Insights into surgical innovation, incremental learning and refinement in practice: a case-study of aortic valve neocuspidization (AVNeo) with autologous pericardium (the Ozaki procedure)

Introduction Modifications and refinements are expected in the surgical innovation lifecycle and are a key characteristic of IDEAL Stage 2a. Little is known, however, about what happens in practice; how/why procedures are modified, the rationale for modifications and the learning gained. The ethnographic Lotus study follows new procedures/devices as they are introduced into NHS practice. Here we report on a cardiology case study (the Ozaki procedure).<br/><br/>Methods Interviews with surgeons performing Ozaki procedures in one UK hospital over time, prior to/between patient cases. Topic guides explored experiences and reflections. Data underwent thematic analysis.<br/><br/>Results 18 interviews with 5 surgeons were conducted (Dec 2019-June 2022) exploring n=20 patient cases. Technical modifications to the procedure were described as surgeons gained experience. Modifications to patient selection criteria (e.g., including abnormal valve anatomies) as learning/confidence grew were described. Rationale for modifications were broadly categorised as patient/anatomical reasons, learning from colleagues/the wider surgical community, and personal drivers (e.g., for perfection).<br/><br/>Conclusions Qualitative data provides insights into surgical innovation and its incremental evolution during introduction into clinical practice. Examining how/why modifications occur facilitates shared learning and efficient innovation by helping to determine whether a procedure/device is ready for the next IDEAL stage of evaluation.