Key result
Injectable pulmonary valve replacement reduces 24-hour chest drain volume by ~278 mL vs. standard surgery.
Why the study?
The effectiveness of injectable tissue pulmonary valves compared with standard pulmonary valves in patients requiring pulmonary valve replacement surgery was uncertain.
RCT (n=19)
Single-blind
Block randomisation, stratified by centre
Yes
Answers are grounded in this paper and cite their sources.
OBJECTIVES: To assess the effectiveness of injectable tissue pulmonary valve compared with standard pulmonary valve in patients requiring pulmonary valve replacement surgery. DESIGN: A multicentre, single-blind, parallel two-group randomised controlled trial. Participants were blind to their allocation. Follow-up continued for 6 months. Randomised allocations were generated by a computer using block randomisation, stratified by centre. SETTING: Two National Health Service secondary care centres in the UK. PARTICIPANTS: People aged 12-80 years requiring pulmonary valve replacement. INTERVENTIONS: Participants were randomly allocated (1:1 ratio) to injectable pulmonary valve replacement (IPVR) without cardiopulmonary bypass (CPB) or standard pulmonary valve replacement (SPVR) with CPB. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was chest drainage volume over the first 24 hours after surgery. Secondary outcomes included in-hospital clinical outcomes; valve and heart function 6 months postsurgery and health-related quality of life 6 weeks and 6 months postsurgery. RESULTS: Nineteen participants agreed to take part. Eleven were allocated to IPVR and eight to SPVR. The trial was stopped before the target sample size of 60 participants was reached due to challenges in recruitment. The primary analysis includes all randomised participants; there were no withdrawals. Chest drain volume 24 hours after surgery was on average 277.6 mL lower with IPVR (IPVR mean 340.0 mL; SPVR mean 633.8 mL; mean difference, -277.6; 95% CI, -484.0 to -71.2; p=0.005). There were no statistically significant differences in time to readiness for extubation (p=0.476), time to fitness for discharge (p=0.577) and time to first discharge from the intensive care unit (p=0.209). Six participants with IPVR required CPB. Safety profiles and quality of life scores were similar. CONCLUSIONS: IPVR reduced chest drain volume despite >50% of participants requiring CPB. There was no evidence of any other benefit of IPVR. TRIAL REGISTRATION NUMBER: ISRCTN23538073.
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Heys et al. (2023) conducted an RCT in Pulmonary valve replacement (n=19). Injectable pulmonary valve replacement (IPVR) without cardiopulmonary bypass vs. Standard pulmonary valve replacement (SPVR) with cardiopulmonary bypass was evaluated on Chest drainage volume over the first 24 hours after surgery (MD -277.6, 95% CI -484.0 to -71.2, p=0.005). Injectable pulmonary valve replacement significantly reduced mean chest drain volume by 277.6 mL in the first 24 hours after surgery compared to standard pulmonary valve replacement.
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