Objectives:

This study compares one year outcomes of two next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3).

Background:

Comparative data on different THV are scarce and registry data are needed to provide a real-world approach to complement data from randomized trials. Recently, the SCOPE I trial showed no significant differences in all-cause death, disabling stroke or other clinical and functional endpoints at one year between NEO and S3.

Methods:

A total of 933 propensity matched (2:1) patients selected from 1121 treated patients in three centers were followed for one year after TAVI with either the S3 (n = 622) or NEO (n = 311). Kaplan-Meier estimates were calculated for the time to the endpoints death, stroke (combined whichever occurred first and separately), readmission for heart failure, repeat procedure and new permanent pacemaker implantation. 

Results:

Mean age of the entire population was 81±6 and median logistic euroscore of 18±12. The composite endpoint of stroke or death occurred in 16.1 % vs. 13.5 % with S3 and NEO, respectively (HR 0.76; CI 95 % 0.52-1.10, p = 0.152, Figure 1). Separately, death (12.1 % vs. 10.0 %; HR 0.75; CI 95% 0.49-1.15; p = 0.183) and stroke (6.6 % vs. 4.1 %; HR 0.61; CI 95 % 0.31-1.18, p= 0.142) were similar both devices (see Table 1). Differences in event rates between the two THV were observed with new permanent pacemaker implantation (PPI) with significant higher rates with the S3 compared to NEO (19.8 % vs. 13.5 %; HR 0.58; CI 95% 0.39-0.85; p = 0.005) after one year. However, need for PPI occurred particularly in the early phase up to 30 days, with no further differences in PPI rate between 30 days and 1 year (3.3 % vs. 3.5 %; HR 0.84; CI 95 % 0.34-2.07; p = 0.701). The influence of PVL II+ and new PPI on mortality was explored. While PVL II+ at discharge was not associated with differences in one year mortality (11.7 % vs. 4.0 %, HR 0.34; CI 95 % 0.04-2.47; p = 0.289), new PPI after 30 days was associated with increased mortality at one year (10.5 % vs 17.1 %; HR 1.66; CI 95 % 1.0-2.7; p = 0.038). However, this effect was independent of valve type (p for interaction 0.649).

Conclusions:

One year clinical outcome was comparable for NEO and S3 with the exception of a higher rate of PPI rate for the S3. However, differences in PPI rate were already present at 30 days and remained stable during follow-up. PPI after 30 days was associated with increased one year mortality however no interaction was found according to THV type. Moderate or more PVL at discharge which was more frequent with the NEO was not associated with increased mortality.