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Adult congenital heart disease (ACHD) patients represent a growing population with increasing use of acute emergency department (ED) care. Providing comprehensive ED care necessitates an understanding of the most common clinical scenarios to improve morbidity and mortality in this population. The aim of this position document is to provide a consensus regarding the management of the most common clinical scenarios of ACHD patients presenting to the ED.

Globally, there has been little change in mortality rates from cardiovascular (CV) diseases or cancers over the past two decades (1997–2018). This is especially true for heart failure (HF) where 5-year mortality rates remain as high as 45–55%. In the same timeframe, the proportion of drug revenue, and regulatory drug approvals for cancer drugs, far out paces those for CV drugs. In 2018, while cancer drugs made 27% of Food and Drug Administration drug approvals, only 1% of drug approvals was for a CV drug, and over this entire 20 year span, only four drugs were approved for HF in the USA. Cardiovascular trialists need to reassess the design, execution, and purpose of CV clinical trials. In the area of oncology research, trials are much smaller, follow-up is shorter, and targeted therapies are common. Cardiovascular diseases and cancer are the two most common causes of death globally, and although they differ substantially, this review evaluates whether some elements of oncology research may be applicable in the CV arena. As one of the most underserved CV diseases, the review focuses on aspects of cancer research that may be applicable to HF research with the aim of streamlining the clinical trial process and decreasing the time and cost required to bring safe, effective, treatments to patients who need them. The paper is based on discussions among clinical trialists, industry representatives, regulatory authorities, and patients, which took place at the Cardiovascular Clinical Trialists Workshop in Washington, DC, on 8 December 2019 (https://www.globalcvctforum.com/2019 (14 September 2020)).

Background MINOCA's physiopathology, treatment and prognosis are yet to be completely understood. The aim of this study is to compare baseline characteristics and prognosis of MINOCA patients and those of patients with myocardial infarction (MI) and obstructive coronary arteries. Methods We analysed all consecutive patients with MI who underwent coronary angiography admitted in a University Hospital covering a population of 220.000 people during a period of 60 months. The database and the all the patient's angiographies were revised by a group of experts in order to adequate MINOCA to 2020 ESC Guidelines definition and the American Heart Association position paper. Results 680 patients, 68 of whom were MINOCA (10%) with a median of follow up of 31±16 months were analysed (see table 1). We found no differences in both groups' age. Female gender was more prevalent among MINOCA patients. The underlying mechanism in MINOCA was coronary spasm (17.6%), plaque rupture (13.2%), coronary embolism (7.4%), coronary dissection (2.9%), type II infarction (19.1%) or unknown (39.7%). Coronary arteries in MINOCA patients had no obstructions at all in 57.4%, and 30–50% obstruction in 42.6% of the cases. MINOCA patients didn't have higher prevalence of cancer, autoimmune or psychiatric diseases, dyslipidaemia, hypertension or inflammatory analytical parameters. However, we found significant differences in atrial fibrillation, migraine, connective tissue diseases, tobacco use and diabetes. We found no effect of stress in the development of MINOCA (measured with validated STAI and DS-14 scales). Symptoms at admission didn't differ between the two groups, but those with MINOCA had normal ECG more frequently. Prognosis showed relevant differences, as MINOCA patients had less major cardiovascular complications, such as inotropic requirements (0% Vs 4.8%, p=0.04), shock (0% vs 6.6%, p=0.013) and left ventricular dysfunction (11.8 vs 30.2, p=0.015). Furthermore, myocardial injury biomarkers' levels were, significantly lower in MINOCA patients. Death rates tend to be lower both in hospital (0% vs 3.1%, p=0.131) and during follow up (9.1% vs 11.5%, p=0.369). Conclusion Analysing MINOCA patients' clinical profile might help us understanding the underlying physiopathology, prognosis and treatment targets. In these patients, classic cardiovascular risk factors don't appear to be as important as in obstructive patients. At admission, we found no clinical differences that could help making an early diagnosis, even if those with normal ECG and lower levels of myocardial injury biomarkers are more likely to have non-obstructive coronary arteries. These patients seem to have better prognosis and lower myocardial injury than those with obstructive coronary arteries. Further research is needed to provide more evidence on the accurate treatment of these patients. Funding Acknowledgement Type of funding sources: None.

Background Physicians can be reluctant to prescribe antithrombotic agents in frail elderly patients with frequent falls due to the fear for severe bleeding, mainly for intracranial haemorrhage (ICH). Presently, there is only a limited amount of inconclusive data available on the topic. Purpose Identification of risk factors for ICH within a cohort of geriatric patients with repeated falls. Methods All patients of 65 years of age and older with repeated falls at our day clinic were eligible. If an MRI of the brain was performed as part of the assessment, patients were included in this analysis. Baseline characteristics including medical, functional, and cognitive state were collected, a Frailty Index (FI) was calculated [1,2]. Cerebral small vessel disease was described and evaluated as proposed in a position paper in 2013 [3]. Follow-up data concerning major bleeding events were retrieved from the electronic medical files. Odds ratios (OR) with confidence intervals (CI) were calculated. Results 670 patients were eligible; an MRI was performed in 486 patients. The average age was 80 years, 50% was severely frail at the time of inclusion. 83 patients (17%) used OAC (mainly Vitamin K antagonists prescribed for atrial fibrillation), 165 patients (34%) used anti platelet agents (APA), 1 patient used both OAC and APA. In total, 29 major bleeding events (MB) occurred, of which 13 were ICH. Among patients using OAC, 8 MB occurred, of which 2 were ICH. The patient with both OAC and APA did not experience a bleeding event. Well known risk factors for ICH such as hypertension, diabetes mellitus and cognitive impairment were not predictive for ICH in this cohort, nor were the use APA (OR 0.86, 95% CI 0.26–2.84), or vitamin K antagonists (OR 0.88, 95% CI 0.19–4.05). However, a composite factor of using either APA or OAC, heightened the risk for MB (OR 3.24, 95% CI 1.35–7.74), but not for ICH (OR 0.83, 95% 0.27–2.49). Of cerebral small vessel disease, predictive factors for ICH were the presence of lacunes (OR 3.81, 95% CI 1.25–11.56), and relevant white matter hyperintensities (WMH) (defined as a Fazekas score of 2 or more) (OR 11.3, 95% CI 1.45–87.3). Furthermore, cognitive decline defined as an MMSE score of ≤26 heightened the risk of MB (OR 2.28, 95% CI 1.05–4.96). The low number of ICH did not allow for a multivariate analysis. Conclusion This analysis has several important findings. First, despite the long follow up of a cohort of severely frail patients that frequently fall, a low number of MB and ICH was observed. Second, well known risk factors for MB do not seem predictive of ICH in this cohort of very elderly patients. Finally, cognitive decline was predictive for MB, and WMH and lacunes were predictive for ICH. Adding cognitive screening and brain imaging to the diagnostic work up of patients with an indication for OAC could be of value when assessing the future risk for major bleeding events. Funding Acknowledgement Type of funding sources: None.

Background Heart failure (HF) admission is a serious event in the follow up of patients with chronic coronary syndromes (CCS). Stratification schemes have been described for predicting this end-point but none of them has been externally validated. Purpose To develop point-scores for predicting incident HF admission with data from previous studies, to perform an external validation in an independent prospective cohort study, and to compare their discriminative ability for this event. Methods We performed a literature review searching for prospective studies including patients with CCS, excluding patients with HF at baseline, with data on HF admission incidence in follow up and predictive variables. If undescribed previously, scores were developed including those variables independently associated with this outcome, and score points were assigned based in the relative magnitude of the coefficients of Cox regression models. The resulting scores were validated and their discriminative ability compared in a prospective, monocentric, 17-years cohort study, that included consecutive outpatients with CCS. Results Four studies were included: two post-hoc analysis of clinical trials (CARE and PEACE) and two observational registries (CORONOR and CLARIFY). The validation cohort included 1212 patients (mean age 67±11 years, 74% male) followed for up to 17 years (median 12 years, p25–75 5–15 years), with 171 patients suffering at least one HF admission in follow-up. The proportions of the variables needed for scores calculation available in the database of the study were 75% (6/8), 88% (15/17), 100% (8/8) and 85% (17/20) respectively, for each of these study-derived scores. Discriminative ability for predicting HF admission was statistically significant for all (C-statistic 0.72, 95% CI 0.68–0.75, p Conclusions All tested scores showed significant discriminative ability for predicting incident HF admission in this independent validation study. Their discriminative ability was similar, except that CORONOR score performed significantly better than CLARIFY score. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): The work for this paper was funded by the Andalusian Society of Cardiology through anunconditional grant from Astra Zeneca. ROC curves for HF predictive scoresHF free survival by CORONOR score

Introduction Out of all patients admitted with Myocardial Infarction, 10 to 15% have Myocardial Infarction with Non-Obstructive Coronaries Arteries (MINOCA). Classification algorithms based on deep learning substantially exceed traditional diagnostic algorithms. Therefore, numerous machine learning models have been proposed as useful tools for the detection of various pathologies, but to date no study has proposed a diagnostic algorithm for MINOCA. Purpose The aim of this study was to estimate the diagnostic accuracy of several automated learning algorithms (Support-Vector Machine [SVM], Random Forest [RF] and Logistic Regression [LR]) to discriminate between people suffering from MINOCA from those with Myocardial Infarction with Obstructive Coronary Artery Disease (MICAD) at the time of admission and before performing a coronary angiography, whether invasive or not. Methods A Diagnostic Test Evaluation study was carried out applying the proposed algorithms to a database constituted by 553 consecutive patients admitted to our Hospital with Myocardial Infarction. According to the definitions of 2016 ESC Position Paper on MINOCA, patients were classified into two groups: MICAD and MINOCA. Out of the total 553 patients, 214 were discarded due to the lack of complete data. The set of machine learning algorithms was trained on 244 patients (training sample: 75%) and tested on 80 patients (test sample: 25%). A total of 64 variables were available for each patient, including demographic, clinical and laboratorial features before the angiographic procedure. Finally, the diagnostic precision of each architecture was taken. Results The most accurate classification model was the Random Forest algorithm (Specificity [Sp] 0.88, Sensitivity [Se] 0.57, Negative Predictive Value [NPV] 0.93, Area Under the Curve [AUC] 0.85 [CI 0.83–0.88]) followed by the standard Logistic Regression (Sp 0.76, Se 0.57, NPV 0.92 AUC 0.74 and Support-Vector Machine (Sp 0.84, Se 0.38, NPV 0.90, AUC 0.78) (see graph). The variables that contributed the most in order to discriminate a MINOCA from a MICAD were the traditional cardiovascular risk factors, biomarkers of myocardial injury, hemoglobin and gender. Results were similar when the 19 patients with Takotsubo syndrome were excluded from the analysis. Conclusion A prediction system for diagnosing MINOCA before performing coronary angiographies was developed using machine learning algorithms. Results show higher accuracy of diagnosing MINOCA than conventional statistical methods. This study supports the potential of machine learning algorithms in clinical cardiology. However, further studies are required in order to validate our results. Funding Acknowledgement Type of funding sources: None. ROC curves of different algorithms

Recent health reforms have created incentives for cardiologists and accountable care organizations to participate in value-based care models for heart failure (HF). Accurate risk stratification of HF patients is critical to efficiently deploy interventions aimed at reducing preventable utilization. The goal of this paper was to compare deep learning approaches with traditional logistic regression (LR) to predict preventable utilization among HF patients. We conducted a prognostic study using data on 93,260 HF patients continuously enrolled for 2-years in a large U.S. commercial insurer to develop and validate prediction models for three outcomes of interest: preventable hospitalizations, preventable emergency department (ED) visits, and preventable costs. Patients were split into training, validation, and testing samples. Outcomes were modeled using traditional and enhanced LR and compared to gradient boosting model and deep learning models using sequential and non-sequential inputs. Evaluation metrics included precision (positive predictive value) at k, cost capture, and Area Under the Receiver operating characteristic (AUROC). Deep learning models consistently outperformed LR for all three outcomes with respect to the chosen evaluation metrics. Precision at 1% for preventable hospitalizations was 43% for deep learning compared to 30% for enhanced LR. Precision at 1% for preventable ED visits was 39% for deep learning compared to 33% for enhanced LR. For preventable cost, cost capture at 1% was 30% for sequential deep learning, compared to 18% for enhanced LR. The highest AUROCs for deep learning were 0.778, 0.681 and 0.727, respectively. These results offer a promising approach to identify patients for targeted interventions. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): internally funded by Diagnostic Robotics Inc.

Background Implantable cardioverter defibrillator (ICD) implant rates in New Zealand (NZ) have increased significantly in recent years. Previous studies in NZ have demonstrated that Māori and Pacific patients had higher rates of ischaemic heart disease compared to other ethnicities. Ethnic variation in ICD implant rates have been reported internationally, but whether this trend exists in NZ is unclear. Purpose This paper aims to provide the first analysis of new ICD implants by ethnicity over an extended time period. Methods All patients who received a new ICD implant were identified for the period of 1st January 2005 to 31st December 2019 using the National Minimum Datasets, which collects information on all public hospital admissions in NZ. Ethnicity prioritisation was performed in the following order: Māori, Pacific, Asian and European. New ICD implant rates were analysed by ethnicity and age-groups. Results A total of 5,514 new ICDs were implanted over the study period. New ICD implant rates increased by 137%, from 41.4/million in 2005 to 98.2/million in 2019, at an average of 5.4%/year (p In the age groups of Conclusion There is marked ethnic variation in ICD implant rates in NZ. Implant rates have increased in ethnic minorities but have plateaued in European patients in the past 7 years. The continued difference in implant rates across ethnicities warrants further investigation. Funding Acknowledgement Type of funding sources: None.

Background Health-related quality of life (HRQoL) is impaired in patients with pulmonary hypertension (PH). The EmPHasis-10 and CAMPHOR questionnaires are developed to evaluate HRQoL specifically in patients with PH. Data on the longitudinal use of both questionnaires are still limited. Purpose This paper will evaluate and compare the longitudinal value of two health-related quality of life questionnaires specific for patients with pulmonary hypertension (CAMPHOR and EmPHasis-10 questionnaires) using a broad spectrum of clinical anchor points. Furthermore we will establish minimal clinically important differences (MCID) for both questionnaires. Methods Sixty-one treatment naïve pulmonary arterial hypertension or chronic thromboembolic patients were prospectively included. Patients were treated according to the current ESC/ERS guidelines. We compared EmPHasis-10 and CAMPHOR scores between baseline, 6 and 12 months of follow-up and evaluated the correlation between these scores and a 5-scale symptom severity score, 5-scale overall health score, NYHA-classification, six minute walk test distance (6MWD), NT-proBNP and echocardiographic parameters. MCIDs were calculated using distribution and anchor based calculations. Results After one year of treatment a significant reduction in EmPHasis-10 score and CAMPHOR QoL and symptoms domain score was observed. Moderate to good correlations were observed between the questionnaires and the overall-health and symptom severity score and 6MWD. No relevant correlations were seen between the questionnaires and NT-pro-BNP and echocardiographic parameters. EmPHasis-10 scores showed strong correlations with all CAMPHOR domains. The MCID for the EmPHasis-10 questionnaire was −8. The MCIDs for the CAMPHOR domains were: activity −3, symptoms −4, QoL −3. Conclusion The EmPHasis-10 and CAMPHOR questionnaires are valid tools for the longitudinal measurement of HRQoL in patients with PH. The much shorter EmPHasis-10 correlates well with the CAMPHOR domain scores and with the clinical endpoints and it may be easier to use in daily practice. We established acceptable MCIDs. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): This research project was supported by an unrestricting grant by Actelion pharmaceuticals.

Background Myocardial infarction with non-obstructive coronary arteries (MINOCA) represents a management conundrum given the poorly understood pathogenic mechanisms. In recent years, novel echocardiographic measures such as deformation/strain analysis have enabled early identification of left atrial (LA) remodelling and dysfunction which take place prior to structural alterations. LA dysfunction is an important biomarker of cardiovascular disease and an independent predictor of atrial arrhythmias which may play a fundamental role in the pathogenesis of MINOCA. Purpose The goal of our study was to evaluate and characterise LA function by speckle tracking strain echocardiography in patients with MINOCA. Methods Patients admitted to our institution with acute myocardial infarction were assessed and those diagnosed with MINOCA who underwent transthoracic echocardiogram (TTE) within 48-hours of their coronary angiogram were included. Diagnosis of MINOCA was based on the 2017 ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Two-dimensional speckle tracking strain analysis of the LA and left ventricle (LV) was performed offline using vendor independent software (TomTec Arena). Clinical and echocardiographic measures were compared to healthy controls identified from our echocardiography database. We excluded patients with history of atrial fibrillation, heart failure and LV dysfunction (LVEF Results The cohort consisted of 82 patients; 41 patients with MINOCA were compared to 41 age and sex matched controls (61% male, mean age 51±12.8 years). At baseline, patients with MINOCA had a higher prevalence of modifiable vascular risk factors including smoking, hypertension and diabetes (p Conclusion Patients with MINOCA demonstrated lower LASr despite normal LV and LA volumes. This suggests that LA dysfunction may play a role in the pathogenesis of MINOCA. Further studies are required to evaluate the significance of our findings. Funding Acknowledgement Type of funding sources: None.

Background Ablation of drivers in persistent atrial fibrillation (AF) has shown controversial results. Purpose To test the efficacy of a tailored approach for persistent AF ablation which includes pulmonary vein isolation (PVI) plus “subjective” identification and ablation of drivers. Methods From May 2017 to December 2019, selected patients with persistent AF and ongoing AF at the beginning of the ablation procedure were included. Conventional high-density mapping catheters (PentaRay NAV, IntellaMap Orion or Advisor HD Grid) were used. Drivers were subjectively identified as: a) fractionated continuous (or quasi-continuous) electrograms on 1–2 adjacent bipoles, without dedicated software (Figure 1A, dashed line; PR = PentaRay NAV); and b) sites with spatiotemporal dispersion (i.e. all the cycle length comprised within the mapping catheter) plus non-continuous fractionation on single bipoles (Figure 1B, arrows; in panels A and B: paper speed 200 mm/s; ORB = 24-pole ORBITER Woven catheter, blue bipoles around tricuspid annulus and green bipoles into the coronary sinus). Ablation included PVI + focal or linear ablation targeting sites with drivers. Ablation success was defined as conversion to sinus rhythm or atrial flutter during ablation. Follow-up included visits with 24h Holter ECG at 3–6–12 months. Survival free from atrial arrhythmias lasting >30 seconds was compared between patients ablated with this tailored approach, and all consecutive patients with persistent AF treated with a PVI-only strategy during the same period. Results 158 Patients received ablation: 35 with the tailored approach (61,7±10,2 years; 29% females) and 123 with only PVI (62,5±9,6 years; 25% females; 89% cryoablation). Basal characteristics were similar (Table 1). In the tailored-approach group, 14 patients (40%) presented 28 detectable sites with continuous fractionated electrograms, 26 on the left atrium and 2 on the right atrium, which was only mapped if ablation of drivers in the left atrium was not successful; 12 (43%) were located within the pulmonary vein antra. 27 patients (77%) showed 103 sites with spatiotemporal dispersion (4 [3–5] per patient). Ablation success was achieved in 17 patients (48%; conversion to sinus rhythm, n=7; conversion to atrial flutter, n=10) in the tailored-approach group and 1 patient (0,8%, sinus rhythm) in the PVI-only group. Excluding a 3-month blanking period, the tailored approach, compared to only PVI, improved one-year freedom from atrial arrhythmias (71% Vs 51%, p=0,05) and mean survival free from atrial arrhythmias (26±3 months; 95% CI 21–32 months Vs 18±2 months; 95% CI 15–22 months) (Figure 1C), at the cost of a longer median procedural time (246 [212–277] vs 108 [81–143] min, p Conclusion Subjective identification and ablation of drivers, added to PVI, improved freedom from atrial arrhythmias. Funding Acknowledgement Type of funding sources: None. Table 1. Basal characteristicsFigure 1

Introduction Stent thrombosis (ST) is a rare yet potentially serious complication associated with percutaneous coronary intervention (PCI). The high morbidity and mortality related to ST is well-documented, but the economic burden is less clear. Patients experiencing ST after PCI may have higher utilization of medical resources compared to patients without ST including longer inpatient stays, rehospitalizations, additional procedures, and increased pharmacotherapy use. Purpose This targeted literature review explores the medical resource use and costs to manage ST in patients treated with PCI. Methods We conducted a PubMed search of literature published from 2000–2020. In addition to publication year, inclusion criteria were: focus on economic burden, cost, or ST management; coronary disease patients; and English language. Two researchers selected and reviewed eligible studies as well as reference lists of included papers. Results From a total of 891 citations identified, 9 studies reported medical resource use and costs of ST. Because ST typically presents as severe ischemia or myocardial infarction (MI), treatment is emergent and usually consists of admission for balloon angioplasty or PCI with stent. Studies in the United States (US), Italy, and Japan documented varying likelihoods of these interventions – differentiated by ST timing (i.e., early, late, or very late) and initial PCI type – which impacts the cost of ST management. The per-patient episodic cost of ST management was quantified in US and European studies. The range in US dollars (USD) was $3,600-$36,180 which varied by ST timing and types of resources included. In one US study that reported detailed cost categories, the catheterization lab was responsible for nearly half of the total ST management cost. Estimates for France and Spain ranged from €926–€3,737; the primary factor that influenced these costs was the patient discharge status (alive or dead). The national economic burden of ST was quantified in two US studies. The annual estimated costs of ST to the US healthcare system were $40 million (2011 USD; very late ST only) and $65 million (2000 USD). Inflating these estimates to 2020 USD results in an annual economic burden of $52 million–$123 million. None of the identified studies comprehensively documented non-medical direct costs or indirect costs of ST in their results. Conclusions Few robust, comprehensive, and contemporary studies of the economic burden of ST have been published. ST costs are driven by management of nonfatal MI and repeat PCI and likely vary by ST timing. However, the magnitude of non-medical costs is uncertain and, therefore, published data underestimate total ST economic burden. The findings from this review are particularly insightful since future prospective studies focused on the economic impact of ST may be unlikely. Stakeholders may find the clinical benefits of ST reduction more compelling than the economic impact. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Abbott Vascular