Frailty and its relationship to outcomes in people undergoing transcatheter aortic valve implantation Surgery
Conditions
Interventions
Current methodology:
The project itself will be split into two different phases:
Phase 1:
This part of the project will aim to assess the ability of CT to predict patient outcomes and identify frailt
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Phase 1: Patients over the age of 18 years who have undergone TAVI implantation who have completed 5 years of follow-up Phase 2: Patients over the age of 18 years who have been referred for Transcatheter Aortic Valve Implantation
Exclusion criteria
Exclusion criteria: Phase 1: 1. No pre-procedure CT 2. Poor quality CT Imaging 3. Previous request to opt out of data usage. Phase 2: 1. No CT prior to procedure 2. Poor quality CT data unsuitable for analysis 3. Emergency Procedure 4. Unable to complete pre-procedure assessments 5. Unable to attend follow-up appointment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 13/04/2026: Phase 1: The primary outcome is the ability of CT markers of frailty to predict 5-year survival (in days). The following measurements will be recorded at a single timepoint for each patient using a section of imaging at the level of the L3 lumbar vertebrae: 1. Muscle Area (Psoas/Abdominal/Long Spine) (cm2) 2. Muscle Density (Psoas/Abdominal/Long Spine) (HU) 3. Total Vertebral Bone Density (HU) 4. Total Subcutaneous Fat Area (cm) 5. Total Subcutaneous Fat Density (HU) 6. Total Visceral Fat Area (cm2) 7. Total Visceral Fat Density (HU) Phase 2: Sarcopenia and its effect on symptomatic/functional capacity following TAVI. Sarcopenia will be assessed by measuring Muscle area (cm2) and density (HU) on CT at the level of the L3 vertebra. Changes in symptoms and functional capacity will be assessed by measuring the following at baseline and then at 3 months post-procedure: 1. Six-minute walk test (metres) 2. Hand Grip Strength (kg) 3. Kansas City Cardiomyopathy Questionnaire Score (Points) Previous primary outcomes: Phase 1: The primary outcome is the ability of CT markers of frailty to predict 5-year survival (in days). The following measurements will be recorded at a single timepoint for each patient using a section of imaging at the level of the L3 lumbar vertebrae: 1. Total Psoas Muscle Area (cm2) 2. Total Psoas Muscle Density (HU) 3. Total Vertebral Bone Density (HU) 4. Total Subcutaneous Fat Area (cm) 5. Total Subcutaneous Fat Density (HU) 6. Total Visceral Fat Area (cm2) 7. Total Visceral Fat Density (HU) Phase 2: Sarcopenia and its effect on symptomatic/functional capacity following TAVI. Sarcopenia will be assessed by measuring Psoas Muscle area (cm2) and density (HU) on CT at the level of the L3 vertebra. Changes in symptoms and functional capacity will be assessed by measuring the following at baseline and then at 3 months post-procedure: 1. Six-minute walk test (metres) 2. Hand Grip Strength (kg) 3. Kansas City C | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Correlation between frailty as assessed using current subjective assessment methods and each of the CT markers of frailty (detailed above). Frailty is currently assessed and scored by TAVI operators using the following frailty indices recorded at baseline: 1. Katz Index of Activities of Daily Living Index (0 (Low: Very Dependent) -6 (High: Independent) 2. Karnofsky Performance Scale (0 (Dead) – 100 (Normal, no complaints, no evidence of disease) 3. Rockwood Clinical Frailty Scale (1 (Very Fit)-9 (Terminally ill) Phase 2: The effects of each of the following frailty markers on symptomatic/functional capacity following TAVI (using the same outcome measures as above): Frailty assessed using the following frailty indices at baseline and at 3 months: 1. Rockwood Clinical Frailty Scale (1-9) 2. Katz Index (0-6) 3. Karnofsky Performance Scale (0-100) 4. Fried Frailty Index (0-5) Blood tests will be measured at baseline, including: 1. Haemoglobin level (g/dL) 2. Albumin (g/L) 3. CRP (mg/L) The following additional CT markers of frailty will be measured at baseline: 1. Vertebral Bone Density (HU) 2. Subcutaneous and Visceral Fat Area (cm2) 3. Subcutaneous and Visceral Fat Density (HU) | — |
Countries
England, United Kingdom
Contacts
Public ContactJessica Parker
Outcome results
None listed