Representation of obesity in contemporary atrial fibrillation ablation randomized controlled trials.

atrial fibrillation body mass index catheter ablation obesity randomized controlled trial

Journal

Journal of cardiovascular electrophysiology

ISSN: 1540-8167

Titre abrégé: J Cardiovasc Electrophysiol

Pays: United States

ID NLM: 9010756

Informations de publication

Date de publication:
13 Aug 2024

Historique:

revised: 13 07 2024

received: 31 01 2024

accepted: 29 07 2024

medline: 13 8 2024

pubmed: 13 8 2024

entrez: 13 8 2024

Statut: aheadofprint

Résumé

The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied. To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available. We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information. Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes. Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.

Sections du résumé

BACKGROUND BACKGROUND

The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied.

OBJECTIVE OBJECTIVE

To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available.

METHODS METHODS

We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information.

RESULTS RESULTS

Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes.

CONCLUSION CONCLUSIONS

Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.

Identifiants

DOI: 10.1111/jce.16396 PMID: 39136311

pubmed: 39136311

doi: 10.1111/jce.16396

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Informations de copyright

Références

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):1142‐1147.

Middeldorp ME, Kamsani SH, Sanders P. Obesity and atrial fibrillation: prevalence, pathogenesis, and prognosis. Prog Cardiovasc Dis. 2023;78:34‐42.

Xu H, Cupples LA, Stokes A, Liu CT. Association of obesity with mortality over 24 years of weight history: findings from the Framingham Heart Study. JAMA Netw Open. 2018;1(7):e184587.

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.

Providencia R, Adragão P, deAsmundis C, et al. Impact of body mass index on the outcomes of catheter ablation of atrial fibrillation: a European Observational Multicenter study. J Am Heart Assoc. 2019;8(20):e012253.

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.

Ward ZJ, Bleich SN, Cradock AL, et al. Projected U.S. state‐level prevalence of adult obesity and severe obesity. N Engl J Med. 2019;381(25):2440‐2450.

Foy AJ, Mandrola J, Liu G, Naccarelli GV. Relation of obesity to new‐onset atrial fibrillation and atrial flutter in adults. Am J Cardiol. 2018;121(9):1072‐1075.

D'Souza S, Elshazly MB, Dargham SR, et al. Atrial fibrillation catheter ablation complications in obese and diabetic patients: insights from the US nationwide inpatient sample 2005‐2013. Clin Cardiol. 2021;44(8):1151‐1160.

Liu M, Mei K, Liu X, Zhao Y. Impact of body mass index on procedural complications, procedure duration, and radiation dose in patients with atrial fibrillation undergoing radiofrequency ablation: a systematic review and meta‐analysis. Clin Cardiol. 2020;43(10):1067‐1075.

Blockhaus C, Waibler HP, Gülker JE, et al. Influence of excess weight and obesity on performance and outcome of pulmonary vein isolation with the cryoballoon. Rev Cardiovasc Med. 2021;22(3):1047‐1052.

Pranata R, Henrina J, Yonas E, et al. BMI and atrial fibrillation recurrence post catheter ablation: a dose‐response meta‐analysis. Eur J Clin Invest. 2021;51(6):e13499.

Winkle RA, Mead RH, Engel G, et al. Impact of obesity on atrial fibrillation ablation: patient characteristics, long‐term outcomes, and complications. Heart Rhythm. 2017;14(6):819‐827.

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.

Chung MK, Eckhardt LL, Chen LY, et al. Lifestyle and risk factor modification for reduction of atrial fibrillation: a scientific statement from the American Heart Association. Circulation. 2020;141(16):e750‐e772.

Lavie CJ, Pandey A, Lau DH, Alpert MA, Sanders P. Obesity and atrial fibrillation prevalence, pathogenesis, and prognosis. J Am Coll Cardiol. 2017;70(16):2022‐2035.

Pathak RK, Middeldorp ME, Meredith M, et al. Long‐term effect of goal‐directed weight management in an atrial fibrillation cohort. J Am Coll Cardiol. 2015;65(20):2159‐2169.

Hess PL, Kim S, Piccini JP, et al. Use of evidence‐based cardiac prevention therapy among outpatients with atrial fibrillation. Am J Med. 2013;126(7):625‐632.e1.

Stout K, Almerstani M, Adomako R, et al. Prevalence and impact of poorly controlled modifiable risk factors among patients who underwent atrial fibrillation ablation. Am J Cardiol. 2023;198:38‐46.

Pestine E, Stokes A, Trinquart L. Representation of obese participants in obesity‐related cancer randomized trials. Ann Oncol. 2018;29(7):1582‐1587.

Campbell J, Sutherland J, Bucknall D, et al. Equity in vaccine trials for higher weight people? A rapid review of weight‐related inclusion and exclusion criteria for COVID‐19 clinical trials. Vaccines. 2021;9(12):1466.

Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14:135.

Sørensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation: durability of pulmonary vein isolation and effect on atrial fibrillation burden: the RACE‐AF randomized controlled trial. Circ Arrhythm Electrophysiol. 2021;14(5):e009573.

Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon ablation as initial therapy for atrial fibrillation. N Engl J Med. 2021;384(4):316‐324.

Bisbal F, Benito E, Teis A, et al. Magnetic resonance imaging‐guided fibrosis ablation for the treatment of atrial fibrillation: the ALICIA trial. Circ Arrhythm Electrophysiol. 2020;13(11):e008707.

Verma A, Jiang C, Betts TR, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015;372(19):1812‐1822.

Scherr D, Derval N, Sohal M, et al. Length of the mitral isthmus but not anatomical location of ablation line predicts bidirectional mitral isthmus block in patients undergoing catheter ablation of persistent atrial fibrillation: a randomized controlled trial. J Cardiovasc Electrophysiol. 2015;26(6):629‐634.

Prabhu S, Mackin V, McLellan AJA, et al. Determining the optimal dose of adenosine for unmasking dormant pulmonary vein conduction following atrial fibrillation ablation: electrophysiological and hemodynamic assessment. DORMANT‐AF study. J Cardiovasc Electrophysiol. 2017;28(1):13‐22.

Kirchhof P, Camm AJ, Goette A, et al. Early rhythm‐control therapy in patients with atrial fibrillation. N Engl J Med. 2020;383(14):1305‐1316.

Huang X, Chen Y, Huang Y, et al. Clinical efficacy of irrigated catheter application of amiodarone during ablation of persistent atrial fibrillation. Clin Cardiol. 2017;40(12):1333‐1338.

Kim TH, Uhm JS, Kim JY, et al. Does additional electrogram‐guided ablation after linear ablation reduce recurrence after catheter ablation for longstanding persistent atrial fibrillation? A prospective randomized study. J Am Heart Assoc. 2017;6(2).

Yang B, Jiang C, Lin Y, et al. STABLE‐SR (electrophysiological substrate ablation in the left atrium during sinus rhythm) for the treatment of nonparoxysmal atrial fibrillation: A prospective, multicenter randomized clinical trial. Circ Arrhythm Electrophysiol. 2017;10(11).

Blomstrom‐Lundqvist C, Gizurarson S, Schwieler J, et al. Effect of catheter ablation vs antiarrhythmic medication on quality of life in patients with atrial fibrillation: the CAPTAF randomized clinical trial. JAMA. 2019;321(11):1059‐1068.

Packer DL, Mark DB, Robb RA, et al. Effect of catheter ablation vs antiarrhythmic drug therapy on mortality, stroke, bleeding, and cardiac arrest among patients with atrial fibrillation: the CABANA randomized clinical trial. JAMA. 2019;321(13):1261‐1274. doi:10.1001/jama.2019.0693

Masuda M, Asai M, Iida O, et al. Additional low‐voltage‐area ablation in patients with paroxysmal atrial fibrillation: results of the randomized controlled VOLCANO trial. J Am Heart Assoc. 2020;9(13):e015927.

Yamaji H, Higashiya S, Murakami T, et al. Efficacy of an adjunctive electrophysiological test‐guided left atrial posterior wall isolation in persistent atrial fibrillation without a left atrial low‐voltage area. Circ Arrhythm Electrophysiol. 2020;13(8):e008191.

Andrade JG, Wells GA, Deyell MW, et al. Cryoablation or drug therapy for initial treatment of atrial fibrillation. N Engl J Med. 2021;384(4):305‐315.

Park J, et al. Risks and benefits of early rhythm control in patients with acute strokes and atrial fibrillation: a multicenter, prospective, randomized study (the RAFAS trial). J Am Heart Assoc. 2022;11(3):e023391.

James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001;9(suppl 4):228S‐233S.

Dinsa GD, Goryakin Y, Fumagalli E, Suhrcke M. Obesity and socioeconomic status in developing countries: a systematic review. Obes Rev. 2012;13(11):1067‐1079.

Pathak RK, Middeldorp ME, Lau DH, et al. Aggressive risk factor reduction study for atrial fibrillation and implications for the outcome of ablation. J Am Coll Cardiol. 2014;64(21):2222‐2231.

Elliott AD, Verdicchio CV, Mahajan R, et al. An exercise and physical activity program in patients with atrial fibrillation. JACC Clin Electrophysiol. 2023;9(4):455‐465.

Mohanty S, Mohanty P, Di Biase L, et al. Long‐term outcome of catheter ablation in atrial fibrillation patients with coexistent metabolic syndrome and obstructive sleep apnea: impact of repeat procedures versus lifestyle changes. J Cardiovasc Electrophysiol. 2014;25(9):930‐938.

Pi‐Sunyer X. The medical risks of obesity. Postgrad Med. 2009;121(6):21‐33.

World Health Organization. Regional Office for the Western Pacific. The Asia‐Pacific Perspective: Redefining Obesity and Its Treatment. Health Communications Australia; 2000.

WHO Expert Consultation. Appropriate body‐mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004;363(9403):157‐163.