Key result
Aortic valve replacement using the Inspiris RESILIA bioprosthesis showed no significant difference in mortality compared to the PERIMOUNT Magna Ease bioprosthesis (OR 1.02; 95% CI 0.36-2.83; P=0.98).
Why the study?
Despite increasing use of bioprosthetic valves during AVR, bioprosthetic durability remains a major concern, prompting an evaluation of outcomes with the novel Inspiris RESILIA bioprosthesis.
Does the Inspiris RESILIA bioprosthesis improve early and mid-term outcomes compared to the PERIMOUNT Magna Ease bioprosthesis in patients undergoing aortic valve replacement?
Systematic Review (n=3,202)
Does the Inspiris RESILIA bioprosthesis improve early and mid-term outcomes compared to the PERIMOUNT Magna Ease bioprosthesis in patients undergoing aortic valve replacement?
The novel Inspiris RESILIA bioprosthesis shows encouraging mid-term safety and hemodynamic performance, with early mortality and stroke rates comparable to the PERIMOUNT Magna Ease bioprosthesis.
Answers are grounded in this paper and cite their sources.
First systematic synthesis of Inspiris RESILIA outcomes supports further evaluation; leaves open long-term durability in randomized data.
OBJECTIVES: While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis. METHODS: A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates. RESULTS: A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2-75.1 years. Isolated AVR was performed in 39.0-86.4% of patients. In-hospital or 30-day postoperative mortality was 0-2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0-3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P = 0.98, odds ratio 1.02, 95% confidence interval 0.36-2.83) and stroke (P = 0.98, odds ratio 1.01, 95% confidence interval 0.38-2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis. CONCLUSIONS: Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis.
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Sef et al. (2024) conducted a systematic review in aortic valve replacement (n=3,202). Inspiris RESILIA bioprosthesis vs. PERIMOUNT Magna Ease bioprosthesis was evaluated on mortality (OR 1.02, 95% CI 0.36-2.83, p=0.98). Aortic valve replacement using the Inspiris RESILIA bioprosthesis showed no significant difference in mortality compared to the PERIMOUNT Magna Ease bioprosthesis (OR 1.02; 95% CI 0.36-2.83; P=0.98).
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