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3307 citation(s) found for "Vu, Alexander".

Renal-Limited Thrombotic Microangiopathy Without Hemolysis: A Rare Native Kidney Presentation
Alam, Sreyoshi Fatima , Keratishvili, Diana, Galeano, Belinda, Alexander, Mariam P., Godby, Richard , Bentall, Andrew

Journal of the American Society of Nephrology | October 23, 2025 | Volume: 36 | Issue: 10S | Pages: No page available

10.1681/asn.20257yyh7v8s Get It

Emergency department-initiated palliative care screening among older adults: a systematic review and meta-analysis protocol
Lin, Dimitri E , Mowbray, Fabrice , Isaacs, E. D., Markwalter, Daniel , Hay, Alison , Manfredi, Rita A. , Westlake, Erica , Bowman, Jason , Rebollo-Lee, Naomi, Gacioch, Brian, Brooten, Justin K. , Pajka, Sarah E. , Selman, Katie, Bain, Paul , Liu, Shan W. , Ouchi, Kei , Markwalter, Daniel , Ginsburg, Alexander D, Bain, Paul , Mowbray, Fabrice , Lin, Dimitri E , Gunaga, Satheesh , Isaacs, Eric D, George, Naomi R. , Akhter, Murtaza , Ginsburg, Alexander , Selman, Katherine , Davis, Joshua J.

BMJ Open | October 22, 2025 | Volume: 15 | Issue: 10 | Pages: e095894

10.1136/bmjopen-2024-095894 | PMID 41125269 Get It

Introduction The rapidly growing population of older adults (individuals aged 65 years and older) presents a new set of challenges for healthcare providers in the emergency department (ED), given the prevalence of severe and life-threatening conditions among this group, such as chronic cancer, Alzheimer’s disease/dementia and congestive heart failure. ED encounters often represent a critical point in an older patient’s trajectory of care and can thus be an important opportunity for various interventions such as palliative care consultation. Therefore, identifying those who will benefit most from palliative care is of high importance, especially in determining the course of future treatment. Thus, we aim to conduct a systematic review assessing the efficacy of palliative care screening in the ED by assessing inpatient length of stay as the primary outcome and quality of life, percentage of hospitalisation and cost of care as secondary outcomes. Methods This study will use Ovid MEDLINE, Embase, EBSCO CINAHL, Web of Science and Cochrane as databases. The study population comprises adults aged 60 years and older, with no focus on any specific clinical specialty or disease. Patients who have not received palliative care screening will serve as the comparator. Only studies with an applicable comparator will be considered. Studies published from 1 January 2000 to 1 July 2025 will be included. All articles will be reviewed independently and in duplicate, and every author will participate in the review, data abstraction and conflict resolution process. Ethics and dissemination Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO registration number CRD42024562389.
Intermuscular adipose tissue in healthy human aging—effects of exercise training and implications to metabolic health
Alexander, Andrew M. , Fitzgibbons, Lucy M., Correa, Zinnarky K Ortiz, Nair, K. Sreekumaran , Kunz, Hawley E , Ortiz Correa, Zinnarky K, Nair, K Sreekumaran , Lanza, Ian R , Kunz, Hawley , Port, John D. , Lanza, Ian R.

Journal of Applied Physiology | October 20, 2025 | Volume: 139 | Issue: 5 | Pages: 1300-1308

10.1152/japplphysiol.00719.2025 | PMID 41115067 Get It

Intermuscular adipose tissue (IMAT) accumulates in the lower leg musculature of healthy older adults. IMAT was negatively associated with the rate of glucose infusion during a hyperinsulinemic-euglycemic clamp and muscle oxidative capacity. Exercise training decreased IMAT to a greater extent in young compared with older adults. Together these data support the implication that IMAT accumulation is linked with metabolic derangements in older adults but the restorative potential of exercise in older adults needs further evaluation.
Conventional Versus High-Complexity Total Pelvic Exenteration for Locally Advanced and Locally Recurrent Rectal Cancer: An International Multicenter Study
Brown, Kilian G. M. , Sutton, Paul , Koh, Cherry , Aguiar, Samuel , Bezerra, Tiago S. , Clouston, H.W., Desouza, Ashwin , Dozois, Eric J. , Ersryd, Amanda L., Frizelle, Frank , Funder, Jonas Amstrup , Garfinkle, Richard , Glyn, Tamara , Kanemitsu, Yukihide , Palmer, Gabriella J., Pappou, Emmanouil P. , Quinn, Martha, Sahakitrungruang, Chucheep , Solbakken, Arne M. , Tiernan, Jim , Verhoef, Cornelis, Steffens, Daniel , Brown, Kilian G M , Garrett, Celine , Solomon, Michael J. , García‐Aguilar, Julio , Heriot, Alexander G. , Kong, Chia Yew , Kristensen, Helle Ø , Malakorn, Songphol , Mens, David M , Nilsson, Per Johan , Palmer, G. , Quyn, Aaron J. , Saklani, Avanish , Verhoef, Cornelis

Diseases of the Colon & Rectum | October 20, 2025 | Volume: 69 | Issue: 1 | Pages: 34-41

10.1097/dcr.0000000000003986 | PMID 41114552 Get It

BACKGROUND: Pelvic exenteration is the treatment of choice for selected patients with locally advanced primary and recurrent rectal cancer. Involvement of major pelvic neurovascular structures and bone was historically considered a contraindication due to unacceptably high rates of morbidity and low R0 resection rates. OBJECTIVE: To compare the outcomes of these “high-complexity” exenterative resections to those of “conventional” pelvic exenteration. DESIGN: International multicenter retrospective cohort study. SETTINGS: Sixteen specialized exenteration centers. PATIENTS: Those who underwent total pelvic exenteration for locally advanced primary and recurrent rectal cancer between 2018 and 2023 at participating centers. MAIN OUTCOME MEASURES: Perioperative resource utilization, morbidity, mortality, and R0 resection rates were reported. RESULTS: Seven hundred sixty-three patients underwent total pelvic exenteration, of whom 478 (63%) and 285 (37%) required conventional and high-complexity procedures, respectively. High-complexity pelvic exenteration was associated with longer operating time (600 vs 480 minutes, p < 0.001 for locally advanced primary rectal cancer, 623 vs 480 minutes, p < 0.001 for locally recurrent rectal cancer), intensive care stay (2 vs 1 day, p < 0.001 and 3 vs 1 day, p < 0.001), hospital stay (19 vs 15 days, p = 0.008 and 23 vs 15 days, p < 0.001), and higher blood loss (2000 vs 1236 mL, p < 0.001 and 3000 vs 1600 mL, p < 0.001). Morbidity and mortality outcomes and R0 resection rates were similar between the groups. LIMITATIONS: Generalizability of findings outside of expert units. CONCLUSIONS: High-complexity pelvic exenteration for the treatment of rectal cancer is associated with similar morbidity, mortality, and R0 resection rates, but it has a significantly higher operative time, blood loss, and hospital resource utilization compared to conventional pelvic exenteration. In high-volume, specialized centers, these techniques are considered the standard of care for appropriately selected patients with tumors that involve major pelvic bone or neurovascular structures. See Video Abstract . EXENTERACIÓN PÉLVICA TOTAL CONVENCIONAL FRENTE A EXENTERACIÓN PÉLVICA TOTAL DE ALTA COMPLEJIDAD PARA EL CÁNCER RECTAL LOCALMENTE AVANZADO Y LOCALMENTE RECURRENTE: UN ESTUDIO MULTICÉNTRICO INTERNACIONAL ANTECEDENTES: La exenteración pélvica es el tratamiento de elección para determinados pacientes con cáncer rectal primario y recurrente localmente avanzado. La afectación de las principales estructuras neurovasculares y óseas pélvicas se consideraba históricamente una contraindicación debido a las tasas inaceptablemente altas de morbilidad y a las bajas tasas de resección R0. OBJETIVO: Comparar los resultados de estas resecciones exenteración «de alta complejidad» con los de la exenteración pélvica «convencional». DISEÑO: Estudio de cohorte retrospectivo multicéntrico internacional. ENTORNOS: Dieciséis centros especializados en exenteración. PACIENTES: Aquellos que se sometieron a una exenteración pélvica total por cáncer rectal primario y recurrente localmente avanzado entre 2018 y 2023 en los centros participantes. PRINCIPALES MEDIDAS DE RESULTADOS: Se informaron la utilización de recursos perioperatorios, la morbilidad, la mortalidad y las tasas de resección R0. RESULTADOS: 763 pacientes se sometieron a una exenteración pélvica total, de los cuales 478 (63 %) y 285 pacientes (37 %) requirieron procedimientos convencionales y de alta complejidad, respectivamente. La exenteración pélvica de alta complejidad se asoció con un tiempo quirúrgico más prolongado (600 frente a 480 minutos, p < 0,001 para el cáncer rectal primario localmente avanzado, 623 frente a 480 minutos, p < 0,001 para el cáncer rectal localmente recurrente), estancia en cuidados intensivos (2 frente a 1 día, p < 0,001 y 3 frente a 1 día, p < 0,001), estancia hospitalaria (19 frente a 15 días, p = 0,008 y 23 frente a 15 días, p < 0,001) y mayor pérdida de sangre (2000 frente a 1236 ml, p < 0,001 y 3000 frente a 1600 ml, p < 0,001). Los resultados de morbilidad y mortalidad, así como las tasas de resección R0, fueron similares entre los grupos. LIMITACIONES: Generalización de los resultados fuera de las unidades especializadas CONCLUSIONES: La exenteración pélvica de alta complejidad para el tratamiento del cáncer de recto se asocia con tasas similares de morbilidad, mortalidad y resección R0, pero con un tiempo quirúrgico, una pérdida de sangre y una utilización de recursos hospitalarios significativamente mayores en comparación con la exenteración pélvica convencional. En centros especializados con un gran volumen de casos, estas técnicas se consideran el tratamiento estándar para pacientes adecuadamente seleccionados con tumores que afectan a los huesos pélvicos principales o a las estructuras neurovasculares. ( AI-generated translation )
Augmented Reality and 3D Printing as an Aid to Surgical Planning in Modern Microtia Reconstruction
Gomez, Diego A. , Hashemi, Kiana, Sharma, Ishpriya, Demeris, Alexander, Patel, Pushpak , Kellogg, Brian C. , Sharma, Ishpriya , Gomez, Diego A , Sharma, Ishpriya, Aycart, Mario A. , Dusseldorp, Joseph R. , Barone, Angelo A. Leto

Journal of Craniofacial Surgery | October 17, 2025 | Volume: 37 | Issue: 3/4 | Pages: 896-900

10.1097/scs.0000000000012082 | PMID 41105048 Get It

Since Tanzer’s seminal work introducing costal cartilage for ear reconstruction, subsequent advances by Brent, Nagata, and Firmin have refined surgical techniques and aesthetic outcomes. However, fundamental aspects of the procedure—such as planning incisions, achieving accurate ear positioning, and guiding chest wall incisions for rib harvest—have seen limited innovation. The current standard practice of using projection paper or transparent templates to replicate the contralateral ear position remains imprecise. Similarly, autologous cartilage harvest can be particularly challenging in patients with higher BMI, due to difficulty in accurate rib palpation and visualization. Misplaced chest wall incisions can result in suboptimal rib harvest, longer operative times, and increased morbidity. In this study, we introduce patient-specific, three-dimensional (3D) printed masks, termed hEARo masks, as a novel and user-friendly tool for ear framework positioning. Furthermore, we present the integration of augmented reality (AR) technology to enhance preoperative planning and intraoperative guidance during microtia repair, enabling more precise incision placement for rib harvest. The combined use of 3D printing and AR facilitates complex ear reconstruction, offering increased surgical precision, reduced operative time, and potentially improved patient outcomes. These innovations represent a significant advancement in the personalization and accuracy of auricular reconstruction.
Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study
Lass, Jonathan H. , Lass, Jonathan H., Benetz, Beth Ann, Verdier, David D., Szczotka-Flynn, Loretta B., Bauza, Colleen E., Reed, Zachariah W., Greiner, Mark A., Mian, Shahzad I., Patel, Sanjay V., Pramanik, Sudeep, Price, Francis W., Soper, Mark C., Terry, Mark A., Titus, Michael S., Kollman, Craig, Beck, Roy W., Price, Marianne O., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lucas, Katelyn, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Baratz, Keith H. , Hardtke, Elainey, Treichel, Emily J., Hood, Christopher , Nallasamy, Nambi , Verkade, Angela , Jones, Kristin, Shapiro, Jeremy N. , Leavy, Lisa, Sinkey, Chris, Tenkman, Lawrence R., Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Coonfield, Kristy, Vislisel, Jesse M., Sharma, Yogi, Young, Angela M. , Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Phillips, Paul, Maloney, Charlene, Jun, Albert S. , Maria, Christina, Boyce, Michelle, Kam, Yong, Crosser, Vicki, Chen, Jessica , Straiko, Michael D., Bauer, Alex, Croasdale, Christopher, Brown, Gayle Waldheim, Veldman, Peter B., Evans, Que, Majmudar, Parag A., Epstein, Rachel , Vaidya, Neal, Rosselson, Marie, Nykaza, Jim, Jurkunas, Ula V., Venkateswaran, Nandini, Cheung, Michael K., Ayres, Brandon D. , Haught, Drew Monteleone, Prasad, Elizabeth, Toti, G, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark, Hardten, David R., Reeves, Sherman, Dreyer, Allison, Mack, Megan, Hamill, M. Bowes , Nguyen, Jessica, Koo, Ellen, Stanfield, Ryan, Greenwood, Michael, Ernst, L, Messer, Brooke, Risbrudt, Nick, Stofferahn, Seth, Saville, Alyson, Castaneda, Leslie, Torres, Nidia, Potts, Luke B. , Alexander, Jamie, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Buckman, Natalie, Ansin, Amy, Clover, Jameson , Pivoney, Charles, Vizzerra, Anthony, Elbanhawy, Lindsey, Mullins, Monica, Statz, Brianne, Fout, Elizabeth, Drury, Donna, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Szczotka-Flynn, Loretta, Richards, Leslie, Raghupathy, Sangeetha, Spruill, Rashad, Bauza, Colleen, Kollman, Craig, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann, Lê, Jimmy T. , Redford, Maryann , Arafah, Baha M. , Greiner, Mark, Johnson, Paula C, Keeler, D. K., Monnier, Vincent M. , Titus, Michael, Verdier, David, Soper, Mark, Velhuisen, Paul Van, Hawkins, Barbara S., Macsai, Marian S., Patel, Sanjay, Mian, Shahzad, Pramanik, Sudeep, Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dawson, Lauren, Dingess, Ryan, Madere, Mark, Sengupta, Pratim , Wadleigh, Garth, Greiner, Mark A. , Lass, Jonathan H., Benetz, Beth Ann, Verdier, David D., Szczotka-Flynn, Loretta B., Bauza, Colleen E., Reed, Zachariah W., Greiner, Mark A., Mian, Shahzad I., Patel, Sanjay V., Pramanik, Sudeep, Price, Francis W., Soper, Mark C., Terry, Mark A., Titus, Michael S., Kollman, Craig, Price, Marianne O., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lucas, Katelyn, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Hood, Christopher, Sáles, Christopher S. , Sinkey, Chris, Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Young, Angela, Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Srikumaran, Divya S. , Daoud, Yassine J. , Eghrari, Allen Omid , Ali, Muhammad , Croasdale, Christopher, Brown, Gayle Waldheim, Epstein, Rachel H. , Vaidya, Neal, Jurkunas, Ula V. , Cheung, Michael, Prasad, Elizabeth, Toti, Gwen, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark, Reeves, Sherman, Dreyer, Allison, Mack, Megan, Nguyen, Jessica, Greenwood, Michael, Messer, Brooke, Saville, Alyson, Omar, Ahmed F. , Castaneda, Leslie, Torres, Nidia, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Schmidt, Gregory A. , Lass, Jonathan, Lass, Jonathan, Price, Marianne O. , Szczotka-Flynn, Loretta, Richards, Leslie, Bauza, Colleen, Beck, Roy W. , Kollman, Craig, McCarthy, Chris, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann, Greiner, Mark, Johnson, Paula, Titus, Michael, Verdier, David, Soper, Mark, Aleppo, Grazia , Bateman-House, Alison , Tu, Elmer Yuchen , Patel, Sanjay, Mian, Shahzad, Pramanik, Sudeep, Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dingess, Ryan, Sengupta, Paromita

JAMA Ophthalmology | October 17, 2025 | Volume: 143 | Issue: 12 | Pages: 1053

10.1001/jamaophthalmol.2025.4261 | PMID 41105099 Get It

Importance The effect of cornea donor diabetes on endothelial cell density (ECD) and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known. Objective To determine whether endothelial cell loss (ECL) and morphometric changes 1 year after successful DMEK are related to cornea donor’s diabetes status. Design, Setting, and Participants This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2024 at 28 US clinical sites (46 surgeons) and 13 eye banks. Included in the trial were the eyes of recipients (some of whom received tissue from donors without diabetes and others who received tissue from donors with diabetes) who underwent successful DMEK, primarily for Fuchs endothelial corneal dystrophy, and had at least 1 analyzable postoperative endothelial image. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure to achieve an approximate 2:1 distribution. Main Outcomes and Measures ECD, ECL, coefficient of variation in cell area (CV), and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images. Results A total 1274 eyes of 982 recipients (mean [SD] age, 70 [8] years; 569 female [57.9%]; 816 [64.1%] with tissue from donors without diabetes and 458 [35.9%] with tissue from donors with diabetes) were included in the study. Preoperatively, mean (SD) central ECD in tissue from donors without diabetes and with diabetes were 2676 (290) cells/mm 2 and 2671 (286) cells/mm 2 , respectively. At 1 year, mean (SD) ECL was 28.3% (16.1%) and 28.0% (17.0%), in the donor groups without and with diabetes, respectively (adjusted mean difference = −0.4%; 95% CI, −2.3% to 1.4%), resulting in a mean (SD) 1-year ECD of 1927 (498) cells/mm 2 and 1920 (496) cells/mm 2 , respectively (adjusted mean difference = 10 cells/mm 2 ; 95% CI, −36 to 56; P = .95). No difference in ECD at 1 year associated with diabetes severity was noted ( P = .97). Mean (SD) CV did not differ at 1 year between the 2 groups of eyes (31.5% [4.1%] vs 31.4% [4.1%]; adjusted mean difference = −0.4%; 95% CI, −0.9% to 0.1%; P = .51), and mean (SD) HEX did not differ at 1 year between the 2 groups of eyes (57.7% [5.8%] vs 57.2% [5.8%]; adjusted mean difference = 0.1%, 95% CI, −0.8% to 0.9%; P = .33). Conclusions and Relevance This randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes status. With comparable 1-year graft success with tissue from donors with and without diabetes demonstrated in this trial, these findings support the use of corneas from donors with diabetes for endothelial keratoplasty procedures. Trial Registration ClinicalTrials.gov Identifier: NCT05134480
Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate
Price, Francis W. , Szczotka‐Flynn, Loretta , Bauza, Colleen , Reed, Zachariah W., Arafah, Baha M. , Greiner, Mark A. , Johnson, Paula, Keeler, Devon B., Pramanik, Sudeep, Soper, Mark, Terry, Mark A., Titus, Michael S. , Verdier, David D. , Kollman, Craig, Lass, Jonathan H. , Lass, Jonathan H., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lynn, A. G., Cole, Shawna, Phelps, Derek, Baratz, Keith H. , Hardtke, Elainey, Treichel, Emily J., Hood, Christopher , Nallasamy, Nambi , Verkade, Angela , Jones, Kristin, Shapiro, Jeremy, Leavy, Lisa, Sinkey, Chris, Tenkman, Lawrence R., Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Coonfield, Kristy, Vislisel, Jesse M., Sharma, Yogi, Young, Angela M. , Schoenberg, Evan, Kelly, Sharra, Huffman, James L. , Sears, Melinda, Stone, Merisa, Phillips, Paul, Maloney, Charlene, Jun, Albert S. , Maria, Christina, Boyce, Michelle, Kam, Yong, Crosser, Vicki, Chen, Jessica , Straiko, Michael D., Bauer, Alex, Croasdale, Christopher, Brown, Gayle Waldheim, Veldman, Peter B., Evans, Que, Majmudar, Parag A., Epstein, Rachel , Vaidya, N. N., Nykaza, Jim, Venkateswaran, Nandini, Ayres, Brandon D. , Haught, Drew Monteleone, Prasad, Elizabeth, Toti, Gwen, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark D., Hardten, David R., Reeves, Sherman W., Dreyer, Allison, Mack, Megan, Hamill, Mark, Nguyen, Jessica , Stanfield, Ryan, Greenwood, Michael , Ernst, Lindsay, Risbrudt, Nick, Saville, Alyson, Castaneda, Leslie, Torres, Nidia, Potts, Luke B. , Alexander, Jamie, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Buckman, Natalie, Ansin, Amy, Clover, Jameson , Pivoney, Charles, Vizzerra, Anthony, Elbanhawy, Lindsey, Mullins, Monica, Statz, Brianne, Fout, Elizabeth, Drury, Donna, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Richards, Leslie, Raghupathy, Sangeetha, Spruill, Rashad, Bauza, Colleen, Beck, Roy, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann , Lê, Jimmy T. , Redford, Maryann , Arafah, Baha, Greiner, Mark, Keeler, Devon, Monnier, Vincent M. , Titus, Michael, Verdier, David, Velhuisen, Paul Van, Hawkins, Barbara S., Macsai, Marian S., Patel, Sanjay, Mian, Shahzad I. , Pramanik, Sudeep , Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dawson, Lauren, Dingess, Ryan, Madere, Mark, Wadleigh, Garth, Price, Marianne O. , Mian, Shahzad I. , Patel, Sanjay V. , Pramanik, Sudeep, Titus, Michael S., Beck, Roy W. , Lass, Jonathan H., Group, Diabetes Endothelial Keratoplasty Study, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Hardtke, Elainey, Hood, Christopher, Shapiro, Jeremy, Sáles, Christopher S. , Leavy, Lisa, Gordon, DJ, Fox, Jenni, Coonfield, Kristy, Young, Angela, Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Srikumaran, Divya S. , Daoud, Yassine J. , Eghrari, Allen Omid , Ali, Muhammad , Crosser, Vicki, Croasdale, Christopher, Brown, Gayle Waldheim, Evans, Que, Epstein, Rachel H. , Nykaza, Jim, Jurkunas, Ula V. , Cheung, Michael, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Mack, Megan, Hamill, M. Bowes, Nguyen, Jessica, Koo, Ellen H. , Stanfield, Ryan, Risbrudt, Nick, Saville, Alyson, Omar, Ahmed F. , Castaneda, Leslie, Torres, Nidia, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Schmidt, Gregory A. , Elbanhawy, Lindsey, Statz, Brianne, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Richards, Leslie, Spruill, Rashad, Bauza, Colleen, Beck, Roy, McCarthy, Chris, Reed, Zachariah, Arafah, Baha, Greiner, Mark, Titus, Michael, Verdier, David, Velhuisen, Paul Van, Aleppo, Grazia , Bateman-House, Alison , Tu, Elmer Yuchen , Patel, Sanjay, Price, Francis, Terry, Mark, Sell, David, Barton, Glenn, Das, Pravamaya, Dingess, Ryan, Madere, Mark, Sengupta, Partha Pratim , Wadleigh, Garth

JAMA Ophthalmology | October 17, 2025 | Volume: 143 | Issue: 12 | Pages: 1043

10.1001/jamaophthalmol.2025.4253 | PMID 41105094 Get It

Importance If the success of Descemet membrane endothelial keratoplasty (DMEK) is not affected by whether the donor has diabetes, then the donor pool should expand. Objective To determine whether the 1-year DMEK success rate is affected by the presence of diabetes in the donor. Design, Setting, and Participants This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2025 at 28 clinical sites (46 surgeons), with donor corneas provided by 13 eye banks in the US. Included in the study were individuals undergoing low to moderate risk DMEK (95% for Fuchs endothelial corneal dystrophy). Study data were analyzed from April to September 2025. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable with randomization) to achieve an approximate 2:1 distribution, respectively. Main Outcomes and Measures Graft success at 1 year Results A total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 female [57.5%]) were included in the study. The 1-year cumulative probability of graft success was 96.3% (95% CI, 95.0%-97.5%) among 912 study eyes (64.2%) receiving tissue from donors without diabetes and 97.1% (95% CI, 95.5%-98.4%) among 509 study eyes (35.8%) receiving tissue from donors with diabetes (difference between groups = 0.7 percentage points; 95% CI, −1.2 to 2.6; P = .63). The 1-year cumulative probability of graft success was 96.5% (95% CI, 93.6%-98.9%) in the mild donor diabetes severity subgroup (n = 173) and 97.3% (95% CI, 95.4%-98.8%) in the moderate to severe donor diabetes severity subgroup (n = 336), using a diabetes severity rating scale based on medical history. The rates of primary donor failure, early failure related to surgical complications, and subsequent failure were as follows: 2.5% (23 of 912), 0.7% (6 of 912), and 0.3% (3 of 912), respectively, in recipients of tissue from a donor without diabetes, and 2.6% (13 of 509), 0.4% (2 of 509), and 0%, respectively, among recipients of tissue from a donor with diabetes. There were no failures due to graft rejection. Conclusions and Relevance The 1-year success rate in eyes undergoing DMEK with successfully prepared tissue was very high regardless of donor diabetes status. These results, supported by the separately reported finding that endothelial cell loss and cornea morphometry after 1 year were not affected by donor diabetes status, provide strong support for having no restrictions on the use of tissue from donors with diabetes for DMEK. Trial Registration ClinicalTrials.gov Identifier: NCT05134480
Abstract FR498: Impact of Switching From High- to Low-Sodium Oxybate on Ambulatory and Office Blood Pressure in Subgroups of People With Narcolepsy From the XYLO Study
Alexander, Jessica, Baranak, Christine, Nichols, Deborah A. , Dai, Jing , Whalen, Marisa, Ajayi, Akinyemi, Hutchinson, B. R., White, William B. , Somers, Virend K. , Kovacs, Richard J. , hutchinson, barbara, Dauvilliers, Yves

Hypertension | October 16, 2025 | Volume: 82 | Issue: Suppl_1 | Pages: No page available

10.1161/hyp.82.suppl_1.fr498 Get It

Introduction: Excess sodium intake is strongly linked with hypertension and cardiovascular disease (CVD); people with narcolepsy (PwN) have increased CV risk. Hypothesis: Switching from high-sodium oxybate (SXB; Xyrem ® ; 6–9 g for ≥6 wks) to low-sodium oxybate (LXB; Xywav ® ; same regimen) reduces mean 24-hr ambulatory systolic blood pressure (ASBP) after ≈6 wks in PwN, regardless of antihypertensive (anti-HTN) use and site type. Methods: XYLO, an open-label, single-arm study (NCT05869773), assessed PwN aged 18−70 y with office SBPs of 130−155 mmHg. The primary and key secondary endpoints were changes from baseline (BL) to end-of treatment (EOT) in mean 24-hr ASBP and seated resting (“office”) SBP (OSBP), respectively; exploratory endpoints were diastolic BP (DBP) changes. Changes are baseline adjusted. Prespecified subgroup analyses explored BL anti-HTN use and participation site (ie, site-based [at study site] vs decentralized [at-home]). Results: In 43 PwN (mean age, 45 y; female, 65%; anti-HTN, 33%), mean±SD BL OSBP and DBP were 138.0±5.7 and 85.2±6.6 mmHg, respectively. Mean±SD total SXB vs LXB dosages were 8.0±1.1 vs 8.1±1.1 g/night, reflecting 1457±206 vs 118±16 mg sodium (difference: ≈1339 mg); median 24-hr urinary sodium was 4232 mg/d at BL and 2703 mg/d at EOT (median change: 1288 mg/d). Mean change in 24-hr ASBP (least squares mean [95% CI]) was −4.1 (−6.9, −1.4; 1-sided P =0.0019) mmHg (Fig 1) ; mean change in OSBP was −9.2 (−11.9, −6.5; 1-sided P <0.0001). Mean changes in 24-hr ambulatory and office DBP were −2.3 (−4.1, −0.5; 2-sided P =0.0118; nominal) and −3.8 (−6.0, −1.6; 2-sided P =0.0014; nominal) mmHg, respectively. In subgroups, mean change in 24-hr ASBP was −4.6 (−9.6, 0.3) mmHg with BL anti-HTN use and −3.9 (−7.3, −0.5) mmHg without BL anti-HTN use; changes in OSBP were −11.8 (−16.5, −7.1) and −7.9 (−11.1, −4.6) mmHg. Mean change in 24-hr ASBP was −3.6 (−8.0, 0.9) mmHg for site-based and −4.5 (−8.1, −1.0) mmHg for decentralized participation. Corresponding changes in OSBP were −9.0 (−13.3, −4.6; site-based) and −9.3 (−12.8, −5.8; decentralized) mmHg with a downward trend over 6 wks ( Fig 2 ). Treatment-emergent adverse events (all mild/moderate) occurred in 40% of PwN (N=67). Conclusions: Switching from SXB to LXB reduced daily medication-related sodium intake in PwN and was associated with clinically meaningful BP reductions overall and across subgroups, consistent with evidence on dietary and medication-related sodium effects.
Effects of High- Versus Low-Sodium Oxybate on Blood Pressure in Patients With Narcolepsy
White, William B. , Kovacs, Richard J. , Alexander, Jessica K., Baranak, Christine, Nichols, Deborah A. , Fuller, Douglas S. , Dai, Jing , Whalen, Marisa, Ajayi, Akinyemi, Hutchinson, B. R., Dauvilliers, Yves , Somers, Virend K. , Kovacs, Richard J. , Alexander, Jessica, Hutchinson, Barbara, Dauvilliers, Yves , Somers, Virend K.

Hypertension | October 15, 2025 | Volume: 82 | Issue: 12 | Pages: 2162-2171

10.1161/hypertensionaha.125.25730 | PMID 41090230 Get It

BACKGROUND: People with narcolepsy are at increased risk for hypertension and cardiovascular disease; excessive sodium intake is linked to both. METHODS: We studied patients with narcolepsy and office systolic blood pressures (BPs) of 130 to 155 mm Hg taking twice-nightly high-sodium oxybate for ≥6 weeks who switched to low-sodium oxybate at the same dosage. The primary end point was the change from baseline in mean 24-hour ambulatory systolic BP at the end of treatment (≈6 weeks after switching). Secondary and exploratory end points included changes in diastolic BP, office BP, and 24-hour sodium excretion. RESULTS: Patients (n=43) had a mean age of 45 years, were 65% female, 33% on antihypertensives, with baseline mean (SD) office BP of 138.0/85.2 (5.7/6.6). Mean (SD) total high- and low-sodium oxybate dosages of 8.0 (1.1) and 8.1 (1.1) g/night, respectively, represented 1456.5 (206.2) and 117.8 (16.3) mg of sodium. The median 24-hour urinary sodium was 4278 mg/d at baseline and 2703 mg/d at the end of treatment (median change, 1288 mg/d). Mean (SE) 24-hour ambulatory systolic BPs at baseline and study end were 132.3 (1.8) and 128.2 (1.8) mm Hg (least-squares mean change, −4.1 [95% CI, −6.9 to −1.4] mm Hg; 1-sided P =0.0019). BP changes by narcolepsy subtype, sex, body mass index, baseline office BP, and baseline antihypertensive use were consistent with the overall effect size. CONCLUSIONS: People with narcolepsy switching from high- to low-sodium oxybate showed substantially reduced daily medication-related sodium intake and significant 24-hour BP reductions. These results demonstrate the importance of reducing pharmaceutical sodium content in this elevated cardiovascular risk patient population. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05869773.