MIAMI BEACH, Fla. – The second-generation ACURATE neo2 transcatheter heart valve (THV) appears to perform at a similar level to other commercially available contemporary THVs, according to European registry data presented Tuesday at Transcatheter Valve Therapies (TVT) 2021.
Previously, the SCOPE I and SCOPE II trials failed to demonstrate non-inferiority of the first-generation ACURATE neo THV compared to older-generation self-expanding and balloon-expandable THVs. However, in September, Boston Scientific (Marlborough, Massachusetts) launched the second-generation ACURATE neo2 THV, which featured an improved sealing skirt to reduce paravalvular leak (PVL) following transcatheter aortic valve replacement (TAVR).
Andreas Rück MD, PhD, of Karolinska University Hospital, Stockholm, presented the initial results from the Early neo2 Registry live at TVT 2021. The investigator-initiated Early neo2 enrolled 554 patients who received the ACURATE neo2 TAVR prosthesis between September and March. Imaging was assessed using the core lab at CORRIB, Galway, Ireland.
Patients in the registry had a mean age of 82 years, 34% were male, and the patients’ mean EuroScore II was 4.5%. TAVR was performed via the transfemoral route in 99.6% of patients, with 87% of patients requiring pre-dilation and 36% requiring post-dilation to facilitate THV deployment. There was a relatively even mixture of THV sizes implanted (23mm: 21%; 25mm: 41%; 27mm: 38%). Only 0.9% of patients required a second THV, and none suffered acute coronary obstruction.
Major vascular complications occurred in 3.4% of patients, and major life-threatening bleeding occurred in 4.8% of patients. Intraprocedural death occurred in just 0.2% of patients. The primary outcomes of moderate PVL (2.7%), permanent pacemaker (PPM) (6.0%), 30-day mortality (1.3%) and in-hospital stroke (2.1%) were all very low and improved from the first-generation ACURATE neo THV.
Overall, improvements in THV design in the ACURATE neo2 THV resulted in less significant PVL and lower rates of PPM than the first-generation ACURATE neo THV. These findings suggests that the ACURATE neo2 THV appears to perform as well as contemporary commercially available THVs.