The news release focuses on a successful kidney transplant in which the donor organ was kept viable using a technique known as “ex vivo organ perfusion.”
The release provides a lot of information on what the surgery entails, and why. However, the release left out some key details. Are there risks associated with this technique? What sort of expenses are involved for patients? What sort of questions and concerns are still outstanding?
The release does tell readers that the transplant was done as part of a phase 1 clinical trial — and that future trials will address whether the technique is effective. Which raises the question: Why are they issuing a news release now?
According to the National Kidney Foundation, there are tens of thousands of people on the waiting list for a kidney donation — with thousands more being added to the list each month. That means there a lot of people, and their loved ones, who are anxious for good news regarding kidney donation.
Trumpeting one successful kidney transplant that took advantage of an experimental ex vivo organ perfusion technique may well raise hopes for no reason. At best, it will likely be years before the technique finds widespread clinical use — it is, after all, in the earliest of clinical trials. We do not know how long those clinical trials will take, or if the technique will even advance beyond a phase 1 clinical trial. We do not know if the technique may cause unforeseen problems even in the patient who has received this initial transplant. And there is no discussion of cost or potential risks — both of which are significant issues for patients.
Cost is not addressed. Does the technology used to keep the kidney viable in ex vivo organ perfusion increase costs? Is this something that would be passed on to patients?
The economics of improving the viability of kidneys for transplant is an important consideration that isn’t mentioned, either. The estimated first-year cost of a kidney transplant is in the $270,000 range and that of renal dialysis about $70,000 annually, so despite its costs, transplantation is economically as well as clinically preferred over the long run. The techniques described likely will add costs over cold storage but knowing how much would have been an important aspect of the story.
The release compares the health of a kidney preserved via ex vivo organ perfusion favorably to the health of a kidney preserved using cold storage preservation, going so far as to say that a kidney preserved using the new technology is “improved.” But the release offers no numbers to support such a claim, and then gives anecdotal comments from the single study participant to have undergone the new procedure–“I feel great”–and from the surgeon: “It’s a champion!” One of the goals of the ongoing study is the outcome of the transplant at just 30 days.
Kidney transplantation poses a number of risks, from infection to rejection of the donor organ to the kidney failing to work normally. The release refers to the phenomenon known as “sleepy kidney,” in which a newly transplanted organ takes some time before it begins functioning. However, it doesn’t address other health risks in a meaningful way, not does it offer any insight into how the new technique may affect those risks. Could ex vivo organ perfusion reduce those risks? Increase those risks? We’re not told.
The release notes that the transplant was done as “part of a Phase I clinical trial…assessing the safety of the device, with subsequent phases examining its efficacy.” It doesn’t make clear that this work has not been published in a peer-reviewed journal, or even presented at a conference. At this point, while it may be a promising anecdote from one patient, it is still only an anecdote.
It’s not disclosed that Dr. Markus Selzner has an existing relationship with Veritas Therapeutics (an offshoot of the University Health Network Toronto Transplant Institute) and is one of the inventors of an assigned patent.
Here’s how the release handles the issue: “This technology has advantages over the usual cold storage method in which a deceased donor kidney is cooled on ice to about four degrees Celsius, with no oxygen, slowing down its metabolism, and inhibiting the repair process. The kidney cannot survive longer than 30 hours in cold preservation. The new warm preservation technique avoids the damage of cold storage and instead allows the donor organ to improve and repair itself, potentially leading to better outcomes for patients.”
This is a direct comparison, which is good, but raises some questions. For example, how long can a kidney survive using the new technique? More than 30 hours? There’s a reference to “the damage of cold storage,” but it doesn’t tell readers what that damage is — or what it means when they say a kidney can “improve and repair itself.”
As noted above, the release does tell readers that this work was done as part of a phase 1 clinical trial, so we’ll rate this Satisfactory. However, many — if not most — readers are not familiar with clinical trials, and we think the release would have been stronger had it translated that.
The release refers to this as the first time such a transplant has been done “in North America.” Which begs the question: Has it previously been done elsewhere? As it happens, the first trial of a similar approach was published in 2013 in the UK.
The release didn’t contain unjustifiable language.
The news release focuses on a successful kidney transplant in which the donor organ was kept viable using a technique known as “ex vivo organ perfusion.”
The release provides a lot of information on what the surgery entails, and why. However, the release left out some key details. Are there risks associated with this technique? What sort of expenses are involved for patients? What sort of questions and concerns are still outstanding?
The release does tell readers that the transplant was done as part of a phase 1 clinical trial — and that future trials will address whether the technique is effective. Which raises the question: Why are they issuing a news release now?
According to the National Kidney Foundation, there are tens of thousands of people on the waiting list for a kidney donation — with thousands more being added to the list each month. That means there a lot of people, and their loved ones, who are anxious for good news regarding kidney donation.
Trumpeting one successful kidney transplant that took advantage of an experimental ex vivo organ perfusion technique may well raise hopes for no reason. At best, it will likely be years before the technique finds widespread clinical use — it is, after all, in the earliest of clinical trials. We do not know how long those clinical trials will take, or if the technique will even advance beyond a phase 1 clinical trial. We do not know if the technique may cause unforeseen problems even in the patient who has received this initial transplant. And there is no discussion of cost or potential risks — both of which are significant issues for patients.
Cost is not addressed. Does the technology used to keep the kidney viable in ex vivo organ perfusion increase costs? Is this something that would be passed on to patients?
The economics of improving the viability of kidneys for transplant is an important consideration that isn’t mentioned, either. The estimated first-year cost of a kidney transplant is in the $270,000 range and that of renal dialysis about $70,000 annually, so despite its costs, transplantation is economically as well as clinically preferred over the long run. The techniques described likely will add costs over cold storage but knowing how much would have been an important aspect of the story.
The release compares the health of a kidney preserved via ex vivo organ perfusion favorably to the health of a kidney preserved using cold storage preservation, going so far as to say that a kidney preserved using the new technology is “improved.” But the release offers no numbers to support such a claim, and then gives anecdotal comments from the single study participant to have undergone the new procedure–“I feel great”–and from the surgeon: “It’s a champion!” One of the goals of the ongoing study is the outcome of the transplant at just 90 days.
Kidney transplantation poses a number of risks, from infection to rejection of the donor organ to the kidney failing to work normally. The release refers to the phenomenon known as “sleepy kidney,” in which a newly transplanted organ takes some time before it begins functioning. However, it doesn’t address other health risks in a meaningful way, not does it offer any insight into how the new technique may affect those risks. Could ex vivo organ perfusion reduce those risks? Increase those risks? We’re not told.
The release notes that the transplant was done as “part of a Phase I clinical trial…assessing the safety of the device, with subsequent phases examining its efficacy.” It doesn’t make clear that this work has not been published in a peer-reviewed journal, or even presented at a conference. At this point, while it may be a promising anecdote from one patient, it is still only an anecdote.
It’s not disclosed that Dr. Markus Selzner has an existing relationship with Veritas Therapeutics (an offshoot of the University Health Network Toronto Transplant Institute) and is one of the inventors of an assigned patent.
Here’s how the release handles the issue: “This technology has advantages over the usual cold storage method in which a deceased donor kidney is cooled on ice to about four degrees Celsius, with no oxygen, slowing down its metabolism, and inhibiting the repair process. The kidney cannot survive longer than 30 hours in cold preservation. The new warm preservation technique avoids the damage of cold storage and instead allows the donor organ to improve and repair itself, potentially leading to better outcomes for patients.”
This is a direct comparison, which is good, but raises some questions. For example, how long can a kidney survive using the new technique? More than 30 hours? There’s a reference to “the damage of cold storage,” but it doesn’t tell readers what that damage is — or what it means when they say a kidney can “improve and repair itself.”
As noted above, the release does tell readers that this work was done as part of a phase 1 clinical trial, so we’ll rate this Satisfactory. However, many — if not most — readers are not familiar with clinical trials, and we think the release would have been stronger had it translated that.
The release refers to this as the first time such a transplant has been done “in North America.” Which begs the question: Has it previously been done elsewhere? As it happens, the first trial of a similar approach was published in 2013 in the UK.
The release didn’t contain unjustifiable language.
Systematic, Criteria-Driven
For breakfast, @GarySchwitzer swallows 2 observational studies with an anti-irritant chaser. https://www.healthnewsreview.org/2020/06/for-breakfast-give-me-2-observational-studies-and-an-anti-irritant/#.XvtqMk8i5e8.twitter
Sitting & cancer...alcohol & improved cognition. Waking up to a double whammy of miscommunicated observational studies.
https://www.healthnewsreview.org/2020/06/for-breakfast-give-me-2-observational-studies-and-an-anti-irritant/
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