Mean Kansas City Cardiomyopathy Questionnaire Research Articles

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596. 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm2 (SD 0·19) at baseline to 0·64 cm2 (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias. This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. Cardiawave.

Abstract 12539: Relationship Between the Kansas City Cardiomyopathy Questionnaire Score and New York Heart Association Class in Patients With Hypertrophic Cardiomyopathy: Insights From EXPLORER-HCM

Background: Treating hypertrophic cardiomyopathy (HCM) aims to improve health status. Given the importance of accurately assessing health status and the limitations of the New York Heart Association (NYHA) Class, the Kansas City Cardiomyopathy Questionnaire (KCCQ) has gained interest. Thus, frameworks for interpreting the KCCQ in the context of the NYHA are needed. Methods: EXPLORER-HCM (NCT03470545) randomized patients with NYHA class II-III HCM to mavacamten or placebo and collected the NYHA and KCCQ. We pooled subjects for analyses who had KCCQ scores and NYHA class at baseline and 30-weeks. KCCQ scores, stratified by class at baseline, 30 weeks, and by change in class were reported as means±standard deviations. We generated two unadjusted models predicting the probability of NYHA class attribution for a given KCCQ-Overall Summary Score (OSS) at 30 weeks and for change in NYHA class by changes in KCCQ-OSS. Results: Of 196 participants, mean age was 57.9±12.2 years, 120 (61.2%) were male, and the baseline mean LVOT gradient was 51.5±30 mm Hg. Mean KCCQ scores by NYHA classes at baseline and 30 weeks are included in Table 1. Figure 1 maps the probability of NYHA Class by KCCQ. KCCQ-OSS Scores <40 mapped to Class III, scores from 40-85 mapped to Class II, and >85 mapped to Class I. Reductions of >25 points on the KCCQ-OSS aligned with worsening class and increases by >8 points on the KCCQ-OSS reflected improvement in class. Conclusion: NYHA Class is concordant with KCCQ, but there is variability in health status within class and changes in class. These analyses may help clinicians interpret both cross-sectional and changes in KCCQ scores for patients with obstructive HCM.

Prevalence of Severity-based Evaluation of Heart Failure (PROBE) and its Impact on Health-related Quality of Life: An Observational Study

Objectives: The study aims to evaluate the severity of heart failure (HF) and its impact on the patient's quality of life (QoL). Methodology: A multicenter, observational study was conducted across 100 medical facilities in Pakistan. Symptomatic HF patients (NYHA Class-II to IV) diagnosed ≥ 1 year ago, aged ≥ 18 years, and advised for echocardiography were invited. A total of 961 patients agreed to participate. HF severity was assessed based on ejection fraction (EF %) and NYHA class. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used to assess the effect of HF on the patient's QoL. Results: The patients' overall health status exhibited poor scores, with a mean KCCQ score of 20.26±8.34. Concerning left ventricular ejection fraction (LVEF), 25.9% of patients displayed moderate dysfunction (LVEF 30% to 39%), while 29.1% had severe dysfunction (LVEF < 30%). The distribution across NYHA classes was Class II included 451 patients (46.9%), Class III included 317 patients (33.0%), and Class IV included 193 patients (20.1%). High-quality-of-life (HR-QoL) assessments using the KCCQ exhibited significant correlations with both LVEF (rs=-0.394, p<0.01) and NYHA class (rs=-0.615, p<0.01). Notably, the mean KCCQ score displayed considerable variation across NYHA classes, Class II had a mean score of 25.42±7.95, Class III had 20.90±7.67, and Class IV had 16.41±8.94. Significant predictors of quality of life (KCCQ score) included age and NYHA. Conclusion: It is concluded from the study results that HR-QoL is significantly correlated with the severity of HF based on ejection fraction and NYHA class.

Left atrial strain is associated with the burden of symptoms in cardiac amyloidosis: a speckle tracking study

Abstract Funding Acknowledgements Type of funding sources: None. Background cardiac amyloidosis (CA) is characterized by an impairment of cardiac diastolic and, in the severe state of the disease, systolic function, with increasing worsening of functional capacity and quality of life (QoL). Six minute walking test (6MWT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) are two well-known and validated methods to assess the impact of heart failure (HF) symptoms and functional capacity. Left atrial strain by speckle tracking echocardiography has emerged as an index of left ventricular (LV) diastolic function and filing pressure, and is also associated with symptoms in HF. However, its possible association with functional capacity and QoL in CA has not yet been investigated. Objectives in this observational pilot study, our aim was to evaluate the relationship of left atrial strain with 6MWT and KCCQ in patients with CA (both AL and ATTR). Methods we enrolled consecutive patients with CA during routine follow up visits. Patients underwent clinical and echocardiographic evaluation. On the same day, 6MWT was performed and KCCQ was administered. Speckle tracking analysis was performed offline by an experienced operator blinded to the other data. Correlation analysis was conducted using Pearsons’ coefficient and linear regression analysis Results overall, 43 patients with CA (25 ATTR, 18 AL) were enrolled. Mean age was 74 ±11, 16% (n=7) were female. Most patients showed normal left ventricular (LV) ejection fraction (55±9) and reduced LV global longitudinal strain (GLS =−12 ± 7%), 32 of them with apical sparing pattern (Table 1). Mean global peak atrial longitudinal strain (PALS) was 14 (median[IQR]=6.5;23.5), mean 6MWT score = 382 ± 104 and mean KCCQ score= 67 ± 24. Global PALS showed a strong direct correlation with 6MWT (Fig 1, P= 0.4, R2=0.2, p-value=0.032) and a trend towards correlation with KCCQ (R2=0.3, p-value=0.06), although not reaching statistical significance, probably due to the low sample size. The correlation between PALS and 6MWT was even stronger in patients with ATTR (p = 0.7, R2 0.4; p-value<0.0001). Conclusions our preliminary results show that, global PALS is associated with functional capacity and the burden of HF symptoms in ATTR and AL, suggesting its role as a more objective marker of disease severity in CA.

Dapagliflozin and Physical and Social Activity Limitations in Heart Failure With Reduced Ejection Fraction

BackgroundHeart failure (HF) is associated with impaired physical function and poor quality of life and affects health status more profoundly than many other chronic diseases. ObjectivesThe authors examined the effects of dapagliflozin on specific physical and social limitations as reported by patients in the DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial. MethodsThe effect of dapagliflozin on the change from baseline to 8 months in each of the individual physical and social activity limitation questions answered by patients completing the Kansas City Cardiomyopathy Questionnaire (KCCQ), and overall scores, were examined with mixed-effects models and responder analyses. ResultsIn total, 4,269 (90.0%) and 3,955 (83.4%) patients had complete data for both the physical and social activity limitation scores at baseline and 8 months, respectively. Compared with placebo, dapagliflozin significantly increased (improved) the mean KCCQ physical and social activity limitation scores at 8 months (placebo-corrected mean difference 1.94 [95% CI: 0.73-3.16] and 1.84 [95% CI: 0.43-3.25], respectively). Dapagliflozin also increased each of the individual components that comprise the physical and social activity limitations domains at 8 months, with the largest improvement seen in “hobbies or recreational activities” (placebo-corrected mean difference: 2.76 [95% CI: 1.06-4.46]) and “doing yardwork, housework, or carrying groceries” (placebo-corrected mean difference: 2.59 [95% CI: 0.76-4.42]). The proportion of patients with a 5-point improvement from baseline to 8 months in the KCCQ physical and social activity limitation scores was greater with dapagliflozin than with placebo (ORs: 1.23 [95% CI: 1.09-1.40] and 1.19 [95% CI: 1.05-1.35], respectively). ConclusionsIn patients with HFrEF, dapagliflozin, compared with placebo, improved physical and social activity limitations as measured by KCCQ. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure [DAPA-HF]; NCT03036124).

Health status across major subgroups of patients with heart failure and preserved ejection fraction.

There are limited data on health status and changes in it over time across major subgroups of patients with heart failure and preserved ejection fraction (HFpEF), including ejection fraction spectrum, age, sex, region, body mass index (BMI), and comorbidities including diabetes, chronic kidney disease (CKD), anaemia, and atrial fibrillation/flutter. In the EMPEROR-Preserved trial, the Kansas City Cardiomyopathy Questionnaire (KCCQ) was assessed at baseline, 12, 32 and 52 weeks. Determinants of baseline KCCQ score and change over time, and the impact of empagliflozin on KCCQ scores were studied in specified subgroups. A Cox model was used to assess the association between 5- and 10-point increase and 5-point decrease in KCCQ score from baseline to week 12 and later outcomes. Among 2979 participants in the placebo arm, mean KCCQ clinical summary score (CSS) was 70.7 (20.8). Older age, female sex, BMI, anaemia, and a history of diabetes, and CKD were associated with worse scores. KCCQ-CSS score improved during follow-up; patients with atrial fibrillation/flutter at enrollment (p trend = 0.014) and CKD (p trend < 0.001) had less improvement. A 5-point increase in KCCQ-CSS at week 12 was associated with lower risk of cardiovascular death or heart failure hospitalization (5%), cardiovascular death (8%), and first heart failure hospitalization (4%) subsequently. A similar trend was seen with KCCQ total symptom score (TSS) and overall summary score (OSS). Empagliflozin improved KCCQ-CSS, -TSS and -OSS scores similarly across subgroups studied except for greater improvement in patients with the highest BMI (p trend = 0.153, 0.08 and 0.078, respectively). Health status in patients with HFpEF is impaired, especially in elderly, women, and those with obesity and comorbidities. Empagliflozin improved health status among all key subgroups studied with a greater effect in obese patients.

796 LEFT ATRIAL STRAIN ASSOCIATION WITH FUNCTIONAL CAPACITY IN CARDIAC AMYLOIDOSIS

Abstract Background cardiac amyloidosis (CA) is characterized by an impairment of cardiac diastolic and, in the severe state of the disease, systolic function, with increasing worsening of functional capacity and quality of life (QoL). Six minute walking test (6MWT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) are two well-known and validated methods to assess the impact of heart failure (HF) symptoms and functional capacity. Left atrial strain by speckle tracking echocardiography has emerged as an index of left ventricular (LV) diastolic function and filing pressure, and is also associated with symptoms in HF. However, its possible association with functional capacity and QoL in CA has not yet been investigated. Objectives in this observational pilot study, our aim was to evaluate the relationship of left atrial strain with 6MWT and KCCQ in patients with CA (both AL and ATTR). Methods we enrolled consecutive patients with CA during routine follow up visits. Patients underwent clinical and echocardiographic evaluation. On the same day, 6MWT was performed and KCCQ was administered. Speckle tracking analysis was performed offline by an experienced operator blinded to the other data. Correlation analysis was conducted using Pearsons’ coefficient and linear regression analysis Results overall, 43 patients with CA (25 ATTR, 18 AL) were enrolled. Mean age was 74 ±11, 16% (n=7) were female. Most patients showed normal left ventricular (LV) ejection fraction (55±9) and reduced LV global longitudinal strain (GLS =-12 ± 7%), 32 of them with apical sparing pattern. Mean global peak atrial longitudinal strain (PALS) was 14 (median[IQR]=6.5;23.5), mean 6MWT score = 382±104 and mean KCCQ score= 67 ± 24. Global PALS showed a strong direct correlation with 6MWT (Fig 1, P= 0.4, R2=0.2, p-value=0.032) and a trend towards correlation with KCCQ (P=0.3, p-value=0.06), although not reaching statistical significance, probably due to the low sample size. The correlation between PALS and 6MWT was even stronger in patients with ATTR (p=0.7, R2 0.4; p-value&amp;lt;0.0001). Conclusions our preliminary results show that, global PALS is associated with functional capacity and the burden of HF symptoms in ATTR and AL, suggesting its role as a more objective marker of disease severity in CA. Fig. 1

Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.

To determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR). This was a pooled analysis of patients (n= 68) who, despite guideline-directed medical therapy had symptomatic heart failure (HF) with mild (n= 25) or moderate (n= 43) SMR treated with percutaneous mitral annuloplasty as part of the TITAN, TITAN II, or REDUCE-FMR trials. Primary outcomes were changes in symptoms, 6-min walk distance, and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 1year. Secondary analyses included changes in LV structure and function. At 1 year, New York Heart Association class status was maintained (48%) or improved (46%) in most patients, mean KCCQ scores increased from baseline by 10units [95% confidence interval (CI) 3 to17; P< 0.01] and mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; P< 0.01). SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of -7mL (95% CI -11 to -3; P< 0.001), vena contracta -0.11 cm (95% CI -0.20 to -0.02; P< 0.05), and effective regurgitant orifice area -0.03 cm2 (95% CI -0.06 to -0.01; P< 0.05). There were non-significant improvements in LV ejection fraction and volumes. Survival over 1year was 89% with no difference between mild (96%) and moderate (86%) SMR (log-rank P= 0.22). Progression-free survival was 70% (82% in mild vs. 63% in moderate SMR; P= 0.16). Freedom from HF hospitalization was 73% (87% in mild SMR vs. 66% in moderate SMR; P= 0.07). Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.

Patient-centered Outcomes in HFrEF Following a Worsening Heart Failure Event: A Survey Analysis

Heart failure is a chronic disease punctuated by intermittent exacerbations that require hospitalization or intravenous diuretic therapy. The association of worsening heart failure events (WHFEs) with patient-centered outcomes in heart failure with reduced ejection fraction (HFrEF) remains unexplored. Patients with HFrEF completed an online survey assessing health status, medication adherence, treatment satisfaction, treatment burden, and medication costs and affordability. Patients with and without WHFEs were compared on all study variables, with adjustment for patient characteristics using linear or logistic regression. Overall, 512 patients (52.0% WHFEs) were included. Patients with WHFEs more commonly had depression (55.3% vs 24.0%), anxiety (46.2% vs 17.9%), and insomnia (77.8% vs 44.7%; P < 0.001 for all). Patients with WHFEs had lower adjusted mean Kansas City Cardiomyopathy Questionnaire values (52.9 vs 56.0) and Satisfaction with Medications Questionnaire values (70.5 vs 72.6) and higher Treatment Burden Questionnaire scores (51.1 vs 45.1; P < 0.001). Medication-related beliefs and long-term concerns were independently associated with nonadherence in patients with WHFE (adjusted odds ratios: 4.2 and 5.2, respectively; P < 0.01 for both). Patients with WHFE incurred 50.0% higher median monthly out-of-pocket HF prescription medication costs and less often perceived HF medications to be affordable. WHFE is associated with several adverse impacts on patients with HFrEF. Additional support is warranted to manage symptoms, comorbidities, and HF treatments to improve adherence and outcomes.

Benefit of Transcatheter Aortic Valve Replacement in Patients With Paradoxical Low-Flow Low-Gradient Versus High-Gradient Aortic Stenosis and Preserved Left Ventricular Function.

[Figure: see text].

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation

BackgroundTricuspid regurgitation (TR) is a prevalent disease with limited treatment options. ObjectivesThis is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. MethodsPatients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. ResultsOf the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). ConclusionsIn this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313)

PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure

In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice. PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting. Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006). In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.

Identifying critical psychotherapy targets in serious cardiac conditions: The importance of addressing coping with symptoms, healthcare navigation, and social support

In seriously ill cardiac patients, several psychotherapy efficacy studies demonstrate little to no reduction in depression or improvement in quality of life, and little is known about how to improve psychotherapies to best address the range of patient needs. An interpersonal and behavioral activation psychotherapy was a key component of the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) multisite randomized clinical trial. Although depressive symptoms did improve in the CASA trial, questions remain about how best to tailor psychotherapies to the needs of seriously ill patient populations. The study objective was to describe psychosocial needs emerging during a clinical trial of a palliative care and interpersonal and behavioral activation psychotherapy intervention that were not specifically addressed by the psychotherapy. During the CASA trial, patient needs were prospectively tracked by the psychotherapist in each visit note using an a priori code list. Preplanned analysis of study data using directed content analysis was conducted analyzing the a priori code list, which were collapsed by team consensus into larger themes. The frequency of each code and theme were calculated into a percentage of visits. A total of 150 patients received one or more visits from the therapist and were included in the analysis. Participants screened positive for depressive disorder (47%), had poor heart failure-specific health status (mean Kansas City Cardiomyopathy Questionnaire score = 48.6; SD = 17.4), and multiple comorbidities (median 4.3). Common needs that emerged during the therapy included difficulty coping with fatigue (48%), pain (28%), and satisfaction issues with medical care (43%). The following broader themes emerged: social support (77% of sessions), unmet symptom needs (67%), healthcare navigation (48%), housing, legal, safety, and transportation (32%), and end of life (12%). Coping with chronic symptoms and case management needs commonly emerged during psychotherapy visits. Future psychotherapy interventions in seriously ill populations should consider the importance of coping with chronic symptoms and case management.

Improvements in Health Status Associated with Medication Adjustments in Outpatients with HFrEF: Insights from the CHAMP-HF Registry

Introduction A principal goal in treating patients with heart failure with reduced ejection fraction (HFrEF) is to minimize their symptoms, improve their function and optimize their quality of life. Patient-reported outcome measures, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ), have been proposed to measure healthcare quality. In previous research, we found substantial variation in mean KCCQ scores across practices. We now explore whether medication adjustments are associated with changes in KCCQ scores over time. Methods Using data from CHAMP-HF, a multicenter observational study of outpatients with HFrEF (LVEF Results Among 3313 patients from 140 practices, we observed marked changes and variability in patients' KCCQ scores at 3 months (Figure). Overall, 23.8% of patients' KCCQ scores worsened and 46.4% improved. At least 1 medication was adjusted in 727 (22%) patients. Adjustment in patients' HF medications was associated with significantly greater improvement in patients' KCCQ scores compared with no adjustment to any HF medications [+7.3 (IQR: -3.1, 20.8) vs + 3.1 (IQR: -4.7, 12.5) points; p Conclusion The health status of patients with HFrEF varies over time and is associated with treatment adjustments recommended by clinicians. Measuring patients' health status may encourage providers to adjust therapy to improve the symptoms, function and quality of life of patients' with HFrEF.

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure

ImportanceMany patients with chronic heart failure experience reduced health status despite receiving conventional therapy.ObjectiveTo determine whether a symptom and psychosocial collaborative care intervention improves heart failure–specific health status, depression, and symptom burden in patients with heart failure.Design, Setting, and ParticipantsA single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach.InterventionsPatients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients’ primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician.Main Outcomes and MeasuresThe primary outcome was patient-reported heart failure–specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality.ResultsOf 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, –1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of –0.29 [95% CI, –0.53 to –0.04] for depressive symptoms and –0.30 [95% CI, –0.55 to –0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52).Conclusions and RelevanceThis multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure–specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved.Trial Registrationclinicaltrials.gov Identifier: NCT01739686

Quality of life determinants inpatients with hypertrophic cardiomyopathy and heart failure

Quality of life (QOL) is often overlooked in clinical practice. Heart failure (HF) is a major complication of HCM, with more than three quarters of HCM patients (pts) developing HF symptoms. The aim of the study was to evaluate the impact of HF on QOL in HCM pts, as well as the associated major clinical determinants. The present study is a cross-sectional single-center study. Evaluation of all pts was performed based on a comprehensive protocol including clinical, laboratory and imaging studies. All pts were administered the translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ) as a health status measure. The study group included 61 pts (55 ± 14.4 years, 62% men). The mean global KCCQ score was 65.6 ± 24.1 (range: 0–100), corresponding to a mild impairment in QOL. Patients in class II and III NYHA had a significantly worse QOL than class I NYHA, reflected in lower global KCCQ scores (class III NYHA 53.5 ± 16.3 vs class II NYHA 64.7 ± 23.1 vs class I NYHA 89 ± 13.2, P < 0.05). Patients with pulmonary hypertension (PH) had a worse QOL compared to those without PH (mean KCCQ score difference 13.8 ± 3.7, P < 0.05) and were significantly more likely to have had at least one episode of atrial fibrillation (76% vs 30%, P < 0.05). The KCCQ score correlated with the end-systolic LV volume ( r = 0.33, P < 0.05), LVEF ( r = 0.30, P < 0.05), pulmonary velocity acceleration time ( r = 0.32, P < 0.05), serum urea and creatinine ( r = −0.41, P < 0.01 and r = −0.33, P < 0.05, respectively) and age ( r = −0.281, P < 0.05). LVEF (st d β = −0.478, P < 0.05) and serum urea level (std β = −0.352, P < 0.05) emerged as independent predictors of QOL score. Out of the 5 items that make up the global KCCQ score, social limitation had the most significant impact on overall QOL ( R 2 : 0.82, P < 0.05). Patients with HCM and HF present a mild degree of alteration in QOL. LVEF and renal function are independent predictors of perceived health status in these patients.

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.

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

Most Important Outcomes Research Papers on Valvular Heart Disease

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Reviews. This series will summarize the most important manuscripts, as selected by the Editor, which have been published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes as well as general cardiology audience. The studies included in this article represent the most significant research in the area of valvular heart disease. ( Circ Cardiovasc Quality and Outcomes . 2012;5:-e103.) In recent years, no field of clinical cardiology has experienced a great influx of transformational therapeutic options as has the area of valvular heart disease. Treatment of severe aortic stenosis (AS) has been revolutionized by transcatheter aortic valve replacement (TAVR), which has been shown to improve life expectancy and functional outcomes in patients with inoperable AS1,2 and to have short-term outcomes comparable to surgical aortic valve replacement (AVR) in patients at high perioperative risk.3,4 Analogously, mitral valve disease has been amenable to percutaneous valve replacement,5,6 as well as clipping procedures7 that can substantively reduce severe mitral regurgitation (MR) and improve functional outcomes. Even right-sided heart disease involving valves in pulmonary8,9 and tricuspid10 positions has been treated successfully with endovascular techniques. Yet, even with this growing focus on percutaneous valvular interventions, open surgical techniques remain the dominant treatment strategies and standard of care for most advanced lesions. Surgical valve repair and replacement account for 10% to 20% of all cardiac surgical procedures,11–13 approximately two thirds of which are for AS.11–13 For patients undergoing surgery, there remains considerable debate about risk stratification,14 intraoperative technique,15 and postoperative …

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.