Compared to Sapien 3, Portico’s hemodynamics were superior, but all-cause mortality, new permanent pacemaker rates were higher
The Portico intra-annular self-expanding showed comparable hemodynamics to Evolut and superior hemodynamics to intra-annular Sapien 3 valve, according to late-breaking trial results presented Monday at Cardiovascular Research Technologies (CRT) 2020 in National Harbor, Maryland.
Raj Makkar, MD, of Cedars-Sinai Hospital, Los Angeles, and colleagues performed a post hoc analysis of the PORTICO IDE (investigational device exemption) trial in which hemodynamics, patient prosthesis mismatch (PPM), and clinical outcomes were evaluated among different valves. Among 750 randomized patients, the Portico valve (Abbott) was implanted in 366 patients, 206 received the balloon-expandable Sapien 3 valve (Edwards Lifescience), and 110 received the supra-annular self-expanding Evolut R or Pro valve (Medtronic).
Clinical outcomes and valve performance at 1 year were assessed using a modified as-treated patient analysis. The patients’ mean age was 83 years in all study groups, and their mean Society of Thoracic Surgeons score was 6.2%. There was no difference in baseline characteristics noted among the three groups. A higher percentage (86%) of pre-balloon aortic valvuloplasty was done with the Portico valve. Also, there was a higher need for a second valve noted with Portico than for the other valves.
At 1 year, the rate of severe PPM was higher with Sapien 3 than with Portico or Evolut. However, there was no relationship between PPM status and mortality. Higher rates of all-cause mortality (14.7%) and new permanent pacemaker (31.7%) were noted with the Portico valve than with the Sapien 3 (mortality, 8.4%; new permanent pacemaker, 8.5%). Evolut’s all-cause mortality rate was 15.5%, and its new permanent pacemaker rate was 19.9%. A landmark analysis at 30days did not show any difference in all-cause mortality between the valves.
The authors also performed an analysis of the Portico valve’s next-generation FlexNav delivery system, and its clinical outcomes are similar to those of other valves. Moderate or severe paravalvular leak (PVL) was significantly higher with the Portico valve, and PVL was linked to more interventions in the Portico group, but Makkar said this was not associated with increased mortality risk. Severe mitral annular calcification was noted to be a significant predictor of PVL, with an odds ratio of 18.91 (95% CI 2.34-152.9).
Makkar concluded that Portico valve with the GEN 1 delivery system had comparable hemodynamics to the self-expanding Evolut valve and superior hemodynamics when compared to Sapien 3 valve. Portico’s long-term safety profile is consistent with that of the self-expanding Evolut R/Pro; however, the Portico valve was noted to have a higher all-cause mortality rate than Sapien 3. The FlexNav delivery system showed an improved safety profile on the Portico valve.
The PORTICO IDE trial is sponsored by Abbott.