Short-Term Outcomes of ACURATE neo2

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Severe aortic stenosis requires transcatheter heart valve (THV) replacement.
• The ACURATE neo THV had limitations, notably higher rates of moderate/severe paravalvular leak (PVL).
• The ACURATE neo2 was developed with an improved sealing skirt to address PVL.

Purpose of the Study:

• To review and analyze the short-term clinical and echocardiographic outcomes of the ACURATE neo2 THV.
• To compare the performance of ACURATE neo2 against its predecessor (ACURATE neo) and contemporary THVs regarding PVL and other adverse events.

Main Methods:

• A systematic literature search was conducted on PubMed, identifying 13 studies (5 single-arm, 8 non-randomized comparative).
• Data on in-hospital or 30-day clinical and echocardiographic outcomes were extracted.
• Propensity-matched analyses were performed for comparative studies.

Main Results:

• In-hospital/30-day all-cause mortality was low (≤3.3%), comparable to contemporary THVs.
• ACURATE neo2 significantly reduced moderate/severe PVL compared to ACURATE neo (3.5% vs. 11.3%).
• PVL rates for ACURATE neo2 were comparable to Evolut Pro/Pro+ and SAPIEN 3 Ultra. Permanent pacemaker implantation rates were low and favorable compared to Evolut Pro/Pro+.

Conclusions:

• ACURATE neo2 demonstrates improved short-term performance over ACURATE neo, primarily through a significant reduction in PVL.
• The safety and efficacy of ACURATE neo2 are comparable to current leading THVs.
• ACURATE neo2 represents a promising advancement in transcatheter aortic stenosis treatment.