Impact of vascular complications after transcatheter aortic valve implantation. VASC-OBSERVANT II sub-study.

BACKGROUND: Trans-femoral (TF) access is the commonest approach for transcatheter aortic valve implantation (TAVI). However this vascular approach is associated with vascular complications (VC) which in turn have prognostic implications. The aim of this study is to evaluate the clinical impact of access site VC in patients undergoing TAVI with newer generation transcatheter prostheses enrolled in the national observational prospective multicenter study OBSERVANT II. METHODS: Vascular events were defined according to the Valve Academic Research Consortium (VARC)-2 criteria. The population enrolled in OBSERVANT II was divided into 3 groups: patients without VC (No-VC), patients with minor VC or percutaneous closure device failure (Minor-VC) and patients with major VC (Major-VC). The primary endpoint was 1-year major adverse cardiac and cerebrovascular event (MACCE), a composite endpoint of all-cause mortality, stroke, myocardial infarction and coronary revascularization. A multivariate Cox regression model was used for risk estimation of MACCE between the three analyzed groups. RESULTS: 2.504 patients were included in this analysis: 2.167 patients in No-VC group; 249 patients in the Minor-VC and 88 patients in the Major-VC. At 1-year Minor-VC group had a freedom from MACCE comparable to the No-VC group, while Major-VC patients had significantly worse outcome (Log-rank test: p = 0.003). These results were driven by higher 1-year mortality in the Major-VC (p < 0.0001). Major-VC was an independent predictor of MACCE in adjusted analysis (hazard ratio 1.89, 95% confidence interval 1.18-3.03, p = 0.008). CONCLUSIONS: Despite a low incidence of major VC with current TF-TAVI devices, our data confirm that major VC is still associated with a significantly worse clinical outcome.

Relative Survival After Adult Cardiac Surgery: Analysis of the Italian Nationwide Registry Data.

OBJECTIVE: The authors aimed to investigate life expectancy after adult cardiac surgery. SETTING: Nationwide study including University and non-University hospitals. PARTICIPANTS: Consecutive adult patients who underwent heart valve and coronary artery surgery from a nationwide administrative registry. INTERVENTIONS: Surgical procedures on the heart valves and coronary arteries. METHODS: The authors estimated the 10-year relative survival of adult patients who underwent surgery for heart valve diseases and coronary artery disease taken from a nationwide administrative registry. MEASUREMENTS AND RESULTS: Overall, data on 415,472 patients were available for this study. Among them, 394,445 (94.9%) survived 90 days after surgery, and their 10-year survival was 58.0% (95% CI 57.8-58.3); the expected survival was 70.1%, and the relative survival was 0.83 (95% CI 0.82-0.83). Patients who underwent surgical repair of the mitral valve and aortic valve had relative survival of 0.96 and 0.92, respectively. Isolated coronary artery bypass grafting had a relative survival of 0.88. Surgical replacement of the heart valves had a relative survival below 0.80. Poor results with relative survival <0.70 were observed after complex cardiac surgery. Relative survival was <0.60 in patients who underwent double- or triple-valve surgery combined with coronary artery surgery. The authors observed markedly lower relative survival among women (0.77, 95% CI 0.77-0.78) compared with men (0.86, 95% CI 0.85-0.86) at 10 years. Such a difference was observed after almost all different procedures. CONCLUSIONS: The present findings provided a picture of the real expectation in terms of the late survival of patients after having undergone adult cardiac surgery. This information should be communicated to patients and their relatives before surgery, and it may be relevant in the decision-making process and in planning tertiary prevention.

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.

Long-term outcomes of self-expanding versus balloon-expandable transcatheter aortic valves: Insights from the OBSERVANT study.

OBJECTIVES: To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. BACKGROUND: To date, no robust, comparative data of BE and SE TAVs at long-term are available. METHODS: We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. RESULTS: Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p < .01) and acute kidney injury (AKI)(HR 3.89, 95% CI 2.47-6.38; p < .01) showed to be independent predictors of 5-year all-cause mortality in multivariable analysis. CONCLUSIONS: Considering the intrinsic limitations of the OBSERVANT study, we found that patients undergoing TF-TAVI with a supra-annular SE valve had a higher all-cause mortality compared to those receiving an intra-annular BE valve at 5 years. A late catch up phenomenon of patients receiving the BE valve was observed beyond 3 years. Post-procedural moderate/severe PVR seems to play a crucial role in determining this finding. Comparative studies of new generation devices with longer follow-up are needed to evaluate the benefit of each specific TAV type.

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.

Transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with anaemia.

OBJECTIVES: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis. METHODS: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis. RESULTS: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12-1.68) and SAVR (HR 1.63, 95% CI 1.37-1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p < .001), major vascular damage (5.7% versus 0.4%, p < .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p < .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p < .001) and blood transfusion (70.0% versus 38.6%, p < .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049). CONCLUSIONS: These results suggest that TAVI is not superior to SAVR in patients with anaemia.

Clinical SYNTAX score predicts outcomes of patients undergoing coronary artery bypass grafting.

BACKGROUND: The SYNTAX score (SS) is a determinant of outcome in patients undergoing percutaneous coronary intervention. In addition, it has been recently shown that the clinical SYNTAX score (cSS), obtained by adding clinical variables to the SS, improves the predictive power of the resulting risk model. We assessed the hypothesis that the use of the cSS may predict outcomes of patients undergoing coronary artery bypass grafting (CABG). METHODS: We measured the SYNTAX score in 874 patients undergoing isolated first time on-pump CABG. The clinical SYNTAX score was calculated at the time of the study using age, creatinine clearance and ejection fraction, the modified ACEF score, and analyses performed for major adverse cardiac and cerebrovascular events (MACCE) and all-cause mortality at 3-year follow-up. RESULTS: The mean age of the study population was 70.9 ± 8.1 years, and the median cSS 14.2 (range 2.1-286.5). The ROC curve analysis showed that a cSS >14.5 (81.4% sensitivity and 67.8% specificity) was a reliable tool in discrimination of patients for the occurrence of MACCE (AUC 0.78) and all-cause mortality (AUC 0.74). Kaplan-Meier survival analysis confirmed that patients belonging to higher cSS quartiles have poorer 3-year survival (P = .0001) and MACCE-free survival (P = .0001), with respect to those with lower cSS. CONCLUSIONS: This observational study has shown that the clinical SYNTAX score, incorporating the lesion-based SS and clinical-based ACEF score, predicted mid-term adverse outcomes of patients undergoing CABG and may play an important role in the risk stratification of this population. Further studies are needed to confirm these findings.

Transcatheter aortic valve replacement in nonagenarians: early and intermediate outcome from the OBSERVANT study and meta-analysis of the literature.

The purpose of this study was to evaluate the outcome of nonagenarians after transcatheter aortic valve replacement (TAVR) from the OBSERVANT study and to pool the results of the literature on this topic. Aortic stenosis is the most common acquired valvular heart disease in the Western countries, and its prevalence is linked to the phenomenon of population aging. TAVR can be considered as a wise approach to treat nonagenarians, but data on its safety and effectiveness are scarce. Data on 80 patients aged >90 years who underwent TAVR from OBSERVANT study were analyzed. A systematic review and meta-analysis of published data were performed. Thirty-day mortality in the OBSERVANT series was 6.3 %. None of these patients experienced stroke. Permanent pacemaker implantation was necessary in 20 % of patients. Paravalvular regurgitation was observed in 57.5 %. Survival at 1, 2, and 3 years was 79.6, 71.9, and 61.5 %. Ten series provided data on 1227 nonagenarians who underwent TAVR. Pooled 30-day mortality rate was 7.1 %, stroke 2.8 %, vascular access complication 8.8 %, and permanent pacemaker implantation 10.6 %. Paravalvular regurgitation was observed in 60.1 % of patients. Pooled 1-, 2-, and 3-year survival rates were 79.2, 68.2, and 55.6 %. Transapical TAVR was associated with a significantly higher risk of early mortality compared with transfemoral TAVR. The results of OBSERVANT study and aggregate data meta-analysis suggest that in nonagenarians, TAVR is associated with low postoperative morbidity and excellent intermediate survival. Transapical TAVR in these very elderly is associated with high postoperative mortality.

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study. SETTING: Multicenter study, including Italian hospitals performing TAVR interventions. PARTICIPANTS: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. INTERVENTIONS: Transfemoral TAVR under general or local anesthesia. MEASUREMENTS AND MAIN RESULTS: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). CONCLUSIONS: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Identification of very high risk octogenarians undergoing coronary artery bypass surgery: results of a multicenter study.

Excellent late survival is expected after coronary artery bypass (CABG) in patients aged ≥80 years, but immediate postoperative mortality can be rather high. This study was planned to identify variables associated with very high operative risk in these fragile patients. This is a multicenter study including 2,246 patients aged ≥80 years who underwent isolated CABG at 68 Italian hospitals. The proportion of patients aged ≥80 years varied from 1.7 to 13.6 % (overall 5.6 %, p < 0.0001) in different institutions. The median logistic EuroSCORE varied from 6.2 to 31.7 % (overall median 11.3 %, p = <0.0001) in different institutions. Thirty-day mortality in patients aged ≥80 years correlated with that of patients aged <80 years (rho: 0.310, p = 0.027). The overall 30-day mortality rate was 6.5 %. Both logistic regression and CART showed that emergency procedure, low left ventricular ejection fraction, unstable hemodynamics, and use of nitrates infusion at arrival in the operating room were independent predictors of 30-day mortality. CART analysis showed that 30-day mortality among patients undergoing emergency CABG with unstable hemodynamic conditions was 32.60 % and it was 20.0 % in patients undergoing non-emergency operation with nitrates infusion at arrival in the operating room and left ventricular ejection fraction <30 %. The proportion and operative risk of patients aged ≥80 years and undergoing CABG significantly varied among institutions. Patients requiring emergency surgery, with unstable hemodynamic conditions, requiring nitrates infusion, and low ejection fraction have a prohibitive operative risk. This small proportion of patients may benefit from percutaneous coronary intervention in order to stabilize their preoperative conditions.

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.

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.

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.

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.

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.

[Twenty years of epidemiology of acute coronary syndromes in Italy: how cardiovascular epidemiology can guide secondary prevention strategies]. / Vent'anni di epidemiologia delle sindromi coronariche acute in Italia: come l'epidemiologia cardiovascolare può orientare la clinica e le strategie di prevenzione secondaria.

Over the last 20 years the epidemiology of acute coronary syndromes (ACS) has significantly changed, affecting both the acute and post-acute phases. In particular, although the progressive reduction in in-hospital mortality, the trend in post-hospital mortality was found to be stable or increasing. This trend was at least in part attributed to the improved short-term prognosis due to coronary interventions in the acute phase, which ultimately have increased the population of survivors at high risk of relapse. Thus, while hospital management of ACS has shown great progress in terms of diagnostic and therapeutic efficacy, post-hospital care has not had a parallel development. This is certainly partly attributable to the inadequacy of post-discharge cardiologic facilities, so far not planned according to the level of risk of individual patients. Hence, it is crucial that patients at high risk of relapse are identified and initiated into more intensive secondary prevention strategies. On the basis of epidemiological data, the cornerstones of post-ACS prognostic stratification are represented on the one hand by the identification of heart failure (HF) at index hospitalization, on the other hand by the assessment of residual ischemic risk. In patients presenting with HF at index hospitalization, the fatal rehospitalization rate increases by 0.90% per year from 2001 to 2011, with a mortality between discharge and the first year which in 2011 was equal to 10%. The risk of fatal readmission at 1 year is therefore strongly conditioned by the presence of HF which, together with age, is the major predictor of new events. The effect of high residual ischemic risk on subsequent mortality shows increasing trend up to the second year of follow-up, moderately increasing over the years until reaching a plateau around the fifth year. These observations confirm the need for long-term secondary prevention programs and implementation of a continuous surveillance in selected patients.

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 Chronic Coronary Artery Disease and Revascularization Strategy in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Implantation.

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n = 1,130) versus no CAD (CAD-, n = 1,505), and compared using a propensity matched analysis. CAD+ group was further stratified according to the revascularization strategy: no revascularization (n = 331), revascularization performed >90 days before index-TAVI (n = 417) and coronary revascularization performed <90 days before index-TAVI or during TAVI (n = 382). In-hospital, 30-day and 1-year clinical outcomes were estimated. The mean age of the overall population was 81.8 years; 54.9% of patients were female. Propensity score matching yielded 813 pairs and their 30-day all-cause mortality was comparable (p = 0.480). Major periprocedural adverse events were also similar between the groups. At 1-year follow-up, the rate of major adverse cardiac and cerebrovascular events (MACCEs) and all-cause mortality were similar between the groups (p = 0.732 and p = 0.633, respectively). Conversely, patients with CAD experienced more often myocardial infarction and need for percutaneous coronary intervention at 1 year (p = 0.007 and p = 0.001, respectively). Neither CAD nor revascularization strategy were independent predictors of 1-year MACCE. About 40% of patients presenting with severe AS and who underwent TAVI had concomitant CAD. The presence of CAD had no impact on all-cause mortality and MACCE 1-year after TAVR. However, CAD carries a higher risk for acute myocardial infarction and need of percutaneous coronary intervention during follow-up.

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.