RT Journal Article
SR Electronic
T1 Conceptual model for early health technology assessment of current and novel heart valve interventions
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e000500
DO 10.1136/openhrt-2016-000500
VO 3
IS 2
A1 Simone A Huygens
A1 Maureen P M H Rutten-van Mölken
A1 Jos A Bekkers
A1 Ad J J C Bogers
A1 Carlijn V C Bouten
A1 Steven A J Chamuleau
A1 Peter P T de Jaegere
A1 Arie Pieter Kappetein
A1 Jolanda Kluin
A1 Nicolas M D A van Mieghem
A1 Michel I M Versteegh
A1 Maarten Witsenburg
A1 Johanna J M Takkenberg
YR 2016
UL http://openheart.bmj.com/content/3/2/e000500.abstract
AB 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.