BRIDGING THE GAP IN DIALYSIS

BRIDGING THE GAP IN DIALYSIS

INNOVATION
By Alex Orlando | Texas Medical Center | March 4, 2015

One Texas Heart Institute surgeon’s latest invention is changing the game for patients with kidney failure

Toting a battered, silver pool-cue case over his shoulder like an Old West gunslinger, William “Billy” E. Cohn, M.D., cardiac surgeon and director of the Center for Technology and Innovation at Texas Heart Institute, as well as director of the Department of Surgery Incubator at Baylor College of Medicine, unveils one of his latest technological innovations. As he meticulously holds two slender catheters parallel to each other, the strong magnets inside pull them into perfect alignment with a barely perceptible “clink.” Once the magnets are lined up, Cohn activates a spring-loaded electrode that shoots out, bridging the gap between the two catheters. While you have to be paying close attention to notice, this tiny connection has huge implications for patients afflicted by kidney failure.

“Anything I put into this case ends up getting patented, and eventually transforms into a new piece of medical technology,” laughed Cohn, also professor of surgery at Baylor College of Medicine, as well as an amateur mechanic whose MacGyver-esque ability to integrate ordinary objects into new biomedical devices is well known. “It’s like magic.”

The device, known as the EverlinQ System, is a catheter-based technology designed to create minimally invasive dialysis access for patients suffering from chronic kidney failure. Currently, upwards of 400,000 Americans need to be connected to a dialysis machine three to four times a week to have their blood filtered—a biological process normally performed by the kidneys.

“As it stands, the best way to take care of a dialysis patient is an arteriovenous fistula (AVF),” explained Cohn, describing a procedure that entails open vascular surgery and often requires repeat procedures in order to connect patients to the dialysis machine. “We actually make an incision, take a vein, dissect it out and swing it over to the artery so that it becomes a short circuit—like taking a coat hanger and putting it across a car battery.” According to Cohn, this short circuit between the artery and the vein dramatically increases the blood flow as well as the size of the vessel, allowing the dialysis nurse easier access.

A surgical AVF has the lowest rate of long-term complications among patients compared to other dialysis solutions that necessitate either a prosthetic graft or a large intravenous catheter, explained Cohn. “Unfortunately, they only work in about half the patients—50 percent of the time, by three to six months, it’s completely failed and closed off,” he added.

The catalyst for Cohn’s innovation came from an unlikely source—the emergency room. “Every once in a while, someone would come into the ER after being shot or stabbed, and they sustained an injury where an artery and a vein are close together,” he noted. “In those cases, they developed an AVF that bled directly from the artery into the vein. So here is an AV fistula that never closed spontaneously and resisted our attempts to close it, whereas the ones that we made in the operating room closed off half the time. That didn’t seem fair.”

Cohn was determined to leverage that innate pathophysiology to create a new type of dialysis access for patients. “We found a place in every person’s arm where there’s an artery and two veins right next to each other,” he said. “We place these two catheters—one in the artery and one in the vein—and use magnets to pull them into alignment before activating the spring- loaded electrode. It makes a hole in the artery and a hole in the vein without any incisions, without dissecting anything out, and without any surgery. Once we retract the electrode and take out both catheters, the patient bleeds right from their artery into their vein, and the veins dilate just like in a surgical AVF—but without ever closing off.”

The EverlinQ system is quickly gaining traction. “We went down to South America and used it in 33 patients—the results are almost too good to be believed,” said Cohn. “Now we’re involved with hospitals in Canada, Australia, and New Zealand as part of the NEAT (Novel Endovascular Access Trial) study, to further evaluate the performance of the system.” Cohn and TVA Medical hope to use the data culled from that study to help design a U.S. trial aimed at gaining approval for domestic use by the Food and Drug Administration.

TVA Medical, the company that Cohn co-founded to develop minimally invasive therapies for end-stage renal disease, including the EverlinQ system, was awarded the 2014 Innovations in Cardiovascular Interventions (ICI) Best Start-Up Innovation Award this past December in Tel Aviv, Israel. The EverlinQ system was selected from a pool of more than 80 international companies according to three main criteria: the impact on novelty, the impact on patient care, and business potential.

“I think this is going to change the game for patients with chronic kidney failure,” concluded Cohn. “They’re going to be able to get better dialysis for longer, spend less time in the hospital and spend more time living and enjoying their life. That’s what motivates all of us at TVA—trying to come up with something that has merit and is meaningful.”

http://www.tmcnews.org/2015/03/bridging-gap-dialysis/