Status:
Ready to upload
Record number:
2309
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
This retrospective study reports the incidence of significant adverse events (SAE, i.e., risk of harm) and significant adverse reactions (SAR, i.e., actual harm to a patient or living donor) from the Spanish Catalonia Biovigilance System for both tissue transplantation (2008-2020; 34,306 donors and 149,981 tissues distributed) and organ transplantation (2016-2020; 2,287 donors and 5,569 transplants). The study covers both malignant and non-malignant (e.g., infectious, procedural, etc.) events. Overall SAEs for tissues and organs were 3.44‰ and 31.48‰, and overall SARs for tissues and organs were 0.22‰ and 8.8‰.
In the case of malignancy and tissue donation: 15 of 118 total SAEs were related to donor malignancy (12 prostate, 1 each: metastatic tumor, hepatocellular carcinoma, non-assessed lung nodule). There were no cases of malignancy transmission among 24 corneal transplants. Other tissues were discarded. There was no organ transmission to 28 organ recipients under malignancy risk from 15 SAE: 1Lung, 9Liver, 18 Kidney recipients from these donors did not have malignancy transmission (after at least two years follow).Malignancy accounted for 0 of 35 confirmed SARs in the tissue transplant group.
In the case of malignancy and organ donation: 30 of 72 total SAEs were related to donor malignancy (10 prostate, 4 renal cell carcinomas, 2 papillary renal carcinomas, 1 cystic renal tumor, 2 prostate intraepithelial neoplasia, 2 pancreatic neuroendocrine tumors, 2 hepatocellular carcinomas, 1 each: breast cancer, colon adenocarcinoma, small bowel adenocarcinoma, gastrointestinal stromal tumor, severe esophageal dysplasia, Hodgkin lymphoma, thyroid carcinoma).There was no organ transmission to 73 organ recipients under the same malignancy risk (the 30 SAE): 13 Lung, 13 liver, 1 liver-kidney, 44 kidney, 1 heart and 1 pancreas-kidneys from these donors did not have malignancy transmission ((after at least two years follow)
11 of 49 confirmed confirmed SARs were related to donor malignancy. In this group 9 donors transmitted tumors to 11 recipients. Donor malignancies transmitted: 2 diffuse B cell lymphomas, 3 gastrointestinal, 1 renal cell carcinoma, 1 cholangiocarcinoma, 1 lung cancer, 1 sarcomas. Recipient's:2 diffuse B cell lymphomas, 4 gastrointestinal, 1 renal cell carcinoma, 1 cholangiocarcinoma, 1 lung cancer, 2 sarcomas.
Time to detection:
Detection time varied among the different forms of cancer transmissions:
46-90 days for tumors of kidney and urinary tract, and blood and lymphoid tissues
1 year for tumor of lung and lower respiratory system
2 years for gastrointestinal tumors
4 years for cholangiocarcinoma (interpreted by authors as donor-derived)
Alerting signals, symptoms, evidence of occurrence:
Specific signs and symptoms of individual patients are not included in this Registry report. It is noted that donor malignancy identified by pathologic exam, including autopsy, was the most frequent reporting criterion.
Demonstration of imputability or root cause:
The authors determined imputability of transmission using the criteria of the Eustite project for tissues and the Disease Transmission Advisory Committee (DTAC) for organs. Cases determined to be certain, probable or possible for transmission are included.
Imputability grade:
3 Definite/Certain/Proven
Groups audience:
Keywords:
Suggest new keywords:
Registry Series
Deceased donor
Living donor
Kidney transplant
Liver transplant
Heart transplant
Lung transplant
Musculoskeletal tissue transplant
Carcinoma of unknown primary site
Lymphoma, B-cell, diffuse large type
Hodgkin lymphoma
Breast cancer, other or type not specified
Gastrointestinal stromal tumor (GIST)
Small bowel adenocarcinoma
Large bowel adenocarcinoma
Gastrointestinal cancer, other or type not specified
Renal cell carcinoma
Cholangiocarcinoma
Hepatocellular carcinoma
Lung cancer, type not specified
Neuroendocrine tumor
Islet cell tumor
Prostate adenocarcinoma
Sarcoma, other or type not specified
Thyroid cancer, other or type not specified
Therapy not discussed
Reference attachment:
Suggest references:
Navarro, A., Len, O., Muñiz-Diaz, E., Vives Corrons, J.-L., Dominguez-Gil, B., Vilarrodona, A., & Tort, J. (2024). The value of organ and tissue biovigilance: a cross-sectional analysis. Frontiers in Transplantation, 3. https://doi.org/10.3389/frtra.2024.1307946
Note:
Uploaded and first review MN 3/18/24. I have made secon review June 30th_AN
Expert comments for publication:
This comprehensive study details the risks (both malignancy-associated and others) involved in organ and tissue donation programs, and discusses resultant actions taken to mitigate those risks. The authors estimate that about 28% of SAEs in their region are preventable, mainly by correction of either equipment, human, or system errors. In the specific case of neoplasia, the creation of an urgent alert from the Pathology Department to the Biovigilance System in appropriate cases is mentioned. Overall, 109 actions were implemented to minimize risk during the course of this study (e.g., changes in blood testing requirements, T. pallidum results, HLA algorithms, etc., detailed in the paper).
The frequency of risk (SAE) was found to be higher than the frequency of harmful events (SAR), similar to some other regions. However, the causes of the risks differ from other reports. This suggests that individual transplant regions study their own data in a similar fashion to stratify their own unique risk factors.
The authors also detail the degree of potential impact for SAEs and actual impact for SARs in this study, which provides an important context to prioritizing improvements that will have the greatest significance.
This paper serves as a good model for analysis of potential and actual risks involved in tissue and organ transplantation.