Results of valve replacement with Omniscience mechanical prostheses.
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.
Edwards
Matthew S
MS
Department of Cardiothoracic Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA.
Russell
Gregory B
GB
Edwards
Angela F
AF
Hammon
John W
JW
Cordell
A Robert
AR
Kon
Neal D
ND
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D002423:Cause of Death; D002648:Child; D019544:Equipment Failure Analysis; D005260:Female; D006350:Heart Valve Prosthesis; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D011183:Postoperative Complications / Q000401:mortality*; D011474:Prosthesis Design; D012086:Reoperation / Q000401:mortality