Tempe, Ariz. -Two Arizona physicians are trying to improve care for patients with chronic kidney disease by pioneering a minimally invasive procedure that provides easier access to a patient's bloodstream for life-saving dialysis treatments.
Kidney specialist Randy Cooper, MD, of SKI Vascular Center, presented his experience with the Ellipsys® Vascular Access System at the meeting of the American Society for Diagnostic and Interventional Nephrology (ASDIN), February 21-23, in Las Vegas.
His initial four-year follow-up data indicates this new type of dialysis access may last longer and require fewer interventions than the current standard of care, which requires an open surgical procedure. Dr. Cooper, a board member of the Phoenix chapter of the National Kidney Foundation, is also a co-author on a recent position paper from ASDIN regarding patient selection for this revolutionary approach to dialysis patient care.
In Arizona, more than 10,000 people are currently on dialysis as a result of kidney failure - an increase of nearly 50 percent in the last decade. For these patients, many of whom must visit a dialysis center several times a week for their life-saving treatments, any improvement in quality of life can have a significant impact.
"The ability to create a minimally invasive dialysis access means no incisions, no scars and less trauma for the patient. Most people want to avoid surgery at all costs, but for patients with kidney failure who already spend so much of their life under a doctor's care, this technology offers a considerable quality of life impact," said Dr. Cooper. "As soon as we learned about this novel technology, we knew we wanted to be able to offer this to our patients."
Nearly 100 kidney patients have now undergone the Ellipsys procedure at SKI Vascular Center.
In 2015, Dr. Cooper and his partner Umar Waheed, MD, were among the first physicians to participate in the U.S. clinical trial and later co-authored an article on the study results showing the safety and efficacy of the Ellipsys system. SKI was the first surgery center in the United States to offer the Ellipsys System following its FDA approval in 2018.
Using a minimally invasive approach, Ellipsys replaces surgery with a single needlestick in order to create a fistula (a type of vascular access for dialysis). For the past 50 years, the only way to create a fistula was with a complex surgery that subjects patients to discomfort and long recovery times. In contrast, the Ellipsys procedure can be done in an outpatient setting and requires little to no recovery time.
Chandler-based data analyst Alex Kaplan, a 32-year old father of one, had his fistula created with Ellipsys in September 2019 and has been successfully using the fistula for dialysis three times a week since December 2019.
"Ellipsys just seemed like the better option in every way. It was a lot less invasive and I had virtually no recovery. With having a young child, I needed to be back in action as soon as possible for my family," he said. "The procedure was quick, with no complications, and I returned to work the next day. My fistula has very little impact on my daily life."
In addition to being more patient-friendly, recently published two-year data has shown this type of access may function better and last longer than the surgical method. Dr. Cooper's ASDIN presentation also suggests Ellipsys fistulas heal faster and can be ready to use for dialysis access sooner than surgical ones - potentially reducing the time from fistula creation to dialysis from six months to four to six weeks.
"For patients with kidney failure, this innovative procedure eliminates a lot of the hurdles they
face in getting a fistula and actually being able to use it for dialysis," said Dr. Waheed. "Patients
come in for a consultation and within a matter of days they are having the Ellipsys fistula
created, and in some cases they've begun dialysis with that fistula in about a month."