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Research Article: Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)

Date Published: 2023-06-01

Abstract:
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 .

Introduction:
Most children born with complex congenital heart disease (CHD) now reach adulthood due to advances in cardiac surgery and cardiology. Consequently, there are now more adults than children living with CHD. Many CHD patients require multiple operations throughout their lives to repair or replace poorly functioning pulmonary valves. The risk of major cardiac surgery increases with each operation and these patients suffer cumulative iatrogenic harm to the heart from repeated exposure to cardiopulmonary bypass (CPB)…

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