The Heart Failure Patient Foundation Position Statement on Research and Patient Involvement.

BACKGROUND: Heart Failure (HF) is a growing global public health problem affecting approximately 64 million people worldwide. OBJECTIVES: The Heart Failure Patient Foundation developed a position statement to advocate for adult patients with HF to be an active participant in research and for HF leaders to integrate patients throughout the research process. METHODS: A review of the literature and best practices was conducted. Based on the evidence, the HF Patient Foundation made recommendations regarding the inclusion of adult patients with HF throughout the research process. RESULTS: Healthcare clinicians, researchers and funding agencies have a role to ensure rigorous quality research is performed and implemented into practice. Inclusion of adult patients with HF throughout the research process can improve the lives of patients and families while advancing HF science. CONCLUSIONS: The HF Patient Foundation strongly advocates that patients with HF be involved in research from inception of the project through dissemination of findings to improve patient outcomes.

Remote Monitoring for Heart Failure Management at Home.

Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs. A signal that is accurate and actionable with response kinetics for early re-assessment is required for the treatment of patients at high risk, while signal specifications differ for surveillance of low-risk patients. Tracking of congestion with cardiac filling pressures or lung water content has shown most impact to decrease hospitalizations, while multiparameter scores from implanted rhythm devices have identified patients at increased risk. Algorithms require better personalization of signal thresholds and interventions. The COVID-19 epidemic accelerated transition to remote care away from clinics, preparing for new digital health care platforms to accommodate multiple technologies and empower patients. Addressing inequities will require bridging the digital divide and the deep gap in access to HF care teams, who will not be replaced by technology but by care teams who can embrace it.

Sustained Reduction in Pulmonary Artery Pressures and Hospitalizations During 2 Years of Ambulatory Monitoring.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Providers' accuracy in decision-making with assessing NYHA functional class of patients with heart failure after use of a classification guide.

BACKGROUND: Correct assignment of New York Heart Association Functional Classification (NYHA-FC) I-IV is essential in applying guideline directed care. OBJECTIVE: Examine the validity, reliability, and accuracy of HF and primary care (PC) provider's assignment of NYHA-FC using the NYHA-FC Guide. METHODS: Study utilized a cross-sectional, quasi-experimental known-groups design with validated vignettes. Providers (n = 75) used the Guide to assign NYHA-FC. Known-group validity comparisons (HF specialist/Non-HF specialist - PC provider) and interrater reliability were used to evaluate validity and reliability of the NYHA-FC Guide. RESULTS: HF provider's accuracy total mean scores were significantly higher compared to PC (M = 6.0 vs. 5.4, p = 0.020). HF (62%) and PC providers (80%) reported that the Guide assisted them with deciding HF class. CONCLUSION: The NYHA-FC Guide showed promise for facilitating accuracy of assignment. Further research to evaluate the accuracy of using the NYHA-FC Guide compared to the gold standard six minute walk test is warranted.

Providers' assignment of NYHA functional class in patients with heart failure: A vignette study.

BACKGROUND: Accuracy of New York Heart Association Functional Classification (NYHA-FC) I-IV assessment is critical to promoting guideline directed care. OBJECTIVE: Examine providers' accuracy when diagnosing NYHA-FC I-IV in patients with heart failure (HF). METHODS: A web-based survey using validated vignettes was conducted with 244 physicians, nurse practitioners (NP), clinical nurse specialists (CNS) and physician assistants (PA) who provide care to patients with HF. RESULTS: Providers comprised of 65% NPs, 19% physicians, 14% CNSs, 2% PAs with an average of 15 years working with HF patients. Accuracy ranged from 36.9% for Class IV to 78.7% for Class I. Increased HF patient volume seen (p=0.024), physician vs. NP/PA/CNS (p=0.021), and typically assigned a HF stage (p<0.001) were associated with increased total correct score accuracy in multivariable modeling. CONCLUSION: It is critical that NYHA-FC is accurately assigned to promote optimal outcomes. Research in the future should focus on improving accuracy in assigning NYHA-FC.

Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study.

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<0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events/patient-years, hazard ratio 0.73 [95% CI, 0.68-0.78], P<0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. 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.

The role of health literacy, depression, disease knowledge, and self-efficacy in self-care among adults with heart failure: An updated model.

BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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, p<0.0005), 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. CONCLUSIONS: 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.

Reasons for Guideline Nonadherence at Heart Failure Discharge.

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<0.001) were discharged without ß-blocker therapy or with lower doses than at admission. Moreover, 46% of patients with HF with reduced ejection fraction (48% academic versus 39% community, 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.

A mixed methods study of symptom perception in patients with chronic heart failure.

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.

Stratifying patients at the risk of heart failure hospitalization using existing device diagnostic thresholds.

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.

Sleep-disordered breathing in heart failure: identifying and treating an important but often unrecognized comorbidity in heart failure patients.

Sleep-disordered breathing (SDB) is the most common comorbidity 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, so it remains untreated in most HF patients. Although recognition of the role of SDB in HF is increasing, clinical guidelines for the management of SDB in HF patients continue to be absent. This article provides an overview of SDB in HF and proposes a clinical care pathway to help clinicians to better recognize and treat SDB in their HF patients.

A critical link between heart failure self-care and intrathoracic impedance.

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<.05) and more days spent above FI threshold (incidence rate ratio, 1.051; 95% confidence interval, 1.002-1.102; P<.05). CONCLUSION: Intrathoracic impedance measurements obtained from implantable devices provide important information regarding the influence of self-care on fluid accumulation in patients with HF.

Predictors of over-the-counter drug and herbal therapies use in elderly patients with heart failure.

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.