RESTORE-TAVI Pilot

Study Overview
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Brief Summary
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This pilot randomised control study will investigate the feasibility and efficacy of a perioperative multi-component frailty intervention in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, cognitive stimulation/delirium avoidance strategies, nutritional supplementation and anaemia correction (where indicated). The primary outcome is to determine the feasibility and safety of delivering this intervention and to investigate the impact on health-related quality of life. Secondary outcomes include changes in functional status, frailty, readmission rates and mortality.

Official Title
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Perioperative Multi-component Frailty Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention: Pilot Study

Conditions
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Frailty, Aortic Stenosis

Intervention / Treatment
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* Other: Perioperative multi-component frailty intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 65 years Scheduled to undergo urgent TAVI during index ADAS presentation [ADAS defined as unplanned hospital admission due to symptoms of breathlessness (NYHA IV), chest pain (CCS III or IV) or syncope/pre-syncope attributed to severe AS and developed within 1 week of hospital admission] Ability to provide written informed consent Ability to speak English Ability to receive intervention within 24 hours post TAVI Exclusion Criteria: Clinical instability defined as use of inotropes/mechanical-circulatory support, cardiogenic shock or post-cardiac arrest Postoperative complication (e.g. acute stroke, acute renal failure) requiring transfer to other centre for specialist input (e.g. hyper-acute stroke centre, intensive care unit, renal unit) Significant cognitive impairment (Addenbrooke's Cognitive Examination (ACE-III) score < 83/100) at time of recruitment Active delirium (Confusion Assessment Method (CAM) definition) at time of recruitment Parkinson's disease (Hoehn & Yahr stage 3-5) Recent stroke (<7 days) Life expectancy less than 12 months due to cancer or other comorbidity (according to investigator clinical impression)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Perioperative multi-component frailty intervention<br>perioperative physical rehabilitation (15 min non-ambulatory exercises, sitting out) delirium avoidance techniques (e.g. polypharmacy review, treatment of urinary retention, constipation, untreated pain) orientation/cognitive stimulation (radio, quizzes, magazines, social interaction) nutrition (high calorie snack, MUST score) anaemia correction (IV iron if ferritin <30μg/L (if LV ≥ 50%); or ferritin <100μg/L or 100-300μg/L if transferrin saturation <20% (if LVEF <50%)) frailty MDT discussion | Other: Perioperative multi-component frailty intervention<br>* as above<br>|
| No Intervention: Control: Standard inpatient care<br>Routine inpatient care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Recruitment rates | Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention | 12 months | 
| Feasibility: Acceptability and uptake | Assessed using a patient-reported questionnaire on discharge from tertiary centre | Inpatient admission | 
| Feasibility: Attrition rates | Proportion of patients who provided outcomes and 30 day and 90 day follow-up | 90 days | 
| Feasibility: Safety | In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality | Daily (during inpatient admission) | 
| Health-related quality of life | Measured using the self-reported EQ-5D-5L scale at 30 days and 90 days post discharge from tertiary centre | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | Measured using the self-reported Older Americans Resources and Services (OARS) scale at 30 days and 90 days post discharge from tertiary centre | 90 days | 
| Frailty | Measured using the self-reported SARC-F scale at 30 days and 90 days post discharge from tertiary centre | 90 days | 
| Postoperative delirium | Assessed once daily using the 4AT delirium assessment tool from day after TAVI until discharge from tertiary centre | Daily (during inpatient admission) | 
| Length of stay at tertiary centre | measured in days | On discharge: e.g. 2-7 days | 
| Discharge destination |  | On discharge: e.g. 2-7 days | 
| Unplanned readmissions | Measured at 30 days and 90 days post discharge from tertiary centre using hospital records and patient telephone-interview | 90 days | 
| Mortality | Measured at 30 days and 90 days post discharge from tertiary centre using hospital records and NHS Spine database | 90 days |