Left atrial strain analysis in the realm of pediatric cardiology: Advantages and implications.

BACKGROUND: Left atrial (LA) strain analysis has emerged as a noninvasive technique for assessing LA function and early detection of myocardial deformation. Recently, its application has also shown promise in the pediatric population, spanning diverse cardiac conditions that demand accurate and sensitive diagnostic measures. OBJECTIVE: This research endeavors to explore the role of LA strain parameters and contribute to the growing body of knowledge in pediatric cardiology, paving the way for more effective and tailored approaches to patient care. METHODS: A comprehensive literature review was conducted to gather evidence from studies using echocardiographic strain imaging techniques across pediatric populations. RESULTS: LA strain parameters exhibited greater sensitivity than conventional atrial function indicators, with early detection of diastolic dysfunction and LA remodeling in pediatric cardiomyopathy, children with multisystem inflammatory syndrome, rheumatic heart disease, as well as childhood renal insufficiency and obesity offering prognostic relevance as potential markers in these pediatric subpopulations. However, there remains a paucity of evidence concerning pediatric mitral valve pathology, justifying further exploration. CONCLUSION: LA strain analysis carries crucial clinical and prognostic implications in pediatric cardiac conditions, with reliable accuracy and sensitivity to early functional changes.

Rest and Stress Left Atrial Dysfunction in Patients with Atrial Fibrillation.

BACKGROUND: Left atrial (LA) myopathy with paroxysmal and permanent atrial fibrillation (AF) is frequent in chronic coronary syndromes (CCS) but sometimes occult at rest and elicited by stress. AIM: This study sought to assess LA volume and function at rest and during stress across the spectrum of AF. METHODS: In a prospective, multicenter, observational study design, we enrolled 3042 patients [age = 64 ± 12; 63.8% male] with known or suspected CCS: 2749 were in sinus rhythm (SR, Group 1); 191 in SR with a history of paroxysmal AF (Group 2); and 102 were in permanent AF (Group 3). All patients underwent stress echocardiography (SE). We measured left atrial volume index (LAVI) in all patients and LA Strain reservoir phase (LASr) in a subset of 486 patients. RESULTS: LAVI increased from Group 1 to 3, both at rest (Group 1 = 27.6 ± 12.2, Group 2 = 31.6 ± 12.9, Group 3 = 43.3 ± 19.7 mL/m2, p < 0.001) and at peak stress (Group 1 = 26.2 ± 12.0, Group 2 = 31.2 ± 12.2, Group 3 = 43.9 ± 19.4 mL/m2, p < 0.001). LASr progressively decreased from Group 1 to 3, both at rest (Group 1 = 26.0 ± 8.5%, Group 2 = 23.2 ± 11.2%, Group 3 = 8.5 ± 6.5%, p < 0.001) and at peak stress (Group 1 = 26.9 ± 10.1, Group 2 = 23.8 ± 11.0 Group 3 = 10.7 ± 8.1%, p < 0.001). Stress B-lines (≥2) were more frequent in AF (Group 1 = 29.7% vs. Group 2 = 35.5% vs. Group 3 = 57.4%, p < 0.001). Inducible ischemia was less frequent in SR (Group 1 = 16.1% vs. Group 2 = 24.7% vs. Group 3 = 24.5%, p = 0.001). CONCLUSIONS: In CCS, rest and stress LA dilation and reservoir dysfunction are often present in paroxysmal and, more so, in permanent AF and are associated with more frequent inducible ischemia and pulmonary congestion during stress.

Sodium-glucose cotransporter-2 inhibitors: a swinging pendulum in the treatment of acute myocardial infarction.

INTRODUCTION: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are integral in treating patients with heart failure, regardless of the existence of diabetes mellitus. In light of their benefits on the heart muscle, the question of their effect on acute coronary syndrome is raised, and a hypothesis as to whether they can be implemented in its treatment is proposed. The aim of the article was to indicate the potential of using SGLT2 inhibitors in the treatment of myocardial infarction (MI). EVIDENCE ACQUISITION: A PubMed search for articles published between October 2017 and May 2022 was conducted using the following keywords: "SGLT2 inhibitors," "Acute Coronary Syndrome," "Treatment," "Prognosis." Reference lists of identified articles were searched for further articles. EVIDENCE SYNTHESIS: Reports from clinical trials and animal studies thus far investigating mechanistic pathways of SGLT2 inhibitors' effect in relation to acute myocardial infarction were interplayed to extract relevant findings and analyze the safety of this therapy in acute coronary syndrome (ACS) patients. CONCLUSIONS: SGLT2 inhibitors indicate beneficial effects in acute cardiovascular incident by various mechanisms, and early initiation of therapy may improve outcomes for AMI survivors.

Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events.

In modern cardiology, sodium-glucose cotransporter 2 (SGLT2) inhibitors are critical components of heart failure (HF) treatment algorithms and exert their effects primarily by preventing glucose reabsorption and facilitating its urinary excretion. The objective was to systematically review randomized controlled trials (RCTs) assessing the effects of SGLT2 inhibitors, particularly canagliflozin, empagliflozin, dapagliflozin, ertugliflozin, sotagliflozin (dual SGLT inhibitor), and their use in HF. Systematic searches of PubMed/Medline, The Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases were performed. There were no restrictions imposed on the date and status of publication; however, there were restrictions on language for the searched studies. A total of 1139 records were identified in the bibliographic searches from both databases and the register of choice for this systematic review. Following duplicate removal, screening for titles and abstracts, and thorough assessment of full-text articles, 12 RCTs met the inclusion criteria. Altogether, 83 878 patients were included in this review. Among the included studies, two RCTs, with six respective reports, investigated canagliflozin, four RCTs with 13 derived reports investigated dapagliflozin, three RCTs with 12 separate reports studied the effects of empagliflozin, one RCT and its three respective reports assessed ertugliflozin's effects, and two RCTs with one added report investigated the dual inhibitor sotagliflozin. Pooled meta-analytic effects of SGLT2 inhibitors were as follows: on atrial fibrillation odds ratio (OR) = 0.83, 95% confidence interval (CI): 0.68-1.01, prediction interval (PI): 0.57-1.19; on HF hospitalization OR = 0.69, 95% CI: 0.60-0.78, PI: 0.60-0.78; on cardiovascular death OR = 0.82, 95% CI: 0.58-1.15, PI: 0.42-1.60; and on major adverse cardiovascular events OR = 0.90, 95% CI: 0.77-1.06, PI: 0.71-1.15. SGLT2 inhibitors significantly improve the quality of life in HF patients. Their beneficial effects on HF, especially in left ventricular dysfunction, have made their use possible irrespective of diabetes mellitus or atrial fibrillation status.

Heat-not-burn tobacco products and cardiovascular risk reduction: A systematic review of randomized controlled trials.

BACKGROUND: Heat-not-burn (HNB) technology by the U.S. Food and Drug Administration has been classified as a modified risk tobacco product, which can be a better option for those populations who cannot give up the habit of smoking. The outlook on the effects of these products is quite controversial in the scientific world. OBJECTIVE: To present the effect of HNB tobacco products on the cardiovascular system, with reference to the existence of possible benefits of the technology. METHODS: The literature search was conducted in PubMed/Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases, with reliance on a well-defined guiding research statement. Quality appraisal was performed using the CASP checklist for randomized controlled trials. RESULTS: The search of three databases identified 167 records, and after selection process, 25 randomized controlled trials were eligible for our study's criteria. Twenty studies investigated the effects of HNB products on biomarkers of clinical relevance. Five studies evaluated other functional heart parameters rather than biomarkers. CONCLUSION: With HNB tobacco products, significant reductions were found in biomarkers of exposure and biological effect related to pathways involved in cardiovascular disease, including inflammation, oxidative stress, lipid metabolism, platelet function, and endothelial dysfunction.

Correction: Cardiovascular Risk Factors and Clinical Outcomes among Patients Hospitalized with COVID-19: Findings from the World Heart Federation COVID-19 Study.

[This corrects the article DOI: 10.5334/gh.1128.].

Pericardial Effusion in Postcoronavirus Disease Patients with Preserved Ejection Fraction of the Left Ventricle and Normal Values of N-Terminal-Pro B-Type Natriuretic Peptide-Link with C-Reactive Protein and D-Dimer.

Aim: The aim of this study was to link the values of D-dimer and C-reactive protein (CRP), with the occurrence of pericardial effusion in patients who had coronavirus disease 2019 (COVID-19) and have preserved systolic function of the left ventricle (LV). Methods: This was a prospective study and included 146 patients who underwent echocardiographic examination 30 days after the acute phase of COVID-19. Patients who were placed on mechanical ventilation, patients who had pulmonary thromboembolism or acute coronary syndrome during the acute period of the disease, patients who had an ejection fraction of the LV <50%, patients who were diagnosed with pericarditis during acute illness or clinical signs of heart failure (or had elevated N-terminal-pro hormone B-type natriuretic peptide value), with verified renal or hepatic dysfunction were excluded from the study, including patients with diabetes mellitus Type 1, patients with cancer, connective tissue disease, or pregnant women. The existence of cardiovascular risk factors (hypertension, diabetes mellitus Type 2, and hyperlipidemia), the presence of previous ischemic heart disease, maximum values of D-dimer, and CRP (during the first 15 days of the disease) was taken into the analysis. Results: Effusion was verified around the right atrium (RA) in 104 patients (3.85 ± 1.75 mm), in 135 patients next to the free wall of the right ventricle (RV) (5.24 ± 2.29 mm), in front of the apex of the LV in 27 patients (2.44 ± 0.97 mm), next to the lateral wall of LV in 35 patients (4.43 ± 3.21 mm), and behind the posterior wall of LV in 30 patients (2.83 ± 1.62 mm). Mean CRP values during the acute phase of the disease were 43.0 mg/L (8.6-76.2 mg/L), whereas D-dimer mean value was 880.00 µg/L (467.00 -2000.00 µg/L). CRP values correlated with effusion next to the free wall of RV (rho = 0.202; P = 0.018). The D dimer correlated with effusion around RA (rho = 0.308; P = 0.0001). Conclusion: The clinical picture of the post-COVID patients could be explained by the appearance of pericardial effusion. D-dimer value correlates with the occurrence of effusion around RA, whereas CRP value correlates with effusion next to the free wall of RV.

Cardiovascular Risk Factors and Clinical Outcomes among Patients Hospitalized with COVID-19: Findings from the World Heart Federation COVID-19 Study.

Background and aims: Limited data exist on the cardiovascular manifestations and risk factors in people hospitalized with COVID-19 from low- and middle-income countries. This study aims to describe cardiovascular risk factors, clinical manifestations, and outcomes among patients hospitalized with COVID-19 in low, lower-middle, upper-middle- and high-income countries (LIC, LMIC, UMIC, HIC). Methods: Through a prospective cohort study, data on demographics and pre-existing conditions at hospital admission, clinical outcomes at hospital discharge (death, major adverse cardiovascular events (MACE), renal failure, neurological events, and pulmonary outcomes), 30-day vital status, and re-hospitalization were collected. Descriptive analyses and multivariable log-binomial regression models, adjusted for age, sex, ethnicity/income groups, and clinical characteristics, were performed. Results: Forty hospitals from 23 countries recruited 5,313 patients with COVID-19 (LIC = 7.1%, LMIC = 47.5%, UMIC = 19.6%, HIC = 25.7%). Mean age was 57.0 (±16.1) years, male 59.4%, pre-existing conditions included: hypertension 47.3%, diabetes 32.0%, coronary heart disease 10.9%, and heart failure 5.5%. The most frequently reported cardiovascular discharge diagnoses were cardiac arrest (5.5%), acute heart failure (3.8%), and myocardial infarction (1.6%). The rate of in-hospital deaths was 12.9% (N = 683), and post-discharge 30 days deaths was 2.6% (N = 118) (overall death rate 15.1%). The most common causes of death were respiratory failure (39.3%) and sudden cardiac death (20.0%). The predictors of overall mortality included older age (≥60 years), male sex, pre-existing coronary heart disease, renal disease, diabetes, ICU admission, oxygen therapy, and higher respiratory rates (p < 0.001 for each). Compared to Caucasians, Asians, Blacks, and Hispanics had almost 2-4 times higher risk of death. Further, patients from LIC, LMIC, UMIC versus. HIC had 2-3 times increased risk of death. Conclusions: The LIC, LMIC, and UMIC's have sparse data on COVID-19. We provide robust evidence on COVID-19 outcomes in these countries. This study can help guide future health care planning for the pandemic globally.

The Influence of Different Risk Factors on COVID-19 Outcomes in Adult Patients - An Observational-Descriptive Study.

OBJECTIVE: The aim of our study was to investigate the predictors of morbidity (age, gender, smoking habits, obesity and the presence of chronic diseases) and COVID-19 outcomes. SUBJECTS AND METHODS: The research was an observational descriptive study, conducted at The Family Medicine Education Center, The Primary Health Care Center, Banja Luka, in the period from 26th June to 31st December 2020. During the research period, seven family medicine teams followed their patients with COVID- 19, and recorded possible predictors for morbidity and their influence on the disease outcome. RESULTS: The study included 934 patients, 46.90% of whom were male. The majority of subjects were non-smokers and overweight. Diabetes was found in 5.57% patients, hypertension in 29.44%, chronic respiratory diseases in 5.25%, cancer in 4.39% patients. In the observed sample, 29.23% subjects contracted pneumonia, 18.52% were hospitalized, while 19 (2.03%) patients with severe clinical features had a fatal outcome. Multivariable regression analysis showed a high risk of pneumonia in male patients [OR=2.45, 95% CI (1.73- 3.46)], elderly [OR=1.07, 95% CI (1.06-1.09)] and obese patients with Body Mass Index ≥30.0 kg/m2 [OR=2.55, 95% CI (1.73- 3.77)]. Male gender [OR=2.19, 95% CI (1.11-4.31)], older age [OR=1.08, 95% CI (1.05-1.11)] and hypertension [OR=2.51, 95% CI (1.06-5.91)] were the most important predictors for the development of severe clinical features in COVID 19. The statistically significant predictors of mortality were male gender [OR=7.16, 95% CI (1.56-32.86)] and older age [OR=1.12, 95% CI (1.06-1.18]. CONCLUSION: Being familiar with the predictors of morbidity and poor outcome in COVID-19 is helpful for carrying out preventive measures, early diagnosis and treatment of risk groups of patients.

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial.

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.

ApPropRiateness of myOcardial revascUlarization assessed by SYNTAX Scores in patients with type 2 diabetes melliTus: the PROUST study.

INTRODUCTION: Results of currently available trials have shown divergent outcomes in diabetic patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Current guidelines do not recommend PCI in patients with diabetes and a SYNTAX score ≥ 23. AIM: To compare all-cause 4-year mortality after revascularization for complex coronary artery disease (CAD) in diabetics. MATERIAL AND METHODS: The study group comprised consecutive patients with three-vessel CAD and/or unprotected left main CAD (≥ 50% diameter stenosis) without major hemodynamic instability, who were treated in two institutions with PCI or referred for CABG. RESULTS: Out of 342 diabetics, 177 patients underwent PCI and 165 patients were referred for CABG. The incidence of all-cause death was different between diabetics treated with PCI or CABG at 4 years (16/177, 9.0% vs. 26/165, 15.8%, respectively, p = 0.03). The difference was not evident in non-diabetics (PCI: 41/450, 9.1% vs. CABG: 19/249, 7.6%, p = 0.173). In diabetics, there was a higher incidence of all-cause mortality in PCI patients with intermediate-high (≥ 23) SYNTAX scores compared with those with low (0-22) SYNTAX scores (10/56, 17.9% vs. 6/121, 5.0%, respectively, p < 0.01). On the other hand, diabetics who underwent CABG showed similar mortality rates irrespective of the SYNTAX scores (SYNTAX 0-22: 3/29, 10.3%; SYNTAX ≥ 23: 23/136, 11.9%, p = 0.46). In the subgroup analysis, there was no interaction according to presence or absence of left main CAD (p for interaction = 0.12) as well as according to diabetes status (p for interaction = 0.38), whereas gender and SYNTAX scores were differentiators between PCI and CABG with a p for interaction < 0.1. CONCLUSIONS: Our analysis supports recent evidence that diabetes is not a differentiator between PCI and CABG.

Screening of undiagnosed depression among elderly primary care patients: a cross-sectional study from the Republic of Srpska, Bosnia and Herzegovina.

Aim To examine the prevalence of undiagnosed depression among primary care elderly patients in the entity of the Republic of Srpska (Bosnia and Herzegovina) as well as the sociodemographic and clinical risk factors associated with depression. Methods A cross-sectional study was conducted between April and June 2019 in nine towns of the Republic of Srpska. The study sample included 1,198 primary care patients older than 65 years of age. Research instruments included a sociodemographic questionnaire and Geriatric Depression Scale - Short Form (GDS-SF). Results Positive screening test (GDS-SF score > 5), which indicates depression was found in 484 (40.4%) participants. Multivariate regression analysis showed that lower education levels [OR = 1.565, 95% CI (1.13-2.17)], divorced and widowed [OR = 1.366, 95% CI (1.16-1.62)], poor financial situation [OR = 1.690 , 95% CI (1.25-2.29)], non-home residents [OR = 2.200, 95% CI (1.41- 3.44)], non-hobby patients [OR = 2.115, 95% CI (1.54-2.91) ], non-friends [OR = 3.881, 95% CI (2.70-5.57)], patients suffering from chronic pain [OR = 2.414, 95% CI (1.72-3.39)], patients with daily life limitation activities [OR = 1.415, 95% CI (1.03-1.95)], patients with three or more chronic diseases [OR = 1.593, 95% CI (1.12-2.27)], patients using five or more drugs [OR = 1.425. 95% CI (1.00-2.03)], and patients with history of previous depression [OR = 2.858, 95% CI (1.94-4.21)] were at higher risk for depression. Conclusion The prevalence of undiagnosed depression in the elderly in Republic of Srpska is high. Future strategies are needed to strengthen screening of geriatric depression in primary health care.

The Presence of Stress, Burnout Syndrome and the Most Important Causes of Working Stress Among Physicians in Primary Health Care - an Observational Study from Banja Luka, Bosnia and Herzegovina.

OBJECTIVE: To investigate the level and causes of stress and the risk of onset of burnout syndrome among physicians employed at the Primary Health Care Centre, Banja Luka. SUBJECTS AND METHODS: Between March 1, 2018, and May 31, 2018 all physicians from the Primary Health Care Centre, Banja Luka were offered the following questionnaires to fill in: a socio-demographic questionnaire, a questionnaire for self-assessment of the level of stress and the Maslach Burnout Inventory for assessment of the risk of burnout syndrome. RESULTS: Out of 211 physicians, 85.8% were female. A high level of stress was found in 77.7% of the subjects. Older doctors had higher levels of emotional exhaustion compared to younger doctors with a shorter length of service (r=0.236, P=0.01). Emotional exhaustion was significantly correlated with a high level of depersonalization, a low level of personal accomplishment and a high level of stress (r=0.380, r=-0.174 and r=0.574, P=0.01, P=0.04 and P<0.01, respectively). Depersonalization correlated with a low level of personal accomplishment and stress (r=-0.347 and r=0.283, P<0.01 and P=0.01, respectively), while the level of personal accomplishment was in a negative correlation with stress (r=-0.281, P=0.01). A high stress level was associated with a high degree of emotional exhaustion (OR 56.543; 95% CI 11.35-213.09; P<0.001) as well as lack of personal accomplishment (OR 0.155; 95% CI 0.04-0.50; P=0.003). CONCLUSION: A high level of stress was associated with older age, female gender, as well as with a high degree of emotional exhaustion and a lack of personal accomplishment. Preventive measures are warranted.

Early, late and very late incidence of bioresorbable scaffold thrombosis: a systematic review and meta-analysis of randomized clinical trials and observational studies.

INTRODUCTION: The aim of this paper was to determine the incidence of bioresorbable vascular scaffold thrombosis. EVIDENCE ACQUISITION: A systematic review of the published literature between October 2012 and August 2016 was performed using PubMed, Medline and Embase databases. Articles published in the English language that reported the rate of bioresorbable scaffold thrombosis according to Academic Research Consortium criteria were included. Titles and abstracts were screened independently by two authors and further evaluated and assessed for study details, population characteristics and scaffold thrombosis rates. Scaffold thrombosis rates were pooled with meta-analysis using a random effect model. Meta-regression was performed to explore the predictors of device thrombosis. Randomized clinical trials (RCT), observational registries and case series of patients with obstructive coronary artery disease treated with the ABSORB bioresorbable scaffolds (BVS) that reported the rate of definite or probable scaffold thrombosis and the time of the event after implantation (i.e., acute, sub-acute, late and very late) were selected. EVIDENCE SYNTHESIS: Overall, 16,830 patients treated with ABSORB BVS in 59 studies were included. A total of 256 definite or probable scaffold thrombosis (ScT) were identified and included in the present analysis. The overall rate of definite or probable ScT was 1.8% (CI 95% 1.5% to 2.0%) the median follow-up was 12.0 months (interquartile range 7.5 to 15). The rate of very late definite or probable ScT was 1.0% (95% CI 0.6% to 1.5%; 10 studies, 2331 patients). A higher rate of definite and probable scaffold thrombosis was found in studies with patients presenting with acute myocardial infarction (3.6% vs. 1.8%, Q=13.9, df=1, P=0.010). In the meta-regression analysis, the residual per cent diameter stenosis was the only factor associated with ST after scaffold implantation (coefficient 0.091, 95% CI -0.0009 to 0.183, P=0.052). CONCLUSIONS: Using the largest available dataset of patients treated in randomized trials and observational registries, the present meta-analysis shows that the overall rate of definite or probable ScT is 1.8%, with a rate of very late ST of 1.0%. Residual stenosis after scaffold implantation was associated with the occurrence of scaffold thrombosis.

ApPropriateness of myocaRdial RevascularizatiOn assessed by the SYNTAX score II in a coUntry without cardiac Surgery faciliTies; PROUST study.

BACKGROUND/OBJECTIVES: The SYNTAX Score II (SSII) was proposed as a novel approach for objective individualized decision-making for optimal myocardial revascularization i.e. percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. We sought to investigate how many lives may be saved by SSII use. METHODS: A total number of 651 consecutive SSII-naive-patients with complex coronary artery disease who were treated with PCI (n=409) or referred to other institutions for CABG (n=242) were included. All-cause mortality was ascertained in 96% of patients. The SSII was calculated for each patient. RESULTS: Based on the SSII treatment recommendation, CABG would have been the treatment of choice in 257/651 (39.5%) patients, PCI in 7/651 (1.1%) patients and CABG or PCI in 387/651 (59.4%) patients. Out of 257 patients in whom the treatment recommendation by SSII was CABG, 113/257 (44.0%) patients had actually CABG, while the remaining 144/257 (56.0%) underwent PCI. It was shown that 144/257 patients with treatment recommendations in favour of CABG who were treated with PCI had significantly higher mortality at 4years when compared with patients with SSII treatment recommendation for PCI or equally favouring CABG and PCI (12.5% vs. 0.0% vs. 6.9%, respectively, P=0.04). CONCLUSION: The intuitive decision-making for choosing the optimal myocardial revascularization method differed predominantly from the SSII recommendation for CABG. The discordance between the SSII recommended revascularization strategy and the clinical decision was associated with a higher 4-year mortality i.e. one life may be saved if SSII would be calculated and followed consequently in 18 patients.

Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease.

AIMS: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. METHODS AND RESULTS: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. CONCLUSIONS: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena.

Risk stratification in 3-vessel coronary artery disease: Applying the SYNTAX Score II in the Heart Team Discussion of the SYNTAX II trial.

BACKGROUND: Heart Team (HT) and the SYNTAX Score II (SSII) have been integrated to the contemporary guidelines with the aim to provide a multidisciplinary decision-making process between coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). AIMS: To prospectively assess the agreement between the HT decision and the SSII recommendation regarding the revascularization strategy in patients with 3-vessel coronary artery disease (CAD) of the SYNTAX II trial. METHODS: The SSII predicts the 4-year mortality of an individual patient both after PCI and after CABG. Patients were treated by PCI when the SSII predicted a mortality risk favoring PCI or when risk predictions were equipoise between PCI and CABG. However, the HT could overrule the SSII and recommend either CABG or PCI. RESULTS: A total of 202 patients have been screened and 24 did not fulfill inclusion criteria. The median age was 67.0 (IQR 59.0-73.3), and 167 (82.7%) were male. The HT endorsed SSII treatment recommendation, for CABG or PCI, in 152 patients (85.4%). Three patients had preference for PCI, irrespective of the HT decision. The main reason for the HT to overrule the SSII and recommend CABG was the prospect of a more complete revascularization (21 of 25 patients). Patients recommended for CABG by the HT had significantly higher anatomical SYNTAX score (P = 0.03) and higher predicted mortality risk for PCI (P = 0.04) when compared with patients that were enrolled in the trial. CONCLUSION: The SYNTAX score II showed to be a suitable tool for guiding treatment decisions of patients with 3-vessel coronary artery disease being endorsed by the HT in the vast majority of the patients that have been enrolled in the SYNTAX II trial.