New Technologies: Edwards EMBOL-X System

I got a tweet from a perfusionist asking for some clinical insight into the application of the Edwards EMBOL-X arterial cannula / system.

I was totally unfamiliar with it, so I looked up some product information and am posting it here.

If any of you have used the system, and have any helpful hints or insights, please leave a comment below in the comments section.

Here is the Upfront & Personal- on this emboli sparing technology…

Thanks  🙂

Frank

General Insert Comments

“The system consists of a net attached to a cannula (not unlike the catheters used by cardiologists for vein graft interventions) that deploys just proximal to the aortic perfusion cannula.

When emboli are showered, which mainly occurs when the clamps are released, they are potentially trapped in the net. Because of the net’s proximal location, it does not interfere with arterial perfusion from the bypass cannula.

In clinical trials, nearly 97% of deployed filters were shown to have captured emboli.

Furthermore, deployed filters have been shown to catch not only atheromatous plaque, but also platelet and fibrin aggregates, calcific debris, and mechanical debris (i.e. sutures).”

Link

http://ht.edwards.com/resourcegallery/products/cardiacsurgery/embol-x/ar01030.pdf

Literature

Click Image Above to View Article…

“Particulate emboli are an important factor in the development of complications after cardiac surgery. The use of an intra-aortic filter during aortic declamping has proved safe and effective in reducing the incidence of embolic complications. Because aortic cross-clamping is also associated with the risk of embolism, we measured the release of particulate emboli at the time of aortic cross-clamping and at declamping.

We deployed intra-aortic filters (Edwards EMBOL-X® Slim Protection System) at 2 different times during 15 consecutive cardiac procedures with cardiopulmonary bypass. Filter A was inserted before aortic cross-clamping and left in place for a mean time of 3 minutes, and Filter B was inserted before aortic declamping for a mean of 17 minutes. An independent institution performed histopathologic examination.

All filters captured particulate emboli, independent of the patients’ degree of proximal aortic atherosclerotic disease. Macroscopy showed that Filter A captured more particles (mean, 7.0 ± 2.6) in 7 of 15 patients (46.7%), Filter B captured more particles (mean, 6.7 ± 2.6) in 5 of 15 patients (33.3%), and the filters captured the same number in 3 of 15 patients (20%). Microscopy showed that both filters captured fibrous atheroma or fibrous cap in 10 of 15 patients. We observed no complications related to the use of the filters.

Aortic cross-clamping is associated with a high risk of embolism. We suggest that optimal protection against embolism during cardiac surgery can be achieved by applying intra-aortic filtration not only before aortic declamping but also before aortic cross-clamping.

The Intra-Aortic Filter

“The intra-aortic filter device (EMBOL-X®, Slim Protection System, Edwards Lifesciences; Irvine, Calif) consists of a 24F metal-tipped aortic cannula that has been modified with a side port so that a collapsible filter can be inserted into and retracted from the aor-ta, in a position immediately distal to the aortic cross-clamp but proximal to the arterial return cannula and the brachiocephalic artery. The filter itself consists of a heparin-coated polyester mesh that can capture particles larger than 120 μm in diameter. The filter is mounted on a flexible frame so that it can conform to the interior diameter of the ascending aorta. The risks associated with the use of this intra-aortic filter are iatrogenic injury and aortic dissection.”

Key words: Aortic cannula, aortic cross-clamping, atherosclerosis, cardiac surgical procedures/adverse effects, cardiopulmonary bypass, clamps, surgical, coronary artery bypass/surgery, embolism/prevention & control, filtration/methods/therapeutic use, heart valve diseases/surgery, postoperative complications”

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