The effectiveness on post-operative recovery of using ‘off pump’ self-expanding tissue valves (IPVR) versus ‘on pump’ conventional tissue valves (PVR) for pulmonary valve replacement: an early phase randomised controlled trial (RCT): In(jectable) V(alve) I(mplantation) T(rial) (InVITe)
Funder: NIHR, Bristol Cardiovascular Biomedical Research Centre (Cardiovascular Theme), and the British Heart Foundation
Sponsor: University Hospitals Bristol
REC Number: 15/SW/0179
Many patients who are born with problems with their heart valves require repeated operations throughout their life to replace the affected valves. The standard operation for valve replacement involves opening the chest, extensive exposure by the surgeon and the use of the heart-lung bypass machine to take over the function of the heart and lungs (pumping blood and oxygen through the body) during the operation. The heart-lung bypass machine is an extremely useful tool, however, using it is not without risk and it often takes patients many weeks to recover after an open heart operation.
Recent advances in technology have introduced new replacement valves which can be ‘injected’ into position with the heart still beating (avoiding the need to use the heart-lung bypass machine) and without a need for the surgeon to expose all the heart. However, the new valve has not been extensively studied and has been used in around 300 patients worldwide so far. Surgeons have reported their experiences but only for small numbers of patients and without comparing their experiences directly with the conventional replacement valves.
InVITe will investigate the effectiveness of injectable pulmonary valve replacement compared to standard pulmonary valve replacement. Patients will be allocated at random (by chance) to receive either the “injectable” valve or standard valve. We will follow patients to determine whether the use of injectable valves results in quicker recovery and shorter stay in hospital and is cost saving for the NHS. We will also determine whether these valves function as well as the conventional ones.
Chief Investigator: Mr Andrew Parry, Consultant Paediatric Cardiac Surgeon, Bristol Royal Hospital for Children