More data confirm improved hemodynamics with next-generation TAVR valve
Pooled data from two registries have confirmed a previous report that a next-generation transcatheter aortic valve replacement system confers less paravalvular aortic regurgitation compared with the previous generation.
Results from the NEOPRO and NEOPRO-2 registries, presented at TVT: The Structural Heart Summit and published in Eurointervention, showed that the next-generation device (Acurate neo2, Boston Scientific) was associated with less paravalvular aortic regurgitation compared with the first-generation device (Acurate neo, Boston Scientific) in patients undergoing TAVR. As Healio previously reported, there were similar findings from the ITAL-neo registry presented at EuroPCR in May.
The present analysis included 2,026 patients (mean age, 82 years; 34% men) from the NEOPRO and NEOPRO-2 registries, of whom 763 received the Acurate neo2 and the rest received the Acurate neo, Andrea Scotti, MD, interventional cardiology research fellow at Montefiore Medical Center, said during a presentation.
“As TAVR candidates are increasingly younger and at lower surgical risk, it becomes crucial to minimize potential procedural complications and provide surgical-like long-term outcomes,” Scotti said during the presentation. “Postprocedural moderate or severe aortic regurgitation is a relevant complication after TAVR that has been found to be associated with adverse short- and long-term outcomes.”
As Healio previously reported, the Acurate neo valve failed to meet noninferiority compared with the CoreValve Evolut valve (Medtronic) in the SCOPE 2 trial and the Sapien 3 valve (Edwards Lifesciences) in the SCOPE 1 trial, mainly due to differences in rates of paravalvular aortic regurgitation.
Technical success occurred in 93% of the Acurate neo2 group and 91% of the Acurate neo group (P = .12), whereas the rates of pacemaker implantation were 8% in the Acurate neo2 group and 9% in the Acurate neo group (P = .46), Scotti said, noting the rate of intended performance at 30 days was better in the Acurate neo2 group (96% vs. 90%; P < .001).
At 30 days, the groups did not differ in mortality, but the Acurate neo2 group had a higher rate of freedom from vascular complications (94% vs. 83%; P < .001) and freedom from bleeding complications (88% vs. 85%; P = .02), according to the researchers.
The proportion of patients with no or trace paravalvular aortic regurgitation on predischarge echocardiography was 59% in the Acurate neo2 group compared with 38% in the Acurate neo group (P < .01), Scotti said, noting heavy calcification was less common in the Acurate neo group (2% vs. 9%; P = .018).
“The latest-generation Acurate neo2 transcatheter heart valve was associated with a significant reduction in post-procedural moderate or severe paravalvular aortic regurgitation as compared to the first-generation neo transcatheter heart valve,” Scotti said during the presentation. “The superior performance of the Acurate neo2 valve was particularly evident in severely calcific aortic valve anatomies.”
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Scotti A, et al. Late-Breaking Clinical Trials. Presented at: TVT: The Structural Heart Summit; June 8-10, 2022; Chicago (hybrid meeting).