National Institute for Health and Care Excellence Final Chronic obstructive pulmonary disease in over 16s: diagnosis and management [G] Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation NICE guideline NG115 Evidence review December 2018 Final This evidence review was developed by the NICE Guideline Updates Team FINAL Error! No text of specified style in document. Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. 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ISBN: 978-1-4731-3175-0 FINAL Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation Contents Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation ............................................................................................................. 6 Review questions ........................................................................................................... 6 Introduction ........................................................................................................... 6 Methods and process ............................................................................................ 7 Clinical evidence ................................................................................................... 7 Summary of clinical studies included in the evidence review ................................. 9 Quality assessment of clinical studies included in the evidence review ............... 17 Economic evidence ............................................................................................. 17 Summary of studies included in the economic evidence review ........................... 17 Evidence statements ........................................................................................... 20 Recommendations ................................................. Error! Bookmark not defined. Rationale and impact .............................................. Error! Bookmark not defined. The committee’s discussion of the evidence ........................................................ 24 Appendices ........................................................................................................................ 30 Appendix A – Review protocols .................................................................................... 30 Review protocol for lung surgery ......................................................................... 30 Appendix B – Methods ................................................................................................. 35 Priority screening ................................................................................................. 35 Incorporating published systematic reviews ......................................................... 35 Evidence synthesis and meta-analyses ............................................................... 37 Evidence of effectiveness of interventions ........................................................... 37 Health economics ................................................................................................ 42 Appendix C – Literature search strategies .................................................................... 44 Main searches ..................................................................................................... 44 Health Economics search strategy ...................................................................... 46 Appendix D – Clinical evidence study selection ............................................................ 49 Appendix E – Clinical evidence tables .......................................................................... 50 Lung volume reduction surgery ........................................................................... 50 Endobronchial valves .......................................................................................... 66 Intra-bronchial ..................................................................................................... 78 Endobronchial coils ............................................................................................. 83 Appendix F – Forest plots ............................................................................................. 91 Lung volume reduction surgery ........................................................................... 91 Endobronchial valves ........................................................................................ 103 Intra-bronchial valves ........................................................................................ 118 Endobronchial coils ........................................................................................... 122 4 FINAL Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation Appendix G – GRADE tables ...................................................................................... 126 Lung volume reduction surgery ......................................................................... 126 Endobronchial valves ........................................................................................ 130 Intra-bronchial valves ........................................................................................ 136 Endobronchial coils ........................................................................................... 138 Appendix H – Economic evidence study selection ...................................................... 141 Appendix I – Health economic evidence profiles ......................................................... 142 Lung volume reduction surgery ......................................................................... 142 Endobronchial valve .......................................................................................... 143 Endobronchial coil ............................................................................................. 145 Appendix J – Excluded Studies .................................................................................. 146 Clinical studies .................................................................................................. 146 Economic studies .............................................................................................. 151 Appendix K – References ........................................................................................... 152 Clinical studies .................................................................................................. 152 Economic studies .............................................................................................. 162 5 FINAL Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation Review questions In people with stable COPD, what are the referral criteria for lung volume reduction procedures? In people with stable COPD, what are the referral criteria for bullectomy? In people with stable COPD, what are the referral criteria for lung transplantation? Introduction The aim of this review was to determine the effectiveness of lung volume reduction procedures, bullectomy and lung transplantation for people with stable COPD, to enable the identification of subgroups of people who show benefit from the treatment. The defining characteristics of these subgroups will inform the referral criteria for these treatments. For the purposes of this question, five treatments were considered – lung volume reduction surgery, bronchoscopic lung volume reduction (either with valves or coils), bullectomy, and lung transplant. Lung volume reduction surgery (LVRS) involves surgically removing the most damaged part of the lung. This allows the remaining healthier, less emphysematous lung tissue to expand. It is usually done as a “keyhole” procedure – video assisted thoracoscopic surgery (VATS) but may require an open surgery. Usually only one side at a time is operated on in modern practice. This surgery is usually done only in selected people