TEVAR system safe, effective in real-world cohort

A thoracic stent graft was safe and effective in a real-world population of patients with thoracic aortic aneurysms, according to findings presented at the Society for Vascular Surgery Vascular Annual Meeting.

According to the study background, the thoracic stent graft (RelayPlus, Bolton Medical) was approved by the FDA in 2012, after which the company launched a post-approval study in 45 patients (mean age, 74 years; 69% men) requiring thoracic endovascular aortic repair for thoracic aortic aneurysms, with no operators who had used the device in the pivotal trial.

Outcomes of interest included device-related adverse events and major adverse events. Mean follow-up was 1.2 years, after which the study was terminated due to success.

Aneurysm-related mortality occurred postoperatively in two patients due to shock and bilateral hemisphere stroke, Mahmoud Malas, MB, MD, MHS, professor of surgery and epidemiology and director of the Center for Research Excellence and Surgical Trials at Johns Hopkins Medical Institutes, said during a presentation.

There were no cases of type I, III or IV endoleaks, endograft migration, post-TEVAR rupture or conversion to open repair, but 5.6% of patients had type II endoleaks at 30 days, according to the researchers.

At 30 days, three patients had major adverse events: One had a stroke, one had paraplegia and one had respiratory failure, Malas said.

The 2-year rate of freedom from aneurysm-related mortality was 95.6%, whereas the 2-year rate of freedom from all-cause mortality was 84% and the 2-year rate of freedom from reintervention was 95.6%, according to the researchers.

“This post-approval clinical trial of the RelayPlus Endograft demonstrates low operative mortality and morbidity in real-world practice and supports use of the device as a safe and effective modality to treat patients with thoracic aortic aneurysms and penetrating ulcers,” Malas and colleagues wrote in an abstract. “In addition, early midterm follow-up showed sustained freedom from aneurysm-related mortality and reintervention. Longer follow-up is needed to further evaluate the durability of this endograft.” – by Erik Swain

Reference:

Malas M, et al. S8: Scientific Session 8. Presented at: Society for Vascular Surgery Vascular Annual Meeting; June 20-23, 2018; Boston.

Disclosure: Malas reports he is a consultant for Silk Road Medical, has served as an investigator for several trials sponsored by Silk Road Medical and is national principal investigator for a trial sponsored by Bolton Medical.