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We present an original and safe experimental model of the rat aorta angioplasty with a paclitaxel-releasing balloon catheter. No toxic effects of the drug on experimental animals were detected. [ABSTRACT FROM AUTHOR]

Background: Hypertension is the most prevalent cardiovascular risk factor, with several detrimental effects on the cardiovascular system. Contrasting results have been reported so far on its prognostic role in patients admitted for ST-segment elevation myocardial infarction (STEMI). Therefore, we investigated the impact of hypertension on short-term mortality in a large multicenter contemporary registry of STEMI patients, including patients treated during COVID-19 pandemic., Methods: The ISACS-STEMI COVID-19 was a retrospective registry that included STEMI patients treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 in 109 high-volume primary PCI centers from 4 continents. We collected data on baseline, clinical and procedural characteristics, in-hospital outcome and 30-day mortality. For this analysis patients were grouped according to history of hypertension at admission., Results: A total of 16083 patients were assessed, including 8813 (54.8%) with history of hypertension. These patients were more often elderly, with a worse cardiovascular risk profile, but were less frequently active smoker. Some procedural differences were observed between the two groups, including lower rate of thrombectomy and use of glycoprotein IIb/IIIa inhibitors or cangrelor but more extensive coronary disease in patients with hypertension. Between patients with and without hypertension, there was no significant difference in SARS-CoV-2 positivity. Hypertensive patients had a significantly higher in-hospital and 30-day mortality, similarly observed in both pre-COVID-19 and COVID-19 era, and confirmed after adjustment for main baseline differences and propensity score (in-hospital mortality: adjusted odds ratio (OR) [95% confidence interval (CI)] =1.673 [1.389-2.014], P < 0.001; 30-day mortality: adjusted hazard ratio (HR) [95% CI] = 1.418 [1.230-1.636], P < 0.001)., Conclusion: This is one of the largest and contemporary study assessing the impact of hypertension in STEMI patients undergoing primary angioplasty, including also the COVID-19 pandemic period. Hypertension was independently associated with significantly higher rates of in-hospital and 30-day mortality., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Aim      To evaluate 5-year results of the HREVS (Hybrid REvascularization Versus Standarts) study.Material and methods  The study included 155 consecutive patients with multivessel coronary artery disease who were randomized into 3 groups: coronary artery bypass grafting (CABG) (n=50), hybrid coronary revascularization (HCR) (n=52) and percutaneous coronary intervention (PCI) (n=53) according to the consensus of the cardiology team on the technical and clinical feasibility of each of the three coronary revascularization strategies. The primary endpoint of the study was residual ischemia 12 months after revascularization according to data of single-photon emission computed tomography (SPECT). Secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) over 5 years of follow-up, which included all-cause death, myocardial infarction, stroke, and clinically determined repeat myocardial revascularization.Results Baseline characteristics of patients did not differ between study groups. Median residual ischemia determined by SPECT data after 12 months was not statistically significantly different in the CABG, HCR and PCI groups: 6.7 [4.6; 8.8]%, 6.4 [4.3; 8.5]% and 7.9 [5.9; 9.8]%, respectively (p=0.45). Mean follow-up period was 76.5 months (at least 60 months). There were no statistically significant differences in all-cause mortality between the CABG, HCR and PCI groups, 10.6, 12.8 and 8.2 %, respectively (p=0.23). Statistically significant differences between the groups of CABG, HCR and PCI in the incidence of myocardial infarction (12.8; 8.5 and 16.3 %; p=0.12), stroke (4.2; 6.4 and 10.2 % ; p=0.13), repeat revascularization for clinical indications (23.4; 23.4 and 34.7 %; p=0.11) were not observed either. However, the cumulative 5-year MACCE value was similar in the HCR group and the CABG group but significantly lower than in the PCI group (51.1, 51.1 and 69.4 %, respectively; p = 0.03).Conclusion      HCR that combines advantages of PCI and CABG is a promising strategy for coronary revascularization in multivessel coronary artery disease. HCR demonstrates satisfactory long-term results comparable to those of CABG but superior to PCI. To confirm the safety and efficacy of HCR, a large multicenter study is required that would have a sufficient power to evaluate clinical endpoints.

SARS-Cov-2 has been suggested to promote thrombotic complications and higher mortality. The aim of the present study was to evaluate the impact of SARS-CoV-2 positivity on in-hospital outcome and 30-day mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) enrolled in the International Survey on Acute Coronary Syndromes ST-segment elevation Myocardial Infarction (ISACS-STEMI COVID-19 registry. The 109 SARS-CoV-2 positive patients were compared with 2005 SARS-CoV-2 negative patients. Positive patients were older ( P = .002), less often active smokers ( P = .002), and hypercholesterolemic ( P = .006), they presented more often later than 12 h ( P = .037), more often to the hub and were more often in cardiogenic shock ( P = .02), or requiring rescue percutaneous coronary intervention after failed thrombolysis (P < .0001). Lower postprocedural Thrombolysis in Myocardial Infarction 3 flow ( P = .029) and more thrombectomy ( P = .046) were observed. SARS-CoV-2 was associated with a significantly higher in-hospital mortality (25.7 vs 7%, adjusted Odds Ratio (OR) [95% Confidence Interval] = 3.2 [1.71-5.99], P < .001) in-hospital definite in-stent thrombosis (6.4 vs 1.1%, adjusted Odds Ratio [95% CI] = 6.26 [2.41-16.25], P < .001) and 30-day mortality (34.4 vs 8.5%, adjusted Hazard Ratio [95% CI] = 2.16 [1.45-3.23], P < .001), confirming that SARS-CoV-2 positivity is associated with impaired reperfusion, with negative prognostic consequences., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The constraints in the management of patients with ST-segment elevation myocardial infarction (STEMI) during the COVID-19 pandemic have been suggested to have severely impacted mortality levels. The aim of the current analysis is to evaluate the age-related effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI within the registry ISACS-STEMI COVID-19., Methods: This retrospective multicenter registry was performed in high-volume PPCI centers on four continents and included STEMI patients undergoing PPCI in March-June 2019 and 2020. Patients were divided according to age (< or ≥75 years). The main outcomes were the incidence and timing of PPCI, (ischemia time longer than 12 h and door-to-balloon longer than 30 min), and in-hospital or 30-day mortality., Results: We included 16,683 patients undergoing PPCI in 109 centers. In 2020, during the pandemic, there was a significant reduction in PPCI as compared to 2019 (IRR 0.843 (95%-CI: 0.825-0.861, p < 0.0001). We found a significant age-related reduction (7%, p = 0.015), with a larger effect on elderly than on younger patients. Furthermore, we observed significantly higher 30-day mortality during the pandemic period, especially among the elderly (13.6% vs. 17.9%, adjusted HR (95% CI) = 1.55 [1.24-1.93], p < 0.001) as compared to younger patients (4.8% vs. 5.7%; adjusted HR (95% CI) = 1.25 [1.05-1.49], p = 0.013), as a potential consequence of the significantly longer ischemia time observed during the pandemic., Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures, with a larger reduction and a longer delay to treatment among elderly patients, which may have contributed to increase in-hospital and 30-day mortality during the pandemic.

Background: Several reports have demonstrated the impact of the COVID-19 pandemic on the management and outcome of patients with ST-segment elevation myocardial infarction (STEMI). The aim of the current analysis is to investigate the potential gender difference in the effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI patients within the ISACS-STEMI COVID-19 Registry., Methods: This retrospective multicenter registry was performed in high-volume primary percutaneous coronary intervention (PPCI) centers on four continents and included STEMI patients undergoing PPCIs in March-June 2019 and 2020. Patients were divided according to gender. The main outcomes were the incidence and timing of the PPCI, (ischemia time ≥ 12 h and door-to-balloon ≥ 30 min) and in-hospital or 30-day mortality., Results: We included 16683 STEMI patients undergoing PPCIs in 109 centers. In 2020 during the pandemic, there was a significant reduction in PPCIs compared to 2019 (IRR 0.843 (95% CI: 0.825-0.861, p < 0.0001). We did not find a significant gender difference in the effects of the COVID-19 pandemic on the numbers of STEMI patients, which were similarly reduced from 2019 to 2020 in both groups, or in the mortality rates. Compared to prepandemia, 30-day mortality was significantly higher during the pandemic period among female (12.1% vs. 8.7%; adjusted HR [95% CI] = 1.66 [1.31-2.11], p < 0.001) but not male patients (5.8% vs. 6.7%; adjusted HR [95% CI] = 1.14 [0.96-1.34], p = 0.12)., Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures similarly observed in both genders. Furthermore, we observed significantly increased in-hospital and 30-day mortality rates during the pandemic only among females. Trial registration number: NCT 04412655.

The so-called “smoking paradox”, conditioning lower mortality in smokers among STEMI patients, has seldom been addressed in the settings of modern primary PCI protocols. The ISACS−STEMI COVID-19 is a large-scale retrospective multicenter registry addressing in-hospital mortality, reperfusion, and 30-day mortality among primary PCI patients in the era of the COVID-19 pandemic. Among the 16,083 STEMI patients, 6819 (42.3%) patients were active smokers, 2099 (13.1%) previous smokers, and 7165 (44.6%) non-smokers. Despite the impaired preprocedural recanalization (p < 0.001), active smokers had a significantly better postprocedural TIMI flow compared with non-smokers (p < 0.001); this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. Active smokers had a significantly lower in-hospital (p < 0.001) and 30-day (p < 0.001) mortality compared with non-smokers and previous smokers; this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. In conclusion, in our population, active smoking was significantly associated with improved epicardial recanalization and lower in-hospital and 30-day mortality compared with previous and non-smoking history.

Background: Chronic obstructive pulmonary disease (COPD) is projected to become the third cause of mortality worldwide. COPD shares several pathophysiological mechanisms with cardiovascular disease, especially atherosclerosis. However, no definite answers are available on the prognostic role of COPD in the setting of ST elevation myocardial infarction (STEMI), especially during COVID-19 pandemic, among patients undergoing primary angioplasty, that is therefore the aim of the current study., Methods: In the ISACS-STEMI COVID-19 registry we included retrospectively patients with STEMI treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 from 109 high-volume primary PCI centers in 4 continents., Results: A total of 15,686 patients were included in this analysis. Of them, 810 (5.2%) subjects had a COPD diagnosis. They were more often elderly and with a more pronounced cardiovascular risk profile. No preminent procedural dissimilarities were noticed except for a lower proportion of dual antiplatelet therapy at discharge among COPD patients (98.9% vs. 98.1%, P = 0.038). With regards to short-term fatal outcomes, both in-hospital and 30-days mortality occurred more frequently among COPD patients, similarly in pre-COVID-19 and COVID-19 era. However, after adjustment for main baseline differences, COPD did not result as independent predictor for in-hospital death (adjusted OR [95% CI] = 0.913[0.658-1.266], P = 0.585) nor for 30-days mortality (adjusted OR [95% CI] = 0.850 [0.620-1.164], P = 0.310). No significant differences were detected in terms of SARS-CoV-2 positivity between the two groups., Conclusion: This is one of the largest studies investigating characteristics and outcome of COPD patients with STEMI undergoing primary angioplasty, especially during COVID pandemic. COPD was associated with significantly higher rates of in-hospital and 30-days mortality. However, this association disappeared after adjustment for baseline characteristics. Furthermore, COPD did not significantly affect SARS-CoV-2 positivity., Trial Registration Number: NCT04412655 (2nd June 2020)., (© 2022. The Author(s).)

Aim    To analyze the number of cases of acute coronary syndrome (ACS) [ST segment elevation myocardial infarction (STEMI), non-ST elevation acute coronary syndrome (nSTEACS)] and results of myocardial revascularization for ACS as a part of the monitoring performed by the Ministry of Health Care of Russia*. This analysis allows, on one hand, providing control of morbidity and mortality of patients with socially significant pathologies and, on the other hand, monitoring the effectivity of treatments to identify and correct their shortcomings. Time-related changes in results of myocardial revascularization performed for ACS patients in the Russian Federation in 2020 were analyzed and compared with the values of 2016-2019 based on data of the Russian Ministry of Health Care monitoring.Material and methods    Yearly absolute, relative, and calculated indices of revascularization for ACS were analyzed and compared based on data of the Russian Ministry of Health Care monitoring in 2016-2020.Results    In the Russian Federation in 2020, the lowest number of hospitalizations for ACS (403, 931) was recorded with an unprecedented ratio of 1 / 1.8 for STEMI/nSTEACS, respectively. In Russia in 2020, the proportion of primary percutaneous coronary interventions (pPCI) for STEMI continued growing; it reached 44% and peaked to the maximum for 2016-2020. At the same time, the thrombolytic therapy (TLT) remained essential in the structure of reperfusion strategies during those years (24.0-27.3 % of all STEMI cases). Total death rate of admitted patients with STEMI in Russia was stable at the level of 13.1-14.6 %. In 2020, there were no significant differences in quality indexes of the treatment for STEMI from the previous period (2016-2019). A yearly relative increase in the number of PCIs for STEACS (from 16 % in 2016 to 30 % in 2020 and from 30% to 46% for high-risk nSTEACS) was observed. In 2020, a significant increase in death rate was observed for nSTEACS as a whole (to 4.1 %) and for individual subgroups (high-risk nSTEACS, to 4.5 %; after PCI for nSTEACS, to 1.8 %; and after PCI for high-risk nSTEACS, to 2.8 %) whereas mean death rate values in these subgroups in 2016-2019 were 2.75 %, 3.45 %, 1.5 %, and 2.3 %, respectively.Conclusion    The analysis of revascularization indexes in ACS patients based on the Ministry of Health Care of Russia monitoring performed in 2016-2020 showed a number of positive trends, including an increase in the total number of revascularization procedures; a decrease in the time from the disease onset to the endovascular treatment; an increase in the availability of stenting for severe ACS; and general stabilization of the mortality. On the other hand, the Russian Federation is considerably behind European countries in several qualitative and quantitative parameters of health care in ACS, such as pPCI availability, symptom-to-balloon time, total mortality of all hospitalized STEMI patients, and revascularization for nSTEACS. Despite the gradual improvement of relative quantitative indexes of myocardial revascularization for ACS, negative changes in the absolute number of myocardial revascularizations for various forms of ACS and a notable increase in the death rate in nSTEACS were observed in 2020, including patients after PCI. There is no doubt that the negative results of myocardial revascularization in Russia in 2020 were due to the effect of the COVID-19 pandemic.* monitoring of measures to reduce the mortality from ischemic heart disease (letters of the Ministry of Health Care of the Russian Federation of 13.03.2015 # 17-6 /10 / 1-177 and of 24.07.2015 # 17-9 / 10 / 2-4128), which includes monthly collection of data on the Federal Research Institute for Health Organization and Informatics portal, the Automated System for Monitoring of Medical Statistics, at http://asmms.mednet.ru.

Background: During the coronavirus disease 2019 (COVID-19) pandemic, concerns have been arisen on the use of renin-angiotensin system inhibitors (RASI) due to the potentially increased expression of Angiotensin-converting-enzyme (ACE)2 and patient's susceptibility to SARS-CoV2 infection. Diabetes mellitus have been recognized favoring the coronavirus infection with consequent increase mortality in COVID-19. No data have been so far reported in diabetic patients suffering from ST-elevation myocardial infarction (STEMI), a very high-risk population deserving of RASI treatment., Methods: The ISACS-STEMI COVID-19 registry retrospectively assessed STEMI patients treated with primary percutaneous coronary intervention (PPCI) in March/June 2019 and 2020 in 109 European high-volume primary PCI centers. This subanalysis assessed the prognostic impact of chronic RASI therapy at admission on mortality and SARS-CoV2 infection among diabetic patients., Results: Our population is represented by 3812 diabetic STEMI patients undergoing mechanical reperfusion, 2038 in 2019 and 1774 in 2020. Among 3761 patients with available data on chronic RASI therapy, between those ones with and without treatment there were several differences in baseline characteristics, (similar in both periods) but no difference in the prevalence of SARS-CoV2 infection (1.6% vs 1.3%, respectively, p  = 0.786). Considering in-hospital medication, RASI therapy was overall associated with a significantly lower in-hospital mortality (3.3% vs 15.8%, p  < 0.0001), consistently both in 2019 and in 2010., Conclusions: This is first study to investigate the impact of RASI therapy on prognosis and SARS-CoV2 infection of diabetic patients experiencing STEMI and undergoing PPCI during the COVID-19 pandemic. Both pre-admission chronic RASI therapy and in-hospital RASI did not negatively affected patients' survival during the hospitalization, neither increased the risk of SARS-CoV2 infection., Trial Registration Number: NCT04412655., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 Published by Elsevier Masson SAS.)

Background and Aims: SARS-Cov-2 predisposes patients to thrombotic complications, due to excessive inflammation, endothelial dysfunction, platelet activation, and coagulation/fibrinolysis disturbances. The aim of the present study was to evaluate clinical characteristics and prognostic impact of SARS-CoV-2 positivity among STEMI patients undergoing primary percutaneous coronary intervention (PPCI)., Methods: We selected SARS-CoV-2 positive patients included in the ISACS-STEMI COVID-19, a retrospective multicenter European registry including 6609 STEMI patients treated with PPCI from March 1st until April 30th, in 2019 and 2020. As a reference group, we randomly sampled 5 SARS-Cov-2 negative patients per each SARS-CoV-2 positive patient, individually matched for age, sex, and hospital/geographic area. Study endpoints were in-hospital mortality, definite stent thrombosis, heart failure., Results: Our population is represented by 62 positive SARS-CoV-2 positive patients who were compared with a matched population of 310 STEMI patients. No significant difference was observed in baseline characteristics or the modality of access to the PCI center. In the SARS-CoV-2 positive patients, the culprit lesion was more often located in the RCA (p < 0.001). Despite similar pre and postprocedural TIMI flow, we observed a trend in higher use of GP IIb-IIIa inhibitors and a significantly higher use of thrombectomy in the SARS-CoV-2 positive patients. SARS-CoV-2 positivity was associated with a remarkably higher in hospital mortality (29% vs 5.5%, p < 0.001), definite in-stent thrombosis (8.1% vs 1.6%, p = 0.004) and heart failure (22.6% vs 10.6%, p = 0.001) that was confirmed after adjustment for confounding factors., Conclusions: Our study showed that among STEMI patients, SARS-CoV-2 positivity is associated with larger thrombus burden, a remarkably higher mortality but also higher rates of in-stent thrombosis and heart failure., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study., Methods: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission., Results: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51-0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33-0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084-0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect., Conclusions: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival., (Copyright © 2021 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

The aim of the study was to determine the potential mechanism of vascular complications due to "catheter-vascular wall" interaction in transcatheter aortic valve replacement using experimental and numerical analysis., Materials and Methods: A series of full-scale bench tests and numerical simulations were carried out using the CoreValve commercial transfemoral delivery system for aortic valve bioprosthesis (Medtronic Inc., USA). Full-scale tests were carried out using a phantom of the vascular system (a polymeric silicone model of Transcatheter Aortic Valve; Trandomed 3D Inc., China) with simulation of all stages of delivery system movement along the vascular bed. They involved introduction into the common femoral artery, movement along the abdominal and thoracic parts of the aorta, the aortic arch, and positioning the system to the implantation site. The force arising from the passage of the delivery system was assessed using sensors of a Z50 universal testing machine (Zwick/Roell, Germany). Numerical simulation of transcatheter valve replacement procedure was carried out in a similar way with allowance for the patient-specific anatomy of the recipient's aorta using the finite element method in the Abaqus/CAE environment (Dassault Systèmes, France)., Results: It was found that in the process of the delivery system passing through the vascular system, there occurred force fluctuations associated with catheter bending and its interaction with the aortic wall in the region of its arch. For example, in the initial straight portions, the pushing force was 3.8-7.9 N; the force increased to the maximum (11.1 and 14.4 N with and without the prosthesis) with bending of the distal portion of the catheter. A similar increase was observed when performing numerical simulation with high-quality graphic visualization of stress on the "spots" of contact between the catheter and the vascular wall with an increase in stress to 0.8 MPa., Conclusion: Numerical and full-scale bench tests prove the significant effect of the properties of delivery system catheter for transcatheter aortic valve replacement on the interaction with the aortic walls., Competing Interests: Conflicts of interest. There are no conflicts of interest related to this study.

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19., Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality., Results: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73-0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78-0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients., Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic., Trial Registration Number: NCT04412655.

Aims: The Stent for Life initiative aims at the reduction of mortality in patients with ST-elevation myocardial infarction by enhancing timely access to primary percutaneous coronary intervention. To assess the associated health and socioeconomic impact, the Stent for Life economic project was launched and applied to four model regions: Romania, Portugal, the Basque Country in Spain, and the Kemerovo region in the Russian Federation., Methods and Results: The Stent for Life economic model is based on a decision tree that incorporates primary percutaneous coronary intervention rates and mortality. Healthcare costs and indirect costs caused by loss of productivity were estimated. A baseline scenario simulating the status quo was compared to the Stent for Life scenario which integrated changes initiated by the Stent for Life programme. In the four model regions, primary percutaneous coronary intervention numbers rose substantially between 29-303%, while ST-elevation myocardial infarction mortality was reduced between 3-10%. Healthcare costs increased by 8% to 70%. Indirect cost savings ranged from 2-7%. Net societal costs were reduced in all model regions by 2-4%., Conclusion: The joint effort of the Stent for Life initiative and their local partners successfully saves lives. Moreover, the increase in healthcare costs was outweighed by indirect cost savings, leading to a net cost reduction in all four model regions. These findings demonstrate that systematic investments to improve the access of ST-elevation myocardial infarction patients to guideline-coherent therapy is beneficial, not only for the individual, but also for the society at large.

Background: The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality., Objectives: The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of "at-risk" patient cohorts for failure to present or delays to treatment., Methods: This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020. Main outcomes are the incidences of PPCI, delayed treatment, and in-hospital mortality., Results: A total of 6,609 patients underwent PPCI in 77 centers, located in 18 countries. In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio: 0.811; 95% confidence interval: 0.78 to 0.84; p < 0.0001). The heterogeneity among centers was not related to the incidence of death due to COVID-19. A significant interaction was observed for patients with arterial hypertension, who were less frequently admitted in 2020 than in 2019. Furthermore, the pandemic was associated with a significant increase in door-to-balloon and total ischemia times, which may have contributed to the higher mortality during the pandemic., Conclusions: The COVID-19 pandemic had significant impact on the treatment of patients with STEMI, with a 19% reduction in PPCI procedures, especially among patients suffering from hypertension, and a longer delay to treatment, which may have contributed to the increased mortality during the pandemic. (Primary Angioplasty for STEMI During COVID-19 Pandemic [ISACS-STEMI COVID-19] Registry; NCT04412655)., Competing Interests: Author Relationship With Industry This study was promoted by the Eastern Piedmont University, Novara, Italy, without any financial support. Dr. Cortese has been funded by PRIN2017 (20178S4EK9). All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI., Methods: Consecutive MV-CAD patients ( n  = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control., Results: Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% ( p =0.71). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days ( p < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks ( p < 0.001). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority p values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% ( p =0.05). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% ( p =0.62). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%; p =0.83)., Conclusion: In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048., Competing Interests: None of the authors has any disclosure relevant to this manuscript to report., (Copyright © 2020 Vladimir Ganyukov et al.)

The aim of the study was to develop a prognostic model based on statistical discriminant analysis to assess the risk of postoperative disturbance of cardiac conduction and paraprosthetic regurgitation after transcatheter aortic valve replacement., Materials and Methods: Clinical data of 10 patients implanted with CoreValve TM prostheses (Medtronic Inc., USA) were used to develop prognostic models. To that end, we analyzed changes in hemodynamic and functional parameters provided by echocardiography in the pre- and postoperative periods., Results: We observed significant positive changes in the severity of left ventricular myocardial hypertrophy; on the contrary, volume indicators did not significantly change, which might be associated with the concentric type of left ventricular hypertrophy. The discriminant analysis made it possible to determine major (preoperative) morphological and functional indicators associated with the two most common complications of the procedure: left bundle branch block and paraprosthetic regurgitation. Left ventricular posterior wall thickness, interventricular septal thickness, left atrium dimension, and myocardial mass are the critical factors that determine the development of these complications., Conclusion: In the prognostic model, the proposed weighting coefficients allow one to assess the risk of postoperative complications; however, the presence of false-positive results requires further refinement of these coefficients within the linear equation., Competing Interests: Conflict of interest. The authors declare no conflict of interest.

Background: There are two main methods used for transcatheter aortic valve replacement (TAVR) FEA modeling for medical devices development: patient specific and general approaches. Advantages and disadvantages of both approaches have never been compared in a single study., Method: Here we propose a bioinformatic algorithm to evaluate the accuracy of patient specific and generalized FEA approaches with regards to proximity configuration of the implanted stent reconstructed by computed tomography. In addition, in this study we also assessed the impact of the level of detail on FEA accuracy in the patient specific approach., Results: Our results demonstrate that in certain cases, the generalized approach can ensure the same accuracy as the patient specific approach. Therefore, considering high cost effectiveness of the generalized approach, we identify it as more feasible in the context of TAVR. Furthermore, we suggest that high level of detail can improve the reproducibility of modeling results in the patient specific approach., Conclusions: Our findings may help medical engineers to better understand the peculiarities of both approaches and therefore make the right decision when choosing a particular approach for computer modeling. Future studies are required to validate our observations., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Objective: We report our initial experience with extracorporeal membrane oxygenation (ECMO) use in elective high-risk complex percutaneous coronary intervention (PCI)., Background: ECMO has been employed as hemodynamic support in patients with cardiac arrest and hemodynamic shock., Methods: We performed a single-center prospectical study, enrolling all patients at very high-risk for coronary artery bypass grafting (CABG). Major adverse cardiac and cerebrovascular events (MACCE) were defined as a composite of death, acute myocardial infarction (MI), stroke and further need for revascularization., Results: Twelve patients underwent elective high-risk PCI with ECMO support (mean age = 63.5 ± 8.7 years). The mean SYNTAX score was 30.1 ± 10.1. All PCI procedures were successful and no in-hospital MACCE was observed. At 6-months, neither death nor MI was noticed. Two patients (17%) required further revascularization, and one patient required chronic hemodialysis., Conclusions: Elective high-risk PCI supported by ECMO is a viable alternative for patients who are at very high risk for CABG., (Copyright © 2015 Elsevier Inc. All rights reserved.)