Simone A Huygens1, Maureen P M H Rutten-van Mölken2, Anahita Noruzi3, Jonathan R G Etnel3, Isaac Corro Ramos4, Carlijn V C Bouten5, Jolanda Kluin6, Johanna J M Takkenberg3. 1. Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands; Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands; Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands. Electronic address: huygens@imta.eur.nl. 2. Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands; Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands. 3. Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands. 4. Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands. 5. Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands. 6. Department of Cardio-Thoracic Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Abstract
BACKGROUND: As a living heart valve substitute with growth potential and improved durability, tissue-engineered heart valves (TEHVs) may prevent reinterventions that are currently often needed in children with congenital heart disease. We performed early health technology assessment to assess the potential cost-effectiveness of TEHVs in children requiring right ventricular outflow tract reconstruction (RVOTR). METHODS: A systematic review and meta-analysis was conducted of studies reporting clinical outcome after RVOTR with existing heart valve substitutes in children (mean age ≤12 years or maximum age ≤21 years) published between January 1, 2000, and May 2, 2018. Using a patient-level simulation model, costs and effects of RVOTR with TEHVs compared with existing heart valve substitutes were assessed from a health care perspective applying a 10-year time horizon. Improvements in performance of TEHVs, divided in durability, thrombogenicity, and infection resistance, were explored to estimate quality-adjusted life year (QALY) gain, cost reduction, headroom, and budget impact associated with TEHVs. RESULTS: Five-year freedom from reintervention after RVOTR with existing heart valve substitutes was 46.1% in patients less than or equal to 2 years of age and 81.1% in patients greater than 2 years of age. Improvements in durability had the highest impact on QALYs and costs. In the improved TEHV performance scenario (durability ≥5 years and -50% other valve-related events), QALY gain was 0.074 and cost reduction was €10,378 per patient, translating to maximum additional costs of €11,856 per TEHV compared with existing heart valve substitutes. CONCLUSIONS: This study showed that there is room for improvement in clinical outcomes in children requiring RVOTR. If TEHVs result in improved clinical outcomes, they are expected to be cost-effective compared with existing heart valve substitutes.
BACKGROUND: As a living heart valve substitute with growth potential and improved durability, tissue-engineered heart valves (TEHVs) may prevent reinterventions that are currently often needed in children with congenital heart disease. We performed early health technology assessment to assess the potential cost-effectiveness of TEHVs in children requiring right ventricular outflow tract reconstruction (RVOTR). METHODS: A systematic review and meta-analysis was conducted of studies reporting clinical outcome after RVOTR with existing heart valve substitutes in children (mean age ≤12 years or maximum age ≤21 years) published between January 1, 2000, and May 2, 2018. Using a patient-level simulation model, costs and effects of RVOTR with TEHVs compared with existing heart valve substitutes were assessed from a health care perspective applying a 10-year time horizon. Improvements in performance of TEHVs, divided in durability, thrombogenicity, and infection resistance, were explored to estimate quality-adjusted life year (QALY) gain, cost reduction, headroom, and budget impact associated with TEHVs. RESULTS: Five-year freedom from reintervention after RVOTR with existing heart valve substitutes was 46.1% in patients less than or equal to 2 years of age and 81.1% in patients greater than 2 years of age. Improvements in durability had the highest impact on QALYs and costs. In the improved TEHV performance scenario (durability ≥5 years and -50% other valve-related events), QALY gain was 0.074 and cost reduction was €10,378 per patient, translating to maximum additional costs of €11,856 per TEHV compared with existing heart valve substitutes. CONCLUSIONS: This study showed that there is room for improvement in clinical outcomes in children requiring RVOTR. If TEHVs result in improved clinical outcomes, they are expected to be cost-effective compared with existing heart valve substitutes.
Authors: Simone A Huygens; Isaac Corro Ramos; Carlijn V C Bouten; Jolanda Kluin; Shih Ting Chiu; Gary L Grunkemeier; Johanna J M Takkenberg; Maureen P M H Rutten-van Mölken Journal: Eur J Health Econ Date: 2020-01-25
Authors: Alexander Horke; Igor Tudorache; Günther Laufer; Martin Andreas; Jose L Pomar; Daniel Pereda; Eduard Quintana; Marta Sitges; Bart Meyns; Filip Rega; Mark Hazekamp; Michael Hübler; Martin Schmiady; John Pepper; U Rosendahl; Artur Lichtenberg; Payam Akhyari; Ramadan Jashari; Dietmar Boethig; Dmitry Bobylev; Murat Avsar; Serghei Cebotari; Axel Haverich; Samir Sarikouch Journal: Eur J Cardiothorac Surg Date: 2020-11-01 Impact factor: 4.191