SOLACI | Latin American Society of Interventional Cardiology

The ACURATE Neo2 valve is an evolution of the first-generation ACURATE Neo valve with a low rate of pacemaker implantation and a decrease in paravalvular leak, also compatible with the 14F introducer.

This prospective study included patients with symptomatic severe aortic stenosis at high surgical risk who underwent ACURATE Neo2 valve implantation.

The primary endpoint (PEP) was all-cause mortality at 30 days. The secondary endpoint (SEP) included procedural and device success, 5-year VARC-2 events, and hemodynamic variables measured by echocardiography at discharge, at 7 days, 30 days, and 1 year.

The study included 120 patients from December 2016 to November 2017. Mean patient age was 82 years old, and most subjects were female. The mean Society of Thoracic Surgeons (STS) score was 4.8%, while the mean EUROSCORE II was 4.7. In terms of the New York Heart Association class, 95% of patients were CF III symptomatic. Basal electrocardiographic alterations were found in 47.5% of subjects, and 6.7% of them had a prior pacemaker.

Procedural success was 97%; the vascular complications rate was 2.5% and the need of pacemaker implantation at discharge was 13%. The most used valve size was M (45%). As regards results, the PEP was 3.3% at 30 days. At 5 years, the all-cause death rate was 44%, the cardiovascular death rate was 31.5%, and the stroke rate was 14.2%. The rate of repeat procedure after the initial procedure was 1.1%. There was no thrombosis or endocarditis. The rate of hospitalization for valve-related symptoms or heart failure at 5 years was 14.6%.

The rate of paravalvular leak at 1 year was, in most cases, no leak (60%) followed by mild leak (37%) and moderate leak (2.7%), and there were no patients with leak greater than moderate.

Conclusion

Patients treated with the ACURATE Neo2 device showed early hemodynamic improvement and low perivalvular leak rates at 1 year. The all-cause mortality and stroke rates at 5 years are comparable with other transcatheter aortic valve replacement studies at intermediate or high surgical risk. This long-term study confirms the favorable performance and safety of the ACURATE Neo2 in high-risk patients.