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. 2022 Sep;10(9):651-661.
doi: 10.1016/j.jchf.2022.03.003. Epub 2022 Jun 8.

Minimally Clinically Important Difference in Health Status Scores in Patients With HFrEF vs HFpEF

Javed Butler  1 , Muhammad Shahzeb Khan  2 , JoAnn Lindenfeld  3 , William T Abraham  4 , Gianluigi Savarese  5 , Afshin Salsali  6 , Cordula Zeller  7 , Barbara Peil  8 , Gerasimos Filippatos  9 , Piotr Ponikowski  10 , Stefan D Anker  11
Affiliations
Free article

Minimally Clinically Important Difference in Health Status Scores in Patients With HFrEF vs HFpEF

Javed Butler et al. JACC Heart Fail. 2022 Sep.
Free article

Abstract

Background: Differences in clinically important thresholds in patient-reported outcomes measures such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) remain less well-established in patients with heart failure with preserved ejection fraction (HFpEF) versus heart failure with reduced ejection fraction (HFrEF).

Objectives: The purpose of this study was to estimate meaningful thresholds for improvement or deterioration in the KCCQ-Total Symptom Score (TSS) in patients with HFrEF versus HFpEF.

Methods: This secondary analysis of EMPERIAL program used anchor- and distribution-based approaches to estimate thresholds for improvement or deterioration in the KCCQ-TSS using Patient Global Impression of Severity (PGIS) as the primary anchor. Mean change in KCCQ-TSS from baseline to week 12 was calculated for each PGIS.

Results: A total of 312 HFrEF and 315 HFpEF patients were enrolled. At week 12, mean changes in KCCQ-TSS corresponding to PGIS changes of "any improvement," "1-category improvement," and "1-category deterioration" were 13 ± 17, 12 ± 17, -3 ± 16 points in HFrEF, and 15 ± 18, 13 ± 17, -7 ± 18 points in HFpEF. Threshold for meaningful within-patient change in KCCQ-TSS was ≥9 points in HFrEF and ≥7 points in HFpEF patients. Sensitivity and specificity of ≥9 points/≥7 points change was 0.65 and 0.70 for HFrEF and 0.64 and 0.66 for HFpEF. Cumulative distribution function curves of KCCQ-TSS change from baseline to week 12 showed a shift to higher scores in both HFrEF and HFpEF patients.

Conclusions: In the EMPERIAL program, a change in KCCQ-TSS of ≥9 points in HFrEF and ≥7 points in HFpEF represents the minimal clinically important difference for improvement, confirming the broad range of 5-10 points as meaningful thresholds.

Keywords: KCCQ-TSS; health status score; heart failure; preserved ejection fraction; reduced ejection fraction.

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Conflict of interest statement

Funding Support and Author Disclosures The EMPERIAL trials were sponsored by Boehringer Ingelheim. Dr Butler has received consulting fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, NovoNordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Ltd, and Vifor. Dr Lindenfeld has received personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, CVRx, Edwards Lifesciences, Impulse Dynamics, and V-Wave Ltd; and has received grants from AstraZeneca, Sensible Medical, and Volumetrix. Dr Abraham has received personal fees from Boehringer Ingelheim; has received consulting fees from Abbott, Respicardia, Sensible Medical, CVRx, and Impulse Dynamics; and has received salary support from V-Wave Ltd. Dr Savarese has received grants and personal fees from Vifor and AstraZeneca; has received grants and nonfinancial support from Boehringer Ingelheim; has received personal fees from Società Prodotti Antibiotici, Roche, Servier, GENESIS, Cytokinetics, and Medtronic; and has received grants from Merck Sharp & Dohme, and Novartis. Drs Salsali, Zeller, and Peil are employees of Boehringer Ingelheim. Dr Filippatos has received Committee Member contributions in trials sponsored by Medtronic, Vifor, Servier, Novartis, and Boehringer Ingelheim. Dr Ponikowski has received personal fees from Boehringer Ingelheim, AstraZeneca, Servier, Bristol Myers Squib, Amgen, Novartis, Merck, Pfizer, and Berlin Chemie; and has received grants and personal fees from Vifor Pharma. Dr Anker has received grants and personal fees from Vifor International and Abbott Vascular; and has received personal fees from Bayer, Boehringer Ingelheim, Novartis, Servier, ID, and Cardiac Dimensions. Dr Khan has reported that he has no relationships relevant to the contents of this paper to disclose.

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