From the Guidelines
The choice between Sapien and Evolut transcatheter aortic valve replacement systems should be based on individual patient factors, including anatomy and specific clinical needs, rather than one being definitively labeled as "better" overall. When considering the options for transcatheter aortic valve replacement (TAVR), both the Sapien and Evolut systems have their own set of advantages and considerations. The Sapien valve, being balloon-expandable, offers precise placement and is supported by extensive clinical data 1. On the other hand, the Evolut valve, which is self-expanding, may provide advantages in certain anatomical situations, such as severe calcification of the aortic annulus or an extremely oval-shaped annulus, and potentially lower rates of patient-prosthesis mismatch.
Key Considerations
- Annulus dimensions and geometry
- Native valve and aortic root/LV outflow tract anatomy
- Coronary height
- Amount and distribution of calcification
- Vascular access routes, including the potential for transfemoral access with smaller femoral artery diameters
The decision between these two systems should be made by a heart team after careful evaluation of the patient's specific anatomical considerations and clinical needs. While the Evolut valve offers the advantage of being recapturable and repositionable prior to full deployment, which can reduce complications from malpositioning, the Sapien valve may be preferable in patients with a dilated ascending aorta or severely angulated aorta. Ultimately, the choice between Sapien and Evolut should prioritize the patient's unique anatomy and clinical situation, aiming to minimize morbidity, mortality, and improve quality of life. Patients should discuss with their cardiologist which valve might be more suitable for their particular situation, as the best choice is highly individualized 1.
From the Research
Comparison of Sapien and Evolut Transcatheter Aortic Valve Replacement
- The Sapien and Evolut valves are two commonly used valves in Transcatheter Aortic Valve Replacement (TAVR) procedures 2.
- A meta-analysis of 9 studies found that the 30-day mortality rate was similar between Sapien 3 and Evolut R valves (odds ratio 1.19,95% confidence interval 0.72 to 1.93, p = 0.47) 2.
- The risk of major or life-threatening bleeding and stroke were also similar between the two types of valves 2.
- However, Evolut R was associated with a statistically significant risk of permanent pacemaker implantation (odds ratio 1.40,95% confidence interval 1.15 to 1.70, p = 0.0007) and moderate to severe paravalvular regurgitation (odds ratio 2.56,95% confidence interval 1.14 to 5.74, p = 0.02) compared to Sapien 3 2.
Hemodynamic Outcomes
- A meta-analysis of randomized and propensity-matched studies found that self-expanding valves (SEV), such as Evolut, had better hemodynamic outcomes, including a larger effective orifice area and lower mean transvalvular gradients, compared to balloon-expandable valves (BEV), such as Sapien 3.
- However, SEV were associated with a higher incidence of paravalvular leakage (PVL) compared to BEV 3.
Valve-Specific Outcomes
- A randomized clinical trial found that the balloon-expandable Sapien XT valve had a higher device success rate compared to the self-expandable Medtronic CoreValve (95.9% vs 77.5%, p < 0.001) 4.
- Another study found that the Sapien 3 valve had a lower risk of moderate or severe prosthetic aortic regurgitation compared to the self-expanding ACURATE neo valve (3% vs 9%, p = 0.02) 5.
- A meta-analysis found that Evolut SEV was associated with a higher risk of permanent pacemaker implantation compared to Sapien BEV, while ACURATE SEV had a lower risk of PPI at 30 days compared to Sapien BEV 3.