Single-center outcome analysis of 1,161 patients with St. Jude medical and ATS open pivot mechanical heart valves.
OBJECTIVE
The clinical performance of mechanical heart valves and valve-related complications are important safety endpoints in patients after heart valve replacement. In this retrospective analysis, the mid- to long-term clinical outcomes of two similar bileaflet heart valves, routinely implanted at the authors' institution over an 11-year period, were compared.


METHODS
Between January 1993 and December 2003, a total of 1,161 patients (758 males, 403 females) received either a St. Jude Medical (SJM) or ATS mechanical heart valve. Follow up was obtained via an in-house Quality Management Database, ascertained by telephone questionnaire of the patients and/or family physicians. Follow up was 98.9% complete; the median follow up was 4.6 years; total follow up was 5,624 patient-years (pt-yr).


RESULTS
A total of 604 SJM and 601 ATS prostheses was implanted as isolated (n = 669) or combined (n = 492) procedures. The overall 30-day mortality for SJM and ATS was 4.1% and 3.4%, respectively (p = 0.45). Cumulative survival and freedom from valve-related mortality at 10 years for SJM and ATS valves were 66 +/- 3% versus 68 +/- 5% (p = 0.84) and 96 +/- 1% versus 97 +/- 1% (p = 0.36), respectively. No structural valve failure was encountered for both valve types. Freedom from overall valve-related complications at 10 years was 79 +/- 4% for SJM and 66 +/- 6% for ATS (p = 0.08). The linearized rates for valve-related adverse events for SJM and ATS valves, respectively, were: thromboembolism 0.9 and 1.1%/pt-yr; major bleeding requiring transfusion 0.3 and 0.5%/pt-yr; prosthetic endocarditis 0.03 and 0.1%/pt-yr; paravalvular leak 0.1 and 0.6%/pt-yr.


CONCLUSIONS
On the basis of an 11-year experience, both bileaflet valves showed very good clinical results, with low incidences of adverse events during the mid-term outcome. Gender and/or concomitant coronary artery disease were not predictors for reduced life expectancy.
Bernet
Franziska H
FH
Division of Cardio-Thoracic Surgery, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. bernetf@uhbs.ch
Baykut
Doan
D
Grize
Leticia
L
Zerkowski
Hans-Reinhard
HR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000601:surgery*; D004696:Endocarditis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000503:physiopathology / Q000601:surgery*; D008946:Mitral Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000401:mortality; D011474:Prosthesis Design; D012107:Research Design; D012189:Retrospective Studies; D016019:Survival Analysis; D013557:Switzerland / Q000453:epidemiology; D013927:Thrombosis / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome