Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement.

BACKGROUND

The self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was designed to overcome the limitations of its forerunner, Evolut R. Evolut PRO/PRO+ offers the lowest delivery profile for 23-29 mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R.

METHODS

We analyzed 300 patients enrolled in the EPROMPT Registry against a historical control cohort of 242 patients who received Evolut R. The two arms were matched (1:1) via propensity-score methodology by accounting for differences in Society of Thoracic Surgeons Predicted Risk of Mortality scores, yielding 440 patients. The endpoints included in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30 days and 1 year.

RESULTS

After propensity-score matching, cardiac death (0.5% vs. 0.5%, p = 0.995), stroke (1.6% vs. 2.8%, p = 0.410), life-threatening bleeding (1.1% vs. 3.3%, p = 0.139), major vascular complications (0.5% vs. 0.9%, p = 0.653), and pacemaker implantation (16.9% vs. 13.6%, p = 0.345) were comparable between the Evolut PRO/PRO+ and Evolut R groups. Likewise, the rates of all-cause mortality were similar both at 30 days (0.5% vs. 1.4%, p = 0.315) and 1 year (1.8% vs. 4.1%, p = 0.159). The rates of moderate paravalvular leak (5.7% vs. 2.6%, p = 0.402), and mean gradient (7.27 ± 3.25 mmHg vs. 8.84 ± 4.36 mmHg, p = 0.105) were also comparable between groups at 1 year.

CONCLUSION

Our largest-to-date observational study suggests that the Evolut PRO/PRO+ system is safe and effective in treating severe aortic stenosis, with commensurate 30-day and 1-year mortality and similar 1-year echocardiographic hemodynamic outcomes in comparison to Evolut R.