Implantable cardiac devices such as implantable cardioverterdefibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices lead to improved survival and better clinical outcomes in appropriately selected patients with heart failure (HF) with a reduced ejection fraction (EF). Although there are significant sex differences in the aetiology, pathophysiology and clinical course of HF, clinical practice guidelines for cardiac device therapy are not sex-specific and are based on clinical trials where the majority of patients enrolled were men. In this review, we explore sex differences in clinical outcomes and utilisation of ICDs and CRT and explore the reasons for these disparities.
Implantable Cardioverter-DefibrillatorsThe annual incidence of sudden cardiac death (SCD) in the US is estimated to be 300,000 to 450,000.1 A major risk factor for SCD is HF with reduced EF. There have been several large randomised controlled studies that have demonstrated a mortality benefit from ICDs in eligible patients for both primary and secondary prevention of SCD. However, under-representation of women in these trials has made it somewhat difficult to determine the sex-specific survival benefit of ICD therapy.
Evidence for the Use of ICD Therapy for Primary and Secondary Prevention of SCD
Sex Differences in Outcomes with ICD Therapy
Sex Differences in ICD Therapy for Secondary Prevention of SCDCurtis et al. 6 analysed a 5 % national sample of patients from the US Centers for Medicare & Medicaid Services eligible for ICD therapy and found that, in the secondary prevention ICD cohort, there was a statistically significant mortality benefit for both sexes even after adjustment for other factors.
Sex Differences in Primary Prevention ICDsIn the MUSTT trial, 3 a total of 301 women were enrolled, and they constituted 10 % (68) of the randomised patients and 16 % (233) of those followed in the registry. Overall, there was no statistically significant difference in mortality between men and women in the electrophysiology (EP)-guided therapy group (21 % versus 32 %; p=0.13) or in the registry (20 % versus 27 %; p=0.15). However, there was a trend towards increased mortality in women, although the trial did not have sufficient power to detect gender differences due to the small number of women enrolled.In MADIT-II, 1,232 patients with ischaemic cardiomyopathy were enrolled of which 192 (16 %) were women. 4 Patients received ICDs versus standard medical therapy, with a total of 119 women receiving ICD therapy. Women were noted to have more advanced HF, as well as
AbstractMultiple studies have demonstrated that implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) provide significant mortality and morbidity benefits to eligible patients irrespective of gender. However, female patients are less likely to receive this life-saving therapy and are significantly under-represented in cardiac device trials. Various performance improvement programmes have proved that this gender disparity can be reduce...