OUTCOMES WITH THE LATEST-GENERATION FLEXNAV DELIVERY SYSTEM ARE CONSISTENT WITH contemporary TAVI VALVES1,2
30-DAY COMPARISON | |||
---|---|---|---|
PORTICO™ WITH FLEXNAV™1 | EVOLUT‡ R/PRO2 (N = 111)** | SAPIEN‡ 32 | |
All-Cause Mortality (%) | 0.6 | 1.8 | 0.0 |
Disabling Stroke (%) | 1.1 | 0.9 | 1.0 |
Life-Threatening Bleeding (%) | 3.9 | 5.4 | 3.4 |
Acute Kidney Injury Stage III (%) | 0.0 | 1.8 | 0.0 |
Major Vascular Complications (%) | 5.0† | 7.2 | 7.3 |
New Permanent Pacemaker (%) | 15.4 | 18.8 | 5.4 |
Mean Gradient (mmHg) | 7.1 | 7.3 | 11.8 |
Aortic Valve Area (cm2) | 1.77 | 1.93 | 1.59 |
Moderate or Greater PVL (%) | 4.1 | 4.0 | 1.6 |
† 3.3% TAVI delivery system access site-related, 1.1% non-TAVI delivery system access site-related and 0.6% non-access site-related
NOTE: Data not from head-to-head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.
*Global cohort data represent a non-randomized sample of high- or extreme-risk patients that underwent an attempted Portico™ valve implant using the FlexNav™ delivery system via a transfemoral access approach between October 2018 and December 2019.
** Data represent a subset of high- or extreme-risk patients that underwent an attempted Evolut‡ R, Evolut‡ PRO or Sapien‡ 3 valve implant via a transfemoral or alternative access approach between May 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.