLE 9. STUDY POPULATION OVERVIEW: COHORT STUDIES COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ....................................................................................................................... 143 TABLE 10. FREEDOM FROM RECURRENCE: RCTS COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ............................................................................................................................................. 145 A. SHORT-TERM OUTCOMES: RADIOFREQUENCY ABLATION VERSUS AADS ............................................................................ 145 B. LONG-TERM OUTCOMES: RADIOFREQUENCY ABLATION VERSUS AADS ................................................................................... 146 C. SHORT-TERM OUTCOMES: CRYOABLATION VERSUS AADS .............................................................................................. 146 TABLE 11. FREEDOM FROM RECURRENCE: COHORT STUDIES COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ....................................................................................................................... 149 TABLE 12. MORTALITY RATES: RCTS COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ................................................................................................................................................ 150 TABLE 13. MORTALITY RATES: COHORT STUDIES COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ............................................................................................................................................. 153 TABLE 14. STROKE RATES: RCTS COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ............................................................................................................................................................. 155 TABLE 15. STROKE RATES: COHORT STUDIES COMPARING PULMONARY VEIN ISOLATION (PVI) WITH ANTI-ARRHYTHMIC DRUGS (AADS) IN PATIENTS WITH AF ................................................................................................................................................ 157 TABLE 16. AF SYMPTOM FREQUENCY AND SEVERITY CHECKLIST SCORES:
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