A Novel Approach in Therapeutic Hypothermia: Interview With Aqeel Sandhu, MD, FACS

Dr. Sandhu is the Medical Director, Chairman, and Founder of Cryothermic Systems, which produces the Excel Cryo Cooling System, a non-invasive solution for effectively cooling the brain after cardiac arrest, stroke, or traumatic brain injury. Find out more about the technology here. 

Tell us about the background and development of the Excel Cryo Cooling System.

As you may know, I am a cardiothoracic surgeon and the Director of Cardiothoracic Surgery at Mercy Medical Center in Canton, Ohio. During my training at Columbia Presbyterian Medical Center, my focus of research was how to protect the brain during cardiopulmonary bypass. One of the worst things a heart surgeon can face is neurologic injury to the patient after heart surgery. What I discovered during my medical research with baboons was that hypothermia protects the brain quite a bit. We use hypothermia all the time in cardiac surgery to protect the heart, and actually, in most surgical literature it’s been known for years that mild hypothermia (e.g., a 1 to 2 ºC drop in temperature) is very neuroprotective. In this particular scenario I was able to selectively cool baboon brains to whatever temperature I wanted, independent of the body temperature. The body temperature could be at normothermia, and the brain could be at hypothermia at whatever temperature I wanted with this extracorporeal circuit that I had created. This was a huge finding for me, because even to this day, people think about the ability to cool the brain only by cooling the whole body and not by selectively cooling the brain. Cooling the whole body can have its drawbacks, some of which are blood dyscrasias, platelet dysfunction, and bleeding; you’re also limited to what you can cool because the heart starts defibrillating at about 32 ºC, which is not much from normothermia (37 ºC). 

So that was what sparked the idea; next we needed to find how we could make this into something practical so that it would be effective in the field. After 15 years of working on this, we finally got to the position where the system is now being manufactured and for sale. With the Excel^® Cryo Cooling System, we can now selectively cool the brain noninvasively and independent of core temperature. 

Discuss the components of the Excel Cryo Cooling System and how it is used. 

The system is composed of two separate components: the collar apparatus, which houses the cooling element, and the Excel Cryo Cooling Element. The collar also doubles as a cervical spine immobilizer. The cooling element is a proprietary formulation that allows this particular cooling element to be much colder than anything else on the planet. That is how we are able to noninvasively have this heat exchange from the carotid arteries where the blood is flowing through; as the cooling element is applied to the neck and the carotid triangles, the warm blood that is circulating through the carotids is cooled, and therefore, the brain is then cooled. We’ve shown that we can cool the brain down up to 1.7 ^ºC in less than half an hour. 

The indications for this system are vast, but the areas that we’re targeting initially is the hospital and pre-hospital market. In the pre-hospital market, ambulance and first responders to cardiac arrest would apply this device and start the process of immediately providing protection, because “time is brain” as they say (or “time is muscle” in the cardiac surgery arena). It has even been shown that for every 5-minute delay in cooling there is 3% greater odds of having a poor neurological outcome. So the sooner one starts this, the better off the patient will be. It’s very easy to use — it only takes about 10 seconds to put on properly, and anyone can do it. Then treatment would continue until the patient is processed through the ED or cath lab, until they have a definitive cooling protocol in place. Therefore, it can work synergistically, and all the while, protect the brain. 

How does the Excel Cryo Cooling System differ from other therapeutic hypothermia options available today?

There is no selective cooling option on the market today. All the solutions are systemic cooling devices, both invasive and noninvasive. The noninvasive methods are essentially cooling blankets or gel pads that circulate cold solution to evoke surface cooling throughout the entire core body temperature. The invasive options are catheters or devices that are put in the venous circulation to cool the blood as it circulates around these cooling elements. The whole reason that you’re trying to cool the entire body is to protect one organ, the brain. We have the only selective brain cooling product out there. 

Is the Excel Cryo Cooling System FDA approved? Are there plans for the Excel Cryo Cooling System to be part of a clinical trial in the near future?

Yes, it is a Class I FDA registered device. We have two studies ongoing right now, both of which are at the Cleveland Clinic. One is a pre-clinical animal study, and the other is a patient study in the Neuro ICU to look at dropping brain temperature in patients with neurogenic fever, which is planned for a January start. We’re studying this device in the population of patients with brain injury that have fever secondary to the brain injury, which is usually very resistant to normal methods of dropping body temperature. 

Where are some of the institutions it is being used at? 

It is being used across the country — University Hospitals in Cleveland has rolled it out to 84 of their municipalities in Cleveland. It is also being utilized in Illinois, West Virginia, and Pennsylvania, just to name a few. There has also been a lot of international interest, especially in Europe but particularly in Germany. 

What type of feedback have you received from those in the field?

The people that have used it really love it because it is easy to use, and it allows EMTs to focus on resuscitating the patient. One thing that is very interesting and really counterintuitive is that people think about utilizing therapeutic hypothermia after return of spontaneous circulation; well, this particular device actually works better before the return of spontaneous circulation, while you’re resuscitating the patient. So for example you have a patient with cardiac arrest; there is no spontaneous circulation, and you’re doing chest compressions. With this device in place, the chest compressions that you’re doing are circulating blood, but much slower than native circulation if the heart was bleeding. So now, the blood being circulated through the carotid arteries is flowing at a much slower rate, and the actual time that that blood has in contact with the cooling element is much greater; therefore, the heat extraction is much greater, and the ability to cool the brain is also much greater. 

What’s next for the company? Do you have additional patents pending? 

Yes, we already have six patents issued on this, and I do have some other ideas for a more permanent, probably invasive solution for selective brain cooling, so that is in the works. Right now we want to get a lot more traction with this device, and most of it is really educating our peers, because of lot of people just don’t know — among physicians even — that this is able to be done and done effectively.