Fulvia Seccareccia | Istituto Superiore di Sanità (original) (raw)
Papers by Fulvia Seccareccia
Italian heart journal. Supplement: official journal of the Italian Federation of Cardiology
Cigarette smoking is one of the most important risk factors for chronic diseases. Major epidemiol... more Cigarette smoking is one of the most important risk factors for chronic diseases. Major epidemiological studies provide consistent evidence that cardiovascular risk is 3-fold among smokers compared to non-smokers, incidence increases with the number of cigarettes smoked daily and cardiovascular risk is less among subjects who have stopped smoking. To support evidence of a time decreasing trend of smoking habits in Italy, data from two observational studies carried out in different Italian regions, the RIFLE Project (1978-1987), the Cardiovascular Epidemiological Observatory (1998), and data collected from the "Multiscopo" ISTAT Investigation on Italian families (1980-1997) have been analyzed. RESULts: During the 1950's, the prevalence of smokers among adult men was about 80%, it decreased to 50% in the 1980's and now is about 30-40%. Contemporarily, the prevalence of smokers among adult women has increased, from 17% in the 1980's to 23% nowadays. The habit is m...
Italian heart journal. Supplement: official journal of the Italian Federation of Cardiology
Italian cardiac surgery units have changed in their characteristics over time. These changes have... more Italian cardiac surgery units have changed in their characteristics over time. These changes have to be monitored. At the moment, there are no regular monitoring systems that could be used to support the processes of evaluation of performance. The Italian Institute of Health has recently started a national prospective study on the short-term outcomes (within 30 days mortality) of coronary artery bypass graft procedures. This study has been preceded by a cross-sectional investigation on the general activities of the Italian cardiac surgery centers. A complete Italian cardiac surgery center directory has been assembled. A questionnaire on hospital characteristics, number of beds, number of yearly coronary artery bypass graft procedures, department computer systems and methods for surgery risk assessment has been sent to the person responsible for each cardiac surgery center. In Italy there are 86 non-pediatric cardiac surgery centers (65% public centers, 31% accountable private and 4%...
Giornale italiano di cardiologia (2006)
The availability of two contemporary sources of information about coronary artery bypass graft (C... more The availability of two contemporary sources of information about coronary artery bypass graft (CABG) interventions, allowed 1) to verify the feasibility of performing outcome evaluation studies using administrative data sources, and 2) to compare hospital performance obtainable using the CABG Project clinical database with hospital performance derived from the use of current administrative data. Interventions recorded in the CABG Project were linked to the hospital discharge record (HDR) administrative database. Only the linked records were considered for subsequent analyses (46% of the total CABG Project). A new selected population "clinical card-HDR" was then defined. Two independent risk-adjustment models were applied, each of them using information derived from one of the two different sources. Then, HDR information was supplemented with some patient preoperative conditions from the CABG clinical database. The two models were compared in terms of their adaptability to...
Lo sviluppo di un sistema in grado di fornire informazioni sulla qualità delle prestazioni erogat... more Lo sviluppo di un sistema in grado di fornire informazioni sulla qualità delle prestazioni erogate dalle strutture sanitarie rappresenta uno degli argomenti più esplorati nella ricerca sui servizi sanitari, sia nell'ottica di migliorare la qualità delle prestazioni che per garantire ...
The Annals of Thoracic Surgery, 2015
Myocardial revascularization in young patients should be durable enough to avoid new cardiovascul... more Myocardial revascularization in young patients should be durable enough to avoid new cardiovascular events or repeated revascularization procedures. The aim of this study was to evaluate the late outcomes of patients less than 50 years of age undergoing coronary artery bypass grafting (CABG) in comparison with older patients. This study was a survival analysis of a pooled multicenter prospective cohort of patients who underwent CABG. Five percent of patients (572 of 11,087) were less than 50 years of age. The prevalence of female sex, pulmonary disease, diabetes, stroke, and extracardiac arteriopathy was lower compared with that in older patients. Left ventricular function was more well preserved in patients less than 50 years of age, but the prevalence of recent myocardial infarction and the need for emergency surgical intervention was significantly higher in young patients. Multiple propensity score-adjusted analysis showed that patients aged less than 50 years had a significantly lower risk of mortality, even when compared with the 50- to 59-year stratum. In the propensity score-matched population (544 pairs), patients less than 50 years of age had significantly better 7-year outcomes compared with patients aged 50 years or more: survival (95.6% versus 81.1%; p < 0.0001), freedom from stroke (97.4% versus 95.3%; p = 0.009), freedom from major adverse cardiac and cerebrovascular events (MACCE) (76.6% versus 63.9%; p = 0.002). Similar freedom from myocardial infarction (90.1% versus 90.1%; p = 0.68) and repeated revascularization (87.1% versus 87.2%; p = 0.65) was observed in patients less than 50 years of age and those older than 50 years. Patients less than 50 years of age undergoing CABG have an excellent outcome compared with elderly patients. These data indicate that despite its premature onset, coronary artery disease in young patients does not have a more aggressive course than that in older patients.
Journal of the American College of Cardiology, 2015
There is a paucity of prospective and controlled data on the comparative effectiveness of transca... more There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
Acta cardiologica
Coronary revascularization methods are among the most common major medical procedures performed i... more Coronary revascularization methods are among the most common major medical procedures performed in industrialized countries. The short- and long-term comparative effectiveness of different techniques remains undetermined. The study population included all adult patients (94,864 subjects) admitted for acute myocardial infarction (AMI) in 2004 in Italy, as recorded in the National Hospital Discharge Records. Invasive reperfusion therapy (coronary artery bypass graft, percutaneous coronary intervention), and standard medical treatments were compared. End points were short-term (30-day) in-hospital mortality and any combination of new revascularizations, re-AMI, stroke, or death (MACCE) occurring within 6 and 12 months from initial treatment. Risk factors and comorbidities were used to define patients' health status. The Cox model was applied to evaluate risk-adjusted hazard ratios (HR) for different approaches. Medical treatment was used as the reference category. Propensity score ...
The Journal of Thoracic and Cardiovascular Surgery, 2015
The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery by... more The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery bypass grafting (CABG) has yet to be resolved. This study was designed to compare the impact of surgical technique on long-term mortality and subsequent revascularization. The Predicting Long-Term Outcomes After Isolated Coronary Artery Bypass Surgery (PRIORITY) project was designed to evaluate the long-term outcomes of 2 large, prospective multicenter cohort studies on CABG conducted in Italy between 2002 and 2004 and in 2007 and 2008. Clinical data on isolated CABG were compiled from 2 administrative databases. The study population consisted of 11,021 patients who underwent isolated CABG (27.2% off-pump CABG). Surgical strategy did not affect in-hospital mortality. Multivariate logistic regression demonstrated that on-pump CABG was the only factor that protected from in-hospital percutaneous coronary intervention after surgery (odds ratio, 0.61). Although unadjusted long-term survival was significantly worse for off-pump CABG, adjustment did not confirm off-pump CABG as a risk factor for mortality (hazard ratio, 0.96; 95% confidence interval, 0.87-1.06). The on-pump CABG group had a significantly lower hospitalization for subsequent percutaneous coronary intervention, a finding confirmed even with adjustment for confounding factors (hazard ratio, 0.70; 95% confidence interval, 0.62-0.80; P < .001). Off-pump CABG thus carried a 42% higher risk for subsequent percutaneous coronary intervention than on-pump CABG. The incidence of repeat CABG was similar between groups. This study demonstrated that off-pump OPCAB did not affect short- and long-term mortality, but it was a significant risk factor for rehospitalization for percutaneous coronary intervention.
JACC: Cardiovascular Interventions, 2015
Cancer
Greater than 20% of patients with apparently localized renal cell carcinoma (RCC) present with di... more Greater than 20% of patients with apparently localized renal cell carcinoma (RCC) present with disease progression after surgery. The objective of the current study was to improve the ability of clinicians to predict prognosis in patients with localized RCC. The authors studied 154 patients with organ-confined RCC classified as pT1 to pT2-pN0-M0 who underwent radical nephrectomy. Follow-up ranged from 24-128 months (median, 72 months). Several morphologic parameters of the tumor were considered. DNA content was analyzed by flow cytometry and tumor size was determined from the surgical specimen. A Cox proportional hazards regression model was used to identify significant independent prognostic factors for disease progression. At 5 and 10 years of follow-up, disease free survival was found to be 87% and 86%, respectively. Univariate analysis revealed that DNA content, Furhman grade, and tumor size had a statistically significant predictive value for disease progression, whereas, with ...
Giornale italiano di cardiologia (2006), 2012
Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospita... more Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospital acute coronary syndrome (ACS) death rates, differences in care and prognosis of ACS patients exist when age, gender and admission department are considered. The national hospital informative system was used. Only data recorded in three Italian Regions from December 1, 2005 to November 30, 2007 were analyzed. This approach allowed to identify 70 413 patients reporting ACS as primary or secondary diagnosis. The ACS cohort was stratified by age (≤64, 65-74 and ≥75 years) and gender. ACS events were divided into two groups: 42 503 patients with non-ST-elevation ACS (NSTE-ACS) and 27 910 patients with ST-elevation ACS (STEMI). The proportion of NSTE-ACS and STEMI patients treated in general medicine or cardiology departments requiring a coronary procedure or extensive investigations, and in-hospital 30-day mortality rates adjusted by age and gender were analyzed. 19% of STEMI and 15% of NST...
Giornale italiano di cardiologia, 1997
The aims of this study were: 1) to assess the relative prognostic value of predischarge dobutamin... more The aims of this study were: 1) to assess the relative prognostic value of predischarge dobutamine echocardiography (DE) and exercise electrocardiography (EE) in patients after a first uncomplicated acute myocardial infarction (AMI), and 2) to evaluate the optimal prognostic strategy by using the two tests in different combinations. DE (dobutamine infusion 5 to 40 micrograms/kg/min plus atropine 0.25 to 1 mg, if needed) and symptom-limited bicycle EE were performed in 208 patients (mean age 58 +/- 9 years, 90% males), on different days and in random order, 12 +/- 4 days after a first uncomplicated AMI and after pharmacological washout. A stress-induced dyssynergy and ST segment depression > 1 mm were considered criteria of positivity for DE and EE, respectively. Only spontaneous cardiac events were considered: cardiac death, reinfarction (= hard events), and unstable angina requiring hospitalization (= soft events). Thirty-eight events occurred during follow-up (16 +/- 13 months;...
Acta cardiologica, 2013
Risk stratification models perform poorly regarding elderly patients. This study aims to evaluate... more Risk stratification models perform poorly regarding elderly patients. This study aims to evaluate the performance of the Italian Coronary Artery Bypass Graft Outcome Project (ItCABG) model and the logistic European System for Cardiac Operative Risk Evaluation (LogEuroSCORE) model by age group to build a model specifically for elderly patients. Data from the ItCABG and Mattone Outcome-BYPASS study (MO-BYPASS) have been used. ItCABG and LogEuroSCORE models were applied to the ItCABG population (n = 34,310) stratified by four age classes: < 60, 60-69, 70-79, > or = 80 years. Each model's ability to predict 30-day mortality was assessed for accuracy (Brier score and pseudo-R2), calibration (Hosmer-Lemeshow test, X(H-L)) and discrimination (area under the receiver operating characteristic curve, AUC) in age classes. To estimate the elderly risk function a logistic regression was performed on 2,255 octogenarian patients from ItCABG and MO-BYPASS. Elderly model's performance ...
Giornale italiano di cardiologia (2006), 2011
In early 2008, a new national prospective study on short-term outcomes of coronary artery bypass ... more In early 2008, a new national prospective study on short-term outcomes of coronary artery bypass graft (CABG) procedures started in Italy. The aim was to describe short-term results in patients undergoing CABG and improve methodologies for comparative outcome evaluation. Only 26 Italian cardiac surgery centers participated in this survey. For each patient undergoing a CABG procedure, all centers were requested to provide specific data (type of procedure, hemodynamic conditions, comorbidities, recent myocardial infarction and unstable angina, ventricular function, emergency conditions, vital status at 30 days). Representativeness was tested by comparing characteristics of the enrolled population with information derived from national hospital discharge records. A multiple logistic regression analysis was used to perform indirect standardization; the mortality rate of the whole population was used as a reference standard. Comparison with the CABG model built on 34 310 patients in 2002...
Heart (British Cardiac Society), 2003
To assess the relative influence of contractile reserve and inducible ischaemia on subsequent lef... more To assess the relative influence of contractile reserve and inducible ischaemia on subsequent left ventricular volume changes after myocardial infarction. Left ventricular end diastolic and end systolic index volumes were calculated prospectively at discharge and at six months in 143 patients referred for early postinfarction dobutamine stress echocardiography. On the basis of their responses to this test, patients were divided into three groups: scar (n = 48; group 1); contractile reserve (n = 36; group 2); inducible ischaemia (n = 59; group 3). At six months, the left ventricular end diastolic index volume decreased in group 2 (mean (SD), -3.9 (9.4) ml/m2) and increased in both group 1 (+2.8 (10.6) ml/m2, p = 0.009 v group 2) and group 3 (+7.5 (11.4) ml/m2, p < 0.0001 v group 2). The end systolic index volume decreased in group 2 (-4.9 (7.3) ml/m2) and increased in both group 1 (+1.3 (8.3) ml/m2, p = 0.0015 v group 2) and group 3 (+2.8 (8.9) ml/m2, p = 0.0002 v group 2). In mul...
Acta cardiologica, 1997
The purpose of this analysis is to relate the performance at cycloergometer of healthy middle age... more The purpose of this analysis is to relate the performance at cycloergometer of healthy middle aged men, identified in a population, with a number of personal characteristics to explain part of their physical fitness indicators. A sample of 5,163 men aged 40-59, belonging to sedentary occupational groups in Florence and Rome, were screened by a complex diagnostic procedure (participation rate = 66.3%). 3,893 were judged "healthy" from the cardiovascular point of view. A cycloergometric test and the measurement of some individual characteristics allowed to correlate indicators of performance at exercise (work load, test duration, work load/heart rate, PWC150 and PWC150/kg) with body mass index, resting pulse rate, systolic, diastolic and mean blood pressure. HDL and non-HDL cholesterol, a score of physical exercise and cigarette consumption. Univariate and multivariate analysis showed significant relationship of exercise performance indicators with age, resting pulse rate, b...
Giornale italiano di cardiologia, 1994
The ECCIS project (Epidemiology and Clinic of Silent Ischemic Heart Disease) is an italian epidem... more The ECCIS project (Epidemiology and Clinic of Silent Ischemic Heart Disease) is an italian epidemiological study based on a population sample of 4,842 totally asymptomatic men aged 40-59 whose primary aim is the evaluation of the prevalence of totally silent myocardial ischemia and silent myocardial infarction. The systemic search for markers of silent ischemia and infarction was pursued along 3 screening stages: the 1st stage included resting electrocardiogram, hyperventilation test, exercise electrocardiogram and 24-hour Holter electrocardiogram; the 2nd stage included echocardiogram, thallium-201 scintigraphy in conjunction with exercise test or dypiridamole test, exercise radionuclide ventriculography and ergometrine test; the 3rd stage included coronary angiography. After the completion of the 1st stage procedures 439 men (9.1%) with abnormal results and low probability of disease were invited to the 2nd stage and 387 accepted to undergo the diagnostic procedures. After the com...
Interactive cardiovascular and thoracic surgery, 2010
The aim of this study is to evaluate the effect of gender and age on outcome following coronary s... more The aim of this study is to evaluate the effect of gender and age on outcome following coronary surgery in several hospitals enrolled in a national quality assessment program. Patients undergoing isolated coronary artery bypass graft (CABG) during 2003-2005 in Italy were included in the study (n=74,577). The outcome measure was 30-day in-hospital mortality. Comorbidities recorded during previous and current hospitalizations were used to define patients' health status and to build the adjustment model. The interaction term (gender*hospital) was introduced into the model to test the effect modification of gender; if present, gender specific models were analyzed to test the effect modification of age. A significant effect modification by gender was found in 39 hospitals; the adjusted odds ratios (AdjORs) showed significant increased risk for females (AdjORs ranging from 3.7 to 21.6). In three of these hospitals a significant increased risk was found for older age (AdjORs for elderl...
JACC: Cardiovascular Interventions, 2015
![Research paper thumbnail of [Results of the OBSERVANT study: clinical characteristics and short-term outcome of the enrolled population treated with transcatheter versus surgical aortic valve implantation]](https://attachments.academia-assets.com/41678129/thumbnails/1.jpg)
](Giornale italiano di cardiologia (2006), 2014
OBSERVANT represents the first national observational study on the comparative effectiveness of t... more OBSERVANT represents the first national observational study on the comparative effectiveness of transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR) at short, medium and long term, in a patient population with severe aortic stenosis (AS). The aim of this paper is to describe patient characteristics and short-term outcomes of the enrolled population. OBSERVANT is an observational prospective multicenter cohort study that enrolled AS patients undergoing SAVR or TAVI from December 2010 to June 2012 in the participating hospitals. Information on demographic characteristics, health status prior to intervention, therapeutic approach, intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on long-term outcomes. The enrolled population included 7618 patients undergoing transfemoral/transubclavian TAVI (TF/TS-TAVI, n=1652), transapical TAVI (TA-TAVI, n=259) or SAVR (n=5707). SAVR patients were younger an...
Italian heart journal. Supplement: official journal of the Italian Federation of Cardiology
Cigarette smoking is one of the most important risk factors for chronic diseases. Major epidemiol... more Cigarette smoking is one of the most important risk factors for chronic diseases. Major epidemiological studies provide consistent evidence that cardiovascular risk is 3-fold among smokers compared to non-smokers, incidence increases with the number of cigarettes smoked daily and cardiovascular risk is less among subjects who have stopped smoking. To support evidence of a time decreasing trend of smoking habits in Italy, data from two observational studies carried out in different Italian regions, the RIFLE Project (1978-1987), the Cardiovascular Epidemiological Observatory (1998), and data collected from the "Multiscopo" ISTAT Investigation on Italian families (1980-1997) have been analyzed. RESULts: During the 1950's, the prevalence of smokers among adult men was about 80%, it decreased to 50% in the 1980's and now is about 30-40%. Contemporarily, the prevalence of smokers among adult women has increased, from 17% in the 1980's to 23% nowadays. The habit is m...
Italian heart journal. Supplement: official journal of the Italian Federation of Cardiology
Italian cardiac surgery units have changed in their characteristics over time. These changes have... more Italian cardiac surgery units have changed in their characteristics over time. These changes have to be monitored. At the moment, there are no regular monitoring systems that could be used to support the processes of evaluation of performance. The Italian Institute of Health has recently started a national prospective study on the short-term outcomes (within 30 days mortality) of coronary artery bypass graft procedures. This study has been preceded by a cross-sectional investigation on the general activities of the Italian cardiac surgery centers. A complete Italian cardiac surgery center directory has been assembled. A questionnaire on hospital characteristics, number of beds, number of yearly coronary artery bypass graft procedures, department computer systems and methods for surgery risk assessment has been sent to the person responsible for each cardiac surgery center. In Italy there are 86 non-pediatric cardiac surgery centers (65% public centers, 31% accountable private and 4%...
Giornale italiano di cardiologia (2006)
The availability of two contemporary sources of information about coronary artery bypass graft (C... more The availability of two contemporary sources of information about coronary artery bypass graft (CABG) interventions, allowed 1) to verify the feasibility of performing outcome evaluation studies using administrative data sources, and 2) to compare hospital performance obtainable using the CABG Project clinical database with hospital performance derived from the use of current administrative data. Interventions recorded in the CABG Project were linked to the hospital discharge record (HDR) administrative database. Only the linked records were considered for subsequent analyses (46% of the total CABG Project). A new selected population "clinical card-HDR" was then defined. Two independent risk-adjustment models were applied, each of them using information derived from one of the two different sources. Then, HDR information was supplemented with some patient preoperative conditions from the CABG clinical database. The two models were compared in terms of their adaptability to...
Lo sviluppo di un sistema in grado di fornire informazioni sulla qualità delle prestazioni erogat... more Lo sviluppo di un sistema in grado di fornire informazioni sulla qualità delle prestazioni erogate dalle strutture sanitarie rappresenta uno degli argomenti più esplorati nella ricerca sui servizi sanitari, sia nell'ottica di migliorare la qualità delle prestazioni che per garantire ...
The Annals of Thoracic Surgery, 2015
Myocardial revascularization in young patients should be durable enough to avoid new cardiovascul... more Myocardial revascularization in young patients should be durable enough to avoid new cardiovascular events or repeated revascularization procedures. The aim of this study was to evaluate the late outcomes of patients less than 50 years of age undergoing coronary artery bypass grafting (CABG) in comparison with older patients. This study was a survival analysis of a pooled multicenter prospective cohort of patients who underwent CABG. Five percent of patients (572 of 11,087) were less than 50 years of age. The prevalence of female sex, pulmonary disease, diabetes, stroke, and extracardiac arteriopathy was lower compared with that in older patients. Left ventricular function was more well preserved in patients less than 50 years of age, but the prevalence of recent myocardial infarction and the need for emergency surgical intervention was significantly higher in young patients. Multiple propensity score-adjusted analysis showed that patients aged less than 50 years had a significantly lower risk of mortality, even when compared with the 50- to 59-year stratum. In the propensity score-matched population (544 pairs), patients less than 50 years of age had significantly better 7-year outcomes compared with patients aged 50 years or more: survival (95.6% versus 81.1%; p &amp;amp;amp;amp;amp;lt; 0.0001), freedom from stroke (97.4% versus 95.3%; p = 0.009), freedom from major adverse cardiac and cerebrovascular events (MACCE) (76.6% versus 63.9%; p = 0.002). Similar freedom from myocardial infarction (90.1% versus 90.1%; p = 0.68) and repeated revascularization (87.1% versus 87.2%; p = 0.65) was observed in patients less than 50 years of age and those older than 50 years. Patients less than 50 years of age undergoing CABG have an excellent outcome compared with elderly patients. These data indicate that despite its premature onset, coronary artery disease in young patients does not have a more aggressive course than that in older patients.
Journal of the American College of Cardiology, 2015
There is a paucity of prospective and controlled data on the comparative effectiveness of transca... more There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
Acta cardiologica
Coronary revascularization methods are among the most common major medical procedures performed i... more Coronary revascularization methods are among the most common major medical procedures performed in industrialized countries. The short- and long-term comparative effectiveness of different techniques remains undetermined. The study population included all adult patients (94,864 subjects) admitted for acute myocardial infarction (AMI) in 2004 in Italy, as recorded in the National Hospital Discharge Records. Invasive reperfusion therapy (coronary artery bypass graft, percutaneous coronary intervention), and standard medical treatments were compared. End points were short-term (30-day) in-hospital mortality and any combination of new revascularizations, re-AMI, stroke, or death (MACCE) occurring within 6 and 12 months from initial treatment. Risk factors and comorbidities were used to define patients' health status. The Cox model was applied to evaluate risk-adjusted hazard ratios (HR) for different approaches. Medical treatment was used as the reference category. Propensity score ...
The Journal of Thoracic and Cardiovascular Surgery, 2015
The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery by... more The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery bypass grafting (CABG) has yet to be resolved. This study was designed to compare the impact of surgical technique on long-term mortality and subsequent revascularization. The Predicting Long-Term Outcomes After Isolated Coronary Artery Bypass Surgery (PRIORITY) project was designed to evaluate the long-term outcomes of 2 large, prospective multicenter cohort studies on CABG conducted in Italy between 2002 and 2004 and in 2007 and 2008. Clinical data on isolated CABG were compiled from 2 administrative databases. The study population consisted of 11,021 patients who underwent isolated CABG (27.2% off-pump CABG). Surgical strategy did not affect in-hospital mortality. Multivariate logistic regression demonstrated that on-pump CABG was the only factor that protected from in-hospital percutaneous coronary intervention after surgery (odds ratio, 0.61). Although unadjusted long-term survival was significantly worse for off-pump CABG, adjustment did not confirm off-pump CABG as a risk factor for mortality (hazard ratio, 0.96; 95% confidence interval, 0.87-1.06). The on-pump CABG group had a significantly lower hospitalization for subsequent percutaneous coronary intervention, a finding confirmed even with adjustment for confounding factors (hazard ratio, 0.70; 95% confidence interval, 0.62-0.80; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Off-pump CABG thus carried a 42% higher risk for subsequent percutaneous coronary intervention than on-pump CABG. The incidence of repeat CABG was similar between groups. This study demonstrated that off-pump OPCAB did not affect short- and long-term mortality, but it was a significant risk factor for rehospitalization for percutaneous coronary intervention.
JACC: Cardiovascular Interventions, 2015
Cancer
Greater than 20% of patients with apparently localized renal cell carcinoma (RCC) present with di... more Greater than 20% of patients with apparently localized renal cell carcinoma (RCC) present with disease progression after surgery. The objective of the current study was to improve the ability of clinicians to predict prognosis in patients with localized RCC. The authors studied 154 patients with organ-confined RCC classified as pT1 to pT2-pN0-M0 who underwent radical nephrectomy. Follow-up ranged from 24-128 months (median, 72 months). Several morphologic parameters of the tumor were considered. DNA content was analyzed by flow cytometry and tumor size was determined from the surgical specimen. A Cox proportional hazards regression model was used to identify significant independent prognostic factors for disease progression. At 5 and 10 years of follow-up, disease free survival was found to be 87% and 86%, respectively. Univariate analysis revealed that DNA content, Furhman grade, and tumor size had a statistically significant predictive value for disease progression, whereas, with ...
Giornale italiano di cardiologia (2006), 2012
Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospita... more Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospital acute coronary syndrome (ACS) death rates, differences in care and prognosis of ACS patients exist when age, gender and admission department are considered. The national hospital informative system was used. Only data recorded in three Italian Regions from December 1, 2005 to November 30, 2007 were analyzed. This approach allowed to identify 70 413 patients reporting ACS as primary or secondary diagnosis. The ACS cohort was stratified by age (≤64, 65-74 and ≥75 years) and gender. ACS events were divided into two groups: 42 503 patients with non-ST-elevation ACS (NSTE-ACS) and 27 910 patients with ST-elevation ACS (STEMI). The proportion of NSTE-ACS and STEMI patients treated in general medicine or cardiology departments requiring a coronary procedure or extensive investigations, and in-hospital 30-day mortality rates adjusted by age and gender were analyzed. 19% of STEMI and 15% of NST...
Giornale italiano di cardiologia, 1997
The aims of this study were: 1) to assess the relative prognostic value of predischarge dobutamin... more The aims of this study were: 1) to assess the relative prognostic value of predischarge dobutamine echocardiography (DE) and exercise electrocardiography (EE) in patients after a first uncomplicated acute myocardial infarction (AMI), and 2) to evaluate the optimal prognostic strategy by using the two tests in different combinations. DE (dobutamine infusion 5 to 40 micrograms/kg/min plus atropine 0.25 to 1 mg, if needed) and symptom-limited bicycle EE were performed in 208 patients (mean age 58 +/- 9 years, 90% males), on different days and in random order, 12 +/- 4 days after a first uncomplicated AMI and after pharmacological washout. A stress-induced dyssynergy and ST segment depression > 1 mm were considered criteria of positivity for DE and EE, respectively. Only spontaneous cardiac events were considered: cardiac death, reinfarction (= hard events), and unstable angina requiring hospitalization (= soft events). Thirty-eight events occurred during follow-up (16 +/- 13 months;...
Acta cardiologica, 2013
Risk stratification models perform poorly regarding elderly patients. This study aims to evaluate... more Risk stratification models perform poorly regarding elderly patients. This study aims to evaluate the performance of the Italian Coronary Artery Bypass Graft Outcome Project (ItCABG) model and the logistic European System for Cardiac Operative Risk Evaluation (LogEuroSCORE) model by age group to build a model specifically for elderly patients. Data from the ItCABG and Mattone Outcome-BYPASS study (MO-BYPASS) have been used. ItCABG and LogEuroSCORE models were applied to the ItCABG population (n = 34,310) stratified by four age classes: < 60, 60-69, 70-79, > or = 80 years. Each model's ability to predict 30-day mortality was assessed for accuracy (Brier score and pseudo-R2), calibration (Hosmer-Lemeshow test, X(H-L)) and discrimination (area under the receiver operating characteristic curve, AUC) in age classes. To estimate the elderly risk function a logistic regression was performed on 2,255 octogenarian patients from ItCABG and MO-BYPASS. Elderly model's performance ...
Giornale italiano di cardiologia (2006), 2011
In early 2008, a new national prospective study on short-term outcomes of coronary artery bypass ... more In early 2008, a new national prospective study on short-term outcomes of coronary artery bypass graft (CABG) procedures started in Italy. The aim was to describe short-term results in patients undergoing CABG and improve methodologies for comparative outcome evaluation. Only 26 Italian cardiac surgery centers participated in this survey. For each patient undergoing a CABG procedure, all centers were requested to provide specific data (type of procedure, hemodynamic conditions, comorbidities, recent myocardial infarction and unstable angina, ventricular function, emergency conditions, vital status at 30 days). Representativeness was tested by comparing characteristics of the enrolled population with information derived from national hospital discharge records. A multiple logistic regression analysis was used to perform indirect standardization; the mortality rate of the whole population was used as a reference standard. Comparison with the CABG model built on 34 310 patients in 2002...
Heart (British Cardiac Society), 2003
To assess the relative influence of contractile reserve and inducible ischaemia on subsequent lef... more To assess the relative influence of contractile reserve and inducible ischaemia on subsequent left ventricular volume changes after myocardial infarction. Left ventricular end diastolic and end systolic index volumes were calculated prospectively at discharge and at six months in 143 patients referred for early postinfarction dobutamine stress echocardiography. On the basis of their responses to this test, patients were divided into three groups: scar (n = 48; group 1); contractile reserve (n = 36; group 2); inducible ischaemia (n = 59; group 3). At six months, the left ventricular end diastolic index volume decreased in group 2 (mean (SD), -3.9 (9.4) ml/m2) and increased in both group 1 (+2.8 (10.6) ml/m2, p = 0.009 v group 2) and group 3 (+7.5 (11.4) ml/m2, p < 0.0001 v group 2). The end systolic index volume decreased in group 2 (-4.9 (7.3) ml/m2) and increased in both group 1 (+1.3 (8.3) ml/m2, p = 0.0015 v group 2) and group 3 (+2.8 (8.9) ml/m2, p = 0.0002 v group 2). In mul...
Acta cardiologica, 1997
The purpose of this analysis is to relate the performance at cycloergometer of healthy middle age... more The purpose of this analysis is to relate the performance at cycloergometer of healthy middle aged men, identified in a population, with a number of personal characteristics to explain part of their physical fitness indicators. A sample of 5,163 men aged 40-59, belonging to sedentary occupational groups in Florence and Rome, were screened by a complex diagnostic procedure (participation rate = 66.3%). 3,893 were judged "healthy" from the cardiovascular point of view. A cycloergometric test and the measurement of some individual characteristics allowed to correlate indicators of performance at exercise (work load, test duration, work load/heart rate, PWC150 and PWC150/kg) with body mass index, resting pulse rate, systolic, diastolic and mean blood pressure. HDL and non-HDL cholesterol, a score of physical exercise and cigarette consumption. Univariate and multivariate analysis showed significant relationship of exercise performance indicators with age, resting pulse rate, b...
Giornale italiano di cardiologia, 1994
The ECCIS project (Epidemiology and Clinic of Silent Ischemic Heart Disease) is an italian epidem... more The ECCIS project (Epidemiology and Clinic of Silent Ischemic Heart Disease) is an italian epidemiological study based on a population sample of 4,842 totally asymptomatic men aged 40-59 whose primary aim is the evaluation of the prevalence of totally silent myocardial ischemia and silent myocardial infarction. The systemic search for markers of silent ischemia and infarction was pursued along 3 screening stages: the 1st stage included resting electrocardiogram, hyperventilation test, exercise electrocardiogram and 24-hour Holter electrocardiogram; the 2nd stage included echocardiogram, thallium-201 scintigraphy in conjunction with exercise test or dypiridamole test, exercise radionuclide ventriculography and ergometrine test; the 3rd stage included coronary angiography. After the completion of the 1st stage procedures 439 men (9.1%) with abnormal results and low probability of disease were invited to the 2nd stage and 387 accepted to undergo the diagnostic procedures. After the com...
Interactive cardiovascular and thoracic surgery, 2010
The aim of this study is to evaluate the effect of gender and age on outcome following coronary s... more The aim of this study is to evaluate the effect of gender and age on outcome following coronary surgery in several hospitals enrolled in a national quality assessment program. Patients undergoing isolated coronary artery bypass graft (CABG) during 2003-2005 in Italy were included in the study (n=74,577). The outcome measure was 30-day in-hospital mortality. Comorbidities recorded during previous and current hospitalizations were used to define patients' health status and to build the adjustment model. The interaction term (gender*hospital) was introduced into the model to test the effect modification of gender; if present, gender specific models were analyzed to test the effect modification of age. A significant effect modification by gender was found in 39 hospitals; the adjusted odds ratios (AdjORs) showed significant increased risk for females (AdjORs ranging from 3.7 to 21.6). In three of these hospitals a significant increased risk was found for older age (AdjORs for elderl...
JACC: Cardiovascular Interventions, 2015
Giornale italiano di cardiologia (2006), 2014
OBSERVANT represents the first national observational study on the comparative effectiveness of t... more OBSERVANT represents the first national observational study on the comparative effectiveness of transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR) at short, medium and long term, in a patient population with severe aortic stenosis (AS). The aim of this paper is to describe patient characteristics and short-term outcomes of the enrolled population. OBSERVANT is an observational prospective multicenter cohort study that enrolled AS patients undergoing SAVR or TAVI from December 2010 to June 2012 in the participating hospitals. Information on demographic characteristics, health status prior to intervention, therapeutic approach, intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on long-term outcomes. The enrolled population included 7618 patients undergoing transfemoral/transubclavian TAVI (TF/TS-TAVI, n=1652), transapical TAVI (TA-TAVI, n=259) or SAVR (n=5707). SAVR patients were younger an...