The Coronary AccEss After Tavr (CAvEAT) Registry: an international, multicenter prospective registry for the coronary access after TAVR

Background. As transcatheter aortic valve replacement (TAVR) is now performed in patients with longer life expectancy, the need for coronary access (CA) after TAVR is expected to rise. Objectives. This study aims to evaluate the feasibility of CA after TAVR with four different types of transcatheter heart valves (THVs). Methods. In the investigator-driven, prospective, multi-center Coronary AccEss After Tavr (CAvEAT) study (NCT04647864), coronary angiography was performed immediately after transfemoral (TF) TAVR for native aortic stenosis (AS) with the short-frame Sapien 3/Ultra, and the tall-frame Acurate Neo/Neo2, Portico/Navitor and Evolut Pro/Pro+ THVs. Commissural alignment (CoA) was attempted in all tall-frame THV cases. The primary endpoint was defined as selective CA of both coronary arteries, as adjudicated by an independent core-laboratory. A sample size of 158 patients per group was calculated to detect significant differences across THVs. Results. 632 patients were enrolled at 18 European centers. Mean age was 82 years, mean STS score was 3.2%, 59% were female. Selective CA of both coronary arteries was achieved in 89% of Sapien 3/Ultra, 63% of Acurate Neo/Neo2, 62% Portico/Navitor and 45% Evolut Pro/Pro+ THVs (p<0.001). Unfeasible CA of at least one coronary artery was observed in 2%, 6%, 6%, and 9% cases (p=0.06). In a pairwise comparison, the incidence of the primary endpoint was higher for Sapien 3/Ultra as compared to all other tall-frame THVs (p<0.001 for each comparison). Among tall-frame devices, no difference was detected between Acurate Neo/Neo2 and Portico/Navitor (p=0.9), while the latter two THVs showed higher rates of the primary endpoint as compared to Evolut Pro/Pro+ (p=0.005 and 0.002, respectively). At multivariate analysis, implantation depth, moderate/severe misalignment and the use of a tall-frame THV were independently associated with unfeasible/non-selective CA. Conclusions. The short frame Sapien 3/Ultra THV grants the highest rate of selective CA after TAVR. Among tall-frame THVs, large-cell Portico/Navitor and Acurate Neo/Neo2 THVs performed better in terms of selective CA as compared to closed-cell Evolut Pro/Pro+. These results may influence THV choice, particularly in younger TAVR candidates with concomitant coronary artery disease (CAD).