Sensing Savvy

Although it was developed to increase transparency and facilitate communications, some healthcare professionals worry the Sunshine Act is negatively impacting their reputation with patients.The Sunshine Act requires drug, medical device and biologics manufacturers participating in federally funded healthcare programs to report to the Centers for Medicare and Medicaid Services (CMS) any compensation given to physicians, teaching hospitals or group purchasing organizations.

Data recordings of these transactions began in August 2013 and since then, physicians and teaching hospitals have worried this information could undermine patient trust and threaten the doctor-patient relationship.

Over the past decade the health of Americans has improved in some areas: Life expectancy at birth has increased; rates of death from coronary heart disease and stroke have decreased. Nonetheless, public health challenges remain, and significant health disparities persist.

As a nephrology professional who has devoted countless hours of volunteer time to support the body of work reflected in the 2006 National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines on vascular access, it is difficult to witness the “march of time” with regards to the arteriovenous fistula (AVF) as the best access for patients on dialysis.

A serious error in the 2019 proposed National Kidney Foundation’s (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) is their grouping of all methods of vascular access surveillance as comparable. They are not! For instance, venous pressure measurements (Vasc Alert), can identify an outflow vascular access stenosis but cannot detect an inflow stenosis. In contrast, Transonic’s indicator dilution measurements can identify inflow and outflow stenoses as well as stenoses between the needles. This is significant because Asif et al, reported in his 2005 study “Inflow stenosis in arteriovenous fistulas and grafts: a multicenter, prospective study,” that 35% of vascular accesses sent for intervention do have inflow stenosis.¹

The 2019 proposed National Kidney Foundation’s (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) recommends a regular physical examination by a knowledgeable and experienced health practitioner to detect flow dysfunction. The proposed Guidelines cite five references to support their position.^1-5 Asif’s 2005 reference “Accuracy of physical examination in the detection of arteriovenous fistula stenosis” from the Miller School of Medicine at the University of Miami was referenced several times. Two other studies^3-4 also originated at that same institution. All four studies^1-4 cited the use of interventionalists, interventionalist fellows, or physicians trained in vascular access physical examinations to monitor for and detect AV-access flow dysfunction.

The same concerns over process of care related to the KDOQI VA proposed changes that reverse the momentum of the past guidelines and Fistula First (identifying early indications of assess dysfunction, staff assessment competency) also apply to hemodialysis catheters. The proposed guidelines suggest that hemodialysis catheters could be a viable long-term access choice. Similar to the limitations on assessment skills, many states restrict the accessing of a central venous catheter to a licensed nurse. Questions raised by the proposed guidelines include:

Dialysis facilities typically open early in the morning Monday to Saturday. The first shift of patients must get their treatments initiated to prevent delays for the later patient shifts. Commonly, limited licensed nursing staff is on duty to perform any needed early morning assessments. The One Minute Check has now been shortened to 10 seconds in some facilities in order to save time. Once the needles are placed, it is not safe to perform the check or a higher-level expert examination. Typically, the nephrologist and advance practice team members see dialysis patients once they are on their way to treatment. They may be able to assess later shift patients before their needles are inserted. However, routine process of care makes it very difficult for nephrologists to fully assess the AVF or AVG with an expert-level physical exam detailed in the current draft of the KDOQI Guideline updates.

A quick review of the process of care is critical to understand how the proposed KDOQI Vascular Access Guidelines will impact the dialysis facilities and thus the patients.

The value of vascular access surveillance has been widely debated over the past decade. Many studies attest to its usefulness for identifying stenoses. A few question its value. 

A 2015 randomized controlled trial (RCT) by Aragoncillo published in Journal of Vascular Surgery underscores the value of regular surveillance of hemodialysis patients.

The proposed 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) Guidelines are now open for review with comments accepted through June 7, 2019. Transonic hopes hemodialysis stakeholders who have pre-registered to review the proposed Guidelines will submit their comments by the June 7th deadline.