Do patient-reported outcome measures measure up? A qualitative study to examine perceptions and experiences with heart failure proms among diverse, low-income patients

Background The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a Patient-Reported Outcome Measure (PROM) used to evaluate the health status of patients with heart failure (HF) but has predominantly been tested in settings serving predominately white, male, and economically well-resourced populations. We sought to examine the acceptability of the shorter version of the KCCQ (KCCQ-12) among racially and ethnically diverse patients receiving care in an urban, safety-net setting. Methods We conducted cognitive interviews with a diverse population of patients with heart failure in a safety net system to assess their perceptions of the KCCQ-12. We conducted a thematic analysis of the qualitative data then mapped themes to the Capability, Opportunity, Motivation Model of Behavior framework. Results We interviewed 18 patients with heart failure and found that patients broadly endorsed the concepts of the KCCQ-12 with minor suggestions to improve the instrument’s content and appearance. Although patients accepted the KCCQ-12, we found that the instrument did not adequately measure aspects of health care and quality of life that patients identified as being important components of managing their heart failure. Patient-important factors of heart failure management coalesced into three main themes: social support, health care environment, and mental health. Conclusions Patients from this diverse, low-income, majority non-white population experience unique challenges and circumstances that impact their ability to manage disease. In this study, patients were receptive to the KCCQ-12 as a tool but perceived that it did not adequately capture key health components such as mental health and social relationships that deeply impact their ability to manage HF. Further study on the incorporation of social determinants of health into PROMs could make them more useful tools in evaluating and managing HF in diverse, underserved populations.

Neuromodulation of Inflammation to Treat Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Clinical Trial

Background A systemic proinflammatory state plays a central role in the development of heart failure with preserved ejection fraction. Low‐level transcutaneous vagus nerve stimulation suppresses inflammation in humans. We conducted a sham‐controlled, double‐blind, randomized clinical trial to examine the effect of chronic low‐level transcutaneous vagus nerve stimulation on cardiac function, exercise capacity, and inflammation in patients with heart failure with preserved ejection fraction. Methods and Results Patients with heart failure with preserved ejection fraction and at least 2 additional comorbidities (obesity, diabetes, hypertension, or age ≥65 years) were randomized to either active (tragus) or sham (earlobe) low‐level transcutaneous vagus nerve stimulation (20 Hz, 1 mA below discomfort threshold), for 1 hour daily for 3 months. Echocardiography, 6‐minute walk test, quality of life, and serum cytokines were assessed at baseline and 3 months. Fifty‐two patients (mean age 70.4±9.2 years; 70% female) were included (active, n=26; sham, n=26). Baseline characteristics were balanced between the 2 arms. Adherence to the protocol of daily stimulation was >90% in both arms ( P >0.05). While the early mitral inflow Doppler velocity to the early diastolic mitral annulus velocity ratio did not differ between groups, global longitudinal strain and tumor necrosis factor‐α levels at 3 months were significantly improved in the active compared with the sham arm (−18.6%±2.5% versus −16.0%±2.4%, P =0.002; 8.9±2.8 pg/mL versus 11.3±2.9 pg/mL, P =0.007, respectively). The reduction in tumor necrosis factor‐α levels correlated with global longitudinal strain improvement (r=−0.73, P =0.001). Quality of life was better in the active arm. No device‐related side effects were observed. Conclusions Neuromodulation with low‐level transcutaneous vagus nerve stimulation over 3 months resulted in a significant improvement in global longitudinal strain, inflammatory cytokines, and quality of life in patients with heart failure with preserved ejection fraction. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03327649.

A Combination of Chest Radiography and Estimated Plasma Volume May Predict In-Hospital Mortality in Acute Heart Failure

Background: Patients with heart failure (HF) often display dyspnea associated with pulmonary congestion, along with intravascular congestion, both may result in urgent hospitalization and subsequent death. A combination of radiographic pulmonary congestion and plasma volume might screen patients with a high risk of in-hospital mortality in the emergency department (ED).Methods: In the pathway of dyspneic patients in emergency (PARADISE) cohort, patients admitted for acute HF were stratified into 4 groups based on high or low congestion score index (CSI, ranging from 0 to 3, high value indicating severe congestion) and estimated plasma volume status (ePVS) calculated from hemoglobin/hematocrit.Results: In a total of 252 patients (mean age, 81.9 years; male, 46.8%), CSI and ePVS were not correlated (Spearman rho <0 .10, p > 0.10). High CSI/high ePVS was associated with poorer renal function, but clinical congestion markers (i.e., natriuretic peptide) were comparable across CSI/ePVS categories. High CSI/high ePVS was associated with a four-fold higher risk of in-hospital mortality (adjusted-OR, 95%CI = 4.20, 1.10-19.67) compared with low CSI/low ePVS, whereas neither high CSI nor ePVS alone was associated with poor prognosis (all-p-value > 0.10; Pinteraction = 0.03). High CSI/high ePVS improved a routine risk model (i.e., natriuretic peptide and lactate)(NRI = 46.9%, p = 0.02), resulting in high prediction of risk of in-hospital mortality (AUC = 0.85, 0.82-0.89).Conclusion: In patients hospitalized for acute HF with relatively old age and comorbidity burdens, a combination of CSI and ePVS was associated with a risk of in-hospital death, and improved prognostic performance on top of a conventional risk model.