Introducing transapical aortic valve implantation (part 1): Effect of a structured training program on clinical outcome in a series of 500 procedures

OBJECTIVES: The purpose of the present study was to test whether the cumulative knowledge from the field of transapical transcatheter aortic valve implantation, when incorporated into a structured training and then gradually dispersed by internal proctoring, might eliminate the negative effect of the learning curve on the clinical outcomes. METHODS: The present study was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical transcatheter aortic valve implantation at our institution from April 2008 to December 2011. Of the 500 patients, 28 were in cardiogenic shock. Differences during the study period in baseline characteristics, procedural and postprocedural variables, and survival were analyzed using different statistical methods, including cumulative sum charts. RESULTS: The overall 30-day mortality was 4.6% (95% confidence interval, 3.1%-6.8%) and was 4.0% (95% confidence interval, 2.6%-6.2%) for patients without cardiogenic shock. Throughout the study period, no significant change was seen in the 30-day mortality (Mann-Whitney U test, P = .23; logistic regression analysis, odds ratio, 0.83 per 100 patients; 95% confidence interval, 0.62-1.12; P = .23). Also, no difference was seen in survival when stratified by surgeon (30-day mortality, P = .92). An insignificant change was seen toward improved overall survival (hazard ratio, 0.90 per 100 patients; 95% confidence interval, 0.77-1.04; P = .15). CONCLUSIONS: The structured training program can be used to introduce transapical transcatheter aortic valve implantation and then gradually dispersed by internal proctoring to other members of the team with no concomitant detriment to patients