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The Silzone effect: how to reconcile contradictory reports?
Gary L Grunkemeier1, YingXing Wu
1Providence Health System, Portland, OR 97225, USA. gary.grunkemeier@providence.org
Summary
Contradictory findings on the St. Jude Medical Silzone heart valve were reconciled. Current data suggest differences in major leak and thromboembolism rates are diminishing, with no new events reported.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
Background:
- Conflicting reports exist regarding the safety and efficacy of the St. Jude Medical Silzone heart valve.
- Previous studies, including AVERT and CERFS, indicated higher rates of major leak and thromboembolism, respectively, with the Silzone valve.
Purpose of the Study:
- To reconcile contradictory findings on the St. Jude Medical Silzone heart valve.
- To analyze and compare event rates from various Silzone valve studies.
Main Methods:
- Data on major leak and thromboembolism were extracted from published Silzone valve studies.
- Linearized rates were calculated to compare event rates across different studies.
Main Results:
- Initial reports (AVERT, CERFS) showed higher major leak and thromboembolism rates with Silzone valves, but current updates indicate these differences are decreasing.
- Three comparative studies found no significant difference between Silzone and non-Silzone valves.
- Three single-arm studies reported acceptable outcomes with Silzone valves.
Conclusions:
- Contradictory findings may stem from clinical and technical factors.
- No new adverse events have been reported since the initial publications of AVERT and CERFS, suggesting improved safety profiles or data stabilization.