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.

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.

Improvements in health-related quality of life of patients admitted for heart failure. The HF-QoL study.

INTRODUCTION AND OBJECTIVES: Heart failure (HF) is associated with a poor prognosis, both in terms of survival and ongoing symptoms. The objectives of this study were to investigate trends in the health-related quality of life (HRQoL) of a heterogeneous group of HF patients, with a focus on subgroups of particular clinical interest, and to identify determinants of mortality. METHODS: Prospective study of 883 HF patients discharged from 50 Spanish hospitals and followed for 1 year, during which six HRQoL assessments were carried out using the generic Short Form-36 (SF-36) questionnaire and the specific Minnesota Living with Heart Failure Questionnaire (MLHFQ). RESULTS: A marked change was noted at the beginning of the study on all dimensions of the SF-36, in its physical (mean 34.1) and mental (mean 40.1) component summary scores, and in the MLHFQ score (mean 37.5). There was a clear improvement in the first month, which subsequently remained unchanged, except in younger patients aged under 40 years whose HRQoL continued to improve progressively. The following predictors of mortality were identified: age, functional class, co-morbidity and baseline HRQoL. CONCLUSIONS: In patients with HF, HRQoL showed a clear improvement during the first month after hospital discharge but subsequently remained unchanged, except in younger patients, whose HRQoL continued to improve progressively.

Predicting in-hospital mortality with coronary bypass surgery using hospital discharge data: comparison with a prospective observational study.

INTRODUCTION AND OBJECTIVES: The aim was to determine the usefulness of the hospital discharge Minimum Basic Data Set (MBDS) for predicting in-hospital mortality with coronary bypass surgery by using data from a prospective observational study as a reference. METHODS: The observational study involved collecting data on all patients undergoing first coronary bypass surgery at five hospitals in Catalonia, Spain between November 2001 and November 2003. In addition, data covering the same period and hospitals were obtained from the MBDS for procedure code 36.1. We investigated the concordance between the information from the two data sources and logistic regression was used to derive predictive models for in-hospital mortality. The model derived using MBDS data was validated using data from the prospective observational study and MBDS data for the years 2004-2006. Model validity was evaluated using discrimination and calibration indices. RESULTS: Some 4.1% of cases in the observational study could not be found in the MBDS. The concordance between the two data sources was highly variable and generally low (kappa values ranged from 0.16 to 0.79). The discriminative ability of the MBDS model was equivalent to that of the observational study model (c=0.80 vs. c=0.79), but when the validity of the former was tested using prospective data and MBDS data for 2004-2006, the discrimination c-index decreased to 0.76 and 0.65, respectively, and the calibration worsened significantly (P< .001). CONCLUSIONS: The risk of in-hospital mortality following coronary surgery cannot be accurately evaluated using MBDS data. However, our results indicate that their use as a predictive tool could be improved.

Predicción de la mortalidad hospitalaria en la cirugía de derivación aortocoronaria mediante datos administrativos: comparación con un estudio observacional prospectivo / Predicting In-Hospital Mortality With Coronary Bypass Surgery Using Hospital Discharge Data: Comparison With a Prospective Observational Study

Introducción y objetivos. Este estudio pretende evaluarla validez del Conjunto Mínimo Básico de Datos(CMBD) al alta hospitalaria para predecir la mortalidadhospitalaria en cirugía coronaria, utilizando como referencia los datos de un estudio observacional prospectivo.Métodos. Entre noviembre de 2001 y noviembre de2003 se recogieron prospectivamente los datos de lospacientes sometidos a una primera intervención de derivación aortocoronaria en cinco hospitales catalanes. Se obtuvieron del CMBD los registros del mismo período ylos mismos centros con código de procedimiento 36.1. Seanalizó la concordancia de la información procedente deambas fuentes y se construyeron modelos predictivos demortalidad hospitalaria mediante regresión logística. Sevalidó el modelo derivado de datos administrativos aplicándolo a los datos procedentes del estudio observacional y a los datos del CMBD del período 2004-2006 mediante los índices de discriminación y calibración.Resultados. El 4,1% de los casos incluidos en el estudioprospectivo no se localizaron en el CMBD. La concordanciaentre la información procedente de ambas fuentesfue variable (kappa, 0,16-0,79) y globalmente baja. La capacidad de discriminación del modelo administrativo fuecomparable a la del modelo del estudio observacional (c= 0,80 frente a c = 0,79), pero al validarlo con los datos prospectivos y los datos del CMBD 2004-2006, la capacidad de discriminación disminuyó (c = 0,76 y c = 0,65) y la calibración empeoró (p < 0,001).Conclusiones. El CMBD es insuficiente para una adecuadavaloración del riesgo de mortalidad hospitalaria encirugía coronaria. Sin embargo, los resultados indican que hay potencial de mejora en su uso como instrumentopredictivo

Introduction and objectives. The aim was todetermine the usefulness of the hospital dischargeMinimum Basic Data Set (MBDS) for predicting in-hospitalmortality with coronary bypass surgery by using data froma prospective observational study as a reference.Methods. The observational study involved collectingdata on all patients undergoing first coronary bypasssurgery at five hospitals in Catalonia, Spain betweenNovember 2001 and November 2003. In addition, datacovering the same period and hospitals were obtainedfrom the MBDS for procedure code 36.1. We investigatedthe concordance between the information from the twodata sources and logistic regression was used to derivepredictive models for in-hospital mortality. The modelderived using MBDS data was validated using data fromthe prospective observational study and MBDS data forthe years 2004-2006. Model validity was evaluated usingdiscrimination and calibration indices.Results. Some 4.1% of cases in the observationalstudy could not be found in the MBDS. The concordancebetween the two data sources was highly variable andgenerally low (kappa values ranged from 0.16 to 0.79).The discriminative ability of the MBDS model wasequivalent to that of the observational study model(c=0.80 vs. c=0.79), but when the validity of the formerwas tested using prospective data and MBDS data for2004-2006, the discrimination c-index decreased to 0.76and 0.65, respectively, and the calibration worsenedsignificantly (P<.001).Conclusions. The risk of in-hospital mortality followingcoronary surgery cannot be accurately evaluated usingMBDS data. However, our results indicate that their useas a predictive tool could be improved

The EuroSCORE and a local model consistently predicted coronary surgery mortality and showed complementary properties.

OBJECTIVE: To revalidate a local model for prediction of in-hospital mortality after coronary surgery several years after its introduction and the EuroSCORE in a specific area within its original scope. To assess the specific advantages of one type of instrument over the other in a definite context. STUDY DESIGN AND SETTING: Data from consecutive patients undergoing a first isolated coronary artery bypass between November 2001 and November 2003 in five hospitals in Catalonia were prospectively collected. RESULTS: The study included 1,605 patients. Areas under the receiver-operating characteristics curves were around 0.75 for both models. Calibration was low for both models and the local model significantly overestimated risk. The ordering of operating centers by performance was identical with each strategy but the centers labeled as outliers differed. CONCLUSION: (1) Evaluation of performance of individual hospitals was consistent using both systems and almost identical when they were internally recalibrated, (2) The impact of the benchmark population characteristics on model performance may be greater than that of risk factors considered for score calculation, (3) Promoting the use of a widely used instrument as the EuroSCORE might be sufficient for most evaluations. Local scales can be useful to highlight locally relevant features and temporal trends.

[Baseline characteristics and determinants of outcome in a patient population admitted for heart failure to a general hospital]. / Características basales y determinantes de la evolución en pacientes ingresados por insuficiencia cardíaca en un hospital general.

INTRODUCTION AND OBJECTIVES: To assess baseline characteristics, management patterns, and clinical outcomes after 18 months in patients diagnosed as heart failure in a tertiary hospital in Catalonia, Spain. METHODS: The records of all 265 patients admitted to the Hospital General Vall d'Hebron from July through December 1998 with a diagnosis of heart failure who met study criteria were identified and analyzed. Patients were interviewed by telephone 18 months later. RESULTS: The mean age of the study population was 75 12 years, 42% were male, 19% were admitted for causes other than heart failure, and 62% had significant comorbidity. Ventricular function was assessed in 68% (preferentially patients with a better prognosis), and was considered normal in 41%. Angiotensin-converting enzyme inhibitors or angiotensin II antagonists were used in 54%, and beta-blockers in 4%. The 18-month mortality was 46% (77% cardiac mortality). Multivariate predictors of death were older age, severe or previous heart failure, and serious comorbidity. At 18 months, 69% of survivors were in functional classes I or II. CONCLUSIONS: 1) As in other geographic areas, patients in this study were an older population with poor survival; 2) local patterns of care definitely need improvement; 3) comorbidity is important for prognosis, and 4) a significant proportion of survivors enjoy an acceptable quality of life long after discharge.

Características basales y determinantes de la evolución en pacientes ingresados por insuficiencia cardíaca en un hospital general / Baseline characteristics and determinants of outcome in a patient population admitted for heart failure to a general hospital

Introducción y objetivos. Analizar las características basales, los patrones de manejo y los resultados clínicos a los 18 meses del ingreso en pacientes diagnosticados de insuficiencia cardíaca en un hospital terciario de Cataluña. Métodos. Se identificaron y analizaron las historias clínicas de los 256 pacientes ingresados en el Hospital General Vall d'Hebron desde julio a diciembre de 1998, diagnosticados de insuficiencia cardíaca y que cumplieran los criterios del estudio. Se entrevistó a los pacientes telefónicamente 18 meses después. Resultados. La edad media de los pacientes era de 75 ñ 12 años, el 42 por ciento correspondía a varones, el 19 por ciento había ingresado por enfermedades distintas de la insuficiencia cardíaca y el 62 por ciento tenía comorbilidad significativa. Se estudió la función ventricular en el 68 por ciento (básicamente en pacientes con mejor pronóstico), y se consideró normal en un 41 por ciento. Se administraron inhibidores de la enzima conversiva o antagonistas de la angiotensina II en un 54 por ciento y bloqueadores beta en un 4 por ciento. La mortalidad a los 18 meses fue del 46 por ciento, siendo de causa cardíaca en el 77 por ciento de éstos. Los predictores independientes de mortalidad fueron la edad avanzada, la insuficiencia cardíaca grave o antigua y la comorbilidad. A los 18 meses, un 69 por ciento de los supervivientes se hallaba en clase funcional I o II. Conclusiones. 1) Al igual que sucede en otras áreas geográficas, los pacientes de este estudio constituyen, como media, una población anciana y con pobre supervivencia; 2) los patrones de manejo registrados son claramente mejorables; 3) la comorbilidad afecta significativamente al pronóstico, y 4) la calidad de vida después del alta es aceptable en una llamativa proporción de supervivientes. (AU)