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The INTACT bioprosthesis--early results.
1Department of Cardiothoracic Surgery, Provincial Hospital, Port Elizabeth, South Africa.
Journal of Cardiac Surgery
|September 1, 1988
Summary
The novel INTACT bioprosthetic valve shows promise for adults, with no failures in this group. However, calcification remains a concern in pediatric patients under 20.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Device Innovation
Background:
- Bioprosthetic valves are crucial for treating valvular heart disease.
- Durability and calcification remain significant challenges for existing bioprostheses.
- The INTACT valve (formerly Xenotech) was developed to address these limitations.
Purpose of the Study:
- To evaluate the safety and durability of the INTACT bioprosthetic valve.
- To assess the incidence of calcification and valve failure in different patient age groups.
- To analyze the hemodynamic performance of the implanted valves.
Main Methods:
- Implantation of 185 INTACT valves in 167 patients over 36 months, with a focus on mitral valve replacement.
- Detailed follow-up including clinical assessment and postoperative catheterization.
- Analysis of valve calcification and failure rates, stratified by age (adults vs. <20 years).
Main Results:
- Overall hospital mortality was 5% (8 deaths), with 2 attributed to ventricular perforation potentially linked to the high-profile stent.
- In patients under 20, a 3-year actuarial calcification rate of 22% was observed.
- No valve failures occurred in the adult group, and hemodynamic performance was satisfactory.
Conclusions:
- The INTACT valve demonstrates excellent durability and hemodynamic function in adult patients.
- Further investigation is needed to mitigate calcification risks in pediatric populations (<20 years).
- Innovations like stress-free fixation and toluidine blue treatment warrant continued evaluation for long-term bioprosthetic valve performance.