Cardiac Prehabilitation, Rehabilitation and Education in First-time Atrial Fibrillation (AF) Ablation (CREED AF): Study Protocol for a Randomised Controlled Trial

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2024 Oct 3

PMID 39361572

Authors

Nakul Chandan

Violet Matthews

Hejie He

Thomas Lachlan

Ven Gee Lim

Shivam Joshi

Siew Wan Hee

Angela Noufaily

Edward Parkes

Shilpa Patel

Lazaros Andronis

Joanna Shakespeare

Helen Eftekhari

Asad Ali

Gordon McGregor

Faizel Osman

Affiliations

Soon will be listed here.

Abstract

Background: Atrial fibrillation (AF) is associated with significant morbidity/mortality. AF-ablation is an increasingly used treatment. Currently, first-time AF-ablation success is 40-80% at 1-year, depending on individual factors. There is growing evidence for improved outcomes through management of AF risk-factors/comorbidities via patient education/exercise-rehabilitation. There are no studies assessing combined prehabilitation/rehabilitation in this cohort. The aim of this randomised controlled trial is to assess efficacy of comprehensive prehabilitation/rehabilitation and combining supervised exercise-training with AF risk-factor modification/education compared with standard care in people undergoing first-time AF ablation.

Methods: This single-centre pragmatic randomised controlled trial will recruit 106 adults with paroxysmal/persistent AF listed for first-time AF-ablation. Participants will be randomised 1:1 to cardiac prehabilitation/rehabilitation/education (CREED AF) intervention or standard care. Both groups will undergo AF-ablation at 8-weeks post-randomisation as per usual care. The CREED AF intervention will involve 6-weeks of prehabilitation (before AF-ablation) followed by 6-weeks rehabilitation (after AF-ablation) consisting of risk factor education/modification and supervised exercise training. Standard care will include a single 30-minute session of risk-factor education. Outcomes will be measured at baseline, 10-weeks and 12-months post AF-ablation, by researchers blinded to treatment allocation. The primary outcome is cardiorespiratory-fitness (peak oxygen uptake, VO2peak) assessed using cardiopulmonary exercise testing (CPET) at 10-weeks post-ablation. Secondary outcomes include health-related quality of life, AF recurrence/burden assessed by 7-day Holter-monitor, requirement for repeat AF-ablation, study defined major adverse cardiovascular events, and cost-effectiveness (incremental cost per quality-adjusted life year (QALY)).

Conclusions: This study will assess clinical-efficacy/cost-effectiveness of comprehensive prehabilitation/rehabilitation/patient-education for people undergoing first time AF-ablation. Results will inform clinical care and design of future multi-centre clinical trials.

Trial Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.

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References

Benjamin E, Wolf P, DAgostino R, Silbershatz H, Kannel W, Levy D . Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998; 98(10):946-52. DOI: 10.1161/01.cir.98.10.946. View

Billingham L, Abrams K, Jones D . Methods for the analysis of quality-of-life and survival data in health technology assessment. Health Technol Assess. 2000; 3(10):1-152. View

Nieuwlaat R, Capucci A, Camm A, Bertil Olsson S, Andresen D, Davies D . Atrial fibrillation management: a prospective survey in ESC member countries: the Euro Heart Survey on Atrial Fibrillation. Eur Heart J. 2005; 26(22):2422-34. DOI: 10.1093/eurheartj/ehi505. View

Kato M, Ogano M, Mori Y, Kochi K, Morimoto D, Kito K . Exercise-based cardiac rehabilitation for patients with catheter ablation for persistent atrial fibrillation: A randomized controlled clinical trial. Eur J Prev Cardiol. 2019; 26(18):1931-1940. DOI: 10.1177/2047487319859974. View

Giles C, Cummins S . Prehabilitation before cancer treatment. BMJ. 2019; 366:l5120. DOI: 10.1136/bmj.l5120. View

Colilla S, Crow A, Petkun W, Singer D, Simon T, Liu X . Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013; 112(8):1142-7. DOI: 10.1016/j.amjcard.2013.05.063. View

Chugh S, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin E . Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2013; 129(8):837-47. PMC: 4151302. DOI: 10.1161/CIRCULATIONAHA.113.005119. View

Liu M, Lee J, Klooster L, Buckner Petty S, Scott L . Influence of endurance sports on atrial fibrillation ablation outcomes. J Arrhythm. 2022; 38(5):694-709. PMC: 9535795. DOI: 10.1002/joa3.12746. View

Rush K, Burton L, Schaab K, Lukey A . The impact of nurse-led atrial fibrillation clinics on patient and healthcare outcomes: a systematic mixed studies review. Eur J Cardiovasc Nurs. 2019; 18(7):526-533. DOI: 10.1177/1474515119845198. View

10.

Pritchard A, Burns P, Correia J, Jamieson P, Moxon P, Purvis J . ARTP statement on cardiopulmonary exercise testing 2021. BMJ Open Respir Res. 2021; 8(1). PMC: 8593741. DOI: 10.1136/bmjresp-2021-001121. View

11.

Brandes A, Smit M, Nguyen B, Rienstra M, Van Gelder I . Risk Factor Management in Atrial Fibrillation. Arrhythm Electrophysiol Rev. 2018; 7(2):118-127. PMC: 6020195. DOI: 10.15420/aer.2018.18.2. View

12.

Fiala M, Bulkova V, Sknouril L, Nevralova R, Toman O, Januska J . Functional improvement after successful catheter ablation for long-standing persistent atrial fibrillation. Europace. 2016; 19(11):1781-1789. DOI: 10.1093/europace/euw282. View

13.

Bjorck S, Palaszewski B, Friberg L, Bergfeldt L . Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013; 44(11):3103-8. DOI: 10.1161/STROKEAHA.113.002329. View

14.

Risom S, Zwisler A, Sibilitz K, Rasmussen T, Taylor R, Thygesen L . Cardiac Rehabilitation for Patients Treated for Atrial Fibrillation With Ablation Has Long-Term Effects: 12-and 24-Month Follow-up Results From the Randomized CopenHeart Trial. Arch Phys Med Rehabil. 2020; 101(11):1877-1886. DOI: 10.1016/j.apmr.2020.06.026. View

15.

McGregor G, Powell R, Kimani P, Underwood M . Does contemporary exercise-based cardiac rehabilitation improve quality of life for people with coronary artery disease? A systematic review and meta-analysis. BMJ Open. 2020; 10(6):e036089. PMC: 7282413. DOI: 10.1136/bmjopen-2019-036089. View

16.

Krahn A, Manfreda J, Tate R, Mathewson F, Cuddy T . The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995; 98(5):476-84. DOI: 10.1016/S0002-9343(99)80348-9. View

17.

Stolk E, Ludwig K, Rand K, van Hout B, Ramos-Goni J . Overview, Update, and Lessons Learned From the International EQ-5D-5L Valuation Work: Version 2 of the EQ-5D-5L Valuation Protocol. Value Health. 2019; 22(1):23-30. DOI: 10.1016/j.jval.2018.05.010. View

18.

Chao T, Liu C, Chen S, Wang K, Lin Y, Chang S . CHADS2 score and risk of new-onset atrial fibrillation: a nationwide cohort study in Taiwan. Int J Cardiol. 2013; 168(2):1360-3. DOI: 10.1016/j.ijcard.2012.12.011. View

19.

Anderson L, Oldridge N, Thompson D, Zwisler A, Rees K, Martin N . Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016; 67(1):1-12. DOI: 10.1016/j.jacc.2015.10.044. View

20.

Hughes M, Hackney R, Lamb P, Wigmore S, Deans D, Skipworth R . Prehabilitation Before Major Abdominal Surgery: A Systematic Review and Meta-analysis. World J Surg. 2019; 43(7):1661-1668. DOI: 10.1007/s00268-019-04950-y. View