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WVU Medicine gets state OK for kidney transplant program; will seek fed OK next

MORGANTOWN — WVU Medicine’s planned kidney transplant program received a state green light this week and is one approval away from serving patients.

Michael Shullo

The state Health Care Authority approved WVUM’s Certificate of Need on Monday. In the next couple weeks, said Michael Shullo, associate vice president for transplant services, they’ll submit their application to the federal United Network of Organ Sharing.

While they can’t predict an exact date – UNOS approval takes on average three months – they could possibly perform their first transplant sometime in the fall, he said.

WVUM President and CEO Albert Wright explained some of the background of the transplant program. They decided about three years ago to explore the possibility of performing solid organ transplants and elected to stat with heart and kidney.

“Transplantation’s something that takes a lot of work and there’s a tremendous amount of sub-specialization and infrastructure to do it,” Wright said. Shullo — who’s led transplant programs in Pittsburgh and elsewhere – was brought aboard to put together the teams.

They submitted the CON applications for both programs last August. The heart application was approved in February and the UNOS application was submitted in March.

But the kidney application faced opposition from Charleston Area Medical Center, which has its own transplant program.

The authority’s CON decision document shows that CAMC presented several arguments. Among them, transplant programs depend not on the supply of patients but the number of kidneys; with a limited supply, WVUM would siphon off supply from CAMC and Pittsburgh, diminishing CAMC’s program.

Also, CAMC said, WVUM’s service area doesn’t include the panhandles, so it’s unclear how it could draw enough patients when surrounded by existing, larger programs.

The authority didn’t accept CAMC’s arguments, supporting instead WVUM’s explanation of the need. WVU explained that from 2008 through 2018, 874 West Virginians had kidney transplants. About 55% of them had them done out of state. With a program in the northern part of the state, many patients – already on the national waiting list or potential future patients – would stay in-state.

And the kidney supply, WVUM said, is not a limited local supply. The regional and national organ networks match organs to patients from coast to coast.

UNOS certification is unique, Wright and Shullo sad, because UNOS requires the hospital have a full team in place before it will accept an application. So the heart and kidney teams are both hired and awaiting the final OK.

The team includes transplant surgeons, transplant nephrologists, surgical and medical directors, pharmacists, nutrition support, social workers and more. “The heart of any good transplant program is the staff. We’ve hired a world class staff,” Shullo said.

As for the demand, “It is sort of over the top,” Shullo said. West Virginia has the highest rate of end stage renal disease in the country. “More people go on dialysis here every year per capita than every other state.”

They’ve been hearing from dialysis centers and nephrologists who are ready to send patients, and from patients who want to transfer their care to WVUM. “We’re going to be able to offer something in the northern half of the state where they can stay home. … So we expect it to be a very positive response, and from what we’re hearing its’ going to be good.”

The CON documents show WVUM estimates transplant numbers to grow from 20 in the first year to 60 by the fifth year.

And WVUM’s reputation has proven a good draw for staff, Wright and Shullo said. When they advertised for transplant surgeons, 31 applied within three weeks. That’s exceptional, with 200 programs in place across the country. Most programs will get just a handful of applicants.

When UNOS OKs the program, Wright and Shullo said, the next step will be building a patient base. The entire staff will evaluate patients to see if they’re good candidates. Those approved will be placed on the national waiting list and then wait for a suitable organ to become available.

WVUM also has a living donor program, they said. Family, friends and folks who just want to donate a kidney out of the goodness of their hearts can volunteer and be evaluated to match their kidneys to awaiting family members or patients in the queue.

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