Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Association of Socioeconomic Status With Ischemic Stroke Survival.

Background and Purpose- The aim of the study was to determine the impact of individuals' socioeconomic status and their Primary Care Service Area Socioeconomic Index on survival after ischemic stroke. Methods- We conducted a nationwide population-based cohort study in Catalonia, Spain. We included all patients with first ischemic stroke admitted to a public hospital between January 1, 2015, and December 31, 2016. We measured both individual socioeconomic status (categorized as exempts, <€18 000 [$US 20 468] income per year, and >€18 000 income per year) and Primary Care Service Area Socioeconomic Index (from 0 to 100 categorized in quartiles). We used mixed-effects logistic and survival models to estimate odds ratios and hazard ratios for the short- (30 days) and the long-term (3 years) all-cause case fatality rates by individuals' socioeconomic status groups. Results- The cohort consisted of 16 344 ischemic stroke patients with 24 638 person-years of follow-up. We did not find an association between the lowest socioeconomic individual status and short-term survival (odds ratio, 1.03; 95% CI, 0.76-1.40), although we found it in patients with <€18 000 income/year (odds ratio, 1.26; 95% CI, 1.10-1.45). At long-term, after adjustment, we observed a gradient in mortality risk with decreasing individual socioeconomic status (hazard ratio, 1.52; 95% CI, 1.30-1.77). The Primary Care Service Area Socioeconomic Index had only an influence on short-term survival (odds ratio, 1.19; 95% CI, 1.03-1.37). Conclusions- Individuals' socioeconomic status was associated with short- and long-term survival in patients with ischemic stroke. Conversely, Primary Care Service Area Socioeconomic Index measures had an influence only in short-term survival. A small fraction of this association is due to differences in comorbidity and cardiovascular risk factors. Interventions addressing both individuals' and primary care service socioeconomic aspects might eventually affect differently short- and long-term survival.

The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

OBJECTIVES: The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. METHODS: This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. RESULTS: As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. CONCLUSIONS: A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Hospital-at-home Integrated Care Program for Older Patients With Orthopedic Processes: An Efficient Alternative to Usual Hospital-Based Care.

OBJECTIVE: To compare outcomes and costs for patients with orthogeriatric conditions in a home-based integrated care program versus conventional hospital-based care. DESIGN: Quasi-experimental longitudinal study. SETTING: An acute care hospital, an intermediate care hospital, and the community of an urban area in the North of Barcelona, in Southern Europe. PARTICIPANTS: In a 2-year period, we recruited 367 older patients attended at an orthopedic/traumatology unit in an acute hospital for fractures and/or arthroplasty. INTERVENTION: Patients were referred to a hospital-at-home integrated care unit or to standard hospital-based postacute orthogeriatric unit, based on their social support and availability of the resource. MEASUREMENTS: We compared home-based care versus hospital-based care for Relative Functional Gain (gain/loss of function measured by the Barthel Index), mean direct costs, and potential savings in terms of reduction of stay in the acute care hospital. RESULTS: No differences were found in Relative Functional Gain, median (Q25-Q75) = 0.92 (0.64-1.09) in the home-based group versus 0.93 (0.59-1) in the hospital-based group, P =.333. Total health service direct cost [mean (standard deviation)] was significantly lower for patients receiving home-based care: €7120 (3381) versus €12,149 (6322), P < .001. Length of acute hospital stay was significantly shorter in patients discharged to home-based care [10.1 (7)] than in patients discharged to the postacute orthogeriatric hospital-based unit [15.3 (12) days, P < .001]. CONCLUSION: The hospital-at-home integrated care program was suitable for managing older patients with orthopedic conditions who have good social support for home care. It provided clinical care comparable to the hospital-based model, and it seems to enable earlier acute hospital discharge and lower direct costs.

Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

OBJECTIVE: To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk. METHODS: Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR. RESULTS: We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant. CONCLUSIONS: In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs.

Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures.

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute "conceptual model." The LVDQ had the highest rated median for "reliability" (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for "validity" (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of "sensitivity to change" (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the "interpretability" attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.

Patterns of use and effectiveness of early invasive strategy in non-ST-segment elevation acute coronary syndromes: an assessment by propensity score.

BACKGROUND: The patterns of use and the benefit of an early invasive strategy (EIS) in patients with non-ST-segment elevation acute coronary syndrome in a real-life population are not well established. METHODS: All consecutive patients hospitalized because of non-ST-segment elevation acute coronary syndrome between November 2004 and June 2005 in 32 randomly selected hospitals were prospectively included. Patients were stratified by their baseline risk profile using the Global Registry of Acute Coronary Events (GRACE) risk score in 2 groups. Inhospital mortality and 1- and 6-month mortality or rehospitalization for acute coronary syndromes were analyzed. To ensure optimal adjustment propensity score, conventional logistic regression and Cox regression were used. RESULTS: Of 2,856 patients analyzed, 1,616 (56%) had low/intermediate risk (GRACE140). Patients who underwent EIS had lower risk than those who did not (GRACE score 128.2+/-41 vs 138.5+/-43, P<.001). Coronary angiography facility emerged as the strongest predictor of EIS (odds ratio [OR] 13.7 [95% CI 7.1-25]). Patients who underwent EIS had lower rate of the 6-month outcome in both the whole population (9% [95% CI 6.6-11.9] vs 14% [95% CI 12.5-15.6], P=.003) and in high-risk patients (16.5% [95% CI 11-23] vs 23.6% [95% CI 20.8-26.5], P=.04). However, this benefit of EIS was not apparent after statistical adjustment in the whole population (OR 0.8, CI 0.55-1.1, P=.17) or in high-risk patients (OR 0.7, CI 0.46-1.1, P=.16). CONCLUSIONS: In a real-life population, EIS was mainly performed in patients of low/intermediate risk. An obvious benefit of this strategy could not be found.

Outcomes in off-pump vs. on-pump coronary artery bypass grafting stratified by pre-operative risk profile: an assessment using propensity score.

AIMS: To assess the benefit of off-pump coronary surgery stratified by the pre-operative risk profile. METHODS AND RESULTS: Prospective and multicentric cohort study. All consecutive patients undergoing a first coronary bypass procedure between November 2001 and November 2003 were potentially eligible. Pre-operative EuroSCORE and in-hospital outcomes were prospectively collected using strictly standardized criteria. To ensure optimal adjustment, a propensity score was constructed using clinically relevant variables and incorporating individual centres. Of 1602 patients who underwent a first coronary bypass, EuroSCORE could be calculated in 1585: 787 were of moderate/high pre-operative risk profile (EuroSCORE > 3), of which 347 underwent off-pump procedures, and 798 were of low pre-operative risk profile (EuroSCORE < or = 3), of which 349 underwent off-pump procedures. After risk adjusting for propensity score, off-pump patients had less major events (post-operative death, myocardial infarction, and need for reoperation). This benefit was higher in the low-risk stratum (OR ranged between 0.27 and 0.4; P = 0.02-0.07) than in the high-risk stratum (OR between 0.4 and 0.7; P, not significant). CONCLUSION: In real-life conditions, off-pump coronary surgery may be more effective than on-pump surgery. In contrast with previous reports, our results suggest that this benefit may be higher in patients with low pre-operative risk.

[Evaluation of risk-adjusted hospital mortality after coronary artery bypass graft surgery in the Catalan public healthcare system. Influence of hospital management type (ARCA Study)]. / Evaluación de la mortalidad hospitalaria ajustada al riesgo de la cirugía coronaria en la sanidad pública catalana. Influencia del tipo de gestión del centro (estudio ARCA).

INTRODUCTION AND OBJECTIVES: Previous studies suggest that the effectiveness of coronary surgery is influenced by the type of management at the healthcare centre where the intervention is performed. The present study assessed the risk-adjusted hospital mortality of coronary surgery in the Catalan healthcare system in hospitals under either private or public management. METHODS: We carried out a prospective study of all consecutive patients receiving a first coronary artery bypass graft, with public financial support, in a period of 2 years at 5 hospitals under either public or private management. Preoperative risk was assessed using the EuroSCORE and Catalan Agency for Health Technology Assessment (CAHTA) predictive models. RESULTS: Overall, 1605 patients underwent interventions, 21% of which were at private hospitals. The percentage of patients undergoing non-elective surgery was higher at private hospitals (64% vs 50%), as was the percentage needing intravenous nitrates (17% vs 11%) and the percentage in functional class IV (20% vs 11%). The odds ratio for in-hospital mortality in private compared with public hospitals was 0.56 (95% CI, 0.29-1.06) when adjusted for EuroSCORE, 0.56 (95% CI, 0.29-1.07) when adjusted for CAHTA score, and 0.43 (95% CI, 0.21-0.87) when adjusted for patient characteristics. The mortality observed, 4.8% (95% CI 3.8-5.6), was not significantly higher than that predicted. CONCLUSIONS: a) Hospital mortality was equivalent to or lower than that expected after adjustment for the 2 risk scores; b) after adjustment for baseline patient characteristics, the results favored privately managed centers; and c) comparison with previous results suggests that coronary surgery effectiveness has improved in recent years.

[Usefulness of coronary risk assessment using the equation of the Framingham study: a case control study]. / Utilidad de la medición del riesgo coronario a partir de la ecuación del estudio de Framingham: estudio de casos y controles.

BACKGROUND AND OBJECTIVE: During the last decade, recommendations for coronary heart disease prevention have emphasized the need of an assessment of coronary risk. The objective of this study was to assess the usefulness of the Framingham risk function for the estimation of coronary risk in our population, assessing the accuracy of the coronary risk as a diagnostic test (assuming that a coronary risk >20% is a positive diagnosis test of coronary disease). PATIENTS AND METHOD: Prospective case-control study, carried out in a public tertiary hospital. RESULTS: 138 cases were identified and matched, according to age and sex, with 223 controls. The level of risk > or =20% was the one which better classified the patients (70% of patients correctly classified as cases and controls) with an area under the ROC curve of 73.5% (moderate accuracy). Patients with a coronary risk >20% had a six times higher probability of being a case than a control (OR=6.09; 95% CI, 3.30-11.22). CONCLUSIONS: The utilization of the Framingham function for the prediction of coronary disease is a useful method to identify high risk patients. It is recommended to use it in clinical practice until we have our own model derived from populations with a baseline risk similar to ours allowing to predict the risk with higher accuracy.