Valvular Intervention: Aortic
Quantitative Angiographic Assessment of Aortic Regurgitation Post 11 Different Types of TAVR Devices (A Multicentre Pooled Analysis of 2665 Valves)
Mahmoud Abdelshafy1, Osama Soliman1, Won-Keun Kim2, Ahmed Elkoumy3, Hesham Elzomor1, Yoshinobu Onuma1, Patrick W. Serruys1
National University of Ireland, Galway, Ireland1, Kerckhoff Heart Center, Germany2, Galway University Hospital, Ireland3
Regurgitation following TAVR impacts all-cause mortality. Thus far, no quantitative comparison of regurgitation by the same core lab has been performed among the various commercially available transcatheter heart valves (THV) We aimed to compare quantitative angiographic aortic regurgitation (AR) of 11 different types of THVs.
This is a multicentre retrospective corelab pooled analysis of aortograms from 2665 consecutive patients treated with 11 different THV devices. Analysis was done by quantitative videodensitometric aortography (LVOT-AR), which is an objective, accurate, and reproducible tool for assessment of AR following TAVR. This method relies on time density changes in contrast medium after injection in the ascending aorta and its regurgitation (and subsequent density increase) in the LVOT. The ratio between the areas under the two-time density curves of these regions quantifies the AR in absolute percentage. The valves evaluated include ACURATEneo2 (Boston Scientific, Massachusetts, USA) (n=120), Lotus (n = 546), Myval (MerilLife Sciences Pvt. Ltd., India) (n =108), VitaFlow (MicroPort, Shanghai, China)(n=105), Evolut PRO (Medtronic, Dublin, Ireland) (n=95), SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) (n=397), Evolut R (n=295), SAPIEN XT (n=239), ACURATE neo (n=120), Venus-A (Venus Medtech Inc., Hangzhou, China) (n=113) and CoreValve (n=532). Stratification of continuous variable regurgitation into categorical variables was performed according to the following pre-determined threshold criteria: 1) none/trace regurgitation (LVOT-AR<6%); 2) mild (6%≤ LVOT-AR≤17%); and 3) moderate or severe (LVOT-AR >17%). The attached video shows step by step example of videodensitomtric analysis.VD analysis example.avi
The attached Figure (1) shows the Cumulative Percentage of the Different Degrees of Post-TAVR Aortic Regurgitation Assessed with Quantitative Aortography. Figure (2) shows the comparison of the mean LVOT-AR after TAVR among the 11 THVs.The main findings of the present study are that:1-The addition of anti-PVR sealing features to the new generations ACURATE neo2 THV proved to be effective in reducing the incidence of significant PVR In comparison with the first generation ACURATE neo. 2- Myval, VitaFlow, and Venus-A THVs are showing promising results. 3- Although the incidence of moderate/severe AR has regressed over time with new generations of THVs, the incidence of mild AR is still prominent with all THVs still exhibiting mild AR with an incidence ranging between 30%- and 50% apart from the Lotus valve that had an 19% incidence of mild AR.
The ACURATE neo2 THV had the lowest severe/moderate percentage of AR showing significant improvements in comparison to ACURATE neo. Myval, VitaFlow, and Venus-A are promising options in the THV armamentarium. These results should be confirmed in prospective randomized, head-to-head comparisons between THVs.