Publications by authors named "Jalal Ghali"

125 Publications

Trends, Predictors and Outcomes of Ischemic Stroke Among Patients Hospitalized with Takotsubo Cardiomyopathy.

J Stroke Cerebrovasc Dis 2021 Jul 28;30(10):106005. Epub 2021 Jul 28.

Department of Medicine, Morehouse School of Medicine, 720 Westview Drive S.W., Atlanta, GA 30310, United States. Electronic address:

Objectives: This study assessed the temporal trends in the incidence of ischemic stroke among patients hospitalized with takotsubo cardiomyopathy (TCM) stratified by the subtypes of ischemic stroke (cardioembolic versus thrombotic).Predictors of each stroke subtype, the association with atrial fibrillation (AF), the occurrence of ventricular fibrillation/ventricular tachycardia (VF/VT),cardiogenic shock (CS), in-hospital mortality, length of stay (LOS), and total healthcare cost were also assessed.

Background: Ischemic stroke in TCM is thought to be primarily cardioembolic from left ventricular mural thromboembolism. limited data are available on the incidence of thrombotic ischemic stroke in TCM.

Materials And Methods: We identified 27,970 patients hospitalized with the primary diagnosis of TCM from the 2008 to 2017 National Inpatient Sample, of which 751 (3%) developed ischemic stroke. Of those with ischemic stroke, 571 (76%) had thrombotic stroke while 180 (24%) had cardioembolic stroke. Cochrane armitage test was used to assess the incidence of thrombotic and cardioembolic strokes and multivariate regression was used to identify risk factors associated with each stroke subtype. We compared the incidence of AF, VF/VT, CS, LOS, in-hospital mortality and total cost between hospitalized patients with TCM alone to those with cardioembolic and thrombotic strokes.

Results: From 2008 - 2017, the incidence of thrombotic stroke (4.7%-9.5% (p< 0.0001) increased while it was unchanged for cardioembolic stroke (0.5%-0.7% P=0.5). In the multivariate regression, peripheral artery disease, prior history of stroke, and hyperlipidemia were significantly associated with thrombotic stroke, while CS, AF, and Asian race (compared to White race) were associated with cardioembolic stroke. Both cardioembolic and thrombotic strokes were associated with higher odds of IHM, AF, CS, longer LOS and increased cost. Trends in in-hospital mortality and the utilization of thrombolysis, cerebral angiography, and mechanical thrombectomy among patients with TCM and ischemic stroke were unchanged from 2008 to 2017.

Conclusion: Among patients with TCM and ischemic stroke, thrombotic stroke was more common compared to cardioembolic stroke. Ischemic stroke was associated with poorer outcomes, including higher in-hospital mortality and increased healthcare resource utilization in TCM.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2021.106005DOI Listing
July 2021

Trends, Associations, and Impact of Atrial Fibrillation in Patients With Light-chain Cardiac Amyloidosis.

Crit Pathw Cardiol 2021 Sep;20(3):168-172

Department of Medicine, Morehouse School of Medicine, Atlanta, GA.

Background: In this study, we investigated the temporal trends in the prevalence and prognostic implication of atrial fibrillation (AF) in patient with light-chain cardiac amyloidosis (AL-CA).

Methods: We identified 3030 patients with AL-CA from the 2015 to 2017 National Inpatient Sample, of which 1577 (52%) had AF. We used trend analysis to assess the temporal trends in the prevalence of AF by subtype from 2015 to 2017. We compared inhospital mortality, acute on chronic heart failure, stroke, length of stay (LOS), and total cost in patients with to those without AF, stratified by subtype of AF.

Results: The prevalence of AF among patients with AL-CA was unchanged from 2015 to 2017 (50%-53%; adjusted odds ratio, 1.1 [0.9-1.5]; P = 0.3). The trend was unchanged in the stratified analysis by subtype of AF. Patients with AF were older and had more comorbidities. After propensity matching, acute on chronic heart failure was significantly higher in patients with AL-CA and AF, compared with those with AL-CA alone (55.6% vs. 48.3%; P < 0.0001). There was no difference in inhospital mortality (7.5% vs. 7.5%; P = 0.9), stroke (2.0% vs. 2.5%; P = 0.5), median LOS (5 [3-9] vs. 5 [3-8]; P = 0.3), and median total hospital cost $42,469 ([$21,309-$92,855] vs. $44,008 [$22,889-$94,200]; P = 0.6). In the stratified analysis, acute on chronic heart failure remained significant higher in patients with paroxysmal and nonparoxysmal AF, while LOS became significantly longer in patients with paroxysmal AF.

Conclusions: Among patients with AL-CA, AF is associated with a higher risk of acute on chronic heart failure.
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http://dx.doi.org/10.1097/HPC.0000000000000257DOI Listing
September 2021

Contemporary Pharmacologic Management of Heart Failure with Reduced Ejection Fraction: A Review.

Curr Cardiol Rev 2020 ;16(1):55-64

Division of Cardiovascular Disease, Morehouse School of Medicine, Atlanta, GA 30303, United States.

Heart failure with reduced ejection fraction (HFrEF) is defined as the presence of typical symptoms of heart failure (HF) and a left ventricular ejection fraction ≤ 40%. HFrEF patients constitute approximately 50% of all patients with clinical HF. Despite breakthrough discoveries and advances in the pharmacologic management of HF, HFrEF patients continue to pose a significant economic burden due to a progressive disease characterized by recurrent hospitalizations and need for advanced therapy. Although there are effective, guideline-directed medical therapies for patients with HFrEF, a significant proportion of these patients are either not on appropriate medications' combination or on optimal tolerable medications' doses. Since the morbidity and mortality benefits of some of the pharmacologic therapies are dose-dependent, optimal medical therapy is required to impact the burden of disease, quality of life, prognosis, and to curb health care expenditure. In this review, we summarize landmark trials that have impacted the management of HF and we review contemporary pharmacologic management of patients with HFrEF. We also provide insight on general considerations in the management of HFrEF in specific populations. We searched PubMed, Scopus, Medline and Cochrane library for relevant articles published until April 2019 using the following key words "heart failure", "management", "treatment", "device therapy", "reduced ejection fraction", "guidelines", "guideline directed medical therapy", "trials" either by itself or in combination. We also utilized the cardiology trials portal to identify trials related to heart failure. We reviewed guidelines, full articles, review articles and clinical trials and focused on the pharmacologic management of HFrEF.
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http://dx.doi.org/10.2174/1573403X15666190709185011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393599PMC
May 2020

Early Recognition of Heart Failure: A Call for Action.

Authors:
Jalal K Ghali

J Card Fail 2018 05 27;24(5):310-312. Epub 2018 Mar 27.

Department of Medicine, Morehouse School of Medicine, Atlanta, Georgia. Electronic address:

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http://dx.doi.org/10.1016/j.cardfail.2018.03.005DOI Listing
May 2018

Circulating T-Cell Subsets, Monocytes, and Natural Killer Cells in Peripartum Cardiomyopathy: Results From the Multicenter IPAC Study.

J Card Fail 2018 01 24;24(1):33-42. Epub 2017 Oct 24.

Heart, Lung, Blood and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.

Objective: The aim of this work was to evaluate the hypothesis that the distribution of circulating immune cell subsets, or their activation state, is significantly different between peripartum cardiomyopathy (PPCM) and healthy postpartum (HP) women.

Background: PPCM is a major cause of maternal morbidity and mortality, and an immune-mediated etiology has been hypothesized. Cellular immunity, altered in pregnancy and the peripartum period, has been proposed to play a role in PPCM pathogenesis.

Methods: The Investigation of Pregnancy-Associated Cardiomyopathy (IPAC) study enrolled 100 women presenting with a left ventricular ejection fraction of <0.45 within 2 months of delivery. Peripheral T-cell subsets, natural killer (NK) cells, and cellular activation markers were assessed by flow cytometry in PPCM women early (<6 wk), 2 months, and 6 months postpartum and compared with those of HP women and women with non-pregnancy-associated recent-onset cardiomyopathy (ROCM).

Results: Entry NK cell levels (CD3-CD56+CD16+; reported as % of CD3- cells) were significantly (P < .0003) reduced in PPCM (6.6 ± 4.9% of CD3- cells) compared to HP (11.9 ± 5%). Of T-cell subtypes, CD3+CD4-CD8-CD38+ cells differed significantly (P < .004) between PPCM (24.5 ± 12.5% of CD3+CD4-CD8- cells) and HP (12.5 ± 6.4%). PPCM patients demonstrated a rapid recovery of NK and CD3+CD4-CD8-CD38+ cell levels. However, black women had a delayed recovery of NK cells. A similar reduction of NK cells was observed in women with ROCM.

Conclusions: Compared with HP control women, early postpartum PPCM women show significantly reduced NK cells, and higher CD3+CD4-CD8-CD38+ cells, which both normalize over time postpartum. The mechanistic role of NK cells and "double negative" (CD4-CD8-) T regulatory cells in PPCM requires further investigation.
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http://dx.doi.org/10.1016/j.cardfail.2017.10.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6467571PMC
January 2018

Role of cannabis in cardiovascular disorders.

J Thorac Dis 2017 Jul;9(7):2079-2092

Division of Cardiology, Mercer University School of Medicine, Macon, GA, USA.

The growing popularity of medical and recreational consumption of cannabis, especially among the youth, raises immediate concerns regarding its safety and long-terms effects. The cardiovascular effects of cannabis are not well known. Cannabis consumption has been shown to cause arrhythmia including ventricular tachycardia, and potentially sudden death, and to increase the risk of myocardial infarction (MI). These effects appear to be compounded by cigarette smoking and precipitated by excessive physical activity, especially during the first few hours of consumption. Cannabinoids, or the active compounds of cannabis, have been shown to have heterogeneous effects on central and peripheral circulation. Acute cannabis consumption has been shown to cause an increase in blood pressure, specifically systolic blood pressure (SBP), and orthostatic hypotension. Cannabis use has been reported to increase risk of ischemic stroke, particularly in the healthy young patients. The endocannabinoid system (ECS) is currently considered as a promising therapeutic target in the management of several disease conditions. Synthetic cannabinoids (SCs) are being increasingly investigated for their therapeutic effects; however, the value of their benefits over possible complications remains controversial. Despite the considerable research in this field, the benefits of cannabis and its synthetic derivatives remains questionable even in the face of an increasingly tolerating attitude towards recreational consumption and promotion of the therapeutic complications. More efforts are needed to increase awareness among the public, especially youth, about the cardiovascular risks associated with cannabis use and to disseminate the accumulated knowledge regarding its ill effects.
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http://dx.doi.org/10.21037/jtd.2017.06.104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542986PMC
July 2017

Newer drugs for heart failure: hype or hope?

Authors:
Jalal K Ghali

Expert Opin Investig Drugs 2017 Jan 22;26(1):5-7. Epub 2016 Nov 22.

a Division of Cardiology, Department of Medicine , Mercer University School of Medicine , Macon , GA USA.

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http://dx.doi.org/10.1080/13543784.2017.1259410DOI Listing
January 2017

Dose response characterization of the association of serum digoxin concentration with mortality outcomes in the Digitalis Investigation Group trial.

Eur J Heart Fail 2016 08;18(8):1072-81

Division of Cardiology, Mercer University School of Medicine, Macon, GA, USA.

Aims: Many patients with heart failure and reduced EF remain at high risk for hospitalization despite evidence-based therapy. Digoxin may decrease hospitalization; however, uncertainty persists concerning its proper administration and effect on mortality. This study investigated whether using dose response concepts to re-evaluate the relationship between serum digoxin concentration and key mortality outcomes in patients with reduced EF in the Digitalis Investigation Group trial would help clarify efficacy and safety.

Methods And Results: Multivariable Cox proportional hazards modelling and propensity score adjustment assessed the relationship between serum digoxin concentration (≥0.5 ng/mL) as a continuous variable and mortality outcomes. In patients treated with digoxin, a significant linear association was found between serum concentration and all-cause mortality [adjusted hazard ratio (HR) 1.25, 95% confidence interval (CI) 1.14-1.38, P < 0.001 per 0.5 ng/mL increase in serum concentration]. Based on this relationship, a bidirectional association was found between digoxin therapy and all-cause mortality when compared with placebo. The lowest serum concentrations (0.5-0.7 ng/mL) were associated with the lowest risk of all-cause mortality (adjusted HR 0.77, 95% CI 0.67-0.89, P < 0.001) while high serum concentrations (1.6-2.0 ng/mL) were associated with increased mortality (adjusted HR 1.33, 95% CI 1.12-1.58, P = 0.001). Consistent with this finding, lower serum concentrations (0.5-0.7 ng/mL) were associated with reduced death from worsening heart failure and a neutral effect on cardiovascular death not due to worsening heart failure.

Conclusion: These findings favour targeting serum concentrations from 0.5 to 0.7 ng/mL when dosing digoxin in patients with heart failure and reduced EF.
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http://dx.doi.org/10.1002/ejhf.584DOI Listing
August 2016

Predictors of postpericardiotomy syndrome.

Am J Emerg Med 2015 Sep 30;33(9):1320. Epub 2015 May 30.

Cardiology Division, Mercer University School of Medicine, Macon, GA.

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http://dx.doi.org/10.1016/j.ajem.2015.05.038DOI Listing
September 2015

Chloride Depletion Alkalosis as a Predictor of Inhospital Mortality in Patients with Decompensated Heart Failure.

Cardiology 2015 6;131(3):151-9. Epub 2015 May 6.

Department of Internal Medicine, Wayne State University School of Medicine, Detroit, Mich., USA.

Objectives: Chloride depletion alkalosis (CDA) is often seen as a consequence of diuresis in heart failure (HF) but its prognostic significance remains unknown. The purpose of this study was to evaluate the prognostic role of CDA in decompensated HF (DHF).

Methods: A retrospective cohort analysis was performed on 674 patients who were admitted with DHF. Patients were assigned to 2 groups based on the change in serum bicarbonate (median = 3 mmol/l) after diuresis, which was calculated by computing the difference in the admission and discharge serum bicarbonate: the CDA group (a change in serum bicarbonate ≥3 mmol/l) and the non-CDA group (change in serum bicarbonate <3 mmol/l). The primary end points were inhospital mortality and the composite end point of all-cause 30-day mortality and hospital readmission for HF.

Results: In a multivariable logistic regression model, the CDA group, i.e. 374 patients, had a lower inhospital mortality than the non-CDA group, i.e. 300 patients (OR 0.11, 95% CI 0.03-0.38; p = 0.0005) after adjusting for other covariates. There was no statistically significant difference in the combined end point of all-cause 30-day mortality and readmission between the 2 groups (OR 1.26, 95% CI 0.74-2.12; p = 0.39).

Conclusion: The presence of CDA during hospitalization for DHF was independently associated with a better inhospital survival rate.
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http://dx.doi.org/10.1159/000377669DOI Listing
March 2016

Authorship in a multicenter clinical trial: The Heart Failure-A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) Authorship and Publication (HAP) scoring system results.

Am Heart J 2015 Apr 10;169(4):457-63.e6. Epub 2015 Jan 10.

Duke University School of Medicine, Durham, NC.

Background: Few guidelines exist regarding authorship on manuscripts resulting from large multicenter trials. The HF-ACTION investigators devised a system to address assignment of authorship on trial publications and tested the outcomes in the course of conducting the large, multicenter, National Heart, Lung, and Blood Institute-funded trial (n = 2,331; 82 clinical sites; 3 countries). The HF-ACTION Authorship and Publication (HAP) scoring system was designed to enhance rate of dissemination, recognize investigator contributions to the successful conduct of the trial, and harness individual expertise in manuscript generation.

Methods: The HAP score was generated by assigning points based on investigators' participation in trial enrollment, follow-up, and adherence, as well as participation in committees and other trial activity. Overall publication rates, publication rates by author, publication rates by site, and correlation between site publication and HAP score using a Poisson regression model were examined.

Results: Fifty peer-reviewed, original manuscripts were published within 6.5 years after conclusion of study enrollment. In total, 137 different authors were named in at least 1 publication. Forty-five (55%) of the 82 sites had an author named to at least 1 article. A Poisson regression model examining incident rate ratios revealed that a higher HAP score resulted in a higher incidence of a manuscript, with a 100-point increase in site score corresponding to an approximately 32% increase in the incidence of a published article.

Conclusions: Given the success in publishing a large number of manuscripts and widely distributing authorship, regular use of a transparent, objective authorship assignment system for publishing results from multicenter trials may be recommended to optimize fairness and dissemination of trial results.
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http://dx.doi.org/10.1016/j.ahj.2014.11.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444064PMC
April 2015

Considerations for drug development for heart failure.

Authors:
Jalal K Ghali

J Am Coll Cardiol 2015 Mar;65(10):1060-1

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http://dx.doi.org/10.1016/j.jacc.2014.11.065DOI Listing
March 2015

Wearing the mask of ST-elevation myocardial infarction: postpericardiotomy syndrome.

Am J Emerg Med 2015 Aug 2;33(8):1115.e5-7. Epub 2015 Feb 2.

Cardiology Division, Mercer University School of Medicine, Macon, GA.

Introduction: Postpericardiotomy syndrome (PPS) is an inflammatory process, affecting 15% to 20% of patients, after surgery involving pleura, pericardium, or both. The role of electrocardiogram (ECG) in diagnosing PPS is uncertain because ECG is rarely normal (especially after cardiac surgery). We report a case of PPS that presented initially with localized ST-segment elevation and also discuss proposed mechanisms.

Clinical Case: A 60-year-old White man presented to the emergency department (ED) after having chest pain, shortness of breath, and palpitation for approximately 2 hours. Patient had known coronary artery disease, status postcoronary artery bypass graft a month earlier with a graft to right coronary artery, and 2 grafts to marginal arteries. In the ED, ECG revealed localized ST-segment elevations in leads II, III, and aVF. Coronary angiography did not reveal significant coronary artery stenosis, and all the grafts were found to be patent. Following ECG showed PR depression along with diffuse ST elevation consistent with pericarditis. Patient was started on nonsteroidal anti-inflammatory drugs and colchicine with significant improvement of his symptoms in a few days.

Discussion: In our patient, injury or surgical manipulation to the area perfused by right coronary artery might have initiated a process, initially localized to the inferior wall with subsequent diffuse involvement of the entire pericardium. The presentation of our patient shortly after the development of chest pain and availability of 2 ECGs a few minutes apart may have shed light on the pathophysiology of PPS.
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http://dx.doi.org/10.1016/j.ajem.2015.01.048DOI Listing
August 2015

A new direction for albuminuria: an enigmatic multibiomarker.

Authors:
Jalal K Ghali

JACC Heart Fail 2014 Dec 1;2(6):597-9. Epub 2014 Oct 1.

Department of Internal Medicine, Division of Cardiology, Mercer University School of Medicine, Macon, Georgia. Electronic address:

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http://dx.doi.org/10.1016/j.jchf.2014.07.006DOI Listing
December 2014

Anemia and iron deficiency in heart failure.

Heart Fail Clin 2014 Apr;10(2):281-94

Division of Cardiology, School of Medicine, Mercer University, 707 Pine Street, Macon, GA 31201, USA. Electronic address:

Anemia is a common comorbidity in patients with heart failure (HF) and is associated with poor prognosis. Iron deficiency, with or without anemia, confers increased risk of mortality and morbidity. Along with the altered iron metabolism in HF patients, inflammation creates challenges in the interpretation of laboratory parameters used to diagnose anemia in HF. Since the RED-HF trial failed to demonstrate any benefit from the use of erythropoiesis-stimulating agents (ESAs) on mortality or morbidity in HF patients, ESAs are no longer considered a treatment option, although intravenous iron has potential as therapy for anemic and nonanemic HF patients.
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http://dx.doi.org/10.1016/j.hfc.2013.11.002DOI Listing
April 2014

A perspective on re-evaluating digoxin's role in the current management of patients with chronic systolic heart failure: targeting serum concentration to reduce hospitalization and improve safety profile.

Eur J Heart Fail 2014 May 23;16(5):483-93. Epub 2014 Feb 23.

Departments of Medicine and Radiology, School of Medicine, Division of Cardiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Digoxin improves exercise tolerance and reduces hospitalizations in patients with systolic heart failure, but its use has declined progressively for the past two decades. The Digitalis Investigation Group trial showed that digoxin reduced hospitalizations but had a neutral effect on total mortality. There was evidence that mortality caused by worsening heart failure was less, but there was also a signal suggesting an increase in other cardiac (presumed arrhythmic) death. Use of digoxin has declined substantially and recent guideline recommendations have significantly de-emphasized the importance of this drug in the management of heart failure. Two developments suggest that re-evaluation of the contemporary role of digoxin in the management of heart failure with reduced ejection fraction is warranted. First, heart failure remains progressive, characterized by chronic debility, exercise intolerance, and frequent and costly hospitalizations, despite evidence-based drug and device therapies that prolong survival. Health economics have made reducing hospitalizations in patients with heart failure a major priority. Second, a strong association has emerged between serum concentration and the safety and efficacy of digoxin, which indicates a change in our approach to dosing this agent is needed. Experimental and clinical results suggest that optimizing therapeutic benefit and avoiding harm means dosing to achieve low serum digoxin concentrations (0.5-0.9 ng/mL). Digoxin is an inexpensive agent and the totality of evidence indicates that it reduces hospitalizations and improves symptoms safely when dosed to achieve low serum concentrations. These findings suggest digoxin should have a more prominent therapeutic role in patients with heart failure and reduced ejection fraction.
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http://dx.doi.org/10.1002/ejhf.64DOI Listing
May 2014

Here we go again.

Authors:
Jalal K Ghali

J Am Coll Cardiol 2013 Jul 20;62(5):482-3. Epub 2013 May 20.

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http://dx.doi.org/10.1016/j.jacc.2013.04.050DOI Listing
July 2013

Evaluation of lixivaptan in euvolemic and hypervolemic hyponatremia and heart failure treatment.

Expert Opin Drug Metab Toxicol 2013 May 9;9(5):645-55. Epub 2013 Apr 9.

Mercer University, Department of Medicine, 707 Pine Street, Macon, Georgia, GA 31201, USA.

Introduction: Lixivaptan is a selective vasopressin type 2 (V2) receptor antagonist that induces aquaresis, the electrolytes sparing excretion of water. Its ability to correct hyponatremia has been demonstrated in experimental animal studies as well as in clinical trials in humans. Recently, three Phase III, double-blind, randomized, placebo-controlled studies have been completed. In two studies, patients with euvolemic hyponatremia were enrolled, one in the inpatient and the other in the outpatient setting and the third study involved patients with hypervolemic hyponatremia hospitalized for decompensated heart failure (HF). The trials confirmed the efficacy of lixivaptan in raising serum sodium but raised concern about its safety in patients hospitalized with decompensated HF.

Areas Covered: The authors review original publications on lixivaptan and summarize their findings. Specifically, the authors present information regarding its structure, pharmacodynamics and kinetics, metabolism as well as its efficacy and safety in laboratory animals and human studies. Furthermore, the FDA website was accessed to obtain information presented at the September 13, 2012 meeting of the Cardiovascular and Renal Drugs Advisory Committee.

Expert Opinion: The published data indicate that lixivaptan raises sodium levels in hyponatremic patients and supports its use in patients with euvolemic hyponatremia. However, the authors note that more safety data are still needed specifically in patients with decompensated HF.
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http://dx.doi.org/10.1517/17425255.2013.783566DOI Listing
May 2013

Association between bilirubin and mode of death in severe systolic heart failure.

Am J Cardiol 2013 Apr 23;111(8):1192-7. Epub 2013 Jan 23.

University of Michigan Health System, Ann Arbor, MI, USA.

The bilirubin level has been associated with worse outcomes, but it has not been studied as a predictor for the mode of death in patients with systolic heart failure. The Prospective Randomized Amlodipine Evaluation Study (PRAISE) cohort (including New York Heart Association class IIIB-IV patients with left ventricular ejection fraction <30%, n = 1,135) was analyzed, divided by bilirubin level: ≤0.6 mg/dl, group 1; >0.6 to 1.2 mg/dl, group 2; and >1.2 mg/dl, group 3. Multivariate Cox proportional hazards models were used to determine the association of bilirubin with the risk of sudden or pump failure death. Total bilirubin was entered as a base 2 log-transformed variable (log2 bilirubin), indicating doubling of the bilirubin level corresponding to each increase in variable value. The higher bilirubin groups had a lower ejection fraction (range 19% to 21%), sodium (range 138 to 139 mmol/L), and systolic blood pressure (range 111 to 120 mm Hg), a greater heart rate (range 79 to 81 beats/min), and greater diuretic dosages (range 86 to 110 furosemide-equivalent total daily dose in mg). The overall survival rates declined with increasing bilirubin (24.3, 31.3, and 44.3 deaths per 100 person-years, respectively, for groups 1, 2, and 3). Although a positive relation was seen between log2 bilirubin and both pump failure risk and sudden death risk, the relation in multivariate modeling was significant only for pump failure mortality (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82, p = 0.0004), not for sudden death mortality (hazard ratio 1.21, 95% confidence interval 0.98 to 1.49, p = 0.08). In conclusion, an increasing bilirubin level was significantly associated with the risk of pump failure death but not for sudden death in patients with severe systolic heart failure.
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http://dx.doi.org/10.1016/j.amjcard.2012.12.048DOI Listing
April 2013

Iron deficiency anemia in heart failure.

Heart Fail Rev 2013 Jul;18(4):485-501

Detroit Medical Center, Wayne State University, Detroit, MI, USA.

Anemia and iron deficiency are quite prevalent in patients with heart failure (HF) and may overlap. Both anemia and iron deficiency are associated with worse symptoms and adverse clinical outcomes. In the past few years, there has been an enormous interest in the subject of iron deficiency and its management in patients with HF. In this review, the etiology and relevance of iron deficiency, iron metabolism in the setting of HF, studies on iron supplementation in patients with HF and potential cardiovascular effects of subclinical iron overload are discussed.
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http://dx.doi.org/10.1007/s10741-012-9342-yDOI Listing
July 2013

Defining hyponatraemia: a call for action.

Eur J Heart Fail 2012 Oct 31;14(10):1085-6. Epub 2012 Aug 31.

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http://dx.doi.org/10.1093/eurjhf/hfs140DOI Listing
October 2012

Standardized reporting criteria for studies evaluating suspected acute heart failure syndromes in the emergency department.

J Am Coll Cardiol 2012 Aug;60(9):822-32

Vanderbilt University, Nashville, TN, USA.

Heart failure requiring urgent therapy represents a burgeoning health care burden. Although acute heart failure syndromes are commonly defined as a change in chronic heart failure signs and symptoms requiring urgent therapy, the presentation, development, and response to treatment is highly dependent on individual patient characteristics. This heterogeneity has led to challenges in interpreting widely differing study methods, including eligibility requirements and outcome measures. To improve interpretation of results and translate such information to better patient care, it is essential to present an accurate description of the patient population and study design. Based on existing recommendations and expert consensus, the authors present standardized reporting criteria to improve interpretability of research in this challenging cohort.
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http://dx.doi.org/10.1016/j.jacc.2012.03.072DOI Listing
August 2012

Effect of fixed-dose combined isosorbide dinitrate/hydralazine in elderly patients in the African-American heart failure trial.

J Card Fail 2012 Aug;18(8):600-6

Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, New York 10032, USA.

Background: Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age <65 or ≥65 years.

Methods And Results: Time-to-event curves were produced by the Kaplan-Meier method. Hazard ratios were calculated with the Cox proportional hazards model. Baseline characteristics showed that patients ≥65 years old had less hypertensive and more ischemic HF, better quality of life (QoL) scores, higher plasma B-type natriuretic peptide and creatinine levels, and received less background neurohormonal therapy. Kaplan-Meier curves showed that FDC I/H improved mortality and event-free survival in elderly patients. The hazard ratios for mortality, first heart failure hospitalization, and event-free survival (both unadjusted and adjusted for baseline differences), were similar quantitatively and in direction of effect in both age groups.

Conclusions: In A-HeFT, FDC I/H improved outcomes in HF patients aged <65 or ≥65 years, despite significant baseline differences between these age groups. Patients aged ≥65 years, a group at greater mortality risk, had the greatest survival benefit from FDC I/H.
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http://dx.doi.org/10.1016/j.cardfail.2012.06.526DOI Listing
August 2012

The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study.

Eur J Heart Fail 2012 Jun 17;14(6):642-51. Epub 2012 Apr 17.

Detroit Medical Center Cardiovascular Institute, Detroit, MI 48201, USA.

Aims: Volume overload is the dominant feature of decompensated heart failure (HF) and it often results in adverse clinical outcomes. Vasopressin receptor antagonists such as lixivaptan may provide effective volume unloading. This study assessed weight loss after 1 day and 8 weeks of treatment with lixivaptan in outpatients with HF and volume overload.

Methods And Results: This phase II, 8-week, multicentre, double-blind, parallel-group study randomized participants (2:1) to receive lixivaptan 100 mg or placebo once daily (in addition to standard HF therapy). Body weight and cardiovascular assessments were made at baseline, Day 1 (not cardiovascular), Weeks 1, 2, 4, and 8, and 7 days post-treatment. The Trail-making Test, part B (TMT-B) and the Medical Outcomes Survey 6-item cognitive function scale (MOS-6) were assessed at baseline and Week 4. The study randomized 170 participants (lixivaptan, n = 111; placebo, n = 59). Most (97.1%) were receiving pharmacological therapy for HF at baseline. Demographic characteristics were generally similar between the two groups. Body weight decreased significantly from baseline to Day 1 with lixivaptan vs. placebo (least-square mean change ± standard error: - 0.38 ± 0.08 kg vs. +0.13 ± 0.11 kg; P < 0.001) and at Weeks 1, 2, and 4 (P < 0.01). Cardiovascular changes were generally similar in both groups, though orthopnoea and dyspnoea improved in the lixivaptan group vs. placebo. The TMT-B and MOS-6 showed no significant differences between groups. Lixivaptan was well tolerated-thirst and polyuria occurred more frequently vs. placebo.

Conclusions: In outpatients with HF and volume overload, lixivaptan 100 mg once daily, when added to standard therapy, reduced body weight, improved dyspnoea and orthopnoea, and was well tolerated.

Trial Registration: NCT01055912.
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http://dx.doi.org/10.1093/eurjhf/hfs051DOI Listing
June 2012

Gender and ethnic differences in red cell distribution width and its association with mortality among low risk healthy United state adults.

Am J Cardiol 2012 Jun 15;109(11):1664-70. Epub 2012 Mar 15.

Division of Cardiology, Department of Internal Medicine, Detroit Medical Center, Wayne State University, Detroit, Michigan, USA.

Limited information is available about gender and ethnic differences in red cell distribution width (RCDW) with regard to its relation to mortality in a population free of cardiovascular (CV) disease and diabetes. To assess gender and ethnic differences in RCDW and their effect on the association between RCDW and mortality, the Third National Health and Nutritional Examination Survey (n = 15,460, 1988 to 1994) data were examined. Multivariate adjusted Cox proportional hazard analysis was performed to assess effect of gender and ethnicity on the association between RCDW and mortality (total, CV disease, and coronary heart disease [CHD]). RCDW (mean ± SE) was greater in black women (13.1 ± 0.03) and men (13.4 ± 0.02) compared to women of white (12.9 ± 0.02) and other (13.0 ± 0.07) ethnicities and men of white (13.3 ± 0.02) and other (13.3 ± 0.07) ethnicities, respectively (p <0.001). The interaction between RCDW and gender was statistically significant for all study outcomes (p <0.001) but nonsignificant for RCDW and ethnicity. After adjusting for key variables, RCDW in women was associated with adjusted hazard ratios of 1.22 (95% confidence interval [CI] 1.14 to 1.31) for all-cause mortality, 1.17 (95% CI 1.07 to 1.28) for CV deaths, and 1.18 (95% CI 1.03 to 1.35) for CHD deaths; in men, adjusted hazard ratios were 1.29 (95% CI 1.20 to 1.38) for all-cause mortality, 1.27 (95% CI 1.17 to 1.37) for CV deaths, and 1.25 (95% CI 1.13 to 1.39) for CHD deaths (p <0.05 for all). In conclusion, blacks and men have significantly greater RCDWs compared to whites and women. Greater RCDW is associated with a greater risk of mortality in men compared to women, whereas no effect modification is observed by ethnicity.
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http://dx.doi.org/10.1016/j.amjcard.2012.01.396DOI Listing
June 2012

The next frontier of clinical trials: personalized medicine for devices.

Authors:
Jalal K Ghali

J Am Coll Cardiol 2012 Apr 7;59(17):1519-20. Epub 2012 Mar 7.

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http://dx.doi.org/10.1016/j.jacc.2012.01.018DOI Listing
April 2012

More is less.

Authors:
Jalal K Ghali

Arch Intern Med 2011 Nov;171(20):1859

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http://dx.doi.org/10.1001/archinternmed.2011.515DOI Listing
November 2011

Cardiac structure and function, remodeling, and clinical outcomes among patients with diabetes after myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both.

Am Heart J 2011 Oct 14;162(4):685-91. Epub 2011 Sep 14.

Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA 02445, USA.

Aims: The mechanisms responsible for the increased risk of heart failure (HF) post-myocardial infarction (MI) may differ between patients with versus without diabetes. We hypothesized that after high-risk MI, patients with diabetes would demonstrate patterns of remodeling that are suggestive of reduced ventricular compliance and that are associated with an increased risk of death or HF.

Methods And Results: We performed quantitative echocardiographic analysis in 153 patients with diabetes and 451 patients without diabetes enrolled in the VALIANT Echo study. Diabetes was associated with a higher risk of death or HF in age-adjusted models (hazard ratio 1.44, 95% CI 1.04-2.00, P = .028). Diabetic patients were similar to nondiabetic patients with respect to left ventricular (LV) volume and ejection fraction but had higher LV mass index (104.1 ± 27.5 vs 97.1 ± 28.6 g/m(2), P = .009), relative wall thickness (0.41 ± 0.08 vs 0.38 ± 0.07, P < .0001), and left atrial volume index (LAVi) (26.2 ± 8.1 vs 24.0 ± 8.2 mL/m(2), P = .008)-all parameters that were significantly related to the risk of death or HF hospitalization. Changes in LV volume and ejection fraction from baseline to 20 months were not different, although diabetic patients demonstrated greater increase in LAVi (4.4 ± 7.7 vs 2.2 ± 6.7 mL/m(2), P = .01).

Conclusions: After high-risk MI, diabetic patients were at higher risk of death or HF and demonstrated greater baseline LV mass index, relative wall thickness, and LAVi as well as greater left atrial enlargement at 20-month follow-up. These findings suggest greater baseline concentric remodeling and long-term elevation in LV diastolic pressure post-MI among diabetic patients, which may partially mediate this risk.
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http://dx.doi.org/10.1016/j.ahj.2011.07.015DOI Listing
October 2011

CABG in patients with left ventricular dysfunction.

Authors:
Jalal K Ghali

N Engl J Med 2011 08;365(5):468; author reply 470-1

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http://dx.doi.org/10.1056/NEJMc1106549DOI Listing
August 2011
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