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Journal Cover JACC : Heart Failure
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   Full-text available via subscription Subscription journal
   ISSN (Online) 2213-1779
   Published by American College of Cardiology Foundation Homepage  [1 journal]
  • Cost-Effectiveness of Sacubitril-Valsartan Combination Therapy Compared
           With Enalapril for the Treatment of Heart Failure With
           Reduced Ejection Fraction
    • Authors: King JB; Shah RU, Bress AP, et al.
      Abstract: ObjectivesThe objective of this study was to determine the cost-effectiveness and cost per quality-adjusted life year (QALY) gained of sacubitril-valsartan relative to enalapril for treatment of heart failure with reduced ejection fraction (HFrEF).BackgroundCompared with enalapril, combination angiotensin receptor–neprilysin inhibition (ARNI), as is found in sacubitril-valsartan, reduces cardiovascular death and heart failure hospitalization rates in patients with HFrEF.MethodsUsing a Markov model, costs, effects, and cost-effectiveness were estimated for sacubitril-valsartan and enalapril therapies for the treatment of HFrEF. Patients were 60 years of age at model entry and were modeled over a lifetime (40 years) from a third-party payer perspective. Clinical probabilities were derived predominantly from PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). All costs and effects were discounted at a 3% rate annually and are presented in 2015 U.S. dollars.ResultsIn the base case, sacubitril-valsartan, compared with enalapril, was more costly ($60,391 vs. $21,758) and more effective (6.49 vs. 5.74 QALYs) over a lifetime. The cost-effectiveness of sacubitril-valsartan was highly dependent on duration of treatment, ranging from $249,411 per QALY at 3 years to $50,959 per QALY gained over a lifetime.ConclusionsSacubitril-valsartan may be a cost-effective treatment option depending on the willingness-to-pay threshold. Future investigations should incorporate real-world evidence with sacubitril-valsartan to further inform decision making.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Interventions Linked to Decreased Heart Failure Hospitalizations
           During Ambulatory Pulmonary Artery Pressure Monitoring
    • Authors: Costanzo MR; Stevenson LW, Adamson PB, et al.
      Abstract: ObjectivesThis study sought to analyze medical therapy data from the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in Class III Heart Failure) trial to determine which interventions were linked to decreases in heart failure (HF) hospitalizations during ambulatory pulmonary artery (PA) pressure-guided management.BackgroundElevated cardiac filling pressures, which increase the risk of hospitalizations and mortality, can be detected using an ambulatory PA pressure monitoring system before onset of symptomatic congestion allowing earlier intervention to prevent HF hospitalizations.MethodsThe CHAMPION trial was a randomized, controlled, single-blind study of 550 patients with New York Heart Association functional class III HF with a HF hospitalization in the prior year. All patients undergoing implantation of the ambulatory PA pressure monitoring system were randomized to the active monitoring group (PA pressure-guided HF management plus standard of care) or to the blind therapy group (HF management by standard clinical assessment), and followed for a minimum of 6 months. Medical therapy data were compared between groups to understand what interventions produced the significant reduction in HF hospitalizations in the active monitoring group.ResultsBoth groups had similar baseline medical therapy. After 6 months, the active monitoring group experienced a higher frequency of medications adjustments; significant increases in the doses of diuretics, vasodilators, and neurohormonal antagonists; targeted intensification of diuretics and vasodilators in patients with higher PA pressures; and preservation of renal function despite diuretic intensification.ConclusionsIncorporation of a PA pressure-guided treatment algorithm to decrease filling pressures led to targeted changes, particularly in diuretics and vasodilators, and was more effective in reducing HF hospitalizations than management of patient clinical signs or symptoms alone.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • The Search for a Crystal Ball to Predict Early Recovery From Peripartum
           Cardiomyopathy' ∗
    • Authors: Elkayam U; Habakuk O.
      Abstract: Peripartum cardiomyopathy (PPCM) is an idiopathic myocardial disease presenting toward the end of pregnancy or in the months following delivery with heart failure secondary to left ventricular (LV) systolic dysfunction (1). Left ventricular ejection fraction (LVEF) at diagnosis is usually markedly reduced, averaging in the published data at around 30% (2–5). Early recovery (within 2 to 6 months) with partial or complete restoration of cardiac function is an additional characteristic of PPCM and has been described in the majority of patients diagnosed with this condition in the United States and Europe (5–7). At the same time, however, PPCM is a leading cause of pregnancy-related nonobstetric morbidity and mortality. Markedly reduced cardiac function and failure to recover reported in 10% to 30% can be associated with major adverse events, including life threatening arrhythmias, thromboembolic complications, clinical deterioration with a need for aggressive therapy (including cardiac mechanical support and heart transplantation), and death (2,5,6). For these reasons, the ability to identify early predicators of failure to recover in women diagnosed with PPCM is of obvious importance and can help to prevent complications and improve outcome.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Championing Effectiveness Before Cost-Effectiveness ∗
    • Authors: Dhruva SS; Krumholz HM.
      Abstract: The proliferation of costly therapies has led to an increased focus on value. In the treatment of patients with advanced heart failure (HF), one such expensive intervention, CardioMEMS (CardioMEMS Heart Failure System, St. Jude Medical Inc., Atlanta, Georgia), is a permanently implanted device to monitor pulmonary artery pressure and enable adjustments in therapy that could avert the need for hospitalization. CardioMEMS was tested in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, a randomized, single-blind multicenter study led by the founder of the company. It included 550 patients with New York Heart Association (NYHA) functional class III HF with ≥1 HF-related hospitalization in the past year (1). All patients underwent implantation with the CardioMEMS device. Treatment patients had specific pulmonary artery pressure targets and treatment algorithms administered by local physicians with contact from study nurses; control patients received routine care. The device was associated with a statistically significant 12% absolute reduction (44% vs. 32%) in the primary efficacy endpoint of HF-related hospitalizations up to 6 months (2). Both primary safety endpoints were also met, including no pressure sensor failures and a 1% rate of device- or system-related complications.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Relaxin-2 and Soluble Flt1 Levels in Peripartum Cardiomyopathy Results of
           the Multicenter IPAC Study
    • Authors: Damp J; Givertz MM, Semigran M, et al.
      Abstract: ObjectivesThis study explored the association of vascular hormones with myocardial recovery and clinical outcomes in peripartum cardiomyopathy (PPCM).BackgroundPPCM is an uncommon disorder with unknown etiology. Angiogenic imbalance may contribute to its pathophysiology.MethodsIn 98 women with newly diagnosed PPCM enrolled in the Investigation in Pregnancy Associated Cardiomyopathy study, serum was obtained at baseline for analysis of relaxin-2, prolactin, soluble fms-like tyrosine kinase 1 (sFlt1), and vascular endothelial growth factor (VEGF). Left ventricular ejection fraction (LVEF) was assessed by echocardiography at baseline and 2, 6, and 12 months.ResultsMean age was 30 ± 6 years, with a baseline of LVEF 0.35 ± 0.09. Relaxin-2, prolactin, and sFlt1 were elevated in women presenting early post-partum, but decreased rapidly and were correlated inversely with time from delivery to presentation. In tertile analysis, higher relaxin-2 was associated with smaller left ventricular systolic diameter (p = 0.006) and higher LVEF at 2 months (p = 0.01). This was particularly evident in women presenting soon after delivery (p = 0.02). No relationship was evident for myocardial recovery and prolactin, sFlt1 or VEGF levels. sFlt1 levels were higher in women with higher New York Heart Association functional class (p = 0.01) and adverse clinical events (p = 0.004).ConclusionsIn women with newly diagnosed PPCM, higher relaxin-2 levels soon after delivery were associated with myocardial recovery at 2 months. In contrast, higher sFlt1 levels correlated with more severe symptoms and major adverse clinical events. Vascular mediators may contribute to the development of PPCM and influence subsequent myocardial recovery. (Investigation in Pregnancy Associate Cardiomyopathy [IPAC]; NCT01085955)
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Digoxin for Worsening Chronic Heart Failure Underutilized and
           Underrated ∗
    • Authors: Ambrosy AP; Pang PS, Gheorghiade M.
      Abstract: Despite more than 200 years of clinical experience and a pivotal trial, digoxin, a purified cardiac glycoside derived from the foxglove plant, remains the most controversial drug in contemporary cardiovascular medicine (1,2). Although the U.S. Food and Drug Administration approved digoxin in 1997, the guidelines currently offer only a secondary recommendation (i.e., class IIa) for digoxin in: 1) patients with HF with reduced ejection fraction (EF) experiencing persistent symptoms despite optimal medical therapy; and 2) as an adjunct for rate control in patients with atrial fibrillation already receiving β-blockers and/or calcium channel blockers (3). However, there have been no major advances in the management of patients hospitalized for worsening chronic HF, and these patients remain at high risk for early readmission or death despite available therapies. Thus, there are compelling public health reasons to reconsider the use of digoxin, a drug that is known to improve signs and symptoms of congestion as well as reduce HF-related hospitalizations and readmissions.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Cost-Effectiveness of Implantable Pulmonary Artery Pressure Monitoring
           in Chronic Heart Failure
    • Authors: Sandhu AT; Goldhaber-Fiebert JD, Owens DK, et al.
      Abstract: ObjectivesThis study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure.BackgroundThe CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial.MethodsWe developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials.ResultsCardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Treating Hemodynamic Congestion Is the Key to Prevent Heart
           Failure Hospitalizations ∗
    • Authors: Klein L.
      Abstract: “I once was lost, but now am found. Was blind, but now I see.”—John Newton, “Amazing Grace” (1)
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Temporal Trends of Digoxin Use in Patients Hospitalized With Heart
           Failure Analysis From the American Heart Association
           Get With The Guidelines-Heart Failure Registry
    • Authors: Patel N; Ju C, Macon C, et al.
      Abstract: ObjectivesThe aim of this study was to assess temporal trends and factors associated with digoxin use at discharge among patients admitted with heart failure (HF).BackgroundDigoxin has class IIa recommendations for treating HF with reduced ejection fraction (HFrEF) in the United States. Digoxin use, temporal trends, and clinical characteristics of HF patients in current clinical practice in the United States have not been well studied.MethodsAn observational analysis of 255,901 patients hospitalized with HF (117,761 with HFrEF and 138,140 with preserved EF [HFpEF]) from 398 hospitals participating in the Get With The Guidelines–HF registry between January 2005 and June 2014 was conducted to assess the temporal trends and factors associated with digoxin use.ResultsAmong 117,761 HFrEF patients, only 19.7% received digoxin at discharge. Digoxin prescriptions decreased from 33.1% in 2005 to 10.7% in 2014 (ptrend < 0.0001). Factors associated with digoxin use in HFrEF included atrial fibrillation (AF) (odds ratio [OR]: 2.14; 95% confidence intervals [CI]: 2.02 to 2.28), history of implantable cardioverter defibrillator use (OR: 1.39; 95% CI: 1.32 to 1.46), chronic obstructive pulmonary disease (OR: 1.13, 95% CI: 1.08 to 1.18), diabetes mellitus (OR: 1.10, 95% CI: 1.06 to 1.14), younger age (OR: 0.96, 95% CI: 0.95 to 0.97), lower blood pressure (OR: 0.96, 95% CI: 0.96 to 0.97), and having no history of renal insufficiency (OR: 0.91, 95% CI: 0.85 to 0.97). Use of digoxin in patients with HFpEF (n = 138,140) without AF was 9.8% in 2005, which decreased to 2.2% in 2014 (ptrend < 0.0001).ConclusionsOne in 5 HFrEF patients received digoxin at discharge, with a significant downward temporal trend in use over the study period. Use of digoxin in HFpEF patients without AF was very low and decreased over the study period.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Digoxin Toxicity and Use of Digoxin Immune Fab Insights From a
           National Hospital Database
    • Authors: Hauptman PJ; Blume SW, Lewis EF, et al.
      Abstract: ObjectivesThis study was developed to determine contemporary management of digoxin toxicity and clinical outcomes.BackgroundAlthough the use of digoxin in heart failure management has declined, toxicity remains a prevalent complication.MethodsThe Premier Perspective Comparative Hospital Database (Premier Inc., Charlotte, North Carolina) was used to retrospectively identify patients diagnosed with digoxin toxicity and/or who received digoxin immune fab (DIF) over a 5-year period (2007 to 2011). DIF was evaluated using treatment date, number of vials administered, and total cost. Clinical outcomes included length of stay (total hospitalization; days after DIF), cost of hospitalization, and in-hospital mortality. Exploratory multivariate analyses were conducted to determine predictors of DIF and effect on length of stay, adjusting for patient characteristics and selection bias.ResultsDigoxin toxicity diagnosis without DIF treatment accounted for 19,543 cases; 5,004 patients received DIF of whom 3086 had a diagnosis of toxicity. Most patients were >65 years old (88%). The predictors of DIF use were urgent/emergent admission, hyperkalemia, arrhythmia associated with digoxin toxicity, acute renal failure, or suicidal intent (odds ratios 1.7, 2.4, 3.6, 2.1, and 3.7, respectively; p < 0.0001 for all). The majority (78%) of DIF was administered on days 1 and 2 of the hospitalization; 10% received treatment after day 7. Digoxin was used after DIF administration in 14% of cases. Among patients who received DIF within 2 days of admission, there was no difference for in-hospital mortality or length of stay compared with patients not receiving DIF.ConclusionsDigoxin toxicity diagnoses are clustered in the elderly. One-fifth of cases receive treatment with DIF, most within 2 days of admission. Opportunities exist for improved diagnosis and post-DIF management. Prospective data may be required to assess the impact of DIF on length of stay.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Love of Angiotensin-Converting Enzyme Inhibitors in the Time of Cholera
    • Authors: Packer M.
      Abstract: The highly acclaimed novel Love in the Time of Cholera by the Nobel Prize-winning Colombian author Gabriel García Márquez is a brilliant exploration of the complexity of love, specifically the struggle between our attraction to the ideal and depraved dimensions of love and the importance of passion and societal expectations in defining the attributes and personal rewards of love (1). Lovesickness is viewed as an illness, just as cholera is defined (from an intriguing Spanish perspective) as a passion, separate from its conventional consideration as a disease. The flow of the story (which evolves over decades) can be viewed simplistically, but that would be a mistake. The author himself has warned readers “you have to be careful not to fall into my trap” (1).
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Neprilysin Inhibition in the Time of Precision Medicine ∗
    • Authors: Feldman AM.
      Abstract: The recent results of the PARADIGM-HF trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) showing that the combination of the neprilysin (NEP) inhibitor sacubitril (sac) and the angiotensin receptor antagonist (ARB) valsartan (sacubitril/valsartan [sac/val]; Entresto, Novartis) decreased the risk of death from cardiovascular cause or first hospitalization for heart failure (HF) while modestly reducing the risk of death from 19.8% to 17.0% (hazard ratio: 0.84) when compared with the angiotensin-converting enzyme inhibitor (ACEi) enalapril engendered considerable interest among cardiologist and HF specialists (1). In this issue of JACC: Heart Failure, Dr. Milton Packer posits that since “the PARADIGM-HF trial has demonstrated the need to inhibit NEP, we should do so as early as possible and not delay until we have achieved target doses of a conventional inhibitor of the renin-angiotensin system” (2). He uses the allegory of the novel Love in the Time of Cholera to make the point that physicians are having difficulty breaking from their long-standing comfort in using an ACEi as a pivotal therapy for patients with HF and reduced ejection fraction (HFrEF). Written by the Nobel laureate Gabriel García Márquez, Love in the Time of Cholera describes how Florentino Ariza meets and falls in love with Fermina Daza, only to have his advances spurned until fate brings them together over 50 years later, albeit with a less than happy ending. This is an interesting allegory to use because Márquez is universally recognized as one of the most preeminent members of a literary movement known as “magic realism” (“marvelous realism”) and Love in the Time of Cholera is a quintessential example of that genre (3). Magic realism mixes elements of fantasy into otherwise realistic or common settings. As physicians, we must however look at the results of PARADIGM-HF from a realistic and scientific perspective based on the elements that we have used to judge all HF therapies: 1) the pre-clinical data; 2) the design and results of all relevant clinical trials; and 3) associated risks – both observed and theoretical.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Are We Really in Love With Old Therapies'
    • PubDate: Sun, 01 May 2016 00:00:00 GMT
  • What Is the Prevalence of Diabetes Mellitus in Patients With
           Principal and Secondary Takotsubo Syndrome'
    • Authors: Madias JE.
      Abstract: I read with great interest the report by Murugiah et al. (1) and the accompanying editorial by Sharkey (2), published in JACC: Heart Failure, about the prevalence of Takotsubo syndrome (TTS) and some relevant particulars of patients in the United States, derived from the 2007 to 2012 Centers for Medicare & Medicaid Services dataset. The authors and the editorialist (1,2) refer to the important issue of the “2 clinical scenarios” of TTS “either as a principal event (P-TTS) or as a secondary event (S-TTS) in the context of a co-existing major illness” (1,2), and the authors report separately on the patient characteristics and outcome in these 2 subcategories of TTS patients. Curiously, the authors refer to the “principal diagnoses of TTS” as “more likely representing primary coronary presentations of TTS” (1), as if it had been already established that TTS is due to some pathological/functional alterations of the coronary arteries, which is not the case. They analyzed data for the years 2007, 2009, and 2011, and in patients with both P-TTS and S-TTS, they found that their mean age was 76.0 versus 76.4 years, respectively, and the prevalence of hypertension (67.4% vs. 63.1%), diabetes mellitus (18.5% vs. 20.1%), and previous diagnosis of atherosclerotic disease (46.1% vs. 47.5%) were similar (1).
      PubDate: Sun, 01 May 2016 00:00:00 GMT
  • Reply What Is the Prevalence of Diabetes Mellitus in Patients With
           Principal and Secondary Takotsubo Syndrome'
    • Authors: Murugiah K; Desai NN, Krumholz HM.
      Abstract: We thank Dr. Madias for his interest in our paper and for his comments. With regard to the first comment concerning the cohort with a principal diagnosis of Takotsubo cardiomyopathy (TTC), we would like to clarify that by “coronary presentations of TTC,” we mean patients presenting with symptoms suggestive of an acute coronary syndrome, as opposed to those being admitted with infective symptoms (e.g., sepsis) or neurological symptoms, as in a stroke, etc. We are not suggesting that the causal mechanism for TTC among principal TTC patients involves a pathological or functional alteration of the coronaries.
      PubDate: Sun, 01 May 2016 00:00:00 GMT
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