Key result
ACURATE neo valve reduces 30-day PPI by ~50% versus CoreValve Evolut.
Why the study?
Detailed data on left bundle branch block and permanent pacemaker implantation were lacking from randomised clinical trials comparing ACURATE neo and CoreValve Evolut devices.
Does the ACURATE neo valve reduce the incidence of permanent pacemaker implantation and new left bundle branch block compared to the CoreValve Evolut valve in patients undergoing TAVR?
RCT (n=648)
randomised
Does the ACURATE neo valve reduce the incidence of permanent pacemaker implantation and new left bundle branch block compared to the CoreValve Evolut valve in patients undergoing TAVR?
Odds Ratio: 0.5 (95% CI 0.31–0.81)
Absolute Event Rate: 12.3% vs 21%
p-value: p=0.005
The ACURATE neo valve is associated with significantly lower rates of new left bundle branch block and permanent pacemaker implantation at 30 days compared to the CoreValve Evolut valve.
ACURATE neo may lower new PPI and LBBB risk versus Evolut in TAVR; confirms device-specific conduction differences in powered randomised data.
BACKGROUND: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices. AIMS: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison. METHODS: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days. Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041). CONCLUSIONS: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.
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Pellegrini et al. (2023) conducted an RCT in Aortic stenosis (undergoing TAVR) (n=648). ACURATE neo vs. CoreValve Evolut was evaluated on Permanent pacemaker implantation (PPI) at 30 days (OR 0.50, 95% CI 0.31-0.81, p=0.005). The ACURATE neo valve resulted in a lower rate of permanent pacemaker implantation at 30 days compared to the CoreValve Evolut (12.3% vs 21.0%; OR 0.50, 95% CI 0.31-0.81; p=0.005).
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