Author + information
- Toby Rogers,
- Arie Steinvil,
- Edward Koifman,
- Kyle Buchanan,
- Chadi Alraies,
- Petros Okubagzi,
- Rebecca Torguson,
- Itsik Ben-Dor,
- Augusto Pichard,
- Lowell Satler and
- Ron Waksman
Two competing TAVR technologies are approved for commercial use in the US: the balloon-expandable Sapien 3 (S3) (Edwards, Irvine, CA) and the self-expanding Evolut R (Medtronic, Minneapolis, MN).
A total of 257 consecutive patients treated with S3 or Evolut R were included. Baseline demographic, procedural, echocardiographic and CT imaging, and follow-up data were prospectively collected at a tertiary referral hospital in the US where both devices are routinely used.
Patients selected for Evolut R were more likely to be female and have lower body surface area (BSA) and smaller iliofemoral vessels (Table 1). There was no difference in the severity of aortic stenosis (valve area 0.70±0.17 vs 0.68±0.13, p=0.27 for S3 vs Evolut R). Balloon valvuloplasty was performed more frequently in the S3 group (65.4% vs 36.7%. p<0.001). Four patients suffered periprocedure ischemic stroke with S3 compared with 1 with Evolut R. Pacemaker implantation rate was higher in the Evolut R group. The major vascular complication rate was similar in both groups (4.8% vs 4.5%, p=1.0, for S3 vs Evolut R) as was the rate of life-threatening and major bleeding (3.5% vs 2.9%, p=1.0, respectively). Dimensionless index was significantly higher in the Evolut R group, but the incidence of >mild paravalvular leak was also numerically higher. There was no difference in 30-day mortality.
In our contemporary experience, both technologies had advantages and disadvantages. These data highlight the importance of individualized decision making, with the choice of TAVR device tailored to each patient. Although there was no difference in 30-day mortality, it will be important to evaluate longer-term prosthesis hemodynamics and clinical outcomes going forward.
|Sapien3 (n=183)||Evolut R (n=74)||p value|
|Body surface area, mean ± SD (m2)||1.9 ± 0.3||1.8 ± 0.3||0.048*|
|Minimal rightiliofemoral diameter,mean ± SD (mm)||6.8 ± 1.5||5.9 ± 1.5||<0.001*|
|Minimal left iliofemoral diameter,mean ± SD (mm)||6.9 ± 1.4||5.9 ± 1.4||<0.001*|
|Successful valve deployment||96.4%||98.4%||0.72|
|Prosthetic valve dimensionlessindex, mean ± SD||0.50 ± 0.10||0.57 ± 0.12||<0.001%|
|Paravalvular leak >mild in severity||4.1%||8.2%||0.31|
(* denotes statistical significance). SD: standard deviation.