Kansas City Cardiomyopathy Questionnaire Score Research Articles

Obesity in heart failure with preserved ejection fraction: Insights from the REDUCE LAP-HF II trial.

Obesity is causally related to the development of heart failure with preserved ejection fraction (HFpEF) but complicates the diagnosis and treatment of this disorder. We aimed to determine the relationship between severity of obesity and clinical, echocardiographic and haemodynamic parameters in a large cohort of patients with documented HFpEF. The REDUCE LAP-HF II trial randomized 626 patients with ejection fraction ≥40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg to atrial shunt or sham procedure. We tested for associations between body mass index (BMI), clinical characteristics, cardiac structural and functional abnormalities, physical limitations, quality of life and outcomes with atrial shunt therapy. Overall, 60.9% of patients had BMI ≥30 kg/m2 . As the severity of obesity increased, symptoms (Kansas City Cardiomyopathy Questionnaire score) and 6-min walk distance worsened. More severe obesity was associated with lower natriuretic peptide levels despite more cardiac remodelling, higher cardiac filling pressures, and higher cardiac output. Lower cut points for E/e' were needed to identify elevated PCWP in more obese patients. Strain measurements in all four chambers were maintained as BMI increased. Pulmonary vascular resistance at rest and exercise decreased with higher BMI. Obesity was associated with more first and recurrent heart failure events. However, there was no significant interaction between obesity and treatment effects of the atrial shunt. Increasing severity of obesity was associated with greater cardiac remodelling, higher right and left ventricular filling pressures, higher cardiac output and increased subsequent heart failure events. Despite significant obesity, many HFpEF patients have preserved right heart and pulmonary vascular function and thus, may be appropriate candidates for atrial shunt therapy.

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes

BackgroundSeveral orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. ObjectivesThis study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. MethodsThe TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. ResultsForty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro–B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. ConclusionsCaval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study – Safety and Efficacy of the TricValve® Device; NCT03723239)

Spanish version of the Heart Failure Somatic Perception Scale (HFSPS v.3) - psychometric properties.

The Heart Failure Somatic Perception Scale (HFSPS) is an instrument that examine the existence and gravity of physical signs and symptoms in patients with heart failure, as well as early and subtle symptoms of HF that have clinical value, we aimed to translate and adapt the HFSPS from English to Spanish and evaluate the psychometric properties. HFSPS translation and back translation were carried out according to the method established by of Beaton et al. A confirmatory factor analysis (CFA) was performed to test the factor structures. To assess criterion-related validity, HFSPS factor scores were correlated with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores using the Spearman correlation method. The reliability of the internal consistency of the HFSPS was determined by calculating the Cronbach's alpha coefficient and the factor score determination coefficient. Data from 173 patients with a mean age of 80.7 years (SD 9.1), women (51.1%), were analyzed. The majority (74.7%) were NYHA class II/III. The confirmatory factor analysis of four factors after eliminating one item showed fit indices close to the recommended indices: χ2 = 169.237, p < 0.001, CFI = 0.920, TLI = 0.901, RMSEA = 0.057 and SRMR = 0.061. Regarding the validity related to the criterion, all the scores of the HFSPS dimensions were correlated with all the scores of the KCCQ dimensions and were statistically significant. The reliability of the HFSPS factors of the coefficient of determination obtained scores of 0.73 for the dyspnea factor and early and subtle and lower for edema and chest discomfort with fewer items. Cronbach's alpha was acceptable for three of the scales >0.71 and poor 0.52 for chest discomfort with two items. The internal consistency index based on the model was 0.850. The Spanish version of the HFSPS is a valid and reliable instrument that that would be feasible to use in clinical and research setting to evaluate in the perception of symptoms in patients with heart failure.

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.

Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial.

Patients with heart failure (HF) with preserved ejection fraction (HFpEF) and obesity experience a high burden of symptoms and functional impairment, and a poor quality of life. In the STEP-HFpEF trial (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity), once-weekly semaglutide 2.4 mg improved symptoms, physical limitations, and exercise function, and reduced inflammation and body weight. This prespecified analysis investigated the effects of semaglutide on the primary and confirmatory secondary end points across the range of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at baseline and on all key summary and individual KCCQ domains. STEP-HFpEF randomly assigned 529 participants with symptomatic HF, an ejection fraction of ≥45%, and a body mass index of ≥30 kg/m2 to once-weekly semaglutide 2.4 mg or placebo for 52 weeks. Dual primary end points change in KCCQ-Clinical Summary Score (CSS) and body weight. Confirmatory secondary end points included change in 6-minute walk distance, a hierarchical composite end point (death, HF events, and change in KCCQ-CSS and 6-minute walk distance) and change in C-reactive protein. Patients were stratified by KCCQ-CSS tertiles at baseline. Semaglutide effects on the primary, confirmatory secondary, and select exploratory end points (N-terminal pro-brain natriuretic peptide) were examined across these subgroups. Semaglutide effects on additional KCCQ domains (Total Symptom Score [including symptom burden and frequency], Physical Limitations Score, Social Limitations Score, Quality of Life Score, and Overall Summary Score) were also evaluated. Baseline median KCCQ-CSS across tertiles was 37, 59, and 77 points, respectively. Semaglutide consistently improved primary end points across KCCQ tertiles 1 to 3 (estimated treatment differences [95% CI]: for KCCQ-CSS, 10.7 [5.4 to 16.1], 8.1 [2.7 to 13.4], and 4.6 [-0.6 to 9.9] points; for body weight, -11 [-13.2 to -8.8], -9.4 [-11.5 to -7.2], and -11.8 [-14.0 to -9.6], respectively; Pinteraction=0.28 and 0.29, respectively); the same was observed for confirmatory secondary and exploratory end points (Pinteraction>0.1 for all). Semaglutide-treated patients experienced improvements in all key KCCQ domains (estimated treatment differences, 6.7-9.6 points across domains; P≤0.001 for all). Greater proportion of semaglutide-treated versus placebo-treated patients experienced at least 5-, 10-, 15-, and 20-point improvements in all KCCQ domains (odds ratios, 1.6-2.9 across domains; P<0.05 for all). In patients with HFpEF and obesity, semaglutide produced large improvements in HF-related symptoms, physical limitations, exercise function, inflammation, body weight, and N-terminal pro-brain natriuretic peptide, regardless of baseline health status. The benefits of semaglutide extended to all key KCCQ domains. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04788511.

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.

Effect of dapagliflozin in patients in Asia with heart failure with mildly reduced or preserved ejection fraction: insights from DELIVER

Abstract Background A large and growing fraction of the global heart failure (HF) population lives in Asia. One-fifth of participants in the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure) trial were enrolled from Asia, providing a rich source of contemporary data to understand their unique clinical profiles and responses to sodium-glucose cotransporter 2 (SGLT2) inhibition. Purpose To assess the differences in clinical characteristics, outcomes, and response to dapagliflozin in patients from Asia vs outside Asia among patients with HF with mildly reduced or preserved ejection fraction in the DELIVER trial. Methods DELIVER was a global randomized clinical trial enrolling across 353 sites in 20 countries. Baseline clinical characteristics from patients enrolled in DELIVER trial were compared between patients in Asia vs outside Asia. The primary outcome was a composite of worsening HF or cardiovascular (CV) death. The effect of dapagliflozin on primary and secondary outcomes were compared in patients in Asia vs outside Asia. Results Among 6,263 participants in the DELIVER trial, 1,226 (19.6%) were enrolled in Asia (310 in China, 422 in Japan, and 318 in Taiwan, and 176 in Vietnam). Compared to patients outside Asia, participants from Asia were similar in age, more likely to be men with previous HF hospitalization, less likely to have obesity, diabetes, hypertension, or history of myocardial infarction, and had lower symptom burden despite similar natriuretic peptide levels (Figure 1). After adjusting for age, sex, and baseline LVEF, those in Asia faced similar risks of HF events but lower risk of mortality compared with those enrolled outside Asia (all-cause mortality Asia vs. outside Asia: HR 0.60, 95% confidence interval [CI] 0.49 – 0.72, Table 1). Within Asia, all-cause mortality was highest in Vietnam (6.8 per 100 person-year [py]), followed by Taiwan (6.7 per 100 py), Japan (3.5 per 100 py) and China (3.3 per 100 py). Dapagliflozin reduced the primary outcome in participants enrolled in Asia (hazard ratio [HR] 0.89, 95% CI 0.67-1.18) and outside Asia (HR 0.80, 95% CI 0.71 – 0.92) to a similar extend (P-interaction = 0.54, Figure 1). Similarly, region did not modify the treatment effect of dapagliflozin on CV death, HF hospitalization, all-cause death, CV death and recurrent HF events, or changes in Kansas City Cardiomyopathy Questionnaire scores (P-interaction &amp;gt; 0.30 for all). Serious adverse events and rates of drug discontinuation were also balanced in both treatment arms, irrespective of enrollment in Asia vs. outside Asia. Conclusions In the global DELIVER trial, dapagliflozin reduced the risk of CV death or HF events and was well tolerated both among participants enrolled in Asia and other geographic regions.Figure 1Table 1

Predictive utility of health-related quality of life and the 6-minute walking test in transthyretin amyloid cardiomyopathy - a comparison

Abstract Introduction Both health-related quality of life (HR-QoL) as well as submaximal physical performance as assessed using the 6-minute walking test (6-MWT) have been shown to predict outcome in heart failure. However, it is currently unclear how the predictive utility of different HR-QoL measurement tools compares to the 6-MWT in transthyretin amyloid cardiomyopathy (ATTR-CM). Aims To evaluate predictive utility of the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the EuroQol Five Dimensions Questionnaire (EQ-5D) in comparison to the 6-MWT in patients with ATTR-CM. Methods and results 186 patients diagnosed with ATTR-CM were included and data from 474 visits (2.55 per patient) was analysed. All scores and distance walked in the 6-MWT were transformed into Z-values by subtracting the mean and dividing by the standard deviation. In a cox regression analysis for all-cause mortality adjusted for age and sex, the KCCQ [Hazard Ratio (HR): 0.560, p = &amp;lt; 0.001], the EQ-5D visual analogue scale (HR: 0.712, p = 0.005) and the MLHFQ (HR: 0.613, p = &amp;lt; 0.001) proved predictive of outcome. For heart failure hospitalisation, the KCCQ (HR: 0.455, p = &amp;lt; 0.001), the EQ-5D overall score (HR: 0.753, p = 0.007), the EQ-5D visual analogue scale (HR: 0.631, p = &amp;lt; 0.001) and the MLHFQ score (HR: 0.466, p = &amp;lt; 0.001) were shown to be of high predictive utility. In comparison, the 6-MWT HRs were 0.434 and 0.544 for mortality and heart failure hospitalisation, respectively (p = &amp;lt; 0.001). Conclusion Prognostic utility of the KCCQ and MLHFQ scores is non-inferior to the 6-MWT in ATTR-CM. While much more simplistic, the EQ-5D is lacking behind the other tested questionnaires with regard to predictive utility.

A prospective, observational multicenter registry of heart failure patients in Germany: preliminary results of the ongoing H2-registry

Abstract Background Heart failure (HF) is a highly prevalent condition affecting 1-2% of the adult population in Europe. Despite pioneering improvements in HF treatment during the last two decades, hospitalization and mortality rates remain relatively high. Gathering real-world data on HF populations is crucial especially in the light of newly emerging therapeutic approaches. Purpose The H2-registry was set up in 2021 to provide up-to-date, real-world data on a contemporary cohort of hospitalized HF patients in Germany using a standardized set of outcome measures. Methods The ongoing H2-registry represents a prospective, investigator-initiated, multicenter observational registry. Inpatients ≥18 years of age with a present diagnosis of chronic or acute HF are recruited in secondary and tertiary hospitals throughout Germany. Patients are excluded if they present in any kind of shock during index hospitalization, or if they previously underwent heart transplantation or ventricular assist device therapy. Routine follow-up (FU) is conducted every 6 months. A standardized set of variables according to the International Consortium of Health Outcome Measurements (ICHOM) including a pre-defined selection of questionnaires to collect patient-reported outcome measures (PROMs) is used to objectively monitor the course of disease. Results Until the reference date 12/31/22, a total of 2,190 patients were included in ten active study centers. Mean age was 72 years, 36.8% were female, and mean left-ventricular ejection fraction (LVEF) was 43.4% (38.1% had an LVEF of ≤ 40%). In-hospital mortality at index case was 1.3%. Within the cohort with completed 6-month FU comprising of 976 patients, all-cause mortality was 11.3% (110). In addition, 24.2% (209) in the survival cohort had at least one HF-related re-hospitalization. Numbers for all-cause mortality and re-hospitalizations at 12-month FU were 21.3% (71) and 32.8% (86), respectively. Evaluations of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores showed a significant improvement overall and in all sub-categories (p &amp;lt; 0.001) at 6- and 12-month FU. Conclusions The H2-registry currently represents the largest ongoing prospective registry of HF inpatients in Germany. Our preliminary data highlights the pronounced mortality risk and healthcare burden in this cohort. However, HF-related therapies initiated during the course of a hospitalization have the potential to significantly improve patients’ quality of life. In the near future, it its foreseeable that the actively recruiting H2-registry based on ICHOM-standards will markedly contribute to the collection of real-world data on HF patients.

Ventricular arterial coupling in patients with ischemia but no obstructive coronary artery disease: novel insight into heart failure progression

Abstract Background Ischemia with no obstructive coronary artery disease (INOCA) is prevalent in women and is associated with increased risk of developing heart failure with preserved ejection fraction (HFpEF). While the exact mechanism contributing to heart failure progression remains incompletely understood, we hypothesize that impaired ventricular-arterial coupling (VAC) plays a key role. Purpose To evaluate VAC across the INOCA-HFpEF continuum. Methods To accomplish our research objective, we leveraged cardiac magnetic resonance images from individuals with INOCA and HFpEF from the WISE Pre-HFpEF (NCT03876223) and WISE HFpEF (NCT02582021) studies, along with reference controls. Aortic pulse wave velocity (aPWV) was measured using velocity-encoded MRI, from the proximal ascending to distal descending aorta. Global longitudinal strain (GLS) was measured by feature tracking of horizontal and vertical long axis cine images. VAC was defined as the ratio between aPWV and GLS. To test for potential mediators, we assessed the relationship between VAC and age, risk factors, systolic blood pressure (SBP), diastolic blood pressure (DBP), myocardial perfusion reserve index (MPRI), LV end diastolic pressure (LVEDP), cardiac structure/function, and Kansas City Cardiomyopathy questionnaire (KCCQ). Results The baseline characteristics of the three study groups are described in the Table. Patients with INOCA had similar KCCQ scores as HFpEF patients, suggesting INOCA patients may have subclinical HFpEF. Consistent with our hypothesis, we observed a progressive impairment in VAC across the three groups (Controls vs INOCA vs HFpEF), being significantly worst in HFpEF(Figure). Importantly, VAC was inversely related with age, systolic/diastolic blood pressure, and LV mass index (R=-0.6, R=-0.4, R=-0.4, R=-0.3 respectively, all p &amp;lt;0.001). Conclusion The data herein support the hypothesis that VAC contributes to heart failure progression, with age, arterial blood pressure and LV mass being key determinants. That VAC was not yet significantly different between INOCA, and reference controls highlights an important opportunity for intervention to prevent heart failure progression.

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 &lt;40 mapped to Class III, scores from 40-85 mapped to Class II, and &gt;85 mapped to Class I. Reductions of &gt;25 points on the KCCQ-OSS aligned with worsening class and increases by &gt;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.

Abstract 18110: Assessing the Impact of a Multidisciplinary Cardio-Kidney Care Team on the Overall Care Satisfaction in Patients With Heart Failure With Reduced Ejection Fraction And Chronic Kidney Disease

Background: Patients with heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD) experience fragmented care in the usual referral-based model given poor care coordination between subspecialists and primary care clinicians (PCCs). Multidisciplinary specialty care teams can improve care coordination, increase use of guideline-directed medical therapies (GDMT), and potentially increase patient satisfaction. Methods: We conducted a randomized controlled trial in a single-center tertiary care institution, enrolling patients with both HFrEF (ejection fraction &lt;50%) and CKD (stages 2-5, not on hemodialysis) over 6 months. The patients’ PCCs were randomized to either the control arm in which usual care was continued, or to the treatment arm where PCCs were supported by a virtually organized cardio-kidney team with a heart failure specialist and nephrologist. Treatment arm PCCs received recommendations from the cardio-kidney team via electronic medical record secure messaging sharing guidance on GDMT use, necessary lab tests, etc. Patients’ quality of life and symptoms were assessed at both baseline and 3 months via the Kidney Disease Quality of Life (KDQoL) survey and Kansas City Cardiomyopathy Questionnaire (KCCQ), respectively. Results: 95 patients had 3 month follow-up data (treatment n=47, control=48). The mean patient age was 67.4±10.8, and 61% were male. The majority (76%) were African American with mean EF of 35.5 ±11.0. The treatment group had higher reported and clinically significant (&gt;at least a 5-point change) improvement of KCCQ scores from baseline to 3 months (52%) compared to the control group (38%), however, this was not statistically significantly different (p=0.15). Meanwhile, the proportion of deterioration was 39% and 40% in the treatment and control groups, respectively. There were no significant differences in KDQOL scores between or within both groups when comparing the baseline to 3 month data. Conclusion: Implementing a multidisciplinary care team to support PCCs is a feasible intervention and at 3 months, there was an increase (although statistically insignificant) in KCCQ scores. A longer duration of follow-up may be better able to assess the effects of multidisciplinary care team models.

Abstract 15228: Impact of Gender and Left Ventricular Ejection Fraction on Health-Related Quality of Life and Its Change in Patients With Heart Failure

Introduction: Health-related quality of life (HRQoL) is an important part in managing patients with heart failure (HF). However, the influence of clinical factors on HRQoL in HF remains limited. Hypothesis: This study aimed to examine HRQoL changes based on gender and left ventricular ejection fraction (LVEF) among patients with HF. Methods: A total of 199 patients hospitalized for acute HF (mean age, 71±14 years; men:women=119:80; mean LVEF=42±16) were enrolled in a prospective way from Jan 2022 to Jan 2023. Baseline and 4-month follow-up Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were assessed. Patients were categorized into 4 subgroups: Group 1, women with LVEF≥50% (n=37); Group 2, men with LVEF≥50% (n=26); Group 3, women with LVEF&lt;50% (n=43); Group 4, and men with LVEF&lt;50% (n=93). Results: Women demonstrated lower KCCQ clinical and overall summary scores than men at baseline (p=0.003, 0.004, respectively) and 4-month follow-up (p=0.029, 0.038, respectively) after adjusting for age and body mass index. In addition, these scores tended to be lower in patients with LVEF ≥50% than those with LVEF &lt;50% at both baseline and follow-up (all p&lt;0.05). When we assessed KCCQ scores according to group, group 1 showed the lowest KCCQ overall summary score (KCCQ-OS: 36.9 [IQR 22.9-49.8], p=0.004) and clinical summary score (KCCQ-CS: 37.8 [IQR: 24.5-51.1], p=0.001). Also, the scores for physical limitation, symptom frequency, symptom burden, social limitation, self-efficacy scale, and total symptom score were lowest in Group 1 (all p&lt;0.05). Although HRQoL improved across all groups, the follow-up KCCQ-OS and KCCQ-CS scores remained lowest in Group 1 (KCCQ-OS: 54.0 [IQR 44.3-64.4], p=0.026; KCCQ-CS: 56.5 [IQR: 45.0-63.9], p=0.031). Conclusions: Among patients with HF, women with LVEF≥50% reported significantly worst HRQoL even after HF treatment, suggesting more attention should be paid to HRQoL in managing this specific population during HF treatment.

Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Background: Patient-reported quality of life (QoL) assessments, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) or Minnesota Living with Heart Failure Questionnaire (MLHFQ), reflect an individual’s health status and symptom severity at a given timepoint, and may have utility as inclusion criteria in heart failure (HF) clinical trials. Method: The Heart Failure Collaboratory-Academic Research Consortium, a group of stakeholders including patients, investigators, and representatives from government and industry, convened to review data from multiple HF clinical trials discuss the use of patient reported QoL-based inclusion criteria in clinical trials of HF. Result: Patient-reported QoL assessments, such as the KCCQ, have high test-retest reliability and, in contrast with the physician-assigned New York Heart Association (NYHA) class, are not subject to clinician bias or influenced by knowledge of prognostic variables such as Left Ventricular Ejection Fraction (LVEF) or N-terminal pro B-type Natriuretic Peptide (NT-proBNP). The U.S. FDA has qualified KCCQ as an effective clinical outcomes assessment for HF, and recent clinical trials that demonstrated substantial reductions in morbidity and mortality also showed improvements in KCCQ scores, provided patients had a decrement at baseline. However, KCCQ use is limited by both complicated clinical interpretability, with total symptom score consisting of aggregate scores from different physical and symptomatic domains and uncertainty around the threshold of clinically important difference, and by its length, with average completion time of 5 to 8 minutes. Conclusion: Patient-reported functional assessments have potential as inclusion criteria in clinical trials of HF by ensuring the enrollment of patients with a diminished QoL who have the potential to improve in response to therapeutic intervention, especially in clinical trials with QoL-based endpoints.

Abstract 14176: Cardiac Structure and Function in Relation to Health-Related Quality of Life in Heart Failure Patients With Preserved Ejection Fraction: Results From the PARAGON-HF Study

Background: Health-related quality of life (HRQL) is reduced in patients with heart failure with preserved ejection fraction (HFpEF). However, the extent to which HRQL outcomes are related to cardiac structure and function in patients with HFpEF is not well understood. Methods: We examined the association between baseline echocardiographic measures and longitudinal Kansas City Cardiomyopathy Questionnaire (KCCQ) measures in patients with HFpEF in the PARAGON-HF trial using longitudinal regression models adjusted for age, sex, baseline KCCQ score, randomization, and other important clinical confounders. Results: Among 1,094 patients with baseline KCCQ data at randomization and a baseline echocardiogram within 6 months of enrollment, the mean age was 74 years and 53% were women. Over 3 years, 78% completed KCCQ measures at baseline, 12, 24, and 36 months. Missing values for non-survivors (n=116) were imputed as zero to avoid survival bias. Posterior wall thickness, septal E/e’, and right ventricular (RV) end diastolic area were negatively associated with the KCCQ Overall Summary Score, and a similar pattern of associations was observed for the KCCQ Clinical Summary Score (Table). Pulmonary artery systolic pressure was additionally negatively associated with the KCCQ Total Symptom Score. Notably, left ventricular (LV) size, septal wall thickness, LV ejection fraction, LV strain, and left atrial size were not significantly associated with longitudinal changes in KCCQ. Conclusion: In patients with HFpEF, increased LV posterior wall thickness, elevated LV filling pressure, elevated pulmonary pressure, and RV enlargement - together suggestive of more advanced diastolic dysfunction - are associated with a decline in KCCQ scores and may influence future worsening of quality of life.

Abstract 13679: Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair

Introduction: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by TEE. Hypothesis: Safety and efficacy of T-TEER can be increased by multimodality imaging (MMI) guidance. Methods: From December 2020 to January 2022, we performed T-TEER in 40 inoperable patients. All patients received TTE, TEE and cardiac CT screening, and were assigned to a MMI (n=17) guidance group, provided good TTE acoustic window, or otherwise classical TEE (n=23). Multimodality imaging employed the 4 right-sided chamber views. Accordingly, the 1-chamber view was obtained in the transgastric short-axis view on TEE, but also from a modified subcostal TTE short axis. The 2-chamber view was visualized from a low-esophageal position, or from a parasternal long axis view of the right ventricle. The 3-chamber view was seen on mid-esophageal TEE 50-100°, but also in the parasternal short axis view. Finally, the 4-chamber view was obtained on mid-esophageal 0-30°, or the classical four-chamber TTE view. CT derived fluoroscopic angulations of these views allowed interventionalists and imaging specialists to speak a common language. Results: Device success was achieved in all patients, with 1.5±0.6 implanted clips / patient in the MMI vs 1.5±0.5 in the TEE group (p=0.851). Device times were 66.1±35.1 vs 58.7±27.5 minutes (p=0.459). TR reduction was successful in 94% vs 95% of patients, p=1.000. Two- or more grade TR improvement occurred in 65% vs 52% of cases. There were no device associated complications but 3 TEE-related gastro-esophageal bleedings occurred in the 2 nd group. By 12 months, 4 vs 8 patients (p=0.504) were readmitted for acute heart failure, and 2 vs 4 (p=0.686) died. NYHA class decreased by one grade in all survivals. However, Kansas City Cardiomyopathy Questionnaire score and 6-minute walk distance significantly increased in each respective group, more with MMI ( Δ 29±21.4 vs 22±13.6 points, p=0.227; Δ 101±100.4 vs 85±64 meters, p=0.121). Conclusions: A patient-tailored MMI approach to T-TEER guidance, by using TTE in patients with good acoustic window and cardiac CT for fluoroscopic determination of the 4 right-sided chamber views, is feasible and improves safety, procedural success and, in turn, clinical outcomes.

Abstract 14120: Characteristics, Outcomes and Treatment Response With Dapagliflozin Across the Range of Ejection Fraction in People With HF and a History of CABG Surgery: A Pooled Analysis From DAPA-HF and DELIVER

Introduction: There is a paucity of data on contemporary outcomes of patients with a history of CABG who have heart failure (HF) with either reduced or preserved left ventricular ejection fraction (LVEF). We aimed to compare the baseline characteristics and outcomes by history of CABG, as well the efficacy and safety of the SGLT2 inhibitor, dapagliflozin, across the full range of LVEF in patients with heart failure. Methods: We conducted a patient-level pooled analysis of two trials testing dapagliflozin in 11,007 participants with HF and LVEF ≤40% (DAPA-HF trial) and &gt;40% (DELIVER trial). The primary outcome was the composite of a worsening HF event or death from CV causes; other outcomes examined included total hospital admissions for HF, MACE, all-cause mortality and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Outcomes were compared by history of CABG. Results: Among 11,007 patients, 1576 had a prior history of CABG (~14%). Patients with CABG were characterised by a higher proportion of men, lower eGFR and LVEF, and higher rates of prior MI, PCTA, type 2 diabetes, antiplatelet and statin therapy. CABG patients were more likely to experience primary outcome (adjusted hazard ratio [aHR] 1.21, 95% CI 1.08-1.36), CV death (aHR 1.22, 95% CI 1.04-1.42), all-cause death (aHR 1.22, 95% CI 1.07-1.38), HF hospitalization (aHR 1.31, 95% CI 1.14-1.51), total HF events (adjusted rate ratio 1.38, 95% CI 1.20-1.59), and MACE (aHR 1.34 (1.17-1.52). Dapagliflozin consistently reduced the primary and key secondary endpoints in both people with and without a history of CABG across the entire spectrum of LVEF (P-interaction for all &gt; 0.48) (Table). Adverse events and tolerability were similar between groups. Conclusions: In patients with HF, a prior history of CABG is associated with higher rates of CV outcomes and mortality compared to those without a history of CABG. The efficacy and safety of dapagliflozin was similar in patients with and without a history of CABG.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study

BackgroundSurgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients. The K-Clip system is a percutaneous approach designed for functional TR; however, its utility remains unknown. ObjectivesThis study aimed to report the 30-day echocardiographic and clinical outcomes with the K-Clip system for severe TR, including changes in TR severity and NYHA functional class. MethodsTranscatheter tricuspid valve annuloplasty was performed in 39 patients with intermediate or high surgical risk who underwent the K-Clip system. The right internal jugular vein procedure was performed with annuloplasty guided by fluoroscopy and echocardiography. The primary outcomes were clinical success and all-cause mortality at the 30-day follow-up. ResultsThe K-Clip was successfully implanted in all cases, with 1 to 3 devices deployed. At the 30-day follow-up, none of the patients had died. TR severity was reduced by at least one grade in all patients. There were no severe procedural or 30-day adverse events, except for 1 new pacemaker implantation. The proportion of NYHA class III-IV patients decreased from 79.5% to 5.1%, and the ascites disappeared. The 6-minute walk distance increased by 78 m (P < 0.05), and the Kansas City Cardiomyopathy Questionnaire score improved by 11 points (P < 0.05). ConclusionsThe K-Clip device is practical, safe, and effective for patients with severe TR. A 30-day reduction in TR and enhanced cardiac function and quality of life were associated with transcatheter tricuspid annuloplasty using the K-Clip device, according to short-term follow-up studies. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System [TriStar]; NCT05173233)

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

BackgroundFavorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. ObjectivesThe authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. MethodsPatients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. ResultsNinety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). ConclusionsAt 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.