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Therapy guided by pulmonary artery (PA) pressure monitoring reduces PA pressures and heart failure hospitalizations (HFH) during the first year, but the durability of efficacy and safety through 2 years is not known.The CardioMEMS Post-Approval Study investigated whether benefit and safety were generalized and sustained. Enrollment at 104 centers in the United States included 1200 patients with NYHA Class III symptoms on recommended HF therapies with prior HFH. Therapy was adjusted toward PA diastolic pressure 8-20 mmHg. Intervention frequency and PA pressure reduction were most intense during first 90 days, with sustained reduction of PA diastolic pressure from baseline 24.7 mmHg to 21.0 at 1 year and 20.8 at 2 years for all patients. Patients completing two year follow-up (n = 710) showed similar 2-year reduction (23.9 to 20.8 mmHg), with reduction in PA mean pressure (33.7 to 29.4 mmHg) in patients with reduced left ventricular ejection. The HFH rate was 1.25 events/patient/year prior to sensor implant, 0.54 at 1 year, and 0.37 at 2 years, with 59% of patients free of HFH during follow-up.Reduction in PA pressures and hospitalizations were early and sustained during 2 years of PA pressure-guided management, with no signal of safety concerns regarding the implanted sensor.

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.

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.

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.

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)