Appraising features and outlook of women and men discharged after an acute coronary syndrome: evidence from the 23,700-patient PRAISE International Registry.

BACKGROUND: Acute coronary syndromes (ACS) are a common cause of morbidity and mortality. Several studies have focused on ACS at admission, but limited evidence is available on sex-based comparison of patients discharged after ACS. We appraised the outlook of women and men discharged after ACS. METHODS: Details on women enrolled in the PRAISE registry, an international cohort study spanning 23,700 patients included between 2003 and 2019, were systematically collected. We focused on patient and procedural features, medications at discharge, and 1-year outcomes. The primary endpoint was the composite of death, myocardial infarction, or major bleeding after discharge. RESULTS: A total of 17,804 (76.5%) men and 5466 (23.5%) women were included. Several baseline differences were found, including risk factors and prior revascularization (all P<0.05). Men underwent more frequently radial access, and at discharge they received more commonly dual antiplatelet therapy and guideline-directed medical therapy (P<0.001). At 1-year follow-up, risks of death, reinfarction, major bleeding, and non-fatal major bleeding, jointly or individually, were all significantly higher in women (all P≤0.01). All such differences however did not hold true at multivariable analysis, with the exception of major bleeding, which appeared surprisingly less common in females at fully adjusted analysis (P=0.017). CONCLUSIONS: Women, albeit only apparently, had worse outcomes 1 year after discharge for ACS, but adjusted analysis suggested instead that they faced a lower risk of major bleeding after discharge. These findings support the call for more aggressive management of women after ACS.

Detecting heart failure using novel bio-signals and a knowledge enhanced neural network.

BACKGROUND: Clinical 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 RESULTS: The 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%. CONCLUSION: Using 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.

Tricuspid leaflet flail after Micra™ leadless pacemaker implantation: a case report.

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.

Grade 3 coronary artery perforations in chronic total occlusion-percutaneous coronary intervention: Mechanisms, locations, and outcomes from the G3CAP Registry.

AIM: The impact of Grade III coronary perforations (G3-CP) in the setting of CTO-PCI is not well assessed. METHODS AND RESULTS: 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 (p < 0.001). 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. CONCLUSIONS: We showed similar in-hospital and long-term outcomes when G3 perforations occurred during CTO PCI and non CTO-PCI.

Impact of weather and pollution on the rate of cerebrovascular events in a large metropolitan area.

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). 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 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. RESULTS: 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 PM <10 µm (all P<0.05), whereas less stringent associations were found for humidity, rainfall, and PM <2.5 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], P<0.001) were the strongest independent predictors of CVE. CONCLUSIONS: 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.

Novel tech throws knock-out punch to ECG improving GP referral decisions to cardiology.

PURPOSE: In a comparator study, designed with assistance from the Food and Drug Administration, a State-of-the-Art (SOTA) ECG device augmented with automated analysis, the comparator, was compared with a breakthrough technology, Cardio-HART (CHART). METHODS: The referral decision defined by physician reading biosignal-based ECG or CHART report were compared for 550 patients, where its performance is calculated against the ground truth referral decision. The ground truth was established by cardiologist consensus based on all the available measurements and findings including echocardiography (ECHO). RESULTS: The results confirmed that CHART analysis was far more effective than ECG only analysis: CHART reduced false negative rates 15.8% and false positive (FP) rates by 5%, when compared with SOTA ECG devices. General physicians (GP's) using CHART saw their positive diagnosis rate significantly increased, from ~10% to ~26% (260% increase), and the uncertainty rate significantly decreased, from ~31% to ~1.9% (94% decrease). For cardiology, the study showed that in 98% of the cases, the CHART report was found to be a good indicator as to what kind of heart problems can be expected (the 'start-point') in the ECHO examination. CONCLUSIONS: The study revealed that GP use of CHART resulted in more accurate referrals for cardiology, resulting in fewer true negative or FP-healthy or mildly abnormal patients not in need of ECHO confirmation. The indirect benefit is the reduction in wait-times and in unnecessary and costly testing in secondary care. Moreover, when used as a start-point, CHART can shorten the echocardiograph examination time.

Reduction in emergency access for acute myocardial infarction during the COVID-19 pandemic: a survey from the greater area of Rome.

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 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, 1068 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.

Impact of environmental pollution and weather changes on the incidence of ST-elevation myocardial infarction.

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 < 0.05). 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.

Renal arteries denervation: from the treatment of resistant hypertension to the treatment of atrial fibrillation.

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.

Complications during chronic total occlusion percutaneous coronary intervention: a sign- and symptom-based approach to early diagnosis and treatment.

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 CTO-PCIs are the most complex procedures in interventional cardiology. In particular, the perceived higher risk of complications during CTO interventions might discourage new operators from engaging in this challenging field. The aim of this work was 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.

A novel algorithm for the computation of the diastolic pressure ratio in the invasive assessment of the functional significance of coronary artery disease.

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, P<0.001), with a mean difference of -0.004±0.014. The diagnostic performance of dPR (best cutoff value: ≤0.89) against iFR was as follows: accuracy =96%; sensitivity =94%; specificity =97%; positive-predictive value =94%; and negative-predictive value =96%. Additionally, AUC to predict iFR≤0.89 was 0.99, which was significantly higher than that of Pd/Pa (0.97, P<0.001). In the iFR range of 0.85-0.93 ("grey zone"), the diagnostic performance was well maintained (accuracy =91%; sensitivity =87%; specificity =93%; and AUC=0.96). Results were supported also by unsupervised learning analysis. CONCLUSIONS: 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.

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

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.