| Primary outcomes |
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| Global cognition |
Addenbrooke’s Cognitive Examination III (ACE-III)[@204618]
Possible scores range from 0 to 100, with higher scores reflecting better cognition.
Parallel versions of the ACE-III facilitated longitudinal assessment. High sensitivity and specificity are reported for the two suggested cut-offs, of 88 for mild cognitive impairment (sensitivity = 1.0, specificity = 0.96) and 82 for dementia (sensitivity = 0.93, specificity = 1.0).[@204618] The ACE-III also demonstrates good internal reliability (α = 0.88). |
X |
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X |
X |
X |
| Delirium |
On the ward and when discharged home, Confusion Assessment Method (CAM)[@204615] was used to ascertain delirium presence or absence, with the Memorial Delirium Assessment Scale (MDAS)[@204616] interview informing CAM scoring and as a measure of severity. In the intensive care unit, CAM-ICU was used to assess delirium, with CAM-ICU-7[@204639] used to ascertain severity.
Altered level of consciousness was assessed using the Observational Scale of Level of Arousal or the Richmond Agitation and Sedation Scale in the ICU.
CAM and CAM-ICU comprise four main features of delirium: (1) acute onset and fluctuating course; (2) inattention; (3) disorganised thinking; and (4) altered level of consciousness. We define a positive diagnosis of delirium as the presence of features 1 and 2 and either 3 or 4 on the CAM or CAM-ICU on days 1 or 2 post-TAVI. |
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| Baseline factors |
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Population
characteristics |
Age, sex, body mass index, education, Comorbidities (pre-existing) from medical history (renal disease, previous stroke/TIA, atrial fibrillation, coronary artery disease, hypertension, peripheral vascular disease), risk scores (EuroSCORE II and Society of Thoracic Surgery score). |
X |
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| Depression |
Geriatric Depression Scale[@204643]
Possible scores ranging from 0 to 15 (higher scores indicating a greater likelihood of depression). |
X |
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Neuropsychiatric
symptoms |
Neuropsychiatric Inventory Questionnaire[@204644]
Indicates presence or absence of 12 neuropsychiatric symptoms (as reported by a family member or spouse). |
X |
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| Insomnia |
Early, middle, and late insomnia items of the Hamilton Rating Scale for Depression[@204645]
Total scores range between 0-6, with higher scores indicating more severe insomnia symptoms. |
X |
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| Gait |
Single- and dual-task gait speed (metres/second), dual-task gait cost and step length (metres).
Each task completed with participants walking 6 metres at comfortable walking speed. |
X |
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| Diplopia |
Eye cover test (developed in discussion with a neuro-ophthalmologist).
Diplopia defined as double vision or blurry vision (by self-report) in addition to any eye movements (in right or left eye) during the eye cover task. |
X |
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| Blink rate |
Blinks per second.
Based on the conversation task by Fitzpatrick et al.[@204646] |
X |
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| Voice pitch |
Average voice pitch (Hz) from sustained phonation /a/
Males and females assessed separately due to expected sex variations in pitch. |
X |
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| Dysphagia |
Visual analogue scale from the Sydney Swallowing Questionnaire[@204647]
Dichotomised as presence (>0) or absence (=0) of swallowing problems. |
X |
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| Frailty |
Clinician-administered Edmonton Frail Scale[@204648]
Comprises 10 domains (scores from 0 to 17, with higher scores representing more frailty) |
X |
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Social
engagement |
How often participants see a family member or friend. Dichotomised as daily or less than daily (e.g., weekly, monthly, never). |
X |
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| Physical activity |
How often participants take part in physical activity. Dichotomised as daily or less than daily (e.g., weekly, monthly, never). |
X |
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| Apolipoprotein E4 (APOE-e4) |
Presence or absence of the APOE-e4 allele determined by saliva sample.
Genotyping of the two single nucleotide polymorphisms (rs439358 and rs7412) determined APOE genotype and were categorised as APOE-e4 carriers or noncarriers. |
X |
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Cognitive
domains |
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Reaction Time (RTI) and Pattern Recognition Memory (PRM) were used, with RTI as a measure of attention and PRM as a measure of visual memory.
Each test provides multiple outcome measures and so a composite score for each test, calculated as an average of relevant outcomes (detailed in Table S8), was used. |
X |
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X |
X |
X |
Procedure
details |
TAVI procedure details (procedure time, access type) were obtained from hospital records. |
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X |
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