Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement.
Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement.
- 2023
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 23-29mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R. 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. Copyright © 2023. Published by Elsevier B.V. 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 endpointsincluded in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30days and 1year. 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 30days (0.5% vs. 1.4%, p=0.315) and 1year (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+/-3.25mmHg vs. 8.84+/-4.36mmHg, p=0.105) were also comparable between groups at 1year.
English
0167-5273
10.1016/j.ijcard.2023.131196 [doi] S0167-5273(23)01003-3 [pii]
IN PROCESS -- NOT YET INDEXED--Automated
MedStar Heart & Vascular Institute
MedStar Washington Hospital Center
Advanced Cardiac Catheterization Research Fellowship
Interventional Cardiology Fellowship
Journal Article
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 23-29mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R. 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. Copyright © 2023. Published by Elsevier B.V. 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 endpointsincluded in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30days and 1year. 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 30days (0.5% vs. 1.4%, p=0.315) and 1year (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+/-3.25mmHg vs. 8.84+/-4.36mmHg, p=0.105) were also comparable between groups at 1year.
English
0167-5273
10.1016/j.ijcard.2023.131196 [doi] S0167-5273(23)01003-3 [pii]
IN PROCESS -- NOT YET INDEXED--Automated
MedStar Heart & Vascular Institute
MedStar Washington Hospital Center
Advanced Cardiac Catheterization Research Fellowship
Interventional Cardiology Fellowship
Journal Article