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Postprocedural Aortic Regurgitation in Balloon-Expandable and Self-Expandable Transcatheter Aortic Valve Replacement Procedures: Analysis of Predictors and Impact on Long-Term Mortality: Insights From the FRANCE2 Registry
Study Questions:
What are the predictors and prognostic impact of aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR)?
Methods:
This registry evaluated 2,769 consecutive patients undergoing TAVR at 34 hospitals with post-procedural echocardiography. Predictors of significant (≥ mild-moderate) AR on post-procedural echocardiography were assessed, and the relationship between significant AR and 1-year mortality was evaluated. Post-procedure echocardiography was performed before hospital discharge.
Results:
Median follow-up was 306 days (interquartile range, 178-406). Balloon-expandable (BE) and self-expanding (SE) valves were performed in 67.6% and 32.4% of individuals, respectively. Significant post-procedural AR was more common in those with a SE-TAVR (21.5%), as compared to BE-TAVR (13.0%) (p < 0.001). On multivariable analysis, the use of a SE-TAVR was associated with increased prevalence of significant AR (p < 0.001). Among those with a BE-TAVR, variables independently associated with significant AR included male gender (p < 0.001), atrial fibrillation (p = 0.04), baseline mitral regurgitation (p = 0.005), femoral artery approach (p = 0.04), increased annulus diameter (p < 0.001), and smaller prosthesis diameter (p < 0.001). In those with a SE-TAVR, variables independently associated with significant AR included baseline AR, and a femoral artery approach (p = 0.003). The presence of significant (≥ mild to moderate) post-procedural AR was associated with increased all-cause mortality (p < 0.001) and cardiovascular mortality (p < 0.001). The presence of mild post-procedural AR was not associated with a difference in total or cardiovascular mortality. Significant AR was associated with increased all-cause mortality for those with both BE-TAVR (hazard ratio 2.5, p < 0.001) and SE-TAVR (hazard ratio 2.1, p < 0.001). Among nine variables independently associated with all-cause mortality, the presence of significant post-procedural AR was the strongest predictor of mortality.
Conclusions:
The use of SE-TAVR is associated with increased prevalence of significant post-procedural AR as compared to BE-TAVR, and significant AR is the strongest predictor of 1-year mortality.
Perspective:
This multicenter registry observes an increased rate of ≥ mild to moderate AR in patients treated with a SE-TAVR. While the presence of mild post-procedural AR was not associated with a difference in mortality, ≥ mild to moderate AR was the strongest independent predictor of mortality, and was associated with increased mortality for both types of valves. As this is a real-world registry study, there are inherent limitations. Appropriate valve sizing may reduce aortic regurgitation, and computed tomographic imaging is increasingly used to measure the aortic valve annulus for this purpose. Prosthesis sizing for patients in this study was not clearly defined, and it is unknown whether this may have influenced the results. Further, AR was defined by post-discharge echocardiography, and as AR may decrease over time, particularly with SE-TAVR devices, these results may overestimate the long-term severity of AR. Overall, these real-world findings highlight the importance of reducing the prevalence of significant AR, which may be achieved by improving valve design, better selection of appropriate valve sizes, and improved delivery and deployment techniques.
Keywords: Heart Valve Prosthesis, Follow-Up Studies, Mitral Valve Insufficiency, Femoral Artery
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