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September 25, 2018 Circulation. 2018;138:e272–e391. DOI: 10.1161/CIR.0000000000000549 e340

CLINICAL STATEMENTS AND GUIDELINES tion, yet the risk versus benefit of primary prevention ICDs has been unclear; data from observational studies have been conflicting, and patients with moderate or severe CKD, especially patients with end-stage renal disease (ESRD) on dialysis were not included in the pivotal RCTs of ICDs.S10.4-1–S10.4-5 Furthermore, prior data had significant limitations given that patients who received ICDs have been compared inconsistently with a control group with CKD that did not receive primary prevention ICDs and the degree of renal insufficiency likely influences survival benefit.S10.4-6 Patients with CKD, especially ESRD on dialysis, appear to be at increased risk of ICDrelated complications. A significant number of sudden deaths are unassociated with VA in this population.S10.4-7 Therefore, the ERC was asked to address the impact of ICDs on mortality in patients with CKD.

The ERC conducted a specific analysis of 5 studies that explored renal dysfunction. A meta-analysis of these studies suggested that an association exists between ICD implantation and improved survival.S10.4-8 An important limitation is that only 2 studies specifically studied patients with ESRD and most data analyzed were from observational studies.S10.4-8,S10.4-9 In view of these limitations, the writing committee concluded there was not enough data to inform a recommendation on ICD implantation in patients with ESRD on dialysis. Decisions regarding ICDs in patients with CKD, especially those with ESRD, should be individualized and take into consideration the patient’s functional status, number of comorbidities, and preferences, among other factors.

10.5 Valvular Heart Disease

Patients with valvular heart disease should be evaluated and treated according to GDMT for valvular heart disease and, when LVEF is depressed, GDMT that applies to NICM to reduce the risk of SCD.S10.6-23 VA in patients with valvular heart disease can be caused by any of the mechanisms responsible for VA in other cardiac disease including ischemic heart disease, MI, severe LV hypertrophy, adrenergic-dependent rhythm disturbances, or an inherited molecular abnormality. Patients with valvular heart disease and VA are generally evaluated and treated using current recommendations for each disorder.S10.6-1 The presence of a VA alone does not constitute an indication for valve repair or replacement. In general, there is more knowledge on the risk for SCD in patients with aortic stenosis than other valvular lesions with a risk of 1% to 1.5% per year.S10.6-2 Most patients who die suddenly have been symptomatic from their valve disease.S10.6-3,S10.6-4 Although recurrent NSVT may place a patient with severe aortic stenosis at risk for syncope, the management of such a patient is guided by the severity of the valvular lesion. Mitral valve prolapse has been implicated as a cause of SCD, although a study of 18 786 patients found no increased risk of SCA for patients with bileaflet mitral valve prolapse versus single leaflet mitral valve prolapse or no mitral valve prolapse.S10.6-5 LV fibrosis in the papillary muscles has been described in some mitral valve prolapse patients with VA or SCD.S10.6-6 Further, a possible syndrome for SCD has been described that includes bileaflet mitral valve prolapse, female sex, T wave abnormality, and complex ventricular ectopy.S10.6-7 Guidance for treatment of patients with NICM, whether valvular or otherwise in origin, is provided in the current guideline (see Sections 7.2.1 and 7.2.2 for primary and secondary prevention).

10.6 Sex-Related Differences in the Risk

of SCD

The information on associations between sex and VA and SCD is largely limited to epidemiological, cohort, and observational studies. Various population studies, primarily focused on SCD due to ischemic heart disease, have demonstrated age gradients in SCD risk among men and women.S10.6-8–S10.6-10 These include a 10-year lag in SCD incidence in women compared with men. However, risk factor burden among women has the same proportional effect as in men, with a 17-fold increase in risk from the lowest to highest deciles.S10.6-9 Importantly, 69% of the SCDs in women were first cardiac events.S10.6-8 A study of lifetime risk of SCD stratified at 45, 55, 65, and 75 years of age identified persistently lower and similar proportions of lifetime risk of SCD among women versus men in each of the strata.S10.6-10 The difference between women and men is somewhat smaller at ages below and above 75 years, largely because of a reduced risk in men. The overall lifetime risk of SCD  was 1 in 9 among men and 1 in 30 among women.S10.6-10 In studies of outcomes after out-of-hospital cardiac arrest, women were older, had more SCAs in homes, and fewer shockable rhythms (VT/VF) than men.S10.6-11,S10.6-12 This was associated with a somewhat lower probability of survival overall; however, women with VT/VF and those with pulseless electrical activity had better outcomes than men.S10.6-12 A retrospective analysis of out-of-hospital cardiac arrest reported that survival improved over a 10-year period, with more favorable outcomes in men as well as younger women.S10.6-13 Two studies demonstrated better outcomes in women with VT/VF, despite adverse risk factor profiles in women.S10.6-14,S10.6-15 Another large study demonstrated that despite similar prehospital return of spontaneous circulation and survival to discharge, younger women had lower 1-month neurologically intact survival than the 50 to 60 age group.S10.6-16 A 17-year retrospective analysis

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