Portico valve implantation with the FlexNav™ Delivery System (DS) was associated with an excellent safety profile at 30 days, characterized by low rates of mortality, stroke and vascular complications, according to a study presented during EuroPCR's e-Course 2020 and simultaneously published in JACC: Cardiovascular Interventions.

Gregory P. Fontana, MD, FACC, et al., sought to characterize the safety profile of an intra-annular self-expanding valve with the next-generation FlexNav™ DS, which builds on the strength of the existing Portico platform. Specifically, key design modifications include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in a vessel diameter 5 mm or more.

The study included 140 high risk and 40 extreme risk patients who underwent an attempted transfemoral Portico™ valve implant between October 15, 2018 and December 10, 2019 from 28 sites in the U.S., Australia and Europe. Their mean age was 85 years, mean STS score was 5.3% and 96.1% presented with one or more frailty factor. Technical device success was 96.7%.

Results showed that at 30 days, the major vascular complications rate was 5.0%, with 4.4% adjudicated as access-site related (3.3% TAVR DS access-site related). Death (0.6%) and disabling stroke (1.1%) were rare and new permanent pacemaker rate was 15.4%.

Furthermore, echocardiography at 30 days revealed a 7.0 mm Hg mean gradient, 1.78 cm² valve area and 4.1% rate of moderate paravalvular leak.

"The FlexNav™ DS addresses a key limitation of the predicate DS by incorporating an integrated sheath to provide one of the smallest insertion of any commercially available TAVR system," the authors conclude. "This study highlights the enhanced safety profile of the Portico valve with the FlexNav™ DS through iterative design features that help minimize vascular trauma."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Echocardiography/Ultrasound

Keywords: Transcatheter Aortic Valve Replacement, Echocardiography, Stroke, Pacemaker, Artificial

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