Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

BACKGROUND: ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). AIMS: The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. METHODS: We collected relevant clinical data of patients undergoing TAVI in a large volume centre. PRIMARY OUTCOME: main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. SECONDARY OUTCOME: any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. RESULTS: Five hundred and seventeen patients undergoing TF-TAVI were included. PRIMARY OUTCOME: In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. SECONDARY OUTCOME: 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). CONCLUSIONS: Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

First worldwide use of pulsed-field ablation for ventricular tachycardia ablation via a retrograde approach.

INTRODUCTION: We present the first worldwide use of pulsed-field ablation (PFA) for ventricular tachycardia (VT) ablation via a retrograde approach. METHODS: The patient had previously failed conventional ablation of an intramural circuit underneath the aortic valve. The same VT circuit was inducible during the procedure. The Farawave PFA catheter and Faradrive sheath were used to deliver PFA applications. RESULTS: Post ablation mapping demonstrated scar homogenization. There was no evidence of coronary spasm during PFA applications and no other complications occurred. VT was non-inducible post ablation and the patient has remained free of arrhythmia at follow-up. CONCLUSION: PFA for VT via a retrograde approach is feasible and effective.

Characterizing passenger-ship emissions: towards improved sustainability for MedMar fleet (gulf of Naples).

Promoting energetic and environmental sustainability in the naval sector requires a necessary understanding of the energy demand of vessels and of the factors affecting it. This article shows the results of a study conducted by the shipping company MedMar aimed at acquiring a detailed analysis of the energetic performances of its fleet. The study involved the analysis of fuel consumption and emissions of the fleet using a specific software and under different scenarios, assuming the navigation speed and the cargo level of the vessels as reference parameters. Simulations also provided a comparison, concerning emissions and externalities, between ships and two different means of transport. The purpose of this study was to identify potential areas of improvement, where ad hoc strategies could be used to further optimise the energetic and environmental performance of MedMar fleet and mitigate its impact on the delicate ecosystem of the gulf of Naples, where the fleet sails. Supplementary Information: The online version contains supplementary material available at 10.1007/s12053-022-10064-7.

Transcatheter Aortic Valve Implantation for Severe Pure Aortic Regurgitation With Dedicated Devices.

Aortic regurgitation (AR) is not the most common valvular disease; however, its prevalence increases with age, with more than 2% of those aged >70 years having at least moderate AR. Once symptoms related to AR develop, the prognosis becomes poor. Transcatheter aortic valve implantation for patients with pure severe AR and at prohibitive surgical risk is occasionally performed, but remains a clinical challenge due to absence of valvular calcium, large aortic root and increased stroke volume. These issues make the positioning and deployment of transcatheter aortic valve implantation devices unpredictable, with a tendency to prosthesis embolisation or malposition. To date, the only two dedicated transcatheter valves for AR are the J-Valve (JC Medical) and the JenaValve (JenaValve Technology). Both devices have been used successfully via the transapical approach. The transfemoral experience is limited to first-in-human publications and to a clinical trial dedicated to AR, for which the completion date is still pending.

Relationship between a single measurement at baseline of body mass index, glycated hemoglobin, and the risk of mortality and cardiovascular morbidity in type 2 diabetes mellitus.

OBJECTIVE: This study aims to evaluate the relationship between a single measurement at baseline of body mass index (BMI), glycated hemoglobin (HbA1c) and subsequent clinical outcomes in patients with type 2 diabetes mellitus (T2DM). METHOD: Patients with T2DM were recruited from an outpatient diabetes clinic in a single large teaching hospital in Kingston upon Hull, UK. At baseline, demographics and HbA1c were recorded. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obese (>30 kg/m2). Multivariable Cox regression models that included demographic, risk factors, and comorbidities were separately constructed for all-cause, cardiovascular, cancer and sepsis-related mortality, using four groups of HbA1c (<6%, 6.0-6.9%, 7.0-7.9%, and >8%). RESULTS: In total, 6220 patients with T2DM (median age 62 years, 54% male) were followed for a median of 10.6 years. HbA1c levels >8.0% were associated with increased risk of all-cause mortality and cardiovascular death. However, this increased risk was not consistent across the weight categories and reached statistical significance only in overweight patients (BMI 25-29.9 kg/m2). CONCLUSIONS: In a large cohort of patients with T2DM elevated HbA1c levels at baseline did not consistently predict increased risk of all-cause and cardiovascular mortality across the different BMI categories.

Coronary Revascularization in Patients With Advanced Chronic Kidney Disease.

Patients with chronic kidney disease (CKD) have an increased risk of obstructive coronary artery disease (CAD), whereas patients with end stage renal disease who are receiving hemodialysis represent a population at particularly high risk of developing cardiac ischemic events. Patients with CKD and acute coronary syndromes should be treated the same way as acute coronary syndromes patients without kidney dysfunction. The benefit of revascularization in patients with advanced kidney failure and CAD is unknown. Observational studies suggest that revascularization might confer a survival benefit compared with medical therapy alone. Little evidence from randomized trials exists regarding the effectiveness of revascularization of patients with CAD with either coronary artery bypass grafting or percutaneous coronary intervention vs medical therapy alone in patients with CKD. The risk of contrast-induced nephropathy is a major concern when percutaneous coronary intervention is performed in patients with CKD. Strict rehydration protocols and techniques to minimize contrast use are paramount to reduce this risk. Finally, in CKD patients who are awaiting kidney transplantation, a noninvasive or invasive CAD screening approach according to the cardiovascular risk profile should be used. Revascularization should be performed in candidates with critical lesions.

Proprotein Convertase Subtilisin/kexin type 9 Inhibition in Cardiovascular Prevention.

Elevated levels of Low Density Lipoprotein cholesterol (LDL-C) are directly associated with increased risk for atherosclerotic cardiovascular and cerebrovascular events. Statins have been used to control serum LDLC and this has translated into reduction in cardiovascular and cerebrovascular events. However, despite high dose statin therapy, LDL-C control may remain inadequate in some patients, particularly those with familial hypercholesterolemia. A new therapeutic approach has emerged in recent years with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. In this review, we describe the development and the use of this new class of drugs.

Clinical and prognostic relationships of pulmonary artery to aorta diameter ratio in patients with heart failure: a cardiac magnetic resonance imaging study.

BACKGROUND: The pulmonary artery (PA) distends as pressure increases. HYPOTHESIS: The ratio of PA to aortic (Ao) diameter may be an indicator of pulmonary hypertension and consequently carry prognostic information in patients with chronic heart failure (HF). METHODS: Patients with chronic HF and control subjects undergoing cardiac magnetic resonance imaging were evaluated. The main PA diameter and the transverse axial Ao diameter at the level of bifurcation of the main PA were measured. The maximum diameter of both vessels was measured throughout the cardiac cycle and the PA/Ao ratio was calculated. RESULTS: A total of 384 patients (mean age, 69 years; mean left ventricular ejection fraction, 40%; median NT-proBNP, 1010 ng/L [interquartile range, 448-2262 ng/L]) and 38 controls were included. Controls and patients with chronic HF had similar maximum Ao and PA diameters and PA/Ao ratio. During a median follow-up of 1759 days (interquartile range, 998-2269 days), 181 patients with HF were hospitalized for HF or died. Neither PA diameter nor PA/Ao ratio predicted outcome in univariable analysis. In a multivariable model, only age and NT-proBNP were independent predictors of adverse events. CONCLUSIONS: The PA/Ao ratio is not a useful method to stratify prognosis in patients with HF.

[Betablockers in patients with heart failure and atrial fibrillation]. / Betabloccanti in pazienti con scompenso cardiaco e fibrillazione atriale.

A recent individual patient data meta-analysis has shown that beta-blockers reduce mortality in patients with heart failure and reduced left ventricular ejection fraction (HFrEF) who are in sinus rhythm but not in those who are in atrial fibrillation. Similar results applied also to cardiovascular death or first hospitalization for heart failure. The European Society of Cardiology guidelines recommend beta-blockers in patients with HFrEF regardless of baseline rhythm. However, despite improving symptoms, the prognostic benefits of beta-blockers have now been questioned by these authors in patients with HFrEF and atrial fibrillation. In this review we comment the findings of this study.

The role of metabolic syndrome in heart failure.

Metabolic syndrome (MS) is a highly prevalent condition in patients affected by heart failure (HF); however, it is still unclear whether, in the setting of cardiac dysfunction, it represents an adverse risk factor for the occurrence of cardiac events. The epidemiologic implications of MS in HF have been studied intensely, as many of its components contribute to the incidence and severity of HF. In particular, insulin resistance, diabetes mellitus, and lipid abnormalities represent the main components that negatively influence disease progression and evolution. Yet, other components of the MS, i.e. overweight/obesity and high blood pressure, are favourably associated with outcome in HF patients. The aim of this review was to report epidemiology and prognostic role of MS in HF and to investigate current clinical implications and future research needs.

The obesity paradox in type 2 diabetes mellitus: relationship of body mass index to prognosis: a cohort study.

BACKGROUND: Whether obesity is associated with a better prognosis in patients with type 2 diabetes mellitus is controversial. OBJECTIVE: To investigate the association between body weight and prognosis in a large cohort of patients with type 2 diabetes followed for a prolonged period. DESIGN: Prospective cohort. SETTING: National Health Service, England. PATIENTS: Patients with diabetes. MEASUREMENTS: The relationship between body mass index (BMI) and prognosis in patients with type 2 diabetes without known cardiovascular disease at baseline was investigated. Information on all-cause mortality and cardiovascular morbidity (such as the acute coronary syndrome, cerebrovascular accidents, and heart failure) was collected. Cox regression survival analysis, corrected for potential modifiers, including cardiovascular risk factors and comorbid conditions (such as cancer, chronic kidney disease, and lung disease), was done. RESULTS: 10,568 patients were followed for a median of 10.6 years (interquartile range, 7.8 to 13.4). Median age was 63 years (interquartile range, 55 to 71), and 54% of patients were men. Overweight or obese patients (BMI >25 kg/m²) had a higher rate of cardiac events (such as the acute coronary syndrome and heart failure) than those of normal weight (BMI, 18.5 to 24.9 kg/m²). However, being overweight (BMI, 25 to 29.9 kg/m²) was associated with a lower mortality risk, whereas obese patients (BMI >30 kg/m²) had a mortality risk similar to that of normal-weight persons. Patients with low body weight had the worst prognosis. LIMITATION: Data about cause of death were not available. CONCLUSION: In this cohort, patients with type 2 diabetes who were overweight or obese were more likely to be hospitalized for cardiovascular reasons. Being overweight was associated with a lower mortality risk, but being obese was not. PRIMARY FUNDING SOURCE: National Institute for Health Research and University of Hull.

Global longitudinal strain in patients with suspected heart failure and a normal ejection fraction: does it improve diagnosis and risk stratification?

Many patients have clinical, structural or bio-marker evidence of heart failure (HF) but a normal left ventricular ejection fraction (LVEF; HeFNEF). Measurement of global longitudinal strain (GLS) may add diagnostic and prognostic information. Patients with symptoms suggesting heart failure and LVEF ≥50% were studied: 76 had no substantial cardiac dysfunction (left atrial diameter (LAD) <40 mm and amino-terminal pro-brain natriuretic peptide (NTproBNP) <400 ng/l); 99 had "possible HeFNEF" (LAD ≥40 mm or NTproBNP ≥400 ng/l); and 138 had "definite HeFNEF" (LAD ≥40 mm and NTproBNP ≥400 ng/L). Mean LVEF was 58% in each subgroup. Patients with definite HeFNEF were older, more likely to have atrial fibrillation, had more symptoms and signs of fluid retention, were more likely to have right ventricular dysfunction and had higher pulmonary pressures than other groups. Mean GLS (SD) was less negative in patients with definite HeFNEF (-13.6 (3.0)% vs. possible HeFNEF: -15.2 (3.1)% vs. no substantial cardiac dysfunction: -15.9 (2.4)%; p < 0.001). GLS was -19.1 (2.1)% in 20 controls. During a median follow up of 647 days, cardiovascular death or an unplanned hospitalisation for heart failure occurred in 62 patients. In univariable analysis, GLS but not LVEF predicted events. However, in a multi-variable analysis, only urea, NTproBNP, left atrial volume, inferior vena cava diameter and atrial fibrillation independently predicted adverse outcome. GLS is abnormal in patients who have other evidence of HeFNEF, is associated with a worse prognosis in this population but is not a powerful independent predictor of outcome.

Intravenous versus intracoronary bolus of glycoprotein IIb/IIIa inhibitor administration during primary percutaneous coronary intervention on long-term left ventricular systolic and diastolic function.

BACKGROUND: In primary percutaneous coronary intervention (PCI), glycoprotein (GP) IIb/IIIa inhibitors are often given in order to attain and maintain better myocardial perfusion. We tested the hypothesis that intracoronary (IC) bolus of GP IIb/IIIa inhibitors might produce a greater improvement in left ventricular (LV) systolic and diastolic function than an intravenous(IV) bolus. METHODS AND RESULTS: Seventy seven patients undergoing primary PCI for their first ST elevation myocardial infarction (STEMI) were randomly assigned to either an IC or IV bolus of GP IIb/IIIa inhibitor, followed by IV infusion. Compared with the echocardiographic findings within 3 days after PCI, LV ejection fraction was higher at 1 year, with no significant differences between the IV and IC groups (IV: 44% vs. 49%, p = 0.001; IC: 43% vs. 48%,p < 0.001). LV diastolic function (E/E') did not significantly change at 1 year by either approach. CONCLUSIONS: LV systolic function improved by a similar magnitude following primary PCI, with either IC or IV bolus administration of GP IIb/IIIa inhibitor therapy. However, no significant changes were observed in LV diastolic function.

Transient ischemic dilation in SPECT myocardial perfusion imaging for prediction of severe coronary artery disease in diabetic patients.

BACKGROUND: Transient ischemic dilation (TID) of the left ventricle during stress myocardial perfusion SPECT (MPS) has been shown to be a useful marker of severe coronary artery disease (CAD). However, investigations in diabetic patients with available coronary angiographic data are still limited. We evaluated the incremental diagnostic value of TID in identifying the presence of angiographically severe CAD in diabetic patients. METHODS AND RESULTS: TID ratio values were automatically derived from rest-stress MPS in 242 diabetic patients with available coronary angiography data. A cutoff of ≥1.19 was considered to represent TID. Severe CAD (≥70% stenosis in the proximal left anterior descending artery or the left main artery, or ≥90% stenosis in two or three vessels) was identified in 69 (29%) patients. At multivariate analysis, the best independent predictors of severe CAD were summed stress score and TID (both P < .001). At incremental analysis, the addition of TID improved the power of a model including clinical data and summed stress score, increasing the global χ(2) value from 14.3 to 28.2 (P < .01). The best cutoff of summed stress score for identifying patients with severe CAD was ≥8. When the TID ratio was considered in patients with summed stress score between 3 and 7, the sensitivity for diagnosing severe CAD significantly improved from 71% to 77% (P < .05). In the overall study population, the net reclassification improvement by adding TID to a model including clinical data and summed stress score in the prediction of severe CAD was 0.40 (P < .005). CONCLUSIONS: TID ratios obtained from rest-stress MPS provide incremental diagnostic information to standard perfusion analysis for the identification of severe and extensive CAD in diabetic patients.

Left ventricular hypertrophy reduction and clinical events. A meta-regression analysis of 14 studies in 12,809 hypertensive patients.

BACKGROUND: Left ventricular hypertrophy (LVH) is an independent risk factor for clinical events (CE), and regression of LVH is associated with reduction of cardiovascular risk. However, whether a continuous relationship between reduction of LVH and risk of CE exists has not been investigated. METHODS: Randomized clinical trials evaluating LVH at baseline and reporting quantitative LVH changes and CE, stroke or new onset heart failure) were included. Meta-regression analysis was performed to test the relationship between changes in LVH and incidence of the composite outcome (all-cause death, MI, stroke or new onset heart failure) and between changes of LVH and occurrence of each component of the composite outcome. Analysis of potential confounder variables was also performed. RESULTS: Fourteen trials including 12,809 participants and reporting 2259 events were included. Follow-up ranged from 0.50 to 5 years, with mean 1.97 ± 1.50 years. Mean age was 62 ± 5 years and 52% of patients were women. The composite outcome was significantly reduced by active treatments (OR: 0.851, IC: 0.780 to 0.929, p<0.001), as well stroke (OR: 0.756, IC: 0.638 to 0.895, p<0.001) whereas MI and new onset heart failure were not significantly reduced by treatments. LVH changes did not predict the reduction of CE. No significant influence on the association of baseline patients and studies characteristics was found. CONCLUSIONS: A significant continuous relationship between LVH changes and CE could not be demonstrated in hypertensive patients, independently on the technique or drug used. Ad hoc designed studies should further explore the relationship between LVH modification and outcomes in hypertensive patients.

A meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heart failure.

OBJECTIVES: The goal of the study was to assess the effects of angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs) on the composite of cardiovascular (CV) death, myocardial infarction (MI), and stroke, and on all-cause death, new-onset heart failure (HF), and new-onset diabetes mellitus (DM) in high-risk patients without HF. BACKGROUND: ACE-Is reduce CV events in high-risk patients without HF whereas the effects of ARBs are less certain. METHODS: Twenty-six randomized trials comparing ARBs or ACE-Is versus placebo in 108,212 patients without HF were collected in a meta-analysis and analyzed for the risk of the composite outcome, all-cause death, new-onset HF, and new-onset DM. RESULTS: ACE-Is significantly reduced the risk of the composite outcome (odds ratio [OR]: 0.830 [95% confidence interval (CI): 0.744 to 0.927]; p = 0.001), MI (OR: 0.811 [95% CI: 0.748 to 0.879]; p < 0.001), stroke (OR: 0.796 [95% CI: 0.682 to 0.928]; p < 0.004), all-cause death (OR: 0.908 [95% CI: 0.845 to 0.975]; p = 0.008), new-onset HF (OR: 0.789 [95% CI: 0.686 to 0.908]; p = 0.001), and new-onset DM (OR: 0.851 [95% CI: 0.749 to 0.965]; p < 0.012). ARBs significantly reduced the risk of the composite outcome (OR: 0.920 [95% CI: 0.869 to 0.975], p = 0.005), stroke (OR: 0.900 [95% CI: 0.830 to 0.977], p = 0.011), and new-onset DM (OR: 0.855 [95% CI: 0.798 to 0.915]; p < 0.001). CONCLUSIONS: In patients at high CV risk without HF, ACE-Is and ARBs reduced the risk of the composite outcome of CV death, MI, and stroke. ACE-Is also reduced the risk of all-cause death, new-onset HF, and new-onset DM. Thus, ARBs represent a valuable option to reduce CV mortality and morbidity in patients in whom ACE-Is cannot be used.

Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials.

OBJECTIVES: The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH). BACKGROUND: 6MWD is used as an endpoint to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown. METHODS: Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes. RESULTS: Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio [OR]: 0.429; 95% confidence interval [CI]: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected. CONCLUSIONS: In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes.

Questioning the predictive role of carotid intima-media thickness.

Interest in carotid intima-media thickness (IMT), as a tool to evaluate cardiovascular risk has been driven by studies that demonstrate a relationship between carotid IMT and the incidence of cardiovascular events. However, no study was designed and powered to demonstrate a relationship between changes in carotid IMT during follow-up and cardiovascular events. Therefore, a pooled analysis of existing clinical studies was performed to investigate this relationship. This analysis failed to demonstrate a predictive role of changes in carotid IMT for cardiovascular events. The reason for the lack of clear evidence for a predictive role for changes in IMT are uncertain but may reflect methodological problems related to intra- and inter-observer variability, as it seems unlikely that progression of carotid atherosclerosis would not predict outcome. A further meta-analysis based on individual patient-data has been planned, that may better address this issue. The variability of ultrasound measurements of carotid IMT are likely to be reduced by further development of automatic calculation of this index by MRI.