CarboMedics mechanical prosthesis: Performance at eight years

Citation
Wre. Jamieson et al., CarboMedics mechanical prosthesis: Performance at eight years, J HEART V D, 9(5), 2000, pp. 678-687
Citations number
34
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Cardiovascular & Respiratory Systems
Journal title
JOURNAL OF HEART VALVE DISEASE
ISSN journal
0966-8519 → ACNP
Volume
9
Issue
5
Year of publication
2000
Pages
678 - 687
Database
ISI
SICI code
0966-8519(200009)9:5<678:CMPPAE>2.0.ZU;2-M
Abstract
Background ann aim of the study: The bileaflet St. Jude Medical mechanical prosthesis has been implanted for over 20 years. The purpose of this study was to evaluate the clinical performance of the bileaflet CarboMedics (CM) prosthesis, which was introduced in 1986. Methods: The CM prosthesis was implanted in 1,258 patients (709 males, 549 females; mean age 60.9 +/- 12.3 years) between 1989 and 1997. The prosthesi s distribution was aortic valve replacement (AVR) 613; mitral valve replace ment (MVR) 447; and multiple replacement (MR) 231. Coronary artery bypass ( CAB) was performed in 334 (26.6%) patients; previous procedures had been pe rformed in 346 (27.5%). The age distribution was <60 years (n = 527), 61-70 years (n = 424) and >70 years (n = 307). Risk factors assessed were age or age groups, gender, CAB, previous surgery, rhythm, valve position, status and NYHA functional class. The total follow up was 4,765.0 patient-years (p t-yr), and was 98.4% complete. Results: The early mortality rate was 5.6% (AVR 4.8%, MVR 3.7%, MR 11.5%). The late mortality rate was 3.7%/pt-yr (n = 174), and valve-related mortali ty 1.1%/pt-yr (n = 50). The total thromboembolism (TE) rate was 4.1%/pt-yr (n = 195) (p = NS by valve position); the major TE rate was 1.9%/pt-yr and fatal TE rate 0.31%/pt-yr (n = 15). The valve thrombosis rate was 0.31%/pt- yr (n = 15; 11 MVR, four MR). The fatal thrombosis rate was 0.06%/pt-yr (n = 3; two MVR, one MR). The hemorrhage rate was 2.7%/pt-yr (n 128) and fatal hemorrhage rate 0.4%/pt-yr (n = 20). The reoperation rate was 1.0%/pt-yr ( n = 46), fatal 0.1%/pt-yr (n = 5). The actuarial freedom from overall TE at eight years was 77.3 +/- 2.8%; major TE 88.5 +/- 1.6%, and hemorrhage 76.4 +/- 3.2% tall p = NS by valve position). There were no independent predict ors of overall TE and TE exclusion of early events. The only predictor for TE major was status (emergency > urgent > elective). The actuarial freedom from valve-related mortality at eight years was 91.4 +/- 1.8% (p = NS by po sition) tactual freedom 93.0 +/- 1.3%). The actuarial freedom from valve-re lated reoperation was 91.1 +/- 2.4% (p <0.05; AVR > MVR and MR, MVR > MR) ( actual freedom 92.2 +/- 2.7%). Overall survival rate at eight years was 68. 2 +/- 2.3% (p <0.05; AVR > MVR and MR, MVR > MR). Conclusion: The clinical performance of the CarboMedics mechanical prosthes is is satisfactory when implanted in the mitral, aortic and multiple positi ons.