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Aims The impact of mitral valve geometry on outcomes after MitraClip treatment in secondary mitral regurgitation (MR) has not been examined. We therefore sought to evaluate the association between mitral valve geometry and outcomes of patients with heart failure (HF) and secondary MR treated with guideline-directed medical therapy (GDMT) and MitraClip. Methods and results Mitral valve geometry was assessed from the baseline echocardiograms in 614 patients from the COAPT trial. The primary endpoint for the present study was the composite of all-cause mortality or HF hospitalization (HFH) within 2 years. Effect of treatment arm (MitraClip plus maximally tolerated GDMT vs. GDMT alone) on outcomes according to baseline variables was assessed. Among 29 baseline mitral valve echocardiographic parameters, increasing anteroposterior mitral annular diameter was the only independent predictor of the composite endpoint of all-cause mortality or HFH [adjusted hazard ratio (aHR) per cm 1.49; P = 0.04]. The effective regurgitant orifice area (EROA) was independently associated with all-cause mortality alone (aHR per cm2 2.97; P = 0.04) but not with HFH, whereas increasing anteroposterior mitral annular diameter was independently associated with HFH alone (aHR per cm 1.85; P = 0.005) but not all-cause mortality. Other mitral valve morphologic parameters were unrelated to outcomes. MitraClip reduced HFH and mortality independent of anteroposterior mitral annular diameter and EROA (P interaction = 0.77 and 0.27, respectively). Conclusion In patients with HF and severe secondary MR, a large anteroposterior mitral annular diameter and greater EROA were the strongest echocardiographic predictors of HFH and death in patients treated with GDMT alone and with the MitraClip. [ABSTRACT FROM AUTHOR]

The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to assess the ability of a voice analysis application to discriminate between wet and dry states in chronic heart failure (CHF) patients undergoing regular scheduled haemodialysis treatment due to volume overload as a result of their chronic renal failure. Methods and results: In this single‐centre, observational study, five patients with CHF, peripheral oedema of ≥2, and pulmonary congestion‐related dyspnoea, undergoing haemodialysis three times per week, recorded five sentences into a standard smartphone/tablet before and after haemodialysis. Recordings were provided that same noon/early evening and the next morning and evening. Patient weight was measured at the hospital before and after each haemodialysis session. Recordings were analysed by a smartphone application (app) algorithm, to compare speech measures (SMs) of utterances collected over time. On average, patients provided recordings throughout 25.8 ± 3.9 dialysis treatment cycles, resulting in a total of 472 recordings. Weight changes of 1.95 ± 0.64 kg were documented during cycles. Median baseline SM prior to dialysis was 0.87 ± 0.17, and rose to 1.07 ± 0.15 following the end of the dialysis session, at noon (P = 0.0355), and remained at a similar level until the following morning (P = 0.007). By the evening of the day following dialysis, SMs returned to baseline levels (0.88 ± 0.19). Changes in patient weight immediately after dialysis positively correlated with SM changes, with the strongest correlation measured the evening of the dialysis day [slope: −0.40 ± 0.15 (95% confidence interval: −0.71 to −0.10), P = 0.0096]. Conclusions: The fluid‐controlled haemodialysis model demonstrated the ability of the app algorithm to identify cyclic changes in SMs, which reflected bodily fluid levels. The voice analysis platform bears considerable potential as a harbinger of impending fluid overload in a range of clinical scenarios, which will enhance monitoring and triage efforts, ultimately optimizing remote CHF management. [ABSTRACT FROM AUTHOR]

Cardiac contractility modulation, also referred to as CCM™, by the Optimizer Smart device is an innovative intracardiac device-based therapy that has been recently US FDA-approved for the treatment of patients with chronic heart failure, left ventricular ejection fraction (LVEF) between 25 and 45%, QRS <130 ms who remain symptomatic despite optimal medical therapy. Clinical trials demonstrate that CCM therapy is safe and effective in reducing heart failure hospitalization and improving heart failure symptoms, quality of life and functional performance. This novel device-based therapeutic offers benefits to patients who do not otherwise qualify for cardiac resynchronization therapy. CCM expands the indication beyond the traditional LVEF cutoff of 35% to a newer group including patients who fall in midrange LVEF group, up to 45%. [ABSTRACT FROM AUTHOR]

Aims: The presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics.Methods and Results: All patients randomized in the remedē System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system.Conclusions: Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life. [ABSTRACT FROM AUTHOR]

Background In a randomized trial, baroreflex activation therapy (BAT) improved exercise capacity, quality of life and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF). In view of different mechanisms underlying HFrEF, we performed a post-hoc subgroup analysis of efficacy and safety of BAT in patients with and without coronary artery disease (CAD). Methods and results Patients with left ventricular ejection fraction <35% and NYHA Class III were randomized 1:1 to guideline-directed medical and device therapy alone or plus BAT. Patients with a history of CAD, prior myocardial infarction or coronary artery bypass graft were assigned to the CAD group with all others assigned to the no-CAD group. Of 71 BAT treated patients, 52 had CAD and 19 had no CAD. In the control group, 49 of 69 patients had CAD and 20 had no CAD. The system- or procedure-related major adverse neurological or cardiovascular event rate was 3.8% in the CAD group vs. 0% in the no-CAD group (p = 1.0). In the whole cohort, NYHA Class, Minnesota Living with Heart Failure score, 6-minute hall walk distance and NTproBNP were improved in BAT treated patients compared with controls. Statistical analyses revealed no interaction between the presence of CAD and effect of BAT (all p > 0.05). Conclusion No major differences were found in BAT efficacy or safety between patients with and without CAD, indicating that BAT improves exercise capacity, quality of life and NTproBNP in patients with ischemic and non-ischemic cardiomyopathy. ClinicalTrials.gov identifier NCT01471860 and NCT01720160 . [ABSTRACT FROM AUTHOR]

Aims: Because of concerns about the safety of aliskiren in patients with diabetes, study treatment was stopped prematurely in the Aliskiren Trial of Minimizing OutcomeS for Patients with HEart failuRE (ATMOSPHERE). We examined outcomes and treatment effect in these patients compared with those without diabetes.Methods and Results: ATMOSPHERE included 7016 patients with heart failure and a reduced ejection fraction (HFrEF) randomly assigned to enalapril plus aliskiren, aliskiren alone, or enalapril. At baseline, 1944 (27.7%) patients had diabetes. Median follow-up was shorter in patients with diabetes compared with those without (24 months vs. 46 months). Among patients with diabetes, the primary endpoint of cardiovascular death or hospitalization for heart failure occurred in 216 patients (33.1%) in the enalapril group (reference), 172 (27.4%) in the aliskiren group [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.67-1.00; P = 0.053], and 196 (29.5%) in the combination group (HR 0.86, 95% CI 0.71-1.04; P = 0.13). The effects of the treatments studied did not differ significantly compared with patients without diabetes. In patients with diabetes, aliskiren monotherapy was associated with a lower risk of symptomatic hypotension compared to enalapril [42 (6.7%) vs. 65 (10.0%); P = 0.04], whereas other adverse events were generally balanced between the three groups.Conclusion: In patients with HFrEF and diabetes, there was no signal of harm and a trend towards benefit when direct renin inhibition monotherapy was compared with an angiotensin-converting enzyme inhibitor, whereas combined aliskiren and enalapril treatment led to more adverse events with no improvement in outcomes. Treatment effects did not differ in patients with diabetes compared with those without. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00853658. [ABSTRACT FROM AUTHOR]

Aims Cardiac resynchronization therapy ( CRT) reduces morbidity and mortality in patients with symptomatic heart failure and QRS prolongation but there is uncertainty about which patient characteristics predict short-term clinical response. Methods and results In an individual patient meta-analysis of three double-blind, randomized trials, clinical composite score ( CCS) at 6 months was compared in patients assigned to CRT programmed on or off. Treatment-covariate interactions were assessed to measure likelihood of improved CCS at 6 months. MIRACLE, MIRACLE ICD, and REVERSE trials contributed data for this analysis ( n = 1591). Multivariable modelling identified QRS duration and left ventricular ejection fraction ( LVEF) as predictors of CRT clinical response ( P < 0.05). The odds ratio for a better CCS at 6 months increased by 3.7% for every 1% decrease in LVEF for patients assigned to CRT-on compared to CRT-off, and was greatest when QRS duration was between 160 and 180 ms. Conclusions In symptomatic chronic heart failure patients ( NYHA class II-IV), longer QRS duration and lower LVEF independently predict early clinical response to CRT. [ABSTRACT FROM AUTHOR]

Rates of heart failure hospitalization remain unacceptably high. Such hospitalizations are associated with substantial patient, caregiver, and economic costs. Randomized controlled trials of noninvasive telemedical systems have failed to demonstrate reduced rates of hospitalization. The failure of these technologies may be due to the limitations of the signals measured. Intracardiac and pulmonary artery pressure-guided management has become a focus of hospitalization reduction in heart failure. Early studies using implantable hemodynamic monitors demonstrated the potential of pressure-based heart failure management, whereas subsequent studies confirmed the clinical utility of this approach. One large pivotal trial proved the safety and efficacy of pulmonary artery pressure-guided heart failure management, showing a marked reduction in heart failure hospitalizations in patients randomized to active pressure-guided management. "Next-generation" implantable hemodynamic monitors are in development, and novel approaches for the use of this data promise to expand the use of pressure-guided heart failure management. [ABSTRACT FROM AUTHOR]

Aims: Haemodynamic-guided heart failure (HF) management effectively reduces decompensation events and need for hospitalizations. The economic benefit of clinical improvement requires further study.Methods and Results: An estimate of the cost-effectiveness of haemodynamic-guided HF management was made based on observations published in the randomized, prospective single-blinded CHAMPION trial. A comprehensive analysis was performed including healthcare utilization event rates, survival, and quality of life demonstrated in the randomized portion of the trial (18 months). Markov modelling with Monte Carlo simulation was used to approximate comprehensive costs and quality-adjusted life years (QALYs) from a payer perspective. Unit costs were estimated using the Truven Health MarketScan database from April 2008 to March 2013. Over a 5-year horizon, patients in the Treatment group had average QALYs of 2.56 with a total cost of US$56 974; patients in the Control group had QALYs of 2.16 with a total cost of US$52 149. The incremental cost-effectiveness ratio (ICER) was US$12 262 per QALY. Using comprehensive cost modelling, including all anticipated costs of HF and non-HF hospitalizations, physician visits, prescription drugs, long-term care, and outpatient hospital visits over 5 years, the Treatment group had a total cost of US$212 004 and the Control group had a total cost of US$200 360. The ICER was US$29 593 per QALY.Conclusions: Standard economic modelling suggests that pulmonary artery pressure-guided management of HF using the CardioMEMS™ HF System is cost-effective from the US-payer perspective. This analysis provides the background for further modelling in specific country healthcare systems and cost structures. [ABSTRACT FROM AUTHOR]

Aims: Haemodynamic-guided heart failure (HF) management using directly measured cardiac filling pressures in symptomatic patients is now recommended in the European Society of Cardiology (ESC) Heart Failure Guidelines [Class IIb(B)]. This meta-analysis evaluates all data from completed clinical trials evaluating this approach in patients with HF.Methods and Results: All trials evaluating the impact of HF management based on haemodynamic monitoring using implantable devices were reviewed using standard search engine methods. PRISMA methods were used to evaluate and screen publications that included an evaluation of an effect on HF hospitalizations. All publications meeting the inclusion criteria were included, and the outcomes data were evaluated using standard meta-analysis methodology. Of 317 publications initially identified, five trials involving 1296 patients with chronic HF met the criteria used in this meta-analysis. Studies included prospective controlled designs, as well as observational studies with historical control. Heterogeneity testing failed to demonstrate instability of analysis due to differences between trials. When compiled, outcomes from these trials favoured remote haemodynamic monitoring with a significant 38% reduction in HF hospitalizations (hazard ratio 0.62, 95% confidence interval 0.50-0.78, P < 0.001).Conclusions: Haemodynamic-guided HF management using permanently implanted sensors and frequent filling pressure evaluation is superior to traditional clinical management strategies in reducing long-term HF hospitalization risk in symptomatic patients. [ABSTRACT FROM AUTHOR]

Aims: As patients with heart failure (HF) and concomitant diabetes carry a poor prognosis, this post-hoc subgroup analysis aimed to compare the outcomes of patients with and without diabetes randomized in the Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) study.Methods and Results: EchoCRT randomized patients with a QRS duration <130 ms and echocardiographic evidence of left ventricular dyssynchrony to CRT turned on (CRT=ON) vs. off (CRT=OFF) following device implantation. At study entry, 328 patients (40.5%) had diabetes. The primary outcome (all-cause death or first hospitalization for worsening HF) occurred more frequently in patients with than without diabetes (32.6% vs. 23%, P = 0.003). A significant treatment interaction was observed for the primary outcome indicating a higher risk for CRT=ON vs. CRT-OFF in patients without [26.5% vs. 19.8%, hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.08-2.31] vs. with diabetes (31.4% vs. 34%; HR 0.86, 95% CI 0.58-1.27; P for interaction 0.041). This effect was mainly driven by a lower rate in HF hospitalizations, but was only of borderline significance after multivariate adjustment (P = 0.063). The most pronounced effect was observed in patients with non-ischaemic cardiomyopathy, where a significantly reduced risk of reaching the primary endpoint for CRT=ON vs. CRT-OFF was observed in patients with (HR 0.27, P = 0.003) vs. patients without diabetes (HR 1.79, P = 0.038; P for interaction 0.005). No treatment interaction by diabetes diagnosis was found for mortality endpoints.Conclusion: In EchoCRT, HF patients with a narrow QRS complex and coexisting diabetes demonstrated a signal for less harm caused by CRT compared with patients without diabetes, which was driven by differences in hospitalizations owing to HF. [ABSTRACT FROM AUTHOR]

Background: In EchoCRT, a randomized controlled trial evaluating the effect of cardiac resynchronization therapy (CRT) in patients with a QRS duration of <130 ms and echocardiographic evidence of left ventricular dyssynchrony, the primary outcome (death from any cause or first hospitalization for worsening heart failure) occurred more frequently in the CRT-ON when compared with the control group. In this prespecified subgroup analysis, we evaluated the effect of sex on clinical outcome in EchoCRT.Methods and Results: In EchoCRT, 585 (72%) of included patients were men. At baseline, male patients had a higher incidence of ischemic cardiomyopathy and longer QRS duration. On uni- and multivariable analysis, no significant interaction was observed regarding sex for the primary or any of the secondary end points. Numerically, a higher all-cause mortality was observed in male patients randomized to CRT-ON versus CRT-OFF on univariable analysis (hazard ratio, 1.83; 95% confidence interval, 1.08-3.12); however, no statistically significant interaction compared with females randomized to CRT-ON versus CRT-OFF was noted (hazard ratio, 0.99; P interaction, 0.56). There was no difference in the primary safety end point of system-related complications, including CRT system- and implantation-related events.Conclusions: The largest hazard for all-cause mortality in EchoCRT was observed in men randomized to CRT-ON; the comparison with women did not reach statistical significance, which may be because of the premature termination of the trial and the limited data. These results suggest that male sex may be a risk factor for harm by CRT in patients with narrow QRS width, an observation which deserves further investigation.Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT00683696. [ABSTRACT FROM AUTHOR]

Background: In the CHAMPION trial, significant reductions in admissions to hospital for heart failure were seen after 6 months of pulmonary artery pressure guided management compared with usual care. We examine the extended efficacy of this strategy over 18 months of randomised follow-up and the clinical effect of open access to pressure information for an additional 13 months in patients formerly in the control group.Methods: The CHAMPION trial was a prospective, parallel, single-blinded, multicentre study that enrolled participants with New York Heart Association (NYHA) Class III heart failure symptoms and a previous admission to hospital. Patients were randomly assigned (1:1) by centre in block sizes of four by a secure validated computerised randomisation system to either the treatment group, in which daily uploaded pulmonary artery pressures were used to guide medical therapy, or to the control group, in which daily uploaded pressures were not made available to investigators. Patients in the control group received all standard medical, device, and disease management strategies available. Patients then remained masked in their randomised study group until the last patient enrolled completed at least 6 months of study follow-up (randomised access period) for an average of 18 months. During the randomised access period, patients in the treatment group were managed with pulmonary artery pressure and patients in the control group had usual care only. At the conclusion of randomised access, investigators had access to pulmonary artery pressure for all patients (open access period) averaging 13 months of follow-up. The primary outcome was the rate of hospital admissions between the treatment group and control group in both the randomised access and open access periods. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661.Findings: Between Sept 6, 2007, and Oct 7, 2009, 550 patients were randomly assigned to either the treatment group (n=270) or to the control group (n=280). 347 patients (177 in the former treatment group and 170 in the former control group) completed the randomised access period in August, 2010, and transitioned to the open access period which ended April 30, 2012. Over the randomised access period, rates of admissions to hospital for heart failure were reduced in the treatment group by 33% (hazard ratio [HR] 0·67 [95% CI 0·55-0·80]; p<0·0001) compared with the control group. After pulmonary artery pressure information became available to guide therapy during open access (mean 13 months), rates of admissions to hospital for heart failure in the former control group were reduced by 48% (HR 0·52 [95% CI 0·40-0·69]; p<0·0001) compared with rates of admissions in the control group during randomised access. Eight (1%) device-related or system related complications and seven (1%) procedure-related adverse events were reported.Interpretation: Management of NYHA Class III heart failure based on home transmission of pulmonary artery pressure with an implanted pressure sensor has significant long-term benefit in lowering hospital admission rates for heart failure.Funding: St Jude Medical Inc. [ABSTRACT FROM AUTHOR]

Aims: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs. those without CRT.Methods and Results: New York Heart Association (NYHA) Class III patients with an ejection fraction (EF) ≤35% were randomized (1 : 1) to ongoing guideline-directed medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety endpoint was system-/procedure-related major adverse neurological and cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations were significantly improved in BAT patients compared with controls. Changes in efficacy endpoints in the CRT group favoured BAT; however, the improvements were less than in the no-CRT group and were not statistically different from control.Conclusions: BAT is safe and significantly improved QoL, exercise capacity, NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF patients. These effects were most pronounced in patients not treated with CRT. [ABSTRACT FROM AUTHOR]

Aims and Methods: To: (i) describe the baseline characteristics of patients in ATMOSPHERE and the changes in the planned analysis of ATMOSPHERE resulting from the mandated discontinuation of study treatment in patients with diabetes; (ii) compare the baseline characteristics of patients in ATMOSPHERE with those in the Prospective comparison of Angiotensin Receptor neprilysin inhibitors with Angiotensin converting enzyme inhibitors to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF); and (iii) compare the characteristics of patients with and without diabetes at baseline in ATMOSPHERE.Results: A total of 7063 patients were randomized into ATMOSPHERE April 2009-April 2014 at 755 sites in 43 countries. Their average age was 63 years and 78% were men. ATMOSPHERE patients were generally similar to those in PARADIGM-HF although fewer had diabetes, renal dysfunction, and were treated with a mineralocorticoid receptor antagonist. In ATMOSPHERE, patients with diabetes differed in numerous ways from those without. Patients with diabetes were older and had worse heart failure status but a similar left ventricular ejection fraction (mean 28%); they had a higher body mass index and more co-morbidity, especially hypertension and coronary heart disease. Mean estimated glomerular filtration rate was slightly lower in those with diabetes compared with those without.Conclusion: ATMOSPHERE will determine whether patients with HF and reduced ejection fraction (particularly those without diabetes) benefit from the addition of a direct renin inhibitor to standard background therapy, including an angiotensin-converting enzyme inhibitor, beta-blocker, and a mineralocorticoid receptor antagonist. ATMOSPHERE will also determine whether aliskiren alone is superior to, or at least non-inferior to, enalapril. [ABSTRACT FROM AUTHOR]

Background We conducted a prospective multicenter study to assess the prognostic value of combined baseline preimplant plasma levels of the biomarkers cardiac troponin T (TnT) and B-type natriuretic peptide (BNP) among cardiac resynchronization therapy (CRT) with or without defibrillator capability (CRT-D) recipients. Methods At CRT-D implant, patients were stratified based on detectable TnT (≥0.01 ng/mL) and elevated BNP (predefined as >440 pg/mL) levels. Patients were classified into three groups: high (both detectable TnT and high BNP), intermediate (either detectable TnT or high BNP), or low (nondetectable TnT and low BNP). Patients were followed for 12 months. Survival curves free from mortality or heart failure hospitalizations (HFH) were assessed. To assess the predictive value of biomarker category, we constructed a multivariate Cox regression model, including the covariates of age, New York Heart Association class, left ventricular ejection fraction (LVEF), and QRS duration. Results A total of 267 patients (age 66 ± 12 years, males 80%, LVEF 25% ± 8%, ischemic cardiomyopathy 52%, QRSd 155 ± 26 ms) were studied. After 1 year, there were 13 deaths and 25 HFH events. A significant difference in event-free survival among the three groups was observed, with high and intermediate categories having worse survival than low (log-rank test, P < 0.001). In the multivariate model, risk category was a significant predictor of outcome: hazard ratios were 7.34 (95% confidence interval [CI]: 2.48-21.69) and 2.50 (95% confidence interval [CI]: 1.04-6.04) for high-risk and intermediate-risk groups, respectively (P < 0.0001). Conclusion Among CRT-D recipients, baseline TnT and BNP values alone or in combination provide significant prognostic value for the outcome of mortality or HFH. [ABSTRACT FROM AUTHOR]

Despite current therapies and disease management approaches, rates of heart failure ( HF) rehospitalization remain high. New tools are needed to assess preclinical (asymptomatic) pulmonary congestion to enable outpatient management. Hence, a novel monitoring system based on noninvasive remote dielectric sensing ( Re DS) technology was developed. Validation of the Re DS technology was conducted in preclinical and clinical studies. In a porcine HF model, acute fluid overload followed by administration of diuretics were performed. Changes in Re DS values were correlated to serial computed tomographic ( CT) assessments of lung fluid concentrations. In hospitalized decompensated HF patients, changes in Re DS values were correlated to net fluid balance changes. A nearly linear pattern between the changes in Re DS and CT fluid concentration values was observed in 6 discrete experiments ( Intraclass correlation=0.95). Results from 24 patients demonstrated a reduction in Re DS values of 17.53%±11% throughout hospitalization, consistent with a reduction in pulmonary congestion. This finding strongly correlated with changes in net fluid balance ( Pearson correlation=0.86; 95% confidence interval, 0.68-0.94; R2=0.74). These findings suggest that Re DS technology accurately quantifies lung fluid concentration and has potential for monitoring HF patients through hospitalization and possibly at home. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a global phenomenon, and the overall incidence and prevalence of the condition are steadily increasing. Medical therapies have proven efficacious, but only a small number of pharmacological options are in development. When patients cease to respond adequately to optimal medical therapy, cardiac resynchronization therapy has been shown to improve symptoms, reduce hospitalizations, promote reverse remodelling, and decrease mortality. However, chalienges remain in identifying the ideal recipients for this therapy. The field of mechanical circulatory support has seen immense growth since the early 200Os, and left ventricular assist devices (LVADs) have transitioned over the past decade from large, pulsatile devices to smaller, more-compact, continuous41ow devices. Infections and haematological issues are still important areas that need to be addressed. Whereas LVADs were once approved only for 'bridge to transplantation', these devices are now used as destination therapy for critically ill patients with HF, allowing these individuals to return to the community. A host of novel strategies, including cardiac contractility modulation, implantable haemodynamic-monitoring devices, and phrenic and vagus nerve stimulation, are under investigation and might have an impact on the future care of patients with chronic HF. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM PUBLISHER]

Congest Heart Fail. 2011;17:220-226. © 2011 Wiley Periodicals, Inc. Despite evidence based medical and pharmacologic advances the management of heart failure remains challenging, especially in the ambulatory setting. There is an urgent need to develop strategies to reduce hospitalizations and re-admission rates for heart failure in general. This focused review illustrates the potential role for remote telemonitoring and implantable hemodynamic devices to address this significant issue. We also explore the growth of cardiac resynchronization therapy and how it has evolved into another tool in our armamentarium for hemodynamic monitoring. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to determine the effects of cardiac resynchronization therapy (CRT) with respect to heart failure etiology among patients in the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. Background: CRT improves outcomes in New York Heart Association functional class III/IV heart failure with wide QRS with a more pronounced effect on left ventricular (LV) reverse remodeling in nonischemic patients. Methods: A total of 277 patients with nonischemic heart disease (IHD) and 333 with IHD etiology in New York Heart Association functional class I or II with QRS ≥120 ms and left ventricular ejection fraction ≤40% received a CRT (± implantable cardioverter-defibrillator) and were randomized to CRT-ON or CRT-OFF for 12 months. The primary end point was the percentage of patients worsened by the HF clinical composite response, and multiple prespecified secondary end points were evaluated regarding etiology using univariable and multivariable analysis. Results: At baseline, IHD patients were significantly older and had more comorbidities and less dyssynchrony than non-IHD patients. In non-IHD patients, 10% worsened in CRT-ON compared with 19% in CRT-OFF (p = 0.01). In IHD patients, 20% worsened in the CRT-ON compared with 24% in the CRT-OFF group (p = 0.10). Non-IHD patients assigned to CRT-ON improved more in left ventricular end-systolic volume index than IHD patients. Randomization to CRT, left bundle branch block, and wider QRS duration independently predicted response to both end points, whereas non-IHD etiology was an independent predictor only for left ventricular end-systolic volume index. Conclusions: This substudy of REVERSE shows that CRT reverses left ventricular remodeling with a more extensive effect on nonischemic patients. Etiology was, however, not an independent predictor of clinical response. (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction [REVERSE]; NCT00271154) [Copyright &y& Elsevier]

Aims: Cardiac resynchronization therapy (CRT) is currently limited to those with left ventricular ejection fraction (LVEF) ≤35%. To evaluate whether patients with LVEF >35% might benefit from CRT, we performed a retrospective analysis of the predictors of response to CRT (PROSPECT) database. [ABSTRACT FROM PUBLISHER]

Background: Cardiac resynchronization therapy (CRT) is an effective treatment for patients suffering from advanced heart failure and electrical dyssynchrony. Limited data suggest that patients may benefit from routine optimization of the atrioventricular (AV) and interventricular (VV) delays; however, there is scarce information available on how and when optimization should be performed. Objective: The objective of this survey was to characterize the current international standard of care for optimization of the AV and VV delays in CRT devices recipients. Methods: Centers participating in the Frequent Optimization Survey Using the QuickOpt Method (FREEDOM) study completed surveys probing into their optimization of AV and VV delays procedures. Probes focused on the methods used to optimizing the delays, visits at which optimization of the delays was performed, percentage of patients that underwent optimization, and factors that limited centers from optimizing the CRT systems. Results: Few of the 118 investigators from 16 countries who responded to the survey routinely optimized the delays in all patients. At follow-up visits and during hospitalizations, a trend was observed to optimize the delays more often in nonresponders than in responders to CRT. Standard echocardiography was the most common method of optimization. Time availability and lack of qualified staff were the main factors limiting the optimization of CRT systems. Conclusions: In real-world practice, AV and VV optimization was not performed in a high proportion of patients. A less time-consuming and easier optimization method might enable a more systematic optimization of the AV and VV delays at routine follow-up visits in all recipients of CRT systems. [ABSTRACT FROM AUTHOR]

Heart failure (HF) guidelines recommend that β blockers be titrated to achieve the target doses shown to be effective in major clinical trials, if tolerated. Little is known, however, regarding the doses of β blockers used in patients with HF in routine clinical practice before, during, and after hospitalization for HF. The Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF) enrolled 5,791 patients admitted with HF in a registry with prespecified 60- to 90-day follow-up at 91 academic and community hospitals throughout the United States. Among 2,373 patients with systolic HF eligible for β blockers at discharge, 1,350 (56.9%) were receiving β-blocker therapy before admission and continued on therapy, and 632 (26.6%) were newly started. The mean total daily dose for β blockers before hospital admission was <1/2 the recommended target dose (carvedilol 21.5 ± 17.8 mg and metoprolol succinate 69.2 ± 51.9 mg), with infrequent up- or down-titration during the HF hospitalization. More than 2/3 of patients had no change in their β-blocker doses in the first 60 to 90 days after hospital discharge. At 60- to 90-day postdischarge follow-up, only 17.5% and 7.9% of patients were being treated with recommended target doses of carvedilol and metoprolol succinate, respectively. In conclusion, these data reveal that the doses of β blockers applied in clinical practice are substantially less that the doses achieved in randomized clinical trials in HF and recommended in national guidelines. In the first 60 to 90 days after hospital discharge, little up-titration in β-blocker dosing occurs. Further efforts are needed to help understand and overcome this β-blocker titration gap. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to examine the renal effects of a V2 receptor arginine vasopressin (AVP) antagonist in heart failure. Background: Arginine vasopressin has been implicated in the renal water retention and dilutional hyponatremia associated with chronic heart failure. Methods: We examined the effects of the oral, non-peptide, selective V2 receptor antagonist lixivaptan in 42 diuretic-requiring patients with mild-to-moderate heart failure in a randomized, double-blind, placebo-controlled, ascending single-dose study. After overnight fluid deprivation, patients received single-blind placebo on day −1 (baseline) and double-blind study medication (placebo [n = 12] or lixivaptan 10, 30, 75, 150, 250, or 400 mg [n = 5 per dose group]) on day 1, followed by 4 h of continued fluid restriction and additional 20 h with ad libitum fluid intake. Results: At all but the 10-mg dose, lixivaptan produced a significant and dose-related increase in urine volume over 4 h, compared with placebo. During 24 h, increases in urine volume ranged from 1.8 l with placebo to 3.9 l after the 400-mg lixivaptan dose (p < 0.01). These increases in urine volumes were accompanied by significant increases in solute-free water excretion. At higher doses, serum sodium was significantly increased; AVP antagonism was well tolerated in these patients. Conclusions: These observations confirm a role for AVP in the renal water retention associated with heart failure and suggest that the V2 receptor antagonist lixivaptan may be a promising therapeutic agent for the treatment of heart failure. [Copyright &y& Elsevier]

Background: Cardiac resynchronization therapy (CRT) is currently indicated in patients with moderate to severe heart failure, a wide QRS complex and significant left ventricular dysfunction despite optimal medical therapy. Adoption of these criteria for CRT results in a favorable response in only two thirds of candidates. Methods: "Predictors of response to cardiac resynchronization therapy (PROSPECT)," a prospective, multicenter, nonrandomized study, aims to identify echocardiographic measures of dyssynchrony and evaluate their ability to predict response to CRT. PROSPECT will enroll approximately 300 patients in up to 75 centers in the United States, Asia, and Europe with clinical follow-up for 6 months. We will prospectively and individually test a variety of conventional echocardiographic and tissue Doppler imaging parameters against measures of clinical response. The primary response criteria are improvement in the heart failure Clinical Composite Score and left ventricular reverse remodeling. Enrollment began in March 2004 and is expected to conclude early 2005. [ABSTRACT FROM AUTHOR]

Context Estimation of mortality risk in patients hospitalized with acute decompensated heart failure (ADHF) may help clinicians guide care. Objective To develop a practical user-friendly bedside tool for risk stratification for patients hospitalized with ADHF. Design, Setting, and Patients The Acute Decompensated Heart Failure National Registry (ADHERE) of patients hospitalized with a primary diagnosis of ADHF in 263 hospitals in the United States was queried with analysis of patient data to develop a risk stratification model. The first 33 046 hospitalizations (derivation cohort; October 2001-February 2003) were analyzed to develop the model and then the validity of the model was prospectively tested using data from 32 229 subsequent hospitalizations (validation cohort; March-July 2003). Patients had a mean age of 72.5 years and 52% were female. Main Outcome Measure Variables predicting mortality in ADHF. Results When the derivation and validation cohorts are combined, 37 772 (58%) of 65 275 patient-records had coronary artery disease. Of a combined cohort consisting of 52 164 patient-records, 23 910 (46%) had preserved left ventricular systolic function. In-hospital mortality was similar in the derivation (4.2%) and validation (4.0%) cohorts. Recursive partitioning of the derivation cohort for 39 variables indicated that the best single predictor for mortality was high admission levels of blood urea nitrogen (≥43 mg/dL [15.35 mmol/L]) followed by low admission systolic blood pressure (<115 mm Hg) and then by high levels of serum creatinine (≥2.75 mg/dL [243.1 μmol/L]). A simple risk tree identified patient groups with mortality ranging from 2.1% to 21.9%. The odds ratio for mortality between patients identified as high and low risk was 12.9 (95% confidence interval, 10.4-15.9) and similar results were seen when this risk stratification was applied prospectively to the validation cohort. Conclusions These results suggest that ADHF patients ... [ABSTRACT FROM AUTHOR]

Evaluates the use of beta-blockers in the treatment of heart failure. Rationale for the use of beta-blockers during the mild stages of heart failure; Distinguishing features of systolic and diastolic heart failure; Clinical support for the use of beta-blockers as a standard therapy for heart failure.

The author reflects the use of parachute ventricular partitioning device in the treatment for patients with heart failure caused by the damage of heart muscle after a heart attack. It informs that preclinical studies have revealed that the device reduces left ventricular diastolic and systolic volumes and restores the conical apical ventricular shape while restoring torsional ventricular contraction.

Background: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.Objectives: This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.Methods: This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.Results: The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).Conclusions: Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079). [ABSTRACT FROM AUTHOR]

More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients' vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration. [ABSTRACT FROM AUTHOR]

Background: Previous studies have suggested that cardiac resynchronization achieved through atrial-synchronized biventricular pacing produces clinical benefits in patients with heart failure who have an intraventricular conduction delay. We conducted a double-blind trial to evaluate this therapeutic approach. Methods: Four hundred fifty-three patients with moderate-to-severe symptoms of heart failure associated with an ejection fraction of 35 percent or less and a QRS interval of 130 msec or more were randomly assigned to a cardiac-resynchronization group (228 patients) or to a control group (225 patients) for six months, while conventional therapy for heart failure was maintained. The primary end points were the New York Heart Association functional class, quality of life, and the distance walked in six minutes. Results: As compared with the control group, patients assigned to cardiac resynchronization experienced an improvement in the distance walked in six minutes (+39 vs. +10 m, P=0.005), functional class (P<0.001), quality of life (–18.0 vs. –9.0 points, P= 0.001), time on the treadmill during exercise testing (+81 vs. +19 sec, P=0.001), and ejection fraction (+4.6 percent vs. –0.2 percent, P<0.001). In addition, fewer patients in the group assigned to cardiac resynchronization than control patients required hospitalization (8 percent vs. 15 percent) or intravenous medications (7 percent vs. 15 percent) for the treatment of heart failure (P<0.05 for both comparisons). Implantation of the device was unsuccessful in 8 percent of patients and was complicated by refractory hypotension, bradycardia, or asystole in four patients (two of whom died) and by perforation of the coronary sinus requiring pericardiocentesis in two others. Conclusions: Cardiac resynchronization results in significant clinical improvement in patients who have moderate-to-severe heart failure and an intraventricular conduction delay. (N Engl J Med 2002;346:1845-53.) [ABSTRACT FROM AUTHOR]

Background: Among patients with chronic heart failure, angiotensin-converting-enzyme (ACE) inhibitors reduce mortality and hospitalization, but the role of a renin inhibitor in such patients is unknown. We compared the ACE inhibitor enalapril with the renin inhibitor aliskiren (to test superiority or at least noninferiority) and with the combination of the two treatments (to test superiority) in patients with heart failure and a reduced ejection fraction.Methods: After a single-blind run-in period, we assigned patients, in a double-blind fashion, to one of three groups: 2336 patients were assigned to receive enalapril at a dose of 5 or 10 mg twice daily, 2340 to receive aliskiren at a dose of 300 mg once daily, and 2340 to receive both treatments (combination therapy). The primary composite outcome was death from cardiovascular causes or hospitalization for heart failure.Results: After a median follow-up of 36.6 months, the primary outcome occurred in 770 patients (32.9%) in the combination-therapy group and in 808 (34.6%) in the enalapril group (hazard ratio, 0.93; 95% confidence interval [CI], 0.85 to 1.03). The primary outcome occurred in 791 patients (33.8%) in the aliskiren group (hazard ratio vs. enalapril, 0.99; 95% CI, 0.90 to 1.10); the prespecified test for noninferiority was not met. There was a higher risk of hypotensive symptoms in the combination-therapy group than in the enalapril group (13.8% vs. 11.0%, P=0.005), as well as higher risks of an elevated serum creatinine level (4.1% vs. 2.7%, P=0.009) and an elevated potassium level (17.1% vs. 12.5%, P<0.001).Conclusions: In patients with chronic heart failure, the addition of aliskiren to enalapril led to more adverse events without an increase in benefit. Noninferiority was not shown for aliskiren as compared with enalapril. (Funded by Novartis; ATMOSPHERE ClinicalTrials.gov number, NCT00853658.). [ABSTRACT FROM AUTHOR]

Expression of different cytokines and growth factors after myocardial injury has been associated with fibroplasia and dilatation versus reverse remodeling and myocardial repair. Specifically, the proinflammatory/fibrotic mediators: interleukin (IL)-6, epidermal growth factor, and fibroblast growth factor (FGF)-2 cause fibroplasia, whereas reparative cytokines including: IL-1α, IL-1β, IL-4, and IL-13 can limit fibrosis. In appropriate patients, cardiac resynchronization therapy (CRT) reverses cardiomyopathy and improves outcome. However, a significant proportion will not respond to this therapy. We conducted this study to assess the association of proinflammatory/fibrotic and/or reparative immune response mediators at baseline with outcome after CRT. In the multicenter RISK study, plasma samples were collected prospectively before CRT implantation. Plasma IL-6, epidermal growth factor, FGF-2, IL-1α, IL-1β, IL-4, and IL-13 were evaluated by Luminex technology. The primary outcome was predefined as freedom from heart failure hospitalization or death and a decrease in echocardiographic end-systolic volume of >15% at 12 months. To determine associations with the outcome, multivariate logistic regression models including baseline clinical characteristics and the specific cytokines and growth factors were constructed. On multivariate analysis of 257 patients, detectable reparative cytokine IL-13 was significantly associated with the primary outcome (odds ratio 3.79; 95% CI 2.10 to 6.82, p <0.0001). In contrast, detectable proinflammatory/fibrotic growth factor FGF-2 was negatively associated (odds ratio 0.31; 95% CI, 0.14 to 0.68; p = 0.004). In conclusion, in CRT recipients, baseline levels of inflammatory mediators affecting cardiac fibrosis versus repair were associated with subsequent clinical outcome. [ABSTRACT FROM AUTHOR]

Background: The impact of transcatheter edge-to-edge repair (TEER) on the rate and prognostic impact of hospitalizations in patients with heart failure (HF) and severe secondary mitral regurgitation is unknown.Objectives: This study sought to evaluate the effect of the MitraClip percutaneous edge-to edge repair system on fatal and nonfatal hospitalizations and their relationship with mortality in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.Methods: Patients with HF (n = 614) with severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) versus GDMT alone. Hospitalizations were classified as fatal if death occurred during that hospitalization or nonfatal if the patient was discharged alive.Results: At 2 years, TEER treatment, compared with GDMT alone, resulted in lower time-to-first-event rates of any heart failure hospitalization (HFH) (34.8% vs 56.4%; HR: 0.51; 95% CI: 0.39-0.66) and fatal HFH (6.5% vs 12.6%; HR: 0.47; 95% CI: 0.26-0.85). TEER also resulted in lower rates of all-cause nonfatal and fatal hospitalizations. During the 2-year follow-up period, patients who underwent TEER spent an average of 2 more months alive and out of the hospital than did patients treated with GDMT alone (581 ± 27 days vs 519 ± 26 days; P = 0.002). All HFHs (adjusted HR: 6.37; 95% CI: 4.63-8.78) and nonfatal HFHs (adjusted HR: 1.78; 95% CI: 1.27-2.49) were consistently independently associated with increased 2-year mortality in both the TEER and GDMT groups (Pinteraction = 0.34 and 0.39, respectively).Conclusions: In the COAPT trial, compared with GDMT alone, patients with HF and severe secondary mitral regurgitation undergoing TEER with the percutaneous edge-to edge repair system had lower 2-year rates of fatal and nonfatal all-cause hospitalizations and HFH and spent more time alive and out of the hospital. HFHs were strongly associated with mortality, irrespective of treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079). [ABSTRACT FROM AUTHOR]

The article discusses the advances of telecommunication technologies that provide telemedical care in the medical management of patients with heart failure. It notes several studies that demonstrate the effectiveness of a standardized and appropriate classification of telemedical system in managing chronic heart failure. It also mentions the classification of four generations of telemedicine, which was proven as efficient approach in managing the disease.

Compares the effectiveness of nesiritide versus milrinone in terms of the improvement of patient hemodynamics, decreased length of stay, and rehospitalization in acute decompensated heart failure (ADHF). Overview of the problem of heart failure in the United States; Similarity of baseline hemodynamic data between the two groups of patients; Cost of therapy.

Background: In the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), among 614 patients with heart failure with 3+ or 4+ secondary mitral regurgitation (MR), transcatheter mitral valve repair (TMVr) with the MitraClip reduced MR, heart failure hospitalizations, and mortality and improved quality of life compared with guideline-directed medical therapy (GDMT) alone. We aimed to examine the prognostic relationship between MR reduction and outcomes after TMVr and GDMT alone.Methods: Outcomes in COAPT between 30 days and 2 years were examined on the basis of the severity of residual MR at 30 days.Results: TMVr-treated patients had less severe residual MR at 30 days than GDMT-treated patients (0/1+, 2+, and 3+/4+: 72.9%, 19.9%, and 7.2% versus 8.2%, 26.1%, and 65.8%, respectively [P<0.0001]). The rate of composite death or heart failure hospitalizations between 30 days and 2 years was lower in patients with 30-day residual MR of 0/1+ and 2+ compared with patients with 30-day residual MR of 3+/4+ (37.7% versus 49.5% versus 72.2%, respectively [P<0.0001]). This relationship was consistent in the TMVr and GDMT arms (Pinteraction=0.92). The improvement in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days was maintained between 30 days and 2 years in patients with 30-day MR ≤2+ but deteriorated in those with 30-day MR 3+/4+ (-0.3±1.7 versus -9.4±4.6 [P=0.0008]) consistently in both groups (Pinteraction=0.95).Conclusions: In the COAPT trial, reduced MR at 30 days was associated with greater freedom from death or heart failure hospitalizations and improved quality of life through 2-year follow-up whether the MR reduction was achieved by TMVr or GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079. [ABSTRACT FROM AUTHOR]

Background: This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF).Objectives: The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group).Methods: Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy. Effectiveness endpoints were the change from baseline to 6 months in 6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The safety endpoint included the major adverse neurological or cardiovascular system or procedure-related event rate (MANCE).Results: Results from, timeline and rationale for, cohorts A, B, and C are presented in detail in the text. Cohort D, which represented the intended use population that reflected the U.S. Food and Drug Administration-approved instructions for use (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001).Conclusions: BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196). [ABSTRACT FROM AUTHOR]

Background: Heart failure education programs are not standardized. The best form of education is unclear. We evaluated whether addition of a novel tablet application to nurse practitioner (NP) education was superior to NP education alone in reducing 30-day readmission after heart failure hospitalization.Methods: From February 2015-March 2016, patients admitted to a quaternary academic center with primary diagnosis of heart failure were randomized to 1) treatment - NP education plus tablet application (interactive conditional logic program that flags patient questions to medical staff), or 2) control - NP education. The primary outcome was reduction in 30-day readmission rate. Secondary outcomes included satisfaction and education assessed via survey.Results: Randomization included 60 patients to treatment and 66 to control. A total of 13 patients withdrew prior to intervention (treatment n = 4, control n = 1) or were lost to follow-up (treatment n = 3, control n = 5). The 30-day readmission rate trended lower for treatment compared with control, but results were not statistically significant (13.2% [7/53], 26.7% [16/60], respectively, P = .08). Similarly, satisfaction trended higher with treatment than control (P = .08). Treatment patients rated explanations from their physicians higher than control (Always: 83.7%, 55.8%, respectively, P = .01).Conclusions: NP education plus tablet use was not associated with significantly lower 30-day readmission rates in comparison with NP alone, but a positive trend was seen. Patient satisfaction trended higher and heart failure explanations were better with NP education plus tablet. A larger study is needed to determine if NP education plus tablet reduces readmission rates following heart failure admission. [ABSTRACT FROM AUTHOR]

Background: Despite increased use of guideline-directed medical therapy (GDMT), some patients with heart failure and reduced ejection fraction (HFrEF) remain at high risk for hospitalization and mortality. Remote monitoring of pulmonary artery (PA) pressures provides clinicians with actionable information to help further optimize medications and improve outcomes.Objectives: CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients trial) analyzed PA pressure-guided heart failure (HF) management in patients with HFrEF based on their ability to tolerate GDMT.Methods: CHAMPION enrolled 550 patients with chronic HF regardless of left ventricular ejection fraction. A pre-specified sub-group analysis compared HF hospitalization and mortality rates between treatment and control groups in HFrEF patients (left ventricular ejection fraction ≤40%). Post hoc analyses in patients who tolerated GDMT were also performed. Hospitalizations and mortality were assessed using Andersen-Gill and Cox proportional hazards models.Results: In 456 patients with HFrEF, HF hospitalization rates were 28% lower in the treatment group than in the control group (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.59 to 0.88; p = 0.0013), with a strong trend for 32% lower mortality (HR: 0.68; 95% CI: 0.45 to 1.02; p = 0.06). A 445-patient subset received at least 1 GDMT (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, or beta-blocker) at baseline; these patients had 33% lower HF hospitalization rates (HR: 0.67; 95% CI: 0.54 to 0.82; p = 0.0002) and 47% lower mortality (HR: 0.63; 95% CI: 0.41 to 0.96, p = 0.0293) than controls. Compared with controls, patients receiving both components of optimal GDMT (n = 337) had 43% lower HF hospitalizations (HR: 0.57; 95% CI: 0.45 to 0.74; p < 0.0001) and 57% lower mortality (HR: 0.43; 95% CI: 0.24 to 0.76; p = 0.0026).Conclusions: PA pressure-guided HF management reduces morbidity and mortality in patients with HFrEF on GDMT, underscoring the important synergy of addressing hemodynamic and neurohormonal targets of HF therapy. (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients [CHAMPION]; NCT00531661). [ABSTRACT FROM AUTHOR]

Objective We tested whether remote dielectric sensing (ReDS)-directed fluid management reduces readmissions in patients recently hospitalized for heart failure (HF). Background Pulmonary congestion is the most common cause of worsening HF leading to hospitalization. Accurate remote monitoring of lung fluid volume may guide optimal treatment and prevent re-hospitalization. ReDS technology is a quantitative non-invasive method for measuring absolute lung fluid volume. Methods Patients hospitalized for acute decompensated HF were enrolled during their index admission and followed at home for 90 days post-discharge. Daily ReDS readings were obtained using a wearable vest, and were used as a guide to optimizing HF therapy, with a goal of maintaining normal lung fluid content. Comparisons of the number of HF hospitalizations during ReDS-guided HF therapy were made, both to the 90 days prior to enrollment and to the 90 days following discontinuation of ReDS monitoring. Results Fifty patients were enrolled, discharged, and followed at home for 76.9 ± 26.2 days. Patients were 73.8 ± 10.3 years old, 40% had LVEF above 40%, and 38% were women. Compared to the pre- and post-ReDS periods, there were 87% and 79% reductions in the rate of HF hospitalizations, respectively, during ReDS-guided HF therapy. The hazard ratio between the ReDS and the pre-ReDS period was 0.07 (95% CI [0.01–0.54] p = 0.01), and between the ReDS and the post-ReDS period was 0.11 (95% CI [0.014–0.88] p = 0.037). Conclusions These findings suggest that ReDS-guided management has the potential to reduce HF readmissions in acute decompensated HF patients recently discharged from the hospital. [ABSTRACT FROM AUTHOR]

Background-Cardiac resynchronization therapy (CRT) decreases mortality, improves functional status, and induces reverse left ventricular remodeling in selected populations with heart failure. We aimed to assess the impact of baseline QRS duration and morphology and the change in QRS duration with pacing on CRT outcomes in mild heart failure. Methods and Results-Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) was a multicenter randomized trial of CRT among 610 patients with mild heart failure. Baseline and CRT-paced QRS durations and baseline QRS morphology were evaluated by blinded core laboratories. The mean baseline QRS duration was 151±23 milliseconds, and 60.5% of subjects had left bundle-branch block (LBBB). Patients with LBBB experienced a 25.3-mL/m² mean reduction in left ventricular end-systolic volume index (P<0.0001), whereas non-LBBB patients had smaller decreases (6.7 mL/m² P=0.18). Baseline QRS duration was also a strong predictor of change in left ventricular end-systolic volume index with monotonic increases as QRS duration prolonged. Similarly, the clinical composite score improved with CRT for LBBB subjects (odds ratio, 0.530; P=0.0034) but not for non-LBBB subjects (odds ratio, 0.724; P=0.21). The association between clinical composite score and QRS duration was highly significant (odds ratio, 0.83 1 for each 10-millisecond increase in QRS duration; P<0.0001), with improved response at longer QRS durations. The change in QRS duration with CRT pacing was not an independent predictor of any outcomes after correction for baseline variables. Conclusion-REVERSE demonstrated that LBBB and QRS prolongation are markers of reverse remodeling and clinical benefit with CRT in mild heart failure. [ABSTRACT FROM AUTHOR]

New devices that modulate the autonomic nervous system are being developed to improve outcomes in patients with chronic heart failure for whom optimal medical therapy is insufficient. Devices for baroreceptor activation therapy, vagal nerve stimulation, cardiac contractility modulation, and sleep apnea are now being evaluated in trials and showing promise. [ABSTRACT FROM AUTHOR]

Two letters to the editor in response to a study conducted by William Abraham and colleagues, on the treatment of class III heart failure patients, and a response by Abraham to the same article, published in the February 19, 2011 issue, are presented.