Robustness of the Comparative Observational Evidence Supporting Class I and II Cardiac Surgery Procedures

Abstract

Background Current cardiac surgery guidelines give Class I and II recommendations to valve‐sparing root replacement over the Bentall procedure, mitral valve (MV) repair over replacement, and multiple arterial grafting with bilateral internal thoracic artery based on observational evidence. We evaluated the robustness of the observational studies supporting these recommendations using the E value, an index of unmeasured confounding. Methods and Results Observational studies cited in the guidelines and in the 3 largest meta‐analyses comparing the procedures were evaluated for statistically significant effect measures. Two E values were calculated: 1 for the effect‐size estimate and 1 for the lower limit of the 95% CI. Thirty‐one observational studies were identified, and E values were computed for 75 effect estimates. The observed effect estimates for improved clinical outcomes with valve‐sparing root replacement versus the Bentall procedure, MV repair versus replacement, and grafting with bilateral internal thoracic artery versus single internal thoracic artery could be explained by an unmeasured confounder that was associated with both the treatment and outcome by a risk ratio of more than 16.77, 4.32, and 3.14, respectively. For MV repair versus replacement and grafting with bilateral internal thoracic artery versus single internal thoracic artery, the average E values were lower than the effect sizes of the other measured confounders in 33.3% and 60.9% of the studies, respectively. For valve‐sparing root replacement versus the Bentall procedure, no study reported effect sizes for associations of other covariates with outcomes. Conclusions The E values for observational evidence supporting the use of valve‐sparing root replacement, MV repair, and grafting with bilateral internal thoracic artery over the Bentall procedure, MV replacement, and grafting with single internal thoracic artery are relatively low. This suggests that small‐to‐moderate unmeasured confounding could explain most of the observed associations for these procedures.