Prefer transplant nephrologist/surgeon for this particular case.
Transplant: 58yo female history of ESRD secondary to Wills tumor s/p right nephrectomy, whom underwent a left living donor kidney transplant into the RLQ with ureteral stent placement on 10/31/2024 at a Tampa, FL hospital.
Hospital notes: “Donor is patient's friend. The donor is 206 pounds and 5 feet 9 inches tall. This is a CMV D-/R- and EBV D+/R+ graft. HLA 1A/2B/0DR Ag mismatch in a recipient with a PRA 0% in both classes. Induced with Campath 20 mg. EPLET Mismatch: Low Eplet Mismatch. Total cold ischemic time: 1 hour 47 minutes Revasc Time: 31 minutes”
However, you will see attached the donor was actually CMV+ in August 2024. It is unknown as to why there was a difference in documentation on transplant admission.
This was not communicated before, during or after the transplant to the IP. Based on her initial D-/R- classification, she was placed on low-risk prophylaxis protocol. Valganciclovir (“Valcyte”) initiated per D-/R- protocol. Her CMV prophylaxis was labeled LOW risk, and she was on acyclovir with a stop date of 1/31/25
Development of CMV: On 1/25/25, she was diagnosed with: CMV viremia. (+441,552), so was still taking Valcyte at this time. Is still undergoing treatments, attached shows her CMV levels from the last 6+ months
Standard of Care questions (If Donor Was Truly CMV+):
If the donor was CMV positive and recipient negative (D+/R- mismatch), our research shows this is the highest risk scenario for CMV disease and standard of care requires: Prolonged valganciclovir prophylaxis (6–12 months, not weeks), regular CMV PCR monitoring (weekly–biweekly during prophylaxis, then monthly after) and consideration of CMV-IVIG in select cases.
Instead, she was treated as low risk (D-/R-), given only acyclovir and then a short burst of valganciclovir once viremia was detected.
Deviation questions: serostatus misclassification. We believe the donor CMV status may have been incorrectly documented as negative. This error cascaded into incorrect prophylaxis planning. Also, possible lack of timely monitoring: No evidence of frequent CMV PCR surveillance between November 2024 and January 2025. With correct classification, she should have had ongoing monitoring.
We have questions about the prognostic impact:
D-/R- (true negative): Late CMV is usually community or transfusion-acquired. Prognosis remains relatively favorable?
D+/R- misclassified as D-/R-, CMV is predictable and preventable with extended prophylaxis or different treatment if was properly aware of mismatch at the time of transplant?
Is there a higher rate of graft rejection and dysfunction? Our research shows 5–10% lower graft survival at 3 years, 10–15% lower at 5 years, 3–10% higher mortality risk at 5 years compared to correctly managed patients.
We understand CMV is not 100% preventable regardless of donor/recipient testing, but the bottom line: would the treatment/prophylactic plan been different and had the likelihood of a more favorable outcome/prevention the CMV infection?
Additionally, how does this truly change her prognosis going forward? Whether if the CMV infection was truly from the donor or from a new infection post-transplant, does her prognosis change in any meaningful way?
Thank you in advance, please see attached info. Questions welcome.
Files:
Q: How is the patient doing today?
A: Under a medication regime, fluctuating CMV levels, but overall is well.
Do you believe there might have been medical error?
A donor does not revert from CMV-positive to CMV-negative. If serology was positive in August, the donor would still be positive at the time of transplant in October. If more recent testing exists, it should be available in the record. In the event of conflicting test results, the standard approach would be to repeat serology and obtain an infectious disease consult for clarification.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The program should have a documented protocol/policy for the prophylaxis of CMV. In this case, the likely incorrect documentation led to breech of protocol and poor care. There is no precedent for treating a D+/R- with acyclovir and not monitoring. It is unfortunate, but I have seen it in another case. Moreover, your research is correct. There are downstream negative effects of CMV viremia. The challenge remains in proving causation. Kidney transplantation and immunosuppression is quite complex and the recipients have multiple co-morbidities. While it is accepted that CMV infection is a risk factor for rejection and graft dysfunction, it is rarely listed as the immediate cause unless it happens during the infection or immediately after. In most cases, CMV serves as an amplifying contributor within a multifactorial landscape rather than a single causative agent. With the update of persistent viremia- it is concerning that it has not been cleared.
What makes you a good expert for this case?
20+ years as an adult and pediatric transplant surgeon. Professor, Chief and Surgical director. Leadership positions in several societies. Have reviewed 10+ transplant cases. Reviewed a CMV mislabeling case which led to a patient death.
How often do you encounter cases similar to this one in your practice?
I treat and prescribe prophylaxis regularly and fortunately I have yet to encounter this error in clinical practice. We have implemented strict protocols in listing patients including requiring 2 coordinators to list the patient. I have previously reviewed such a case.
Do you believe there might have been medical error?
I would need more details, however, CMV status can change. Given that though and given they used Campath this patient would be considered intermediate risk at lease. This will in part depend on Florida's definition of medical error and their protocol.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
This is possible given it appears they did not use the optimized valcyte dose and time of use. Need more details again here.
What makes you a good expert for this case?
I have 27 years experience dealing with this issue. I have a PhD in immunology. I have published and been the PI for a number of CMV trials.
How often do you encounter cases similar to this one in your practice?
Daily we encounter this decision tree and management.
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