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Valvular heart disease
Conceptual model for early health technology assessment of current and novel heart valve interventions
  1. Simone A Huygens1,2,3,
  2. Maureen P M H Rutten-van Mölken2,3,
  3. Jos A Bekkers1,
  4. Ad J J C Bogers1,
  5. Carlijn V C Bouten4,
  6. Steven A J Chamuleau5,
  7. Peter P T de Jaegere6,
  8. Arie Pieter Kappetein1,
  9. Jolanda Kluin7,
  10. Nicolas M D A van Mieghem6,
  11. Michel I M Versteegh8,
  12. Maarten Witsenburg6 and
  13. Johanna J M Takkenberg1
  1. 1Department of Cardio-Thoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands
  2. 2Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands
  3. 3Department of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands
  4. 4Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands
  5. 5Department of Cardiology, University Medical Centre, Utrecht, The Netherlands
  6. 6Department of Cardiology, Erasmus University Medical Centre, Rotterdam, The Netherlands
  7. 7Department of Cardio-Thoracic Surgery, Academic Medical Centre, Amsterdam, The Netherlands
  8. 8Department of Cardio-Thoracic Surgery, Leiden University Medical Centre, Leiden, The Netherlands
  1. Correspondence to Simone A Huygens; s.huygens{at}erasmusmc.nl

Abstract

Objective The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective.

Methods After scoping the decision problem, a workgroup developed the draft CM based on clinical guidelines. This model was compared with existing models for cost-effectiveness of heart valve interventions, identified by systematic literature search. Next, it was discussed with a Delphi panel of cardiothoracic surgeons, cardiologists and a biomedical scientist (n=10).

Results The CM starts with the valve implantation. If patients survive the intervention, they can remain alive without complications, die from non-valve-related causes or experience a valve-related event. The events are separated in early and late events. After surviving an event, patients can experience another event or die due to non-valve-related causes. Predictors will include age, gender, NYHA class, left ventricular function and diabetes. Costs and quality adjusted life years are to be attached to health conditions to estimate long-term costs and health outcomes.

Conclusions We developed a CM that will serve as foundation of a decision-analytic model that can estimate the potential cost-effectiveness of TEHV in early development stages. This supports developers in deciding about further development of TEHV and identifies promising interventions that may result in faster take-up in clinical practice by clinicians and reimbursement by payers.

  • Cost-Effectiveness
  • Conceptual Model
  • Tissue-Engineered Heart Valves
  • Early Health Technology Assessment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/openhrt-2016-000500

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    Footnotes

    • Funding The study was supported by the Netherlands Cardio Vascular Research Initiative (CVON).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; internally peer reviewed.

    • Data sharing statement No additional data are available.