Influence of Minimally Invasive Resection Technique on Sphincter Preservation and Short-term Outcome in Low Rectal Cancer in the Netherlands.

BACKGROUND: Transanal and robotic-assisted total mesorectal excision are techniques that can potentially overcome challenges encountered with a pure laparoscopic approach in patients with rectal cancer. OBJECTIVE: The aim of this study was to evaluate the proportion and predictive factors of restorative procedures and subsequent short-term outcomes of 3 minimally invasive techniques to treat low rectal cancer. DESIGN: This is a nationwide observational comparative registry study. SETTINGS: Patients with rectal cancer were selected from the mandatory Dutch ColoRectal Audit. PATIENTS: Patients with low rectal cancer (≤5 cm) who underwent curative minimally invasive total mesorectal excision between 2015 and 2018 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the proportion of restorative procedure, positive circumferential resection margin, and postoperative complications. RESULTS: A total of 3466 patients were included for analysis, of which 33% underwent a restorative procedure. Resections were performed laparoscopically in 2845 patients, transanally in 448 patients, and were robot-assisted in 173 patients, with a proportion of restorative procedures of 28%, 66%, and 40%. The transanal approach was independently associated with a restorative procedure (OR, 4.11; 95% CI, 3.21-5.26; p < 0.001). Independent risk factors for a nonrestorative procedure, irrespective of the surgical technique, were age >75 years, ASA physical status ≥3, BMI >30, history of abdominal surgery, clinical T4-stage, mesorectal fascia ≤1 mm, neoadjuvant therapy, and having a procedure in 2015 to 2016 versus 2017 to 2018. The circumferential resection margin involvement was similar for all 3 groups (5.4%, 5.1%, and 5.1%). Short-term postoperative complications were less favorable for the newer techniques than for the laparoscopic approach. LIMITATIONS: This study was limited because of the registry's variables and different group sizes. CONCLUSION: Patients with low rectal cancer in the Netherlands are more likely to receive a restorative procedure with a transanal approach, compared with a laparoscopic or robotic procedure. Short-term oncological outcomes are comparable between the 3 minimally invasive techniques. See Video Abstract at http://links.lww.com/DCR/B608. INFLUENCIA DE LA TCNICA DE RESECCIN MINIMAMENTE INVASIVA CON PRESERVACIN DE ESFNTERES EN LA RESOLUCIN A CORTO PLAZO EN CANCER DE TERCIO INFERIOR DE RECTO EN LOS PASES BAJOS: ANTECEDENTES:La excisión mesorrectal transanal y asistida por robot son técnicas que potencialmente pueden superar algunos obstáculos que podemos encontrar en un abordaje exclusivamente laparoscópico en pacientes con cáncer de recto.OBJECTIVOS:El objetivo de este estudio es evaluar la proporción y los factores de predicción positivos de los procedimientos restauradores y los resultados subsecuentes a corto plazo de tres técnicas mínimamente invasivas para tratar el cáncer de tercio inferior de recto.DISEÑO:Es un estudio comparativo observacional del registro nacional.ESCENARIO:Pacientes con cáncer de recto seleccionados del Registro Oficial de la Auditoría Holandesa Colo-rectal.PACIENTGES:Pacientes con cáncer de tercio inferior de recto (≤5 centimetros) sometidos a excision mesorrectal total mínimamente invasiva curativa.PRINCIPALES PARAMETROS DE EFECTIVIDAD:Proporción de procedimientos restauradores, margen de resección circunferencial positivo y complicaciones postoperatorias.RESULTADOS:Se incluyeron un total de 3,466 pacientes para análisis, de los cuales 33% fueron sometidos a procedimiento restaurador. Las resecciones fueron laparoscópica en 2,845 pacientes, transanal en 448 y asistidas por robot en 173, con una proporción de procedimientos restauradores en 28%, 66% y 40% respectivamente. El abordaje transanal se correlacionó en forma independiente con el procedimiento restaurador (OR 4.11; 95% CI 4.11; 95% CI 3.21-5.26; p<0.001). Los factores de riesgo independientes para un procedimiento no restaurador, sin tomar en cuenta la técnica quirúrgica fueron: edad >75, American Society of Anesthesiologist ≥3, índice de masa corporal >30, antecedente de cirugía abdominal, Estadio clínico T4, fascia mesorrectal ≤1 millimetro, terapia neoadyuvante y haber sido sometido al procedimiento en 2015-2016 y no en 2017-2018. El margen circunferencial de resección involucrado fue similar para los tres grupos (5.4%, 5.1% y 5.1%). Las complicaciones postquirúrgicas a corto plazo fueron menos favorables para las técnicas nuevas comparadas con el abordaje laparoscópico.LIMTANTES:El estudio tiene la limitación de las variables dependientes del registro y la diferencia entre el número de pacientes en cada grupo.CONCLUSION:Los pacientes con cáncer de tercio inferior de recto en Holanda se tratan con mayor frecuencia mediante un procedimiento restaurador transanal en comparación con los abordajes laparoscópico o robótico. Los resultados favorables desde el punto de vista oncológico a corto plazo son comparables entre las tres técnicas de invasión mínima. Consulte Video Resumenhttp://links.lww.com/DCR/B608.

Delayed Implantation of Pumped Kidneys Decreases Renal Allograft Futility in Combined Liver-Kidney Transplantation.

BACKGROUND: Combined liver-kidney transplantation (CLKT) improves survival for liver transplant recipients with renal dysfunction; however, the tenuous perioperative hemodynamic and metabolic milieu in high-acuity CLKT recipients increases delayed graft function and kidney allograft failure. We sought to analyze whether delayed KT through pumping would improve kidney outcomes following CLKT. METHODS: A retrospective analysis (University of California Los Angeles [n = 145], Houston Methodist Hospital [n = 79]) was performed in all adults receiving CLKT at 2 high-volume transplant centers from February 2004 to January 2017, and recipients were analyzed for patient and allograft survival as well as renal outcomes following CLKT. RESULTS: A total of 63 patients (28.1%) underwent delayed implantation of pumped kidneys during CLKT (dCLKT) and 161 patients (71.9%) received early implantation of nonpumped kidneys during CLKT (eCLKT). Most recipients were high-acuity with median biologic model of end-stage liver disease (MELD) score of, 35 for dCLKT and 34 for eCLKT (P = ns). Pretransplant, dCLKT had longer intensive care unit stay, were more often intubated, and had greater vasopressor use. Despite this, dCLKT exhibited improved 1-, 3-, and 5-year patient and kidney survival (P = 0.02) and decreased length of stay (P = 0.001), kidney allograft failure (P = 0.012), and dialysis duration (P = 0.031). This reduced kidney allograft futility (death or continued need for hemodialysis within 3 mo posttransplant) for dCLKT (6.3%) compared with eCLKT (19.9%) (P = 0.013). CONCLUSIONS: Delayed implantation of pumped kidneys is associated with improved patient and renal allograft survival and decreased hospital length of stay despite longer kidney cold ischemia. These data should inform the ethical debate as to the futility of performing CLKT in high-acuity recipients.

Salvage Surgery With Organ Preservation for Patients With Local Regrowth After Watch and Wait: Is It Still Possible?

BACKGROUND: Patients with rectal cancer who achieve complete clinical response after neoadjuvant chemoradiation have been managed nonoperatively. Thirty percent of these patients may develop a local regrowth, and salvage resection with radical surgery is usually recommended. However, selected patients could be offered additional organ preservation by local excision. We hypothesized that patients with baseline T2 who underwent neoadjuvant therapy (for the specific purpose of achieving a complete clinical response) were more likely to harbor recurrent disease at an earlier stage and amenable to organ preservation strategies (local excision) when compared with T3/T4 (undergoing neoadjuvant chemoradiation for oncologic reasons). OBJECTIVE: The purpose of this study was to compare patients with local regrowth requiring salvage resection according to their baseline stage. DESIGN: This was a retrospective review of consecutive patients with nonmetastatic distal rectal cancer undergoing neoadjuvant chemoradiation. SETTINGS: The study included 2 independent tertiary centers with institutional watch-and-wait organ preservation programs. PATIENTS: Consecutive patients with distal rectal cancer (cT2-4N1-2M0) managed by watch and wait and local regrowth from 2 institutions were included. MAIN OUTCOMES MEASURES: Final pathologic features and surgical and oncologic outcomes were compared according to baseline staging. RESULTS: A total of 73 of 257 patients experienced local regrowth. cT2 presented similar to ypT, ypN, R0, and abdominal perineal resection rates (p > 0.05) at the time of salvage when compared with cT3 to cT4. Patients with cT2 at baseline were more likely to undergo an organ preservation procedure for salvage (56.2% vs 26.5%; p = 0.03). Overall and disease-free survival after salvage were similar between groups irrespective of the type of surgery for the regrowth. LIMITATIONS: Retrospective study, small sample size, and possible inaccurate baseline staging. CONCLUSIONS: Although patients with baseline cT2 rectal cancer had similar pathologic stage at the time of recurrence, these patients were more likely to continue an organ preservation pathway after local regrowth through transanal local excision when compared with cT3 to cT4. Despite differences in the use of radical salvage resection, there were no differences in oncologic outcomes. See Video Abstract at http://links.lww.com/DCR/B254. CIRUGÍA DE RESCATE CON PRESERVACIÓN DE ORGANO PARA PACIENTES CON RECIDIVA LOCAL LUEGO DE WATCH & WAIT: ¿SIGUE SIENDO POSIBLE?: Los pacientes con cáncer rectal que logran una respuesta clínica completa luego de la quimiorradiación neoadyuvante han sido tratados de forma no quirúrgica. El treinta por ciento de estos pacientes pueden desarrollar un nuevo crecimiento local y generalmente se recomienda la resección de rescate con cirugía radical. Sin embargo, en pacientes seleccionados se podría ofrecer la posibilidad de preservación de órgano mediante escisión local. Se formuló la hipótesis de que los pacientes con estadio clinico inicial T2 y sometidos a terapia neoadyuvante (con el propósito específico de lograr una respuesta clínica completa) tenían más probabilidades de presentar una recurrencia local en una etapa más temprana y suceptibles de estrategias de preservación de órgano (escisión local) en comparación con T3 / T4 (sometidos a nCRT por razones oncológicas).Comparar los pacientes con recidiva local que requirieron cirugia de rescate de acuerdo con su estadio inicial.Revisión retrospectiva de pacientes consecutivos con cáncer de recto distal no metastásico sometidos a quimiorradiación neoadyuvante.Dos centros terciarios independientes con programas institucionales de preservación de órgano - Watch & Wait.Pacientes consecutivos con cáncer rectal distal (cT2-4N1-2M0) manejados por Watch & Wait y recidiva local.Las características patológicas finales, los resultados quirúrgicos y oncológicos se compararon de acuerdo con la estadificación inicial.Un total de 73 de 257 pacientes presentaron recidiva local. cT2 presentaron similares ypT, ypN, R0 y tasas de resección abdominoperineal (p>0,05) en el momento del rescate en comparación con cT3-4.Los pacientes con cT2 de base tuvieron más probabilidades de someterse a un procedimiento de preservación de órgano durante el rescate (56,2% frente a 26,5%; p = 0,03). Supervivencia general y DFS después del rescate fueron similares entre los grupos, independientemente del tipo de cirugía para la recidiva.Estudio retrospectivo, tamaño de muestra pequeño, la posible estadificación basal inexacta.Aunque los pacientes con cáncer rectal cT2 de base presentaron estadio patologico similar en el momento de la recidiva, estos pacientes tuvieron más probabilidades de continuar una vía de preservación de órgano luego de una recidiva local a través de la escisión local transanal en comparación con cT3-4. A pesar de las diferencias en el uso de la resección radical de rescate, no hubo diferencias en los resultados oncológicos. Consulte Video Resumen en http://links.lww.com/DCR/B254.

Transplantation of discarded livers following viability testing with normothermic machine perfusion.

There is a limited access to liver transplantation, however, many organs are discarded based on subjective assessment only. Here we report the VITTAL clinical trial (ClinicalTrials.gov number NCT02740608) outcomes, using normothermic machine perfusion (NMP) to objectively assess livers discarded by all UK centres meeting specific high-risk criteria. Thirty-one livers were enroled and assessed by viability criteria based on the lactate clearance to levels ≤2.5 mmol/L within 4 h. The viability was achieved by 22 (71%) organs, that were transplanted after a median preservation time of 18 h, with 100% 90-day survival. During the median follow up of 542 days, 4 (18%) patients developed biliary strictures requiring re-transplantation. This trial demonstrates that viability testing with NMP is feasible and in this study enabled successful transplantation of 71% of discarded livers, with 100% 90-day patient and graft survival; it does not seem to prevent non-anastomotic biliary strictures in livers donated after circulatory death with prolonged warm ischaemia.

Endoscopic Step Up: A Colon-Sparing Alternative to Colectomy to Improve Outcomes and Reduce Costs for Patients With Advanced Neoplastic Polyps.

BACKGROUND: The optimal strategy for colonic polyps not amenable to traditional endoscopic polypectomy is unknown. Endoscopic step up is a promising strategy for definitive treatment. OBJECTIVE: The purpose of this study was to determine whether endoscopic step up leads to improved outcomes and decreased costs compared with planned colectomy for endoscopically unresectable colon polyps. DESIGN: This was a retrospective review of a prospective database. SETTING: The study was conducted at a tertiary referral center. PATIENTS: Consecutive patients referred for endoscopically unresectable colon polyps 15 to 50 mm in size were included. INTERVENTIONS: Patients underwent planned colectomy or endoscopic step up at the surgeon's discretion. Endoscopic step up began with diagnostic colonoscopy in the operating room. If the polyp was amenable to endoscopic removal, endoscopic mucosal resection or endoscopic submucosal dissection was performed with progression to combined endoscopic-laparoscopic surgery or laparoscopic colectomy, as indicated. MAIN OUTCOME MEASURES: The primary outcome was 30-day adverse events. We also examined length of stay, hospital charges, insurer payments, and polyp recurrence. RESULTS: A total of 52 patients underwent planned colectomy (48 laparoscopic), and 38 underwent endoscopic step up (28 endoscopic mucosal resection, 2 endoscopic submucosal dissection, 6 combined endoscopic-laparoscopic surgery, and 2 colectomy). Compared with planned colectomy, endoscopic step-up patients had fewer complications (13% vs 33%; p = 0.03) and shorter length of stay (median, 0 vs 4 d; p < 0.001). There was 1 readmission in the endoscopic step-up group and 5 in the planned colectomy group. Endoscopic step-up patients had lower hospital costs ($4790 vs $13,004; p < 0.001) and insurer payments ($2431 vs $19,951; p < 0.001). One-year polyp recurrence-free survival was 84% (95% CI, 67%-93%) in endoscopic step-up patients. All of the recurrences were benign, <1 cm, and managed endoscopically. LIMITATIONS: The study was limited by its nonrandomized design and short follow-up. CONCLUSIONS: An endoscopic step-up approach to colon polyps is associated with less morbidity, decreased healthcare costs, and colon preservation in 95% of patients. Additional studies are needed to evaluate long-term quality of life and polyp recurrence in this group. See Video Abstract at http://links.lww.com/DCR/B188. ENDOSCOPIC STEP UP: UNA ALTERNATIVA A COLECTOMíA PARA PRESERVACIóN DE COLON CON LOS PROPóSITOS DE MEJORAR RESULTADOS Y REDUCIR COSTOS EN PACIENTES CON PóLIPOS NEOPLáSICOS AVANZADOS: Se desconoce la estrategia óptima para los pólipos de colon no susceptibles a la polipectomia endoscópica tradicional. Endoscopic Step Up es una estrategia prometedora para el tratamiento definitivo.Determinar si Endoscopic Step Up produce mejores resultados y menores costos en comparación con la colectomía programada para pólipos de colon endoscópicamente no resecables.Revisión retrospectiva de una base de datos prospectiva.Centro de referencia de tercer nivel.Pacientes consecutivos remitidos para pólipos de colon endoscópicamente irresecables de tamaño 15-50 mm.Los pacientes se sometieron a colectomía programada o Endoscópico Step Up a discreción del cirujano. Endoscopic Step Up comenzó con una colonoscopia diagnóstica en el quirófano. Si el pólipo era susceptible de extirpación endoscópica, la resección endoscópica de la mucosa o la disección submucosa endoscópica se realizaba con progresión a cirugía endoscópica-laparoscópica combinada o colectomía laparoscópica, según a cosnideraciones clínicas en el transoperatorio.El resultado primario fue los eventos adversos a 30 días. Duración de la estadía hospitalaria, los cargos hospitalarios, los pagos de las aseguradoras y la recurrencia de pólipos también fueron examinados.Un total de 52 pacientes se sometieron a colectomía programada (48 laparoscópicas) y 38 se sometieron a Endoscopic Step Up (28 resección endoscópica de la mucosa, 2 disección submucosa endoscópica, 6 cirugía endoscópica-laparoscópica combinada y 2 colectomía). En comparación con la colectomía programada los pacientes endoscópicos Step Up tuvieron menos complicaciones (13% versus 33%, p = 0.03) y una estadía hospitalaria más corta (mediana 0 versus 4 días, p <0.001). Hubo 1 reingreso hospitalario en el grupo Endoscopic Step Up y 5 en el grupo de colectomía programada. Los pacientes endoscópicos Step Up tuvieron costos hospitalarios más bajos ($ 4,790 versus $ 13,004, p <0,001) y pagos de la aseguradora ($ 2,431 versus $ 19,951, p <0,001). La supervivencia libre de recurrencia de pólipos a un año fue del 84% (IC 95% 67-93) en pacientes endoscópicos Step Up. Todas las recurrencias fueron benignas, <1 cm, y manejadas endoscópicamente.Diseño no aleatorizado y seguimiento corto.El abordaje endoscópico Step Up para pólipos de colon se asocia con menos morbilidad, disminución de los costos de atención médica y preservación del colon en el 95% de los pacientes. Se ocupan más estudios para evaluar la calidad de vida a largo plazo y la recurrencia de pólipos en este grupo. Consulte Video Resumen en http://links.lww.com/DCR/B188. (Traducción-Dr Adrián Ortega Robles).

Retrieval Practice or Overall Donor and Recipient Risk: What Impacts on Outcomes After Donation After Circulatory Death Liver Transplantation in the United Kingdom?

Parameters of retrieval surgery are meticulously documented in the United Kingdom, where up to 40% of livers are donation after circulatory death (DCD) donations. This retrospective analysis focuses on outcomes after transplantation of DCD livers, retrieved by different UK centers between 2011 and 2016. Donor and recipient risk factors and the donor retrieval technique were assessed. A total of 236 DCD livers from 9 retrieval centers with a median UK DCD risk score of 5 (low risk) to 7 points (high risk) were compared. The majority used University of Wisconsin solution for aortic flush with a median hepatectomy time of 27-44 minutes. The overall liver injury rate appeared relatively high (27.1%) with an observed tendency toward more retrieval injuries from centers performing a quicker hepatectomy. Among all included risk factors, the UK DCD risk score remained the best predictor for overall graft loss in the multivariate analysis (P < 0.001). In high-risk and futile donor-recipient combinations, the occurrence of liver retrieval injuries had negative impact on graft survival (P = 0.023). Expectedly, more ischemic cholangiopathies (P = 0.003) were found in livers transplanted with a higher cumulative donor-recipient risk. Although more biliary complications with subsequent graft loss were found in high-risk donor-recipient combinations, the impact of the standardized national retrieval practice on outcomes after DCD liver transplantation was minimal.

Kidney transplantation from donors after uncontrolled circulatory death: the Spanish experience.

Donation after uncontrolled circulatory death (uDCD) refers to donation from persons who have died following cardiac arrest and unsuccessful attempt at resuscitation. We report the Spanish experience of uDCD kidney transplantation, and identify factors related to short-term post-transplant outcomes. The Spanish CORE system compiles data on all donation and transplant procedures in the country. Between 2012-2015, 517 kidney transplants from 288 uDCD donors were performed. The incidence of primary non-function was 10%, and the incidence of delayed graft function was 76%. One-year death-censored graft survival was 87%. In a Cox-Model, donor age ≥ 60 years (odds ratio [OR] 2.7; 95% confidence interval [CI] 1.2-6.1), in situ cooling of kidneys versus normothermic regional perfusion (OR 5.6; 95% CI 2.7-11.5) or hypothermic regional perfusion based on the use of extracorporeal membrane oxygenation devices (OR 4.3; 95% CI 2.1-8.6), and a recipient history of prior kidney transplant (OR 3.5; 95% CI 1.5-8.3) all significantly increased the risk of graft loss during the first year after transplantation. Kidney transplantation from uDCD donors provides acceptable 1-year outcomes, although there is room for improvement. Hypothermic and normothermic regional perfusion strategies are preferable to in situ cooling of kidneys from uDCD donors.

Chronological Factors of the Process of Donation and Classification of Corneal Tissue.

INTRODUCTION: The quality of corneal tissue is influenced by several factors inherent to the recipient, donor, donation process, and transplantation that may primarily or secondarily interfere in the survival of a corneal graft. OBJECTIVE: The objective of this study was to identify the factors inherent to the donation process, specifically related to the harvesting and processing of tissue and to the donor, that may interfere with the quality of corneal tissue. MATERIALS AND METHODS: This was a cross-sectional, descriptive, and analytical study carried out from January to April 2015 at the Onofre Lopes University Hospital, Natal/RN, Brazil. A survey of the keratoplasties performed between the years 2010 and 2014 was carried out, totaling 258 donated corneas. RESULTS: The mean age of donors was 42.08 years, ranging from 2-80 years. As for quality, 64.45% of the corneas were classified as good, 23.05% as regular, 11.33% as poor, and 1.17% as excellent. The mean time between death and preservation was approximately 7 hours and 15 minutes, and the mean time elapsed until use was 10 days after immersion in preservation medium. DISCUSSION AND CONCLUSIONS: Factors inherent in the donation process that may interfere with the quality of the corneal graft correspond to factors of a chronological nature: donor age and time elapsed between death and preservation of the graft.

Optimizing outcomes in pancreas transplantation: Impact of organ preservation time.

Recent changes to pancreas graft allocation policy have increased the number of organs available for regional and distant sharing, which results in a corresponding increase in preservation time. We sought to systematically assess the impact of cold ischemia time (CIT) on outcomes post-transplant. A retrospective review of 1253 pancreas transplants performed at a single transplant center was performed to correlate CIT to transplant outcomes. The rate of technical failure (TF) increased with 20+ hours of CIT, with a 2.7-fold to 6.2-fold increased rate of TF for pancreas after kidney (PAK), simultaneous pancreas and kidney (SPK), and pancreas transplants overall. Long-term graft survival was best with <12 hours of CIT; graft failure increased 1.2-fold to 1.4-fold with 12-24 hours of CIT and 2.2-fold with 24+ hours. CIT had less influence on the pancreas transplant alone category than either SPK or PAK and had markedly more influence on grafts from older (age >25 years) and overweight (body mass index >25) donors. In the final analysis, grafts with <12 hours of CIT performed the best overall, and strategies that reduce CIT (such as early allocation, pre-recovery cross-matching, and chartered flights for organs) should be considered whenever possible.

Survival analysis of 287 oropharyngeal squamous cell carcinoma patients in a single institution: a retrospective comparison of two consecutive time intervals with surgical and conservative treatment approaches.

This study is a retrospective analysis of clinico-pathological data to investigate survival rates of patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with different modalities in a single academic head and neck cancer center in different time intervals. Altogether, 287 patients with OPSCC were included in this comparison. Patients were analysed during two different treatment periods: Group 1 included patients treated mainly with primary surgery ± adjuvant radio(chemo)therapy between 2002 and 2007, while Group 2 included patients treated with organ/function-preservation protocols if indicated. Main outcome measures were overall survival (OS) and recurrence-free survival (RFS). Between 2002 and 2007, early-stage OPSCC showed a 5-year OS of 75% compared to that of 86% between 2008 and 2013. Locally advanced OPSCC showed a 5-year OS of 66% between 2002 and 2007 compared to that of 74% between 2008 and 2013. RFS in early-stage OPSCC was 48% between 2002 and 2007 in contrast to that of 77% between 2008 and 2013. With locally advanced OPSCC, RFS was 55% between 2002 and 2007 compared to that of 56% between 2008 and 2013. These differences were statistically not significant. The OS and RFS remained generally unchanged over the analysed time period. There was no significant difference in the outcomes with regards to HPV status and to their treatment modality.

Impact of Cold Ischemia Time on Outcomes of Liver Transplantation: A Single Center Experience.

BACKGROUND: Significant geographic disparities exist in access to liver transplantation and consequently the current liver allocation system is being challenged. We sought to describe our unique experience with using organs with long cold ischemia times from the largest donation service area. MATERIAL AND METHODS: From 2009-2014 we performed 350 liver transplants. 167 (48%) had a cold ischemia time <8 hours, 134 (38%) between 8 and 12 hours, and 49 (14%) greater than 12 hours. RESULTS: Early allograft dysfunction was observed more commonly with increasing cold ischemia times. 53% of the recipients in the >12 h group had early allograft dysfunction compared to 28% in the 8-12 h group, and 18% in the <8 h group (P<0.001). We found no correlation between early allograft dysfunction and allograft or patient survival. One-year liver allograft survival was 92%, 94%, 87%, three-year graft survival was 82%, 89%, and 87%, and five-year graft survival was 82%, 89%, and 79% in the <8 h, 8-12 h, and >12 h cold ischemia time groups, respectively. One-year patient survival was 95%, 94%, and 92% and five-year patient survival was 90%, 89%, and 83% in the <8 h, 8-12 h, and >12 h cold ischemia time groups, respectively. Both unadjusted and multivariate Cox regression analyses indicated no statistically significant associations between cold ischemia time and graft or patient survival. CONCLUSIONS: In conclusion, the prolonged cold ischemia time led to early allograft dysfunction but did not have a deleterious association with graft or patient survival.

Recommendations for donation after circulatory death kidney transplantation in Europe.

Donation after circulatory death (DCD) donors provides an invaluable source for kidneys for transplantation. Over the last decade, we have observed a substantial increase in the number of DCD kidneys, particularly within Europe. We provide an overview of risk factors associated with DCD kidney function and survival and formulate recommendations from the sixth international conference on organ donation in Paris, for best-practice guidelines. A systematic review of the literature was performed using Ovid Medline, Embase and Cochrane databases. Topics are discussed, including donor selection, organ procurement, organ preservation, recipient selection and transplant management.

Machine perfusion: not just for marginal kidney donors.

Interest in machine perfusion (MP) for donated kidneys has markedly increased in the past decade as a means to improve graft function, although the donor populations in which it should be applied have not yet been resolved. All adults undergoing de-novo isolated kidney transplantation from standard-criteria donors in the UNOS database 2005 to 2011 were reviewed with the primary endpoint of delayed graft function (DGF), defined as dialysis within seven days of transplantation, in those who received kidneys that underwent MP versus cold storage (CS) alone. Three methods were used to control for differences between groups. Multivariable logistic regression was performed, adjusting for donor and recipient characteristics significantly associated with DGF. Rates were also compared in a cohort of propensity-matched MP vs CS recipients. Finally, a paired-kidney study was performed, where one kidney underwent MP and the contralateral underwent CS. There were 36,323 patients, with unadjusted DGF rates of 18.6 per cent (n = 1830/9882) and 22.4 per cent (n = 5931/26,441; P < 0.001) in the MP vs CS groups, respectively. After multivariable analysis, the odds ratio for DGF in the MP group was 0.59 (P < 0.001) versus CS. In the propensity-matched cohort, there were 8929 patients each in the MP and CS groups. DGF occurred in 16.8 per cent of the MP group vs 25.3 per cent with CS (P < 0.001, OR 0.59). In the paired-kidney study, rates of DGF were 16.7 per cent vs 24.3 per cent (P < 0.001) in the 1665 recipients each in the MP versus CS groups (OR 0.6). In conclusion, machine perfusion is beneficial in reducing DGF even when standard donors are utilized, and thus should not be limited to marginal kidneys.

Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

BACKGROUND: The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. METHODS: We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. FINDINGS: Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. INTERPRETATION: Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. FUNDING: TransMedics.

Living donor bone banking: processing and discarding--from procurement to therapeutic use.

Skeletal muscle and osteoarticular tissue banks are responsible to procure, process, store and distribute tissues, from living and cadaveric donors. The procedures involve the application of protocols covering all aspects of the banking, ensuring the best tissue quality and maximum safety for the recipient. An analysis on the causes of bone tissue discarded by Biotar Tissue Bank between January 2005 and December 2012 was carried. Bone tissue was obtained from both hip and knee replacement (femoral heads and tibial plateau respectively) in living donors treated at different medical-surgical institutions in Argentina. These tissues were processed at the Bank to produce both frozen and lyophilized cancellous bone. Out of 3413 donated bones received by the Bank, 77.55 % resulted in final product, while the remaining 22.44 % was discarded in compliance with the quality standards of both the Bank and the regulatory authority. Comparing the last and the first year of the studied period, the number of discarded tissue increased 3.6 times, while the number of collected bones was approximately 10 times higher. Related to total disposed tissue, reactive serology was the most frequent cause (62.14 %), followed by inappropriate collection/storage of blood sample (30.81 %). A progressive reduction in the percentages of total discard was observed, and this was proportional to inappropriate collection/storage of blood sample. No significant differences were found in the discard rates due to positive serology throughout all the years studied. The success of a tissue bank requires full commitment of all the personnel especially the team members responsible for donor selection and the processing of allografts. It is important to critically screen donors in the early stages of donor recruitment. All of the procedures carried out by the tissue bank are parts of the quality control system which must be strictly carried out. Biotar Tissue Bank is continuously committed to ensure safety to the recipients.

Lung transplantation from donors after circulatory death using portable ex vivo lung perfusion.

BACKGROUND: Donation after circulatory death is a novel method of increasing the number of donor lungs available for transplantation. Using organs from donors after circulatory death has the potential to increase the number of transplants performed. METHODS: Three bilateral lung transplants from donors after circulatory death were performed over a six-month period. Following organ retrieval, all sets of lungs were placed on a portable ex vivo lung perfusion device for evaluation and preservation. RESULTS: Lung function remained stable during portable ex vivo perfusion, with improvement in partial pressure of oxygen/fraction of inspired oxygen ratios. Mechanical ventilation was discontinued within 48 h for each recipient and no patient stayed in the intensive care unit longer than eight days. There was no postgraft dysfunction at 72 h in two of the three recipients. Ninety-day mortality for all recipients was 0% and all maintain excellent forced expiratory volume in 1 s and forced vital capacity values post-transplantation. CONCLUSION: The authors report excellent results with their initial experience using donors after circulatory death after portable ex vivo lung perfusion. It is hoped this will allow for the most efficient use of available donor lungs, leading to more transplants and fewer deaths for potential recipients on wait lists.

Survival extrapolation using the poly-Weibull model.

Recent studies of (cost-) effectiveness in cardiothoracic transplantation have required estimation of mean survival over the lifetime of the recipients. In order to calculate mean survival, the complete survivor curve is required but is often not fully observed, so that survival extrapolation is necessary. After transplantation, the hazard function is bathtub-shaped, reflecting latent competing risks which operate additively in overlapping time periods. The poly-Weibull distribution is a flexible parametric model that may be used to extrapolate survival and has a natural competing risks interpretation. In addition, treatment effects and subgroups can be modelled separately for each component of risk. We describe the model and develop inference procedures using freely available software. The methods are applied to two problems from cardiothoracic transplantation.

[Organ and kidney function preservation in renal cell carcinoma]. / Organ- und Funktionserhalt beim Nierenzellkarzinom.

BACKGROUND: The organ-preserving partial nephrectomy has increasingly established itself in small unilateral renal tumours (<4 cm) with contralateral healthy kidney and counter gained in recent years in importance. There was found a significantly increased cardiovascular mortality rate and deteriorated quality of life, the more intact kidney tissue has been removed. OBJECTIVES: In the present study, the influence of pre- and perioperative factors on direct postoperative course was examined, including 5-year survival rate and relapse behaviour after open organ-preserving partial nephrectomy in our own collective. MATERIALS AND METHODS: In this retrospective study of 1657 patients were collected, who underwent surgery between 2007 and 2013 in the Department of Urology at the University Hospital Essen because of a renal tumour. 38 % of these operations (n = 636) were performed organ-preserving. In this trial there are factors identified that have an impact on need of blood transfusion and length of hospitalization in organ-preserving operation method. RESULTS: No independent parameter can be determined for the need of blood transfusion. Tumour size and thus time of resection procedure does not affect the need of erythrocytes administration. In addition, the tumour size influences neither the postoperative serum-haemoglobin nor serum-creatinine. Increased patient age and female gender are identified as non-modifiable factors, which cause a longer hospitalisation. Postoperative pain therapy can be considered as a variable size, which does not affect the length of hospital stay. Modifiable factors that increase the overall length of stay, however, are the type of direct postoperative monitoring (ICU vs. anaesthetic recovery room) and the administration of blood transfusions. CONCLUSIONS: There are constant factors, which can be associated with a longer residence time in the framework of an organ-preserving partial nephrectomy. Further there is shown evidence of the independence of the tumour size - in addition to proven good oncological results - of an extension of indication of organ-preserving nephrectomy of tumours > 4 cm.

Normothermic ex vivo allograft blood perfusion in clinical heart transplantation.

BACKGROUND: Cold ischemia associated with cold static storage is an independent risk factor for primary allograft failure and survival of patients after orthotopic heart transplantation. The effects of normothermic ex vivo allograft blood perfusion on outcomes after orthotopic heart transplantation compared to cold static storage have been studied. METHODS: In this prospective, nonrandomized, single-institutional clinical study, normothermic ex vivo allograft blood perfusion has been performed using an organ care system (OCS) (TransMedics, Andover, MA, USA). Included were consecutive adult transplantation patients who received an orthotopic heart transplantation (oHTx) without a history of any organ transplantation, in the absence of a congenital heart disorder as an underlying disease and not being in need of a combined heart-lung transplantation. Furthermore, patients with fixed pulmonary hypertension, ventilator dependency, chronic renal failure, or panel reactive antibodies >20% and positive T-cell cross-matching were excluded. Inclusion criteria for donor hearts was age of <55 years, systolic blood pressure >85 mmHg at the time of final heart assessment under moderate inotropic support, heart rate of <120 bpm at the time of explantation, and left ventricular ejection fraction >40% assessed by an transcutaneous echo/Doppler study with the absence of gross wall motion abnormalities, absence of left ventricular hypertrophy, and absence of valve abnormalities. Donor hearts which were conventionally cold stored with histidine-tryptophan-ketoglutarate solution (Custodiol; Koehler Chemie, Ansbach, Germany) constituted the control group. The primary end point was the recipients' survival at 30 days and 1 and 2 years after their heart transplantation. Secondary end points were primary and chronic allograft failure, noncardiac complications, and length of hospital stay. RESULTS: Over a 2-year period (January 2006 to July 2008), 159 adult cardiac allografts were transplanted. Twenty-nine were assigned for normothermic ex vivo allograft blood perfusion and 130 for cold static storage with HTK solution. Cumulative survival rates at 30 days and 1 and 2 years were 96%, 89%, and 89%, respectively, whereas in the cold static storage group survival after oHTx was 95%, 81%, and 79%. Primary graft failure was less frequent in the recipients of an oHTx who received a donor heart which had been preserved with normothermic ex vivo allograft blood perfusion using an OCS (6.89% versus 15.3%; P = .20). Episodes of severe acute rejection (23% versus 17.2%; P = .73), as well as, cases of acute renal failure requiring haemodialysis (25.3% versus 10%; P = .05) were more frequent diagnosed among recipients of a donor heart which had been preserved using the cold static storage. The length of hospital stay did not differ (26 days versus 28 days; P = .80) in both groups. CONCLUSIONS: Normothermic ex vivo allograft blood perfusion in adult clinical orthotopic heart transplantation contributes to better outcomes after transplantation in regard to recipient survival, incidence of primary graft dysfunction, and incidence of acute rejection.