The PORTICO IDE trial randomized 750 patients in a 1:1 manner to treatment with the Portico TAVR valve system or commercial TAVR.  

Participants had severe symptomatic aortic stenosis, were suitable for TAVR, and were deemed high or extreme risk for surgery.  The commercial arm included Edwards Sapien 3 (n=206), Medtronic Evolut R and Evolut Pro (n=110).  Mean age was 83 years (±7) and notably 395 (57%) were female.  

The primary safety endpoint at 30 days (composite of all-cause mortality, disabling stroke, life-threatening bleeding, acute kidney injury requiring dialysis, or major vascular complication) was higher in the Portico group 13.8% vs. 9.6% though did not meet statistical significance for non-inferiority p=0.03.  

The primary efficacy endpoint (all-cause mortality or disabling stroke at 1-year) was similar at 1 year; 14.8% for Portico vs. 13.4% for Commercial pnon-inferiority = 0.006.

Permanent pacemaker rates were higher in the Portico group 27.7% vs. 11.6% p<0.001 as was moderate or severe regurgitation at one year 7.8% vs. 1.5% pnon-inferiority = 0.57.

Based upon these study results the US Food and Drug Administration (FDA) approved the Portico with FlexNav TAVR system for patients with severe aortic stenosis at high or extreme surgical risk.  

All Editors: Jared M. O’Leary, MD