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SENTRY: Use of bioconvertible IVC filter safe, effective at 2 years

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Michael D. Dake

LAS VEGAS — Use of a bioconvertible inferior vena cava filter in patients with pulmonary embolism conferred few adverse events and a high bioconversion rate at 2 years, according to findings from the SENTRY study presented at VIVA 18.

“This represents an important paradigm shift in the prevention of PE,” Michael D. Dake, MD, senior vice president of health sciences and professor of medical imaging, surgery and medicine at the University of Arizona, said during a presentation.

Cardiology Today’s Intervention previously reported that the bioconvertible IVC filter (Sentry, BTG/Novate Medical) successfully prevented new-onset PE in high-risk patients and was bioresorbed within 1 year in most cases. Dake presented 2-year results here.

Dake said the study evaluated the safety and efficacy of the bioconvertible IVC filter in 129 patients with PE who underwent an intensive imaging protocol, including a CT venogram at 24 months.

“The filter is designed to automatically bioconvert after a transient PE risk period of 60 days has passed,” he said. “Hydrolysis of the bioabsorbable element allows the filter arms to retract to the IVC wall, leaving a patent lumen. This can reduce the risk for IVC occlusion and remove the requirement for and risk and cost of IVC filter retrieval.”

At 2 years, 94% of eligible patients underwent a CT venogram, he said.

There were two reported cases (2.4%) of new symptomatic PE between 1 and 2 years, according to the researchers.

Dake said there were no reports of any device-related complications on imaging at 2 years, including tilt, migration, fracture and IVC perforation.

“There were two symptomatic PEs on days 581 and 632 in patients with fully bioconverted filters,” he said. “The clinical events committee adjudicated these as non-device-related.”

The bioconversion rate at 2 years was 96.5%, which “compares favorably to published retrieval rates,” Dake said. – by Erik Swain

Reference:

Dake MD, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.

Disclosure: The study was funded by Novate Medical, now part of BTG. Dake reports he received honoraria from Bard Peripheral Vascular and Cook Medical, consulted for Cook Medical, Novate Medical and W.L. Gore and Associates, and received research funding from Essential Medical, Novate Medical, Shockwave Medical and W.L. Gore and Associates.