I've seen lots of discussion about reverse taper style PICCs on the list serve over the past few days. I would like to take a few minutes and give you my take on this subject.
I will start by making a disclaimer that my opinions may be a
little biased as I work for Bard Access Systems, however, I will try to present
what I know in an unbiased manner and let you draw your own conclusions.
Also, there really isn't any good data out there to support claims one way or
the other. The paper everyone
keeps citing is old and is really not applicable any
longer.
So
here goes.
First, I think we need to look at this type of device
objectively. Why was it created in the first place? The answer to
that question is pretty simple. Clinicians identified a concern.
That concern was that clinicians were seeing many PICC lines that kinked at
the insertion site and prevented medication infusion. Manufacturer's
response to that concern was to create the reverse taper PICC. This design
virtually eliminates the kinking issue, and by the way has several other
advantages that I'm sure you are all aware of. A couple of those advantages are
tamponading of bleeding at the insertion site, and of course extra strength to
the portion of the catheter that is most likely to be stressed and
strained.
I
think it is also important that we look at some of the other benefits this style
of device can bring, namely minimized exposure to blood at the insertion
site. We all have to be wary of blood exposure as the consequences
can be very hazardous. Also, I think it is important to remember that skin
flora love the nutrients that blood and blood products can provide to
them. We are just asking for PICC track infections and BSIs when we allow
blood to remain on the catheter and skin at the insertion site. I
know that these infections can be propogated merely by the fact that we can't
remove all layers of skin containing normal microbes when doing a skin prep, but
we can minimize the environment they have to grow in by taking away nutrients
that are provided in blood.
In
addition, I think it is important to think about how and where PICCs are being
inserted these days. While not everyone has made the transition to upper
arm placement, many have. You know as well as I do that the upper arm
basilic vessel is rarely close to the surface. Additionally, some
clinicians actually tunnel their PICC into the vessel. In many cases
the tapered portion of the PICC is either not in the vessel or just begins to
enter the vessel. I do think it is important to ensure that the PICC you
are inserting is adequately sized for the vessel you are accessing. As you
know, INS has long been a proponent of placing the smallest access device
possible for the ordered therapy. I have been all over the country asking
clinicians what their PICC practices are. How do they know the PICC they
are inserting is appropriate for the vessel they have chosen to access?
Ultimately many are using the unwritten rule of ensuring that the PICC does not
occupy any more than 1/3 of the vessel's internal diameter. In my opinion,
this is a very good practice because most clinicians only have ultrasound to
evaluate vessels, and unless that vessel is damaged or partially occlued, it is
difficult if not impossible to see the true inner diameter of the
vessel.
With
all of that being said, let's also look at some history here, because reverse
tapered PICCs are not new to the market. In fact, one radiology
vendor has had a reverse tapered PICC on the market for more than 7
years. If you look at the market today, 80% of all PICCs being sold in the US are
reverse taper PICCs. All of the PICCs that are in the number one
selling positions in the US incorporate a reverse taper design. Let
me be specific. The Groshong NXT 5Fr dual lumen PICC has been on
the market since 2002. The Poly Per-Q-Cath, also with a reverse
taper, has been on the market since 2001 . The PowerPICC has been on
the market for over two years now. All incorporate the reverse taper design.
Several other vendors also provide reverse tapered
PICCs.
Okay,
here's where I try to remain objective, and understand that there will be
differing opinions out there, but perhaps some data will be helpful. I can
tell you that Bard tracks all Bard PICC catheter sales very
closely. We have a Field Assurance department that receives all
complaints about Bard products. In the five years these products have been
available, we have not seen increased reports of thrombosis related to the PICC
or the reverse taper design. Additionally, I have reviewed the
FDA MAUDE data base, and do not seen increased numbers of reports there
either. As you may be aware, Bard can not control the information that is
submitted to the MAUDE data base. I also understand that all of us
are too busy to submit reports to regulatory authorities every time an incident
arises, however, if it becomes a recurring issue, we are ethically
compelled to inform the manufacturer and/or the
FDA.
Finally, I have the opportunity to travel all over the
country and interact with many 100's of clinicians each year. Frankly, I
have had many questions asked about thrombosis related to reverse taper
designs, but have not had anyone tell me that they are seeing this as a
recurring problem. Of the few that I have discovered, I have also had
discussions with them regarding the size vessel they are placing the PICC
into in the first place--and have found that the PICC was too large for the
vessel they were accessing.
In conclusion, we don't have evidence to
support the claim that reverse tapered PICCs increase thrombosis
rates. Before we believe any manufacturer's claims on this subject,
we each need to conduct our own research so we can base our opinions on
hard and fast research rather
than hearsay or
innuendo.
I apologize for making this so
long, but felt it necessary to really lay out the entire
issue. Thanks for giving me some of your time today.
Paul
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