Impella

A doctor told me that she was likely going to need a heart transplant because her...

Her heart function had dropped precipitously, and they had elected to put her on the Impella pump to give her heart a chance to recover.

An impella heart pump is a device used temporarily.

It is often referred to as a backup heart.

And the one other thing that I will say, I know you asked Dr. Corbett whether the product was internal or external.

And I do just want to clarify that while you can use our products around the vascular access sites and around Impella's and ECMO devices and things like that, the indication for all of our products is temporary topical external.

So we are not an internal absorbable product, which means no non-perpressible areas of the body like liver, spleen, kidney, abdominal aorta.

So just wanted to clarify that one thing for the audience.

When you put an intra-aortic balloon pump, it would selectively, by causing afterload reduction in the arterial system, potentially has the benefits to reduce the shunt fraction and improve anti-grade perfusion.

Now, there's a number of case reports where folks have used an Impella and other devices to support patients, so intra-aortic balloon pump is not the only supportive device we could use.

But the way this question was framed, it was clearly the correct answer.

Now, the other part that appears in the guidelines for the first time, because this has not been previously mentioned, is there are very few guidelines where the level of evidence is based on expert consensus.

In fact, most studies in cardiogenic shock have more than fifty percent of people with cardiac arrest.

So the question does come, is the benefit o-of the Impella device in danger because of the device itself or because of our ability to exclude patients who would not have benefited from putting in the device, that is arrest patients? And that's a question we certainly can't answer.

The second part was the trial took a whole ten years to enroll, and while the, the mortality benefit is clear-cut, the frailty index of the trial is fairly small.

So a few patients not meeting the endpoint could have changed the results of the study.

Now, speaking of cost, let's talk microaxial flow pump cost analysis of the DANGER-SHOCK trial.

Of course, the microaxial flow pump is Impella, but on this podcast, we try to use generic names rather than brand names.

Now, JACC has published a research letter from the DANGER-SHOCK researchers on hospital cost of the microaxial flow pump in patients in DANGER-SHOCK.

These are patients with cardiogenic shock due to MI.

Now, before I tell you about cost, let's briefly review DANGER-SHOCK.

It's one of the most important trials of 2024.

Recall that before DANGER-SHOCK, there was zero, zero compelling RCT-level evidence that the microaxial flow pump, brand name Impella, uh, actually improved outcomes in MI-related cardiogenic shock.

Now, the DANGER-SHOCK trialists were careful about who got into this trial.

Like really simple.

This is how you troubleshoot the Impala.

This is what this alarm means on the A-line.

This is how to zero out the A-line.

He came there and, uh, it was an artificial heart company, which sounds really cool, but it turns out that wasn't a viable product that most patients could have.

And so he found this technology called Impella.

It's the world's smallest heart pump.

He invested in it.