Results of valve replacement with Omniscience mechanical prostheses

Ann Thorac Surg. 2002 Sep;74(3):665-70. doi: 10.1016/s0003-4975(02)03720-7.


Background: The Omniscience mechanical valve has been the subject of multiple clinical investigations with variable results, including reports of high complication and reoperation rates.

Methods: Records of all patients who received Omniscience valves were reviewed, and follow-up interviews were conducted to determine the incidence of valve-related morbidity, mortality, and functional results. Incidence of complications was expressed as events per 100 patient-years follow-up. Survival and freedom from valve-related complications and mortality were calculated using a product limit method.

Results: Between 1984 and 1988, 192 patients received 213 Omniscience valves [93 mitral (M), 79 aortic (A), and 20 multiple (D) valve replacements]. Perioperative mortality was 9%. The incidence of major valve-related morbidity was as follows: thrombosis, 1.30 M, 0.17 A, 0.72 D; endocarditis, 0.48 M, 0.18 A, 0 D; hemorrhagic, 4.67 M, 2.84 A, 5.00 D; embolic, 2.90 M, 2.27 A, 1.57 D; nonstructural dysfunction, 1.66 M, 1.08 A, 2.27 D; reoperation, 4.02 M, 1.99 A, 6.48 D. All explanted valves (n = 43) were examined, and 40% (n = 17) were found to have limited disc excursion in the absence of thrombus. Freedom from valve-related morbidity, mortality, or reoperation at 10 years was 22% for mitral, 39% for aortic, and 17% for multivalve replacements. At follow-up, only 73% of patients were New York Heart Association class I or II. Five- and 10-year estimated survivals were 72% and 55% for M, 80% and 51% for A, and 65% and 50% for D replacements.

Conclusions: Use of the Omniscience valve provided poor functional improvement and a significant incidence of valve-related complications, including the need for reoperation.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Cause of Death
  • Child
  • Equipment Failure Analysis*
  • Female
  • Heart Valve Prosthesis*
  • Hospital Mortality
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / surgery*
  • Postoperative Complications / mortality*
  • Prosthesis Design
  • Reoperation / mortality