Guest Post by Jeffrey Hull, MD
In the United States alone, nearly half a million people currently suffer from end-stage kidney disease and must undergo hemodialysis several times a week. For these patients, the vascular access site is quite literally their lifeline, as it provides direct access to their bloodstream for the life-saving treatments.
Yet due to the current COVID-19 outbreak, procedures to establish these vascular access sites have been deemed “non-essential” elective procedures by CMS and HHS, and nephrologists and vascular surgeons are finding themselves unable to secure operating room time.
Though we must all work together during this crisis to reduce the intense strain on our healthcare system, this decision could have devastating implications for patients with end-stage kidney disease — a group that is already highly vulnerable to potential complications of COVID-19. Limiting access to these procedures will increase reliance on riskier vascular access options that significantly increase patients’ chances of infection, hospitalization and even death. This will only add to the strain on resources as hospitals continue to deal with the outbreak.
While many aspects of life can be paused as the world grapples with this pandemic, kidney failure is unfortunately not one of them. As the outbreak continues to unfold, we must be sure we’re protecting our most vulnerable patients — and a new minimally invasive vascular access technology that shifts procedures to the outpatient setting could help do just that.
Fistulas – The Gold Standard for Vascular Access
For most people with kidney failure, the first step in preparing for hemodialysis is attaching an artery to a vein in the patient’s arm to create a sort of “super vein,” otherwise known as a fistula. The fistula provides fast-moving blood for dialysis and is strong enough to be punctured by a needle three or four times a week.
A fistula is the preferred form of vascular access, as it reduces the risk of infection and other complications compared to alternatives, such as synthetic grafts and central venous catheters (CVC). CVC-related infections are a leading cause of morbidity and mortality in dialysis patients. In fact, a patient with a hemodialysis CVC has a four times greater likelihood of death compared to a patient with a fistula.
Unfortunately, classifying vascular access procedures like fistula creation as “elective” will result in more patients starting hemodialysis with a CVC, putting them at a greater risk of potentially life-threatening complications. Delaying vascular access placement may also lead to more patients beginning dialysis in the hospital, rather than at home or in a dialysis center — further straining hospital resources.
Transforming Dialysis Access from the OR to Outpatient Settings
Until recently, surgery was the only way to create a fistula, which meant discomfort, long recovery times and delayed dialysis for patients.
So in 2010, we began developing the Ellipsys Vascular Access System — the first innovation in fistula creation in more than 50 years. Approved by the FDA in 2018, Ellipsys replaces surgery with a small needle puncture to create access to a patient’s bloodstream for dialysis treatments. Not only does this spare patients the pain and trauma of undergoing surgery, recent research suggests this less invasive approach actually creates a more durable form of vascular access that requires fewer procedures to maintain compared to the surgical method.
With the ability to create fistulas using just a small needle stick and a catheter, Ellipsys turns a complex surgery into a minimally invasive outpatient procedure that can be done in as little as 30 minutes. The patient goes home with just a band-aid and there is little to no recovery — they can resume normal activities within 24 hours.
Recently published two-year data showed high levels of patient satisfaction with the Ellipsys procedure, as many patients want to avoid surgery at all costs — like my patient Jerry Williams, a 64-year old retired railroad carpenter. He knew for several years that he would most likely need dialysis as a result of his kidney disease, but he put it off as long as he could. Finally, in December 2018, he and his doctor decided it was time due to his declining health. Fortunately, he was a candidate for the Ellipsys procedure.
Mr. Williams is one of the more than 150 patients in my practice—and more than 1,500 patients worldwide—who have benefited from this less invasive approach. Not only did Ellipsys spare him from the pain and discomfort of surgery, but it also enabled him to avoid the need for a CVC altogether. For patients suffering from kidney failure, who already spend so much of their life under a doctor’s care, the impact of this procedure on their quality of life cannot be overstated.
Protecting Kidney Patients is Essential
In addition to urging HHS to re-classify vascular access procedures as “essential,” physicians caring for end-stage kidney patients should look to the Ellipsys System as a way to shift vascular access procedures to the outpatient setting. This will ensure patients still get the optimal dialysis access while reducing potential exposure to COVID-19 and preserving limited hospital resources for those affected by the virus. As long as patients have a favorable anatomy that ensures a high chance of success with Ellipsys, there is no reason these procedures should not continue in the midst of this ongoing crisis.