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Dual antiplatelet therapy (DAPT) is the gold standard after acute coronary syndromes (ACS) or chronic coronary syndromes (CCS) undergoing percutaneous coronary intervention (PCI). Because local and systemic ischemic complications can occur particularly in the early phase (i.e. 1-3 months) after ACS or PCI, the synergistic platelet inhibition of aspirin and a P2Y

Preserving coronary artery access is a crucial goal during transcatheter aortic valve replacement (TAVR) procedures, especially in case of self-expandable transcatheter heart valve (SE-THV) implantation. In this light, a proper commissural alignment is needed to avoid the risk of coronary obstruction and to permit easy vessels re-cannulation for diagnostic and interventional purposes. New-generation SE-THVs have been furnished of different markers, able to guide operators to perform a correct commissural alignment. In this case series, we describe key procedural aspects of commissural alignment for the different available SE-THVs, providing a step-by-step tutorial for each device. Lastly, we illustrate a commissural alignment in a contrast-zero TAVR.

BACKGROUND The radial artery is recommended by international guidelines as the default vascular access in patients with acute coronary syndromes (ACS) managed invasively. However, crossover from radial to femoral access is required in 4-10% of cases and has been associated with worse outcomes. No standardised algorithm exists to predict the risk of radial crossover. AIMS We sought to derive and externally validate a risk score to predict radial crossover in patients with ACS managed invasively. METHODS The derivation cohort consisted of 4,197 patients with ACS undergoing invasive management via the randomly allocated radial access from the MATRIX trial. Using logistic regression, we selected predictors of radial crossover and developed a numerical risk score. External validation was accomplished among 3,451 and 491 ACS patients managed invasively and randomised to radial access from the RIVAL and RIFLE-STEACS trials, respectively. RESULTS The MATRIX score (age, height, smoking, renal failure, prior coronary artery bypass grafting, ST-segment elevation myocardial infarction, Killip class, radial expertise) showed a c-index for radial crossover of 0.71 (95% CI: 0.67-0.75) in the derivation cohort. Discrimination ability was modest in the RIVAL (c-index: 0.64; 95% CI: 0.59-0.67) and RIFLE-STEACS (c-index: 0.66; 95% CI: 0.57-0.75) cohorts. A cut-off of ≥41 points was selected to identify patients at high risk of radial crossover. CONCLUSIONS The MATRIX score is a simple eight-item risk score which provides a standardised tool for the prediction of radial crossover among patients with ACS managed invasively. This tool can assist operators in anticipating and better addressing difficulties related to transradial procedures, potentially improving outcomes.

Aims ST-segment elevation myocardial infarction (STEMI) is associated with an intense acute inflammatory response and an increased risk of death and heart failure (HF). In this study, we sought to evaluate the effect of anakinra, a recombinant interleukin-1 receptor antagonist, on the incidence of HF. Methods and results We performed a pooled analysis of three early phase randomized clinical trials. The endpoints included the composite of all-cause death and new-onset HF, and the composite of all-cause death and hospitalization for HF at 1-year follow-up. Safety events, including injection site reaction and serious infections, were also recorded. We analysed 139 patients with STEMI from three separate trials: VCUART (N = 10), VCUART2 (N = 30), and VCUART3 (N = 99). Of these, 84 (60%) patients were randomized to anakinra and 55 (40%) to placebo. Treatment with anakinra significantly reduced the incidence of all-cause death or new-onset HF (7 [8.2%] vs. 16 [29.1%], log-rank P = 0.002) and of all-cause death or HF hospitalization (0 [0] vs. 5 [9.1%], log-rank P = 0.007). Patients treated with anakinra had significantly higher injection site reactions (19 [22.6%] vs. 3 [5.5%], P = 0.016) without a significant difference in the incidence of serious infections (11 [13.1%] vs. 7 [12.7%], P = 0.435). Treatment with anakinra significantly reduced the area under the curve for high-sensitivity C-reactive protein between baseline and 14 days (75.48 [41.7–147.47] vs. 222.82 [117.22–399.28] mg day/L, P Conclusion IL-1 blockade with anakinra for 14 days in patients with STEMI reduces the incidence of new-onset HF or hospitalization for HF at 1 year following STEMI.

Renal denervation (RDN) is a therapeutic strategy for patients with uncontrolled arterial hypertension characterized by considerable fluctuations during its progression. After initial strong enthusiasm, the procedure came to an abrupt halt following the publication of the Symplicity HTN-3 study results. The results of recently published studies highlight the reduction in blood pressure values after RDN and justify the inclusion in the Guidelines of new recommendations for the use of RDN in clinical practice, in selected patients. Additionally, RDN findings are summarized in view of other potential indications such as atrial fibrillation. Six prospective, randomized studies are presented that evaluated RDN as an adjunct therapy to pulmonary vein isolation for the treatment of atrial fibrillation. In five studies, patients had uncontrolled hypertension despite therapy with three antihypertensive drugs. The analysis of these studies showed that RDN reduced the recurrence of atrial fibrillation (AF) by 57% compared to patients with pulmonary vein isolation (PVI) only. Modulation of the autonomic nervous system by RDN has been shown not only to reduce blood pressure but also to have an antiarrhythmic effect in symptomatic AF patients when the strategy is combined with PVI, thus opening up new therapeutic scenarios.

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The 4 risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, in contrast, better calibration compared with the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently.

Objectives The evidence supporting the use of the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score for risk stratification is controversial. We performed a systematic review and meta-analysis of all the randomized controlled trials comparing percutaneous coronary intervention versus coronary artery bypass grafting that reported their outcomes stratified by SYNTAX score, focusing on between-strata comparisons. Methods A systematic review of MEDLINE, EMBASE, Cochrane Library databases was performed. Incidence rate ratios were pooled with a random effect model. Between-group statistical heterogeneity according to accepted SYNTAX score tertiles was computed in the main analysis. Ratios of incidence rate ratios were computed to appraise between-strata effect, as sensitivity analysis. Primary and secondary outcomes were major adverse cardiac and cerebrovascular events and all-cause mortality, respectively. Separate sub-analyses were performed for left main and multivessel disease. Results From 425 citations, 6 trials were eventually included (8269 patients [4134 percutaneous coronary interventions, 4135 coronary artery bypass graftings]; mean follow-up: 6.2 years [range: 3.8-10]). Overall, percutaneous coronary intervention was associated with a significant increase in major adverse cardiac and cerebrovascular events (incidence rate ratio, 1.39, 95% confidence interval, 1.27-1.51) and nonsignificant increase in all-cause mortality (incidence rate ratio, 1.17, 95% confidence interval, 0.98-1.40). There was no significant statistical heterogeneity of treatment effect by SYNTAX score for major adverse cardiac and cerebrovascular events or mortality (P = .40 and P = .34, respectively). Results were consistent also for patients with left main and multivessel disease (major adverse cardiac and cerebrovascular events: P = .85 in left main, P = .78 in multivessel disease 0.78; mortality: P = .12 in left main; P = .34 in multivessel disease). Results of analysis based on ratios of incidence rate ratios were consistent with the main analysis. Conclusions No significant association was found between SYNTAX score and the comparative effectiveness of percutaneous coronary intervention and coronary artery bypass grafting. These findings have implications for clinical practice, future guidelines, and the design of percutaneous coronary intervention versus coronary artery bypass grafting trials.

Background: The T2238C variant of the atrial natriuretic peptide (ANP) gene has emerged as a novel risk factor for the incidence of cardiovascular events. However, the impact of this variant on cardiovascular outcome in patients with atrial fibrillation (AF) is unknown. Methods: We included 557 anticoagulated patients with non-valvular AF randomly selected from the prospective ATHERO-AF cohort. Patients underwent genetic analysis for the T2238C/ANP variant and were grouped as wild type or heterozygous or homozygous for C2238 variant allele. Primary endpoint was a composite of cardiovascular events (CVEs) including cardiovascular death, fatal/non-fatal ischemic stroke and myocardial infarction. Overall, 429 patients carried the TT wild type genotype, 110 patients (19.7%) were heterozygous (T/C) and 18 patients (3.2%) were homozygous (CC). Results: Incidence of CVEs was higher in homozygous patients for C2238 allele at unadjusted analysis (log-rank test, p = 0.042 for additive model, p = 0.043 for recessive model). The multivariable Cox proportional hazards regression analysis confirmed that C2238 ANP allele was associated with CVEs in the additive (p = 0.008) and recessive models (p = 0.005). Conclusions: Carrier status for the C2238/ANP variant allele is associated with an increased risk of CVEs in anticoagulated AF patients.

Background Dual antiplatelet therapy (DAPT) with acetylsalicylic acid and oral P2Y12 inhibitor (P2Y12-I) represents the standard of care for patients with acute coronary syndromes (ACS) or with chronic coronary syndromes (CCS) treated with percutaneous coronary intervention (PCI). Cangrelor, the first intravenous P2Y12-I, is deemed to overcome the drawbacks of the oral administration; nevertheless real world data on this new drug are scanty. We sought to investigate routine clinical use of cangrelor in four interventional centers of Italy. Methods We enrolled 241 consecutive patients (196 ACS, 45 CCS) treated with cangrelor during PCI. Drug administration modalities and in-hospital clinical outcomes were evaluated. A subanalysis in patients selected on the basis of the CHAMPION Phoenix trial inclusion/exclusion criteria (CHAMPION-like subpopulation) was also performed. Results Cangrelor was mainly utilized in ACS patients, who presented poorer clinical conditions and higher bleeding risk. Cangrelor was given only in P2Y12-I naive patients; switch to clopidogrel was always done at the end of the infusion, while ticagrelor or prasugrel were prevalently given 30 minutes before. In-hospital mortality was 10.0% and GUSTO moderate/severe bleeding was 2.5%. Bleeding data showed nevertheless to be in line with the CHAMPION Phoenix results in the "CHAMPION-like" subpopulation. Conclusions Cangrelor was predominantly used in ACS with modalities substantially in accord with the label indications. Poor clinical outcomes are due to the prevalent utilization in highly challenging clinical settings, nevertheless the rate of bleeding and stent thrombosis are in line with the randomized trials if analyzed in a subpopulation of comparable risk profile.

Initial studies on renal denervation (RDN) for the treatment of non-controlled arterial hypertension (HTN) through radiofrequency ablation of renal arteries demonstrated that RDN is an effective therapeutic strategy to reduce arterial blood pressure (BP). Nonetheless, the first randomized study, SYMPLICITY-HTN-3, failed to demonstrate a clear benefit for RND over the control group. Technologic evolution, with the introduction of new second generation multi-electrode devices, allowed deep energy delivery along the full circumference of the vessel. Two recent randomized studies involving patients assuming (SPYRAL HTN-ON MED) or not (SPYRAL HTN-OFF MED) antihypertensive pharmacologic treatment, demonstrated the efficacy and safety of RDN using second generation systems for radiofrequency ablation. Another recent randomized study demonstrated that RDN with ultrasounds (RADIANCE-HTN SOLO) of the main renal arteries led to a significant BP reduction compared to the control group. These studies have once again raised the interest of the scientific community towards attempting to define the appropriate role of RDN in the treatment of hypertension. Nonetheless, larger and longer clinical trials will be necessary to draw further conclusions.

The differential outcomes across the age spectrum of transcatheter aortic valve implantation (TAVI) recipients are still debated. Aim of the study was to evaluate the clinical outcomes of oldest-old patients undergoing TAVI in the large "Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea (RISPEVA)" registry. A total of 3,507 patients were stratified according to age: 1,381 were ≥85 years, 2,126 were85 years. Primary endpoints were death at 30-days and complete follow-up (FU) (medium 368 days). Cerebrovascular events, myocardial infarction, bleedings, vascular complications at 30-days and complete FU were considered. In the unadjusted analysis, 30-days mortality in the oldest-old group was higher than in younger patients (4.2% vs 2.4%; p = 0.007); this difference kept true also at complete FU (19.6% vs 15.9%; p = 0.014). After propensity score (PS) matching, the oldest-old population showed a higher mortality solely at 30-days (4.7% vs 2.4%; p = 0.016), while the survival at complete FU was similar to that of younger patients (20.1% vs 18.0%; p = 0.286). The incidence of non-fatal outcomes resulted comparable between the 2 groups, also after propensity score matching. At the multivariate logistic regression analysis procedural major or disabling bleedings, cerebrovascular events, cardiogenic shock resulted predictors of 30-days death in the oldest-old cohort. In conclusion, patients ≥85 years can safely undergo TAVI being not more exposed to procedural complications than those85 years; nevertheless they showed worse 30-days mortality, probably driven by reduced tolerance to complications. Passed the critical periprocedural phase, patients ≥85 years had a similar survival to those85 years with comparable risk profile.

According to previous epidemiological studies, we can reduce the thickness of epicardial fat and improve cardiovascular risk factors through exercise, and the changes may depend on the form of exercise. We systemically reviewed published studies that evaluated exercise intervention on epicardial adipose tissue (EAT) levels. We included randomized controlled trials (RCTs) comparing one exercise with another exercise or diet for the treatment to reduce EAT. We used fixed effects models for meta-analyses; effects of exercise on outcomes were described as mean differences (MD) or standardized difference of means (SMD) was used, their 95% confidence intervals (CI). Five RCTs were included (n = 299), 156 in exercise group and 143 in the control. In comparison to the control group, exercise significantly reduced EAT (SMD − 0.57, 95%CI − 0.97 to − 0.18) and waist circumference (MD − 2.95 cm, 95%CI − 4.93 to − 0.97). Exercise did not have an effect on BMI (MD − 0.23 kg/m2, 95%CI − 0.73 to 0.27), weight (MD − 0.06 kg, 95%CI − 1.46 to 1.34), or HDL (SMD 0.26, 95%CI − 0.06 to 0.57).VO2 was significantly increased by exercise (SMD 1.58, 95%CI 1.17 to 1.99). Risk of bias was high for 3 studies, and GRADE quality of evidence was very low to moderate. Exercise reduced epicardial adipose tissue and waist circumference, and did not have effect on weight, BMI, or HDL. Newer trials with better design and methods are necessary to improve the quality of the evidence. PROSPERO registration number (CRD42018096581)

Fractional flow reserve (FFR) provides an objective measurement of the severity of ischemia caused by coronary stenoses in downstream myocardial regions. Data from the interventional cardiology realm have suggested benefits of a FFR-guided percutaneous coronary intervention (PCI) strategy. Limited evidence is available on the use of FFR to guide coronary artery bypass grafting (CABG). The most recent data have shown that FFR might simplify CABG procedures and optimize patency of arterial grafts without any clear impact on clinical outcomes. The aim of this review was to summarize the available data on FFR-based CABG and discuss the rationale and potential consequences of a switch toward FFR-based surgical revascularization strategy.

BACKGROUND The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies. METHODS BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup. RESULTS A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), whereas non-ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P = .012 and P = .022, respectively). CONCLUSIONS In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non-ST-segment elevation ACS patients and in those discharged on ticagrelor.

The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (1-year) stent-related MACE have not been well described.The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type.Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons.Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis.In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.

Optimal timepoint for the discontinuation of dual antiplatelet therapy (DAPT) after an acute coronary syndrome is still debated. In fact, despite a shortening of DAPT duration should be advocated, based on the negligible risk of thrombotic complications observed with newer generations of drug-eluting stents (DES), in order to reduce the hemorrhagic risk, a more prolonged anti-ischemic protection would be suitable for certain higher-risk patients, rendering the traditional 12 months strategy outdated. We performed an updated meta-analysis and indirect comparison of randomized trials comparing shorter vs extended DAPT duration in ACS patients undergoing percutaneous coronary interventions with DES. Literature and main scientific session abstracts were searched for studies comparing 3–6 (short-term) or prolonged (> 12 months) DAPT vs traditional 12 months in ACS patients treated with DES. The primary efficacy endpoint was mortality, primary safety endpoint was the occurrence of major bleedings. Secondary endpoints were myocardial infarction and stent thrombosis. We included three randomized clinical trials and six study sub-analysis comparing alternative (short-term or prolonged) DAPT vs 12 months in post-ACS, with a total of 15,738 patients. Mortality occurred in 1.8% of patients, with no difference according to DAPT duration (short-term vs standard DAPT: OR [95% CI] 1.00 [0.72–1.39], p = 0.99; > 12 vs 12 months: OR [95% CI] 0.87 [0.61–1.22], p = 0.41). No difference in the risk of recurrent myocardial infarction and stent thrombosis was observed between short-term and standard DAPT, while a significant reduction was achieved only when extending the duration beyond 12 months (MI: OR [95% CI] 0.49 [0.36–0.67], p

Aims To develop a set of quality indicators (QIs) for the evaluation of the care and outcomes for atherosclerotic cardiovascular disease (ASCVD) prevention. Methods and results The Quality Indicator Committee of the European Society of Cardiology (ESC) formed the Working Group for Cardiovascular Disease Prevention Quality Indicators in collaboration with Task Force members of the 2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice and the European Association of Preventive Cardiology (EAPC). We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care for ASCVD prevention by constructing a conceptual framework of care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. In total, 17 main and 14 secondary QIs were selected across six domains of care for ASCVD prevention: (i) structural framework, (ii) risk assessment, (iii) care for people at risk for ASCVD, (iv) care for patients with established ASCVD, (v) patient education and experience, and (vi) outcomes. Conclusion We present the 2021 ESC QIs for Cardiovascular Disease Prevention, which have been co-constructed with EAPC using the ESC methodology for QI development. These indicators are supported by evidence from the literature, underpinned by expert consensus and aligned with the 2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice to offer a mechanism for the evaluation of ASCVD prevention care and outcomes.

Recurrence is the most frequent complication following acute pericarditis and may occur in 30% patients, rising to 50% in case of multiple recurrences, lack of colchicine treatment or use of glucocorticoids. Available treatments include aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), colchicine, glucocorticoids, immunosuppressive agents, immunoglobulins, anti-interleukin-1 (IL-1) agents.This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to assess the efficacy of pharmacological treatments for acute and recurrent pericarditis. Bibliographic databases were searched (PubMed, MEDLINE, Embase, Scopus, and the Cochrane Library) using the terms "acute pericarditis" or "recurrent pericarditis" and "colchicine" or "NSAIDs" or "glucocorticoids" or "immunosuppressive agents" or "immunoglobulins" or "anti-IL1 agents." Random-effects meta-analysis was used to assess the risk of recurrent pericarditis. Publication bias was assessed using the Egger test, and meta-regression was performed to assess sources of heterogeneity.Eleven RCTs assessed the efficacy of pharmacological treatments for acute and recurrent pericarditis (colchicine and anti-interleukin-1 agents). Colchicine, assessed in nine RCTs, was effective in the reduction of recurrent pericarditis, compared with standard treatment (17% vs .34%, RR=0.50; 95% CI 0.42-0.60, P0.001), without any differences according to clinical setting (i.e. acute pericarditis, recurrent pericarditis, post-pericardiotomy syndrome; P=0.58). Anti-interleukin-1 agents (anakinra, rilonacept), assessed in two RCT, were effective in the reduction of recurrences, compared with placebo (10% vs.78%, RR=0.14; 95% CI 0.05-0.35, P0.001).A correct pharmacological management of pericarditis is key to prevent recurrences. Colchicine is the mainstay of treatment in acute and recurrent pericarditis, while anti-IL1 agents are a valuable option in case of recurrent pericarditis refractory to conventional drugs.

Background New messenger RNA (mRNA) and adenovirus-based vaccines (AdV) against Coronavirus disease 2019 (COVID-19) have entered large scale clinical trials. Since healthcare professionals (HCPs) and armed forces personnel (AFP) represent a high-risk category, they act as a suitable target population to investigate vaccine-related side effects, including headache, which has emerged as a common complaint. Methods We investigated the side-effects of COVID-19 vaccines among HCPs and AFP through a 38 closed-question international survey. The electronic link was distributed via e-mail or via Whatsapp to more than 500 contacts. Responses to the survey questions were analyzed with bivariate tests. Results A total of 375 complete surveys have been analyzed. More than 88% received an mRNA vaccine and 11% received AdV first dose. A second dose of mRNA vaccine was administered in 76% of individuals. No severe adverse effects were reported, whereas moderate reactions and those lasting more than 1 day were more common with AdV (P=0.002 and P=0.024 respectively). Headache was commonly reported regardless of the vaccine type, but less frequently, with shorter duration and lower severity that usually experienced by participants, without significant difference irrespective of vaccine type. Conclusions Both mRNA and AdV COVID-19 vaccines were safe and well tolerated in a real-life subset of HCPs and AFP subjects.

BackgroundEchocardiography (ECHO) is not widely available in primary care, the key structural (chamber enlargements) and functional abnormality are not easily available precluding the ability to diagnose HF other than through mainly symptomatic means. The opportunity for earlier detection of HF is lost.MethodsUsing a unique database, the etiology of HF is explored by prevalence analysis to unravel the diagnostic makeup of each HF category. Various relationships and patterns of comorbidities have been extracted between the Electrocardiogram (ECG) and ECHO parameters that contribute to HF, those relationships are then confirmed and categorized by a Principal Component Analysis (PCA). Finally, it was summarized what type of non-invasive ECG-like device should be used in primary care to better diagnose HF.ResultsThe sensitivity of abnormal ECHO reaches 92% over the abnormal ECG of 81% in the detection of HF. The first five PCA are discovered, which cover 49% of all the variance. Left atrial enlargement is the most representative finding in the overall comorbidity rate, which coincides with the probability direction of HF (3rdas input, 1stas finding in the coefficients), and reaches the highest (250%) prevalence increase in function of decreasing LVEF.ConclusionsThe core structural and functional abnormalities diagnosed by ECHO with the ECG interpretation provide sufficient information to diagnose “consider HF” in primary care. This paper overview of a novel bio-signal-based system supported by Artificial Intelligence, able to replicate Echo-findings, predict HF and indicates its phenotype, suitable for use in Primary Care.

The burden of chronic kidney disease (CKD) in patients with diabetes is high, and recent studies have highlighted the key role of perirenal fat (PRF) thickness in its pathophysiology (1,2). Indeed, increased PRF thickness has been associated with an unfavorable profile of inflammatory cytokines, atherosclerosis, dyslipidemias, metabolic syndrome, and unfavorable outcomes after nephrectomy (3–11). In this issue of Diabetes , …

Objectives: Non-ST-elevation acute coronary syndrome (NSTE-ACS) affects millions of patients. Although an invasive strategy can improve survival, the optimal treatment (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) is not clear. We performed a meta-analysis of studies reporting outcomes between PCI and CABG in patients with NSTE-ACS.Methods: MEDLINE, EMBASE and Cochrane Library were assessed. The primary outcome was long-term mortality. Inverse variance method and random model were performed.Results: We identified 13 observational studies (48,891 patients). No significant difference was found in the primary endpoint (CABG vs. PCI, incidence rate ratio [IRR]= 0.93, 95% confidence interval [CI] 0.70; 1.23). CABG was associated with lower long-term major adverse cardiovascular events (MACE) (IRR= 0.64, 95% CI 0.54; 0.76) and lower long-term re-revascularization (IRR= 0.37, 95% CI 0.30; 0.47). There was no significant difference in long-term myocardial infarction (CABG vs. PCI, IRR= 0.96, 95% CI 0.50; 1.84) and peri-operative mortality (CABG vs. PCI, odds ratio [OR]= 1.36, 95% CI 0.94; 1.95).Conclusion: For the treatment of NSTE-ACS, CABG and PCI are associated with similar rates of long-term mortality and myocardial infarction. CABG is associated with lower rates of long-term MACE and re-revascularization. Randomized comparisons in this setting are necessary.

The treatment of acute myocardial infarction is early revascularization. Heart failure and cardiogenic shock may complicate acute myocardial infarction despite applying the best available strategy. Levosimendan is a relatively new drug to treat heart failure with a peculiar mechanism of action: calcium sensitization of myocardial fibres. Levosimendan has a direct inotropic effect but also pleiotropic effects; through the K+ATP channel’s opening, it also has a vasodilator effect which may participate concretely in the global effects of the drug. The focus of the literature is on the anti-heart failure and anti-cardiogenic shock properties of Levosimendan, but it may have effects also preventing the development of myocardial insufficiency in acute myocardial infarction. The aim of the meta-analysis is to evaluate the effect of Levosimendan on acute myocardial infarction in placebo-controlled trials. Based on the eight studies selected, we found a beneficial effect of Levosimendan on acute and long-term mortality of patients affected by acute myocardial infarction. With caution in interpreting the results of this meta-analysis, our data support the idea that Levosimendan may already have a role in the treatment of acute ischemic heart disease. Further studies specifically designed to investigate the early role in the treatment of ischemic heart failure are needed.

BACKGROUND The optimal management of patients with ST-elevation acute coronary syndromes and multivessel coronary artery disease is challenging. There is a growing body of evidence supporting invasive functional evaluation of multivessel disease with FFR or iFR, which it has been added to the literature. In this regard, the WAVE Study recently demonstrated the diagnostic accuracy of instantaneous wave-free ratio (iFR) functional assessment of non-culprit lesions in multivessel patients with STEMI. However, no studies have still verified the long-term clinical impact of an iFR-guided revascularization in this setting of patients. METHODS Patients undergoing primary PCI for STEMI and presenting multivessel disease will be enrolled. After the treatment of the culprit lesion, an iFR-guided functional assessment of non-culprit lesions will be done if iFR≤0.89 PCI will be performed during the index procedure or staged. Conversely, iFR>0.89 will direct the patient towards a conservative approach. RESULTS The study start date was May 1, 2018. The enrollment phase was completed on March 30, 2020. The primary endpoint is the occurrence of target lesion failure (TLF), a composite of cardiovascular death, non-fatal myocardial infarction, and ischemia-driven revascularization of the vessel previously assessed with iFR. Secondary endpoints include MACE (cardiovascular death, non-fatal MI, any revascularization). CONCLUSIONS The aim of the present study was to evaluate the long-term clinical impact of an iFR-guided revascularization of the non-culprit lesions in STEMI patients with multivessel coronary artery disease.

Background: The aim was to determine the impact of diabetes mellitus (DM) on outcomes after percutaneous coronary intervention (PCI). There is limited data on the impact of DM and its subtypes among patients who underwent PCI during hospitalization. Methods: All PCI hospitalizations from the National Inpatient Sample (October 2015–December 2018) were stratified by the presence and subtype of DM. Multivariable logistic regression was performed to determine the adjusted odds ratios (aOR) of in-hospital adverse outcomes in type 1 DM (T1DM) and type 2 DM (T2DM) compared to no-DM. Results: Out of 1, 363, 800 individuals undergoing PCI, 12, 640 (0.9%) had T1DM and 539, 690 (39.6%) had T2DM. T1DM patients had increased aOR of major adverse cardiovascular and cerebrovascular events (MACCE) (1.26, 95%CI 1.17–1.35), mortality (1.56, 95%CI 1.41–1.72), major bleeding (1.63, 95%CI 1.45–1.84), and stroke (1.75, 95%CI 1.51–2.02), while T2DM patients had only increased aOR of MACCE (1.02, 95%CI 1.01–1.04), mortality (1.10, 95%CI 1.08–1.13) and stroke (1.22, 95%CI 1.18–1.27), compared to no-DM patients. However, both T1DM and T2DM had lower aOR of cardiac complications (0.87, 95%CI 0.77–0.97 and 0.87, 95%CI 0.85–0.89, respectively), in comparison to no-DM patients. When accounting for the indication, both DM subgroups had higher aOR of MACCE, mortality, and stroke compared to no-DM patients in the acute coronary syndrome setting (p < 0.001, for all), while only increased aOR of stroke (1.59, 95%CI 1.17–2.15 for T1DM and 1.12, 95%CI 1.05–1.20 for T2DM) persisted in the elective setting. Conclusions: Patients with DM who have undergone PCI during hospitalization are more likely to experience adverse in-hospital outcomes, and T1DM patients are a particularly high-risk cohort.

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.

BACKGROUND: Invasive functional assessment is a mainstay in the management of patients with coronary artery disease (CAD), but there is uncertainty on the comparative accuracy of diagnostic indices of functional significance. We aimed to validate the diagnostic performance of a novel non-hyperemic diastolic pressure ratio (dPR).METHODS: We performed a retrospective analysis including two separate registries (VERIFY 2, Latina, Italy) of patients in whom functional indices were measured for lesions with angiographically moderate severity. On top of fractional flow reserve, distal coronary pressure (Pd)/aortic pressure (Pa) ratio, instantaneous wave-free ratio (iFR) and diastolic pressure ratio (dPR) were computed using a novel dedicated algorithm over 4 consecutive beats. Agreement/discrepancy between indexes was appraised Bland-Altman analysis, area under the receiver operating characteristic curve (AUC), and unsupervised machine learning.RESULTS: A total of 525 lesions from 479 patients were included. The novel dPR was highly correlated with iFR (R2=0.99, PCONCLUSIONS: This multicenter registry suggests this novel dPR algorithm provides results that are numerically equivalent to iFR. Pending further studies, physicians may consider using this novel dPR algorithm to gauge the functional significance of a coronary lesion.

AIMS: To evaluate the associations of blood pressure (BP) categorization based on the 2017 American Heart Association and the American College of Cardiology guideline with the risk of peripheral artery disease (PAD). METHODS: Among 13,113 middle-aged participants, we investigated the associations of 2017 BP categories (systolic

We aim to compare Polymer-Free Biolimus-Eluting Stent (PF-BES) with Durable Polymer Everolimus-Eluting stent (DP-EES) in unselected patients. PF-BES showed a favorable profile in high-bleeding risk patients who underwent percutaneous coronary intervention. Limited data are available on PF-BES compared with second-generation durable polymer-coated drug-eluting stents in patients eligible for standard dual antiplatelet therapy. A total of 848 consecutive patients were enrolled: 306 patients were treated with PF-BES and 542 with DP-EES. Stent performance was tested in a propensity score-matched population and in a Complex Higher-Risk and Indicated Patients (CHIP) subpopulation. A per-lesion analysis on 1,204 lesions (PF-BES = 424 vs DP-EES = 780) was also performed. At a medium follow-up of 18.5 ± 5.0 months, no differences in the matched population were found in terms of major adverse cardiac events (PF-BES 9.0% vs DP-EES 4.5%; p 0.091), myocardial infarction (PF-BES 6.2% vs DP-EES 2.3%; p 0.111), stent restenosis (PF-BES 2.3% vs DP-EES 0.0%; p 0.123), definite or probable stent thrombosis (PF-BES 2.8% vs DP-EES 1.1%; p 0.448). A significant inferior rate of restenosis was observed in the DP-EES arm in the whole (PF-BES 2.3% vs DP-EES 0.6%; p 0.041) and CHIP populations (PF-BES 4.3% vs DP-EES 0.5%; p 0.023), as well as in the per-lesion analysis (DP-EES 0.4% vs PF-BES 1.7%; p 0.039). In conclusion, in a real-world cohort PF-BES performed similarly to DP-EES in terms of restenosis and stent thrombosis in the matched population. Nonetheless, in the whole and CHIP populations, as well as in the per-lesion analysis, restenosis occurrence resulted higher in the PF-BES group.

Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis, thanks to key improvements achieved by new-generation devices. Their comparative effectiveness and safety are, however, still uncertain.We queried a prospective registry on transcatheter aortic valve implantation to compare Evolut and Portico devices, focusing on procedural, in-hospital, and mid-term outcomes. Unadjusted and propensity-adjusted analyses were carried out.In all, 233 patients were included, 119 (51.1%) receiving Evolut and 114 (48.9%) Portico. Several differences in baseline and procedural features were evident, including comorbidities, device size, and postdilation (all P 0.05). Unadjusted analysis for procedural results showed significant differences in fluoroscopy time, left ventricular ejection fraction, and aortic regurgitation (all P 0.05), whereas device and procedural success rates were not significantly different (both P 0.05). In-hospital outcomes were not significantly different (all P 0.05). Survival analysis for mid-term follow-up (6 ± 7 months) outcomes showed no significant differences in death, stroke, myocardial infarction, major vascular complication, or major bleeding (all P 0.05). Conversely, Evolut appeared associated with lower peak and mean aortic gradients (both P 0.05), but higher rate of permanent pacemaker implantation (P = 0.043). Propensity-score-adjusted analysis largely confirmed the similar performance of the two devices, including peak and mean aortic gradients (both P 0.05). However, Evolut continued to be associated even at adjusted analysis with an increased risk of pacemaker implantation (P = 0.018).The acute and mid-term comparative safety and effectiveness of Evolut and Portico in experienced hands are similar, with the notable exception of a lower risk of permanent pacemaker implantation with Portico.

Relative benefits of coronary artery bypass (CABG) using single and multiple arterial grafting (SAG, MAG) and drug eluting stent (DES) in multivessel coronary disease remain uncertain. We compared SAG, MAG, and DES in a pairwise and network meta-analysis. Randomized trials and adjusted observational studies comparing CABG versus DES were included (primary end point: long-term mortality; secondary end points: operative mortality, perioperative stroke, and follow-up repeated revascularization [RR]). Studies with ≥1.7 arterial grafts and/or patient were classified as MAG. Bayesian network meta-analyses and random-model pairwise meta-analyses were performed. A total of 53,239 patients (8 randomized, 17 observational studies) were included (26,306 DES; 26,933 CABG). In pairwise comparison (mean follow-up: 5.42 years), CABG (MAG + SAG) was associated with lower long-term mortality (incident rate ratio [IRR] 0.77, 95% confidence interval [CI] 0.66 to 0.90), lower RR (IRR 0.37, 95% CI 0.27 to 0.51), increased perioperative stroke (odds ratio [OR] 3.18, 95% CI 1.70 to 5.97), and similar operative mortality (OR 1.04, 95% CI 0.64 to 1.70) compared with DES. There was a nonsignificant trend toward lower long-term mortality for studies with higher mean number of arterial grafts. In network meta-analyses, compared with DES, MAG was associated with lower long-term mortality (IRR 0.72, 95% credible interval [CrI] 0.57 to 0.92) and late RR (IRR 0.32, 95% CrI 0.21 to 0.49), SAG was associated with lower long-term mortality and RR (IRR 0.80, 95% CrI 0.66 to 0.97 and IRR 0.42, 95% CrI 0.29 to 0.61, respectively). In conclusion, CABG was associated with reduced 5-year mortality and need for RR compared with DES. MAG was ranked as the best treatment for the primary and all secondary outcomes.

Aim Little is known about the association between admitting physician specialty and care quality and outcomes for non-ST-segment elevation myocardial infarction (NSTEMI). Methods and results We identified 288 420 patients hospitalized with NSTEMI between 2010 and 2017 in the UK Myocardial Infarction National Audit Project database. The cohort was dichotomized according to care under a non-cardiologist (n = 146 722) and care under a cardiologist (n = 141 698) within the first 24 h of admission to hospital. Patients admitted under a cardiologist were significantly younger (70 vs. 75 years, P Conclusion Patients with NSTEMI admitted under a cardiologist within 24 h of hospital admission were more likely to receive guideline-directed management and had better clinical outcomes.

Background Cardiac involvement significantly contributes to coronavirus disease 2019 (COVID-19)mortality.12-lead electrocardiogram (ECG) represents a fast, cheap, and easy to perform exam with the adjunctive advantage of the remote reporting possibility. In this study, we sought to investigate if electrocardiographic parameters are able to identify patients, deemed at low-risk at admission,who will face in-hospital unfavourable course. Methods From March 1, 2020 through March 30, 2021, 384 consecutive patients with confirmed low-risk COVID-19 were hospitalized at the AziendaOspedalieroUniversitariaPoliclinico di Bari (Italy). Criteria for low-risk were: admission to the division of Pneumology or Infectious Diseases, no need for immediate (within 24 hours from admission) transfer to Intensive Care Unit or for respiratory support with invasive mechanical ventilation (IMV) or for circulation support (either mechanical or pharmacological). Admission ECGs were reviewed and interpreted by two expert cardiologists. The primary outcomes were in-hospital death and the composite outcome of in-hospitaldeath and IMV. Results In low-risk COVID-19 patients, atrial fibrillation (AF), poor R wave progression (PRWP), tachycardia, and right bundle branch block (RBBB) resulted as statistically significant and independent predictors of in-hospital all-cause mortality; AF, PRWP, Tachycardia, RBBB, and corrected QT interval showed to be statistically significant and independent risk factors for the occurrence of the composite endpoint of death and IMV. Conclusions Our study demonstrated for the first time that RBBB and PRWP, assessed upon admission with ECG, are associated with unfavourable clinical course in a baseline low-risk population hospitalized for COVID-19.

We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age.We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, distinguishing patients80 vs ≥80 years of age.In total, 1853 patients were included, 751 (40.5%) octogenarians and 1102 (59.5%) non-octogenarians. Several baseline and procedural features were significantly different, including gender, regurgitation etiology, and functional class (all p 0.05). In-hospital outcomes were similarly satisfactory, with death occurring in 18 (2.4%) and 32 (2.9%, p = 0.561), respectively, and improvement in mitral regurgitation in 732 (97.4%) and 1078 (97.8%, p = 0.746), respectively. After a mean follow-up of 15 months, death occurred in 152 (20.2%) and 264 (24.0%), and cardiac death in 85 (11.3%) and 138 (12.5%), respectively (both p 0.05). Rehospitalization for heart failure and the composite of cardiac death or rehospitalization for heart failure were significantly less common in octogenarians: 63 (8.4%) vs 156 (14.2%, p 0.001), and 125 (16.6%) vs 242 (22.0%, p = 0.005), respectively. Multivariable analysis showed that these differences were largely due to confounding features, as after adjustment for baseline, clinical and imaging characteristics no significant difference was found for the above clinical endpoints.Transcatheter mitral valve repair with the MitraClip in carefully selected octogenarians appears feasible and safe, and is associated with favorable clinical outcomes at mid-term follow-up.

Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk. However, access site complications may occur more frequently in extreme body mass index (BMI) categories. The aim of this study was to describe the features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry, focusing on BMI classes.A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI categories: underweight (BMI18.5 kg/mA total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all P0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all P0.05), with postprocedural aortic regurgitation2+ significantly more common in underweight patients (P0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all P0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (P=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (P=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (P=0.015 when comparing obese vs. normal weight subjects), but disproved differences in long-term mortality and other outcomes (P0.05 for all comparisons).Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects.

BACKGROUND The management of patients with unprotected left main (LM) coronary artery disease remains challenging, with recent data casting a shadow of doubt on the safety of percutaneous coronary intervention. We aimed at describing the features of patients undergoing myocardial perfusion imaging (MPI) subsequently found to have LM disease. METHODS We queried our institutional database for subjects without prior revascularization or myocardial infarction (MI), who had undergone MPI followed by invasive coronary angiography within 6 months, comparing those with evidence of angiographically significant LM disease (i.e. diameter stenosis ≥50%) to those without significant coronary artery disease (CAD), or those with CAD not involving LM. Baseline, stress and imaging features were systematically collected and analyzed, and clinical outcomes (death, myocardial infarction, revascularization) sought. RESULTS We included a total of 74 patients with LM disease, which were compared with 70 without CAD, and 920 with significant CAD not involving LM. MPI was remarkably safe in all subjects, and significant differences were found for several features, but particularly so for ST change, rate pressure product, and left ventricular ejection fraction (all P

BACKGROUND Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR. METHODS Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p

Background The COVID-19 pandemic with the stay-at-home orders and lockdown has dramatically forced athletes to stop team training and competitions, causing deep changes in habits and lifestyle. Aim of this study was to evaluate in a retrospective single center study the cardiovascular (CV) health and fitness of elite football player after COVID-19 lockdown in Italy and to compare such findings with the 2019 off-season period, in order to identify potential differences in the CV features and outcomes. Methods All 29 professional Football players of the first male team were enrolled before resuming training and competition after COVID-19 lockdown and underwent several exams including physical examination, resting and stress electrocardiography (ECG), echocardiography, spirometry and blood tests. Results Median age was 27 years (23; 31), with no athlete being COVID-19 positive at the time of the evaluation. In comparison with the usual off-season 2-month detraining, significant differences were found for left ventricular (LV) mass (189g [172; 212] vs. 181g [167; 206], p=0.024) and LV mass index for body surface area (94g/m2 [85; 104] vs 88g/m2 [79.5; 101.5], p=0.017), while LV mass/fat free mass remained unchanged (2.8 g/Kg [2.6; 2.9] vs 2.9 g/Kg [2.6; 3.2], p=0.222). Respiratory function and metabolic profile were improved, while no significant changes were found in ECG findings, at rest and during exercise. Conclusions Prolonged abstinence from training and competitions induced by lockdown elicited significant changes in comparison with off-season in parameters ascribable to detraining, as the changes in LV mass, in respiratory function and in metabolic profile.

Thrombocytopenia after TAVI is common and clinically detrimental. Retrospectively, we observed Portico recipients had a more profound platelet drop than Evolut recipients. We thus investigated periprocedural platelet damage and/orpro-inflammatory state in 64 TAVI recipients at baseline and after implantation. Platelet damage was assessed by annexin V staining and monocyte-phagocytic phenotype was assessed according to CD14/CD36 expression. Serum cytokines were measured in 20 patients. The formaldehyde-based storage solution altered platelets. When, before being loaded onto the delivery system, Portico underwent one additional flushing to those recommended, the receiving patients showed thrombocytopenia, platelet damage, and CD36-monocyte count were mitigated. A general increase in IL-6 was recorded in overall TAVI recipients, but a high serum level of IL-8, a potent thrombocytopenia inducer, was measured in Portico recipients only, including those with extra-rinsed valve. Our study suggests a platelet-injury effect by storage-solution and generates the hypothesis of a role for the biomaterial in stimulating innate-immunity. Larger prospective studies are needed. Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s12265-021-10117-9.

Omega-3 fatty acid (O3FA) supplementation has shown conflicting evidence regarding its benefit in cardiovascular events. We performed a pairwise and network meta-analysis to elucidate the benefit of different doses of O3FA supplementation in cardiovascular prevention.Fourteen studies were identified providing data on 125,763 patients. A prespecified cut-off value of 1 g per day was set for low-dose (LD) O3FA and 1 g per day for high-dose (HD) O3FA. The efficacy outcomes of interest were total death, cardiac death, sudden cardiac death, myocardial infarction, stroke, coronary revascularization, unstable angina, and major vascular events. Safety outcomes of interest were bleeding, gastrointestinal disturbances, and atrial fibrillation events. HD treatment was associated with a lower risk of cardiac death (IRR 0.79, 95% CI [0.65-0.96], p = 0.03 versus control), myocardial infarction (0.71 [0.62-0.82], p 0.0001 versus control and 0.79 [0.67-0.92], p = 0.003 versus LD), coronary revascularization (0.74 [0.66-0.83], p 0.0001 versus control and 0.74 [0.66-0.84], p 0.0001 versus LD), unstable angina (0.73 [0.62-0.86], p = 0.0001 versus control and 0.74 [0.62-0.89], p = 0.002 versus LD), and major vascular events (0.78 [0.71-0.85], p 0.0001 versus control and 0.79 [0.72-0.88], p 0.0001 versus LD). HD treatment was associated with increased risk for bleeding events (1.49 [1.2-1.84], p = 0.0002 versus control and 1.63 [1.16-2.3], p = 0.005 versus LD) and increased atrial fibrillation events compared to control (1.35 [1.1-1.66], p = 0.004). HD O3FA treatment was associated with lower cardiovascular events compared to LD and to control, but increased risk for bleeding and atrial fibrillation events.

Background Environmental pollution and weather changes unfavorably impact on cardiovascular disease. However, limited research has focused on ST-elevation myocardial infarction (STEMI), the most severe yet distinctive form of acute coronary syndrome. Methods and results We appraised the impact of environmental and weather changes on the incidence of STEMI, analysing the bivariate and multivariable association between several environmental and atmospheric parameters and the daily incidence of STEMI in two large Italian urban areas. Specifically, we appraised: carbon monoxide (CO), nitrogen dioxide (NO2), nitric oxide (NOX), ozone, particulate matter smaller than 10 μm (PM10) and than 2.5 μm (PM2.5), temperature, atmospheric pressure, humidity and rainfall. A total of 4285 days at risk were appraised, with 3473 cases of STEMI. Specifically, no STEMI occurred in 1920 (44.8%) days, whereas one or more occurred in the remaining 2365 (55.2%) days. Multilevel modelling identified several pollution and weather predictors of STEMI. In particular, concentrations of CO (p = 0.024), NOX (p = 0.039), ozone (p = 0.003), PM10 (p = 0.033) and PM2.5 (p = 0.042) predicted STEMI as early as three days before the event, as well as subsequently, and NO predicted STEMI one day before (p = 0.010), as well as on the same day. A similar predictive role was evident for temperature and atmospheric pressure (all p Conclusions The risk of STEMI is strongly associated with pollution and weather features. While causation cannot yet be proven, environmental and weather changes could be exploited to predict STEMI risk in the following days.

Background ST ‐segment–elevation myocardial infarction is associated with an intense acute inflammatory response and risk of heart failure. We tested whether interleukin‐1 blockade with anakinra significantly reduced the area under the curve for hsCRP (high sensitivity C‐reactive protein) levels during the first 14 days in patients with ST ‐segment–elevation myocardial infarction (VCUART3 [Virginia Commonwealth University Anakinra Remodeling Trial 3]). Methods and Results We conducted a randomized, placebo‐controlled, double‐blind, clinical trial in 99 patients with ST ‐segment–elevation myocardial infarction in which patients were assigned to 2 weeks treatment with anakinra once daily (N=33), anakinra twice daily (N=31), or placebo (N=35). hsCRP area under the curve was significantly lower in patients receiving anakinra versus placebo (median, 67 [interquartile range, 39–120] versus 214 [interquartile range, 131–394] mg·day/L; P P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, −1.6% to 10.2%] versus 2.7% [interquartile range, −1.8% to 9.3%]; P =0.61) at 12 months. The incidence of death or new‐onset heart failure or of death and hospitalization for heart failure was significantly lower with anakinra versus placebo (9.4% versus 25.7% [ P =0.046] and 0% versus 11.4% [ P =0.011], respectively), without difference between the anakinra arms. The incidence of serious infection was not different between anakinra and placebo groups (14% versus 14%; P =0.98). Injection site reactions occurred more frequently in patients receiving anakinra (22%) versus placebo (3%; P =0.016). Conclusions In patients presenting with ST ‐segment–elevation myocardial infarction, interleukin‐1 blockade with anakinra significantly reduces the systemic inflammatory response compared with placebo. Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier: NCT 01950299.

BACKGROUND PCI in CBL is common and technically demanding. Whether such patients have adverse outcome during the follow-up after successful PCI is unclear. We aim to compare the clinical outcome after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation of coronary bifurcation lesions (CBL) and non-CBL. METHODS We performed a systematic literature search to identify studies reporting the clinical outcome of patients undergoing PCI in CBL or not. Patients with left main disease constituted a predefined subgroup. Primary study end-point was major adverse cardiac events (MACE). RESULTS Fifteen publications on 23 891 patients with coronary artery disease treated by DES in CBL or not were identified. Median follow-up length was 24 months (range: 12-60). MACE at the longest available follow-up were significantly higher in CBL as compared with non-CBL (19.0 vs. 12.1%, P

Modified risk products (MRP) are promoted as a safer alternative to traditional combustion cigarettes (TCC) in chronic smokers. Evidence for their lower hazardous profile is building, despite several controversies. Yet, it is unclear whether individual responses to MRP differ among consumers. We hypothesized that different clusters of subjects exist in terms of acute effects of MRP. Pooling data from a total of 60 individuals, cluster analysis identified at least three clusters (labelled 1 to 3) of subjects with different electronic vaping cigarettes (EVC) effects and at least two clusters (labelled 4 to 5) of subjects with different heat-not-burn cigarettes (HNBC) effects. Specifically, oxidative stress, platelet aggregation, and endothelial dysfunction after EVC were significantly different cluster-wise (all p

Background Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap. Methods and design The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary endpoint will be the patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year. The key secondary endpoint will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5years. The sample size for the study is 1400 patients. Implications The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD in order to improve their clinical outcomes.