Kansas City Cardiomyopathy Questionnaire Summary Scores Research Articles

Accelerometer-measured physical activity in patients with heart failure and reduced ejection fraction: Determinants and relationship with patient-reported health status

Background: Accelerometer-measured physical activity is an increasingly used endpoint in heart failure (HF) trials. We investigated the determinants of accelerometer-measured physical activity and the relationship with patient-reported health status. Methods: Post-hoc analysis of the Empire HF trial, including outpatients with HF with reduced ejection fraction (HFrEF). Physical activity was quantified as average accelerometer counts per minute (CPM) with higher values representing higher activity. We investigated associations between activity level and clinical variables, including age, sex, and body mass index, as well as patient-reported health status assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: Complete data were available in 180 (95%) patients (86% male, mean age 65 year). Baseline median physical activity level was 1318 CPM (Q1-Q3 1111–1585). Age and anemia were independently associated with activity level (β-coefficients: -10 CPM per year age increase [95% CI -16 to -5.1], p=0.00015, and -126 CPM for anemia [95% CI -9.1 to -244], p=0.035). Significant independent associations were observed between activity level and all KCCQ summary scores (β-coefficient point estimates of 3.7, 4.6, and 4.9 CPM, all p<0.02). For 12-week changes in KCCQ-summary scores, only the KCCQ-CSS was associated with activity level; mean increase of 17.5 CPM [95% CI 1.5 to 34.0], p=0.032, per 5-point increase in KCCQ-CSS. Associations were not modified by treatment allocation (interaction p-values>0.05). Conclusions: In patients with HFrEF, older age and anemia were independently associated with lower activity. Moreover, physical activity only weakly increased with better health status, suggesting that changes in physical activity reflect improvements in patients’ health status to a limited degree. This highlights the need to better understand the endpoint with regards to all other health parameters to ease interpretation in future HF trials.

Platelet and Leukocyte Mitochondrial Function With Cardiac Function and Self-Reported Health Status Among Obese Patients With Heart Failure.

Mitochondrial dysfunction plays a key role in the development of heart failure (HF), including HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). Impaired mitochondrial function negatively affects cardiac function and, subsequently, the health status of patients. However, measuring mitochondrial function in human myocytes is difficult because of the high risk associated with myocardial biopsy. Platelets and leukocytes have functional mitochondria and can potentially serve as a surrogate for myocardial mitochondria. Roles of platelet and leukocyte mitochondrial function in HF have not yet been fully explored. We aimed to explore the relationships of platelet and leukocyte mitochondrial function with cardiac function and self-reported health status among obese patients with HF and examine if the relationships vary between HFrEF and HFpEF. Forty-five obese patients with HF were recruited. Maximal enzymatic activities (Vmax) of platelet cytochrome c oxidase (COX) and citrate synthase (CS) were assessed. Leukocyte mitochondrial mass, membrane potential, superoxide production, and apoptosis were measured in a subset of the sample. Data on cardiac function were retrieved from electronic health records. Self-reported health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Pearson correlations were performed. Platelet COX Vmax was negatively correlated with left ventricular end-systolic diameter. Positive correlations of leukocyte mitochondrial mass and superoxide production with left ventricular mass and mass index were observed, respectively. Leukocyte mitochondrial mass and superoxide production also negatively correlated with KCCQ summary scores. These relationships varied between HFrEF and HFpEF. Platelet and leukocyte mitochondrial function was found to significantly correlate with some echocardiographic parameters and KCCQ scores. These findings provided preliminary data to support future research to further explore the potential of using platelets and leukocytes as surrogate biomarkers. Identifying easy-accessible mitochondrial biomarkers will be useful for assessing mitochondrial function to assist with early diagnosis and monitoring the effectiveness of mitochondrial-targeted therapy in HF patients.

Relationship between change in Kansas City Cardiomyopathy Questionnaire scores and outcomes in patients with HFrEF

Abstract Background Although a 5-point change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores is widely recognized as representing a clinically meaningful change in symptoms and quality of life, it is not known how changes KCCQ scores relate to risk of hospitalization and death. Purpose To evaluate how changes in KCCQ summary scores relate to subsequent risk of hospitalization and death in a large cohort of patients with heart failure and reduced ejection fraction (HFrEF). Methods We used individual patient data from 3 HFrEF trials (ATMOSPHERE, PARADIGM-HF, and DAPA-HF) to examine the association between changes in KCCQ summary scores between baseline and 8-months and the subsequent risk of cardiovascular death or HF hospitalization, using Cox-proportional hazard models. Change in score was categorized as very small (&amp;gt;0 &amp;lt;5), small (&amp;gt; = 5 &amp;lt;10), moderate (&amp;gt; = 10 &amp;lt;20), and large (&amp;gt; = 20) points. We examined the KCCQ total symptom score (KCCQ-TSS), KCCQ clinical summary score (KCCQ-CSS), and KCCQ overall summary score (KCCQ-OSS). Results Among 15,892 participants with HFrEF, 1403 patients (8.8%) had a large deterioration in KCCQ score, 1688 (10.6%) a moderate deterioration, 1442 (9.1%) a small deterioration, 1527 (9.6%) a very small deterioration, and 2326 (14.6%) no deterioration. Conversely, 1836 patients (11.6%) had a very small improvement, 1732 (10.9%) a small improvement, 2202 (13.9%) a moderate improvement, and 1736 (10.9%) a large improvement. Patients with larger changes in KCCQ scores were older and more often female and had lower baseline summary scores and worse heart failure characteristics. Worsening heath status i.e., decrease in the KCCQ-TSS, was associated with a higher risk of the composite outcome (and each of its components), as well as all-cause mortality (Figure 1). On the contrary, improvements in KCCQ-TSS were not associated with better clinical outcomes (Figure 1). The findings were similar for 4-month changes of KCCQ-TSS, and changes in other KCCQ scores (KCCQ-CSS and KCCQ-OSS) at both 4 and 8-months. Conclusion Decreases (deterioration) in KCCQ summary scores during follow-up were associated with worse outcomes in patients with HFrEF but no association was seen between improvement in KCCQ scores and outcomes. These findings have potential implications for the interpretation of the effect of treatment on KCCQ scores.

Patient reported outcomes in obstructive hypertrophic cardiomyopathy undergoing myectomy: Results from SPIRIT-HCM study

BackgroundPatient reported outcomes (PRO) can assess quality of life (QOL) in obstructive hypertrophic cardiomyopathy (oHCM). In symptomatic oHCM patients, we sought to study the correlation between various PROs, their association with physician reported New York Heart Association (NYHA) class and changes after surgical myectomy. MethodsWe prospectively studied 173 symptomatic oHCM patients undergoing myectomy (age 51 years, 62% men) between 3/17–6/20. PROs, including a) Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score b) Patient-Reported Outcomes Measurement Information System [PROMIS] c) Duke Activity Status Index [DASI] & d) European QOL score [EQ-5D], along with NYHA class, 6-min walk test (6MWT) distance and peak left ventricular outflow tract gradient (PLVOTG) were recorded at baseline and 12 month follow-up. ResultsThe median baseline PRO scores (KCCQ summary, PROMIS physical, PROMIS mental, DASI, EQ-5D) were 50, 67, 63, 25, 50, 37, 44, 25 and 0.61, respectively; 6MWT distance was 366 m. There were significant correlations between various PROs (r-values between 0.66 and 0.92, p < 0.001), but only modest correlations with 6MWT and provokable LVOTG (r-values between 0.2 and 0.5, p < 0.01). At baseline, 35–49% patients in NYHA class II had PROs worse than median, while 30–39% patients in NYHA Class III/IV had PROs better than median. At follow-up, a 20 point improvement in KCCQ summary score was observed in 80%, 4 point improvement in DASI score in 83%, 4 point improvement in PROMIS physical score 86% and a 0.04 point improvement in EQ-5D in 85%); along with improvements in NYHA class (67% in Class I) and peak LVOTG (median 13 mmHg) and 6MWT (median distance 438 m). ConclusionsIn a prospective study of symptomatic oHCM patients, surgical myectomy significantly improved PROs, LVOT obstruction, and functional capacity, with a high correlation between various PROs. However, there was high rate of discordance between PROs and NYHA class. Study registrationClinicalTrials.gov: NCT03092843.

Abstract P175: Shared Medical Appointments in Heart Failure for Post-Hospitalization Follow-Up

Introduction: Shared medical appointments (SMAs) are medical visits where several patients with a common disease have clinic at the same time with medical provider(s). SMAs in heart failure (HF) is a unique opportunity where providers of different disciplines, one of which is a prescriber with HF expertise, can improve the health of patients recently discharged with HF. Hypothesis: Compared with usual care, patients discharged with HF randomized to a HF-SMA will experience better cardiac health status as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and overall health status as measured by the EQ-5D Visual Analog Scale (EQ5D-VAS) Methods: We conducted a 3-site open label randomized-controlled trial of parallel design. Participants within 12 weeks of a HF hospitalization were randomized to receive either HF-SMA versus usual care. The HF-SMA team consisted of a nurse, nutritionist, psychologist, nurse practitioner and/or a clinical pharmacist and included four 2 hour sessions that met every other week for 8 weeks. Primary outcomes are overall health status measured by EQ5D-VAS (range 0-100 with 0 = worst health and 100 = Best health) and cardiac health status by KCCQ (range 0-100, higher score is better cardiac health), after 180 days post randomization. Results: Of the 242 patients enrolled (mean age 69.3±9.4 years, 71.5% white, 94.6% male), 83.8% HF-SMA and 84.8% usual care participants completed the study. Although both groups had significant improvements from baseline in their overall health status, patients in the HF-SMA intervention experienced a greater improvement in EQ5D-VAS scores than usual care (change = 7.2 ± 15.8 versus -0.4 ± 19.0 points, p&lt;0.001, respectively). There were no significant differences between the groups in the cardiac health status KCCQ Summary or Clinical Scores. Conclusion: HF-SMA achieved higher Improvements in overall health status than usual care but not in cardiac health status. Future studies should power to compare data on event outcomes to better understand impact.

Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department.

We conducted a secondary analysis of changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 over 30 days in a randomized trial of self-care coaching versus structured usual care in patients with acute heart failure who were discharged from the emergency department. Patients in 15 emergency departments completed the KCCQ-12 at emergency department discharge and at 30 days. We compared change in KCCQ-12 scores between the intervention and usual care arms, adjusted for enrollment KCCQ-12 and demographic characteristics. We used linear regression to describe changes in KCCQ-12 summary scores and logistic regression to characterize clinically meaningful KCCQ-12 subdomain changes at 30 days. There were 350 patients with both enrollment and 30-day KCCQ summary scores available; 166 allocated to usual care and 184 to the intervention arm. Median age was 64 years (interquartile range, 55-70), 37% were female participants, 63% were Black, median KCCQ-12 summary score at enrollment was 47 (interquartile range, 33-64). Self-care coaching resulted in significantly greater improvement in health status compared with structured usual care (5.4-point greater improvement, 95% CI, 1.12-9.68; P=0.01). Improvements in health status in the intervention arm were driven by improvements within the symptom frequency (adjusted odds ratio, 1.62 [95% CI, 1.01-2.59]) and quality of life (adjusted odds ratio, 2.39 [95% CI, 1.46-3.90]) subdomains. In this secondary analysis, patients with acute heart failure who received a tailored, self-care intervention after emergency department discharge had clinically significant improvements in health status at 30 days compared with structured usual care largely due to improvements within the symptom frequency and quality of life subdomains of the KCCQ-12. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02519283.

Abstract 15379: A Novel Acoustic Biomarker of Quality of Life in Left Ventricular Assist Device Recipients

Introduction: Left ventricular assist device (LVAD) recipients experience variable improvements in quality of life (QoL). Methods for optimizing LVAD support to improve QoL are needed. Hypothesis: We hypothesized that acoustic signatures obtained from digital stethoscopes can predict patient-centered outcomes in LVAD recipients. Methods: Subjects were recruited from the LVAD clinic at Duke University Medical Center. Subjects were trained to use a digital stethoscope and recorded their precordial sounds weekly for 6 months. Subjects also completed a Kansas City Cardiomyopathy Questionnaire (KCCQ) weekly. The primary outcome for this study was QoL, as measured by the KCCQ summary score. Results: Twenty-four subjects, 8 supported by a HeartWare LVAD and 16 supported by a HeartMate3 (HM3) LVAD, were enrolled. We developed a novel algorithm to filter LVAD sounds from recordings. Unsupervised clustering of LVAD-mitigated sounds revealed discrete groups of acoustic features. Six out of 16 [38%] HM3 recipients made up a unique cluster and shared a common acoustic feature that we have termed the pulse synchronized sound (PSS) based on its temporal association to the artificial pulse of the HM3. Subjects with the PSS had significantly better KCCQ scores at baseline (median, 89.1 [IQR, 86.2-90.4] vs 66.1 [IQR, 31.1-73.7], P = 0.03) and over the 6 months of the study (mean = 79.67 [95% CI, 74.55 - 84.78] vs 60.57 [95% CI, 55.58 - 65.55], P &lt; .001). Mechanistically, the PSS shares acoustic features with patient-derived intrinsic sounds. Because the PSS cannot be detected by routine auscultation, we developed a robust machine learning algorithm to detect the PSS in precordial sound recordings (AUC = 0.95 by leave-one-subject out cross-validation). Conclusions: We have identified a novel acoustic feature associated with better QoL in HM3 recipients. This novel biomarker is the first of its kind in LVAD recipients and may provide a method for assaying optimized LVAD support.

Quality of life and treatment preference for ventricular assist device therapy in ambulatory advanced heart failure: A report from the REVIVAL study

The Registry Evaluation of Vital Information for Ventricular Assist Devices (VADs) in Ambulatory Life study is a prospective multicenter cohort of 400 ambulatory patients with advanced chronic systolic heart failure (HF). The aim of the study is to better understand disease trajectory and optimal timing of advanced HF therapies. We examined patient health-related quality of life (HRQOL) data collected at enrollment and their association with patient treatment preferences for VAD placement. Baseline assessment of HRQOL included the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol EQ-5D-3L Visual Analogue Scale (VAS), along with patient self-assessment of remaining life (PSARL). Descriptive statistics were used to present baseline HRQOL data and Spearman correlation tests to assess the association between KCCQ, VAS, and VAD treatment preference with patient clinical characteristics of interest. The median age was 60 years, 75% were male, and the median left ventricular ejection fraction was 20%. The median (25th percentile, 75th percentile), baseline KCCQ summary score was 64 (48, 78), VAS score 65 (50, 75), and PSARL 7 years (5, 10). There were statistically significant associations of baseline KCCQ and VAS with New York Heart Association class and Interagency Registry of Mechanically Assisted Circulatory Support profile (p < 0.005 for all comparisons). Baseline KCCQ and VAS revealed a modest association with PSARL (correlation = 0.45 and 0.35, respectively; p < 0.001), and many patients were overly optimistic about their expected survival. VAD treatment preference was associated with KCCQ scores (p < 0.031), but the absolute differences were small. VAD treatment preference was independent of other key clinical characteristics such as subject age, VAS, and PSARL. We found a lack of strong association between HRQOL and patient preference for VAD therapy. Better understanding of patients' perceptions of their illness and how this relates to HRQOL outcomes, clinician risk assessment, and patient decision-making is needed. This may in turn allow better guidance toward available HF therapies in this vulnerable population.

SUPPORTIVE CARE IN HEART FAILURE: ESTABLISHING A NEW INTEGRATIVE CARE INITIATIVE

Supportive care (SC) is an under-utilized resource for heart failure (HF) patients. Given the symptom burden experienced by HF patients, they would greatly benefit from SC. However, there is a big gap between demand and services when it comes to SC for HF patients. The most challenging barrier to integrating SC in HF patient care is patient screening. Various screening tools were evaluated for their predictive value, and a summary score < 29 on the Kansas City Cardiomyopathy Questionnaire (KCCQ) was the strongest predictor of subsequent SC need. HF patients with SC needs were identified using a KCCQ summary score < 29 as the cut-off. Patient demographic and baseline clinical characteristics including medical history, discharge medication, laboratory results and echocardiography parameters were compared between patients with and without SC needs. Patients with SC needs were referred to and followed up at our SC clinic (SCC). Outcomes in terms of home care access, goals of care (GOC) changes, implantable cardioverter defibrillator (ICD) deactivation and hospitalization at end-of-life were measured for those referred to SC services. SC needs was identified in 41 patients (9%), among 456 who completed the KCCQ. Demographics were similar between the two groups of patients, except patients with SC needs have significantly higher BMIs and have more severe NYHA classes. Mineralocorticoid receptor antagonists (MRAs) were used more frequently in patients without SC needs. Of those with SC needs, 22 were referred to SC services: 2 passed away before being seen, 1 refused SC and 19 were seen at the SCC. Of these 19, 10 passed away and 9 are currently followed. All patients were referred to home care, and 53% changed their GOC to care focused on symptom control and comfort. One patient had their ICD deactivated. The median number of emergency department visit/hospitalization post-SC consultation is 1 (IQR: 0-2). Median survival after SC initiation is 3 months, with patients spending less than a month to 11 months before passing away. Of the 10 patients that passed away, 2 passed away at the emergency department, 1 at the internal medicine unit, 4 at home and 3 at hospital palliative care units. There is clearly an unmet need for SC among HF patients. A KCCQ summary score < 29 is useful for identifying patients with SC needs in routine clinical practice. Incorporating SC into cardiac care for HF patients is essential to improve their quality of life.

Abstract 16800: Sarcopenia in Advanced Systolic Heart Failure Patients Receiving Left Ventricular Assist Devices

Introduction: Sarcopenia is the age-related deterioration in skeletal muscle mass and function, which can be accelerated by chronic comorbidities. The prevalence in advanced systolic heart failure (HF) and impact on HF health status are currently uncertain. Sarcopenia diagnostic criteria from the Foundation for the National Institutes of Health (FNIH) and European Working Group on Sarcopenia in Older People (EWGSOP) have not been applied to HF cohorts. Hypothesis: We hypothesized that at the time of left ventricular assist device (LVAD) implantation systolic HF patients have prevalent sarcopenia, and that sarcopenia is associated with poorer nutritional and HF health status. Methods: We recruited 18 adults with systolic HF ±21 days from LVAD implantation. All underwent whole-body dual X-ray absorptiometry (DXA) to calculate appendicular lean mass (ALM). Subjects also underwent a 3-day food recall, Simplified Nutritional Appetite Questionnaire (SNAQ), Kansas City Cardiomyopathy Questionnaire (KCCQ) for HF health status, handgrip strength and blood testing. Sarcopenia was defined by 2 ALM criteria: FNIH – males &lt;19.75kg, females &lt;15.02kg; EWGSOP – males &lt;7.26kg/m 2 , females &lt;5.5kg/m 2 . Linear regression determined relationships between appendicular lean mass and age, weight, handgrip strength, KCCQ summary score, SNAQ score, 24-hour protein intake, and key blood variables, without/with adjustment for sex and height. Results: Sarcopenia was diagnosed in 5 subjects (28%) by FNIH criteria and an additional 5 (10 total, 56%) by EWGSOP criteria (Figure). There were unadjusted associations between lower appendicular lean mass and lower handgrip strength; higher SNAQ score (higher malnutrition risk); lower sodium; and lower hemoglobin. After adjustment for sex and height, lower lean mass remained associated with lower hemoglobin. Lower appendicular lean mass was also independently associated with higher (more favorable) KCCQ scores. Conclusions: As many as half of advanced systolic HF patients meet standard DXA criteria for sarcopenia. Lower appendicular lean mass is independently associated with lower hemoglobin but does not appear to be associated with poorer HF status.

Exercise-based cardiac rehabilitation for people with implantable ventricular assist devices.

Heart failure is the end stage of heart disease, and the prevalence and incidence of the condition is rapidly increasing. Although heart transplantation is one type of surgical treatment for people with end-stage heart failure, donor availability is limited. Implantable ventricular assist devices (VADs) therefore offer an alternative treatment to heart transplantation. Although two studies reported the beneficial effects of exercise-based cardiac rehabilitation (CR) on functional capacity and quality of life (QOL) by performing systematic reviews and meta-analyses, both systematic reviews included studies with limited design (e.g. non-randomised, retrospective studies) or participants with implantable or extracorporeal VADs. To determine the benefits and harms of exercise-based CR for people with implantable VADs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, PsycINFO, Conference Proceedings Citation Index-Science (CPCI-S) on Web of Science, CINAHL, and LILACS on 3 October 2017 with no limitations on date, language, or publication status. We also searched two clinical trials registers on 10 August 2017 and checked the reference lists of primary studies and review articles. Randomised controlled trials (RCTs) regardless of cluster or individual randomisation, and full-text studies, those published as abstract only, and unpublished data were eligible. However, only individually RCTs and full-text publications were included. Two review authors independently extracted outcome data from the included studies. We double-checked that data were entered correctly by comparing the data presented in the systematic review with the study reports. We had no dichotomous data to analyse and used mean difference or standardised mean difference with 95% confidence intervals (CIs) for continuous data. Furthermore, we assessed the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes, using GRADEpro software. We included two studies with a total of 40 participants in the review. Exercise-based CR consisted of aerobic or resistance training or both three times per week for six to eight weeks. Exercise intensity was 50% of oxygen consumption (VO2) reserve, or ranged from 60% to 80% of heart rate reserve. Two serious adverse events were observed in one trial, in which participants did not complete the study due to infections. Furthermore, a total of four participants in each group required visits to the emergency department, although these participants did complete the study. Summary scores from the 36-item Short Form Health Survey (SF-36) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) were measured as quality of life. One trial reported that the KCCQ summary score improved by 14.4 points in the exercise group compared with 0.5 points in the usual care group. The other trial reported that the SF-36 total score improved by 29.2 points in the exercise group compared with 16.3 points in the usual care group. A large difference in quality of life was observed between groups at the end of follow-up (standardised mean difference 0.88, 95% CI -0.12 to 1.88; 37 participants; 2 studies; very low-quality of evidence). However, there was no evidence for the effectiveness of exercise-based CR due to the young age of the participants, high risk of performance bias, very small sample size, and wide confidence intervals, which resulted in very low-quality evidence. Furthermore, we were not able to determine the effect of exercise-based CR on mortality, rehospitalisation, heart transplantation, and cost, as these outcomes were not reported. The evidence is currently inadequate to assess the safety and efficacy of exercise-based CR for people with implantable VADs compared with usual care. The amount of RCT evidence was very limited and of very low quality. In addition, the training duration was very short term, that is from six to eight weeks. Further high-quality and well-reported RCTs of exercise-based CR for people with implantable VADs are needed. Such trials need to collect data on events (mortality and rehospitalisation), patient-related outcomes (including quality of life), and cost-effectiveness.

Impact of a Comprehensive Heart Failure Self Care Review

Introduction Heart failure (HF) is one of the common reasons for hospital admissions in patients 65 years and older. Despite recent advances, patients are still frequently hospitalized with efforts to reduce readmissions. The 2013 ACCF/AHA guidelines list HF education, including self-care, as a class I recommendation. The purpose of this study is to assess self-care education in a HF clinic. Methods Since July 2015, 57 patients new to Advanced Integrated Medical and Surgical (AIMS) HF program were enrolled. After informed consent and baseline data collection including the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Morisky Medication Adherence Score (MMAS-4), New York Heart Association (NYHA) functional classification, and medication knowledge score, patients underwent self-care education using a standardized self-care education tool developed by the PI. The education was customized based on health literacy as assessed by the Rapid Assessment of Adult Literacy in Medicine (REALM) score. Patients were contacted at 6 and 12-months for re-assessment of outcomes. Changes in numerical values were compared pre- and post-intervention using paired student's t tests and changes in categorical variables were compared using Wilcoxon Signed Ranks test. Results Twelve-month analysis was completed in 50 patients. Of these, 100% were Caucasian and 74% (37) were male, with a mean age of 66.7 ± 10.6 years. Mean baseline ejection fraction (EF) was 29.2% ± 13.3% and ranged from 15-60%. Most patients (74%, n = 37) were NYHA class III at baseline. NYHA functional class significantly improved from baseline: I-2 (4%), II-10 (20%), III-37 (74%), IV-1 (2%) to 12 months post-intervention: I-11 (23%), II-10 (21%), III-25 (53%), IV-1 (2%), p = 0.003. The following KCCQ parameters also significantly improved: symptom burden score pre-72.8 ± 25.1 vs post-82.4 ± 22.9, p = 0.02, total symptom score pre-73.0 ± 23.2 vs post-81.1 ± 21.4, p = 0.03, self-efficacy pre-80.9 ± 20.1 vs post-92.9 ± 10.9, p Conclusion A customized self-care HF review using a standardized tool was associated with significant improvements in NYHA class and improvements in patients’ perceptions of symptom burden, self-efficacy, QOL, social limitation, and overall KCCQ summary scores at 12-months post intervention. Medication adherence and knowledge also improved. Larger, longitudinal studies are further warranted to assess the durability of results and to determine if these improvements translate into other improved clinical outcomes.

292 - Impact of a Comprehensive Heart Failure Self-Care Review 12-Month Assessment

Purpose: Heart failure (HF) is one of the most common reasons for hospital admissions in patients ≥65 years. Despite recent advances, patients are still frequently hospitalized with efforts to reduce readmissions. The 2013 ACCF/AHA guidelines list HF education, including self-care, as a class I recommendation. The purpose of this study is to assess a self-care education program in a HF clinic. Methods: Since July 2015, 49 patients new to the Advanced Integrated Medical and Surgical (AIMS) program for HF were enrolled in the study. After informed consent and baseline data collection including the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Morisky Medication Adherence Score (MMAS-4), and medication knowledge score, patients underwent self-care education with the Principal Investigator (PI) using a standardized self-care education tool developed by the PI. The education was customized based on health literacy as assessed by the Rapid Assessment of Adult Literacy in Medicine (REALM) score. Patients were contacted at 6 and 12-months for re-assessment of clinical outcomes. Changes in numerical values were compared pre- and post-intervention using paired student's t tests and changes in categorical variables were compared using Wilcoxon Signed Ranks test. Results: Twelve-month interim analysis was completed in 25 patients. Of these, 100% were Caucasian and 64% (16) were male, with a mean age of 70.6 ± 8.1 years. Mean baseline ejection fraction (EF) was 34.5%±12.5% and ranged from 15–60%. Most patients (80%, n = 20) were New York Heart Association (NYHA) class III at baseline. The following KCCQ parameters significantly improved at 12-months: symptom burden score pre-65.0 ± 25.7 vs post-77.1 ± 26.1, P = .03, total symptom score pre-66.2 ± 24.8 vs post-76.5 ± 22.6, P = .046, self-efficacy pre-78.1 ± 19.2 vs post-90.4 ± 12.3, P = .002; quality of life (QOL) pre-56.4 ± 24.5 vs post-70.3 ± 19.9, P = .003; social limitation pre-59.2 ± 34.1 vs post-80.8 ± 20.2, P < .001; overall summary score pre-62.5 ± 24.1 vs post-76.1 ± 20.0, P < .001; and clinical summary score pre-67.3 ± 23.6 vs post-76.8 ± 22.6, P = .03. Patients also experienced improvements in their MMAS-4 score; pre-0.48 ± 0.6 vs post 0.05 ± 0.2, P = .002. Percentage score on knowledge assessment also increased from 75 + 2 to 95 + 8, P < .001. Conclusion: A customized self-care HF review using a standardized tool was effective in improving patients' perceptions of symptom burden, self-efficacy, QOL, social limitation, overall and clinical KCCQ summary scores at 12-months post intervention. Medication adherence and knowledge also improved. Larger, longitudinal studies are further warranted to determine if these improvements translate into improved clinical outcomes.

Abstract 208: Impact of Symptoms and Degree of Valvular Regurgitation on Patient-perceived Health Status in Patients With Aortic Regurgitation

Background: Patients (pts) with severe aortic regurgitation (AI) often present with symptoms of shortness of breath (SOB) or heart failure (HF); however, the effect of these symptoms and severity of aortic regurgitation on patient-perceived health status is unknown. Methods: Kansas City Cardiomyopathy Questionnaire (KCCQ) data were collected using tablet computers from pts presenting for routine outpatient cardiovascular assessment between 6/1/2011 and 8/31/2012 who also underwent echocardiography within 90 days. Pts with other valvular lesions (including aortic stenosis) moderate or greater in severity, congenital heart disease, hypertrophic cardiomyopathy, pericarditis or constriction, cardiac amyloid, sarcoid, restrictive cardiomyopathy, or pulmonary hypertension were excluded. Demographic, clinical, historical, and echocardiographic data was collected as per routine. Multiple linear regression was used to assess the association of this information and valve lesion severity with KCCQ summary score (SS). Results: 590 pts [age 61.9±13.8 years, 363 (61.5%) men, 132 (22%) with prior aortic valve surgery] were identified; 452 with mild, 86 with moderate and 52 with severe AI. Mean KCCQ SS was 74.5±23.7; 74.3±23.0 with mild AI, 73.8±26.2 with moderate AI, and 76.7±19.4 with severe AI (p=NS). SOB was present in 290 pts (49%, KCCQ SS 65.3±23.7), HF in 43 (7.3%, KCCQ SS 50.1±22.3) and both in 36 pts (KCCQ SS 47.0±21.7). After adjusting for multiple factors, linear regression (r2=0.28, p&lt;0.001) revealed that the presence of SOB (β: -13.841, p&lt;0.001) and heart failure (β:-19.484, p&lt;0.001) were associated with lower SS; however, the degree of AI and history of aortic valve surgery were not associated with KCCQ SS. Male sex (β: 7.279, p=0.001), heart rate (β: -0.223, p=0.005), prior CAD (β: -4.364, p=0.038) and BMI (β:-0.357, p=0.035) were also significant in this model. Pt age, presence of atrial fibrillation, angina, hypertension, diabetes, prior CAD, renal disease, cancer, cerebrovascular disease, peripheral vascular disease, left ventricular diastolic dimension and ejection fraction were not significant predictors. Conclusions: In stable outpatients with AI, KCCQ scores correlate with the presence of shortness of breath and heart failure symptoms, but are not affected by the degree of AI or history of aortic valve surgery. Symptoms rather than diagnosis drives patient perceived health status.

The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy: Initial first in man clinical results

BackgroundA tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and resultsEleven male patients (aged 44 to 74years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of <40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24months.A total of 9 (81.8%) patients completed 24months of follow-up. Two patients withdrew consent after day 8 and at the 3month visit. Operative mortality was 0% (n=10 with 30day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (±7.3) % at screening to a mean LVEF of 34.8 (±18.6) % 24months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. ConclusionsAdministration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.

Racial Differences in Heart Failure Outcomes: Evidence From the Tele-HF Trial (Telemonitoring to Improve Heart Failure Outcomes)

ObjectivesThe purpose of this study was to determine whether there are racial differences in patient-reported health status as well as mortality and rehospitalization after hospitalization for heart failure (HF). BackgroundLittle is known about whether racial differences exist in patient-reported outcomes after HF hospitalization. MethodsWe analyzed data from 1,427 patients (636 non-Hispanic African Americans [45%]; 791 non-Hispanic whites [55%]) enrolled in the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) trial. Health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and then at 3 and 6 months. Generalized linear mixed models and propensity score methods were used to adjust for clustering within sites and differences between races. ResultsAlthough black patients reported better adjusted health status at baseline (black vs. white difference in KCCQ summary scores was 6.22; 95% confidence interval [CI]: 2.98 to 9.46; p < 0.001), after adjusting for patient demographics, comorbidities, clinical laboratory values, and baseline KCCQ score, we detected no significant racial differences in patient-reported health status at 3 months (black vs. white difference in KCCQ score: 2.28; 95% CI: −0.84 to 5.41; p = 0.15) or 6 months (black vs. white difference in KCCQ score: 1.91; 95% CI: −1.31 to 5.13; p = 0.24). ConclusionsCompared with white patients, black patients with HF had better patient-reported health status shortly after HF admission but not at 3 or 6 months. Our study failed to show that black patients were disadvantaged with regard to health status after HF hospitalization. (Tele-HF: Yale Heart Failure Telemonitoring Study; NCT00303212)

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy.

In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Comparable Performance of the Kansas City Cardiomyopathy Questionnaire in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

Despite the growing epidemic of heart failure with preserved ejection fraction (HFpEF), no valid measure of patients' health status (symptoms, function, and quality of life) exists. We evaluated the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of HF with reduced EF, in patients with HFpEF. Using a prospective HF registry, we dichotomized patients into HF with reduced EF (EF≤ 40) and HFpEF (EF≥50). The associations between New York Heart Association class, a commonly used criterion standard, and KCCQ Overall Summary and Total Symptom domains were evaluated using Spearman correlations and 2-way ANOVA with differences between patients with HF with reduced EF and HFpEF tested with interaction terms. Predictive validity of the KCCQ Overall Summary scores was assessed with Kaplan-Meier curves for death and all-cause hospitalization. Covariate adjustment was made using Cox proportional hazards models. Internal reliability was assessed with Cronbach's α. Among 849 patients, 200 (24%) had HFpEF. KCCQ summary scores were strongly associated with New York Heart Association class in both patients with HFpEF (r=-0.62; P<0.001) and HF with reduced EF (r=-0.55; P=0.27 for interaction). One-year event-free rates by KCCQ category among patients with HFpEF were 0 to 25=13.8%, 26 to 50=59.1%, 51 to 75=73.8%, and 76 to 100=77.8% (log rank P<0.001), with no significant interaction by EF (P=0.37). The KCCQ domains demonstrated high internal consistency among patients with HFpEF (Cronbach's α=0.96 for overall summary and ≥0.69 in all subdomains). Among patients with HFpEF, the KCCQ seems to be a valid and reliable measure of health status and offers excellent prognostic ability. Future studies should extend and replicate our findings, including the establishment of its responsiveness to clinical change.

Health-Related Quality of Life After Transcatheter Aortic Valve Replacement in Inoperable Patients With Severe Aortic Stenosis

Background- Transcatheter aortic valve replacement (TAVR) has been shown to improve survival compared with standard therapy in patients with severe aortic stenosis who cannot have surgery. The effects of TAVR on health-related quality of life have not been reported from a controlled study. Methods and Results- The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgical valve replacement to TAVR (n=179) or standard therapy (n=179). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 12-item Short Form-12 General Health Survey (SF-12). The primary end point was the KCCQ overall summary score (range, 0-100; higher=better). At baseline, mean KCCQ summary scores (35±20) and SF-12 physical summary scores (28±7) were markedly depressed. Although the KCCQ summary score improved from baseline in both groups, the extent of improvement was greater after TAVR compared with control at 1 month (mean between-group difference, 13 points; 95% confidence interval, 8-19; P<0.001) with larger benefits at 6 months (mean difference, 21 points; 95% confidence interval, 15-27; P<0.001) and 12 months (mean difference, 26 points; 95% confidence interval, 19-33; P<0.001). At 12 months, TAVR patients also reported higher SF-12 physical and mental health scores with mean differences compared with standard care of 5.7 and 6.4 points, respectively (P<0.001 for both comparisons). Conclusions- Among inoperable patients with severe aortic stenosis, compared with standard care, TAVR resulted in significant improvements in health-related quality of life that were maintained for at least 1 year. Clinical Trials Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Physical and emotional symptom burden of patients with end-stage heart failure: what to measure, how and why

Much of our understanding about symptom burden near the end of life is based on studies of cancer patients. The aim of this study was to explore physical and emotional symptom experience among end-stage chronic heart failure patients, looking for those symptoms mostly related to their global health status. Forty-six patients with end-stage heart failure compiled the following: Edmonton Symptom Assessment Scale (ESAS) and Kansas City Cardiomyopathy Questionnaire (KCCQ). End-stage heart failure patients have many complaints and poor global health status. The most distressing symptoms reported were general discomfort and tiredness followed by anorexia and dyspnea. The KCCQ summary scores were highly correlated with ESAS (r = -0.78; P = 0.0001). Among the domains explored by the KCCQ, social functioning and self-efficacy showed the lowest correlation coefficients with ESAS (r = -0.50; P = 0.001 and r = -0.31; P = 0.003, respectively); concerning the physical limitation domain, the symptom score and the quality-of-life domain, the correlation coefficients were as follows: r = -0.71 (P = 0.0001), r = -0.75 (P = 0.0001) and r = -0.74 (P = 0.0001), respectively. In the multiple regression analysis of ESAS and KCCQ scores, general discomfort, depression and anxiety were the symptoms that mostly related with the results in the domains explored by the KCCQ. No independent predictor was found among symptoms and quality of life. General discomfort together with depression and anxiety were the symptoms that were mostly related with the physical limitation domain of global health status, but did not influence the social functioning and the self-efficacy domains. When ESAS is used together with KCCQ, comprehensive and quantitative information on a patient's physical, emotional and social distress is provided.