In recent years, there has been a steady increase in the use of transcatheter aortic valve replacement (TAVR) in younger patients, with an average age of 74 years, as observed in US medical records. This trend goes alongside encouraging durability results, as demonstrated in the 10-year NOTION study, where structural valve degeneration (SVD) with first-generation CoreValve was lower compared with surgery, and the all-cause mortality rate was similar between groups.
It is important to note that SVD should not be overlooked, as its presence has been associated with nearly double the risk of cardiovascular mortality or rehospitalization.
The purpose of this study was to report on the clinical and hemodynamic follow-up at 4 years for patients who underwent TAVR compared with surgical aortic valve replacement (SAVR), using data from the EVOLUT Low Risk Trial. There was a 94.7% follow-up in the TAVR group and 89.2% in the SAVR group.
There was a mean gradient ≥20mmHg in 4% of all TAVR patients compared with 8.9% of all SAVR patients (p=0.002). The prosthetic mismatch was lower (1.1% vs. 3.5%; p=0.008). When evaluating the primary clinical endpoint (all-cause mortality or disabling stroke), there was a 26% reduction (hazard ratio [HR]=0.74, 95% confidence interval [CI], 0.54-1.00; Log-rank p = 0.05), primarily due to a reduction in all-cause mortality (HR, 0.74; 95% CI, 0.53-1.03; Log-rank p = 0.07).
In terms of paravalvular regurgitation (PVR), there were no significant differences in terms of moderate or severe PVR (p = 0.50). PVR was most frequently trivial (84.7%) or mild (14.9%) in the TAVR group. Additionally, the hemodynamic performance was better in patients in the TAVR group, with lower effective orifice area and mean gradients (p < 0.001). In terms of safety, the TAVR group had a higher pacemaker implantation rate (24.6% vs. 9.9%; p<0.001).
In summary, patients who underwent TAVR had lasting results in follow-up, with superior hemodynamic profiles compared with SAVR. Event curves continued to show a divergent trend over the years, favoring TAVR. These results suggest that, in low-risk patients, the Evolut platform should be considered as a preferred option, in light of the aforementioned results.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Presented by Michael J. Reardon in Late-Breaking Clinical Trials at TCT 2023, San Francisco, October 23, 2023.
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