Mortality and healthcare assessment among patients with chronic disease over 2 years of COVID-19: a population-based study in a large hard-hit Italian region.

OBJECTIVES: We aimed to provide a region-wide comprehensive account of the indirect effects of COVID-19 on patients with chronic disease, in terms of non-COVID-19 mortality, and access to both inpatient and outpatient health services over a 2-year pandemic period. DESIGN: Population-based retrospective study. SETTING: Adult patients, affected by at least 1 of 32 prevalent chronic conditions, residing in the Emilia-Romagna Region in Italy, during the years 2020 (N=1 791 189, 47.7% of the overall adult regional population) and 2021 (N=1 801 071, 47.8%). RESULTS: Overall, non-COVID-19 mortality among patients with chronic disease during the pandemic (2.7%) did not differ substantially from the expected mortality (2.5%), based on a 3 years prepandemic period (2017-2019) and adjusting for the demographic and clinical characteristics of the population under study. Indeed, while the first pandemic wave was characterised by a significant non-COVID-19 excess mortality (March: +35%), the subsequent phases did not show such disruptive variations in non-COVID-19 deaths, which remained around or even below the excess mortality threshold. End-of-life care of patients with chronic disease, especially for non-COVID-19 cases, significantly shifted from hospitalisations (-19%), to homecare (ADI: +7%; w/o ADI: +9%). Overall, healthcare of patients without COVID-19 chronic disease decreased, with similar negative trends in hospitalisations (-15.5%), major procedures (-19.6%) and ER accesses (-23.7%). Homecare was the least affected by the pandemic, with an overall reduction of -9.8%. COVID-19 outbreak also impacted on different types of outpatient care. Rehabilitation therapies, specialist visits, diagnostic and lab tests were considerably reduced during the first pandemic wave and consequent lockdown, with access rates of patients without COVID-19 chronic disease below -60%. CONCLUSIONS: This work thoroughly describes how a large and well-defined population of patients without COVID-19 chronic disease has been affected by the changes and reorganisation in the healthcare system during 2 years of the pandemic, highlighting health priorities and challenges in chronic disease management under conditions of limited resources.

Direct impact of 2 years of COVID-19 on chronic disease patients: a population-based study in a large hard-hit Italian region.

OBJECTIVES: We aimed to provide a region-wide comprehensive account of the direct effects of COVID-19 on chronic disease patients, in terms of disease incidence, severity and mortality, over a 2-year pandemic period (2020-2021). DESIGN: Population-based retrospective study. SETTING/PARTICIPANTS: Adult patients, affected by at least 1 of 32 prevalent chronic conditions, residing in the Emilia-Romagna Region in Italy, during the years 2020 (N=1 791 189, 47.7% of the overall adult regional population) and 2021 (N=1 801 071, 47.8%). RESULTS: COVID-19 incidence among chronic disease patients was 4.1% (74 067 cases) in 2020 and 7.3% (126 556 cases) in 2021, varying across pathologies, with obesity and dementia showing the highest incidence. Hospitalisation rate for pneumonia or acute respiratory distress syndrome among SARS-CoV-2-positive patients was 15.4%. COVID-19-related excess mortality, that is, deaths from COVID-19 as either main or contributing (1.5% of the total) cause of death, was observed during the three pandemic waves, with observed/expected death ratios ranging from +38% (March 2020) to +11% (December 2021). Increased risks of both COVID-19-related hospitalisation and death were associated with male gender, elderly age and many pre-existing pathologies, including cardiovascular, cerebrovascular and respiratory diseases, neurological and psychiatric disorders, and metabolic dysfunctions. The higher the number of concomitant pathologies, the greater the risk of COVID-19-related adverse outcomes: the likelihood of hospitalisation and death more than doubled for people with more than two comorbidities, compared with those with one underlying condition. CONCLUSIONS: This study presents a thorough and up-to-date quantification of the direct impact of COVID-19 on chronic disease patients. The results obtained are particularly relevant considering that people with pre-existing chronic conditions accounted for almost all cases of COVID-19-related hospitalisation (82.6%) and death (91.5%) in a vast region of Italy, among the hardest hit by the pandemic.

How Many Cancer Patients Need Palliative Care? A Population-Based Study.

BACKGROUND: The number of cancer patients potentially amenable to palliative care is conventionally estimated from cancer deaths, as reported in the death certificates. However, a more representative population should also include cancer patients who die from causes other than cancer, as they may develop other life-limiting chronic conditions leading to terminal prognosis. AIM: This study aimed at refining the assessment of the number of cancer patients potentially in need of palliative care, by linked hospital and death data. DESIGN: Retrospective study. SETTING/PARTICIPANTS: Residents in the Emilia Romagna Region in Italy, who died between 2009 and 2017. RESULTS: We identified a potential palliative care population of 157,547 cancer patients. The use of different administrative data sources enhanced the sensitivity of our selection. Starting from a standard estimate of 129,212 patients based on cancer as the primary cause of death, we showed that the additional use of hospital records identified a further 11.4% of possible palliative care patients 14,687. Also considering cancer as secondary cause of death, the estimate further increased by 10.6% (13,648 new cases). Notably, the proportion of cancer patients selected by the additional data sources were characterized by more advanced age and higher prevalence of comorbidity. CONCLUSION: Healthcare services addressing the issue of estimating palliative care needs of cancer patients at a population level should consider that relying on the death certificate alone may lead to underestimating these needs of about 22%.

General and COVID-19-Related Mortality by Pre-Existing Chronic Conditions and Care Setting during 2020 in Emilia-Romagna Region, Italy.

In 2020, the number of deaths increased in Italy, mainly because of the COVID-19 pandemic; mortality was among the highest in Europe, with a clear heterogeneity among regions and socio-demographic strata. The present work aims to describe trends in mortality and to quantify excess mortality variability over time and in relation to demographics, pre-existent chronic conditions and care setting of the Emilia-Romagna region (Northern Italy). This is a registry-based cross-sectional study comparing the 2020 observed mortality with figures of the previous five years by age, sex, month, place of death, and chronicity. It includes 300,094 deaths in those 18 years of age and above resident in the Emilia-Romagna region. Excess deaths were higher during the first pandemic wave, particularly among men and in March. Age-adjusted risk was similar among both men and women (Mortality Rate Ratio 1.15; IC95% 1.14-1.16). It was higher among females aged 75+ years and varied between sub-periods. Excluding COVID-19 related deaths, differences in the risk of dying estimates tended to disappear. Metabolic and neuropsychiatric diseases were more prevalent among those that deceased in 2020 compared to the deaths that occurred in 2015-2019 and therefore can be confirmed as elements of increased frailty, such as being in long-term care facilities or private homes as the place of death. Understanding the impact of the pandemic on mortality considering frailties is relevant in a changing scenario.

Early palliative/supportive care in acute myeloid leukaemia allows low aggression end-of-life interventions: observational outpatient study.

OBJECTIVES: Early palliative supportive care has been associated with many advantages in patients with advanced cancer. However, this model is underutilised in patients with haematological malignancies. We investigated the presence and described the frequency of quality indicators for palliative care and end-of-life care in a cohort of patients with acute myeloid leukaemia receiving early palliative supportive care. METHODS: This is an observational, retrospective study based on 215 patients consecutively enrolled at a haematology early palliative supportive care clinic in Modena, Italy. Comprehensive hospital chart reviews were performed to abstract the presence of well-established quality indicators for palliative care and for aggressiveness of care near the end of life. RESULTS: 131 patients received a full early palliative supportive care intervention. All patients had at least one and 67 (51%) patients had four or more quality indicators for palliative care. Only 2.7% of them received chemotherapy in the last 14 days of life. None underwent intubation or cardiopulmonary resuscitation and was admitted to intensive care unit during the last month of life. Only 4% had either multiple hospitalisations or two or more emergency department access. Approximately half of them died at home or in a hospice. More than 40% did not receive transfusions within 7 days of death. The remaining 84 patients, considered late referrals to palliative care, demonstrated sensibly lower frequencies of the same indicators. CONCLUSIONS: Patients with acute myeloid leukaemia receiving early palliative supportive care demonstrated high frequency of quality indicators for palliative care and low rates of treatment aggressiveness at the end of life.

In- and out-of-hospital mortality for myocardial infarction during the first wave of the COVID-19 pandemic in Emilia-Romagna, Italy: A population-based observational study.

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<0.001). As compared to those before the pandemic, MI patients admitted during and after the first wave were younger and with fewer risk factors. The 30-day mortality remained in line with that expected based on previous years (ratio observed/expected was 0.96, 95%CI 0.84-1.08). MI patients positive for SARS-CoV-2 were few (1.5%) but showed poor prognosis (around 5-fold increase in 30-day mortality). In 2020, the number of out-of-hospital cardiac deaths was significantly higher (ratio observed/expected 1.17, 95%CI 1.08-1.27). The peak was reached in April. INTERPRETATION: In Emilia-Romagna, MI hospitalizations significantly decreased during the first wave of the COVID-19 pandemic. Management and outcomes of hospitalized MI patients remained unchanged, except for those with SARS-CoV-2 infection. A concomitant increase in the out-of-hospital cardiac mortality was observed. FUNDING: None.

Multimorbidity epidemiology and health care utilization through combined healthcare administrative databases.

BACKGROUND: 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. OBJECTIVES: 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. SETTING AND PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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). RESULTS: 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 aged <40 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). CONCLUSIONS: 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.

[Indirect effects of the COVID-19 pandemic on cardiovascular mortality]. / Effetti indiretti della pandemia COVID-19 sulla mortalità cardiovascolare.

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.

[Nursing sensitive outcomes: the results of a multicentre study]. / Gli esiti sensibili alle cure infermieristiche:i risultati di uno studio multicentrico.

. Nursing sensitive outcomes: the results of a multicentre study. INTRODUCTION: The relationship between staffing characteristics and nursing sensitive outcomes has been explored in several studies. AIMS: To assess the effect of staffing characteristics, nurses' wellbeing at work and hours of care on pressure sores, falls and physical restrains occurrence. METHODS: Longitudinal study including from February 2014 to June 2015 a total of 24110 consecutive patients and 2606 nurses of 134 units (geriatrics and medicine (GM), orthopedic-traumatology (OT) and rehabilitation and long-term care (LR) of 12 Italian regions. Data was collected up to 15 days for each included patient, and regarding the staff of each shift by ad hoc trained personnel. RESULTS: There is a large variability in both patients and nurses' characteristics across wards, as well as of outcomes, even in the same area (e.g., GM). Patients in GM received a mean of 144±35 minutes of care/day; 186±146 in OT and 140±40 in LR. The incidence of pressure sores was 5.3%±4.8% in GM; 5.1%±5.6% in OT and 8.6%±10.1% in LR. The incidence of falls was 1.9%±2.1% in GM, 0.8%±1% in OT and 2.9%±3.8% in LR. Restraints were used in 41.4%±30.3% of patients in GM, among 24.8%±23.4% in OT and 54.7%±29.7% in LR. The multilevel analyses confirmed the importance of clinical factors but also the positive effects of staff characteristics such as the number of expert nurses and the negative effects of a negative work environment, although with wide variations across settings have emerged. CONCLUSIONS: Staff characteristics related to work environment affect patient outcomes but the large variability across wards would require further stratification of the data to better understand and interpret the findings.

Triple valve surgery: results from a multicenter experience.

AIMS: Triple valve surgery (TVS) may still be considered a challenge in cardiac surgery, and is still associated with a not negligible mortality and morbidity. This study analyzed retrospectively patients' data from RERIC (Registro Regionale degli Interventi Cardiochirurgici) registry, to evaluate early and mid-term results of TVS. METHODS: From April 2002 to December 2013, data from n = 44 211 cardiac surgical procedures were collected from six Cardiac Surgery Departments (RERIC). Two hundred and eighty patients undergoing TVS were identified, including aortic and mitral replacement with tricuspid repair in 211 patients (75.3%), aortic replacement with mitral and tricuspid repair in 64 (22.9%) and triple valve replacement in 5 (1.8%). Univariate and multivariate analyses were performed to identify predictors of overall mortality or adverse outcomes. RESULTS: The mean age of the patients was 67.5 ±â€Š12.2. Overall in-hospital mortality rate was 7.9%: in-hospital mortality was 10.9% in mitral valve repair and 6.6% in mitral valve replacement, respectively. Tricuspid valve replacement was associated with the highest mortality rate (40%). Independent predictors of in-hospital mortality were serum creatinine greater than 2 mg/dl [odds ratio (OR) 4.5; P = 0.03], concomitant coronary artery bypass graft (CABG) (OR 3.8; P = 0.01) and previous cardiac surgery (OR 5.1; P = 0.04). Overall cumulative mortality rate at 1, 3 and 5 years was 14.7, 24.1 and 28.9%, respectively. Mitral valve replacement associated with tricuspid valve repair showed better survival rate (hazard ratio 0.1; P = 0.007). CONCLUSION: TVS has demonstrated satisfactory results in terms of in-hospital and mid-term mortality rate. Renal failure, reoperations and concomitant CABG resulted as risk factors for mortality; moreover, we could not demonstrate a mid-term better survival rate of mitral valve repair compared with the replacement.

Effectiveness of palliative care services: A population-based study of end-of-life care for cancer patients.

BACKGROUND: Multiple studies demonstrate substantial utilization of acute hospital care and, potentially excessive, intensive medical and surgical treatments at the end-of-life. AIM: To evaluate the relationship between the use of home and facility-based hospice palliative care for patients dying with cancer and service utilization at the end of life. DESIGN: Retrospective, population-level study using administrative databases. The effect of palliative care was analyzed between coarsened exact matched cohorts and evaluated through a conditional logistic regression model. SETTING/PARTICIPANTS: The study was conducted on the cohort of 34,357 patients, resident in Emilia-Romagna Region, Italy, admitted to hospital with a diagnosis of metastatic or poor-prognosis cancer during the 6 months before death between January 2013 and December 2015. RESULTS: Patients who received palliative care experienced significantly lower rates of all indicators of aggressive care such as hospital admission (odds ratio (OR) = 0.05, 95% confidence interval (CI): 0.04-0.06), emergency department visits (OR = 0.23, 95% CI: 0.21-0.25), intensive care unit stays (OR = 0.29, 95% CI: 0.26-0.32), major operating room procedures (OR = 0.22, 95% CI: 0.21-0.24), and lower in-hospital death (OR = 0.11, 95% CI: 0.10-0.11). This cohort had significantly higher rates of opiate prescriptions (OR = 1.27, 95% CI: 1.21-1.33) ( p < 0.01 for all comparisons). CONCLUSION: Use of palliative care at the end of life for cancer patients is associated with a reduction of the use of high-cost, intensive services. Future research is necessary to evaluate the impact of increasing use of palliative care services on other health outcomes. Administrative databases linked at the patient level are a useful data source for assessment of care at the end of life.

Cholecystectomy in Emilia-Romagna region (Italy): A retrospective cohort study based on a large administrative database.

BACKGROUND: The aim of this study was to ascertain the variability and to identify a trend for the outcome of cholecystectomy surgery when used to treat cholelithiasis and acute cholecystitis. METHODS: This was a large retrospective cohort study following patients up to 11 years post surgery, based on administrative data collected from 2002 to 2012 in the Emilia-Romagna Region (Northern Italy) and comparing the effectiveness and efficiency of surgical activity (laparoscopic (LC) and open cholecystectomy (OC)). Analyses included patient characteristics, length of hospital stay, type of admission and mortality risk. Outcomes considered were death from all causes (during the index hospital admission or thereafter), hospital readmissions with cholecystitis or cholelithiasis as principal diagnosis and time to surgery. RESULTS: A total of 84,628 cholecystomies were performed from 2002 to 2012 out of 123,061 admissions with primary diagnostic category of cholecystitis or cholelitiasis. Laparoscopic procedure was used in 69,842 patients. Over time there was a rising linear statistically significant trend in the use of LC. Mortality rate at 1 year of OC treated patients showed a statistically significant difference compared to LC treated patients (using a cohorts match with propensity score). Only a small number of patients with acute cholecystitis was operated according guidelines within 72 hours. CONCLUSIONS: The analysis of aggregate administrative data is a powerful tool to support regional health management, improve the quality of medical care, and assess the appropriateness of therapeutic or diagnostic approaches. It is important to stress a short hospital stay for laparoscopic cholecystectomy patients (50% less than open surgery): this shorter hospital stay leads to a significant economic advantage. Moreover, mortality is significantly higher in open surgery for acute cholecystitis. Interestingly, the same finding was confirmed after 30 days and 1 year, probably due to comorbidities that are more evident in open surgery. KEY WORDS: Cholecystitis, Cholelithiasis, Delivery of health care, Disease management, Surgical.

The Impact of Age on Clinical Outcomes of Coronary Artery Bypass Grafting: Long-Term Results of a Real-World Registry.

The aim of this retrospective multicenter registry study was to investigate age-dependent trends in mortality, long-term survival, and comorbidity over time in patients who underwent isolated CABG from 2003 to 2015. The percentage of patients < 60 years of age was 18.9%. Female sex, chronic pulmonary disease, extracardiac arteriopathy, and neurologic dysfunction disease were significantly less frequent in this younger population. The prevalence of BMI ≥ 30, previous myocardial infarction, preoperative severe depressed left ventricular ejection fraction, and history of previous PCI were significantly higher in this population. After PS matching, at 5 years, patients < 60 years of age reported significantly lower overall mortality (p < 0.0001), cardiac-related mortality (p < 0.0001), incidence of acute myocardial infarction (p = 0.01), and stroke rates (p < 0.0001). Patients < 60 years required repeated revascularization more frequently than older patients (p = 0.05). Patients < 60 who underwent CABG had a lower risk of adverse outcomes than older patients. Patients < 60 have a different clinical pattern of presentation of CAD in comparison with more elderly patients. These issues require focused attention in order to design and improve preventive strategies aiming to reduce the impact of specific cardiovascular risk factors for younger patients, such as diet, lifestyle, and weight control.

Gender differences in outcomes following isolated coronary artery bypass grafting: long-term results.

BACKGROUND: The main purpose of this study was to evaluate the impact of gender on outcomes after isolated coronary artery bypass grafting, in terms of 5-year rates of overall death, cardiac-related death, myocardial infarction, re-hospitalization, repeat percutaneous or surgical revascularization, stroke, new pacemaker implantation, postoperative renal failure, heart failure and need for long-term care. METHODS: Two propensity-score matched cohorts, each of 1331 patients, undergoing isolated surgical coronary revascularization at the regional public and private centers of Emilia-Romagna region (Italy) from January 1st 2003 to December 31th 2013, were used to compare long-term outcomes of male (5976 patients) versus female gender (1332 patients). RESULTS: In the matched cohort, males received significantly more bypass grafts (3.0 ± 1.0 vs 2.8 ± 1.0, p = 0.001). Left internal mammary artery use and total arterial revascularization were similarly performed in both matched subgroups. Both groups reported similar cumulative rate of all-cause, cardiac-related mortality and stroke at five years. Females experienced significantly higher rate of myocardial infarction, and not significantly higher occurrence of heart failure, and need for long-term care. Males experienced significantly higher rate of cumulative re-hospitalization and higher need for pacemaker implantation. Female gender was not an independent predictor of death at long-term follow-up. CONCLUSIONS: Women are more likely to be readmitted with myocardial infarction and congestive heart failure after CABG but experience survival similar to that observed in men. Female gender was not an independent risk factor for mortality. Prevention of new occurrence of postoperative myocardial infarction and enhancement of complete coronary revascularization should be future endpoints.

Long-Term Outcomes of Conventional Aortic Valve Replacement in High-Risk Patients: Where Do We Stand?

PURPOSE: The introduction of transcatheter aortic valves has focused attention on the results of conventional aortic valve surgery in high-risk patients. The aim of the study was to evaluate 5-years outcomes in this category of patients in the current surgical era. METHODS: This is an observational retrospective study of 581 high-risk patients undergoing aortic valve replacement from 2008 to 2013, with a mean logistic EuroSCORE of 26.6% ± 14.6%. Data were prospectively collected in a database of Emilia-Romagna region (Italy). RESULTS: Overall 30-day mortality was 9.3%. Stroke rate was 1.5%. At 1-, 3-, and 5-years overall mortality was 18.2%, 30.4%, and 42.2%, cardiac death rate was 3.9%, 9.2%, and 12.9%, stroke rate 2.5%, 7.7%, and 10.2%, re-operation occurrence 0.2%, 0.9% and 1.3%, and new pacemaker implantation was 2.3%, 5.1% and 7.8%. At multivariate analysis, urgency, hemodynamic instability, LVEF ≤30%, NYHA III-IV, severe chronic obstructive pulmonary disease (COPD), extra-cardiac arteriopathy, cerebrovascular disease, and creatinine >2.0 mg/dL remained independent predictors of 5-year mortality. CONCLUSION: The results of the current study add weight to the evidence that traditional aortic valve replacement can be performed in high-risk patients with satisfactory 5-year mortality and morbidity. Our study may help to improve decision-making in this category of high-risk patients with aortic valve disease.

Comparison between off- and on-pump coronary artery bypass grafting: long-term results of a real-world registry.

OBJECTIVES: The aim of this study was to compare 5-year rates of overall death, cardiac-related death, myocardial infarction, repeat revascularization, stroke and new occurrence of postoperative renal failure in a large cohort of patients with coronary disease, treated with on- or off-pump coronary artery bypass grafting (CABG). METHODS: Two propensity score-matched cohorts, each of 560 patients, undergoing isolated surgical coronary revascularization at the regional public and private centres of Emilia-Romagna region (Italy) over the period 1 January 2003 - 31 December 2013, were used to compare long-term outcomes of on-pump CABG (6711 patients) and off-pump CABG (597 patients). RESULTS: The matched on-pump group received significantly more bypass grafts than the matched off-pump group (2.4 ± 1.1 vs 1.6 ± 0.9, P < 0.0001). The on-pump group reported statistically significant lower cardiac-related mortality. There was a trend towards higher overall mortality and the need for repeat revascularization procedures in the off-pump group. No difference was found for myocardial infarction, stroke or new occurrence of postoperative renal failure between groups in the follow-up. The multivariate analysis of significant predictors of mortality in the overall population confirmed that the off-pump revascularization strategy was an independent predictor of death at long-term follow-up. On-pump CABG reported significantly better results in terms of mortality in the subgroups of patients with a depressed left ventricular ejection fraction and in patients with three-vessel disease. CONCLUSIONS: In patients undergoing elective isolated CABG, on-pump strategy conferred a long-term survival advantage compared with off-pump strategy, particularly for patients with more extensive coronary disease. No benefits were found in terms of reduction of postoperative morbidity with the off-pump strategy. On-pump surgery should be the preferred revascularization technique, and off-pump surgery reserved for patients for whom the perioperative risk of cardiopulmonary bypass is greater than the risk of a less complete coronary revascularization.

[Cognitive and quality of life trajectory after either surgical or transcatheter aortic valve replacement in high-risk patients]. / Evoluzione dello stato cognitivo e della qualità di vita in pazienti con stenosi aortica ad alto rischio clinico sottoposti a sostituzione valvolare chirurgica o per via transcatetere.

RATIONALE: The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated. METHODS: We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up. RESULTS: A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p<0.001). Overall, 35.5% of patients showed some degree of cognitive impairment at baseline, with no differences between groups. No significant changes in the cognitive status were observed between baseline and follow-up and between groups at any time point. TAVI patients had a lower quality of life at baseline as compared with AVR patients. Generic and heart failure-related quality of life improved significantly after either procedure. CONCLUSIONS: In high-risk patients, both TAVI and AVR are associated with a significant improvement of quality of life up to 1 year without a detrimental effect on cognitive function.

[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.

Coronary artery surgery versus percutaneous coronary intervention in octogenarians: long-term results.

BACKGROUND: The aim of this study was to compare 7-year rates of all-cause death, cardiac death, myocardial infarction, target vessel revascularization, and stroke in a large cohort of octogenarians with left main coronary artery or multivessel disease, treated with coronary artery bypass grafting or percutaneous coronary intervention. METHODS: Two propensity score-matched cohorts of patients undergoing revascularization procedures at regional public and private centers of Emilia-Romagna, Italy, from July 2002 to December 2008 were used to compare long-term outcomes of percutaneous coronary intervention (947 patients) and coronary artery bypass grafting (441 patients). RESULTS: There were no significant differences between groups in 30-day mortality. In the follow-up the overall and the matched percutaneous coronary intervention population experienced significantly worse outcomes in terms of cardiac mortality, myocardial infarction, and target vessel revascularization. No difference was found for stroke between treatment groups. Percutaneous coronary intervention was an independent predictor of increased death at long-term follow-up. The subgroups in which coronary artery bypass grafting reduced more clearly the risk of death were age 80 to 85 years, previous myocardial infarction, history of cardiac heart failure, chronic renal failure, peripheral vascular disease, and patients with three-vessel disease associated with the left main coronary artery. CONCLUSIONS: In this real-world setting, surgical coronary revascularization remains the standard of care for patients with left main or multivessel disease. The long-term outcomes of current percutaneous coronary intervention technology in octogenarians are yet to be determined with adequately powered prospective randomized studies.

Pre-Operative, High-IL-6 Blood Level is a Risk Factor of Post-Operative Delirium Onset in Old Patients.

BACKGROUND: Post-operative delirium (POD) is a common complication in elderly patients undergoing surgery, but the underpinning causes are not clear. We hypothesized that inflammaging, the subclinical low and chronic grade inflammation characteristic of old people, can contribute to POD onset. Accordingly, we investigated the association of pre-operative and circulating cytokines in elderly patients (>65 years), admitted for elective and emergency surgery. METHODS: This is a secondary analysis of a sub-cohort of patients belonging to a previous large case-control study, where 351 patients were clinically and cognitively thoroughly characterized, together with the assessment of POD (47 patients) by confusion assessment method and delirium rating scale. Seventy-four pre-operative plasma samples were selected from a larger bio-bank and they included 37 subjects with POD and 37 without POD. Inflammaging related cytokines, i.e., IL-1ß, IL-2, IL-6, IL-8, IL-10, and TNF-α, were assayed by ELISA in pre-operative blood samples; univariate and multivariable analyses have been applied to identify cytokines independently associated to POD. Associations of cytokine levels with functional status, cognitive decline, intra-hospital mortality, and comorbidity were also analyzed independently of POD onset. RESULTS: High IL-6 and low-IL-2 levels were significantly associated with POD. After adjustment for potential confounders in multivariate analysis, high level of pre-operative IL-6 was confirmed to be significantly associated with risk of POD onset. High level of IL-6 was also associated with several baseline features (including poor functional status, cognitive impairment, emergency admission, and higher comorbidity burden) and intra-hospital mortality. CONCLUSION: Pre-operative, high-plasma level of IL-6 (≥9 pg/mL) was significantly associated with POD onset. We propose IL-6 as an additional risk factor of POD onset together with the previously identified factors. Discovery of all risk factors contributing to POD onset will permit to improve hospitalized patient management and the decrease of healthcare cost.