BACKGROUND Accumulated experience and advances in device technology have led to the increasing off-label use of transcatheter aortic valve replacement (TAVR) for pure native aortic valve regurgitation (PNAR). The aim of this study was to evaluate the use of newer-generation transcatheter heart valves (THVs) to treat PNAR versus the early-generation self-expanding CoreValve (Medtronic, Minneapolis, Minnesota).
METHODS TAVR were performed with the use of early- (n=15) and newer-generation (n=10) THVs in a total of 25 consecutive patients with PNAR at intermediate-to-high risk for surgical aortic valve replacement (mean Society of Thoracic Surgeons [STS] score of 6.8±4.5). Procedural and clinical outcomes were reported following Valve Academic Research Consortium 2 criteria. The primary end-point was all-cause mortality, myocardial infarction (MI), disabling stroke, and readmission for heart failure.
RESULTS Device success rate was significantly higher with newer-generation THVs compared with that of the early-generation CoreValve (100% vs. 33%, p＜0.01); this was mainly driven by less second THV implantations (0%% vs. 53%, p＜0.01). Although the procedural success rates were 100% for both early- and newer-generation valves, mean procedure time and mean fluoroscopic time were significantly shorter (p＜0.01). Furthermore, significantly less amount of contrast medium was used in the newer-generation device group, compared to that of the early-generation CoreValve group (p＜0.01). During a median follow-up of 48 months, event-free survival was better in patients undergoing TAVR with newer-generation THVs, although the statistical differences were non-significant (log-rank test, P=0.137). According to multivariate analysis, higher baseline STS score and longer intensive care unit stays are independent predictors of adverse outcomes.
CONCLUSIONS TAVR using the newer-generation THVs in the treatment of patients with PNAR was associated with improved procedural outcomes and is a valuable therapeutic option in selective patients.
Key words: transcatheter aortic valve replacement, pure native aortic regurgitation, transcatheter heart valves, procedural and clinical outcomes