Assessment of coronary cannulation after TAVI with the Evolut FX valve: the CANNULATE TAVR EXPANDED study

BACKGROUND: The new-generation supra-annular, self-expanding Evolut FX system has the potential to facilitate commissural alignment. AIMS: We sought to assess the feasibility of coronary cannulation (CC) and the impact of commissural and coronary alignment on CC execution, as confirmed by post-transcatheter aortic valve implantation (TAVI) computed tomography (CT). METHODS: The CANNULATE TAVR EXPANDED study is a multicentre, prospective study which included consecutive patients who underwent transfemoral TAVI with the Evolut FX, CC, and angiography after valve deployment. Post-TAVI CT was performed to assess commissural and coronary alignment. Moderate-to-severe commissural and coronary misalignments based on the ALIGN-TAVR Consortium definition were categorised as the misalignment group. The primary endpoint was the rate of successful CC after Evolut FX implantation. RESULTS: A total of 126 patients were included. CC was successful in 100% of cases for the left coronary artery (LCA) and 96.7% for the right coronary artery (RCA). Moderate-to-severe commissural misalignment was observed in 13.5%, and moderate-to-severe coronary misalignment was observed in 20.6% (LCA) and 22.2% (RCA). Misaligned LCA and RCA required significantly longer CC times. In multivariable analysis, factors associated with suboptimal LCA cannulation were coronary height (odds ratio [OR] 0.73, 95% confidence interval [CI]: 0.57-0.90; p=0.006) and coronary misalignment (OR 4.58, 95% CI: 1.45-14.47; p=0.009), whereas right coronary cusp width (OR 0.63, 95% CI: 0.44-0.90; p=0.007) and coronary misalignment (OR 4.64, 95% CI: 1.29-16.74; p=0.019) were identified for the RCA. CONCLUSIONS: High rates of CC, and commissural and coronary alignment post-TAVI with the Evolut FX were observed in this prospective, multicentre study. Coronary misalignment was identified as the strongest predictor of suboptimal CC for both the LCA and the RCA.