Outcome analysis of 245 CarboMedics and St. Jude valves implanted at the same institution

Background. Thromboembolism and valve-related death are major complications associated with prosthetic valve implants, but it is difficult to evaluate the relative incidence of these complications based on studies in which th e implantation of only one valve is reported from any given institution. We therefore report the outcome of patients implanted at our institution duri ng the same time period with either the recently released CarboMedics (CM) or the St. Jude Medical (SJ) valve prostheses. Methods. Between October 1994 and January 1996, 245 consecutive patients re ceived either SJ (116 patients) or CM (129 patients) valves at our institut ion. Follow up of these patients was 99.6% complete, for a total of 318.5 c umulative patient-years (median follow-up, 1.4 years). Results. The 30-day mortality rates for ST and CM implants were 3.4% and 3. 1%, respectively. Actuarial survival and freedom from valve related mortali ty rates at 1.5 years for SJ and CM valves were 94% +/- 2% versus 86% +/- 3 % (p = 0.03) and 100% versus 94% +/- 2% (p = 0.005), respectively. There wa s no structural valve failure for either implant, but there were five throm bosed valves in the CM group and none in the SJ group (p = 0.04). All throm bosed valves were mitral (four mitral valve replacement, one aortic and mit ral valve replacement). Two of the thrombosed valves were successfully expl anted, whereas the three remaining patients died. Freedom from a thromboemb olic event in the mitral position at 1.5 years, including thrombosed valves was 97% +/- 3% and 83% +/- 5% for SJ and CM valves, respectively (p = 0.04 ). Conclusions. The results of this study suggest that further evaluation of t hromboembolic outcomes after CM compared with SJ valve implantation is warr anted. (C) 1998 by The Society of Thoracic Surgeons.