February 2024

This is a single-center retrospective study comparing risk of surgical bleeding in infants who underwent early versus delayed repair of congenital diaphragmatic hernia (CDH) on extracorporeal membrane oxygenation (ECMO) support. The study determined that there is a significantly lower incidence of bleeding with early CDH repair (occurring within the first 48 hours after cannulation) and shorter duration of ECMO.

Summary: The optimal timing of surgical repair for infants with CDH requiring ECMO support remains controversial. While most centers prefer early repair for infants with CDH on ECMO, there is no consensus on the definition of early repair. Conversely, some centers prefer later repair, when infants are closer to decannulation or even defer repair until after successful decannulation from ECMO.

This single-center retrospective study included 146 infants with CDH at a large tertiary center that had a repair on ECMO from May 1995 to December 2021. Infants were grouped into cohorts based on early repair (ER), defined as repair within the first 48 hours of ECMO cannulation, or delayed repair (DR), after 48 hours. The primary aim was to evaluate the impact of timing of CDH repair on surgical bleeding, as defined by the need for operative intervention for decompression and/or hemostasis while on ECMO support.

Of the 451 infants with CDH treated, 167 (37%) utilized ECMO support and underwent surgical repair. Infants who had surgical repair following ECMO decannulation or who only required ECMO support after CDH repair were excluded from the study, with 146 infants remaining for analysis. Of the 146 infants evaluated, 102 (70%) were repaired during the first 48 hours after ECMO cannulation (ER) and 44 (30%) had repair after 48 hours (DR). Multivariable logistic regression showed that surgical bleeding requiring reoperation was more frequent in the DR group (36% vs. 5%, p <0.001), with the odds of bleeding 11.7 times higher in the DR group (OR 11.7, 95% CI: 3.48 – 39.8, p<0.001). Additionally, the risk of bleeding progressively increased with later surgical repair on ECMO, with a bleeding complication rate up to 67% for operations occurring >10 days after cannulation. Another risk factor noted was level of azotemia on the day of repair; BUN was markedly elevated among those infants who had a bleeding complication compared to those who did not (63 mg/dL vs 9mg/dL, p <0.0001). Among the 21 patients with surgical bleeding, 17 (81%) had BUN/Cr >20 compared to only 33 of 125 (26%) of non-bleeders (p <0.0001). Overall survival for infants with CDH repaired on ECMO was 59% with no significant difference between the two groups.

Sample size was a big limitation of this study, as noted by the large confidence intervals. Similarly, as noted by the authors, this institution prefers to perform early CDH repairs and thus, the patients receiving delayed repair might be clinically different than those receiving early repair.

Bottom Line: Delayed CDH repair on ECMO poses a significantly higher risk of surgical bleeding and profound azotemia at the time of repair may serve as an independent, potentially modifiable risk factor.

This study examined the effect of gender-affirming mastectomy in transmasculine and nonbinary patients on psychosocial functioning and clinical outcomes. The authors found that gender-affirming mastectomy improved psychosocial and sexual well-being, patient satisfaction, body image-related quality of life, and gender congruence.
 
Summary: In this single institution cohort study, a total of 111 transmasculine and nonbinary patients from 2017-2022 underwent mastectomy and were included in the analysis. To assess psychosocial functioning, the authors used only validated patient-reported outcomes measures, a distinction from prior studies, which included modules of the BREAST-Q, BODY-Q, PHQ-9 and GAD-7. All patients were included in descriptive analyses and all patients completed post-operative surveys and assessments. Additionally, of the total 111 patients, 20 patients were also enrolled in the prospective portion of the study, which involved the comparison of pre-operative and post-operative assessments.

In the entire cohort, patients ranged from 18 to 63 years of age (average 26.5). All patients were assigned female at birth and most patients identified as trans-male (63.1%), with the other identifying as non-binary (34.2%) or other (2.8%). At baseline, 55% of patients were diagnosed with depression and 45% of patients had an anxiety disorder. 

In terms of surgical outcomes, the most commonly used surgical technique for mastectomy was double incision (n=94) followed by periareolar (n=17). Surgical outcomes included hematoma, seroma, infection, and hypertrophic scarring. Hematomas occurred in 3 breasts (1.4%), all of which required surgical intervention. Seromas occurs in 7 breasts (3.2%) and infections occurred in 2 breasts (0.9%) but there was no significant difference in complications rates among the two techniques. Hypertrophic scarring occurred in 36.9% of patients, all of which occurred after double incision mastectomy. Nine patients underwent revision surgery, of which 6 were for nipple reduction, which only occurred after peri-areolar resections. 

Psychosocial measures were assessed in 96 patients who underwent surgery with fully completed surveys, which was then compared to 35 control patients who were scheduled for but had not yet undergone surgery. Compared to patients who had not yet undergone surgery, those who had a mastectomy had higher overall psychosocial and sexual well-being, as measured by the BREAST-Q (72.2 vs 37.2, p<0.001; 59.9 vs 39.0, p<0.001, respectively). Similar results were found on the other assessments as well as the depression and anxiety instruments. 

In the prospective subgroup, surveys administered 1 - 2 weeks before surgery were compared those administered a mean of 51.5 weeks after surgery. For these patients, significant improvements were found in BREAST-Q psychosocial well-being (72.2 vs. 33.9, p <0.001), BREAST-Q sexual well-being (59.0 vs. 37.1, p <0.001), BODY-Q chest contour satisfaction (92.7 vs. 11.7, p <0.001), BODY-Q nipple satisfaction (87.0 vs. 26.8, p < 0.001), body image-related QOL assessment (1.1 vs. -0.8, p <0.001), gender congruence (4.2 vs. 3.0, p <0.001), and anxiety scores (4.8 vs. 9.2, p = 0.023). However, differences in depression scores (6.0 vs. 7.3, p = 0.474) were not significant, likely due to low numbers of pre-operative depression.
  
This study is limited by small sample size, which impacts the power of the study, particularly the analysis of mental health outcomes in the prospective cohort and the analysis of surgical outcomes stratified by patient factors. Additionally, all patients were selected from a single institution with a comprehensive and interdisciplinary Gender Health Program, which may limit the generalizability of these findings to lower-resourced institutions and patients. 
 
Bottom Line: Among transmasculine and nonbinary adults, gender-affirming mastectomy is followed by measurable and significant improvements in psychosocial functioning and mental health. 

This prospective cohort study evaluated the effect of acute kidney injuries (AKI) in deceased-donor kidneys on clinical transplant outcomes of the recipient, such as acute rejection and allograft failure. This study found that donor AKI (by biomarkers and clinical assessment) were not associated with graft failure, rejection, nor de novo donor specific antibody development.

Summary: This study investigates the association between deceased-donor acute kidney injury (AKI) and transplant outcomes, hypothesizing that donor AKI-related biomarkers (such as IL-18, KIM-1, NGAL) and clinical AKI, assessed using the AKI Network criteria, correlate with higher rates of biopsy-proven acute rejection (BPAR) and allograft failure. The primary outcome was a composite of BPAR and graft failure, with a secondary outcome included these factors plus development of de novo donor-specific antibody (DSA) within the first-year post-transplant. 

This prospective cohort study included 1,137 adult kidney recipients from 862 deceased donors across 13 centers. Mean recipient age of transplant was 53.7 ± 13.3 years; the cohort was 61% males, 99% first-time recipients, and 15% of patients had PRA titers > 80%. For induction immunosuppression, 82% of recipients had anti-thymocyte globulin induction, 15% received basiliximab, and 3% received alemtuzumab. A multivariable regression using death as a competing risk showed no significant associations between the urinary injury biomarkers and the primary or secondary outcomes, suggesting that there is no significant increased risk of acute rejection for recipients of deceased-donor kidneys with AKI compared to recipients of kidneys without AKI. Compared to those who did not experience the primary outcome of rejection or allograft failure, those who did experience the primary outcome were more likely to be Black race (57% versus 45%, p-value = 0.003), have prior transplants (19% versus 13%, p-value = 0.04), and have calculated PRA titers >80% (21% versus 14%, p-value = 0.05). Recipients who experienced the primary outcome were more likely to have delayed graft function (54% versus 35%, p-value < 0.001).

This study's null findings, which challenge the initial hypothesis, imply that current induction and immunosuppression regimens may effectively mitigate the inflammatory state of donor allografts with AKI. The study may be critiqued for its reliance on biopsies performed only in the setting of suspicion for the primary outcome (“for-cause biopsies”), though the long-term clinical significance of subclinical rejection found on surveillance biopsies, which can expose patients to undue risk, is uncertain. In contrast, the study used DSA data only from centers that screened recipients for de novo DSA regardless of clinical concern for acute rejection. In all, this investigation adds valuable evidence to the ongoing discourse on transplantation of deceased donor kidneys with AKI, highlighting the potential for safe transplantation of allografts previously considered marginal or high-risk in the setting of a limited resource.

Bottom line: This large prospective cohort study found that biomarkers of donor acute AKI are not associated with development of renal allograft failure or rejection in the recipient. 

This is a Michigan-based multicenter retrospective analysis of the relationship between negative financial factors—deemed “financial toxicity”—and health-related quality of life (hrQOL) measures following traumatic injury. They found that a majority of trauma survivors experienced financial toxicity, which was associated with worse risk-adjusted hrQOL.

Summary: In the United States, traumatic injury remains a leading cause of death and disability among working age adults and survivors of trauma are at high risk of negative financial outcomes following traumatic injury. Traumatic injury presents with a number of financial burdens for patients regardless of income or insurance status including medical debt or high out of pocket costs, loss of work and income, burdensome non-medical expenses, and delayed or foregone care due to inability to pay. These four factors were included in a “financial toxicity score” defined by the Health Economics Committee of the American Association for the Surgery of Trauma and utilized by the authors to assess the relationship between financial toxicity and long-term health outcomes.

The present study used data from a Michigan-based, statewide quality improvement initiative – the Michigan Quality Improvement Program (MTQIP). The MTQIP includes data from 35 level 1 and 2 trauma centers across the state of Michigan and collected hrQOL data at various intervals over a 24-month period. Using multivariate regression analysis, the authors examined data from 510 completed surveys from 403 patients in nine MTQIP participating trauma centers. Survey questions included information on financial outcomes, opioid use, hrQOL measures as defined by the validated EuroQOL-5D instrument, and caregiver burden.

Among the study participants, 65% experienced at least one financial toxicity measure, which was ultimately associated with worse summary measures of hrQOL and higher problem rates as measured by the EQ-5D domains (p<0.05). Surprisingly, neither injury severity nor treatment intensity were independently associated with financial toxicity. However, as one might expect, sociodemographic measures such as younger age, lower household income, lack of insurance, more comorbidities, discharge to facility, and air ambulance transportation were independently associated with higher odds of financial toxicity (p<0.05).

The authors provide analysis that helps to define areas for future intervention and study related to individual financial burden of traumatic injury. This offers potential sociodemographic targets that may help providers and policy makers develop novel interventions. Notable limitations, however, do exist; namely, the study cohort is a single state study, with a 93.1% non-Hispanic White population with a median age of 65 years, and a <3% uninsured rate, making it somewhat difficult to apply to a more diverse trauma population. Further, only 2% of the study cohort experienced penetrating trauma, making it difficult to extrapolate this data to that population.

Bottom line: In a non-penetrating trauma population, financial toxicity affects a majority of trauma patients and is associated with worse mental and physical health, and functional status. Drivers of financial toxicity in this setting were not injury severity or treatment intensity but related to socioeconomic markers of financial risk.