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Outcome analysis of 245 CarboMedics and St. Jude valves implanted at the same institution
T K Rosengart1, M O'Hara, S J Lang
1Department of Cardiothoracic Surgery, The New York Hospital-Cornell Medical Center, New York 10021, USA.
Insights
The St. Jude Medical (SJ) valve showed better outcomes than the CarboMedics (CM) valve regarding thromboembolism and valve-related mortality. Further evaluation of CM valve thromboembolic outcomes is recommended.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Outcomes Research
Background:
- Prosthetic heart valves are crucial for treating valvular heart disease.
- Thromboembolism and valve-related death are significant complications following prosthetic valve implantation.
- Comparative studies evaluating different valve types are essential for optimizing patient care.
Purpose of the Study:
- To compare the clinical outcomes of CarboMedics (CM) and St. Jude Medical (SJ) mechanical heart valves.
- To assess the incidence of thromboembolism and valve-related mortality between CM and SJ valves.
- To provide data for informed clinical decision-making in prosthetic valve selection.
Main Methods:
- A consecutive series of 245 patients received either SJ (116) or CM (129) valves between October 1994 and January 1996.
- Follow-up was 99.6% complete, totaling 318.5 patient-years (median 1.4 years).
- Outcomes analyzed included 30-day mortality, actuarial survival, freedom from valve-related mortality, and thromboembolic events.
Main Results:
- Thirty-day mortality rates were similar: 3.4% for SJ and 3.1% for CM.
- Actuarial survival at 1.5 years was higher for SJ valves (94%±2%) versus CM valves (86%±3%, p=0.03).
- Freedom from thromboembolic events at 1.5 years was significantly better for SJ valves (97%±3%) compared to CM valves (83%±5%, p=0.04), with five thrombosed CM valves observed.
Conclusions:
- The St. Jude Medical valve demonstrated superior performance regarding thromboembolic complications compared to the CarboMedics valve in this cohort.
- The higher incidence of valve thrombosis in the CarboMedics group warrants further investigation.
- Comparative data on mechanical heart valve performance are critical for improving patient safety and long-term outcomes.
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 the implantation of only one valve is reported from any given institution. We therefore report the outcome of patients implanted at our institution during 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 received either SJ (116 patients) or CM (129 patients) valves at our institution. Follow up of these patients was 99.6% complete, for a total of 318.5 cumulative patient-years (median follow-up, 1.4 years).
Results:
The 30-day mortality rates for SJ and CM implants were 3.4% and 3.1%, respectively. Actuarial survival and freedom from valve related mortality 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 was no structural valve failure for either implant, but there were five thrombosed valves in the CM group and none in the SJ group (p = 0.04). All thrombosed valves were mitral (four mitral valve replacement, one aortic and mitral valve replacement). Two of the thrombosed valves were successfully explanted, whereas the three remaining patients died. Freedom from a thromboembolic 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 thromboembolic outcomes after CM compared with SJ valve implantation is warranted.