Proprietary Chitosan Promotes Clotting and is an Antimicrobial Barrier: The Clo-SurPlus P.A.D.

Cath Lab Digest talks with Barry R. Alter, MD, FACP, FACC*, Hollywood, Florida, about his experience with the pad. The Clo-SurPlus P.A.D. is manufactured by Scion Cardio-Vascular (www.scioncv.com).

What are the advantages of pads over closure devices?

From a procedural standpoint, invasive closure devices are really a second invasive procedure after a cardiac catheterization or intervention has been completed. You are starting with a new piece of equipment and actually doing a second invasive procedure. The problem with that, is first, that the price of these devices is considerable and costs between $150-200 or perhaps even up to $250. If you take a look at the literature on invasive devices, each one carries significant complication rates. Some complications can be extremely serious. The literature cites anywhere from a 5–6% up to a 10–16% complication rate, depending on the device and which study you read. There have been deaths, there have been total occlusions of arteries, and there have been failures that have caused massive hemorrhages. Yes, it’s very nice to get complete closure in 5 minutes, with the patient able to get up soon after, but it is done at a risk. Using a non-invasive pad, the complication rate virtually cannot be higher than doing manual compression itself. Pads do not introduce anything that can cause a significant complication. If the pad is effective, then you are going to wind up with a lower complication rate than just doing regular manual or mechanical compression. That being the case, pads are of nominal cost and can be very effective in obtaining more rapid hemostasis with an exceedingly low complication rate. In our study (completed in April 2003 and published in Endovascular Today1), we looked at a total of 1,488 patients, including over 1,100 diagnostic procedure, 317 interventional procedures and the removal of 3 intra-aortic balloon pumps. In over 1,488 patients, our entire complication rate was 6 complications. We had 3 hematomas that occurred in post-interventional patients. All 3 were extremely obese females that were very difficult to control from the time the sheath was removed. One actually went to the operating room and had a laceration of the femoral artery, but still, we counted those as complications of the device. There were also 3 pseudoaneurysms, for a total 0.5% complication rate. If you compare that rate to the literature for manual compression, using mechanical devices for compression or to using invasive devices, there is nothing with a complication rate that low.

Tell us about the Clo-SurPlus P.A.D., which is the pad you used for the study.

The Clo-SurPlus P.A.D. is unique in that its active ingredient, which makes up the entire pad, is a substance called chitosan. Chitosan is a material that comes from the shells of crustaceans. There are a variety of different chitosans depending the particular animal from which it is retrieved. The chitosan that is used in the Clo-SurPlus P.A.D. is extremely bioactive. It’s very highly positively charged, and the minute it comes into contact with negatively charged red blood cells, it causes them to clump immediately, which then causes rapid stimulation of the clotting cascade and very quick clotting. The pad is easy to handle because it has a thickness and body to it, and it’s also water soluble. It can be left on the patient and removed the following day. Just put the usual dressing over the area, either a transparent dressing or a 4x4, whatever the standard is for your lab. When you send the patient home, tell them that the next day, when they take the dressing off, not to try and pull the pad off — just go in the shower. As soon as the Clo-SurPlus P.A.D. gets wet, it dissolves. So the pad is very easy to take off. It doesn’t have to be pulled or yanked off; you leave it on and send the patient home, and they can remove it themselves the next day.

What time and level of pressure are required?

For the first few minutes, you can use the same amount of pressure that you would normally use with manual compression, i.e. enough to basically occlude the artery and maintain hemostasis. Within a few minutes, you can usually ease up on the pressure, and in non-coagulated patients, within usually 6 minutes or so, you can slowly lift up, and if there is good hemostasis, you can just stop at that point. In anti-coagulated patients or post-intervention patients, we usually recommend that you keep moderate pressure until about 10 minutes, then lift up slowly and check the wound. If it is dry, you are done.

What was your experience adopting the Clo-SurPlus P.A.D.?

We had successfully used one of the other pads in my lab. When we were presented with an opportunity to try the Clo-SurPlus P.A.D., it wasn’t me, it was the nurses and technologists who really pull the lines, who came to me and said, we love this and want to switch to this pad. What we found was that it was easy to use compared to some of the other pads, because as I said, it has a thickness and body to it. That makes it easy to handle. It’s 100% active ingredient, so there is no right side or wrong side, you just open it up, put it on the wound and that’s it. The thing that we noticed that was so striking was that not only did we get excellent rapid hemostasis, but we literally stopped getting those calls, 2-4 hours after the patient went from the lab up to the floor saying that the patient coughed, or the patient tried to get out of bed and started bleeding again. Those calls virtually disappeared. There wasn’t a day that went by in our busy lab that we didn’t have a few patients where one of the nurses or techs had to run up and apply pressure again for a wound that started bleeding. That disappeared virtually overnight when we started using the Clo-SurPlus P.A.D.

What is your experience with larger sheath sizes and pad use?

Our diagnostic cases were performed with 5 French sheaths. The interventional cases were done with 6 French sheaths. However, at the time of the study, I had personally used the Clo-SurPlus P.A.D. on three patients with intra-aortic balloons with 8 French sheaths. Subsequently, I used the P.A.D. on many more intra-aortic balloon removals with 8 French sheaths and had 100% success.

There are different types of chitosan used in hemostasis pads. What is unique about the type used in the Clo-SurPlus P.A.D.?

Chitosan is found in the shells of every crustacean. Studies by bench scientists have shown that different chitosans have different levels of bioactivity. The chitosan used in the Clo-SurPlus P.A.D. is proprietary and appears to have the highest level of bioactivity from all chitosans that have been tested in laboratory settings. It causes very prompt and vigorous clotting. The company also has FDA approval now to say that the pad can be used as an anti-microbial barrier. Testing demonstrates 100% growth inhibition of virtually every bacteria that you can find in a hospital setting and fungi as well, for up to 10 days. If you have an indwelling line that will be there for a while, this is a very good pad to use. In addition, in April, the company will be coming out with a version of the pad with a slit. It will be small, and will actually go around an indwelling catheter in order to prevent infection.

What is the future outlook for the pad?

The company currently has ongoing studies in the wound healing area. The chitosan in the Clo-SurPlus P.A.D. seems to promote wound healing. In addition to being antibacterial and antifungal, we are finding that chitosan seems to be a ‘miracle drug’ in terms of its different bioactivities.

References

1. Alter BA. Noninvasive Hemostasis Pad. Endovascular Today April 2003. Available online at https://www.evtodayarchive.com /03_archive/0403/171.html. Accessed March 19, 2010. 2. lter BA. Clo-Sur P.A.D.: A New, Non-Invasive Closure Device. Cath Lab Digest March 2002. Available online at https://cathlabdigest. com/articles/Clo-Sur-PAD-A-New-Non-Invasive-Closure-Device. Accessed March 19, 2010.

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