ORIGINAL ARTICLE. Received December 4, 2013; accepted March 9, 2014.

Transcription

1 LIVER TRANSPLANTATION 20: , 2014 ORIGINAL ARTICLE Inferior Long-Term Outcomes of Liver-Kidney Transplantation Using Donation After Cardiac Death Donors: Single-Center and Organ Procurement and Transplantation Network Analyses Hani M. Wadei, Ilynn G. Bulatao, Thomas A. Gonwa, Martin L. Mai, Mary Prendergast, Andrew P. Keaveny, Barry G. Rosser, and C. Burcin Taner Department of Transplantation, Mayo Clinic, Jacksonville, FL Limited data are available for outcomes of simultaneous liver-kidney (SLK) transplantation using donation after cardiac death (DCD) donors. The outcomes of 12 DCD-SLK transplants and 54 SLK transplants using donation after brain death (DBD) donors were retrospectively compared. The baseline demographics were similar for the DCD-SLK and DBD-SLK groups except for the higher liver donor risk index for the DCD-SLK group ( versus , P ). The rates of surgical complications and graft rejections within 1 year were comparable for the DCD-SLK and DBD-SLK groups. Delayed renal graft function was twice as common in the DCD-SLK group. At 1 year, the serum creatinine levels and the iothalamate glomerular filtration rates were similar for the groups. The patient, liver graft, and kidney graft survival rates at 1 year were comparable for the groups (83.3%, 75.0%, and 82.5% for the DCD-SLK group and 92.4%, 92.4%, and 92.6% for the DBD-SLK group, P for all). The DCD-SLK group had worse patient, liver graft, and kidney graft survival at 3 years (62.5%, 62.5%, and 58.9% versus 90.5%, 90.5%, and 90.6%, P for all) and at 5 years (62.5%, 62.5%, and 58.9% versus 87.4%, 87.4%, and 87.7%, P < 0.05 for all). An analysis of the Organ Procurement and Transplantation Network database showed inferior 1- and 5-year patient and graft survival rates for DCD-SLK patients versus DBD-SLK patients. In conclusion, despite comparable rates of surgical and medical complications and comparable kidney function at 1 year, DCD-SLK transplantation was associated with inferior long-term survival in comparison with DBD-SLK transplantation. Liver Transpl 20: , VC 2014 AASLD. Received December 4, 2013; accepted March 9, Since the application of the Model for End-Stage Liver Disease (MELD) scoring system for allocating liver allografts in 2002, the number of simultaneous liverkidney (SLK) transplants performed in the United States has more than tripled. 1 Because comparable outcomes have been observed with kidney transplantation using donation after cardiac death (DCD) donors and kidney transplantation using donation after brain death (DBD) donors and because certain centers have achieved relative improvements in the outcomes of liver transplantation using DCD donors, SLK transplantation using DCD donors is worth Additional Supporting Information may be found in the online version of this article. Abbreviations: DBD, donation after brain death; DCD, donation after cardiac death; DGF, delayed graft function; igfr, iothalamate glomerular filtration rate; MELD, Model for End-Stage Liver Disease; OPTN, Organ Procurement and Transplantation Network; RRT, renal replacement therapy; SLK, simultaneous liver-kidney; UNOS, United Network for Organ Sharing. This work was supported in part by Health Resources and Services Administration contract C. The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. Address reprint requests to Hani M. Wadei, M.D., Department of Transplantation, Mayo Clinic, 4500 San Pablo Road, Jacksonville FL Telephone: ; FAX: ; wadei.hani@mayo.edu DOI /lt View this article online at wileyonlinelibrary.com. LIVER TRANSPLANTATION.DOI /lt. Published on behalf of the American Association for the Study of Liver Diseases VC 2014 American Association for the Study of Liver Diseases.

2 LIVER TRANSPLANTATION, Vol. 20, No. 6, 2014 WADEI ET AL. 729 exploring on account of the shortage in the organ supply. 2-7 However, because of concerns regarding the cumulative effects of an increased risk of posttransplant biliary complications in liver grafts and the higher rate of delayed kidney graft function, transplant programs have not embraced the use of DCD donors for SLK. This has resulted in a limited experience with SLK transplantation using organs from DCD donors, with only 94 DCD-SLK transplants performed in the United States between 2000 and 2010 [based on Organ Procurement and Transplantation Network (OPTN) data as of June 28, 2013]. One center demonstrated similar 1-year patient and graft survival rates for 5 DCD-SLK transplants and 32 SLK transplants using DBD donors. 8 Our center has been performing solitary liver and kidney transplants with DCD donors since 1998, and we started to perform DCD-SLK transplantation in The aim of this retrospective analysis was to compare the long-term outcomes of DCD-SLK transplants and DBD-SLK transplants performed during the same time period at our center. We also aimed to assess the national trends and outcomes of DCD-SLK transplantation as reported to the United Network for Organ Sharing (UNOS) database. PATIENTS AND METHODS Study Patients This was a retrospective analysis of 66 patients who underwent SLK transplantation (12 DCD-SLK patients and 54 DBD-SLK patients) at Mayo Clinic Florida between January 1, 2000 and December 31, Reviews and analyses of the clinical records of these patients were undertaken with the approval of the Mayo Clinic institutional review board. DBD and DCD procurement has been described elsewhere. 5,9 Briefly, all organs were flushed and preserved in static cold storage with University of Wisconsin solution. For DCD-SLK transplantation, heparin was administered at the time of the withdrawal of life support, and thrombolytic agents were not used in either donors or recipients. None of the kidney grafts in either group were pumped before implantation. Patients were followed at 1, 4, and 12 months and annually thereafter by both the transplant hepatologist and the transplant nephrologist. Study Aims The primary aim of this study was to compare patient and graft survival rates for DCD-SLK and DBD-SLK patients at our center. The secondary aims were to compare endpoints for DCD-SLK and DBD-SLK patients [ie, the prevalence of surgical and medical complications occurring within the first posttransplant year and kidney function at 1 year as measured by the serum creatinine level and iothalamate glomerular filtration rate (igfr)] and to compare our center s experience with DCD-SLK transplantation to DCD-SLK transplants performed in the United States as reported to UNOS. Definitions Biliary complications were defined as biliary leaks, anastomotic strictures, or ischemic cholangiopathy. Ischemic cholangiopathy was defined as diffuse, intrahepatic bile duct strictures in the absence of hepatic artery thrombosis that were diagnosed either with a cholangiogram via an intraoperatively placed transcystic duct, biliary tube or with an endoscopic retrograde cholangiopancreatogram or percutaneous transhepatic cholangiogram. Urological complications were defined as urine leaks or ureteral strictures. Vascular complications were defined as hepatic artery thrombosis/stenosis, portal vein thrombosis, or renal artery thrombosis/stenosis. Delayed graft function (DGF) of the kidney graft was defined as the need for dialysis in the first posttransplant week. The DCD warm ischemia time was defined as the time from the withdrawal of life support to cross-clamping of the donor aorta. Kidney Function Assessment Kidney function was assessed with serum creatinine 1, 4, and 12 months after transplantation. igfr was measured 1 year after transplantation via the clearance of subcutaneous nonradiolabeled iothalamate as previously described. 10 Results were corrected for the body surface area and were expressed as milliliters per minute per 1.73 m 2. Patients who were receiving renal replacement therapy (RRT) at any of these time points were recorded separately, and serum creatinine and igfr values were not computed for these patients. Statistical Analysis Numerical variables were summarized as sample medians, minimums, and maximums. Categorical variables were summarized as numbers and percentages. Patient, donor, and transplant characteristics and posttransplant complications were compared for DCD-SLK and DBD-SLK transplants. The Mann- Whitney U test was used for comparing continuous variables, whereas the chi-square test was used for analyzing categorical variables. Kaplan-Meier plots and log-rank tests were used to examine patient and graft survival. The time to graft loss due to death, liver retransplantation, and/or dialysis initiation was recorded. Censoring was done at the time of graft loss, death, or last follow-up, whichever came first. P values of 0.05 or less were considered statistically significant. RESULTS The baseline donor and recipient demographics and operative data are summarized in Table 1. The recipient cohort consisted primarily of male Caucasians.

3 730 WADEI ET AL. LIVER TRANSPLANTATION, June 2014 TABLE 1. Recipient, Transplant, and Donor Characteristics of 66 SLK Transplants Using DBD and DCD Organs DBD-SLK DCD-SLK All (n 5 66) Group (n 5 54) Group (n 5 12) P Value Recipient characteristics Male sex [n (%)] 43 (65) 35 (65) 8 (67) 0.90 Age at transplant (years)* MELD score* Waiting list (days) 42 (2-771) 43 (2-771) 58 (5-737) 0.76 Body mass index (kg/m 2 )* Caucasian race [n (%)] 52 (79) 41 (76) 11 (92) 0.34 Pretransplant diabetes [n (%)] 28 (42) 21 (39) 7 (58) 0.33 Serum creatinine at transplant (mg/dl)*, RRT at transplant [n (%)] 34 (52) 26 (48) 8 (67) 0.25 Causes of end-stage renal disease [n (%)] 0.89 Diabetic nephropathy 16 (24) 13 (24) 3 (25) Polycystic kidney disease 9 (14) 7 (13) 2 (17) Glomerulonephritis 16 (24) 14 (26) 2 (17) Calcineurin inhibitor toxicity 8 (12) 7 (13) 1 (8) Other 17 (26) 13 (24) 4 (33) Causes of end-stage liver disease [n (%)] 0.89 Hepatitis C virus 24 (36) 19 (35) 5 (42) Polycystic liver disease 9 (14) 7 (13) 2 (17) Alcoholic cirrhosis 5 (7) 5 (9) 0 (0) Cryptogenic 8 (12) 6 (11) 2 (17) Nonalcoholic steatohepatitis 7 (11) 5 (9) 2 (17) Other 13 (20) 12 (22) 1 (8) Transplant characteristics Kidney cold ischemia time (hours)* Liver cold ischemia time (hours)* Kidney warm ischemia time (minutes)* Liver warm ischemia time (minutes)* DCD warm ischemia time (minutes)* Not applicable Not applicable Not applicable Operative time (hours)* Induction immunosuppression [n (%)] 0.83 Anti-thymocyte globulin 35 (53) 29 (54) 6 (50) Interleukin-2 receptor blocker 30 (45) 24 (44) 6 (50) No induction 1 (2) 1 (2) 0 (0) Donor characteristics Age (years)* Male sex [n (%)] 37 (56) 28 (52) 9 (75) 0.14 Causes of death [n (%)] 0.03 Trauma 35 (53) 29 (54) 6 (50) Anoxia 10 (15) 5 (9) 5 (42) Cerebrovascular accident 18 (27) 17 (31) 1 (8) Other 3 (5) 3 (6) 0 (0) Caucasian race [n (%)] 48 (73) 38 (70) 10 (83) 0.65 Liver donor risk index* *The data are presented as means and standard deviations. The data are presented as medians and ranges. For patients not on RRT at the time of transplantation (n 5 32). Thirty-six percent of the recipients had a hepatitis C virus infection as the cause of their liver failure, and 51% were receiving RRT at the time of SLK. All but 1 patient in the DBD-SLK group received induction immunosuppression with either anti-thymocyte globulin or interleukin-2 receptor blockers. Maintenance immunosuppression included prednisone, mycophenolate mofetil, and tacrolimus. The operative characteristics were similar for the DCD-SLK and DBD-SLK groups except for the longer liver warm ischemia time and the longer operative time for the DBD-SLK group versus the DCD-SLK group, but these differences did not reach statistical significance. Notably, the waiting times on the transplant list were similar for the DBD- SLK and DCD-SLK patients (P ). Although trauma was the most common cause of donor deaths in both groups, asphyxia in the DCD-SLK group and cerebrovascular accidents in the DBD-SLK group

4 LIVER TRANSPLANTATION, Vol. 20, No. 6, 2014 WADEI ET AL. 731 TABLE 2. Patient, Kidney, and Liver Graft Survival at 1, 3, and 5 Years for DBD-SLK and DCD-SLK Patients All (n 5 66) Survival (%) Survival (%) Events (n) DBD Group (n 5 54) DCD Group (n 5 12) Remaining (n) Survival (%) Events (n) Remaining (n) P Value Patient survival 1 year years years Kidney graft survival 1 year years years Liver graft survival 1 year years years were the second most common reasons (P ). As expected, the liver donor risk index was higher for the DCD-SLK group versus the DBD-SLK group ( versus , P ). 11 Patient and Graft Survival and Kidney Function The median follow-up period for the whole cohort was 39.1 months (range months). The actuarial 1-, 3-, and 5-year patient, kidney graft, and liver graft survival rates are presented in Table 2 and Fig. 1. At 1 year, the patient, liver graft, and kidney graft survival rates were comparable for the DCD-SLK and DBD-SLK groups. The patient, liver graft, and kidney graft survival rates at 3 and 5 years were inferior for the DCD-SLK group versus the DBD-SLK group. Table 3 summarizes kidney function and RRT requirements 1 month and 1 year after transplantation. At 1 month, there was no difference in serum creatinine levels or RRT requirements between the DCD-SLK and DBD-SLK groups. Eleven DCD-SLK patients and 43 DBD-SLK patients completed their first annual posttransplant evaluation. Two patients in each group were on RRT at 1 year, and this provided similar rates of death-censored kidney graft loss at this time point (P ). For the remaining patients, the serum creatinine levels ( versus mg/dl, P ) and igfrs ( versus ml/minute/1.73 m 2, P ) of the DCD-SLK and DBD-SLK groups were comparable. Posttransplant Complications and Causes of Death The length of the initial posttransplant hospitalization and the prevalence of medical and surgical complications within the first posttransplant year are illustrated in Table 4. One DCD-SLK recipient had primary nonfunction of the liver graft and required immediate liver retransplantation. The overall prevalence of posttransplant complications and the lengths of the hospital and intensive care unit stays were also similar for the study groups. Although DGF of the renal graft was twice as common among DCD-SLK patients versus DBD-SLK patients, this did not reach statistical significance (P ). Wound, biliary, vascular, and urological complication rates and liver and kidney graft acute rejection rates were comparable between the study groups. One patient in the DCD- SLK group was diagnosed with severe ischemic cholangiopathy; this patient died approximately 6 months after transplantation. Two patients in the DCD-SLK group and 1 patient in the DBD-SLK group were diagnosed with mild ischemic cholangiopathy, and none of them required repeated biliary interventions, chronic antibiotic treatment, or retransplantation. Fourteen patients died during the study period. Septicemia, disseminated infections, or both were the primary causes of death and accounted for 8 of the patient deaths. One of these 14 patients, a member of the DBD-SLK group, had recurrent hepatitis C virus and deteriorating graft function, which contributed to his death. The remaining 13 patients died with functioning grafts. During the period of our retrospective analysis, 3395 SLK transplants were performed in the United States: 94 (2.8%) used DCD donors, and 3301 (97.2%) used DBD donors. Similarly to the overall trend of SLK transplantation in the United States, the number of DCD-SLK transplants increased over time (Table 5). The 1-year patient, liver, and kidney survival rates for DCD-SLK patients were lower than those for DBD-SLK patients (Table 6). Five-year survival data were reported to UNOS for only 50 DCD- SLK patients and 2248 DBD-SLK patients. As

5 732 WADEI ET AL. LIVER TRANSPLANTATION, June 2014 Figure 1. Actuarial 1-, 3-, and 5-year (A) patient, (B) kidney, and (C) liver survival for 54 DBD-SLK transplants and 12 DCD- SLK transplants. demonstrated in Table 6, 5-year patient, liver, and kidney graft survival rates for DCD-SLK transplantation were inferior to those for DBD-SLK transplantation. DISCUSSION With the increasing number of patients in need of SLK transplants, transplant programs are exploring ways to increase the donor pool. Organs from DCD donors may be an important source for helping to close the gap between the supply and the demand for both liver and kidney grafts. Although comparable long-term outcomes of solitary kidney transplantation with DCD and DBD donors are known, liver transplantation using DCD donors has been hampered by the high risk of biliary complications and lower graft survival rates The reported outcomes with this type of liver graft have been inferior to the outcomes with DBD donors. The majority of liver transplants are performed with DBD donors; however, the number of DCD donors will likely increase. According to the 2011 report of the Scientific Registry of Transplant Recipients, 16 the percentage of DCD liver transplants has increased since the 1990s, and these transplants accounted for approximately 6% of all liver transplants performed in the United States in Advances in traumatology, neurosurgery, and neuroradiology have improved immediate survival after devastating brain injury. As a result, patients who are eventually destined to become organ donors are increasingly not meeting brain death criteria. 17 Families wishing to donate the organs of the critically ill can do so only after cardiac death occurs after the discontinuation of life support. Even though the transplant community has recognized the imperative of increasing the number of organs to decrease the number of deaths of patients on the waiting list, an overall reluctance to use DCD liver grafts still remains. We previously reported our experience with DCD grafts for liver transplantation. 9,18,19 We have demonstrated that outcomes can be improved with careful donor selection and with a rigorous procurement technique. Our experience with solitary kidney and liver transplants has encouraged us to use DCD organs for SLK transplantation. At our center, we achieved comparable 1-year patient, liver graft, and kidney graft survival rates for DCD-SLK and DBD-SLK recipients. These results did not occur at the expense of a prolonged operative time or hospital stay or a higher risk of reoperation or other surgical complications in the immediate posttransplant period. The findings are consistent with a previously published single-center experience that showed comparable 1-year outcomes for 5 DCD-SLK patients and 32 DBD-SLK patients. 8 However, our single-center results differ from those obtained through an OPTN database analysis, which showed inferior DCD-SLK outcomes 1 year after transplantation. The reasons for the discrepancy between our center and the national experience are unclear. One possible explanation is that the small number of patients who underwent DCD-SLK transplantation at our center did not allow the detection of any statistical difference in 1-year patient or graft survival rates, but statistical significance was achieved over time. Another explanation is that centers with more experience in DCD transplantation might have better 1-year DCD-SLK outcomes. Regardless of the explanation, the results of the current analysis demonstrate that these initially acceptable 1-year outcomes with DCD- SLK transplantation are not sustained, and there is

6 LIVER TRANSPLANTATION, Vol. 20, No. 6, 2014 WADEI ET AL. 733 TABLE 3. Kidney Graft Function and RRT Requirements 1 Month and 1 Year After DBD-SLK and DCD-SLK Transplantation DBD-SLK Group (n 5 54) DCD-SLK Group (n 5 12) P Value 1-month RRT [n (%)] 2 (4) 1 (8) month creatinine (mg/dl)*, year RRT [n (%)] 2 (4) 2 (17) year serum creatinine (mg/dl)*, year igfr (ml/minute/1.73 m 2 ) (n 5 36) (n 5 9) 0.23 *For patients not on RRT. The data are presented as means and standard deviations. TABLE 4. Rates of Surgical and Medical Complication Within the First Posttransplant Year and Causes of Death for 54 DBD-SLK Patients and 12 DCD-SLK Patients DBD-SLK DCD-SLK All (n 5 66) Group (n 5 54) Group (n 5 12) P Value* Hospitalization (days) Hospital stay 12 (6-86) 12 (7-78) 11.5 (6-86) 0.53 Intensive care unit stay 3 (0-43) 3 (0-30) 3 (0-43) 0.95 Surgical complications [n (%)] Primary liver nonfunction 1 (2) 0 (0) 1 (8) 0.18 Wound infection 9 (14) 7 (13) 2 (17) 0.66 Lymphocele 3 (5) 3 (6) 0 (0) 0.99 Biliary complications 9 (14) 6 (11) 3 (25) 0.35 Urological complications 7 (11) 7 (13) 0 (0) 0.33 Vascular complications 6 (9) 6 (11) 0 (0) 0.58 Reoperation 15 (23) 11 (20) 4 (33) 0.45 Biliary duct revision 2 (3) 0 (0) 2 (17) Postoperative bleeding 6 (9) 4 (7) 2 (17) Allograft nephrectomy 2 (3) 2 (4) 0 (0) Other 5 (8) 5 (4) 0 (0) Kidney DGF 17 (26) 12 (22) 5 (42) 0.14 Medical complications [n (%)] Rejection, kidney 8 (12) 6 (11) 2 (17) 0.63 Rejection, liver 20 (30) 18 (33) 2 (17) 0.32 Cytomegalovirus viremia 11 (17) 9 (17) 2 (17) 0.99 Bacteremia/fungemia 12 (18) 8 (15) 4 (33) 0.21 Peritonitis 11 (17) 6 (11) 5 (42) 0.02 Polyoma virus-associated nephropathy 5 (8) 3 (6) 2 (17) 0.71 Posttransplant diabetes 14 (21) 13 (24) 1 (8) 0.63 Causes of death [n (%)] 0.58 Sepsis/infection 8 (57) 5 (50) 3 (75) Other 6 (43) 5 (50) 1 (25) *Between the DBD-SLK and DCD-SLK groups. The data are presented as medians and ranges. higher patient and graft attrition at 3 and 5 years; this observation was confirmed by the OPTN analysis. The results of the OPTN analysis indicate that these inferior long-term outcomes are not center-specific and represent an overall trend for DCD-SLK transplantation. The reasons for the inferior late patient survival are not currently known because pretransplant patient characteristics, MELD scores at the time of SLK transplantation, operative times, cold ischemia times, warm ischemia times, and peritransplant surgical and medical complication rates were comparable between the DCD-SLK and DBD-SLK groups at our center. SLK transplants are performed in patients with advanced liver disease and significant renal dysfunction or failure. In these patients, early recovery of the renal graft is crucial because of the effect of posttransplant renal failure on overall transplant outcomes DGF was twice as common in the DCD-

7 734 WADEI ET AL. LIVER TRANSPLANTATION, June 2014 SLK group versus the DBD-SLK group, but because of the limited number of DCD-SLK patients with DGF, we could not determine whether DGF affected longterm outcomes. Although it is unlikely that DGF alone could have resulted in the inferior results of the DCD- SLK group because kidney function at 1 month and 1 year was comparable between the DCD-SLK and DBD-SLK groups, we cannot exclude the idea that the interaction between renal allograft DGF and early liver graft dysfunction could have adversely affected the DCD-SLK outcomes. 23 In addition to the efforts by the transplant community to increase organ availability, the issue of allocating organs to maximize the benefit to individual patients should be considered. This study raises a serious dilemma about the best way to use DCD organs. An important question raised by the current study is whether organs from DCD donors should be TABLE 5. Number of DCD-SLK Transplants Performed in the United States by Year Between January 1, 2000 and December 31, 2010 DCD-SLK Transplant Year Transplants [n (%)] (0) (1.1) (3.2) (1.1) (7.4) (11.7) (12.8) (12.8) (11.7) (20.2) (18.1) Total 94 (100.0) NOTE: Based on OPTN data as of June 28, allocated for solitary kidney and solitary liver transplants only because our experience indicates that the transplantation of these organs is associated with long-term patient and graft survival comparable to that associated with transplants from DBD donors. We reviewed our center s experience with solitary DCD kidney and liver transplantation in the same time period in an effort to address this question. Between 1998 and 2010, we performed 1862 solitary liver transplants and 747 solitary kidney transplants. One hundred ninety-five of these liver transplants and 102 of these kidney transplants were performed with DCD donors. The overall 1-, 3-, and 5-year patient and graft survival rates were comparable for solitary liver and kidney transplants using DCD and DBD organs (Supporting Table 1). These findings indicate that DCD organs may be best used for solitary liver or kidney transplantation. One advantage of DCD organs is the potentially shorter waiting time for transplantation, which can be crucial in select situations. In our experience, the waiting times were similar for the DBD-SLK and DCD-SLK groups, and this indicates that DCD organ utilization had no effect on the waiting time in our UNOS region. Overall, whether accepting DCD organs for SLK transplantation constitutes the best use of these organs is an important question that we cannot answer definitively on the basis of the small number of patients who underwent SLK transplantation. This question, however, should be the subject of future investigations with a larger number of patients. The current study is limited by its retrospective nature and the small number of patients in the DCD- SLK transplant group. However, our transplant center performed 13% of the DCD-SLK transplants in the United States between 2000 and 2010, and our results parallel the overall national data concerning DCD-SLK transplantation. Future studies using a larger group of patients should be directed at identifying the reasons for the inferior long-term patient and graft survival rates associated with DCD-SLK TABLE 6. Patient and Graft Survival Rates and 95% Confidence Intervals for SLK Transplants Performed in the United States Between January 1, 2000 and December 31, 2010 Survival DBD-SLK Group (n ) DCD-SLK Group (n 5 94) 95% Confidence Survival 95% Confidence Rate (%) Interval Rate (%) Interval P Value Patient survival 1 year years Kidney graft survival 1 year years Liver graft survival 1 year years NOTE: Based on OPTN data as of June 28, 2013.

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