Dimensionless index and outcome in patients with aortic valve disease.

PURPOSE: Assessment of aortic stenosis (AS) is based on aortic valve (AV) gradients and calculation of aortic valve area (AVA). These parameters are influenced by flow and dependent on geometric assumptions. The dimensionless index (DI), the ratio of the LVOT time-velocity integral to that of the AV jet, is simple to perform, and is less susceptible to error but has only been examined in small selected groups of AS patients. The objective of this study was to assess the DI and prognosis in a large cohort. METHODS: All subjects who underwent echocardiography with an assessment of the AV that included DI were included. Association between AV parameters including mean gradient, AVA, DI and AV resistance and mortality and cardiovascular hospitalizations was examined. RESULTS: A total of 9393 patients (mean age 71 ± 16 years; 53% male) were included. 731 (7.7%) patients had DI less than .25. Increasing age and a diagnosis of heart failure were significantly associated with lower DI. Subjects with low DI had significantly lower ventricular function, a higher incidence of mitral and tricuspid regurgitation, worse diastolic function and more elevated pulmonary pressures. Decreasing DI was associated with significantly decreased survival and event-free survival which remained highly significant on multivariate analysis. CONCLUSIONS: In a large population of patients with AV disease, decreased DI, was associated with increased mortality and decreased event-free survival. The easily obtained DI identifies a broad range of AS subjects with worse prognosis and should be integrated into the assessment of these complex patients.

Aortic Arch Plaques and the Long-Term Risk of Stroke and Cardiovascular Events in the Statin Era.

BACKGROUND: Aortic arch plaques are associated with an increased risk of ischemic stroke in patients with cryptogenic stroke or prior embolic events. However, this relationship is unclear in the community. We investigated (1) the long-term risk of stroke and cardiovascular events associated with arch plaques and (2) whether statin therapy prescribed for any indication modified the association. METHODS: A total of 934 stroke-free participants (72±9 years; 37% men) from the CABL study (Cardiovascular Abnormalities and Brain Lesion) were evaluated. Arch plaques were assessed by suprasternal transthoracic echocardiography; plaques ≥4 mm in thickness were classified as large plaques. The primary outcome was ischemic stroke; the secondary outcome was combined cardiovascular events (ischemic stroke, myocardial infarction, and cardiovascular death). The plaque-related risk of outcomes was also analyzed according to the presence of statin treatment. No plaque was used as a reference. RESULTS: Aortic arch plaques were present in 645 participants (69.1%), with large plaques in 114 (12.2%). During a mean follow-up of 11.3±3.6 years, 236 (25.3%) cardiovascular events occurred (76 ischemic strokes, 27 myocardial infarctions, and 133 cardiovascular deaths). Large arch plaques were independently associated with combined events (adjusted hazard ratio, 2.19 [95% CI, 1.40-3.43]) but not stroke alone (adjusted hazard ratio, 1.09 [95% CI, 0.50-2.38]). The association between large plaques and cardiovascular events was significant in participants receiving statins (adjusted hazard ratio, 2.57 [95% CI, 1.52-4.37]) but not in others; however, participants on statin treatment also had a worse risk profile (higher body mass index, greater frequencies of hypertension, diabetes, and coronary artery disease). CONCLUSIONS: Aortic arch plaques may be a marker of cardiovascular risk rather than a direct embolic stroke source in older adults without prior stroke. The efficacy of broader cardiovascular risk factors control, beyond cholesterol levels alone, for primary prevention of cardiovascular events in individuals with aortic arch plaques may require further investigation.

The impact of aging on cardiac remodeling in chronic mitral regurgitation.

BACKGROUND: Chronic mitral regurgitation (MR) is a volume overload state that causes dilatation of the left sided cardiac chambers. The presence of significant dilatation is considered an indication for mitral valve intervention, however, aging may affect left ventricular (LV) remodeling independently of valvular disease. The objective of this study was to examine age-related changes in cardiac remodeling in a broad population of patients with chronic MR. METHODS: Consecutive subjects that underwent echocardiography examinations recorded in the echocardiography database of a university-affiliated laboratory were retrieved. Subjects were categorized into none/mild, moderate or severe MR. For purposes of analysis of differences with aging, the population was divided into groups above and below 70 years of age and standard echocardiographic measurements were compared between the groups. RESULTS: A total of 3492 subjects with at least moderate MR (mean age: 76 years, 52% female) were included in the study and compared to 18,250 subjects with none or mild MR. Older patients had significantly smaller LV end-diastolic diameters and volumes and significantly larger left atrial (LA) volumes when compared to the younger group. LA volume index increased in both age groups as MR severity increased, while LV end-diastolic volume increased with increasing MR only in the younger population. CONCLUSIONS: Cardiac remodeling in chronic MR is significantly influenced by age. Guideline based recommendations of timing of mitral valve interventions in asymptomatic MR patients, based on assessment of LA and LV remodeling, may need to take age into account.

Mitral Regurgitation Severity Assessment after Transcutaneous Edge-to-Edge Mitral Valve Repair: Recommended Integration versus Volumetric Assessment Guidelines.

Objectives: This article aims to evaluate the accuracy of the color-Doppler-based technique to evaluate residual mitral regurgitation post TEER. Background: The evaluation of residual mitral regurgitation (MR) post-mitral transcutaneous edge-to-edge repair (mitral TEER) is a critical determinant in patients' outcomes. The common methods used today, based on the integration of color flow Doppler parameters, may be misleading because of the multiple jets and high velocities created by the TEER devices. Methods: Patients undergoing TEER at Hadassah hospital were recruited between 2015 and 2019. Post-procedural MR was evaluated using the integrated qualitative approach as recommended by the guidelines. In addition, the MR volume for each patient was calculated by subtracting the forward stroke volume (calculated by multiplying the LVOT area with the velocity time integral of the LVOT systolic flow) from the total stroke volume (calculated by the biplane Simpson method of discs). We compared the two methods for concordance. Results: Overall, 112 cases were enrolled. In 55.4% of cases, the volumetric residual MR was milder than the MR severity assessed by the guidelines' recommended method. In 25.1%, the MR severity was similar in both methods. In 16.2%, the MR severity was worse when calculated using the volumetric method (pValue < 0.001, Kappameasure of agreement = 0.053). The lower residual MR degree using the volumetric approach was mostly observed in patients classified as "moderate" by the integrated approach. Conclusions: MR severity after TEER is often overestimated by the guideline-recommended integrative method when compared with a volumetric method. Alternative methods should be considered to assess the MR severity after mitral TEER.

Outcomes of patients with acute coronary syndrome according to COVID-19 vaccination status.

BACKGROUND: COVID-19 vaccination has been associated with reduced risk of acute coronary syndrome (ACS); however, several studies have reported cardiovascular complications following vaccination. We aimed to investigate the effect of COVID-19 vaccination status on the treatment and outcome of ACS patients. METHODS: The study was based on the 2021 Acute Coronary Syndrome Israeli Survey. Patients were stratified into two groups according to COVID-19 vaccination status, vaccinated compared to unvaccinated. Patients who had received at least 2 vaccination doses up to 1 week prior to ACS hospitalization were considered vaccinated. The primary endpoint was 1-year all-cause mortality. RESULTS: A total of 1261 patients with ACS were included, of whom 990 (78.5%) were vaccinated. Vaccinated patients were older and less frequently smokers. There were no significant differences in coronary reperfusion rates and treatment with guideline-based medical therapy during hospital stay and at discharge. The primary endpoint of 1-year all-cause mortality occurred in 38 (3.8%) and 14 (5.2%) patients in the vaccinated and unvaccinated groups respectively (P = 0.42). 30-day MACE occurred in 94 (9.5%) in the vaccinated patients compared to 31 (11.5%) in the unvaccinated group (P = 0.39). These results remained similar following adjustment for confounders. CONCLUSION: There was no association between COVID-19 vaccination status and the outcomes of patients with ACS. Our findings provide support for the cardiovascular safety of COVID-19 mRNA vaccines in patients at high cardiovascular risk.

Pathway for the Diagnosis and Management of Cardiac Amyloidosis.

The systemic amyloidoses are a broad spectrum of diseases that result from misfolding of proteins that aggregate into amyloid fibrils. In cardiac amyloidosis, amyloid fibrils accumulate in the interstitial space between cardiac myocytes causing cellular injury and impairing compliance. Current data suggest that cardiac amyloidosis is more common than previously thought. Advances in cardiac imaging, diagnostic strategies, and therapies have improved the recognition and treatment of cardiac amyloidosis. A position statement for the diagnosis and treatment of cardiac amyloidosis has been published in 2021 by the European Society of Cardiology and an expert consensus decision pathway was published in 2023 by the American College of Cardiology. These are excellent documents but quite lengthy and complex. For this reason, our team developed a novel and simple pathway to help health care providers diagnose and treat patients with cardiac amyloidosis. Our pathway starts with a section titled "suspicion" in which we provide simple clues or "red flags" that are associated with the cardiac amyloidosis phenotype. It is followed by a section titled "diagnosis," where we present in a simplified 2 × 2 format the laboratory and imaging tests that must be performed for an accurate diagnosis. In the section titled "treatment," we describe the 4 pillars in the management of patients with cardiac amyloidosis, which includes the following: heart failure treatments, management of arrhythmias, treatment of significant aortic stenosis, and appropriate selection of disease modifying therapies. Our algorithm ends with our simplified recommendation for follow-up.

Outcomes following transcatheter repair in patients with functional mitral regurgitation not receiving guideline directed medical therapy in Israel.

BACKGROUND: Transcatheter edge to edge repair (TEER) improves prognosis in patients with functional mitral regurgitation (FMR) receiving guideline directed medical therapy (GDMT). Many patients with FMR do not receive GDMT and the utility of TEER in this population remains unclear. METHODS: We retrospectively studied patients undergoing TEER. Clinical, echocardiographic and procedural variables were recorded. GDMT was defined as use of RAAS inhibitors and MRAs unless GFR was under 30 as well as beta blockers. The primary endpoint of the study was one year mortality. RESULTS: 168 patients (mean age 71.3 ± 9.3; 66% males) with FMR who underwent TEER were included of whom 116 (69%) received GDMT at the time of TEER and 52 (31%) did not. There were no significant demographic or clinical differences between the groups. There were no significant differences in procedural success and complications between groups. One year mortality was identical in the two groups (15% vs. 15%; RR 1.06, CI 0.43-2.63, P = 0.90). CONCLUSIONS: Our findings suggest that procedural success and one year mortality following TEER was not significantly different in HFREF patients with FMR with or without GDMT. Larger, prospective studies are necessary to define the benefit of TEER in this population.

The association between myocardial contraction fraction assessed by echocardiography and mortality.

BACKGROUND: Left ventricular ejection fraction (EF) is the most commonly used echocardiographic measurement of LV systolic function. Myocardial contraction fraction (MCF) may be a more accurate assessment of LV systolic function than EF. Limited data are available regarding the prognostic value of MCF compared to EF in a population referred for echocardiography. OBJECTIVES: To assess whether MCF was predictive of all-cause mortality in a population referred for echocardiography. METHODS: All consecutive subjects undergoing echocardiography in a university-affiliated laboratory during a 5-year period were retrieved for analysis. MCF was calculated by dividing LV stroke volume (LV end diastolic volume-LV end systolic volume) by LV myocardial volume and multiplied by 100. All cause mortality was the primary endpoint. Multivariate Cox proportional hazards regression analysis was used to evaluate independent variables associated with survival. RESULTS: 18,149 continuous subjects (median age 60 years, 53% male) were included. Median MCF in the cohort was 52% (interquartile range 40-64) while median EF was 64% (56-69). Any reduction in MCF from a value of 60 was significantly associated with survival on multivariable analysis. When echo parameters including EF, e:e', elevated TR gradient and significant MR were added to the model, MCF less than 50% remained significantly associated with mortality. MCF was also independently associated with both death and cardiovascular hospitalization. The AUC for MCF was .66 (95% confidence interval (CI): .65-.67) while for EF the AUC was only .58 (95% CI: .57-.59), a statistically significant difference (p < .0001). CONCLUSIONS: Reduced MCF is independently associated with mortality in a large population referred for echocardiography.

Long term aortic arch plaque progression in older adults.

Background and aims: The presence of aortic arch plaques (AAP) is significantly associated with increased cardiovascular morbidity and mortality. Few studies have examined the incidence of AAP progression and factors which may contribute to it using transthoracic echocardiography (TTE). The objective of this study was to utilize sequential imaging of the aortic arch using TTE to examine the rate of AAP progression and its risk factors in a cohort of older adults. Methods: Participants enrolled in both the Cardiovascular Abnormalities and Brain Lesion study (years 2005-2010) and the Subclinical Atrial Fibrillation and Risk of Ischemic Stroke study (2014-2019) who underwent TTE with assessment of aortic arch plaques at both time points represent the study cohort. Results: 300 participants were included in the study. Mean age was 67.8 ± 7.5 years at baseline, and 76.7 ± 6.8 years at follow-up; 197 (65.7%) were women. At baseline, 87 (29%) had no significant AAP, 182 (60.7%) had evidence of small AAP (2.0-3.9 mm) and 31 (10.3%) had evidence of large (≥4 mm) AAP. At the time of follow-up assessment, 157 (52.3%) of participants exhibited progression of AAP with 70 (23.3%) having mild progression and 87 (29%) having severe progression. There were no significant demographic or clinical predictors of AAP progression except baseline plaque thickness itself which was significantly lower in the group with AAP progression. Conclusions: Our study demonstrates a high prevalence of AAP on TTE exam in a population-based cohort of older adults with a high incidence of AAP progression. TTE is a useful test for baseline and follow up imaging of AAP, even in subjects with no or little AAP at baseline.

Factors associated with the progression of aortic valve calcification in older adults.

BACKGROUND: Aortic valve calcification (AVC) is a common valvular abnormality that predisposes to stenosis; AVC progression and factors associated with it remain unclear. We investigated the association of clinical factors and serum biomarkers with AVC progression in a population-based cohort of older adults. METHODS: Participants enrolled in both the Cardiovascular Abnormalities and Brain Lesion study (CABL; years 2005-2010) and the Subclinical Atrial Fibrillation And Risk of Ischemic Stroke study (SAFARIS;2014-2019) represent the study cohort. AVC was defined as bright dense echoes >1 mm in size on ≥1 cusps; each cusp was graded on a scale of 0 (normal) to 3 (severe calcification) at baseline and follow up. Serum biomarkers were measured at the time of follow-up assessment. RESULTS: 373 participants (mean 68.1 ± 7.6 years of age, 146 M/ 227F) were included. 139 (37%) had AVC progression;93 (25%) had mild progression (1 grade), and 46 (12%) had moderate-severe progression (≥2 grades). The only significant clinical predictor of any progression was the use of anti-hypertensive medication which was associated with older age, higher BMI and more frequent hypertension, diabetes and hyperlipidemia. In multivariable analysis including biomarkers, transforming growth factor beta 1 (TGF-ß1) was significantly associated with both all and moderate-severe AVC progression. CONCLUSIONS: A significant number of elderly subjects with AVC show progression of their valve disease; individual vascular risk factors are not associated with AVC progression, although a combined effect may exist. Higher levels of TGF-ß1 are observed in individuals with AVC progression.

Mild Tricuspid Regurgitation: A Marker of Disease Burden Independently Associated with Increased Mortality.

INTRODUCTION: Tricuspid regurgitation (TR) is a common finding which appears to be associated with a worse prognosis. There are conflicting data regarding the prognostic impact of mild TR. We examined the clinical characteristics and echocardiographic properties of subjects with TR and its impact on clinical outcome with particular emphasis on subjects with mild TR. METHODS: Consecutive echocardiography examinations during 5 years were evaluated for TR severity and outcome including mortality and cardiovascular hospitalizations. RESULTS: The study included 21,429 subjects; 45% of the subjects had mild TR, 15% had moderate TR, and 6.5% had severe TR. Primary organic TR was evident in 7% of the subjects, a percentage that increased with increasing TR severity. TR severity was incrementally associated with older subjects with an increasing number of comorbidities and echocardiographic abnormalities. 29% of the subjects died at a median follow-up duration of 8.7 years. Increasing severity of TR was independently and incrementally associated with mortality. Subjects with mild TR had a 25% increased mortality rate compared to subjects with minimal TR (HR 1.25, 95% CI: 1.12-1.39, p < 0.001) after adjustment for significant clinical parameters. TR severity was also an independent incrementally graded predictor of cardiovascular hospitalization and mortality (mild TR: HR 1.23, 95% CI: 1.12-1.34, p < 0.001). CONCLUSIONS: TR is associated with older and sicker patients with numerous comorbidities. TR severity is a predictor of a worse clinical outcome. Mild TR was independently associated with decreased survival. TR should be considered a marker of a disease burden with a poor prognosis.

Echocardiographic Characteristics and Clinical Outcomes of the Hyperdynamic Heart: A 'Super-Normal' Heart is not a Normal Heart.

A hyperdynamic heart is defined as a left ventricular (LV) with an ejection fraction (EF) above the normal range. Is this favorable? We looked at the diastolic properties of subjects with a hyperdynamic heart and its impact on outcome. Consecutive echocardiography examinations during 5 years were evaluated by EF subgroups, including a hyperdynamic heart (EF >70%). All examinations with significant LV hypertrophy or valve disease were excluded. The study included 16,994 subjects. A total of 720 subjects (4.2%) had a hyperdynamic heart. Subjects with a hyperdynamic heart were older, more likely to be women, and more likely to have hypertension, diabetes, and obesity. A total of 20% of patients had a diagnosis of heart failure. This group had a higher heart rate, smaller ventricular size, and the highest relative wall thickness. All indexes of diastolic dysfunction were significantly more prevalent in the hyperdynamic group. This included a higher LV mass, larger left atrial volume, reduced relaxation (smaller mitral e'), longer deceleration time, and higher LV end-diastolic pressures (high mitral E/e' ratio) and peak tricuspid regurgitation gradient. Diastolic dysfunction, defined by an abnormal functional or structural parameter, was present in 78% of the subjects. Survival was significantly lower in the group with a hyperdynamic heart. The Cox regression analysis after adjustment demonstrated reduced survival during a median 9-year follow-up in the hyperdynamic group compared with those with a normal EF (hazard ratio 1.56, 95% confidence interval 1.38 to 1.76, p <0.001). In conclusion, subjects with a hyperdynamic systolic function have increased prevalence of diastolic dysfunction and reduced survival. A hyperdynamic heart is not a normally functioning heart.

Myocardial contraction fraction predicts mortality in the oldest old.

Background: People over the age of 85 are the world's most rapidly growing age group. Ejection fraction (EF) may be limited prognostically in this population and myocardial contraction fraction (MCF) may be more accurate. The objective of this longitudinal study was to assess the prognosis of MCF in an age-homogenous, community-dwelling population of subjects. Methods: Subjects were recruited from the Jerusalem Longitudinal Cohort Study. Echocardiography was performed with a portable echocardiograph at the subjects place of residence. Standard echocardiographic assessment of cardiac structure and function including MCF was performed. Values of EF and MCF above and below the median for males and females were defined as normal and abnormal in categorical analysis. 5-year mortality was assessed via a centralized government database. Results: 418 subjects (199 males, 219 females) were enrolled in the study of whom 113 (27 %) died at the time of 5-year follow-up. Subjects who died had significantly lower MCF (32 ± 14 % vs 36 ± 12 %; p < 0.004) and EF (51.6 ± 11.6 % vs 56.3 ± 9.4 %; p < 0.0001) than survivors. The association between MCF and mortality remained significant on clinical multivariate analysis as both a categorical and continuous variable while EF was only significant as a continous variable. When both EF and MCF were added to the model only MCF as a categorical variable remained significant. Conclusions: MCF assessed by home echocardiography provides additional prognostic information to EF and may be a superior predictor of 5-year mortality in a community-dwelling population of the oldest old.

The Diagnosis and Management of Immune Checkpoint Inhibitor Cardiovascular Toxicity: Myocarditis and Beyond.

Recent years have brought major advancements in the use of immune therapy and specifically immune checkpoint inhibitors (ICIs) in cancer patients, with expanding indications for various malignancies resulting in the treatment of a large and increasing number of patients. While this therapy significantly improves outcomes in a variety of hematologic and solid tumors, the use of ICIs is associated with a substantial risk of immune-related adverse events. Cardiovascular toxicity, while not the most common side effect of ICIs, is associated with significant morbidity and mortality. It is therefore crucial for oncologists and cardiologists, as well as internists and emergency room physicians, to have a good understanding of this increasingly common clinical problem. In the present review, we discuss the cardiac aspects of ICI therapy with special emphasis on the clinical manifestations of their cardiovascular toxicity, diagnostic approaches, treatment and suggested surveillance.

Mass to voltage ratio index predicts mortality following TAVI.

Transcatheter aortic valve implantation (TAVI) is commonly performed in elderly patients with aortic stenosis. Better methods of risk stratification are needed in this population with high morbidity. There is a relatively high incidence of cardiac amyloidosis in this population and high LV mass index (LVMI) to QRS voltage may help identify patients with worse prognosis following TAVI. This retrospective study enrolled consecutive patients who underwent TAVI in our institution between the years 2008-2019. Mass voltage ratio index (MVRi) was calculated as the ratio of LV mass index on echocardiogram to voltage using the Sokolow-Lyon criteria on 12 lead ECG performed within 3 months before the intervention. Two hundred and fifty-one patients (mean age 80.8 years, 49% men) were enrolled. One hundred and sixty-eight (67%) patients were alive at 3 years follow up. MVRi was a statistically significant predictor of 3 year mortality (p < 0.005). Patients were divided categorically into tertiles based on MVRi score; the "high" group had significantly higher 3-year mortality (p < 0.001). In the multivariate model only Euroscore (p < 0.009) and MVRi (p < 0.011; OR: 2.32; CI: 1.15-4.964) were statistically significant predictors of mortality. The "high" group had a significantly lower survival rate after 3 years follow up on Kaplan-Meier analysis (p < 0.001). Our findings suggest that MVRi is a strong, independent predictor of increased post-TAVI mortality. This may be a simple clinical tool to assist in the assessment of patients prior to before TAVI.

A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.

The goal of therapy for patients with essential thrombocythemia (ET) and polycythemia vera (PV) is to reduce thrombotic events by normalizing blood counts. Hydroxyurea (HU) and interferon-α (IFN-α) are the most frequently used cytoreductive options for patients with ET and PV at high risk for vascular complications. Myeloproliferative Disorders Research Consortium 112 was an investigator-initiated, phase 3 trial comparing HU to pegylated IFN-α (PEG) in treatment-naïve, high-risk patients with ET/PV. The primary endpoint was complete response (CR) rate at 12 months. A total of 168 patients were treated for a median of 81.0 weeks. CR for HU was 37% and 35% for PEG (P = .80) at 12 months. At 24 to 36 months, CR was 20% to 17% for HU and 29% to 33% for PEG. PEG led to a greater reduction in JAK2V617F at 24 months, but histopathologic responses were more frequent with HU. Thrombotic events and disease progression were infrequent in both arms, whereas grade 3/4 adverse events were more frequent with PEG (46% vs 28%). At 12 months of treatment, there was no significant difference in CR rates between HU and PEG. This study indicates that PEG and HU are both effective treatments for PV and ET. With longer treatment, PEG was more effective in normalizing blood counts and reducing driver mutation burden, whereas HU produced more histopathologic responses. Despite these differences, both agents did not differ in limiting thrombotic events and disease progression in high-risk patients with ET/PV. This trial was registered at www.clinicaltrials.gov as #NCT01259856.

Apixaban vs. warfarin in patients with left ventricular thrombus: a prospective multicentre randomized clinical trial‡.

AIMS: Current guidelines recommend anticoagulation with a vitamin K antagonist to treat left ventricular (LV) thrombus after myocardial infarction (MI). Data on the use of direct oral anticoagulants (DOACs) in this setting are limited. The aim of the study was to assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI. METHODS AND RESULTS: We conducted a prospective, randomized, multicentre open-label clinical trial including patients with LV thrombus detected by 2D transthoracic echocardiography 1-14 days after acute MI. Thirty-five patients were enrolled in three medical centres; 17 patients were randomized to warfarin and 18 patients to apixaban. The primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation. Secondary outcomes were major bleeding, stroke or systemic embolism, re-hospitalization, and all-cause mortality. Mean LV thrombus size at enrolment was 18.5 mm × 12.3 mm in the warfarin group and 19.9 mm × 12.4 mm in the apixaban group (P = NS). Thirty-two patients completed 3 months follow-up. In the warfarin group, two patients withdrew, and in the apixaban group one patient died. Thrombus completely resolved in 14 of 15 patients in the warfarin group and in 16 of 17 patients in the apixaban group (P = NS and P = 0.026 for non-inferiority). Two patients had major bleeding in the warfarin group, while no major bleeding events were recorded in the apixaban group. There was one stroke in the warfarin group and one death in the apixaban group. CONCLUSION: Our results suggest that apixaban is non-inferior to warfarin for treatment of patients with LV thrombus after acute MI with a 20% non-inferiority margin.

Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is common in elderly people and is increasing in prevalence. No specific treatment for this condition exists. Coenzyme Q10 (CoQ10) is an essential cofactor for energy production, with reduced levels being noted in HF. Previous studies have suggested a possible role for CoQ10 in the treatment of HF. This study examined the effect of CoQ10 supplementation on diastolic function in HFpEF patients. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled trial including patients aged > 55 years presenting with New York Heart Association class II-IV heart failure symptoms and left ventricular ejection fraction > 50%, with impaired diastolic function. Echocardiography and levels of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) were performed at baseline and following 4 months of CoQ10 or placebo supplementation. RESULTS: A total of 39 patients were enrolled-19 in the CoQ10 group and 20 in the placebo group. Baseline clinical characteristics were similar between groups, while compliance was high and also similar between the CoQ10 and placebo groups. There was no significant effect of treatment on indices of diastolic function (difference in the lateral E/e' ratio: -0.86 ± 6.57 in the CoQ10 group, +0.18 ± 3.76 in the placebo group; p = 0.561) or on serum NT-proBNP levels (- 72 pg/mL vs. - 42 pg/mL; p = 0.195). CONCLUSIONS: In this pilot trial in elderly patients with HFpEF, treatment with CoQ10 did not significantly affect echocardiographic indices of diastolic function and serum NT-proBNP levels. TRIAL REGISTRATION: This trial was registered in the US National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02779634).