Incidence and predictors of 30-day and 6-month stroke after TAVR: Insights from the multicenter OBSERVANT II study.

BACKGROUND: The incidence and predictors of 30-day stroke after transcatheter aortic valve replacement (TAVR) were derived from early studies investigating first-generation devices. The incidence of 6-month stroke and its related predictors are unknown. AIMS: To investigate the incidence and to identify procedural and patient-related predictors of 30-day and 6-month stroke after TAVR. METHODS: Data from 2753 consecutive patients with severe aortic stenosis undergoing TAVR were obtained from the OBSERVANT-II study, an observational, prospective, multicenter cohort study. The study endpoints were symptomatic 30-day and 6-month stroke after TAVR. RESULTS: The occurrence of a 30-day and 6-month stroke was low (1.3% and 2.4%, respectively) but with significant impact on survival. Aortic valve predilatation (odds ratio [OR]: 2.28, 95% confidence interval [CI]: 1.12-4.65, p = 0.023), diabetes (OR: 3.10, 95% CI: 1.56-6.18, p = 0.001), and left ventricle ejection fraction < 50% (OR: 2.15, 95% CI: 1.04-4.47, p = 0.04) were independent predictors of 30-day stroke, whereas diabetes (sub-distribution hazard ratio [SHR]: 2.07, 95% CI: 1.25-3.42, p = 0.004), pre-existing neurological dysfunction (SHR: 3.92, 95% CI: 1.54-10, p = 0.004), bicuspid valve (SHR: 4.75, 95% CI: 1.44-15.7, p = 0.011), and critical status (SHR: 3.05, 95% CI: 1.21-7.72, p = 0.018) were predictive of 6-month stroke. Conversely, antiplatelet therapy and anticoagulation were protective factors at both 30 days and 6 months. CONCLUSIONS: Stroke after TAVR was rare. Predilatation was the only procedural factor predictive of 30-day stroke, whereas the remaining were patient-related risk factors, suggesting appropriate risk stratification preoperatively.

Financial Burden of Transcatheter Aortic Valve Implantation.

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs.

Impact of COVID-19 Diagnosis on Mortality in Patients with Ischemic Stroke Admitted during the 2020 Pandemic in Italy.

AIMS: The impact of the COVID-19 pandemic on the event rate of patients with ischemic stroke has been poorly investigated. We sought to evaluate the impact of the COVID-19 infection on mortality in patients with ischemic stroke admitted during the 2020 pandemic in Italy. METHODS: We analyzed a nationwide, comprehensive, and universal administrative database of patients who were admitted for ischemic stroke during and after the national lockdown for the COVID-19 infection in 2020, and the equivalent periods over the previous 5 years in Italy. The 2020 observed hospitalization and mortality rates of stroke patients with and without COVID-19 infection were compared with the expected rates, in accordance with the trend of the previous 5 years. RESULTS: During the period of observation, 300,890 hospitalizations for ischemic stroke occurred in Italy. In 2020, 41,302 stroke patients (1102 with concomitant COVID-19 infection) were admitted at 771 centers. The rate of admissions for ischemic stroke during the 2020 pandemic was markedly reduced compared with previous years (percentage change vs. 2015: -23.5). Based on the 5 year trend, the 2020 expected 30 day and 1 year mortality rates were 9.8% and 23.9%, respectively, and the observed incidence of death rates were 12.2% and 26.7%, respectively (both p < 0.001). After multiple corrections, higher rates of mortality were observed among patients admitted for stroke with a concomitant COVID-19 diagnosis. CONCLUSIONS: During the COVID-19 pandemic in 2020 in Italy, the rate of hospitalizations for ischemic stroke was dramatically reduced, although both the 30 day and 1 year mortality rates increased compared with the previous 5 year trend.

Bilateral Internal Thoracic Arteries Improve 10-Year Outcomes of Coronary Artery Bypass Grafting.

BACKGROUND: This observational cohort study was designed by the PRIORITY (PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgery) steering committee to evaluate the 10-year follow-up outcome of bilateral internal thoracic arteries (BITA) versus single internal thoracic artery. METHODS: The PRIORITY project was designed to evaluate long-term outcome of 2 large prospective multicenter cohort studies of coronary artery bypass grafting. Clinical data on isolated coronary artery bypass grafting were merged with administrative data to collect follow-up information. The primary endpoint was the composite outcome of major adverse cardiac and cerebrovascular events at 10-year follow-up. Secondary endpoints were individual components of major adverse cardiac and cerebrovascular events at 10 years and surgical site complications or infections. A propensity score-based inverse probability treatment weighting (IPTW) was used to overcome the selection bias related to the observational nature of the study. RESULTS: The study population consisted of 10,988 patients who underwent isolated coronary artery bypass grafting. BITA was used in 23.5%. The use of BITA is related to lower incidence of major adverse cardiac and cerebrovascular events at 10 years (adjusted hazard ratio [HR] 0.88, 95% CI 0.79-0.98, P < .001). BITA correlated with better 10-year survival (IPTW adjusted HR 0.87, 95% CI 0.78-1.00, P = .05), re-revascularization (IPTW adjusted HR 0.83, 95% CI 0.74-0.92, P < .001), and myocardial infarction (IPTW adjusted HR 0.86, 95% CI 0.77-0.95, P = .005) but to increased incidence of surgical site complications or infections (HR 2.12, 95% CI 1.39-3.24, P < .001). CONCLUSIONS: In propensity-matched patients, use of BITA was associated with improved 10-year survival, freedom from repeat revascularization, and myocardial infarction but also higher incidence of surgical site complications.

Covid-19 diagnosis and mortality in patients with non-ST-elevation myocardial infarction admitted in Italy during the national outbreak.

INTRODUCTION: We sought to assess the clinical impact of Covid-19 infection on mortality in patients with Non-ST elevation myocardial infarction (NSTEMI) admitted during the national outbreak in Italy. METHODS: We analysed a nationwide, comprehensive, and universal administrative database of consecutive NSTEMI patients admitted during lockdown for Covid-19 infection (March,11st - May 3rd, 2020) and the equivalent periods of the previous 5 years in Italy. The observed rate of 30-day and 6-month all-cause mortality of NSTEMI patients with and without Covid-19 infection during the lockdown was compared with the expected rate of death according to the trend of the previous 5 years. RESULTS: During the period of observation, 48.447 NSTEMI hospitalizations occurred in Italy. Among these, 4981 NSTEMI patients were admitted during the 2020 outbreak: 173 (3.5%) with and 4808 (96.5%) without a Covid-19 diagnosis. According to the 5-year trend, the 2020 expected rate of 30-day and 6-month all-cause mortality was 6.5% and 12.2%, while the observed incidence of death was 8.3% (p = 0.001) and 13.6% (p = 0.041), respectively. Excluding NSTEMI patients with a Covid-19 diagnosis, the 6-month mortality rate resulted in accordance with the prior 5-year trend. After multiple corrections, the presence of Covid-19 diagnosis resulted one of the independent predictors of all-cause mortality at 30 days [adjusted odds ratio (OR) 4.3; 95% confidence intervals (CI) 2.90-6.23; p < 0.0001] and 6 months (adjusted OR 3.5; 95% CI: 2.43-5.03; p < 0.0001). CONCLUSIONS: During the 2020 national outbreak in Italy, a concomitant diagnosis of Covid-19 in NSTEMI was associated with a significantly higher rate of mortality.

Impact of COVID-19 Diagnosis on Mortality in Patients with ST-Elevation Myocardial Infarction Hospitalized during the National Outbreak in Italy.

Background. We sought to assess the clinical impact of COVID-19 infection on mortality in patients with ST-elevation myocardial infarction (STEMI) admitted during the national outbreak in Italy. Methods. We analysed a nationwide, comprehensive, and universal administrative database of consecutive STEMI patients admitted during lockdown for COVID-19 infection (11 March−3 May 2020) and the equivalent periods of the previous 5 years in Italy. The observed rate of 30-day and 6-month all-cause mortality of STEMI patients with and without COVID-19 infection during the lockdown was compared with the expected rate of death, according to the trend of the previous 5 years. Results. During the study period, 32.910 STEMI hospitalizations occurred in Italy. Among these, 4048 STEMI patients were admitted during the 2020 outbreak: 170 (4.2%) with and 3878 (95.8%) without a COVID-19 diagnosis. According to the 5-year trend, the 2020 expected rates of 30-day and 6-month all-cause mortality were 9.2% and 12.6%, while the observed incidences of death were 10.8% (p = 0.016) and 14.4% (p = 0.017), respectively. Excluding STEMI patients with a COVID-19 diagnosis, the mortality rate resulted in accordance with the prior 5-year trend. After multiple corrections, the presence of COVID-19 diagnosis was an independent predictor of all-cause mortality at 30 days [adjusted odds ratio (OR) 4.5; 95% confidence intervals (CI) 3.09−6.45; p < 0.0001] and 6 months (adjusted OR 3.6; 95% CI: 2.47−5.12; p < 0.0001). Conclusions.During the 2020 national outbreak in Italy, COVID-19 infection significantly increased the mortality trend in patients with STEMI.

Functional and metabolic frailty predicts mortality in patients undergoing TAVI: Insights from the OBSERVANT II study.

BACKGROUND/AIM: Despite the prognostic role of frailty among elderly patients undergoing transcatheter aortic valve implantation (TAVI) is known, its assessment still represents a challenge due to the multitude of scales proposed in literature. The aim of this study was to define the prognostic impact of a simple combined frailty model including both functional and metabolic parameters in a large cohort of patients undergoing TAVI with new generation devices. METHODS AND RESULTS: We examined 1-year survival of patients affected by aortic valve stenosis treated with new generation TAVI devices from the OBSERVANT II study. Frailty of patients undergoing TAVI was stratified in four groups according to a combination of functional (geriatric status scale - GSS) and metabolic (global nutritional risk index - GNRI) assessment. Among 1985 patients included in the analysis, 1008 (51%) had no significant frailty, 246 (12%) had only functional impairment, 522 (26%) had only metabolic impairment and 209 (11%) had both functional and metabolic impairment. The presence of combined functional and metabolic frailty was associated with a two-fold increased risk of 1-year all-cause mortality (HR 2.06 [95% CI 1.35-3.14]; p = 0.001). GNRI as a single parameter had a lower impact on mortality (HR 1.48 [95% CI 1.05 - 2.09]; p = 0.027), whereas GSS did not impact on mortality (HR 1.23 [95% CI 0.77-1.97]; p = 0.386). CONCLUSIONS: In a large real-world cohort of patients undergoing TAVI with new generation devices, combined functional and metabolic frailty had a significant and incremental impact on 1-year mortality.

Ten-year outcomes after off-pump and on-pump coronary artery bypass grafting: an inverse probability of treatment weighting comparative study.

AIMS: The debate on the advantages and limitations of off-pump myocardial revascularization (OPCAB) on long-term outcomes has not still arrived to a conclusion. This study was designed to compare the impact of OPCAB vs, on-pump coronary artery bypass grafting (CABG) on long-term mortality and major adverse cardiac and cerebrovascular events (MACCEs). METHODS: The PRIORITY project was designed to evaluate the long-term outcomes of two large prospective multicenter cohort studies on CABG. Data on isolated CABG were linked to two administrative datasets. The inverse probability of treatment weight was employed to balance the treatment groups. Time-to-event methods were employed to analyze endpoints. RESULTS: The cohort consisted of 10 988 patients who underwent isolated CABG (27.2% OPCAB). The median follow-up time was 7.9 years and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, confirmed by weighted models (hazard ratio 1.08, 95% confidence interval (CI) 1.01-1.14, P = 0.01). OPCAB was associated to an increased risk of MACCE at 10 years (weighted hazard ratio 1.18, 95% CI 1.12-1.23, P < 0.001). Inside the MACCEs, OPCAB was significantly related to increased incidence of repeat revascularization (hazard ratio 2.27, 95% CI 1.39-3.85, P < 0.001, in the first 6 months, hazard ratio 1.19, 95% CI 1.09-1.32, P < 0.001 afterward) and stroke (hazard ratio 1.22, 95% CI 1.10-1.35, P < 0.001). CONCLUSION: The results of this study suggest that OPCAB was associated with an increased risk of mortality, repeat myocardial revascularization and stroke at 10 years compared with on-pump CABG.

Impact of myocardial revascularization on long-term outcomes in a nationwide cohort of first acute myocardial infarction survivors.

The long-term clinical benefits of myocardial revascularization in a contemporary, nationwide cohort of acute myocardial infarction (AMI) survivors are unclear. We aimed to compare the mortality rates and clinical outcomes at 8 years of patients admitted in Italy for a first AMI managed with or without myocardial revascularization during the index event. This is a national retrospective cohort study that enrolled patients admitted for a first AMI in 2012 in all Italian hospitals who survived at 30 days. The outcomes of interest were all-cause mortality, major cardio-cerebrovascular events (MACCE), and re-hospitalization for heart failure (HF) at 8 years. Time to events was analysed using a Cox and Fine and Gray multivariate regression model. A total of 127 431 patients with AMI were admitted to Italian hospitals in 2012. The study cohort consisted of 62 336 AMI events, of whom 63.8% underwent percutaneous or surgical revascularization ≤30 days of the index hospital admission. At 8 years, the cumulative incidence of all-cause death was 36.5% (24.6% in revascularized and 57.6% in not revascularized patients). After multiple corrections, the hazard ratio (HR) for all-cause mortality in revascularized vs. not revascularized patients was 0.61 (P < 0.0001). The rate of MACCE was 45.7% and 65.8% (adjusted HR 0.83; P < 0.0001), while re-hospitalizations for HF occurred in 17.6% and 29.8% (adjusted HR 0.97; P = 0.16) in AMI survivors revascularized and not revascularized, respectively. In our contemporary nationwide cohort of patients at their first AMI episode, those who underwent myocardial revascularization within 1 month from the index event compared to those not revascularized presented an adjusted 39% risk reduction in all-cause mortality and 17% in MACCE at 8-year follow-up.

One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice.

BACKGROUND: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse. AIMS: To compare outcomes and trends of two TAVI eras from real Italian practice. METHODS: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010-2012 and 2016-2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching. RESULTS: The median age (83.0 (79.0-86.0) vs. 83.0 (79.0-86.0)) and EuroSCORE II (5.2 (3.2-7.7) vs. 5.1 (3.1-8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52-0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60-0.84)), whereas rates of stroke (3.1% vs. 3.6%) and permanent pacemaker implantation (PPI) (16.6% vs. 18.0%) were comparable between study groups. CONCLUSIONS: Age and risk profile among patients undergoing TAVI in Italy remained substantially unchanged between the 2010-2012 and 2016-2018 time periods. After adjustment, patients undergoing TAVI in the most recent era had lower risk of all-cause death and rehospitalization for HF at 1 year, whereas rates of stroke and PPI did not differ significantly.

Impact of age, gender and heart failure on mortality trends after acute myocardial infarction in Italy.

BACKGROUND: The outcome of patients with acute myocardial infarction (AMI) may vary substantially based on baseline risk. We aimed at analyzing the impact of gender, age and heart failure (HF) on mortality trends, based on a nationwide, comprehensive and universal administrative database of AMI. METHODS: This is a nationwide cohort study of patients admitted with AMI from 2009 to 2018 in all Italian hospitals. In-hospital mortality rate (I-MR) and 1-year post-discharge mortality rate (1-Y-MR) were assessed. RESULTS: Among the 1,000,965 AMI events included in the analysis, 43.6% occurred in patients aged ≥75 years, 34.7% in females and 21.8% in AMI complicated by HF at the index hospitalization. Both I-MR and 1-Y-MR significantly decreased over time (from 8.87% to 6.72%; mean annual change -0.23%; confidence intervals (CI): - 0.26% to -0.20% and from 12.24% to 10.59%; mean annual change -0.18%; CI: - 0.24% to -0.13%, respectively). This trend was confirmed in younger and elderly AMI patients, in both sexes. In AMI patients complicated by HF, both I-MR and 1-Y-MR were markedly high, regardless of age and gender. CONCLUSIONS: This contemporary, nationwide study suggests that I-MR and 1-Y-MR are still elevated, albeit decreasing over time. Elderly patients and those with HF at the time of index admission, present a particularly high risk of fatal events, regardless of gender.

One-Year Outcomes after Surgical versus Transcatheter Aortic Valve Replacement with Newer Generation Devices.

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33-0.71), in females (HR 0.57, 0.38-0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32-0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

Impact of gender on 10-year outcome after coronary artery bypass grafting.

OBJECTIVES: Our goal was to evaluate the impact of gender on the 10-year outcome of patients after isolated coronary artery bypass grafting (CABG) included in the Italian nationwide PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgery (PRIORITY) study. METHODS: The PRIORITY project was designed to evaluate the long-term outcomes of patients who underwent CABG and were included in 2 prospective multicentre cohort studies. The primary end point of this analysis was major adverse cardiac and cerebrovascular events. Baseline differences between the study groups were balanced with propensity score matching and inverse probability of treatment. Time to events was analysed using Cox regression and competing risk analysis. RESULTS: The study population comprised 10 989 patients who underwent isolated CABG (women 19.6%). Propensity score matching produced 1898 well-balanced pairs. The hazard of major adverse cardiac and cerebrovascular event was higher in women compared to men [adjusted hazard ratio (HR) 1.13, 95% confidence interval (CI) 1.03-1.23; P = 0.009]. The incidence of major adverse cardiac and cerebrovascular event in women was significantly higher at 1 year (HR 1.31, 95% CI 1.11-1.55; P < 0.001) and after 1 year (HR 1.11, 95% CI 1.00-1.24; P = 0.05). Mortality at 10 years in the matched groups was comparable (HR 1.04, 95% CI 0.93-1.16; P = 0.531). Women have significantly a higher 10-year risk of myocardial infarction (adjusted HR 1.40, 95% CI 1.17-1.68; P = 0.002) and percutaneous coronary intervention (adjusted HR 1.32, 95% CI 1.10-1.59; P = 0.003). CONCLUSIONS: The present study documented an excess of non-fatal cardiac events after CABG among women despite comparable 10-year survival with men. These findings suggest that studies investigating measures of tertiary prevention are needed to decrease the risk of adverse cardiovascular events among women.

Early and late outcomes after transcatheter versus surgical aortic valve replacement in obese patients.

INTRODUCTION: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients. MATERIAL AND METHODS: Obese patients (body mass index ≥ 30 kg/m2) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics. RESULTS: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures. CONCLUSIONS: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates.

[First results from the OBSERVANT II study: clinical characteristics of patients with aortic stenosis undergoing transcatheter treatment with new generation devices]. / Primi risultati dello studio OBSERVANT II: caratteristiche cliniche dei pazienti con stenosi aortica sottoposti a procedure transcatetere con dispositivi di nuova generazione.

BACKGROUND: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population. METHODS: OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes. RESULTS: The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p<0.000) and 2.4% vs 7.7% (p<0.000), respectively. CONCLUSIONS: The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study.

OBJECTIVES: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI. BACKGROUND: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years. METHODS: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years). RESULTS: Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061). CONCLUSION: Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome.

High thrombotic risk increases adverse clinical events up to 5 years after acute myocardial infarction. A nationwide retrospective cohort study.

The risk of recurrent events among survivors of acute myocardial infarction (AMI) is understudied. The aim of this analysis was to investigate the role of residual high thrombotic risk (HTR) as a predictor of recurrent in-hospital events after AMI. This retrospective cohort study included 186,646 patients admitted with AMI from 2009 to 2010 in all Italian hospitals who were alive 30 days after the index event. HTR was defined as at least one of the following in the 5 years preceding AMI: previous myocardial infarction, ischemic stroke/other vascular disease, type 2 diabetes mellitus, renal failure. Risk adjustment was performed in all multivariate survival analyses. Rates of major cardiac and cerebrovascular events (MACCE) within the following 5 years were calculated in both patients without fatal readmissions at 30 days and in those free from in-hospital MACCE at 1 year from the index hospitalization. The overall 5-year risk of MACCE was higher in patients with HTR than in those without HTR, in both survivors at 30 days [hazard ratio (HR), 1.49; 95% confidence interval (CI), 1.45-1.52; p<0.0001] and in those free from MACCE at 1 year (HR, 1.46; 95% CI, 1.41-1.51; p<0.0001). The risk of recurrent MACCE increased in the first 18 months after AMI (HR, 1.49) and then remained stable over 5 years. The risk of MACCE after an AMI endures over 5 years in patients with HTR. This is also true for patients who did not have any new cardiovascular event in the first year after an AMI. All patients with HTR should be identified and addressed to intensive preventive care strategies.

Risk stratification models in elderly patients: recalibrating or remodeling?

OBJECTIVE: 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. METHODS AND RESULTS: 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 was tested. Model accuracy is fair in all age classes although the explained variance is poor. ItCABG and LogEuroSCORE models revealed good discrimination power in patients aged < (60, 60-69, and 70-79 years, but not in patients aged > or = 80 years (AUCs: 0.82, 0.77, 0.76, 0.64, and 0.78, 0.75, 0.74, 0.65, respectively). Calibration of both models is poor in patients 80 years (ItCABG: X(H-L) = 18.1, P = 0.05; LogEuroSCORE: X(H-L) = 129.7, P < 0.001). When a new model specific to octogenarian patients was built, discrimination power remained poor (AUC = 0.66), although calibration power improved (X(H-L) = 3.93, P = 0.86). CONCLUSIONS: ItCABG and LogEuroSCORE models were poor predictors of mortality in octogenarian patients. Elderly-specific risk factors must be assessed to improve risk stratification in patients aged 80 years and older.

Thirty-day mortality after coronary artery bypass surgery in patients aged <50 years: results of a multicenter study and meta-analysis of the literature.

BACKGROUND: Young patients requiring myocardial revascularization are considered at low operative risk, but data on their outcome are scarce. This study was undertaken to evaluate the prevalence and 30-day mortality of patients aged <50 years after isolated coronary artery bypass surgery (CABG). MATERIALS AND METHODS: This is a multicenter study including 2207 patients aged <50 years undergoing isolated CABG at 68 Italian hospitals. RESULTS: The proportion of patients aged <50 years in this series was 5.3% and varied significantly from 0% to 9.9% in different institutions (p < 0.0001). The 30-day mortality rate was 0.9%. One-to-one propensity score matching of patients aged <50 years versus older patients resulted in 2013 pairs whose 30-day mortality was 0.9% and 2.2%, respectively (p = 0.001). Logistic regression showed that left ventricular ejection fraction <30% (OR 5.5, 95% CI 1.6-18.6), peripheral vascular disease (OR 3.6, 95% CI 1.1-12.0), pulmonary hypertension (OR 18.1, 95% CI 1.8-187.0), critical preoperative state (OR 4.7, 95% CI 1.5-14.3), and emergency operation (OR 3.8, 95% CI 1.1-12.9) were independent predictors of 30-day mortality. Meta-analysis of five studies reporting on patients aged <50 years who underwent isolated CABG showed that operative mortality in these patients was 0.9% (95% CI, 0.8-1.1%, I(2) 0%, 135/14,316 patients). CONCLUSIONS: The proportion of patients aged <50 years undergoing CABG is low and varies significantly among institutions. The results of this study and a meta-analysis of the literature data showed that CABG can be carried out in young patients with an extremely low risk of operative mortality.

[In-hospital management of acute coronary syndrome patients: influence of age, gender and admission department on medical policy and outcome]. / Gestione ospedaliera del paziente con sindrome coronarica acuta: influenza dell'età, del genere e del reparto di ricovero sulle scelte mediche e l'esito.

BACKGROUND: 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. METHODS: 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. RESULTS: 19% of STEMI and 15% of NSTE-ACS patients are admitted to a general medicine department. For STEMI patients, the proportion increases up to 37.6% when females aged ≥75 years are considered. Patients undergo a coronary procedure or extensive investigations less commonly in general medicine than in cardiology departments; in-hospital 30-day adjusted mortality rates in general medicine departments are approximately 2-fold higher than those recorded in cardiology departments (STEMI: 26.4 vs 16.7%; NSTE-ACS: 7.7 vs 4.2%). CONCLUSIONS: In-hospital mortality rates of ACS patients admitted to cardiology departments are lower than those reported in general medicine departments. Nevertheless, in-hospital management of women and elderly ACS patients does not completely comply with the recommended guidelines and exposes them to unfavorable prognosis.