[Show abstract][Hide abstract] ABSTRACT: Biovigilance systems to assess and analyze risks for disease transmission through the transfer of organs, tissue, cells and blood between people is part of administrative oversight and has impact upon clinical practice and policy. In 2009, a formal recommendation by the Public Health Service requested that Health and Human Services fund and support efforts to consolidate national biovigilance efforts. There are differences in the biovigilance issues involved in organ and tissue donation/transplantation. If disease avoidance is made the dominant principle guiding organ donor testing, an unintended consequence may be an increase in deaths on the waiting list. We propose that overall benefit for the organ transplant recipient, tempered by patient informed awareness of limited organ availability and assessment processes, should be the guiding principle of such a system.
American Journal of Transplantation 04/2012; 12(5):1099-101. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Federal legislation has been proposed to modify the National Organ Transplant Act in a way that would permit government-regulated strategies, including financial incentives, to be implemented and evaluated. The Council and Ethics Committee of the American Society of Transplant Surgeons conducted a brief web-based survey of its members' (n = 449, 41.6% response rate) views on acceptable or unacceptable strategies to increase organ donation. The majority of the membership supports reimbursement for funeral expenses, an income tax credit on the final return of a deceased donor and an income tax credit for registering as an organ donor as strategies for increasing deceased donation. Payment for lost wages, guaranteed health insurance and an income tax credit are strategies most strongly supported by the membership to increase living donation. For both deceased and living donation, the membership is mostly opposed to cash payments to donors, their estates or to next-of-kin. There is strong support for a government-regulated trial to evaluate the potential benefits and harms of financial incentives for both deceased and living donation. Overall, there is strong support within the ASTS membership for changes to NOTA that would permit the implementation and careful evaluation of indirect, government-regulated strategies to increase organ donation.
American Journal of Transplantation 08/2009; 9(9):2172-6. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The American Society of Transplant Surgeons (ASTS) champions efforts to increase organ donation. Controlled donation after cardiac death (DCD) offers the family and the patient with a hopeless prognosis the option to donate when brain death criteria will not be met. Although DCD is increasing, this endeavor is still in the midst of development. DCD protocols, recovery techniques and organ acceptance criteria vary among organ procurement organizations and transplant centers. Growing enthusiasm for DCD has been tempered by the decreased yield of transplantable organs and less favorable posttransplant outcomes compared with donation after brain death. Logistics and ethics relevant to DCD engender discussion and debate among lay and medical communities. Regulatory oversight of the mandate to increase DCD and a recent lawsuit involving professional behavior during an attempted DCD have fueled scrutiny of this activity. Within this setting, the ASTS Council sought best-practice guidelines for controlled DCD organ donation and transplantation. The proposed guidelines are evidence based when possible. They cover many aspects of DCD kidney, liver and pancreas transplantation, including donor characteristics, consent, withdrawal of ventilatory support, operative technique, ischemia times, machine perfusion, recipient considerations and biliary issues. DCD organ transplantation involves unique challenges that these recommendations seek to address.
American Journal of Transplantation 08/2009; 9(9):2004-11. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In 2008, the United Network for Organ Sharing issued a request for information regarding a proposed revision to kidney allocation policy. This plan described combining dialysis time, donor characteristics and the estimated life years from transplant (LYFT) each candidate would gain in an allocation score that would rank waiting candidates. Though there were some advantages of this plan, the inclusion of LYFT raised many questions. Foremost, there was no clear agreement that LYFT should be the main criterion by which patients should be ranked. Moreover, to rank waiting candidates with this metric, long-term survival models were required in which there was no incorporation of patient preference or discounting for long survival times and for which the predictive accuracy did not achieve accepted standards. The American Society of Transplant Surgeons was pleased to participate in the evaluation of the proposal. Ultimately, the membership did not favor this proposal, because we felt that it was too complicated and that the projected slight increase in overall utility was not justified by the compromise in individual justice that was required. We offer alternative policy options to address some of the unmet needs and issues that were brought to light during this interesting process.
American Journal of Transplantation 07/2009; 9(7):1501-6. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Candidates for, and recipients of, transplants face numerous risks that receive varying degrees of attention from the media and transplant professionals. Characterizations such as 'high risk donor' are not necessarily accurate or informative unless they are discussed in context with the other risks patients face before and after transplantation. Moreover, such labels do not provide accurate information for informed consent discussions or decision making. Recent cases of donor-transmitted diseases from donors labeled as being at 'high risk' have engendered concern, new policy proposals and attempts to employ additional testing of donors. The publicity and policy reactions to these cases do not necessarily better inform transplant candidates and recipients about these risks. Using comparative risk analysis, we compare the various risks associated with waiting on the list, accepting donors with various risk characteristics, posttransplant survival and everyday risks we all face in modern life to provide some quantitative perspective on what 'high risk' really means for transplant patients. In our analysis, donor-transmitted disease risks are orders of magnitude less than other transplantation risks and similar to many everyday occupational and recreational risks people readily and willingly accept. These comparisons can be helpful for informing patients and guiding future policy development.
American Journal of Transplantation 12/2008; 9(1):23-30. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Liver transplantation in 2006 generally resembled previous years, with fewer candidates waiting for deceased donor liver transplants (DDLT), continuing a trend initiated with the implementation of the model for end-stage liver disease (MELD). Candidate age distribution continued to skew toward older ages with fewer children listed in 2006 than in any prior year. Total transplants increased due to more DDLT with slightly fewer living donor liver transplants (LDLT). Waiting list deaths and time to transplant continued to improve. In 2006, there also were fewer DDLT for patients with MELD <15, fewer pediatric Status 1A/B transplants and more transplants from donation after cardiac death (DCD) donors. Adjusted patient and graft survival rates were similar for LDLT and DDLT. This article also contains in-depth analyses of transplantation for hepatocellular carcinoma (HCC). Recipients with HCC had lower adjusted 3-year posttransplant survival than recipients without HCC. HCC recipients who received pretransplant ablative treatments had superior adjusted 3-year posttransplant survival compared to HCC recipients who did not. Intestinal transplantation continued to slowly increase with the largest number of candidates on the waiting list since 1997. Survival rates have increased over time. Small children waiting for intestine grafts continue to have the highest waiting list mortality.
American Journal of Transplantation 04/2008; 8(4 Pt 2):958-76. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Equitable liver allocation should ensure that nonelective removal rates are fairly distributed among waiting candidates. We compared removal rates for adults entered with nonmalignant (NM) (N = 9379) and hepatocellular cancer (HCC) (N = 2052) diagnoses on the Organ Procurement and Transplantation Network (OPTN) list between April 30, 2003, and December 31, 2004. Unadjusted removal rates for NM vs. HCC diagnoses were 9.4% vs. 8.7%, 13.5% vs. 16.9% and 19.1% vs. 31.8% at 90, 180 and 365 days, respectively after listing. For NM candidates, model for end-stage liver disease (MELD) score (RR = 1.16), age (RR = 1.03) and metabolic disease diagnoses (RR = 1.66) had higher risks of removal; and PSC (RR = 0.62) and alcoholic cirrhosis (RR = 0.82) had lower risks of removal. For HCC candidates, MELD score at listing (RR = 1.09), AFP (RR = 1.02), maximum tumor size (RR = 1.16) and age at listing (RR = 1.02) had increased risks of removal. The equation 1 - 0.920 exp[0.09369 (MELD at listing - 12.48) + 0.00193 (AFP - 97.4) + 0.1505 (maximum tumor size - 2.59) defined the probability of dropout for HCC candidates within 90 days of listing. We conclude that factors associated with the risk of removal for HCC are different from NM candidates, although MELD score at listing remains the most predictive for both groups. Liver transplant candidates with HCC may be prioritized using a risk score analogous to the MELD score.
American Journal of Transplantation 07/2006; 6(6):1416-21. · 6.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The MELD/PELD (M/P) system for liver allocation was implemented on February 27, 2002, in the United States. Since then sufficient time has elapsed to allow for assessment of posttransplant survival rates under this system. We analyzed 4163 deceased donor liver transplants performed between February 27, 2002, and December 31, 2003, for whom follow-up reporting was 95% and 67% complete at 6 and 12 months, respectively. Kaplan-Meier survival analysis revealed 1-year patient and graft survival rates for status 1 of 76.9% and 70.4%, respectively, and 87.3% and 82.9% for patients prioritized by M/P (P < .0001 for status 1 vs M/P). When adult candidates were stratified by MELD score quartile at transplant, 1-year survival rates were 89.5%, 88.3%, 86.6%, and 78.1% for lowest to highest quartile (P = .0002) and graft survival rates were similarly distributed (85.0%, 84.5%, 82.7%, 73.0%, P < .0001). Candidates with hepatocellular cancer (89.6%) and other MELD score exceptions (88.8%) had slightly higher 1-year survival rates compared with standard MELD recipients (86.0%), which did not reach statistical significance (P = .089). Pediatric recipients had slightly better patient (88.7%) and graft (86.5%) survival rates at 1 year than adults but there were no significant differences among the PELD strata due to small numbers of patients in each PELD quartile. We conclude that patient and graft survival have remained excellent since implementation of the MELD/PELD system. Although recipients with MELD scores in the highest quartile have reduced survival compared with other quartiles, their 1-year survival rate is acceptable when their extreme risk of dying without a transplant is taken into consideration.
[Show abstract][Hide abstract] ABSTRACT: The liver allocation policy in the United States was changed on February 27, 2002, to a continuous scale with almost no weight given to time waiting on the list. This was based on the dissatisfaction with the old categorical system and an understanding that waiting time as not a good discriminator of medical urgency. To assess the effects of this change, liver allocation results for the first 6 months of this new system (February 27, 2002, to August 30, 2002, era 2) with the corresponding 6 month period 1 year earlier (February 27, 2001, to August 30, 2001, era 1) were compared. Fewer registrations on the waiting list, fewer removals from the waiting list because of death or "too sick," and an increase in the number of cadaveric transplants under the new system were observed. Patients with hepatocellular cancer received additional priority with the new policy and there was a significant increase in the number of candidates transplanted with this diagnosis in era 2. Early posttransplant patient survival has not changed under the new system. Although there are many areas for improvement, which will be addressed in future refinements, the new US liver allocation plan has provided a more objective, patient-specific system to better rank waiting liver transplant candidates.
[Show abstract][Hide abstract] ABSTRACT: Measuring medical students' experience on their surgical clerkship rotations to assess the adequacy of the breadth of exposure is essential for producing generalist clinicians.
A Surgical Clinical Checklist was developed by surveying the surgical faculty for those surgical problems and procedures that every generalist physician should experience. The checklist was then distributed to 48 consecutive third-year medical students for completion during their core clerkship in surgery.
Students reported encounters with surgical procedures more frequently than with surgical problems (64.3% of procedures versus 21.9% of problems were encountered by 80% of respondents). Students actively participated as often as they reported passive observation alone. Students assigned to two different teaching sites encountered similar numbers of items at each site although the distribution of individual items was different.
The Surgical Clinical Checklist provides a valuable measurement tool to assess student experiences on their surgical clerkship and can be used to direct future teaching initiatives.
The American Journal of Surgery 05/2001; 181(4):341-6. · 2.52 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Liver allocation remains problematic because current policy prioritizes status 2B or 3 patients by waiting time rather than medical urgency. On February 21, 2000, we implemented a variance to the United Network for Organ Sharing liver allocation policy that redefined status 2A by much more rigid, definable criteria and prioritized status 2B patients by using a continuous medical urgency score based on the Child-Turcotte-Pugh score and other medical conditions. In this system, waiting time is used only to differentiate status 2B candidates with equal medical urgency scores. Comparing the 6-month period (period 1; n = 67) before implementation of this system to the 6-month period after implementation (period 2; n = 75), there was a significant reduction in the number of transplantations performed for patients listed as status 2A (46.3% to 14.7%; P =.002) and an increase in the number of patients listed as status 2B who received transplants (44.8% to 70.7%; P =.10). Most dramatically, there was a 37.1% reduction in overall deaths on the waiting list from 94 deaths in period 1 to 62 deaths in period 2 (P =.005), with the most significant reduction for patients removed from this list at status 2B (52 v 18 patients; P =.04). There were 3 postoperative deaths in each period, with only 1 graft lost in period 2. Status 2B patients with the greatest degree of medical urgency received transplants without multiple peer reviews requesting elevation to 2A status. We conclude that a continuous medical urgency score system allocates donor livers much more fairly to those in medical need and reduces waiting list mortality without sacrificing efficacy.
[Show abstract][Hide abstract] ABSTRACT: Factors associated with the risk for mortality once placed on the liver transplant waiting list and how this risk relates to center-specific waiting time and transplant activity have not been adequately evaluated. We performed this study to determine the association between center-specific waiting time and waiting list mortality among liver transplant candidates stratified by medical urgency at the time of registration. A Cox proportional hazards model was used to calculate 2-year mortality risk for a cohort of 16, 414 registrants added to the United Network for Organ Sharing liver transplant waiting list between January 1, 1997, and December 31, 1997. After controlling for confounding variables, we calculated the mortality risk for centers, organ procurement organizations (OPOs), and states. The relation between center-specific waiting list mortality risk and median waiting time or transplant activity was determined by linear regression. In multivariate analyses, higher initial medical urgency status (relative risk [RR] = 12.8; P <.001), increasing age (P <.001), black ethnicity (RR = 1.29; P <.001), history of previous transplant (RR = 1.2; P =.009), certain liver diagnoses, and smaller center size (RR = 1.39; P =.008) were associated with significantly increased waiting list mortality. Candidates with blood type A (RR = 0.87; P <.001) and those with cholestatic cirrhosis as the primary diagnosis (RR = 0.73; P < 0. 001) had a reduced risk for dying. There were significant variations in 2-year waiting list mortality risk among centers, OPOs, and states. However, when stratified by medical urgency status at waiting list entry, center-specific waiting time and transplantation rates accounted for almost none of the center-specific waiting list mortality. Although there are variations in waiting list mortality risk among centers, OPOs, and states, there is very little relation between center-specific waiting list mortality and center-specific median waiting time or center-specific transplantation rates when stratified by medical urgency. Waiting time and center transplant rates should not influence liver allocation policy.
[Show abstract][Hide abstract] ABSTRACT: Transjugular intrahepatic portosystemic shunt has become an accepted intervention to treat sequelae of end-stage liver disease such as refractory ascites and esophageal varices for patients awaiting liver transplantation. Technical difficulties in such patients at the time of transplantation are usually limited to malpositioning of the stent requiring modification of the usual vascular anastomoses. Migration of the stent intraoperatively has not been a reported complication in the literature. We report a case in which a patient with a previously placed transjugular intrahepatic portosystemic shunt underwent successful liver transplantation complicated by intraoperative migration of the stent into the left pulmonary artery. The stent was removed from the pulmonary artery postoperatively using interventional radiology techniques.
[Show abstract][Hide abstract] ABSTRACT: A multicenter trial was conducted to evaluate the efficacy and safety of tacrolimus in the treatment of refractory renal allograft rejection. Renal transplant recipients experiencing biopsy-proven recurrent acute allograft rejection were eligible if the current rejection episode was refractory to corticosteroids. A total of 73 patients were enrolled, of whom 59 (81%) had previously received at least one course of antilymphocyte antibody as rejection therapy. One-year follow-up was available in 93% of patients. Median time to tacrolimus rescue therapy was 75 days after transplantation (range, 18-1448 days). Therapeutic responses to tacrolimus included improvement in 78% of patients, stabilization in 11%, and progressive deterioration in 11%. The risk of experiencing progressive deterioration was related to the pretacrolimus serum creatinine level: serum creatinine < or = mg/dl, 3%; 3.1-5 mg/dl, 16% (P < 0.04); > 5 mg/dl, 23% (P < 0.02). Twelve-month (from the time of initiation of tacrolimus therapy) actuarial patient and graft survival rates were 93% and 75%. Graft loss occurred in 19 patients (25%) at a median time of 108 days. Fourteen episodes of recurrent rejection were diagnosed in 10 patients (14%), at a median time of 101 days. Eleven episodes of recurrent rejection were treated (three patients underwent transplant nephrectomy), with resolution achieved in nine patients. Antilymphocyte antibody therapy was not used to treat recurrent rejection. Serum creatinine values improved during tacrolimus therapy: median serum creatinine level before tacrolimus, 3.2 mg/dl; median at 1 year after tacrolimus, 1.8 mg/dl. Twelve infections were documented in 11 patients (15%), including cytomegalovirus infection in three patients (4%). Posttransplant lymphoproliferative disorder was diagnosed in a single patient. Tacrolimus whole blood levels averaged 15.0 +/- 9.9 ng/ml at day 7 of tacrolimus therapy and 9.4 +/- 5.1 ng/ml at 1 year, and were consistent among individual centers. Treatment outcome did not correlate with tacrolimus blood levels. The most commonly observed adverse events were neurological and gastrointestinal. Seventy-four percent of patients received tacrolimus for at least 1 year. Tacrolimus therapy was discontinued in 18% of patients for rejection (11% for progressive, unrelenting rejection, and 7% for recurrent rejection). Tacrolimus therapy was discontinued in 8% of patients due to adverse events. In conclusion, tacrolimus rescue therapy provides (1) prompt, effective reversal of refractory renal allograft rejection, (2) good long-term renal allograft function, (3) a low incidence of recurrent rejection, and (4) an acceptable safety profile in renal allograft recipients experiencing refractory rejection.
[Show abstract][Hide abstract] ABSTRACT: The degree to which immunosuppression and/or rejection influences recurrent hepatitis C (HCV) after liver transplantation (LT) for end-stage HCV cirrhosis remains poorly defined. We quantified serum HCV-RNA in 84 serum samples from 28 anti-HCV-positive patients taken 223 days prior to and up to 1719 days after liver transplantation to determine if cumulative immunosuppression, rejection, or histologic recurrence correlated with HCV-RNA levels. Histologic, serum chemistry, cumulative steroid, and OKT3 and alpha-interferon (INF) dose data were collected at the time of HCV-RNA sampling. Eighteen of 24 evaluable patients (75%) had HCV-RNA detected in their sera after transplant. Eight patients had 14 rejection episodes, 9 patients received OKT3, and 5 were given INF for histologically moderate hepatitis. Five patients died - two of recurrent hepatitis C - and no retransplants were performed for recurrent hepatitis. Of the 23 survivors, 7 have histologic hepatitis - 2 with persistent ascites, and 2 with mild fibrosis. We could show no correlation between HCV-RNA levels and any of the variables examined although a trend toward increasing HCV-RNA levels with increasing numbers of rejection episodes was observed. In addition, histologic recurrence occurred more frequently for patients treated with OKT3. We conclude that the quantity of circulating viral genome is not influenced by immunosuppressive load and does not correlate with laboratory or histologic signs of recurrence. The roles that rejection, and possibly OKT3, play in the recurrence of HCV after liver transplant need further study.