Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Osteoprotegerin Is Essential for the Development of Endothelial Dysfunction Induced by Angiotensin II in Mice.

Opinions on the effects of osteoprotegerin (OPG) have evolved over the years from a protein protecting the vasculature from calcification to a cardiovascular risk factor contributing to inflammation within the vascular wall. Nowadays, the link between OPG and angiotensin II (Ang II) appears to be particularly important. In this study, the endothelial function was investigated in OPG-knockout mice (B6.129.S4-OPG, OPG-) and wild-type (C57BL/6J, OPG+) mice under basic conditions and after Ang II exposure by assessing the endothelium-dependent diastolic response of aortic rings to acetylcholine in vitro. A further aim of the study was to compare the effect of Ang II on the expression of cytokines in the aortic wall of both groups of mice. Our study shows that rings from OPG- mice had their normal endothelial function preserved after incubation with Ang II, whereas those from OPG+ mice showed significant endothelial dysfunction. We conclude that the absence of OPG, although associated with a pro-inflammatory cytokine profile in the vascular wall, simultaneously protects against Ang II-induced increases in pro-inflammatory cytokines in the murine vascular wall. Our study also demonstrates that the absence of OPG can result in a decrease in the concentration of pro-inflammatory cytokines in the vascular wall after Ang II exposure. The presence of OPG is therefore crucial for the development of Ang II-induced inflammation in the vascular wall and for the development of Ang II-induced endothelial dysfunction.

Implementation of Microcirculation Examination in Clinical Practice-Insights from the Nationwide POL-MKW Registry.

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.

Electromechanical factors associated with favourable outcome in cardiac resynchronization therapy.

AIMS: Electromechanical coupling in patients receiving cardiac resynchronization therapy (CRT) is not fully understood. Our aim was to determine the best combination of electrical and mechanical substrates associated with effective CRT. METHODS AND RESULTS: Sixty-two patients were prospectively enrolled from two centres. Patients underwent 12-lead electrocardiogram (ECG), cardiovascular magnetic resonance (CMR), echocardiography, and anatomo-electromechanical mapping (AEMM). Remodelling was measured as the end-systolic volume (ΔESV) decrease at 6 months. CRT was defined effective with ΔESV ≤ -15%. QRS duration (QRSd) was measured from ECG. Area strain was obtained from AEMM and used to derive systolic stretch index (SSI) and total left-ventricular mechanical time. Total left-ventricular activation time (TLVAT) and transeptal time (TST) were derived from AEMM and ECG. Scar was measured from CMR. Significant correlations were observed between ΔESV and TST [rho = 0.42; responder: 50 (20-58) vs. non-responder: 33 (8-44) ms], TLVAT [-0.68; 81 (73-97) vs. 112 (96-127) ms], scar [-0.27; 0.0 (0.0-1.2) vs. 8.7 (0.0-19.1)%], and SSI [0.41; 10.7 (7.1-16.8) vs. 4.2 (2.9-5.5)], but not QRSd [-0.13; 155 (140-176) vs. 167 (155-177) ms]. TLVAT and SSI were highly accurate in identifying CRT response [area under the curve (AUC) > 0.80], followed by scar (AUC > 0.70). Total left-ventricular activation time (odds ratio = 0.91), scar (0.94), and SSI (1.29) were independent factors associated with effective CRT. Subjects with SSI >7.9% and TLVAT <91 ms all responded to CRT with a median ΔESV ≈ -50%, while low SSI and prolonged TLVAT were more common in non-responders (ΔESV ≈ -5%). CONCLUSION: Electromechanical measurements are better associated with CRT response than conventional ECG variables. The absence of scar combined with high SSI and low TLVAT ensures effectiveness of CRT.

Revascularization in Ischemic Heart Failure with Reduced Left Ventricular Ejection Fraction.

PURPOSE OF REVIEW: Coronary artery disease (CAD) is estimated to account for over 60% of heart failure (HF) patients and is associated with worse outcomes than a non-ischemic etiology. In patients with ischemic HF, myocardial revascularization has multiple mechanisms of action based on the concept that blood flow restoration of viable but underperfused myocardium might reverse the hibernation of the left ventricle and prevent future spontaneous myocardial infarction, which could potentially improve patients' outcomes. Here, we aim to elaborate on indications, timing, type, and impact of completeness of revascularization in patients with heart failure with reduced ejection fraction (HFrEF) and ischemic etiology. RECENT FINDINGS: For decades, coronary artery bypass graft surgery has been the pilar of revascularization in patents with multivessel CAD and reduced EF. Recent development in the interventional field led to overall increase of percutaneous coronary intervention (PCI) adoption in treatment of ischemic HFrEF. However, recently published randomized study demonstrated no added benefit of PCI over optimal medical therapy in patients with severe ischemic cardiomyopathy challenging the beneficial role of revascularization in this setting. Since the decision on revascularization in ischemic cardiomyopathy frequently cannot be made based strictly on guidelines, tailored treatment strategy should be mandated with the essential role of multidisciplinary approach. These decisions should be based on capability to achieve complete revascularization, with the consideration that in certain situations it may not be accomplished.

Osteoprotegerin and RANKL-RANK-OPG-TRAIL signalling axis in heart failure and other cardiovascular diseases.

Osteoprotegerin (OPG) is a glycoprotein involved in the regulation of bone remodelling. OPG regulates osteoclast activity by blocking the interaction between the receptor activator of nuclear factor kappa B (RANK) and its ligand (RANKL). More and more studies confirm the relationship between OPG and cardiovascular diseases. Numerous studies have confirmed that a high plasma concentration of OPG and a low concentration of tumour necrosis factor-related apoptosis inducing ligand (TRAIL) together with a high OPG/TRAIL ratio are predictors of poor prognosis in patients with myocardial infarction. A high plasma OPG concentration and a high ratio of OPG/TRAIL in the acute myocardial infarction are a prognostic indicator of adverse left ventricular remodelling and of the development of heart failure. Ever more data indicates the participation of OPG in the regulation of the function of vascular endothelial cells and the initiation of the atherosclerotic process in the arteries. Additionally, it has been shown that TRAIL has a protective effect on blood vessels and exerts an anti-atherosclerotic effect. The mechanisms of action of both OPG and TRAIL within the cells of the vascular wall are complex and remain largely unclear. However, these mechanisms of action as well as their interaction in the local vascular environment are of great interest to researchers. This article presents the current state of knowledge on the mechanisms of action of OPG and TRAIL in the circulatory system and their role in cardiovascular diseases. Understanding these mechanisms may allow their use as a therapeutic target in cardiovascular diseases in the future.

Annual operator volume among patients treated using percutaneous coronary interventions with rotational atherectomy and procedural outcomes: Analysis based on a large national registry.

BACKGROUND: Low operator and institutional volume are associated with poorer procedural and long-term clinical outcomes in the general population of patients treated with percutaneous coronary interventions (PCI). AIM: To assess the relationship between operator experience and procedural outcomes of patients treated with PCI and rotational atherectomy (RA). METHODS: Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covers data from January 2014 to December 2020. RESULTS: During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed by 851 operators (377 RA operators [44.3%]). Of those, 5188 were PCI with RA procedures; average 30 ± 61 per site/7 years (Me: 3; Q1-Q3: 0-31); 6 ± 18 per operator/7 years (Me: 0; Q1-Q3: 0-3). Considering the number of RA procedures annually performed by individual operators during the analyzed 7 years, the first quartile totaled (Q1: < =2.57), the second (Q2: < =5.57), and the third (Q3: < =11.57), while the fourth quartile was (Q4: > 11.57). The maximum number of procedures was 39.86 annually per operator. We demonstrated, through a nonlinear relationship with annualized operator volume and risk-adjusted, that operators performing more PCI with RA per year (fourth quartile) have a lower number of the overall periprocedural complications (p = 0.019). CONCLUSIONS: High-volume RA operators are related to lower overall periprocedural complication occurrence in patients treated with RA in comparison to low-volume operators.

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.

Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Cardiac muscle hypercontractility is a key pathophysiological abnormality in hypertrophic cardiomyopathy, and a major determinant of dynamic left ventricular outflow tract (LVOT) obstruction. Available pharmacological options for hypertrophic cardiomyopathy are inadequate or poorly tolerated and are not disease-specific. We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy. METHODS: In this phase 3, randomised, double-blind, placebo-controlled trial (EXPLORER-HCM) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or placebo for 30 weeks. Visits for assessment of patient status occurred every 2-4 weeks. Serial evaluations included echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration. The primary endpoint was a 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO2) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO2 increase without NYHA class worsening. Secondary endpoints assessed changes in post-exercise LVOT gradient, pVO2, NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB). This study is registered with ClinicalTrials.gov, NCT03470545. FINDINGS: Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned to mavacamten (n=123 [49%]) or placebo (n=128 [51%]). 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19·4%, 95% CI 8·7 to 30·1; p=0·0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1; p<0·0001), greater increase in pVO2 (+1·4 mL/kg per min, 0·6 to 2·1; p=0·0006), and improved symptom scores (KCCQ-CSS +9·1, 5·5 to 12·7; HCMSQ-SoB -1·8, -2·4 to -1·2; p<0·0001). 34% more patients in the mavacamten group improved by at least one NYHA class (80 of 123 patients in the mavacamten group vs 40 of 128 patients in the placebo group; 95% CI 22·2 to 45·4; p<0·0001). Safety and tolerability were similar to placebo. Treatment-emergent adverse events were generally mild. One patient died by sudden death in the placebo group. INTERPRETATION: Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with obstructive hypertrophic cardiomyopathy. The results of this pivotal trial highlight the benefits of disease-specific treatment for this condition. FUNDING: MyoKardia.

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.

OBJECTIVES: The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. BACKGROUND: The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. METHODS: The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. RESULTS: No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). CONCLUSION: In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months.

Accuracy of the PARIS score and PCI complexity to predict ischemic events in patients treated with very thin stents in unprotected left main or coronary bifurcations.

BACKGROUND: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed. METHODS: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents. RESULTS: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI. CONCLUSIONS: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.

Cardiovascular magnetic resonance and transesophageal echocardiography in patients with prosthetic valve paravalvular leaks: towards an accurate quantification and stratification.

BACKGROUND: Objective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement. METHODS: Thirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild < 10%; moderate 10%-30%; severe > 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%-39%, or (3) severe ≥ 40%). RESULTS: All patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters. CONCLUSION: The SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL.

Acute Angulation and Sequential Lesion Increase the Risk of Rotational Atherectomy Failure.

BACKGROUND: The aim of the study was to assess anatomical and procedural predictors of clinical and procedural failure of rotational atherectomy (RA) in an all-comers population.Methods and Results:A total of 534 consecutive patients who underwent RA were included in a double-center observational study. The primary composite endpoint consisted of: rota-wire introduction failure, burr-passage failure, periprocedural complications and procedure-related major adverse events. The second primary endpoint included rota-wire introduction failure and burr-passage failure. The primary endpoint occurred in 76 (14.2%) patients and the second primary endpoint occurred in 64 (12%) Periprocedural complications occurred in 23 (4.3%) and procedure-related adverse events in 23 (4.3%) patients. Multivariable analysis revealed angulation on lesion ≤90° (HR=2.18, 95% CI: 1.21-3.94, P=0.0096) and sequential lesion (HR=1.89, 95% CI: 1.01-3.54, P=0.046) as independent predictors of no clinical success of RA. Multivariable analysis revealed again that angulation on lesion ≤90° (HR=2.26, 95% CI: 1.16-4.40, P=0.02) and sequential lesion (HR=3.77, 95% CI: 1.64-8.69, P<0.01) as independent predictors of no procedural success of RA. CONCLUSIONS: The presence of an acute angulation on lesion and sequential lesion are independent determinants of clinical and procedural failure of RA. Further research is necessary to establish a score predicting RA failure, which can help in preproceduralrisk stratification of patients undergoing complex percutaneous coronary intervention with RA.

Impact of acute total occlusion of the culprit artery on outcome in NSTEMI based on the results of a large national registry.

BACKGROUND: The impact of acute total occlusion (TO) of the culprit artery in non-ST-segment elevation myocardial infarction (NSTEMI) is not fully established. We aimed to evaluate the clinical and angiographic phenotype and outcome of NSTEMI patients with TO (NSTEMITO) compared to NSTEMI patients without TO (NSTEMINTO) and those with ST-segment elevation and TO (STEMITO). METHODS: Demographic, clinical and procedure-related data of patients with acute myocardial infarction who underwent percutaneous coronary intervention (PCI) between 2014 and 2017 from the Polish National Registry were analysed. RESULTS: We evaluated 131,729 patients: NSTEMINTO (n = 65,206), NSTEMITO (n = 16,209) and STEMITO (n = 50,314). The NSTEMITO group had intermediate results compared to the NSTEMINTO and STEMITO groups regarding mean age (68.78 ± 11.39 vs 65.98 ± 11.61 vs 64.86 ± 12.04 (years), p < 0.0001), Killip class IV on admission (1.69 vs 2.48 vs 5.03 (%), p < 0.0001), cardiac arrest before admission (2.19 vs 3.09 vs 6.02 (%), p < 0.0001) and death during PCI (0.43 vs 0.97 vs 1.76 (%), p < 0.0001)-for NSTEMINTO, NSTEMITO and STEMITO, respectively. However, we noticed that the NSTEMITO group had the longest time from pain to first medical contact (median 4.0 vs 5.0 vs 2.0 (hours), p < 0.0001) and the lowest frequency of TIMI flow grade 3 after PCI (88.61 vs 83.36 vs 95.57 (%), p < 0.0001) and that the left circumflex artery (LCx) was most often the culprit lesion (14.09 vs 35.86 vs 25.42 (%), p < 0.0001). CONCLUSIONS: The NSTEMITO group clearly differed from the NSTEMINTO group. NSTEMITO appears to be an intermediate condition between NSTEMINTO and STEMITO, although NSTEMITO patients have the longest time delay to and the worst result of PCI, which can be explained by the location of the culprit lesion in the LCx.

Impact of short-term air pollution exposure on acute coronary syndrome in two cohorts of industrial and non-industrial areas: A time series regression with 6,000,000 person-years of follow-up (ACS - Air Pollution Study).

BACKGROUND: There is a lack of studies directly comparing the effect of air pollution on acute coronary syndrome (ACS) occurrence in industrial and non-industrial areas. OBJECTIVES: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas. MATERIALS AND METHODS: The study covered 6,000,000 person-years of follow-up and five pollutants between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS. RESULTS: A total of 9046 patients with ACS were included in the analysis, of whom 3895 (43.06%) had ST-elevation myocardial infarction (STEMI) - 45.39% from non-industrial area, and 42.37% from industrial area; and 5151 (56.94%) had non-ST-elevation myocardial infarction (NSTEMI) - 54.61% from non-industrial area and 57.63% from industrial area. The daily concentrations of PM2.5, PM10, NO2, SO2, CO were higher in industrial than in non-industrial area (P < 0.001). In non-industrial area, an increase of 10 µg/m3 of NO2 concentration (Odds Ratio (OR) = 1.126, 95%CI = 1.009-1.257; P = 0.034, lag-0) and an increase of 1 mg/m3 in CO concentration (RR = 1.055, 95%CI = 1.010-1.103; P = 0.017, lag-0) were associated with an increase in the number of hospitalization due to NSTEMI (for industrial area increase of 10 µg/m3 in NO2 (OR = 1.062, 95%CI = 1.020-1.094; P = 0.005, lag-0), SO2 (OR = 1.061, 95%CI = 1.010-1.116; P = 0.018, lag-4), PM10 (OR = 1.010, 95%CI = 1.001-1.030; P = 0.047, lag-6). In STEMI patients in industrial area, an increased hospitalization was found to be associated with an increase of 10 µg/m3 in SO2 (OR = 1.094, 95%CI = 1.030-1.162; P = 0.002, lag-1), PM2.5 (OR = 1.041, 95%CI = 1.020-1.073; P < 0.001, lag-1), PM10 (OR = 1.030, 95%CI = 1.010-1.051; P < 0.001, lag-1). No effects of air pollution on the number of hospitalization due to STEMI were noted from non-industrial area. CONCLUSION: The risk of air pollution-related ACS was higher in industrial over non-industrial area. The effect of NO2 on the incidence of NSTEMI was observed in both areas. In industrial area, the effect of PMs and SO2 on NSTEMI and STEMI were also observed. A clinical effect was more delayed in time in patients with NSTEMI, especially after exposure to PM10. Chronic exposure to air pollution may underlie the differences in the short-term effect between particulate air pollution impact on the incidence of STEMI.

Artificial Intelligence Can Improve Patient Management at the Time of a Pandemic: The Role of Voice Technology.

Artificial intelligence-driven voice technology deployed on mobile phones and smart speakers has the potential to improve patient management and organizational workflow. Voice chatbots have been already implemented in health care-leveraging innovative telehealth solutions during the COVID-19 pandemic. They allow for automatic acute care triaging and chronic disease management, including remote monitoring, preventive care, patient intake, and referral assistance. This paper focuses on the current clinical needs and applications of artificial intelligence-driven voice chatbots to drive operational effectiveness and improve patient experience and outcomes.

Clinical and procedural characteristics of COVID-19 patients treated with percutaneous coronary interventions.

BACKGROUND: COVID-19 pandemic has affected healthcare systems worldwide. Resources are being shifted and potentially jeopardize safety of non-COVID-19 patients with comorbidities. Our aim was to investigate the impact of national lockdown and SARS-CoV-2 pandemic on percutaneous treatment of coronary artery disease in Poland. METHODS: Data on patients who underwent percutaneous coronary procedures (angiography and/or percutaneous coronary intervention [PCI]) were extracted for March 13-May 13, 2020 from a national PCI database (ORPKI Registry) during the first month of national lockdown and compared with analogous time period in 2019. RESULTS: Of 163 cardiac catheterization centers in Poland, 15 (9.2%) were indefinitely or temporarily closed down due to SARS-CoV-2 pandemic. There were nine physicians (9 of 544; 1.7%) who were infected with SARS-CoV-2. There were 13,750 interventional cardiology procedures performed in Poland in the analyzed time period. In 66% of cases an acute coronary syndrome was diagnosed, and in the remaining 34% it was an elective procedure for the chronic coronary syndrome in comparison to 50% in 2019 (p < .001). There were 362 patients (2.6% of all) with COVID-19 confirmed/suspected who were treated in interventional cardiology centers and 145 with ST-Elevation Myocardial Infarction (STEMI) diagnosis (6% of all STEMIs). CONCLUSIONS: Due to SARS-CoV-2 pandemic there was an absolute reduction in the number of interventional procedures both acute and elective in comparison to 2019 and a significant shift into acute procedures. COVID-19 confirmed/suspected patients do not differ in terms of procedural and baseline characteristics and reveal similar outcomes when treated with percutaneous coronary interventions.

Impact of structural features of very thin stents implanted in unprotected left main or coronary bifurcations on clinical outcomes.

OBJECTIVES: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents. BACKGROUND: Clinical impact of structural features of contemporary stents remains to be defined. METHODS: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 µm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models. RESULTS: Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed. CONCLUSIONS: Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting.

The influence of scar on the spatio-temporal relationship between electrical and mechanical activation in heart failure patients.

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.

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.