Key result
Small Edwards Intuity rapid deployment aortic prostheses (19-21 mm) showed similar mid-term mortality compared to larger prostheses (>21 mm) (3.41 vs 2.45 per 100 patient-years; P=0.58).
Why the study?
Evidence about the clinical behaviour of smaller sizes of the Edwards Intuity rapid deployment aortic prosthesis is scarce.
Does the small Edwards Intuity rapid deployment aortic prosthesis (19-21 mm) provide comparable mid-term survival and clinical outcomes to larger prostheses (>21 mm) in patients with severe aortic stenosis?
Observational (n=122)
Does the small Edwards Intuity rapid deployment aortic prosthesis (19-21 mm) provide comparable mid-term survival and clinical outcomes to larger prostheses (>21 mm) in patients with severe aortic stenosis?
The Edwards Intuity rapid deployment aortic prosthesis in sizes 19-21 mm demonstrates good clinical and hemodynamic performance with mid-term survival comparable to larger sizes, making it a viable option for patients with a small aortic annulus.
Supports small Intuity use in small annuli; leaves open randomized confirmation of outcomes.
OBJECTIVES: The Edwards Intuity valve is a rapid deployment aortic prosthesis that favours less invasive approaches. However, evidence about the clinical behaviour of their smaller sizes is scarce. Herein, we studied haemodynamic behaviours and clinical outcomes of small Intuity prostheses (19-21 mm) in comparison to larger Intuity prostheses (>21 mm). METHODS: This is an observational study including patients implanted with an Edwards Intuity rapid deployment aortic prosthesis. Patients with prosthesis sizes 19-21 and >21 mm were included. Baseline and perioperative variables, as well as adverse events during the follow-up were recorded and compared between groups. RESULTS: A total of 122 patients (37% female, mean age 75 ± 4.5 years) were included, of whom 54 (45%) were implanted with a small prosthesis and 68 (55%) with a prosthesis >21 mm. There were no significant differences between patients with small Intuity prostheses and patients with larger prostheses regarding in-hospital mortality (2% vs 4%, P = 0.43) or mortality during the follow-up (3.41 vs 2.45 per 100 patients-years; P = 0.58). Survival in the small Intuity valve group was 95% at 1 year and 83% at 6 years, whereas in the larger Intuity valve group was 96% at 1 year and 78% at 6 years. The presence of a small prosthesis did not influence mid-term survival (log-rank P-value = 0.62). CONCLUSIONS: This study showed good clinical performance of Intuity aortic prostheses with appropriate mid-term survival in patients with the small aortic annulus. Thus, the Edwards Intuity rapid deployment aortic prosthesis may be considered as a potential option in patients with the small aortic annulus.
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Arribas et al. (2021) conducted an observational in Aortic valve disease requiring prosthesis (n=122). Small Intuity prostheses (19-21 mm) vs. Larger Intuity prostheses (>21 mm) was evaluated on Mortality during follow-up (per 100 patient-years) (p=0.58). Small Edwards Intuity rapid deployment aortic prostheses (19-21 mm) showed similar mid-term mortality compared to larger prostheses (>21 mm) (3.41 vs 2.45 per 100 patient-years; P=0.58).
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