Journal of the American Medical Association最新文献

Importance: Catastrophic facial injury with globe loss remains a formidable clinical problem with no previous reports of reconstruction by whole eye or combined whole eye and facial transplant.

Objective: To develop a microsurgical strategy for combined whole eye and facial transplant and describe the clinical findings during the first year following transplant.

Design, setting, and participant: A 46-year-old man who sustained a high-voltage electrical injury with catastrophic tissue loss to his face and left globe underwent combined whole eye and face transplant using personalized surgical devices and a novel microsurgical strategy at a specialized center for vascularized composite allotransplantation.

Main outcomes and measures: Reperfusion and viability of the whole eye and facial allografts, retinal function, and incidence of acute rejection.

Results: The patient underwent a combined whole eye and face transplant from an immunologically compatible donor with primary optic nerve coaptation and conventional postoperative immunosuppression. Globe and retinal perfusion were maintained throughout the immediate postoperative period, evidenced by fluorescein angiography. Optical coherence tomography demonstrated atrophy of inner retinal layers and attenuation and disruption of the ellipsoid zone. Serial electroretinography confirmed retinal responses to light in the transplanted eye. Using structural and functional magnetic resonance imaging, the integrity of the transplanted visual pathways and potential occipital cortical response to light stimulation of the transplanted eye was demonstrated. At 1 year post transplant (postoperative day 366), there was no perception of light in the transplanted eye.

Conclusions and relevance: This is the first report of whole eye transplant combined with facial transplant, demonstrating allograft survival including rejection-free graft survival and electroretinographic measurements indicating retinal response to light stimuli. These data highlight the potential for clinical allotransplantation for globe loss.

Importance: Bronchopulmonary dysplasia (BPD) is a common adverse outcome in extremely preterm infants born at less than 28 weeks' gestation. Systemic corticosteroids are effective against BPD but may be associated with adverse outcomes. Corticosteroids given directly into the lungs may be effective and safer.

Objective: To investigate the effectiveness of early intratracheal corticosteroid administration on survival free of BPD in extremely preterm infants.

Design, setting, and participants: Double-blind randomized clinical trial conducted in 21 neonatal units in 4 countries (Australia, New Zealand, Canada, and Singapore), enrolling infants born at less than 28 weeks' gestation and less than 48 hours old who were mechanically ventilated (regardless of ventilator settings or oxygen requirements) or who were receiving noninvasive respiratory support and had a clinical decision to treat with surfactant. Recruitment occurred from January 2018 to March 2023. The last participant was discharged from the hospital in August 2023.

Interventions: Infants were randomly allocated (1:1) to receive budesonide, 0.25 mg/kg, mixed with surfactant (poractant alfa), administered via an endotracheal tube or thin catheter, or surfactant only.

Main outcomes and measures: The primary outcome was survival free of BPD at 36 weeks' postmenstrual age. There were 15 secondary outcomes, including the 2 components of the primary outcome (survival at 36 weeks and BPD among survivors), and 9 predefined safety outcomes (adverse events).

Results: The primary analysis included 1059 infants, 524 in the budesonide and surfactant group and 535 in the surfactant-only group. Overall, infants had a mean gestational age of 25.6 weeks (SD, 1.3 weeks) and a mean birth weight of 775 g (SD, 197 g); 586 (55.3%) were male. Survival free of BPD occurred in 134 infants (25.6%) in the budesonide and surfactant group and 121 infants (22.6%) in the surfactant-only group (adjusted risk difference, 2.7% [95% CI, -2.1% to 7.4%]). At 36 weeks' postmenstrual age, 83.2% of infants were alive in the budesonide and surfactant group and 80.6% in the surfactant-only group. Of these, 69.3% and 71.9% were diagnosed with BPD, respectively.

Conclusions and relevance: In extremely preterm infants receiving surfactant for respiratory distress syndrome, early intratracheal budesonide may have little to no effect on survival free of BPD.

Trial registration: anzctr.org.au Identifier: ACTRN12617000322336.

Importance: Inferior vena cava filters (IVCFs) are commonly used to prevent pulmonary embolism in selected clinical scenarios, despite limited evidence to support their use. Current recommendations from professional societies and the US Food and Drug Administration endorse timely IVCF retrieval when clinically feasible. Current IVCF treatment patterns and outcomes remain poorly described.

Objectives: To evaluate temporal trends and practice patterns in IVCF insertion and retrieval among older US patients and report the incidence of periprocedural and long-term safety events of indwelling and retrieved IVCFs.

Design, setting, and participants: Prespecified, retrospective, observational cohort of Medicare Fee-for-Service (FFS) beneficiaries, leveraging 100% of samples of inpatient and outpatient claims data from January 1, 2013, to December 31, 2021.

Exposure: First-time IVCF insertion while insured by Medicare FFS.

Main outcomes and measures: The primary safety outcome was the composite of all-cause death, filter-related complications (eg, fracture, embolization), operating room visits following filter-related procedures, or new diagnosis of deep vein thrombosis (DVT). Events were considered periprocedural if they occurred within 30 days of IVCF insertion or retrieval and long-term if they occurred more than 30 days after.

Results: Among 270 866 patients with IVCFs placed during the study period (mean age, 75.1 years; 52.8% female), 64.9% were inserted for first-time venous thromboembolism (VTE), 26.3% for recurrent VTE, and 8.8% for VTE prophylaxis. Of these patients, 63.3% had major bleeds or trauma within 30 days of IVCF insertion. The volume of insertions decreased from 44 680 per year in 2013 to 19 501 per year in 2021. The cumulative incidence of retrieval was 15.3% at a median of 1.2 years and 16.8% at maximum follow-up of 9.0 years. Older age, more comorbidities, and Black race were associated with a decreased likelihood of retrieval, whereas placement at a large teaching hospital was associated with an increased likelihood of retrieval. The incidence of caval thrombosis and DVT among patients with nonretrieved IVCFs was 2.2% (95% CI, 2.1%-2.3%) and 9.2% (95% CI, 9.0%-9.3%), respectively. The majority (93.5%) of retrieval attempts were successful, with low incidence of 30-day complications (mortality, 0.7% [95% CI, 0.6%-0.8%]; filter-related complications, 1.4% [95% CI, 1.2%-1.5%]).

Conclusions and relevance: In this large, US real-world analysis, IVCF insertion declined, yet retrievals remained low. Strategies to increase timely retrieval are needed, as nonretrieved IVCFs may have long-term complications.