Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker (Paradox)

Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker : a Korean Nationwide Cohort Study

In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients who underwent pacemaker insertion, using a nationwide population based cohort.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Arrhythmias, Cardiac; Cardiovascular Morbidity; Pacemaker Complication
• Intervention / Treatment: Device: Pacemaker insertion

Detailed Description

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020.

The investigators included patients who underwent pacemaker insertion between January 2015 and December 2020. Patients aged <20 years, those who were already taken pacemaker insertion before 2015, and those with cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of device procedure) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.

Patients' demographic data, comorbidities, concomitant medications, and income level were collected from the Korean NHIS database. The recent health check-up data from the index date was also ascertained, including height, weight, waist circumference, blood pressure, health surveys, and laboratory exam. Health survey included family history, smoking history, alcohol history, and the level of individual physical activity.

According to BMI following the World Health Organization recommendation for Asian population, study patients were categorized into 5 groups: underweight, <18.5 kg/m2; normal range, 18.5 to <23 kg/m2; overweight, 23 to <25 kg/m2; obese I, 25 to <30 kg/m2; and obese II, ≥30 kg/m2[4]. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.

During the follow-up period, the investigators assessed 3 clinical outcomes, including all-cause death, cardiovascular hospitalization and the recurrence rate. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes or the end of the study period (December 31, 2020), whichever came first.

All categorical variables are presented as frequencies and percentages. Normally distributed data were presented as mean ± standard deviation, whereas nonparametric data are presented as median and interquartile range by BMI.

Cox proportional hazard regression analyses were performed to identify the association of BMI with the primary and secondary outcomes, calculating hazard ratio (HR) and 95% confidence interval (CI) and adjusting for the following potential confounders: sex, age, systolic blood pressure, fasting glucose level, total cholesterol level, alcohol consumption, smoking status, physical activity, household income, use of antihypertensive agents, use of statins, use of antiplatelet agents, previous history of MI, previous history of stroke, and index year. All analyses were conducted using R-statistics.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Kwang-No LEE; Phone Number: +82-9286-1123; Email: knlee81@ajou.ac.kr
• Study Contact Backup: Name: Moon-Seung SOH; Phone Number: +82-10-5386-7701; Email: mssoh7701@gmail.com

Study Locations

• Korea, Republic of
  • Gyeong-gido
    • Suwon, Gyeong-gido, Korea, Republic of, 16499
      • Recruiting
      • Ajou University School of Medicine
      • Principal Investigator: Kwang-No LEE
      • Sub-Investigator: Moon-Seung SOH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We included patients who underwent pacemaker insertion between January 2015 and December 2020. Patients aged <20 years, those who were already taken pacemaker insertion before 2015, and those with cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of device procedure) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.

Description

Inclusion Criteria:

• Patients who underwent pacemaker insertion between January 2015 and December 2020

Exclusion Criteria:

• Patients aged <20 years
• Patients already taken pacemaker insertion before 2015
• Patients with cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who underwent pacemaker insertion during study period; Patients who underwent pacemaker insertion between January 2015 and December 2020	Device: Pacemaker insertion; Patients who underwent pacemaker insertion between January 2015 and December 2020; Other Names: Insertion of pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Outcomes	Death + CV hospitalization + Fatal arrest event + Infective endocarditis	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Mortality	5 years
CV hospitalization	Admission caused by Cardiovacular disease	5 years
Fatal arrest event	Event of cardiac arrest by ventricular tachycardia and fibrillation	5 years
Infective endocarditis	Diagnosed with infective endocarditis	5 years

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Study Chair: Kwang-No LEE, Ajou University School of Medicine

Publications and helpful links

General Publications

• Kim MS, Kim WJ, Khera AV, Kim JY, Yon DK, Lee SW, Shin JI, Won HH. Association between adiposity and cardiovascular outcomes: an umbrella review and meta-analysis of observational and Mendelian randomization studies. Eur Heart J. 2021 Sep 7;42(34):3388-3403. doi: 10.1093/eurheartj/ehab454.
• Prasitlumkum N, Chokesuwattanaskul R, Kaewput W, Thongprayoon C, Bathini T, Boonpheng B, Vallabhajosyula S, Cheungpasitporn W, Jongnarangsin K. Utilization and in-hospital complications of catheter ablation for atrial fibrillation in patients with obesity and morbid obesity. Clin Cardiol. 2022 Apr;45(4):407-416. doi: 10.1002/clc.23795. Epub 2022 Feb 16.
• Seo J, Li W, Safiriyu I, Kharawala A, Nagraj S, Tahir A, Doundoulakis I, Koliastasis L, Rios S, Palaiodimos L, Kokkinidis DG. A Meta-Analysis on the Impact of High BMI in Patients Undergoing Transcatheter Aortic Valve Replacement. J Cardiovasc Dev Dis. 2022 Nov 9;9(11):386. doi: 10.3390/jcdd9110386.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pacemaker; Obesity paradox
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Arrhythmias, Cardiac
• Other Study ID Numbers: AJOUIRB-EXP-2021-398-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No