[HSF] Embol-X

[Timothy Sloan]

Members:

One of our group has had experience with Embol-X catheters.  We have placed 
over 200 in the past several years that they have been out.  I was initially 
asked to review the literature and the FDA information at the hospital.  Our 
stroke rate for valves was approximately 1-2% pre Embol-X.  We routinely use 
CO2 for all left sided surgery.  The cost was very high - $ 350  vs $9  for 
the standard arterial cannula.

However we felt the cost is nothing in comparison to someone waking up with 
a bad infarct.  The literature that was generated by the company to the FDA 
DID NOT SHOW statistically decreased CVA's, however it did show decreased 
acute renal insufficiency.  Our findings mimicked this.  We had no obvious 
stroke in our patients, however we did not perform all those elegant 
neurologic tests pre op and post op.

We also didn't have any of the complications associated with the Embol-X - 
aortic dissections etc..

The literature and the company always took pictures of the net to convince 
us that there was significant particulate matter.  The magnification in the 
photographs was much greater than our loops.

I guess that the bottom line is that this catheter cost $ 70,000  vs  $1800 
over three years and we didn't have a stroke.  Did we "prevent" a stroke - I 
doubt that statistical significance was obtained.

We now use the Embol-X very selectively and I believe that within the next 
year it will be off our shelves.  We continue to irrigate profusely with 
cold saline after debridement and we use 5 liters of CO2 from opening the 
left side to final closure.

Hope this helps.

Tim Sloan


----- Original Message ----- 
From: "Jean BACHET" <jean.bachet at imm.fr>
To: <OpenHeart-L at lists.hsforum.com>
Sent: Thursday, March 01, 2007 4:36 AM
Subject: Re: [HSF] Embol-X


>
> ----- Original Message ----- 
> From: "Ani Anyanwu" <anianyanwu at hotmail.com>
> To: <OpenHeart-L at lists.hsforum.com>
> Sent: Thursday, March 01, 2007 3:38 AM
> Subject: Re: [HSF] Embol-X
>
>
> I would like to know list members experience in using the Embol-X
> intra-aortic filter - indications and capture rate. I know some - notably
> Hal - have said they use it on all valves - what prompted this?
>
> I ask because in the last two weeks we have had two devastating strokes in
> 40 year olds undergoing degenerative mitral repair, having not had a 
> single
> stroke in almost 300 degenerative repairs in our institution the preceding 
> 2
> years and am wondering if one should consider using this device routinely.
> At present we have used it only in cases with high embolic risk and even
> then our yield has been low.
>
> Thank you
>
> Ani Anyanwu
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