Long-term clinical experience with the Omnicarbon prosthetic valve

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Clinical Outcomes Research

Background:

• A total of 781 Omnicarbon valve prostheses were implanted in 647 patients between February 1985 and December 1994.
• The patient cohort included 357 males and 290 females with a mean age of 53.5 years.
• Prior to surgery, 81% of patients were in New York Heart Association (NYHA) class III or IV, indicating severe cardiac dysfunction.

Purpose of the Study:

• To evaluate the long-term clinical performance and safety of the Omnicarbon valve prosthesis.
• To assess survival rates, complication incidence, and functional status following valve replacement surgery.

Main Methods:

• The study involved 227 aortic valve replacements (AVR), 286 mitral valve replacements (MVR), and 134 double-valve replacements (DVR).
• Follow-up data was 96.3% complete, accumulating 2,746 patient-years with a maximum follow-up of 10.7 years.

Main Results:

• Hospital mortality rates ranged from 7.0% (AVR) to 8.2% (DVR).
• Annualized complication rates included 0.8% for hemorrhage and 0.7% for thromboembolism.
• No structural valve failure was observed; nonstructural dysfunction occurred at 0.8% per patient-year, with dehiscence being the most common cause.
• Prosthetic valve endocarditis occurred at 0.3% per patient-year.
• At 10 years, 91% of survivors were in NYHA class I or II.
• Overall 10-year survival was 82.5%; valve-related mortality yielded a 10-year survival of 91.9%.

Conclusions:

• The Omnicarbon prosthesis exhibits excellent clinical results over a decade of follow-up.
• High survival rates and good functional recovery are achieved.
• The prosthesis demonstrates a favorable safety profile with low rates of major complications.