Commissural Alignment With ACURATE neo2 Valve in an Unselected Population

Area of Science:

• Cardiology
• Interventional Cardiology
• Biomedical Engineering

Background:

• Commissural alignment in transcatheter aortic valve replacement (TAVR) is crucial for enhancing coronary access, future valve interventions, and valve longevity.
• The effectiveness of commissural alignment using the ACURATE neo2 prosthetic heart valve in a large patient cohort remains under investigation.

Purpose of the Study:

• To evaluate the feasibility and success rate of achieving commissural alignment in a broad TAVR patient population receiving the ACURATE neo2 valve.
• To assess the safety and procedural outcomes associated with this dedicated alignment technique.

Main Methods:

• A cohort of 170 consecutive patients undergoing TAVR with the ACURATE neo2 valve were implanted using a specific technique for commissural alignment.
• Valve orientation was adjusted by rotating the unexpanded valve within the aortic root, guided by right-left overlap and three-cusp fluoroscopic views.
• Effectiveness was quantified by comparing post-procedure fluoroscopic valve orientation with pre-procedural computed tomography cusp orientation, while safety was monitored for mortality, stroke, and other complications within 30 days.

Main Results:

• Out of 170 patients, 167 were analyzed for alignment, with 97% achieving successful alignment (mild or less misalignment).
• Specifically, 80% of patients demonstrated optimal commissural alignment.
• Minor degrees of misalignment were observed in 17% (mild), 1.2% (moderate), and 1.8% (severe) of cases, with no significant safety concerns reported.

Conclusions:

• This extensive study demonstrates that commissural alignment with the ACURATE neo2 valve is achievable in the vast majority of TAVR patients.
• The technique proved safe, with no adverse impact on procedure duration or increased safety risks.
• Commissural alignment using this novel method is both effective and safe for TAVR procedures.