Intra-Annular Versus Supra-Annular Self-Expanding Valves for Valve-in-Valve TAVR

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Prosthetic Heart Valves

Background:

• Patient-prosthesis mismatch (PPM) is a limitation of Valve-in-Valve Transcatheter Aortic Valve Replacement (VIV TAVR), linked to diminished quality of life and increased heart failure hospitalizations.
• Strategies to mitigate PPM are crucial for improving VIV TAVR outcomes.
• This study compares intra-annular self-expanding valves (IA SEV) with supra-annular self-expanding valves (SA SEV) in the VIV TAVR context.

Purpose of the Study:

• To evaluate and compare the hemodynamic performance and clinical outcomes of IA SEV versus SA SEV platforms in VIV TAVR procedures.
• To assess the safety and efficacy of different self-expanding valve configurations for VIV TAVR.

Main Methods:

• A comparative study involving patients undergoing VIV TAVR with either IA SEV (Navitor) or SA SEV (Evolut) across two centers.
• Primary endpoint: 30-day mean transvalvular gradient. Secondary endpoints included 30-day effective orifice area (EOA) and key clinical events (mortality, stroke, reintervention, etc.).
• Statistical analysis employed a linear effects model to adjust for factors influencing PPM, such as surgical valve inner dimension and body surface area.

Main Results:

• No significant difference in the 30-day mean transvalvular gradient was observed between IA SEV (10.6 ± 3.6 mmHg) and SA SEV (12.3 ± 6.9 mmHg) groups (p=0.44).
• Effective orifice area (EOA) was slightly larger in the IA SEV group (1.69 ± 0.6 cm²) compared to the SA SEV group (1.40 ± 0.5 cm²) in unadjusted analysis (p=0.04), but this difference was not significant after adjustment.
• A small subset of IA SEV patients undergoing bioprosthetic valve fracture showed no adverse events at 30 days, indicating procedural safety.

Conclusions:

• VIV TAVR utilizing IA SEV demonstrated safety and comparable hemodynamic performance to SA SEV in this case series.
• The findings support the use of IA SEV in VIV TAVR and warrant further investigation through prospective studies.
• IA SEV represents a viable option for VIV TAVR, potentially helping to avoid patient-prosthesis mismatch.