Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Severely Reduced Left Ventricular Systolic Function in the Low Systolic Function and Transcatheter Aortic Valve Implantation (LOSTAVI) International Registry.

Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p = 0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p = 0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p = 0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p = 0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes.

Supra-renal aortic atheroma extent and composition predict acute kidney injury after transcatheter aortic valve replacement: A three-dimensional computed tomography study.

OBJECTIVE: Acute kidney injury (AKI) may complicate transcatheter aortic valve replacement (TAVR) and could be linked to atheroembolization associated with catheter manipulation in the supra-renal (SR) aorta. We sought to determine the impact of SR aortic atheroma burden (SR-AAB) and composition, as well as of the aortic valve calcium score (AV-CS), measured at pre-operative multislice computed tomography (PO-MSCT), on AKI-TAVR. METHODS: All TAVR-patients 3 January-2018 to December-2020 were included. A three-dimensional analysis of PO-MSCT was performed, calculating percentage SR-AAB (%SR-AAB) as [(absolute SR-AAB volume)*100/vessel volume]. Types of plaque were defined according to Hounsfield unit (HU) intensity ranges. Calcified plaque was subcategorized into 3 strata: low- (351-700 HU), mid- (701-1000 HU), and high­calcium (>1000 HU, termed 1 K-plaque). RESULTS: The study population included 222 patients [mean age 83.3 ± 5.7 years, 95 (42.8%) males], AKI-TAVR occurred in 67/222 (30.2%). Absolute SR-AAB (41.3 ± 16.4 cm3 vs. 32.5 ± 10.7 cm3,p < 0.001) and %SR-AAB (17.6 ± 5.1% vs. 13.9 ± 4.3%,p < 0.001) were significantly higher in patients developing AKI-TAVR. Patients who developed AKI-TAVR had higher mid­calcium (6.9 ± 3.8% vs. 4.2 ± 3.5%,p < 0.001) and 1 K-plaque (5.4 ± 3.7% vs. 2.4 ± 2.4%,p < 0.001) with no difference in AV-CS (p = 0.691). Adjusted multivariable logistic regression analysis showed that %SR-AAB [OR (x%increase): 1.12, 95%CI: 1.04-1.22,p = 0.006] and %SR-calcified plaque [OR (x%increase): 5.60, 95%CI: 2.50-13.36,p < 0.001] were associated with AKI-TAVR. Finally, 3-knots spline analyses identified %SR-AAB >15.0% and %SR-calcified plaque >7.0% as optimal thresholds to predict an increased risk of AKI-TAVR. CONCLUSIONS: Suprarenal aortic atheroma, when highly calcified, is associated with AKI-TAVR. Perioperative-MSCT assessment of aortic atherosclerosis may help in identification of patients at high-risk for AKI-TAVR, who could benefit from higher peri-operative surveillance.

Acute Kidney Injury After Transcatheter Aortic Valve Replacement Mediates the Effect of Chronic Kidney Disease.

Background Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. However, it is controversial whether AKI affects prognosis per se, being linked to baseline chronic kidney disease (CKD) and bleeding complications. The aim of this study was to disentangle, applying mediation analysis, the association between AKI and clinical outcome, considering CKD and bleedings. Methods and Results Consecutive patients undergoing TAVR were prospectively enrolled at 5 high-volume centers in Italy. AKI was defined according to Valve Academic Research Consortium-3 consensus, whereas bleeding with Bleeding Academic Research Consortium. Primary outcome was all-cause mortality after 1-year follow-up. Among 2621 patients undergoing TAVR, AKI occurrence was associated with 1-year mortality. This association of AKI with the primary end points remained significant after adjusting for baseline risk estimators, either Society of Thoracic Surgeons score (hazard ratio [HR], 2.78 [95% CI, 1.95-3.80], P<0.001) or EuroSCORE-II (HR, 1.85 [95% CI, 1.35-2.56], P<0.001). Both AKI and CKD significantly and independently affected primary outcome (HR, 3.06 [95% CI, 2.01-4.64], P<0.001 and HR, 1.82 [95% CI 1.27-2.65], P<0.01, respectively). The estimated proportion of the total effect of CKD mediated via AKI was, on average, 15%, 95% CI, 4%-29%, P<0.001. The significant effect of Bleeding Academic Research Consortium 2-5 bleedings on the primary outcome was not mediated by AKI. Conclusions AKI occurs in 1 out of 6 patients and significantly mediates one fifth of the effect of baseline CKD on all-cause mortality after TAVR. Our analysis supports a systematic effort to prevent AKI during TAVR, which may potentially translate into improved patients' 1-year survival.

Mechanical Unloading of the Left Ventricle before Coronary Reperfusion in Preclinical Models of Myocardial Infarction without Cardiogenic Shock: A Meta-Analysis.

Aim: to compare a conventional primary reperfusion strategy with a primary unloading approach before reperfusion in preclinical studies. Methods: we performed a meta-analysis of preclinical studies. The primary endpoint was infarct size (IS). Secondary endpoints were left ventricle end-diastolic pressure (LVEDP), mean arterial pressure (MAP), heart rate (HR), cardiac output (CO). We calculated mean differences (MDs) and associated 95% confidence intervals (CIs). Sensitivity and subgroup analyses on the primary and secondary endpoints, as well as a meta-regression on the primary endpoint using the year of publication as a covariate, were also conducted. Results: 11 studies (n = 142) were selected and entered in the meta-analysis. Primary unloading reduced IS (MD −28.82, 95% CI −35.78 to −21.86, I2 96%, p < 0.01) and LVEDP (MD −3.88, 95% CI −5.33 to −2.44, I2 56%, p = 0.02) and increased MAP (MD 7.26, 95% CI 1.40 to 13.12, I2 43%, p < 0.01) and HR (MD 5.26, 95% CI 1.97 to 8.55, I2 1%, p < 0.01), while being neutral on CO (MD −0.11, 95% CI −0.95 to 0.72, I2 88%, p = 0.79). Sensitivity and subgroup analyses showed, overall, consistent results. The meta-regression on the primary endpoint demonstrated a significant influence of the year of publication on effect estimate. Conclusions: in animal models of myocardial infarction, a primary unloading significantly reduces IS and exerts beneficial hemodynamic effects compared to a primary reperfusion.

Case Report: Challenging Treatment of an AorticParavalvular Leak: How We Avoided Interference With Mechanical Valve Function?

Background: Aortic paravalvular leak (APVL) after surgical valve replacement (AVR) is an ominous complication with a high risk of morbidity and mortality. Approximately 1-5% of PVLs can lead to serious clinical consequences, including congestive heart failure and/or hemolytic anemia. Case Summary: A 69-year-old man with multiple comorbidities underwent surgical replacement of the aortic valve with a mechanical tilting disc prosthetic valve (Medtronic Starlight 27 mm). Several years later, recurrent episodes of congestive heart failure and hemolytic anemia developed due to a large crescent-shaped aortic PVL located at non coronary cusp (NCC) 9-12 o'clock, with moderate-to-severe regurgitation. The patient was deemed at prohibitive surgical risk due to significant multiple comorbidities and a transcatheter PVL closure (TPVLc) was planned. The huge PVL was partially closed by a first specifically designed paravalvular leak device (PLD). The procedure was complicated by transient interference of the second PLD with mechanical prosthetic valve function. This issue has however been solved with correct manipulation, orientation and downsizing of the second device implanted. At 3-month and 13-month follow-up, the patient showed a relevant clinical improvement and good quality of life. 2D TTE color Doppler confirmed the stable position of the two PLDs with trace residual leak. Discussion: Surgical redo has been considered the treatment of choice for symptomatic patients with PVLs. Notwithstanding, TPVLc is a less invasive alternative, particularly in patients at high surgical risk in whom early diagnosis and prompt interventional treatment are crucial for improving expectancy and quality of life. Dedicated devices, appropriate procedural techniques, and the close interaction between imaging modalities, allowed to deal successfully with a challenging case of severe symptomatic aortic PVL.

Corrigendum: Catheter-based Closure of a Post-infective Aortic Paravalvular Pseudoaneurysm Fistula With Severe Regurgitation After Two Valve Replacement Surgeries: A Case Report.

[This corrects the article DOI: 10.3389/fcvm.2021.693732.].

Percutaneous Closure of Paravalvular Regurgitation After Third-Generation Transcatheter Aortic Valve Replacement.

Significant paravalvular leak regurgitation (PVLR) after transcatheter aortic valve replacement (TAVR) is a well-known complication associated with disabling symptoms related to heart failure and hemolysis or both, with poor prognostic implications. Although challenging and technically demanding, percutaneous closure is an effective treatment option for high-risk patients with symptomatic PVLR. Here, we present two cases of transcatheter PVLR closure after replacement of third-generation (one self-expandable and one balloon-expandable) transcatheter aortic valves, each with peculiar challenges, and the strategies adopted to increase the success rate of percutaneous closure.

Catheter-based Closure of a Post-infective Aortic Paravalvular Pseudoaneurysm Fistula With Severe Regurgitation After Two Valve Replacement Surgeries: A Case Report.

Backgsround: Infective endocarditis (IE) of prosthetic valves is a dire complication of cardiac valve replacement surgery and is associated with high rates of morbidity and mortality. Case Summary: A 72-year-old woman with multiple comorbidities underwent surgical replacement of the aortic valve with a mechanical prosthetic valve after recurrent IE. After 10 years, IE recurred and the mechanical valve was surgically replaced with a bioprosthetic valve. Ten years later, severe heart failure developed due to severe paravalvular leak (PVL) caused by an aortic annulus abscess complicated by a paravalvular pseudoaneurysm fistula (PPF). The patient was deemed at prohibitive surgical risk and a catheter-based PVL closure procedure was planned. However, the interventional procedure was delayed several months due to the Covid-19 pandemic with progressive heart failure worsening. Despite an acute satisfactory result of the PPF transcatheter closure and a significant clinical improvement, the patient died 10 months later due to multiorgan failure. It is likely that this was due, at least in part, to the long treatment delay caused by the unprecedented strain on the healthcare system. Discussion: In patients at high surgical risk, early diagnosis and prompt interventional treatment of severe PVL are crucial for improving expectancy and quality of life. However, the recent outbreak of COVID-19 caused deferral of elective and semi-elective structural heart disease procedures (SHD) as in our case. Thus, a proactive and vigilant stance on managing SHD should be a priority even in the context of the COVID-19 pandemic.

[Management of cardiogenic shock: a proposal for a shared protocol]. / Gestione dello shock cardiogeno: una proposta di percorso integrato.

Cardiogenic shock (CS) is a complex and relatively rare disease. Whilst its mortality remains unacceptably high, a multidisciplinary approach based on pre-established and shared protocols may improve prognosis and ensure appropriate resource allocation. Comprehensive hemodynamic assessment and monitoring as well as tailored, goal-directed medical therapy are part of an optimal management. Moreover, mechanical support devices may be helpful as they sustain hemodynamics to a greater extent as compared to inotropes and vasopressors, while lacking their cardiotoxic effects. Therefore, they are increasingly used in CS patients. In 2019, a new protocol for the management of patients with CS was adopted at the Ospedale Policlinico San Martino (HSM) in Genoa, Italy. Following in the footsteps of similar international experiences, the HSM protocol aims at streamlining the management of these high-risk patients improving the cooperation among healthcare specialists, and also addressing the key issues of mechanical support device implantation and appropriate referral for palliative care.

BMI and acute kidney injury post transcatheter aortic valve replacement: unveiling the obesity paradox.

AIMS: Acute kidney injury (AKI) may complicate transcatheter aortic valve replacement (TAVR) leading to higher mortality. The relationship between AKI, obesity, and mortality, however, is controversial. We sought to investigate the impact of body habitus on the prognostic value of AKI in TAVR. METHODS: Among the 645 patients who underwent successful TAVR in a single high-volume centre, we retrospectively evaluated the association between AKI-TAVR and 30-day, 6-month, and 1-year mortality, and whether this relationship was affected by BMI. AKI was defined according to the Valve Academic Research Consortium-2 criteria. Patients were categorized into three groups by BMI: low-to-normal weight (<25 kg/m2), overweight (25-30 kg/m2), obese (>30.0 kg/m2). RESULTS: Three-hundred and twenty-four (50.2%) patients were low-to-normal weight, 223 (34.6%) overweight, and 98 (15.2%) obese. AKI occurred in 141 (21.9%), similarly across BMI groups. Thirty-day, 6-month, and 1-year mortality rates were 2.2, 3.7, and 7.9%, without differences across BMI groups. Among patients who developed AKI-TAVR, 30-day (8.7 vs. 2.0 vs. 0.0%), 6-month (13.0 vs. 6.1 vs. 4.3%), and 1-year (20.3 vs. 12.2 vs. 4.3%) mortality showed a decreasing trend across increasing BMI categories (all P < 0.05); the same trend was not observed for patients without AKI-TAVR. In multivariate models, AKI was associated with 30-day [odds ratio (OR): 2.46, 95% confidence interval (CI): 1.70-8.67], 6-month (OR: 2.75, 95% CI: 1.32-7.59), and 1-year mortality (OR: 1.84, 95% CI: 1.22-3.71, all P < 0.05). The interaction between AKI and BMI, when added to the models, was consistently significant (all P < 0.05). CONCLUSION: Higher BMI is associated with better survival in TAVR patients who develop AKI.

Impact of bioprosthetic valve type on peri-procedural myocardial injury and mortality after transcatheter aortic valve replacement.

Peri-procedural myocardial injury (PPMI) is a common complication after transcatheter valve replacement (TAVR), often remaining clinically silent. The role of valve type on PPMI and the association between PPMI and mortality are still unclear. We sought to evaluate predictors and outcome of PPMI after TAVR, and the impact of self-expandable valve (SEV) vs. balloon-expandable valve (BEV) deployment on PPMI. Consecutive patients who underwent successful TAVR in a single-center from January 2014 to December 2019 were included. PPMI was defined according to a modified Valve Academic Research Consortium (VARC)-2 definition as a post-procedure elevation of troponin (with a peak value ≥ 15-times the upper-reference limit) < 72 h after TAVR. We included 596 patients, of whom 258 (43.3%) were men. Mean age was 83.4 ± 5.5 years. We deployed 368 (61.7%) BEV and 228 (38.3%) SEV. PPMI was observed in 471 (79.0%) patients. At multivariable analysis, SEV (OR 2.70, 95% CI 1.64-4.55, p < 0.001), creatinine clearance (OR 0.98, 95% CI 0.97-1.00, p = 0.011), and baseline ejection fraction (OR 1.05, 95% CI 1.02-1.07, p < 0.001) were independent predictors of PPMI; these findings were also confirmed using a propensity-weighted analysis. Thirty-day and 1-year all-cause mortality rates were 2.5% and 8.1%, respectively. No associations between PPMI and 30-day (p = 0.488) or 1-year (p = 0.139) all-cause mortality were found. Independent predictors of 30-day mortality were increasing EUROSCORE II (HR 1.16 per score point, 95% CI 1.08-1.19, p < 0.001) and life-threatening/major bleeding complications (HR 5.87, 95% CI 1.28-26.58, p = 0.019), whereas EUROSCORE II (HR 1.08, 95% CI 1.04-1.13, p = 0.031) and acute kidney injury (HR 2.59, 95% CI 1.20-5.35, p = 0.020) were related to 1-year mortality. PPMI is frequent after TAVR, but it does not affect 30-day or 1-year all-cause mortality. SEV implantation is associated with an increased frequency of PPMI.

Risk definition and outcomes with the application of the PEGASUS-TIMI 54 trial inclusion criteria to a "real world" STEMI population: results from the Italian "CARDIO-STEMI SANREMO" registry.

BACKGROUND: The PEGASUS-TIMI 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months. It is unknown how many real-world patients meet these criteria during the acute phase of ST-elevation MI (STEMI), or the extent to which these criteria predict a patient's risk and prognosis. Study objectives were: (1) determine the proportion of PEGASUS-TIMI 54-like patients (PG-l) in a real-world cohort of patients hospitalized with STEMI and to assess their ischemic and hemorrhagic risk; (2) examine their ischemic and hemorrhagic in-hospital events (major adverse cardiovascular and cerebrovascular events [MACCE] and clinically relevant bleeding); (3) evaluate their long-term outcomes and the impact on the long-term prognosis of the type of DAPT prescribed at discharge. METHODS: This observational study was conducted in 1086 patients admitted to hospital with a diagnosis of STEMI between February 2011 and March 2018 and enrolled in the CARDIO-STEMI Sanremo registry. Patients' demographic and clinical characteristics, procedural variables, and individual ischemic and hemorrhagic risk scores were assessed in-hospital. Four-year survival was also analyzed. RESULTS: The proportion of PG-I patients was 69.2%. Compared with non-PG-l patients, PG-l patients were older, had more multivessel disease and comorbidities, and experienced more frequent MACCE (8.3% vs. 3.6%, p = 0.005) and clinically significant bleeding events (6.7% vs. 2.7%, p = 0.008), a higher rate of in-hospital death (6.5% vs. 1.5%, p < 0.001), and higher follow-up mortality rate (14.8% vs. 7.7%; p = 0.002). Four-year survival was significantly lower in the PG-l group (83.9% vs. 91.8%; Log-rank = 0.001) and was related to the cumulative number of concurrent risk factors. In the unadjusted analysis, survival was greater in patients discharged on ticagrelor than on another P2Y12 inhibitor (90.2% vs. 76.7%, Log-rank = 0.001), and the difference was particularly evident in PG-l patients. CONCLUSIONS: The risk of MACCE for PG-l patients increased with the number of concurrent PEGASUS-TIMI 54 risk features. Treatment with ticagrelor on discharge was associated with improved survival rates during 4 years of follow-up.

Early infections after successful transcatheter aortic valve replacement are associated with increased short- and long-term mortality: A single-center study.

BACKGROUND: We reviewed frequency, microbiological pattern, predictors, and outcomes of early infections following transcatheter aortic valve replacement (TAVR). METHODS: Five hundred thirty-nine patients who underwent successful TAVR at a single, high-volume center between January 2014 and December 2019 were enrolled. We defined early infections as occurring within 30-day from TAVR. RESULTS: Mean age was 83.5 ± 5.4 years; 230 (42.7%) patients were men. Median follow-up was 12.0 (5.7-18.3) months; 30-day and 1-year death rates were 8/539 (1.5%) and 30/539 (5.6%), respectively. Early infections occurred in 61/539 (11.3%) patients, of whom 2 had infections in two sites. Of the 63 infections, 10 were bloodstream infections (BSI), 5 urinary tract, 27 pulmonary (2 with sepsis), 6 access site infections, 1 enterocolitis, and 14 were clinically diagnosed (no specific site). We observed 31/63 (49.2%) microbiologically-documented infections: Gram+ bacteria were isolated in 12/31 (38.7%), Gram- in 17/31 (54.3%), both Gram+ and Gram- in 2/31 (6.5%); in thirty-two infections no specific pathogen could be isolated (clinically-documented infections). Early infections were more prevalent in patients who died within 30-day (8.2% vs. 0.6%, p < 0.001) or 1-year (14.8% vs. 4.4%, p < 0.001) from TAVR. At multivariable analysis, early infections were independently associated with 30-day (HR: 8.82, 95% CI: 1.11-19.83, p = 0.035) and 1-year mortality (HR: 2.10, 95%CI: 1.28-6.21, p = 0.041). The predictive value for 1-year mortality was maintained even restricting the analysis to documented infections only, or to more severe infections (BSI and pneumonia only) (all p < 0.05). CONCLUSIONS: Early infections occur in 1/10th of TAVR and are associated with increased short- and long-term mortality. Whereas a causal relationship between early infections and the risk of death cannot be unequivocally proven, careful surveillance of infected patients may improve TAVR results.

Invasive strategy for COVID patients presenting with acute coronary syndrome: The first multicenter Italian experience.

OBJECTIVE: To report our initial experience of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/acute coronary syndrome (ACS) patients undergoing standard of care invasive management. BACKGROUND: The rapid diffusion of the SARS-CoV-2 together with the need for isolation for infected patients might be responsible for a suboptimal treatment for SARS-CoV-2 ACS patients. Recently, the group of Sichuan published a protocol for COVID/ACS infected patients that see the thrombolysis as the gold standard of care. METHODS: We enrolled 31 consecutive patients affected by SARS-COV-2 admitted to our emergencies room for suspected ACS. RESULTS: All patients underwent urgent coronary angiography and percutaneous coronary intervention (PCI) when required except two patients with severe hypoxemia and unstable hemodynamic condition that were conservatively treated. Twenty-one cases presented diffuse ST-segment depression while in the remaining cases anterior and inferior ST-elevation was present in four and six cases, respectively. PCI was performed in all cases expect two that were diagnosed as suspected myocarditis because of the absence of severe coronary disease and three with apical ballooning at ventriculography diagnostic for Tako-Tsubo syndromes. Two patients conservatively treated died. The remaining patients undergoing PCI survived except one that required endotracheal intubation (ETI) and died at Day 6. ETI was required in five more patients while in the remaining cases CPAP was used for respiratory support. CONCLUSIONS: Urgent PCI for ACS is often required in SARS-CoV-2 patients improving the prognosis in all but the most advanced patients. Complete patient history and examination, routine ECG monitoring, echocardiography, and careful evaluation of changes in cardiac enzymes should be part of the regular assessment procedures also in dedicated COVID positive units.

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

BACKGROUND: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic. METHODS: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression. RESULTS: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis. CONCLUSION: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.

Rationale and design of the MULTISTARS AMI Trial: A randomized comparison of immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease.

About half of patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD). Recent evidence supports complete revascularization in these patients. However, optimal timing of non-culprit lesion revascularization in STEMI patients is unknown because dedicated randomized trials on this topic are lacking. STUDY DESIGN: The MULTISTARS AMI trial is a prospective, international, multicenter, randomized, two-arm, open-label study planning to enroll at least 840 patients. It is designed to investigate whether immediate complete revascularization is non-inferior to staged (within 19-45 days) complete revascularization in patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI). After successful primary PCI of the culprit artery, patients are randomized in a 1:1 ratio to immediate or staged complete revascularization. The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year. CONCLUSIONS: The MULTISTARS AMI trial tests the hypothesis that immediate complete revascularization is non-inferior to staged complete revascularization in stable patients with STEMI and MVD.

Decrease and Delay in Hospitalization for Acute Coronary Syndromes During the 2020 SARS-CoV-2 Pandemic.

The diffusion of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) forced the Italian population to restrictive measures that modified patients' responses to non-SARS-CoV-2 medical conditions. We evaluated all patients with acute coronary syndromes admitted in 3 high-volume hospitals during the first month of SARS-CoV-2 Italian-outbreak and compared them with patients with ACS admitted during the same period 1 year before. Hospitalization for ACS decreased from 162 patients in 2019 to 84 patients in 2020. In 2020, both door-to-balloon and symptoms-to-percutaneous coronary intervention were longer, and admission levels of high-sensitive cardiac troponin I were higher. They had a lower discharged residual left-ventricular function and an increased predicted late cardiovascular mortality based on their Global Registry of Acute Coronary Events (GRACE) scores.

Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions.

BACKGROUND: Calcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland). METHODS: We retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45-50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE. RESULTS: Angiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patients coronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported. CONCLUSION: The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.