EXPERIMENTAL AND CLINICAL TRANSPLANTATION

Objectives: Donor pathways (donation after neuro-logical death, ie, brain death; and donation after circulatory death) are influenced, within each country, by several factors such as social trends and disease prevalence, which profoundly affect the mechanism and age of deaths in a population. An informed perspective on this process requires a rigorous analysis of donor efficiency (number of organs retrieved and transplanted, utilization rate, and organs per donor) and procurement policies.
Materials and Methods: We assessed the procurement activity regarding deceased donors in the Tuscany region from the period 2022-2025. We focused on trends in donation after brain death and donation after circulatory death (both controlled and uncontrolled donation after circulatory death), and on deceased donor pathway efficiency as assessed by utilization rate and organs per donor.
Results: In the Tuscany region, 1517 donors were assessed from the period 2022-2025. Most were donations after brain death (1260/1517, 83%), and the remaining 257 (17%) were donations after circulatory death (162 uncontrolled, 63%; and 95 controlled, 37%). The number of uncontrolled donations after circulatory death remained stable, whereas the number of controlled donations after circulatory death showed progressive growth. Utilization rate remained stable in donations after brain death and controlled donations after circulatory death, whereas the rate progressively increased in uncontrolled donations after circulatory death (from 56% in 2022, to 73% in 2025). During the study period, 1367 transplants were performed, and donations after brain death were the main source for transplants.
Conclusions: Among 1517 deceased donors, the high performance of the donation after brain death pathway, particularly regarding transplant volume and transplant type, underscores the critical need for the systematic identification and optimal management of all potential donations after brain death within the territory.

Key words : Brain death donors, Donation after circulatory death, Organs per donor, Organ transplantation, Utilization rate

Organ donation and transplantation systems are known to be complex aspects of the health care field and are sensitive to several factors ranging from population epidemiology variables to local organi-zational issues. Organ donation and transplantation systems require detailed organization, management, and oversight, due to the persistent shortage of organs for transplant.¹
Organ donation rate, mainly indicated by donors per million population, is addressed as the main goal for each country to achieve self-sufficiency with regard to the demand for transplants. The World Health Organization continues to urge countries to prioritize deceased donation and maximize its therapeutic potential, including the implementation of programs for donation after circulatory death (DCD), as recommended by the 2023 Santander Summit.² Recent years have shown a progressive increase in DCD donors (mainly controlled DCD [ie, cDCD], but also uncontrolled DCD [ie, uDCD]) due to normothermic regional perfusion (NRP) and organ ex vivo perfusion techniques.³
Donor pathways (donation after neurological death, ie, brain death [DBD]; and both cDCD and uDCD) are influenced, within each country, by several factors such as social trends and disease prevalence, which profoundly affect the mechanism and age of deaths in a population.⁴
As the rate of DCD continues to increase, stake-holders should prepare for a crossover event, that is, when DCD recoveries exceed DBD recoveries. This evolution requires a rigorous analysis of donor effi-ciency (number of organs retrieved and transplanted, utilization rate, and organs per donor) and procu-rement policies. Proactive management of this shift is essential due to implications in allocation policies and outcomes.⁵
The Tuscany region has a comparatively high annual rate of organ donation (about 100 donors per million population).⁶ This is the highest proportion of organ donation in Italy and in most European countries. Three deceased donor pathways (DBD, uDCD, and cDCD) are active in our region, with the uDCD program implemented since 2016. According to Italian law, death certification with circulatory criteria requires a 20-minute no-touch period. This time frame is one of the longest in Europe, and as such it may exacerbate the ischemia-reperfusion injury in DCD donors and may potentially degrade organ suitability for transplant.
In the present investigation, we assessed the pro-curement activity of deceased donors in the Tuscany region from the period 2022-2025. We focused on trends in DBD and DCD activities (both cDCD and uDCD) and on deceased donor pathway efficiency as assessed by utilization rate and organs per donor.

Materials and Methods

We evaluated deceased donors consecutively asses-sed by the Tuscany Regional Transplant Center from January 1, 2022, through December 31, 2025 (Ethics Committee approval, AOUC nP/903/217/2012).
Donor data and allocation of organs in the regional area were prospectively recorded in the eGIT database, which is a prospective, dedicated regional registry and clinical data management platform of the Regional Transplant Authority.

Donation after brain death
In DBD donors, the diagnosis of death was confir-med by strict adherence to standardized clinical, neurological, and electroencephalogram criteria in accordance with the Italian law and related guidelines. According to the Italian law, death by neurological criteria (ie, brain death) can be certified after a 6-hour observation period. All potential DBD donors were treated and monitored as previously described.^7,8
In 2019, the Tuscany Transplant Authority imple-mented the use of a monitoring schedule for which systolic and diastolic blood pressure, heart rate, central venous pressure, and diuresis were reported by the transplant coordinator during the 6-hour observation period. Hemodynamic instability is defined as (1) the need for an incremental dose of vasoactive agents after adequate volume replacement and (2) the need for vasopressin in addition to norepinephrine. In the presence of hemodynamic instability, organ retrieval is scheduled within 2 to 4 hours after the end of the 6-hour observation period.^7,8

Uncontrolled donation after circulatory death
The uDCD program,^9,10 which has been active in our region since 2016, may occur in 2 different models, according to logistic and/or clinic factors. The uDCD only lung program can be performed in hospitals not equipped with an extracorporeal membrane oxygenation (ECMO) team or in presence of acute aortic dissection.

Uncontrolled donation after circulatory death program: bicompartmental model
The bicompartmental model of the uDCD program, described previously,^9,10 can be applied in hospitals equipped with a local ECMO team, available 24 hours a day, 7 days a week. The Emergency Medical System alerts the physician in charge at the emergency department in all cases of witnessed cardiac arrest with the perspective of the therapeutic fast track or donation path. A certified ECMO team (including an intensivist, a cardiac surgeon, a cardiologist, and a perfusionist) is immediately activated as well as contextually the procurement and transplant coordinator. In the emergency department, in cases of irreversible circulatory death certification, the local procurement coordination is involved, and, if all the inclusion criteria are fulfilled, then the patient is recognized as a potential donor.

Controlled donation after circulatory death program
In the Tuscany region, the cDCD program was implemented in 2018. In 2021, the Regional Transplant Authority launched a cDCD NRP mobile program to facilitate a feasible cDCD pathway even in peripheral hospitals. The availability of NRP mobile teams has been crucial for the implementation of cDCD programs even in peripheral hospitals not equipped with a local ECMO team.^11,12 The protocol for the cDCD pathway has been previously described.^11,12
The performance of each deceased donor path-way was assessed¹³ by means of the following factors: (1) the utilization rate, calculated as the percentage of donors who were converted into utilized donors; (2) organs per donor, calculated as the number of organs recovered for the purpose of solid-organ transplants from donors within the country versus the total number of donors; and (3) the number and type of organ transplants.

Statistical analyses
We used SPSS statistical software (version 20) to analyze data. P < .05 was considered statistically significant. We reported categorical variables as frequencies and percentages and used chi-square tests to compare categorical variables.

In the Tuscany region, 1517 donors were assessed by the Tuscany Regional Transplant Center, from the period 2022-2025 (Table 2). Most cases were DBD (1260/1517, 83%), and the remaining 257 cases (17%) were DCD (162 uDCD, 63%; and 95 cDCD, 37%). The number of uDCD remained stable, whereas the number of cDCD showed progressive growth.

Deceased donor pathway performance
The performance of each donor pathway was assessed by utilization rate, organs per donor, and the number of transplants (Table 1). The utilization rate remained stable in DBD and cDCD, whereas it progressively increased in uDCD (from 56% in 2022 to 73% in 2025). The mean value for organs per donor was 2.22 for DBD, 2.22 for cDCD, and 2.05 for uDCD.
The percentage of transplants from DCD progres-sively increased during the study period (from 11.7% in 2022 to 18.8% in 2025). Table 2 and Table 3 show the number of organs retrieved and transplanted from each type of donor throughout the study period. In 2025, a decrease in lung transplants and kidney transplants from DBD donors was observed, alongside a progressive increase in lung transplants from uDCD donors.
During the study period (Table 4), 1367 transplants were performed. Among these, there were 76 heart transplants, 100 lung transplants, 651 liver transplants, 529 kidney transplants, and 11 pancreas transplants. Among overall transplants, uDCD donors contributed 17 lung transplants (17/100, 17%), 10 liver transplants (10/651, 1.5%), and 18 kidney transplants (18/529, 3.4%), whereas cDCD donors contributed 3 heart transplants (3/76, 4%), 2 lung transplants (2/100, 2%), 58 liver transplants (58/651, 8.9%), and 47 kidney transplants (47/529, 8.8%).
As shown in Table 4, DBD donors remained the main source for liver transplants (583/651, 89.6%), lung transplants (81/100, 81%), heart transplants (73/76, 96%), kidney transplants (464/529, 87.8%), and pancreas transplants (11/11, 100%).

This investigation encompassed 1517 deceased donors from the period 2022-2025 and yielded the following findings: (1) a progressive increase in cDCD donors was observed, whereas uDCD donors remained stable; (2) utilization rate increased in DCD donors (both cDCD and uDCD); and (3) DBD donors remained the main source for transplants.
The present investigation examined, for the first time, the landscape of the 3 deceased donor pathways during a 4-year period. Specifically, we evaluated donor volume and clinical performance, as measured by utilization rates, organs per donor, and the total number and types of transplants performed.
Studies specifically addressing trends in DBD and DCD donors are scarce. Lomero and colleagues¹³ have described DCD activity for the period 2008-2016 in different European countries. During that period, 9702 DCD donors were reported, mainly cDCD (69%). The uDCD activity was quantitatively promi-nent in France, Russia, and Spain. The highest DCD activity was reported in the United Kingdom, followed by Spain, Russia, the Netherlands, Belgium, and France. At the time of the study by Lomero and colleagues,¹³ the Netherlands had the higher DCD activity among deceased donors (49%). There has been a progressive increase in DCD activity from 2008 to 2016, especially in Belgium, France, Spain, and the United Kingdom. Parallel with this increase in DCD activity, DBD activity remained stable.
According to the Global Observatory on Donation and Transplantation,¹⁴ uDCD accounted for 1.3% of all DCD activity in 2023 (150 donors), which is slightly higher than in 2022 (1%, 106 donors). Controlled DCD represented 93% (10 592 donors). In Italy, data from the National Transplant Center for 2023 showed that uDCD activity (limited to the lung program) accounted for 11% of all DCD, increasing to 19% in 2024.6,¹⁵
Bashian and colleagues⁵ analyzed national donor trends using Scientific Registry of Transplant Reci-pients Explorer data for the period 2015-2025. Donor type (DCD vs DBD) was evaluated across organ types and organ procurement organizations. During the first half of 2025 (n = 181 days), the DCD rolling donor count demonstrated a significant increase per unit time, with an average rise of 2.69 organs per day (P < .001). In contrast, in the same time frame, DBD organs declined significantly. The authors reported that DCD growth was 3-fold higher than DBD growth during the past decade. The evaluation of changes by organ type (heart, lung, liver, and kidney) with linear regression analysis documented a significant increase in DCD utilization for all 4 organs. In contrast, all organ types exhibited a significant decrease in DBD utilization per unit time.
These investigations, performed in different countries, align with our findings in emphasizing the necessity to monitor trends in deceased donor types at the regional and/or national level by organ dona-tion and transplantation systems. Due to significant organizational and legal disparities, results from any specific jurisdiction are rarely generalizable to another jurisdiction. Furthermore, clinical variables, particularly donor age and cause of death, as well as the utilization of machine perfusion and NRP, vary considerably across international systems.
In Italy, a 20-minute no-touch period is required for death certification with cardiac criteria. Therefore, NRP is mandatory for DCD donors as well as the use of ex vivo machine perfusion. Despite the long period of warm ischemia time (WIT) associated with cDCD, a cDCD heart transplant program was started in Italy in May 2023. According to preliminary results, DCD heart transplants can be successful despite a long duration of WIT.¹⁴
Each deceased donor pathway (DBD vs cDCD vs uDCD) has demonstrated different performance metrics. These metrics were assessed through utiliza-tion rates, the number of organs recovered per donor, and the specific volume and types of resulting transplants. Because DCD pathways generally yield fewer transplantable organs than the DBD pathway, some critics argue that the expansion of DCD programs could conceivably detract from DBD numbers.^16,17
The magnitude of this phenomenon varies signifi-cantly among regions due to differing legal and organizational frameworks. This regional variability underscores the need for transplant authorities to rigorously monitor trends and performance metrics for both DBD and DCD pathways within their respective territories.
In our investigation, performed in a large popu-lation of deceased donors in Tuscany from the period 2022-2025, we observed a progressive increase in the cDCD pathway, also due to the implementation of this program in peripheral hospitals facilitated by NRP mobile teams. The stability of uDCD volume throug-hout the study period may be the result of an established regional network of support for out-of-hospital cardiac arrest,^12,18 according to which the uDCD pathway may be implemented in patients with refractory cardiac arrest for whom no ther-apeutic options have been identified by the treatment team.¹⁹ An increase in utilization rate of the uDCD pathway was observed, which may be attributed to stricter donor inclusion criteria, accuracy of donor-recipient matches, and the acquisition of more in-depth knowledge in NRP management^12,20 and use of ex vivo machine perfusion.²¹
Despite the increase in DCD transplants during the study period, the DBD pathway remained the main source of transplants, not only regarding the volume of transplants but also the type of transplants. All pancreas transplants and most heart transplants were performed only via the DBD pathway. This is primarily due to the prolonged WIT associated with cDCD in Italy, resulting from the legal requirement of a 20-minute no-touch period for cardiac death certification.
Our results confirmed the importance for transplant authorities to strictly monitor trends and performance metrics for both DBD and DCD pathways within their respective territories. Our findings strongly advocate for maximizing the utilization rate across all 3 donor pathways and expanding DCD activity throughout all hospital centers. Furthermore, the high performance of the DBD pathway, particularly regarding transplant volume and type of transplanted organ, underscores the critical need for the systematic identification and optimal management of all potential DBD donors within the territory.

Limitations
Although the present investigation may be limited by its single-region focus in Italy, the substantial cohort size and the active implementation of the 3 deceased donor pathways (DBD, cDCD, and uDCD) may provide clinical significance to the findings.

Given the well-known and inherent difficulty in generalized procurement activity across different legal and organizational frameworks, our results underscore the need for each transplant authority to achieve and maintain continuous monitoring.

Volume: 24 Issue: 7 July 2026

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