2022 Volume 86 Issue 1 Pages 158-165
Background: Heart failure in elderly people causes physical and cognitive dysfunction and often requires long-term care insurance (LTCI); however, among patients with left ventricular (LV) systolic dysfunction, the incidence and risk factors of future LTCI requirements need to be elucidated.
Methods and Results: The study included 1,852 patients aged ≥65 years with an echocardiographic LV ejection fraction (LVEF) ≤50%; we referred to their LTCI data and those of 113,038 community-dwelling elderly people. During a mean 1.7-year period, 332 patients newly required LTCI (incidence 10.7 per 100 person-years); the incidence was significantly higher than that for the community-dwelling people (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.32–1.64). On multivariate analysis, the risk factors at the time of echocardiography leading to future LTCI requirement were atrial fibrillation (HR, 1.588; 95% CI, 1.279–1.971), history of stroke (HR, 2.02; 95% CI, 1.583–2.576), osteoporosis (HR, 1.738; 95% CI, 1.253–2.41), dementia (HR, 2.804; 95% CI, 2.075–3.789), hypnotics (HR, 1.461; 95% CI, 1.148–1.859), and diuretics (HR, 1.417; 95% CI, 1.132–1.773); however, the LVEF was not a risk factor (HR, 0.997; 95% CI, 0.983–1.011).
Conclusions: In elderly patients with LV systolic dysfunction, the incidence of LTCI requirement was more common than that for community-dwelling people; its risk factors did not include LVEF, but included many other non-cardiac comorbidities and therapies, suggesting the need for interdisciplinary cooperation to prevent disabilities.
The proportion of elderly people aged ≥65 years continues to grow globally. In Japan, the rate of aging has reached 28.1% in 2018, which represents the highest rate worldwide; furthermore, the elderly population is projected to account for approximately 40% of the total population by 2065.1 One of the primary problems in such a super-aging society is the increase of patients with disabilities, which deprives their independence in activities of daily living. Since 2000, the Japanese government has implemented a social long-term care insurance (LTCI) system called “Kaigo Hoken” to support elderly patients with disabilities.2–5 Every person aged ≥65 years is eligible and needs to be certified and classified according to their physical and cognitive dysfunction to obtain benefits from the system. Therefore, the new LTCI requirement has been used as an indicator of disabilities in elderly patients.
Heart failure in elderly patients, compared to that in young patients, consists more of left ventricular (LV) diastolic dysfunction with wide varieties of comorbidities; it has been reported to cause physical dysfunction, including frailty, sarcopenia, osteoporosis,6–8 and cognitive dysfunction, which predicts high LTCI coverage.9,10 However, previous studies did not focus on elderly patients with systolic dysfunction and their disabilities. Guideline-based optimal medical therapies for LV systolic dysfunction have been introduced, although present guidelines are mainly based on evidence concerning life expectancy and hospitalization due to heart failure regardless of patient age.11,12 We hypothesized that elderly patients with LV systolic dysfunction have various comorbidities and thus more commonly require LTCI than others in the general population.
Hence, the present study aimed to examine the incidence of new LTCI requirements as a marker of physical and cognitive deterioration, and to identify risk factors leading to disabilities, using our database of patients with echocardiographic LV systolic dysfunction.
In this multicentered, retrospective, observational cohort study, consecutive patients aged ≥65 years exhibiting echocardiographic LV ejection fraction (LVEF) <50% were retrospectively enrolled at 7 hospitals (Niigata University Medical and Dental Hospital, Niigata Cancer Center Hospital, Niigata Bandai Hospital, Niigata Minami Hospital, Niigata City General Hospital, Minoso Hospital, and Kuwana Hospital) in Niigata City from January 2011 to December 2016. All echocardiography records captured at the clinical laboratory for outpatients and inpatients during the recruitment period were reviewed and patients who met the criteria were enrolled. Echocardiography records captured at the emergency rooms were excluded. Available baseline clinical records were reviewed with respect to demographic data, medical history, etiology of heart failure, associated comorbidities and history (cardiovascular diseases, neurological diseases, orthopedic diseases, and cancer), therapies, and echocardiographic data. The etiology of heart failure was determined as follows: ischemic heart disease was defined based on a history of myocardial infarction or angina pectoris, or coronary artery stenosis of >75% in at least 1 vessel. Dilated cardiomyopathy was diagnosed as impaired systolic function without specific causes. Cardiomyopathy included dilated cardiomyopathy, hypertrophic cardiomyopathy in the dilated phase, sarcoidosis, and amyloidosis. Valvular heart disease was diagnosed when moderate-to-severe mitral or aortic valve stenosis or regurgitation was confirmed using echocardiography. Comorbidities, history, and therapies were confirmed through past examination, hospitalizations, and drugs used at the time of enrollment. Stroke included brain infarction, brain hemorrhage, and subarachnoid hemorrhage. Connective tissue disease included rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and other collagen vascular diseases. Hypnotics included benzodiazepines and non-benzodiazepines. Patients without the abovementioned clinical data and those who had already been registered for LTCI were excluded.
Patients were observed from the time of enrollment until January 2017, or until death or transfer to another health facility. The incidence of LTCI requirement was defined as the creation of new official documents for insurance registration, which was created at the early stage of application, based on the doctor’s opinion. All LTCI data were extracted and collected from individual medical records. Data on classifications of bedriddenness (normal, J: independence/autonomy; A: house-bound; B: chair-bound; and C: bed-bound) and cognitive function (normal, 1, 2, 3, 4, and M) at the time LTCI requirement were obtained as well (Table 1). LTCI data from the community-dwelling elderly people aged ≥65 years in Niigata City were also obtained to compare it with data obtained from patients with LV systolic dysfunction.
Category | Criteria | Sub category |
Characteristics |
---|---|---|---|
(1) Bedriddenness rank in daily living for disabled elderly patients | |||
J Independence/autonomy |
Slight disorders with being almost independent in daily living and can go for an outing. |
J1 | Use public transport. |
J2 | Go out only within the neighborhood. | ||
A House-bound |
Almost independent at home without the ability of going out alone. |
A1 | Spend most of the time away from the bed and sometimes go out with some assistance. |
A2 | Spend most of the time in bed and rarely go out even with some assistance. |
||
B Chair-bound |
Dependent even at home and spend almost all the time in bed in the daytime with the ability to maintain a sitting position alone. |
B1 | Move to wheelchair alone, eat and excrete away from bed. |
B2 | Move to wheelchair with help. | ||
C Bed-bound |
Bedridden and dependent for excretion, eating, and clothing. |
C1 | Roll over alone. |
C2 | Roll over with help. | ||
(2) Cognitive function score for cognitively impaired elderly patients | |||
1 | Almost independent in daily living; only have a slight cognitive impairment. |
||
2 | Independent with slight difficulty in daily living or communication and living under careful supervision. |
2a | Applicable only outside. |
2b | Applicable even at home. | ||
3 | Dependent in daily living or communication. | 3a | Applicable mainly during daytime. |
3b | Applicable mainly at nighttime. | ||
4 | Dependent in daily living or communication and requiring constant care. |
||
M | Severe psychological symptoms, troubled behaviors, or severe physical disorders requiring specialized medical service. |
In this study, the primary event of interest was the incidence of long-term care in community-dwelling elderly patients, and the competing event was death prior to LTCI, which could affect the probability of event incidence over time. Cumulative incidence of long-term care and hazard ratios (HRs) were estimated using Fine-Gray models based on Cox proportional hazards models, with death prior to LTCI as the competing event, to evaluate the significance of various background clinical data as risk factors of cumulative incidence of long-term care. Plots of the estimated incidence over time were constructed using the Kaplan-Meier method and HRs and 95% confidence intervals (CIs) were presented using the forest plot method. All values are presented as mean±standard deviation or as frequency (%) for descriptive results. Continuous and categorical variables were compared using the unpaired t-test and chi-squared test, respectively.
EthicsThe study was approved by individual sites’ institutional review boards and independent ethics committees. We used the opt-out method for the retrospective nature of the present study. This study was registered with the University Hospital Medical Information Network in Japan (UMIN Registration Number: UMIN-000043255). We performed the study in accordance with Japanese clinical research ethics guidelines.
Of patients who underwent echocardiography in participating hospitals during the study period, 3,550 had a LVEF ≤50%; of these, 2,362 were elderly patients aged ≥65 years. Additionally, 482 patients who had already been registered for LTCI at the time of echocardiography and 28 patients who lacked clinical data were excluded. Finally, 1,852 individuals were analyzed.
The mean age of patients was 75.8 years, and 71.2% were male. The median LVEF was 43.0 (35.7–47.0) %. Details about patient heart diseases, comorbidities, non-drug therapies, and drug therapies are provided in Table 2. Cardioprotective drugs, such as angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), β-blockers, and mineralocorticoid receptor antagonists (MRA) were administered in only approximately 50% of patients at the time of enrollment.
Total (N=1,852) | |
---|---|
Age (years) | 75.8±7.1 |
Male sex (%) | 1,318 (71.2) |
Heart disease (%) | |
IHD | 921 (49.7) |
CM | 283 (15.3) |
VHD | 532 (28.7) |
AF | 702 (37.9) |
Comorbidity and history (%) | |
HT | 1,204 (65.0) |
DM | 666 (36.0) |
DL | 892 (48.2) |
Smoking history | 792 (42.8) |
ASO | 109 (5.9) |
Stroke | 334 (18.0) |
Dementia | 128 (6.9) |
COPD | 121 (6.5) |
CTD | 73 (3.9) |
Osteoporosis | 156 (8.4) |
Hip fracture | 57 (3.1) |
Cancer | 201 (10.9) |
ESRD on HD | 92 (5.0) |
Non-drug therapy (%) | |
CRT-P | 4 (0.2) |
CRT-D | 23 (1.3) |
PCI | 588 (31.7) |
Catheter ablation | 46 (2.5) |
CABG | 142 (7.7) |
Heart valve surgery | 136 (7.3) |
Drug therapy | |
ACEi or ARB | 1,015 (54.8) |
β-blocker | 880 (47.5) |
MRA | 471 (25.4) |
Diuretic | 971 (52.4) |
CCB | 577 (31.2) |
Digitalis | 151 (8.2) |
Steroid | 82 (4.4) |
Antiplatelet drug | 873 (47.1) |
Anticoagulant drug | 753 (40.7) |
Hypnotic | 375 (20.2) |
Echocardiography | |
LVEF (%) | 40.6±8.1 |
LVDd (mm) | 55.1±8.9 |
LVDs (mm) | 43.9±8.3 |
IVST (mm) | 9.8±2.5 |
PWT (mm) | 9.9±2.0 |
LAD (mm) | 42.9±8.9 |
Values are presented as mean±standard deviation or as frequency (percentage). ACEi, angiotensin-converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin receptor blocker; ASO, arteriosclerosis obliterans; CABG, coronary artery bypass graft; CCB, calcium channel blockers; CM, cardiomyopathy; COPD, chronic obstructive pulmonary disease; CRT, cardiac resynchronization therapy; CTD, connective tissue disease; DL, dyslipidemia; DM, diabetes mellitus; ESRD on HD, end-stage renal disease on hemodialysis; HT, hypertension; IHD, ischemic heart disease; IVST, interventricular septum thickness; LAD, left atrial diameter; LVDd, left ventricular end-diastolic diameter; LVDs, left ventricular end-systolic diameter; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; PCI, percutaneous coronary intervention; PWT, posterior wall thickness; VHD, valvular heart disease.
In patients with LV systolic dysfunction, the total observation period was 3,116 person-years; the mean observation period was 1.7±1.7 years. During this period, 332 patients newly demanded LTCI, with the incidence being 10.7 per 100 person-years.
Data of 113,038 residents aged ≥65 years were used to represent that of community-dwelling elderly people. The total observation period was 587,834 person-years, and 5.2±1.6 years. During the study period, 23,743 people were newly registered for LTCI, with the incidence of long-term care being 4.0 per 100 person-years. The incidence was significantly higher in patients with LV systolic dysfunction (HR, 1.47; 95% CI, 1.32–1.64; P<0.001) (Figure 1).
Comparison of patients with systolic dysfunction with community-dwelling elderly people in the incidence of new long-term care insurance requirement. (A) The Kaplan-Meier curve with competing risks. (B) The Kaplan-Meier curve without competing risks.
In patients with LV systolic dysfunction, some comorbidities were associated with an increased incidence of new LTCI requirement. The risk factors for new LTCI requirement were determined using multivariate analysis (Figure 2). Male sex (HR, 0.581; 95% CI, 0.466–0.726), atrial fibrillation (HR, 1.588; 95% CI, 1.279–1.971), comorbidities such as arteriosclerosis obliterans (HR, 1.893; 95% CI, 1.29–2.78), history of stroke (HR, 2.02; 95% CI, 1.583–2.576), dementia (HR, 2.804; 95% CI, 2.075–3.789), osteoporosis (HR, 1.738; 95% CI, 1.253–2.41), a history of hip fracture (HR, 1.947; 95% CI, 1.272–2.982), cancer under treatment (HR, 2.222; 95% CI, 1.43–3.453), end-stage renal disease on hemodialysis (HR, 2.652; 95% CI, 1.724–4.078), and therapies such as percutaneous coronary intervention (HR, 4.078; 95% CI, 0.487–0.814), ACE inhibitors and ARBs (HR, 0.726; 95% CI, 0.584–0.902), diuretics (HR, 1.417; 95% CI, 1.132–1.773), steroids (HR, 1.938; 95% CI, 1.277–2.942), and hypnotics (HR, 1.461; 95% CI, 1.148–1.859) were all independent risk factors. LVEF was not associated with an increased risk for new LTCI requirement (HR, 0.997; 95% CI, 0.983–1.011). The incidence over time was shown using the Kaplan-Meier method for LVEF and for each risk factor (Figure 3).
Forest plot. Multivariate competing risk analysis based on a Cox proportional hazard model adjusted using confounding factors. ACEi, angiotensin-converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin receptor blocker; ASO, arteriosclerosis obliterans; CABG, coronary artery bypass graft; CCB, calcium channel blockers; CM, cardiomyopathy; COPD, chronic obstructive pulmonary disease; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; CTD, connective tissue disease; DL, dyslipidemia; DM, diabetes mellitus; ESRD on HD, end-stage renal disease on hemodialysis; HT, hypertension; IHD, ischemic heart disease; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; PCI, percutaneous coronary intervention; VHD, Valvular heart disease.
Incidence of long-term care insurance requirement by left ventricular ejection fraction and risk factors. (A) Left ventricular ejection fraction ≤40%. (B) Age ≥75 years. (C) Male sex. (D) Atrial fibrillation. (E) Arteriosclerosis obliterans. (F) Stroke. (G) Dementia. (H) Osteoporosis. (I) Hip fracture. (J) Cancer. (K) End-stage renal disease on hemodialysis. (L) Percutaneous coronary intervention. (M) Angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. (N) Diuretic. (O) Steroid. (P) Hypnotic.
The bedriddenness rank and cognitive function score at the time of new LTCI requirement were analyzed for 332 patients with LV systolic dysfunction. Most patients had moderate to severe physical dysfunction at a rank of A1 or severer (68.1%), and normal or mildly reduced cognitive dysfunction at rank 1 (53.4%) (Figure 4).
Bedriddenness rank and cognitive function score at the time of the incidence of long-term care requirement. There were 5.7% of unknown patients.
To the best of our knowledge, the present study is the first to report the incidence of new LTCI requirement in Japanese elderly patients with LV systolic dysfunction. We revealed that the incidence was higher in these patients than in community-dwelling elderly people, with an incidence of 10.7 per 100 person-years. Age, sex, various comorbidities (cardiovascular diseases, neurological diseases, orthopedic diseases, and cancer), and several therapies were identified as risk factors leading to future requirement of LTCI. The results will help medical professionals and caregivers of patients to prepare for long-term care.
The present study is the first study using LTCI requirement as the primary endpoint for Japanese elderly patients with LV systolic dysfunction. For a long time, the endpoints of clinical studies on LV systolic dysfunction have been mortality, cardiovascular mortality, and heart failure hospitalization. LV reverse remodeling and biomarkers such as B-type natriuretic peptide, N-terminal pro-b-type natriuretic peptide, and troponin level have also been used. However, in this era of long-life expectancy, the Japanese National Plan for Promotion of Measures Against Cerebrovascular and Cardiovascular Disease (Japanese National Plan) was published in October 2020 by the Ministry of Health, Labour and Welfare on the basis of the Cerebrovascular and Cardiovascular Disease Control Act.13 Extending healthy life expectancy is one of the goals of the plan; therefore, quality of life has increasingly drawn attention. In patients with heart failure, LTCI is a marker of disability and a risk factor of hospitalization and mortality.10 We believe that LTCI requirement will be a novel and valuable clinical endpoint in patients with heart failure.
In this study, the incidence of new LTCI requirement was 10.7 per 100 person-years and higher than 4.0 per 100 person-years in community-dwelling elderly people, which is comparable to that in past reports on LTCI in community residents. For example, the incidence was 2.0 per 100 person-years for men with a mean age of 76.5 years and 2.5 per 100 person-years for women with a mean age of 75.2 years, and it tended to be higher in the age strata people aged ≥80 years; however, the incidence was <10 per 100 person-years even in the age stratum of ≥85 years.14 Elderly patients with LV systolic dysfunction seemed to be in need of disability prevention strategies. In comparison with the results of representative Japanese registries of heart failure patients with reduced ejection fraction,15,16 the average age of our study population was slightly higher because we targeted elderly patients aged ≥65 years, and the gender distribution was not apparently different. We believe that the results of this study represent the general epidemiology of Japanese elderly patients with LV systolic dysfunction.
The elderly patients with LV systolic dysfunction had a high demand for future long-term care compared with community-dwelling elderly people. In the patient population, 52.4% of patients, who were anticipated to have symptomatic heart failure, were prescribed diuretics and the proportion of patients with symptomatic heart failure would have been higher in the patient population. Moreover, patients had various comorbidities. Patients with heart failure, including those with LV systolic dysfunction, commonly have various comorbidities.17,18 The elderly patients with LV systolic dysfunction will have more comorbidities than that of the general population. These features may cause the higher incidence of long-term care in elderly patients with LV systolic dysfunction.
We considered that knowing the mode of disability was important to develop methods to prevent disabilities and found that physical disability estimated using bedriddenness was the dominant mode of new LTCI requirements. This contradicts a report on the risk of fall that showed more cognitive dysfunction in Japanese inpatients in an acute care hospital,19 although studies on bedriddenness and cognitive dysfunction assessed using LTCI evaluation are still extremely rare. Past reports have indicated that cognitive function might indirectly affect the incidence of disability through physical dysfunction,20,21 but in patients with LV systolic dysfunction, the physical function may decline ahead of cognitive function. Taken together, our results indicate that comprehensive patient assessment involving cardiovascular and non-cardiovascular diseases and therapies may be required to prevent future disabilities in elderly patients with LV systolic dysfunction.
Study LimitationsThis study had some limitations. First, this is a retrospective observational hospital-based study. The incidence of LTCI requirement shown in this study needs to be verified through prospective registration studies.
Second, this is a study of elderly patients with LV systolic dysfunction, even though heart failure with a preserved LVEF is a more common cause of heart failure in the elderly. The incidence of new LTCI requirement in patients with heart failure with preserved LVEF remains to be investigated.
Third, the drugs used for treatment were confirmed at the time of echocardiography and were not assessed in terms of subsequent changes. This may explain the poor administration rates of β-blockers and ACE inhibitors or ARB.
Fourth, in elderly patients with LV systolic dysfunction, the number of patients continuously followed up over 1 year from enrollment was 953. Another 899 patients had discontinued observation due to new LTCI requirements (n=214), death (n=143), and transfer to another health facility (n=542). Patients who dropped out of the follow up due to a transfer may have subsequently obtained LTCI at other hospitals. The accuracy of the incidence of LTCI requirement shown in this study must be verified through prospective registration studies.
Fifth, bedriddenness rank and cognitive function scores were extracted from the official documents described by individual primary care physicians. Therefore, the results may be influenced by their subjective judgments.
Sixth, as this was a retrospective study, data were limited. Data on BMI, muscle strength, and physical ability that have been indicated to be risk factors for long-term care17 could not be extracted.
Seventh, the definition of new LTCI requirement was the creation of new official documents for insurance registration. This is the first step of the administrative procedures, and it takes approximately 1 month from the application to certification. Furthermore, not all LTCI applicants might be certified. For example, if the applicants died during the administrative procedures, they would be withdrawn. This might influence the statistical analysis for the calculation of the incidence and comparison with community-dwelling elderly people; however, most applicants between April 2018 and March 2020 in Niigata City were certified (97%). Therefore, even if administrative procedures affect statistical analysis, the impact would be minimal.
Finally, this study was performed in only 7 hospitals in Niigata city, and the characteristics of patients were different at each of these hospitals. In sensitivity analyses performed separately at the 7 hospitals, some of the risk factors did not match those for all patients, probably because of the lack of analytical power due to the low number of patients (data not shown). We believe that our results on risk factors for new LTCI requirement are common in elderly patients with LV systolic dysfunction, but research on a larger scale is needed for validation.
In elderly patients with heart failure, a comprehensive patient assessment that is not limited to cardiovascular diseases is important. Comorbidities and therapies, which predict new LTCI requirement, need to be identified. Interdisciplinary clinical practice will lead to prediction and protection for the incidence of long-term care.
The authors are grateful to the Niigata City Welfare Department Nursing Care Insurance Division who contributed to data extraction of community-dwelling elderly people.
This work was supported, in part, by Grants-in-Aid for The Community Health by The Medical Association of Niigata City (GC02520183).
T.M., T.I. are members of Circulation Journal’s Editorial Team.
The study protocol was reviewed and approved by the ethical committee of Niigata University (approval number: Niigata University 1788). This study was conducted in accordance with the guidelines of the Declaration of Helsinki and in compliance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects. We made public information concerning the implementation of the research, including handling of existing specimens or information, and the research implementation, and opportunities to withdraw. Such consent shall be ensured for the research subject.
The deidentified participant data will not be shared.