Newly FDA-approved device for central venous occlusions hailed as exciting advance

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Eric Peden

HOUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last year—“and that’s not always been easy to say because dialysis has had not too much change for many decades.”

That’s starting to change, the division chief and program director for vascular surgery at Houston Methodist DeBakey Heart & Vascular Center said.

And so it was that, in the middle of February, one of those latest developments gained Food and Drug Administration (FDA) approval. The new piece of technology, named the Surfacer Inside-Out Access Catheter System and developed by private medical technology company Bluegrass Vascular Technologies (BVT), was designed to help patients with central venous occlusions.

As Peden, also an associate professor of cardiovascular surgery, explained, he and his colleagues had a front row seat as the device was trialed in the U.S.

The Surfacer System, which employs a novel inside-out approach, is the first FDA-cleared medical device that facilitates upper-body central venous access for patients with venous obstruction. The approval came by way of the results of the SAVE-US (Surfacer System to facilitate access in venous occlusions–United States) trial, with Houston Methodist one of seven sites where the research was conducted.

The brainchild of interventional cardiologist John Gurley, MD, of the University of Kentucky Medical Center, the Surfacer System received CE Mark approval in 2016 followed by a Post-Market Registry (SAVE Registry) on 30 patients, proving to be safe without mortality, Peden went on. Similarly, the stateside trial confirmed that, of the 30 enrolled patients, 90% met both primary and secondary efficacy endpoints, with no adverse events related to the device reported.

The prospective, non-randomized controlled trial saw Houston Methodist contribute 10 of the patients involved in the study.

How it works

The device, as Peden outlines, works thus: “John said, ‘You can take one of my central venous accesses, and that’s it,’” explains Peden. “‘And after that, I want a device that takes me back to the right side of the neck every time.’ And that’s what he created.

“It’s kind of a unique thing because we wind up obliterating much of the central venous circulation in these dialysis patients.”

Surfacer System

Peden drew attention to the coming advance in a talk entitled “New solutions to dialysis access” held at the Houston Methodist in October last year. He demonstrated how the device is used. “You come from below—and [John’s] done this through the liver and other things—but in this case the SVC [superior vena cava] or brachiocephalic veins are occluded. And we’re coming from below, through the heart, and the SVC stem … You can see collateral veins coming in from below.

“You would get what we would call a sheath. This is our first case. You get this large sheath up there and make sure it is embedded. You have to give up wire access at this point, which is a little disconcerting to most of us. Then you advance this device, which is a straight metal rod, with a blunted tip. It tells the sheath where to go because it’s a fairly stiff device. You advance it out of that, up through the soft tissues … get above the clavicle and poke out. You put a skin marker up on top so you can aim this device.” It’s an exciting development, Peden said. “Because for most of these patients, they were relegated to going down to leg access or being stuck with catheters only down the legs, etc., and this for patients with uncrossable venous lesions.”

It poses some interesting questions, he said, continuing: “If the right side is occluded, should you put the catheter on the left or should you use this device to go through on the right side and not injure the left side? [Here’s what] we know [about] left- sided catheters in dialysis patients: Remember, these are big catheters, these are 15Fr, that stay there a long time—and patients already have coagulopathy and disorders, and then go on to occlude their left side. So now they have both sides occluded, which is a real problem.”

One of the Houston cases in the stateside version of the trial was aborted. This occurred because the team “couldn’t direct the catheter in the right direction,” explained Peden.

Image intensive

This brought the surgeon to a larger point on what he described as an imaging-intensive procedure. “Is anything ever as easy as it appears?” Peden asked. “Someone comes and shows you this slick device. You say, ‘Wow, it’s great, I’m going to try that.’ There’s lots of behind-the- scenes manipulation with approaching commercially available devices.”

Summing up, Peden hailed the device as an important new piece of the dialysis puzzle, explaining: “It’s really exciting technology for really challenged dialysis patients. I’m not sure though it’s going to be widely applicable to every single patient. My own personal bias is that it is image intensive. In our case we have always had cardiac surgery on standby at the time.”

He added: “I think it needs a generation two device that’s steerable but that’s going to allow central venous access in patients who otherwise couldn’t have it. It is pretty easy to perform but the potential hazards are very real and I think it needs careful attention.”

The interventional radiologist and SAVE-US lead principal investigator Mahmood Razavi, from St. Joseph Hospital, Orange, California, said: “The Surfacer System offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites.”

The current approach to treat venous obstruction is to use an alternative vein. This process results in increased catheter days and costs due to the reduced ability to place and mature a functioning fistula.

Milestone

Bluegrass Vascular CEO and president Gabriele Niederauer said: “We are thrilled BVT has reached this important milestone. For the first time ever, physicians in the U.S. can offer patients a reliable and repeatable solution to treat central venous obstructions and restore access to the right internal jugular vein, the preferred access site.

“Through our experience in Europe and other international sites, the Surfacer System has consistently demonstrated a positive clinical impact. We are eager to bring the Surfacer System and its important benefits to patients in the U.S.”

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