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

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.

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.

Ultrasound guided cannulation is slowly becoming the standard of care outside the US.  See the 2017 guidelines on the use from Canada.  As IN’s you routinely use ultrasound imaging.  Many of you may even provide cannulation maps of a patient’s access to the dialysis unit.   The Associates program at the Feb meeting will be reviewing cannulation techniques and the issue of ultrasound imaging.  Wanted to get feedback on the interest in ultrasound guided cannulation or at least visualization before cannulation by your dialysis staff.  Do you support the idea?  Would an easy to use non-diagnostic imaging be of value to your clinics?  What about cost of the device?  The major adoption hurdle of training has already been disproven by Dr. Agarwal's study utilizing an easy to use simple point and see device.   

Again, ASDIN has an opportunity to lead the way in vascular access.  Please help our colleague with her inquiry below.

A social worker posted on the CNSW listserv that her patient had a clotted access that has caused a lot of pain over the last few years, so we are cross-posting here. Patient now has a CVC and is getting a fistula in her other arm. The patient has swelling and pain in the arm where the fistula is clotted and has told the Social Worker that when the CVC is used it feels like her veins are being pulled out. Her surgeon has told her there isn’t a surgical option to resolve the pain she is feeling. Hate to hear of a patient having pain during each dialysis treatment.   Asking for ideas to see if you have tips or suggestions.

Dear Colleagues,

We had the Privilege to perform our first three endovascular AVF's using the wavelinQ system early this week.

All were an immediate technical success. We will follow the patients closely to the time of cannulation. 

I am very grateful to my team at the VAC and the patients that put their trust on us.

Here are the most meaningful images of our very first patient - these include a the final run and blood flow volume by me two days later

The second video is the final run of the second patient. 

The third is a still corresponding to the final patient.

Now we will follow them until the are ready to be accessed

Thanks,

Alejandro Alvarez

SSM VAC STL MO

ASDIN Members - We have received an inquiry from a CRNA on grafts clotting during surgery..  Please assist by responding to this post.

From Michael-Malachi Cohen CRNA, MSN

We have had at least 3 Dialysis grafts fail during surgery.  The cases were at least 4 hours each and with the patient in Trendelenburg positioning.  None of the cases involved direct pressure on the graft sites.  If possible please supply any information, algorithm, or standard of care that you have available on intraoperative monitoring of these access sites. 

Thank you for your time and effort as you look into this for our facility. 

Malachi