title: Conceptual model for early health technology assessment of current and novel heart valve interventions.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Cardio-Thoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands; Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands; Department of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands.
authors.forename: Simone A
authors.initials: SA
authors.lastname: Huygens
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands; Department of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands.
authors.forename: Maureen P M H
authors.initials: MP
authors.lastname: Rutten-van Mölken
authors.affiliation: Department of Cardio-Thoracic Surgery , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Jos A
authors.initials: JA
authors.lastname: Bekkers
authors.affiliation: Department of Cardio-Thoracic Surgery , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Ad J J C
authors.initials: AJ
authors.lastname: Bogers
authors.affiliation: Department of Biomedical Engineering , Eindhoven University of Technology , Eindhoven , The Netherlands.
authors.forename: Carlijn V C
authors.initials: CV
authors.lastname: Bouten
authors.affiliation: Department of Cardiology , University Medical Centre , Utrecht , The Netherlands.
authors.forename: Steven A J
authors.initials: SA
authors.lastname: Chamuleau
authors.affiliation: Department of Cardiology , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Peter P T
authors.initials: PP
authors.lastname: de Jaegere
authors.affiliation: Department of Cardio-Thoracic Surgery , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Arie Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.affiliation: Department of Cardio-Thoracic Surgery , Academic Medical Centre , Amsterdam , The Netherlands.
authors.forename: Jolanda
authors.initials: J
authors.lastname: Kluin
authors.affiliation: Department of Cardiology , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Nicolas M D A
authors.initials: NM
authors.lastname: van Mieghem
authors.affiliation: Department of Cardio-Thoracic Surgery , Leiden University Medical Centre , Leiden , The Netherlands.
authors.forename: Michel I M
authors.initials: MI
authors.lastname: Versteegh
authors.affiliation: Department of Cardiology , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: Witsenburg
authors.affiliation: Department of Cardio-Thoracic Surgery , Erasmus University Medical Centre , Rotterdam , The Netherlands.
authors.forename: Johanna J M
authors.initials: JJ
authors.lastname: Takkenberg
keywords: Conceptual Model; Cost-Effectiveness; Early Health Technology Assessment; Tissue-Engineered Heart Valves