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Background Heart failure and sleep-disordered breathing have been increasingly recognized as co-occurring conditions. Their bidirectional relationship warrants investigation into whether heart failure therapy improves sleep and sleep-disordered breathing. We sought to explore the effect of treatment with sacubitril/valsartan on sleep-related endpoints from the AWAKE-HF study. Methods and Results AWAKE-HF was a randomized, double-blind study conducted in 23 centers in the United States. Study participants with heart failure with reduced rejection fraction and New York Heart Association class II or III symptoms were randomly assigned to receive treatment with either sacubitril/valsartan or enalapril. All endpoints were assessed at baseline and after 8 weeks of treatment. Portable sleep-monitoring equipment was used to measure the apnea-hypopnea index, including obstructive and central events. Total sleep time, wake after sleep onset and sleep efficiency were exploratory measures assessed using wrist actigraphy. The results were as follows 140 patients received treatment in the double-blind phase (sacubitril/valsartan, n = 70; enalapril, n = 70). At baseline, 39% and 40% of patients randomly assigned to receive sacubitril/valsartan or enalapril, respectively, presented with undiagnosed, untreated, moderate-to-severe sleep-disordered breathing (≥ 15 events/h), and nearly all had obstructive sleep apnea. After 8 weeks of treatment, the mean 4% apnea-hypopnea index changed minimally from 16.3/h to 15.2/h in the sacubitril/valsartan group and from 16.8/h to 17.6/h in the enalapril group. Mean total sleep time was long at baseline and decreased only slightly in both treatment groups at week 8 (–14 and –11 minutes for sacubitril/valsartan and enalapril, respectively), with small changes in wake after sleep onset and sleep efficiency in both groups. Conclusions In a cohort of patients with heart failure with reduced rejection fraction who met prescribing guidelines for sacubitril/valsartan, one-third had undiagnosed moderate-to-severe obstructive sleep apnea. The addition of sacubitril/valsartan therapy did not significantly improve sleep-disordered breathing or sleep duration or efficiency. Patients who meet indications for treatment with sacubitril/valsartan should be evaluated for sleep-disordered breathing.

AWAKE-HF evaluated the effect of the initiation of sacubitril/valsartan versus enalapril on activity and sleep using actigraphy in patients who have heart failure with reduced ejection fraction (HFrEF). In this randomized, double-blind study, patients with HFrEF (n = 140) were randomly assigned to sacubitril/valsartan or enalapril for 8 weeks, followed by an 8-week open-label phase with sacubitril/valsartan. Primary endpoint was change from baseline in mean activity counts during the most active 30 min/day at week 8. The key secondary endpoint was change in mean nightly activity counts/minute from baseline to week 8. Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) was an exploratory endpoint. There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:enalapril]; 95% confidence interval [CI] 0.8863–1.0088; P = 0.0895) or in mean change from baseline in activity during sleep (difference: 2.038 counts/min; 95% CI − 0.062 to 4.138; P = 0.0570). Change from baseline to week 8 in KCCQ-23 was 2.89 for sacubitril/valsartan and 4.19 for enalapril, both nonsignificant. In AWAKE-HF, no detectable differences in activity and sleep were observed when comparing sacubitril/valsartan with enalapril in patients with HFrEF using a wearable biosensor. ClinicalTrials.gov, NCT02970669.

Aims Limited data are available regarding the ability of sacubitril/valsartan to provide clinically meaningful health‐related quality of life (HRQoL) improvements among individuals with heart failure (HF). Objective measurement of physical activity and sleep using actigraphy can provide insight into daily functioning and HRQoL. Methods and results We designed an 18 week, multicenter, randomized, double‐blind, double‐dummy, parallel‐group study to objectively assess changes in function and HRQoL directly after initiating sacubitril/valsartan vs. enalapril in participants with HF in their home environments. A total of 136 outpatient, ambulatory participants with New York Heart Association Class II or III HF with reduced ejection fraction (HFrEF) will be included in the study. Patients will undergo a 2 week baseline observational phase (continuing current HF treatment); data from the second week of this phase will be the baseline value for comparison with those of subsequent periods. Patients will then enter an 8 week blinded‐treatment phase (randomly assigned 1:1 to sacubitril/valsartan or enalapril), followed by an 8 week open‐label extension phase (treatment with only sacubitril/valsartan). The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement. Secondary endpoints include the change in mean sleep activity during the randomized and open‐label phases; questionnaires will also assess HRQoL measures. Rather than analysing pooled actigraphy data, the researchers are considering each participant to be acting as his or her own control. Conclusions This will be the first study to assess the effects of sacubitril/valsartan on objective measures of sleep and activity in individuals with HFrEF within the context of their daily lives. Wearable accelerometer devices will be used to gain insight into how the medication affects physical activity and sleep.

Introduction: Transcatheter mitral valve repair (TMVr) reduces heart failure (HF) hospitalizations and improves survival in patients with HF and secondary mitral regurgitation (MR), but the hemodynamics of TMVr are not well studied. Patients with a pulmonary artery pressure (PAP) monitor (CardioMEMS TM ) provide a unique opportunity to study ambulatory hemodynamics following TMVr. Methods: TMVr implants occurring July 2014 to Sept 2019 were identified from Medicare claims data and were linked to PAP data from CardioMEMS TM . Patients with CardioMEMS TM implant ≥3 mo prior to TMVr and with ≥3 mo PAP data post TMVr were included. Diastolic PAP (DPAP) and area under the curve (AUC) at 3 and 6 mo post TMVr were compared to 4 wks prior to TMVr (baseline). Analysis was repeated for those with elevated baseline DPAP, defined as ≥15 mmHg. Results: The cohort included 32 patients (74 ± 8 yrs, 66% male) with high prevalence of hypertension, ischemic heart disease, AF, and kidney disease. LVEF was available in 17 patients (32 ± 14%). Compared to baseline, DPAP was significantly lower at 3 mo (-2.1 ± 4.7 mmHg, p=0.019) and remained lower at 6 mo post TMVr (-2.5 ± 6.7 mmHg, p=0.070). AUC showed a cumulative reduction in DPAP of -129 ± 257 mmHg-days (p=0.008) at 3 mo and -438 ± 719 mmHg-days (p=0.005) at 6 mo post TMVr. Similar trends were observed for mean PAP. Sub-group analyses suggested lower DPAP after TMVr in patients with elevated baseline DPAP (3 mo Δ: -2.6 ± 4.6 mmHg, p=0.009; 6 mo Δ: -3.8 ± 6.3 mmHg, p=0.014, 3 mo AUC: -158 ± 255 mmHg-day, p=0.004; 6 mo AUC: -575 ± 721 mmHg-day, p=0.002). Conclusions: In CardioMEMS TM -monitored patients with significant MR, TMVr is associated with a clinically relevant and sustained reduction in DPAP, including patients with an elevated baseline DPAP. Although the clinical and survival benefits of TMVr are paramount, these data add to our understanding of the hemodynamic improvements of TMVr. CardioMEMS TM is an additional tool to improve filling pressures in those with HF.

Introduction: Effective management of ambulatory heart failure (HF) requires active patient (pt) participation. In telemonitoring of weights and symptoms, pt adherence to transmission is often halved within 6 months (M). Although ambulatory pulmonary pressure-guided management decreases hospitalizations and improves quality of life, the time course of pt perception of illness and sense of security in relation to monitoring frequency is not known. Hypothesis: Pts will perceive decreased impact of their HF during pulmonary pressure-guided management, which may contribute to their engagement in transmission of ambulatory PAP. Methods: The post-approval study for the implanted PA sensor was amended to include serial measurements of pt reported outcomes, (PRO, n=143), including the Brief Illness Perception Questionnaire (BIPQ). Treatment was adjusted to a target PA diastolic pressure 8 to 20 mmHg and adherence to transmitting pressure data from home was collected. Results: In the PRO cohort, mean age was 68 years, 58% were male, and 55% with HFpEF. Negative illness perception (BIPQ) decreased during each measurement interval. Pts reported improvement in symptoms, sense of security, sense of control and less impact of illness on their emotions at each time point, equally with HFpEF or HFrEF. In this cohort pt adherence to transmitting pressures was high throughout 24 M, Fig.1. Perception of illness was most favorable at 2 years, at which time there was a slight decline in transmission frequency. Conclusions: Pt perception of HF was positively impacted during ambulatory hemodynamic monitoring including improvement in symptoms, less emotional effect of illness, improved sense of security and control over their HF throughout follow-up. This was associated with high-level pt adherence to pressure data transmission. The optimal level of chronic monitoring for stable pts to maintain clinical benefit while minimizing disease awareness beyond 2 years is still unknown.

Background: Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction. Methods: This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years. Results: Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76±24% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events/patient-years, hazard ratio 0.43 [95% CI, 0.39–0.47], P P Conclusions: In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02279888.

In the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients) trial, heart failure hospitalization (HFH) rates were lower in patients managed with guidance from an implantable pulmonary artery pressure sensor compared with usual care.This study examined the effectiveness of ambulatory hemodynamic monitoring in reducing HFH outside of the clinical trial setting.We conducted a retrospective cohort study using U.S. Medicare claims data from patients undergoing pulmonary artery pressure sensor implantation between June 1, 2014, and December 31, 2015. Rates of HFH during pre-defined periods before and after implantation were compared using the Andersen-Gill extension to the Cox proportional hazards model while accounting for the competing risk of death, ventricular assist device implantation, or cardiac transplantation. Comprehensive heart failure (HF)-related costs were compared over the same periods.Among 1,114 patients receiving implants, there were 1,020 HFHs in the 6 months before, compared with 381 HFHs, 139 deaths, and 17 ventricular assist device implantations and/or transplants in the 6 months after implantation (hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.49 to 0.61; p 0.001). This lower rate of HFH was associated with a 6-month comprehensive HF cost reduction of $7,433 per patient (IQR: $7,000 to $7,884), and was robust in analyses restricted to 6-month survivors. Similar reductions in HFH and costs were noted in the subset of 480 patients with complete data available for 12 months before and after implantation (HR: 0.66; 95% CI: 0.57 to 0.76; p 0.001).As in clinical trials, use of ambulatory hemodynamic monitoring in clinical practice is associated with lower HFH and comprehensive HF costs. These benefits are sustained to 1 year and support the "real-world" effectiveness of this approach to HF management.

Background: Elevated pulmonary artery (PA) pressures in patients with heart failure are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and heart failure hospitalization risk reduction with a novel implantable PA pressure monitoring system (CardioMEMS HF System, St. Jude Medical). This study examines PA pressure changes in the first 2000 US patients implanted in general practice use. Methods: Deidentified data from the remote monitoring Merlin.net (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated with an area under the curve methodology to estimate the total sum increase or decrease in pressures (mm Hg-day) during the follow-up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients). The area under the curve results are presented as mean±2 SE, and P values comparing the area under the curve of the general-use cohort with outcomes in the CHAMPION trial were computed by the t test with equal variance. Results: Patients were on average 70±12 years old; 60% were male; 34% had preserved ejection fraction; and patients were followed up for an average of 333±125 days. At implantation, the mean PA pressure for the general-use patients was 34.9±10.2 mm Hg compared with 31.3±10.9 mm Hg for CHAMPION treatment and 32.0±10.5 mm Hg for CHAMPION control groups. The general-use patients had an area under the curve of −32.8 mm Hg-day at the 1-month time mark, −156.2 mm Hg-day at the 3-month time mark, and −434.0 mm Hg-day after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. Conclusions: The first 2000 general-use patients managed with hemodynamic-guided heart failure care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared with the pivotal CHAMPION clinical trial. These data demonstrate that general use of implantable hemodynamic technology in a nontrial setting leads to significant lowering of PA pressures.

Introduction Heart Failure (HF) undermines daily quality of life even when not severe enough to warrant hospitalization. Ambulatory pulmonary pressure-guided management decreases hospitalizations across all ranges of EF. This management improves HF symptom scores, but it is not known whether it improves health expectations and perceptions of disease control as reported directly by patients. Hypothesis Patients with prior HF hospitalization and NYHA class III symptoms will report improved health expectations and an increased sense of control over their HF disease progression. Methods Patient-reported outcomes were explored in a substudy of 286 class III CHF patients during the post-approval study for the implanted pulmonary artery pressure sensor. Patients completed validated measures of key appraisals of their cardiac disease and health expectations (e.g. 8-item Brief Illness Perception Questionnaire (BIPQ)) and the 24-item Cardiac Health Security Survey (CHSS) at baseline, 6 months and 12-month timepoints. All patients continued to receive optimal guideline directed medical therapy during ambulatory hemodynamic monitoring with a target PAD pressure of 8-20 mmHg. Results In this substudy, age was 69 ± 11 years and 62% were male, 53% with preserved ejection fraction. From the Baseline BIPQ of 46 ± 10.5, illness perception was reduced by 3.3 and 4.4 points at 6 and 12 months, respectively (p Conclusion Patient management guided by ambulatory pulmonary pressure monitoring was associated with improved patient perception of illness spanning sense of control, symptom reduction, and reduced concerns about their illness over time. The lack of change in health expectations likely reflects patient understanding regarding chronicity of HF on recommended therapies. Patients reported high levels of end user satisfaction and benefit with the hemodynamic monitoring system itself. This technology offers sustained benefits to patients beyond reduction of hospitalizations.

The clinical presentation of shock has been recognized for centuries but the pathophysiology of the transition from stable hemodynamic equilibrium to widespread metabolic failure is still incompletely understood. Thus, it is not surprising that mortality remains high for individuals developing the shock syndrome. Progress is being made to determine the biologic abnormalities that accompany shock. The terminal phase of congestive heart failure is frequently cardiogenic shock. The syndrome may develop over may months or develop almost instantly with the complete cessation of cardiac function. Rapid diagnosis of cardiogenic shock requires both clinical skills and appreciation of the underlying metabolic effects that low blood pressure and poor organ perfusion produce. Early treatment is predicated on this recognition and rapid reversal is critical to improve patient survival.

While most patients admitted with congestive heart failure have preserved blood pressure and adequate organ perfusion, an important minority present with low cardiac output and profound organ dysfunction. A careful physical examination can help detect these patients who exhibit signs of volume overload (elevated neck veins, peripheral edema) and impaired cardiac output (narrow pulse pressure, cool or cold extremities). The cold wet patient has significantly increased mortality, even during the hospitalizations because of a cascade of physiologic abnormalities which must be recognized and reversed quickly to avoid multiorgan failure. Worsening renal function is often the first marker of critical illness in the cold wet patient and is one cause of the cardiorenal syndrome. Although low cardiac output may be the cause of a minority of cases of the cardiorenal syndrome, its contribution when present must be recognized and corrected, if possible, to prevent further renal deterioration and patient demise.

Objectives This 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. Background Elevated 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. Methods The 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. Results Both 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. Conclusions Incorporation 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.

Introduction Hemodynamic monitoring has been shown to reduce admissions for heart failure in both the large randomized CHAMPION Trial (CHMP) and a 1200 patient Post Approval Study registry (PAS). A persistent observation in heart failure (HF) studies is that trial patient populations differ from patients who are treated in clinical practice. After identifying patients who could be propensity matched to the CHMP trial patients, we studied the characteristics and outcomes of the patients who could not be matched. Methods PAS was an FDA mandated registry to determine if results of the CHMP trial could be replicated in clinical practice, as reported previously. Propensity matching was done between CHMP Control and PAS patients. 387 PAS patients could be propensity matched and can be considered “Trial-Type” patients (TT) and 813 were not match able (NM). For each patient group heart failure (HFH) and all-cause (ACH) hospitalization rates at 1 year were compared to the rate in the year prior to enrollment. Results Compared to CHMP Treatment patients, NM patients were older 61.3 vs 71.8, more likely to be female (18.1% vs 39.6%) and have heart failure with normal ejection fraction (HFpEF) (23% vs 55.9%), p Conclusion Of the 1200 patients in the PAS, 67% (813/1200) patients were not match able to typical trial subjects. Nonetheless, these patients with older age, worse renal function, and more hospitalizations still had significant reduction in rates of HFH and ACH during ambulatory hemodynamic monitoring.

In the left ventricular assist device (LVAD) population, right ventricular (RV) failure represents a significant cause of morbidity and mortality. It is unclear whether hemodynamic monitoring with the implantable CardioMEMS system can improve outcomes within this population. This case report highlights two patients in our clinic who had CardioMEMS implanted after LVAD, enabling us to modify their medical regimens remotely and more frequently in the management of their RV failure.

The treatment of congestive heart failure is an expensive undertaking with much of this cost occurring as a result of hospitalization. It is not surprising that many remote monitoring strategies have been developed to help patients maintain clinical stability by avoiding congestion. Most of these have failed. It seems very unlikely that these failures were the result of any one underlying false assumption but rather from the fact that heart failure is a progressive, deadly disease and that human behavior is hard to modify. One lesson that does stand out from the myriad of methods to detect congestion is that surrogates of congestion, such as weight and impedance, are not reliable or actionable enough to influence outcomes. Too many factors influence these surrogates to successfully and confidently use them to affect HF hospitalization. Surrogates are often attractive because they can be inexpensively measured and followed. They are, however, indirect estimations of congestion, and due to the lack specificity, the time and expense expended affecting the surrogate do not provide enough benefit to warrant its use. We know that high filling pressures cause transudation of fluid into tissues and that pulmonary edema and peripheral edema drive patients to seek medical assistance. Direct measurement of these filling pressures appears to be the sole remote monitoring modality that shows a benefit in altering the course of the disease in these patients. Congestive heart failure is such a serious problem and the consequences of hospitalization so onerous in terms of patient well-being and costs to society that actual hemodynamic monitoring, despite its costs, is beneficial in carefully selected high-risk patients. Those patients who benefit are ones with a prior hospitalization and ongoing New York Heart Association (NYHA) class III symptoms. Patients with NYHA class I and II symptoms do not require hemodynamic monitoring because they largely have normal hemodynamics. Those with NYHA class IV symptoms do not benefit because their hemodynamics are so deranged that they cannot be substantially altered except by mechanical circulatory support or heart transplantation. Finally, hemodynamic monitoring offers substantial hope to those patients with normal ejection fraction (EF) heart failure, a large group for whom medical therapy has largely been a failure. These patients have not benefited from the neurohormonal revolution that improved the lives of their brothers and sisters with reduced ejection fractions. Hemodynamic stabilization improves the condition of both but more so of the normal EF cohort. This is an important observation that will help us design future trials for the 50% of heart failure patients with normal systolic function.

Clinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities.The purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%).Data from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics.The ICD/cardiac resynchronization defibrillator (CRT-D)-eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D-eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device-race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device-race/ethnicity interaction was not significant (p = 0.5413).The use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial/ethnic group. Device therapies should be offered to eligible heart failure patients, without modification based on race/ethnicity.

Background— We classified patients’ atrial fibrillation (AF), assessed its impact on biventricular pacing (BIVP%), and determined whether AF classification or BIVP% independently correlate with mortality in cardiac resynchronization therapy defibrillator patients. Methods and Results— Cardiac resynchronization therapy defibrillator patients were classified as permanent (daily mean AF burden ≥23 hours), persistent (≥7 consecutive days of AF ≥23 hours/d), paroxysmal (≥1 day with AF ≥6 hours), or no/little AF (all others) using device-detected AF during the 6 months postimplant. We evaluated subsequent all-cause mortality using a multivariable Cox proportional hazard regression. Among 54 019 patients (age, 70±11 years; 73% male; follow-up, 2.3±1.2 years), 8% of patients each had permanent (N=4449), persistent (N=4237), and paroxysmal AF (N=4219). A high proportion of patients with permanent (69%) and persistent (62%) AF did not achieve high BIVP (>98%). Relative to no/little AF, patients with AF had increased mortality after adjusting for age, sex, BIVP, and shocks (permanent: hazard ratio=1.28 [1.19–1.38]; P P 98%, patients with reduced BIVP had increased mortality after adjusting for age, sex, AF, and shocks (90%–98%: hazard ratio=1.20 [1.15–1.26]; P P Conclusions— High BIVP% was not achieved in two thirds of 8686 patients with persistent or permanent AF, and these patients had an increased risk of death. A shift toward more aggressive rate control and more pacing may be necessary in patients with AF to maximize the benefits of cardiac resynchronization therapy.

Introduction Volume overload continues to be a common complication after left ventricular assist device (LVAD) implantation due to years of heart failure complicated with pulmonary hypertension, right ventricle dysfunction and poor nutritional status. In fact, fluctuation in volume status is one of the most dynamic parameters in patients with LVADs and becomes one of the key components of the routine clinical evaluation in these patients. We hypothesize that postural changes in the pulsatility index (PI) may be an accurate non-invasive measure of volume status that can potentially be easily used in clinic or by patients at home to adjust their fluid intake and diuretics. Methods We included patients at least 1 month post-LVAD implantation being followed in the Advance Heart Failure Clinic at Scripps Clinic. We excluded patients unable to stand for at least 10 minutes or too unstable to cooperate. We measured systolic (SBP), diastolic and mean (MAP) blood pressure, heart rate and LVAD parameters including PI supine and after 2 minutes of standing. Supine and standing inferior vena cava (IVC) assessment was performed by bedside echocardiography. All measurements were obtained within 1 hour with no interval intervention. Results We included 20 patients status post continuous flow LVAD. Mean time from implant was 947.5 days (range 55 - 2533 days). We were able to obtain both supine and standing echocardiograms for IVC assessment in 14 (70%) patients. We found a positive and significant correlation between postural changes in PI and postural changes in IVC (R= 0.61, p = 0.02). There were no significant changes in supine and standing SBP and MAP (SBP: 101 ± 10 and 100 ± 10 mmHg, p=0.59; MAP: 82 ± 6 and 85 ± 7 mmHg, p=0.13). We did not find a statistically significant correlation between postural changes in PI and postural changes in MAP (r = 0.15, p = 0.55). Five patients (25%) had positive orthostatic vital signs and 14 (70%) had documented PI events the days prior to the study inclusion. There was a trend for larger postural PI changes in patients with positive orthostatic vital signs or PI events, although this did not reach statistical significance (p = 0.88 and p = 0.79, respectively). Conclusion Changes in LVAD PI seem to correlate with volume status rather than systemic blood pressure. There is a trend for larger postural PI changes in orthostatic patients and those with documented PI events. Postural PI change assessment could aid in the immediate bedside evaluation of volume status in LVAD patients. Furthermore, PI changes could be documented by patients remotely and used by providers for interval treatments without presentation to clinic.

The AWAKE-HF study evaluated the effect of sacubitril/valsartan (S/V) versus enalapril on sleep using actigraphy and a home sleep study in patients (pts) with heart failure with reduced ejection fraction (HFrEF). Pts 18 to 80 years of age with New York Heart Association (NYHA) class II/III HFrEF

Angiotensin receptor-neprolysin inhibitors (ARNI) are treatment for HFrEF. Sacubitril/valsartan (S/V) has shown improved outcomes, but it is unclear what influence ARNI have on EF. We investigated changes in EF and global longitudinal strain (GLS) after therapy with S/V. Patients started on S/V

We present a case of a patient being treated with immune checkpoint inhibitors (ICIs) for cervical cancer who developed myocarditis. A 62 year-old female with cervical cancer on ipilimumab and nivolumab presented acutely with palpitations. Labs revealed elevated troponin I of 4 and CKMB 8700. She

Elevated pulmonary artery (PA) pressures are associated with adverse prognosis across a wide spectrum of cardiac diseases including mitral regurgitation. CardioMEMS is a remote PA pressure monitoring device that allows for daily reproducible hemodynamic measurements. Recent trials have demonstrated

The AWAKE-HF trial evaluated the effect of sacubitril/valsartan (S/V) vs enalapril on daytime activity and sleep in patients with heart failure with reduced ejection fraction (HFrEF), using actigraphy. After a 2-week baseline period and 36-hour washout, individuals 18 to 80 years of age with New

Background Heart failure (HF) care takes place in multiple settings, with a variety of providers, and generally involves patients who have multiple comorbidities. This situation is a “perfect storm” of factors that predispose patients to medication errors. Methods and Results The goals of this paper are to outline potential roles for clinical pharmacists in a multidisciplinary HF team, to document outcomes associated with interventions by clinical pharmacists, to recommend minimum training for clinical pharmacists engaged in HF care, and to suggest financial strategies to support clinical pharmacy services within a multidisciplinary team. As patients transition from inpatient to outpatient settings and between multiple caregivers, pharmacists can positively affect medication reconciliation and education, assure consistency in management that results in improvements in patient satisfaction and medication adherence, and reduce medication errors. For mechanical circulatory support and heart transplant teams, the Centers for Medicare and Medicaid Services considers the participation of a transplant pharmacology expert (e.g., clinical pharmacist) to be a requirement for accreditation, given the highly specialized and complex drug regimens used. Although reports of outcomes from pharmacist interventions have been mixed owing to differences in study design, benefits such as increased use of evidence-based therapies, decreases in HF hospitalizations and emergency department visits, and decreases in all-cause readmissions have been demonstrated. Clinical pharmacists participating in HF or heart transplant teams should have completed specialized postdoctoral training in the form of residencies and/or fellowships in cardiovascular and/or transplant pharmacotherapy, and board certification is recommended. Financial mechanisms to support pharmacist participation in the HF teams are variable. Conclusions Positive outcomes associated with clinical pharmacist activities support the value of making this resource available to HF teams.

Background An implantable left atrial pressure (LAP) monitoring system for guiding the management of patients with advanced heart failure has the potential to require extraction, particularly in the setting of infection. The LAP sensor lead was designed to be suitable for ease of percutaneous extraction using standard techniques for extracting pacemaker and defibrillator leads. The clinical experience, to date, with percutaneous extraction of the LAP sensor lead is presented. Methods A total of 82 patients underwent successful implantation of the LAP sensor lead using transseptal catheterization. Five patients of the 82 patients during a cumulative follow-up period of 267 patient-years (median of 2.9 years/patient) underwent percutaneous extraction using manual traction with a locking stylet and/or an excimer laser sheath to bore through adhesions. The distal fixation anchors of the LAP sensor lead are designed to fold forward during extraction so that the sensor module can easily separate from the interatrial septum. Results Percutaneous extraction of the LAP sensor lead was accomplished successfully in all five patients with no embolic events, vascular tears, perforations, or other complications requiring surgical intervention. Manual traction alone was sufficient to detach the LAP sensor lead from the interatrial septum in all cases. Use of the excimer laser sheath was needed in selected cases to bore through scar tissue within the venous insertion site, but not within the heart. Conclusions The extraction of the LAP sensor lead was accomplished safely using standard techniques and equipment for percutaneously extracting pacemaker and defibrillator leads.

Background There is a well-recognized gap between the number of patients in whom cardiac resynchronization therapy (CRT) is indicated based on current guidelines and its actual utilization. In the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) study, there was a significant increase in the use of CRT at 24 months in patients with heart failure (HF) in comparison to baseline. This study evaluated patient, physician, and practice factors associated with this increase in CRT utilization. Methods Patients with reduced left ventricular ejection fraction and chronic HF who met the eligibility criteria for CRT at baseline and 24 months were analyzed. Multivariate analyses using patient, physician, and practice characteristics were performed to evaluate factors associated with increased CRT utilization at 24 months. Results There were 440 patients eligible for CRT both at baseline and 24 months, with 217 (49.3%) treated at baseline and 374 (85%) treated at 24 months, leading to an absolute increase in use of CRT of 35.7%, P < 0.001. Although serum sodium and the absence of rales had modest associations, none of the patient, physician, or practice characteristics had any significant association with the extent of increase in CRT utilization. There was a significant reduction in the variation of CRT utilization across practice sites after the implementation of the performance improvement initiative. Conclusions The performance improvement initiative in IMPROVE HF was the most important factor associated with an increase in guideline-recommended CRT utilization. This improvement in CRT utilization and reduced practice variability was found across a variety of cardiology and multispecialty practice sites.

Despite numerous pharmacologic and nonpharmacologic treatment strategies, heart failure remains a complex, progressive disorder with significant morbidity and mortality. Angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and β-blockers have been used as routine treatment options for heart failure for the majority of patients with left ventricular systolic dysfunction who tolerate these agents. Mineralocorticoid receptor antagonists (MRAs) have also demonstrated significant benefits in the treatment of heart failure, which include a reduction in sudden cardiac death and ventricular remodeling; however, these agents have not been recommended for most patients with heart failure. In the most recent American College of Cardiology Foundation and American Heart Association guidelines, MRAs are recommended for patients with New York Heart Association class III or IV symptoms or previous acute myocardial infarction, provided an absence of contraindications or risk factors for developing hyperkalemia. Based on more recent evidence, it is likely that future recommendations and guidelines will further expand the use of MRAs to patients with mild heart failure as well. These agents have the potential to be recommended nearly as universally as ACE inhibitors and β-blockers because of the potential to reduce mortality and hospital admissions for heart failure. The risk of hyperkalemia should be carefully assessed when using these drugs; nonetheless, new strategies being developed may reduce the occurrence of hyperkalemia as well.

Patients perceive different symptoms of heart failure decompensation. It is not known whether the nature of the worst symptom relates to hemodynamic profile, response to therapy, or improvement in clinical trials.Patients in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial were hospitalized with advanced heart failure, ejection fraction ≤30%, and at least 1 sign and 1 symptom of elevated filling pressures. Visual analog scales (VAS) for symptoms were completed by 371 patients, who selected their worst symptom as difficulty breathing, fatigue, abdominal discomfort, or body swelling and also scored breathing and global condition at baseline and discharge. The dominant symptom identified was difficulty breathing by 193 (52%) patients, fatigue by 118 (32%), and abdominal discomfort and swelling each by 30 (8%) patients, combined as right-sided congestion for analysis. Clinical and hemodynamic assessments were not different between groups except that right-sided congestion was associated with more hepatomegaly, ascites, third heart sounds, and jugular venous distention. This group also had greater reduction in jugular venous distention and trend toward higher blood urea nitrogen after therapy. By discharge, average improvements in worst symptom and global score were 28 points and 24 points. For those with ≥10 points in improvement in worst symptom, 84% also improved global assessment ≥10 points. Initial fatigue was associated with less improvement (P = .002) during and after hospitalization, but improvements in symptom scores were sustained when re-measured during 6 months after discharge.In most patients hospitalized with clinical congestion, therapy will improve symptoms regardless of the worst symptom perceived, with more evidence of baseline fluid retention and reduction during therapy for worst symptoms of abdominal discomfort or edema. Improvement in trials should be similar when tracking worst symptom, dyspnea, or global assessment.

B-type natriuretic peptide (BNP) levels provide diagnostic and prognostic information in heart failure. This study determined the frequency of BNP assessment and analyzed demographic characteristics, clinical variables and the utilization of guideline-recommended heart failure therapies by BNP level in outpatients with reduced left ventricular ejection fraction (LVEF).The IMPROVE HF registry (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) is a prospective cohort study of patients at least 18 years of age with a LVEF 35% or less and chronic heart failure or previous myocardial infarction (MI) presenting to cardiology and multispecialty practices. The medical records of 15,381 patients were reviewed. BNP was measured in 4213 (27.4%) patients and the median plasma BNP level was 384 pg/ml (interquartile range 158-877 pg/ml). Patients were stratified by plasma BNP measurements into the following tertiles: 219 pg/ml or less, more than 219 to 649 pg/ml, and more than 649 pg/ml. Jugular venous distension, pedal edema, rales and systolic murmur on physical examination and elevated renal function parameters were associated with higher BNP levels. BNP assessment and elevated BNP levels were not associated with greater use of any of the quality of care measures. However, patients with a BNP in the top tertile were less likely to be treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or aldosterone antagonists compared with patients with a BNP in the bottom tertile.Among practices participating in IMPROVE HF, BNP was not measured in most outpatients with reduced LVEF and chronic heart failure or previous MI. BNP assessment or the BNP level in patients with recorded measurements, with few exceptions, did not impact the utilization of guideline-recommended therapies.

Background: IMPROVE HF, a 24-month performance improvement initiative for outpatient cardiology and multispecialty practices, demonstrated significant improvement in guideline-based use of implantable cardioverter-defibrillators (ICDs) for patients with heart failure (HF). We investigated patient, physician, and practice factors associated with improvements in ICD use. Methods: Patients with HF or postmyocardial infarction (MI) left ventricular systolic dysfunction who met eligibility criteria for ICDs at baseline and 24 months were analyzed. Multivariate analyses were performed to identify patient, physician, and practice characteristics associated with greater improvement in ICD therapy rates from baseline to 24 months. Results: There were 4,058 patients eligible for ICD therapy at baseline and 24 months, with 2,600 (64.1%) treated at baseline and 3,361 (82.8%) treated at 24 months (+18.7%, P < 0.001). Practice heterogeneity in ICD use was significantly decreased after implementation of the performance improvement initiative. Characteristics independently associated with improvement in use of ICD therapy included race, history of MI, presence of edema, QRS duration, months since last measured left ventricular ejection fraction, and number of physicians in the practice. Improvement in ICD use was independent of other patient, physician, and practice characteristics, including age and sex. Conclusions: The IMPROVE HF performance improvement initiative was associated with substantially improved adherence to guideline-recommended ICD therapy. Certain patient and practice characteristics, including race, history of MI, edema, QRS duration, and number of physicians in the practice, were independently associated with improvement in ICD use. These findings highlight the need for ongoing quality improvement monitoring and performance improvement activities. (PACE 2012; 35:135–145)

able for 7605 patients. At baseline, target dose treatment rates were 36.1%, 20.5%, and 74.4%, respectively. Absolute and relative improvements of 9.8% and 47.7% (P

Congest Heart Fail. 2011;17:248–254. ©2011 Wiley Periodicals, Inc. Clinical trial results support the hypothesis that implantable hemodynamic monitoring (IHM) systems may reduce hospitalizations among patients with chronic heart failure (HF). The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCE hf ) study was a prospective, randomized, multicenter, single-blinded trial that enrolled patients with New York Heart Association class II or III symptoms, an indication for an implantable cardioverter-defibrillator (ICD), and a previous HF hospitalization. A combination IHM-ICD was implanted and patients were randomly assigned to a treatment group in which hemodynamic information was used or a control group in which hemodynamic information was not available. Patients were followed for 12 months to evaluate the primary efficacy end point of HF hospitalizations, emergency department visits, or urgent clinic visits. The trial was designed to enroll 1300 patients, but stopped at 400 patients because of IHM lead failures experienced from previous trials. A total of 202 treatment patients and 198 controls were randomized for 12-month follow-up. The primary safety end point was met, but the rate of HF equivalents was not different between groups. REDUCE hf was unable to test clinical efficacy end points adequately. The device combining IHM-ICD technology was safe and functioned appropriately. Patients at high risk for decompensated HF have high baseline filling pressures and demonstrate consistent increases as the process of congestion worsens to the time of hospitalization.

Background— Modulation of novel cardiorenal and inflammatory markers may provide insight into the disease process and outcomes of patients with acute decompensated heart failure. Methods and Results— In this open-labeled, prospective, randomized study, 89 patients received either nesiritide (NES) or nitroglycerin (NTG) infusion by standard protocol. The serum or plasma concentrations of cystatin-C and inflammatory markers (high-sensitivity C-reactive protein, tumor necrosis factor-α, transforming growth factor-β1, and interleukin-6) were measured in 66 patients with acute decompensated heart failure at baseline and during drug infusion. Mean baseline values for demographics were not significantly different between NTG and NES groups; however, baseline inflammatory markers were elevated on admission. In NES compared with NTG groups, lower cystatin-C (1449 versus 2739 ng/mL, P P Conclusions— The differential modulation effects of cystatin-C and interleukin-6 but not other inflammatory markers, in response to NES compared with NTG therapy, may provide important implications for vasodilator therapy. Further studies are warranted to confirm these findings. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00842023.

Diverse factors are associated with variations in evidence-based treatment of outpatients with heart failure (HF). However, patient and practice characteristics associated with improved use of guideline-recommended therapies over time have not been well studied. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) is a prospective evaluation of a performance improvement initiative conducted at 167 practices treating outpatients with diagnosed HF or previous myocardial infarction and left ventricular ejection fraction ≤35%. Patient characteristics and care practice data were collected by chart abstraction at baseline and 24 months for 14,236 patients. Seven individual care measures and a composite measure were assessed. Practices were stratified by tertiles of composite measure improvement, and significant, independent patient and practice factors associated with improvement in the composite measure at 24 months were examined. The baseline composite performance measure was 68.4%, which increased to 80.1% at 24 months (+11.6%, p0.001). The composite measure improvement tertiles were ≤8%,8% to 15%, and15%. Multivariate analyses revealed greater improvements associated only with lower practice baseline composite measure rates (p0.001). Logistic regression showed that 2 additional variables were inversely associated with practices in the highest tertile in composite measure improvement (15%): southern practice location (p = 0.0239) and edema (p = 0.0047). In conclusion, few patient and practice factors were associated with greater or lesser overall improvements over time in the use of guideline-recommended HF therapies. Other factors may be more important determinates of the magnitude of care improvements over time among cardiology practices participating in a performance improvement initiative.

Introduction Obesity is a common comorbidity which can complicate management of advance heart failure (AHF) and preclude heart transplant. The use of bariatric surgery has been studied as a weight-loss therapy in AHF patients. The left ventricular assist device (LVAD) has been used as either destination therapy or bridge to candidacy in these obese AHF patients. Methods We reviewed bariatric surgery in LVAD patients who were implanted as bridge to candidacy as a means to expedite candidacy for cardiac transplant. A retrospective chart review was performed on LVAD patients to identify those who underwent bariatric surgery. Clinical data were collected at baseline prior to bariatric surgery and 3 months post-surgery. Data collected included age, etiology of cardiomyopathy, body mass index (BMI), bariatric procedure performed, complications, time to transplant candidacy and ultimate clinical outcome. Three patients (2 female), with a mean age of 51 (range 50-53) were reviewed. All 3 patients had a diagnosis of non-ischemic cardiomyopathy. The average baseline BMI was 39 kg/m2 (range 37- 42). Laparoscopic sleeve gastrectomy was performed on all three patients. Results One patient had significant postoperative bleeding requiring multiple transfusions and reversal of anticoagulation. Anticoagulation was interrupted multiple times during the hospitalization due to bleeding and labile INR levels. A rise in LDH was noted during the hospitalization. One-month post discharge from bariatric surgery the patient was admitted for suspected pump thrombosis with power spikes. She was discharged home after intravenous anticoagulation with baseline LDH and power levels without any neurologic or hemodynamic sequelae. The 3-month average BMI and total weight loss percentage was 34 kg/m2 (range 30 - 38) and 12.5% (range 3.3-20.2%), respectively. All three patients were listed for transplantation with an average time to transplant candidacy of 116 days (range 105-123) following bariatric surgery. Two of the 3 patients received a heart transplant at an average of 145 days (range 130-161) from bariatric surgery. The other patient developed an intracranial hemorrhage 476 days following bariatric surgery and ultimately deemed not a transplant candidate. Conclusion Our retrospective cohort analysis confirms the efficacy of bariatric surgery as a weight loss therapy in obese LVAD patients as a method to shorten time to transplant candidacy. Postoperative bleeding must be managed carefully in consideration of the risk of prolonged cessation of anticoagulation.

Introduction Sacubitril/valsartan (S/V) has been shown to decrease N-terminal pro-B-type natriuretic peptide (NT-pro BNP) levels. Reduction of NT-proBNP is associated with lower morbidity and mortality rates. However, there is very little data with the effects of low dose S/V on NT-proBNP. Methodology This was a retrospective study conducted between October 2015 and January 2018 of patients who received either low dose or very low dose S/V. Patients were divided into 3 groups based on S/V dosing. Group 1 patients received very low dose, group 2 patients received very low dose titrated to low dose, and group 3 patients received low dose. The primary endpoint was the change in NT-proBNP levels between baseline and the most recent obtained value. Results A total of 293 patients were reviewed and 45 patients met inclusion criteria. Across all S/V dosing groups, there was a statistically significant reduction in NT-proBNP levels. The average days of therapy between NT-proBNP values were 108, 149, and 196 in group 1, 2, and 3, respectively. 71% of patients were on loop diuretics prior to S/V with an average furosemide equivalent dose of 73mg which decreased by 27% to 53mg after receiving S/V. Conclusion Low doses of S/V, including half of the lowest dose clinically available, appears to have substantial benefit in terms of NT-proBNP which can be seen within 3 to 6 months. Despite a reduction in loop diuretic dose, there was still a significant reduction in NT-proBNP which may be attributed to the natriuretic effect of S/V. Although reductions in NT-proBNP levels are associated with improvements in survival, these data cannot be used to infer that a similar reduction in mortality would be expected. However, they do suggest that very low doses of S/V appear to have a biochemical effect and perhaps should be studied in future trials since not all patients can be titrated to the maximum dose of S/V. While patients should be titrated to guideline recommended doses, low doses seem to be beneficial in terms of reducing NT-proBNP levels.

Background— A treatment gap exists between heart failure (HF) guidelines and the clinical care of patients. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) prospectively tested a multidimensional practice-specific performance improvement intervention on the use of guideline-recommended therapies for HF in outpatient cardiology practices. Methods and Results— Performance data were collected in a random sample of HF patients from 167 US outpatient cardiology practices at baseline, longitudinally after intervention at 12 and 24 months, and in single-point-in-time patient cohorts at 6 and 18 months. Participants included 34 810 patients with reduced left ventricular ejection fraction (≤35%) and chronic HF or previous myocardial infarction. To quantify guideline adherence, 7 quality measures were assessed. Interventions included clinical decision support tools, structured improvement strategies, and chart audits with feedback. The performance improvement intervention resulted in significant improvements in 5 of 7 quality measures at the 24-month assessment compared with baseline: β-blocker (92.2% versus 86.0%, +6.2%), aldosterone antagonist (60.3% versus 34.5%, +25.1%), cardiac resynchronization therapy (66.3% versus 37.2%, +29.9%), implantable cardioverter-defibrillator (77.5% versus 50.1%, +27.4%), and HF education (72.1% versus 59.5%, +12.6%) (each P Conclusions— The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting, a defined and scalable practice-specific performance improvement intervention, was associated with substantial improvements in the use of guideline-recommended therapies in eligible patients with HF in outpatient cardiology practices. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00303979.

National guidelines recommend a team model of care to facilitate adherence to evidence-based practices; however, previous studies suggesting benefit may have limited generalizability. The aim of this study was to examine the influence of advanced practice nurse (APN) and physician assistant (PA) staffing on the delivery of guideline-recommended therapies for outpatients with heart failure (HF). The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF), a prospective cohort study, enrolled 167 cardiology practices to characterize outpatient management of 15,381 patients with chronic HF and left ventricular ejection fractionsor =35%. Adherence to guideline-recommended HF therapies was recorded, and the presence of APN and PA staffing was assessed by survey. Multivariate models identified contributions to the delivery of guideline-recommended HF therapies. Of cardiology outpatient practices, 66.0% had APNs and PAs. Practices with 0,0 to2, andor =2.0 APN and PA staffing had similar adherence to the 7 guideline-recommended HF therapies. After adjustment, staffing withor =2 APNs or PAs was associated with greater conformity with 2 of 7 measures (implantable cardioverter-defibrillator therapy and delivery of HF education, por =0.01 for both) and similar conformity to angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy, beta-blocker therapy, aldosterone antagonist therapy, anticoagulation for atrial fibrillation, and cardiac resynchronization therapy. In conclusion, staffing with APNs and PAs varied in cardiology outpatient practices. Compared to no APNs or PAs,or =2.0 APNs or PAs per cardiology practice was associated with the greater use of implantable cardioverter-defibrillator therapy and delivery of HF education and equivalent use of drug and cardiac resynchronization therapies.

Background— Previous studies suggest that management of ambulatory hemodynamics may improve outcomes in chronic heart failure. We conducted a prospective, observational, first-in-human study of a physician-directed patient self-management system targeting left atrial pressure. Methods and Results— Forty patients with reduced or preserved left ventricular ejection fraction and a history of New York Heart Association class III or IV heart failure and acute decompensation were implanted with an investigational left atrial pressure monitor, and readings were acquired twice daily. For the first 3 months, patients and clinicians were blinded as to these readings, and treatment continued per usual clinical assessment. Thereafter, left atrial pressure and individualized therapy instructions guided by these pressures were disclosed to the patient. Event-free survival was determined over a median follow-up of 25 months (range 3 to 38 months). Survival without decompensation was 61% at 3 years, and events tended to be less frequent after the first 3 months (hazard ratio 0.16 [95% confidence interval 0.04 to 0.68], P =0.012). Mean daily left atrial pressure fell from 17.6 mm Hg (95% confidence interval 15.8 to 19.4 mm Hg) in the first 3 months to 14.8 mm Hg (95% confidence interval 13.0 to 16.6 mm Hg; P =0.003) during pressure-guided therapy. The frequency of elevated readings (>25 mm Hg) was reduced by 67% ( P P P P P P =0.15). Conclusions— Physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamics, symptoms, and outcomes in advanced heart failure. Clinical Trial Registration Information— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00547729.

Background National guidelines recommend heart failure (HF) disease management programs to facilitate adherence to evidence-based practices. This study examined the influence of dedicated HF clinics on delivery of guideline-recommended therapies for cardiology practice outpatients with HF and reduced left ventricular ejection fraction. Methods IMPROVE HF, a prospective cohort study, enrolled 167 cardiology practices to characterize outpatient management of 15,381 patients with chronic systolic HF. Adherence to guideline-recommended HF therapies was recorded, and the presence of a dedicated HF clinic was assessed by survey. Multivariate models identified contributions to delivery of guideline-recommended HF therapies. Results Of practices, 41.3% had a dedicated HF clinic. Practices with a dedicated HF clinic had greater adherence to 3 of 7 guideline-recommended HF therapy measures: angiotensin-converting enzyme inhibitor/angiotensin receptor blocker ( P = .02), β-blocker ( P = .025), and HF education ( P = .009). After adjustment, use of a dedicated HF clinic was associated with greater conformity in 2 of 7 measures: cardiac resynchronization therapy ( P = .036) and HF education ( P = .005) but not angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, β-blocker, aldosterone antagonist, implantable cardioverter-defibrillator therapy, and anticoagulation for atrial fibrillation. Conclusions Use of dedicated HF clinics varied in cardiology outpatient practices and was associated with greater use of cardiac resynchronization therapy and HF education but not other guideline-recommended therapies.

Background Cardiac resynchronization therapy (CRT) has established efficacy for patients with systolic heart failure (HF). Treatment rates and factors associated with CRT utilization among eligible patients in outpatient cardiology practices have not been well studied. Methods IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and left ventricular ejection fraction ≤35% in a registry of outpatient cardiology practices located throughout the United States. Baseline data were abstracted by trained chart review specialists from May 31, 2005, through June 22, 2007, for 15,381 patients attending 167 outpatient cardiology practices. Multivariable analyses of patient and practice characteristics identified predictors of CRT for eligible patients. Results A total of 1,373 patients were eligible for CRT based on current guideline criteria, and 533 (38.8%) received a CRT device, with 84.1% of these treated with a CRT-defibrillator. Cardiac resynchronization therapy use varied widely among practices, with 11.1% at the 25th percentile and 53.4% at the 75th percentile. Patient age, insurance, longer QRS duration, and practice location were independently associated with higher CRT utilization rates among eligible patients, whereas sex, HF etiology, and other clinical and laboratory parameters were not. Conclusions Despite being evidence based and guideline recommended, CRT is underutilized in eligible patients with significant variations associated with age, insurance, QRS duration, and geographic location of practices. Practice-specific performance improvement initiatives may be needed to reduce variations in use of CRT for eligible patients. (Am Heart J 2009;158:956-64.)

Background Clinical guidelines recommend implantable cardioverter-defibrillators (ICDs) for selected patients with chronic left ventricular dysfunction (LVD) to improve survival, yet ICD treatment rates for eligible patients with LVD or heart failure (HF) in cardiology practices remain poorly studied. Objective This study sought to determine patient and practice characteristics associated with ICD use in the outpatient setting. Methods IMPROVE HF (Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), a prospective cohort study, is designed to characterize management of HF with reduced left ventricular ejection fraction (LVEF ≤35%). Baseline data were collected for 15,381 patients attending 167 outpatient cardiology practices located in the U.S. Results By current guidelines, 7,221 patients met eligibility for ICD implantation (± cardiac resynchronization therapy [CRT]), of whom 3,659 (50.7%) received either ICD (63.8%) or CRT with defibrillator (36.2%). Individual practice conformity for guideline-recommended ICD use ranged from 0% to 100% (27.3% to 74.6% at the 10th and 90th percentiles, respectively). Adjusted analyses revealed lack of adherence for ICD use most notably with advancing age (odds ratio: 0.87; 95% confidence interval: 0.82 to 0.93 per 10 years), black race (odds ratio: 0.75; 95% confidence interval: 0.60 to 0.94), and lack of insurance (odds ratio: 0.45; 95% confidence interval: 0.26 to 0.78). Characteristics of increased adherence included male sex, ischemic disease, atrial fibrillation, and wider QRS. Practices in the Northeast U.S. were more likely to adhere to guidelines ( P P = .004) and electrophysiologists on staff ( P Conclusion Although a number of patient and practice characteristics are associated with guideline-based ICD use, there is significant unexplained variation in the use of ICD therapy for sudden death prophylaxis across cardiology practices.

Background We assessed the effect of increases in serum creatinine on mortality in nesiritide-treated versus control subjects with acute decompensated heart failure (ADHF). Hypothesis Mortality effect of nesiritide-related increases in serum creatinine differs from that of standard therapies. Methods Scios Inc., granted unrestricted access to data from all 5 randomized, controlled nesiritide infusion trials completed to date in patients hospitalized with ADHF. We used 2 different definitions of acute serum creatinine increase: >0.3 mg/dL and > 0.5mg/dL within 30 days of study enrollment and determined 30-day mortality risk for nesiritide-treated versus control subjects utilizing each definition. Results A total of 1,270 subjects participated in the 5 trials. A >0.3 mg/dL increase in serum creatinine was associated with a significant increase in mortality risk in control subjects, (hazard ratio [HR]: 3.47, 95% confidence interval [CI]: 1.49–8.09) but not in nesiritide-treated subjects (HR: 1.65, 95% CI: 0.90–3.05). Results were similar for a >0.5 mg/dL increase (control HR: 5.12, 95% CI: 2.09–12.57 and nesiritide HR: 1.77, 95% CI: 0.90–3.51). In subjects with >0.3 mg/dL and >0.5 mg/dL increases in serum creatinine, respectively, the 30-day mortality odds ratios for nesiritide relative to control were 0.73 (95% CI: 0.29–1.93) and 0.52 (95% CI: 0.17–1.63) using a stratified Mantel-Haenszel analysis. Conclusions The impact of increased serum creatinine on mortality was attenuated in nesiritide-treated patients compared to control, suggesting that the mechanism and clinical significance of increases in serum creatinine associated with nesiritide treatment may differ from those associated with standard therapies. Further investigation is warranted. Copyright © 2009 Wiley Periodicals, Inc.

Heart failure is the terminal stage of cardiac disease and, as such, potentially involves spiritual issues and suffering. Spirituality has been shown to be related to adaptation, life satisfaction, and depression. Further, as depression is an independent predictor of mortality in patients with heart failure, spirituality is important for clinicians to consider. Patients with heart failure are disadvantaged compared to patients with other terminal diseases. The heart failure illness trajectory is unpredictable and the potential for sudden, unanticipated death exists. The management of end-stage heart failure is often associated with distressing symptoms, multiple hospitalizations and the potential for suffering. Patients are often less likely to understand their illness, have access to supportive care and have the opportunity to plan for death and dying. Unmet spiritual needs and suffering may go under diagnosed and treated. This suggests the need for a more palliative approach emphasizing the opt...

Background— Few data exist regarding contemporary care patterns for heart failure (HF) in the outpatient setting. IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and ejection fraction ≤35% in a national registry of 167 US outpatient cardiology practices. Methods and Results— Baseline patient characteristics and data on care of 15381 patients with diagnosed HF or prior myocardial infarction and left ventricular dysfunction were collected by chart abstraction. To quantify use of therapies, 7 individual metrics (use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, β-blocker, aldosterone antagonist, anticoagulation, implantable cardioverter defibrillator, cardiac resynchronization therapy, and HF education) and composite metrics were assessed. Care metrics include only patients documented to be eligible and without contraindications or intolerance. Among practices, 69% were nonteaching. Patients were 71% male, with a median age of 70 years, and a median ejection fraction of 25%. Use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (80%) and β-blocker (86%) was relatively high in eligible patients in the outpatient cardiology setting; other metrics, such as aldosterone antagonist (36%), device therapy (implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator, 51%; cardiac resynchronization therapy, 39%), and education (61%), showed lower rates of use. A median 27% of patients received all HF therapies for which they were potentially eligible on the basis of chart documentation. Use of guideline-recommended therapies by practices varied widely. Conclusions— These data are among the first to assess treatment in the outpatient setting since the release of the latest national HF guidelines and to demonstrate substantial variation among cardiology practices in the documented therapies provided to HF patients.