The Carpentier-Edwards pericardial aortic valve: intermediate results

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Technology

Background:

• The Edwards pericardial aortic valve is designed to minimize stress and abrasion wear.
• Previous wear and in vivo fluid dynamic tests indicated superior performance compared to other bioprostheses.

Purpose of the Study:

• To evaluate the long-term performance and safety of the Edwards pericardial aortic valve in a large patient cohort.
• To assess valve hemodynamics, survival rates, and complications following implantation.

Main Methods:

• A prospective study involving 719 isolated aortic valve implantations across 10 US centers between August 1981 and July 1985.
• Patient data collected included demographics, preoperative conditions, concomitant procedures, and follow-up for mortality, valve-related events, and echocardiographic parameters.
• Long-term follow-up included assessment of valve survival, reoperation rates, and hemodynamic performance up to 7 years post-implantation.

Main Results:

• Hospital mortality was 4.7%, with one early valve-related death. Late mortality included 23 valve-related deaths over 7 years, with endocarditis being the most common cause.
• Seven-year freedom from valve-related death was 95.5%. No cusp tears were observed. Freedom from all valve reoperation at 7 years was 95.5%.
• Echocardiographic follow-up at 7 years demonstrated excellent effective orifice areas and acceptable mean gradients. 78% of patients showed improvement in New York Heart Association functional class.

Conclusions:

• The Carpentier-Edwards pericardial valve demonstrates excellent hemodynamics and durability.
• The valve is associated with high rates of freedom from valve-related death and reoperation at 7 years.
• The study confirms the valve's ease of use and favorable clinical outcomes, meeting Food and Drug Administration guidelines.