Why the study?
New-generation self-expanding transcatheter aortic heart valves were designed to overcome constraints of preceding generations, prompting a comparison of the efficacy and safety of ACURATE neo2 versus Evolut PRO devices.
Does the ACURATE neo2 valve improve clinical outcomes compared to the Evolut PRO valve in patients undergoing transfemoral TAVI?
Does the ACURATE neo2 valve improve clinical outcomes compared to the Evolut PRO valve in patients undergoing transfemoral TAVI?
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The ACURATE neo2 valve is associated with lower permanent pacemaker rates but higher major vascular complications compared to the Evolut PRO valve in patients undergoing TAVI.
BACKGROUND: New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices. METHODS: Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria. RESULTS: Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328). CONCLUSIONS: Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate-severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.
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Rheude et al. (2023) studied this question.
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