Does the use of a stentless bioprosthesis increase surgical risk?

Stentless aortic bioprostheses (SBPs) convey hemodynamic and perhaps survival benefit over stented counterparts. The aim of this study was to determine whether the more taxing operation increases surgical risk. We studied contemporary multicenter (USA) data submitted to the Food and Drug Administration (FDA) for Freestyle stentless (group I, n = 583) and Mosaic stented xenograft approval (group II, n = 1260). The study compared 30-day mortality for the two groups overall, then for isolated aortic valve replacement (AVR) and for AVR and coronary bypass (CABG). Because the USA Freestyle valves were used in selected patients (pts) we included SBP data (group III) from Oxford, where Freestyle valves were used consecutively within the same time frame. We also reviewed hospital mortality in the stentless bioprosthesis literature and compared this with the Society of Thoracic Surgery Database. There were no differences in age, NYHA, or incidence of CABG between the groups. There was no significant difference in operative mortality between stented (group II) and exclusive (group III) SBP patient groups (P = .233 for AVR and P = .478 for AVR + CABG), or between selective (group I) and exclusive (P = .929 for AVR and P = .390 for AVR + CABG) groups, after adjustment for risk factors. However, there was a significantly higher mortality both for isolated AVR (P = .026) and AVR + CABG (P = .001) in the selected stentless group compared with stented. This was partly attributed to greater mortality when the Freestyle was used in elderly patients by the full root replacement method, and to the higher proportion of females, and subjects with intra-aortic balloon pump insertion in this group. A meta-analysis of published stentless valve series, showed mortality rates to be lower than those of the STS National Database average. During the learning curve selective use of SBPs increased hospital mortality for AVR ± CABG. Consecutive use dispelled the difference and the literature now suggests that SBPs may reduce hospital mortality for high-risk patients.