Banff 2022 pancreas transplantation multidisciplinary report: Refinement of guidelines for T cell-mediated rejection, antibody-mediated rejection and islet pathology. Assessment of duodenal cuff biopsies and noninvasive diagnostic methods.

The Banff pancreas working schema for diagnosis and grading of rejection is widely used for treatment guidance and risk stratification in centers that perform pancreas allograft biopsies. Since the last update, various studies have provided additional insight regarding the application of the schema and enhanced our understanding of additional clinicopathologic entities. This update aims to clarify terminology and lesion description for T cell-mediated and antibody-mediated allograft rejections, in both active and chronic forms. In addition, morphologic and immunohistochemical tools are described to help distinguish rejection from nonrejection pathologies. For the first time, a clinicopathologic approach to islet pathology in the early and late posttransplant periods is discussed. This update also includes a discussion and recommendations on the utilization of endoscopic duodenal donor cuff biopsies as surrogates for pancreas biopsies in various clinical settings. Finally, an analysis and recommendations on the use of donor-derived cell-free DNA for monitoring pancreas graft recipients are provided. This multidisciplinary effort assesses the current role of pancreas allograft biopsies and offers practical guidelines that can be helpful to pancreas transplant practitioners as well as experienced pathologists and pathologists in training.

Evolution of Pancreas Transplantation At A Single Institution-50+ Years and 2,500 Transplants.

OBJECTIVE: To describe the evolution of pancreas transplantation, including improved outcomes and factors associated with improved outcomes over the past five decades. BACKGROUND: The world's first successful pancreas transplant was performed in December 1966 at the University of Minnesota. As new modalities for diabetes treatment mature, we must carefully assess the current state of pancreas transplantation to determine its ongoing role in patient care. METHODS: A single-center retrospective review of 2,500 pancreas transplants performed over >50 years in bivariate and multivariable models. Transplants were divided into six eras; outcomes are presented for the entire cohort and by era. RESULTS: All measures of patient and graft survival improved progressively through the six transplant eras. The overall death censored (DC) pancreas graft half-lives were >35 years for simultaneous pancreas and kidney (SPK), 7.1 years for pancreas after kidney (PAK), and 3.3 years for pancreas transplants alone (PTA). The 10-year DC pancreas graft survival rate in the most recent era was 86.9% for SPK recipients, 58.2% for PAK recipients, and 47.6% for PTA. Overall graft loss was most influenced by patient survival in SPK transplants, whereas graft loss in PAK and PTA recipients was more often due to graft failures. Predictors of improved pancreas graft survival were primary transplants, bladder drainage of exocrine secretions, younger donor age, and shorter preservation time. CONCLUSIONS: Pancreas outcomes have significantly improved over time via sequential, but overlapping, advances in surgical technique, immunosuppressive protocols, reduced preservation time, and the more recent reduction of immune-mediated graft loss.

Robotic kidney transplantation from deceased donors: A single-center experience.

Robotic-assisted kidney transplant (RAKT) has proven to be a successful approach for patients with elevated body mass index (BMI). To date, a paucity of studies comprehensively analyzing the clinical outcomes of RAKT by using the grafts from deceased donors exists. This was a single-center retrospective analysis of RAKT from deceased donor kidneys (n = 93) from 2009 to 2021. The cohort was divided into 3 groups on the basis of recipient BMI (BMI ≤ 41.2 vs BMI 41.2-44.5 vs BMI ≥ 44.5 kg/m2, n = 31). Delayed graft function was significantly higher in the group with the highest BMI (BMI ≤ 41.2 vs BMI 41.2-44.5 vs BMI ≥ 44.5 kg/m2, 12.5% vs 10% vs 45.16%, P = .001). Graft survival after 12 months of follow-up was significantly lower in the group with BMI of ≥44.5 kg/m2 (BMI ≤ 41.2 vs BMI 41.2-44.5 vs BMI ≥ 44.5 kg/m2, 93.7% vs 100% vs 83.9%. P = .05). For BMI, the relative risk of patient survival was 1.10 for each increase in a BMI in the range of 5 (CI 95%, 0.98-1.21). Death-censored graft survival after 5 years was significantly better than the UNOS-matched cohort (dRAKT vs match, 86.2% vs 68.9%, P = .03). This single-center analysis shows that RAKT can be performed safely; however, caution should be used when matching marginal kidneys with patients with high BMI.

Dual living donor organ transplants.

INTRODUCTION: Dual organ donation and transplantation from living donors (LDs) is a rare practice. Dual organ transplants can be done from the same LD or from different LDs and either simultaneously or sequentially. Simultaneous dual organ transplants from the same LD are of considerable concern due to the magnitude of the donor procedure. METHODS AND RESULTS: According to the UNOS/OPTN and IPTR databases, the US experience of LD dual organ transplants from 1981 to 2021 comprised 101 simultaneous or sequential dual organ transplants from the same LD and 111 transplants from different LDs for a total of 212 LD dual transplants. The first simultaneous or sequential dual organ transplants from either the same LD or different LDs were pancreas-kidney transplants (n = 92). Four additional LD organ transplant combinations have been performed in the United States: liver-kidney (n = 93), lung-kidney (n = 16), liver-intestine (n = 9), and intestine-kidney (n = 2). Only for dual pancreas-kidney (n = 49) and liver-intestinal transplants (n = 4), organs from the same LD have been procured simultaneously. Importantly, no donor deaths have been reported after any simultaneous or sequential procurement. LD dual organ outcomes in all recipient categories have been excellent. CONCLUSIONS: LD dual organ donation and transplantation is safe and successful. Any potential dual organ LD candidate must be subject to the highest level of evaluation scrutiny. A (dual) organ donor registry is warranted for long-term follow-up.

Impact of early corticosteroid withdrawal on simultaneous pancreas-kidney transplant long-term outcomes: Single center experience and comparison to the International Pancreas Transplant Registry.

BACKGROUND: There remains a paucity of modern data comparing early steroid withdrawal (ESW) versus chronic corticosteroid (CCS) immunosuppression in simultaneous pancreas kidney (SPK) transplant recipients with long-term follow-up. Therefore, the purpose of this study is to assess the effectiveness and tolerability of ESW compared to CCS post-SPK. METHODS: This was a retrospective single-center matched comparison with the International Pancreas Transplant Registry (IPTR). Patients from University of Illinois Hospital (UIH) represented the ESW group and were compared to those matched CCS patients from the IPTR. Included patients were adult recipients of a primary SPK transplant between 2003 and 2018 within the US receiving rabbit anti-thymocyte globulin induction. Patients were excluded if they had early technical failures, missing IPTR data, graft thrombosis, re-transplant, or positive crossmatch SPK. RESULTS: A total of 156 patients were matched and included in the analysis. Patients were predominantly African American (46.15%) males (64.1%) with Type 1 diabetes etiology (92.31%). Overall pancreas allograft survival (hazard ratio [HR] = .89, 95% confidence interval [CI] .34-2.30, p = .81) and kidney allograft survival (HR = .80, 95%CI .32-2.03, p = .64) were similar between the two groups. Immunologic pancreas allograft loss was statistically similar at 1-year (ESW 1.3% vs. CCS 0%, p = .16), 5-year (ESW 1.3% vs. CCS 7.7%, p = .16), and 10-year (ESW 11.0% vs. CCS 7.7%, p = .99). The 1-year (ESW 2.6% vs. CCS 0%, p > .05), 5-year (ESW 8.3% vs. CCS 7.0%, p > .05), and 10-year (ESW 22.7% vs. CCS 9.9%, p = .2575) immunologic kidney allograft loss were also statistically similar. There was no difference in 10-year overall patient survival (ESW 76.2% vs. CCS 65.6%, p = .63). CONCLUSIONS: No differences were found between allograft or patient survival post-SPK when comparing an ESW or CCS protocol. Future assessment is needed to determine differences in metabolic outcomes.

User-Centered Mobile Applications for Stroke Survivors (MAPPS): A Mixed-Methods Study of Patient Preferences.

OBJECTIVE: Investigate stroke survivors' (SS) preferences for a hypothetical mHealth app for post-stroke care and to study the influence of demographic variables on these preferences. DESIGN: Mixed-methods, sequential, observational study. SETTING: Focus groups (phase 1) were conducted to identify SS perceptions and knowledge of mHealth applications (apps). Using grounded theory approach, recurring themes were identified. A multiple-choice questionnaire of 5 desired app features was generated using these themes and mailed to SS (national survey, phase 2). SS' demographics and perceived usefulness (yes/no) for each feature were recorded. In-person usability testing (phase 3) was conducted to identify areas of improvement in user interfaces of existing apps. Summative telephone interviews (phase 4) were conducted for final impressions supplementary to national survey. PARTICIPANTS: SS aged >18 years recruited from study hospital, national stroke association database, stroke support and advocacy groups. Non-English speakers and those unable to communicate were excluded. INTERVENTIONS: None. MAIN OUTCOME MEASURES: (1) Percentage of SS (phase 2) identifying proposed app features to be useful. (2) Influence of age, sex, race, education, and time since stroke on perceived usefulness. RESULTS: Ninety-six SS participated in focus groups. High cost, complexity, and lack of technical support were identified as barriers to adoption of mHealth apps. In the national survey (n=1194), ability to track fitness and diet (84%) and communication (70%) were the most and least useful features, respectively. Perceived usefulness was higher among younger SS (P<.001 to .006) and SS of color (African American and Hispanic) (ORs 1.73-4.41). Simple design and accommodation for neurologic deficits were main recommendations from usability testing. CONCLUSIONS: SS are willing to adopt mHealth apps that are free of cost and provide technical support. Apps for SS should perform multiple tasks and be of simple design. Greater interest for the app's features among SS of color may provide opportunities to address health inequities.

First World Consensus Conference on pancreas transplantation: Part II - recommendations.

The First World Consensus Conference on Pancreas Transplantation provided 49 jury deliberations regarding the impact of pancreas transplantation on the treatment of diabetic patients, and 110 experts' recommendations for the practice of pancreas transplantation. The main message from this consensus conference is that both simultaneous pancreas-kidney transplantation (SPK) and pancreas transplantation alone can improve long-term patient survival, and all types of pancreas transplantation dramatically improve the quality of life of recipients. Pancreas transplantation may also improve the course of chronic complications of diabetes, depending on their severity. Therefore, the advantages of pancreas transplantation appear to clearly surpass potential disadvantages. Pancreas after kidney transplantation increases the risk of mortality only in the early period after transplantation, but is associated with improved life expectancy thereafter. Additionally, preemptive SPK, when compared to SPK performed in patients undergoing dialysis, appears to be associated with improved outcomes. Time on dialysis has negative prognostic implications in SPK recipients. Increased long-term survival, improvement in the course of diabetic complications, and amelioration of quality of life justify preferential allocation of kidney grafts to SPK recipients. Audience discussions and live voting are available online at the following URL address: http://mediaeventi.unipi.it/category/1st-world-consensus-conference-of-pancreas-transplantation/246.

A new model to determine Optimal Exposure to Tacrolimus and Mycophenolate Mofetil after renal transplantation.

BACKGROUND: Drug dosing for Tacrolimus (TAC) and Mycophenolate Mofetil (MMF) after kidney transplantation remains challenging. Therapeutic drug monitoring (TDM) offers a means to individualize drug dosing and improve outcomes. METHODS: In this observational study, patients having mycophenolic acid (MPA) exposure assessed by limited sampling strategy (LSS) within the first 6 months were included and followed for 1 year. RESULTS: A total of 113 clinical events occurring in 110 patients were classified into 3 groups: Group 1 Stable (n = 34), Group 2 Over drug exposed (n = 64) having infections or drug toxicity and Group 3 Under drug exposed (n = 15) developing rejection or de novo donor-specific alloantibodies. Although TAC levels, MMF dose, MPA, and MPA Glucuronide (MPAG) exposure, expressed as area under curve (AUC), individually failed to predict outcomes, a scoring model incorporating all 3 drug levels TAC TDM × (MPA AUC + MPAG/10 AUC) correctly classified outcomes. A score over 1071 had a sensitivity and specificity of 0.94 (95% CI 0.56-0.83) and 0.84 (95% CI 0.69-0.89) for over exposure. A score below 625 had a sensitivity and specificity of 0.76 (95% CI 0.53-0.93) and 0.80 (95% CI 0.41-0.70) for under exposure. CONCLUSIONS: This integrated model of assessing TAC and MMF exposure may facilitate individualized therapy.

Simultaneous Pancreas and Kidney Transplantation-Is It a Treatment Option for Patients With Type 2 Diabetes Mellitus? An Analysis of the International Pancreas Transplant Registry.

PURPOSE OF REVIEW: Pancreas transplantation remains the best long-term treatment option to achieve euglycemia and freedom from insulin in patients with labile diabetes mellitus. It is an approved procedure for type 1 (T1DM), but it is still considered controversial for type 2 diabetes mellitus (T2DM). RECENT FINDINGS: This study analyzed all primary deceased donor pancreas transplants in patients with T2DM reported to IPTR/UNOS between 1995 and 2015. Characteristics, outcomes, and risk factors over time were determined using univariate and multivariate methods. The focus was on simultaneous pancreas/kidney (SPK) transplants, the most common pancreas transplant category. Patient, pancreas, and kidney graft survival rates increased significantly over time and reached 95.8, 83.3, and 91.1%, respectively, at 3 years posttransplant for transplants performed between 2009 and 2015. SPK is a safe procedure with excellent pancreas and kidney graft outcome in patients with T2DM. The procedure restores euglycemia and freedom from insulin and dialysis. Based on our results, SPK should be offered to more uremic patients with labile T2DM.

Preoperative Patient-Recorded Outcome Measures Predict Patient Discharge Location Following Unicondylar Knee Arthroplasty.

BACKGROUND: Advantages of unicondylar knee arthroplasty (UKA) over total knee arthroplasty include rapid recovery and shorter lengths of stay following surgery. Patients requiring extended postoperative care fail to recognize these benefits. Patient-reported outcome measures have proved useful in predicting outcomes following joint arthroplasty. The purpose of this study was to identify and report preoperative patient-reported outcome measures and clinical variables that predict discharge to skilled nursing facilities following UKA. METHODS: A prospective cohort of 174 patients was used to collect 36-Item Short Form scores and objective clinical data. Univariate and multivariate analysis with backward elimination were conducted to find a predictive risk model. RESULTS: The predictive model reported (78.7% concordance, receiver operating characteristic curve c-statistic 0.719, P = .0016) demonstrates that risk factors for discharge to skilled nursing facilities are: older age (odds ratio 4.18; 95% confidence interval [CI] 1.256-13.911, P = .019), bilateral UKA procedures (odds ratio 1.887; 95% CI 1.054-3.378, P = .0326) and lower patient-reported preoperative 36-Item Short Form physical function scores (odds ratio 0.968; CI 0.938-1, P = .0488). CONCLUSION: The information presented here regarding possible patient disposition following UKA could aid informed decision-making regarding patients' short-term needs following surgery and help streamline preoperative planning.

Surgery of pancreas transplantation.

PURPOSE OF REVIEW: The surgical techniques of pancreas transplantation have been evolving and significantly improved over time. This article discusses different current techniques and their modifications. RECENT FINDING: At this time, the most commonly used technique is systemic venous drainage (for venous outflow) and enteric drainage (for management of exocrine pancreatic secretions). However, new modifications of established techniques such as gastric or duodenal exocrine drainage and venous drainage to the inferior vena cava continue to be introduced. SUMMARY: This article provides a state-of the-art review of the most prevalent up-to-date surgical techniques as well as a synopsis of their specific risks and benefits. The article also provides the most current registry data regarding utilization of different surgical techniques in the United State and worldwide.

Levetiracetam Prophylaxis for Post-traumatic Brain Injury Seizures is Ineffective: A Propensity Score Analysis.

INTRODUCTION: Early seizures after severe traumatic brain injury (TBI) have a reported incidence of up to 15 %. Prophylaxis for early seizures using 1 week of phenytoin is considered standard of care for seizure prevention. However, many centers have substituted the anticonvulsant levetiracetam without good data on the efficacy of this approach. Our hypothesis was that the treatment with levetiracetam is not effective in preventing early post-traumatic seizures. METHODS: All trauma patients sustaining a TBI from January 2007 to December 2009 at an urban level-one trauma center were retrospectively analyzed. Seizures were identified from a prospectively gathered morbidity database and anticonvulsant use from the pharmacy database. Statistical comparisons were made by Chi square, t tests, and logistic regression modeling. Patients who received levetiracetam prophylaxis were matched 1:1 using propensity score matching with those who did not receive the drug. RESULTS: 5551 trauma patients suffered a TBI during the study period, with an overall seizure rate of 0.7 % (39/5551). Of the total population, 1795 were diagnosed with severe TBI (Head AIS score 3-5). Seizures were 25 times more likely in the severe TBI group than in the non-severe group [2.0 % (36/1795) vs. 0.08 % (3/3756); OR 25.6; 95 % CI 7.8-83.2; p < 0.0001]. Of the patients who had seizures after severe TBI, 25 % (9/36) received pharmacologic prophylaxis with levetiracetam, phenytoin, or fosphenytoin. In a matched cohort by propensity scores, no difference was seen in seizure rates between the levetiracetam group and no-prophylaxis group (1.9 vs. 3.4 %, p = 0.50). CONCLUSIONS: In this propensity score-matched cohort analysis, levetiracetam prophylaxis was ineffective in preventing seizures as the rate of seizures was similar whether patients did or did not receive the drug. The incidence of post-traumatic seizures in severe TBI patients was only 2.0 % in this study; therefore we question the benefit of routine prophylactic anticonvulsant therapy in patients with TBI.

Long-term outcome after pancreas transplantation: a registry analysis.

PURPOSE OF REVIEW: Pancreas transplantation provides the only proven method to restore long-term normoglycemia in patients with insulin-dependent diabetes mellitus. Although many studies describe the most important risk factors for short-term survival of a pancreas transplant, more information about factors that distinguish short-term from long-term graft function is needed. RECENT FINDINGS: Analysis of 21 328 pancreas transplants from the International Pancreas Transplant Registry, performed from 1984 to 2009 (minimum 5-year follow-up), shows a significant improvement in long-term patient survival and pancreas graft function. Total 5-and 10-year pancreas graft function rates are 73 and 56%, respectively, for simultaneous pancreas-kidney transplants; 64 and 38%, respectively, for pancreas after kidney; and 53 and 36%, respectively, for pancreas transplants alone. The most influential period is the first year posttransplant. Recipients who reach this time point with a functioning graft have a much higher probability for excellent long-term graft function. Important factors influencing long-term function were features that described the quality of the deceased donor. Pancreas transplants in younger, high panel reactive antibody, or African-American recipients also showed an increased risk of early graft failure. Anti-T-cell induction therapy had a significant impact on long-term survival in solitary transplants. SUMMARY: With careful recipient and donor selection and close follow-up in the first year posttransplant, not only good short-term but also long-term pancreas graft function and, therefore, durable metabolic control can be achieved for the diabetic patient.

Pancreas transplantation: a decade of decline.

PURPOSE OF REVIEW: In the past decade, the annual number of pancreas transplants performed in the United States has steadily declined. The purpose of this review is to discuss the multifactorial nature of this decline. RECENT FINDINGS: In 2014, only 954 pancreas transplants were performed in the United States. From 2004 to 2011, the annual number of simultaneous pancreas-kidney transplants in the United States declined by 10%, whereas the corresponding annual decreases in pancreas after kidney and pancreas transplants alone were 55 and 34%, respectively. Paradoxically, this drop-off has occurred in the setting of improvements in graft and patient survival and transplanting higher risk patients. This national trend in decreasing numbers of pancreas transplants is related to a number of factors, including lack of a primary referral source, lack of acceptance by the diabetes care community, improvements in diabetes care and management, changing donor and recipient considerations, inadequate training opportunities, and increasing risk aversion because of regulatory scrutiny. SUMMARY: Given that the incidence of end-stage renal disease secondary to diabetes remains high, a national initiative is needed to 're-invigorate' either simultaneous pancreas kidney or pancreas after kidney as preferred transplant options for appropriately selected uremic patients taking insulin irrespective of C-peptide levels or 'type' of diabetes. Moreover, many patients may benefit from pancreas transplants alone as well because all categories of pancreas transplantation are not only life-enhancing but life-extending procedures.

Geographic inequity results in disparate mortality: a multivariate intent-to-treat analysis of liver transplant data.

CONTEXT: The distribution of livers to listed transplant candidates shows substantial geographic inequity. OBJECTIVE: To compare mortality between the 11 UNOS (United Network of Organ Sharing) regions from the time of listing and to show that the geographic region impacts survival. DESIGN, SETTING, AND PATIENTS: We studied the data of 1930 adults listed with a Model for End-Stage Liver Disease (MELD) score of 18 for a liver transplant from March 1, 2002 through December 31, 2007. We calculated one- and three-yr survival rates and performed multivariate Cox regression analysis to determine significant risk factors for mortality. MAIN OUTCOME MEASURES: Patient survival from the time of listing for transplantation. RESULTS: Actual one-yr mortality rate from the time of listing ranged from 30.5% (Region 2) to 12.9% (Region 4). The three-yr mortality rate ranged from 42.0% (Region 2) to 21.6% (Region 4). Multivariate analysis showed a significant increase in mortality in Region 2 (odds ratio [OR], 1.49; 95% confidence interval [CI], 1.21 to 1.83) and a significant decrease in mortality in Region 3 (OR, 0.74; 95% CI, 0.59 to 0.93). CONCLUSIONS: We found significant differences in one- and three-yr mortality rates among UNOS regions. Regional disparities significantly affect patient survival and result in national inequality.

Effect of small donor weight and donor-recipient weight ratio on the outcome of liver transplantation in children.

A small donor weight is a risk factor for HAT with potential for graft loss. To test this hypothesis, we evaluated outcomes of pediatric liver transplants utilizing donors <20 kg using the UNOS database from 01/2003 to 01/2012 (n = 1311). All isolated liver transplants with whole organ grafts were included. Recipients were divided into four groups based on donor weight: group 1, donor weight <5 kg (n = 34 [2%]); group 2, 5-10 kg (431 [33%]); group 3, 10-15 kg (560 [43%]); and group 4, 15-20 kg (286 [22%]). Actuarial patient survival for the first year post-transplant was significantly lower in groups 1 and 2 compared to groups 3 and 4 (p = 0.002), similarly the one-yr graft function (p < 0.0001). The difference was due to graft loss within the first month for groups 1 and 2. HAT was significantly higher in groups 1 and 2 compared to others (p = 0.0006). Logistic regression analysis demonstrated donor weight as the most predictive factor with analysis of the ROC curve showing a cutoff point at 7.8 kg. The donor-recipient weight ratio did, in none of the models, gain statistical significance.

Early liver retransplantation in adults.

Up to 23% of liver allografts fail post-transplant. Retransplantation is only the recourse but remains controversial due to inferior outcomes. The objective of our study was to identify high-risk periods for retransplantation and then compare survival outcomes and risk factors. We performed an analysis of United Network for Organ Sharing (UNOS) data for all adult liver recipients from 2002 through 2011. We analyzed the records of 49,288 recipients; of those, 2714 (5.5%) recipients were retransplanted. Our analysis included multivariate regression with the outcome of retransplantation. The highest retransplantation rates were within the first week (19% of all retransplantation, day 0-7), month (20%, day 8-30), and year (33%, day 31-365). Only retransplantation within the first year (day 0-365) had below standard outcomes. The most significant risk factors were as follows: within the first week, cold ischemia time >16 h [odds ratio (OR) 3.6]; within the first month, use of split allografts (OR 2.9); and within the first year, use of a liver donated after cardiac death (OR 4.9). Each of the three high-risk periods within the first year had distinct causes of graft failure, risk factors for retransplantation, and survival rates after retransplantation.

Medical and Surgical Management of the Failed Pancreas Transplant.

Despite the continued improvements in pancreas transplant outcomes in recent decades, a subset of recipients experience graft failure and can experience substantial morbidity and mortality. Here, we summarize what is known about the failed pancreas allograft and what factors are important for consideration of retransplantation. The current definition of pancreas allograft failure and its challenges for the transplant community are explored. The impacts of a failed pancreas allograft are presented, including patient survival and resultant morbidities. The signs, symptoms, and medical and surgical management of a failed pancreas allograft are described, whereas the options and consequences of immunosuppression withdrawal are reviewed. Medical and surgical factors necessary for successful retransplant candidacy are detailed with emphasis on how well-selected patients may achieve excellent retransplant outcomes. To achieve substantial medical mitigation and even pancreas retransplantation, patients with a failed pancreas allograft warrant special attention to their residual renal, cardiovascular, and pulmonary function. Future studies of the failed pancreas allograft will require improved reporting of graft failure from transplant centers and continued investigation from experienced centers.

Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery.

BACKGROUND: Popliteal artery stenting is not routinely performed due to concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. Open bypass is traditionally considered the gold standard for popliteal artery atherosclerotic lesions. The Supera stent (IDEV Technologies Inc, Webster, Tex) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial United States experience in the management of popliteal artery atherosclerotic disease with the Supera interwoven wire stent. METHODS: Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to Trans-Atlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis. RESULTS: A total of 39 stents were placed in 34 patients due to isolated popliteal artery occlusive disease. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0-26.8 months). Most patients had critical limb ischemia (CLI), with tissue loss (38.2%) or rest pain (35.3%) as the indication for intervention. In 20 patients (58.8%), the most distal end of the stent(s) landed in the below-the-knee popliteal segment, 12 (35.3%) landed in the above-the-knee segment, and two (5.9%) landed precisely at the knee. Other than angioplasty and stenting, 47% of patients did not receive any adjuvant concomitant therapy in the treated leg. Two patients underwent concomitant atherectomy of the popliteal segment. Primary, primary assisted, and secondary patency rates by duplex ultrasound imaging were 79.2%, 88.1% and 93%, respectively, by Kaplan-Meier estimates, with a mean stented length of 12 cm. Six instances of stent occlusion were noted, and six patients were identified with hemodynamically significant in-stent stenosis. Three patients sustained limb loss (8.8%), two related to uncontrolled infections, and one due to perioperative ischemic complications (both with patent stents at the time of limb loss). The overall mortality was 8.8% during the study period. Knee roentgenography was performed in all but one patient, and no stent fractures were identified. CONCLUSIONS: Stenting of the popliteal artery using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this highly diseased patient population justify a prospective trial in this subject.

The survival outcomes following liver transplantation (SOFT) score: validation with contemporaneous data and stratification of high-risk cohorts.

Models to project survival after liver transplantation are important to optimize outcomes. We introduced the survival outcomes following liver transplantation (SOFT) score in 2008 (1) and designed to predict survival in liver recipients at three months post-transplant with a C statistic of 0.70. Our objective was to validate the SOFT score, with more contemporaneous data from the OPTN database. We also applied the SOFT score to cohorts of the sickest transplant candidates and the poorest-quality allografts. Analysis included 21 949 patients transplanted from August 1, 2006, to October 1, 2010. Kaplan-Meier survival functions were used for time-to-event analysis. Model discrimination was assessed using the area under the receiver operating characteristic (ROC) curve. We validated the SOFT score in this cohort of 21 949 liver recipients. The C statistic was 0.70 (CI 0.68-0.71), identical to the original analysis. When applied to cohorts of high-risk recipients and poor-quality donor allografts, the SOFT score projected survival with a C statistic between 0.65 and 0.74. In this study, a validated SOFT score was informative among cohorts of the sickest transplant candidates and the poorest-quality allografts.