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4085 citation(s) found for "Uy, Jonathan J".

Impact of aspiration catheter inner diameter on first-pass effect: A systematic review and meta-analysis
Jazayeri, Seyed Behnam , Cortese, Jonathan , Reda, Abdelrahman, Maroufi, Seyed Farzad , Ghozy, Sherief , Kadirvel, Ramanathan , Kallmes, David F. , Cortese, Jonathan , Maroufi, Seyed Farzad , Ghozy, Sherief , Kadirvel, Ram , Kallmes, David F , Reda, Abdullah , Reda, Abdelrahman

Interventional Neuroradiology | June 10, 2025 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1177/15910199251345637 | PMID 40491282 Get It

Background The first-pass effect (FPE) refers to the complete or near-complete revascularization with a single pass of mechanical thrombectomy devices. While previous claims suggest a link between larger catheters and the effectiveness of contact aspiration (CA) thrombectomy, no extensive research has confirmed if larger distal inner diameter (ID) catheters achieve higher FPE rates. Methods We searched PubMed, Scopus, and Web of Science to assess the impact of aspiration catheter distal ID size on FPE. The primary outcome was FPE rate, defined as thrombolysis in cerebral ischemia (TICI) grades 2c-3 at first pass, and the secondary outcome was modified FPE (TICI 2b-3 in a single pass). Aspiration catheters were categorized based on distal ID: 0.060–0.069 (medium bore), 0.070–0.074 (large bore), and greater than 0.074 inches (super-large bore). Rates of FPE were pooled using random effect models and compared using a Chi-square test. Results Our study included 34 articles with 4831 patients. FPE rates were 27.7% (95% CI, 15.1–45.3) for medium bore, 46.6% (95% CI, 33.7–59.9) for large, and 58.3% (95% CI, 44.8–70.7) for super-large catheters. The FPE rate was significantly higher for super-large bore catheters compared with other groups (χ² = 7.26, p = 0.03). A similar trend was observed for modified FPE rates, which were 51.1% (95% CI, 45.3–56.8) for medium bore, 60.0% (95% CI, 52.8–66.8) for large bore, and 80% (95% CI, 56.3–94.2) for super-large bore catheters (χ² = 8.14, p = 0.03). Conclusion Our analysis indicates that larger CA catheters are correlated with higher FPE rates.
Developing a Decision Support Tool to Guide Shared Decision‐Making in Bipolar Depression Treatment: Results From a Collaboration Between Clinicians and People With Lived Experience
Fuentes‐Salgado, Manuel, Gardea‐Resendez, Manuel , Ercis, Mete , Kremin, Ashley, Joyce, Jeremiah B. , Park, Jin Hong , Keeth, Nicola , Moore, Katherine M. , Betcher, Hannah K. , Yang, Padao, Williams, Mark D. , Michael, P., Frye, Mark A. , Lam, Angie, Ercis, Mete , Moore, Katherine, Betcher, Hannah, Savitz, Samuel T. , Frye, Mark , Joyce, Jeremiah , Gardea-Resendez, Manuel , Smith, Andrew, Lam, Angie, Allen, Kimberly, Kremin, Ashley, Leung, Jonathan G. , Özerdem, Ayşegül , Montori, Víctor M.

Bipolar Disorders | June 10, 2025 | Volume: 27 | Issue: 5 | Pages: 358-364

10.1111/bdi.70037 | PMID 40491157 Get It

ABSTRACTObjectiveTo build consensus from different stakeholders on the content and digital interactivity of a shared decision making (SDM) tool to guide patient‐clinician collaborative conversations about treatment for bipolar depression.Patients and MethodsThis study was conducted between September 2022 and September 2023. In the first phase, we conducted a narrative review on pharmacological, neuromodulatory, and psychotherapeutic treatments available for bipolar depression. For each option, we assessed treatment effectiveness, side effects, need for clinical monitoring, clinical considerations, and cost. In the second phase, committees comprised of mental health clinicians and people with lived experience with bipolar disorder from a national mood disorders advocacy group identified key features and content to be included in the SDM tool. A thematic analysis of these data then contributed to populate the SDM tool.ResultsTwenty‐one evidence‐based treatment options identified from the narrative review were presented to the four convened committees (clinical, lived experience, peer council, and integrated steering committees) in five meetings. After discussions and thematic analysis, 12 outcomes of interest for each of the therapeutic interventions were delineated for inclusion in a web‐based SDM tool. A detailed description of the development process and SDM tool is provided.ConclusionThis is the first partnership between clinicians and persons with bipolar disorder lived experience charged with the development of a patient‐centered SDM tool to integrate clinical evidence with real‐world clinical practice and patient preferences for use during clinical encounters. Human‐centered design and testing in real clinical encounters will now contribute to refining the instrument and readying it for rigorous evaluation and implementation in practice.
International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma
Avet‐Loiseau, Hervé , Davies, Faith E. , Samur, Mehmet , Corre, Jill , D’Agostino, Mattia , Kaiser, Martin , Raab, Marc S. , Weinhold, Niels , Gutiérrez, Norma C. , Paiva, Bruno , Walker, Brian A. , Bustoros, Mark , Stewart, A. Keith , Hillengaß, Jens , Martínez‐López, Joaquín , Sperling, Adam S. , Dhodapkar, Madhav V. , Spencer, Andrew , Parekh, Samir , Sonneveld, Pieter , Bergsagel, P. Leif , Orlowski, Robert Z. , Mateos, María‐Victoria , Kumar, Shaji , Munshi, Nikhil C. , Martinez-Lopez, Joaquin , Bergsagel, P. Leif , Samur, Mehmet K , Kaiser, Martin F , Weisel, Katja C , Maura, Francesco , Walker, Brian A , Bustoros, Mark , Stewart, A Keith , Usmani, Saad , Hillengass, Jens , Chng, Wee Joo , Keats, Jonathan J , Martinez-Lopez, Joaquin , Sperling, Adam S , Touzeau, Cyrille , Zhan, Fenghuang , Raje, Noopur S , Bolli, Niccolo' , Ghobrial, Irene M , Dhodapkar, Madhav V , Jagannath, Sundar , Spencer, Andrew , Parekh, Samir , Bahlis, Nizar Jacques , Sonneveld, Pieter , Orlowski, Robert Z. , Mateos, María-Victoria , San-Miguel, Jesus , Anderson, Kenneth C , Moreau, Philippe , Kumar, Shaji K , Munshi, Nikhil C , Raab, Marc S , Martinez-Lopez, Joaquin , Paiva, Bruno , Davies, Faith E , Corre, Jill , Mattia, D'Agostino , Neri, Paola , Maura, Francesco , Usmani, Saad Z. , Chng, Wee Joo , Keats, Jonathan J. , Touzeau, Cyrille , Zhan, Fenghuang , Raje, Noopur , Cavo, Michèle , Bolli, Niccolò , Ghobrial, Irene M. , Jagannath, Sundar , Lonial, Sagar , Morgan, Gareth J. , Rajkumar, S. Vincent , Miguel, Jesús F. San , Anderson, Kenneth C. , Moreau, Philippe , Prósper, Felipe

Journal of Clinical Oncology | June 9, 2025 | Volume: 43 | Issue: 24 | Pages: 2739-2751

10.1200/jco-24-01893 | PMID 40489728 Get It

Despite significant improvements in survival of patients with multiple myeloma (MM), outcomes remain heterogeneous, and a significant proportion of patients experience suboptimal outcomes. Importantly, traditional prognostic factors based on data from patients treated with older therapies no longer capture prognosis accurately in the contemporary era of novel triplet or quadruplet therapies. Therefore, risk stratification requires refinement in the context of available and investigational treatment options in routine practice and clinical trials, respectively. The current identification of high-risk MM (HRMM) in routine practice is based on the Revised International Staging System, which stratifies patients using a combination of widely available serum biomarkers and chromosomal abnormalities assessed via fluorescence in situ hybridization. In recent years, a substantial body of evidence concerning additional clinical, biological, and molecular/genomic prognostic factors has accumulated, along with new MM risk stratification tools and consensus reports. The International Myeloma Society, along with the International Myeloma Working Group, convened an Expert Panel with the primary aim of revisiting the definition of HRMM and formulating a practical and data-driven consensus definition, based on new evidence from molecular/genomic assays, updated clinical data, and contemporary risk stratification concepts. The Panel proposes the following Consensus Genomic Staging (CGS) of HRMM which relies upon the presence of at least one of these abnormalities: (1) del(17p), with a cutoff of >20% clonal fraction, and/or TP53 mutation; (2) an IgH translocation including t(4;14), t(14;16), or t(14;20) along with 1q+ and/or del(1p32); (3) monoallelic del(1p32) along with 1q+ or biallelic del(1p32); or (4) β2 microglobulin ≥5.5 mg/L with normal creatinine (<1.2 mg/dL).
Hurting More Than Helping? Decompressive Craniectomy in Patients With Symptomatic Intracerebral Hemorrhage After Mechanical Thrombectomy in Acute Ischemic Stroke: Insights From Stroke Thrombectomy and Aneurysm Registry
Pressman, Elliot , Vakharia, Kunal , Guerrero, Waldo R. , Maier, Ilko , Raai, Ansaar, Jabbour, Pascal , Kim, Joon-Tae , Grossberg, Jonathan A , Wolfe, Stacey Q , Stark, Robert M., Psychogios, Marios‐Nikos , Dye, Justin , Alaraj, Ali , Yoshimura, Shinichi , Ezzeldin, Mohamad , Tanweer, Omar , Polifka, Adam , Siddiqui, Fazeel , Moss, Mark, Brinjikji, Waleed , Dağlıoğlu, Ergün , Williamson, Richard , Altschul, David , Ogilvy, Christopher S. , Crosa, Roberto , Gory, Benjamin , Kan, Peter , Casagrande, Walter, Chowdhry, Shakeel , Stiefel, Michael , Spiotta, Alejandro M , Mokin, Maxim, STAR, on behalf of, Crosa, Roberto , Alaraj, Ali , Altschul, David J , Wolfe, Stacey Quintero , Ogilvy, Christopher S , Sowlat, Mohammad‐Mahdi , Schimmel, Samantha J. , Jabbour, Pascal , Alawieh, Ali , Stark, Robert M., Samaniego, Edgar A , Goyal, Nitin , Fiorella, David , Romano, Daniele G., Navía, Pedro , Cuellar, Hugo, Fragata, Isabel , Mascitelli, Justin R , Osbun, Joshua W , Limaye, Kaustubh , Matouk, Charles , Park, Min S. , Levitt, Michael R. , Gory, Benjamin , Grandhi, Ramesh , Paul, Alexandra R , Mokin, Maxim , STAR, on behalf of

Neurosurgery | June 9, 2025 | Volume: 98 | Issue: 2 | Pages: 345-357

10.1227/neu.0000000000003563 | PMID 40488514 Get It

BACKGROUND AND OBJECTIVES: It remains unclear whether decompressive craniectomy (DC) is beneficial in patients who suffer symptomatic intracerebral hemorrhage (sICH) after acute ischemic stroke (AIS). We sought to study the effect of DC on functional outcomes in patients with sICH after AIS who underwent mechanical thrombectomy (MT). METHODS: Patients with AIS from anterior circulation large vessel occlusion who underwent MT and subsequently developed sICH were identified from the Stroke Thrombectomy and Aneurysm Registry database. The primary outcome was acceptable 90-day functional neurological outcome, defined as modified Rankin scale (mRS) 0-3. Multivariable logistic regression and propensity-score matching were used to identify and quantify risk factors. RESULTS: Of 464 patients identified with sICH after AIS after MT, 97 patients (20.9%) underwent DC. Patients who underwent DC were more likely to be female ( P < .001), younger ( P < .001), have a measured medical comorbidity, have higher baseline mRS ( P = .02), and have higher-grade hemorrhages ( P = .01). At 90 days, 14% of patients had the primary outcome of mRS 0-3 and 56% had died. The primary outcome was observed in 11 patients who underwent DC (11%) and 55 (15%) of those without DC (odds ratio [OR] 0.7, 95% CI 0.4-1.4, P = .40). DC did not affect mRS shift at 90 days ( P = .10) but was associated with lower mortality (OR 0.5, 95% CI 0.3-0.8, P = .01). Multivariable analysis demonstrated that DC decreased the odds of primary outcome (adjusted OR 0.2, 95% CI 0.02-0.9, P = .045), but did not affect mortality ( P = .94), mRS shift ( P = .50), or length of stay ( P = .90). Propensity-matched analysis similarly demonstrated that non-DC patients were more likely to achieve the primary outcome (24% vs 8%, P = .045). CONCLUSION: In patients with sICH after AIS after MT, those selected for DC had less favorable outcomes and similar rates of mortality at 90 days.
A comprehensive guide to high‐fidelity 3D neuroanatomical modeling techniques: A quantitative comparison between photogrammetry and structured light scanning
Bauman, Megan M. J. , Price, Charles Wes, Leonel, Luciano, Celda, María Peris, Torregrossa, Fábio , Bauman, Megan , Piazza, Amedeo , Price, Charles Wes, Morris, Jonathan M.

Anatomical Sciences Education | June 5, 2025 | Volume: 18 | Issue: 7 | Pages: 697-708

10.1002/ase.70062 | PMID 40470726 Get It

Abstract Cadaveric dissections, which are considered the most realistic model to study neuroanatomy, are expensive and not readily available in all centers. Given the surge of technological advances, incorporation of three‐dimensional (3D) scanning technologies and 3D models has gained popularity, both in the educational and clinical settings. We present our institutional experience in creating high‐fidelity neuroanatomical 3D models using three 3D scanning techniques: structured light 3D scanning, “manual” photogrammetry with a single DSLR camera, and “automatic” photogrammetry using a scanner equipped with five vertically arranged DSLR cameras and an automatic turntable within a square box. A survey study was conducted with 20 neurosurgical residents to assess the quality of the three resulting 3D models. In the study, “manual” photogrammetry was determined to be the most cost‐effective technique, while “automatic” photogrammetry was the most time‐effective and user‐friendly technique. The best visual quality was obtained using “manual” photogrammetry, as determined from survey results of 20 neurosurgical residents. While structured light 3D scanning had the lowest quality of resolution of the texture map, this technique was the most accurate to use for determining measurements, with a fixed accuracy of 0.05 mm. Overall, “manual” photogrammetry can allow for the most detailed 3D models and is the most cost‐effective strategy, while structured light 3D scanning is most suitable for obtaining clinically relevant measurements given the high degree of structural accuracy. Alternatively, “automatic” photogrammetry can serve as a hybrid between obtaining relatively high‐quality models in a time‐effective and user‐friendly manner.
The Dublin International Society of Urological Pathology (ISUP) Consensus Conference on Best Practice Recommendations on the Pathology of Urachal Neoplasms
Reis, Henning , Cunha, Isabela W. , Amin, Mahul B. , Aron, Manju , Athanazio, Daniel Abensur , Bambury, Richard , Cheng, Liang , Gopalan, Anuradha , Gulmann, Christian, Harris, Carole A. , Jiménez, Rafael E. , Jinzaki, Masahiro , Lal, Priti , Miyai, Kosuke , Netto, George J. , Pan, Chin-Chen, Rhijn, Bas W. van, Smith, Steven C. , Wobker, Sara E. , Paner, Gladell P. , Lesions, the ISUP Expert Panel on Urachal Neoplasms and Urinary Bladder Glandular, Cheng, Liang , Cheng, Liang , Al-Ahmadie, Hikmat A , Gaisa, Nadine Therese , López-Beltrán, Antonio , Maclean, Fiona M. , Tsuzuki, Toyonori , Aning, Jonathan J. , Guo, Charles Chuanhai , Iyer, Gopa , Kikuchi, Eiji , Pan, Chin‐Chen , Panebianco, Valeria , Siefker-Radtke, Arlene Odelia , Szarvas, Tibor , Kristiansen, Glen , Lesions, the ISUP Expert Panel on Urachal Neoplasms and Urinary Bladder Glandular

American Journal of Surgical Pathology | June 5, 2025 | Volume: 49 | Issue: 11 | Pages: e18-e26

10.1097/pas.0000000000002416 | PMID 40471793 Get It

This manuscript summarizes the first part of the proceedings of the 2023 Dublin ISUP Consensus Conference encompassing the best practice recommendations on the pathology of neoplasms of urachal origin. The rationale for convening this consensus conference was the lack of structured and consented histopathologic recommendations in these rare tumors. Consensus among the meeting participants (n=80) was reached on the following statements: (1) combination of gross, histologic, clinical and imaging findings with exclusion of secondary tumor metastasis are to be used in the diagnosis of urachal carcinoma; (2) the 2022 World Health Organization (WHO) separate criteria for the diagnosis of urachal adenocarcinoma and for nonglandular carcinoma should be applied; (3) specific elements are to be evaluated and recorded in the gross examination of resection specimens containing urachal tumors; (4) sampling considerations for resection specimens containing urachal tumors are advised; (5) participants are against using 5% or 10% cutoff for the extent of intraepithelial carcinoma in urachal mucinous cystic tumor of low malignant potential; (6) use of immunohistochemical markers for the differential diagnosis of urachal adenocarcinomas in transurethral resection (TUR) specimen is considered optional; (7) similar tumor classificatory (nosology) rules for carcinomas arising from bladder mucosa (eg, urothelial carcinoma, squamous cell carcinoma, and neuroendocrine carcinoma) should be applied for nonglandular urachal carcinomas; (8) a new staging approach other than the previously proposed systems should be designed for urachal carcinoma; (9) a system modifying the current Tumor-Node-Metastasis (TNM)/American Joint Committee on Cancer (AJCC) staging system for urinary bladder cancer is considered appropriate for a study in urachal carcinoma; and (10) several histologic elements are to be reported when diagnosing urachal carcinoma in TUR and resection specimens. This report from the Dublin ISUP consensus conference will serve as a practice recommendation for pathologists and as a guide for future standardized reporting protocols and research regarding urachal tumors. In addition, an international database for urachal cancers under the guidance of ISUP is being planned to be established to address pertinent issues in the pathology of urachal cancers.
Molecular subtyping based on hippocampal cryptic exon burden reveals proteome-wide changes associated with TDP-43 pathology across the spectrum of LATE and Alzheimer’s Disease
Trautwig, Adam N., Chung, Mingee, Dammer, Eric B. , Ping, Lingyan, Duong, Duc M. , Petrucelli, Leonard , Ward, Michael E. , Glass, Jonathan D. , Nelson, Peter T. , McEachin, Zachary T. , Seyfried, Nicholas T. , Dammer, Eric B , Ward, Michael E , Seyfried, Nicholas T , Shantaraman, Anantharaman , Ping, Lingyan, Levey, Allan I.

No container title available | June 4, 2025 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1101/2025.05.30.656396 | PMID 40501554 Get It

Abstract TDP-43 pathology is a defining feature of Limbic-Predominant Age-Related TDP-43 Encephalopathy neuropathologic change (LATE-NC) and is frequently comorbid with Alzheimer’s disease neuropathologic change (ADNC). However, the molecular consequences of co-occurring LATE-NC and ADNC pathology (TDP-43, β-amyloid, and tau protein pathologies) remain unclear. Here, we conducted a comparative biochemical, molecular, and proteomic analysis of hippocampal tissue from 90 individuals spanning control, LATE-NC, ADNC, and ADNC+LATE-NC groups to assess the impact of cryptic exon (CE) inclusion, phosphorylated TDP-43 pathology (pTDP-43), and AD-related pathologies (β-amyloid, and tau) on the proteome. ADNC+LATE-NC cases exhibited the highest burden of CE inclusion as quantified by measuring the levels of known TDP-43 regulated CEs within eight transcripts: STMN2, UNC13A, ELAVL3, KALRN, ARHGAP32, CAMK2B, PFKP, and SYT7 . While CE levels correlated with pTDP-43 pathology, they were more strongly correlated with each other, suggesting that the molecular signature of CE inclusion may serve as a more sensitive measure of TDP-43 dysfunction than pTDP-43 pathology alone. Unbiased classification based on the relative abundance of these eight CEs stratified individual cases into low, intermediate, and high CE burden subtypes, largely independent of β-amyloid and tau pathology. Proteome-wide correlation analysis revealed a bias toward reduced protein levels from genes harboring TDP-43-regulated CEs in cases with high cumulative CE burden. Notably, proteins significantly decreased under high CE burden included canonical STMN2, ELAVL3, and KALRN, as well as kinesin proteins that are genetically associated with amyotrophic lateral sclerosis. Co-expression network analysis identified both shared and distinct biological processes across CE subtypes and pathways associated with pTDP-43, tau, β-amyloid pathologies, and CE accumulation in the hippocampus. Protein modules associated with TDP-43 loss of function were prioritized by integrating proteomic data from TDP-43–depleted human neurons with the hippocampal co-expression network. Specifically, we observed decreased endosomal vesicle, microtubule-binding, and synaptic modules, alongside an increase in RNA-binding modules. These results provide new insights into the proteomic impact of CE burden across the spectrum of LATE and AD pathological severity, highlighting the molecular consequences of TDP-43 dysfunction in neurodegenerative disease
Longitudinal multi-omic profiling uncovers immune escape and predictors of response in multiple myeloma
Ohlstrom, Denis , Pilcher, William , Michaud, Marina E. , Acharya, Chaitanya R. , Gonzalez‐Kozlova, Edgar , Jayasinghe, Reyka G. , Ferguson, Katherine E., Mumme, Hope , Nanda, Shivani , Mantrala, Sowmitri Karthikeya , Karagkouni, Dimitra , Pabustan, Nick , Santos, Junia Vieira Dos , Gout, Alex, Kourelis, Taxiarchis , Vij, Ravi , Dhodapkar, Madhav V. , Avigan, David , Kumar, Shaji , Ding, Li, Gnjatic, Sacha , Gnjatic, Sacha , Jayasinghe, Reyka G , Pilcher, William , Ohlstrom, Denis J , Acharya, Chaitanya , Mumme, Hope L , Satpathy, Sarthak , Ferguson, Katherine E., Song, Yizhe , Schulman, Jessica , Sherbenou, Daniel W , Keats, Jonathan J. , Foltz, Steven , Lagana, Alessandro , Cho, Hearn Jay , Baughn, Linda B. , Nooka, Ajay K. , Lonial, Sagar , Samur, Mehmet , Vlachos, Ioannis S. , Mulligan, George , Bhasin, Manoj K

No container title available | June 1, 2025 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1101/2025.05.27.656392 Get It

Abstract Multiple myeloma (MM) is an incurable malignancy of clonally expanded plasma cells shaped by complex interactions with the immune microenvironment. To investigate immune factors driving treatment response and resistance, we conducted multi-omics profiling including CD138 neg single-cell RNA sequencing of 243 bone marrow samples from 102 patients (631,226 cells) and CD138 pos bulk RNA and whole-genome sequencing from 209 samples. Longitudinal analyses revealed that interferon gamma signaling impairs T cell memory after autologous stem cell transplant, while naïve B cell abundance and immunoglobulin diversity correlated with improved progression-free survival (HR = 0.48, p = 2.3e -4 ). At disease progression, MM cells upregulated cancer-testis antigens and immune effector genes, with concurrent B cell depletion, enrichment of myeloid-derived suppressor cell genes in monocytes, and T cell exhaustion. These findings highlight dynamic immune-tumor interactions, identifying naïve B cell reconstitution as a biomarker of durable response, and cancer-testis antigens as potential targets for high-risk disease at progression. Statement of Significance Longitudinal profiling of multiple myeloma and the immune microenvironment revealed dynamic immune-tumor interactions across the disease course. Dysfunctional CD8⁺ T cells limited memory formation post-transplant, while naïve B recovery associated with sustained treatment response. At progression, cancer-testis antigen expression associated with immunosuppression, revealing novel mechanisms of immune escape.
Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings
Goodman, Michael D. , Bercker, Sven , Breitenbeck, Nancy, Cañada-Vilalta, C., Canepa, Daisy D., Clarke, William , Ganser, Edward O., Geerts, Nienke, Goldsmith, Barbara, Headden, Gary , Hoppensteadt, Debra, Klapperich, Birgit, Matika, Ryan W., Miles, Gabrielle, Mukhopadhyay, Sagori , O’Dell, Rebecca M., Rafique, Zubaid , Schuetzenmeister, Andre, Stankiewicz, Ann F., Swanson, Jonathan R. , Wu, Alan H.B. , Karon, Brad S. , Goodman, Michael , Nichols, James H , Tran, Nam K , Wu, Alan H B , Canepa, Daisy D., Farnsworth, Christopher W , Hoppensteadt, Debra , Nichols, James H. , O’Dell, Rebecca M., Schützenmeister, André , Slingerland, Robbert Jan , Stankiewicz, Ann F.

Journal of Diabetes Science and Technology | May 31, 2025 | Volume: 20 | Issue: 4 | Pages: 1322-1331

10.1177/19322968251325873 | PMID 40448557 Get It

Background: Evaluation of the performance of Cobas ® Pulse (Roche Diagnostics GmbH, Mannheim, Germany), a new blood glucose (BG) monitoring system (BGMS; referred to here as BGMSA) intended for point-of-care testing using samples from patients in diverse clinical settings by intended point-of-care test operators. Methods: Arterial, capillary, venous, or heel stick whole blood (WB) samples from patients in non-critical and critical care settings were collected and analyzed using BGMSA and the Nova StatStrip ® BGMS (Nova Biomedical, Waltham, MA; referred to here as BGMSB), and a hexokinase comparator (Cobas 6000 Analyzer Series; Roche Diagnostics GmbH). The blood glucose measurement accuracy was assessed by the Food and Drug Administration guidance criteria. Results: Two studies are presented. In the first, 2678 samples (622 arterial, 706 capillary, 1203 venous, 147 heel stick) were collected from 1577 patients in 14 US and three European sites. All accuracy criteria were met for arterial and venous samples considering all data combined. BGMSA showed better accuracy than BGMSB for arterial, venous, and heel stick, and similar results to BGMSB for capillary WB vs venous comparator. No endogenous interference from pO 2 , hematocrit, and sodium was identified. BGMSA was also accurate when analyzing contrived samples used to show accuracy over a wide range of glucose concentrations, alone and when combined with extreme hematocrit. In the second study, 117 capillary fingerstick samples collected at one US site were measured on both BGMSA and the comparator, and all accuracy criteria were met. No clinically significant medical risks were observed via Diabetes Technology Society Error Grids. Conclusions: BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.