Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis†
Key result
The Avalus stented aortic valve bioprosthesis demonstrated linearized adverse event rates below 2x objective performance criteria for death, thromboembolism, thrombosis, PVL, and endocarditis.
Why the study?
Does a new bovine stented aortic valve bioprosthesis (Avalus) provide acceptable safety and haemodynamic performance compared to objective performance criteria in patients with symptomatic moderate/severe aortic stenosis or chronic severe aortic regurgitation?
Structured PICO
Does a new bovine stented aortic valve bioprosthesis (Avalus) provide acceptable safety and haemodynamic performance compared to objective performance criteria in patients with symptomatic moderate/severe aortic stenosis or chronic severe aortic regurgitation?
P
Population
686 patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation, followed for up to 1 year.
I
Intervention
Bovine stented aortic valve bioprosthesis (Avalus)
C
Comparator
Objective performance criteria (OPC) for adverse events in accordance with EN ISO 5840:2009
O
Outcome
'Late' (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditissafety
The Avalus stented aortic valve bioprosthesis demonstrated good safety and haemodynamic performance at 1 year, though bleeding rates exceeded objective performance criteria.
Limitations
- The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort.
- Linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort
Authors
Discussion
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Implication
Supports safety of Avalus bioprosthesis in aortic valve disease; leaves open comparative efficacy versus other valves in randomized trials.
Cite This Study
Klautz et al. (2017) studied Symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation (n=686). Avalus bovine stented aortic valve bioprosthesis vs. Objective performance criteria (OPC) was evaluated on Late (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis. The Avalus stented aortic valve bioprosthesis demonstrated linearized adverse event rates below 2x objective performance criteria for death, thromboembolism, thrombosis, PVL, and endocarditis.