Abstract

IntroductionThere 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.MethodsWe 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.DiscussionThe 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 registrationPROSPERO CRD42020204804

Highlights

  • There is abundant evidence for sex differences in the diagnosis, implantation, and outcomes for cardiac resynchronization therapy (CRT) devices

  • Cardiac resynchronization therapy (CRT), known as biventricular pacing is the latest cardiac implantable electronic device (CIED) aimed to reduce symptoms for Heart failure (HF) and improve ventricular function heart. This device exists in two types: CRT-pacemaker (CRT-P), which synchronizes the heart beating pattern through improving the pumping action the lower ventricles, and CRTdefibrillator (CRT-D), which in addition to synchronizing heart rhythm, can detect and treat sudden cardiac death (SCD) [7]

  • The aim of this review is to determine the presence of differences in CRT implantation between women and men as well as differences in efficacy and safety of CRT post device implantation

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Summary

Introduction

There is abundant evidence for sex differences in the diagnosis, implantation, and outcomes for cardiac resynchronization therapy (CRT) devices. Biological differences cause women to more frequently experience heart failure with atypical symptoms unlike men which results in underdiagnosis [5, 6]. Cardiac resynchronization therapy (CRT), known as biventricular pacing is the latest cardiac implantable electronic device (CIED) aimed to reduce symptoms for HF and improve ventricular function heart. This device exists in two types: CRT-pacemaker (CRT-P), which synchronizes the heart beating pattern through improving the pumping action the lower ventricles, and CRTdefibrillator (CRT-D), which in addition to synchronizing heart rhythm, can detect and treat sudden cardiac death (SCD) [7]. International cardiovascular guidelines have declared CRT devices as the highest recommendation (class 1 indication) for patients with left ventricular ejection fraction (LVEF) ≤ 35%, New York Heart Association (NYHA) heart failure classification 2, 3, or 4 symptoms (scale corresponding to patient’s inability to conduct physical activity), left bundle block (LBBB) with a QRS duration ≥ 150 ms, and sinus rhythm [8]

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