Does lung procurement and exposure to Perfadex impact heart transplantation outcomes.

INTRODUCTION: Some studies have shown increased incidence of Primary Graft Dysfunction (PGD) after heart and lung procurement for heart transplant recipients. There have been limited investigations of the impact of lung procurement on heart procurement and the potential effects of the exposure to the type of lung preservation solution, the volume of the lung preservation solution and adequacy of decompression of the heart during heart and lung procurement and the impact on heart transplant outcomes. METHODS: Adult heart transplant recipients in the UNOS database recorded from January 1, 2000 to June 30, 2022 formed the study cohort. Any heart that was procured with a lung team that utilized Perfadex preservation solution (XVIVO, Gothenburg, Sweden) was classified as exposed to Perfadex and otherwise classified as not exposed to Perfadex. Lung procurements performed with a preservation solution other than Perfadex or unknown were excluded (n = 2486). Simple comparisons were made with t-tests or chi-squared tests. Logistic regression models were used to predict 30 day and 1 year survival. Accelerated failure time models were employed to analyze time to death and time to rejection. RESULTS: The cohort consisted of 34 192 heart transplants, of which 21 928 donors were not exposed to Perfadex (64.1%). There were statistically, but not clinically, significant differences in donor characteristics for these groups including in donor age (33.34 ± 11.01 not exposed vs. 30.70 ± 10.69 exposed; p < .001), diabetic donor (4% not exposed vs. 3% exposed; p = .004), and ischemic time (3.28 ± 1.09 h not exposed vs. 3.24 ± 1.05 h exposed; p = .002). In adjusted models, for all included donors, Perfadex exposure was associated with increased short term mortality, but no long term difference (1 year mortality OR 1.10, p = .014). CONCLUSION: Perfadex exposure was associated with increased short-term mortality for heart transplant recipients. Mechanistic investigation is warranted.

Does donor treatment with inotropes and/or vasopressors impact post-transplant outcomes?

PURPOSE: The purpose was to evaluate the effects of the most commonly used cardiac donor inotropes/vasopressors on subsequent post-heart transplant survival. METHODS: Adult heart transplant recipients from January 2000 to June 2022 were identified in the United Network for Organ Sharing (UNOS) database. Exclusion criteria included: multiorgan transplants, donor age < 15, and recipient age < 18. Donors receiving vasoactive medications at the time of procurement were compared to donors not receiving these medications. Those on vasoactive medications were stratified by medication: phenylephrine, dopamine, dobutamine, norepinephrine and epinephrine, the combination of these agents, and the concomitant administration of vasopressin with any single agent alone or in combination. The primary area of interest was short-and-long-term survival. Survival at 30 days, 1 year, and long-term (Median = 13.6 years) was compared using logistic and Cox models to quantify survival endpoints. RESULTS: A total of 45,198 donors met inclusion criteria and had data on the use of vasoactive agents available. Mean donor age was 32.3 years with 71% male. Vasoactive medications and potential combinations included phenylephrine in 8156 donors (18.0%), dopamine in 9550 (21.1%), dobutamine in 718 (1.6%), epinephrine in 332 (.73%), and norepinephrine in 4854 (10.7%). A total of 25,856 donors (57.2%) were receiving vasopressin at the time of procurement. There was no impact of donor inotropes on 30-day survival. Donors receiving one inotrope and no vasopressin were associated with increased 1 year mortality (OR 1.14; p = .021), as were donors receiving 2+ inotropes and no vasopressin (OR 1.26; p = .006). For individual agents, 1 year mortality was increased for dopamine (OR 1.11; p = .042) and epinephrine (OR 1.59; p = .004). CONCLUSIONS: There is no difference in heart transplant recipient survival at 30 days when the donor is receiving inotropes without vasopressin at the time of procurement. Inotropic support without vasopressin is associated with greater 1 year mortality. The impact of donor inotropic support on long term heart transplant survival, and the interaction with vasopressin warrants further study.

Do outcomes for heart transplantation differ based on donor and recipient race?

PURPOSE: There are limited data examining the impact of both donor and recipient race on outcomes following orthotopic heart transplant (OHT). The purpose of this study was to evaluate the relationship between donor and recipient race and OHT outcomes. METHODS: The United Network for Organ Sharing (UNOS) database was retrospectively reviewed from January 2000 to March 2018 for donor hearts. A comparison was conducted based on donor and recipient race (White, Black, Hispanic, Other/Unknown). Races for which there were limited numbers were excluded from the analysis (Asian, n = 1292; American Indian, n = 132; Pacific Islander, n = 132, Multiple ethnicities, n = 225). The primary endpoint was survival at 30 days, 1 year survival, and post-transplant rejection. Logistic and Cox models were used to quantify survival endpoints. RESULTS: A total of 41 841 OHT were included. Of the recipients, 29 894 (71%) were White, 8475 (20%) were Black, and 3472 (8%) were Hispanic. Of the donors 27 783 (66%) were White, 6277 (15%) were Black, 6576 (16%) were Hispanic, and 1205 (3%) were Unknown/Other race. In a comparison of recipient demographics, White recipients were older (54.09 ± 12.21 years) compared to Black (49.44 ± 12.83 years) and Hispanic (49.97 ± 13.27 years) recipients. All other differences between groups were not clinically significant. Black recipients were more likely to receive a heart with an "urgent" status (probability .80) compared to White (.73) and Hispanic (.75) recipients (p < .001). Hispanic recipients were more likely to receive a transplant when listed as "non-urgent" (Probability .47) compared to White (.37) and Black (.30) recipients (p < .001). In terms of outcomes, compared to White recipients, Hispanic patients experienced a decreased 30-day survival (OR 1.27; p = .011) and 1-year survival (OR 1.17; p = .016). In comparing Donor/Recipient combinations compared to a White Donor/White Recipient combination, overall survival was decreased in White donor/African American recipient (HR 1.36; p < .001), African American donor/African American recipient (HR 1.41; p < .001) and Hispanic donor/African American recipient (HR 1.30; p < .001) combinations (Table 1). CONCLUSIONS: African American and Hispanic recipients have decreased survival compared to White recipients after heart transplant. The African American donor does not decrease survival. Racial differences still exist in donor and recipient characteristics and recipient outcomes after OHT. Increasing the donor pool for all races and ethnicities would potentially benefit all recipients. Continued study is warranted in order to minimize these differences among recipients and identify factors that could be contributing to decreased survival, in order to optimize outcomes for African American and Hispanic recipients post-transplant and eliminate disparities.

Positive donor blood cultures are not associated with worse heart transplant survival.

BACKGROUND: Recent evidence has demonstrated that transplantation of hearts with blood culture positive donors (BCPDs) to pediatric recipients is safe and effective. Few studies have analyzed the effect of BCPD on adult heart transplant recipients. METHODS: The United Network for Organ Sharing (UNOS) database was retrospectively reviewed from September, 1987 to March, 2021. Exclusion criteria included pediatric donors/recipients, donor ejection fraction <10% or >85%, inactive listed recipients, donors missing blood cultures, and recipients missing follow-up time. Outcomes were compared with fully adjusted logistic models. To account for discrepancies in BCPD and non-BCPD covariates, an inverse proportionally weighted model with regression adjustment (IPWRA) was used. RESULTS: A total of 60 592 donors were non-BCPD, while 4009 were BCPD. 7% of hearts not transplanted were BCPD, while 6% of hearts transplanted were BCPD (p = .001). These rates have been nearly constant since 2005. There were no differences in short term survival between the two groups in the adjusted or IPWRA models (p = .103 and .277, respectively). Additionally, the BCPD group had longer ischemic time (3.24 vs. 3.06 h, p < .001), older donor age (32.73 vs. 31.65 years, p < .001), and older recipient age (52.76 vs. 52.09 years, p = .001). The IPWRA revealed an average additional 3.4 years of overall survival and 2.25 years of graft function for BCPD versus non-BCPD recipients, although these results failed to reach statistical significance (p = .387 and .527, respectively). CONCLUSIONS: Given the need for more donor hearts, donors with positive blood cultures should be considered. Great care in evaluating such patients is advised to eliminate donors with untreated infections, while carefully selected donors can be considered and used.

Impact of 2016 UNOS pediatric heart allocation policy changes on VAD utilization, waitlist, and post-transplant survival outcomes in children with CHD versus Non-CHD.

AIMS: We analyzed the impact of the revised pediatric heart allocation policy on types of ventricular assist device (VAD) utilization, and waitlist (WL) and post-heart transplant (HT) survival outcomes in congenital heart disease (CHD) versus non-CHD patients before (Era-1) and after (Era-2) pediatric heart allocation policy implementation. METHODS: We retrospectively reviewed the UNOS database from December 16, 2011, through March 31, 2021, for patients < 18 years old and listed for primary HT. We compared the differences observed between Era-1 and Era-2. RESULTS: 5551 patients were listed for HT, of whom 2447(44%) were in Era-1 and 3104(56%) were in Era-2. CHD patients were listed as status 1A unchanged, but the number of patients listed as status 1B decreased in Era-2, whereas the number of non-CHD patients listed as status 1A decreased, but status 1B increased. In Era-2 compared to Era-1, both temporary (1% to 4%, p < .001) and durable VAD (13.6% to 17.8%, p < .001) utilization increased, and the transplantation rate per 100-patient years increased in both groups. The median WL period for CHD patients increased marginally from 70 to 71 days (p = .06), whereas for non-CHD patients it decreased from 61 to 54 days (p < .001). Adjusted 90-day WL survival increased from 84% to 88%, p = .016 in CHD, but there was no significant change in non-CHD patients (p = .57). There was no significant difference in 1-year post-HT survival in CHD and non-CHD patients between Era-1 and Era-2. CONCLUSIONS: In summary, after the revised heart allocation policy implementation, temporary and durable VAD support increased, HT rate increased, waitlist duration marginally increased in the CHD cohort and decreased in the non-CHD cohort, and 90-day WL survival probability improved in children with CHD without significant change in 1-year post-HT outcomes. Future studies are needed to identify changes to the policy that may further improve the listing criteria to improve WL duration and post-HT survival.

Do vasoactive medications impact donor hearts clinical outcomes in pediatric heart transplantation?

OBJECTIVES: There is limited data examining donor vasopressor and/or inotrope medications (vasoactives) on pediatric orthotopic heart transplant (OHT) outcomes. We aim to evaluate the effects of vasoactives on pediatric OHT outcomes. METHODS: The United Network for Organ Sharing database was retrospectively reviewed from January 2000 to March 2018 for donor hearts. Exclusion criteria included multiorgan transplants and recipient age >18. Donors receiving vasoactives at the time of procurement were compared to donors not on vasoactives, including the number of vasoactives and the type. End-points of interest were survival at 30 days and 1 year as well as post-transplant rejection at 1 year. Logistic and Cox models were used to quantify survival end-points. RESULTS: Of 6462 donors, 3187 (49.3%) were receiving at least one vasoactive. Comparing any vasoactive medication versus none, there was no difference in 30-day survival (p = .27), 1 year survival (p = .89), overall survival (p = .68), or post-transplant rejection (p = .98). There was no difference in 30-day survival for donors receiving 2 or more vasoactive infusions (p = .89), 1 year survival (p = .53), overall survival (p = .75), or post-transplant rejection at 1 year (p = .87). Vasopressin was associated with decreased 30-day mortality (OR = 0.22; p = .028), dobutamine with decreased 1-year mortality (OR = 0.37; p = .036), overall survival (HR = 0.51; p = .003), and decreased post-transplant rejection (HR = 0.63; p = .012). CONCLUSIONS: There is no difference in pediatric OHT outcomes when the cardiac donor is treated with vasoactive infusions at procurement. Vasopressin and dobutamine were associated with improved outcomes. This information can be used to guide medical management and donor selection.

Quantifying Individual-Level Inaccuracy in Glomerular Filtration Rate Estimation : A Cross-Sectional Study.

BACKGROUND: Although the population-level differences between estimated glomerular filtration rate (eGFR) and measured glomerular filtration rate (mGFR) are well recognized, the magnitude and potential clinical implications of individual-level differences are unknown. OBJECTIVE: To quantify the magnitude and consequences of the individual-level differences between mGFRs and eGFRs. DESIGN: Cross-sectional study. SETTING: Four U.S. community-based epidemiologic cohort studies with mGFR. PATIENTS: 3223 participants in 4 studies. MEASUREMENTS: The GFRs were measured using urinary iothalamate and plasma iohexol clearance; the eGFR was calculated from serum creatinine concentration alone (eGFRCR) and with cystatin C. All GFR results are presented as mL/min/1.73 m2. RESULTS: The participants' mean age was 59 years; 32% were Black, 55% were women, and the mean mGFR was 68. The population-level differences between mGFR and eGFRCR were small; the median difference (mGFR - eGFR) was -0.6 (95% CI, -1.2 to -0.2); however, the individual-level differences were large. At an eGFRCR of 60, 50% of mGFRs ranged from 52 to 67, 80% from 45 to 76, and 95% from 36 to 87. At an eGFRCR of 30, 50% of mGFRs ranged from 27 to 38, 80% from 23 to 44, and 95% from 17 to 54. Substantial disagreement in chronic kidney disease staging by mGFR and eGFRCR was present. Among those with eGFRCR of 45 to 59, 36% had mGFR greater than 60 whereas 20% had mGFR less than 45; among those with eGFRCR of 15 to 29, 30% had mGFR greater than 30 and 5% had mGFR less than 15. The eGFR based on cystatin C did not provide substantial improvement. LIMITATION: Single measurement of mGFR and serum markers without short-term replicates. CONCLUSION: A substantial individual-level discrepancy exists between the mGFR and the eGFR. Laboratories reporting eGFR should consider including the extent of this uncertainty to avoid misinterpretation of eGFR as an mGFR replacement. PRIMARY FUNDING SOURCE: National Institutes of Health.

Pulmonary Surface Irregularity Score as a New Quantitative CT Marker for Idiopathic Pulmonary Fibrosis-a Pilot Study.

The purpose of this study is to evaluate the accuracy and inter-observer agreement of a quantitative pulmonary surface irregularity (PSI) score on high-resolution chest CT (HRCT) for predicting transplant-free survival in patients with IPF. For this IRB-approved HIPAA-compliant retrospective single-center study, adult patients with IPF and HRCT imaging (N = 50) and an age- and gender-matched negative control group with normal HRCT imaging (N = 50) were identified. Four independent readers measured the PSI score in the midlungs on HRCT images using dedicated software while blinded to clinical data. A t-test was used to compare the PSI scores between negative control and IPF cohorts. In the IPF cohort, multivariate cox regression analysis was used to associate PSI score and clinical parameters with transplant-free survival. Inter-observer agreement for the PSI score was assessed by intraclass correlation coefficient (ICC). The technical failure rate of the midlung PSI score was 0% (0/100). The mean PSI score of 5.38 in the IPF cohort was significantly higher than 3.14 in the negative control cohort (p < .001). In the IPF cohort, patients with a high PSI score (≥ median) were 8 times more likely to die than patients with a low PSI score (HR: 8.36; 95%CI: 2.91-24.03; p < .001). In a multivariate model including age, gender, FVC, DLCO, and PSI score, only the PSI score was associated with transplant-free survival (HR:2.11 per unit increase; 95%CI: 0.26-3.51; p = .004). Inter-observer agreement for the PSI score among 4 readers was good (ICC: 0.88; 95%CI: 0.84-0.91). The PSI score had high accuracy and good inter-observer agreement on HRCT for predicting transplant-free survival in patients with IPF.

Functional status of heart transplant recipients predicts survival.

INTRODUCTION: Recipient functional status prior to transplantation can significantly impact post-transplant survival. METHODS: The United Network for Organ Sharing database was queried for adult heart transplants including data on functional capacity and from February 1, 2005 to March 1, 2021; there were 32 875 cases included. The four functional categories studied were based on adult daily activities of living and were separated into total assistance required, some assistance required, no assistance required, and near death. Survival outcomes were compared for recipient's pretransplant level of functional status versus those with near death status. These were compared using adjusted logistic regression (odds of death at 30 days and 1 year) and conditional Cox models (overall survival and time until post-transplant rejection). All models were adjusted for donor age, sex, ethnicity, ischemic time, as well as recipient age, sex, ethnicity, length of stay, UNOS region, ventricular assist device, creatinine, days on the waiting list, and status at transplant. RESULTS: There were 12 953 recipients classified as "near death" or "severely disabled"; 7711 "required total assistance in daily living", 7,328 "needed some", and 4883 "needed none". In adjusted models, the probabilities of death for the lowest functioning groups within 30 days and 1 year were 5% and 10%, respectively. Those "requiring total assistance" had analogous probabilities of 3% (OR = 0.58; p < 0.001) and 9% (OR = 0.81; p < 0.001). Those "requiring some assistance" had probabilities of 3% (OR = 0.56; p < 0.001) and 9% (OR = 0.74; p < 0.001). Lastly, those "requiring no assistance" had probabilities of death of 2% (OR = 0.35; p < 0.001) and 7% (OR = 0.63; p < 0.001). CONCLUSION: Recipient functional status assessed pre-transplant and recorded in the UNOS database is a strong predictor of post-transplant survival.

Multiinstitutional Evaluation of the Liver Surface Nodularity Score on CT for Staging Liver Fibrosis and Predicting Liver-Related Events in Patients With Hepatitis C.

BACKGROUND. In single-institution multireader studies, the liver surface nodularity (LSN) score accurately detects advanced liver fibrosis and cirrhosis and predicts liver decompensation in patients with chronic liver disease (CLD) from hepatitis C virus (HCV). OBJECTIVE. The purpose of this study was to assess the diagnostic performance of the LSN score alone and in combination with the (FIB-4; fibrosis index based on four factors) to detect advanced fibrosis and cirrhosis and to predict future liver-related events in a multiinstitutional cohort of patients with CLD from HCV. METHODS. This retrospective study included 40 consecutive patients, from each of five academic medical centers, with CLD from HCV who underwent nontargeted liver biopsy within 6 months before or after abdominal CT. Clinical data were recorded in a secure web-based database. A single central reader measured LSN scores using software. Diagnostic performance for detecting liver fibrosis stage was determined. Multivariable models were constructed to predict baseline liver decompensation and future liver-related events. RESULTS. After exclusions, the study included 191 patients (67 women, 124 men; mean age, 54 years) with fibrosis stages of F0-F1 (n = 37), F2 (n = 44), F3 (n = 46), and F4 (n = 64). Mean LSN score increased with higher stages (F0-F1, 2.26 ± 0.44; F2, 2.35 ± 0.37; F3, 2.42 ± 0.38; F4, 3.19 ± 0.89; p < .001). The AUC of LSN score alone was 0.87 for detecting advanced fibrosis (≥ F3) and 0.89 for detecting cirrhosis (F4), increasing to 0.92 and 0.94, respectively, when combined with FIB-4 scores (both p = .005). Combined scores at optimal cutoff points yielded sensitivity of 75% and specificity of 82% for advanced fibrosis, and sensitivity of 84% and specificity of 85% for cirrhosis. In multivariable models, LSN score was the strongest predictor of baseline liver decompensation (odds ratio, 14.28 per 1-unit increase; p < .001) and future liver-related events (hazard ratio, 2.87 per 1-unit increase; p = .03). CONCLUSION. In a multiinstitutional cohort of patients with CLD from HCV, LSN score alone and in combination with FIB-4 score exhibited strong diagnostic performance in detecting advanced fibrosis and cirrhosis. LSN score also predicted future liver-related events. CLINICAL IMPACT. The LSN score warrants a role in clinical practice as a quantitative marker for detecting advanced liver fibrosis, compensated cirrhosis, and decompensated cirrhosis and for predicting future liver-related events in patients with CLD from HCV.

Pre-emptive intraoperative administration of PCC4 in cardiac surgery patients at high risk of bleeding: A pilot study.

BACKGROUND: Four-factor prothrombin complex (PCC4), a concentrate of factors II, VII, IX, and X and proteins C and S, has been used selectively for reversal of oral anticoagulation before surgery. There is data to support PCC4 as opposed to supplemental fresh frozen plasma (FFP) to manage postoperative bleeding following cardiac surgery. The preemptive, intraoperative use of PCC4 in cardiothoracic surgery has not been studied though it may prevent postoperative bleeding, the need for blood transfusion and the risk of transfusion-related acute lung injury, volume overload, and right ventricular (RV) heart failure. The purpose of this study is to evaluate the intraoperative administration of PCC4 to decrease bleeding and lower the rate of blood transfusion. METHODS: A single institution retrospective chart review was conducted from May 2020 to November 2021 of patients who received PCC4 intraoperatively during cardiothoracic surgery of high-risk variety. Patients were evaluated for the type of surgery, demographics, baseline anticoagulation, PCC4 dose, type and quantity of blood transfusion within 72 hours (h) postoperatively, chest tube output, the incidence of RV failure, hypersensitivity reactions, acute kidney injury (AKI), thrombosis, acute lung injury, and mortality within 45 days of the operative dose of PCC4. RESULTS: Thirty-five patients received PCC4 at a mean dose of 2920 units (U). Sixty-five percent of cases were left ventricular assist devices (LVADs) or heart transplants. The protocol is to use PCC4 30 units (U)/kg immediately after the completion of protamine administration. Inclusion criteria are cardiothoracic surgery with increased risk of postoperative right heart failure commonly secondary to blood product transfusion, or cardiothoracic surgery associated with increased risk of bleeding, including heart transplant, LVAD implant, aortic dissection, and redo sternotomy (e.g., coronary artery bypass). Total chest tube output was recorded as a mean of 757 ml for 24 h after surgery (32 ml/h). Overall median event rates of FFP and red blood cell (RBC) transfusions were 0 (interquartile range [IQR]: 0-3 U) and 4 (IQR: 2-5 U). Overall, 43% and 89% of cases received FFP and RBC, respectively. There was one occurrence of RV failure, one occurrence of AKI requiring renal replacement therapy, one occurrence of venoarterial extracorporeal membrane oxygenation, one occurrence of venous thromboembolism related to a central venous access line, and one death unrelated to surgery or PCC4 that was attributed to advanced heart failure not amenable to advanced therapies. CONCLUSION: Overall patients received a low rate of blood transfusion, had minimal chest tube output, and there was a small incidence of right heart failure. Patients did not have an increased risk of adverse effects such as AKI or venous thromboembolism. A randomized controlled clinical trial comparing the observed dose and timing of PCC4 versus routine postoperative bleeding management with blood product transfusion is recommended.

Enhanced recovery after surgery multimodality pain regimen performs similar to PRN narcotics on outcomes and pain control after cardiac surgery: A quality improvement project.

BACKGROUND: While enhanced recovery after surgery (ERAS) pathways have been successfully applied for cardiac surgery, there has been limited research directly comparing ERAS protocols to ad hoc narcotic use after surgery. We hypothesized that a standardized ERAS protocol would provide similar pain management and psychoemotional outcomes while decreasing the use of opioids in the hospital and after discharge. METHODS: As part of a 7-month quality improvement project, cardiac surgery patients on a fast-tracked to extubate pathway were assigned pro re nata (PRN) narcotic pain management for 3 months (n = 49). After a 1-month ERAS protocol optimization period, a separate group of patients were given the ERAS protocol (n = 34). Clinical outcomes were gathered, and participants completed a quality of recovery survey that allowed for the assessment of pain and symptom control at four-time points after surgery. RESULTS: Among 83 participants, 66% were male and the mean age was 53 years. There were no differences in patient characteristics between PRN and ERAS groups (all p > .244). There were no differences between ERAS and PRN groups for surgery characteristics (all p > .060), inpatient outcomes (all p > .658), or after-discharge outcomes (all p > .397). Furthermore, across all time-point comparisons, there were no supported differences in patient-reported outcome and pain control between the ERAS and PRN narcotic groups (all p > .075). CONCLUSIONS: An ERAS protocol demonstrated similar patient outcomes and pain control to traditional opioid use for postoperative cardiac surgery patients. Further research is recommended to further confirm the results of this study.

Ischemic time and patient outcomes after the 2018 UNOS donor heart allocation system change.

BACKGROUND: The allocation system for heart donors in the United States changed on October 18, 2018. The typical distance from donor hospitals to recipient hospitals has increased as has the ischemic time. We investigated patient outcomes with the new allocation system and the differential effects of ischemic time under both the old and new allocation schemas. METHODS: The United Network for Organ Sharing Registry (UNOS) was queried for data regarding heart transplants occurring from October 1, 1987 to March 1, 2021. In total, 62,301 adult heart transplants were examined. Survival outcomes at 30 days and 1 year and ischemic times were compared via adjusted logistic and Cox models (overall survival and time until post-transplant rejection). RESULTS: Mean ischemic time was slightly increased in the new system (3.43 h vs. 3.03 h, p < .001). Survival differences between old versus new systems were not observed in adjusted models (p = .818). However, there was evidence to suggest longer ischemic times are more detrimental to long-term survival under the new system (hazard ratio [HR] = 1.15 per hour increase; p = .001) versus the old system (HR = 1.08 per hour increase; p < .001), although this relationship did not reach statistical significance (p = .150). CONCLUSIONS: Although travel distances have significantly increased under the new allocation system, survival outcomes remain largely unchanged. Ischemic time is an influential factor in recipient survival that should be limited during organ transport. Further studies on the impact of travel distances and ischemic time under the new allocation system are needed.

Low-energy Gunshot-induced Tibia Fractures: What Proportion Develop Complications?

BACKGROUND: Gunshot injuries of the extremities are common in the United States, especially among people with nonfatal gunshot wounds. Controversy persists regarding the proper management for low-energy gunshot-induced fractures, likely stemming from varying reports on the likelihood of complications. There has yet to be published a study on a large cohort of patients with gunshot-induced tibia fractures on which to base our understanding of complications after this injury. QUESTIONS/PURPOSES: (1) What percentage of patients with low-energy gunshot-induced tibia fractures developed complications? (2) Was there an association between deep infection and fracture location, injury characteristics, debridement practices, or antibiotic use? METHODS: This was a multicenter retrospective study. Between January 2009 and December 2018, we saw 201 patients aged 16 years or older with a gunshot-induced fracture who underwent operative treatment; 2% (4 of 201) of those screened had inadequate clinical records, and 38% (76 of 201) of those screened had inadequate follow-up for inclusion. In all, 121 patients with more than 90 days of follow-up were included in the study. Nonunion was defined as a painful fracture with inadequate healing (fewer than three cortices of bridging bone) at 6 months after injury, resulting in revision surgery to achieve union. Deep infection was defined according to the confirmatory criteria of the Fracture-Related Infection Consensus Group. These results were assessed by a fellowship-trained orthopaedic trauma surgeon involved with the study. Complication proportions were tabulated. A Kaplan-Meier chart demonstrated presentations of deep infection by fracture location (proximal, shaft, or distal). Univariate statistics and multivariate Cox regression were used to examine the association between deep infection and fracture location, entry wound size, vascular injury, intravenous (IV) antibiotics in the emergency department (ED), deep and superficial debridement, the duration of postoperative IV antibiotics, and the use of topical antibiotics, while adjusting for age, race/ethnicity, smoking status, and BMI. A power analysis for the result of deep infection demonstrated that we would have had to observe a hazard ratio of 4.28 or greater for shaft versus proximal locations to detect statistically significant results at 80% power and alpha = 0.05. RESULTS: The overall complication proportion was 49% (59 of 121), with proportions of 14% (17 of 121) for infection, 27% (33 of 121) for wound complications, 20% (24 of 121) for nonunion, 9% (11 of 121) for hardware breakage, and 26% (31 of 121) for revision surgery. A positive association was present between deep infection and deep debridement (HR 5.51 [95% confidence interval 1.12 to 27.9]; p = 0.04). With the numbers available, we found no association between deep infection and fracture location, entry wound size, vascular injury, IV antibiotics in the ED, superficial debridement, the duration of postoperative IV antibiotics, and the use of topical antibiotics. CONCLUSION: In this multicenter study, we found a higher risk of complications in operative gunshot-induced tibia fractures than prior studies have reported. Infection, in particular, was much more common than expected based on prior studies. Consequently, surgeons might consider adopting the general management principles for nongunshot-induced open tibia fractures with gunshot-induced fractures, such as the use of IV antibiotics both initially and after surgery. Further research is needed to test and validate these approaches. LEVEL OF EVIDENCE: Level IV, therapeutic study.

The effects of increased donor support time from organ donation referral to donor procurement on heart transplant recipient survival.

INTRODUCTION: Given the known deleterious cardiac effects of brain death (BD) physiology, we hypothesized that time from cardiac donation referral to procurement (donor support time [DST]), would negatively impact cardiac transplant recipient survival. METHODS: The United Network for Organ Sharing database was queried from 2007 to 2018, identifying 22,593 donor hearts for analysis. Multivariate logistic models for 30-day and 1-year survival, as well as Cox models for overall survival and posttransplant rejection, were used to assess adjusted outcomes. RESULTS: median DST was 3 days (interquartile range: 2-5 days). Ischemic time; distance between donor and recipient hospitals; and recipient age, creatinine, waitlist time, and length of stay were adjusted predictors of survival and rejection. DST was not associated with either outcome in aggregate; however, differential association by donor race was identified, with DST in any race recipient associated with 4% higher odds of 1-year mortality (p = .001; p value for interaction .005) but only a trend towards worse overall mortality (p = .064; p value for interaction .046). CONCLUSION: Thus, duration of exposure to BD physiology may have a differential impact on recipient outcomes based on donor race, suggesting that additional research is needed on donor immunologic, socioeconomic, and healthcare access factors that may impact cardiac transplant recipient outcomes.

Initial Institutional Experience with 18F-Fluciclovine PET-CT in Biochemical Recurrence of Prostate Cancer.

OBJECTIVES: 18F-fluciclovine (fluciclovine) is an amino acid analog approved by the Food and Drug Administration for use as a radiotracer in positron emission tomography (PET) in men with biochemical recurrence of suspected prostate cancer. The purpose of this study was to investigate the initial institutional experience with 18F-fluciclovine in the evaluation of prostate cancer with biochemical recurrence. METHODS: This study was a retrospective review of 135 patients who underwent 18F-fluciclovine PET-computed tomography (PET-CT) at a single institution from August 2018 through January 2020. Prognostic information, including prostate-specific level antigen (PSA) at the time of diagnosis, initial risk, initial Gleason score, and initial stage, was reviewed as well as the PSA level at the time of the scan. The images were reviewed by two radiologists with fellowship training in nuclear medicine and additional training to interpret the fluciclovine studies. A minority of studies were reviewed by a third fellowship-trained radiologist under the guidance of the two nuclear medicine-trained radiologists. In cases with abnormal radiopharmaceutical uptake in lymph nodes, the short-axis dimension of the lymph node or largest lymph node with abnormal uptake was noted. If CT or bone scan was performed within 4 months of the 18F-fluciclovine PET-CT, findings on the alternate imaging were compared with the results of the 18F-fluciclovine PET-CT. RESULTS: Our institutional positivity rate was 75.6%, with 64 (67.4%) patients with metastatic disease and 71 (52.6%) patients with local recurrence detected by fluciclovine. As expected, the rate of positive examinations increased with increasing PSA values measured at the time of imaging (P < 0.001). Of the 54 patients with nodal disease, 35 had nonpathologically enlarged lymph nodes measuring <1 cm in maximum short-axis dimension. In more than half of the patients in this study, with conventional imaging, fluciclovine either discovered otherwise undetectable metastatic disease or suggested the presence of local recurrence. CONCLUSIONS: Our single-institution experience with 18F-fluciclovine PET-CT has the largest number of patients to date in the literature and demonstrates the ability of fluciclovine to help guide clinical management in the detection of early recurrent disease.

Does pediatric heart transplant survival differ with various cardiac preservation solutions?

BACKGROUND: Few studies directly compare outcomes between the most commonly used preservation solutions in pediatric heart transplantation in a large cohort of recipients. The purpose of this study is to investigate the effect of cardiac preservation solution on survival in pediatric heart transplant recipients. METHODS: The United Network for Organ Sharing (UNOS) database was retrospectively reviewed from 01/2004-03/2018 for pediatric donor hearts. Saline, University of Wisconsin (UW), "cardioplegia," Celsior, and Custodiol preservation solutions were evaluated. The primary endpoints were recipient survival at 30 days, 1 year, and long term. RESULTS: After exclusion criteria, 3012 recipients had preservation solution data available. The most common preservation solution used was UW in 1203 patients (40%), followed by Celsior in 542 (18%), cardioplegia in 461 (15%), saline in 408 (14%), and Custodiol in 398 (13%). Survival of recipients whose donor hearts were procured with UW was as follows: 97%-30 day, 92%-1 year; Celsior: 97%-30 day, 92%-1 year; cardioplegia: 97%-30 day, 91%-1 year; saline: 97%-30 day, 91%-1 year; and Custodiol: 96%-30 day and 92%-1 year. Analysis of Cox models for 30-day and long-term survival revealed no statistical differences when comparing UW to Celsior (p = .333), cardioplegia (p = .914), saline (p = .980), or Custodiol (p = .642) in adjusted models. CONCLUSIONS: There were no significant differences in 30-day or 1-year survival detected between commonly used preservation solutions in the pediatric heart transplant population.

Third-trimester in utero fetal brain diffusion tensor imaging fiber tractography: a prospective longitudinal characterization of normal white matter tract development.

BACKGROUND: White matter is responsible for inter-neuronal connections throughout the brain that are a driving force in cognitive development. Diffusion tensor imaging (DTI) fiber tractography has been used to evaluate white matter development in the fetal brain; however, longitudinal studies of DTI fiber tractography to assess white matter development in the third trimester are lacking. OBJECTIVE: To characterize in utero longitudinal changes in the fetal brain DTI fiber tracts of normal third-trimester fetuses. MATERIALS AND METHODS: For this single-center prospective longitudinal observational pilot study, we recruited 28 pregnant females with normal third-trimester pregnancies who had routine prenatal ultrasound. MRI of the in utero fetal brain was performed with a Siemens 1.5-tesla (T) Espree scanner at 31 weeks, 33 weeks and 36 weeks of gestation, with 14 DTI tractography parameters quantified in 7 brain regions using DTI-studio version 2.4 (Johns Hopkins University, Baltimore, MD; n=98 measurements). We used multilevel mixed models to examine the relationship between longitudinal changes in DTI measurements and between 98 DTI measurements at 31 weeks and 4 routine fetal brain anatomical biometrics (n=392 assessments). RESULTS: We observed statistically significant decreases in radial diffusivity and apparent diffusion coefficient in 13 of 14 brain regions from 31 weeks to 36 weeks of gestation (P<0.001 for all regions except the genu of the corpus callosum). Significant decreases in radial diffusivity from weeks 33 to 36 and weeks 31 to 36 were seen in the corticospinal tracts, centrum semiovale, posterior limb of the internal capsule, and crus cerebri (P<0.001 for all). When considering all possible combinations of DTI fiber tract measurements and the routine morphological fetal brain biometrics, only 6% (24/392) had a significant association (P<0.05), indicating relative independence of the DTI fiber tract measurements from anatomical biometrics. CONCLUSION: In utero longitudinal changes in fetal brain DTI fiber tractography are quantifiable in normal third-trimester fetuses and are largely independent of morphological brain changes.

Single-Institution Experience of Synovial Sarcoma.

OBJECTIVES: The purpose of this study was to investigate the patient population and outcomes of synovial sarcoma at a single institution. METHODS: A retrospective review of the medical records of 28 patients with synovial sarcoma diagnosed from 1992 to 2017 was performed. Demographics, staging, disease location, treatment, and response to treatment were reviewed. RESULTS: Individuals with larger tumors at the time of presentation had an increased risk of death. An additional factor associated with poor prognosis in synovial sarcoma was increasing patient age. The patient population had a higher rate of nonextremity disease and lower overall survival when compared with national averages. CONCLUSIONS: Nonextremity disease and large size of tumor at presentation may have contributed to the disparity in institutional outcomes from the national averages. The advanced presentation of synovial sarcoma remains a significant challenge in improving patient survival.

The Effect of Cardiac Preservation Solutions on Heart Transplant Survival.

BACKGROUND: Limited data exist that compare the predominant cardiac preservation solutions (CPSs). MATERIALS AND METHODS: The United Network for Organ Sharing database was retrospectively reviewed from January 1, 2004 to March 31, 2018, for donor hearts. Of 34,614 potential donors, 21,908 remained after applying the exclusion criteria. The CPS analyzed included saline, the University of Wisconsin (UW), cardioplegia, Celsior, and Custodiol. The primary endpoints were recipient survival and posttransplant rejection. Logistic and Cox models were used to quantify survival endpoints. RESULTS: Saline was used as the CPS in 2549 patients (12%), UW in 10,549 (48%), cardioplegia in 1307 (6%), Celsior in 5081 (23%), and Custodiol in 2422 (11%). Donor age ranged from 15 to 68 y (mean = 32.0 y, median = 30.0 y), and 71% were male. Adjusted survival probabilities of recipients whose donor hearts were procured with saline was 96% 30 d, 90% 1 y, UW: 97% 30 d, 92% 1 y, cardioplegia: 95% 30 d, 87% 1 y, Celsior: 96% 30 d, 90% 1 y, and Custodiol: 97% 30 d, 92% 1 y. When these comparisons were adjusted for donor age, sex, ethnicity, ischemic time, recipient age, sex, ethnicity, creatinine, ventricular assist device (VAD), length of stay, region and days on waiting list, cardioplegia solution was demonstrated to have a higher risk of death (30 d, 1 y, overall) and posttransplant rejection versus UW (odds ratio 1.70, P = 0.001; odds ratio 1.63, P < 0.001; hazard ratio 1.22, P < 0.001; hazard ratio 1.21, P < 0.001, respectively). CONCLUSIONS: Cardioplegia solutions for cardiac preservation are associated with a higher mortality in heart transplant recipients.