Search

Aims Non-invasive imaging of electrical activation requires high-density body surface potential mapping. The nine electrodes of the 12-lead electrocardiogram (ECG) are insufficient for a reliable reconstruction with standard inverse methods. Patient-specific modelling may offer an alternative route to physiologically constraint the reconstruction. The aim of the study was to assess the feasibility of reconstructing the fully 3D electrical activation map of the ventricles from the 12-lead ECG and cardiovascular magnetic resonance (CMR). Methods and results Ventricular activation was estimated by iteratively optimizing the parameters (conduction velocity and sites of earliest activation) of a patient-specific model to fit the simulated to the recorded ECG. Chest and cardiac anatomy of 11 patients (QRS duration 126–180 ms, documented scar in two) were segmented from CMR images. Scar presence was assessed by magnetic resonance (MR) contrast enhancement. Activation sequences were modelled with a physiologically based propagation model and ECGs with lead field theory. Validation was performed by comparing reconstructed activation maps with those acquired by invasive electroanatomical mapping of coronary sinus/veins (CS) and right ventricular (RV) and left ventricular (LV) endocardium. The QRS complex was correctly reproduced by the model (Pearson’s correlation r = 0.923). Reconstructions accurately located the earliest and latest activated LV regions (median barycentre distance 8.2 mm, IQR 8.8 mm). Correlation of simulated with recorded activation time was very good at LV endocardium (r = 0.83) and good at CS (r = 0.68) and RV endocardium (r = 0.58). Conclusion Non-invasive assessment of biventricular 3D activation using the 12-lead ECG and MR imaging is feasible. Potential applications include patient-specific modelling and pre-/per-procedural evaluation of ventricular activation.

This review comprises 2 main subjects: the percutaneous and surgical closure of the left atrial appendage (LAA) and atrial septal defect (ASD). The aim of the authors was to provide a detailed description of: 1) anatomy of LAA, normal interatrial septum, and the various types of ASD as revealed by noninvasive imaging techniques; 2) preprocedure planning of secundum ASD and LAA percutaneous closure; 3) key steps of the procedural guidance emphasizing the role of 2-dimensional/3-dimensional transesophageal echocardiography; and 4) surgical closure of LAA and ASD.

Objectives: We aimed to investigate the prognostic utility of the anatomical CABG SYNTAX and logistic clinical SYNTAX scores for mortality after percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafts (CABG). Background: The anatomical SYNTAX score evaluated the anatomical complexity of coronary artery disease and helped predict the prognosis of patients undergoing PCI. The anatomical CABG SYNTAX score was derived from the anatomical SYNTAX score in patients with prior CABG, whilst the logistic clinical SYNTAX score was developed by incorporating clinical factors into the anatomical SYNTAX score. Methods: We calculated the anatomical CABG SYNTAX score and logistic clinical SYNTAX score in 205 patients in the GLOBAL LEADERS trial. The predictive abilities of these scores for 2-year all-cause mortality were evaluated. Results: Using the median scores as categorical thresholds between low and high score groups, the logistic clinical SYNTAX score was able to discriminate the risk of 2-year mortality, unlike the anatomical CABG SYNTAX score. The logistic clinical SYNTAX was significantly better at predicting 2-year mortality, compared to the anatomical CABG SYNTAX score, as evidenced by AUC values in receiver-operating characteristic curve analysis (0.806 vs. 0.582, p

Introduction and objectives Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. Methods The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). Results MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. Conclusions In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.

The spectrum of inherited arrhythmogenic diseases (IADs) includes disorders without overt structural abnormalities (i.e. primary inherited arrhythmia syndromes) and structural heart diseases (i.e. arrhythmogenic ventricular cardiomyopathy, hypertrophic cardiomyopathy). The aim of this European Heart Rhythm Association (EHRA) survey was to evaluate current clinical practice and adherence to 2015 European Society of Cardiology Guidelines regarding the management of patients with IADs. A 24-item centre-based online questionnaire was presented to the EHRA Research Network Centres and the European Cardiac Arrhythmia Genetics Focus Group members. There were 46 responses from 20 different countries. The survey revealed that 37% of centres did not have any dedicated unit focusing on patients with IADs. Provocative drug challenges were widely used to rule-out Brugada syndrome (BrS) (91% of centres), while they were used in a minority of centres during the diagnostic assessment of long-QT syndrome (11%), early repolarization syndrome (12%), or catecholaminergic polymorphic ventricular tachycardia (18%). While all centres advised family clinical screening with electrocardiograms for all first-degree family members of patients with IADs, genetic testing was advised in family members of probands with positive genetic testing by 33% of centres. Sudden cardiac death risk stratification was straightforward and in line with current guidelines for hypertrophic cardiomyopathy, while it was controversial for other diseases (i.e. BrS). Finally, indications for ventricular mapping and ablation procedures in BrS were variable and not in agreement with current guidelines in up to 54% of centres.

Objective To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents. Background Second-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications. Methods DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up. Results A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not. Conclusions Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes.

Individual parameters of complete blood count (CBC) have been associated with worse outcome in patients with acute coronary syndrome (ACS). However, the prognostic role of CBC taken as a whole has never been evaluated for long-term incidence of major adverse cardiovascular events (MACEs). Patients were grouped according to their hematopoietic cells’ inflammatory response at different time points during hospital stay. Patients with admission white blood cell count >10 × 109/L, discharge hemoglobin 250 × 109/L were defined as “high-risk CBC.” Among 1076 patients with ACS discharged alive, 129 (12%) had a “high-risk CBC” and 947 (88%) had a “low-risk CBC.” Patients with “high-risk CBC” were older and had more comorbidities. Over a median follow-up of 665 days, they experienced a higher incidence of MACE compared to “low-risk CBC” patients (18.6% vs 8.1%). After adjustment for age, age-adjusted Charlson comorbidity index, female sex, cardiac arrest, suboptimal discharge therapy, coronary artery bypass, and ejection fraction, a high-risk CBC was significantly associated with increased MACE occurrence (adjusted hazard ratio 1.80; 95% CI: 1.09-3.00). The CBC was a prognostic marker in patients with ACS, and its evaluation at admission and discharge could better classify patient’s risk and improve therapeutic management.

Background The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions. Methods GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years. Results Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment. Conclusions After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial. AstraZeneca; Biosensors International Group; Medicines company

Aims To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. Methods and results This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21–3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58–1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. Conclusion In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. Clinical trial registration unique identifier NCT01813435.

Background and aim Systemic lupus erythematosus (SLE) is associated with accelerated atherogenesis. Traditional risk factors do not seem to fully explain this process in patients with SLE and no other imaging/serum biomarkers have so far improved risk stratification. Here, we focused on the role of adiponectin in women with SLE. Methods and results This is a sub-analysis of a validated cohort enrolling eighty females (age 18–65 years) affected by SLE. Patient underwent a single blood sampling and carotid echography. Serum adipocytokines (i.e. leptin, resistin and adiponectin) were assessed by enzyme-linked immunosorbent assay (ELISA). Patients with a carotid plaque (n = 23) were older, with longer duration of the disease, chronic use of corticosteroids, and immunosuppressive therapies. As expected, patients with a carotid plaque had increased vascular risk and high serum levels of inflammatory biomarkers, total and LDL cholesterol and adiponectin. Significant positive correlation between serum adiponectin and presence of a carotid plaque was found independently of patient age, SCORE Risk Charts, duration of disease, and SLE treatments. Conclusions These results indicate that high serum adiponectin is associated with accelerated carotid atherosclerosis in SLE young women and it might be useful to improve vascular risk stratification in this patient setting.

BACKGROUND Sex-related electrocardiographic differences are a well-known phenomenon, but not their expression in patients with atrial fibrillation (AF). In this study we aim to assess the presence of significant sex-related differences in ECG features, with particular attention to P-wave parameters, of a large cohort of patients affected by different types of AF. METHODS A 5-min resting 16-lead ECG was evaluated for 1119 AF patients in sinus rhythm. The durations of the main ECG waves and intervals were measured for both atrial and ventricular activity. Moreover, the beat-to-beat P-wave variability was computed for lead II and for the first principal component (PC1) computed across the 16 leads. The percentage of variance explained by PC1 was computed. RESULTS Males compared to females showed significantly longer RR interval (1.02 ± 0.16 s vs 0.97 ± 0.15 s, p

Aims The aim of this study was to determine the relationship between electrical and mechanical activation in heart failure (HF) patients and whether electromechanical coupling is affected by scar. Methods and results Seventy HF patients referred for cardiac resynchronization therapy or biological therapy underwent endocardial anatomo-electromechanical mapping (AEMM) and delayed-enhancement magnetic resonance (CMR) scans. Area strain and activation times were derived from AEMM data, allowing to correlate mechanical and electrical activation in time and space with unprecedented accuracy. Special attention was paid to the effect of presence of CMR-evidenced scar. Patients were divided into a scar (n = 43) and a non-scar group (n–27). Correlation between time of electrical and mechanical activation was stronger in the non-scar compared to the scar group [R = 0.84 (0.72–0.89) vs. 0.74 (0.52–0.88), respectively; P = 0.01]. The overlap between latest electrical and mechanical activation areas was larger in the absence than in presence of scar [72% (54–81) vs. 56% (36–73), respectively; P = 0.02], with smaller distance between the centroids of the two regions [10.7 (4.9–17.4) vs. 20.3 (6.9–29.4) % of left ventricular radius, P = 0.02]. Conclusion Scar decreases the association between electrical and mechanical activation, even when scar is remote from late activated regions.

OBJECTIVES: Degenerative mitral regurgitation (DMR) is classified into different phenotypes based on the extent of leaflet degeneration. Our aim is to demonstrate that phenotype complexity predicts the extent of structural abnormalities of mitral annulus (MA). METHODS AND RESULTS: Seventy-five patients with DMR and severe valve regurgitation and 23 patients with normal mitral valve were studied using 3D transesophageal echocardiography. Classification of DMR was done by allocating each 3D echocardiography result under five categories: fibroelastic deficiency (FED), FED+, forme fruste, Barlow's disease Mitral annular disjunction (BD MAD)- or BD MAD+. MA was reconstructed in early systole and in end systole. We tested for a trend toward enlargement and flattening of MA in end systole and for a difference in MA dynamics from early systole to end systole with a worsening of DMR phenotype, in the whole spectrum of subjects ranging from controls to BD MAD+. A significant trend was observed toward larger anteroposterior diameter, intercommissural diameter, annulus circumference, and annulus area (P

Background: The association between alcohol consumption and the occurrence of coronary heart disease is well described in the literature, while data regarding the impact of regular alcohol consumption on in-hospital outcomes in the setting of acute coronary syndrome (ACS) are lacking. We aimed to evaluate the impact of self-reported alcohol consumption on in-hospital outcomes in patients with ACS. Methods: Data derived from patients enrolled between 2007 and 2019 in the Acute Myocardial Infarction in Switzerland (AMIS) Plus registry were retrospectively analyzed. Patients were stratified based on alcohol drinking pattern. Primary outcome was all-cause in-hospital mortality, while secondary outcomes were set as incidence of major adverse cardiac and cerebrovascular events (MACCEs). Outcome comparisons according to quantity of daily alcohol intake were also performed. Results: Records concerning alcohol consumption were available in 25,707 patients; 5,298 of them (21%) fulfilled the criteria of regular alcohol consumption. Regular drinkers were predominantly male, younger, smokers, more comorbid and with a worse clinical presentation as compared with abstainers/occasional drinkers. Daily alcohol intake was reported in 4,059 (77%) of these patients (regular drinkers). Among them, 2,640 were light drinkers (≤2 drinks/day) and 1,419 heavy drinkers (>2 drinks/day). In-hospital mortality and MACCEs of heavy drinkers were significantly higher compared with those of light drinkers (5.4 vs. 3.3% and 7.0 vs. 4.4%, both p = 0.001). When tested together with Global Registry of Acute Coronary Events risk score parameters, heavy alcohol consumption was independently associated with in-hospital mortality (p = 0.004). Conclusions: Our results support that heavy alcohol consumption is an independent predictor of in-hospital mortality in patients presenting with ACS.

Backgrounds: Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited. Methods: This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. Results: Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62–1.20; Pinteraction = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47–0.97; Pinteraction = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63–0.97; Pinteraction = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62–1.54; Pinteraction = 0.981). Conclusions: The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years.

Aims The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days. Methods and results In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99–1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44–1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77–3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients. Conclusion In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion.

Cardiac resynchronization therapy (CRT) is an established non-pharmacological treatment for selected heart failure patients with wide QRS duration. However, there is a persistent number of non-responders throughout. The prediction of the CRT response is paramount to adequately select the correct patients for CRT. One of the expanding fields of research is the development of biomarkers that predict the response to CRT. A review of the available literature on biomarkers in CRT patients has been performed to formulate a critical appraisal of the available data. The main conclusion of our review is that biomarker research in this patient population is very fragmented and broad. This results in the use of non-uniform endpoints to define the CRT response, which precludes an in-depth comparison of the available data. To improve research development in this field, a uniform definition of the CRT response and relevant endpoints is necessary to better predict the CRT response.

OBJECTIVES: Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties. METHODS: Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEXTM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected. RESULTS: Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage. CONCLUSIONS: The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting.

We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared with the results from a cohort of 485 STEMI patients undergoing primary PCI without additional imaging. Imaging of the infarct-related artery at baseline (and follow-up) was successful in 92.2 % (96.6 %) of patients using OCT and in 93.2 % (95.5 %) using IVUS. Imaging of the non-infarct-related vessels was successful in 88.7 % (95.6 %) using OCT and in 90.5 % (93.3 %) using IVUS. Periprocedural complications occurred < 2.0 % of OCT and none during IVUS. There were no differences throughout 2 years between the imaging and control group in terms of MACE (16.7 vs. 13.3 %, adjusted HR1.40, 95 % CI 0.77-2.52, p = 0.27). Multi-modality three-vessel i.c. imaging in STEMI patients undergoing primary PCI is consistent a high degree of success and can be performed safely without impact on cardiovascular events at long-term follow-up.

Considering that there is a lack of evidence and guideline-based recommendations on the best preoperative oral anticoagulation management (OAC) for transcatheter aortic valve implantation (TAVI), this cohort study aimed to evaluate bleeding, access site complications, and early safety in patients undergoing TAVI on continued OAC therapy vs no-OAC therapy. Three-hundred forty-four patients submitted to a TAVI procedure (66.3% no-OAC vs 33.7% OAC) were consecutively enrolled. Primary endpoint was defined as in-hospital VARC-2 life-threatening or disabling bleeding. Secondary endpoints were in-hospital VARC-2 major vascular complications and VARC-2 early safety at 30 days. Propensity score matching analysis was performed to reduce potential distribution bias, resulting in 2 well-balanced groups (92 patients in each arm). In the overall cohort, mean age, median EuroScore II, and STS-score were 78.7±7.6 years, 2.9% (1.7-5.9), and 2.3% (1.6-3.6), respectively. Despite being older (78 ± 8 vs 80 ± 6, p = 0.004) and having higher STS score (2.1 vs 2.6, p = 0.001), patients on OAC had similar incidence of in-hospital VARC-2 life-threatening or disabling bleeding (1.3% vs. 0.9%, p = 0.711), major vascular complications (4.8% vs 5.2%, p = 0.888), and VARC-2 early safety at 30 days (10.1% vs 12.1%, p = 0.575). No significant differences in the main outcomes were observed when propensity score matching was applied. In conclusion, the management of patients on OAC submitted to a TAVI procedure is challenging and requires balancing the risk of bleeding with the risk of thromboembolic events. The present study suggests that continued OAC was not associated with increased in-hospital VARC-2 life-threatening or disabling bleeding, major vascular complications, and VARC-2 early safety at 30 days.

OBJECTIVES To investigate periprocedural and long-term outcome of left atrial appendage closure (LAAC) using Amplatzer occluders with respect to individual pre-procedural stroke risk. BACKGROUND LAAC is a proven strategy for prevention from stroke and bleeding in patients with nonvalvular atrial fibrillation not amenable to oral anticoagulation. Whether individual pre-procedural stroke risk may affect procedural and long-term clinical outcome after LAAC is unclear. METHODS Multicenter study of consecutive patients who underwent Amplatzer-LAAC. Using pre-procedural CHADS$_{2}$ score, outcomes were compared between a low (0-2 points) and a high stroke risk group (3-6 points). RESULTS Five hundred consecutive patients (73.9 ± 10.1 years) who underwent Amplatzer-LAAC. Two hundred and forty eight had preprocedural CHADS$_{2}$ score ≤ 2 points (low-risk group) and the remaining 252 patients had 3-6 points (high-risk group). Periprocedural complication rates (6.0% vs. 5.6%, p = .85), procedural success (LAAC without major periprocedural or device-related complications or major para-device leaks: 89.4% vs. 87.9%, p = .74), and 30-day-mortality (2.4% vs. 2.6%, p = .77) were comparable. After 1,346 patient-years (PY), the long-term composite efficacy endpoint (stroke, systemic embolism, cardiovascular, and unexplained death) was reached in 23/653 (3.5/100 PY) versus 52/693 (7.5/100 PY); HR = 2.13; 95%-CI, 1.28-3.65, p = .002) with stroke rates 67% and 68% lower than anticipated by preprocedural CHADS$_{2}$ score. Combined safety endpoint (major periprocedural complications and major, life-threatening or fatal bleedings) occurred in 22/653 (3.4/100 PY) versus 28/693 (4.0/100 PY); HR = 1.20; 95%-CI, 0.66-2.20, p = .52). CONCLUSIONS Compared with patients at low risk of stroke, LAAC with Amplatzer devices is associated with similar safety and efficacy in high-risk patients in our study.

Background A recent study showed that the presence and characteristics of myocardial scar could independently predict appropriate implantable cardioverter-defibrillator therapies and the risk of sudden cardiac death in patients receiving a de novo cardiac resynchronisation device. Design The aim was to evaluate the cost-effectiveness of cardiac magnetic resonance imaging-based algorithms versus clinical practice in the decision-making process for the implantation of a cardiac resynchronisation device pacemaker versus cardiac resynchronisation device implantable cardioverter-defibrillator device in heart failure patients with indication for cardiac resynchronisation therapy. Methods An incidental Markov model was developed to simulate the lifetime progression of a heart failure patient cohort. Key health variables included in the model were New York Heart Association functional class, hospitalisations, sudden cardiac death and total mortality. The analysis was done from the healthcare system perspective. Costs (€2017), survival and quality-adjusted life years were assessed. Results At 5-year follow-up, algorithm I reduced mortality by 39% in patients with a cardiac resynchronisation device pacemaker who were underprotected due to misclassification by clinical protocol. This approach had the highest quality-adjusted life years (algorithm I 3.257 quality-adjusted life years; algorithm II 3.196 quality-adjusted life years; clinical protocol 3.167 quality-adjusted life years) and the lowest lifetime costs per patient (€20,960, €22,319 and €28,447, respectively). Algorithm I would improve results for three subgroups: non-ischaemic, New York Heart Association class III–IV and ≥65 years old. Furthermore, implementing this approach could generate an estimated €702 million in health system savings annually in European Society of Cardiology countries. Conclusion The application of cardiac magnetic resonance imaging-based algorithms could improve survival and quality-adjusted life years at a lower cost than current clinical practice (dominant strategy) used for assigning cardiac resynchronisation device pacemakers and cardiac resynchronisation device implantable cardioverter-defibrillators to heart failure patients.

OBJECTIVES Available apical occluders do not fulfil requirements for full-percutaneous transapical valve procedures with large-sized introducer sheaths. A self-expanding closure device designed for closed-chest transapical valve procedures was tested in an animal model to verify safety, efficacy and thrombogenicity. METHODS Large-sized 21-Fr introducer sheaths (Certitude™ system for Sapien™ valves) were percutaneously placed in the ventricles of nine 3-month old minipigs. To seal the apical access, delivery catheters carrying folded self-expanding plugs were inserted. Then, the plugs were deployed while sheaths were removed. Echocardiograms verified tamponade and cardiac function, drains were not placed and a 3-month long aspirin therapy was administered. After 6 and 9 months, animals were euthanized and organs were analysed for macroembolic lesions search. Histological analysis was also performed. RESULTS Nine minipigs (weight: 28±3 kg) were used for this study. Eight plugs were successfully deployed in 8 ventricles without cardiac tamponade or ventricular dysfunction (success rate: 88.9%). In a failed procedure (the animal died after 1 month of cardiac tamponade), the outer disc of the apical plug got stuck in the intercostal space and did not correctly deploy. Post-mortem analysis in 8 minipigs at 6 (n = 4) and 9 months (n = 4) confirmed full deployment and good fixation of all plugs with internal surfaces covered by new endocardium. Macroscopic analysis of myocardium and vital organs showed absence of embolic lesions. Histological analysis showed absence of significant inflammatory infiltration and thrombosis. CONCLUSIONS In this animal model, self-expanding closure devices sealed 21-Fr large percutaneous apical accesses without acute tamponade, thrombosis or embolization. Further tests to evaluate full-percutaneous closed-chest apical procedures are required.

Background: Left bundle branch block (LBBB) morphology is associated with improved outcome of cardiac resynchronisation therapy (CRT) and is an important criterion for patient selection. There are, however, multiple definitions for LBBB. Moreover, applying these definitions seems subjective. We investigated the inter- and intraobserver agreement in the determination of LBBB using available definitions, and clinicians' judgement of LBBB.Methods: Observers were provided with 12-lead ECGs of 100 randomly selected CRT patients. Four observers judged the ECGs based on different LBBB-definitions (ESC, AHA/ACC/HRS, MADIT, and Strauss). Additionally, four implanting cardiologists scored the same 100 ECGs based on their clinical judgement. Observer agreement was summarized through the proportion of agreement (P) and kappa coefficient (k).Results: Relative intra-observer agreement using different LBBB definitions, and within clinical judgement was moderate (range k 0.47-0.74 and k = 0.76 (0.14), respectively). The inter-observer agreement between observers using LBBB definitions as well as between clinical observers was minimal to weak (range k 0.19-0.44 and k = 0.35 (0.20), respectively). The probability of classifying an ECG as LBBB by available definitions varied considerably (range 0.20-0.76). The agreement between different definitions of LBBB ranged from good (P = 0.95 (0.07)) to weak (P = 0.40 (0.22)). Furthermore, correlation between the different LBBB definitions and clinical judgement was poor (range phi 0.30-0.55).Conclusion: Significant variation in the probability of classifying LBBB is present in using different definitions and clinical judgement. Considerable intra-and inter-observer variability adds to this variation. Interdefinition agreement varies significantly and correlation of clinical judgement with LBBB classification by definitions is modest at best. (C) 2019 Elsevier B.V. All rights reserved.

The mitral annulus (MA) is not a continuous ring of connective tissue from which are suspended mitral leaflets. Instead, it is a much more complex structure made up of a mix of fibrous, muscular, and adipose tissues. MA is a key structure in any type of mitral valve repair and recently it has been targeted for transcutaneous devices. Thus, a deep understanding of MA anatomy has never been more important. Traditionally, cardiac anatomy has been described using anatomic specimens. Currently, sophisticated non-invasive techniques allow imaging of MA with a richness of anatomical details unimaginable only two decades ago. The aim of this review is to provide a better understanding of the peculiar aspects of MA as they are revealed through these imaging techniques and discuss clinical implications related to this complex structure.

Interest in the anatomy of the interatrial septum (IAS) and its adjoining atrioventricular (AV) junction has risen enormously in the past two decades with the simultaneous evolution of left-sided percutaneous structural heart disease and complex electrophysiologic procedures. These procedures require, in fact, a direct route to the left atrium through the IAS. Thus, a thorough understanding of the complex anatomy of the IAS and AV junction is essential for performing a safe and effective transseptal puncture. There is a large amount of literature carefully describing the anatomy of the IAS and AV junction. These studies are based almost exclusively on anatomic specimens. Conversely, in this review the authors emphasize the role of noninvasive imaging techniques, in particular cardiac magnetic resonance, two- and three-dimensional transesophageal echocardiography, and computed tomography in visualizing specific aspects of the normal IAS and AV junction. Where appropriate, the authors present images side by side, with corresponding anatomic specimens.

Aims The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown. Methods and results We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39–0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22–0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25–0.66, P Conclusion Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type. Clinical Trial Registration http://www.clinicaltrials.gov. Unique identifier: NCT00962416.

Background The likelihood of return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA) is influenced by unmodifiable (gender, aetiology, location, the presence of witnesses and initial rhythm) and modifiable factors (bystander CPR and the time to EMS arrival). All of these have been included in the ROSC After Cardiac Arrest (RACA) score. Purpose To test the ability of the RACA score to predict the probability of ROSC in two different regions with different local resuscitation networks: the Swiss Canton Ticino and the Italian Province of Pavia. Methods and Results All OHCAs occurred between January 1st 2015 and December 31st 2017 were included. The original regression coefficients for all RACA score variables were applied. The probability to obtain the ROSC as measured with the RACA score was divided in tertiles. Overall, 2041 OHCAs were included in the analysis. The RACA score showed good discrimination for ROSC (AUC 0.76) and calibration, without interaction (p 0.28) between the region and the probability of ROSC. The probability of ROSC was 15% for RACA scores 0.42. Conclusions The application of the RACA score reliably assess the probability to obtain the ROSC, with equal effectiveness in the two regions, despite different organization of the resuscitation network. Patients with a RACA score >0.42 had more than 50% probability to obtain ROSC.

Over the past two decades, our understanding of inherited primary arrhythmia syndromes has been enriched by studies that have aimed to define the clinical characteristics and the genetic, cellular and molecular features predisposing patients to an enhanced risk of ventricular arrhythmias. In contrast, very little is known about the causative role of inherited cardiac channelopathies on atrial conduction abnormalities possibly leading to different atrial tachyarrhythmias. The diagnostic and therapeutic management of patients with an inherited cardiac channelopathy presenting with atrial arrhythmias remains highly challenging and is in urgent need of improvement. This review will assess the current knowledge on atrial electrical abnormalities affecting patients with different forms of inherited primary arrhythmia syndromes, including long and short QT syndromes, early repolarisation syndrome, catecholaminergic polymorphic ventricular tachycardia and Brugada syndrome.

BACKGROUND: Unrecognized incomplete pulmonary vein isolation (PVI), as opposed to post-PVI pulmonary vein reconnection, may be responsible for clinical recurrences of atrial fibrillation (AF). To date, no data are available on the use of high-resolution mapping (HRM) during cryoballoon (CB) ablation for AF as the index procedure. The aims of this study were: - to assess the value of using a HRM system during CB ablation procedures in terms of ability in acutely detecting incomplete CB lesions; - to compare the 8-pole circular mapping catheter (CMC, Achieve) and the 64-pole mini-basket catheter (Orion) with respect to pulmonary vein (PV) signals detection at baseline and after CB ablation; - to characterize the extension of the lesion produced by CB ablation by means of high-density voltage mapping. METHODS: Consecutive patients with drug-resistant paroxysmal or early-persistent AF undergoing CB ablation as the index procedure, assisted by a HRM system, were retrospectively included in this study. RESULTS: Atotal of 33 patients (25 males; mean age: 59 ± 18 years, 28 paroxysmal AF) were included. At baseline, CMC catheter revealed PV activity in 102 PVs (77%), while the Orion documented PV signals in all veins (100%). Failure of complete CB-PVI was more frequently revealed by atrial re-mapping with the Orion as compared to the Achieve catheter (24% vs 0%, p 0.5 mV. A total of 29 patients (88%) remained free of symptomatic AF during a mean follow-up of 13.2 ± 3.7 months. CONCLUSION: Atrial re-mapping after CB ablation by means of a HRM system improves the detection of areas of incomplete ablation, characterizes the extension of the cryo-ablated tissue and can identify abolishment of potential non-PVI related sources of AF.

Objective: The aim was to evaluate the performance of a newly developed magnetically suspended centrifugal pump head intended for use as a ventricular assistance device with a newly developed extracorporeal membrane oxygenator setup. Methods: In an experimental setup, an extracorporeal membrane oxygenator circuit was established in three calves with a mean weight of 68.2 ± 2.0 kg. A magnetically levitated centrifugal pump was tested, along with a newly designed extracorporeal membrane oxygenator console, at three different flow ranges: (a) 0.0 to 5.2 L/min, (b) 0.0 to 7.1 L/min, and (c) 0.0 to 6.0 L/min. For each setup, the animals were supported by a circuit for 6 h. Blood samples were collected just before caridiopulmonary bypass (CPB) after 10 min on bypass and after 1, 2, 5, and 6 h of perfusion for hemolysis determination and biochemical tests. Values were recorded for blood pressure, mean flow, and pump rotational speed. Analysis of variance was used for repeated measurements. Results: Mean pump flows achieved during the three 6 h pump runs for the three pump heads studied were as follows: (a) flow range 0.0 to 5.2 L/min, 3.6 ± 1.5 L/min, (b) flow range 0.0 to 7.1 L/min, 4.9 ± 1.3 L/min, and (c) flow range 0.0 to 6.0 L/min, 3.8 ± 1.5 L/min. Blood trauma, evaluated by plasma hemoglobin and lactate dehydrogenase levels, did not help in detecting any significant hemolysis. Thrombocytes and white blood cell count profiles showed no significant differences between the groups at the end of the 6 h perfusion. At the end of testing, no clot deposition was found in the oxygenator, and there was no evidence of peripheral emboli. Conclusion: The results suggest that the newly developed magnetically suspended centrifugal pump head provides satisfactory hydrodynamic performance in an acute perfusion scenario without increasing hemolysis.

N/A

Patients undergoing staged percutaneous coronary intervention (SPCI) are exposed to extended duration of antiplatelet therapy, and a novel aspirin-free antiplatelet regimen after SPCI should be specifically evaluated among these patients. This is a prespecified substudy of the GLOBAL LEADERS which is a randomized, open-label trial, comparing an experimental regimen of 1-month dual antiplatelet therapy (DAPT; ticagrelor and aspirin) followed by 23-month ticagrelor monotherapy to a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy. Patients were stratified according to whether or not SPCI was performed. The impact of the timing of SPCI on clinical outcomes was also investigated. Of 15,968 randomized patients, 1,651 patients underwent SPCI within 3 months. These patients with SPCI had a significantly higher risk of bleeding and ischemic endpoints than those without SPCI. In patients undergoing SPCI, the primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5) were similar in the 2 regimens. However, in patients presenting with acute coronary syndrome (ACS), the experimental regimen reduced a risk of BARC 3 or 5 bleeding (1.8% vs 4.5%; HR 0.387; 95% CI 0.179 to 0.836; p = 0.016). In patients undergoing SPCI later than 10 days after index procedure, this risk reduction was still prominent (0.8% vs 2.3%; HR 0.321; 95% CI 0.116 to 0.891; p = 0.029). In conclusion, patients undergoing SPCI are at high risk and may need special attention from clinicians. In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.

Background Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy. Methods Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years. Results Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (Pinteraction = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13–0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26–0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction. Conclusions Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed. Clinical Trial Registration: ClinicalTrials.gov ( NCT01813435 ).

Background His bundle pacing (HBP) is an alternative to biventricular pacing (BVP) for delivering cardiac resynchronisation therapy (CRT) in patients with heart failure and left bundle branch block (LBBB). It is not known whether ventricular activation times and patterns achieved by HBP are equivalent to intact conduction systems and not all patients with LBBB are resynchronised by HBP. Objective To compare activation times and patterns of His-CRT with BVP-CRT, LBBB and intact conduction systems. Methods In patients with LBBB, non-invasive epicardial mapping (ECGI) was performed during BVP and temporary HBP. Intrinsic activation was mapped in all subjects. Left ventricular activation times (LVAT) were measured and epicardial propagation mapping (EPM) was performed, to visualise epicardial wavefronts. Normal activation pattern and a normal LVAT range were determined from normal subjects. Results 45 patients were included, 24 with LBBB and LV impairment and 21 with normal 12-lead ECG and LV function. In 87.5% of patients with LBBB, His-CRT successfully shortened LVAT by ≥10ms. In 33.3%, His-CRT resulted in complete ventricular resynchronisation, with activation times and patterns indistinguishable from normal subjects. EPM identified propagation discontinuity artifacts in 83% of patients with LBBB. This was the best predictor of whether successful resynchronisation was achieved by HBP (logarithmic odds ratio (logOR) 2.19, 95% CI 0.07 to 4.31, p=0.04). Conclusion Non-invasive electrocardiographic mapping appears to identify patients whose LBBB can be resynchronized by HBP. In contrast to BVP, His-CRT may deliver the maximum potential ventricular resynchronization, returning activation times and patterns to those seen in normal hearts. This article is protected by copyright. All rights reserved.

OBJECTIVES To compare the predictive performances of the prewiring, postwiring MI-SYNTAX scores, prewiring, and postwiring Updated Logistic Clinical SYNTAX score (LCSS) for 2-year all-cause mortality post percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients. BACKGROUND In patients with STEMI and undergoing primary PCI, coronary stenosis(es) distal to the culprit lesion is often observed after the restoration of coronary flow. To address comprehensively the complex coronary anatomy in these patients, prewiring and postwiring MI-SYNTAX scores have been reported in the literature. Furthermore, to enable individualized risk estimation for long-term all-cause mortality, the Updated LCSS has been developed by combining the anatomical SYNTAX score and clinical factors. METHODS In the randomized GLOBAL LEADERS trial, anatomical SYNTAX score analysis was performed by an independent angiographic corelab for the first 4,000 consecutive patients as a prespecified analysis; of these, 545 presented with STEMI. The efficacy of the mortality predictions of the four scores at 2���years were evaluated based on their discrimination and calibration abilities. RESULTS Complete data was available in 512 patients (93.9%). When the patients were stratified into two groups based on the median of the scores, the prewiring and postwiring Updated LCSSs demonstrated that the high-score groups were associated with higher rates of 2-year all-cause mortality compared to the low-score groups (6.6 vs. 1.2%; log-rank p��=��.001 and 6.6 vs. 1.2%; log-rank p��=��.001, respectively). There were no statistically significant differences for predicting the mortality between the prewiring (area under the curve [AUC] 0.625), postwiring MI-SYNTAX score (AUC 0.614), prewiring (AUC 0.755), and postwiring Updated LCSS (AUC 0.757). In the integrated discrimination improvement (IDI), the prewiring MI-SYNTAX score had a better discrimination for the mortality than the postwiring MI-SYNTAX score (IDI -0.0082; p��=��.029). The four scores had acceptable calibration abilities for 2-year all-cause mortality. CONCLUSIONS The prewiring Updated LCSS predicts long-term all-cause mortality with clearly useful discrimination and acceptable calibration. Since the postwiring MI-SYNTAX score does not improve mortality prediction, the prewiring MI-SYNTAX score may be preferred for the 2-year mortality prediction using the Updated LCSS.

Background: The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI).Methods: The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a timevarying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status.Results: 12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p 9.0 g/dl (HR 4.01; p-interaction 9.0g/dl. This suggests possible harm of transfusion in those groups. (C) 2020 Elsevier B.V. All rights reserved.

Aims The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). Methods and results Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only. Conclusions Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.

The aim of this study was to evaluate the prognostic impact of target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA) after stent failure.Although drug-eluting stents are safe and effective for treatment of the ULMCA, increased rates of repeat revascularization have been observed.This is a patient-level pooled analysis of the randomized ISAR-LEFT-MAIN (Drug-Eluting-Stents for Unprotected Left Main Stem Disease) and ISAR-LEFT-MAIN-2 (Drug-Eluting Stents to Treat Unprotected Coronary Left Main Disease) trials, in which patients underwent stenting of the ULMCA. The present analysis includes patients who underwent angiography during follow-up. Patients with TLR were compared with those without. Additional long-term clinical follow-up after TLR was conducted, and its influence on mortality was evaluated. Mortality was calculated using the Kaplan-Meier method. Predictors of mortality were assessed in a multivariate analysis.A total of 1,001 patients were eligible, of whom 166 experienced TLR. The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p 0.001). In the multivariate analysis, glomerular filtration rate (-30 ml/min; hazard ratio [HR]: 2.25; 95% confidence interval [CI]: 1.54 to 3.27; p 0.001), chronic obstructive pulmonary disease (HR: 4.95; 95% CI: 1.33 to 18.42; p = 0.02), and body mass index (+5 kg/mMortality after TLR for left main stent failure is high. Patient-related factors seem to have a greater impact on mortality after TLR than other variables.

OBJECTIVES Transcatheter aortic root repair (TARR) consists of the simultaneous endovascular replacement of the aortic valve, the root and the proximal ascending aorta. The aim of the study is to set-up a computational model of TARR to explore the impact of the endovascular procedure on the coronary circulation supported by chimney grafts. METHODS Computed tomography of a patient with dilated ascending aorta was segmented to obtain a 3-dimensional representation of the proximal thoracic aorta, including aortic root and supra-aortic branches. Computed assisted design tools were used to modify the geometry to create the post-procedural TARR configuration featuring the main aortic endograft integrated with 2 chimney grafts for coronary circulation. Computational Fluid Dynamics simulations were run in both pre- and post-procedural configurations using a pulsatile inflow and lumped parameter models at the outflows to simulate peripheral aortic and coronary circulation. Differences in coronary flow and pressure along the cardiac cycle were evaluated. RESULTS After the virtual implant of the TARR device with coronary grafts, the flow became more organized and less recirculation was seen in the ascending aorta. Coronary perfusion was guaranteed with negligible flow differences between pre- and post-procedural configurations. However, despite being well perfused by chimney grafts, the procedure induces an increase of the pressure drop between the coronary ostia and the ascending aorta of 8 mmHg. CONCLUSIONS The proposed numerical simulations, in the specific case under investigation, suggest that the TARR technique maintains coronary perfusion through the chimney grafts. This study calls for experimental validation and further analyses of the impact of TARR on cardiac afterload, decrease of aortic compliance and local pressure drop induced by the coronary chimney grafts.

Background: Endocardial pacing may be beneficial in patients who fail to improve following conventional epicardial cardiac resynchronization therapy (CRT). The potential to pace anywhere inside the left ventricle thus avoiding myocardial scar and targeting the latest activating segments may be particularly important. The WiSE-CRT system (EBR systems, Sunnyvale, CA) reliably produces wireless, endocardial left ventricular (LV) pacing. The purpose of this analysis was to determine whether this system improved symptoms or led to LV remodeling in patients who were nonresponders to conventional CRT. Method: An international, multicenter registry of patients who were nonresponders to conventional CRT and underwent implantation with the WiSE-CRT system was collected. Results: Twenty-two patients were included; 20 patients underwent successful implantation with confirmation of endocardial biventricular pacing and in 2 patients, there was a failure of electrode capture. Eighteen patients proceeded to 6-month follow-up; endocardial pacing resulted in a significant reduction in QRS duration compared with intrinsic QRS duration (26.6 ± 24.4 ms; P =.002) and improvement in left ventricular ejection fraction (LVEF) (4.7 ± 7.9%; P =.021). The mean reduction in left ventricular end-diastolic volume was 8.3 ± 42.3 cm3 (P =.458) and left ventricular end-systolic volume (LVESV) was 13.1 ± 44.3 cm3 (P =.271), which were statistically nonsignificant. Overall, 55.6% of patients had improvement in their clinical composite score and 66.7% had a reduction in LVESV ≥15% and/or absolute improvement in LVEF ≥5%. Conclusion: Nonresponders to conventional CRT have few remaining treatment options. We have shown in this high-risk patient group that the WiSE-CRT system results in improvement in their clinical composite scores and leads to LV remodeling.

AIMS The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined consensus-based criteria for patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). We aimed to validate the ARC-HBR criteria for the bleeding outcomes using a large cohort of patients undergoing PCI. METHODS AND RESULTS Between 2009 and 2016, patients undergoing PCI were prospectively included in the Bern PCI Registry. Patients were considered to be at HBR if at least one major criterion or two minor criteria were met. The primary endpoint was Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at one year; ischaemic outcomes were assessed using the device-oriented composite endpoints (DOCE) of cardiac death, target vessel myocardial infarction, and target lesion revascularisation. Among 12,121 patients, those at HBR (n=4,781, 39.4%) had an increased risk of BARC 3 or 5 bleeding (6.4% vs 1.9%; p

The detailed anatomy of the interatrial septum (IAS) and mitral annulus (MA) as observed on cardiac magnetic resonance, computed tomography and two-dimensional/three-dimensional transthoracic and transesophageal echocardiography is reviewed. The IAS comprises of two components: the septum primum that is membrane-like forming the floor of the fossa ovalis (FO) and the septum secundum that is a muscular rim that surrounds the FO. The latter is an enfolding of atrial wall forming an interatrial groove. Named Waterston’s groove, it is filled with adipose tissue on the epicardial side. Thus, the safest area for transseptal puncture (TSP) is within the limits of the FO floor, which provides direct interatrial access. While crossing an intact septum is a well-established procedure, TSP is a more complex and time-consuming procedure in the presence of patent foramen ovalis, aneurysmal FO or atrial septal defect closure devices. MA comprises two distinctive segments: an anterior-straight and a posterior-curved segment. The posterior MA is a thin, discontinuous fibrous ‘string’, interspersed with adipose tissue, where four components converge: the atrial and ventricular musculature, epicardial adipose tissue and the leaflet’s hinge line. In parts of where this fibrous string is deficient or absent, the posterior leaflet is inserted directly on ventricular and atrial myocardium rendering the MA less robust and producing an ‘asymmetric’ dilation. The marked vulnerability of posterior MA to calcifications might be due to its insertion on the crest of ventricular myocardium being subject to friction injury due to the contraction and relaxation of LV.