Moss, Joe W. E.
Todd, Derick
Grodzicki, Lukasz
Palazzolo, Beatrice
Mattock, Richard
Mealing, Stuart
Souter, Maxim
Brown, Benedict
Bromilow, Tom
Lewis, Damian
McCready, James
Tayebjee, Muzahir
Shepherd, Ewen
Sasikaran, Thiagarajah
Coyle, Clare
Ismyrloglou, Eleni
Johnson, Nicholas A.
Kanagaratnam, Prapa
Article History
Accepted: 26 December 2023
First Online: 20 January 2024
Declarations
:
: Joe Moss, Lukasz Grodzicki, Beatrice Palazzolo, Richard Mattock, Stuart Mealing, Tom Bromilow, and Damian Lewis were employees of York Health Economics Consortium (YHEC) at the time of this study. YHEC received payment from Medtronic, manufacturer of the Arctic Front Advance Cryoballoon, to conduct the cost-effectiveness analyses and to write the manuscript. Derick Todd and Prapa Kanagaratnam have received personal speaking fees from Medtronic in the past. Maxim Souter, Benedict Brown and Eleni Ismyrloglou were employees of Medtronic at the time of this study. Benedict Brown and Eleni Ismyrloglou also declare holding stock and stock options in Medtronic. James McCready has received personal speaking and consulting fees from Medtronic in the past. Muzahir Tayebjee has previously received a research grant from Medtronic. Ewen Shepherd has previously received honoraria for lectures from Medtronic. Thiagarajah Sasikaran, Clare Coyle and Nicholas A. Johnson have no conflicts of interest to declare.
: Ethical approval was part of the original study but this was a post hoc analysis of data therefore no approval was required.
: Consent to participate was required as part of the original study but this was a post hoc analysis of data therefore no approval was required.
: Consent for publication was required as part of the original study but this was a post hoc analysis of data therefore no approval was required.
: Medtronic is the manufacturer of the Arctic Front Advance Cryoballoon. Medtronic provided payment to YHEC to conduct the cost-effectiveness analyses and to write the manuscript. The analyses conducted by YHEC were supervised by a Steering Committee made up of two representatives from the AVATAR-AF Steering Committee, two representatives from Imperial College, two representatives from Medtronic and two representatives from YHEC. The AVATAR clinical trial was funded by the British Heart Foundation and an unrestricted research grant from Medtronic Inc. This work was funded by Medtronic, who also provided the medical writing fees.
: JM, DT, LG, BP, RM, SM, TB, and DL were responsible for developing the underlying structure of the economic model. JM and BP were responsible for the statistical analysis. JM, DT, SM, MS, BB, CC, NJ, and PK were project steering group members. JM, DT, LG, BP, SM, MS, BB, DL, EI, NJ and PK wrote the main manuscript text. All authors reviewed the manuscript and provided comments, and read and approved the final manuscript.
: The data underlying this article will be shared upon reasonable request to the primary clinical investigator, Professor Prapa Kanagaratnam (p.kanagaratnam@imperial.ac.uk).
: The code used in this analysis can be made available upon reasonable request to the primary clinical investigator, Professor Prapa Kanagaratnam (p.kanagaratnam@imperial.ac.uk).