Results from the PORTICO NG study of Abbott’s Navitor transcatheter aortic valve implantation (TAVI) platform, presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA), provide “promising” signals on safety and efficacy for the device.
This is according to Michael J Reardon (Houston Methodist Hospital, Houston, USA), who presented the results at CRT 2023, where he highlighted the design of the valve—which features a fabric cuff, NaviSeal—as offering potential advances in reducing or eliminating paravalvular leak (PVL).
Following the development of its next-generation TAVI system, Abbott launched the PORTICO NG (Next Generation) study; a prospective, multicentre, international, single-arm trial that supported the US Food and Drug Administration (FDA) approval of the Navitor TAVI system.
Navitor features an active sealing cuff to reduce or eliminate the backflow of blood around the valve (paravalvular leak, or PVL), a known challenge with early generation TAVI devices. Based on the results from that study, Navitor was found to be a safe and effective treatment option for patients with severe, symptomatic aortic stenosis who are at high or greater surgical risk.
In the PORTICO NG study, Navitor was found to offer a 97% procedural success rate, 1.9% all-cause mortality rate and a 1.9% rate of disabling stroke at 30 days. The results, also indicate a 0% moderate or greater rate of PVL at 30 days, which demonstrating effectiveness of the NaviSeal, active sealing cuff, Abbott said in a press release.
“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” said Reardon, who served as principal investigator for the study that led to FDA approval of Navitor. “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.”
Data from the 1,800-patient Amulet IDE trial, described by Abbott as the largest randomised left atrial appendage occlusion (LAAO) study to date, were also presented at CRT 2023, demonstrating that the Amplatzer Amulet LAAO device had fewer unresolved, severe peridevice leaks (PDLs) compared to Boston Scientific’s Watchman device.
In a press release, Abbott said that the data demonstrate that larger LAA anatomy was a predictor of severe PDL with the Watchman device whereas there were no anatomical predictors with the Amplatzer Amulet. Added to this, the company highlighted that severe PDLs with the Amulet device were less common and resolved over time more often than with Watchman, and that severe PDLs with Amulet were less commonly associated with adverse events and deaths than Watchman.
