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What is the potential of tissue-engineered pulmonary valves in children?

Ann Thorac Surg. 2018 Dec 31;:

Authors: Huygens SA, Rutten-van Mölken MPMH, Noruzi A, Etnel JRG, Ramos IC, Bouten CVC, Kluin J, Takkenberg JJM

Abstract
BACKGROUND: As a living heart valve substitute with growth potential and improved durability, tissue-engineered heart valves (TEHV) may prevent re-interventions that are currently often needed in children with congenital heart disease. We performed early Health Technology Assessment to assess the potential cost-effectiveness of TEHV 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 and/or maximum age≤21 years) published between 1/1/2000-2/5/2018. Using a patient-level simulation model, costs and effects of RVOTR with TEHV compared to existing heart valve substitutes were assessed from a healthcare perspective applying a 10-year time horizon. Improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored to estimate quality-adjusted life years (QALY) gain, cost reduction, headroom, and budget impact associated with TEHV.
RESULTS: Five-year freedom from re-intervention after RVOTR with existing heart valve substitutes was 46.1% in patients ≤2 years old and 81.1% in patients >2 years old. 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 to existing heart valve substitutes.
CONCLUSIONS: This study showed that there is room for improvement in clinical outcomes in children requiring RVOTR. If TEHV result in improved clinical outcomes, they are expected to be cost-effective compared to existing heart valve substitutes.

PMID: 30605643 [PubMed – as supplied by publisher]

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