Quality Control Of Isolated Bioprosthetic Aortic Valve Replacement In The Post-TAVI Period: Impact Of Innovative Operative Techniques
Joseph NADER1, Charles-Henri GAUTIER1, Gilles TOUATI1, Christophe TRIBOUILLOY1, Hélène ELTCHANINOFF2 ,
1- Amiens University Hospital, Amiens, France; 2- Rouen University Hospital, Rouen, France
OBJECTIVE: To assess quality control of actual single center surgical outcomes for bioprosthetic isolated aortic valve replacement (AVR) by using sequential analysis of VARC-2 early outcomes
METHODS: We retrospectively reviewed a consecutive series of 463 patients operated on for isolated AVR with conventional (369) or sutureless bioprosthesis (94). Surgical approach was a complete median sternotomy in 412 patients and an upper hemi-sternotomy in 51 patients. We considered overall and in-hospital mortality as well as the composite endpoints “device success” and “early safety” as defined in the VARC-2 endpoints for TAVI.
Results of patient groups were screened through funnel plots lowering the confidence interval to 1.5 SD before being scrutinized with CUSUM (Cumulative Sum) or SPRT (Sequential Probability Ratio Test) methods whenever required.
LIMITATION: It is likely that, due to significant changes in transfusion policy post-operatively during the study period, transvalvular mean gradients might have been worsen in the most recent patients who received the largest proportion of sutureless valves therefore inducing a bias in device success estimates.
CONCLUSION: Introducing innovative operative techniques in a standard practice of surgical bioprosthetic AVR with can be performed safely especially concerning mini-invasive approach. However technical challenge with nitinol-stented bioprostheses must not be under-estimated and prolonged ad-hoc support may be required in the present product conformation.