The Journal of Thoracic and Cardiovascular Surgery

In February, Abbott issued another urgent letter to hospitals about the blockage problem, asking them to inform physicians, complete and return an, an acknowledgement form, and pay attention to low flow alarms on the device's monitor that may indicate an obstruction.

The company said in a letter that it is working on, quote, "a design solution to prevent the blockages." A study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other class one recall issued for the HeartMate 3 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes additional guidance for physicians to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

I said, "Well, but let's, let's look at it." So we actually, um, we pulled off the shelf all of the different products that we have, whether it's cardiac patch tissue made from, you know, porcine or, or, or bovine pericardium, uh, the valves that were out there from all the different suppliers and everything- And we tested them, and we looked, said, "How much alpha-gal is still on these things?" The ones that come right off the shelf that go into our, our h- patients.

And we published a paper in, uh, 2022 in the Journal of Thoracic and Cardiovascular Surgery looking at this, and they were all littered with alpha-gal residues.

Wow.

Every single one, despite all the different ways that they were processed to get rid of this, littered with this.

Our fourth paper is just looking at how we can expand donor lung acceptability, especially in brain-dead donors, because the acceptance rate's pretty low.

So Varun Puri, from St. Louis and Yuzhan Bai from Washington have published in JTCVS an article basically saying if you take the validated lung donor score, the London score, and actually add CT rather than chest x-ray into the variables that predict whether you can take the lungs, can you do better? So this London score has nine variables on it.

and used to do chest x-ray.

Some of the most important variables include emphysema, pulmonary oedema or trauma.