Creating a Live Renal Donor Program: Overcoming the 4 hurdles to achieve excellence

| 28 June 2017

This is the story of how we are beginning to perform live donor renal transplant (LDT) at Kingston Health Sciences Center (KHSC). Like many of the stories in this News Discovery and Innovation blog much of the high tech is built on a strong team of doctors (surgeons and physicians) from several Departments, nurses, and technicians. This story emphasizes a common series of barriers that must be overcome to create programs of innovation such as this one. Kidney failure is a big problem-for the patient and for society. In 2013, 41,931 Canadians were living with end stage kidney disease (ESKD) an increase of 35% since 2004. Of these, 58% were on dialysis at an annual cost well over $100,000 and less than half (42.7%) of the patients treated with dialysis survive 5 years! To read this blog imagine that you have kidney failure. This is your life. Three times a week you drive to Kingston Health Sciences Center (KHSC). You look for parking. You walk to the Dialysis unit. You sit in an overstuffed chair. Nurses connect you to a hemodialysis machine. It processes your blood, substituting (more or less) for the kidneys that failed you. You look at the other 30 people receiving this same therapy. The time slowly passes, tick-tock. Perhaps you think about life’s fairness, tick-tock or perhaps you think, there must be some better way to do this, tick-tock. You might even ponder why, at a cost of >$100,000/year per patient, this isn’t a more enjoyable experience! Thoughts like this have been pushing us to do home dialysis and other alternatives to the central dialysis unit model. However, there is a way to replace failed kidneys and this alternative to dialysis is better for the patient and cheaper for the health care system. What you say? If there is a better and cheaper alternative to dialysis why are we still dialysing patients in 2017? Before I start a revolt, let me come clean, the better cheaper solution is renal transplantation and the best version of renal transplantation is to receive a kidney from a living donor (LDT), as opposed to, receiving a kidney from someone who has died (still better than dialysis, just not as good as LDT). Neither form of transplantation is available to all patients, either because of the lack of a suitably matched donor-patient pair or because of patient factors that preclude surgery. There are a multitude of reasons why transplantation may not be an option, including patient choice, medical and surgical contraindications and system reasons. Patients may choose not to undergo dialysis or transplantation. The reasons are diverse but are not dissimilar for the reasons patients declining chemotherapy and other treatments that offer potential gain at the price of some definite pain (or at least inconvenience). Physicians may decline to offer transplantation (or dialysis) for reasons including therapeutic futility (e.g. due to the presence of severe co-morbid conditions, such as advanced cancer or heart disease the treatment will not extend life or improve the quality of life). The system (locally or provincially) may fail to offer this option or provide inadequate access to meet the demands for renal transplantation. However, if you are a candidate it is best to undergo kidney transplantation (instead of being dialyzed). The main two impediments to success are immunologic rejection of the transplanted kidney and damage to the transplanted kidney during the harvesting process (due to the absence of blood supply after harvesting the organ-this is called ischemia). So where do we get kidneys for transplantation? From people who have died (deceased donor kidney transplantation), from people who have undergone cardiac death in a supervised hospital setting (donor after cardiac death), and from volunteers who agree to be living donors. This latter group is ideal because they are optimally matched immunologically, which reduces the risk of rejection (the main problem for renal transplantation) and the harvesting of the kidney is done in parallel with implantation in the recipient, ensuring the shortest time of interruption of blood flow (kidneys like all organs don’t like interruption of blood flow). For a living donor, the organ is harvested electively while the recipient is simultaneously readied in another operating room. To minimize the risk of rejection and ischemia the best donor is therefore a) a perfect genetic match (i.e. an identical twin) and b) live (i.e. the kidney is harvested from the donor and immediately transferred into an adjacent operating room and implanted in the recipient). However, few people have identical twins and the next best scenario is to receive a kidney from a living donor who is related to the recipient and matched for HLA type and blood type, even though they are not identical. Once again by using a live donor the kidney can be removed and immediately transferred into the recipient (who is being cared for in a parallel operating suite by their own team of surgeons and nephrologists). Using living donors and a parallel operation on the recipient ensures the procedure is elective (and thus well supported by staff) and minimizes renal ischemic time. The next best option is to receive a kidney from a live but unrelated donor (i.e. a spouse). This offers excellent graft (kidney) survival. For example, Gjertson and Ceka (Kidney International, Vol. 58 (2000), pp. 491–499) showed that when the spouse donated a kidney it was still functioning ~80% of the time at 5 years (open circles in graph below). Decorative Image

So we now know that transplantation is desirable but not always feasible or indicated. However, there is one reason for not being transplanted that is not acceptable, namely lack of willingness on the part of the physicians or a University hospital to create the capacity to offer the service. Failure to offer complex care services at academic health sciences centres often reflects personnel and system level impediments to overcoming the 4 Barriers to Excellence, which I will discuss subsequently. Note that I am not talking about community hospitals, who may best obtain transplantation (which requires tremendous technical expertise) for their patients by referral to designated centres. However, for University hospitals, such as our centre in Queen’s, a number of hurdles had to be overcome to allow LDT to become a reality. It turns out these hurdles are similar for any new high tech program and by recognizing their existence one can envision a systems approach to ensuring a clean pass over the hurdles. I call these hurdles, Inertia, Chaos, Lack of expertise, and Fear of failure (see Figure below). Decorative Image

Overcoming the 4 barriers to implementation of living renal transplantation program (or any tertiary care medical program)

Barrier 1: Inertia (The old ways- dialysis and cadaveric transplantation - will do) Solution 1: Vision Barrier 2: Chaos (Lack of a formal table at which to consider innovative programs and technologies) Solution 2: Creation of an Innovation Committee to provide planning and administrative support Barrier 3: Lack of expertise (We don’t have the right doctors/equipment/nurses/technologists-or some combination of these) Solution 3: Coordination of a Strategic Priorities Committee that has hospital and university representation and a mandate to accelerate the hiring of the types of physicians, nurses, physician assistants and technologists required for innovative programs that been endorsed as priorities at the innovation table. This accelerates the assembly of a competent team Barrier 4: Fear of failure (doing the first case frightens some physicians/hospitals) Solution 4: Courage. Ultimately the properly planned and constituted group must have leaders and patients willing to take the leap forward together. Of course, beginning with carefully selected, straightforward cases, is key. To launch the program a small group of passionate experts, usually those that will perform the procedure and their Department Heads must create the vision. In the absence of vision nothing happens; inertia dictates that the status quo persists. Our vision was that patients with renal failure in the SELHIN are better and more economically served by provision of a local live donor transplantation program (LDP) than by referring them to other University hospitals or by performing more of the cadaveric renal transplants that we have been doing. We overcame barrier 1 several years ago when we developed a vision shared by Urology/Nephrology/Medicine and Surgery. We then engaged the hospital and created an ad hoc table, which considered the vision and, having accepted it, provided the administrative support and legitimacy to cross the second hurdle. Getting over barrier 2 involved many meetings and included formal consultation with other renal transplantation centres in Ontario (who said, “Please start a program-we are swamped”!). Armed with hospital approval we then began to assemble the team required to propel us over barrier 3. This required recruitment of Dr. Tom McGregor, a talented and experienced renal transplantation surgeon, to co-lead this initiative with Dr. Shamseddin (a transplantation nephrologist). The team of course is much larger than this and the program requires each member be an expert in his or her craft (see image). Before clearing hurdle 3 we still need approval from Health Canada to begin this new program. With help from our administrative lead, Mr. Richard Jewitt, this was obtained, and several years after crossing hurdle 1 we did our first case (see story below). Decorative Image

Kingston Health Sciences Dialysis Unit

TEAM PHOTOS

Dr. Lois Shepherd and the HLA and Microbiology Team

Kristina Jones, Leslie Todd, Kelly Clark, Dr. Lois Shepherd, Marie Guthrie, Laura Webber, Julie McClatchey and Tammy Edwards

Nephrology Transplant Team

Dr. David Holland, Sharon Mulkerns, Arlene Funnell, Jenine Kramer, Dr. Khaled Shamseddin

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Surgery Team

Dr. T. McGregor, Ms. Laurie Thomas, Dr. S. Nanji (absent Dr. R. Siemens)

Recent advances include the ability to harvest the kidney for the donor (who is a healthy volunteer-so it’s a high stakes low risk surgery and a small scar is ideal). One of our key team leaders, Dr. Tom McGregor has been a champion of living donor transplantation and has shown that laparoscopic harvesting of the donated kidney is safer and better tolerated (if slightly more expensive and slower) than an open nephrectomy (think big incision and large, painful wound). Transplantation raises many considerations. For living renal transplant procedures all must go well when operating on a healthy volunteer. Surgeons are used to operating on a patient to cure a disease- a major procedure on a healthy person is a gut check for most surgeons. Our case: Living Related Donor Transplant- With the consent of the donor and recipient we summarize the story of Case 1 at KHSC On June 13^th, 2017, Mr. RH was our first patient to receive his live donor kidney transplantation from his son (donor) at our Kingston Health Science Center – KGH Site. Recipient story Mr. RH is a 67 year-old gentleman with a history of kidney disease caused by high blood pressure (hypertensive nephrosclerosis). He had been on dialysis for several years (first hemodialysis and later peritoneal dialysis). The morning of the first day post his live related kidney transplantation, Mr. RH said: “Doc, I really feel good, I’m great. I can’t even remember when was the last time I felt like this”. He added, “I’m not sure why I didn’t get this done many years ago. No more machines. I definitely will not miss my dialysis machine or the dialysis unit, even though I will miss people and nurses there. They were my family”. Mr. RH’s serum creatinine improved significantly from 645 umol/L (immediately after transplant surgery) to 189 umol/L - 24 hours post-transplant. By the time he was discharged, seven days later, his creatinine was 136 umol/L. A week later, he was seen in the Kidney Transplant Clinic. His creatinine remained stable (~ 140umol/L). His surgical wound healed well and he is doing well at home. Donor story Meanwhile, Mr. RH’s son, the donor, was discharged home two days post his laparoscopic nephrectomy (the surgery that yielded the kidney-below-which was given to his father) in stable condition.

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Kidney from donor about to be transplanted into recipient

He was able to resume his daily life activities without major limitations and within a week was back at work. His creatinine was only mildly higher than his baseline. He (the donor) will be followed up closely in our Post Live Kidney Donation Clinic at 1, 6, and 12 months post donation to monitor his kidney function as well as to optimize his blood pressure and monitor him for albumin/proteinuria. Although his (the donors) live kidney donation surgery was not associated with any extra physical or health gain, he has always wanted to provide his father with a better quality of life and longer life survival so that his father can enjoy his grandchildren. Their picture below highlights the joy and satisfaction that the transplantation has brought to their lives.

Picture of father (recipient) and son (donor)

Surgery We have now completed our first two living-donor kidney transplants. Both donors were performed laparoscopically and the surgeries went off without any hitches. Both donors were fully mobile the day after surgery and were discharged home within 24-36 hrs thanks to the minimally invasive nature of the surgery, which allows for an expedited recovery. Furthermore, the recipient surgeries went equally as well, with both transplanted kidneys making urine immediately and functioning very well in the days to follow.

Illustration of how the new kidney is reattached to the recipient’s vascular bed and the ureter attached to the bladder.

Which scar would you like?

Open procedure

vs.

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Laparoscopic renal harvest

Result: Our patient and donor did well. A laparoscopic approach was utilized. Moving forward: So our program has launched and our first cases went well. However, challenges remain. These include a shortage of donors and some concerns about risks to the donor. First and foremost, there are not enough kidney donors to meet demand. In Canada only 1/3 of potential kidney transplant recipients on the waiting list are transplanted each year (see Figure below). Decorative Image

To try and increase the availability of living donor kidneys a new program has begun. Some patients have a living related donor who wants to give them a kidney but is not a good immunological match. Instead of wasting that kidney the donor gives their kidney to some other person (that they have never met) and another donor (somewhere else in the country) who is a match for the first patient supplies the first patient with their kidney. Patients who have a willing living donor are entered in a national LDPE Registry that identifies these other potential transplant opportunities. Decorative Image

Not every donor is able to give their kidney to the intended recipient; however, they can be matched through a registry another recipient. A second donor then helps their original recipient.

Currently this program sends the donated kidney across the country (by plane train or automobile, see map below). Decorative Image

Map showing the movement of kidneys from donors to recipients in Canada

For anyone who has traveled recently this imposes some logistical challenges and the kidney can be protected by shipping it in a specialized pod that perfuses the organ with oxygenated solution to keep it happy until transplantation. Decorative Image

Kidney perfusion and transportation pod

So is it safe to give a kidney? The answer, yes - but their risk is not zero. In what at first appears paradoxical donors live longer than the average population. For example, in a study of 1332 Norwegian kidney donors followed up for an average of 32 years, there was a survival benefit for kidney donors, relative to the general population (0.7 for female and 0.5 for male donors). The apparent (and surprising) increased survival reflects not the benefit of giving a kidney but the fact donors are selected and screened to ensure they don’t have disease (Holdaas H, et al. Mortality of kidney donors during 32 years of observation. J Am Soc Nephrol1997; 8:685A). However when one corrects for the health state of donors some risk of donation emerges. In UptoDate, the acute and long-term risks for donors are summarized. The acute surgical and perioperative risks include a 90-day perioperative mortality of 1/3000. In addition to death, important perioperative risks to the donor include haemorrhage, pneumothorax, pneumonia, urinary tract infection, wound complications, and deep vein thrombosis with or without pulmonary embolism. Longer term, there is a very small increase in risk to the donor of developing end stage kidney disease, although it is low. A US registry study compared 96,217 donors with healthy participants in NHANES III, estimated lifetime ESRD risk of 90 per 10,000 donors compared with 14 per 10,000 among healthy non-donors (Muzaale AD et al JAMA. 2014 Feb;311(6):579-86). Are kidney donors remorseful later? 95% of the time no! In an interesting study of living donors only 1.4% of donors whose recipient was alive regretted making the donation (although this % was higher when the recipient was dead 4.3%) (see Table below).

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https://academic.oup.com/ndt/article/18/5/871/1833143/The-risk-of-living-kidney-donation

Lessons to be learned? We have begun the journey to making live donor transplantation the norm for appropriate candidates requiring renal replacement therapy. We also need to learn from the arduous process that was required in this case to surmount the 4 barriers to excellence. KHSC still needs a formal innovation table at which to consider proposals for new programs of excellence. At this table proposals by physician leaders can be discussed and ultimately refined so there is an accepted and well-understood vision. The proposal can be accepted, rejected and prioritized. The table will require input from KHSC (where the work is done and infrastructure resides), Queen’s University (with which the faculty are aligned), SEAMO (the alternative funding plan which controls physician hiring), the Southeast local health integrated network, SELHIN (which controls resources for health care) and the physician leadership (Department Heads and others who offer the vision and/or are technical experts). This much-needed new table will ensure that early in the process there is the clarity of vision that is a prerequisite for clearing the hurdles and doing so with a speed and ease that an Olympic hurdler would appreciate. So KHSC, SEAMO, Queen’s University, and the SELHIN-next hurdle neurostimulation for Parkinson’s disease and epilepsy surgery: On your mark, get set, GO!