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Evaluating Weight Gain in Infants Treated With Presurgical Lip, Alveolus, and Nose Approximation (PLANA): A Pilot Study

Perez Rivera, Lucas R; Rosa-Chaves, Melanie; Multani, Neha; Plana, Natalie M; Malkoff-Cohen, Deborah; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R; Lico, Margaret M
Presurgical lip, alveolus, and nose approximation (PLANA) is a novel form of presurgical infant orthopedics (PSIO) designed without an intraoral molding plate. While early studies on PLANA have demonstrated improvements in nasolabial morphology, its impact on infant feeding and weight gain has not been assessed. A single-institution, retrospective review of all patients with cleft lip and palate (CL±P) treated with PLANA over a 1-year period was therefore performed. Weight values at baseline and at surgery were compared with World Health Organization (WHO) Child Growth Standards, and weight-for-age z-scores (WAZ) as well as changes in weight-for-age z-scores (WAZ) were obtained. A cohort of patients who underwent PSIO with NasoAlveolar Molding (NAM) was evaluated as a reference group. The PLANA (n=19) and NAM (n=25) groups were comparable in age (15.63 versus 21.16 d, P=0.2), weight (3.38 versus 3.50 kg, P=0.2), and WAZ (-0.80 versus -0.94, P=0.8) at baseline, and in age (103.11 versus 113.04 d, P=0.06), weight (5.82 versus 5.68 kg, P=0.3), and WAZ (-0.92 versus -1.47, P=0.2) at surgery. Both groups had similar weight gain (2.44 versus 2.18 kg, P=0.1) and WAZ (-0.12 versus -0.53, P=0.2). The PLANA group exhibited statistically significant greater daily weight gain (0.028 versus 0.024 kg/d, P=0.04). None of the patients experienced surgical delays due to insufficient weight gain. PLANA did not interfere with presurgical weight gain in infants with CL±P.
PMID: 41129194
ISSN: 1536-3732
CID: 5957112

Categorical and phenotypic image synthetic learning as an alternative to federated learning

Truong, Nghi C D; Bangalore Yogananda, Chandan Ganesh; Wagner, Benjamin C; Holcomb, James M; Reddy, Divya D; Saadat, Niloufar; Bowerman, Jason; Hatanpaa, Kimmo J; Patel, Toral R; Fei, Baowei; Lee, Matthew D; Jain, Rajan; Bruce, Richard J; Madhuranthakam, Ananth J; Pinho, Marco C; Maldjian, Joseph A
Multi-center collaborations are crucial in developing robust and generalizable machine learning models in medical imaging. Traditional methods, such as centralized data sharing or federated learning (FL), face challenges, including privacy issues, communication burdens, and synchronization complexities. We present CATegorical and PHenotypic Image SyntHetic learnING (CATphishing), an alternative to FL using Latent Diffusion Models (LDM) to generate synthetic multi-contrast three-dimensional magnetic resonance imaging data for downstream tasks, eliminating the need for raw data sharing or iterative inter-site communication. Each institution trains an LDM to capture site-specific data distributions, producing synthetic samples aggregated at a central server. We evaluate CATphishing using data from 2491 patients across seven institutions for isocitrate dehydrogenase mutation classification and three-class tumor-type classification. CATphishing achieves accuracy comparable to centralized training and FL, with synthetic data exhibiting high fidelity. This method addresses privacy, scalability, and communication challenges, offering a promising alternative for collaborative artificial intelligence development in medical imaging.
PMCID:12550077
PMID: 41130949
ISSN: 2041-1723
CID: 5957222

Advocacy for State Acknowledgment of the 2023 Brain Death/Death by Neurologic Criteria Guidelines as the Accepted Medical Standards

Lewis, Ariane; Landau, Dylan; Kirschen, Matthew P; Greer, David Matthew
State death determination acts require brain death/death by neurologic criteria (BD/DNC) determination to be in accordance with "accepted medical standards." The American Academy of Neurology/American Academy of Pediatrics/Child Neurology Society/Society of Critical Care Medicine published updated BD/DNC guidelines in October 2023 to replace earlier iterations of separate guidelines for BD/DNC determination in adults and pediatric persons. There are no other medical society guidelines for BD/DNC determination in the United States. As of early 2024, only Nevada, New Jersey, and New York identified the 2023 BD/DNC guidelines as the "accepted medical standards." Delineation of the "accepted medical standards" in state death determination acts or by state health organizations (SHOs) could help facilitate consistency and accuracy in BD/DNC determination, prevent false-positive death determination, and promote public trust. SHOs are comprised of policy experts and medical professionals responsible for addressing medical, ethical, and legislative problems related to health. In April 2024, we began iteratively contacting state health departments, medical boards, medical societies, and hospital associations requesting acknowledgment of the 2023 BD/DNC guidelines as the "accepted medical standards." From April 2024 to March 2025, we contacted 168 SHOs and received responses from 108 of 168 (64%, median: 2 per state, range: 0-4 per state). The effects of this advocacy effort continue to evolve, but as of March 31, 2025, 4 states had an SHO that acknowledged the 2023 BD/DNC guidelines as the "accepted medical standards" (Delaware, Louisiana, Oklahoma, and Vermont), 9 states had an SHO discussing acknowledgment, 4 states had an SHO that would consider a resolution submitted by a member about acknowledgment, and 30 states showed no SHO interest in acknowledgment. The Medical Society of Delaware and the Oklahoma State Medical Association formalized acknowledgment in a resolution while the Louisiana Department of Health and the Vermont Department of Health and Board of Medical Practice disseminated communication about acknowledgment. This effort also prompted discussion about the "accepted medical standards" by the American Medical Association. Ongoing advocacy may expand recognition of the 2023 BD/DNC guidelines as the "accepted medical standards" for BD/DNC determination. Communication to hospitals indicating that adherence to these guidelines is crucial and regulations to ensure adherence are essential.
PMID: 40997286
ISSN: 1526-632x
CID: 5937732

Total Joint Replacement of the Lumbar Spine: 12-Month Pain and Functional Outcomes From an Investigational Device Exemption Clinical Trial

Nunley, Pierce D; Sielatycki, J Alex; Humphreys, S Craig; Hodges, Scott D; Block, Jon E; Coric, Domagoj; Goldstein, Jeffrey A
BACKGROUND:Lumbar fusion eliminates motion at the operative level and is associated with altered load transfer and adjacent segment degeneration. Total joint replacement (TJR) of the lumbar spine is a motion segment reconstruction procedure performed via a bilateral transforaminal approach that allows direct neural decompression and replacement of both disc and facet function. This prospective investigational device exemption clinical trial compared TJR with a concurrent, propensity-score-weighted real-world evidence cohort treated with either instrumented transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody spine fusion (PLIF). METHODS:. RESULTS:= 0.04). CONCLUSIONS:Substantial decreases in back impairment and pain severity were realized in both study groups. However, longitudinal improvement in ODI significantly favored patients treated with TJR. CLINICAL RELEVANCE/CONCLUSIONS:Lumbar TJR combines decompression with motion preservation in a single procedure, potentially offering an alternative to fusion in selected patients. The advantage of utilizing a standard posterior operative approach with TJR is that it allows for direct decompression of the neural elements prior to implant placement. LEVEL OF EVIDENCE/METHODS:2b.
PMID: 41120216
ISSN: 2211-4599
CID: 5956832

Factors affecting infection risk and revision rates in shunted pediatric hydrocephalus: 10 years of data from a single academic center

de Souza, Daniel N; Palla, Adhith; Yan, Rachel E; Grin, Eric A; Farid, Michael; Eremiev, Alexander; Kremer, Caroline; Gajic, Zoran Z; Wisoff, Jeffrey H; Hidalgo, Eveline Teresa; Harter, David H
PURPOSE/OBJECTIVE:To identify clinical variables associated with ventricular shunt infection and shunt failure in pediatric hydrocephalus. METHODS:Patients ≤ 18 years treated with ventricular shunts between 2013 and 2024 were identified from one institution's electronic medical record. Children with a confirmed diagnosis of hydrocephalus and ≥ 6 months of postoperative follow-up were included. Primary and revision shunt surgeries were included. Records were manually reviewed for clinical variables. Statistical analyses were performed using R (version 4.2.3). RESULTS:The dataset included 474 surgeries, 146 primary and 328 revisions, undergone by 226 patients. Infection necessitating removal of a previously placed shunt occurred following 3.59% (17/474) of cases. Discharge in ≤ 4 days had a 75% lower relative risk for infection compared to stays > 4 days (1.5% vs. 6% 100-day infection risk; p = 0.011). Patients who underwent revision surgeries for shunt infections were more likely to experience subsequent infections in the first 100 days postoperatively than those revised for other causes (2.42% vs. 21.05%; p < 0.0001). Patient characteristics associated with shunt failure during the 10-year study included younger age (median age: 2.23 years in those with failure vs. 6.62 years in those without; p < 0.0002) and lower weight (median weight: 11.8 kg vs. 20.3 kg; p < 0.0002) at the time of admission. Congenital hydrocephalus (OR = 1.86; p = 0.0045) and aqueductal stenosis (OR = 1.75; p = 0.025) were also associated with shunt failure. CONCLUSIONS:Length of stay > 4 days and previous shunt infection are associated with an increased risk of infection after shunt surgery. These findings are important to consider when counseling pediatric patients and during postoperative monitoring.
PMID: 41117858
ISSN: 1433-0350
CID: 5956732

Evaluating the Stapes as a Landmark for Round Window Identification in Cochlear Implantation

McMenomey, Sean; Tubbs, Richard S; Kveton, John; Cottrell, Justin
OBJECTIVE:To better understand the distance relationship of the stapes to the round window, to assist in intraoperative round window identification. STUDY DESIGN/METHODS:Retrospective review of CT temporal bone imaging and multiplanar image reformat analysis. SETTING/METHODS:Tertiary referral center. PATIENTS/METHODS:Patients above 18 years of age who underwent cochlear implantation between January 2020 and April 2025 and had preoperative computed tomography (CT) imaging of the temporal bone. Patients were excluded if they had prior surgical procedures that could distort the stapes superstructure (eg, stapedectomy) or if image quality/resolution precluded adequate visualization of the stapes crus. INTERVENTION/METHODS:None. MAIN OUTCOME MEASURE/METHODS:Prediction accuracy of the stapes intercrural width to locate the level of the round window. RESULTS:There were 102 ears that were studied, including 51 (50%) left and 51 (50%) right ears. The average measured intercrural width was 2.1 mm (SD: 0.17 mm). The maximum intercrural distance was found to be 2.6 mm, and the minimum distance was 1.7 mm. In all 102 (100%) ears, the intercrural distance of the stapes accurately predicted the level of the RW on image analysis. CONCLUSION/CONCLUSIONS:The stapes intercrural width can be utilized as an accurate predictor of the round window level and is a simple and intuitive intraoperative tool surgeons can utilize to safely gain access to the cochlea.
PMID: 41094712
ISSN: 1537-4505
CID: 5954902

Impact of cephalad versus caudal lumbar lordosis correction on spinal shape and outcomes of complex deformity spine surgery

Diebo, Bassel G; Singh, Manjot; Lafage, Renaud; Lenke, Lawrence G; Lewis, Stephen M; Klineberg, Eric O; Eastlack, Robert K; Mundis, Gregory M; Gum, Jeffrey L; Hostin, Richard; Passias, Peter G; Protopsaltis, Themistocles S; Kebaish, Khaled M; Kim, Han Jo; Shaffrey, Christopher I; Smith, Justin S; Uribe, Juan S; Mummaneni, Praveen V; Turner, Jay; Bess, Shay; Lafage, Virginie; Schwab, Frank J; Daniels, Alan H
PURPOSE/OBJECTIVE:To compare the impact of lumbar lordosis correction achieved by cephalad versus caudal distribution on radiographic alignment and surgical outcomes among adult spinal deformity (ASD) patients. METHODS:Patients who underwent ASD surgery with uppermost instrumented vertebrae (UIV) at or above L1, had preoperative pelvic incidence-lumbar lordosis (PI-LL) > 10°, and had full-body radiographs available were included. Eligible patients were categorized by the focus of lordosis correction: caudal (L4-S1 lordosis between 35 and 45°) and cephalad lordosis-based correction. Patient demographics, preoperative and 2 years spinopelvic alignment and PROMs, and 2 years postoperative surgical complications were compared. RESULTS:In total, 187 (111 caudal and 76 cephalad) patients were included, with mean age of 66.2 years, 78.6% female, and mean frailty score of 3.6. Caudally-restored patients often had an upper thoracic UIV, sacrum/ilium LIV, longer length of fusion, and no lateral lumbar interbody fusion (LLIF) while cephaladly-restored patients had two or more LLIFs above L4 (p < 0.001). Preoperatively, there were no significant differences in radiographic alignment and PROMs between the two groups (p > 0.02). Two years postoperatively, caudally-restored patients had higher L1-S1 LL (p = 0.015) and L4-S1 LL (p < 0.001), and lower PI-LL (p = 0.039) and SVA (p = 0.001). In addition, they had higher SRS-22 activity (p = 0.045), pain (p = 0.047), appearance (p = 0.046), and total (p = 0.016) scores. Finally, they had lower rates of sensory deficits (p < 0.001), motor deficits (p = 0.003), implant failure (p = 0.092), and reoperation (p = 0.020). CONCLUSION/CONCLUSIONS:Caudal lordosis-based correction of spinal deformity patients was associated with higher PROMs and lower rates of neurologic deficits, implant failure, and revisions at 2 years. These findings, while subject to unmeasured confounding, indicate that great caution should be taken when considering cephalad-based correction of ASD.
PMID: 41099916
ISSN: 2212-1358
CID: 5955072

Comparative Efficacy of Perioperative Blood Conservation Agents in Pediatric Cranial Vault Remodeling: A Systematic Review and Network Meta-Analysis

Padilla, Christopher C; Farid, Michael; Smith, Parker; Darko, Kwadwo; O'Leary, Sean; Levy, Bennett; Barrie, Umaru; Khan, Hammad; Aoun, Salah G; Harter, David H
BACKGROUND AND OBJECTIVES/OBJECTIVE:Red blood cell transfusions are commonly required in pediatric cranial vault remodeling (CVR); however, they carry risks and potential complications. This study evaluates the evidence on perioperative blood conservation agents assessing their efficacy in optimizing and reducing transfusion requirements in CVR. METHODS:A systematic review was conducted using PubMed/MEDLINE, Scopus, Embase, Web of Sciences, and Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to assess articles discussing blood conservation agents in pediatric CVR. A network meta-analysis compared the effectiveness of different agents including tranexamic acid (TXA), aminocaproic acid (ACA), aprotinin, erythropoietin (EPO), and iron. RESULTS:Sixteen studies analyzing 1072 patients with a mean age of 15.6 months and weight of 8.78 kg were included. The most reported craniosynostosis subtypes were sagittal (30.2%) and metopic (13.8%). TXA and ACA were independently associated with lower transfusion rates and volumes compared with placebo (ACA: odds ratio [OR], 0.25; 95% CI, 0.08-0.80; TXA: OR, 0.17; 95% CI, 0.07-0.42). Combination therapy with TXA + EPO + iron (OR: 0.004, 95% CI: 0.002-0.10) or ACA + EPO (OR: 0.04, 95% CI: 0.01-0.32) were associated with reductions in transfusion rates. Network meta-analysis ranking revealed TXA + EPO + iron (Surface Under the Cumulative Ranking [SUCRA]: 98.90%) and ACA + EPO (SUCRA: 75.41%) as the most effective treatments for reducing transfusion rates. While TXA was associated with significant reductions in blood loss compared with placebo (standard mean difference: -1.26, 95% CI: -1.97 to -0.56), ACA ranked highest for blood loss reduction (ACA: SUCRA, 84.58% vs TXA: SUCRA, 72.43%). Combination of TXA + EPO + iron was associated with significantly reduced hospital length of stay (standard mean difference: -1.00, 95% CI: -1.71 to -0.29). No treatment significantly affected the duration of surgery, and there were no reported treatment-associated thromboembolic events. CONCLUSION/CONCLUSIONS:Our meta-analysis reveals that TXA + ACA reduce red blood cell transfusion rates and volumes, with TXA + EPO + iron and ACA + EPO being most effective. This highlights the superiority of combination therapies and underscores the need for structured multimodal protocols in perioperative blood conservation for pediatric CVR.
PMID: 41090904
ISSN: 1524-4040
CID: 5954782

Surgical steps to perform an accurate apical cochleostomy

Cottrell, Justin; Landsberger, David; Winchester, Arianna; Shapiro, William; Friedmann, David R; Jethanamest, Daniel; McMenomey, Sean; Roland, J Thomas
OBJECTIVE/UNASSIGNED:We sought to consolidate the anatomical findings from radiologic research and prior surgical literature to develop a stepwise surgical approach utilizing cadaveric specimens which can serve to improve the accuracy and scalability of surgical apical cochleostomies in the future. METHODS/UNASSIGNED:Cadaveric temporal bone dissections, with subsequent image documentation and distance measurements to confirm surgical accuracy. RESULTS/UNASSIGNED:All four temporal bones (100%) that were drilled utilizing the newly developed surgical approach had an accurately placed apical cochleostomy. No inadvertent entry into the middle turn of the cochlea occurred. There was no violation of the labyrinthine facial nerve, or carotid artery. CONCLUSIONS/UNASSIGNED:Preliminary findings are promising for the described steps to achieve a substantial improvement in apical cochleostomy accuracy, with reduced trauma compared to historically taught techniques.
PMID: 41088766
ISSN: 1754-7628
CID: 5954722

Development and validation of clinical screening systems for Cushing disease in the United States

Salcedo-Sifuentes, Jorge E; Mehta, Sonal; Suryadevara, Carter M; Bergsneider, Marvin; Yuen, Kevin C J; Gardner, Paul A; Silverstein, Julie M; Kim, Albert H; Evans, James J; Barkhoudarian, Garni; Fernandez-Miranda, Juan C; Couldwell, William T; Rennert, Robert C; Kshettry, Varun R; Wu, Kyle C; Benjamin, Carolina; Zada, Gabriel; Chicoine, Michael R; Van Gompel, Jamie J; Catalino, Michael P; Karsy, Michael; Mamelak, Adam; Torok, Ildiko; Low, Trevor; Kim, Won; Pacione, Donato R; Agrawal, Nidhi
PURPOSE/OBJECTIVE:Clinical screening systems (CSSs) for Cushing syndrome (CS) validated in Europe have not been evaluated for CS or Cushing disease (CD) in the United States (US). We aimed to evaluate existing CSSs in US patients and develop two new symptom-based CSSs to identify patients with high pre-test probability of disease warranting referral for definitive biochemical workup-one for broad CS screening and one specifically for CD. METHODS:Data were obtained from the Registry of Adenomas of the Pituitary and Related Disorders (RAPID)-comprising 615 patients who underwent transnasal transsphenoidal resection for CD at one of 11 US pituitary centers, the Centers for Disease Control and Prevention's 2019 National Health Interview Survey (NHIS)-comprising 31,997 US respondents, and a single institution CD-NFA cohort-comprising 468 US patients diagnosed with either CD (n = 385) or nonfunctioning adenoma (n = 83). The RAPID Community Cushing CSS was derived from differences between the RAPID and NHIS cohorts, and the RAPID CD CSS from differences between patients with CD versus NFA. RESULTS:In external validation using US-based cohorts, the RAPID Community CSS achieved an AUC of 0.707, compared to the Spanish (AUC = 0.691) and Italian (AUC = 0.685) models, and the RAPID CD CSS demonstrated greater external sensitivity (0.836, threshold = 0.5) at the Youden-optimized threshold than the Spanish (0.605, threshold = 4) and Italian (0.735, threshold = 6) CSSs. CONCLUSIONS:In US patient populations, the RAPID Community Cushing CSS demonstrated superior discriminative ability for CD compared to the Italian and Spanish CSSs, and the RAPID CD CSS achieved the highest sensitivity for CD among all CSSs evaluated.
PMCID:12513928
PMID: 41071234
ISSN: 1573-7403
CID: 5952352