Background: Initial reports on the clinical performance of patients undergoing a transcatheter aortic valve implantation (TAVI) with the ACURATE neo (Boston Scientific) are promising, however information regarding one-year outcome is scarce, especially when the composite endpoints proposed by the updated Valve Academic Research Consortium (VARC-2) are considered.

Objectives: We therefore aimed to analyse outcome with the ACURATE neo at one year according to the VARC-2 criteria with emphasis on the composite endpoints “clinical efficacy after 30 days” and “time-related valve safety”.

Methods: Between January 2014 and October 2016,151 consecutive patients undergoing TAVI with the ACURATE neo for severe stenosis of the native aortic valve were enrolled and data prospectively collected. Event rates during follow-up were calculated using Kaplan-Meier estimates.

Results: Mean age was 81.1±5.9 years, 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.465]. The distribution across the small, medium and large size was 33.1% (50/151), 36.4% (55/151) and 30.5% (46/151), respectively. VARC-2 defined device success was achieved in 88.1% (133/151) of patients; 7.9% (12/151) cases developed moderate paravalvular leakage. Procedure related mortality was 0.7% (1/151) and rates of in-hospital life-threatening bleeding, major vascular complications and all stroke were 5.3% (8/151), 13.9% (21/151) and 1.3% (2/151), respectively. Permanent pacemaker implantation (PPI) in pacemaker naïve patients (n=137) was required in 10.2% (14/137).

At one year all-cause and cardiac mortality were 3.3% (5/151) and 1.3% (2/151), respectively, while PPI occurred in 14.0% (19/137). The “clinical efficacy after 30 days” was observed in 24.8% (37/151) while “Time-related valve safety” occurred in 22.0% (33/151). The single contributors to these endpoints are depicted in the Figure. 7.4% of patients required a hospitalization for worsening of congestive heart failure at one year. From baseline to 1 year, symptom improvement of at least one NYHA functional class was observed in 70.9% of patients, .with 86.7% of patients reporting a NYHA functional class II or less at 1 year.

Conclusions: In this single-center analysis using the novel ACURATE neo, we found a favorable safety profile with low all-cause mortality and high symptomatic benefit at one year. For the first time, VARC-2 defined composite endpoints at one year are reported and reveal a low proportion of patients experiencing the composite endpoint of time-related valve safety (22.0%) and clinical efficacy after 30 days (24.8%).