Single-center outcome analysis of 1,161 patients with St. Jude medical and ATS open pivot mechanical heart valves.

ABSTRACT

BACKGROUND AND AIM OF THE STUDY 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. CONCLUSION: 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.