Drug-coated balloon combined with drug-eluting stent for the treatment of coronary bifurcation lesions: insights from the HYPER study.

True coronary bifurcation lesions (CBL) represent a challenging scenario for percutaneous coronary interventions (PCI), and are associated with a higher risk of target lesion failure (TLF), particularly when two stents are implanted. A hybrid strategy combining a drug-eluting stent (DES) in the main branch, and a drug-coated balloon in the side branch may improve outcomes by reducing the total stent length while maintaining an effective anti-prolipherative action. In this sub-study of the HYPER trial, 50 patients with true CBL were treated with a hybrid strategy: procedural success was 96%, one case of peri-procedural myocardial infarction and one case of TLF (in a DES-treated segment) at 1 year were reported. This study suggests that such a hybrid strategy may be a safe and effective option for true CBL PCI, and warrants additional investigations to compare outcomes with standard of care strategies.

The association between sexual orientation and eating disorders-related eating behaviours in adolescents: A systematic review and meta-analysis.

BACKGROUND: Sexual orientation is usually developed during the adolescence, which coincides with the eating disorders peak onset. This paper aims to explore existing literature to identify whether there is an association between sexual orientation and eating disorder-related eating behaviours (EDrEBs) in this age-group. METHODS: This review was based on the PRISMA guidelines, covering the published articles between 1990 and 2021. A meta-analysis of the proportion of sexual orientation and the adjusted odds ratio (OR) with 95% confident intervals was reported. RESULTS: Ten studies (412,601 participants) were included in this review. The results demonstrated adolescents identified as minority sexual orientation, particularly homosexual males were with higher OR of EDrEBs, as follows: Homosexual (binge eating: M = 7.20, F = 2.14; purging: M = 5.40, F = 2.41; diet pills use: M = 3.50, F = 2.59; dieting: M = 3.10, F = 1.75); Bisexual (binge eating: M = 4.60, F = 2.26; purging: M = 4.44, F = 2.37; diet pills use: M = 3.42, F = 2.30; dieting: M = 2.36, F = 1.86). CONCLUSIONS: Adolescents who were of a minority sexual orientation were more vulnerable to EDrEBs than their heterosexual peers. Healthcare professionals and sexual minority communities should be primed to facilitate earlier recognition and access to services in these vulnerable groups.

Microthrombi as a Major Cause of Cardiac Injury in COVID-19: A Pathologic Study.

BACKGROUND: Cardiac injury is common in patients who are hospitalized with coronavirus disease 2019 (COVID-19) and portends poorer prognosis. However, the mechanism and the type of myocardial damage associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain uncertain. METHODS: We conducted a systematic pathological analysis of 40 hearts from hospitalized patients dying of COVID-19 in Bergamo, Italy, to determine the pathological mechanisms of cardiac injury. We divided the hearts according to presence or absence of acute myocyte necrosis and then determined the underlying mechanisms of cardiac injury. RESULTS: Of the 40 hearts examined, 14 (35%) had evidence of myocyte necrosis, predominantly of the left ventricle. Compared with subjects without necrosis, subjects with necrosis tended to be female, have chronic kidney disease, and have shorter symptom onset to admission. The incidence of severe coronary artery disease (ie, >75% cross-sectional narrowing) was not significantly different between those with and without necrosis. Three of 14 (21.4%) subjects with myocyte necrosis showed evidence of acute myocardial infarction, defined as ≥1 cm2 area of necrosis, whereas 11 of 14 (78.6%) showed evidence of focal (>20 necrotic myocytes with an area of ≥0.05 mm2 but <1 cm2) myocyte necrosis. Cardiac thrombi were present in 11 of 14 (78.6%) cases with necrosis, with 2 of 14 (14.2%) having epicardial coronary artery thrombi, whereas 9 of 14 (64.3%) had microthrombi in myocardial capillaries, arterioles, and small muscular arteries. We compared cardiac microthrombi from COVID-19-positive autopsy cases to intramyocardial thromboemboli from COVID-19 cases as well as to aspirated thrombi obtained during primary percutaneous coronary intervention from uninfected and COVID-19-infected patients presenting with ST-segment-elevation myocardial infarction. Microthrombi had significantly greater fibrin and terminal complement C5b-9 immunostaining compared with intramyocardial thromboemboli from COVID-19-negative subjects and with aspirated thrombi. There were no significant differences between the constituents of thrombi aspirated from COVID-19-positive and -negative patients with ST-segment-elevation myocardial infarction. CONCLUSIONS: The most common pathological cause of myocyte necrosis was microthrombi. Microthrombi were different in composition from intramyocardial thromboemboli from COVID-19-negative subjects and from coronary thrombi retrieved from COVID-19-positive and -negative patients with ST-segment-elevation myocardial infarction. Tailored antithrombotic strategies may be useful to counteract the cardiac effects of COVID-19 infection.

Determinants and long-term outcomes of largely uncovered struts in thin-struts drug-eluting stents assessed by optical coherence tomography.

BACKGROUND: Uncovered struts are a determinant of stent failure. The impact of plaque composition and procedural factors on the occurrence, evolution, and outcomes of uncovered struts in a high-risk setting has not been investigated. OBJECTIVE: To investigate the determinants and long-term clinical impact of largely uncovered struts (LUS) in thin-struts drug-eluting stents (DES) implanted in complex lesions by intracoronary optical coherence tomography (OCT). METHODS: Ninety patients with multivessel disease undergoing staged complete revascularization were randomly assigned to bioabsorbable or durable polymer DES. OCT were serially performed during the index procedure, at 3- and 18-month follow-up, and analyzed by an independent core lab. Struts were defined uncovered by OCT if no tissue was visible above the struts. LUS were defined as ≥30% of uncovered struts at 3-month follow-up. Clinical outcomes were the occurrence of target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up. RESULTS: LUS occurred in 31 patients (34.4%) regardless of stent platform. At 5 years, no differences were observed in the rate of TVF (12.7% vs. 13.4%; p = 0.91) and MACCE (23.9% vs. 24.9%; p = 0.88) between the two groups. At multivariate logistic regression, plaque rupture, mean lumen diameter, proximal reference vessel area, and maximum stent deployment pressure were independent predictors of LUS. CONCLUSIONS: LUS are a frequent finding in complex coronary lesions treated with thin-struts DES, especially in the presence of plaque rupture. However, in this study, no significant safety signal related to LUS emerged in long-term follow-up.

Effect of Respiratory Impairment on the Outcomes of Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction and Coronavirus Disease-2019 (COVID-19).

BACKGROUND: Coronavirus Disease-2019 (COVID-19) may impair outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The extent of this phenomenon and its mechanisms are unclear.Methods and Results:This study prospectively included 50 consecutive STEMI patients admitted to our center for primary percutaneous coronary intervention (PCI) at the peak of the Italian COVID-19 outbreak. At admission, a COVID-19 test was positive in 24 patients (48%), negative in 26 (52%). The primary endpoint was in-hospital all-cause mortality. Upon admission, COVID-19 subjects had lower PO2/FiO2 (169 [100-425] vs. 390 [302-477], P<0.01), more need for oxygen support (62.5% vs. 26.9%, P=0.02) and a higher rate of myocardial dysfunction (ejection fraction <30% in 45.8% vs. 19.2%, P=0.04). All patients underwent emergency angiography. In 12.5% of COVID-19 patients, no culprit lesions were detected, thus PCI was performed in 87.5% and 100% of COVID-19 positive and negative patients, respectively (P=0.10). Despite a higher rate of obstinate thrombosis in the COVID-19 group (47.6% vs. 11.5%, P<0.01), the PCI result was similar (TIMI 2-3 in 90.5% vs. 100%, P=0.19). In-hospital mortality was 41.7% and 3.8% in COVID-19 positive and negative patients, respectively (P<0.01). Respiratory failure was the leading cause of death (80%) in the COVID-19 group, frequently associated with severe myocardial dysfunction. CONCLUSIONS: In-hospital mortality of COVID-19 patients with STEMI remains high despite successful PCI, mainly due to coexisting severe respiratory failure. This may be a critical factor in patient management and treatment selection.

Covid-19 and gender: lower rate but same mortality of severe disease in women-an observational study.

BACKGROUND: Gender-related factors might affect vulnerability to Covid-19. The aim of this study was to describe the role of gender on clinical features and 28-day mortality in Covid-19 patients. METHODS: Observational study of Covid-19 patients hospitalized in Bergamo, Italy, during the first three weeks of the outbreak. Medical records, clinical, radiological and laboratory findings upon admission and treatment have been collected. Primary outcome was 28-day mortality since hospitalization. RESULTS: 431 consecutive adult patients were admitted. Female patients were 119 (27.6%) with a mean age of 67.0 ± 14.5 years (vs 67.8 ± 12.5 for males, p = 0.54). Previous history of myocardial infarction, vasculopathy and former smoking habits were more common for males. At the time of admission PaO2/FiO2 was similar between men and women (228 [IQR, 134-273] vs 238 mmHg [150-281], p = 0.28). Continuous Positive Airway Pressure (CPAP) assistance was needed in the first 24 h more frequently in male patients (25.7% vs 13.0%; p = 0.006). Overall 28-day mortality was 26.1% in women and 38.1% in men (p = 0.018). Gender did not result an independent predictor of death once the parameters related to disease severity at presentation were included in the multivariable analysis (p = 0.898). Accordingly, the Kaplan-Meier survival analysis in female and male patients requiring CPAP or non-invasive ventilation in the first 24 h did not find a significant difference (p = 0.687). CONCLUSION: Hospitalized women are less likely to die from Covid-19; however, once severe disease occurs, the risk of dying is similar to men. Further studies are needed to better investigate the role of gender in clinical course and outcome of Covid-19.

Role of optical coherence tomography for distal left main stem angioplasty.

OBJECTIVE: The objective is to analyze the acute and midterm angiographic outcome of percutaneous treatment of left main coronary stem (LM-PCI) guided by optical coherence tomography (OCT). BACKGROUND: LM-PCI is a complex procedure, and several anatomical factors may impair its outcome. Intravascular imaging is emerging as a useful tool to guide the procedure. METHODS: We conducted a retrospective analysis of patients undergoing LM-PCI at three European centers between 2014 and 2017 with a control angiography at 6-12 months. Patients were divided into two groups: OCT-guidance (pre- and post-PCI) and control group (standard angiographic guidance with/out intravascular ultrasound [IVUS]). A blinded core lab analyzed all angiographic images. Primary endpoint was late lumen loss (LLL) after 6 months. RESULTS: A total of 112 patients entered the study, 55 in the OCT group and 57 in the control group (10 IVUS). Baseline and procedural characteristics were similar between groups. Overall, reference vessel diameter of the LM was 3.98 ± 0.65 mm. OCT guidance detected four cases of stent underexpansion (7.2%) and six cases of acute malapposition (10.9%). After a median of 207 ± 23 days, LLL of LM tended to be lower in the OCT group (0.12 ± 0.41 vs. 0.26 ± 0.52 mm, p = .10), and was significantly reduced in the distal portion of the main vessel (0.03 ± 0.45 vs. 0.24 ± 0.53 mm, p = .025). Percent diameter stenosis was also lower (14 ± 9 vs. 19 ± 16%, p = .05). Adverse event rates were similar in the two groups. CONCLUSIONS: In this study, systematic OCT guidance during LM-PCI allowed a timely detection and correction of acute stent underexpansion and malapposition, and was associated with signs of improved angiographic outcome at midterm, compared to standard practice.

How Digital Health Can Be Applied for Preventing and Managing Hypertension.

PURPOSE OF REVIEW: To summarize available data on digital health strategies for the prevention and management of hypertension, discussing the state-of-the-art, current limitations, and future perspective of this approach. RECENT FINDINGS: Technology is developing at a fast pace and is providing a number of novel solutions for cardiovascular patients, in particular in the field of digital health. Even if the benefit of these approaches is intuitive, the methodological heterogeneity of the available studies and their small sample size have made it difficult to provide robust evidence regarding the usefulness and cost-effectiveness of digital health technologies. Recently, studies with larger sample sizes and some meta-analyses have provided more convincing data on the favorable impact of such strategies. Digital health solutions may offer a chance to improve primary prevention and for timely diagnosis and effective management of hypertension. Results from small studies are promising, but there is a strong need for larger, long-term, and well-designed clinical trials to make these novel solutions really applicable in real-life patients' care.

Smartphone Applications for Hypertension Management: a Potential Game-Changer That Needs More Control.

PURPOSE OF THE REVIEW: This review article will summarize available data on mobile applications for the management of hypertension, by highlighting their potential for clinical use, the current limitations and the yet pending issues to be addressed in future studies. RECENT FINDINGS: The number of available applications related to arterial hypertension and their usage by smartphone owners is constantly increasing. However, most applications lack standardization and scientific validation, and security flaws could be an important, yet still underrated, issue. Small studies showed that treatment strategies based on telemonitoring of home blood pressure with mobile applications could improve blood pressure control, but there are no data on strong outcomes and the high heterogeneity of available studies severely limits the possibility of reaching a definitive conclusion on the impact of such strategies. Smartphone applications for arterial hypertension represent a great chance to improve management of this condition. Results from small studies are promising, but there is a strong need for large, long-term, well-designed clinical trials, before these potential solutions might be reliably applied in real-life patients' care.

A novel balloon-expandable transcatheter aortic valve bioprosthesis: Myval and Myval Octacor.

INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

INTRODUCTION: Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. METHODS: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). RESULTS: A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. CONCLUSION: Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis.

BACKGROUND: The new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. METHODS: The EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. RESULTS: At 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2-5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. CONCLUSIONS: Both THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Performance of the Mammoth Balloon Catheter in Patients with Severe Aortic Valve Stenosis Undergoing Percutaneous Treatment.

Background: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. Methods: A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. Results: A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV "stand-alone group", three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. Conclusions: Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators.

Association Between Coronary Artery Spasm and Atherosclerotic Disease.

In at least one-half of the patients with angina or ischemia and nonobstructive coronary arteries undergoing coronary function testing, coronary artery spasm (CAS) is detected. CAS is associated with an adverse prognosis regarding recurrent complaints and ischemic events. Current treatment options are mainly focused on the complaints, not on the underlying pathophysiological process. In this review we discuss available evidence regarding the presence, amount, and morphology of atherosclerosis in CAS patients. The reviewed evidence confirmed that atherosclerosis and vulnerable plaque characteristics are often detected in patients with CAS. The amount of atherosclerosis is higher in patients with focal CAS compared with patients with diffuse CAS. Severity of atherosclerosis is associated with the presence of CAS and the prognosis in CAS patients with atherosclerotic stenosis is worse. Therefore, CAS patients with atherosclerosis might benefit from targeted atherosclerotic treatment. Longitudinal studies are needed to elucidate the exact relation between atherosclerosis and CAS.

Percutaneous Coronary Intervention before or after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis Involving 1531 Patients.

Background: The optimal timing to perform percutaneous coronary interventions (PCIs) in patients undergoing transcatheter aortic valve replacement (TAVR) is not well established. In this meta-analysis, we aimed to compare the outcomes of patients undergoing PCI before versus after TAVR. Methods: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to 5 April 2024 for studies that compared PCI before and after TAVR reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were mortality, stroke, and myocardial infarction (MI) at follow-up. Results: A total of 3 studies involving 1531 patients (pre-TAVR PCI n = 1240; post-TAVR PCI n = 291) were included in this meta-analysis following our inclusion criteria. Mortality was higher in the pre-TAVR PCI group (OR: 2.48; 95% CI: 1.19-5.20; p = 0.02). No differences were found between PCI before and after TAVR for the risk of stroke (OR: 3.58; 95% CI: 0.70-18.15; p = 0.12) and MI (OR: 0.66; 95% CI: 0.30-1.42; p = 0.29). Conclusions: This meta-analysis showed in patients with stable CAD undergoing TAVR that PCI after TAVR is associated with lower mortality compared with PCI before TAVR.

Percutaneous Treatment of Left Main Disease: A Review of Current Status.

Percutaneous treatment of the left main coronary artery is one of the most challenging scenarios in interventional cardiology, due to the large portion of myocardium at risk the technical complexity of treating a complex bifurcation with large branches. Our aim is to provide un updated overview of the current indications for percutaneous treatment of the left main, the different techniques and the rationale underlying the choice for provisional versus upfront two-stent strategies, intravascular imaging and physiology guidance in the management of left main disease, and the role of mechanical support devices in complex high-risk PCI.