Early experience with a 3-D printed porous surface, fixed-bearing, total ankle arthroplasty: A minimum of 2-year follow-up.

BACKGROUND: This is a pilot study reviewing patients undergoing ankle replacement with the 3-D printed INFINITY™ with ADAPTIS™ total ankle arthroplasty (TAA) system. METHODS: A retrospective review was conducted of patients with a minimum two-year follow-up who underwent TAA with the INFINITY™ with ADAPTIS™ implant system. Outcome measures include implant survivorship, complications with subsequent reoperations, patient reported outcomes, and radiologic subsidence or radiolucency. RESULTS: Thirty patients were included with median follow-up of 26 months (range, 24-36). Implant survival rate was 90% (27/30). Two patients experienced linear radiolucency > 2 mm: one required a revision TAA secondary to tibial subsidence; the other patient was asymptomatic and nonprogressive on serial radiographs. No cystic radiolucencies > 5 mm were identified. VAS, PROMIS PF, and FADI scores improved significantly. CONCLUSION: TAA performed with the 3-D printed INFINITY™ with ADAPTIS™ implant technology led to ninety percent short term implant survivorship and improvement in patient reported outcomes with comparable results to other 4th generation arthroplasty systems as a treatment modality for end-stage ankle arthritis. LEVEL OF EVIDENCE: Level III, Retrospective cohort study, Prognostic.

Epidemiology and long-term outcomes of cytomegalovirus DNAemia and disease in pediatric solid organ transplant recipients.

Despite prevention strategies, cytomegalovirus (CMV) remains a common infection in pediatric solid organ transplant recipients (SOTR). We sought to determine the frequency, associations with, and long-term outcomes of CMV DNAemia in pediatric SOTR. We performed a single-center retrospective cohort study, including 687 first time SOTR ≤21 years receiving universal prophylaxis from 2011 to 2018. Overall, 159 (23%) developed CMV DNAemia, the majority occurring after completing primary prophylaxis. CMV disease occurred in 33 (5%) SOTR, 25 (4%) with CMV syndrome and 10 (1%) with proven/probable tissue-invasive disease. CMV contributed to the death of three (0.4%) patients (all lung). High-risk (OR 6.86 [95% CI, 3.6-12.9]) and intermediate-risk (4.36 [2.3-8.2]) CMV status and lung transplantation (4.63 [2.33-9.2]) were associated with DNAemia on multivariable analysis. DNAemia was associated with rejection in liver transplant recipients (p < .01). DNAemia was not associated with an increase in graft failure, all-cause mortality, or other organ-specific poor outcomes. We report one of the lowest rates of CMV disease after SOTR, showing that universal prophylaxis is effective and should be continued. However, we observed CMV morbidity and mortality in a subset of patients, highlighting the need for research on optimal prevention strategies. This study was IRB approved.

Intent-to-treat survival in liver transplantation has not improved in 3 decades due to donor shortage relative to waitlist growth.

BACKGROUND: Liver Transplantation has advanced over the past 3 decades, with 1-year survival rates improving 25%. Survival rates for those transplanted has increased to remarkable levels, but survival from the time of listing may not be as revolutionary. METHODS: Kaplan-Meier with log-rank test as well as Cox regression analysis was used to retrospectively analyze 211 610 adults listed for LT and 116 299 adult transplant recipients from 1987 to 2016. Our primary endpoints were survival from time of listing to waitlist death or posttransplant death. RESULTS: One-year survival following LT improved dramatically (68% in 1987-1988 vs. 93% in 2016, P < .001). There was no improvement in 1-year intent-to-treat survival: 78.4% for those listed in 1987 and 81.8% for those listed in 2016 (P = .1). Also observed were decreases in the percentage of transplanted candidates from 74.8% in 1987-1988 to 54.7% in 2016 (P < .001) and increased 1-year wait-list mortality from 12.5% in 1987-1988 to 22.6% in 2016 (P = .002). CONCLUSION: As transplant rate has decreased while waitlist mortality has increased, no improvements have been made in intent-to-treat survival of patients listed for transplant over the past 3 decades. We speculate this observation to be resultant of a relative donor shortage outpaced by waitlist growth. SUMMARY: Liver Transplantation has experienced vast increases in survival rates over the past 3 decades; however, due to an increased donor supply outpaced by waitlist growth, the rate of transplantation has decreased significantly while the waitlist mortality has increased, leading to no improvement in 1-year intent-to-treat survival rates.

Factors associated with long-term graft survival in pediatric kidney transplant recipients.

Pediatric kidney transplant recipients generally have good outcomes post-transplantation. However, the younger age and longer life span after transplantation in the pediatric population make understanding the multifactorial nature of long-term graft survival critical. This investigation analyzes factors associated with 10-year survival to identify areas for improvement in patient care. Kaplan-Meier with log-rank test and univariable and multivariable logistic regression methods were used to retrospectively analyze 7785 kidney transplant recipients under the age of 18 years from January 1, 1998, until March 9, 2008, using United Network for Organ Sharing (UNOS) data. Our end-point was death-censored 10-year graft survival after excluding recipients whose grafts failed within one year of transplant. Recipients aged 5-18 years had lower 10-year graft survival, which worsened as age increased: 5-9 years (OR: 0.66; CI: 0.52-0.83), 10-14 years (OR: 0.43; CI: 0.33-0.55), and 15-18 years (OR: 0.34; CI: 0.26-0.44). Recipient African American ethnicity (OR: 0.67; CI: 0.58-0.78) and Hispanic donor ethnicity (OR: 0.82; CI: 0.72-0.94) had worse outcomes than other donor and recipient ethnicities, as did patients on dialysis at the time of transplant (OR: 0.82; CI: 0.73-0.91). Recipient private insurance status (OR: 1.35; CI: 1.22-1.50) was protective for 10-year graft survival. By establishing the role of age, race, and insurance status on long-term graft survival, we hope to guide clinicians in identifying patients at high risk for graft failure. This study highlights the need for increased allocation of resources and medical care to reduce the disparity in outcomes for certain patient populations.

Twenty-year survival following lung transplantation.

Background: Lung transplantation median survival has seen improvements due to recognition of short-term survival factors but continues to trail behind other solid organs due to limited understanding of long-term survivorship. Given the creation of the United Network for Organ Sharing (UNOS) database in 1986, it was difficult to accrue data on long-term survivors until recently. This study characterizes factors impacting lung transplant survival beyond 20 years, conditional to 1-year survival. Methods: Lung transplant recipients listed in UNOS from 1987 to 2002 who survived to 1 post-transplant year were reviewed. Kaplan-Meier and adjusted Cox regression analyses were performed at 20 and 10 years to identify risk factors associated with long-term outcomes independent of their short-term effects. Results: A total of 6,172 recipients were analyzed, including 472 (7.6%) recipients who lived 20+ years. Factors associated with increased likelihood of 20-year survival were female-to-female gender match, recipient age 25-44, waitlist time >1 year, human leukocyte antigen (HLA) mismatch level 3, and donor cause of death: head trauma. Factors associated with decreased 20-year survival included recipient age ≥55, chronic obstructive pulmonary disease/emphysema (COPD/E) diagnosis, donor smoking history >20 pack-years, unilateral transplant, blood groups O&AB, recipient glomerular filtration rate (GFR) <10 mL/min, and donor GFR 20-29 mL/min. Conclusions: This is the first study identifying factors associated with multiple-decade survival following lung transplant in the United States. Despite its challenges, long-term survival is possible and more likely in younger females in good waitlist condition without COPD/E who receive a bilateral allograft from a non-smoking, gender-matched donor of minimal HLA mismatch. Further analysis of the molecular and immunologic implications of these conditions are warranted.

Trends in Survival for Pediatric Transplantation.

OBJECTIVES: Progress in pediatric transplantation measured in the context of waitlist and posttransplant survival is well documented but falls short of providing a complete perspective for children and their families. An intent-to-treat analysis, in which we measure survival from listing to death regardless of whether a transplant is received, provides a more comprehensive perspective through which progress can be examined. METHODS: Univariable and multivariable Cox regression was used to analyze factors impacting intent-to-treat survival in 12 984 children listed for heart transplant, 17 519 children listed for liver transplant, and 16 699 children listed for kidney transplant. The Kaplan-Meier method and log-rank test were used to assess change in waitlist, posttransplant, and intent-to-treat survival. Wait times and transplant rates were compared by using χ2 tests. RESULTS: Intent-to-treat survival steadily improved from 1987 to 2017 in children listed for heart (hazard ratio [HR] 0.96, 95% confidence interval [CI] 0.96-0.97), liver (HR 0.95, 95% CI 0.94-0.97), and kidney (HR 0.97, 95% CI 0.95-0.99) transplant. Waitlist and posttransplant survival also improved steadily for all 3 organs. For heart transplant, the percentage of patients transplanted within 1 year significantly increased from 1987 to 2017 (60.8% vs 68.7%); however, no significant increase was observed in liver (68.9% vs 72.5%) or kidney (59.2% vs 62.7%) transplant. CONCLUSIONS: Intent-to-treat survival, which is more representative of the patient perspective than individual metrics alone, steadily improved for heart, liver, and kidney transplant over the study period. Further efforts to maximize the donor pool, improve posttransplant outcomes, and optimize patient care while on the waitlist may contribute to future progress.

Recipient Age Predicts 20-Year Survival in Pediatric Liver Transplant.

Introduction: Pediatric liver transplant recipients have demonstrated excellent long-term survival. The purpose of this analysis is to investigate factors associated with 20-year survival to identify areas for improvement in patient care. Methods: Kaplan-Meier with log-rank test as well as univariate and multivariate logistic regression methods were used to retrospectively analyze 4,312 liver transplant recipients under the age of 18 between September 30, 1987 and March 9, 1998. Our primary endpoint was 20-year survival among one-year survival. Results: Logistic regression analysis identified recipient age as a significant risk factor, with recipients below 5 years old having a higher 20-year survival rate (p < 0.001). A preoperative primary diagnosis of a metabolic dysfunction was found to be protective compared to other diagnoses (OR 1.64, CI 1.20-2.25). African-American ethnicity (OR 0.71, CI 0.58-0.87) was also found to be a risk factor for mortality. Technical variant allografts (neither living donor nor cadaveric) were not associated with increased or decreased rates of 20-year survival. Conclusions: Our analysis suggests that long-term survival is inversely correlated with recipient age following pediatric liver transplant. If validated with further studies, this conclusion may have profound implications on the timing of pediatric liver transplantation.

Trends in Outcomes for Marginal Allografts in Liver Transplant.

IMPORTANCE: Investigating outcomes after marginal allograft transplant is essential in determining appropriate and more aggressive use of these allografts. OBJECTIVE: To determine the time trends in the outcomes of marginal liver allografts as defined by 6 different sets of criteria. DESIGN, SETTING, AND PARTICIPANTS: In this cohort, multicenter study, 75 050 patients who received a liver transplant between March 1, 2002, and September 30, 2016, were retrospectively analyzed to last known follow-up (n = 55 395) or death (n = 19 655) using the United Network for Organ Sharing Database. The study period was divided into three 5-year eras: 2002-2006, 2007-2011, and 2012-2016. Kaplan-Meier survival analysis with log-rank test and Cox proportional hazards regression analysis were used to examine the allograft after transplant with marginal allografts, which were defined as 90th percentile Donor Risk Index allografts (calculated over the entire study period), donor after circulatory death allografts, national share allografts, old age (donors >70 years) allografts, fatty liver allografts, and 90th percentile Discard Risk Index allografts. Statistical analysis was performed from August to December 2019. MAIN OUTCOMES AND MEASURES: Allograft failure after transplant as defined by the Organ Procurement and Transplantation Network database. RESULTS: Among the 75 050 patients (44 394 men; mean [SD] age, 54.3 [9.9] years) in the study, Donor Risk Index, patient Model for End-stage Liver Disease scores, and balance of risk scores significantly increased over time. Multivariate Cox proportional hazards regression analysis indicated that 90th percentile Donor Risk Index allograft survival increased across the study period (2002-2006: hazard ratio, 1.41 [95% CI, 1.34-1.49]; 2007-2011: hazard ratio, 1.25 [95% CI, 1.17-1.34]; 2012-2016: hazard ratio, 1.10 [95% CI, 0.98-1.24]). Secondary definitions of marginal allografts (donor after circulatory death, national share, old age donors, fatty liver, and 90th percentile Discard Risk Index) showed similar improvements in allograft survival. CONCLUSIONS AND RELEVANCE: The study's findings encourage the aggressive use of liver allografts and may indicate a need for a redefinition of allograft marginality in liver transplantation.

Trends in Outcomes for Marginal Allografts in Liver Transplant.

IMPORTANCE: Investigating outcomes after marginal allograft transplant is essential in determining appropriate and more aggressive use of these allografts. OBJECTIVE: To determine the time trends in the outcomes of marginal liver allografts as defined by 6 different sets of criteria. DESIGN, SETTING, AND PARTICIPANTS: In this case-control, multicenter study, 75 050 patients who received a liver transplant between March 1, 2002, and September 30, 2016, were retrospectively analyzed to last known follow-up (n = 55 395) or death (n = 19 655) using the United Network for Organ Sharing Database. The study period was divided into three 5-year eras: 2002-2006, 2007-2011, and 2012-2016. Kaplan-Meier survival analysis with log-rank test and Cox proportional hazards regression analysis were used to examine the allograft after transplant with marginal allografts, which were defined as 90th percentile Donor Risk Index allografts (calculated over the entire study period), donor after circulatory death allografts, national share allografts, old age (donors >70 years) allografts, fatty liver allografts, and 90th percentile Discard Risk Index allografts. Statistical analysis was performed from August to December 2019. MAIN OUTCOMES AND MEASURES: Allograft failure after transplant as defined by the Organ Procurement and Transplantation Network database. RESULTS: Among the 75 050 patients (44 394 men; mean [SD] age, 54.3 [9.9] years) in the study, Donor Risk Index, patient Model for End-stage Liver Disease scores, and balance of risk scores significantly increased over time. Multivariate Cox proportional hazards regression analysis indicated that 90th percentile Donor Risk Index allograft survival increased across the study period (2002-2006: hazard ratio, 1.41 [95% CI, 1.34-1.49]; 2007-2011: hazard ratio, 1.25 [95% CI, 1.17-1.34]; 2012-2016: hazard ratio, 1.10 [95% CI, 0.98-1.24]). Secondary definitions of marginal allografts (donor after circulatory death, national share, old age donors, fatty liver, and 90th percentile Discard Risk Index) showed similar improvements in allograft survival. CONCLUSIONS AND RELEVANCE: The study's findings encourage the aggressive use of liver allografts and may indicate a need for a redefinition of allograft marginality in liver transplantation.