Kansas City Cardiomyopathy Questionnaire Overall Summary Research Articles

Impact of Elevated Gradients After Transcatheter Aortic Valve Implantation for Degenerated Surgical Aortic Valve Bioprostheses.

Elevated aortic valve gradients are common after transcatheter aortic valve implantation for degenerated surgical aortic valve replacement bioprostheses, but their clinical impact is uncertain. A total of 12 122 patients who underwent transcatheter aortic valve implantation-in-surgical aortic valve replacement from November 2011 to December 2019 in the Society of Thoracic Surgery/American College of Cardiology Transvalvular Therapeutics Registry were included. The primary outcome was a composite of 1-year all-cause mortality, stroke, myocardial infarction, or valve reintervention. Secondary outcomes included 1-year all-cause mortality, readmission, and change from baseline 12-question self-administered Kansas City Cardiomyopathy Questionnaire-Overall Summary Score. Due to nonlinearity observed with restricted cubic splines analysis, a Cox regression analysis with aortic valve mean gradient modeled as a spline-continuous variable (with 20 mm Hg as a cutoff) was used to study the 1-year composite outcome and mortality. The composite outcome occurred most frequently in patients with aortic valve mean gradient ≥30 and <10 mm Hg, as compared with those with 10 to 20 and 20 to 30 mm Hg ranges (unadjusted rates, 13.9%, 12.1%, 7.5%, and 6.5%, respectively; P=0.002). When the mean aortic valve gradient was ≥20 mm Hg, higher gradients were associated with greater risk of the 1-year composite outcome (adjusted hazard ratio, 1.02 [1.02-1.03] per mm Hg; P<0.001) and 1-year mortality (adjusted hazard ratio, 1.02 [1.00-1.03] per mm Hg; P=0.007). Whereas when the mean aortic valve gradient was <20 mm Hg, higher gradients were not significantly associated with the composite outcome (adjusted hazard ratio, 0.99 [0.98-1.003] per mm Hg; P=0.12) but were associated with lower 1-year mortality (adjusted hazard ratio, 0.98 [0.97-0.99] per mm Hg; P=0.007). The relationship between postprocedural aortic valve mean gradient after transcatheter aortic valve implantation-in-surgical aortic valve replacement and clinical outcomes is complex and nonlinear, with relatively greater adverse events occurring at low and high gradient extremes. Further study of factors mediating the relationship between postprocedural gradients and clinical outcomes, including low-flow states, is necessary.

The evaluation of goal-directed activities to promote well-being and health in heart failure: EUROIA scale.

The EvalUation of goal-diRected activities to prOmote well-beIng and heAlth (EUROIA) scale is a novel patient-reported measure that was administered to individuals with chronic heart failure (CHF). It assesses goal-directed activities that are self-reported as being personally meaningful and commonly utilized to optimize health-related quality of life (HRQL). Our aim was to evaluate psychometric properties of the EUROIA, and to determine if it accounted for novel variance in its association with clinical outcomes. This study was a secondary analysis of the CHF-CePPORT trial, which enrolled 231 CHF patients: median age = 59.5 years, 23% women. Baseline assessments included: EUROIA, Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS), Patient Health Questionnaire-9 for depression (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7). 12-month outcomes included health status (composite index of incident hospitalization or emergency department, ED, visit) and mental health (PHQ-9 and GAD-7). Exploratory Principal Axis Factoring identified four EUROIA factors with satisfactory internal reliability: i.e., activities promoting eudaimonic well-being (McDondald's ω = 0.79), social affiliation (⍺=0.69), self-affirmation (⍺=0.73), and fulfillment of social roles/responsibilities (Spearman-Brown coefficient = 0.66). Multivariable logistic regression indicated that not only was the EUROIA inversely associated with incidence of 12-month hospitalization/ED visits independent of the KCCQ-OS (Odds Ratio, OR = 0.95, 95% Confidence Interval, CI, 0.91, 0.98), but it was also associated with 12-month PHQ-9 (OR = 0.91, 95% CI, 0.86, 0.97), and GAD-7 (OR = 0.94, 95% CI, 0.90, 0.99) whereas the KCCQ-OS was not. The EUROIA provides a preliminary taxonomy of goal-directed activities that promote HRQL among CHF patients independently from a current gold standard state-based measure. NCT01864369; https://classic. gov/ct2/show/NCT01864369 .

Effect of long-term tafamidis treatment on health-related quality of life in patients with transthyretin amyloid cardiomyopathy.

To evaluate the effect of long-term tafamidis treatment on health-related quality of life (HRQoL) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) enrolled in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension (LTE) study. We examined change from baseline in Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) and clinical summary (KCCQ-CS) scores in patients who received tafamidis meglumine 80 mg for 30 months in ATTR-ACT and tafamidis (meglumine 80 mg or bioequivalent free acid 61 mg) for 30 months in the LTE study, and in patients who received placebo for 30 months in ATTR-ACT and tafamidis for 30 months in the LTE study. In ATTR-ACT, 176 and 177 patients were randomized to tafamidis 80 mg and placebo, respectively. Patients who continuously received tafamidis had a 6- to 7-point reduction in least squares (LS) mean (standard error) KCCQ-OS and KCCQ-CS scores at month 30 (-6.25 [1.53] and -7.48 [1.39]), with little or no further decline over the next 30 months (-5.92 [1.77] and -9.21 [1.88] at month 60). Patients who received placebo in ATTR-ACT had a 20-point reduction in LS mean KCCQ-OS and KCCQ-CS scores at month 30 (-19.60 [1.94] and -19.90 [2.01]), but the decline slowed after initiating tafamidis (-24.70 [3.04] and -25.30 [3.36] at month 60). Tafamidis reduced HRQoL decline in patients with ATTR-CM. Patients continuously treated with tafamidis for 60 months demonstrated stabilized HRQoL. In patients who initially received placebo in ATTR-ACT, tafamidis reduced the decline in HRQoL during the LTE study.

Effects of SGLT2 inhibitors on cardiac function and health status in chronic heart failure: a systematic review and meta-analysis

PurposeNumerous clinical studies have explored sodium–glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes mellitus (T2DM), and SGLT2i were proved to significantly reduce CHF hospitalization, cardiovascular death, cardiovascular mortality, all-cause mortality and myocardial infarction in patients with or without T2DM. However, only a limited few have investigated the effects of SGLT-2i on HF disease-specific health status and cardiac function. This meta-analysis aims to assess the effects of SGLT2i on disease-specific health status and cardiac function in CHF patients.MethodsA comprehensive search was conducted of trials by searching in PubMed, EMBASE, CENTRAL, Scopus, and Web of Science, and two Chinese databases (CNKI and Wanfang), Clinical Trials (http://www.clinicaltrials.gov) were also searched.ResultsA total of 18 randomized controlled trials (RCTs) involving 23,953 participants were included in the meta-analysis. The effects of SGLT2 inhibitors were compared with control or placebo groups in CHF with or without T2DM. The SGLT2 inhibitors group exhibited a significant reduction in pro b-type natriuretic peptide (NT-proBNP) levels by 136.03 pg/ml (95% confidence interval [CI]: −253.36, − 18.70; P = 0.02). Additionally, a greater proportion of patients in the SGLT2 inhibitors group showed a ≥ 20% decrease in NT-proBNP (RR = 1.45, 95% CI [0.92, 2.29], p = 0.072). However, no statistically significant difference was observed for the effects on B-type natriuretic peptide (BNP). The use of SGLT-2 inhibitors led to a noteworthy improvement in LVEF by 2.79% (95% CI [0.18, 5.39];P = 0.036). In terms of health status, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance, SGLT2 inhibitors led to a significant improvement in KCCQ clinical summary (KCCQ-CS) score (WMD = 1.7, 95% CI [1.67, 1.73], P < 0.00001), KCCQ overall summary (KCCQ-OS) score (WMD = 1.73, 95% CI [0.94, 2.52], P < 0.00001), and KCCQ total symptom (KCCQ-TS) score (WMD = 2.88, 95% CI [1.7, 4.06], P < 0.00001). Furthermore, the occurrence of KCCQ-CS and KCCQ-OS score increases ≥ 5 points had relative risks (RR) of 1.25 (95% CI [1.11, 1.42], P < 0.00001) and 1.15 (95% CI [1.09, 1.22], P < 0.00001), respectively. Overall, SGLT2 inhibitors increased the 6-minute walk distance by 23.98 m (95% CI [8.34, 39.62]; P = 0.003) compared to control/placebo from baseline.ConclusionsThe SGLT2 inhibitors treatment offers an effective strategy for improving NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance in CHF with or without T2DM. These findings indicate that SGLT2i improve cardiac function and health status in CHF with or without T2DM, and provide valuable guidance for clinicians making treatment decisions for patients with CHF.

Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study

BackgroundTafamidis was approved to treat patients with transthyretin amyloid cardiomyopathy (ATTR-CM) on the basis of findings from the phase 3 Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT). ObjectivesThis study was a post hoc analysis exploring tafamidis efficacy in octogenarian patients. MethodsAnalysis of patients aged <80 and ≥80 years in ATTR-ACT and its ongoing open-label long-term extension (LTE) study, where all patients receive tafamidis. ResultsAfter 30 months in ATTR-ACT, least squares (LS) mean change from baseline in 6-minute walk test (6MWT) distance, N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score were smaller (all P < 0.05) in patients aged ≥80 years treated with tafamidis (n = 51) vs placebo (n = 37). At the LTE study interim analysis, patients aged ≥80 years treated continuously with tafamidis had a smaller decline in KCCQ-OS score (P < 0.05) and trended toward longer median survival (45 vs 27 months; all-cause mortality HR: 0.6828 [95% CI: 0.4048-1.1517]; P = 0.1526) than those initially treated with placebo in ATTR-ACT. Similar efficacy was observed in patients aged <80 years in ATTR-ACT, including smaller LS mean change from baseline in 6MWT distance, NT-proBNP concentration, and KCCQ-OS score, and lower rate of cardiovascular-related hospitalizations with tafamidis (n = 125) vs placebo (n = 140). In the LTE study, patients aged <80 years treated continuously with tafamidis had a longer median survival (80 vs 41 months; HR = 0.4513 [95% CI: 0.3176-0.6413]; P < 0.0001) and a smaller decline in KCCQ-OS score than those initially treated with placebo. ConclusionsThe findings demonstrate tafamidis efficacy for patients with ATTR-CM both in those aged <80 and those aged ≥80 years. (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial [ATTR-ACT]; NCT01994889/Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy; NCT02791230)

Patisiran Treatment in Patients with Transthyretin Cardiac Amyloidosis

BackgroundTransthyretin amyloidosis, also called ATTR amyloidosis, is associated with accumulation of ATTR amyloid deposits in the heart and commonly manifests as progressive cardiomyopathy. Patisiran, an RNA interference therapeutic agent, inhibits the production of hepatic transthyretin.MethodsIn this phase 3, double-blind, randomized trial, we assigned patients with hereditary, also known as variant, or wild-type ATTR cardiac amyloidosis, in a 1:1 ratio, to receive patisiran (0.3 mg per kilogram of body weight) or placebo once every 3 weeks for 12 months. A hierarchical procedure was used to test the primary and three secondary end points. The primary end point was the change from baseline in the distance covered on the 6-minute walk test at 12 months. The first secondary end point was the change from baseline to month 12 in the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score (with higher scores indicating better health status). The second secondary end point was a composite of death from any cause, cardiovascular events, and change from baseline in the 6-minute walk test distance over 12 months. The third secondary end point was a composite of death from any cause, hospitalizations for any cause, and urgent heart failure visits over 12 months.ResultsA total of 360 patients were randomly assigned to receive patisiran (181 patients) or placebo (179 patients). At month 12, the decline in the 6-minute walk distance was lower in the patisiran group than in the placebo group (Hodges–Lehmann estimate of median difference, 14.69 m; 95% confidence interval [CI], 0.69 to 28.69; P=0.02); the KCCQ-OS score increased in the patisiran group and declined in the placebo group (least-squares mean difference, 3.7 points; 95% CI, 0.2 to 7.2; P=0.04). Significant benefits were not observed for the second secondary end point. Infusion-related reactions, arthralgia, and muscle spasms occurred more often among patients in the patisiran group than among those in the placebo group.ConclusionsIn this trial, administration of patisiran over a period of 12 months resulted in preserved functional capacity in patients with ATTR cardiac amyloidosis. (Funded by Alnylam Pharmaceuticals; APOLLO-B ClinicalTrials.gov number, NCT03997383.)

Diastolic Dysfunction and Health Status Outcomes After Transcatheter Aortic Valve Replacement

BackgroundBaseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. MethodsPatients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. ResultsOf 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). ConclusionsChange in LVDD grade was associated with change in health status 1 year following TAVR.

PO-02-157 IMPACT OF ATRIAL FIBRILLATION ON QUALITY OF LIFE IN HYPERTROPHIC CARDIOMYOPATHY

In hypertrophic cardiomyopathy (HCM) atrial fibrillation (AF) has been historically described as unrelenting, a driver for heart failure, with a decisive impact on quality of life. AF treatment has been deemed less effective in HCM due to high rates of AF recurrence. However, AF has predominantly been characterized from physicians perspective and there is no data on impact on patient reported outcome measures (PROMs). To evaluate the impact of AF on PROMs in HCM. PROMs were collected using the Atrial Fibrillation Severity Scale (AFSS) and Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) reflecting symptom burden and quality of life in 250 consecutive HCM patients. Among the 250 patients, 51 (20%) were diagnosed with AF at 56±10 years of age, 6.5±5.5 years prior to evaluation and reported health status. At evaluation, 45 of the 51 AF patients (88%) were in sinus rhythm, and 6 in AF (12%) including 5 in permanent AF. Each of the 51 patients required AF treatment for symptoms: 27 (53%) solely with medications (17 with AV nodal medications and 10 on antiarrhythmic drugs); and 24 (47%) with AF ablation (16 with catheter ablation and 8 surgical Cox-Maze IV at time of myectomy). Of the 24 AF ablation patients, 15 (63%) had recurrent AF including 6 (25%) requiring multiple ablation procedures. After most recent ablation, AF burden was reported as infrequent ≤1 episode per month in 17 (71%), including 10 with ≤1 episode/year. 75% had AFSS symptom score consistent with mild symptoms, and 91% had KCCQ-OS with mild or no disability. There was no difference in either KCCQ-OS or AFSS in patients with and without AF recurrence after ablation (p=0.68). The 27 patients treated solely with medications each had recurrent AF episodes on current therapy, but 15 (56%) reported infrequent AF burden ≤1 per month including 11 with ≤1 episode/year. With treatment, 67% had AFSS symptom score consistent with mild symptoms and 82% had KCCQ-OS with mild or no disability. There was no difference in KCCQ-OS in the 51 HCM patients with AF compared to 199 patients without AF (p=0.2). Recurrent AF in HCM is common despite treatment, however episodes tend to be infrequent. With treatment, the majority of patients with AF have no or mild symptom burden. These data support that despite recurrent AF episodes after treatment, quality of life metrics are not significantly impaired for most HCM patients.

Abstract 9337: The Association of Echo Parameters With Health Status in Patients With Obstructive Hypertrophic Cardiomyopathy. Insights From the Explorer-HCM Trial

Introduction: The EXPLORER-HCM trial showed mavacamten, a direct cardiac myosin inhibitor, improved the health status of patients with obstructive hypertrophic cardiomyopathy (HCM). To explore physiologic mechanisms for this improvement, we examined cross-sectional and longitudinal associations of echocardiographic parameters with health status. Methods: EXPLORER-HCM was a 13-country, double-blind randomized trial of mavacamten or placebo for 30 weeks in symptomatic patients with obstructive HCM and peak LVOT gradient ≥50 mmHg. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score (KCCQ-OS, range 0-100, higher=better). Using a series of multivariable linear regression models, we examined the association of 1) echo parameters with KCCQ-OS at baseline and 2) change in echo parameters with change in KCCQ-OS. Nonlinear associations were explored with cubic splines. As this was a mechanistic analysis, treatment was not included. Results: Among 196 patients (mean age 58±12 years, 39% women), mean KCCQ-OS was 67±18 at baseline and 76±19 at 30 weeks; mean change of 10±16 points. At baseline, only interventricular septal thickness (IVST) was significantly associated with KCCQ-OS in adjusted analyses (1.2-point decrease in KCCQ-OS per 1 mm higher IVST; 95% CI -2.2 to -0.2, p=0.015). However, when comparing changes in echo parameters with changes in KCCQ-os, decreases in LVOT gradient at rest, LVOT gradient post-exercise, LVOT gradient with Valsalva, LV mass, posterior wall thickness, and IVST were each associated with significant improvements in KCCQ-OS (FIGURE). Measures of diastolic function were not associated with KCCQ-OS, either cross-sectionally or longitudinally. Conclusions: Among patients with obstructive HCM, reductions in LVOT gradients, LV mass, and wall thickness (IVST&gt;posterior wall) were associated with significant improvements in patients’ symptoms, function, and quality of life.

Abstract 13672: Quality of Life Impact of Transcatheter Edge to Edge Repair of Mitral Valve With the Mitraclip System in Patients With Mitral Regurgitation and Cardiogenic Shock

Introduction: Transcatheter Edge to Edge Repair (TEER) of the mitral valve is a viable option for patients with moderate to severe mitral regurgitation (MR) who are at high surgical risk. TEER has been shown to improve quality of life (QOL) in patients with MR. Data is limited regarding QOL in patients with MR and cardiogenic shock (CS) who undergo TEER. Methods: A single-center, retrospective cohort study including adult patients with moderate to severe MR and CS who underwent TEER between January 2012 and December 2021. CS was defined as a sustained systolic blood pressure &lt;90mmHg for at least 1 hour, use of inotropes, vasopressors, or mechanical circulatory support, and clinical and lab findings of end-organ damage. The primary outcome was change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS] at 30 days. Statistical analysis was done using Wilcoxon signed-rank test and t-test. Results: Thirty-three patients with mod-severe MR and CS had undergone TEER (See table 1 for baseline characteristics) . KCCQ data were available on 30% survivors at 30 days. KCCQ increased from 17.19 (11.88) before TEER to 53.85 (30.89) in 30 days (mean change 36.67; 95% CI 14.24-59.09; P&lt;0.05, see table2). There was an improvement in 2 out of 4 KCCQ domains; symptoms frequency (mean change 49.17; 95% CI 18.17-80.16; P&lt;0.05) and social limitation (mean change 49.54; 95% CI 22.25-76.83); P&lt;0.05). Conclusion: TEER of the mitral valve improves QOL at 30 days in patients with moderate to severe MR and CS.

Therapeutic components of digital counseling for chronic heart failure.

Task force statements support the use of cognitive behavioral therapy (CBT) and motivational interviewing (MI) to promote self-care in chronic heart failure (CHF) patients. Digital counseling interventions have the potential to complement conventional programs. However, therapeutic components of digital programs associated with improved outcomes are not clearly established. Identify therapeutic components of the Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) protocol that were associated with improved health-related quality of life (HRQL). Ordinal logistic regression was used to identify therapeutic components of the CHF-CePPORT protocol. The primary outcome was the 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) tertile. Logistic regressions determined the association between 12-month KCCQ-OS tertile, using logon hours for key segments of the protocol, modality of content delivery, and clinical themes. A total of 117 patients were enrolled in the e-Counseling arm of the CHF-CePPORT trial. Median age was 60 years (IQR 52-69). Total logon hours in the initial 4-month segment of CHF-CePPORT (Sessions 1-16) was associated with increased 12-month KCCQ-OS tertile (Odds Ratio, OR = 1.31, 95% CI, 1.1-1.5, P = 0.001). Within sessions 1-16, improved KCCQ-OS was associated with logon hours for self-assessment tools/trackers (OR = 1.49, 95% CI, 1.1-2.0, P = 0.007), and videos (OR = 1.57, 95% CI, 1.03-2.4, P = 0.04), but not for CHF information pages. This study highlights the importance of using evidence-based guidelines from CBT and MI as core components of digital counseling, delivered through videos and interactive tools/trackers, to improve HRQL with CHF.

AN ASSESSMENT OF GOAL-DIRECTED BEHAVIOURS THAT PROMOTE HEALTH-RELATED QUALITY OF LIFE: A PROOF-OF-CONCEPT STUDY

AN ASSESSMENT OF GOAL-DIRECTED BEHAVIOURS THAT PROMOTE HEALTH-RELATED QUALITY OF LIFE: A PROOF-OF-CONCEPT STUDY

Impact of frailty on mortality and quality of life in patients with a history of cancer undergoing transcatheter aortic valve replacement.

BackgroundTranscatheter aortic valve replacement (TAVR) is increasingly offered for aortic stenosis (AS) treatment in patients with a history of cancer. The impact of frailty on outcomes in this specific patient population is not well described.HypothesisFrailty is associated with mortality and poorer quality of life (QOL) outcomes in patients undergoing TAVR with a history of cancer.MethodsThis retrospective single center cohort study included AS patients who underwent TAVR from August 1, 2012 to May 15, 2020. Frailty was measured using serum albumin, hemoglobin, gait speed, functional dependence, and cognitive impairment. The primary outcome was a composite of all‐cause mortality and QOL at 1 year. A poor primary outcome was defined as either all‐cause mortality, Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ‐OS) score <45 or a KCCQ‐OS score decline of ≥10 points from baseline. Regression analysis was used to determine the impact of frailty on the primary outcome.ResultsThe study population was stratified into active/recent cancer (n = 107), remote cancer (n = 85), and non‐cancer (n = 448). Univariate analysis of each cohort showed that frailty was associated with the primary outcome only in the non‐cancer cohort (p = .004). Multivariate analysis showed that cancer history was not associated with a poor primary outcome, whereas frailty was (1.7 odds ratio, 95% confidence interval [CI]: 1.1–2.8; p = .028).ConclusionsFrailty is associated with mortality and poor QOL in the overall and non‐cancer cohorts. Further investigation is warranted to understand frailty's effect on the cancer population. Frailty should be heavily considered during TAVR evaluation.

Therapeutic components of an automated digital counselling intervention for chronic heart failure

Abstract Background/Introduction Task force statements advocate digital health interventions to promote self-care behaviour and health-related quality of life (HRQL) in patients with chronic heart failure (CHF). There is a need to identify therapeutic components of digital interventions to improve the efficacy and replicability of these CHF interventions. Purpose The Canadian e-Platform to PrOmote BehavioRal Self-ManagemenT in Chronic Heart Failure trial (CHF-CePPORT) evaluated the efficacy of automated digital counseling to improve HRQL at 12 months, using the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS). Our aim was to identify therapeutic components of the CHF-CePPORT protocol that were independently associated with KCCQ-OS endpoint. Methods CHF-CePPORT was a multicenter, randomized controlled trial with a 2-parallel group, double blind design, and assessments at baseline, 4- and 12-months. This substudy focused on patients randomized to the automated digital counseling arm of CHF-CePPORT. Ordinal logistic regression was used to identify components of the protocol that predicted higher KCCQ-OS tertile at 12-months, according to schedule of automated digital contact, modality of content, and clinical content theme – see Figure. Results From the sample enrolled in CHF-CePPORT (n=230), 117 patients were included in this substudy: female, n=24 (20.5%), median age=60 years (IQR, 52, 69), New York Heart Association Class 1, n=45 (38.5%), Class 2, n=48 (41.0%), and Class 3, n=16 (13.7%). Baseline KCCQ-OS was median=82.3 (IQR, 67, 93). Patient engagement with the digital counseling platform over 12 months was as follows: Median (IQR) total logons = 79 (24, 133), Total logon time = 5.8 hours (1.6, 9.8). Total logon time during the initial phase of the trial (sessions 1–16), with weekly scheduled sessions was independently associated with a higher 12-month KCCQ-OS tertile score (p=0.003). Subsequent sections (sessions 17–24, and 25–28) were not independently associated with the 12-month KCCQ-OS (p=0.56 and p=0.91 respectively). Within sessions 1–16, the 12-month KCCQ-OS was associated with the use of counseling and dramatic videos (p=0.04) and e-tools/trackers (p=0.007), but not conventional information/education pages (p=0.80). Content themes associated with the 12-month KCCQ-OS included motivational counseling (sessions 5–8) with self-assessment tools and trackers (p=0.04). Cognitive behavioural guidelines for HF self-care were also associated with 12-month KCCQ-OS tertiles when presented by expert and dramatic videos (p=0.02) as well as self-assessment etools/etrackers (p=0.02). Self-assessment tools and trackers for HRQL (sessions 15–16) were also associated with higher KCCQ tertiles at 12 months (p=0.01) – see Table. Conclusion(s) The results of this study confirm the importance of using key components from evidence-based, clinically organized protocols of behavioural counseling to promote HRQL for patients with CHF. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Canadian Institutes of Health Research

Automated E-Counseling for Chronic Heart Failure

Background: International task force statements advocate telehealth programs to promote health-related quality of life for patients with chronic heart failure (CHF). To that end, we evaluated the efficacy and usability of an automated e-counseling program. Methods: This Canadian multi-site double-blind randomized trial assessed whether usual care plus either internet-based e-counseling (motivational and cognitive-behavioral tools for CHF self-care) or e-based conventional CHF self-care education (e-UC) improved 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS). Secondary outcomes included program engagement (total logon weeks, logons, and logon hours), total CHF self-care behaviors, diet (fruit and vegetable servings), 6-minute walk test, and 4-day step count. The association between program engagement and health-related quality of life was assessed using KCCQ-OS tertiles. Results: We enrolled 231 patients, median age =59.5 years, 22% female, and elevated median KCCQ-OS=83.0 (interquartile range, 68–93). KCCQ-OS increase ≥5 points was not more prevalent for e-counseling, n=29 (29.6%) versus e-UC, n=32 (34.0%), P =0.51. E-Counseling versus e-UC increased total logon weeks ( P =0.02), logon hours ( P =0.001), and logons ( P &lt;0.001). Only e-counseling showed a positive association between 12-month KCCQ-OS tertile and logon weeks ( P =0.04) and logon hours ( P =0.004). E-Counseling increased CHF self-care behavior and diet but not 6-minute walk test or 4-day step count. Conclusions: The primary KCCQ-OS end point was negative for this trial. Only e-counseling showed a positive association between program engagement and 12-month KCCQ-OS tertile, and it improved CHF self-care behavior and diet. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01864369.

Reverse Cardiac Remodeling Following Initiation of Sacubitril/Valsartan in Patients With Heart Failure With and Without Diabetes

ObjectiveThis study sought to determine whether patients with heart failure and reduced ejection fraction (HFrEF) with type 2 diabetes mellitus (T2DM) have similar reverse cardiac remodeling with sacubitril/valsartan as patients without T2DM. BackgroundSacubitril/valsartan promotes reverse cardiac remodeling and improves outcomes in patients with HFrEF. Patients with HFrEF with T2DM have worse prognosis than those without T2DM. MethodsIn this post hoc analysis of PROVE-HF (Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure), we examined changes in N-terminal pro–b-type natriuretic peptide (NT-proBNP), measures of cardiac remodeling, and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) scores from baseline to 12 months following initiation of sacubitril/valsartan between patients with HFrEF with and without T2DM. Using latent growth curve modeling, we evaluated the longitudinal association between changes in NT-proBNP, left ventricular ejection fraction, and KCCQ-OS. ResultsAmong 794 patients enrolled, 361 (45.5%) had T2DM. NT-proBNP concentrations were modestly higher at baseline among patients with T2DM but were reduced after initiation of sacubitril/valsartan. Cross-sectional improvement was observed in left ventricular ejection fraction (T2DM: 28.3% at baseline and 37% at 12 months vs. non-T2DM: 28.1% at baseline and 38.3% at 12 months) and KCCQ-OS (T2DM: 71 at baseline and 83 at 12 months vs. non-T2DM: 76 at baseline and 88 at 12 months). Similar changes were also observed for other echocardiographic measures. In longitudinal analyses, the average NT-proBNP change was similar in patients with T2DM (–5.6% vs. –7.1% per 90-day interval; p = 0.64), whereas improvements in KCCQ-OS scores were slightly smaller (2.1 vs. 3.46 per 90-day interval; p = 0.07). ConclusionsSacubitril/valsartan favorably affects natriuretic peptide levels, reverse cardiac remodeling, and health status in patients with HFrEF with and without T2DM. (Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes [PROVE-HF]; NCT02887183)

Impact of Tafamidis on Health-Related Quality of Life in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial)

In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial, tafamidis significantly reduced all-cause mortality and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM is associated with a significant burden of disease; further analysis of patient-reported quality of life will provide additional data on the efficacy of tafamidis. In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial, 441 adult patients with ATTR-CM were randomized (2:1:2) to tafamidis 80 mg, tafamidis 20 mg, or placebo for 30 months, with pooled tafamidis (80 mg and 20 mg) compared with placebo. Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) domain scores, EQ-5D-3L scores, and patient global assessment, were prespecified exploratory end points. A greater proportion of patients improved KCCQ-OS score at month 30 with tafamidis (41.8%) versus placebo (21.4%). Tafamidis significantly reduced the decline in all 4 KCCQ-OS domains (p <0.0001 for all), and in EQ-5D-3L utility (0.09 [confidence interval 0.05 to 0.12]; p <0.0001) and EQ visual analog scale (9.11 [confidence interval 5.39 to 12.83]; p <0.0001) scores at month 30 versus placebo. A larger proportion of tafamidis-treated patients reported their patient global assessment improved at month 30 (42.3% vs 23.8% with placebo). In conclusion, tafamidis effectively reduced the decline in patient-reported outcomes, providing further insight into its efficacy in health-related quality of life in patients with ATTR-CM.

Abstract 14666: Association Between Right Ventricular Systolic Pressure and Health Status Following Transcatheter Aortic Valve Replacement

Introduction: Pulmonary hypertension (PH) was shown in multiple studies to be associated with an increased risk of mortality after transcatheter aortic valve replacement (TAVR). However, it is unclear if echocardiogram derived right ventricular systolic pressure (RVSP) is associated with health status outcomes in surviving patients after TAVR. We explored for an association between baseline RVSP and quality of life in patients before and after undergoing TAVR. Methods: We estimated RVSP by echocardiography using the modified Bernoulli equation in a single-center cohort of patients undergoing TAVR from 2012-2017 . Disease-specific health status was assessed at baseline and 1-month and 12-months after TAVR with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS). We then explored the association between baseline RVSP and KCCQ-OS before and after TAVR using a linear mixed model with an interaction for time and baseline RVSP and adjusted for baseline mitral valve regurgitation and systolic blood pressure. Results: Among 485 patients who underwent TAVR (mean age 81.7±7.9 years, 54.8% men), baseline RVSP was 42±15 mmHg, and 73% had RVSP &gt;34 mmHg. After TAVR, mean RVSP decreased to 37±13 mmHg at 1 month and 36±14 mmHg at 12 months. Baseline KCCQ-OS was 46±25 and improved to 66.9±23.6 at 1 month and 69.5± 22.6 at 12 months. In the linear mixed model, there was a significant cross-sectional association between baseline RVSP and baseline KCCQ-OS, with higher RVSP associated with worse health status. However, baseline RVSP was not significantly associated with KCCQ-OS at 1 month or 12 months (Figure). Conclusions: RVSP is not associated with worse health status after TAVR. This suggests that while patients with high RVSP are at an increased risk for mortality after TAVR, surviving patients appear to have similar health status as those with normal RVSP.

Functional Capacity, Health-related Quality-of-life and Cardiac Biomarker Improvement with Tafamidis in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT)

Introduction In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis significantly reduced all-cause mortality and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Tafamidis inhibits formation of amyloid and may result in improvement of additional endpoints associated with disease stage. Hypothesis Patients with ATTR-CM treated with tafamidis are more likely to show improvement in functional capacity, health related quality-of-life and cardiac biomarkers compared with patients treated with placebo. Methods In ATTR-ACT, 441 adult patients with ATTR-CM (variant or wild-type) were randomized (2:1:2) to tafamidis 80 mg, tafamidis 20 mg, or placebo for 30 months, with pooled tafamidis (80mg and 20mg; n = 264) compared with placebo (n = 177). In this post-hoc analysis, change from baseline to Month 30 was assessed to determine the proportion of patients who improved in: 6-minute walk test distance (6MWT); Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score; Patient Global Assessment (PGA); NYHA class; and NT-proBNP concentration. Results In total, 33.5% of tafamidis-treated patients had an improved 6MWT distance, compared with 12.9% of placebo-treated patients. KCCQ-OS score improved in 41.8% of patients treated with tafamidis compared with 21.4% with placebo. As reported on the PGA, a greater proportion of patients were ‘very much improved’, ‘much improved’, or ‘minimally improved’ with tafamidis (42.3%) compared with placebo (23.8%). For patients with baseline NYHA Class II, 8.2% of tafamidis-treated patients and 3.7% of placebo-treated patients improved to Class I. There was a greater proportion of patients whose NT-proBNP concentration decreased with tafamidis (37.6%) compared with placebo (12.5%). Conclusions ATTR-CM is a progressive disease for which either stabilization or improvement indicates an efficacious treatment. In ATTR-ACT over one-third of patients at Month 30 had improvements in measures of functional capacity, health-related quality of life, and cardiac biomarkers. These data provide evidence of clinical improvement for patients with ATTR-CM treated with tafamidis, in addition to the benefits in survival and reduced cardiovascular hospitalization.

Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial

BackgroundTranscatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF). ObjectivesThis study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial. MethodsPatients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone. Super-responders were defined as those alive without HF hospitalization and with ≥20-point improvement in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score at 12 months. Responders were defined as those alive without HF hospitalization and with a 5 to <20-point KCCQ-OS improvement at 12 months. Nonresponders were those who either died, were hospitalized for HF, or had <5-point improvement in KCCQ-OS at 12 months. ResultsAmong 614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified. At 12 months, there were 79 super-responders (27.2%), 55 responders (19.0%), and 156 nonresponders (53.8%) in the MitraClip arm compared with 29 super-responders (10.2%), 46 responders (16.3%), and 208 nonresponders (73.5%) in the GDMT-alone arm (overall p < 0.0001). Independent baseline predictors of clinical responder status were lower serum creatinine and KCCQ-OS scores and treatment assignment to MitraClip. MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders. ConclusionsBaseline predictors of clinical super-responders in patients with HF and severe secondary MR in the COAPT trial were lower serum creatinine, KCCQ-OS score and MitraClip treatment. Improved MR severity and reduced right ventricular systolic pressure at 30 days are associated with a long-term favorable clinical response after transcatheter mitral valve repair. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)