FRANCE-TAVI Registry: Balloon-Expandable versus Self-Expandable TAVR on Paravalvular Regurgitation and 2-Year Mortality

Two of the most widely used transcatheter heart valves (THV) designs may not achieve the same clinical outcomes, according to new study results from the American Heart Association 2019 Scientific Sessions.

In this study, from January 2013 to December 2015 researchers evaluated 12,141 patients undergoing self-expandable (SE) or balloon-expandable (BE) transcatheter heart valve (THV) for implant for native aortic stenosis. Subsequently, using a propensity-score based on 25 clinical, anatomical and procedural variables, 3,910 patients treated with BE-THV were matched 1:1 with a group of 3,910 patients treated with SE-THV. The study consisted of two primary endpoints: the occurrence of pulmonary vascular resistance (PVR)≥moderate and/or in-hospital mortality, as well as death from all occurrences over two years.

Following analysis, the results of the study showed that the first co-primary outcome was notably higher with SE- THV (19.8%) compared to BE-THV (11.9%; matched RR=1.67; 95% CI, 1.46 to 1.89; P<0.0001) with each component of the endpoint observed as higher in SE-THV patients: PVR≥moderate (15.5% vs. 8.3%; matched-RR=1.86; 95% CI, 1.59 to 2.18, P<0.0001) and in-hospital mortality (5.6% vs. 4.2%, matched-RR=1.33; 95% CI, 1.06 to 1.65; P=0.01).

The researchers further observed that during follow-up, death from all causes occurred in 899 patients treated with SE-THV and in 801 patients treated with BE-THV, which was consistent respective of age, gender, diabetes, pre-procedural AR status, pre procedural MR status, aortic annulus dimension, delivery approach, year of intervention.

“In this nationwide propensity-score matched comparison, implantation of SE-THV to treat patients with native AS was associated with a higher risk of PVR and/or in-hospital mortality and a higher risk of 2-year mortality as compared with BE-THV,” the study authors wrote in their study abstract. “They added that these data “strongly support the need for a direct randomized superiority trial sufficiently powered to compare head-to -head the latest generation of SE and BE-THV.”