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Background Many trials supported pembrolizumab as a first-line monotherapy to significantly improve overall survival (OS) in selected patients with previously untreated metastatic Non–Small Cell Lung Cancer (mNSCLC) and a PD-L1 TPS of ≥50% without EGFR/ALK mutations. The aim of this study was to reveal the correlation between OS and adverse events in real-world settings after 42 months. Methods This retrospective observational study involved 98 patients with mNSCLC, TPS ≥ 50%, and no EGFR/ALK aberrations. Patients were treated with pembrolizumab (200 mg q3w) as a first-line treatment. Clinical data, including PD-L1 expression, Performance Status (ECOG-PS), treatment duration, toxicity, and outcomes were retrieved from local electronic medical records and from the Italian Regulatory Agency Registry. Results The cohort’s main characteristics were as follows: median age 73 [44-89] years, 64.3% were male and 35.7% were female, an ECOG-PS score of 0 (n = 73) and 1 or 2 (n = 25), and a PD-L1 > 90% in 29.6% of patients. The entire cohort had stage IV NSCLC at diagnosis. The median number of cycles was 8.5 at a median follow-up of 13 months. The median OS of 13.6 months (95% CI: 11.7-NA) was not influenced by sex and PD-L1, but was significantly associated with ECOG-PS (p = 0.02). Immune-Related Adverse Events (irAEs) occurred in 77.5% of patients (30.1% cutaneous, 27.5% gastrointestinal, and 20.4% endocrinological), but no grade 4 or 5 irAEs were identified. Patients experiencing any type of toxicity had a significantly longer median OS (20.39 months, 95% CI: 13.08-NA) than those with no toxicities (6.46 months, 95% CI: 1.41-NA, p = 0.006). Conclusion The percentage of irAEs detected was comparable to that reported in KEYNOTE-024 and KEYNOTE-042. These real-world findings demonstrated the significant correlation between OS and cutaneous toxicities.

In Italy, there is scant evidence on the impact of Community Hospitals (CHs) on clinical outcomes.To assess the effectiveness of CHs versus long-term care hospital or inpatient rehabilitation facilities on mortality, re-admission, institutionalization, and activation of a home care programme in the Emilia-Romagna Region (ERR-Italy) after acute hospitalisation.We implemented a cohort study drawing upon the ERR Administrative Healthcare Database System and including hospital episodes of ERR residents subject ≥ 65 years, discharged from a public or private hospital with a medical diagnosis to a CH or to usual care between 2017 and 2019. To control for confounding, we applied a propensity score matching.Patients transferred to CHs had a significantly lower risk of dying but an increased risk of being readmitted to community or acute hospital within 30/90 days from discharge. The hazard of institutionalisation within 30/90 days was significantly lower in the whole population of the CH exposed group but not among patients with cardiac or respiratory chronic diseases or diabetes. The activation of a home care program within 90 days was slightly higher for those who were transferred to a CH.The findings of our study show mixed effects on outcomes of patients transferred to CHs compared to those who followed the post-acute usual care and should be taken with cautious as could be affected by the so-called 'confounding by indication'.The study contributes to the intermediate care available evidence from a region with a well-established care provision through CHs.

Although the study of the association between interventions in primary care and health outcomes continues to produce mixed findings, programs designed to promote the greater compliance of General Practitioners and their diabetic patients with treatment guidelines have been increasingly introduced worldwide, in an attempt to achieve better quality diabetes care through the enhanced standardisation of patient supervision. In this study we use clinical data taken from the Diabetes Register of one Local Health Authority (LHAs) in Italy’s Emilia-Romagna Region for the period 2014-2015. Firstly, we test to see whether the monitoring activities prescribed for diabetics by regional diabetes guidelines, actually have a positive impact on patients’ health outcomes and increase appropriateness in health care utilization. Secondly, we investigate whether GPs’ participation in the local Diabetes Management Program (DMP) leads to improved patient compliance with regional guidelines. Our results show that such a program, which aims to increase GPs’ involvement and cooperation in following regional guidelines for best practices, achieves its goal of improved patient compliance with the prescribed actions. In turn, through the implementation of the DMP and the greater involvement of physicians, regional policies have succeeded in promoting better health outcomes and the improved appropriateness of health care utilization.

multimorbidity analysis provides essential information to support health policy in the field of prevention, clinical management, and resources allocation in order to guarantee personalized and adequate strategies for patients with multiple chronic pathologies.to present the application of a methodology based upon data retrieved in healthcare administrative databases to investigate the extent of multimorbidity (coexistence of two or more chronic condition), evaluating its epidemiology, its impact on healthcare resources, and identifying patterns of associative multimorbidity, based on non-random association among chronic diseases. DESIGN: observational study based on regional healthcare data record linkage.all people aged 18 years or older permanently or temporarily resident in Emilia-Romagna Region (Northern Italy) during 2017 (amounting to 3,901,252 persons) were included.period prevalence and incidence of 32 chronic diseases; identification of patients affected by two or more concurrent chronic diseases (multimorbid patients), and evaluation of their period prevalence, incidence, healthcare resources use, and costs. Factorial analysis was applied to assess association among chronic diseases and to estimate groups of chronic conditions non-randomly coexisting (patterns of multimorbidity) among the elderly (people aged 65+ years).the multimorbidity incidence rate in 2017 was 2.7% (4.9% in the elderly) and the multimorbidity period prevalence, evaluated on the 3,901,252 adult residents, was 25.2%, ranging from 2.8% in people aged40 years to 72.5% in octogenarians, with no major difference by gender. Sixty one percent of the elderly suffered from two or more concurrent chronic diseases and, among these, four groups of chronic condition non-randomly coexisting were recognized (cardiovascular, neuropsychiatric, metabolic, and pain pattern). These four multimorbidity patterns affected 39.6% of over 65. The impact on healthcare resources use was considerable: about 70% of all provided healthcare services and 72% of the costs incurred by Regional Health Service was allocated to multimorbid patients (81% and 86.7%, respectively, among the elderly).healthcare administrative databases are a valuable tool to assess the frequency of multimorbidity and its impact on healthcare resources. Patients belonging to the four common patterns of multimorbidity identified in this study explained a high proportion of multimorbidity prevalence and healthcare resources use.

Many factors affect the healthcare costs and outcomes in patients with hip fracture (HF). Through the construction of a Continuum-Care Episode (CCE), we investigated the costs of CCEs for HF and their determinants. We used data extracted from administrative databases of 5094 consecutive elderly patients hospitalized in 2017 in Emilia Romagna, Italy, to evaluate the overall costs of the CCE. We calculated the acute and post-acute costs from the date of the hospital admission to the end of the CCE. The determinants of costs by type of surgical intervention (total hip replacement, partial hip replacement, open reduction, and internal fixation) were investigated using generalized linear regression models. Regardless of the type of surgical intervention, hospital bed-based rehabilitation in public or private healthcare facilities either followed by rehabilitation in a community hospital/temporary nursing home beds or not were the strongest determinants of costs, while rehabilitation in intermediate care facilities alone was associated with lower costs. CCE’s cost and its variability is mainly related to the rehabilitation setting. Cost-wise, intermediate care resulted to be an appropriate setting for providing post-acute rehabilitation for HF, representing the one associated with lower overall costs. Intermediate care organizational setting should be privileged when planning integrated care HF pathways.

The dramatic impact of the COVID-19 pandemic extends beyond the risk of deaths related to virus infection. Excess deaths from other causes, particularly cardiovascular deaths, have been reported worldwide. Our study based on administrative databases of the Emilia-Romagna region demonstrates a 17% excess of out-of-hospital cardiac deaths in the first 2020 semester with a peak of +62% on April. The excess of cardiac deaths may be explained by the indirect consequences of the response to the COVID-19 pandemic. These include a dramatic reduction of hospital admissions during the pandemic, particularly for acute coronary syndromes; an increase of out-of-hospital cardiac arrests; a reduction of outpatient clinic activities and cardiac procedures; long-term cardiovascular effects of COVID-19; and unfavorable cardiac effects of the lockdown imposed by the spread of COVID-19 infection. The knowledge of the indirect consequences of COVID-19 pandemic is important for planning cardiologic strategies.

BACKGROUND: The COVID-19 pandemic has put several healthcare systems under severe pressure. The present analysis investigates how the first wave of the COVID-19 pandemic affected the myocardial infarction (MI) network of Emilia-Romagna (Italy). METHODS: Based on Emilia-Romagna mortality registry and administrative data from all the hospitals from January 2017 to June 2020, we analysed: i) temporal trend in MI hospital admissions; ii) characteristics, management, and 30-day mortality of MI patients; iii) out-of-hospital mortality for cardiac cause. FINDINGS: Admissions for MI declined on February 22, 2020 (IRR -19.5%, 95%CI from -8.4% to -29.3%, p=0.001), and further on March 5, 2020 (IRR -21.6%, 95%CI from -9.0% to -32.5%, p=0.001). The return to pre-COVID-19 MI-related admission levels was observed from May 13, 2020 (IRR 34.3%, 95%CI 20.0%-50.2%, p

Introduzione. L’impatto economico del diabete mellito è in costante crescita e numerosi studi hanno calcolato i costi dei pazienti con diabete con risultati difficilmente confrontabili perché ottenuti con metodologie e prospettive differenti. Una valutazione delle prestazioni assistenziali erogate e della spesa correlata per la cura del diabete che sia specifica per il contesto regionale e nazionale è essenziale per sviluppare e migliorare programmi volti ad ottenere cure efficaci, garantendo la sostenibilità economica. Obiettivo. Valutare l’impatto economico dei pazienti con diabete mellito di tipo 2 nelle Aziende Usl di Parma, Modena e Bologna. Metodi. Studio cost-of-illness condotto secondo un’ottica di prevalenza e con un approccio comprensivo globale. Sono stati calcolati i costi diretti sanitari annuali dei pazienti con diabete mellito di tipo 2, nel 2015, relativi a ricoveri, farmaci e prestazioni specialistiche, attraverso il linkage di banche dati da flussi amministrativi correnti. I costi sono stati stimati secondo la prospettiva del Servizio sanitario nazionale e con un approccio bottom-up. Risultati. La popolazione in studio è composta da 101.334 soggetti con un’età media di 70,9 anni e una leggera predominanza di soggetti di genere maschile (54,1%). Nel 2015, il costo mediano per paziente diabetico è stato di 1012,6 euro. È stato possibile individuare due distinti gruppi di pazienti: a ‘basso costo’ e ad ‘alto costo’ che differiscono principalmente per età, durata di malattia e complicanze. I determinanti dei costi più rilevanti sono stati le complicanze, le comorbidità e l’età avanzata. Conclusioni. I nostri risultati mettono in evidenza l’eterogeneità dei pazienti diabetici per caratteristiche cliniche e consumo di risorse e forniscono indicazioni per programmare misure di controllo e contenimento dei costi attraverso l’organizzazione di interventi di prevenzione e una presa in carico appropriata rispetto ai bisogni assistenziali.

Background and Objectives Many studies and systematic reviews have estimated the healthcare costs of diabetes using a cost-of-illness approach. However, in the studies based on this approach patients’ heterogeneity is rarely taken into account. The aim of this study was to stratify patients with type 2 diabetes into homogeneous cost groups based on demographic and clinical characteristics. Methods We conducted a retrospective cost-of-illness study by linking individual data on health services utilization retrieved from the administrative databases of Emilia-Romagna Region (Italy). Direct medical costs (either all-cause or diabetes-related) were calculated from the perspective of the regional health service, using tariffs for hospitalizations and outpatient services and the unit costs of prescriptions for drugs. The determinants of costs identified in a generalized linear regression model were used to characterize subgroups of patients with homogeneous costs in a classification and regression tree analysis. Results The study population consisted of a cohort of 101,334 patients with type 2 diabetes, followed up for 1 year, with a mean age of 70.9 years. Age, gender, complications, comorbidities and living area accounted significantly for cost variability. The classification tree identified ten patient subgroups with different costs, ranging from a median of €483 to €39,578. The two subgroups with highest costs comprised dialysis patients, and the largest subgroup (57.9%) comprised patients aged ≥ 65 years without renal, cardiovascular and cerebrovascular complications. Conclusions Classification of patients into homogeneous cost subgroups can be used to improve the management of, and budget allocation for, patients with type 2 diabetes.

Beta-blockers (BB), ACE inhibitors/angiotensin receptor blockers(ACEi/ARBs) and aldosterone antagonists (AA) do represent diseasemodifying drugs and have become the cornerstone of heart failure(HF) pharmacological therapy [1]. However, it is never safe to assumethat treatments of proven efficacy in younger, healthier patients willprovide equivalent benefit in older patients [2] but current guidelinesrarely distinguish the use of these therapies on the basis of age [3].To help clarify these issues a retrospective cohort study was under-taken byidentifyingall patients hospitalized for HF and never hospital-ized for HFin theprevious 10 years, discharged from 1 January 2009 to31December 2010in theEmilia–Romagna, 4.3 million resident inhabi-tants in the Italian region. Inclusion criteria were one of the followingICD9-CM codes as principal discharge diagnosis: 428.0, 428.1, 428.2x,428.3x, 428.4x, 428.9x, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11,404.13, 404.91, 404.93, and 398.91. Exclusion criteria were: age≤75 years,residenceoutsideEmilia–Romagnaregionanddeathwithin90 days of discharge. Accordingly, the eventual HF disease-modifyingdrug was prescribed away from the known clinically “vulnerable”phase regardless of standard medical therapy [4].Theeligiblecohortwascategorizedin6groupsofpatientsbasedonadrugprescriptionwithin90daysfromhospitaldischarge:1)noBB/ACEi/ARBs/AA (“No drug”); 2) single ACEi/ARBs (“only ACEi/ARBs”); 3) singleBB (“only BB”); 4) ACEi/ARBs plus BB (“double therapy”); 5) BB plusACEi/ARBs plus AA (“triple therapy”); and 6) other different combina-tions between BB and/or ACEi/ARBs and/or AA ( “other combinations”).Data were collected from the Emilia–Romagna Region administra-tive healthcare databases, which capture information about health ser-vice utilization from the entire region. Patients' information wasretrievedfromtheregionaldatabaseofhospitaldischarges,theregionaloutpatient and inpatient drug prescription database and the regionalmortality registry. The following ATC classes were used: C07 class(BB); C09A' 'C09B' 'C09C' 'C09D class (ACEi/ARBs); and C03DA class(AA). Individuals were linked across data files with anonymous patientidentifiers and were followed for 1 year.Foreachpatient,informationonage,gender,comorbiditiesandproce-dures was retrieved from the previous 10 years of hospitalization fromindex admission. The study outcomes were 1-year all-cause mortality,HFrehospitalizationandall-causerehospitalizationfromindexdischarge.All the outcomes were calculated crude and adjusted. Continuous vari-ables were expressed as mean ± SD a nd median and compared using aK-sample equality of median test. Categorical variables were expressedas percentages and the Chi-squar e test was used for comparison.IncidenceofeventswasestimatedbytheKaplan–Meiermethodandcompared using the Log-rank test. Observations were censored at thetime of the event or at the end of follow-up. One-year adjusted risk ofevents was evaluated by using Cox's proportional hazards modelsadjusting for all variables reported in Table 1. We used a multivariatestepwise Cox regression analysis for variable selection with entry andstay probability of 0.1 (10%). Results are reported as Hazard Ratios(HR) with 95% confidence intervals.Allstatisticaltestsweretwo-sided(p-valueb0.05wasconsideredtobe significant). All analyses were performed with the SAS 9.1.3 version(Service Pack 4, SAS Institute Inc., Cary, NC, USA) (SAS Institute, Cary,NC,USA)andtheSTATA12.1(STATACorpLP,CollegeStation,TX,USA).Clinical baseline and demographic characteristics of patients areshownin Table1.After1-yearfollow-upperiodfromindexHFhospital-ization,1690(18.1%)deathand5273(56.4%)hospitalreadmissionshadoccurred. The 1-year HF-related hospital readmissions were 1686 (31%of the total hospital readmissions).

Objectives: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe.Methods: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants’ opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents.Results: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support.Conclusions: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

BACKGROUND: Consensus guidelines define indications for cardiac resynchronization therapy (CRT), but the variability in implant rates in 'real world' clinical practice, as well as the relationship with the epidemiology of heart failure are not defined. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.4 million inhabitants, a registry was instituted to collect data on implanted devices for CRT, with (CRT-D) or without defibrillation (CRT-P) capabilities. Data from all consecutive patients resident in this region who underwent a first implant of a CRT device in years 2006-2010 were collected and standardized (considering each of the nine provinces of the region). The number of CRT implants increased progressively, with a 71% increase in 2010 compared to 2006. Between 84 and 90% of implants were with CRT-D devices. The variability in standardized implant rates among the provinces was substantial and the ratio between the provinces with the highest and the lowest implant rates was always greater than 2. Considering prevalent cases of heart failure in the period 2006-2010, the proportion of patients implanted with CRT per year ranged between 0.23 and 0.30%. CONCLUSIONS: The application in 'real world' clinical practice of CRT in heart failure is quite heterogeneous, with substantial variability even among areas belonging to the same region, with the need to make the access to this treatment more equitable. Despite the increased use of CRT, its overall rate of adoption is low, if a population of prevalent heart failure patients is selected on the basis of administrative data on hospitalizations.

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.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.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.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.

To investigate the predictive value of 64-slice computed tomography coronary angiography (CTCA) for major adverse cardiac events (MACEs) in patients with suspected or known coronary artery disease (CAD).Seven hundred and sixty-seven consecutive patients (496 men, age 62±11 y) with suspected or known heart disease referred to an outpatient clinic underwent 64-slice CTCA. The patients were followed for the occurrence of MACE (ie, cardiac death, nonfatal myocardial infarction, unstable angina).Eleven thousand five hundred and sixty-four coronary segments were assessed. Of these, 178 (1.5%) were not assessable because of insufficient image quality. Overall, CTCA revealed the absence of CAD in 219 (28.5%) patients, nonobstructive CAD (coronary plaque ≤50%) in 282 (36.8%) patients, and obstructive CAD in 266 (34.7%) patients. A total of 21 major cardiac events (4 cardiac deaths, 12 myocardial infarctions, and 5 unstable angina) occurred during a mean follow-up of 20 months. One noncardiac death occurred. Seventeen events occurred in the group of patients with obstructive CAD, and 4 events occurred in the group with nonobstructive CAD. The event rate was 0% among patients with normal coronary arteries at CTCA. In multivariate analysis, the presence of obstructive CAD and diabetes were the only independent predictors of MACE.Coronary plaque evaluation by CTCA provides an independent prognostic value for the prediction of MACE. Patients with normal CTCA findings have an excellent prognosis at follow-up.

Aims International and national consensus guidelines define appropriate indications for implantable cardioverter–defibrillators (ICDs), but the variability in implant rates in ‘real world’ clinical practice is still unknown. Methods and results In Emilia-Romagna, an Italian region with around 4.3 million inhabitants, a web-based registry was instituted to collect data for all ICDs implanted. Between January 2006 and December 2008, data from all consecutive patients resident in this region who underwent first implant of an ICD or a biventricular ICD were collected and standardized, considering each regional area (i.e. each of the nine provinces). The overall number of implanted ICDs had an increase in years 2007 and 2008, with a relative increase in comparison to 2006, by 14 and 48% respectively, reaching an average value of 16.2 per 100 000 inhabitants in 2008. Most of the increase was due to a rise in ICDs for primary prevention. The ratio between the implant rates of the provinces with the highest and the lowest implant rates, respectively, was around 2 in 2008. Conclusion Implant rates for ICDs, considering both primary and secondary prevention of sudden death, show up to two-fold variations even in a geographical region where the general level of health care is advanced and well appreciated by the population. The lack of a common strategy for sudden death prevention, approved by both physicians and institutional regional authorities, together with some degree of variability in translating guidelines into clinical practice, were identified as the main factors explaining the heterogeneity in ICD implant rates.

Multislice Spiral Computed Tomography (MSCT) is an emerging non-invasive diagnostic modality to detect coronary artery disease, which may alter diagnostic pathways and change the current clinical role of conventional coronary angiography. Aims: To retrieve and critically assess information from the available literature on MSCT (>= 16-slice) concerning its diagnostic accuracy, safety, applicability, clinical impact and cost-effectiveness. Methods and results: Articles published between January 2002 and March 2007 were identified through searches of the Cochrane Library, MEDLINE, and other websites of manufacturers, cardiac professional societies, guidelines and abstracts from conference meetings. We identified 1768 potentially relevant articles: 262 out of these were considered eligible for full evaluation and 150 were selected ( 57 assessed diagnostic accuracy, 130 applicability, 103 safety, 1 clinical impact and none cost-effectiveness). The pre test probability of coronary artery disease was 56.7% (95% Confidence Interval: 55.1%-58.3%). A positive MSCT finding (pooled LR+: 5.4 (4.4-6.7)) increased the probability of CAD to 87.7% (84.3%-90.3%), whereas a negative MSCT result ( pooled LR-: 0.09 (0.07-0.12)) reduced the probability of CAD to 10.7% (7.9%-14.4%). Conclusions: MSCT is a promising technology for the assessment of coronary artery stenosis. However, the available literature is of limited value in providing guidance to support the development of policies for its appropriate utilization in clinical practice. (c) 2008 Elsevier Ireland Ltd. All rights reserved.

Aortic stenosis is the most common valve disease and transcatheter aortic valve replacement is considered as an alternative to surgical valve replacement or to medical treatment in inoperable or high-risk patients, but it is not suitable for all patients with severe aortic stenosis, taking into account also the high cost associated.To evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis via percutaneous, (transfemoral, or endovascular approach) or surgically (transapical, or transventricular) approach.The present review includes 10 randomized controlled trials (RCTs) and 29 observational studies. We combined the outcomes from the individual trials through meta-analysis where possible. We assessed the overall quality of the evidence for the primary outcome using the GRADE system. Regarding TAVI vs. standard surgery, there were no significant differences between TAVI and conventional surgery for mortality at 1 year or more, the frequency of stroke, and heart attack; for mortality at 30 days, no difference was observed in RCTs and the result was in favor of TAVI in observational studies. Another outcome in favor of TAVI was the frequency of major bleeding that was significantly lower in patients treated with TAVI. The quality of the evidence ranged from moderate to very low. Regarding TAVI vs. medical therapy, for the outcome death at 1 year or more, if we consider the RCTs, the results are favorable to TAVI, while in observational studies no significant differences were observed between the two interventions. In contrast, for the outcome mortality at 30 days, in RCTs no significant differences between the two interventions were observed, while the results were favorable to TAVI in observational studies. For the frequency of stroke in the single RCT that reported this outcome, it was significantly lower in patients treated with medical therapy, with no significant differences in the results of observational studies. The results related to the frequency of heart attack from observational studies are in favor of TAVI. The quality of the evidence ranged from low to very low.Candidates for TAVI are those patients for which conventional open-heart surgery is not recommended because of the risk due to advanced age or important comorbidities.

The service strategy (same-day transfer between spoke hospital and hub centre with catheterisation laboratory (cath-lab) facility to perform invasive procedures) has been suggested to improve the management of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) admitted to spoke hospitals. We used data from a large prospective Italian registry to describe application, performance and outcome of the service strategy in the daily clinical practice.This study was based on an observational, post-hoc analysis of all consecutive NSTEACS patients admitted to spoke non-invasive hospitals of the Emilia-Romagna regional network and receiving coronary artery angiography (CAA)±percutaneous coronary intervention (PCI). We evaluated: application of service strategy, time to cath-lab access, hospital stay length, 30-days occurrence of adverse events.From January 2011-December 2012, 2952 NSTEACS consecutive patients were admitted to spoke non-invasive hospitals and received CAA. Overall, 1765 (60%) patients were managed with a service strategy. After multivariable analysis, service strategy emerged as independent predictor of faster access to cath-lab (within 72 h: hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.9-2.7, p0.0001; within 24 h: HR 2.8, 95% CI 2.2-3.3, p0.0001, respectively). Service strategy significantly reduced hospital stay length (-5.5 days, p0.0001). We estimated a mean of €1590 saved for each patient managed with service strategy. Thirty-day occurrence of adverse events did not differ between patients managed with or without a service strategy.In our daily clinical practice, a service strategy seems to be an effective approach to optimise the invasive management of NSTEACS patients admitted to spoke hospitals.

This article presents a summary of the discussion which took place during the works of PRIER II in the session dedicated to the methodology of registries. Following a thorough analysis of the possible methods and the limits which deal with the collection of clinical data through the registries, the different points of view were compared, perhaps the most relevant, related to this activity. All this has been done by taking advantage by the possibility to observe aspects from different points of view. In particular, the exercise considered those who have to deal with the methodological aspects of the registries as an operator of public health or as a private operator who creates services for companies. The final goal, again, was to line up a few essential points accompanied by reasoning and comments useful to anyone who wants to address the issue of registries from the methodological point of view.

The assessment of the regional network for ST-segment elevation acute myocardial infarction (STEMI) is fundamental for quality assurance. Since 2011 all Italian Health Authorities, in addition to hospital discharge records (HDR), must provide a standardized information flow (ERD) about emergency department (ED) and emergency medical system (EMS) activities. The aim of this study was to evaluate whether data integration of ERD with HDR may allow the development of appropriate quality indicators.Patients admitted to coronary care units (CCU) for STEMI between January 1 to December 31, 2013, were identified from the regional HDR database. All data were linked to those of the regional ERD database. Four quality indicators were defined: 1) rates of EMS activation, 2) rates of EMS direct transfer to the catheterization laboratory (Cath-lab), 3) transfer rates from a Spoke to a Hub hospital with angioplasty facilities, and 4) median time spent in ED.In 2013, 2793 patients with STEMI were admitted to the CCU. Of these, 1684 patients (60%) activated EMS and were transported to Spoke or Hub hospitals; 955 (57%) entered directly in CCU/Cath-lab; 677 were transferred directly to a Hub hospital ED without being admitted to a Spoke hospital. The median ED time in Hub hospital was 47 min (IQR 24-136) and in Spoke hospital 53 min (IQR 30-131).The integration among administrative data banks (i.e., HDR with ERD) allowed the assessment of the regional STEMI network and the identification of potentially useful quality indicators. Their easy availability should enable comparisons with local, national and international standards, and may favor quality improvement.

Background The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in ‘real world’ patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. Methods and results A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006–2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. Conclusions Patients who were implanted in ‘real world’ clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62–64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.

The quality of 39 guidelines developed locally was assessed, using a standardised instrument addressing five quality domains (scope and purpose, stakeholders involvement, rigour of development, applicability and clarity). For each of them a domain‐specific quality score (ranging from 0 to 100) was estimated. Overall, local guidelines scored particularly low on rigour (mean: 5.1; sd: 12.1) and applicability (mean: 16.9; sd: 12.9). Scores for other domains were only slightly better. This study suggests that local guidelines do not assure neither scientific validity of the recommendations nor attention to their adoption in clinical practice. Without substantial changes in their local use, practice guidelines will not be of any benefit in supporting the implementation of clinical governance.

Tyrosine phosphorylation depends on the activity of receptor and non-receptor tyrosine kinases and promote cell growth, differentiation and apoptosis. Different stressors are known to stimulate tyrosine kinase activities and this could explain a wide spectrum of effects that these agents produce on different organisms. We studied the effects of heavy metals and pro-oxidants on tyrosine kinase signalling in trout hepatoma cells (RTH 149) by Western immunoblotting. Use of antiphosphotyrosine showed that Hg(2+) and Cu(2+)in the microM range, and H(2)O(2) in the mM range, induced tyrosine phosphorylation. The effect of Cu(2+)was prevented by pre-incubation with genistein, while those of Hg(2+)and H(2)O(2) were only decreased, probably due to tyrosine kinase stimulation coupled to phosphatase inhibition. Phosphospecific antibodies against the three types of MAPKs showed that ERK is activated by heavy metals only, while p38 and SAPK/JNK are activated by H(2)O(2), Hg(2+), and Cu(2+) plus low H(2)O(2). Cell pre-incubation with p38 inhibitors indicated that ERK activation by H(2)O(2) is prevented by concomitant activation of p38. Phosphospecific STAT antibodies revealed activation by H(2)O(2) only. In conclusion, fish cell exposure to heavy metals and pro-oxidants produce specific tyrosine kinase responses, involving cross talk and redox modulatory effects.

BACKGROUND: The objective was to report recent trends in the incidence, adoption of evidence-based treatment, and clinical outcomes for first-time hospitalization for acute myocardial infarction. METHODS: This is a large retrospective population-based cohort study using medical administrative data (International Classification of Diseases, Ninth Revision, Clinical Modification, codes) performed in the Emilia-Romagna Region of Italy (approximately 4.5 million inhabitants). We identified 60,673 patients with a first hospitalization for acute myocardial infarction from 2002 through 2009. RESULTS: The standardized incidence rate per 100,000 person-years of acute myocardial infarction increased from 173 cases in 2002 to a peak of 197 cases in 2004 and then decreased each year thereafter to 167 cases in 2009. The proportion of patients who underwent coronary angiography and angioplasty in the acute phase increased over time, respectively, from 45.4% and 27.1% to 72.3% and 57.2% (P < .001). Medication use within 12 months of discharge increased for aspirin, β-blockers, and statins. A reduction in crude and adjusted in-hospital all-cause (16.1% in 2002 vs 12.8% in 2009, P < .001) and cardiovascular mortality (13.6% in 2002 vs 9.5% in 2009, P < .001) was observed over time. At 1 year after hospital discharge, no significant variations occurred in adjusted risk for all-cause mortality or cardiovascular mortality. Notably, crude and adjusted risk for in-hospital and postdischarge bleeding showed a significant increment. CONCLUSIONS: The utilization of evidence-based treatments in patients with myocardial infarction increased between 2002 and 2009. These changes in practice over time favored a reduction in early case fatality at the cost of a significant increase in bleeding.

Objectives: Information on the impact of computed tomography coronary angiography (CTCA) on patterns of care is scarce. In particular, it is not clear if, and to what extent, its adoption actually leads to a reduction in the use of other diagnostics tools. The aim of this study was to evaluate whether the adoption of CTCA in Emilia-Romagna (an Italian region with a population of 4.4 million) had any effect on utilization rates of myocardial perfusion scintigraphy (MPS) and coronary angiography (CA).Methods: Interrupted time series (ITS) were applied to monthly volumes of MPS and CA tests performed from 2003 to 2010, to assess trends in usage rates for those procedures before and after CTCA was adopted by all the healthcare organizations operating in the region.Results: After an increase in the first year of CTCA introduction, its use remained stable over the study period. After September 2006, a significant decrease in MPS volumes (31 percent; p < .0001) and a much less tangible decrease in CA volumes (5 percent; p < .0001), were detected by ITS analyses.Conclusions: This study demonstrates that the use of CTCA had a greater impact on MPS usage rates than on CA.

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.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).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).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.

Aims Despite the American Society of Echocardiography (ASE)/European Association of Echocardiography (EAE) recommended the use of left ventricular (LV) mass to diagnose left ventricular hypertrophy (LVH), several laboratories continue to use only the septal thickness by M-mode because it appears easier to measure. Aim of the study was to investigate the discrepancy between the categorization of LVH severity based on measurement of septal thickness and indexed LV mass and the relative prognostic utility of these two methods. Methods and results Observational cohort study. Unselected adults (>18 years) referred to the echocardiography laboratory for any indication had septal thickness and LV mass measured by the ASE/EAE formula using LV linear dimensions indexed to body surface area. LVH was categorized as absent, mild, moderate, and severe according to the ASE/EAE guideline sex-specific categorization cut-offs for septal thickness and LV mass. Follow-up for death was obtained from the national death index. A total of 2545 subjects (mean age 61.9 ± 15.8, 53% women, mean diastolic septal thickness 10.3 ± 2.2 mm, and mean indexed LV mass 107.5 ± 37.3 g/m2) were enrolled. Agreement between the two methods in classifying LVH degree across the four categories was 52.6% (Kappa = 0.29, 95% confidence interval (CI): 0.26–0.32, P < 0.001). Of the 2513 subjects without severely thickened septum, 472 (18.9%) had severely abnormal indexed LV mass. Vice versa, of the 2045 individuals without severely abnormal indexed LV mass, only 4 (0.1%) were classified as severe LVH by septal thickness. After a mean follow-up of 2.5 ± 1.2 years 121 (4.7%) deaths occurred. Using indexed LV mass partition values there was a graded association between LVH degree and survival. Compared with patients with normal indexed LV mass, the adjusted hazard ratio (HR) for death from all causes was 2.17 for mild (95% CI: 1.23–3.81, P = 0.007), 3.04 for moderate (95% CI: 1.76–5.24, P < 0.001), and 3.81 for severe (95% CI: 2.43–5.97, P < 0.001) LVH by indexed LV mass. The area under the receiver-operator characteristic (ROC) curve for the four degrees of LVH by indexed LV mass was superior [area under the curve (AUC) = 0.66] to that of the septal thickness partition values (AUC = 0.58, P = 0.0004). Conclusion In a large cohort study of unselected adult outpatients referred to the echocardiography laboratory, the measurements of indexed LV mass applying the ASE/EAE recommended cut-offs yielded remarkable discrepancy in the diagnosis of LVH severity and offered prognostic information beyond that provided by septal thickness only criteria.

The American Society of Echocardiography (ASE) and European Association of Echocardiography (EAE) recommend the use of quantitative estimation of left ventricular (LV) mass and defined partition values for mild, moderate, and severe hypertrophy. However, the prognostic implications associated with this categorization are unknown.In this observational cohort study of unselected adults undergoing echocardiography for any indication, LV hypertrophy was assessed using the ASE/EAE-recommended formula and measurement convention from LV linear dimensions indexed to body surface area. Mortality and incident hospitalizations for cardiovascular disease were the outcomes of this study.Of 2,545 subjects (mean age, 61.9 ± 15.8 years; 56.3% women), 52.9% had normal LV mass, and 15.4% had mild, 12.1% moderate, and 19.6% severe LV hypertrophy. During a mean follow-up period of 2.5 ± 1.2 years, 121 deaths and 292 incident hospitalizations for cardiovascular disease occurred. In multivariate models including age, gender, LV ejection fraction, wall motion score index, significant valvular disease, and atrial fibrillation, the adjusted hazard ratios for death were 1.81 (95% confidence interval [CI], 1.03-3.20; P = .041) for mild, 2.31 (95% CI, 1.33-4.01; P = .003) for moderate, and 2.30 (95% CI, 1.39-3.79, P = .001) for severe LV hypertrophy. The adjusted hazard ratios for incident cardiovascular hospitalizations were 1.24 (95% CI, 0.84-1.82; P = .277) for mild, 2.02 (95% CI, 1.42-2.88; P = .0001) for moderate, and 2.38 (95% CI, 1.75-3.22, P.0001) for severe LV hypertrophy. After adjustment for known risk predictors, there was a 1.3-fold risk for death and cardiovascular disease events per category of LV mass (P = .001).In a cohort study of unselected adult outpatients, the categorization of LV mass according to the ASE/EAE recommendations offered prognostic information independently of age, gender, and other known predictors.

Aim To assess the prognostic relevance of 64-slice computed tomography coronary angiography (CT-CA) and symptoms in diabetics and non-diabetics referred for cardiac evaluation. Methods We followed 210 patients with diabetes type 2 (DM) and 203 non-diabetic patients referred for CT-CA for ruling out coronary artery disease (CAD). Patients were without known history of CAD and were divided into four categories on the basis of symptoms at presentation (none, atypical angina, typical angina and dyspnoea). Clinical end points were major cardiac events (MACE): cardiac-related death, non-fatal myocardial infarction, unstable angina and cardiac revascularizations. Cox proportional hazard models, with and without adjustment for risk factors and multiplicative interaction term (obstructive CAD × DM), were developed to predict outcome. Results DM patients with dyspnoea or who were asymptomatic showed a higher prevalence of obstructive CAD than non-diabetics (p ≤ 0.01). At mean follow-up of 20.4 months, DM patients had worse cardiac event-free survival in comparison with non-DM patients (90% vs. 81%, p = 0.02). In multivariate analysis, CT-CA evidence of obstructive CAD (in DM patients: HR: 6.4; 95% CI: 2.3–17.5; p 100 in non-DM patients (HR: 5.6; 95% CI: 1.4–21.5; p = 0.01). In Cox regression analysis of the overall population, interaction term obstructive CAD × DM resulted in non-significance. Conclusions Among DM patients, dyspnoea carried a high event risk with a MACE rate four times higher. CT-CA findings were strongly predictive of outcome and proved valuable for further risk stratification.

Objective To evaluate diagnostic accuracy of exercise ECG (ex-ECG) versus 64-slice CT coronary angiography (CT-CA) for the detection of significant coronary artery stenosis in a population with low-to-intermediate pretest likelihood of coronary artery disease (CAD). Design Retrospective single centre. Setting Tertiary academic hospital. Patients 177 consecutive patients (88 men, 89 women, mean age 53.5 +/- 7.6 years) with chest pain and low-to-intermediate pre-test likelihood of CAD were retrospectively enrolled. Interventions All patients underwent ex-ECG, CT-CA and invasive coronary angiography (ICA). Main outcome measure A lumen diameter reduction of >= 50% was considered as significant stenosis for CTCA. Ex-ECG was classified as positive, negative or non-diagnostic. Results were compared with ICA. Diagnostic accuracy of CT-CA and ex-ECG was calculated using ICA as the reference standard. A parallel comparative analysis using a cut-off value of 70% for significant lumen reduction was also performed too. Results ICA disclosed an absence of significant stenosis (>= 50% luminal narrowing) in 85.3% (151/177) patients, single-vessel disease in 9.0% (16/177) patients and multivessel disease in 5.6% (10/177) patients. Prevalence of obstructive disease at ICA was 14.7% (26/177). Sensitivity, specificity, positive and negative predictive values at the patient level were 100.0%, 98.7%, 92.9%, 100%, respectively, for CT-CA and 46.2%, 16.6%, 8.7%, 64.1%, respectively, for ex-ECG. Agreement between CT-CA and ex-ECG was 20.9%. CTCA performed equally well in men and women, while ex-ECG had a better performance in men. After considering the cut-off value of 70% for significant stenosis, the difference between CT-CA and ex-ECG remained significant (p

Background: Several countries have developed policy frameworks allowing timely access to promising health technologies on the condition that additional evidence is generated. However, an important barrier to evidence generation is the lack of structured collaboration among health technology assessment (HTA) agencies.Objectives: One of the aims of Work Package 7 (WP7) of the European network for Health Technology Assessment (EUnetHTA) Project was to determine the types of structured collaboration that could facilitate evidence generation and to develop a Web-based toolkit to support such collaboration.Methods: Collaboration modalities were defined by all WP7 Partners. Initial emphasis was on information sharing. Standardized forms for information sharing were developed and tested. An information technology development phase followed with the creation of the Web-based toolkit (Web site).Results: Three levels of collaboration were agreed on: (i) sharing information, (ii) coordinated action, and (iii) joint action. The Web site allows access to structured and standardized forms for requesting information, posting information in response to a request, and posting information spontaneously. An online database contains all of the information requested or posted. Pilot tests on twenty-one promising technologies were satisfactory.Conclusions: This new Web site for sharing information on evidence generation should help countries reach robust decisions on the timely adoption of promising health technologies. It will only become fully operational if EUnetHTA Partners supply relevant, accurate, and updated information, and regularly use the Web site.

We sought to investigate the performance of 64-slice CT in symptomatic patients with different coronary calcium scores. Two hundred patients undergoing 64-slice CT coronary angiography for suspected coronary artery disease were enrolled into five groups based on Agatston calcium score using the Mayo Clinic risk stratification: group 1: score 0, group 2: score 1-10, group 3: score 11-100, group 4: score 101-400, and group 5: score > 401. Diagnostic accuracy for the detection of significant (a parts per thousand yen50% lumen reduction) coronary artery stenosis was assessed on a per-segment and per-patient base using quantitative coronary angiography as the gold standard. For groups 1 through 5, sensitivity was 97, 96, 91, 90, 92%, and specificity was 99, 98, 96, 88, 90%, respectively, on a per-segment basis. On a per-patient basis, the best diagnostic performance was obtained in group 1 (sensitivity 100% and specificity 100%) and group 5 (sensitivity 95% and specificity 100%). Progressively higher coronary calcium levels affect diagnostic accuracy of CT coronary angiography, decreasing sensitivity and specificity on a per-segment base. On a per-patient base, the best results in terms of diagnostic accuracy were obtained in the populations with very low and very high cardiovascular risk.

Different exogenous compounds are known to stimulate tyrosine kinase signaling, and this could explain a wide spectrum of pollutant effects on different organisms. We studied the effects of various seawater contaminants on tyrosine phosphorylation levels in different tissues of the mussel (Mytilus edulis), by using Western immunoblotting. Mussels were exposed in aquarium for 3 weeks to North Sea oil alone or to a mixture of North Sea oil, alkyl phenols, and polycyclic aromatic hydrocarbons (PAH). In another experiment, mussels were exposed for 3 weeks to each of the following potential endocrine disruptors: bisphenol A, diallyl phthalate, or tetrabromodiphenylether-47. In a third experiment, mussels were caged at four sites along a copper field gradient. Use of antiphosphotyrosine antibody showed that treatments with oil alone, or with oil, alkyl phenols and PAH induced phosphorylation increases in the digestive gland, gills and mantle. Bisphenol A produced significant effects in the gills and mantle, while diallyl phthalate and tetrabromodiphenylether-47 had a slight effect only on the gill tissue. Mussels exposed to the copper field gradient showed phosphotyrosine increases in the gills and mantle at intermediate levels of contamination. This latter result was also confirmed by using phosphospecific p38 antibody. In summary, the strength of induction was: oil mixture > oil > bisphenol A ≥ copper; while the degree of tissue responsiveness was: mantle > gill > digestive gland. Based on these data, the use of tyrosine phosphorylation levels as a biomarker of seawater pollution is proposed.

Amoebic Dictyostelium discoideum cells were employed in a bioassay to evaluate stress responses after exposures to the polyaromatic hydrocarbon benzo[a]pyrene (B[a]P) and two heavy metals (copper and mercury). Furthermore, we developed a recombinant cell line expressing a labile Green Fluorescent Protein (GFP) variant expressed under the control of an actin promoter to monitor stress-related protein degradation. Finally, cell viability was monitored to discriminate lethal exposure concentrations. The results demonstrated that exposure to sub-micromolar concentrations of mercury rendered significant changes in all studied physiological parameters, whereas B[a]P became toxic at low micromolar, and copper at high micromolar concentrations. Exposure to 0.5 microM mercury significantly reduced lysosomal membrane stability (LMS), endocytosis rate, GFP expression, and further resulted in the elevation of cytosolic free Ca(2+) ([Ca(2+)](i)). LMS in mercury-treated cells that had been pre-incubated with a specific Ca(2+)-dependent phospholipase A2 blocking agent was however not affected by the exposure, indicating that the toxic action of mercury is linked to the activation of phospholipase A2 via a Ca(2+)-signaling pathway. Exposure to 20 microM B[a]P significantly reduced LMS, endocytosis rate, and GFP expression, however without affecting [Ca(2+)](i), suggesting a calcium-independent route of toxicity for this compound. None of the physiological parameters were significantly affected by copper exposure at concentrations400 microM, demonstrating a high resistance to this metal. Our results further showed that neither cell growth nor viability was affected by concentrations altering the studied physiological parameters. LMS, endocytosis rate, and [Ca(2+)](I), therefore, appear sensitive biomarkers of pollutant-related stress in amoebic cells.

Assessment of the impact of the regionalisation of cardiac surgery through the organisational form of a hubspoke model introduced in the year 2000.Case mix adjusted before (1998-1999)-after (2000-2002) comparison of: (a) in-hospital and 30 days mortality rates; (b) proportion of patients timely (within one day) referred for surgery from spoke to hub centres; (c) patients' waiting times to surgery.Emilia-Romagna, an Italian region with four million residents.16,512 patients agedor =18 years and referred to cardiac surgery over the period 1998-2002.Overall, taking into account differences in case mix across the whole study period, the implementation of the regionalisation policy was associated with a 22% reduction (OR: 0.79, 95%CI: 0.66 to 0.93) in in-hospital mortality rate. The corresponding figure for 30 day mortality was 18% (OR: 0.82: 95%CI: 0.69 to 0.98). The individual centres' volume of cases changed over the study period for all hospitals but two, and the biggest reduction in mortality was seen at the centre with the largest increase in caseload.This study provides additional evidence on the benefit of regionalisation of cardiac surgery interventions. The system allowed each centre to reach the minimum caseload required to assure good quality of care. These findings suggest that policies aimed at increasing cooperation rather than competition among health service providers have a positive impact on quality of care. Timely referrals for surgery increased by 21% (95%CI: 1.12 to 1.31), and mean waiting times were reduced by 7.5 average days (95%CI: -10.33 to -4.71).

Health services and teams of professionals should be able to monitor the process and outcomes of the care provided, in order to assess and maintain quality. In this paper the application of the control chart technique as a tool for the evaluation of in-hospital mortality of patients with acute myocardial infarction is presented and discussed.The control chart technique, based on the comparison between the outcome observed and the one expected in each individual patient, taking into account prognostic factors, has been applied in the evaluation of in-hospital mortality of 193 patients cared for at four centers of one of the AUSL of Bologna, during the year 2000. Yearly case volume for each of the four centers ranged from 14 to 68 patients. Overall mortality was 8.8, 18.0, 18.0, and 28.6% in the four centers.Use of control charts made it possible to identify relevant differences in outcomes among the four study centers, which would have been otherwise overlooked with usual statistical approaches. In particular, over the whole study period two centers showed relevant variations in their ability to achieve the desired clinical outcome.Clinical teams may use control charts as a tool to monitor their performance and for a timely identification of aspects of care deserving further investigation and analysis.

Primary benign tumors of the heart are particularly rare; cardiac hemangioma is one of the most rare primary benign cardiac tumors. Natural history, symptoms and prognosis of the disease depend on the potential complications due to the location and diffusion of the mass. We report on 2 cases of cardiac hemangioma, diagnosed occasionally in the first patient or due to gastroenteric symptoms in the second patient. The diagnosis was obtained by 2-D-echo and magnetic resonance imaging. In both cases the hemangioma was located on the right ventricle. Both patients underwent tumor resection in hypothermic cardiopulmonary bypass. In one case, a graft to the right coronary artery was associated; in the other case, the right ventricular outflow tract was reconstructed with an infundibular patch. Histology showed mixed hemangioma in one case and cavernous hemangioma in the other. The postoperative course was uneventful. At a follow-up of 8 years and 1 year, respectively, both patients are classified as NYHA 1 and both 2-D-echo and magnetic resonance imaging did not show any residual tumoral mass. This experience demonstrates that, depending on their location, benign neoplastic masses may be radically resected with acceptable operatory risks and excellent long-term results.

The growing importance in medical practice of a standardized diagnosis in cyto- and histopathology and the recent recommendations for the adoption of standardized schemes for quality control in anatomic pathology by International Committees stimulated the medical staff of the Institute of Anatomic Pathology of the University of Bologna to adopt a pertinent method. The method used by the Department of Pathology of the Yale University (New Haven, Connecticut, USA) was chosen. A Committee for the quality control was appointed and two kinds of controls were set up: an External Quality Assessment (review of the difficult cases by external experts, slide seminars) and an Internal Quality Assessment performed by the members of the Committee on the diagnostic and laboratory routine of the Institute. Such a survey is periodically monitored during the monthly meetings of the Committee and described in the monthly reports. The present paper illustrates the method adopted and the preliminary results obtained in order to stimulate the discussion of such a critical theme in contemporary Anatomic Pathology at a national level.