Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves: The...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Limited comparative data exist for self-expanding Navitor (NAV) and balloon-expandable SAPIEN 3 Ultra (ULTRA) transcatheter heart valves (THVs).
• Understanding the comparative performance of these intra-annular THVs is crucial for clinical decision-making.

Purpose of the Study:

• To investigate and compare the 1-year clinical outcomes of transcatheter aortic valve replacement (TAVR) using the intra-annular Navitor (NAV) and SAPIEN 3 Ultra (ULTRA) THVs.
• To evaluate differences in safety and efficacy between the NAV and ULTRA THVs in a real-world setting.

Main Methods:

• The NAVULTRA registry included consecutive patients undergoing transfemoral TAVR with either NAV or ULTRA THVs across 16 centers.
• Propensity score matching was employed to adjust for baseline differences between the two groups.
• Primary outcomes included all-cause death and a composite of all-cause death, disabling stroke, and heart failure hospitalization at 1 year.

Main Results:

• In the propensity score-matched cohort (1,363 pairs), 1-year all-cause mortality was similar (9.7% for NAV vs. 9.9% for ULTRA; P=0.585).
• The primary composite outcome also showed no significant difference between the groups (13.6% for NAV vs. 12.6% for ULTRA; P=0.218).
• However, the NAV group experienced higher rates of permanent pacemaker implantation (20.6% vs. 10.6%; P<0.01), heart failure rehospitalization (4.6% vs. 2.8%; P<0.05), and mild paravalvular leak (P<0.05), alongside lower mean transprosthetic gradients.

Conclusions:

• Both intra-annular Navitor and SAPIEN 3 Ultra THVs demonstrate comparable 1-year clinical outcomes following TAVR.
• Significant differences were noted in secondary endpoints, including higher rates of pacemaker implantation and paravalvular leak with the Navitor valve.
• Hemodynamic performance varied, with the Navitor valve showing lower transprosthetic gradients compared to the SAPIEN 3 Ultra valve.