@article{f81a16ddc24e4647b4f03963123cf1f6,
title = "Aortic filtration system's impact on preventing adverse clinical events",
author = "Allen, {Keith B.} and Keith Horvath",
note = "Funding Information: Intuitively, embolic capture should reduce clinical events; however, well-designed clinical trials including the pivotal FDA trial for this device, have failed to tie the surrogate end point of embolic capture to better outcomes. This device was approved by the FDA Circulatory Device Panel because it was safe and made sense, not because it demonstrated a reduction in adverse events. As noted in the conclusion of our original article, “further study of high-risk patients is warranted.” A larger randomized, controlled trial with patients at higher risk that incorporates imaging in addition to clinical endpoints is needed to determine the impact of filtration. Such a study is being sponsored by the National Heart, Lungs, and Blood Institute.",
year = "2015",
doi = "10.1016/j.jtcvs.2015.01.029",
language = "English (US)",
volume = "149",
pages = "1674--1675",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "6",
}