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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.

BACKGROUND: On March 9, 2020, the Italian government imposed a national lockdown to tackle the COronaVIrus Disease 19 (COVID-19) pandemic, including stay at home recommendations. The precise impact of COVID-19 scare and lockdown on emergency access for acute myocardial infarction (MI) is still subject to debate. METHODS: Data on all patients undergoing invasive coronary angiography at 9 hospitals in the greater area of Rome, Italy, between February 19, 2020 and March 29, 2020, 9, 2020, were retrospectively collected. Incidence of ST-elevation MI (STEMI), and non-ST-elevation MI (NSTEMI), as well as corresponding percutaneous coronary intervention (PCI), was compared distinguishing two different 20-day time periods (before vs on or after March 10, 2020). RESULTS: During the study period, 1,068 patients underwent coronary angiography, 142 (13%) with STEMI and 169 (16%) with NSTEMI. The average daily number of STEMI decreased from 4.3 before the lockdown to 2.9 after the lockdown (p=0.021). Similarly, the average daily number of NSTEMI changed from 5.0 to 3.5 (p=0.028). The average daily number of primary PCI changed from 4.2 to 2.9 (p=0.030), while the average daily number of PCI for NSTEMI changed from 3.5 to 2.5 (p=0.087). For STEMI patients, the time from symptom onset to hospital arrival (onset-to-door time less than three hours) showed a significant increase after the lockdown (p=0.018), whereas door-to-balloon time did not change significantly from before to after the lockdown (p=0.609). CONCLUSIONS: The present study, originally reporting on the trends in STEMI and NSTEMI in the Rome area, highlights that significant decreases in the incidence of both acute coronary syndromes occurred between February 19, 2020 and March 29, 2020, together with increases in time from symptom onset to hospital arrival, luckily without changes in door-to-balloon time.

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group. Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.

Primary PCI plus stent implantation is indicated for treatment of acute coronary syndrome. Technically, due to the difference in lumen diameter between vessel portions and stent size in some coronary arteries, post-expansion of the stent is usually necessary to match proximal reference diameter and optimize stent apposition. Incomplete stent apposition has been associated with increased risk of in stent restenosis (ISR) and stent thrombosis (1) despite new stent technologies have largely reduced this risk (2-3). Although new antiplatelet drugs showed a more rapid onset of action and a stronger effect (4-5), stent apposition remains an important risk factor for stent thrombosis. As stent post-dilatation is commonly performed, typically with large over-expansion in the setting of long tapering vessel segment. There is an increasing recognition that information with regard to the different stent model designs can have a critical impact on results

1AbstractBackgroundClinical decisions about Heart Failure (HF) are frequently based on measurements of left ventricular ejection fraction (LVEF), relying mainly on echocardiography measurements for evaluating structural and functional abnormalities of heart disease. As echocardiography is not available in primary care, this means that HF cannot be detected on initial patient presentation. Instead, physicians in primary care must rely on a clinical diagnosis that can take weeks, even months of costly testing and clinical visits. As a result, the opportunity for early detection of HF is lost.Methods and resultsThe standard 12-Lead ECG provides only limited diagnostic evidence for many common heart problems. ECG findings typically show low sensitivity for structural heart abnormalities and low specificity for function abnormalities, e.g., systolic dysfunction. As a result, structural and functional heart abnormalities are typically diagnosed by echocardiography in secondary care, effectively creating a diagnostic gap between primary and secondary care. This diagnostic gap was successfully reduced by an AI solution, the Cardio-HART™ (CHART), which uses Knowledge-enhanced Neural Networks to process novel bio-signals. Cardio-HART reached higher performance in prediction of HF when compared to the best ECG-based criteria: sensitivity increased from 53.5% to 82.8%, specificity from 85.1% to 86.9%, positive predictive value from 57.1% to 70.0%, the F-score from 56.4% to 72.2%, and area under curve from 0.79 to 0.91. The sensitivity of the HF-indicated findings is doubled by the AI compared to the best rule-based ECG-findings with a similar specificity level: from 38.6% to 71%.ConclusionUsing an AI solution to process ECG and novel bio-signals, the CHART algorithms are able to predict structural, functional, and valve abnormalities, effectively reducing this diagnostic gap, thereby allowing for the early detection of most common heart diseases and HF in primary care.

Despite mounting evidence, there is uncertainty on the impact of the interplay between weather and pollution features on the risk of acute cerebrovascular events (CVE). We aimed at appraising role of weather and pollution on the daily risk of CVE.Anonymized data from a hub CVE center in a large metropolitan area were collected and analyzed according to weather (temperature, pressure, humidity, and rainfall) and pollution (carbon monoxide [CO], nitrogen dioxide [NO2], nitrogen oxides [NOX], ozone [O3], and particulate matter [PM]) on the same and the preceding days. Poisson regression and time series analyses were used to appraise the association between environmental features and daily CVE, distinguishing also several subtypes of events.We included a total of 2534 days, with 1363 days having ≥1 CVE, from 2012 to 2017. Average daily rate was 1.56 (95% confidence interval: 1.49; 1.63) for CVE, with other event rates ranging between 1.42 for stroke and 0.01 for ruptured intracranial aneurysm. Significant associations were found between CVE and temperature, pressure, CO, NO2, NOX, O3, and PM10 µm (all P0.05), whereas less stringent associations were found for humidity, rainfall, and PM2.5 µm. Time series analysis exploring lag suggested that associations were stronger at same-day analysis (lag 0), but even environmental features predating several days or weeks were significantly associated with events. Multivariable analysis suggested that CO (point estimate 1.362 [1.011; 1.836], P=0.042) and NO2 (1.011 [1.005; 1.016], P0.001) were the strongest independent predictors of CVE.Environmental features are significantly associated with CVE, even several days before the actual event. Levels of CO and NO2 can be potentially leveraged for population-level interventions to reduce the burden of CVE.

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 impact of Grade III coronary perforations (G3-CP) in the setting of CTO-PCI is not well assessed.We reviewed 7773 CTO-PCI and 98,819 non CTO-PCI performed in 10 European centers: G3 perforation occurred in 87 patients (1.1%) during CTO PCI and 224 patients (0.22%) during non CTO-PCI (p0.001). G3-CP involved the CTO segment in 68% of patients and the retrograde channels in 14% of cases. In the CTO PCI group, wire induced G3-CP (50.5% vs. 32.5%, p = 0.02) occurred predominantly when dedicated CTO tapered and highly penetrative wires were used. Intra-procedural and in-hospital death rates were 4.6% vs. 5.8% and 3.6% vs. 7.5% respectively for CTO PCI and non-CTO PCI groups (p = NS). At a median follow up of 24 months, the overall mortality and MAE were respectively 7.8% and MAE 19% without difference among groups.We showed similar in-hospital and long-term outcomes when G3 perforations occurred during CTO PCI and non CTO-PCI.

Background Currently, the leadless pacemaker indications are limited to few and highly selected cases. Case summary We describe the first reported case of an atrioventricular Micra™ leadless pacemaker implantation complicated by tricuspid posterior leaflet flail with severe regurgitation in a 29-year-old man affected by asymptomatic and progressive high degree atrio-ventricular block. The patient was then treated with endoscopic tricuspid valve repair, leadless pacemaker removal and implantation of an epicardial pacemaker. Discussion Leadless pacemaker complications are multiple, hence it is essential to ensure a safe procedure, especially in the younger patients. We thought that the application of a transesophageal echocardiography guidance might mitigate the risk of major complications.

Coronary chronic total occlusions (CTO) are frequently found in patients undergoing coronary angiography. Despite their high prevalence and indication for revascularization in a relevant proportion of cases, CTO recanalization is attempted only in a minority of cases. This is due to higher risk of procedural complications compared to non-CTO interventions and because the CTO-PCIs are the most complex procedures in interventional cardiology. In particular, the perceived higher risk of complications during CTO intervention might discourage new operators from engaging in this challenging field. The aim of this work is to review the potential complications of CTO percutaneous coronary intervention, and to provide an algorithmic, sign- and symptom-based approach to facilitate early recognition and effective management.

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.

Anomalous origin of the left coronary artery from the right sinus is a relatively uncommon finding, with a reported prevalence of 0.02%-0.05% on angiographic studies [1]. Nevertheless, it is a leading cause of Sudden Cardiac Death (SCD) in young athletes and its clinic manifestations are strictly related to strenuous exertion. It is thought that the main mechanism of SCD relies on external compression of the abnormal coronary artery

Funding Acknowledgements Type of funding sources: None. BACKGROUND Despite mounting evidence, there is uncertainty on the impact of the interplay between weather and pollution features on the risk of acute cerebrovascular events (CVE). PURPOSE We aimed at appraising role of weather and pollution on the daily risk of CVE. METHODS Anonymized data from a hub CVE center in a metropolitan area were collected analyzed according to weather and pollution on the same and the preceding days. Generalized additive models were used to explore the impact of individual and combined factors on the risk of daily CVE. RESULTS We collected data from 2012 to 2017, including a total of 2534 CVE, with a 1.56 daily rate (bootstrapped 95% confidence interval 1.48-1.64). In particular, CVE were distinguished as follows: ischemic stroke, hemorrhagic stroke, arterial dissection, ruptured aneurysm, and transient ischemic attacks, with daily rates ranging from 1.422 for stroke to 0.005 for ruptured aneurysm. Unadjusted analysis showed that daily temperature, atmospheric pressure, and humidity, among weather features, were all significantly associated with CVE (all P CONCLUSION Cerebrovascular events, and stroke in particular, are more common in days with lower temperature, pressure and humidity, and higher concentrations of NO2 and PM10. Abstract Figure. Association between PM10 and CVE

Background/Introduction Several reports have highlighted the detrimental impact of environmental pollution and climate changes on cardiovascular disease. However, detailed analyses aiming at disentangling the differential impact of pollution versus climate are lacking. Most importantly, limited research has focused on ST-elevation myocardial infarction (STEMI), the most severe yet distinctive form of acute coronary syndrome. Purpose/Methods We aimed at appraising the impact of environmental pollution and climate changes on the incidence of STEMI, analyzing the bivariate and multivariate 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. On top of same day association, we appraised STEMI risk 1, 2, and 3 days later. Computations were performed using a multilevel mixed-effects generalized linear model with Poisson likelihood and log link, yielding incidence ratios (95% confidence intervals) and corresponding p values. Results A total of 4458 days at risk were appraised, 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 modeling identified several pollution and climate predictors of STEMI, either occurring on the same day, or on the following ones. In particular, concentrations of CO (p=0.024), NOX (p=0.039), O3 (p=0.003), PM10 (p=0.033), and PM2.5 (p=0.042) predicted STEMI as early as three day before the event, as well 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 in the current primary percuntaneous coronary intervention area is strongly associated with pollution and climate features. Most notably, environmental and climate changes can be exploited to predict STEMI risk in the following days. Funding Acknowledgement Type of funding source: None

In the past 20 years, numerous percutaneous vascular closure devices have been tested and compared with manual compression and to surgical cut-down. The suture-mediated closure device Perclose ProGlide™ system (Abbott Vascular, CA, USA) emerged as a safe and effective alternative for many procedures requiring either small or large bore vascular accesses. In this review, we will discuss the characteristics of this vascular closure device and the main studies that proved its potential to reduce vascular complications, time to deambulation, time to discharge and patient discomfort.

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.

We read with great interest the recently published paper by Hulot et al. ([1][1]), who investigated the routine use of cytochrome P450 2C19 ( CYP2C19 ) genotyping to guide treatment with thienopyridine in patients with ST-segment elevation myocardial infarction. The data suggest that CYPC2C19

Background Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3–12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes. Methods and results The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004–2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents. Conclusions Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.

Aims To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. Background Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. Methods 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. Results After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). Conclusion Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

FFR-guided coronary intervention is recommended for patients with intermediate stenoses. However, concerns exist with this approach in anatomically prognostic disease.In this prospective, multicentre study, we consecutively enrolled patients found to have FFR negative lesions in anatomically significant sites: left main; proximal LAD; last remaining patent vessel; and multiple vessels with concomitant impaired left ventricular systolic function (EF 40%). As per recommendation, revascularisation was deferred, and patients included into a registry. The primary endpoint was MACE (death, myocardial infarction and unplanned target lesion revascularization). Secondary endpoints were the above individual components. Subgroup analyses were performed for clinical presentation (stable vs. ACS), localization of lesion (ostial vs. non ostial) and renal function.The registry included 292 patients with 297 deferred stenoses. After 1-year, the primary endpoint occurred in 5% of patients, mainly driven by TLR (2.7%). Cardiovascular death occurred in 0.8% and AMI in 0.8%. During a follow-up of 22.2 ± 11 months, MACE occurred in 11.6%. Cardiovascular death occurred in 1.8% and AMI in 2.1%. After multivariate analysis, impaired renal function (OR 1.99; CI 95% 1.74-5.41; p = 0.046) and ostial disease (OR 2.88; CI 95% 1.04-7.38; p = 0.041) were found to be predictors of MACE. Impaired renal function also predicted TLR (OR 2.43; CI 95% 1.17-5.02; p = 0.017).FFR-guided revascularisation deferral is safe in the majority of anatomically prognostic disease. However, further evaluation is required in the risk stratification of those patients with ostial disease and renal disease. Registered on ClinicalTrials, NCT02590926.

Background Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57-1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47-2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50-6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34-1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36-3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus ( P interaction=0.003). Conclusions The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

Background: Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results: Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure—a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57–1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47–2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50–6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34–1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36–3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus ( P interaction=0.003). Conclusions: The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

Background. Residual angina after PCI is a frequently occurring disease. Ivabradine improves symptoms but its role in patients without left ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function. Methods. Twenty-eight consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day (IG) or standard therapy (CG). All patients performed a stress echocardiography at the enrollment and after 30 days. MVO2 was estimated from double product (DP) and triple product (TP) integrating DP with ejection time (ET). Diastolic function was evaluated determining E and A waves, E′ measurements, and E/E′ ratio both at rest and at the peak of exercise. Results. The exercise time was longer in IG 9′49″ ± 48″ vs 8′09″ ± 59″ in CG (p=0.0001), reaching a greater workload (IG 139.3 ± 13.4 vs CG 118.7 ± 19.6 Watts; p=0.003). MVO2 expressed with DP and TP was significantly higher in IG (DP: IG 24194 ± 2697 vs CG 20358 ± 4671.8, p=0.01; TP: IG 17239 ± 4710 vs CG 12206 ± 4413, p=0.007). At peak exercise, the ET was diminished in IG than CG. The analysis of diastolic function after the exercise revealed an increase of E and A waves, without difference in the E/A ratio. The E′ wave was higher in IG than CG, and in the same group, the differences between baseline and peak exercise were greater (∆E′3.14 ± 0.7 vs 2.4 ± 1.13, p=0.047). The E/E′ ratio was reduced in patients treated with ivabradine (IG 10.2 ± 2.0 vs CG 7.9 ± 1.6, p=0.002). Conclusions. Ivabradine seems to produce a significant improvement of ischemic threshold, chronotropic reserve, and diastolic function.

Transcatheter aortic valve implantation (TAVI) has become the therapy of choice for patients with severe aortic stenosis (AS) who are deemed to be inoperable or at high/intermediate risk for conventional surgical aortic valve replacement (SAVR). Despite improving experience and techniques, ischaemic and bleeding events in the periprocedural period and months after TAVI still remain a relevant concern and impair survival in this generally old and comorbid-rich population. Empirically, dual antiplatelet therapy (DAPT) is currently recommended after TAVI with oral anticoagulation (OAC) restricted for specific indications. However, atrial fibrillation is common after the procedure and embolic material often thrombin-rich. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. Recent evidence has therefore questioned this approach, suggesting that DAPT may be futile compared with aspirin alone and that OAC could be a relevant alternative. Future randomised and appropriately powered trials comparing different strategies of antithrombotic therapy, including new antiplatelet and anticoagulant agents, are necessary to increase the available evidence on this topic. Temporarily, it remains rational to follow the current guidelines, with routine DAPT and recourse to OAC when specifically indicated.

Surgical and perioperative care are much improved in the last years but postoperative complications after cardiac surgery remain frequent, which are directly involved to increase the mortality, morbidity, and costs (1). Atrial arrhythmias and atrial fibrillation (AF) in particular are well-known complications after cardiac surgery with a reported incidence between 10% and 60% (2). Postoperative atrial arrhythmias extend the hospitalization, decreasing the hemodynamic condition and increasing the risk of stroke and mortality (3). The incidence is higher in patients undergoing valve surgery than in patients undergoing coronary artery bypass surgery (CABG) (4). Despite lower, post-operative atrial arrhythmias also occur after non-cardiac surgery (from 0.3% to 29%) (5,6), especially after oesophagectomy (7), lung surgery (6), and large abdominal surgery (8).

OBJECTIVES To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions. BACKGROUND The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level. METHODS Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate. RESULTS Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P

Background A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non–ST-segment elevation myocardial infarction. Objectives The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non–ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization. Methods In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year. Results The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups. Conclusions In multivessel non–ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI] Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984)

Prasugrel or ticagrelor is recommended in patients with ST-segment–elevation myocardial infarction (STEMI). Patients with diabetes mellitus are characterized by enhanced platelet reactivity (PR) and a reduced response to oral antiplatelet agents.1 The RESET 2D trial (Prasugrel vs Ticagrelor in ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus) was a prospective, randomized, pharmacodynamic study evaluating platelet inhibition by loading dose (LD) of ticagrelor or prasugrel in P2Y12-naive patients with diabetes mellitus presenting with STEMI. The local ethics committee approved the study (ClinicalTrials.gov NCT01531114). All consecutive patients with STEMI with diabetes mellitus undergoing primary percutaneous coronary intervention who were P2Y12 naive were considered for PR assessment. Major exclusion criteria were bleeding diathesis, periprocedural glycoprotein IIb/IIIa receptor inhibitor use, morphine administration, previous ischemic/hemorrhagic stroke, and any contraindication to antiplatelet therapy. Eligible patients were randomized 1:1 to receive ticagrelor 180-mg LD or prasugrel 60-mg LD at the time of percutaneous coronary intervention. All patients received oral aspirin 325 mg and intravenous unfractionated heparin (70 U/kg). Platelet function testing was performed with VerifyNow (Accumetrics, San Diego, CA) at baseline and …

Cerebral ischemic lesions occurring during transcatheter valve interventions are common feared complications and the use of filter device seems to reduce their incidence. We report the case of an 84-year old female patient with severe mitral regurgitation undergoing MitraClip. During the trans-esophageal echocardiography (TEE)-guided procedure was detected the presence of a little fibrin strand adherent to the steerable guide catheter for which we decided to implant the Claret CE Pro (Claret Medical, Inc. Santa Rosa, CA, USA) cerebral protection device and to continue the procedure during which the thrombus disappeared. At the end of the procedure a big thrombus was detected in the distal filter. The histologic analysis of the debris captured by the filters showed the presence of a thrombus, compatible with the image identified by TEE.

Background Covered stent (CS) implantation is considered a useful device in the setting of Grade III Coronary Perforation (G3CP), one of the most harmful PCI complication. However, data regarding efficacy of this device and clinical outcomes are still limited. Methods and results From 1993 to 2015, among 97,779 patients from 9 European centres undergoing PCI, 224 patients had G3CP (0.23%), and 102 patients were managed with CS implantation (96 with PTFE, 6 with pericardium). Device oriented composite endpoint (DOCE), a composite of cardiac death, target lesion revascularization, and stent thrombosis (ST) in-hospital and at long term follow-up were evaluated. G3-CP perforations were successfully sealed with CS in 88 patients (86.3%) with need of intraprocedural pericardiocentesis in one-third of cases. Protamine as heparin reversal agent was administered in 36 (35%) of cases. The cumulative incidence of in-hospital DOCE were 16.6% (17/102): death 14.7%, TLR 2.9%, ST 3.9%. At long-term follow-up (mean 42 ± 38 months), DOCE rates occurred in 19.7%: death 7.4%, TLR 11%, and ST 6.2%. Indication to Dual Antiplatelet Therapy (DAPT) was lifelong in 20% of cases, 1 to 6 months in 22.5% and 12-months in 57.5% without differences in long-term DOCE before and after DAPT interruption (8.0 vs. 6.6%, respectively, P = 0.20). Conclusions Use of CS was successful in sealing grade 3 coronary artery perforations in the majority of cases. Beside the high rate of clinical events at short and long-term, ST remains the leading cause of device failure.