Key result
ACURATE neo2 cuts ≥moderate PVL by ~69% versus ACURATE neo.
Why the study?
ACURATE neo was limited by higher rates of moderate/severe paravalvular leak, prompting development of the ACURATE neo2 with an enlarged sealing skirt, but synthesized data on its short-term performance remained needed.
Does the ACURATE neo2 transcatheter heart valve improve short-term clinical and echocardiographic outcomes compared to its predecessor and contemporary valves in patients with severe aortic stenosis?
Does the ACURATE neo2 transcatheter heart valve improve short-term clinical and echocardiographic outcomes compared to its predecessor and contemporary valves in patients with severe aortic stenosis?
Absolute Event Rate: 3.5% vs 11.3%
p-value: p=< 0.01
ACURATE neo2 demonstrates improved short-term performance by significantly reducing paravalvular leak compared to its predecessor, achieving outcomes comparable to contemporary transcatheter heart valves.
Supports consideration of ACURATE neo2 to minimize leak risk; leaves open need for randomized confirmation versus contemporary THVs.
Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.
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Tobe et al. (2024) conducted a review in severe aortic stenosis. ACURATE neo2 vs. ACURATE neo, Evolut Pro/Pro+, and SAPIEN 3 Ultra was evaluated on postprocedural ≧moderate paravalvular leak (PVL) (p=< 0.01). ACURATE neo2 significantly reduced the rate of ≧moderate paravalvular leak compared to ACURATE neo (3.5% vs. 11.3%, p < 0.01), with short-term outcomes comparable to other contemporary THVs.
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