An Economic Evaluation of a Streamlined Day-Case Atrial Fibrillation Ablation Protocol and Conventional Cryoballoon Ablation versus Antiarrhythmic Drugs in a UK Paroxysmal Atrial Fibrillation Population.


Journal

PharmacoEconomics - open
ISSN: 2509-4254
Titre abrégé: Pharmacoecon Open
Pays: Switzerland
ID NLM: 101700780

Informations de publication

Date de publication:
20 Jan 2024
Historique:
accepted: 26 12 2023
medline: 20 1 2024
pubmed: 20 1 2024
entrez: 20 1 2024
Statut: aheadofprint

Résumé

Symptom control for atrial fibrillation can be achieved by catheter ablation or drug therapy. We assessed the cost effectiveness of a novel streamlined atrial fibrillation cryoballoon ablation protocol (AVATAR) compared with optimised antiarrhythmic drug (AAD) therapy and a conventional catheter ablation protocol, from a UK National Health Service (NHS) perspective. Data from the AVATAR study were assessed to determine the cost effectiveness of the three protocols in a two-step process. In the first stage, statistical analysis of clinical efficacy outcomes was conducted considering either a three-way comparison (AVATAR vs. conventional ablation vs. optimised AAD therapies) or a two-way comparison (pooled ablation protocol data vs. optimised AAD therapies). In the second stage, models assessed the cost effectiveness of the protocols. Costs and some of the clinical inputs in the models were derived from within-trial cost analysis and published literature. The remaining inputs were derived from clinical experts. No significant differences between the ablation protocols were found for any of the clinical outcomes used in the model. Results of a within-trial cost analysis show that AVATAR is cost-saving (£1279 per patient) compared with the conventional ablation protocol. When compared with optimised AAD therapies, AVATAR (pooled conventional and AVATAR ablation protocols efficacy) was found to be more costly while offering improved clinical benefits. Over a lifetime time horizon, the incremental cost-effectiveness ratio of AVATAR was estimated as £21,046 per quality-adjusted life-year gained (95% credible interval £7086-£71,718). The AVATAR streamlined protocol is likely to be a cost-effective option versus both conventional ablation and optimised AAD therapy in the UK NHS healthcare setting.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
Symptom control for atrial fibrillation can be achieved by catheter ablation or drug therapy. We assessed the cost effectiveness of a novel streamlined atrial fibrillation cryoballoon ablation protocol (AVATAR) compared with optimised antiarrhythmic drug (AAD) therapy and a conventional catheter ablation protocol, from a UK National Health Service (NHS) perspective.
METHODS METHODS
Data from the AVATAR study were assessed to determine the cost effectiveness of the three protocols in a two-step process. In the first stage, statistical analysis of clinical efficacy outcomes was conducted considering either a three-way comparison (AVATAR vs. conventional ablation vs. optimised AAD therapies) or a two-way comparison (pooled ablation protocol data vs. optimised AAD therapies). In the second stage, models assessed the cost effectiveness of the protocols. Costs and some of the clinical inputs in the models were derived from within-trial cost analysis and published literature. The remaining inputs were derived from clinical experts.
RESULTS RESULTS
No significant differences between the ablation protocols were found for any of the clinical outcomes used in the model. Results of a within-trial cost analysis show that AVATAR is cost-saving (£1279 per patient) compared with the conventional ablation protocol. When compared with optimised AAD therapies, AVATAR (pooled conventional and AVATAR ablation protocols efficacy) was found to be more costly while offering improved clinical benefits. Over a lifetime time horizon, the incremental cost-effectiveness ratio of AVATAR was estimated as £21,046 per quality-adjusted life-year gained (95% credible interval £7086-£71,718).
CONCLUSIONS CONCLUSIONS
The AVATAR streamlined protocol is likely to be a cost-effective option versus both conventional ablation and optimised AAD therapy in the UK NHS healthcare setting.

Identifiants

pubmed: 38244143
doi: 10.1007/s41669-023-00471-6
pii: 10.1007/s41669-023-00471-6
doi:

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2024. The Author(s).

Références

National Clinical Guideline Centre. Atrial fibrillation: diagnosis and management. 2021. https://www.nice.org.uk/guidance/ng196 .
Mann I, Sasikaran T, Sandler B, Babalis D, Johnson N, Falaschetti E, et al. Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation (AVATAR-AF): design and rationale. Am Heart J. 2019;214:36–45. https://doi.org/10.1016/j.ahj.2019.04.015 .
doi: 10.1016/j.ahj.2019.04.015 pubmed: 31152874
Kanagaratnam P, McCready J, Tayebjee M, Shepherd E, Sasikaran T, Todd D, et al. Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation: a prospective, randomized, multi-centre, open label trial. EP Europace. 2023;25(3):83–872. https://doi.org/10.1093/europace/euac253 .
doi: 10.1093/europace/euac253
National Institute for Health and Care Excellence. NICE health technology evaluations: the manual. 2022. https://www.nice.org.uk/process/pmg36 .
van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–15. https://doi.org/10.1016/j.jval.2012.02.008 .
doi: 10.1016/j.jval.2012.02.008 pubmed: 22867780
Calkins H, Hindricks G, Cappato R, Kim Y-H, Saad EB, Aguinaga L, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275–444. https://doi.org/10.1016/j.hrthm.2017.05.012 .
doi: 10.1016/j.hrthm.2017.05.012 pubmed: 28506916 pmcid: 6019327
Bhaskar S, Stanwell P, Bivard A, Spratt N, Walker R, Kitsos GH, et al. The influence of initial stroke severity on mortality, overall functional outcome and in-hospital placement at 90 days following acute ischemic stroke: a tertiary hospital stroke register study. Neurol India. 2017;65(6):1252–9. https://doi.org/10.4103/0028-3886.217947 .
doi: 10.4103/0028-3886.217947 pubmed: 29133696
Zhang R, Ma S, Shanahan L, Munroe J, Horn S, Speedie S. Discovering and identifying New York heart association classification from electronic health records. BMC Med Inform Decis Mak. 2018;18(Suppl 2):48. https://doi.org/10.1186/s12911-018-0625-7 .
doi: 10.1186/s12911-018-0625-7 pubmed: 30066653 pmcid: 6069768
Curtis, A. Lesley, Burns, Amanda. Unit Costs of Health & Social Care 2020. Personal Social Services Research Unit; 2020. p. 185. https://doi.org/10.22024/UniKent/01.02.84818.
All NHS trusts and NHS foundation trusts. National Schedule of NHS Costs Year: 2019-20—HRG Data. NHS; 2021.
Kind P, Hardman G, Macran S. UK population norms for EQ-5D. In: Centre for Health Economics, University of York, Working Papers. 1999.
Witassek F, Springer A, Adam L, Aeschbacher S, Beer JH, Blum S, et al. Health-related quality of life in patients with atrial fibrillation: the role of symptoms, comorbidities, and the type of atrial fibrillation. PLoS ONE. 2019;14(12):e0226730. https://doi.org/10.1371/journal.pone.0226730 .
doi: 10.1371/journal.pone.0226730 pubmed: 31869399 pmcid: 6927649
Luengo-Fernandez R, Gray AM, Bull L, Welch S, Cuthbertson F, Rothwell PM. Quality of life after TIA and stroke: ten-year results of the Oxford Vascular Study. Neurology. 2013;81(18):1588–95. https://doi.org/10.1212/WNL.0b013e3182a9f45f .
doi: 10.1212/WNL.0b013e3182a9f45f pubmed: 24107865 pmcid: 3806919
Shore J, Russell J, Frankenstein L, Candolfi P, Green M. An analysis of the cost-effectiveness of transcatheter mitral valve repair for people with secondary mitral valve regurgitation in the UK. J Med Econ. 2020;23(12):1425–34. https://doi.org/10.1080/13696998.2020.1854769 .
doi: 10.1080/13696998.2020.1854769 pubmed: 33236939
Wynn GJ, Todd DM, Webber M, Bonnett L, McShane J, Kirchhof P, et al. The European Heart Rhythm Association symptom classification for atrial fibrillation: validation and improvement through a simple modification. Europace. 2014;16(7):965–72. https://doi.org/10.1093/europace/eut395 .
doi: 10.1093/europace/eut395 pubmed: 24534264 pmcid: 4070972
Office for National Statistics. Nomis: Mortality statistics - underlying cause, sex and age. Office for National Statistics; 2020.
Saposnik G, Cote R, Phillips S, Gubitz G, Bayer N, Minuk J, et al. Stroke outcome in those over 80: a multicenter cohort study across Canada. Stroke. 2008;39(8):2310–7. https://doi.org/10.1161/strokeaha.107.511402 .
doi: 10.1161/strokeaha.107.511402 pubmed: 18556583
Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012;33(12):1500–10. https://doi.org/10.1093/eurheartj/ehr488 .
doi: 10.1093/eurheartj/ehr488 pubmed: 22246443
Christiansen MN, Køber L, Weeke P, Vasan RS, Jeppesen JL, Smith JG, et al. Age-specific trends in incidence, mortality, and comorbidities of heart failure in Denmark, 1995 to 2012. Circulation. 2017;135(13):1214–23. https://doi.org/10.1161/circulationaha.116.025941 .
doi: 10.1161/circulationaha.116.025941 pubmed: 28174193
Vaartjes I, Hoes AW, Reitsma JB, de Bruin A, Grobbee DE, Mosterd A, et al. Age- and gender-specific risk of death after first hospitalization for heart failure. BMC Public Health. 2010;10:637. https://doi.org/10.1186/1471-2458-10-637 .
doi: 10.1186/1471-2458-10-637 pubmed: 20969758 pmcid: 3091563
Joint Formulary Committee. British National Formulary. London: BMJ Group and Pharmaceutical Press. 2022. http://www.medicinescomplete.com . Accessed 14 Mar 2022.
Xu XM, Vestesson E, Paley L, Desikan A, Wonderling D, Hoffman A, et al. The economic burden of stroke care in England, Wales and Northern Ireland: Using a national stroke register to estimate and report patient-level health economic outcomes in stroke. Eur Stroke J. 2018;3(1):82–91. https://doi.org/10.1177/2396987317746516 .
doi: 10.1177/2396987317746516 pubmed: 29900412
R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing [program]. Vienna, Austria. 2020. https://www.R-project.org/ .
Saglietto A, Gaita F, De-Ponti R, De-Ferrari GM, Anselmino M. Catheter ablation vs anti-arrhythmic drugs as first-line treatment in symptomatic paroxysmal atrial fibrillation: a systematic review and meta-analysis of randomized clinical trials. Front Cardiovasc Med. 2021;8:664647. https://doi.org/10.3389/fcvm.2021.664647 .
doi: 10.3389/fcvm.2021.664647 pubmed: 34095254 pmcid: 8175669
Asad ZUA, Yousif A, Khan MS, Al-Khatib SM, Stavrakis S. Catheter ablation versus medical therapy for atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. Circ Arrhythm Electrophysiol. 2019;12(9):e007414. https://doi.org/10.1161/circep.119.007414 .
doi: 10.1161/circep.119.007414 pubmed: 31431051
Yi F, Hou W, Zhou C, Yin Y, Lu S, Duan C, et al. Radiofrequency ablation versus antiarrhythmic drug therapy for atrial fibrillation: meta-analysis of safety and efficacy. J Cardiovasc Pharmacol. 2019;73(4):241–7. https://doi.org/10.1097/fjc.0000000000000654 .
doi: 10.1097/fjc.0000000000000654 pubmed: 30688797
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, et al. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42(40):4194–294. https://doi.org/10.1093/eurheartj/ehab648 .
doi: 10.1093/eurheartj/ehab648 pubmed: 34520521
Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, et al. Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial. JAMA. 2019;321(13):1275–85. https://doi.org/10.1001/jama.2019.0692 .
doi: 10.1001/jama.2019.0692 pubmed: 30874716 pmcid: 6450275
Reynolds MR, Lamotte M, Todd D, Khaykin Y, Eggington S, Tsintzos S, et al. Cost-effectiveness of cryoballoon ablation for the management of paroxysmal atrial fibrillation. Europace. 2014;16(5):652–9. https://doi.org/10.1093/europace/eut380 .
doi: 10.1093/europace/eut380 pubmed: 24390386
Rodgers M, McKenna C, Palmer S, Chambers D, Van Hout S, Golder S, et al. Curative catheter ablation in atrial fibrillation and typical atrial flutter: systematic review and economic evaluation. Health Technol Assess. 2008;12(34):1–198. https://doi.org/10.3310/hta12340 .
doi: 10.3310/hta12340
Eckard N, Davidson T, Walfridsson H, Levin L. Cost-effectiveness of catheter ablation treatment for patients with symptomatic atrial fibrillation. J Atr Fibrill. 2009;2(2):195. https://doi.org/10.4022/jafib.195 .
doi: 10.4022/jafib.195
Assasi N, Xie F, Blackhouse G, Gaebel K, Robertson D, Hopkins R, et al. Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. J Interv Card Electrophysiol. 2012;35(3):259–75. https://doi.org/10.1007/s10840-012-9723-0 .
doi: 10.1007/s10840-012-9723-0 pubmed: 23054128
Leung LWM, Imhoff RJ, Marshall HJ, Frame D, Mallow PJ, Goldstein L, et al. Cost-effectiveness of catheter ablation versus medical therapy for the treatment of atrial fibrillation in the United Kingdom. J Cardiovasc Electrophysiol. 2022;33(2):164–75. https://doi.org/10.1111/jce.15317 .
doi: 10.1111/jce.15317 pubmed: 34897897
National Institute for Health and Care Excellence. Atrial fibrillation: diagnosis and management. Cost-effectiveness analysis J3: Ablation. NICE guideline NG196. Economic analysis report. 2021. https://www.nice.org.uk/guidance/ng196/evidence/j3-ablation-health-economics-analysis-pdf-326949243734 .
Sgreccia D, Manicardi M, Malavasi VL, Vitolo M, Valenti AC, Proietti M, et al. Comparing outcomes in asymptomatic and symptomatic atrial fibrillation: a systematic review and meta-analysis of 81,462 patients. J Clin Med. 2021;10(17):14. https://doi.org/10.3390/jcm10173979 .
doi: 10.3390/jcm10173979
Gibbs H, Freedman B, Rosenqvist M, Virdone S, Mahmeed WA, Ambrosio G, et al. Clinical outcomes in asymptomatic and symptomatic atrial fibrillation presentations in GARFIELD-AF: implications for AF screening. Am J Med. 2021;134(7):893-901.e11. https://doi.org/10.1016/j.amjmed.2021.01.017 .
doi: 10.1016/j.amjmed.2021.01.017 pubmed: 33607088
Xiong Q, Proietti M, Senoo K, Lip GY. Asymptomatic versus symptomatic atrial fibrillation: a systematic review of age/gender differences and cardiovascular outcomes. Int J Cardiol. 2015;191:172–7. https://doi.org/10.1016/j.ijcard.2015.05.011 .
doi: 10.1016/j.ijcard.2015.05.011 pubmed: 25974193
Wazni O, Moss J, Kuniss M, Andrade J, Chierchia GB, Mealing S, et al. An economic evaluation of first-line cryoballoon ablation vs antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation from a U.S. Medicare perspective. Heart Rhythm O2. 2023;4(9):528–37. https://doi.org/10.1016/j.hroo.2023.07.007 .
doi: 10.1016/j.hroo.2023.07.007 pubmed: 37744940 pmcid: 10513914
De With RR, Marcos EG, Dudink E, Spronk HM, Crijns H, Rienstra M, et al. Atrial fibrillation progression risk factors and associated cardiovascular outcome in well-phenotyped patients: data from the AF-RISK study. Europace. 2020;22(3):352–60. https://doi.org/10.1093/europace/euz339 .
doi: 10.1093/europace/euz339 pubmed: 31865391

Auteurs

Joe W E Moss (JWE)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK. joe.moss@york.ac.uk.

Derick Todd (D)

Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool, L14 3PE, UK.

Lukasz Grodzicki (L)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

Beatrice Palazzolo (B)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

Richard Mattock (R)

Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Stuart Mealing (S)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

Maxim Souter (M)

Medtronic Limited, Watford, UK.

Benedict Brown (B)

Medtronic International Trading Sarl, Tolochenaz, Switzerland.

Tom Bromilow (T)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

Damian Lewis (D)

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

James McCready (J)

Brighton and Sussex University Hospital, Brighton, UK.

Muzahir Tayebjee (M)

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Ewen Shepherd (E)

Newcastle-upon-Tyne NHS Foundation Trust, Newcastle, UK.

Thiagarajah Sasikaran (T)

Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.

Clare Coyle (C)

National Heart and Lung Institute, Imperial College London, London, UK.
Imperial College Healthcare NHS Trust, London, UK.

Eleni Ismyrloglou (E)

Medtronic Bakken Research Center B.V., Maastricht, The Netherlands.

Nicholas A Johnson (NA)

Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.

Prapa Kanagaratnam (P)

National Heart and Lung Institute, Imperial College London, London, UK.
Imperial College Healthcare NHS Trust, London, UK.

Classifications MeSH