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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.

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.

Introduction: Heart failure (HF) is a major public health problem and timely evidence-based guideline directed treatment is essential to ensure optimal patient outcomes. New York Heart Association (NYHA) functional class of HF patients is a clinically important assessment as it relates to treatment recommendations. Purpose: The purpose of this study was to examine HF providers’ decision making and ability to correctly assign NYHA functional class. Methods: A cross-sectional, correlational study using survey methods with 244 physicians, advanced practice nurses and physician assistants practicing in the United States in acute and ambulatory care settings that treat adult patients with HF was conducted. Providers completed 8 validated clinical vignettes focused on decision making that related to the four NYHA functional classes. Descriptive statistics and multivariable regression were used to analyze the data. Results: Participants were predominately female (83%), Caucasian (87%) and were on average 51 years of age (SD=11). Sixty-five percent were nurse practitioners and 18% physicians, most were certified in HF (59%) and on average worked with HF patients for 15.1 years (SD=9.6). Providers reported assigning NYHA class to 83% of their patients, with 39% reporting it was useful. Accurate identification of NYHA Class I was 78.7%, for Class II 57.4%, for Class III 59.8% and for Class IV 36.9%. Correct NYHA class scores were associated with providers who typically reported assigning HF stage (p Conclusions: Advanced practice providers who saw fewer HF patients had greater difficulty with accurately assigning NYHA Functional Class. When patients are incorrectly classed, they may not be recommended for evidence-based therapies at the optimal time, thus decreasing patient outcomes. Future research should focus on ways to improve accuracy in assigning NYHA Functional Class to improve patient outcomes.

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.

Patients with inadequate health literacy and heart failure face high healthcare costs, more hospitalizations, and greater mortality. To address these negative consequences, patients need to improve heart failure self-care. Multiple factors may influence self-care, but the exact model by which they do so is not fully understood.The objective of this study was to examine a model exploring the contribution of health literacy, depression, disease knowledge, and self-efficacy to the performance of heart failure self-care.Using a cross-sectional design, patients were recruited from a heart failure clinic and completed validated assessments of their cognition, health literacy, depression, knowledge, self-efficacy and self-care. Patients were separated into two groups according to their health literacy level: inadequate/marginal and adequate. Differences between groups were assessed with an independent t-test. Hypothesized paths and mediated relationships were estimated and tested using observed variable path analysis.Participants (n = 100) were mainly male (67%), white (93%), and at least had a high school education (85%). Health literacy was associated with disease knowledge (path coefficient=0.346, p = 0.002), depression was negatively associated with self-efficacy (path coefficient=-0.211, p = 0.037), self-efficacy was positively associated with self-care (path coefficient=0.402, p0.0005), and there was evidence that self-efficacy mediated the link between depression and self-care. There was no evidence of: mediation of the link between health literacy and self-care by knowledge or self-efficacy; positive associations between knowledge and self-efficacy or self-care; or mediation of the disease knowledge and self-care relationship by self-efficacy. Further, depression was associated with self-care indirectly rather than also directly as hypothesized.Self-efficacy and depression are associated with heart failure self-care. Data generated from the model suggest that healthcare professionals should actively engage all patients to gain self-efficacy and address depression to positively affect heart failure self-care.

Background Early heart failure (HF) symptoms are frequently unrecognized for reasons that are unclear. We explored symptom perception in patients with chronic HF. Methods We enrolled 36 HF out-patients into a longitudinal sequential explanatory mixed methods study. We used objectively measured thoracic fluid accumulation and daily reports of signs and symptoms to evaluate accuracy of detected changes in fluid retention. Patterns of symptom interpretation and response were explored in telephone interviews conducted every 2 weeks for 3-months. Results In this sample, 44% had a mismatch between objective and subjective fluid retention; younger persons were more likely to have mismatch. In interviews, two patterns were identified: those able to interpret and respond appropriately to symptoms were higher in decision-making skill and the quality of social support received. Conclusion Many HF patients were poor at interpreting and managing their symptoms. These results suggest a subgroup of patients to target for intervention.

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.

Background Cardiology has advanced guideline development and quality measurement. Recognizing the substantial benefits of guideline‐directed medical therapy, this study aims to measure and explain apparent deviations in heart failure ( HF ) guideline adherence by clinicians at hospital discharge and describe any impact on readmission rates. Methods and Results The extent of decongestion and prescription of neurohormonal therapy were recorded prospectively for 226 HF discharges, including 132 (58%) from an academic hospital and 94 (42%) from a community hospital. Among all discharges, 25% were discharged with residual congestion (30% academic versus 18% community, P =0.070). Among discharges of patients with HF with reduced ejection fraction, 37% (45% academic versus 18% community, P P =0.390) were discharged without an angiotensin‐converting enzyme inhibitor or angiotensin II receptor blocker or with lower doses than at admission. Renal dysfunction was the most common reason for discharge with congestion, and hypotension the most common reason for discharge with no or decreased neurohormonal therapy. There was a trend toward higher 90‐day readmission rates after discharge with residual congestion. Conclusions Clinicians frequently deviate from guidelines in both academic and community hospitals; however, this deviation may not always indicate poor quality. Application of guidelines recommended for stable populations is increasingly limited for hospitalized patients by hypotension, renal dysfunction, and inotrope use. Patients with renal dysfunction, hypotension, and recent inotrope use merit further study to determine best practices and possibly to adjust quality metrics for HF severity.

Background Heart failure hospitalizations (HFHs) cost the US health care system ∼$20 billion annually. Identifying patients at risk of HFH to enable timely intervention and prevent expensive hospitalization remains a challenge. Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization devices with defibrillation capability (CRT-Ds) collect a host of diagnostic parameters that change with HF status and collectively have the potential to signal an increasing risk of HFH. These device-collected diagnostic parameters include activity, day and night heart rate, atrial tachycardia/atrial fibrillation (AT/AF) burden, mean rate during AT/AF, percent CRT pacing, number of shocks, and intrathoracic impedance. There are thresholds for these parameters that when crossed trigger a notification, referred to as device observation, which gets noted on the device report. We investigated if these existing device observations can stratify patients at varying risk of HFH. Methods We analyzed data from 775 patients (age: 69 ± 11 year, 68% male) with CRT-D devices followed for 13 ± 5 months with adjudicated HFHs. HFH rate was computed for increasing number of device observations. Data were analyzed by both excluding and including intrathoracic impedance. HFH risk was assessed at the time of a device interrogation session, and all the data between previous and current follow-up sessions were used to determine the HFH risk for the next 30 days. Results 2276 follow-up sessions in 775 patients were evaluated with 42 HFHs in 37 patients. Percentage of evaluations that were followed by an HFH within the next 30 days increased with increasing number of device observations. Patients with 3 or more device observations were at 42× HFH risk compared to patients with no device observation. Even after excluding intrathoracic impedance, the remaining device parameters effectively stratified patients at HFH risk. Conclusion Available device observations could provide an effective method to stratify patients at varying risk of heart failure hospitalization.

Background Ambulatory pulmonary artery (PA) pressure-directed clinical management of Heart Failure (HF) patients has been shown to reduce HF hospitalizations; however the work flow associated with remote hemodynamic monitoring in such patients has not been studied. We performed a time and motion study in a group of patients with heart failure. Methods A non-interventional, single site “time and motion” study of usual care processes was conducted in the Heart Failure clinic of a 630-bed community hospital between July - October 2017. All enrolled patients were NYHA class III. Patients previously implanted with an ambulatory PA pressure sensor (CardioMEMSTM, Abbott; CMEM group), as well as sensor-eligible patients who had not previously received the implant (non-CMEM group), were recruited at a routine HF clinic visit. The usual care visit, for both CMEM and non-CMEM group, was observed from the time the patient arrived at the clinic to the time they left. The in-clinic observation was quantified based on the time spent in the prep area, exam room area, dictation, and scheduling desk. Primary reason for telephone calls made to CMEM group was captured. Results The HF clinic workflow was observed for 53 patients (n = 24 CMEM, n = 29 non-CMEM). The mean clinic visit time were 48:55 ± 15:34 minutes for CMEM and 55:57 ± 21:42 minutes non-CMEM (p = 0.07). 75% of the visit time was spent in the exam room with the provider. Telephone call duration was 5:47 ± 15:09 minutes (N = 92) with a median of 2:13 minutes of which, 52% were related to review of pulmonary artery pressures, 29% to HF monitoring, 12% to labs, and 3% to medication change. Conclusion This is the first characterization of the practical implications of utilizing remote hemodynamic monitoring. The additional time spent during follow-up calls was partially offset by shorter office visits. In addition, since most of the office time involved the provider (exam room) as opposed to nurse time (phone calls), the utilization of CardioMEMS™ may improve provider efficiency. The economic implications of remote hemodynamic management and office visits for HF patients can be studied based on these data.

The prevalence of heart failure has increased by 500% over the past 30 years, creating a significant burden on the health care system. Traditional means of detecting worsening heart failure, such as subjective assessment, symptoms, and physical examination, lack sensitivity and specificity. Many nurses who manage heart failure patients have become interested in the role implantable cardiac devices play in monitoring patients' clinical status. In addition to providing therapies, some devices track and report diagnostic information that allows clinicians to more closely and effectively monitor patients, with the possibility of helping to prevent hospitalizations and improve patient outcomes. Optimal use of device diagnostics requires clinics to establish systems for recognizing patients who are eligible for device monitoring. This paper highlights various methods clinics have used to identify patients with implantable cardiac devices so that their device data can be used in conjunction with clinical evaluations to help guide patient care.

Since its inception, the American Association of Heart Failure Nurses (AAHFN) has assisted heart failure nurses providing appropriate education for their patients. In the most recent strategic plan the Board of Directors specifically targeted ways to enhance and expand patient education resources that our members can use in their clinical practice. This is particularly important as the recognition of 60 min, of inpatient education has been set as a goal by programs that measure outcomes and recognize quality.1,2 The goal of 60 min was supported by research that found a reduction in early readmission in those patients with a total of at least 1 h of inpatient education.3 To provide a baseline assessment as part of our quality improvement efforts, AAHFN devised a survey for membership that would: 1. Assess heart failure (HF) patient provision of 60 min of patient education (60MPE) and preparation for self-care, 2. Identify the barriers to patient education, 3. Assess the difficulty of teaching various topics, and 4. Examine institutional and nurse variables that promote 60MPE. A brief report of the results of the first question was published in a recent AAHFN publication.4 This paper provides a more detailed report of the survey.

found a 4.65% increase in cardiac mortality during the Christmas/ New Year holiday period. The investigators hypothesized that this increase was due in part to changes in behavior during the holidays with changes in diet and alcohol consumption, activity and delays in seeking medical care. Redman and colleagues examined whether there was a specific increase in heart failure hospitalizations during the Christmas/New Year holiday period. 2 They conducted a retrospective review of heart failure visits to 18 different emergency rooms in New Jersey and New York from 1996 through 2004. The investigators found a 23% increase in daily visits for December 25 through January 7 and 30% increase in the 4 days following Christmas and New Year’s Day. Redman and colleagues proposed that the increases in HF visits to the emergency room during the holiday season were due to dietary indiscretion, delays in seeking medical care, increased stress and anxiety. As heart failure providers it is important to recognize that our patients may be at increased risk during the holiday season. We know our patients may choose not to live within their everyday diet, opting to partake in holiday overindulgences instead. Heavy meals, too much salt, skipping medications and excess alcohol can all exacerbate heart failure. During the holiday season, it is important for providers to reinforce heart failure self-care behaviors. Providers should proactively discuss with patients how to manage their diet, medications, and stress level during the holiday season. For patients, recognition and prompt reporting of worsening symptoms of heart failure is paramount. Providers should plan for increased surveillance with telephone follow-up or outpatient visits for patients at high risk for readmission or with poor self-care. Anxiety and depression loom around the holiday season. For many patients, this time of year only worsens their feelings of isolation, depression and loneliness, and for others the struggle to cope with the pressures associated with the holidays, managing finances, family and all of the associated stressors creates a tremendous feeling of anxiety. 3 Both depression and anxiety are barriers to patients being able to engage in self-care behaviors. 4 In addition to reinforcing self-care behaviors, providers should incorporate screening and clinical management of depression. Despite the stressors and flurry of activity, the holiday season can be a wonderful time of year filled with celebration. For patients with heart failure, some common sense strategies can help make a big difference in keeping a person at home for the holidays, instead of in an emergency room or a hospital bed or worse.

Sleep disordered breathing (SDB) is the most common co-morbidity in patients with heart failure (HF) and has a significant impact on quality of life, morbidity, and mortality. A number of therapeutic options have become available in recent years that can improve quality of life and potentially the outcomes of HF patients with SDB. Unfortunately, SDB is not part of the routine evaluation and management of HF, thus it remains untreated in most HF patients. While recognition of the role of SDB in HF is increasing, clinical guidelines for the management of SDB in HF patients continue to be absent. In this article we provide an overview of SDB in HF and propose a clinical care pathway to help clinicians better recognize and treat SDB in their HF patients.

BACKGROUND Effective self-care is regarded as essential to the management of heart failure (HF). The influence of self-care on HF decompensation, however, is not well understood. Accordingly, we examined the relationship between self-care and fluid accumulation accompanying worsening HF as indexed by decreasing intrathoracic impedance (Z). METHODS Z data were collected from 58 HF patients with OptiVol enabled devices (Medtronic Inc, Minneapolis, Minnesota). Heart failure self-care was measured with the European Heart Failure Self-care Behaviour Scale. Regression modeling was used to describe the influence of HF self-care on the likelihood of a fluid index (FI) threshold crossing, the number of threshold crossings, and number of days spent above threshold. RESULTS Patients were elderly (74.98 [SD, 8.12] years), with a mean left ventricular ejection fraction of 26.21% (SD, 9.77%), and 63.7% had class New York Heart Association III HF. Patients were followed up for 317 (SD, 96) days; 65.5% had FI threshold crossings (mean 1.45 [SD, 1.56] crossings), spending an average of 33.8 (SD, 42.4) days above FI threshold. Controlling for age, sex, left ventricular ejection fraction, functional class, and duration of follow-up, each additional point on the European Heart Failure Self-care Behaviour Scale was associated with an increase in the odds of having had an FI threshold crossing (adjusted odds ratio, 1.201; 95% confidence interval, 1.013-1.424; P

Background Over-the-counter (OTC) drug and herbal therapies (HT) may worsen heart failure or interact with prescription medications. Frequency of and predictors for routine OTC drug and HT use are not well studied. Methods and Results We examined routine use of OTC drug and HT in patients at 8 medical centers. Medical conditions independently associated with use of OTC drugs, HT, or both were assessed using multivariable logistic regression models. Of 374 subjects, OTC drug and HT were routinely used by 349 and 43 patients, respectively. Mean age was 69.6 ± 13.1 years, 63% were male, and 81% were Caucasian. Common OTC drugs were antiplatelets (baby-dose aspirin), vitamins, acetaminophen, antacids, laxatives, and calcium. The most common HT used was echinacea. History of hypercholesterolemia was associated with higher OTC drug use (OR 4.36; 95% CI 1.60–11.87; P = .004); renal failure predicted less use (OR 0.09; 95% CI 0.01–0.59; P = .013). History of hypertension was associated with less HT use (OR 0.47, 95% CI 0.24–0.92; P = .028). Conclusions In HF patients, routine use of OTC drugs was common, but HT use was not. OTC drugs were used more often in patients with hypercholesterolemia and were used for a variety of reasons; thus, routine assessment and individualized education are advocated.

Heart failure (HF) is a complex and costly disease process associated with high morbidity and mortality. Implanted cardiac rhythm management devices are increasingly used in the HF population to provide therapies such as protection from sudden death and cardiac resynchronization therapy. Device-based diagnostic monitoring provides clinicians with information that can assist in identifying patients at risk for HF decompensation and subsequent hospitalization. This article will review the evidence for using diagnostic information from cardiac rhythm management devices in the management of HF patients. Future advanced monitoring devices will also be discussed.

CHRISTOPHER S. LEE, RN, PhD, BARRY H. GREENBERG, MD, ANN S. LARAMEE, APRN, MS, SUSAN E. AMMON, RN, MS, FNP, MARILYN PRASUN, PhD, CCNS-BC, MARIE GALVAO, MSN, ANP-BC, CHFN, LYNN V. DOERING, DNSC, M. EUGENE SHERMAN, MD, LYNNE WARNER STEVENSON, MD, DOUGLAS D. GREGORY, PHD, PAUL A. HEIDENREICH, MD, MS, NAVIN K. KAPUR, MD, JOHN B. O’CONNELL, MD, ANNE L. TAYLOR, MD, JOSEPH A. HILL, MD, PhD, LINDA BAAS, RN, PhD, ACNP, CHFN, ASHLEY GIBBS, RN, MSN, ANP/GNP-BC, CHFN, KISMET RASMUSSON, FNP-BC, CHFN, CONNIE LEWIS, MSN, ACNP-BC, NP-C, CCRN, CHFN, PEGGY KIRKWOOD, RN, MSN, ACNPC, AACC, CHFN, JUANITA REIGLE, RN, MSN, ACNP-BC, CHFN, LISA RATHMAN, MSN, CRNP, CHFN, AND CYNTHIA BITHER, RN, MSN, APN-C, ACNP-C

Inadequate Self-Care Practices in Patients with Implantable Devices: Implications for Remote Monitoring Lisa D. Rathman, Roy S. Small, J. Thomas Heywood, John A. Andriulli, W.H. Wilson Tang; Heart Failure Clinic, The Heart Group/Lancaster Heart and Stroke Foundation, Lancaster, PA; Scripps Clinic Torrey Pines, La Jolla, CA; UMDNJ, Voorhees, NJ; Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH