Donor Management Protocols Research Articles

The feasibility of organ procurement at a hospital-independent facility: A working model of efficiency

The feasibility of organ procurement at a hospital-independent facility: A working model of efficiency

The Effect of a Protocol of Aggressive Donor Management: Implications for the National Organ Donor Shortage

The disparity between the number of people awaiting organ transplantation and the number of organs available has become a public health crisis. As many as 25% of potential donors are lost as a result of cardiovascular collapse (CVC) before organ harvest. A policy of aggressive donor management (ADM) may decrease the number of cadaveric donors lost as a result of CVC. Retrospective analysis of potential brain-dead donors evaluated from January 1995 to December 2003 at nine American College of Surgeons-verified Level I trauma centers covered by a regional organ procurement agency. One center (Los Angeles County + University of Southern California Medical Center [LAC]) had an ADM protocol in place instituted January 1999; the remaining eight centers with no ADM protocol were grouped as Center A. The incidence of CVC and organ donation demographics were compared between centers and within LAC before (LAC-Pre) and after (LAC-Post) adoption of ADM. ADM consists of early identification of potential organ donors, a dedicated team that provides medical management, and aggressive fluid resuscitation as well as hormone replacement therapy with solumedrol and thyroxin. The incidence of CVC was significantly higher in LAC-Pre (odds ratio [OR] 15.0, p < 0.001) and Center A (OR 5.8, p < 0.001) compared with LAC-Post. The number of organs harvested per potential donor for LAC-Post (2.4) was significantly higher than LAC-Pre (2.0, p = 0.02) and Center A (2.1, p < 0.01). An aggressive donor management protocol decreases the number of donors lost as a result of cardiovascular collapse and increases the number of harvested organs per potential donor.

Impact of a Lung Transplantation Donor–Management Protocol on Lung Donation and Recipient Outcomes

One of the limitations associated with lung transplantation is the lack of available organs. To determine whether a lung donor-management protocol could increase the number of lungs for transplantation without affecting the survival rates of the recipients. We implemented the San Antonio Lung Transplant protocol for managing potential lung donors according to modifications of standard criteria for donor selection and strategies for donor management. We then compared information gathered during a 4-yr period, during which the protocol was used with information gathered during a 4-yr period before protocol implementation. Primary outcome measures were the procurement rate of lungs and the 30-d and 1-yr survival rates of recipients. We reviewed data from 711 potential lung donors. The mean rate of lung procurement was significantly higher (p < 0.0001) during the protocol period (25.5%) than during the pre-protocol period (11.5%), with an estimated risk ratio of 2.2 in favor of the protocol period. More patients received transplants during the protocol period (n = 121) than during the pre-protocol period (n = 53; p < 0.0001). Of 98 actual lung donors during the protocol period, 53 (54%) had initially been considered poor donors; these donors provided 64 (53%) of the 121 lung transplants. The type of donor was not associated with significant differences in recipients' 30-d and 1-yr survival rates or any clinical measures of adequate graft function. The protocol was associated with a significant increase in the number of lung donors and transplant procedures without compromising pulmonary function, length of stay, or survival of the recipients.

Complications of Brain Death: Frequency and Impact on Organ Retrieval

Brain death is associated with complex hemodynamic, endocrine, and metabolic dysfunction that can lead to major complications with the potential donor. Untreated, this can progress to cardiovascular collapse with loss of valuable organs for transplantation. We hypothesized that brain death-related complications would have no effect on the number of organs donated if an aggressive donor management protocol was in place. We identified all successful organ donations between January 2000 and December 2003 and evaluated them for brain death-associated complications (defined as vasopressor requirement, coagulopathy, diabetes insipidus, cardiac ischemia, lactic acidosis, renal failure, and acute respiratory distress syndrome) and donated organs per donor. Sixty-nine organ donors were identified. Complications identified were as follows: intravenous vasopressor requirement in 97.1 per cent, coagulopathy in 55.1 per cent, thrombocytopenia in 53.6 per cent, diabetes insipidus in 46.4 per cent, cardiac ischemia in 30.4 per cent, lactic acidosis in 24.6 per cent, renal failure in 20.3 per cent, and acute respiratory distress syndrome in 13 per cent. There was no significant effect of complications on the average number of organs harvested, with the exception of an increase in organs harvested in the presence of diabetes insipidus. With the implementation of an aggressive organ donor management protocol, these complications can be effectively managed with no impact on the number of organs harvested for transplant.

Does Heart Transplantation Confer Survival Benefit in All Risk Groups?

Over 50,000 heart transplants have been performed in the last 3 decades. The global shortage of donor organs and the relaxation of candidate selection criteria over time has resulted in recent controversy about the benefits of heart transplantation for some risk groups. We assessed the survival benefit acquired in the Papworth Hospital heart transplant population overall, taking into account resuscitated marginal donors and high-risk recipients. All heart transplant patients listed between 1979 and June 2002 were analyzed (n = 1,212). Of these, 931 cardiac transplantations were done, including the use of 126 marginal donors. High-risk recipients (n = 163) were defined as patients being in the hospital, on intravenous inotropic drugs, and/or with a high transpulmonary gradient (>15 mm Hg). Using Cox regression with transplantation as a time-dependent covariate, we assessed the survival benefit of transplantation. In our model we assumed that after transplantation the initial risk of death is high relative to continued waiting, followed by an exponential decline in risk. The crossover point (COP) is the time at which the risk of death after transplantation is equal to that of continued waiting (i.e., the relative risk is 1). The equity point (EP) determines the time at which the early post-operative risk is offset by the later period of lower risk and, therefore, the time at which transplantation has a survival advantage. Overall, the COP was at 54 days and EP at 141 days. In the marginal donor sub-group, COP was achieved at 32 days with EP at 72 days, indicating a survival benefit. The difference in the COP and EP between the borderline donor and normal donor sub-groups was not statistically significant. Post-transplant survival was not significantly different from recipients of normal cardiac allografts (p = .43). Likewise, for the high-risk recipient group, the COP and EP were at 72 and 203 days. Although post-op survival was significantly shorter than the normal-risk group, both groups achieved survival benefits. Heart transplantation provides survival benefit in these risk groups of recipients in our population. This is a reflection of our active donor management protocol and rigorous donor and recipient selection process.

Hormonal therapy stabilizes hemodynamics during donor procurement

Purpose: Abnormal hormone levels following brain death result in diffuse metabolic derangement that can lead to hemodynamic instability and deterioration of organ function. We investigated whether methylprednisolone (MP) or the combination of MP and thyroxine (T4) used in routine donor management improves hemodynamic stability.Methods: Procurement records of 133 consecutive donors with successful organ recovery were reviewed. Donors under age 10 (11), with incomplete records (1) and with excessive vasopressor requirements (2) were excluded.Standard donor management protocols were used. Vasopressin (VP) was used routinely, soley to control excessive urine output. A control group received no other hormonal therapy. A second group received MP alone.. A third group received a hormonal “cocktail” consisting of MP,T4,glucose and insulin followed by T4 infusion at the start of donor management. Doses of adrenergic agents are expressed as inotrope and vasoconstrictor units based on relative β1 and α1 receptor potency.Results: Groups were similar in baseline demographic measures including cause of death and time from brain death to procurement, as well as metabolic measures during procurement. From start of donor management to OR, doses of adrenergic agents declined in all groups (p<0.05). The decline was greater in both treatment groups compared to controls.There was no difference in number of organs procured.Conclusion: Routine use of hormonal therapy in donor management improves hemodynamic stability and reduces the use of potentially deleterious vasoactive drugs. The incremental value of MP vs MP/T4 requires further study.TableTableChange in Adrenergic Dose∗Control (n = 64)MP (n = 19)MP/T4 (n = 36)Inotrope UnitsStart1.97 ± 1.452.03 ± 1.751.86 ± 1.77OR1.34 ± 1.400.52 ± 0.550.62 ± 0.63∗∗Vasoconstrictor UnitsStart1.88 ± 2.641.69 ± 1.222.19 ± 3.72OR0.99 ± 1.720.07 ± 0.180.18 ± 0.42∗∗∗mean ± SD∗∗p < 0.05 vs control.

Increased Transplanted Organs from the Use of a Standardized Donor Management Protocol

The organ shortage has resulted in increasing recipient waiting lists and waiting-list deaths. The increased use of expanded donors has been associated with increased discarding of procured organs because of poor organ function. A structured donor management algorithm or critical pathway was tested to determine its effect on the donor management and procurement process. A pilot study examined donors from 88 critical care units in 10 organ procurement organizations managed under the critical pathway and compared them to retrospective data collected at those same pilot sites. The total number of organs both procured and transplanted per 100 donors was significantly greater (p <0.01) in the critical pathway group when compared to the control group. There was no significant difference in 1-year graft survival for any of the organs recovered, and no significant difference in the rate of delayed graft function in the kidneys transplanted. Use of a structured donor management algorithm results in significant increases in organs procured and organs transplanted without any reduction in the quality of the organs being transplanted.

Improved outcome with organs from carbon monoxide poisoned donors for intrathoracic transplantation

Background. The success of intrathoracic organ transplantation has lead to a growing imbalance between the demand and supply of donor organs. Accordingly, there has been an expansion in the use of organs from nonconventional donors such as those who died from carbon monoxide poisoning. We describe our experience with 7 patients who were transplanted using organs after fatal carbon monoxide poisoning. Methods. A retrospective study of the 1,312 intrathoracic organ transplants between January 1979 and February 2000 was completed. Seven of these transplants (0.5%) were fulfilled with organs retrieved from donors after fatal carbon monoxide poisoning. There were six heart transplants and one single lung transplant. The history of carbon monoxide inhalation was obtained in all of these donors. Results. Five of 6 patients with heart transplant are alive and well with survival ranging from 68 to 1,879 days (mean, 969 ± 823 days). One patient (a 29-year-old male) died 12 hours posttransplant caused by donor organ failure. The patient who had a right single lung transplant did well initially after the transplant, but died after 8 months caused by Pneumocystis carinii pneumonia. All those recipients who were transplanted from carbon monoxide poisoned donors and ventilated for more than 36 hours, survived for more than 30 days. Moreover, these donors were assessed and optimized by the Papworth donor management protocol. Conclusions. Carbon monoxide poisoned organs can be considered for intrathoracic transplantation. In view of the significant risk of donor organ failure, a cautious approach is still warranted. Ideally, the donor should be hemodynamically stable for at least 36 hours from the time of poisoning and on minimal support. A formal approach of invasive monitoring and active management further improves the chances of successful outcome.

Pediatric heart transplantation: Improving results in high-risk patients

Objectives: Our institutional experience with 73 pediatric patients undergoing cardiac transplantation between January 1, 1990, and December 31, 1999, was reviewed to determine the impact of unconventional donor and recipient management protocols implemented to extend the availability of this therapy. Methods and results: The introduction of donor blood cardioplegic solution with added insulin was associated with a significant improvement in patient and graft survival (hazard ratio [Cox] = 0.25, P =.08), despite significantly longer ischemic times with this protocol compared with the use of crystalloid-based donor procurement techniques (P <.01). Eleven patients underwent intentional transplantation of ABO-incompatible donor hearts with the aid of a protocol of plasma exchange on bypass. In this subgroup, there were 2 early deaths caused by nonspecific graft failure (n = 1) and respiratory complications with mild vascular rejection (n = 1), and there was 1 late death caused by lymphoma. ABO-incompatible transplantation was not a risk factor for death by multivariate analysis. The postoperative course in these patients suggests minimal reactivity directed against incompatible grafts on the basis of low anti-donor blood group antibody production, in association with a favorable rejection profile. Ten of 13 patients requiring preoperative support with an extracorporeal membrane oxygenator survived transplantation; there were 3 additional late deaths in this subgroup (hazard ratio = 2.88, P =.05). Conclusions: The results with pediatric cardiac transplantation continue to improve as a result of changes in both surgical and medical protocols permitting successful treatment of patients conventionally considered at high risk or unsuitable for transplantation. (J Thorac Cardiovasc Surg 2001;121:782-91)

Pediatric Heart Transplantation: Improving Results in High-Risk Patients

Our institutional experience with 68 pediatric patients undergoing cardiac transplantation was reviewed to determine the impact of unconventional donor and recipient management protocols implemented to extend the availability of this therapy. The introduction of donor blood insulin cardioplegia was associated with a significant improvement in patient and graft survival. Among 63 ABO-matched transplant procedures, both the patient and graft loss rate were significantly lower (by multivariable analysis) with the use of the donor blood insulin cardioplegia versus conventional cardioplegia, despite significantly longer ischemic times in the former group. Twenty-three (33.8%) patients were deemed at ultra-high risk: eight of 11 patients with cardiomyopathy transplanted following ECMO support survived without major sequelae; three of four additional patients survived early retransplantation. Ten patients underwent intentional ABO-incompatible transplantation under a protocol of plasma exchange on bypass. There were two early deaths because of nonspecific graft failure and respiratory complications with mild vascular rejection, and one late death because of lymphoma. Among seven surviving ABO-incompatible patients followed up to 31 months, there have been no episodes of humoral rejection despite development of antidonor blood group antibodies in A to O, but not B to O, mismatches. The results with pediatric cardiac transplantation continue to improve as a result of changes in both surgical and medical protocols permitting salvage of patients conventionally considered at high risk or nontransplantable.

THE EFFECT OF TRIIODOTHYRONINE REPLACEMENT THERAPY ON MAINTENANCE CHARACTERISTICS AND ORGAN AVAILABILITY IN HEMODYNAMICALLY UNSTABLE DONORS

104 Purpose: Elevated inotrope requirements are a limiting factor for extra-renal organ procurement from hemodynamically unstable brain dead donors. Triiodothyronine (T3) replacement has been suggested to reduce hemodynamic instability and inotropic dependency, although literature data remain conflicting. We retrospectively investigated the effect of T3 therapy on hemodynamic changes, need for inotropic support and ultimate organ yield. Methods: From 47 local donors referred from January 1995 to October 1998, 19 (group I) were considered eligible to receive T3 replacement therapy, according to our standard donor management protocol (inclusion criteria: persistently elevated dopamine/dobutamine (DOPB) (>5 μg/kg/min) and/or noradrenaline (NA) dependency, despite adequate fluid resuscitation (CVP>5 cm H2O) after brain death confirmation. Group I did not differ from the remaining 28 stable donors (group II) with regard to mean age, gender, cause of death, occurrence and duration of resuscitation, time from admission to death, and time from death to explantation. Results: Inotropic requirements at time of death were significantly different between group I & II (mean DOPB: 6.9±5.2 vs 3.3±3.2 μg/kg/min, P=.009; mean NA: .134±.19 vs .025±.048 μg/kg/min, P=.025), as did mean systolic blood pressure (BPsyst) (112±24 vs 126±19 mmHg, P=.031) and mean central venous pressure (CVP) (7.7±2.8 vs 5.5±3.7, P=.035). Between start of T3 therapy and organ explantation (mean duration: 11.9 hrs) there was a significant gradual increase in BPsyst (from 106±24 to 128±26 mmHg, P=.032), and a decrease in DOPB (from 7.4±4.8 to 3.9±3.5 μg/kg/min, P=.004) and NA requirements (from .127±.194 to .057±.124 μg/kg/min, P=.039), whereas these parameters remained unchanged in group II between death and explantation (mean duration: 11.2 hrs). T3 treatment in group I resulted in a high organ availability per donor that was not different from group II: 4.6±1.3 vs 4.6±1.7 organs, with procurement rates of 63.1 vs 64.3% for hearts, 84.2 vs 82.1% for livers, 36.8 vs 35.7% for lungs and 42.1 vs 46.4% for pancreases (P=n.s.). Conclusions: Our data suggest that hemodynamically unstable donors may benefit from a hormonal substitution therapy with T3, resulting in significantly improved hemodynamic variables with considerable reductions in inotrope requirements. By limiting the unnecessary wastage of potential organs with T3 replacement we were able to reach an ultimate yield of organs that was similar to that of 'ideal' multi-organ donors.

The Effects of Donor Sodium Levels on Recipient Liver Graft Function

A great deal of discussion has been generated regarding the effects of donor hypernatremia on recipient liver graft function. Much of this discussion is anecdotal and focuses on the detrimental effects of hypernatremia in the organ donor. The treatment of donor hypernatremia often leads to changes in donor management protocols. A retrospective study was conducted to determine if donor hypernatremia measurably alters the liver graft function of recipients. Results indicated that donor sodium values were unrelated to any recipient parameter assessed. Although further studies are pending, these findings suggest that a moderate rather than a severe approach to the management of donor hypernatremia may be preferred.

The effects of donor sodium levels on recipient liver graft function

A great deal of discussion has been generated regarding the effects of donor hypernatremia on recipient liver graft function. Much of this discussion is anecdotal and focuses on the detrimental effects of hypernatremia in the organ donor. The treatment of donor hypernatremia often leads to changes in donor management protocols. A retrospective study was conducted to determine if donor hypernatremia measurably alters the liver graft function of recipients. Results indicated that donor sodium values were unrelated to any recipient parameter assessed. Although further studies are pending, these findings suggest that a moderate rather than a severe approach to the management of donor hypernatremia may be preferred.