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Valve replacement with the Starr-Edwards and Hancock prostheses: comparative analysis of late morbidity and mortality
Insights
The Hancock glutaraldehyde-fixed porcine xenograft valve showed comparable hospital mortality to the Starr-Edwards caged-ball valve in aortic and mitral replacements. This xenograft valve may offer an alternative with reduced need for long-term anticoagulation.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Outcomes Research
Background:
- The Starr-Edwards caged-ball valve is a benchmark prosthesis.
- Significant thromboembolic and hemorrhagic complications are associated with caged-ball valves.
- The Hancock glutaraldehyde-fixed porcine xenograft presents an alternative valve option.
Purpose of the Study:
- To compare the clinical outcomes of Starr-Edwards (SE) valves versus Hancock xenograft (X) valves in aortic and mitral valve replacements.
- To evaluate differences in mortality and morbidity between the two prosthetic valve types.
- To assess the impact of anticoagulation strategies on patient outcomes.
Main Methods:
- Retrospective comparison of 435 Starr-Edwards aortic valve replacements (SE-AVR) and 251 xenograft aortic valve replacements (X-AVR).
- Comparison of 515 SE mitral valve replacements (SE-MVR) and 338 X mitral valve replacements (X-MVR).
- Comparison of 121 SE double valve replacements (SE-AVRMVR) and 88 X double valve replacements (X-AVR-MVR) between 1963-1976, with differing anticoagulation protocols.
Main Results:
- Hospital mortality rates were not significantly different between SE and X valves for AVR (6.9% vs 6.4%), MVR (9.7% vs 8.6%), and AVR-MVR (7.5% vs 10.2%).
- Patients receiving SE valves required long-term anticoagulation, whereas X-valve patients received it only for specific indications.
- Total follow-up was 3944 patient-years for SE valves and 947 patient-years for X valves.
Conclusions:
- The Hancock xenograft valve demonstrates comparable hospital mortality to the Starr-Edwards valve in aortic and mitral positions.
- The xenograft valve may allow for reduced anticoagulation requirements, potentially decreasing associated hemorrhagic complications.
- Further analysis of linearized morbidity and mortality data is needed to fully elucidate long-term outcomes.
Abstract:
Although the Starr-Edwards caged-ball valve remains a standard of comparison for more recently introduced prostheses, a substantial incidence of thromboembolic and hemorrhagic complications prompted our evaluation of the Hancock glutaraldehyde-fixed porcine xenograft. We have compared the results of 435 aortic valve replacements using the Starr- Edwards valve (SE-AVR), 515 mitral valve replacements (SE-MVR), and 121 double-valve replacements (SE-AVRMVR) with 251 aortic valve replacements using the xenograft aortic valve (X-AVR), 338 mitral valve replacements (X-MVR), and 88 double-valve replacements (X-AVR-MVR). The Starr- Edwards valves were used during the period 1963 through 1973 and the xenograft valves between 1971 and 1976. No significant differences in patient age, sex, or preoperative hemodynamic data were noted between comparable groups. All patients with Starr-Edwards valves received long-term anticoagulation while anticoagulants were used only for specific indications in patients with xenograft valves. Total follow up was 3944 patient years for the Starr-Edwards patients and 947 patient years for the xenograft patients. Hospital mortality was not significantly different for comparable groups: SE-AVR 6.9% vs. X-AVR 6.4%, SE-MVR 9.7% vs X-MVR 8.6%, and SE-AVR-MVR 7.5% vs. X-AVR-MVR 10.2%. Linearized mortality and morbidity data expressed as percent per patient- year are tabulated below. Pairs which differ significantly (p < .05) are italicized.