Short-Term Outcomes of ACURATE neo2

Akihiro Tobe, Scot Garg, Helge Möllmann, Andreas Rück, Won Keun Kim, Andrea Buono, Andrea Scotti, Azeem Latib, Stefan Toggweiler, Antonio Mangieri, Mika Laine, Christopher U. Meduri, Tobias Rheude, Ivan Wong, Chenniganahosahalli Revaiah Pruthvi, Tsung Ying Tsai, Yoshinobu Onuma, Patrick W. Serruys

Research output: Contribution to journalReview articlepeer-review

Abstract

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.

Original languageEnglish (US)
Article number100277
JournalStructural Heart
DOIs
StateAccepted/In press - 2024

Keywords

  • ACURATE TA
  • ACURATE neo
  • ACURATE neo2
  • Self-expanding
  • TAVI
  • TAVR

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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