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The Journal of Thoracic and Cardiovascular Surgery, Vol 100, 44-54, Copyright © 1990 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
LS Czer, A Chaux, JM Matloff, MA DeRobertis, SA Nessim, D Scarlata, SS Khan, RM Kass, TP Tsai and C Blanche
The St. Jude Medical valve is a bileaflet prosthesis with excellent
hemodynamic characteristics, but the long-term surgical experience with
this valve, its durability, and its biocompatibility are unknown. During a
10-year period from March 1978 to 1988, 690 prostheses (290 aortic, 252
mitral, and 74 double aortic-mitral) were inserted as the initial valve
replacement substitute in 616 patients (mean age 63 years). Coronary
atherosclerosis was present in 58%. Follow-up totaled 2031 patient-years
(mean 3.3 years) and was 95% complete (32 lost). Early (30-day) mortality
rates were 5.2%, 11.9%, and 8.1% after aortic, mitral, and double valve
replacement; 5- and 9-year actuarial survival rates were 71% +/- 3% and 51%
+/- 8%, 59% +/- 4% and 41% +/- 6%, and 69% +/- 6% and 47% +/- 15%,
respectively. Deaths were associated with extensive coronary
atherosclerosis (p less than 0.001), older age (p less than 0.001),
advanced preoperative New York Heart Association functional class (p less
than 0.05), and malignant ventricular arrhythmias (p less than 0.05). No
structural failures have been observed. Embolism (40 events) occurred at a
rate of 2.0%/pt-yr (2.3% aortic, 1.6% mitral, 2.0% double). There were six
cases of valve thrombosis (0.3%/pt-yr; one fatal). Hemorrhage was the most
frequent complication (2.6%/pt-yr); 13 (25%) of 52 events were fatal,
accounting for 62% of all valve-related deaths. After the target
prothrombin time ratio was lowered, the rate of hemorrhage decreased by 44%
(2.7% to 1.5%/pt-yr), while the combined rate of embolism and valve
thrombosis increased slightly (2.2% to 2.5%/pt-yr, a 14% change). In
summary, the St. Jude Medical valve remains a durable valve substitute.
Survival was strongly related to the presence of associated coronary
atherosclerosis. The most common complication has been hemorrhage; a less
intensive warfarin regimen may reduce hemorrhagic risk while maintaining
thromboembolic protection.
ARTICLES
Ten-year experience with the St. Jude Medical valve for primary valve replacement
Department of Thoracic and Cardiovascular Surgery, Cedars-Sinai Medical Center, Los Angeles, Calif 90048.
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