FloSeal: For Epistaxis Try High-Tech Foam

by Jason Wagner, MD 

 

While infrequently a critical event in the ED, epistaxis is often that little rock in the shoe of an otherwise smooth shift. And it can be as frustrating for the EP as it can be for the patient. FloSeal represents a new, effective yet expensive answer to this common problem.

Epistaxis comes in three versions:  the fountain, the trickle and the dam. The first and last are usually easy to treat. The fountain, or gusher, you just pack, hope it’s not too posterior, and then observe. The dam – in which the patient fixes their own problem but still wants you to do something – you basically leave alone. The resistant trickle, the bleed that keeps slowly oozing despite direct pressure and/or cautery, is the real problem child of epistaxis. It doesn’t quite seem worthy of a full packing, but you have to do something in order to satisfy yourself as well as your patient.  Full packings are uncomfortable, unattractive and can cause cardiac and infectious issues particularly in the elderly.  So what to do?  FloSeal to the rescue.

FloSeal Hemostatic Matrix is a proprietary combination of cross-linked gelatin granules and topical human thrombin produced by Baxter Pharmaceuticals.  Originally created and used for interoperative bleeding it is seeing increasing use for control of bleeding in epistaxis.  While not the best at controlling severe epistaxis, as there is no pressure or tamponade created by FloSeal it is perfect for everything short of the “pumper.”  While some of the traditional packing methods are impregnated with hemostatic agents the benefit of FloSeal over these is mainly patient comfort.  Another nice benefit is that FloSeal does not require platelet activation allowing it to fully function even in anticoagulated patients.

FloSeal comes as three separate components that require mixing.  The kit comes with a bottle of calcium chloride, a bottle of human thrombin, a syringe pre-filled with gelatin matrix, a syringe for the CaCl/thrombin mixture, a mixing syringe, and a cute little mortar.  Mixing the product involves multiple steps but is pretty straightforward.  First you draw up the CaCl with a syringe and inject the liquid into the bottle containing the thrombin.  You then swirl the bottle to mix the solution.  Once mixed the solution is drawn out and then transferred to the mortar.  The solution is then aspirated into the mixing syringe which mates up with the syringe containing the gelatin matrix.  Finally you push the solution into the matrix side and then push the total mixture from side to side for a total of at least 20 transfers.  Wait 30 seconds and FloSeal is ready to use anytime in the next 30 minutes.

Now that the chemistry fun is over its time to put the final product to use.  Attach one of the two sizes of applicator tips to the syringe.  Place the tip deep into the nare and begin injecting the matrix solution as you slowly pull the syringe out uniformly filling the patient’s nare with foam.  The FloSeal will expand about 20% more in size filling the nare fully.  At this point it has the appearance of the same canned foam you might use to fill cracks in your house.  After 5 minutes FloSeal will form a gelatinous foam.  You can then use saline to remove any excess FloSeal from the patient’s face.  What the patient is left with is a comfortable non-bleeding nose filled with barely visible foam as opposed to a large uncomfortable balloon or packing with a tube or string taped to the side of their face.  The FloSeal will begin to break down in 3-5 days on its own and be gone in 5-7 days.

Per product literature and supported studies, FloSeal will stop 97% of bleeding within two minutes. This advance in patient comfort and technology does not come without a price, however.  FloSeal is sold in packs of 6 at a cost of $2,940 dollars or nearly $500 per use. This cost can be recouped by billing it as a medication separate from the procedure itself.  In my ED many of our patients are uninsured so in order to control out-of-pocket cost to the patient I address the expense with them prior to use of FloSeal.  FloSeal is FDA approved for general use in control of bleeding with no specific approval for epistaxis but has been used safely in the ENT literature.

How We Rate
1.  Seriously flawed, even hazardous
2.  Downsides outweigh upsides
3.  We could take it or leave it
4.  Excellent, with room to improve
5.  What did I do without this?