November 10, 2024

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A multicenter observational study to establish practice for circulatory death declaration for organ donation in South Korea

A multicenter observational study to establish practice for circulatory death declaration for organ donation in South Korea

To determine the suitability for organ transplantation after circulatory death, confirming that potential donors have received LST with no apparent medical benefits is necessary. This process involves securing the patient’s and family’s consent for organ donation, withdrawing life support, declaring circulatory death through a clearly defined protocol, and procuring organs for transplantation. For each step, ethical considerations must be carefully identified and addressed. Notably, in this study, we did not conduct an in-depth investigation of the ethical issues of the participants. However, the wishes of the patients and their families regarding organ transplantation were rather simply confirmed.

The primary objective of this study was to obtain basic epidemiological data from Korean ICUs about the proportion of patients with potential and suitable DCD status among those who died after LST withdrawal. Our study revealed that, of the 177 patients who died after LST discontinuation, 20 (11.3%) were designated as suitable DCD donors, which is in line with the findings of previous studies12,22. For example, data from the potential donor audit courtesy of the NHS Blood and Transplant Service demonstrated that, of 3,825 potential DCD cases from October 2009 to December 2010, 397 (10.4%) resulted in actual organ donation or were categorized as suitable for organ donation22. The dataset defines potential DCD donors, eligible or medically suitable DCD donors, and actual DCD donors according to the guidelines published by the World Health Organization27. In contrast to the study by Manara et al., our study was not a nationwide survey; however, it prospectively analyzed the data of patients who were declared dead and screened possible DCD donors in multicenter ICUs. According to the medical and legal criteria, all participants died after withholding or withdrawing LST. A single-center study in a French ICU reported that among 76 patients who were categorized as having foreseeable circulatory death under any form of life support, 32 (42.1%) theoretically met the medical criteria for organ donation12. Notably, Lesieur et al. overestimated this proportion, as they included patients on LST rather than those who died after LST withdrawal. This indicates that the results of the present study might have reflected the real epidemiological data more accurately.

The key to successful organ transplantation is the reduction of warm ischemia time. A French study classified 32 patients of a total of 79 patients as eligible donors; however, only 3 (3.9%) patients died within 2 h of discontinuing life support, a timeframe considered compatible with organ viability12. The present study identified 20 medically suitable DCD donors according to the established medical criteria. Among those, 14 patients died within 60 min of progression to asystole after discontinuing life support, whereas 2 died between 60 and 120 min after LST discontinuation. The remaining patients experienced asystole for approximately > 2 h after discontinuing LST, a timeframe incompatible with organ donation. These results suggested that a standardized definition of medically eligible DCD donors, a universal procedure for withholding/withdrawing LST, and clear standard criteria for circulatory death are essential for reducing ischemic time in viable organs.

In contrast to the results of previous studies, the causes of death were notably different in the current study. For example, the proportion of patients with hypoxic brain damage (14.3%) was lower in our study than that reported by Lesieur et al. (post-cardiac arrest brain injury, 56%)12 and Manara et al. (hypoxic brain damage, 25%)22. These differences might be attributed to variations in disease prevalence, medical practices, social culture, and ethical and legal frameworks for withdrawing LST.

In this study, we also aimed to investigate the prevailing practices and criteria for death declaration in Korean ICUs. Notably, the majority of respondents declared the death of patients upon observing a flat ECG signal. Based on previous studies, several European countries also use the flat ECG signal as a parameter for declaring DCD, with some countries additionally requiring invasive arterial blood pressure measurement or echocardiography for death declaration. In particular, the code of practice in the United Kingdom suggests that circulatory death should be declared only after identifying the absence of a palpable pulse and audible heart sounds, which can be supplemented by the presence of a flat ECG signal, the absence of a pulse wave on invasive arterial blood pressure monitoring, or the absence of cardiac contraction as seen on echocardiography28.

Most physicians (87.5%) who participated in this survey reported declaring cardiac death immediately or within 5 min of a flat ECG signal. In addition, only 59.2% of the respondents agreed that a “5-minute no-touch” period was sufficient for declaring circulatory death. Nevertheless, among the physicians who disagreed with the “5-min no-touch” (66.1%), many believed that a 5-min duration was excessive. Meanwhile, 86.2% of the physicians believed that cardiac death could be declared in ≤ 5 min. Notably, among 18 European countries, 13 recognize the “5-min no-touch” period as either a national guideline or an expert opinion23.

In Europe, where DCD is widely accepted, several countries have established legally binding national legislation or non-legally binding national guidelines23. In this survey, 72.4% of the respondents agreed that legislation to define circulatory death and DCD was necessary.

To the best of our knowledge, this is the first multicenter prospective study that assessed DCD in South Korea and provided fundamental epidemiological evidence in this context. A total of 11 medical centers, where organ transplantation surgeries are performed, participated in this study. In particular, adult patients who fulfilled the Modified Maastricht Classification category III and were deemed medically futile by healthcare professionals were considered. Moreover, the study adhered to the general and precise medical eligibility criteria for organ transplantation, thereby ensuring accurate classification of the DCD donors.

Our study also has some limitations. As this was a multicenter study, the declaration of death was not consistently made by a single physician, particularly during nighttime hours. Moreover, not all deaths in the ICUs were examined. We could not enlist and monitor every single patient who were deceased after LST withdrawal in the ICU, since every candidate were not immediately notified by researchers. We could only access to the medical records of 180 deceased individuals who are classified as Category III of Maastricht Classification of Donation after Circulatory Death. Therefore, the number of patients who died after LST withdrawal or those eligible for DCD might be higher.

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