1-Year Outcomes of TAVR With ACURATE neo2 vs SAPIEN/Evolut: A SWEDEHEART Target Trial Emulation Study

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Device Technology

Background:

• Previous studies indicated potential safety concerns with ACURATE neo2 transcatheter aortic valve replacement (TAVR) devices.
• These concerns, including increased death, stroke, and rehospitalization, were possibly linked to suboptimal pre- and post-dilation techniques.

Purpose of the Study:

• To evaluate the clinical outcomes of TAVR using the ACURATE neo2 valve compared to control valves (SAPIEN or Evolut).
• To investigate the impact of rigorous pre- and post-dilation procedures on TAVR outcomes.

Main Methods:

• A nationwide registry study emulating a target trial using the SWEDEHEART registry in Sweden.
• Inclusion and exclusion criteria mirrored the investigational device exemption trial.
• The primary outcome was a composite of mortality, stroke, and heart failure hospitalization at 1 year, with adjustments made using balancing weights.

Main Results:

• No significant difference in the primary endpoint at 12 months was observed between the ACURATE neo2 group (n=644) and the control group (n=1,299).
• Individual outcomes, myocardial infarction, percutaneous intervention, and major bleeding also showed no significant differences.
• Within the ACURATE neo2 group, post-dilation was not associated with adverse clinical outcomes.

Conclusions:

• Clinical outcomes at 1 year were comparable between the ACURATE neo2 and control valves (Evolut or SAPIEN).
• The findings suggest that rigorous pre- and post-dilation techniques may explain the discrepancy with previous investigational device exemption trial results.