Balloon-Expandable Valve Performance Beyond 10 Years After Transcatheter Aortic Valve Implantation.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Limited data exists on the very long-term durability of bioprosthetic valves after transcatheter aortic valve implantation (TAVI).
• Assessing bioprosthetic valve performance beyond 10 years is crucial for understanding long-term outcomes.

Purpose of the Study:

• To evaluate the very long-term clinical efficacy and durability of balloon-expandable valves used in TAVI.
• To identify factors associated with structural valve deterioration (SVD) and valve-related complications.

Main Methods:

• A prospective single-center registry analysis of consecutive patients undergoing TAVI with balloon-expandable valves (2007-2015).
• Focus on patients alive at one-year post-TAVI, with a primary outcome of valve-related long-term clinical efficacy per VARC-3 criteria.
• Death was considered a competing risk in the analysis.

Main Results:

• At 10 years, 71% of patients remained free from the composite endpoint of valve failure, stroke, or bleeding.
• Moderate or severe HVD (structural valve deterioration) occurred in 17% of patients.
• Independent predictors of HVD included younger age, severe patient-prosthesis mismatch, and absence of anticoagulant therapy.

Conclusions:

• Balloon-expandable valves demonstrate reassuring very long-term durability after TAVI, with a majority of patients remaining free from major valve-related events.
• Approximately one-fifth of patients experienced moderate or severe HVD, highlighting the need for ongoing monitoring.
• The potential protective effect of anticoagulation on valve durability warrants further investigation.