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Excessive clotting of Acuseal grafts - a brief return

Posted By Marc Webb, Wednesday, January 29, 2020

As I mentioned in a previous post, I became enthused about early cannulation grafts because they let me revise or replace a failing access without needing an interval catheter. Then I started using them primarily, first Flixene, then Acuseal when Flixene went into a prolonged backorder situation. Over a ten year period, I put in several hundred of each. Recently, I became concerned about an abnormal rate of repeat thrombosis in relatively new Acuseal grafts. I no longer use them.

Here, I have images of a graft placed in April 2018, and replaced with a Flixene graft (no catheter) this month, lasting less than 2 years. Ironically, her first graft was a Flixene, placed in 2012, and replaced in 2018 with the Acuseal. I took segments out during this last transition because I wanted to know why the Acuseal did not last as long as the Flixene. In one image, fibrosis in the zone of frequent cannulation pushes a partly disrupted silicone layer further into the lumen. In the other, the graft wall is fairly well preserved, but the lumen is full of an amorphous hyaline material, also present in the other image. I don't see many sectioned dialysis grafts, but I have never seen this kind of hyaline material in a newer graft, and especially not where the graft has not experienced heavy use. Remember that these graft segments were running and not thrombosed when they were excised and replaced. Any ideas? I will be reviewing this with a pathologist this week, and may have better images then. The specimens have been preserved if there is an interest.

I will be doing a retrospective review of the Acuseal versus the Flixene, perhaps with a standard PTFE, and a BVT group as well.

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Excessive clotting of Acuseal grafts - a brief return

Posted By Marc Webb, Wednesday, January 29, 2020

As I mentioned in a previous post, I became enthused about early cannulation grafts because they let me revise or replace a failing access without needing an interval catheter. Then I started using them primarily, first Flixene, then Acuseal when Flixene went into a prolonged backorder situation. Over a ten year period, I put in several hundred of each. Recently, I became concerned about an abnormal rate of repeat thrombosis in relatively new Acuseal grafts. I no longer use them.

Here, I have images of a graft placed in April 2018, and replaced with a Flixene graft (no catheter) this month, lasting less than 2 years. Ironically, her first graft was a Flixene, placed in 2012, and replaced in 2018 with the Acuseal. I took segments out during this last transition because I wanted to know why the Acuseal did not last as long as the Flixene. In one image, fibrosis in the zone of frequent cannulation pushes a partly disrupted silicone layer further into the lumen. In the other, the graft wall is fairly well preserved, but the lumen is full of an amorphous hyaline material, also present in the other image. I don't see many sectioned dialysis grafts, but I have never seen this kind of hyaline material in a newer graft, and especially not where the graft has not experienced heavy use. Remember that these graft segments were running and not thrombosed when they were excised and replaced. Any ideas? I will be reviewing this with a pathologist this week, and may have better images then. The specimens have been preserved if there is an interest.

I will be doing a retrospective review of the Acuseal versus the Flixene, perhaps with a standard PTFE, and a BVT group as well.

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Excessive clotting of Acuseal grafts - a brief return

Posted By Marc Webb, Wednesday, January 29, 2020

As I mentioned in a previous post, I became enthused about early cannulation grafts because they let me revise or replace a failing access without needing an interval catheter. Then I started using them primarily, first Flixene, then Acuseal when Flixene went into a prolonged backorder situation. Over a ten year period, I put in several hundred of each. Recently, I became concerned about an abnormal rate of repeat thrombosis in relatively new Acuseal grafts. I no longer use them.

Here, I have images of a graft placed in April 2018, and replaced with a Flixene graft (no catheter) this month, lasting less than 2 years. Ironically, her first graft was a Flixene, placed in 2012, and replaced in 2018 with the Acuseal. I took segments out during this last transition because I wanted to know why the Acuseal did not last as long as the Flixene. In one image, fibrosis in the zone of frequent cannulation pushes a partly disrupted silicone layer further into the lumen. In the other, the graft wall is fairly well preserved, but the lumen is full of an amorphous hyaline material, also present in the other image. I don't see many sectioned dialysis grafts, but I have never seen this kind of hyaline material in a newer graft, and especially not where the graft has not experienced heavy use. Remember that these graft segments were running and not thrombosed when they were excised and replaced. Any ideas? I will be reviewing this with a pathologist this week, and may have better images then. The specimens have been preserved if there is an interest.

I will be doing a retrospective review of the Acuseal versus the Flixene, perhaps with a standard PTFE, and a BVT group as well.

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SPECIAL EDITION JANUARY ARTICLES

Posted By Abigail Falk, Thursday, January 23, 2020
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January 2020 Articles

Posted By Abigail Falk, Monday, January 6, 2020
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December 2019 Articles

Posted By Abigail Falk, Thursday, December 19, 2019
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Query about statistics software for individual practices

Posted By Marc Webb, Monday, December 16, 2019
I am looking for recommendations on statistics software to be used in my office practice to translate cases into "data" - Kaplan-Meier graphs, and so on. I have no real institutional alliance at present, and am looking for something that would help me follow and analyze 300 central venous stents, for example. I am sure there is expertise out there to help me avoid a costly mistake and wasting time with the wrong product. Any reflections or advice would be much appreciated.

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Unexplained frequent clotting in Acuseal grafts

Posted By Marc Webb, Saturday, December 14, 2019

Brief background: I have been a full-time vascular access surgeon for 20 years, placing grafts, creating fistulas, and performing endovascular maintenance and rescue, including declots. I am a big fan of early cannulation grafts, and have used them frequently since 2011, first Flixene, then after 2015, Acuseal, without major problems. However, in July of 2019 I noticed an unexplained rise in thrombotic events in patients with relatively newly placed grafts, along with some imaging suggesting delamination of the inner PTFE layer of the Acuseal graft. The middle layer of silicone is both ultrasound and radiolucent, and the inner layer of PTFE is quite thin, so imaging is difficult. The only remedy I have found is a covered stent in the zones of cannulation (Fluency). I have stopped using this graft.

Has anyone else had these problems with Acuseal grafts? Are there any insights to share?

 

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Coding/Billing Question

Posted By Nephrology Associates PA Vascular Access Center, Tuesday, September 10, 2019

We received this email from our Billing Coordinator today:

 

"We are still not getting paid when we bill the 36595 with modifier 52.  I called Medicare again today to clarify and the code is being bundled with the  36581.  The only way to un-bundle this would be with a modifier.  I am not sure if there is an appropriate modifier to use in these cases as the 36595 is being done at the same site as the 36581.  Any guidance you could give me on this would be appreciated.  Thank you!"

 

I offered to share it here to see if anyone has had any luck getting this code paid, what modifiers they are using, etc.  We do use the coding manual tip of adding an additional statement to our procedure note.

 

Any info would be appreciated, thanks!

Tags:  billing  codes  reimbursements 

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August 2019 Articles of Interest

Posted By Abigail Falk, Monday, August 5, 2019
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President Trump's Speech encouraging in-home Dialysis and Transplantation

Posted By Eric Ladenheim, Friday, July 12, 2019

President Trump’s overall strategy of addressing the ballooning of expenditures for End Stage Renal Disease (ESRD) care by encouraging less expensive home dialysis and transplantation is brilliant but the devil is in the details. The tactics the Administration proposes to use are unnecessarily complicated and resemble a communist Chinese large scale transformative policy experiment rather than a democratic American legislative initiative.

 

At 4:45PM EST today on 7/11/2019 the detailed proposal was released for public inspection at https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-14902.pdf. The proposed rules are 413 pages. Ironically, the authority for the regulation comes from the Obamacare Law that the Administration supports eliminating.

 

Here is the experiment being proposed: The USA will be divided into 306 groups of zip codes called Hospital Referral Regions.  153 Hospital Referral Regions will be randomized to provide incentives for nephrologists to refer for home dialysis (mainly peritoneal dialysis) and transplantation and 153 regions will be randomized to the status quo.  The providers whose payments will be affected by the randomization will be the dialysis unit and the nephrologist.  Since this is a legislative experiment rather than a clinical trial the requirement for informed consent will be waived; rather, participation will be mandatory for the providers. It is called the ESRD Treatment Choices Model (ETC Model).

 

When the study is concluded in 2026, the data can be analyzed to determine whether the clinical and financial outcomes are better with the payment incentives and whether the administration’s goal of increasing home dialysis and transplantation through the incentive program is being achieved. Then the incentives could be implemented systemwide.

 

As we well know, in recent years, CMS has been trying to reduce ESRD expenditures by reducing the payment rates for the services are were needed to maintain hemodialysis access and has run into increasingly loud resistance from providers (like myself)  that performed those services and who had an opposing concentrated interest. This policy does an end-run around the HD maintenance payment conflict by incentivizing home dialysis (mainly peritoneal dialysis) and transplantation which all virtually all specialists agree is much cheaper to maintain. 

 

That home dialysis and transplantation are less costly than in-center hemodialysis there is no doubt. Whether the clinical outcomes of home dialysis are better than the clinical outcomes of in-center dialysis are presently uncertain. In my opinion the data currently available suggests clinical outcomes are about the same.  CMS proposes to resolve this uncertainty by structuring the payment reform measures as a massive nationwide prospective randomized non-blinded study that will study the effect of home dialysis/transplant payment incentives on cost and outcomes.

 

It is obvious that the costs of ESRD care have grown so high that something must be done or the Medicare system will be bankrupted.  But America doesn’t need a grand social experiment to decide whether to  incentivize less costly home dialysis and transplantation.  The administration has the legal authority under the Obamacare Act to implement the proposed innovation systemwide without limiting them to  randomly chosen geographic areas.  I would urge that the regulations be revised before the final rule is issued making the incentives applicable throughout the America, while it monitors clinical and financial outcomes.  Ultimately, the Secretary of HHS has the authority to stop the study  program as soon as it is clear that money is being saved without adversely affecting clinical outcomes and make the changes permanent. I hope this is done as soon as possible.

 

Sincerely,

Eric

Eric Ladenheim MD

LDAC Vascular Centers

 

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Patient with acute thrombosis in radiocephalic fistula

Posted By Sun Ryoung Choi, Friday, June 28, 2019

A patient on hemodialysis three times a week visited the emergency room

The patient complained of dyspnea and chest x-ray showed cardiomegaly.

Vascular ultrasound was performed on suspicion of vascular access thrombosis.

Radiocephalic fistula had no thrill.

The attached image is an ultrasound examination performed at admission.

The ultrasound waveform is thought to be somewhat different from that of general thrombosis.

In conclusion, the patient underwent pericardiocentesis as an emergency after diagnosis with

acute cardiac tamponade.

I wonder if the shape of the ultrasonic waveform of the attached file is related to the cardiac

tamponade.

Thank you.

 

 

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Trerotola Device Issues

Posted By Terry Litchfield, Friday, April 26, 2019

Is anyone having issues with the tip of the Trerotola thrombectomy device separating from the basket portion?  Over the last year, we have seen several of these occur and note the MAUDE database is reporting many of them.  The tip is often not able to be retrieved.

The manufacturing changed to Mexico and there appears to be something happening.

And of course would want to make sure that anyone seeing a product defect should report the device failure to the manufacturer.  And please report additional catheters that have the same problem.  

Would love to hear if others are seeing this.

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March 2019 Articles of Interest

Posted By Abigail Falk, Monday, March 25, 2019
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Hand-held US devices

Posted By Ryan D. Evans, Thursday, March 21, 2019

Just a general technology question for the forum.  I am ordering new ultrasound equipment for our surgery center.  There have been recent advances allowing for hand-held US technology, such as the Sonosite iVis, Android, and Ipad devices.  However, I don't see any handheld US equipment which can measure fistula flow / pulse wave doppler.  I evaluate new fistulae by US to access maturation and measure flows.

Does anyone know if there are any hand-held US devices which can measure flow?  Thanks.

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