Citations

AbstractA new generation of disease‐specific molecular imaging agents is poised to revolutionize fluorescence‐guided surgery. Pafolacianine has been approved for adult lung and ovarian cancers. We demonstrate a proof of concept for pediatric surgeons treating young adults with pulmonary metastatic sarcomas. Five successful fluorescence‐guided pulmonary metastasectomy operations were performed in young adult patients with metastatic osteosarcoma or Ewing sarcoma following administration of pafolacianine. All osteosarcoma lesions identified using standard techniques were also markedly fluorescent in patients. Novel fluorescent molecular agents targeted to tumor‐specific receptors have promise of increased sensitivity and specificity for detecting metastatic nodules and enhancing surgical clearance of disease.

Background. Static cold storage is a mainstay of the heart transplantation (HTx) process. However, the temperature distribution within the organ at each stage of HTx is unknown. In this study, we aimed to quantify how long it took for the heart to warm up and cool down and the nature of temperature distribution with the organ at each stage of HTx. Methods. We used high-fidelity computational time-varying biothermal modeling on an anatomical human heart model to model the HTx process in 5 interdependent stages, including cardioplegia, back-table preparation, static cold storage ice box storage and transport, back-table preparation at the recipient institution and warm-up within the recipient body before cross-clamp release. Results. Results indicate that the heart experiences roller-coaster-like temperature changes in stage, including rapid cool down from body temperature to <10 °C within 15 min in stage 1 with a maximum cooling rate of 5 °C/min. This was followed by cooling and extended duration of temperatures <2 °C in the ice box and rapid warming up to body temperature within 10 min at rates of 2 °C/min and 4 °C/min for the left and right sides, respectively, during implantation. Temperature distribution throughout the heart was heterogeneous, with right-sided temperature change occurring nearly 2× faster than on the left side. Conclusions. We present, for the first time, detailed temperature distributions and evolution at each stage of HTx. Quantification of the rapid and heterogeneous temperature changes is crucial to optimize HTx and improve organ viability.

AbstractBackgroundThe use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real‐World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data.MethodsThe ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave.ResultsBy December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status.ConclusionsDocumentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi‐institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows.Plain Language Summary Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.

CSF-venous fistulas (CVFs) are a common cause of spontaneous intracranial hypotension. These fistulas usually occur without any preceding major trauma, surgery, or other iatrogenic cause. Occasionally, patients have a history of minor trauma, though such cases are usually still considered spontaneous. Little is known about predisposing factors that cause patients to develop spontaneous CVFs. Most patients with CVFs have multiple meningeal diverticula on spine imaging, and fistulas usually arise in association with a diverticulum. In the vast majority of cases, the culprit diverticulum from which the CVF arises is atraumatic in origin, presumably on the spectrum of normal variation in spinal anatomy. Here, we present two cases of CVFs that arose in association with posttraumatic pseudomeningoceles. To our knowledge, this phenomenon has not yet been reported, and it potentially represents a novel etiology for CVFs that furthers understanding of their pathogenesis.

Background: The Clinical Treatment Score post-5 years (CTS5) is a risk stratification tool used to determine the risk of late recurrence in hormone receptor–positive (HR+), HER2-negative breast cancer (BC). Limited data exist on its use in HR+, HER2-positive (HER2+) BC. Patients and Methods: CTS5 was evaluated in HR+, HER2+ BC in the North Central Cancer Treatment Group (NCCTG) N9831 (Alliance) and NSABP B-31 (NRG) trials. Results: A total of 1,862 patients with HR+, HER2+ BC without recurrence 5 years after enrollment were included. Overall, the CTS5 score was significantly associated with recurrence-free survival (RFS), with a hazard ratio (HR) of 1.35 (95% CI, 1.12–1.63; P=.002), but did not reach statistical significance in patients who received trastuzumab (n=829; HR, 1.29; 95% CI, 0.98–1.71; P=.07). CTS5 risk category was not significantly associated with RFS. In patients who received trastuzumab, other variables used in CTS5, including patient age and tumor size, were not significantly associated with RFS. N3 was significantly associated with worse outcomes (HR, 1.86; 95% CI, 1.09–3.17; P=.02) compared with N0–N1. Paradoxically, higher tumor grade was associated with better outcomes after 5 years in the multivariate analysis (HR, 0.71; 95% CI, 0.50–1.00; P=.05). The incidence of recurrences or deaths between years 5 to 10 was 10.6% in the CTS5 low-risk category, 5.6% in the intermediate-risk category, and 9.8% in the high-risk category. Conclusions: The CTS5 model does not accurately predict the risk of late recurrence in HR+, HER2+ BC treated with adjuvant trastuzumab in the N9831 and B-31 trials. This study underlines the need to develop a new prognostic model to better delineate the risk of late recurrence in patients with HR+, HER2+ BC receiving adjuvant trastuzumab. ClinicalTrials.gov identifiers: NCT00005970 (NCCTG N9831) and NCT00004067 (NRG/NSABP B-31).

Objectives Hospital-based behavioral emergency response teams (BERT) respond to acute behavioral disturbances among hospitalized patients. We aimed to examine associations between altered mental status in postanesthesia care unit (PACU) and behavioral disturbances on surgical wards requiring BERT activation. Methods Electronic medical records of patients who underwent general anesthesia and were admitted to the PACU between May 2018–December 2020 were reviewed for episodes of BERT activations on surgical wards. Characteristics of BERT patients were compared with the rest of surgical population during the same period to examine risk factors for BERT. Results Of 56,275 adult surgical patients, 133 patients had 178 BERT activations (incidence 2.4, 95% confidence interval [CI] 2.0–2.8 per 1000 admissions), with 21 being for physical assault. The risk for BERT activation was increased with each decade over age of 50 as well as younger age (30 versus 50 y), male sex (odds ratio [OR] = 2.48, 95% CI 1.69, 3.62), longer procedures (OR = 1.08 per 30 minutes, 95% CI 1.05, 1.11), and alterations in mental status in PACU, with both moderate/deep sedation (OR = 1.63, 95% CI 1.04, 2.57) and agitation/combative state (OR = 8.47, 95% CI 5.13, 14.01), P < 0.001 for all comparisons. Conclusions Early postoperative agitation and oversedation are associated with BERT activation on surgical wards. Altered mental status in PACU should be conveyed to accepting hospital units so healthcare staff can be vigilant for the potential development of behavioral disturbances.