Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation

Suzanne V Arnold; John A Spertus; Kensey Gosch; Shannon M Dunlay; Danielle M Olds; Philip G Jones; Fraser D Bocell; Changfu Wu; David J Cohen

doi:10.1001/jamacardio.2024.4266

. 2024 Oct 30;10(2):117–125. doi: 10.1001/jamacardio.2024.4266

Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation

Suzanne V Arnold ^1,^5,^✉, John A Spertus ^1,⁵, Kensey Gosch ^1,⁵, Shannon M Dunlay ², Danielle M Olds ^1,⁵, Philip G Jones ^1,⁵, Fraser D Bocell ³, Changfu Wu ³, David J Cohen ^4,⁶

¹Healthcare Institute for Innovations in Quality, University of Missouri-Kansas City

²Mayo Clinic, Rochester, Minnesota

³US Food and Drug Administration, Silver Spring, Maryland

⁴St Francis Hospital, Roslyn, New York

⁵Saint Luke’s Mid America Heart Institute, Kansas City, Missouri

⁶Cardiovascular Research Foundation, New York, New York

Accepted for Publication: September 18, 2024.

Published Online: October 30, 2024. doi:10.1001/jamacardio.2024.4266

^✉

Corresponding Author: Suzanne V. Arnold, MD, MHA, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO 64111 (sarnold@saint-lukes.org).

Author Contributions: Drs Arnold and Gosch had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Arnold, Spertus, Olds, Jones, Bocell, Cohen.

Acquisition, analysis, or interpretation of data: Arnold, Spertus, Gosch, Dunlay, Olds, Wu, Cohen.

Drafting of the manuscript: Arnold, Olds, Cohen.

Critical review of the manuscript for important intellectual content: Arnold, Spertus, Gosch, Dunlay, Olds, Jones, Bocell, Wu.

Statistical analysis: Gosch, Jones.

Obtained funding: Wu, Cohen.

Administrative, technical, or material support: Spertus, Olds, Bocell, Wu.

Supervision: Arnold, Spertus.

Conflict of Interest Disclosures: Dr Arnold reported grants from the US Food and Drug Administration (FDA) during the conduct of the study. Dr Spertus reported personal fees from Abbott during the conduct of the study; a copyright patent with royalties for the Kansas City Cardiomyopathy Questionnaire (KCCQ); providing consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Bristol Myers Squibb, Cytokinetics, Edwards Lifesciences, Imbria, Janssen, and Terumo; holding research grants from Bristol Myers Squibb, Cytokinetics, Imbria, and Janssen; owning the copyright to the Seattle Angina Questionnaire, the KCCQ, and the Peripheral Artery Questionnaire; and serving on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr Olds reported grants from the FDA during the conduct of the study. Dr Jones reported grants from the FDA during the conduct of the study. Dr Cohen reported grants from the FDA during the conduct of the study; grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work; and personal fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. No other disclosures were reported.

Funding/Support: This research was funded by an investigator-initiated contract from the US Food and Drug Administration (75F40122C00183).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Disclaimer: This article reflects the views of the authors and does not necessarily represent the practices, policies, requirements, or recommendations of the US Food and Drug Administration. The mention of commercial products, their sources, or their use in connection with material reported here is not to be construed as either an actual or implied endorsement of such products by the US Department of Health and Human Services.

Data Sharing Statement: See Supplement 2.

^✉

Corresponding author.

PMCID: PMC11525660 PMID: 39476153

Key Points

Question

Is the Kansas City Cardiomyopathy Questionnaire (KCCQ) a valid disease-specific health status measure in patients with severe tricuspid regurgitation (TR)?

Findings

In this cohort study, data on 2693 patients from 11 clinical trials of various transcatheter tricuspid valve interventions (TTVI) from 2 device manufacturers were pooled and then analyzed by an academic analytic center. The KCCQ had strong psychometric properties, including reliability, perceived responsiveness, and validity in patients with severe TR.

Meaning

These data support continued use of the KCCQ in rigorous clinical trials of TTVI as a measure of the impact of treatment on patients’ symptoms, function, and quality of life.

Abstract

Importance

Improving patients’ health status is a key goal of treating tricuspid regurgitation (TR). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure disease-specific health status measure used to capture the health status impact of TR and the benefit of transcatheter tricuspid valve intervention (TTVI), but its validity in this clinical setting is unknown.

Objective

To evaluate the psychometric properties of the KCCQ in patients with TR.

Design, Setting, and Participants

Data were pooled from patients with severe TR enrolled in 11 manufacturer-sponsored trials of TTVI. The data were transferred to the US Food and Drug Administration to harmonize and anonymize prior to analysis by an independent center. Data were collected from December 2015 to April 2023, and data analysis was performed from July to October 2023.

Main Outcomes and Measures

Prespecified analyses included evaluation of internal consistency, reproducibility, responsiveness, construct validity, and predictive validity. Outcomes were determined using Cronbach α, score comparisons, intraclass correlation, Cohen d, Spearman correlations with best available reference measures, and association of scores and changes in scores with risk of subsequent clinical events.

Results

The study cohort was composed of 2693 patients enrolled in either single-arm (n = 1517) or randomized (n = 1176) investigations of TTVI. Mean (SD) patient age was 78.6 (8.0) years, 1658 of 2693 patients (61.6%) were female, and the mean (SD) baseline KCCQ Overall Summary (KCCQ-OS) score was 50 (23). There was strong internal consistency within individual domains (Cronbach α, .77-.83). Among clinically stable patients between 1 and 6 months, there were small mean changes in KCCQ domain and summary scores (differences of −0.1 to 1.9 points), demonstrating reproducibility. In contrast, domain and summary scores of patients who underwent TTVI showed large improvements at 1 month after treatment (mean changes, 12.1-21.4 points), indicating excellent perceived responsiveness. Construct validity was moderately strong when domains were compared with best available reference measures (Spearman correlations, 0.47-0.69). In both cross-sectional and longitudinal analyses, the KCCQ-OS was associated with clinical events, with lower scores associated with an increased risk of mortality (hazard ratio, 1.34 per 10-point decrement; 95% CI, 1.22-1.47) and heart failure hospitalization (hazard ratio, 1.24 per 10-point decrement; 95% CI, 1.17-1.31).

Conclusions and Relevance

In this cohort study, the KCCQ had strong psychometric properties in patients with severe TR, including reliability, responsiveness, and validity. These data support use of the KCCQ in patients with severe TR as a measure of their symptoms, function, and quality of life and also for assessing the impact of interventions, such as TTVI, in rigorously controlled trials.

This cohort study evaluates the psychometric properties of the Kansas City Cardiomyopathy Questionnaire in patients with tricuspid regurgitation using pooled data from 11 manufacturer-sponsored trials of transcatheter tricuspid valve interventions.

Introduction

Beyond its impact on survival, severe tricuspid regurgitation (TR) is associated with symptoms of dyspnea, fatigue, and edema that result in reduced functional capacity^1,2 and impaired quality of life.^{3,4,5,6,7,8,9} Tricuspid valve surgery can improve patients’ symptoms and quality of life,^{10,11,12,13,14} but it is rarely performed due to the high burden of comorbidities and concomitant right heart dysfunction that increase the risk for perioperative morbidity and mortality.^15,16,17 In recent years, a number of transcatheter tricuspid valve interventions (TTVI) have been introduced,^2,18 which are less invasive than cardiac surgery and may increase the number of patients potentially eligible for TR treatment. Since improving health status is a key treatment goal for patients with TR, it is critically important to reliably, validly, and sensitively measure patient-reported health status to quantify the benefit of TTVI from patients’ perspectives.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure–specific health status questionnaire originally developed for use in patients with heart failure with reduced left ventricular ejection fraction.¹⁹ It has subsequently undergone extensive reliability and validity testing in other forms of left-sided heart failure^{20,21,22,23,24} and was used as the primary health status outcome in most of the pivotal clinical trials of transcatheter aortic and mitral valve interventions.^{25,26,27,28,29,30,31,32} It has also been used as the primary disease-specific health status outcome for many clinical investigations of TTVI,^{3,4,5,8,33,34} but its validity and psychometric properties in this clinical setting are unknown. Given the prominent role of health status in the evaluation of TTVI, data from multiple clinical trials were used to assess the reliability, responsiveness, and validity of the KCCQ among patients with TR.

Methods

Study Design

The Tri-QOL study was an investigator-initiated study funded by a US Food and Drug Administration (FDA) contract to examine the validity of the KCCQ in patients with TR. As part of this study, we collaborated with device manufacturers to obtain patient-level data from multiple TTVI trials (eTable 1 in Supplement 1), including 8 single-arm and 3 randomized trials of various TTVIs conducted by Edwards Lifesciences or Abbott. Patient-level data were transferred to the FDA to harmonize and anonymize the variables and then transferred to the academic analytic center for this study. The analytic plan was developed by the investigators and executed independently of the device manufacturers that contributed the data, and there was no formal or informal review of the results or manuscript by the device manufacturers prior to submission. The investigators were masked to the trial sponsors, the devices under study, and, in randomized trials, to treatment assignment. Each trial received appropriate review and approval for initial data collection, including written informed consent from all participants. These secondary psychometric analyses were approved by the Advarra central institutional review board, and a waiver of informed consent was granted, given the anonymized nature of the data transferred to the analytic center.

Health Status and Clinical Assessment

The KCCQ is a 23-item self-administered questionnaire that addresses the following specific health domains pertaining to heart failure: physical limitations, symptoms, quality of life, social limitation, symptom stability, and self-efficacy.¹⁹ The physical limitations and symptoms domains are combined into a clinical summary score (KCCQ-CS), with the quality of life and social limitations domains added to form the overall summary score (KCCQ-OS). Values for each domain and the summary scores range from 0 to 100, with higher scores indicating lower symptom burden and better quality of life. The symptom stability domain uses a single question to assess recent changes in patients’ heart failure symptoms and is not appropriate for internal consistency or longitudinal analyses; thus, this domain was excluded. The self-efficacy domain is designed to assess whether a patient feels they have the knowledge and skills to manage their heart failure and is not a direct measure of patients’ health status, so it was also excluded from these analyses. As such, analyses focused on the clinical and overall summary scores and the 4 domains that contribute to them.

As additional measures to explore the validity of the KCCQ, generic health status was assessed with the Medical Outcomes Study 12-Item Short-Form (SF-12) Health Survey,²⁵ a reliable and valid measure of generic health status that provides summary component scores for overall physical health (PCS) and mental health (MCS).³⁵ Scores are standardized using norm-based methods to generate a mean (SD) score of 50 (10), with higher scores indicating better health status.³⁶ Data were also collected on physician-estimated New York Heart Association (NYHA) class and 6-minute walk test distance. The included trials had different time points of health status assessment and follow-up, and thus not all patients were included in each analysis.

Statistical Analysis

Since the identity of the specific trials was masked, analyses were performed among all eligible patients, without adjustment for treatment unless otherwise specified. Where appropriate, analyses were performed exclusively in the single-arm studies, in which all patients underwent TTVI. The specific analytic cohort and the tests used to assess each of the psychometric properties are described in detail below and summarized in eTable 2 in Supplement 1. All analyses were repeated after stratification by patient sex to explore whether there were any meaningful differences in the psychometric properties of the KCCQ by sex. Analyses were conducted using SAS version 9.2 (SAS Institute), and statistical significance was determined by a 2-sided P < .05.

Determining Questionnaire Reliability

Internal consistency of the KCCQ domains at baseline was assessed among all patients using Cronbach α, which ranges from 0 to 1 and reflects the internal consistency of different items within each individual domain. An α of .9 or greater indicates excellent consistency (but may also indicate redundancy), α between .8 and .9, good consistency, α between .7 and .8, acceptable consistency, α between .6 and .7, questionable consistency, and α less than .6, poor consistency.³⁷ For test-retest reproducibility, a clinically stable cohort was identified between 2 time points—patients who were alive at 6 months and had no change in NYHA class and no heart failure hospitalizations between 1 and 6 months. Within this cohort, the mean changes in each KCCQ domain and summary score between 1 and 6 months were calculated. Reproducibility was then tested using the intraclass correlation coefficient (ICC),³⁸ which is the ratio of between-group variance to total variance and ranges from 0 to 1, with higher scores indicating greater test-retest reproducibility (0 to 0.2, poor agreement; 0.3 to 0.4, fair agreement; 0.5 to 0.6, moderate agreement; 0.7 to 0.8, strong agreement; and 0.8 or greater, excellent agreement).³⁹

Determining Questionnaire Responsiveness

The responsiveness of the KCCQ domains to a clinical change was assessed among patients from the single-arm studies who underwent TTVI and were alive 1 month after their procedure. Scores at baseline and 1 month were compared using paired t tests. Cohen d effect size,⁴⁰ which quantifies the magnitude of change relative to baseline variation, was also used to assess the responsiveness of the questionnaire to clinical change. An effect size of 0.2 to 0.3 indicates a small effect; 0.5, a moderately large effect; and 0.8 or higher, a large effect.⁴¹

Determining Questionnaire Validity

The validity of the different domain and summary scores was evaluated by Spearman correlations and associated 95% confidence intervals between the scores and by other prespecified measures that quantify similar concepts. For these analyses, the analytic cohort consisted of all patients alive at 1 month to allow for a wide range of KCCQ scores (including patients who were managed medically or with TTVI). For the physical limitations domain, correlations were examined with the 6-minute walk test, SF-12 PCS, and NYHA class. For the symptoms domain, KCCQ-CS, and KCCS-OS, correlations with NYHA class were examined. Finally, correlations between the quality of life and social limitations scales were examined with the SF-12 MCS. The criterion standards chosen for these comparisons closely mirror those used in the original validation of the KCCQ.¹⁹

To examine the ability of the KCCQ to discriminate between different levels of change, we calculated the change in domain and summary scores for all patients from baseline to 1 month, stratified by their concurrent change in NYHA class, and compared these changes using linear trend tests. Finally, among patients in the single-arm studies, linear trend tests were used to compare the change in each KCCQ domain and summary score from baseline to 1 month after TTVI with the change in TR grade (assessed by core laboratories on a 6-level scale⁴²). For these analyses, patients who were treated with the FORMA device (Edwards Lifesciences) were excluded, owing to challenges in determining follow-up TR grade with a spacer device.¹⁸ We also constructed linear regression models for change in KCCQ (domain and summary scores) from baseline to 1 month as a function of change in TR grade, adjusted for baseline TR grade and baseline KCCQ-OS score (modeled using restricted cubic splines).

Predictive Validity

We examined 2 questions about prognosis with the KCCQ in patients with TR: (1) the cross-sectional association of the KCCQ-OS score with subsequent risk of outcomes and (2) the association of a change in KCCQ-OS with subsequent risk of outcomes. The goal of these analyses was not to determine whether there was a causal association between change in TR and longer-term clinical outcomes, but rather to provide insight into the relevance of any observed differences or changes by benchmarking them to other observed phenomena.

These analyses used all patients at 1 month (including both treatment and control group patients from the randomized clinical trials), in order to provide a wide range of KCCQ scores. We first examined the relationship between KCCQ-OS at 1 month as a categorical variable (0-25; 26-50; 51-75; and greater than 75)²¹ and 1-year death, heart failure hospitalization, and the composite of death or heart failure hospitalization using Kaplan-Meier event curves. Cox proportional hazards regression was used to evaluate the independent association between 1-month KCCQ-OS as a continuous linear variable (restricted cubic splines were not significant) and 1-year death, heart failure hospitalization (censored at death), and death or heart failure hospitalization. Models were adjusted for age, sex, body mass index, chronic lung disease, atrial fibrillation or flutter, coronary artery disease, prior myocardial infarction, prior coronary artery bypass graft surgery, prior stroke, permanent pacemaker, and left ventricular ejection fraction. Continuous covariates were modeled using restricted cubic splines to accommodate potential nonlinear associations.

For the longitudinal analyses, Cox proportional hazards regression models were used to test the association of change in KCCQ-OS at 1 month as a continuous linear variable (restricted cubic splines were not significant) with 1-year death, heart failure hospitalization (censored at death), and death or heart failure hospitalization. These models adjusted for baseline KCCQ-OS (modeled nonlinearly) and the aforementioned patient covariates.

Results

Patient Population

The analytic cohort was composed of 2693 patients with symptomatic TR, which was severe in 872 of 2569 patients (33.9%), massive in 749 patients (29.2%), and torrential in 792 patients (30.8%) (Table 1). Mean (SD) patient age was 78.6 (8.0) years, 1658 of 2693 patients (61.6%) were female, 2464 of 2693 patients (91.5%) had atrial fibrillation or flutter, and 1686 patients (62.6%) were enrolled in the US. Mean (SD) KCCQ-OS score was 50.3 (22.8) at baseline (n = 2645) and 66.4 (22.8) at 1 month (n = 2345). Compared with patients with 1-month KCCQ data, those with missing data (348 patients [13%]) had lower baseline KCCQ scores but were otherwise similar with respect to demographic and clinical characteristics (eTable 3 in Supplement 1).

Table 1. Baseline Characteristics of Study Cohort.

Characteristic	No./total No. (%)
Enrolled in the US	1686/2693 (62.6)
Enrolled in randomized trial	1176/2693 (43.7)
Age, mean (SD) [No.], y	78.6 (8.0) [2693]
Sex
Female	1658/2693 (61.6)
Male	1035/2693 (38.4)
Body mass index, mean (SD) [No.]^a	26.6 (5.6) [2685]
Hypertension	1345/1597 (84.2)
Pulmonary hypertension	947/1498 (63.2)
Chronic lung disease	405/2668 (15.2)
Atrial fibrillation/flutter	2464/2693 (91.5)
Coronary artery disease	485/2693 (18.0)
Prior myocardial infarction	264/2693 (9.8)
Prior percutaneous coronary intervention	517/2693 (19.2)
Prior coronary bypass graft surgery	424/2693 (15.7)
Prior aortic valve surgery	340/2152 (15.8)
Prior mitral valve surgery	500/2152 (23.2)
Pacemaker or implantable defibrillator	689/2668 (25.8)
Prior stroke	269/2693 (10.0)
Heart failure hospitalization in the past 12 mo	1035/2687 (38.5)
Tricuspid regurgitation grade
None, trace, or mild	8/2569 (0.3)
Moderate	148/2569 (5.8)
Severe	872/2569 (33.9)
Massive	749/2569 (29.2)
Torrential	792/2569 (30.8)
Left ventricular ejection fraction, mean (SD) [No.], %	55.8 (10.3) [2302]
TAPSE, mean (SD) [No.], cm^b	1.6 (0.4) [2328]
Right ventricular FAC, %^c	37.9 (8.1) [2198]
Kansas City Cardiomyopathy Questionnaire scores, mean (SD) [No.]
Physical limitation	53.1 (25.5) [2613]
Symptoms	54.5 (25.1) [2643]
Quality of life	45.1 (24.6) [2643]
Social limitation	48.3 (30.1) [2532]
Clinical summary	53.8 (23.1) [2645]
Overall summary	50.3 (22.8) [2645]
New York Heart Association class
1	16/2687 (0.6)
2	765/2687 (28.5)
3	1765/2687 (65.7)
4	141/2687 (5.2)

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Abbreviations: FAC, fractional area of change; TAPSE, tricuspid annular plane systolic exertion.

^{^a}

Calculated as weight in kilograms divided by height in meters squared.

^{^b}

Normal TAPSE greater than 1.7 cm.

^{^c}

Normal FAC greater than 35%.

Reliability of the KCCQ

The quality of life and social limitations domains demonstrated acceptable internal consistency (α, .77 and .78, respectively) while all other domains showed good or excellent consistency (Table 2). Among 803 patients who were deemed clinically stable, the mean differences between 1-month and 6-month KCCQ scores were less than 1 point for all domain and summary scores, except the quality of life domain, for which the mean within-patient change was 1.9 points (95% CI, 0.4 to 3.4) (Table 2). The ICC was moderate to high for all domain and summary scores (range, 0.63-0.71) demonstrating that between-patient variability was greater than within-patient variability.

Table 2. Internal Consistency, Test-Retest Reproducibility, and Responsiveness of the Kansas City Cardiomyopathy Questionnaire (KCCQ).

KCCQ score	Consistency among all patients, Cronbach α (N = 2645)^a	Test-retest reproducibility among stable patients (n = 803)^b		Responsiveness among patients receiving TTVI (n = 1323)^c
KCCQ score	Consistency among all patients, Cronbach α (N = 2645)^a	Difference, mean (95% CI)	ICC^d	Difference, mean (95% CI)	Cohen d^e
Domain scores
Physical limitation	.83	−0.1 (−1.4 to 1.3)	0.68	12.1 (10.8 to 13.4)	0.47
Symptoms	.83	0.4 (−0.8 to 1.7)	0.65	17.8 (16.5 to 19.1)	0.71
Quality of life	.77	1.9 (0.4 to 3.4)	0.63	21.4 (20.0 to 22.8)	0.88
Social limitation	.78	0.9 (−0.9 to 2.7)	0.63	16.6 (14.9 to 18.3)	0.56
KCCQ summary scores
Clinical	NA	0.4 (−0.8 to 1.5)	0.70	15.1 (13.9 to 16.2)	0.65
Overall	NA	0.9 (−0.2 to 2.1)	0.71	17.0 (15.9 to 18.2)	0.75

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Abbreviations: ICC, intraclass correlation; NA, not applicable; TTVI, transcatheter tricuspid valve intervention.

^{^a}

Cronbach α of .9 or greater indicates excellent consistency (but may also indicate redundancy); between .9 and .8, good consistency; between .8 and .7, acceptable consistency; between .7 and .6, questionable consistency; and less than .6, poor consistency.

^{^b}

Test-retest reproducibility measured from 1 month to 6 months among stable patients.

^{^c}

Responsiveness measured from baseline to 1 month among patients receiving TTVI.

^{^d}

ICC of 0 to 0.2 indicates poor agreement; 0.3 to 0.4, fair agreement; 0.5 to 0.6, moderate agreement; 0.7 to 0.8, strong agreement; and 0.8 or higher, excellent agreement.

^{^e}

Cohen d of 0.2 to 0.3 indicates a small effect; approximately 0.5, a medium effect; and 0.8 or greater, a large effect.

Responsiveness of the KCCQ

Among 1323 patients who underwent TTVI, there were moderate to large differences in the KCCQ domain and summary scores before and after intervention (Table 2). The mean (SD) KCCQ-OS score increased from 49.8 (22.6) before intervention to 66.9 (22.3) 1 month after intervention, with a mean difference of 17.0 points (95% CI, 15.9 to 18.2) and an effect size (ratio of mean change to SD at baseline) of 0.75. The physical limitations domain had the smallest change from baseline to 1 month (mean difference, 12.1 points; 95% CI, 10.8-13.4; effect size, 0.47), while the quality of life domain demonstrated the largest change (mean difference, 21.4 points; 95% CI, 20.0-22.8; effect size, 0.88).

Criterion Validity of the KCCQ

The KCCQ domain and summary scores demonstrated moderately strong correlations with the best available reference measures (Spearman correlations, 0.47-0.69; eTable 4 in Supplement 1). When comparing change in KCCQ vs concurrent change in NYHA class from baseline to 1 month, there were strong linear correlations between the 2 measures, with substantially larger increases in both domain and summary scores among those with greater reductions in NYHA class (Table 3). Among patients who underwent TTVI, there was also a graded association between the change in KCCQ scores from baseline to 1 month and concurrent change in TR grade (Table 4). Finally, in regression models that adjusted for baseline KCCQ and baseline TR grade, there were strong, independent associations between change in TR grade from baseline to 1 month and concurrent changes in all domain and summary scores, with an estimated increase of 2.7 points on the KCCQ-OS (95% CI, 1.5 to 3.9) for each 1-grade reduction in TR (Table 4).

Table 3. Mean Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores According to Change in New York Heart Association (NYHA) Class From Baseline to 1 Month.

KCCQ score	Change in NYHA class from baseline to 1 mo, mean (SD)				P value for trend
KCCQ score	Improvement by 2 or 3 (n = 340)	Improvement by 1 (n = 1046)	No change (n = 837)	Worsening (n = 103)	P value for trend
Physical limitation	20.1 (24.6)	13.8 (22.8)	5.3 (21.5)	−6.1 (21.7)	<.001
Symptoms	29.3 (23.2)	18.0 (22.4)	8.5 (22.3)	0.9 (24.5)	<.001
Quality of life	33.9 (26.3)	22.7 (25.3)	13.0 (24.9)	−1.1 (22.7)	<.001
Social limitation	30.1 (31.2)	16.6 (29.3)	8.8 (28.6)	−5.2 (28.3)	<.001
Clinical summary	24.7 (20.8)	16.1 (19.8)	7.0 (19.3)	−2.8 (21.2)	<.001
Overall summary	28.3 (21.3)	18.0 (20.6)	9.0 (20.0)	−2.8 (20.5)	<.001

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Table 4. Mean Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores According to Change in Tricuspid Regurgitation (TR) Grade at 1 Month after Transcatheter Tricuspid Valve Intervention.

KCCQ score	Change in TR grade from baseline to 1 mo, mean (SD)					P value, unadjusted^a	Estimate for change in KCCQ per 1-grade reduction in TR (95% CI)^b	P value, adjusted^c
KCCQ score	−4 (n = 109)	−3 (n = 299)	−2 (n = 415)	−1 (n = 268)	No change (n = 108)	P value, unadjusted^a		P value, adjusted^c
Physical limitation	13.2 (24.1)	16.0 (23.9)	11.7 (23.8)	8.7 (24.6)	8.3 (19.2)	.01	1.5 (0.1-3.0)	.04
Symptoms	20.8 (24.8)	21.2 (23.5)	18.1 (22.2)	13.5 (23.1)	11.0 (21.9)	<.001	2.9 (1.7-4.2)	<.001
Quality of life	24.6 (29.9)	25.1 (25.9)	22.8 (25.8)	17.9 (25.3)	12.7 (23.5)	<.001	3.4 (2.0-4.9)	<.001
Social limitation	23.2 (32.2)	20.6 (30.7)	16.3 (29.5)	11.9 (28.5)	10.2 (25.8)	<.001	2.8 (1.0-4.6)	.002
Clinical summary	17.2 (22.6)	18.8 (20.9)	15.1 (20.0)	11.1 (20.6)	9.6 (17.2)	<.001	2.3 (1.2-3.5)	<.001
Overall summary	20.3 (24.7)	20.7 (21.3)	17.4 (20.8)	13.5 (20.8)	10.3 (18.3)	<.001	2.7 (1.5-3.9)	<.001

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^{^a}

Trend test across the changes in TR.

^{^b}

Adjusted for baseline KCCQ Overall Summary (KCCQ-OS) and baseline TR grade.

^{^c}

Model also included baseline KCCQ and baseline TR.

Predictive Validity

Among 2345 patients with 1-month assessments, there was a graded association between KCCQ-OS at 1 month and the incidence of death, heart failure hospitalization, and the composite of death or heart failure hospitalization through 1 year of follow-up (eFigure A-C in Supplement 1; Table 5). In Cox proportional hazards models, every 10-point decrement in the KCCQ-OS score was associated with a hazard ratio (HR) of 1.34 (95% CI, 1.22-1.47) for death, 1.24 (95% CI, 1.17-1.31) for heart failure hospitalization, and 1.27 (95% CI, 1.20-1.33) for the composite of death or heart failure hospitalization (Table 5). Changes in KCCQ-OS from baseline to 1 month (either after TTVI or with continued medical therapy) were also associated with the risk of subsequent outcomes. In Cox proportional hazards models adjusted for baseline KCCQ-OS, every 10-point improvement in the KCCQ-OS score at 1 month was associated with an HR of 0.78 (95% CI, 0.70-0.87) for death, 0.82 (95% CI, 0.76-0.89) for heart failure hospitalization, and 0.81 (95% CI, 0.77-0.87) for the composite of death or heart failure hospitalization (Table 5). In both analyses, the associations between KCCQ and subsequent outcomes were essentially unchanged after adjusting for patient demographic and clinical factors.

Table 5. Association of Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Score and Change in KCCQ-OS Score with Death and Heart Failure Hospitalization (HFH).

Outcome	Association of KCCQ-OS with end point (per 10-point decrement)^a				Association of change in KCCQ-OS with end point (per 10-point increase)^b
Outcome	Unadjusted HR (95% CI)	P value	Adjusted HR (95% CI)^c	P value	Unadjusted HR (95% CI)^d	P value	Adjusted HR (95% CI)^e	P value
Death	1.33 (1.21-1.46)	<.001	1.34 (1.22-1.47)	<.001	0.78 (0.70-0.87)	<.001	0.80 (0.72-0.89)	<.001
HFH	1.25 (1.18-1.32)	<.001	1.24 (1.17-1.31)	<.001	0.82 (0.76-0.89)	<.001	0.83 (0.77-0.90)	<.001
Death or HFH	1.27 (1.20-1.33)	<.001	1.26 (1.19-1.32)	<.001	0.81 (0.77-0.87)	<.001	0.83 (0.78-0.88)	<.001

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Abbreviation: HR, hazard ratio.

^{^a}

KCCQ-OS at 1 month from trial enrollment, with end points assessed from 1 month through 1 year of follow-up.

^{^b}

Change in KCCQ-OS from baseline to 1 month, with end points assessed from 1 month through 1 year of follow-up.

^{^c}

Adjusted for age, sex, body mass index (calculated as weight in kilograms divided by height in meters squared), chronic lung disease, atrial fibrillation or flutter, coronary artery disease, prior myocardial infarction, prior coronary artery bypass graft surgery, prior stroke, permanent pacemaker, and left ventricular ejection fraction.

^{^d}

Adjusted for baseline KCCQ-OS.

^{^e}

Adjusted for baseline KCCQ-OS, age, sex, body mass index, chronic lung disease, atrial fibrillation or flutter, coronary artery disease, prior myocardial infarction, prior coronary artery bypass graft surgery, prior stroke, permanent pacemaker, and left ventricular ejection fraction.

Stratification by Sex

The demographic and clinical characteristics of the 1035 male and 1658 female patients are shown in eTable 5 in Supplement 1. Compared with male patients, female patients reported lower baseline KCCQ scores by approximately 5 to 7 points across the domains and summary scores. Internal consistency, reproducibility, and perceived responsiveness were similar in male and female patients (eTable 6 in Supplement 1), as were correlations of the domain and summary scores with available reference measures (eTable 7 in Supplement 1). The associations between change in KCCQ and change in NYHA class (eTable 8 in Supplement 1), change in KCCQ and change in TR grade (eTable 9 in Supplement 1), 1-month KCCQ-OS with subsequent death and heart failure (eTable 10 in Supplement 1), and change in KCCQ-OS at 1 month with subsequent death and heart failure (eTable 10 in Supplement 1) were consistent between male and female patients. The 1 notable difference by sex was that the KCCQ appeared to be more responsive to clinical change in female vs male patients, with consistently higher mean changes and effect sizes across the domains and summary scores after TTVI—a finding that may reflect the lower KCCQ scores at baseline in female patients.

Discussion

With the development and refinement of transcatheter interventions to treat valvular heart disease, there is increased recognition of the critical need to understand the impact of these innovative therapies on the symptoms, functional limitations, and quality of life of patients. As such, disease-specific health status, measured using the KCCQ, has been incorporated as a key secondary outcome for nearly all of the pivotal trials of transcatheter aortic valve replacement and transcatheter mitral valve repair and replacement therapies.^{25,26,27,28,29,30,31,32} As the field of transcatheter valvular interventions has expanded into treatment of TR, trials have continued to rely on the KCCQ to quantify the health status benefit of TTVI^{3,4,5,8,33,34}—notwithstanding lack of evidence regarding the validity of this approach. While the KCCQ has been validated in a multiple forms of left-sided heart disease (including aortic stenosis),^{19,20,21,22,23,24} its performance as a disease-specific health status measure was unknown among patients with TR, where symptoms of right-sided heart failure may be more prominent. Given the importance of the KCCQ in defining the clinical benefit of TTVI, understanding the validity of the KCCQ in this clinical setting is even more critical.

In this study of more than 2500 patients with symptomatic TR enrolled in both randomized and single-arm trials of TTVI, we found that the KCCQ demonstrated similar performance as in patients with heart failure with reduced ejection fraction.¹⁹ The 1 difference compared with the original validation studies was in reproducibility, where ICCs in patients with TR for the domain and summary scores ranged from 0.63 to 0.71 (compared with 0.82 to 0.92 in patients with heart failure with reduced ejection fraction).⁴³ These differences may be explained by the fact that this study’s validation analyses were performed over a longer time frame for follow-up (5 months vs 6 weeks) and without an additional criterion for clinical stability (patient and physician global health assessments) to ensure the identification of a stable cohort for test-retest reproducibility. The psychometric properties of the KCCQ in patients with TR were also similar to those seen in patients with severe aortic stenosis.²³ Finally, KCCQ scores and changes in scores were correlated with the risk of subsequent death and heart failure hospitalization. Worse health status was associated with a higher risk of adverse outcomes, but improvement in health status was associated with lower risk. Although it cannot be concluded from these associations that TTVI improves the prognosis of patients with severe TR, it is worth noting that the magnitude of these prognostic associations is similar to what has been observed in patients with chronic heart failure^21,44 and after other transcatheter valve interventions.⁴⁵

Importantly, similar performance of the KCCQ was observed in male and female patients with TR. Previous studies have found that female patients with heart failure generally report worse health status compared with males⁴⁶—a difference also observed in this study. As a result, there have been concerns that male and female patients may interpret questions about symptoms, function, and quality of life differently. Prior quantitative⁴⁷ and qualitative⁴⁸ studies in patients with heart failure have generally dispelled this concern, but this was also essential to investigate in the current study, given the predominance of female patients in TTVI trials.

KCCQ as a Clinical Trial End Point

Within TTVI trials, health status outcomes have played a particularly prominent role. Unlike transcatheter treatment of other valve conditions,^49,50 TTVI has not yet been shown to reduce mortality or heart failure hospitalizations,³⁴ making health status improvement the main treatment benefit and underscoring the importance of establishing the validity of the KCCQ in this clinical setting. The present findings provide reassurance that the KCCQ is a psychometrically sound disease-specific health status measure for patients with severe TR. Although the KCCQ was not originally developed to describe the health status of patients with symptomatic TR, our analyses support the continued use of the KCCQ as a reliable and valid end point in TTVI trials, including any future sham-controlled trials.

Importantly, these analyses do not exclude the possibility that some (or even all) of the benefit of TTVI observed in open-label clinical trials could be explained by a placebo effect. Determining the precise contribution of TTVI to improved health status beyond that explained by the placebo effect can only be achieved in a blinded, sham-controlled trial.

In addition to demonstrating the validity of the KCCQ as a health status measure for patients with TR, several aspects of this study demonstrate the clinical relevance of the KCCQ for this population. First, a strong, independent correlation was found between the change in TR severity across a broad range of devices and short-term improvement in the KCCQ-OS score. Although these findings were based on unblinded trials, and patients may have been aware of their echocardiographic results at the time they completed the KCCQ, the dose-response relationship among patients who all underwent open-label device therapy suggests that there may be a true effect of TR reduction on disease-specific health status. Sham-controlled trials are nonetheless necessary to demonstrate the proportion of the observed benefit that is biologically mediated, rather than a placebo effect. Moreover, associations were found between improvement in KCCQ-OS at 1 month (after TTVI or with continued medical therapy) and a lower risk of subsequent death and heart failure hospitalization. Importantly, this association does not mean that the KCCQ should be considered a surrogate for clinical outcomes or that procedures that improve health status will invariably lead to reductions in death and heart failure hospitalization. However, this finding provides further reassurance that differences in disease-specific health status observed in these studies are meaningful (regardless of their underlying cause).

Limitations

This study should be interpreted in the context of several potential limitations. First, not all KCCQ domains had independent reference standards for the validity analyses, so some domains were compared against the same metrics (eg, the quality of life and social limitations domains were both compared against the SF-12 MCS). These metrics do not directly measure the same concepts of quality of life and social limitations, making a lower correlation to be expected, rather than a concern about the criterion validity of these scales. Second, although these analyses demonstrated strong psychometric performance of the KCCQ in patients with TR, we could not assess its content validity in the current study, as there could be manifestations of TR not captured by the KCCQ. For example, the KCCQ does not capture abdominal distension or anorexia, which may be prominent symptoms for some patients with symptomatic TR. Further qualitative work is needed (and is ongoing) to identify whether there are unique manifestations of TR that are not captured by the KCCQ. Finally, since these studies were not masked to treatment, some assessments, such as NYHA class, may have been biased.

Conclusions

In summary, in this cohort study of more than 2500 patients enrolled in clinical trials of several forms of TTVI, the KCCQ was found to be a reliable, responsive, and valid disease-specific health status instrument for patients with TR. These results support its use in patients with severe TR as a measure of their symptoms, function, and quality of life, and also support its use for assessing the impact of interventions, such as TTVI, in rigorously controlled trials.

Supplement 1.

eTable 1. Summary of Trials Included

eTable 2. Study Design

eTable 3. Characteristics of Patients With vs Without 1-Month KCCQ Data

eTable 4. Spearman Correlations of KCCQ Domain and Summary Scores With Other Measures

eTable 5. Characteristics of Study Cohort, Stratified by Sex

eTable 6. Internal Consistency, Test-Retest Reproducibility, and Responsiveness of the KCCQ, Stratified by Sex

eTable 7. Spearman Correlations of KCCQ Domain and Summary Score With Other Measures, Stratified by Sex

eTable 8. Mean Change in KCCQ Scores According to Change in NYHA Class From Baseline to 1 Month, Stratified by Sex

eTable 9. Mean Change in KCCQ Score According to Change in TR Grade at 1 Month After TTVI, Stratified by Sex

eTable 10. Association of KCCQ-OS Score With Death and Heart Failure Hospitalization, Stratified by Sex

eFigure. Kaplan-Meier Event Curves According to 1-Month Scores on the KCCQ Overall Summary Scale

eReferences.

jamacardiol-e244266-s001.pdf^{(457.4KB, pdf)}

Supplement 2.

Data Sharing Statement

jamacardiol-e244266-s002.pdf^{(13.2KB, pdf)}

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