Cost-utility of VISITAG SURPOINT in catheter ablation of atrial fibrillation.
clinical
cost-effectiveness
economic
model
quality-adjusted life years
radiofrequency
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
26 Feb 2024
26 Feb 2024
Historique:
revised:
20
10
2023
received:
20
09
2023
accepted:
04
01
2024
medline:
26
2
2024
pubmed:
26
2
2024
entrez:
26
2
2024
Statut:
aheadofprint
Résumé
Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.
Sections du résumé
BACKGROUND
BACKGROUND
Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives.
METHODS
METHODS
We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model.
RESULTS
RESULTS
CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation.
CONCLUSIONS
CONCLUSIONS
CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Biosense Webster
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016;354:i4482.
Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2016 (GBD 2016). Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. 2016; Accessed 2018-04-20. http://ghdx.healthdata.org/gbd-results-tool
Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2018;20(1):e1-e160.
Macle L, Frame D, Gache LM, Monir G, Pollak SJ, Boo LM. Atrial fibrillation ablation with a spring sensor-irrigated contact force-sensing catheter compared with other ablation catheters: systematic literature review and meta-analysis. BMJ Open. 2019;9(6):e023775.
Natale A, Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-656.
Reddy VY, Pollak S, Lindsay BD, et al. Relationship between catheter stability and 12-month success after pulmonary vein isolation: a subanalysis of the SMART-AF trial. JACC Clin Electrophysiol. 2016;2(6):691-699.
Das M, Loveday JJ, Wynn GJ, et al. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017;19(5):775-783.
Dhillon G, Ahsan S, Honarbakhsh S, et al. A multicentered evaluation of ablation at higher power guided by ablation index: establishing ablation targets for pulmonary vein isolation. J Cardiovasc Electrophysiol. 2019;30(3):357-365.
Hussein A, Das M, Riva S, et al. Use of ablation index-guided ablation results in high rates of durable pulmonary vein isolation and freedom from arrhythmia in persistent atrial fibrillation patients: the PRAISE study results. Circ Arrhythm Electrophysiol. 2018;11(9):e006576.
Munkler P, Kroger S, Liosis S, et al. Ablation index for catheter ablation of atrial fibrillation-clinical applicability and comparison with force-time integral. Circ J. 2018;82(11):2722-2727.
Phlips T, Taghji P, El Haddad M, et al. Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, ablation index, and contact force variability in the ‘CLOSE’-protocol. Europace. 2018;20(FI_3):f419-f427.
Solimene F, Schillaci V, Shopova G, et al. Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. J Interv Card Electrophysiol. 2019;54(1):9-15.
Taghji P, El Haddad M, Phlips T, et al. Evaluation of a strategy aiming to enclose the pulmonary veins with contiguous and optimized radiofrequency lesions in paroxysmal atrial fibrillation: a pilot study. JACC Clin Electrophysiol. 2018;4(1):99-108.
Pranata R, Vania R, Huang I. Ablation-index guided versus conventional contact-force guided ablation in pulmonary vein isolation - systematic review and meta-analysis. Indian Pacing Electrophysiol J. 2019;19(4):155-160.
Gupta D, Potter T, Disher T, et al. Comparative effectiveness of catheter ablation devices in the treatment of atrial fibrillation: a network meta-analysis. J Comp Eff Res. 2020;9(2):115-126.
Leung LWM, Imhoff RJ, Marshall HJ, 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):164-175.
Statistisches Bundesamt (Destatis). Sterbetafel (Periodensterbetafel): Deutschland, Jahre, Geschlecht, Vollendetes Alter. 2021;https://www-genesis.destatis.de/genesis/online?operation=previous&levelindex=0ystep=0&titel=Tabellenaufbauylevelid=1648824766891&acceptscookies=false#abreadcrumb
STATBEL. Mortality table for Belgium by sex and gender, 1885-2020. 2021;https://statbel.fgov.be/fr/themes/population/mortalite-et-esperance-de-vie/tables-de-mortalite-et-esperance-de-vie#figures
STATBEL. Health index since 1994, by base year, last 13 months. 2021; . Accessed January 27, 2022. https://statbel.fgov.be/en/themes/consumer-prices/health-index
Statistisches Bundesamt (Destatis). Verbraucherpreisindex (inkl. Veränderungsraten):Deutschland, Jahre. 2022; Accessed January 27, 2022 https://www-genesis.destatis.de/genesis/online?sequenz=tabelleErgebnis&selectionname=61111-0001&startjahr=1991#abreadcrumb
Steg PG, Alam S, Chiang CE, et al. Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry. Heart. 2012;98(3):195-201.
ISPOR. German. General Methods for the Assessment of the Relation of Benefits to Costs (Version 1.0, dated 19/11/2009).
ISPOR. Belgian. Guidelines for Economic Evaluations and Budget Impact Analyses: Second Edition (July 17, 2012).
Aronsson M, Walfridsson H, Janzon M, et al. The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation: results from a MANTRA-PAF substudy. Europace. 2015;17(1):48-55.
Blackhouse G, Assasi N, Xie F, et al. Cost-effectiveness of catheter ablation for rhythm control of atrial fibrillation. Int J Vasc Med. 2013;2013:262809.
Chan PS, Vijan S, Morady F, Oral H. Cost-effectiveness of radiofrequency catheter ablation for atrial fibrillation. J Am Coll Cardiol. 2006;47(12):2513-2520.
McKenna C, Palmer S, Rodgers M, et al. Cost-effectiveness of radiofrequency catheter ablation for the treatment of atrial fibrillation in the United Kingdom. Heart. 2009;95(7):542-549.
Reynolds MR, Zimetbaum P, Josephson ME, Ellis E, Danilov T, Cohen DJ. Cost-effectiveness of radiofrequency catheter ablation compared with antiarrhythmic drug therapy for paroxysmal atrial fibrillation. Circ Arrhythm Electrophysiol. 2009;2(4):362-369.
Tulchinsky TH. Bismarck and the long road to universal health coverage. Case Studies in Public Health. 2018;131-179. Available at.
Tikkanen R, Osborn R, Mossialos E, Djordjevic A, Wharton GA. International health care system profiles: Germany. The Commonwealth Fund 2020; Accessed January 20, 2023. https://www.commonwealthfund.org/international-health-policy-center/countries/germany
Princeton Public Health Review. Health Care Reform: Learning From Other Major Health Care Systems. 2017; . Accessed January 19, 2023. https://pphr.princeton.edu/2017/12/02/unhealthy-health-care-a-cursory-overview-of-major-health-care-systems/
Gandjour A. Willingness to pay for new medicines: a step towards narrowing the gap between NICE and IQWiG. BMC Health Serv Res. 2020;20(1):343.
Gandjour A. Germany's decision rule for setting ceiling prices of drugs: a comparative analysis with other decision rules. Appl Health Econ Health Policy. 2011;9(2):65-71.
Cleemput I, Neyt M, Thiry N, De Laet C, Leys M. Threshold values for cost-effectiveness in health care Health Technology Assessment (HTA). Brussels: Belgian Health Care Knowledge Centre (KCE). 2008;KCE reports 100C (D/2008/2010.2273/2096).
Steinberg BA, Hellkamp AS, Lokhnygina Y, et al. Higher risk of death and stroke in patients with persistent vs. paroxysmal atrial fibrillation: results from the ROCKET-AF Trial. Eur Heart J. 2015;36(5):288-296.
Link MS, Giugliano RP, Ruff CT, et al. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017;10(1).
Mark DB, Anstrom KJ, Sheng S, 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):1275-1285.
Bertaglia E, Senatore G, De Michieli L, et al. Twelve-year follow-up of catheter ablation for atrial fibrillation: a prospective, multicenter, randomized study. Heart Rhythm. 2017;14(4):486-492.
aG-DRG-System. Cost according to DRG reimbursement F71B 2021 + reimbursement for nursing care costs with the mean LOS of 3 days. 2021. . Accessed January 27, 2022. https://www.g-drg.de/aG-DRG-System_2021
McBride D, Mattenklotz AM, Willich SN, Bruggenjurgen B. The costs of care in atrial fibrillation and the effect of treatment modalities in Germany. Value Health. 2009;12(2):293-301.
Diel R, Lampenius N. Cost-benefit analysis of VKA versus NOAC treatment in German patients with atrial fibrillation utilizing patient self-testing. J Health Econ Outcomes Res. 2019;6(3):142-159.
Mensch A, Stock S, Stollenwerk B, Muller D. Cost effectiveness of rivaroxaban for stroke prevention in German patients with atrial fibrillation. Pharmacoeconomics. 2015;33(3):271-283.
Bassand JP, Apenteng PN, Atar D, et al. GARFIELD-AF: a worldwide prospective registry of patients with atrial fibrillation at risk of stroke. Future Cardiol. 2021;17(1):19-38.
Reynolds MR, Essebag V, Zimetbaum P, Cohen DJ. Healthcare resource utilization and costs associated with recurrent episodes of atrial fibrillation: the FRACTAL registry. J Cardiovasc Electrophysiol. 2007;18(6):628-633.
aG-DRG-System. 2021;Cost according to DRG reimbursement 2021 + reimbursement for nursing care costs with the mean LOS of 3 days. Accessed January 27, 2022. https://www.g-drg.de/aG-DRG-System_2021
IQWiG. General Methods. 2020;https://www.iqwig.de/methoden/general-methods_version-6-0.pdf?rev=194070
STATBEL. Health index since 1994, by base year, last 13 months. 2021;https://statbel.fgov.be/en/themes/consumer-prices/health-index
Lamotte M, Gerlier L, Caekelbergh K, Lalji K, Polifka J, Lee E. Impact of pharmacological cardioversion with vernakalant on the management cost of recent atrial fibrillation in Belgium. Value Health. 2014;17:A323-A686.
(KCE) BHCKC. Catheter ablation of atrial fibrillation. 2012;https://kce.fgov.be/sites/default/files/atoms/files/KCE_184C_catheter_ablation_0.pdf
Kongnakorn T, Lanitis T, Annemans L, et al. Stroke and systemic embolism prevention in patients with atrial fibrillation in Belgium: comparative cost effectiveness of new oral anticoagulants and warfarin. Clin Drug Investig. 2015;35(2):109-119.
APR-DRG Tariffs 2021. Tariff 2021 for low variable care ( = all honoraria) + tariff 2021 ablation material + tariff 2021 3D mapping catheter + tariff 2021 average Belgian stay cost for 1 day (as per Financial feedback per pathology APR-DRG 175).
Sharma P, Scotland G, Cruickshank M, et al. The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation. Health Technol Assess. 2015;19(48):1-172.