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Abstract
[ Table Omitted - see PDF ] Table 1 Data collection timetable Baseline Procedure (up to 2 h post-TAVI) Day 1 Day 2c Day 3c Discharge 30 ± 12 days 12 months Informed consent x Demographics x Clinical characteristics x Physical examinationa x x x x x x x Laboratory analysisb x x x x x Current medication x x x x ECG x x x x x x x x Echocardiogram x x x x x x MMSE x SF-12 x x x Clinical event assessment x x x x Legend: ECG, electrocardiogram; MMSE, mini-mental state examination; SF-12, short-form-12 quality of life questionnaire. aIncludes symptoms, mobility, self-care; bincludes blood and urine analysis (complete blood count, electrolytes, renal function etc.); cif still in hospital Patients will be discharged when it is deemed appropriate by the treating physician. New York Heart Association (NYHA) class ? II No chest pain attributable to cardiac ischaemia No untreated major arrhythmias Complications on day 0 to 1, but free of signs or symptoms on day 3 No fever during the last 24 h (infection-related) Independent mobilisation and capability of self-care Preserved diuresis (>40 ml/h during the last 24 h) No unresolved acute kidney injury type 3 (according to VARC-2 criteria) No red blood cell transfusion during the last 72 h Stable haemoglobin in 2 consecutive samples (defined as a decrease of no more than 2 mg/dl) No stroke or transient ischaemic attack (TIA) No sign of systemic inflammation or infection (clinic or laboratory) No haemodynamic instability Primary endpoint The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (placement of aortic Transcatheter valves) trial (cohort a). Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.