EUnetHTA JA2 Transcatheter implantable devices for mitral valve repair for chronic mitral valve regurgitation WP5B EUnetHTA WP5 Joint Action 2 (2012-2015), Rapid assessment of other technologies Pilot rapid assessment of other technologies using the HTA Core Model® for Rapid Relative Effectiveness Assessment TRANSCATHETER IMPLANTABLE DEVICES FOR MITRAL VALVE REPAIR IN ADULTS WITH CHRONIC MITRAL VALVE REGURGITATION FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMAPWORKING MANUAL FOR PILOTPilot ID:ING SB THE-15 RAPID MODEL Version 1.4, September 2015 Final version Sep2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA JA2 Transcatheter implantable devices for mitral valve repair for chronic mitral valve regurgitation WP5B DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V 1.1 30/06/2015 First draft. Input from co-author has been processed. V 1.2 17/07/2015 Second draft. Input from dedicated reviewers has been processed. V 1.3 02/09/2015 Third draft. Input from external experts, manufacturers and Strand B members has been processed. V 1.4 25/09/2015 Fourth draft. Input from medical editor has been processed. Disclaimer The assessment represents a consolidated view of the European Network for Health Technology Assessment (EUnetHTA) members and is in no case the official opinion of the participating institu- tions or individuals. EUnetHTA Joint Action 2 is supported by a grant from the European Commis- sion. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the infor- mation contained therein. Pilot team Authors Agenzia Nazionale per i Servizi Sanitari Regionali (Agenas), Italy Co-authors Agency for Quality and Accreditation in Health Care and Social Welfare (AAZ), Croatia Section of European Programmes and Projects – Ministry of Health of the Slovak Republic Reviewers AVALIA-T Galician Agency for HTA, Spain French National Authority for Health (Haute Autorité de Santé/HAS), France Gesundheit Österreich GmbH (GÖG), Austria Andalusian HTA Agency – Ministry of Equality, Health, and Social Services (AETSA), Spain Agency for Quality and Accreditation in Health Care and Social Welfare (AAZ), Croatia Health Information and Quality Authority (HIQA), Ireland Healthcare Improvement Scotland (HIS), Scotland Consultation of the draft Pilot Rapid Assessment The following WP5 Strand B members have Swiss Network for HTA, Switzerland provided comments during WP5 consultation [V 1.2] LBI HTA, Austria Manufacturers [V 1.2] Abbott Vascular International, Belgium Cardiac Dimensions Inc., USA NeoChord Inc., USA External experts [V 1.2] Cardiology Division, DIMES Department University of Bologna, Italy NHS Lothian, Scotland (Scoping Phase) Medical editor [V 1.3] Non Solus Communications Ltd, UK Sep2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 2 EUnetHTA JA2 Transcatheter implantable devices for mitral valve repair for chronic mitral valve regurgitation WP5B Conflict of interest All authors and reviewers involved in the production of this pilot assessment have declared that they have no conflicts of interest in relation to the technology assessed according to the EUnet- HTA Declaration of interest and confidentiality undertaking of interest (DOICU) statement form. Sep2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 3 EUnetHTA JA2 Transcatheter implantable devices for mitral valve repair for chronic mitral valve regurgitation WP5B TABLE OF CONTENTS LIST OF ABBREVIATIONS ............................................................................................................. 6 SUMMARY OF RELATIVE EFFECTIVENESS OF TRANSCATHETER IMPLANTABLE DEVICES FOR MITRAL VALVE REPAIR IN ADULTS WITH CHRONIC MITRAL VALVE REGURGITATION ...................................................................................................................... 9 SCOPE ........................................................................................................................................... 9 INTRODUCTION ............................................................................................................................... 9 METHODS..................................................................................................................................... 11 RESULTS ...................................................................................................................................... 11 DISCUSSION ................................................................................................................................. 16 CONCLUSION ................................................................................................................................ 17 1 SCOPE ...................................................................................................................................... 22 2 DESCRIPTION AND TECHNICAL CHARACTERISTICS OF TECHNOLOGY ....................... 24 2.1 RESEARCH QUESTIONS ..................................................................................................... 24 2.2 RESULTS .......................................................................................................................... 24 2.3 DISCUSSION ..................................................................................................................... 31 3 HEALTH PROBLEM AND CURRENT USE OF THE TECHNOLOGY .................................... 32 3.1 RESEARCH QUESTIONS ..................................................................................................... 32 3.2 RESULTS .......................................................................................................................... 32 3.3 DISCUSSION ..................................................................................................................... 41 4 CLINICAL EFFECTIVENESS ................................................................................................... 42 4.1 METHODS ......................................................................................................................... 42 4.2 RESULTS .......................................................................................................................... 43 4.3 DISCUSSION ..................................................................................................................... 52 5 SAFETY .................................................................................................................................... 54 5.1 RESEARCH QUESTIONS ..................................................................................................... 54 5.2 RESULTS .......................................................................................................................... 54 5.3 DISCUSSION ..................................................................................................................... 61 6 POTENTIAL ETHICAL, ORGANISATIONAL, SOCIAL, AND LEGAL ASPECTS ................. 62 6.1 RESEARCH QUESTIONS ..................................................................................................... 62 6.2 RESULTS .......................................................................................................................... 62 6.3 DISCUSSION ..................................................................................................................... 62 7 REFERENCES .......................................................................................................................... 63 APPENDIX 1: METHODS AND DESCRIPTION OF THE EVIDENCE USED .............................. 69 OVERALL DESCRIPTION OF METHODS ................................................................................. 69 DOCUMENTATION OF THE SEARCH STRATEGIES ............................................................. 70 DESCRIPTION OF THE EVIDENCE USED ............................................................................... 73 APPENDIX 2: CHECKLIST FOR POTENTIAL ETHICAL, ORGANISATIONAL, SOCIAL AND LEGAL ASPECTS ......................................................................................................................... 99 Sep2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 4 EUnetHTA JA2 Transcatheter implantable devices for mitral valve repair for chronic mitral valve regurgitation WP5B LIST OF TABLES AND FIGURES Tables Table 1: Summary table of relative effectiveness of the MitraClip® System for MV repair in adults with chronic MR ......................................................................... 18 Table 2: Summary table of relative effectiveness of CARILLON® Mitral Contour System® for MV repair in adults with chronic MR .................................. 20 Table 3: Summary table of relative effectiveness of NeoChord DS1000 for MV repair in adults with chronic MR ......................................................................... 21 Table 4: Features of the technologies ......................................................................................... 24 Table 5: Aetiologies of MR and their characteristics ................................................................... 33 Table 6: Stages of DMR ............................................................................................................... 33 Table 7: Stages