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Comparative Study
. 2024 Nov 26;24(1):1474.
doi: 10.1186/s12913-024-11967-0.

An economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation from a German healthcare payer perspective

Malte Kuniss  1 , Lucy Hillcoat  2 , Joe Moss  2 , Florian Straube  3 , Jason Andrade  4 , Oussama Wazni  5 , Gian Battista Chierchia  6 , Lukas Schwegmann  7 , Eleni Ismyrloglou  8 , Alicia Sale  9 , Stuart Mealing  2 , Tom Bromilow  2 , Emily Lane  2 , Damian Lewis  2 , Andreas Goette  10
Affiliations
Comparative Study

An economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation from a German healthcare payer perspective

Malte Kuniss et al. BMC Health Serv Res. .

Abstract

Background: Three recent randomized controlled trials demonstrated that, in patients with symptomatic paroxysmal atrial fibrillation (PAF), first-line pulmonary vein isolation with cryoballoon catheter ablation reduces atrial arrhythmia recurrence compared to initial antiarrhythmic drug (AAD) therapy. This study aimed to evaluate the cost-effectiveness of first-line cryoablation compared to first-line AADs from a German healthcare payer perspective.

Methods: Individual patient-level data from 703 participants with untreated PAF enrolled into three randomized clinical trials (Cryo-FIRST, STOP AF First and EARLY-AF) were used to derive parameters for the cost-effectiveness model (CEM). The CEM structure consisted of a hybrid decision tree and Markov model. The decision tree (one-year time horizon) informed initial health state allocation in the first cycle of the Markov model (40-year time horizon; three-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Cost inputs were sourced from German diagnosis-related groups and the Institute for the Hospital Remuneration System (InEK). Costs and benefits were discounted at 3% per annum.

Results: Cryoablation was cost-effective, incurring ~ €200 per patient while offering an increase in QALYs (~ 0.18) over a lifetime. This produced an average incremental cost-effectiveness ratio of ~ €1,000 per QALY gained. Individuals were expected to receive ~ 1.2 ablations over a lifetime, regardless of initial treatment. However, those initially treated with cryoablation as opposed to AADs experience 0.9 fewer re-ablations and a 45% reduction in time spent in AF health states.

Conclusion: Initial rhythm control with cryoballoon ablation in symptomatic PAF is a cost-effective treatment option in a German healthcare setting.

Keywords: Ablation; Antiarrhythmic drug; Cost-effectiveness; Cryoablation; Paroxysmal atrial fibrillation.

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Conflict of interest statement

Ethics approval and consent to participate: Studies were approved by the below ethics committees (EE) or institutional review boards (IRB): CRYO-FIRST Country Site Site EE/IRB France Paris Grenoble Amiens Tours Rouen CPP Nord-Ouest IV, Lille, France Germany Bad Nauheim Kaiserslautern Frankfurt Ethik-Kommission bei der Landesarztekammer Hessen, Im Vogelsang 3, 60488 Frankfurt am Main, Germany Germany Hamburg Ethik-Kommission der Arztekammer, Hamburg, Germany Germany Munich Ethik-Kommission, Munchen, Germany Italy Massa Carrara Comitato Etico per la Sperimentazione Clinica dei medicinali dell'azienda, USL 1 di Massa e Carrara - Massa Italy Italy Cotignola CEIIAV Comitato Etico IRST IRCCS AVR Norway Bergen REK vest, Bergen, Norway Belgium Brussel Commissie Medische Ethiek, Brussels, Belgium Argentina Buenos Aires Comité de Etica en Investigacion Instituto Cardiovascular Buenos Aires Australia Clayton Human Research Ethics Committee - Monash Health Netherlands Eindhoven Local EC Catharina - Eindhoven NL Netherlands Rotterdam METC Erasmus, Rotterdam - NL Croatia Zagreb (Dr. Pavlovic) Zagreb (Dr. Velagic) Agencija za lijekove i medicinske proizvode; SREDISNJE ETICKO PROVJERENSTVO; Ksaverska cesta 4; 10 000 Zagreb STOP-AF FIRST Site Name IRB Alaska Heart Institute Western Institutional Review Board Aurora Cardiovascular Services Western Institutional Review Board BayCare Medical Group Cardiology Advarra Institutional Review Board Bryan Heart Western Institutional Review Board Cleveland Clinic Cleveland Clinic IRB Geisinger Medical Center Geisinger IRB EARLY-AF The IRB approval was obtained from each of the participating sites: University of British Columbia, Royal Jubilee Hospital, University of Alberta, University of Saskatchewan, University of Manitoba, University of Western Ontario, McMaster University, University of Ottawa, Montreal Heart Institute, Université de Montreal, Sherbrooke University, Université de Laval, Dalhousie University, Rouge Valley Hospital, University of Toronto, Southlake Hospital. All studies were carried out in accordance with relevant guidelines and regulations, more specifically, STOP AF FIRST: • Principles of Declaration of Helsinki (including privacy and data protection laws), or the laws and regulations of each participating country, whichever affords greater protection for the study subjects. • 21 CFR Part 11 (Electronic Records, Electronic Signatures) • 21 CFR Part 54 (Financial Disclosure by Clinical Investigators) CRYO-FIRST: • Declaration of Helsinki, • The international standard ISO 14155: 2011 EARLY-AF • Principles of Good Clinical Practice and the Declaration of Helsinki Informed consent was obtained from all study participants. Consent for publication: Not applicable. Competing interests: MK reports honoraria for teaching, participation in clinical trials, proctoring and lectures/presentations from Medtronic. LH, JM, SM, TB, EL, DL report being employees of a consultancy company and to have undertaken the work in this manuscript as part of a wider consulting agreement. FS reports received honoraria for lectures from Medtronic, Boston Scientific, Philips, Bristol-Myers-Squibb, and Astra Zeneca outside the submitted work. JA reports grants and personal fees from Medtronic, grants from Baylis, personal fees from Biosense-Webster. OW reports grants from Medtronic and personal fees from Biosense Webster and Boston Scientific. GBC reports compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. LS, EI, AS report being employees and stockholders of Medtronic. AG reports EU Grant Horizon 2020 MAESTRIA Consortium; grant number 965286. Speaker fees from Abbott, Astra Zeneca, Bayer Health Care, Berlin Chemie, Biotronik, Boehringer Ingelheim, BMS/Pfizer, Boston Scientific, Daiichi-Sankyo, Medtronic, Omeicos, and Sanofi-Aventis.

Figures

Fig. 1
Fig. 1
Schematic of the economic model: a Decision tree used to model the first 12 months of the economic evaluation, where the endpoints constitute initial Markov model health state allocation b Markov model used to model the remaining lifetime in the economic evaluation. NSR, ST episodic and LT persistent AF states are broken down into four subhealth states, from zero to three, indicating the number of re-ablations received (either one initial and two repeat ablations in the cryoablation arm or three repeat ablations in the AAD arm. The maximum number of possible total ablations in both arms was set to three). Death is permitted from all other health states. AF – Atrial Fibrillation, AADs – Antiarrhythmic Drugs, ST – Short term, NSR – Normal Sinus Rhythm, LT– Long Term
Fig. 2
Fig. 2
Probabilistic sensitivity analysis (PSA) graphical outputs: a Cost-effectiveness plane – Most iterations fell into the North-East quadrant below the €35,000 WTP threshold per QALY gained, signifying cryoablation is more effective and costlier than AADs, b Cost-acceptability curve – Illustrating the impact of uncertainty on results. The blue line indicates that cryoablation has 98.0% likelihood of being cost-effective at the WTP threshold
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