No serious paravalvular leak at 30 days in study of next-generation TAVR system
In the PORTICO NG study of a next-generation transcatheter aortic valve replacement system, there were no cases of moderate or greater paravalvular leak at 30 days, researchers reported at Cardiovascular Research Technologies.
As Healio previously reported, the TAVR system (Navitor, Abbott), which includes a fabric cuff (NaviSeal, Abbott) to reduce or eliminate paravalvular leak, received FDA approval in January.
“Paravalvular leak (PVL) remains a common postprocedural complication that can have a negative impact on patient survival,” Michael J. Reardon, MD, Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, said during a presentation. “The Navitor valve is a next-generation, self-expanding valve with intra-annular leaflet position that has an outer fabric cuff to actively minimize the risk of PVL.”
Reardon and colleagues enrolled 260 patients (mean age, 83.4 years; 57.3% women) with severe aortic stenosis at high or extreme risk for surgical AVR in the prospective, single-arm PORTICO NG study. The primary endpoints were mortality and moderate or greater PVL at 30 days.
Procedural success occurred in 97.3% of patients, Reardon said during the presentation.
At 30 days, 1.9% of patients died, 1.9% had a stroke, 0.8% had acute kidney injury, 3.8% had life-threatening bleeding, 4.2% had a major vascular complication and 16.9% (19% of those without a pacemaker at baseline) had a pacemaker implantation.
Mean gradient declined from 41.4 mm Hg at baseline to 7.4 mm Hg at 30 days, whereas effective orifice area increased from 0.72 cm2 at baseline to 2 cm2 at 30 days, Reardon said.
There were no cases of moderate or greater PVL at 30 days, with 20.2% of patients having mild PVL and the rest having none or trace amounts, he said.
Most patients (86.5%) improved at least one NYHA class between baseline and 30 days, and 96.4% were NYHA class I or II at 30 days, according to the researchers.
“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” Reardon said in a press release. “The trial provides promising results on the safety and effectiveness of Navitor in addressing this common heart valve disease, highlighting a reduction in the backflow of blood around the valve due to the system’s design.”
Reference:
- Abbott. www.prnewswire.com/news-releases/late-breaking-data-reinforce-benefits-of-abbotts-minimally-invasive-heart-devices-301757721.html. Published Feb. 28, 2023. Accessed Feb. 28, 2023.
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Reardon MJ, et al. Late-Breaking Trials | Session Three. Presented at: Cardiovascular Research Technologies; Feb. 25-28, 2023; Washington, D.C.