Factors Impacting Physician Prognostic Accuracy in Heart Failure Patients With Reduced Left Ventricular Ejection Fraction

Objective:To provide procedure-specific estimates of symptomatic venous thromboembolism (VTE) and major bleeding after abdominal surgery.Background:The use of pharmacological thromboprophylaxis represents a trade-off that depends on VTE and bleeding risks that vary between procedures; their magnitude remains uncertain.Methods:We identified observational studies reporting procedure-specific risks of symptomatic VTE or major bleeding after abdominal surgery, adjusted the reported estimates for thromboprophylaxis and length of follow-up, and estimated cumulative incidence at 4 weeks postsurgery, stratified by VTE risk groups, and rated evidence certainty.Results:

We report the short-and long-term results of the SOLIDARITY Finland on mortality and other patient-important outcomes in patients hospitalised for COVID-19. Between 08/2021 and 03/2023, we randomised 156 patients in 15 hospitals. In the imatinib group, 7.2% of patients had died at 30 days and 13.3% at 1 year and in the standard of care group 4.1% and 8.3%(adjusted HR at 30 days 1.09, 95% CI 0.23-5.07). In a meta-analysis of randomised trials of imatinib versus standard of care (n= 732), allocation to imatinib was associated with a mortality risk ratio of 0.73 (95% CI 0.32-1.63). At 1-year, self-reported recovery occurred in 79.0% in imatinib and in 88.3% in standard of care (RR 0.91, 95% CI 0.78-1.06). Of the 21 potential long COVID symptoms, patients often reported moderate or major bother from fatigue (24%), sleeping problems (19%) and memory difficulties (17%). We found no convincing difference between imatinib and standard of care groups in quality of life or symptom outcomes. The evidence raises serious doubts regarding the benefit of imatinib in reducing mortality, improving recovery and preventing potential long COVID symptoms when given to patients hospitalised for COVID-19.

Annals of Allergy, Asthma & Immunology

BackgroundGuidance addressing atopic dermatitis (AD) management, last issued in 2012 by the American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force, requires updating as a result of new treatments and improved guideline and evidence synthesis methodology.ObjectiveTo produce evidence-based guidelines that support patients, clinicians, and other decision-makers in the optimal treatment of AD.MethodsA multidisciplinary guideline panel consisting of patients and caregivers, AD experts (dermatology and allergy/immunology), primary care practitioners (family medicine, pediatrics, internal medicine), and allied health professionals (psychology, pharmacy, nursing) convened, prioritized equity, diversity, and inclusiveness, and implemented management strategies to minimize influence of conflicts of interest. The Evidence in Allergy Group …

JAMA

To the Editor Although sometimes considered the pinnacle of scientific evidence, meta-analyses can be problematic. Combining outcomes from heterogeneous trials performed in different settings or populations may give results directly applicable to few. Conclusions are also beholden to methodological design, often discordant from those of subsequent randomized clinical trials. 1 Such may be the case with the recently published dose-response meta-analysis of studies examining efficacy and tolerability of gefapixant for refractory or unexplained chronic cough. 2 Because gefapixant is the first novel efficacious therapy for refractory and unexplained chronic cough, its development involved changes in study design and participant inclusion criteria as well as drug formulation. 3 Four drug formulations were ultimately tested, with maximum bioavailability achieved for the formulation used in the phase 3 trials, such that …

The Lancet

Their stated aim is to summarise the “benefits and harms of weight-lowering drugs”, but the main findings and discussion focus on weight loss, without due consideration to the scarcity of evidence for benefits to health and wellbeing. For instance, quality of life and depression data are reported as low quality or insufficient, and there is no mention of the absence of long-term cardiovascular outcomes. A review on long-term effects of weight-reducing pharmacotherapy included only one trial with cardiovascular outcomes; it found no benefit.

Journal of Critical Care

IntroductionThe objective of this study was to create a definition of patient-important upper gastrointestinal bleeding during critical illness as an outcome for a randomized trial.DesignThis was a sequential mixed-methods qualitative-dominant multi-center study with an instrument-building aim. In semi-structured individual interviews or focus groups we elicited views from survivors of critical illness and family members of patients in the intensive care unit (ICU) regarding which features indicate important gastrointestinal bleeding. Quantitative demographic characteristics were collected. We analyzed qualitative data using inductive content analysis to develop a definition for patient-important upper gastrointestinal bleeding.SettingCanada and the United States.Participants51 ICU survivors and family members of ICU patients.ResultsParticipants considered gastrointestinal bleeding to be important if it resulted in death …

Journal of Clinical Epidemiology

ObjectiveAssessment of the certainty of evidence (CoE) from network meta-analysis is critical to convey the strength of inferences for clinical decision-making. Both the GRADE Working Group (GWG) and the CINeMA framework have been designed to assess the CoE of treatment effects informed by network meta-analysis; however, the concordance of results is uncertain.Study design and settingWe assessed the CoE for treatment effects of individual opioids on pain relief and physical functioning from a network meta-analysis for chronic noncancer pain using the GWG approach and the CINeMA framework. Both approaches evaluate the CoE as high, moderate, low or very low. We quantified the number of discrepant CoE ratings between approaches, and the magnitude of the difference (i.e., 1-level, 2-levels, or 3-levels).ResultsAcross 105 comparisons among individual opioids for pain relief, the GWG and CINeMA …

Objectives To make inferences regarding the effectiveness of respiratory interventions and case isolation measures in reducing or preventing the transmission of mpox based on synthesis of available literature. Methods The WHO Clinical Management and Infection Prevention and Control 2022 guideline and droplet precautions in healthcare facilities and home isolation infection prevention control measures for patients with mpox. We conducted a systematic review that included a broad search of five electronic databases. In a two-stage process, we initially sought only randomized controlled trials and observational comparative studies; when the search failed to yield eligible studies, the subsequent search included all study designs including clinical and environmental sampling studies. Results No studies were identified that directly addressed airborne and droplet precautions and home isolation infection prevention control measures. To inform the review questions the review team synthesized route of transmission data in mpox. There were 2366/4309 (54.9%) cases in which investigators identified mpox infection occurring following transmission through direct physical sexual contact. There were no reported mpox cases in which investigators identified inhalation as a single route of transmission. There were 2/4309 cases in which investigators identified fomite as a single route of transmission. Clinical and environmental sampling studies isolated mpox virus in a minority of saliva, oropharangeal swabs, mpox skin lesions, and hospital room air. Conclusions Current findings provide compelling evidence that transmission of mpox occurs …

Hypophosphatasia (HPP) is a rare inborn error of metabolism that presents variably in both age of onset and severity. HPP is caused by pathogenic variants in the ALPL gene, resulting in low activity of tissue nonspecific alkaline phosphatase (TNSALP). Patients with HPP tend have a similar pattern of elevation of natural substrates that can be used to aid in diagnosis. No formal diagnostic guidelines currently exist for the diagnosis of this condition in children, adolescents, or adults. The International HPP Working Group is a comprised of a multidisciplinary team of experts from Europe and North America who have expertise in the diagnosis and management of patients with HPP. This group reviewed 93 papers through a Medline, Medline In-Process, and Embase search for the terms “HPP” and “hypophosphatasia” between 2005 and 2020 and that explicitly address either the diagnosis of HPP in children, clinical …

Journal of Evaluation in Clinical Practice

Background To realize the potential of precision medicine, predictive models should be integrated within the framework of decision analysis, such as the decision curve analysis (DCA). To date, its application has required individual patient data (IPD) that are often unavailable. Performing DCA using aggregate data without requiring IPD may advance the goals of precision medicine. Methods We present a statistical framework demonstrating that DCA can be conducted by using only the mean and standard deviation (SD) from the raw probabilities of the predictive model. We tested our theoretical framework by performing extensive simulations and comparing the aggregate‐based DCA with IPD DCA. The latter was conducted using IPD from four predictive models that employed logistic regression, Cox or competing risk time‐to‐event modeling including (a) statins for primary prevention of cardiovascular disease (n …

Background Cough severity represents an important subjective endpoint to assess the impact of therapies for patients with refractory or unexplained chronic cough (RCC/UCC). Objective To develop, using FDA guidance, a new patient-reported outcome measure addressing cough severity in patients with RCC/UCC. Methods Phase 1 (item generation): A systematic survey, patient focus groups, and expert consultation generated 51 items. Phase 2 (item reduction): From a list of 51 items, 100 patients identified those they had experienced in the previous year and rated their importance on a 5-point scale. The draft MCSQ included, in general, items reported to occur most frequently and that had the highest importance scores (impact method). Patient feedback on the draft MCSQ led to elimination of redundant items and selection of a one-week recall period for each item. Phase 3 (cross-sectional testing): Another 100 …

Background Proton pump inhibitors (PPIs) are the most commonly prescribed drugs for preventing upper gastrointestinal bleeding in critically ill patients. However, concerns have arisen about the possible harms of using PPIs, including potentially increased risk of pneumonia, Clostridioides difficile infection, and more seriously, an increased risk of death in the most severely ill patients. Triggered by the REVISE trial, which is a forthcoming large randomized trial comparing pantoprazole to placebo in invasively mechanically ventilated patients, we will conduct this systematic review to evaluate the efficacy and safety of PPIs versus no prophylaxis for critically ill patients. Methods We will systematically search randomized trials that compared gastrointestinal bleeding prophylaxis with PPIs versus placebo or no prophylaxis in adults in the intensive care unit (ICU). Pairs of reviewers will independently screen the …

Frontiers in Pediatrics

Background Cardiopulmonary failure refractory to medical management after moderate-to-high-risk congenital cardiac surgery may necessitate mechanical support with veno-arterial extracorporeal membrane oxygenation (ECMO). On the extreme, ECMO can also be initiated in the setting of cardiac arrest (extracorporeal cardiopulmonary resuscitation, ECPR) unresponsive to conventional resuscitative measures. Methods This was a single-center retrospective cohort study of patients (n = 510) aged <3 years old who underwent cardiac surgery with cardiopulmonary bypass with a RACHS-1 score ≥3 between 2011 and 2014. Perioperative factors were reviewed to identify predictors of ECMO initiation and mortality in the operating room (OR) and the intensive care unit (ICU). Results A total of 510 patients with a mean surgical age of 10.0 ± 13.4 months were included. Among them, 21 (4%) patients received postoperative ECMO—12 were initiated in the OR and 9 in the ICU. ECMO cannulation was associated with cardiopulmonary bypass duration, aortopulmonary shunt, residual severe mitral regurgitation, vaso-inotropic score, and postprocedural lactate (p < 0.001). Of the 32 (6%) total deaths, 7 (22%) were ECMO patients—4 were elective OR cannulations and 3 were ICU ECPR. Prematurity [hazard ratio (HR): 2.61, p < 0.01), Norwood or Damus–Kaye–Stansel procedure (HR: 4.29, p < 0.001), postoperative left ventricular dysfunction (HR: 5.10, p = 0.01), residual severe tricuspid regurgitation (HR: 6.06, p < 0.001), and postoperative ECMO (ECPR: HR: 15.42, p < 0.001 vs. elective: HR: 5.26, p = 0.01) were associated with …

The commentary of Dr. Clarke and colleagues [1] includes several inaccuracies regarding the 2017 Canadian Guideline for opioid therapy and chronic noncancer pain, including some we have already addressed after three of the authors made the same misrepresentations in a different journal.[2, 3]The authors suggest that the 2017 Canadian opioid Guideline led to regulatory investigations of doctors who prescribe high doses, yet the reference they provide makes clear this investigation began in November 2016, six months before the Guideline was published.[4]

BackgroundCritical bleeding events in adults and children with ITP are medical emergencies; however, evidence-based treatment protocols are lacking. Due to the severe thrombocytopenia, (typically platelet count less than 20 × 109/L), a critical bleed portends a high risk of death or disability. We plan to perform a systematic review and meta-analysis of treatments for critical bleeding in patients with ITP that will inform evidence-based recommendations.MethodsLiterature searches will be conducted in four electronic databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and PubMed. Eligible studies will be randomized controlled trials or observational studies that enrolled patients with ITP describing one or more interventions for the management of critical bleeding. Title and abstract screening, full-text screening, data extraction, and risk of bias evaluation will be …

BackgroundThis manuscript provides a summary of the current evidence to support the criteria for diagnosing a child or adult with hypophosphatasia (HPP). The diagnosis of HPP is made on the basis of integrating clinical features, laboratory profile, radiographic features of the condition, and DNA analysis identifying the presence of a pathogenic variant of the tissue nonspecific alkaline phosphatase gene (ALPL). Often, the diagnosis of HPP is significantly delayed in both adults and children, and updated diagnostic criteria are required to keep pace with our evolving understanding regarding the relationship between ALPL genotype and associated HPP clinical features.MethodsAn International Working Group (IWG) on HPP was formed, comprised of a multidisciplinary team of experts from Europe and North America with expertise in the diagnosis and management of patients with HPP. Methodologists (Romina …

Introduction Clinical practice guidelines provide inconsistent recommendations regarding progestogen supplementation for threatened and recurrent miscarriage. We conducted a systematic review and meta‐analysis to assess the effectiveness and safety of progestogens for these patients. Material and methods We searched Medline, Embase, and Cochrane Central Registry of Controlled Trials up to October 6, 2023 for randomized control trials (RCTs) comparing progestogen supplementation to placebo or no treatment for pregnant women with threatened or recurrent miscarriage. We assessed the risk of bias using a modified version of the Cochrane risk‐of‐bias tool and the certainty of evidence using the GRADE approach. Results Of 15 RCTs (6616 pregnancies) reporting on threatened or recurrent miscarriage, 12 (5610 pregnancies) reported on threatened miscarriage with or without a prior history of …

BackgroundPrognostic models incorporate multiple prognostic factors to estimate the likelihood of future events for individual patients based on their prognostic factor values. Evaluating these models crucially involves conducting studies to assess their predictive performance, like discrimination. Systematic reviews and meta-analyses of these evaluation studies play an essential role in selecting models for clinical practice.MethodsIn this paper, we outline three thresholds to determine the target for certainty rating in the discrimination of prognostic models, as observed across a body of validation studies.Results and ConclusionWe propose three thresholds when rating the certainty of evidence about a prognostic model's discrimination. The first threshold amounts to rating certainty in the model's ability to classify better than random chance. The other two approaches involve setting thresholds informed by other …

JACC: Heart Failure

BackgroundHeart failure (HF) is the leading cause of hospitalization in individuals over 65 years of age. Identifying noninvasive methods to detect HF may address the epidemic of HF. Seismocardiography which measures cardiac vibrations transmitted to the chest wall has recently emerged as a promising technology to detect HF.ObjectivesIn this multicenter study, the authors examined whether seismocardiography using commercially available smartphones can differentiate control subjects from patients with stage C HF.MethodsBoth inpatients and outpatients with HF were enrolled from Finland and the United States. Inpatients with HF were assessed within 2 days of admission, and outpatients were assessed in the ambulatory setting. In a prespecified pooled data analysis, algorithms were derived using logistic regression and then validated using a bootstrap aggregation method.ResultsA total of 217 participants …

JACC: Heart Failure

BackgroundInterventricular interactions may be responsible for the decline in ventricular performance observed in various disease states that primarily affect the contralateral ventricle.ObjectivesThis study sought to quantify the impact of such interactions on right ventricular (RV) size and function using clinically stable individuals with left ventricular assist devices (LVADs) as a model for assessing RV hemodynamics while LV loading conditions were acutely manipulated by changing device speed during hemodynamic optimization studies (ie, ramp tests).MethodsThe investigators recorded RV pressure-volume loops with a conductance catheter at various speeds during ramp tests in 20 clinically stable HeartMate3 recipients.ResultsWith faster LVAD speeds and greater LV unloading, indexed RV end-diastolic volume increased (72.28 ± 15.07 mL at low speed vs 75.95 ± 16.90 at high speed; P = 0.04) whereas …

JACC: Heart Failure

Background Little is known regarding differences in cause-specific costs between HF with EF≤ 40% versus> 40%, and potential cost implications of SGLT2i therapy. Objectives To compare cause-specific healthcare costs following hospitalization for heart failure (HF) with ejection fraction (EF)≤ 40% versus> 40%, and estimate the cost offset with implementation of SGLT2 inhibitor (SGLT2i) therapy. Methods We examined Medicare beneficiaries hospitalized for HF in the Get With The Guidelines-Heart Failure registry from 2016-2020. Mean per-patient total (excluding drug costs) and cause-specific costs from discharge through 1-year follow-up were calculated and compared between EF≤ 40% vs> 40%. We then estimated risk reductions on total all-cause and HF hospitalizations in a trial-level meta-analysis of 5 pivotal trials of SGLT2i in HF. Finally, we applied these relative treatment effects to Medicare …

JACC: Heart Failure

BackgroundPatients recently hospitalized for heart failure (HF) are at a higher risk of adverse clinical outcomes, but they may experience a greater absolute and relative benefit from effective therapies than individuals who are considered more “stable.”ObjectivesThe authors examined the effects of dapagliflozin according to the timing of prior HF hospitalization in a patient-level pooled analysis of DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure).MethodsA total of 11,007 patients were randomized in DAPA-HF and DELIVER. The primary outcome was the composite of worsening HF or cardiovascular death.ResultsIn total, 12.4% were hospitalized for HF within 3 months of randomization, 14.2% between 3 and 12 months, and 16.8% more than 1 year before …

JACC: Heart Failure

BackgroundA recent study showed that the accuracy of heart failure (HF) cardiologists and family doctors to predict mortality in outpatients with HF proved suboptimal, performing less well than models.ObjectivesThe authors sought to evaluate patient and physician factors associated with physician accuracy.MethodsThe authors included outpatients with HF from 11 HF clinics. Family doctors and HF cardiologists estimated patient 1-year mortality. They calculated predicted mortality using the Seattle HF Model and followed patients for 1 year to record mortality (or urgent heart transplant or ventricular assist device implant as mortality-equivalent events). Using multivariable logistic regression, the authors evaluated associations among physician experience and confidence in estimates, duration of patient-physician relationship, patient-physician sex concordance, patient race, and predicted risk, with concordant results …

JACC: Heart Failure

BackgroundSodium glucose co-transporter-2 inhibitor (SGLT2i) therapy improves health status in heart failure (HF). There is insufficient description regarding the timing, rate, and extent of the health status changes in heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) after initiation of SGLT2is.ObjectivesThe authors sought to model the association of canagliflozin treatment with rates of change in HF symptom status in HFpEF and HFrEF.MethodsStudy participants with HFrEF and HFpEF were treated with either canagliflozin 100 mg or placebo for 12 weeks. The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) was assessed at baseline and at 2, 4, 6, and 12 weeks. Longitudinal modeling assessed slope of KCCQ change across the study.ResultsAmong 448 individuals with HF (181 with HFrEF and 267 with HFpEF), participants …

JACC: Heart Failure

BackgroundThe landmark EAT-Lancet Commission proposed that a planetary health diet is comprised mainly of plant-based foods. However, studies examining whether this diet is associated with heart failure (HF) are currently lacking. In addition, the potential proteomics mechanism on the association between diet and HF warrants further elucidation.ObjectivesThis study aims to both examine the association between the EAT-Lancet diet index and risk of HF and identify plasma proteins underlying such an association.MethodsThis prospective cohort study included 23,260 participants. HF cases during the follow-up were identified through the Swedish national register. An EAT-Lancet diet index (score range: 0-42) was created to assess adherence to the EAT-Lancet reference diet. In a subcohort (n = 4,742), fasting plasma proteins were quantified.ResultsDuring a median follow-up of 25.0 years, 1,768 incident HF …

JACC: Heart Failure

BackgroundWhether iron deficiency contributes to incident heart failure (HF) and cardiac dysfunction has important implications given the prevalence of iron deficiency and the availability of several therapeutics for iron repletion.ObjectivesThe aim of this study was to estimate the associations of plasma ferritin level with incident HF overall, HF phenotypes, and cardiac structure and function measures in older adults.MethodsParticipants in the ongoing, longitudinal ARIC (Atherosclerosis Risk In Communities) study who were free of prevalent HF and anemia were studied. The associations of plasma ferritin levels with incident HF overall and heart failure with preserved ejection fraction (HFpEF) and HF with reduced ejection fraction (HFrEF) were estimated using Cox proportional hazards regression models. Linear regression models estimated the cross-sectional associations of plasma ferritin with echocardiographic …

JACC: Heart Failure

BackgroundThe use of recommended heart failure (HF) medications has improved over time, but opportunities for improvement persist among women and at rural hospitals.ObjectivesThis study aims to characterize national trends in performance in the use of guideline-recommended pharmacologic treatment for HF at U.S. Department of Veterans Affairs (VA) hospitals, at which medication copayments are modest.MethodsAmong patients discharged from VA hospitals with HF between January 1, 2013, and December 31, 2019, receipt of all guideline-recommended HF pharmacotherapy among eligible patients was assessed, consisting of evidence-based beta-blockers; angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor neprilysin inhibitors; mineralocorticoid receptor antagonists; and oral anticoagulation.ResultsOf 55,560 patients at 122 hospitals, 32,304 (58.1 …

JACC: Heart Failure

Background Little is known regarding differences in cause-specific costs between HF with EF≤ 40% versus> 40%, and potential cost implications of SGLT2i therapy. Objectives To compare cause-specific healthcare costs following hospitalization for heart failure (HF) with ejection fraction (EF)≤ 40% versus> 40%, and estimate the cost offset with implementation of SGLT2 inhibitor (SGLT2i) therapy. Methods We examined Medicare beneficiaries hospitalized for HF in the Get With The Guidelines-Heart Failure registry from 2016-2020. Mean per-patient total (excluding drug costs) and cause-specific costs from discharge through 1-year follow-up were calculated and compared between EF≤ 40% vs> 40%. We then estimated risk reductions on total all-cause and HF hospitalizations in a trial-level meta-analysis of 5 pivotal trials of SGLT2i in HF. Finally, we applied these relative treatment effects to Medicare …

JACC: Heart Failure

BackgroundIn the Revascularization for Ischemic Ventricular Dysfunction (REVIVED-BCIS2) trial, percutaneous coronary intervention (PCI) did not reduce the incidence of death or hospitalization for heart failure.ObjectivesThis prespecified secondary analysis investigated the effect of PCI on health status measured with the KCCQ combined with the primary outcome in a win ratio.MethodsParticipants with severe ischemic left ventricular dysfunction were randomized to either PCI in addition to optimal medical therapy (PCI) or optimal medical therapy alone (OMT). The primary outcome was a hierarchical composite of all-cause death, HHF and KCCQ overall summary score (OSS) at 24 months analysed using the unmatched win ratio. The key secondary endpoint was a KCCQ-OSS responder analysis.Results347 participants were randomized to PCI and 353 to OMT. Median (IQR) age was 70.0 (63.3 to 76.1) years …

JACC: Heart Failure

BackgroundHeart failure (HF) is the leading cause of hospitalization in individuals over 65 years of age. Identifying noninvasive methods to detect HF may address the epidemic of HF. Seismocardiography which measures cardiac vibrations transmitted to the chest wall has recently emerged as a promising technology to detect HF.ObjectivesIn this multicenter study, the authors examined whether seismocardiography using commercially available smartphones can differentiate control subjects from patients with stage C HF.MethodsBoth inpatients and outpatients with HF were enrolled from Finland and the United States. Inpatients with HF were assessed within 2 days of admission, and outpatients were assessed in the ambulatory setting. In a prespecified pooled data analysis, algorithms were derived using logistic regression and then validated using a bootstrap aggregation method.ResultsA total of 217 participants …

JACC: Heart Failure

BackgroundPatients recently hospitalized for heart failure (HF) are at a higher risk of adverse clinical outcomes, but they may experience a greater absolute and relative benefit from effective therapies than individuals who are considered more “stable.”ObjectivesThe authors examined the effects of dapagliflozin according to the timing of prior HF hospitalization in a patient-level pooled analysis of DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure).MethodsA total of 11,007 patients were randomized in DAPA-HF and DELIVER. The primary outcome was the composite of worsening HF or cardiovascular death.ResultsIn total, 12.4% were hospitalized for HF within 3 months of randomization, 14.2% between 3 and 12 months, and 16.8% more than 1 year before …

JACC: Heart Failure

Background Little is known regarding differences in cause-specific costs between HF with EF≤ 40% versus> 40%, and potential cost implications of SGLT2i therapy. Objectives To compare cause-specific healthcare costs following hospitalization for heart failure (HF) with ejection fraction (EF)≤ 40% versus> 40%, and estimate the cost offset with implementation of SGLT2 inhibitor (SGLT2i) therapy. Methods We examined Medicare beneficiaries hospitalized for HF in the Get With The Guidelines-Heart Failure registry from 2016-2020. Mean per-patient total (excluding drug costs) and cause-specific costs from discharge through 1-year follow-up were calculated and compared between EF≤ 40% vs> 40%. We then estimated risk reductions on total all-cause and HF hospitalizations in a trial-level meta-analysis of 5 pivotal trials of SGLT2i in HF. Finally, we applied these relative treatment effects to Medicare …

JACC: Heart Failure

BackgroundGender and racial disparities exist after left ventricular assist device (LVAD) implantation. Compared with older devices, the HeartMate 3 (HM3) (Abbott Cardiovascular) has demonstrated improved survival. Whether HM3 differentially improves outcomes by gender or race and ethnic groups is unknown.ObjectivesThe purpose of this study is to examine differences by gender and race in the use of HM3 among patients listed for heart transplantation (HT) and associated waitlist and post-transplant outcomes.MethodsThe authors examined all patients (20% women, 33% Black) who received LVADs as bridge to transplantation (BTT) between January 2018 and June 2020, in the OPTN (Organ Procurement and Transplantation Network) database. Trends in use of HM3 were evaluated by gender and race. Competing events of death/delisting and transplantation were evaluated using subdistribution hazard …

JACC: Heart Failure

BackgroundA recent study showed that the accuracy of heart failure (HF) cardiologists and family doctors to predict mortality in outpatients with HF proved suboptimal, performing less well than models.ObjectivesThe authors sought to evaluate patient and physician factors associated with physician accuracy.MethodsThe authors included outpatients with HF from 11 HF clinics. Family doctors and HF cardiologists estimated patient 1-year mortality. They calculated predicted mortality using the Seattle HF Model and followed patients for 1 year to record mortality (or urgent heart transplant or ventricular assist device implant as mortality-equivalent events). Using multivariable logistic regression, the authors evaluated associations among physician experience and confidence in estimates, duration of patient-physician relationship, patient-physician sex concordance, patient race, and predicted risk, with concordant results …

JACC: Heart Failure

BackgroundAlthough sodium glucose co-transporter 2 inhibitors (SGLT2is) improve heart failure (HF)-related symptoms and outcomes in HF with preserved ejection fraction (HFpEF), underlying mechanisms remain unclear. In HF with reduced EF, dapagliflozin altered ketone and fatty acid metabolites vs placebo; however, metabolite signatures of SGLT2is have not been well elucidated in HFpEF.ObjectivesThe goal of this study was to assess whether SGLT2i treatment altered systemic metabolic pathways and their relationship to outcomes in HFpEF.MethodsTargeted profiling of 64 metabolites was performed from 293 participants in PRESERVED-HF (Dapagliflozin in PRESERVED Ejection Fraction Heart Failure), a 12-week, placebo-controlled trial of dapagliflozin. Linear regression assessed changes in metabolite factors defined by principal components analysis (PCA) with dapagliflozin vs placebo. The …

JACC: Heart Failure

BackgroundPotential organ donors often exhibit abnormalities on electrocardiograms (ECGs) after brain death, but the physiological and prognostic significance of such abnormalities is unknown.ObjectivesThis study sought to characterize the prevalence of ECG abnormalities in a nationwide cohort of potential cardiac donors and their associations with cardiac dysfunction, use for heart transplantation (HT), and recipient outcomes.MethodsThe Donor Heart Study enrolled 4,333 potential cardiac organ donors at 8 organ procurement organizations across the United States from 2015 to 2020. A blinded expert reviewer interpreted all ECGs, which were obtained once hemodynamic stability was achieved after brain death and were repeated 24 ± 6 hours later. ECG findings were summarized, and their associations with other cardiac diagnostic findings, use for HT, and graft survival were assessed using univariable and …

JACC: Heart Failure

BackgroundPatients recently hospitalized for heart failure (HF) are at a higher risk of adverse clinical outcomes, but they may experience a greater absolute and relative benefit from effective therapies than individuals who are considered more “stable.”ObjectivesThe authors examined the effects of dapagliflozin according to the timing of prior HF hospitalization in a patient-level pooled analysis of DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure).MethodsA total of 11,007 patients were randomized in DAPA-HF and DELIVER. The primary outcome was the composite of worsening HF or cardiovascular death.ResultsIn total, 12.4% were hospitalized for HF within 3 months of randomization, 14.2% between 3 and 12 months, and 16.8% more than 1 year before …

JACC: Heart Failure

BackgroundWhether iron deficiency contributes to incident heart failure (HF) and cardiac dysfunction has important implications given the prevalence of iron deficiency and the availability of several therapeutics for iron repletion.ObjectivesThe aim of this study was to estimate the associations of plasma ferritin level with incident HF overall, HF phenotypes, and cardiac structure and function measures in older adults.MethodsParticipants in the ongoing, longitudinal ARIC (Atherosclerosis Risk In Communities) study who were free of prevalent HF and anemia were studied. The associations of plasma ferritin levels with incident HF overall and heart failure with preserved ejection fraction (HFpEF) and HF with reduced ejection fraction (HFrEF) were estimated using Cox proportional hazards regression models. Linear regression models estimated the cross-sectional associations of plasma ferritin with echocardiographic …