Department of Cardiac Surgery, University Hospitals of Leicester, Leicester, UK.
Faculty of Medicine, Department of Surgery and Cancer, Imperial College London & Imperial College Healthcare NHS Trust, London, UK.
Eur J Cardiothorac Surg. 2024 Feb 1;65(2). doi: 10.1093/ejcts/ezae045.
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.
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.
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.
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.
尽管目前的数据显示在主动脉瓣置换术（AVR）中使用生物瓣的趋势明显，但生物瓣的耐久性仍然是最重要的关注点。我们对所有可用证据进行了首次系统评价，分析了使用 Inspiris RESILIA™生物瓣进行 AVR 的早期和中期结果。
进行了系统的文献检索，以确定所有评估使用 Inspiris RESILIA 生物瓣进行 AVR 的早期和中期结果的相关研究，并纳入至少 20 名无出版日期限制的患者。进行亚组荟萃分析以比较 Inspiris RESILIA 和 PERIMOUNT Magna Ease 生物瓣，并汇总早期术后死亡率和卒中发生率。
共确定了 416 项研究，其中 15 项研究符合纳入标准。这些研究共纳入了 3202 名患者，平均随访时间长达 5.3 年。研究中患者的平均年龄为 52.2-75.1 岁。孤立的 AVR 在 39.0-86.4%的患者中进行。住院或 30 天术后死亡率为 0-2.8%。在中期随访时，全因死亡率的无事件生存率高达 85.4%。在具有中期随访的研究中，检测到微量/轻度瓣周漏的比例为 0-3.0%，而仅在 2.0%的患者中发现了严重瓣周漏。在死亡率方面，Inspiris RESILIA 生物瓣与 PERIMOUNT Magna Ease 生物瓣之间没有统计学意义的差异（P=0.98，比值比 1.02，95%置信区间 0.36-2.83），在卒中方面也没有统计学意义的差异（P=0.98，比值比 1.01，95%置信区间 0.38-2.73）。在亚组荟萃分析中观察到。
新型主动脉生物瓣的安全性和血液动力学性能的中期数据令人鼓舞。仍需要与其他生物瓣进行进一步的比较研究，并进行更长时间的随访，以支持新型生物瓣的耐久性和安全性。
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