A clinical study of the next-generation Sapien 3 implantable heart valve made by Edwards Lifesciences (NYSE:EW) showed a higher rate of pacemaker implantation than with an earlier version of the device.
The study, published online in the journal JACC: Cardiovascular Interventions, compared the 1st 206 patients treated using the Sapien 3 with 371 patients treated with the Sapien XT transcatheter aortic valve replacement, excluding any patients previously implanted with a pacemaker or implantable cardioverter defibrillator.
The study showed that the Sapien 3 group’s rate of pacemaker implantation was significantly higher that for the Sapien XT group, at 19.1% and 12.2%, respectively.
Importantly, implantation height seemed to play a big role; a change in the technique used to deploy the Sapien 3 device cut the rate of pacer implantation from 25.9% to 12.3% – equivalent to the rate for Sapien XT.
“The [pacemaker implantation rate] after TAVR is higher with the S3 than with the XT and is independently associated with the implantation height. This increase in the PMIR may be avoided by intending an aortic stent extension >70%,” according to the study’s authors.
Earlier this month Irvine, Calif.-based Edwards presented results from the Partner II trial from 1,077 intermediate-risk patients at the American College of Cardiology’s annual meeting, showing that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints. The news pushed EW shares to an all-time high April 5.
The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients.
