Utility of the Kansas City Cardiomyopathy Questionnaire for Monitoring
Health Status in Patients with Aortic Stenosis
Arnold et al: KCCQ in Patients with Aortic Stenosis
Suzanne V. Arnold MD MHA*; John A. Spertus MD MPH*; Yang Lei MS*;
Keith B. Allen MD*; Adnan K. Chhatriwalla MD*; Martin B. Leon MD†;
Craig R. Smith MD†; Matthew R. Reynolds MD MSc‡; John G. Webb MD§;
Lars G. Svensson MD¶; David J. Cohen MD MSc*
*Saint Luke’s Mid America Heart Institute, Kansas City, MO; †Columbia-Presbyterian Hospital, New York, NY; ‡Harvard Clinical Research Institute, Boston, MA; §University of British Columbia and St. Paul’s Hospital, Vancouver, BC, Canada; ¶Cleveland Clinic Foundation, Cleveland, OH Correspondence to Suzanne V. Arnold MD MHA Saint Luke’s Mid America Heart Institute 4401 Wornall Rd Kansas City, MO 64111 Phone: 816-932-8606 Fax: 816-932-5613 Email: [email protected] DOI: 10.1161/CIRCHEARTFAILURE.112.970053
Journal Subject Codes: [19] Valvular heart disease, [100] Health policy and outcome research, [11] Other heart failure, [23] Catheter-based coronary and valvular interventions: other
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Abstract
Background—Improving functional status and quality of life are important goals of treatment
for patients with severe aortic stenosis. The Kansas City Cardiomyopathy Questionnaire (KCCQ)
is a health status measure designed for monitoring heart failure and has been used in studies of
patients with aortic stenosis (AS). However, its psychometric properties have not yet been
evaluated in patients with severe valvular heart disease.
Methods and Results—We analyzed data from 955 patients who were enrolled in the
PARTNER trial of transcatheter aortic valve replacement (TAVR) to evaluate the reliability,
responsiveness, validity, and prognostic importance of the KCCQ in patients with severe AS.
The KCCQ was administered to all patients at baseline and at 1, 6, and 12 months after
randomization to medical therapy, TAVR, or surgical valve replacement. Among patients who
were clinically stable, there were only small changes in the KCCQ domain scores over time
(mean differences 0.1 to 4.2 points), and the intraclass correlation coefficients for the domains
showed good agreement between paired assessments (0.65-0.76). In contrast, the domain scores
of patients who underwent TAVR showed large changes after treatment (mean differences 13-30
points). The construct validity of each of the domains was demonstrated by comparing the
domains against relevant reference measures (Spearman correlations 0.46-0.69). Finally, among
157 patients who were randomized to medical management, lower KCCQ overall summary
scores at baseline were strongly associated with an increased risk of mortality over the following
12 months, even after adjusting for STS mortality risk score (HR 1.34 per 10 point reduction,
95% CI 1.17-1.54).
Conclusions—The KCCQ is a highly reliable, responsive, and valid measure of symptoms,
functional status, and quality of life in patients with severe, symptomatic AS.
Key Words: quality of life, aortic stenosis, heart failure, valves
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Aortic stenosis (AS) is prevalent among the elderly and, once symptoms develop, is associated
with considerable risk of morbidity and mortality. Although surgical aortic valve replacement
(AVR) has been considered the “gold standard” therapy for patients with symptomatic AS,
transcatheter aortic valve replacement (TAVR) has recently emerged as a less invasive
therapeutic option. While TAVR has been shown to have a substantial mortality advantage over
medical therapy in patients who are considered to be too high-risk for surgical AVR,1, 2 for many
of these patients who are very elderly and have multiple comorbid conditions, improvements in
symptoms and quality of life may be more important goals of therapy.3, 4 As such, a thorough
understanding of health status outcomes should be an integral part of any study examining
treatment options for severe AS, including TAVR.5
Currently, there are no instruments designed specifically for the assessment of health
status and quality of life among patients with AS. Previous studies have used either generic
health status measures (such as the SF-36 or EuroQol-5D) or relatively crude scales such as the
New York Heart Association (NYHA) classification scheme.6-8 These scales have a number of
important limitations, however, including limited responsiveness to clinically important changes
and reliance on external assessors (rather than the patients themselves). Although patients with
severe AS may experience angina or syncope as their major presenting symptom, heart failure
symptoms are predominant among patients presenting for AVR.9, 10 As such, use of a heart-
failure-specific instrument has been suggested as a potentially useful approach for this
population.5 The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific
instrument originally developed to describe and monitor health status in patients with heart
failure.11 The KCCQ has undergone extensive reliability and validity testing in various heart
failure populations11-13 and has been shown to predict mortality14 and healthcare costs15 in such
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patients. However, its psychometric properties have not been evaluated in patients with AS. We
therefore designed a secondary analysis of a series of clinical trials to assess the reliability,
responsiveness, validity, and prognostic importance of the KCCQ among patients with severe AS
undergoing a range of therapeutic approaches as part of the Placement of Aortic Transcatheter
Valves (PARTNER) trial.
Methods
Patient Population
Patients for our validation study were drawn from the PARTNER trial of patients with severe
symptomatic AS who were being considered as potential candidates for TAVR. Full details of
the study inclusion and exclusion criteria have been described previously.1, 16 Enrolled patients
were required to have severe AS (defined as an aortic-valve area of <0.8 cm2 with either a mean
aortic-valve gradient of 40 mmHg or a /peak aortic-jet velocity of 4.0 m/s); New York Heart
Association (NYHA) class II, III, or IV heart failure symptoms; and high surgical risk based on
the Society for Thoracic Surgeons (STS) risk score. Depending on the assessment of 2 cardiac
surgeons, eligible patients were classified as either high risk but suitable for surgical aortic valve
replacement (cohort A)16 or ineligible for cardiac surgery due to coexisting medical conditions
associated with a predicted probability of death or permanent disability 50% (Cohort B).1
Cohort A patients were randomized to undergo either surgical AVR or TAVR, whereas Cohort B
patients were randomized to TAVR vs. medical therapy. The study was approved by the
institutional review board at each participating site, and all patients provided written informed
consent.
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Health Status and Clinical Assessment
Patients were assessed for clinical factors and health status at baseline and at 1, 6, and 12 months
after randomization. Health status, which includes symptoms, functional status, and quality of
life, was evaluated with the KCCQ, the Medical Outcomes Study Short-Form 12 (SF-12) Health
Survey, and the EuroQol-5D.17 Linguistically and culturally validated translations of the
questionnaires were provided to non-English speakers. Disease-specific health status was
assessed with the KCCQ,11 a 23-item self-administered questionnaire that addresses specific
health domains pertaining to heart failure: physical limitation, symptoms, quality of life, social
limitation, symptom stability, and self-efficacy—the first 4 of which are combined into an
overall summary scale. Values for the domains range from 0 to 100 with higher scores indicating
lower symptom burden and better quality of life. The self-efficacy domain is designed to assess
whether or not a patient feels they have the knowledge and skills to manage their heart failure as
an outpatient. Since patients with severe AS often have symptoms and hospitalizations that are
unrelated to their knowledge of their disease, the self-efficacy domain of the KCCQ does not
apply to patients with AS and thus was excluded from these analyses. The symptom stability
domain uses a single question to assess the change in the patient’s heart failure symptoms over
the past 2 weeks. As such, longitudinal analyses of this domain are difficult to interpret (i.e., a
change of a change). This domain was thus excluded from the reliability and responsiveness
analyses.
Generic health status was assessed with the SF-12 and EuroQol-5D. The SF-12 is a
reliable and valid measure of generic health status that provides summary component scales for
overall physical (PCS) and mental (MCS) health.18 Scores are standardized using norm-based
methods to generate a mean of 50 and a standard deviation of 10, with higher scores indicating
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better health status.19 The EuroQol-5D is a 5-item instrument that assesses specific domains of
health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.20 Responses
to these questions were converted to utility weights according to an algorithm developed for the
U.S. population.21, 22 In addition to patient-reported health status, patients were assessed for
NYHA functional class and the distance covered during a 6-minute walk test at baseline and at
each of the follow-up time points.
Statistical Analysis
Determining Questionnaire Reliability. Internal consistency of the KCCQ domains was assessed
using Cronbach’s alpha. All patients at baseline were included in this analysis (n=940). Values of
the Cronbach’s alpha statistic range from 0-1 and reflect the consistency of different items within
each individual domain. In general, 0.9 indicates excellent consistency; 0.9 > 0.8 is quite
good; 0.8 > 0.7 is acceptable; 0.7 > 0.6 is questionable; and 0.6 > is poor.23
To test the instrument’s test-retest reproducibility, we first identified a cohort that was
clinically stable throughout the period of observation. This cohort was comprised of patients who
were 12 months post-TAVR, had no hospitalizations in the prior 6 months, and had no change in
NYHA functional class from 6 to 12 months. A total of 152 patients met the inclusion criteria for
the stable cohort. Domain scores at 6 and 12 months were then compared using paired t-tests.
Reproducibility was further examined with the intraclass correlation coefficient,24 which is the
ratio of between-groups variance to total variance. The ICC ranges from 0 to 1 with higher
scores indicating increased test-retest reliability. In general, an ICC 0-0.2 indicates poor
agreement, 0.3-0.4 indicates fair agreement, 0.5-0.6 indicates moderate agreement, 0.7-0.8
indicates strong agreement, and >0.8 indicates excellent agreement.25
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Determining Questionnaire Responsiveness. The responsiveness of the KCCQ domains
to a clinical change was first assessed among patients who underwent TAVR and were alive at 1
month after the procedure (n=419). Scores at baseline and 1 month were compared using paired
t-tests. Cohen’s d effect size,26 which quantifies the magnitude of change relative to baseline
variation, was also used to assess the responsiveness of the questionnaire to clinical change. In
general, an effect size of 0.2 to 0.3 indicates a small effect; ~0.5 is a medium effect; and 0.8 is a
large effect.27
To examine the sensitivity of the KCCQ to clinically relevant changes and its ability to
discriminate between different levels of change, we calculated the change in domain scores for
all patients from baseline to 1 month (n=761) stratified by their change in NYHA class over the
same time period and examined the relationship between the change in domain scores vs. the
change in NYHA class using a linear trend test.
Determining Questionnaire Validity. The validity of the different domains was tested by
comparing the domains with other measures that quantify similar concepts. For the symptom
stability domain, we compared 2 cohorts of patients at 1 month: a stable cohort of 15 patients
who were medically managed, had no interval hospitalizations and no change in NYHA class
from baseline to 1 month; and an unstable cohort of 347 patients who underwent TAVR and had
an improvement in NYHA class from baseline to 1 month. Symptom stability scores at 1 month
were compared between the 2 groups using an independent t-test.
For all other domains, the analytic cohort consisted of all patients alive at 6 months after
randomization (n=739). For the KCCQ physical limitations domain, we examined the correlation
with the 6-minute walk test, the SF-12 PCS, and NYHA functional class. For the KCCQ
symptoms domain and the overall summary score, we examined their correlations with NYHA
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functional class. Finally, we examined the correlations between both the KCCQ quality of life
and social limitations scales and the SF-12 MCS. The criterion standards chosen for these
comparisons closely mirror those used in the original validation of the KCCQ.11 Spearman's
rank correlation coefficients were used to test all correlations.
Prognostic Importance. The association between the KCCQ overall summary score and
survival was examined among patients who were randomized to medical therapy alone (n=157).
We first compared the mean baseline scores between patients who died (n=77) vs. those who
survived the 12 months after randomization (n=80) using independent t-tests. Cox proportional
hazard regression was used to evaluate the association between baseline scores as a continuous
variable (scaled per 10 points) and 12-month mortality, adjusting for the STS risk score which
incorporates multiple prognostically important demographic and clinical factors (e.g., age, sex,
multiple comorbidities, cardiac structure and function; Supplemental Table I) into a mortality
risk estimate. Finally, we examined the relationship between the KCCQ overall summary scale
as a categorical variable (0-25, 26-50, and >50)14 and 12-month survival using Kaplan-Meier
survival curves and the log-rank test. Cox regression was used to evaluate the association of
KCCQ scores as a categorical variable (Reference group: scores >50) with 12-month mortality
after adjusting for the STS mortality risk score.
All analyses were conducted using SAS v9.2 (SAS Institute, Inc., Cary, NC), and
statistical significance was determined by a 2-sided p-value of <0.05.
Results
Patient Population. The overall patient population was comprised of 955 patients with severe
AS (mean AVA=0.64 cm2). The mean age of the population was 84 years, 46% were female, the
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mean left ventricular ejection fraction was 53%, and 94% had NYHA Class 3 or 4 heart failure
symptoms. As participants in the PARTNER trial, a total of 157 patients were randomized to
medical therapy, 498 were assigned to TAVR, and 300 were assigned to surgical aortic valve
replacement (Table 1). Descriptions of the patients included in each of the analyses and the tests
used to assess each of the psychometric properties are shown in Table 2 and Supplemental Table
II.
Reliability of the KCCQ. The results of the internal consistency analysis of the domains
of the KCCQ are shown in Table 3. The quality of life domain demonstrated acceptable
consistency ( =0.72) while all other domains showed good or excellent consistency ( >0.8).
The reproducibility of the KCCQ among 159 patients who were clinically stable between
assessments is shown in Table 4. Serial assessments were similar between 6 and 12 months for
all domains except the Physical Limitations domain, in which the mean within-patient change in
scores decreased by 4.2 points (95% CI 0.9 to 7.4, p=0.013), although the ICC was high
suggesting greater inter-subject than within-subject variability. In fact, the ICC indicated
moderate-to-strong agreement between the 2 assessments for all domains, supporting the
reproducibility of the KCCQ in stable patients.
Responsiveness of the KCCQ. Among patients who underwent treatment for their AS
with TAVR, there were dramatic differences in the KCCQ scores before and after treatment
(Table 5). The symptom, quality of life, and overall summary domains of the KCCQ all showed
large effect sizes with the physical limitations and social limitations domains showing moderate
effect sizes. When all of the patients alive at 1 month were stratified by change in NYHA class
from baseline, the KCCQ demonstrated excellent discriminatory ability (Table 6). There was
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little difference in the change in KCCQ between those with a 2-class vs. 3-class decrease in
NYHA, possibly reflecting the coarseness of the NYHA measurement.
Validity of the KCCQ. The results of correlation analyses between the KCCQ domains
and relevant criterion standards (based on 6 month results for all scales) are summarized in Table
7. The Physical Limitations domain was significantly correlated with measures of functional
status including the 6-minute walk test (r=0.46), the SF-12 PCS (r=0.69), and NYHA class (r=-
0.49; p<0.0001 for all). The Quality of Life domain was highly correlated with measures of
generic health status including the SF-12 physical (r=0.52) and mental components (r=0.50) as
well as EuroQol-5D derived utilities (r=0.52; p<0.0001 for all). The Social Limitations domain
was highly correlated with the SF-12 mental component (r=0.50; p<0.0001). The KCCQ
Symptom scale and Overall Summary Score were highly correlated with NYHA class (r=-0.50
and -0.53, respectively; p<0.0001 for both; Figure 1). Finally, for the symptom stability scale,
comparison of 1-month scores between patients who were stable over the prior month vs. those
who had improved clinically demonstrated a substantial difference between the 2 groups, as
expected (stable vs. unstable: 48.3 vs. 72.3, p<0.0001).
Prognostic Importance. Over the 12 months following randomization, 77 of the 157
patients (49%) who were randomized to medical management died. At baseline, mean scores on
the KCCQ Overall Summary Scale of those patients who died were significantly lower than
those who were alive at 12 months (28.2 vs. 41.0, p<0.0001). In a Cox proportional hazards
model adjusted for STS mortality risk score, every 10 point decline in the KCCQ Overall
Summary Scale at baseline was associated with an 34% greater hazard of dying over the
following 12 months (HR 1.34, 95% CI 1.17-1.54, p<0.0001). Similar findings were noted in
categorical analyses in which there was a strong association between ranges of the baseline
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KCCQ summary scale and 12 month survival (Figure 2). Compared with patients who had
baseline scores >50, patients with scores of 25 faced a nearly 4-fold increased risk of dying
over the following 12 months, even after adjusting for the STS mortality risk score (HR 3.75,
95% CI 1.93-7.29, p<0.0001). The prognosis for patients with scores 26-50 did not differ
significantly from those with higher scores (HR 1.40, 95% CI 0.68-2.85, p=0.36).
Discussion
With the rapid development and expanded use of non-surgical approaches for treatment of
patients with severe aortic stenosis, there is an increasing need to understand the impact of these
innovative therapies on the short- and long-term quality of life of patients. While improved long-
term survival is a fundamental goal of treatment for patients with severe AS, improved health
status may be an equally important goal for the elderly, complex patients who are increasingly
considered candidates for such therapies. Indeed, for many such patients, therapies that lead to
improved survival without improved quality of life may not be considered worthwhile. As such,
it is critically important that studies of TAVR and its alternatives use a health status instrument
that reliably and validly quantifies the spectrum of symptoms, functional status, and quality of
life of patients with AS.
Previous studies have demonstrated that the KCCQ is a valid, sensitive, and
prognostically relevant tool for quantifying health status and quality of life in patients with heart
failure.11-15 Since heart failure symptoms are the predominant clinical manifestation of patients
with severe AS,9, 10 we hypothesized that the KCCQ could serve as a valid disease-specific
measure in such patients. In this study of nearly 1000 patients with severe symptomatic AS
undergoing a variety of treatment approaches for their AS, we found that the KCCQ retains its
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previously documented psychometric properties. In addition, we found that among patients who
were medically managed for their AS, KCCQ scores were strongly associated with long-term
mortality, even after adjusting for the STS mortality risk score that integrates multiple
prognostically important demographic and clinical characteristics, and thus could be used to help
inform patients’ expectations of the course of their disease.
Comparison with Prior Studies. The psychometric characteristics of the KCCQ in our
study were comparable to those observed in the original KCCQ validation study, with similar
internal consistency, reproducibility, responsiveness and construct validity.11 Importantly, the
mean age of our population was 84 years versus 64 years in the original validation cohort of
heart failure patients. Despite the older age of our population, the psychometric properties and
interpretability of the KCCQ were similar to those observed in prior studies of heart failure
patients. In addition to the original set of analyses, we also examined the sensitivity to change of
the KCCQ and its ability to discriminate between different levels of change and found that the
KCCQ also performed well in this regard. Of note, we did not include the self-efficacy domain in
our analyses as we felt that the domain questions, which are designed to assess a patient’s
knowledge and confidence in managing his or her disease, would not be as applicable to patients
with severe AS. There has been one study that examined the psychometric qualities of the
Minnesota Living with Heart Failure Questionnaire in 50 patients undergoing valve surgery, 11
of whom had aortic stenosis.28 By evaluating the scale at baseline and after surgery, as compared
with the SF-36, the authors found that this heart failure scale demonstrated acceptable internal
consistency, construct validity and responsiveness. Importantly, reliability, sensitivity to change,
and prognostic associations were not assessed in this small sample of patients with mixed
valvular heart disorders.
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The prognostic value of the KCCQ has been demonstrated previously among patient with
heart failure. In a cohort of 1516 patients with recent acute MI and heart failure or reduced left
ventricular function, Soto and colleagues reported that patients who had KCCQ Overall
Summary scores <25 had a 2-fold increased hazard of death or rehospitalization over the
following 11 months as compared with those with scores 75.14 Heidenreich and colleagues
reported similar findings in an outpatient heart failure population.29 In the PARTNER trial
population, we found that patients with severe AS and low KCCQ scores who were treated
medically had a nearly 4-fold higher risk of death over the following year as compared with
those with higher KCCQ scores. The stronger association with mortality seen in our study most
likely reflects both the older age of our patient population and the generally poorer prognosis of
patients with severe, symptomatic AS compared with the post-myocardial infarction heart failure
population that has been studied previously. Of note, we did not include rehospitalization in our
prognosis analyses given the high mortality rate (50% dead by 1-year) and the high frequency of
hospital admissions for procedures such as balloon aortic valvuloplasty.
Limitations. Our study should be interpreted in the context of several potential
limitations. First, virtually all of the patients in our study had advanced heart failure symptoms,
as indicated by the high prevalence of NYHA Class III or IV functional status at baseline. Thus,
it is unclear if our findings apply to patients with less severe symptomatic manifestations of heart
failure, although there is no a priori reason to expect that the KCCQ would be less valid in these
patients. It is important to note that many of the analyses were performed using data from 6-
month follow-up after TAVR or AVR, at which time there was a much broader range of
symptom levels and functional abilities, further underscoring the validity of the KCCQ in less
symptomatic AS patients. Second, not all KCCQ domains had independent reference standards
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for the validity analyses, so some domains were compared against the same metrics (e.g., the
quality of life and social limitations domains were compared against the SF-12 MCS). While we
still observed strong correlations with the corresponding measures demonstrating acceptable
validity of these domains, use of the more comprehensive SF-36 would have improved the
specificity of our validity testing. Moreover, there is no ‘gold standard’ for quantifying the
impact of a disease on patients’ perceptions of its impact on their function, symptoms and quality
of life. Finally, while we were able to assemble several appropriate patient groups in which to
test the psychometric properties of the KCCQ in severe AS patients, these analytic populations
were retrospectively constructed as secondary data analyses. As such, we were unable to
examine every facet of its psychometric properties, such as face and content validity, which
would need to be tested in a prospective manner.
Conclusions. Based on this study of patients from the PARTNER trial, the KCCQ
appears to be a reliable, responsive, and valid health status instrument for patients with aortic
stenosis. Importantly, the psychometric characteristics of the KCCQ were comparable to those
observed in the original KCCQ validation study performed in post-MI patients, despite
differences in the age of the population and primary disease process. Given the importance of
symptoms, functional status, and quality of life in elderly patients with severe AS, the KCCQ
should be considered a highly relevant and meaningful outcome for both clinical trials and
registry-based studies TAVR. In addition, given its prognostic value, the KCCQ could also serve
as an important tool in the clinical management of patients with severe AS. Future studies are
necessary to determine whether the KCCQ can help guide the appropriate timing of valve
intervention—both when symptoms and quality of life are impaired enough to intervene but
before patients are too sick to benefit from valve replacement.
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Sources of Funding
This study was self-funded.
Disclosures
John Spertus owns the copyright to the KCCQ. Martin Leon is a nonpaid member of the
Scientific Advisory Board of Edwards Lifesciences and has received travel reimbursement from
Edwards for activities related to his participation on the Executive Committee of the PARTNER
Trial. Craig Smith has received travel reimbursement from Edwards Lifesciences for activities
related to his participation on the Executive Committee of the PARTNER Trial. Matthew
Reynolds has received research support from Edwards Lifesciences, Biosense Webster, Sanofi-
Aventis; and consulting fees from Biosense Webster, Sanofi-Aventis, St. Jude Medical, and
Medtronic. John Webb has received consulting fees from Edwards Lifesciences and travel
reimbursement for activities related to his participation on the Executive Committee of the
PARTNER Trial. Lars Svensson has received travel reimbursement from Edwards Lifesciences
for activities related to his participation on the Executive Committee of the PARTNER Trial.
David Cohen has received research support from Edwards Lifesciences, Medtronic, Boston
Scientific, Abbott Vascular, MedRad, Merck/Schering-Plough, and Eli Lilly-Daiichi Sankyo;
consulting income from Schering-Plough, Eli Lilly, Medtronic, and Cordis; and speaking
honoraria from Eli Lilly, The Medicines Company, and St. Jude Medical. The other authors have
no potential conflicts to disclose.
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MS, MoMMMM on MMRRR, MMMenennenndded lofffffffff EEEEN,N,N,, HuHudddddddd leleston CCBBB, PPPasque MKMKM , ife after aortic vaaaalvlvlvve eeee rerererereplplplplp acaaaa emeeee enenenennt tttt atatatatat ttthehehehehe aaaagegegegege ooooof >80 years. Cir
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28. Supino PG, Borer JS, Franciosa JA, Preibisz JJ, Hochreiter C, Isom OW, Krieger KH, Girardi LN, Bouraad D, Forur L. Acceptability and psychometric properties of the minnesota living with heart failure questionnaire among patients undergoing heart valve surgery: Validation and comparison with sf-36. J Card Fail. 2009;15:267-277.
29. Heidenreich PA, Spertus JA, Jones PG, Weintraub WS, Rumsfeld JS, Rathore SS, Peterson ED, Masoudi FA, Krumholz HM, Havranek EP, Conard MW, Williams RE. Health status identifies heart failure outpatients at risk for hospitalization or death. J Am Coll Cardiol. 2006;47:752-756.
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Table 1. Baseline Demographic and Clinical Characteristics of the Analytic Population
Characteristic N=955
Age (y) 83.6 ± 7.3
Female 46.3%
Caucasian 93.2%
STS Mortality Risk Score (%) 11.6 ± 4.2
Aortic Valve Area (cm2) 0.64 ± 0.19
Mean Aortic Valve Gradient (mmHg) 43.4 ± 14.8
Ejection Fraction (%) 52.8 ± 13.8
Prior Myocardial Infarction 26.1%
Prior Bypass Graft Surgery 41.8%
Oxygen-Dependent Lung Disease 13.6%
Creatinine >2mg/dL 18.9%
NYHA Class
II 6.3%
III 44.5%
IV 49.2%
Treatment
Medical Management 16.4%
Surgical Valve Replacement 31.4%
Transcatheter Valve Replacement 52.1% STS, Society of Thoracic Surgeons
6.6.3%%%
4444.5%55%5%
494949 22.2%%%
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Table 2. Summary of Analytic Approaches
Attribute Patients Reference Measure Analysis
Internal Consistency All patients at baseline (n=955) Baseline KCCQ items Cronbach's alpha
Test-Retest Reliability Stable patients post-TAVR (n=152) 6M in KCCQ scores Paired t-test, Intraclass correlation coefficient
Responsiveness TAVR patients alive at 1M (n=419) 1M in KCCQ scores Paired t-test, Cohen's d
Sensitivity to Change All patients alive at 1M (n=761) 1M in KCCQ by in NYHA class Paired t-tests
Construct Validity
Physical Limitations All patients alive at 6M (n=739) 6MWT, NYHA class, SF-12 PCS Correlation
Symptom Scale All patients alive at 6M (n=739) NYHA class Correlation, Linear trend
Symptom Stability Stable MM patients at 1M (n=15); TAVR patients at 1M; (n=347)
1M scores of stable vs. unstable patients Two-sample independent t-test
Quality of Life All patients alive at 6M (n=739) SF-12 PCS, SF-12 MCS, EuroQol-5D Correlation
Social Limitation All patients alive at 6M (n=739) SF-12 MCS Correlation
Overall Summary Scale All patients alive at 6M (n=739) NYHA class Correlation, Linear trend
Prognostic Importance MM patients (n=157) Survival at 12M
Two-sample independent t-test (dead vs. alive), Cox
proportional hazards regression, Log-rank test
TAVR, transcatheter aortic valve replacement; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; MM, medical management; = change; M = months
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Table 3. Internal Consistency of the KCCQ Domains
Domain Cronbach's Alpha
Physical limitation 0.88
Symptoms 0.83
Quality of life 0.72
Social limitation 0.89
Overall summary 0.94
KCCQ, Kansas City Cardiomyopathy Questionnaire
0.9 indicates excellent consistency; 0.9> 0.8 is quite good; 0.8> 0.7 is acceptable; 0.7> 0.6 is questionable; and 0.6> is poor23
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Table 4. Six-Month Change in KCCQ Scores Among Patients in the Reliability Cohort (n=159)
6M Mean 12M Mean Mean Difference p-value ICC*
Physical limitation 68.6 65.6 -4.2 0.013 0.74
Symptoms 80.1 78.1 -1.9 0.138 0.65
Quality of life 79.7 79.8 0.1 0.954 0.69
Social limitation 73.2 73.0 0.6 0.781 0.71
Overall summary 76.1 74.5 -1.5 0.200 0.76
KCCQ, Kansas City Cardiomyopathy Questionnaire; ICC, Intraclass Correlation Coefficient *ICC 0-0.2 indicates poor agreement, ICC 0.3-0.4 is fair; ICC 0.5-0.6 is moderate; ICC 0.7-0.8 is strong; and >0.8 is excellent25
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Table 5. One-Month Change in KCCQ Scores Among Patients Who Underwent TAVR (n=419)
Baseline Mean 1M Mean Mean Difference p-value Effect Size*
Physical limitation 40.0 54.3 +12.9 <0.0001 0.51
Symptoms 49.4 68.5 +19.2 <0.0001 0.84
Quality of life 34.8 64.4 +29.7 <0.0001 1.16
Social limitation 32.0 54.1 +21.9 <0.0001 0.69
Overall summary 39.2 61.1 +22.0 <0.0001 0.94
KCCQ, Kansas City Cardiomyopathy Questionnaire * Effect size 0.2 to 0.3 indicates a small effect; ~0.5 is a medium effect; and 0.8 is a large effect27
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Table 6. Mean One-Month Change in KCCQ Score, Stratified by Change in NYHA Class
NYHA Change from Baseline to 1 Month
by 3 (n=79)
by 2 (n=255)
by 1 (n=278)
No change (n=146)
Worsening (n=28)
p-value for trend
Physical limitation 18.9 16.8 4.2 -0.5 -2.5 0.0003
Symptoms 26.4 24.3 13.0 6.2 -12.4 <0.0001
Quality of life 30.4 33.2 22.8 13.3 2.6 <0.0001
Social limitation 27.2 26.3 11.7 6.7 -6.7 <0.0001
Overall summary 27.0 26.0 14.4 6.7 -5.4 <0.0001
KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association
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Table 7. Convergent Validity Testing: Correlations of KCCQ Domains with Other Measures (n=739)
NYHA SF-12 PCS SF-12 MCS 6MWT EuroQol-5D
Physical limitation -0.49 0.69 0.46
Symptoms -0.50
Quality of life 0.52 0.50 0.52
Social limitation 0.50
Overall summary -0.53
KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; SF-12, Medical Outcomes Study Short-Form 12; PCS, physical components summary; MCS, mental components summary; 6MWT, 6-minute walk test
P<0.0001 for all correlations
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Figure Legends
Figure 1. A. Mean scores on the KCCQ Symptom Scale according to baseline NYHA
classification. B. Mean scores on the KCCQ Overall Summary Scale by baseline NYHA
classification. KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart
Association
Figure 2. Kaplan-Meier survival curves according to baseline scores on the KCCQ Overall
Summary Scale among medically-managed patients (n=157). KCCQ, Kansas City
Cardiomyopathy Questionnaire
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Leon, Craig R. Smith, Matthew R. Reynolds, John G. Webb, Lars G. Svensson and David J. CohenSuzanne V. Arnold, John A. Spertus, Yang Lei, Keith B. Allen, Adnan K. Chhatriwalla, Martin B.
Patients with Aortic StenosisUtility of the Kansas City Cardiomyopathy Questionnaire for Monitoring Health Status in
Print ISSN: 1941-3289. Online ISSN: 1941-3297 Copyright © 2012 American Heart Association, Inc. All rights reserved.
is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231Circulation: Heart Failure published online December 10, 2012;Circ Heart Fail.
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SUPPLEMENTAL MATERIAL Supplemental Table I. Components of the Society for Thoracic Surgeons Mortality Risk Score
Demographics
Age
Sex
Risk Factors
Weight
Height
Diabetes
Diabetes Treatment
Creatinine
Dialysis
Hypertension
Infective Endocarditis
Chronic Lung Disease
Immunosuppression
Peripheral Artery Disease
Previous Interventions
Prior Bypass Surgery
Prior Valve Surgery
Number of Prior Cardiac Surgeries
Preoperative Cardiac Status
Prior Myocardial Infarction
Congestive Heart Failure
New York Heart Association Heart Failure Class
Angina
Cardiogenic Shock
Resuscitation
Arrhythmias
Inotropes
Intra-aortic Balloon Pump
Left Main Disease
Left Ventricular Ejection Fraction
Mitral Stenosis
Status of the Procedure (Elective, Urgent, Emergent)
Supplemental Table II. Baseline Demographic and Clinical Characteristics of the Different Analytic Populations
Characteristic Reliability
n=159 Responsiveness
n=419
Sensitivity to Change n=761
Construct Validity n=739
Prognostic n=157
Age (y) 83.7 ± 7.1 83.4 ± 7.6 83.4 ± 7.5 83.6 ± 7.3 82.9 ± 8.7
Female 46.7% 46.5% 46.1% 46.1% 51.6%
Caucasian 96.1% 93.1% 92.9% 92.0% 91.7%
STS Mortality Risk Score (%) 11.0 ± 3.8 11.5 ± 4.3 11.5 ± 4.1 11.4 ± 3.9 11.8 ± 4.9
Aortic Valve Area (cm2) 0.65 ± 0.19 0.66 ± 0.19 0.65 ± 0.20 0.65 ± 0.19 0.64 ± 0.21
Mean Gradient (mmHg) 45.6 ± 14.5 43.9 ± 15.0 43.6 ± 15.1 44.1 ± 14.9 42.9 ± 15.5
Ejection Fraction (%) 53.0 ± 13.9 53.3 ± 13.9 52.8 ± 14.1 52.9 ± 13.8 49.5 ± 15.2
Prior Myocardial Infarction 23.2% 24.7% 26.6% 26.0% 26.8%
Prior Bypass Graft Surgery 38.8% 39.9% 43.6% 43.3% 43.9%
Oxygen-Dependent Lung Disease 7.9% 12.4% 12.5% 12.2% 26.1%
Creatinine >2mg/dL 14.5% 18.7% 18.6% 17.2% 19.2%
NYHA Class
II 5.9% 7.2% 6.4% 7.2% 5.7%
III 42.8% 44.4% 44.0% 45.3% 49.7%
IV 51.3% 48.4% 49.5% 47.5% 44.6%
Treatment
Medical Management 16.2% 14.7% 100.0%
Surgical Valve Replacement 28.8% 30.0%
Transcatheter Valve Replacement 100.0% 100.0% 55.1% 55.2%
STS, Society of Thoracic Surgeons