By Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com)
The paravalvular leak (PVL) has long been considered the Achilles’ heel of TAVR. The frequent complication of aortic valve replacement occurs at a much higher rate after the transcatheter approach than conventional surgical replacement. Research has indicated that PVL is linked to late mortality in valve replacement patients. However, due to the minimal invasiveness of TAVR, it remains an important intervention with major benefits for patients who have already undergone heart surgery and those who have preexisting lung disease.
The Study
The transcatheter heart valve (THV) manufactured by Centera shows greater promise in addressing PVL post TAVR, according to recent data. The study looked at the self-expanding nitinol valve’s safety in over 200 patients across Europe, Australia, and New Zealand. All were considered to be high risk for traditional surgical replacement and had severe aortic stenosis. At 30 days post, not only did the patients have lower rates of PVL but also had lower rates of other post-procedure complications necessitating permanent pacemaker implantation.
The Centera Valve Technology
The device is developed by Edwards Lifesciences demonstrates potential to solve the PVL conundrum.
“The novel motorized delivery system of the Centera valve seems to give extraordinary stability to the implantation process, demonstrated by the low rate (3.5 percent) of resheathing. An accurate position within the annulus is a key factor for both the low PPI and PVL rates,” says Luis Nombela-Franco, MD, Ph.D.
Dr. Nombela-Franco wrote an editorial highlighting the device’s pivotal study which was published in the Journal of the American College of Cardiology in December.
Key Takeaways
When compared with other commercially available TAVR systems, in the self-expanding category, the low rate of new PPM implantation and the decreased incidence of more than mild PVL are notable. The limited study size and short follow-up period, are important to consider, as more extensive research will be needed to establish the superiority and discover the mechanism behind the improved outcomes. This is warranted as significant improvements in hemodynamic and clinical functional assessments were clearly shown.
