Hope for hard-to-match kidney patients

The first (unsuccessful) human-to-human kidney transplant took place 75 years ago.  Some 16 years later, the first successful human transplant took place. Now, according to the United Network for Organ Sharing (UNOS), there are currently 111,714 people in the US awaiting organ transplantation.  Approximately 20,000 of these are so called “hard-to-match” kidney transplant patients.

In other words, their immune systems will reject most kidneys because of antibodies circulating in their blood that react to proteins known as human leukocyte antigens (HLA). These proteins are found on most cells and are used by the immune system to recognize what is foreign to the body.

In HLA-sensitized patients, the body has been exposed to foreign HLA in the past, either through pregnancy, blood transfusion or previous kidney transplant. As such, it immediately recognizes most donor organs as unfamiliar. And, unless these antibodies can be removed, they will result in severe antibody mediated rejection (AMR) and early loss of the transplanted organ.

Apart from the scarcity of donor kidneys, the biggest barrier to kidney transplant is the percentage (nearly 1:3) of patients on the waiting list whose immune systems make them likely to reject most kidneys available to them. Highly HLA-sensitized patients are very difficult to match with less than 7% receiving transplants each year.

SRxA’s Word on Health was therefore interested to hear of a new study from Johns Hopkins which showed that desensitizing such patients with a combination of therapeutic plasmapheresis and intravenous immunoglobulin (IVIG) doubled their chance of survival eight years after transplant surgery, as compared with those who stay on dialysis awaiting compatible organs.

Additionally, the protocol enabled a dramatic 98% transplant rate rather than the traditional 7%.

The results of this study should be a game changer for health care decision makers, including insurance companies, Medicare and transplant centers,” said lead investigator Robert A. Montgomery, M.D., D. Phil. “There’s a dramatic survival benefit, so people should take note. If this were a cancer drug that doubled chances of survival, people would be lined up out the door to get it. It’s really extraordinary to go from 30 percent survival to 80 percent survival after eight years.”

Widespread use of the pre-surgery protocol developed at Johns Hopkins could potentially lead to 3,000 more kidney transplants from living donors each year. The protocol uses plasmapheresis to remove the HLA from the blood before the transplant, then the patient receives low-dose intravenous immune globulin (a human plasma protein) to replace the problematic antibodies and prevent their return. This process is performed every other day for several days before transplant and then for up to 10 days following the surgery.

Although the protocol has great benefit in living donor transplants, it cannot be used in patients receiving cadaver organs – where time is of the essence,  because several days of plasmapheresis and IVIG are needed before surgery can take place.

Additionally, the patient will still to take the same anti-rejection drugs as all other organ transplantation patients.

The desensitization protocol also makes kidney transplants more expensive, However, the cost savings when compared to remaining on dialysis are enormous. Better still, the patient no longer has to endure the difficulties of dialysis, a process that takes about five hours a day, three days a week, and which often makes the tasks of daily life from working to caring for children nearly impossible.

“This treatment increases survival, ensures a better lifestyle and saves the health care system money,” says Montgomery. “There aren’t many things like that.”

Let’s hope healthcare insurers are reading this and taking note.

A New, Less Invasive Technique for Kidney Donation

Surgeons at a leading US hospital are studying a new way to make kidney donation safer, less invasive and almost scar free for women by using a new technique that removes kidneys transvaginally.

The technique is called natural orifice translumenal endoscopic surgery (NOTES), in which surgeons use a natural opening in the body to minimize pain and scarring, making recovery much easier.

According to the United Network for Organ Sharing (UNOS), more than 60% of living kidney donors are female.

Currently, kidney donors undergo either open or minimally invasive laparoscopic surgery.  During the latter operation the surgeon prepares the kidney for removal by working through three ¼-inch incisions. However, when it comes time to remove the kidney, a larger three- to four-inch incision must still be made for the extraction. The larger incision is the source for most of the pain and scarring. Other complications of current surgical techniques include hernias and wound infection.

Removing the kidney transvaginally, where there are relatively few pain fibers, results in a nearly painless operation with no extraction scar.  The first procedure was performed, to media fanfare in February 2009 at Johns Hopkins University, in Baltimore, MD.  Although deemed a success, there was, at the time, considerable skepticism from other clinicians.

Now, a study is being undertaken at the Methodist Hospital in Houston, TX, which intends to examine some of these concerns.

The investigators will conduct a microbiological analysis of the cervix and vagina of patients undergoing laparoscopic transvaginal hysterectomy. A sterile mock kidney will be placed in the patient’s abdomen and extracted transvaginally at the end of the hysterectomy procedure. They will conduct a microbiological analysis of the mock kidney after the procedure, as well.

If this analysis shows no evidence of contamination, or other adverse effects, this technique may become a future standard, improving donor and recipient safety while reducing pain and recovery time for the donor.  Ultimately, it is hoped, it will also increase the number of donors.

According to UNOS there are, as of today, over 108,000 people in the US awaiting a transplant. For them, and their potential living donors, the results can probably not come soon enough.