[Transcatheter aortic valve implantation versus aortic valve replacement: cost analysis from the regional health service and hospital perspectives]. / I costi di ricovero e follow-up delle procedure di sostituzione valvolare aortica per via percutanea e cardiochirurgica a confronto: analisi secondo le prospettive del Sistema Sanitario Regionale e dell'Ospedale.

BACKGROUND: The aim of this study was to estimate the cost of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) procedures, together with the cost of the first-year hospitalizations following the index ones, in 4 Italian regions where diffusion level of TAVI and coverage decisions are different. METHODS: The cost analysis was performed evaluating 372 patients enrolled consecutively from December 1, 2012 to September 30, 2015. The index hospitalization cost was calculated both from the hospital perspective through a full-costing approach and from the regional healthcare service perspective by applying the regional reimbursement tariffs. The follow-up costs were calculated for one year after the index hospitalization, from the regional healthcare sservice perspective, through the identification of hospital admissions for cardiovascular pathologies after the index hospitalization and computation of the relative regional tariffs. RESULTS: The mean hospitalization cost was € 32 120 for transfemoral TAVI (232 procedures), € 35 958 for transapical TAVI (31 procedures) and € 17 441 for AVR (109 procedures). From the regional healthcare service perspective, the mean transfemoral TAVI cost was € 29 989, with relevant regional variability (range from € 19 987 to € 36 979); the mean transapical TAVI cost was € 39 148; the mean AVR cost was € 32 020. The mean follow-up costs were € 2294 for transfemoral TAVI, € 2335 for transapical TAVI, and € 2601 for AVR. CONCLUSIONS: In our study, transapical TAVI resulted more expensive than transfemoral TAVI, while surgical AVR was cheaper than both (less than 40%). Costs of the transfemoral approach showed great variability between participating regions, probably due to different hospital costs, logistics, patients' selection and reimbursement policy. A central level of control would be appropriate to avoid unjustified differences in access to innovative procedures between different Italian regions.

Factors influencing surgical delay after hip fracture in hospitals of Emilia Romagna Region, Italy: a multilevel analysis.

Hip fracture is becoming a major public health concern, with associated mortality and morbidity particularly in the elderly. This study aims to investigate factors (i.e. patient factors and hospital variables) associated with increased risk for delaying surgery after hip fractures, and to assess whether and to what extent timing was associated with mortality risk. All patients aged 65 and over, resident in Emilia Romagna Region (Italy) and admitted to hospital for hip fracture (2009 - 2010) were selected. Data on surgical delay were adjusted using multilevel logistic regression model. A Cox proportional hazard model was fitted to a propensity score matched sample to assess mortality between delayed and early treated patients. Of the 10, 995 patients included (mean age: 83.3 years), 44.9% underwent surgery within 2 days. Significant risk factors for delayed surgery were: gender (OR: 1.16), comorbidity (OR: 1.29), anticoagulant (OR: 7.64) ,antiplatelet medication (OR: 2.43) , type of procedure (OR: 1.37) and day of admission (OR: Thu-Fri: 6.05; Sat-Sun: 1.17). Type of hospital and annual volume of hip fracture surgeries were not sufficient to explain hospital variability. A significant difference in mortality rate between early and delayed surgery emerged six months post surgery.

[The cost of innovation in treating aortic stenosis: transcatheter aortic valve implantation]. / Il costo dell'innovazione nel trattamento della stenosi aortica: l'impianto transcatetere di protesi valvolare aortica.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) represents a promising therapeutic option for patients affected by severe aortic stenosis, but it is currently associated with high costs. Therefore, the assessment of its economic impact becomes urgent to support decision-makers' choices about its use, patient access to treatment and reimbursement mechanisms. METHODS: A retrospective, observational, single-center (the teaching hospital located in Bologna, Italy) study was conducted. All patients with severe symptomatic aortic stenosis undergoing TAVI during the enrolment period (February 2008-August 2010) were included. The procedures were performed with both bioprostheses approved for clinical use and through different vascular access: CoreValve transfemoral (CV-TF), CoreValve transsubclavian (CV-TS), Edwards Sapien transapical (ES-TA), Edwards Sapien transfemoral (ES-TF). Costs of the whole index hospitalization have been calculated from the hospital perspective. Healthcare resource consumption was measured at patient level and assessed using unit costs (micro-costing approach). RESULTS: Overall, 87 consecutive patients (48 CV-TF, 12 CV-TS, 20 ES-TA, 7 ES-TF) were included in the study. They presented a high-risk profile (age 83.3 ± 5.4 years; logistic EuroSCORE 23.3 ± 12.3%) and important comorbidity. In-hospital mortality was 3.4%. Total cost of hospitalization was, on average, €35.841 (range €27.267-69.744) of which 68% was attributable to the procedure. A huge variation in costs was observed among different treatment groups. Patients treated with transfemoral implant (CV-TF: €33.977; ES-TF: €31.442) were on average less expensive than others (CV-TS: €37.035; ES-TA: €41.139). CONCLUSIONS: Our findings show that treating patients with TAVI places a heavy burden on hospital budget. Hence, due to the shortage of financial resources, affordability of TAVI requires further attention.

Impact on quality of life of urinary incontinence and overactive bladder: a systematic literature review.

The paper provides a systematization of the scientific evidence on quality of life of patients affected by urinary incontinence (UI) and overactive bladder (OAB) through a systematic literature review. A single search strategy was performed through the databases and papers collected are reviewed by independent researchers finally, including 39 papers. A strong heterogeneity of studies emerged from the evidence. The multidimensionality of the consequences produced by UI and OAB increased the attention on the identification of the most affected dimension of life quality (i.e. physical, emotional) and on the attempt of predicting life quality impairment through specific variables.

Avoiding adverse drug reactions by pharmacogenetic testing: a systematic review of the economic evidence in the case of TPMT and AZA-induced side effects.

OBJECTIVES: The study aims at evaluating the economic evidence related to testing for genetic variants of the drug-metabolizing enzyme, TPMT. Detecting TPMT genetic variants before the administration of azathioprine (AZA) has the potential to prevent serious and costly adverse drug reactions (ADRs), such as neutropenia. In particular, our analysis concentrated on assessing the reliability of data on costs of neutropenia and performing the tests, the two main cost categories that could inform an economic evaluation of TPMT pharmacogenetic testing. METHODS: A systematic literature review was performed to gather evidence on the costs of testing and neutropenia. Articles were critically appraised for their comprehensiveness and quality. To better estimate costs of TPMT tests, a small-scale survey of European diagnostic laboratories was conducted. RESULTS: Only seven articles were retrieved specifying the costs associated with the management and treatment of AZA-induced neutropenia. Most of these studies are based on theoretical modeling reconstructed with key-informants or on very few cases of ADRs, and either the methodology for cost calculation is not specified or costs are based on national cost databases and tariffs. After critical appraisal of these studies, we considered 2,116 euros as the most reliable estimate for the cost of a case of neutropenia. Literature review accompanied by the survey of several diagnostic laboratories also provided an estimate (68 euros) for TPMT testing. Based on these values, the net cost per prevented case of neutropenia equals to 5,300 euros. CONCLUSIONS: Solid economic considerations related to TPMT pharmacogenetic testing are still limited by underreporting of ADRs and high level of approximation related to cost data. Ad hoc observational studies and the ADR recording process embedded in pharmacovigilance systems, established across Europe, should represent more reliable sources of cost data in the future.