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Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement
Sukhdeep Bhogal1, Toby Rogers2, Ilan Merdler1
1Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
International Journal of Cardiology
|July 21, 2023
Summary
The Evolut PRO/PRO+ transcatheter aortic valve demonstrated comparable safety and efficacy to the Evolut R in treating severe aortic stenosis. Outcomes including mortality and valve function were similar at 30 days and 1 year.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- The self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was developed to address limitations of the Evolut R model.
- Evolut PRO/PRO+ features a low delivery profile and an external tissue wrap across all valve sizes, enhancing its design.
- This study compares the safety and efficacy of the Evolut PRO/PRO+ against the Evolut R system.
Purpose of the Study:
- To evaluate and compare the safety and efficacy of the Evolut PRO/PRO+ transcatheter aortic valve system versus the Evolut R system.
- To assess clinical outcomes, including mortality and complications, at 30 days and 1 year post-procedure.
- To analyze echocardiographic parameters at 30 days and 1 year to determine hemodynamic performance.
Main Methods:
- A propensity-score matched analysis of 300 patients from the EPROMPT Registry (Evolut PRO/PRO+) and 242 historical controls (Evolut R).
- Matching was performed 1:1 based on Society of Thoracic Surgeons Predicted Risk of Mortality scores to balance baseline characteristics.
- Key endpoints included in-hospital safety, all-cause mortality at 30 days and 1 year, and echocardiographic assessments at 30 days and 1 year.
Main Results:
- No significant differences were observed in cardiac death (0.5% vs. 0.5%), stroke (1.6% vs. 2.8%), life-threatening bleeding (1.1% vs. 3.3%), major vascular complications (0.5% vs. 0.9%), or pacemaker implantation (16.9% vs. 13.6%) between the groups.
- All-cause mortality rates were similar at 30 days (0.5% vs. 1.4%) and 1 year (1.8% vs. 4.1%).
- Echocardiographic outcomes, including moderate paravalvular leak (5.7% vs. 2.6%) and mean gradient (7.27 vs. 8.84 mmHg), were comparable at 1 year.
Conclusions:
- The Evolut PRO/PRO+ system is a safe and effective option for treating severe aortic stenosis, as supported by this large observational study.
- The system demonstrates comparable 30-day and 1-year mortality rates to the Evolut R.
- Evolut PRO/PRO+ achieves similar 1-year echocardiographic hemodynamic outcomes compared to the Evolut R, validating its clinical performance.
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