That is interesting to know. Yesterday, I was providing an educational in-service to the staff and my colleague nephrologist at one of our dialysis center.s. As I was showing them a sample of the early cannulation graft, the nurses at the dialysis center talked about the same problem- early and recurrent thrombosis of the acuseal grafts, I passed it away with the quick comment “that the mother-board vascular structures, i.e., the veins probability were not sturdy enough to hold the heavy-duty early cannulation graft”. !!!!.🤔
I had not done any thrombectomy of the these newly placed grafts, since the patients end up going back to the surgeon who had done the surgery following the early post-op thrombosis. I will have to look into the thrombectomy procedure notes of these patients (mostly done in the hospitals) and try to figure out the problem.
Hope, other interventionalists in this forum who had experienced this problem will be able to provide some insight or opinion regarding this issue.
-Suresh K. Margassery

Interesting you mentioned that, I have noticed the same thing as of late. Not a graft frequently used in the patients I cover. Two patients as of the last six months due to early thrombosis post creation and early recurrence. Both acuseal and both abandoned.

What you describe is exactly why our practice has stopped using Accuseal. It would seem that when declotting them the balloon might tear the inner lining, forcing one to use a stent graft to salvage it. The Flixene grafts don’t have these problems at all.

Who else has seen these problems and been rebuffed by Gore? I have been told that some providers are reluctant to bring the topic up for fear of losing industry support.
I went to Gore to ask about other complaints (they said essentially none), but I posed the following questions to them back in May 2019 - " As for the very serious Acuseal delamination problem, there are several points:
We know it happens - there are enough anecdotal reports to make it a credible concern. When did you become aware of it, and what have you done to look into it?
We don't know how often it happens, or since when. I have used hundreds of Acuseal grafts and only became aware of it recently. What are the numbers? Is this a big problem, or a rare one? Is there a recent change in the manufacturing process?
We don't know why it happens, or under what conditions. Is it because of inappropriate use of mechanical thrombectomy devices? I find your explanation unconvincing. The June 2018 EV Today article by Treretola specifically states that there is no evidence that the PTD damages conduits being declotted, and the advice about withdrawing the device during use refers specifically about the risk of the PTD tip getting tangled up in tissue. Has Dr. Treretola had anything more recent or more specific to say? Have you posed the the delamination question to him? (Aside - I did speak with him at the CIDA meeting in San Diego,Novermber 2019 and he discounted the possibility that the Arrow PTD was damaging Acuseal grafts during thrombectomy)
There are many physician leaders with extensive experience with the Acuseal graft. Have you discretely surveyed them as to their experience or perspectives?. I would like to know what Drs. Glickman and Ross have to say without quizzing them myself.
I found NO specific advice anywhere about the proper technique to be used in declotting an Acuseal graft. To say that rotational thrombectomy devices are contraindicated in declotting Acuseal grafts is unreasonable, considering how widely they are used. I have had push-back already.
I do not have any information about how durable the inner lining of the Acuseal graft is. I presume that the engineers would have tested the product against this stressor, Since thrombosis of a graft and subsequent thrombectomy is one of the most common events that can be expected during the useful life of a dialysis graft, and again, rotational thrombectomy devices are widely used in that eventuality. If this was most tested in the development of the device, maybe it could be now.
I have seen disturbances and disruptions in zones of too frequent cannulation, and wonder in these areas present a special risk for initiating a flap with an advancing PTD. The problem here is that they are more evident on ultrasound than fluoroscopy, and might not be appreciated.

So, at present I am concerned enough to suspend my use of the Acuseal graft until I get a better handle on the problem. Please update me as soon as possible with all the information you get, so perhaps I can resume using this valuable tool." - end of communication with Gore.
Again, I have used this graft recently in very vulnerable patients, and am now wrestling with the consequences of repeated graft failure. I need to know what to tell them.

I echo all the concerns highlighted above. We have experienced the exact same problem this past year to the point that I had to ask (very kindly) our local surgeons to refrain from using them. The issues are again: 1) early thrombosis, 2) u can easily tell the difference during percutaneous thrombectomy which one is an accuseal graft, it has a tendency to have a "hang up" or "stuttering" of the Fogarty balloon during the sweeping of the graft, 3) I have also seen short delimitation looking like an intimal tear (that I did not have to stent). I am for sure not a big fan of this graft.

Until these issues are thoroughly looked into and resolved beyond any doubt or concern, it will be sensible to avoid using this graft and probably use only the Flixene graft for the new early cannulation graft surgery.
Also need to avoid thrombectomy hardware device other than Fogarty or angioplasty balloons for the thrombectomy of all Acuseal grafts whether new or old.

Anyone have experience with other mechanical throm devices with it (Argon Cleaner or Angiojet)? I will have to start paying attention to the accuseal patients. But nothing has stood out so far for me. I use Cleaner more than the Trerotola PTD. Thanks for highlighting this issue

I can be hard to tease out issues with early graft thrombosis. Sometimes it’s a technical implantation issue, sometimes it’s a patient issue (small vessels, hypotension, etc..). But the group concerns on Accuseal in particular may warrant further attention when approaching these for thrombectomies.

As far as my approach to any early graft thrombosis, I generally wait at least about 2-4 weeks to even attempt a thrombectomy of a newly placed graft – with the thought of letting the suture sites heal before I subject them to angioplasty. Usually the thrombus volume is fairly small, with the absence of cannulation area pseudoaneurysms seen in more mature grafts.

I also tend to approach newly thrombosed grafts more cautiously then more mature grafts – utilizing the smallest sheaths and balloons as I possibly can, while being relatively gentle with the Fogarty at the anastomosis.
For conventional, mature graft thrombectomies I usually use 7F or 8F sheaths and 7mm or 8mm balloons. However; for “newly” placed grafts I use 5F or 6F sheaths, and generally 6mm angioplasty balloons. I pretty much always place a stent-graft at the venous anastomosis.
I very rarely use any rotational thrombectomy devices in my practice, and find that angioplasty balloon clot maceration and a Fogarty balloon do the job for me most of the time. I do occasionally use a Cleaner device for large thrombosed aneurysms and pseudoaneurysms when needed.

The Trerotola and Cleaner devices are extremely powerful, rotating at 3000-4000 RPM. The Accuseal lining is relatively delicate, and it would likely be prudent to approach any Accuseal graft in a similar fashion to a newly placed graft – using relatively smaller balloons and avoidance of rotational thrombectomy devices to avoid damage to the graft.

The challenge is being aware of what type of graft you are working with – and if you’re in area of high early cannulation graft prevalence, it may be worth the extra efforts to try and obtain operative reports to determine what type of graft was placed.

I am a Nephrology fellow going into Interventional Nephrology, and just came across this thread. It seems that there is enough here to warrant a communication to FDA.....?

I have seen none of these problems. We don’t use a ton of Acuseal grafts. I’ve never been enamored of the early-stick concept; not afraid to use a catheter for 4-6 weeks while a graft heals. I think the fear-mongering over catheters is ridiculous. The Acuseal grafts I’ve worked on have not demonstrated any delamination problems, to my knowledge. 99% of our thrombectomies are done using the Turmel-Rodriquez aspiration technique, which does not involve any high speed wall-contact. So just aspirating thrombus hasn’t led to any apparent graft complications. If you ever experience a complication that you believe is related to a medical device, it is very easy to report it directly to the FDA: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=professional.reporting1
Ted

We rarely see Acuseal AVGs. Our practice mirrors Ted's thoughts above: "not afraid to use a catheter for 4-6 weeks while a graft heals. I think the fear-mongering over catheters is ridiculous". If not ridiculous, then at least over stated. Little if any data to support the notion that one additional month of TDC time causes significant morbidity/mortality. It seems to me that a patient who would have been a reasonable candidate for AVF or AVG but gets to dialysis with a TDC (error #1) should still have a reasonable decision made with regard to appropriate vascular access. No point in committing 2 unforced errors. To that end I will commonly consider a 2 stage transposed basilic vein AVF with transposition at week 2 and use by week 6.

My institution uses a lot of Acuseal AVG's. There are instances in which some patients just keep on thrombosing for no obvious reason, and in whom the surgeon places a Flixene and the patient does well.