Key result
The repositionable Evolut R system significantly reduced the incidence of permanent pacemaker implantation compared to the CoreValve prosthesis (10.9% vs 21.6%; p=0.01).
Why the study?
The recapturable and repositionable Evolut R CoreValve was designed for more precise implantation, prompting a comparison of permanent pacemaker implantation incidence and implantation depth against the CoreValve.
Does the Evolut R CoreValve system reduce the incidence of permanent pacemaker implantation compared to the CoreValve prosthesis in patients with severe aortic stenosis?
Cohort (n=345)
Does the Evolut R CoreValve system reduce the incidence of permanent pacemaker implantation compared to the CoreValve prosthesis in patients with severe aortic stenosis?
Absolute Event Rate: 10.9% vs 21.6%
p-value: p=0.01
The recapturable Evolut R system allows for a higher and more precise valve implantation depth, which significantly reduces the incidence of conduction disturbances and the need for permanent pacemaker implantation compared to the earlier generation CoreValve.
Evolut R was associated with lower PPI rates than CoreValve; leaves open whether repositionability improves outcomes in prospective randomized settings.
OBJECTIVES: To compare the incidence of permanent pacemaker implantation (PPI) with the CoreValve and Evolut R prostheses, to evaluate the implantation depth with both types of prostheses, and to study factors predicting the need for PPI. BACKGROUND: The Evolut R CoreValve can be recaptured and repositioned during deployment, allowing a more precise implantation. METHODS: A total of 208 patients treated with CoreValve and 137 patients treated with Evolut R were analyzed. The depth of the prosthesis in the LVOT was measured by angiography in the annular perpendicular view projection after deploymen in all patients. RESULTS: Baseline conduction abnormalities were comparable between the groups (85/208, 40.9% vs. 53/137, 38.7%; p = 0.69). The mean prosthesis depth was 10.3 ± 8.6 mm in the CoreValve group and 5.5 ± 2.7 mm in the Evolut R group; p < 0.0001. Conduction disturbances after valve implantation were more frequent with the CoreValve (new-onset left bundle branch block: 93, 44.7% vs. 16, 11.7%; p < 0.05, first-degree atrioventricular block: 23, 11.1% vs. 5, 3.6%; p < 0.05). In addition, the incidence of PPI was significantly lower with Evolut R (45, 21.6% vs. 15, 10.9%; p = 0.01). The predictors of the need for PPI were the mean depth of the prosthesis (OR: 1.13, 95% CI: 1.06-1.21; p < 0.0001) and prior right bundle branch block (OR 10.22, 95% CI: 4.62-22.63; p < 0.0001). CONCLUSIONS: The recapturable capability of the Evolut R system allowed for higher and precise valve implantation. This fact had an impact on the reduction in the need for PPI.
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Ojeda et al. (2019) conducted a cohort in severe aortic stenosis (n=345). Evolut R CoreValve system vs. CoreValve prosthesis was evaluated on permanent pacemaker implantation (PPI) (p=0.01). The repositionable Evolut R system significantly reduced the incidence of permanent pacemaker implantation compared to the CoreValve prosthesis (10.9% vs 21.6%; p=0.01).
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