Cost Outcomes Study of Transcatheter Aortic Valve Implantation with contemporary valves: the COS-TAVI Trial
Transcatheter aortic valve implantation (TAVI) procedure for patients who suffer from significant symptoms due to a narrowed aortic valve and who cannot undergo an open-heart operation
All patients with severe symptomatic narrowing of the aortic valve, where the local clinical team decides to offer the TAVI procedure to them, will be screened to assess suitability for the trial. Patients who meet the inclusion and exclusion criteria and are willing to participate after reading the patient information sheet will be enrolled in this trial. Patients will sign the study consent form. The research team will then collect baseline demographic and clinical data, including routine tests performed as work-up for TAVI. Participants will have their baseline quality of life assessment as part of the trial. Participants would then be randomised to one of three study arms – the Myval THV series, the Sapien THV series or the Evolut THV series – and undergo the TAVI procedure as per the clinical guidelines and local study centre protocols. Participants will have standard post-TAVI care as per local guidelines and be discharged when the clinical team makes that decision. The research team will collect the details of the procedure, any adverse events/serious adverse events and the costs of the procedure and care. The research team will review participants either face-to-face or in a telephone call at 30 (+15) days post-TAVI to assess quality of life and any adverse/serious adverse events. Participants would also be enquired about the number of times they had to approach health and social care services (e.g., GP visits, hospital admissions, care home or nursing home stays), and they would be costed as per the national average tariff for each visit/use. This would be the end of the study, but patients will continue to have their clinical care and follow-up as per the local protocol of the study centre.
1. Age >= 18 years 2. Informed consent to participate in the trial 3. Patients with severe aortic stenosis are eligible for TAVI with all the study devices as per the local heart team 4. TAVI planned via percutaneous transfemoral access
1. Any participant who, in expert opinion of the local heart team, is not suitable for at least one of the study devices due to either technical limitations, high/unacceptable risk of complications if the device is implanted in that participant or reported hypersensitivity or allergy to any of the elements of the study device. 2. Participation in another clinical trial using TAVI devices not approved for routine clinical use 3. Participation in another trial which may affect cost outcomes 4. Patients undergoing any planned concomitant procedures, for example, percutaneous coronary intervention (PCI) or peripheral arterial stenting at the time of TAVI 5. Patient needing another planned surgery or procedure (for example, to treat a cancer) within 6 weeks of TAVI 6. The following patient groups will be excluded as they represent a small proportion of patients undergoing transfemoral TAVI in the UK and are associated with substantially different procedural pathways and clinical risk profiles, which may introduce significant heterogeneity in short-term clinical outcomes and resource utilisation. Exclusion of these groups is intended to ensure comparability between treatment arms and preserve the internal validity of the cost-effectiveness analysis. 6.1. TAVI procedure planned under general anaesthesia (GA) 6.2. Patients with advanced kidney disease (CKD stage 4 or 5 or patients on haemodialysis) 6.3. Severely impaired left ventricular systolic function with ejection fraction (EF) less than 30% 6.4. Patient admitted to hospital for inpatient TAVI 6.5. TAVI in failed surgical aortic valve prosthesis with high risk of coronary obstruction requiring leaflet modification or coronary protection (VIVID class IIB, IIIB and IIIC) 6.6. Redo TAVI in failed TAVI prosthesis