Cath Lab Digest

[Editor's note: Check back on Friday, April 13 - we will have some of the later article images enlarged for full viewing. We apologize for the inconvenience.]

“I have heard that there are specific ways to prepare balloons and stents for use. All of the doctors seem to have a different way to do so. What is the standard?” 
— From an RCIS Review online student

Well, there is a simple answer. “Always refer to the manufacturer’s instructions/directions for use.” You can often see this as “IFU” or “DFU.” This is the specific step-by-step detail on how to use the product according to the manufacturer’s recommendations. These recommendations are generally based upon their testings of their products and what processes should be used to properly deploy balloons and balloons with stents mounted on them. For the purposes of this article, we will only talk about coronary devices, not peripheral devices.

Following the manufacturer’s steps can be important for a few reasons. First, it can help assure proper delivery of the item. Second, it can reduce complications or adverse events related to its use. Finally, should something go wrong and there is an adverse outcome related to the product usage, the manufacturer will want assurance that their product was used according to their specific instructions and recommendations.

That is the short answer to your question.

While I have worked with cardiologists who prep EXACTLY according to manufacturer’s instructions/directions for use, I have also worked with cardiologists who do NO prep whatsoever. And then I have worked with cardiologists who do their own thing somewhere in-between, at each end of the spectrum. Following the manufacturer’s instructions/directions for usage is certainly the most appropriate way to utilize the product. Physicians are ultimately responsible for the usage of interventional equipment, and have every right to adjust the usage of equipment in a way that they feel most appropriate. 

We asked CLD’s clinical editor, Dr. Morton Kern, for a physician perspective on this point. He commented:

“Interesting question. From my personal experience and teaching, the preparation steps of the balloon and stent have nearly been the same for the past 20 years. I haven’t read an IFU, although it might prove enlightening. My preference, and it may not be that of others, is simple. For balloons alone, flush the monorail lumen. Hook up to indeflator, draw negative, point syringe down to let 50/50 contrast saline mix fill vacated space on release of vacuum. Then pull negative once more and it’s ready to insert. The only difference for stents is I don’t pull negative the second time and leave the indeflator neutral during insertion. Also, we try not to touch the drug-eluting stent with our fingers if possible. I am sure there is widespread variation on this approach and look forward to hearing about it.”

        — M. Kern

It would be outside of the limitation of space for this article to list the specific IFU/DFU for each and every coronary balloon (with or without stent) on the market. I will summarize the basic steps of balloon preparation by combining most of the IFUs/DFUs. Since many of the products no longer have the IFU/DFU ‘in the box’ as they used to, at the end of this article, I will provide links to a sample of the major vendors’ IFUs/DFUs for a product that they may manufacture.  It is up to you to perform the research to obtain these for any product that you may use. (In other words, I am providing a disclaimer that the information listed below is a general presentation of product preparation, and that the product you use may use slightly different processes.)