INTRODUCTION: Obesity and atrial fibrillation (AF) pose a significant burden on healthcare systems worldwide. Reduction of body weight has been documented to reduce the risk of AF. Little is known about the effect of different weight-reducing interventions including bariatric surgery in obese individuals on the risk of arrhythmia recurrence following catheter ablation (CA) for AF, and about the pathophysiological mechanisms linking these two conditions. METHODS: The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF. One hundred and sixty individuals (age 18-70 years, body mass index ≥ 30 kg/m2) will be randomised in a 1:1 fashion to undergo a structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group). Two-week continuous ECG monitoring will be used 3 and 18 months after CA to assess the arrhythmia burden. Other investigations will include transthoracic echocardiography with quantification of epicardial adipose tissue, and markers of low-grade inflammation and circulating adipokines. PLANNED OUTCOMES: The main objective is to assess the effect of complex weight-reducing interventions on the arrhythmia burden and quality of life. Subgroup analyses to identify patient subgroups preferentially benefiting from weight loss related to a decrease in arrhythmia burden will be performed. Exploratory objectives will include investigation of potential mechanisms linking weight reduction with amelioration of arrhythmia burden such as changes in markers of low-grade inflammation, circulating adipokines, cytokines, monocytes or reduction of epicardial adipose tissue volume. TRIAL REGISTRATION: NCT04560387.

1st Faculty of Medicine Charles University Prague Czech Republic

3rd Faculty of Medicine Charles University Prague Czech Republic

Centre for Experimental Medicine IKEM Prague Czech Republic

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of Oncology and Metabolism University of Sheffield Sheffield UK

Diabetes Centre Institute for Clinical and Experimental Medicine Vídeňská 1958 140 21 Prague 4 Czech Republic

Zobrazit více v PubMed

Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019;15(5):288–298. doi: 10.1038/s41574-019-0176-8. PubMed DOI

WHO. Obesity and overweight. 2016. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Accessed 25 Oct 2020.

Morin DP, Bernard ML, Madias C, Rogers PA, Thihalolipavan S, Estes NA., 3rd The state of the art: atrial fibrillation epidemiology, prevention, and treatment. Mayo Clin Proc. 2016;91(12):1778–1810. doi: 10.1016/j.mayocp.2016.08.022. PubMed DOI

Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014;129(8):837–847. doi: 10.1161/CIRCULATIONAHA.113.005119. PubMed DOI PMC

Colilla S, Crow A, Petkun W, Singer DE, 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. PubMed

Withrow D, Alter DA. The economic burden of obesity worldwide: a systematic review of the direct costs of obesity. Obes Rev. 2011;12(2):131–141. doi: 10.1111/j.1467-789X.2009.00712.x. PubMed DOI

Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum P. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value Health. 2006;9(5):348–356. doi: 10.1111/j.1524-4733.2006.00124.x. PubMed DOI

Huxley RR, Lopez FL, Folsom AR, et al. Absolute and attributable risks of atrial fibrillation in relation to optimal and borderline risk factors: the Atherosclerosis Risk in Communities (ARIC) study. Circulation. 2011;123(14):1501–1508. doi: 10.1161/CIRCULATIONAHA.110.009035. PubMed DOI PMC

Wong CX, Sullivan T, Sun MT, et al. Obesity and the risk of incident, post-operative, and post-ablation atrial fibrillation: a meta-analysis of 626,603 individuals in 51 studies. JACC Clin Electrophysiol. 2015;1(3):139–152. doi: 10.1016/j.jacep.2015.04.004. PubMed DOI

Guijian L, Jinchuan Y, Rongzeng D, Jun Q, Jun W, Wenqing Z. Impact of body mass index on atrial fibrillation recurrence: a meta-analysis of observational studies. Pacing Clin Electrophysiol. 2013;36(6):748–756. doi: 10.1111/pace.12106. PubMed DOI

Jamaly S, Carlsson L, Peltonen M, Jacobson P, Sjostrom L, Karason K. Bariatric surgery and the risk of new-onset atrial fibrillation in Swedish Obese Subjects. J Am Coll Cardiol. 2016;68(23):2497–2504. doi: 10.1016/j.jacc.2016.09.940. PubMed DOI PMC

Abed HS, Wittert GA, Leong DP, et al. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013;310(19):2050–2060. doi: 10.1001/jama.2013.280521. PubMed DOI

Pathak RK, Middeldorp ME, Meredith M, et al. Long-term effect of goal-directed weight management in an atrial fibrillation cohort: a long-term follow-up study (LEGACY) J Am Coll Cardiol. 2015;65(20):2159–2169. doi: 10.1016/j.jacc.2015.03.002. PubMed DOI

Pathak RK, Mahajan R, Lau DH, Sanders P. The implications of obesity for cardiac arrhythmia mechanisms and management. Can J Cardiol. 2015;31(2):203–210. doi: 10.1016/j.cjca.2014.10.027. PubMed DOI

Scridon A, Dobreanu D, Chevalier P, Serban RC. Inflammation, a link between obesity and atrial fibrillation. Inflamm Res. 2015;64(6):383–393. doi: 10.1007/s00011-015-0827-8. PubMed DOI

Issac TT, Dokainish H, Lakkis NM. Role of inflammation in initiation and perpetuation of atrial fibrillation: a systematic review of the published data. J Am Coll Cardiol. 2007;50(21):2021–2028. doi: 10.1016/j.jacc.2007.06.054. PubMed DOI

Ziccardi P, Nappo F, Giugliano G, et al. Reduction of inflammatory cytokine concentrations and improvement of endothelial functions in obese women after weight loss over one year. Circulation. 2002;105(7):804–809. doi: 10.1161/hc0702.104279. PubMed DOI

Nakamura K, Fuster JJ, Walsh K. Adipokines: a link between obesity and cardiovascular disease. J Cardiol. 2014;63(4):250–259. doi: 10.1016/j.jjcc.2013.11.006. PubMed DOI PMC

Cinkajzlova A, Mraz M, Haluzik M. Lymphocytes and macrophages in adipose tissue in obesity: markers or makers of subclinical inflammation? Protoplasma. 2017;254(3):1219–1232. doi: 10.1007/s00709-017-1082-3. PubMed DOI

Trachta P, Dostalova I, Haluzikova D, et al. Laparoscopic sleeve gastrectomy ameliorates mRNA expression of inflammation-related genes in subcutaneous adipose tissue but not in peripheral monocytes of obese patients. Mol Cell Endocrinol. 2014;383(1–2):96–102. doi: 10.1016/j.mce.2013.11.013. PubMed DOI

Chung MK, Martin DO, Sprecher D, et al. C-reactive protein elevation in patients with atrial arrhythmias: inflammatory mechanisms and persistence of atrial fibrillation. Circulation. 2001;104(24):2886–2891. doi: 10.1161/hc4901.101760. PubMed DOI

Gedikli O, Dogan A, Altuntas I, et al. Inflammatory markers according to types of atrial fibrillation. Int J Cardiol. 2007;120(2):193–197. doi: 10.1016/j.ijcard.2006.09.015. PubMed DOI

Cinar T, Tanik VO, Gurkan K. Comparison of apolipoprotein-A1 levels between paroxysmal atrial fibrillation patients and healthy subjects. J Cardiovasc Thorac Res. 2020;12(2):140–144. doi: 10.34172/jcvtr.2020.23. PubMed DOI PMC

Mraz M, Cinkajzlova A, Klouckova J, et al. Coronary artery disease is associated with an increased amount of T lymphocytes in human epicardial adipose tissue. Mediators Inflamm. 2019;2019:4075086. PubMed PMC

Al Chekakie MO, Welles CC, Metoyer R, et al. Pericardial fat is independently associated with human atrial fibrillation. J Am Coll Cardiol. 2010;56(10):784–788. doi: 10.1016/j.jacc.2010.03.071. PubMed DOI

Thanassoulis G, Massaro JM, O'Donnell CJ, et al. Pericardial fat is associated with prevalent atrial fibrillation: the Framingham Heart Study. Circ Arrhythm Electrophysiol. 2010;3(4):345–350. doi: 10.1161/CIRCEP.109.912055. PubMed DOI PMC

Batal O, Schoenhagen P, Shao M, et al. Left atrial epicardial adiposity and atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3(3):230–236. doi: 10.1161/CIRCEP.110.957241. PubMed DOI PMC

Arbelo E, Brugada J, Hindricks G, et al. ESC-EURObservational Research Programme: the Atrial Fibrillation Ablation Pilot Study, conducted by the European Heart Rhythm Association. Europace. 2012;14(8):1094–1103. doi: 10.1093/europace/eus153. PubMed DOI

Pathak RK, Middeldorp ME, Lau DH, et al. Aggressive risk factor reduction study for atrial fibrillation and implications for the outcome of ablation: the ARREST-AF cohort study. J Am Coll Cardiol. 2014;64(21):2222–2231. doi: 10.1016/j.jacc.2014.09.028. PubMed DOI

Chen LY, Chung MK, Allen LA, et al. Atrial fibrillation burden: moving beyond atrial fibrillation as a binary entity: a scientific statement from the American Heart Association. Circulation. 2018;137(20):e623–e644. doi: 10.1161/CIR.0000000000000568. PubMed DOI PMC

Dorian P, Guerra PG, Kerr CR, et al. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophysiol. 2009;2(3):218–224. doi: 10.1161/CIRCEP.108.812347. PubMed DOI

Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;42(5):373–498. PubMed

Cummings DE, Rubino F. Metabolic surgery for the treatment of type 2 diabetes in obese individuals. Diabetologia. 2018;61(2):257–264. doi: 10.1007/s00125-017-4513-y. PubMed DOI PMC

The effect of obesity, hypertension, diabetes mellitus, alcohol, and sleep apnea on the risk of atrial fibrillation

Zobrazit více v PubMed

ClinicalTrials.gov
NCT04560387