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

Rachael L Heys; Terrie A F Walker-Smith; Rebecca N Evans; Massimo Caputo; Lucy Culliford; Barnaby C Reeves; Chris A Rogers; Mark Turner; Karen Sheehan; Nicola Viola; Mark Hamilton; Serban C Stoica; Kim Wright; Gianni  Angelini; Andrew Parry

doi:10.1136/bmjopen-2022-065192

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

Rachael L Heys, Terrie A F Walker-Smith, Rebecca N Evans, Massimo Caputo, Lucy Culliford, Barnaby C Reeves, Chris A Rogers, Mark Turner, Karen Sheehan, Nicola Viola, Mark Hamilton, Serban C Stoica, Kim Wright, Gianni Angelini, Andrew Parry^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

1 Citation (Scopus)

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.

Original language	English
Article number	065192
Number of pages	10
Journal	BMJ Open
Volume	13
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2022-065192
Publication status	Published - 1 Jun 2023

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Heys, R. L., Walker-Smith, T. A. F., Evans, R. N., Caputo, M., Culliford, L., Reeves, B. C., Rogers, C. A., Turner, M., Sheehan, K., Viola, N., Hamilton, M., Stoica, S. C., Wright, K., Angelini, G., & Parry, A. (2023). Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE). BMJ Open, 13(6), Article 065192. https://doi.org/10.1136/bmjopen-2022-065192

@article{976fc58131434e53b63eeb6e645bc6c2,

title = "Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)",

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.",

author = "Heys, {Rachael L} and Walker-Smith, {Terrie A F} and Evans, {Rebecca N} and Massimo Caputo and Lucy Culliford and Reeves, {Barnaby C} and Rogers, {Chris A} and Mark Turner and Karen Sheehan and Nicola Viola and Mark Hamilton and Stoica, {Serban C} and Kim Wright and Gianni Angelini and Andrew Parry",

year = "2023",

month = jun,

day = "1",

doi = "10.1136/bmjopen-2022-065192",

language = "English",

volume = "13",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

}

Heys, RL, Walker-Smith, TAF, Evans, RN , Caputo, M , Culliford, L , Reeves, BC , Rogers, CA, Turner, M, Sheehan, K, Viola, N, Hamilton, M, Stoica, SC, Wright, K, Angelini, G & Parry, A 2023, 'Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)', BMJ Open, vol. 13, no. 6, 065192. https://doi.org/10.1136/bmjopen-2022-065192

TY - JOUR

T1 - Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)

AU - Heys, Rachael L

AU - Walker-Smith, Terrie A F

AU - Evans, Rebecca N

AU - Caputo, Massimo

AU - Culliford, Lucy

AU - Reeves, Barnaby C

AU - Rogers, Chris A

AU - Turner, Mark

AU - Sheehan, Karen

AU - Viola, Nicola

AU - Hamilton, Mark

AU - Stoica, Serban C

AU - Wright, Kim

AU - Angelini, Gianni

AU - Parry, Andrew

PY - 2023/6/1

Y1 - 2023/6/1

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2022-065192

DO - 10.1136/bmjopen-2022-065192

M3 - Article (Academic Journal)

C2 - 37263697

SN - 2044-6055

VL - 13

JO - BMJ Open

JF - BMJ Open

IS - 6

M1 - 065192

ER -

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

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