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. 2022 Jan;15(1):e008797.
doi: 10.1161/CIRCHEARTFAILURE.121.008797. Epub 2021 Dec 23.

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study

Shelby D Reed  1   2 , Jui-Chen Yang  2 , Timothy Rickert  2 , F Reed Johnson  1   2 , Juan Marcos Gonzalez  1   2 , Robert J Mentz  2   3 , Mitchell W Krucoff  2   3 , Sreekanth Vemulapalli  2   3 , Philip B Adamson  4 , David J Gebben  5 , Liliana Rincon-Gonzalez  6 , Anindita Saha  5 , Daniel Schaber  7 , Kenneth M Stein  8 , Michelle E Tarver  5 , Dean Bruhn-Ding  9
Affiliations

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study

Shelby D Reed et al. Circ Heart Fail. 2022 Jan.

Abstract

Background: Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.

Methods: Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario. Device scenarios offered an additional year of physical functioning equivalent to New York Heart Association class III or a year with improved (ie, class II) symptoms, or both, with 30-day mortality risks ranging from 0% to 15%, in-hospital complication risks ranging from 0% to 40%, and a remote adjustment device feature. Logit-based regression models fit participants' choices as a function of health outcomes, risks and remote adjustment.

Results: Latent-class analysis of 613 participants (mean age, 65; 49% female) revealed that two-thirds were best represented by a pro-device, more risk-tolerant class, accepting up to 9% (95% CI, 7%-11%) absolute risk of device-associated mortality for a one-year gain in improved functioning (New York Heart Association class II). Approximately 20% were best represented by a less risk-tolerant class, accepting a maximum device-associated mortality risk of 3% (95% CI, 1%-4%) for the same benefit. The remaining class had strong antidevice preferences, thus maximum-acceptable risk was not calculated.

Conclusions: Quantitative evidence on benefit-risk tradeoffs for implantable heart-failure device profiles may facilitate incorporating patients' views during product development, regulatory decision-making, and clinical practice.

Keywords: decision making; heart failure; patient preference; risk assessment; surveys and questionnaires.

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Figures

Figure 1.
Figure 1.
Example discrete-choice question. One example of 320 possible choice questions
Figure 2.
Figure 2.
Preference weights for online-panel and Duke University Health System (DUHS) samples. Larger weights represent more positive preference, and smaller weights represent more negative preference. Vertical bars represent 95% CIs. NYHA indicates New York Heart Association.
Figure 3.
Figure 3.
Maximum-acceptable risks (MAR) of 30-day mortality and complications: sensitivity analysis. Better includes participants who appropriately chose no device in the dominant-choice question and correctly answered at least 5 of 10 comprehension questions. Best further limits the subset to participants who correctly answered at least 8 of the 10 comprehension questions. All MAR estimates are censored at the maximum risk levels included in device scenarios (15% for death and 40% for in-hospital complications). NYHA indicates New York Heart Association.
Figure 4.
Figure 4.
Maximum-acceptable risks (MAR) of 30-day mortality and complications by latent class. All MAR estimates are censored at the maximum risk levels included in device scenarios (15% for death and 40% for in-hospital complications). NYHA indicates New York Heart Association.
See this image and copyright information in PMC

References

    1. Griffin JM, Borlaug BA, Komtebedde J, Litwin SE, Shah SJ, Kaye DM, Hoendermis E, Hasenfuß G, Gustafsson F, Wolsk E, et al. . Impact of interatrial shunts on invasive hemodynamics and exercise tolerance in patients with heart failure. J Am Heart Assoc. 2020; 9:e016760. doi: 10.1161/JAHA.120.016760 - PMC - PubMed
    1. Kaye DM, Hasenfuß G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, et al. . One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction. Circ Heart Fail. 2016; 9:e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662 - PMC - PubMed
    1. Karki R, Friedman PA, Killu AM. The future of percutaneous epicardial interventions. Card Electrophysiol Clin. 2020; 12:419–430. doi: 10.1016/j.ccep.2020.04.007 - PubMed
    1. Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex activation therapy in patients with heart failure with reduced ejection fraction. J Am Coll Cardiol. 2020; 76:1–13. doi: 10.1016/j.jacc.2020.05.015 - PubMed
    1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and other Stakeholders. Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/.... Issued August 24, 2016

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