Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study

Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.

Study Overview

• Status: Completed
• Conditions: Cohort Studies; Pacemaker, Artificial; Cardiac Pacing, Artificial; Arrhythmias Requiring Therapy
• Intervention / Treatment: Other: No intervention, retrospective analysis only.

• Study Type: Observational
• Enrollment (Actual): 11444

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Women and men with implanted cardiac Pacemaker and at least one follow up in our Pacemaker Office of the Department of Cardiology at the Medical University Vienna. Patients were enrolled regardless of time and place of pacemaker implantations.

Description

Inclusion Criteria:

• All patients registered in the pacemaker database of the Department of Cardiology at the Medical University Vienna. Patients get registered when clinical follow up of an implanted Pacemaker is done.

Exclusion Criteria:

• For survival analysis: No valid match of first name AND surname AND date of birth with patients' insurance data.
• For analysis of comorbidities: Not a single documented diagnose was found in our electronic clinic-wide patients' information system.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with implanted pacemaker; Patients with implanted cardiac pacemaker registered in pacemaker database of the Department of Cardiology at the Medical University Vienna were included.	Other: No intervention, retrospective analysis only.; No intervention, retrospective analysis only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival after pacemaker implantation	Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rates of single- or dual-chamber Pacemaker in women/men.	Null hypothesis: Women and men have equal implantation rates of single- and dual-chamber pacemakers.	Data obtained: April 30th, 2015
Survival of women/men after single- or dual-chamber pacemaker implantation.	Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
First implantation age in single- or dual-chamber pacemaker	Null hypothesis: There is no difference in first implantation age between sexes and single- or dual-chamber pacemakers.	Data obtained: April 30th, 2015
Time to device- or lead-replacement	Null hypothesis: There is no difference between women and men in time to device- or lead-replacement.	10 years
Prevalence of Comorbidities	Null hypothesis: There is no difference in survival and first pacemaker implantation when selected comorbidity was found.	Survival analysis: 10 years; data obtained: March 2nd, 2016
Survival and device/lead-replacement in patients with diabetes.	Null hypothesis: There is no difference in survival or device/lead-replacement rates in women/men with diabetes.	10 years
Pacemaker parameters	Null hypothesis: There is no difference between women and men in pacing threshold and lead impedance.	Data obtained: April 30th, 2015
Laboratory results	Null hypothesis: There is no difference between women and men in troponin T, N-terminal pro-brain natriuretic Peptide, HbA1c and low-density lipoprotein.	Data obtained: March 2nd, 2016

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Mariann Gyöngyösi, MD, PhD, Medical University of Vienna

Publications and helpful links

General Publications

• Riesenhuber M, Spannbauer A, Rauscha F, Schmidinger H, Boszotta A, Pezawas T, Schukro C, Gwechenberger M, Stix G, Anvari A, Wrba T, Khazen C, Andreas M, Laufer G, Hengstenberg C, Gyongyosi M. Sex Differences and Long-Term Outcome in Patients With Pacemakers. Front Cardiovasc Med. 2020 Sep 22;7:569060. doi: 10.3389/fcvm.2020.569060. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Survival; Pacemaker; Retrospective; Gender differences
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: EK1525/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of IPD is planned.

Drug and device information, study documents

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