SARS-CoV-2 Positive Hospitalized Cancer Patients during the Italian Outbreak: The Cohort Study in Reggio Emilia.

In the coronavirus disease (COVID-19) pandemic, cancer patients could be a high-risk group due to their immunosuppressed status; therefore, data on cancer patients must be available in order to consider the most adequate strategy of care. We carried out a cohort study on the risk of hospitalization for COVID-19, oncological history, and outcomes on COVID-19 infected cancer patients admitted to the Hospital of Reggio Emilia. Between 1 February and 3 April 2020, a total of 1226 COVID-19 infected patients were hospitalized. The number of cancer patients hospitalized with COVID-19 infection was 138 (11.3%). The median age was slightly higher in patients with cancers than in those without (76.5 vs. 73.0). The risk of intensive care unit (ICU) admission (10.1% vs. 6.7%; RR 1.23, 95% Confidence Interval (CI) 0.63-2.41) and risk of death (34.1% vs. 26.0%; RR 1.07, 95% CI 0.61-1.71) were similar in cancer and non-cancer patients. In the cancer patients group, 89/138 (64.5%) patients had a time interval >5 years between the diagnosis of the tumor and hospitalization. Male gender, age > 74 years, metastatic disease, bladder cancer, and cardiovascular disease were associated with mortality risk in cancer patients. In the Reggio Emilia Study, the incidence of hospitalization for COVID-19 in people with previous diagnosis of cancer is similar to that in the general population (standardized incidence ratio 98; 95% CI 73-131), and it does not appear to have a more severe course or a higher mortality rate than patients without cancer. The phase II of the COVID-19 epidemic in cancer patients needs a strategy to reduce the likelihood of infection and identify the vulnerable population, both in patients with active antineoplastic treatment and in survivors with frequently different coexisting medical conditions.

Influence of adherence with guideline-driven recommendations on survival in women operated for breast cancer: Real-life evidence from Italy.

BACKGROUND: A set of indicators to assess the quality of care for women operated for breast cancer was developed by an expert working group of the Italian Health Ministry in order to compare the Italian regions. A study to validate these indicators through their relationship with survival was carried out. METHODS: The 16,753 women who were residents in three Italian regions (Lombardy, Emilia-Romagna and Lazio) and hospitalized for breast cancer surgery during 2011 entered the cohort and were followed until 2016. Adherence to selected recommendations (i.e., surgery timeliness, medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up) was assessed. Multivariable proportional hazards models were fitted to estimate hazard ratios for the association between adherence with recommendations and the risk of all-cause mortality. RESULTS: Adherence to recommendations was 53% for medical therapy timeliness, 73% for appropriateness of mammographic follow-up, 74% for surgery timeliness and 82% for appropriateness of complementary radiotherapy. Risk reductions of 26%, 62% and 56% were observed for adherence to recommendations on medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up, respectively. There was no evidence that mortality was affected by surgery timeliness. CONCLUSIONS: Clinical benefits are expected from improvements in adherence to the considered recommendations. Close control of women operated for breast cancer through medical care timeliness and appropriateness of radiotherapy and mammographic monitoring must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

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.

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.

Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry.

Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

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.

Diagnosis and treatment of rheumatoid arthritis in the Emilia Romagna region: a prospective population-based study.

OBJECTIVES: To perform a population-based study in rheumatoid arthritis (RA) patients, in order to evaluate the efficacy and safety of pharmacologic treatments. METHODS: 1087 patients with RA were enrolled; inclusion criteria were: newly diagnosed RA, already diagnosed RA with high disease activity (HDA) (DAS28≥4.2) starting biologic DMARDs (bDMARDs), already diagnosed RA with HDA continuing with conventional DMARDs (cDMARDs). The following data were collected: demographics, clinical and laboratory features, imaging and prescribed drugs. All parameters except immunology and imaging (performed yearly) were repeated at each follow-up evaluations (after 3, 6 and 12 months, and thereafter every 12 months). In order to evaluate clinical response, the EULAR response criteria were used as the gold standard. RESULTS: 414 (38.1%) newly diagnosed patients with RA, 477 (43.9%) RA patients who started bDMARDs and 196 (18.0%) RA patients who continued with cDMARDs were enrolled from April 2012 to March 2015 at 12 Rheumatology Centres in the Emilia Romagna Region. Statistical analyses showed a relative risk ratio (RRR) for moderate response of 1.65 in RA patients who started bDMARDs (p=0.16) and 2.49 for newly diagnosed RA (p=0.01). Sex, age and Health Assessment Questionnaire were not statistically significant. A RRR of 2.00 has been confirmed for RA patients who started bDMARDs (p<0.0005) for a good response as well as 2.20 for newly diagnosed RA (p<0.0005). An increase in adverse events among bDMARDs was found, but when looking at infections or neoplasia, no differences were highlighted between RA which started bDMARDs and RA who continued with cDMARDs. CONCLUSIONS: Our results are in line with already published papers from British and Swedish Registries: a greater likelihood to have a good response is demonstrated for not longstanding RA starting cDMARDs or RA with HDA when a bDMARD is started. Also a good safety profile is demonstrated.

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.

Variation in hospital utilization at the end of life for patients with cancer in the Emilia-Romagna region of Italy.

INTRODUCTION: Despite the preference of many patients to die at home, high proportions of patients with advanced cancer undergo major procedures, receive intensive care, and die in the hospital. The goal of this study is to examine variation in hospital utilization and site of death for patients dying with poor-prognosis cancer in the Regione Emilia-Romagna (RER), Italy. METHODS: We conducted a retrospective, population-level study using administrative data. Patients were included if they died in 2012 and had at least one hospital admission for metastatic or poor-prognosis cancer within 180 days of death. Variations in the use of the hospital, intensive care, and procedures performed were evaluated. RESULTS: 11,470 patients died with metastatic or poor-prognosis cancer in 2012. Seventy-eight percent of patients were hospitalized in the last month of life while 50.7% of patients died in the hospital. Results varied by local health authority from 38.3% to 69.3%. Of patients who had an ICU stay, 55.1% in the community hospitals and 59.8% in the teaching hospitals were admitted to the ICU on the day of death or the day before death. 7.5% of patients underwent a major procedure in the last 30 days of life. CONCLUSIONS: The overall high rate, and substantial variation, in hospital care at the end of life offers the RER the opportunity to evaluate if increasing availability of palliative care, along with provider and patient education, could reduce utilization of high-cost hospital care and increase patient and family satisfaction.

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.

[Transcatheter aortic valve implantation: a systematic review of the literature on efficacy and safety data]. / Protesi valvolari aortiche transcatetere: revisione sistematica della letteratura su efficacia e sicurezza.

BACKGROUND: 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. OBJECTIVE: 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. RESULTS: 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. CONCLUSIONS: 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.

Risk of Adverse Cardiac and Bleeding Events Following Cardiac and Noncardiac Surgery in Patients With Coronary Stent: How Important Is the Interplay Between Stent Type and Time From Stenting to Surgery?

BACKGROUND: Epidemiology and consequences of surgery in patients with coronary stents are not clearly defined, as well as the impact of different stent types in relationship with timing of surgery. METHODS AND RESULTS: Among 39 362 patients with previous coronary stenting enrolled in a multicenter prospective registry and followed for 5 years, 13 128 patients underwent 17 226 surgical procedures. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively, and of cardiac and noncardiac surgery was 0.8%, 2.1%, 2.6%, and 4.0% and 1.3%, 5.1%, 9.1%, and 31.7%, respectively. We assessed the incidence and the predictors of cardiac death, myocardial infarction, and serious bleeding event within 30 days from surgery. Cardiac death occurred in 438 patients (2.5%), myocardial infarction in 256 (1.5%), and serious bleeding event in 1099 (6.4%). Surgery increased 1.58× the risk of cardiac death during follow-up. Along with other risk factors, the interplay between stent type and time from percutaneous coronary intervention to surgery was independently associated with cardiac death/myocardial infarction. In comparison with bare-metal stent implanted >12 months before surgery, old-generation drug-eluting stent was associated with higher risk of events at any time point. Conversely, new-generation drug-eluting stent showed similar safety as bare-metal stent >12 months and between 6 and 12 months and appeared trendly safer between 0 and 6 months. CONCLUSIONS: Surgery is frequent in patients with coronary stents and carries a considerable risk of ischemic and bleeding events. Ischemic risk is inversely related with time from percutaneous coronary intervention to surgery and is influenced by stent type.

Long-term outcomes and causes of death after acute coronary syndrome in patients in the Bologna, Italy, area.

We sought to evaluate the rates, time course, and causes of death in the long-term follow-up of unselected patients with acute coronary syndromes (ACS). We enrolled 2046 consecutive patients hospitalized from January 2004 to December 2005 with an audited final diagnosis of ACS. The primary study end point was 5-year all-cause mortality. In our series, 896 patients had ST-segment elevation (STE) and 1,150 non-ST-segment elevation (NSTE). Mean age of the study population was 71.6 years. Primary percutaneous coronary intervention was performed in 86% of STE-ACS, and 70% of NSTE-ACS was managed invasively. The 5-year all-cause mortality was 36.4% for STE-ACS and 42.0% for NSTE-ACS, with patients with STE-ACS showing a trend boarding statistical significance toward a lower risk of mortality (hazard ratio [HR] = 0.88, 95% confidence interval [CI] 0.76 to 1.02, p = 0.08). Landmark analysis demonstrated that patients with STE-ACS had a higher risk of 30-day mortality (STE-ACS vs NSTE-ACS HR = 1.53, 95% CI 1.16 to 2.06, p = 0.003) whereas the risk of NSTE-ACS increased markedly after 1 year (STE-ACS vs NSTE-ACS HR = 0.67, 95% CI 0.53 to 0.84, p = 0.001). The contribution of noncardiovascular (CV) causes to overall mortality increased from 3% at 30 days to 34% at 5 years, with cancer and infections being the most common causes of non-CV death both in STE-ACS and NSTE-ACS. In conclusion, long-term mortality after ACS is still too high both for STE-ACS and NSTE-ACS. Although patients with STE-ACS have a higher mortality during the first year, the mortality of patients with NSTE-ACS increases later, when non-CV co-morbidities gain greater importance.

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.

Outcomes of patients undergoing concomitant mitral and aortic valve surgery: results from an Italian regional cardiac surgery registry.

OBJECTIVES: There are limited reliable data on the long-term survival of patients operated upon with double-valve surgery (DVS) in the literature. In this study, in-hospital mortality and 5-year survival were determined and the potential risk factors for increased mortality were identified and discussed. METHODS: This is a report of an observational retrospective study of 1167 patients undergoing concomitant aortic and mitral valve surgery from 2002 to 2011. Data were prospectively collected in a regional database from Emilia-Romagna (Italy). RESULTS: The overall in-hospital mortality rate for DVS was 6.9%. Both in-hospital and 1-year mortality were statistically significant between age groups. In-hospital mortality was significantly higher for patients with a smaller body mass index (BMI), for those who had concomitant coronary artery bypass grafting (CABG) and those who received mitral valve replacement (MVR) instead of plasty (MVP). In-hospital and 1-year mortality were highest in patients ≥70 who had implantation of mitral and aortic mechanical valves. There were significant differences in 5-year follow-up survival according to age, BMI and concomitant CABG. The choice of MVR and MVP did not affect 5-year survival. Multivariable analysis showed that patient-related factors appear to be the major determinant of late survival, irrespective of the type of operation or other intraoperative variables. CONCLUSIONS: Advanced age, smaller BMI and concomitant CABG are significant risk factors for mortality in DVS. MVP provided comparable 5-year outcomes with MVR. Multivariable analysis demonstrates that preoperative and clinical patient-related factors are the real burden in the successful treatment of patients undergoing double-valve procedures.

Effects of anticoagulant and antiplatelet drugs on the risk for hospital admission for traumatic injuries: a case-control and population-based study.

BACKGROUND: The current cardiovascular literature advocates an overall beneficial balance between the advantages of oral anticoagulants and antiplatelet drugs in preventing and treating thromboembolic events and their disadvantages in promoting hemorrhage. However, traumatic injuries have usually received little attention despite several studies from the surgical literature showing worse outcomes in anticoagulated trauma registry patients. To quantify at population level too this seemingly deleterious impact, we investigated the effects of anticoagulants and antiplatelet use on the risk for hospital admission for acute traumatic causes. METHODS: A population-based, case-control study in an Italian region with 4.5 million inhabitants was conducted. Cases were all the 59,348 adult residents admitted to the hospital for traumatic injuries in the years 2010 and 2011. Controls were age- and sex-matched residents selected by incidence density sampling. By conditional logistic regression adjusted for comorbidities, we estimated the risk for traumatic hospital admission while on anticoagulant, antiplatelet, and combined medications. RESULTS: The odds ratios (ORs) for anticoagulation and combined medications were 1.21 (95% confidence interval [CI], 1.15-1.28) and 1.39 (95% CI, 1.21-1.62). These effects were generally consistent across subgroups of demographic and clinical characteristics and particularly important in the head injured (e.g., OR for anticoagulation, 2.00; 95% CI, 1.77-12.27). Antiplatelets alone had no overall effect (OR, 1.02; 95% CI, 0.99-1.05). The number-needed-to-harm of anticoagulation was 595. CONCLUSION: Oral anticoagulation increased the population risk for traumatic hospital admission, with a further increase in case of concurrent antiplatelet use. Because this effect is most likely to derive from the prohemorrhagic properties of these drugs, injured patients should be included in the future evaluations of the cost-benefit profiles of these medications. LEVEL OF EVIDENCE: Epidemiologic/prognostic study, level III.

Does breast cancer screening level health inequalities out? A population-based study in an Italian region.

BACKGROUND: Although population-based screening has the potential to reduce inequalities in breast cancer survival, evidence on this topic is controversial. The objective of this study was to evaluate whether the full implementation of a mammography screening programme in Emilia-Romagna in Italy had an impact on variations in breast cancer survival by educational level. METHODS: A cohort study was performed, including all women <70 years and residing in Emilia-Romagna who had infiltrating breast cancer registered in 1997-2000 (transitional screening period) or 2001-03 (consolidation screening period). Cancer cases were retrieved from the regional Breast Cancer Registry and followed up for 5 years. Educational level was determined from census data and allocated to cancer cases by individual record linkage. Age at diagnosis was classified into two groups (30-49, 50-69: screening target population). RESULTS: A total of 9639 cases were analyzed. In the 1997-2000 period, low-educated women had significantly lower survival compared with high-educated women, both in the younger and in the older age-groups. After the full implementation of the screening programme, these differences decreased in both age-groups, until disappearing completely among women in the age-group invited to screening. CONCLUSIONS: Our findings suggest that a fee-free population-based organized mammography screening programme with active invitation of the whole target population could be effective in reducing differences in survival in the population targeted by the screening.

Incidence and outcome of high on-treatment platelet reactivity in patients with non-ST elevation acute coronary syndromes undergoing percutaneous coronary intervention (from the VIP [VerifyNow and Inhibition of Platelet Reactivity] study).

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y12 reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y12 reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y12 reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.