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CADTH Technology Report Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé CADTH Technology Report Issue 128 Ablation Procedures for Rhythm Control in September 2010 Patients with Atrial Fibrillation: Clinical and Cost-Effectiveness Analyses Supporting Informed Decisions Until April 2006, the Canadian Agency for Drugs and Technologies in Health (CADTH) was known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Publications can be requested from: CADTH 600-865 Carling Avenue Ottawa ON Canada K1S 5S8 Tel.: 613-226-2553 Fax: 613-226-5392 Email: [email protected] or downloaded from CADTH’s website: http://www.cadth.ca Cite as: Assasi N, Blackhouse G, Xie F, Gaebel K, Robertson D, Hopkins R, Healey J, Roy D, Goeree R. Ablation Procedures for Rhythm Control in Patients with Atrial Fibrillation: Clinical and Cost-Effectiveness Analyses [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010 (Technology report; no. 128). [cited 2010-09-17]. Available from: http://www.cadth.ca/index.php/en/hta/reports-publications/search?&type=16 Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government. Reproduction of this document for non-commercial purposes is permitted provided appropriate credit is given to CADTH. CADTH is funded by Canadian federal, provincial, and territorial governments. Legal Deposit – 2010 Library and Archives Canada ISSN: 1922-6101 (print) ISSN: 1922-611X (online) H0491 – September 2010 PUBLICATIONS MAIL AGREEMENT NO. 40026386 RETURN UNDELIVERABLE CANADIAN ADDRESSES TO CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH 600-865 CARLING AVENUE OTTAWA ON K1S 5S8 Canadian Agency for Drugs and Technologies in Health Ablation Procedures for Rhythm Control in Patients with Atrial Fibrillation: Clinical and Cost-Effectiveness Analyses Nazila Assasi, MD, PhD1,2 Gord Blackhouse, MSc1,2 Feng Xie, PhD1,2,3 Kathryn Gaebel, MSc1,3 Diana Robertson, MLIS1,2 1,2 Rob Hopkins, MSc 4 Jeff Healey, MD, MSc, FRCPC 5, 6 Denis Roy, MD 1,2,3 Ron Goeree, MA September 2010 1 Programs for Assessment of Technology in Health, McMaster University, Hamilton, Ontario 2 Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario 3 Centre for Evaluation of Medicines, St. Joseph’s Healthcare, Hamilton, Ontario 4 Population Health Research Institute, McMaster University, Hamilton, Ontario 5 Department of Medicine, University of Montreal, Montreal, Quebec 6 Montreal Heart Institute, Montreal, Quebec Reviewers This document was externally reviewed by content experts, and the following individuals granted permission to be cited. External Reviewers Jafna L. Cox, BA, MD Adrian Baranchuk, MD, FACC Professor of Medicine and of Community Associate Professor of Medicine and Health and Epidemiology Physiology Dalhousie University Queen’s University Halifax, Nova Scotia Kingston, Ontario Craig Mitton, PhD Tanya Horsley, PhD Associate Professor Educational Research Scientist University of British Columbia Royal College of Physicians and Vancouver, British Columbia Surgeons of Canada Ottawa, Ontario Rick Audas, BBA, MBA, MA(Econ), PhD Assistant Professor of Medicine Memorial University St. John’s, Newfoundland CADTH Peer Review Group Reviewers Chris Skedgel, MDE James Brophy, MEng, MD, FRCPC, PhD Research Health Economist Professor of Medicine and Epidemiology Department of Medicine McGill University Dalhousie University Montreal, Quebec Halifax, Nova Scotia Industry The following manufacturers were provided with an opportunity to comment on an earlier version of this report: Bard Canada Inc., Boston Scientific Ltd., Cardima Inc., Biosense Webster Inc., Medtronic Canada Inc., and St. Jude’s Medical Inc. All comments that were received were considered when preparing the final report. This report is a review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) that are available to CADTH. The accuracy of the contents of the source documentation on which this report is based is not warranted, assured, or represented in any way by CADTH, and CADTH does not assume responsibility for the quality, propriety, inaccuracies, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH takes sole responsibility for the final form and content of this report. The statements and conclusions in this report are those of CADTH and not of its Panel members or reviewers. i Ablation Procedures for Rhythm Control in Patients with Atrial Fibrillation: Clinical and Cost-Effectiveness Analyses Authorship Nazila Assasi was the clinical research lead and a systematic reviewer. Nazila wrote the protocol, designed the screening questionnaires, conducted the clinical review and data abstraction, and wrote the clinical review portion of the report. She assisted with the creation of the Review Manager database and produced the clinical review results tables. Gord Blackhouse was one of the health economists. Gord wrote the primary economic model section of the report and assisted in the review of economic evidence. Gord completed and wrote the budget impact analysis section of the report. Feng Xie was one of the health economists. Feng reviewed the economic evidence and helped developed the primary economic evaluation. Kathryn Gaebel was the systematic reviewer. Kathryn helped create the study protocol, screening questionnaires, and data abstraction forms. Kathy was responsible for the implementation issues section of the report. Diana Robertson was the information specialist. She developed and conducted the literature search strategy and retrieved copies of relevant articles. Diana helped develop screening questionnaires and data abstraction forms and screened citations that were identified in the literature search. Diana wrote the methods for the systematic reviews. Rob Hopkins served as a statistician. He conducted and advised on the statistical component of the meta-analyses. Jeff Healey was a clinical content expert. Denis Roy was a clinical content expert. Ron Goeree was the project advisor and the project coordinator. All authors reviewed drafts of the report and approved the final report. Conflict of Interest Gord Blackhouse has been a consultant on economic evaluations for Eli Lilly Canada Inc., GlaxoSmithKline Inc., Pfizer Canada Inc., and Bristol-Myers Squibb Canada. Ron Goeree has been an advisor or consultant for Actelion Pharmaceuticals Canada Inc., Sanofi- aventis Groupe (Global), and Amgen Canada. He has received research funding or grants from Eli Lilly Canada Inc., GlaxoSmithKline Inc., Pfizer Canada Inc., and Bristol-Myers Squibb Canada. Ablation Procedures for Rhythm Control in Patients with Atrial Fibrillation: ii Clinical and Cost-Effectiveness Analyses Denis Roy has been an advisory board member for Sanofi-aventis, Merck, and Boehringer Ingelheim, and he has been an events committee member for Cryocath/Medtronic. Jeff Healey has received research funding or grants from Boston Scientific, Boehringer Ingelheim, AstraZeneca, and Sanofi-aventis. He has been a speaker for Boehringer Ingelheim and Boston Scientific. iii Ablation Procedures for Rhythm Control in Patients with Atrial Fibrillation: Clinical and Cost-Effectiveness Analyses EXECUTIVE SUMMARY The Issue Atrial fibrillation (AF) leads to more disability than any other cardiac arrhythmia, because of its high incidence and the potential for adverse outcomes. It affects more than 200,000 Canadians. The prevalence increases with age (more than 5% of the population over 65 years of age have AF). The first-line medical therapy for AF is antiarrhythmic drugs (AADs). Although medical treatment has the advantage of being non-invasive and available, chronic administration may be needed. On the other hand, ablation of AF may prevent long-term use of AADs. There remains uncertainty about the health impact of using ablation and its place in therapy. Ablation procedures for AF are funded in at least five Canadian provinces. Some jurisdictions are interested in developing guidelines on ablation procedures for the management of patients with AF. In this technology assessment report, only the ablation procedures aimed at controlling cardiac rhythm in adults with AF are evaluated. Objectives The aims of this health technology assessment were to: evaluate the comparative clinical effectiveness of minimally invasive ablation procedures (pulmonary vein isolation [PVI] alone and with other adjunctive atrial ablations) for AF and to compare these with other modalities for converting AF to normal sinus rhythm, including pharmacological or electrical cardioversion, and to more invasive surgical procedures evaluate the comparative cost-effectiveness of minimally invasive ablation procedures for AF and to compare these with pharmacological or electrical cardioversion and to more invasive surgical procedures evaluate the impact of using minimally invasive procedures on patients with paroxysmal AF, patients with persistent
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