Early and mid-term outcomes after aortic valve replacement using a novel tissue bioprosthesis: a systematic review

Abstract

OBJECTIVES While current data shows 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 first 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 (PVL) was detected in 0–3.0%, while major PVL was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (p = 0.98, OR 1.02, 95% CI: 0.36–2.83) and stroke (p = 0.98, OR 1.01, 95% CI: 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.

The Outcomes for Different Biological Heart Valve Prostheses in Surgical Aortic Valve Replacement before and after the Introduction of Transcatheter Aortic Valve Implantation

“…At 5 years, these results were sustained [62]. In a meta-analysis, no differences in the outcomes were observed compared to the conventional Carpentier-Edwards valve, but long-term studies are needed [63].…”

“…The surgical option still has a competitive value for the foreseeable future for both older and younger patients. Perimount valves have proven their value in this respect [63]. The rapid deployment of valves, such as the Perceval BHV, with a minimally invasive approach seems a good option for relatively old patients, while the Inspiris Resilia valve can be offered to their younger counterparts.…”