Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure

Abstract

Background-Implantable cardioverter defibrillators (ICDs) are lifesaving devices for patients with heart failure (HF) and reduced ejection fraction. However, utilization and determinants of ICD insertion in Asia are poorly defined. We determined the utilization, associations of ICD uptake, patient-perceived barriers to device therapy and, impact of ICDs on mortality in Asian patients with HF. Methods and Results-Using the prospective ASIAN-HF (Asian Sudden Cardiac Death in Heart Failure) registry, 5276 patients with symptomatic HF and reduced ejection fraction (HFrEF) from 11 Asian regions and across 3 income regions (high: Hong Kong, Japan, Korea, Singapore, and Taiwan; middle: China, Malaysia, and Thailand; and low: India, Indonesia, and Philippines) were studied. ICD utilization, clinical characteristics, as well as device perception and knowledge, were assessed at baseline among ICD-eligible patients (EF ≤35% and New York Heart Association Class II-III). Patients were followed for the primary outcome of all-cause mortality. Among 3240 ICD-eligible patients (mean age 58.9±12.9 years, 79.1% men), 389 (12%) were ICD recipients. Utilization varied across Asia (from 1.5% in Indonesia to 52.5% in Japan) with a trend toward greater uptake in regions with government reimbursement for ICDs and lower out-ofpocket healthcare expenditure. ICD (versus non-ICD) recipients were more likely to be older (63±11 versus 58±13 year; P<0.001), have tertiary (versus ≤primary) education (34.9% versus 18.1%; P<0.001) and be residing in a high (versus low) income region (64.5% versus 36.5%; P<0.001). Among 2000 ICD nonrecipients surveyed, 55% were either unaware of the benefits of, or needed more information on, device therapy. ICD implantation reduced risks of all-cause mortality (hazard ratio, 0.71; 95% confidence interval, 0.52-0.97) and sudden cardiac deaths (hazard ratio, 0.33; 95% confidence interval, 0.14-0.79) over a median follow-up of 417 days. Conclusions-ICDs reduce mortality risk, yet utilization in Asia is low; with disparity across geographic regions and socioeconomic status. Better patient education and targeted healthcare reforms in extending ICD reimbursement may improve access. Clinical Trial Registration

Heart failure around the world

“…47,48 This difference is likely related to differences in reimbursement; a separate study from ASIAN-HF showed that on a country level, there was a strong association between device usage and out-of-pocket pay. 49 Significant differences in mortality were seen in the PARADIGM-HF trial; patients from LA [10 (95% confidence interval-CI 9-11) deaths per 100 patient-years] and AP [9 (95% CI 8-10) deaths per 100 patient-years] had worse mortality compared to WE [7 (95% CI 6-8) deaths per 100 patient-years] independent of differences in clinical characteristics ( Table 1). 8 Regional variations in clinical outcome are more pronounced when looking at hospitalization for HF.…”

“…In addition, advanced HF therapies, including left ventricular assist devices and heart transplantation, are still very limited in most low‐middle‐income countries compared to WE and NA . This difference is likely related to differences in reimbursement; a separate study from ASIAN‐HF showed that on a country level, there was a strong association between device usage and out‐of‐pocket pay …”

“…These include differences in country income level, inequality in income levels and out‐of‐pocket costs, which are major determinants of healthcare systems organizations, education level, access to and quality of care. While these are plausible drivers of what is often described as geographic differences, a limited number of studies have explored their influence on patient heterogeneity in trials and registries …”

“…For example, patients from low‐income countries are more likely to be smokers, which might be an important opportunity for intervention . Device usage also seems to be driven by socioeconomic determinants, with data from ASIAN‐HF showing a strong association between underusage of devices in eligible patients with HFrEF and country income level as well as out‐of‐pocket costs …”

“…The clearest example illustrating the effects of differences in background therapy is from the Platelet Inhibition and Patient Outcomes (PLATO) trial, where ticagrelor compared to placebo was less effective in patients from NA; an effect attributable to differences in background aspirin dosing wherein ticagrelor was most effective in patients on low aspirin maintenance dose . Specifically for global HF clinical trials, newer therapies are often tested on top of optimal guideline‐directed medical treatment for HF; yet the background HF medical therapy is known to vary by region, with even greater variation in background HF device therapy . At the very least, background therapy should be closely monitored by region during the conduct of global HF trials, with measures taken to close treatment gaps in specific regions as needed (e.g.…”