Perspectives on donor-derived infections from Germany.

Area of Science:

• Transplantation Medicine
• Infectious Diseases
• Public Health Surveillance

Background:

• Organ transplantation is vital for patients with terminal organ failure, offering improved life expectancy and quality of life.
• Despite advancements in donor and organ assessment, a persistent risk of disease transmission from donor to recipient remains.
• Donor-derived diseases necessitate robust vigilance and surveillance systems for effective management and reporting.

Purpose of the Study:

• To analyze and report suspected and proven/probable donor-derived infections (DDIs) in Germany.
• To assess the incidence and impact of DDIs over an 8-year period (2016-2023).
• To evaluate the role of vigilance and surveillance in recipient safety.

Main Methods:

• Evaluation of serious adverse event and serious adverse reaction (SAE/SAR) reports from 2016 to 2023 for suspected DDIs.
• Imputability analysis based on the US Disease Transmission Advisory Committee (DTAC) definitions.
• Inclusion of only probable and proven cases as defined by DTAC classification for DDI analysis.

Main Results:

• Over 9,771 donors and 27,919 recipients were included; 612 SAE/SAR cases were reported, with 377 (62%) involving infections.
• Forty-one cases were classified as proven/probable DDIs, affecting 58 recipients, resulting in seven deaths (12%) and organ loss in some.
• Bacterial DDIs (48%) did not lead to recipient death but caused organ loss; fungal (36%) and viral (15%) DDIs were associated with higher mortality rates.

Conclusions:

• Donor-derived infections (DDIs) are infrequent in solid organ transplantation (0.21%) but are linked to substantial recipient morbidity and mortality.
• Effective donor evaluation and a reliable vigilance and surveillance system are essential for enhancing recipient safety.
• The findings underscore the importance of continuous monitoring and reporting for managing infectious risks in organ transplantation.