Quantitative Aortography Analysis of JenaValve's Trilogy Transcatheter Aortic Valve Implantation System in Patients With Aortic Regurgitation or Stenosis

Background: JenaValve's Trilogy transcatheter heart valve (THV) (JenaValve Inc, Irvine, CA) is the only conformité européenne-marked THV system for the treatment of aortic regurgitation (AR) or aortic stenosis (AS). However, its efficacy has not been quantitatively investigated pre- and post-implantation using video-densitometric analysis. Methods: Using the CAAS-A-Valve 2.1.2 software (Pie Medical Imaging, Maastricht, the Netherlands), an independent core lab retrospectively analyzed the aortograms of 88 consecutive patients (68 severe AR; 20 severe AS) receiving the JenaValve THV in three European centers. Video-densitometric AR was categorized by the regurgitant fraction (RF) as none/trace AR (RF ≤ 6%), mild (6% < RF ≤ 17%), and moderate/severe AR (RF > 17%). Results: Pre- and post-THV aortograms were analyzable in 17 (22.4%) and 47 (54.0%) patients, respectively. The main reasons preventing analysis were the descending aorta overlap of the outflow tract (30%) and insufficient frame count (6%). The median RF pre- and post-THV implant was 31.0% (interquartile range 21.5-38.6%) and 5.0% (interquartile range 1.0-7.0%, p < 0.001), respectively. The post-THV incidence of none/trace AR was 72.3%, and of mild AR, 27.7%, with no cases of moderate/severe AR. Video-densitometry analysis of the 12 AR cases with paired pre- and post-THV showed a reduction in the RF of 21.8% ± 8.1%. Conclusions: Quantitative aortography confirms the low rates of AR and the large reduction in RF following the implantation of Jenavalve's Trilogy THV, irrespective of implant indication. However, these limited data need corroborating in prospective studies using standardized acquisition protocols.