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Open Access 01-12-2021 | Heart Failure | Protocol

Sex differences in CRT device implantation rates, efficacy, and complications following implantation: protocol for a systematic review and meta-analysis of cohort studies

Authors: Omar Dewidar, David Birnie, Irina Podinic, Vivian Welch, George A. Wells

Published in: Systematic Reviews | Issue 1/2021

Abstract

Introduction

There is abundant evidence for sex differences in the diagnosis, implantation, and outcomes for cardiac resynchronization therapy (CRT) devices. Controversial data suggesting women are less likely to receive the device regardless of the greater benefit. The aim of this review is to assess sex differences in the implantation rate, clinical effectiveness, and safety of patients receiving CRT devices.

Methods

We will conduct a systematic literature search of MEDLINE, Embase, and Web of Science to identify cohort studies that meet our eligibility criteria. Title and full text screening will be conducted in duplicate independently. Eligible studies report clinical effectiveness or safety of patients receiving CRT device while providing sex-disaggregated data. Implantation rate will be extracted from the baseline characteristics tables of the studies. The effectiveness outcomes include the following: all-cause death, hospitalization, peak oxygen consumption (pVO₂), quality of life (QoL), 6-min walk test, NYHA class reduction, LVEF, and heart failure hospitalization. The complication outcomes include the following: contrast-induced nephropathy, pneumothorax, pocket-related hematoma, pericardial tamponade, phrenic nerve stimulation, device infection, death, pulmonary edema, electrical storm, cardiogenic shock, and hypotension requiring resuscitation. Description of included studies will be reported in detail and outcomes will be meta-analyzed and presented using forest plots when feasible. Risk of bias will be assessed using the Newcastle-Ottawa Scale (NOS) by two review authors independently. GRADE approach will be used to assess the certainty of evidence.

Discussion

The aim of this review is to determine the presence of differences in CRT implantation between women and men as well as differences in clinical effectiveness and safety of CRT after device implantation. Results from this systematic review will provide important insights into sex differences in CRT devices that could contribute to the development of sex-specific recommendations and inform policy.

Systematic review registration

PROSPERO CRD42020204804

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Title: Sex differences in CRT device implantation rates, efficacy, and complications following implantation: protocol for a systematic review and meta-analysis of cohort studies
Authors: Omar Dewidar
David Birnie
Irina Podinic
Vivian Welch
George A. Wells
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Heart Failure
Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy
Published in: Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/s13643-021-01746-x

At a glance: The STEP trials

Springer Medicine

Sex differences in CRT device implantation rates, efficacy, and complications following implantation: protocol for a systematic review and meta-analysis of cohort studies

Abstract

Introduction

Methods

Discussion

Systematic review registration

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Methods

Discussion

Systematic review registration

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