Fabrizio Monaco, Chong Lei, Matteo Aldo Bonizzoni, Sergey Efremov, Federica Morselli, Fabio Guarracino, Giuseppe Giardina, Cristina Arangino, Domenico Pontillo, Michelangelo Vitiello, Alessandro Belletti, Valentina Ajello, Margherita Licheri, Caetano Nigro Neto, Gaia Barucco, Nazar A Bukamal, Carolina Faustini, Lorenzo Filippo Mantovani, Alessandro Oriani, Cristina Santonocito, Marta Mucchetti, Francesco Federici, Chiara Gerli, Sabrina Porta, Anna Mara Scandroglio, Hui Zhang, Marina Pieri, Roman Osinsky, Stefano Lazzari, Elizaveta Leonova, Maria Grazia Calabrò, Daniele Amitrano, Stefano Turi, Paolo Prati, Stefano Fresilli, Filippo D'Amico, Jacopo D'Andria Ursoleo, Rosa Labanca, Marilena Marmiere, Alessandro Pruna, Tommaso Scquizzato, Kaan Kırali, Giacomo Monti, Maria José Carvalho Carmona, Kenichi Tanaka, Valery Likhvantsev, Lian Kah Ti, Tiziana Bove, Gianluca Paternoster, Karen Singh, Mustafa Emre Gürcü, Vladimir Lomivorotov, Giovanni Landoni, Rinaldo Bellomo, Alberto Zangrillo
{"title":"A Randomized Trial of Acute Normovolemic Hemodilution in Cardiac Surgery.","authors":"Fabrizio Monaco, Chong Lei, Matteo Aldo Bonizzoni, Sergey Efremov, Federica Morselli, Fabio Guarracino, Giuseppe Giardina, Cristina Arangino, Domenico Pontillo, Michelangelo Vitiello, Alessandro Belletti, Valentina Ajello, Margherita Licheri, Caetano Nigro Neto, Gaia Barucco, Nazar A Bukamal, Carolina Faustini, Lorenzo Filippo Mantovani, Alessandro Oriani, Cristina Santonocito, Marta Mucchetti, Francesco Federici, Chiara Gerli, Sabrina Porta, Anna Mara Scandroglio, Hui Zhang, Marina Pieri, Roman Osinsky, Stefano Lazzari, Elizaveta Leonova, Maria Grazia Calabrò, Daniele Amitrano, Stefano Turi, Paolo Prati, Stefano Fresilli, Filippo D'Amico, Jacopo D'Andria Ursoleo, Rosa Labanca, Marilena Marmiere, Alessandro Pruna, Tommaso Scquizzato, Kaan Kırali, Giacomo Monti, Maria José Carvalho Carmona, Kenichi Tanaka, Valery Likhvantsev, Lian Kah Ti, Tiziana Bove, Gianluca Paternoster, Karen Singh, Mustafa Emre Gürcü, Vladimir Lomivorotov, Giovanni Landoni, Rinaldo Bellomo, Alberto Zangrillo","doi":"10.1056/NEJMoa2504948","DOIUrl":"https://doi.org/10.1056/NEJMoa2504948","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing cardiac surgery often receive red-cell transfusions, along with the associated risks and costs. Early intraoperative normovolemic hemodilution (i.e., acute normovolemic hemodilution [ANH]) is a blood-conservation technique that entails autologous blood collection before initiation of cardiopulmonary bypass and reinfusion of the collected blood after bypass weaning. More data are needed on whether ANH reduces the number of patients receiving allogeneic red-cell transfusion.</p><p><strong>Methods: </strong>In a multinational, single-blind trial, we randomly assigned adults from 32 centers and 11 countries who were undergoing cardiac surgery with cardiopulmonary bypass to receive ANH (withdrawal of ≥650 ml of whole blood with crystalloids replacement if needed) or usual care. The primary outcome was the transfusion of at least one unit of allogeneic red cells during the hospital stay. Secondary outcomes were death from any cause within 30 days after surgery or during the hospitalization for surgery, bleeding complications, ischemic complications, and acute kidney injury.</p><p><strong>Results: </strong>A total of 2010 patients underwent randomization; 1010 were assigned to ANH and 1000 to usual care. Among patients with available data, 274 of 1005 (27.3%) in the ANH group and 291 of 997 (29.2%) in the usual-care group received at least one allogeneic red-cell transfusion (relative risk, 0.93; 95% confidence interval, 0.81 to 1.07; P = 0.34). Surgery for postoperative bleeding was performed in 38 of 1004 patients (3.8%) in the ANH group and 26 of 995 patients (2.6%) in the usual-care group. Death within 30 days or during hospitalization occurred in 14 of 1008 patients (1.4%) in the ANH group and 16 of 997 patients (1.6%) in the usual-care group. Safety outcomes were similar in the two groups.</p><p><strong>Conclusions: </strong>Among adults undergoing cardiac surgery, ANH did not reduce the number of patients receiving allogeneic red-cell transfusion. (Funded by the Italian Ministry of Health; ANH ClinicalTrials.gov number, NCT03913481.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Regan W Bergmark, Yuh-Shin Chang, Orhan Efe, Soma Jobbagy
{"title":"Case 16-2025: A 34-Year-Old Man with a Nasopharyngeal Mass.","authors":"Regan W Bergmark, Yuh-Shin Chang, Orhan Efe, Soma Jobbagy","doi":"10.1056/NEJMcpc2412524","DOIUrl":"https://doi.org/10.1056/NEJMcpc2412524","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 22","pages":"2257-2265"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amanda N Kallen, Shannon Whirledge, Kara N Goldman, Joshua Johnson
{"title":"Undermining Women's Health Research - Gambling with the Public's Health.","authors":"Amanda N Kallen, Shannon Whirledge, Kara N Goldman, Joshua Johnson","doi":"10.1056/NEJMp2503576","DOIUrl":"10.1056/NEJMp2503576","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"2185-2187"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144174891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-Term Effects of Empagliflozin in Chronic Kidney Disease.","authors":"Norifumi Yoshimoto, Tatsuhiko Azegami, Kaori Hayashi","doi":"10.1056/NEJMc2504181","DOIUrl":"https://doi.org/10.1056/NEJMc2504181","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 22","pages":"2285"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Blinatumomab in Childhood B-Cell Acute Lymphoblastic Leukemia. Reply.","authors":"Sumit Gupta, Rachel E Rau, Mignon L Loh","doi":"10.1056/NEJMc2504183","DOIUrl":"https://doi.org/10.1056/NEJMc2504183","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 22","pages":"2286-2287"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ulrike M Reiss, Andrew M Davidoff, Edward G D Tuddenham, Pratima Chowdary, Jenny McIntosh, Vincent Muczynski, Malo Journou, Giulia Simini, Lydia Ireland, Saira Mohamed, Anne Riddell, Arnulfo J Pie, Andrew Hall, Alberto Quaglia, Sarah Mangles, Johnny Mahlangu, Kristina Haley, Michael Recht, Yu-Min Shen, Kathleen G Halka, Gail Fortner, Christopher L Morton, Zhengming Gu, Randall T Hayden, Ellis J Neufeld, Victoria I Okhomina, Guolian Kang, Amit C Nathwani
{"title":"Sustained Clinical Benefit of AAV Gene Therapy in Severe Hemophilia B.","authors":"Ulrike M Reiss, Andrew M Davidoff, Edward G D Tuddenham, Pratima Chowdary, Jenny McIntosh, Vincent Muczynski, Malo Journou, Giulia Simini, Lydia Ireland, Saira Mohamed, Anne Riddell, Arnulfo J Pie, Andrew Hall, Alberto Quaglia, Sarah Mangles, Johnny Mahlangu, Kristina Haley, Michael Recht, Yu-Min Shen, Kathleen G Halka, Gail Fortner, Christopher L Morton, Zhengming Gu, Randall T Hayden, Ellis J Neufeld, Victoria I Okhomina, Guolian Kang, Amit C Nathwani","doi":"10.1056/NEJMoa2414783","DOIUrl":"10.1056/NEJMoa2414783","url":null,"abstract":"<p><strong>Background: </strong>Adeno-associated virus (AAV)-mediated gene therapy has emerged as a promising treatment for hemophilia B. Data on safety and durability from 13 years of follow-up in a cohort of patients who had been successfully treated with scAAV2/8-LP1-hFIXco gene therapy are now available.</p><p><strong>Methods: </strong>Ten men with severe hemophilia B received a single intravenous infusion of the scAAV2/8-LP1-hFIXco vector in one of three dose groups (low-dose: 2×10<sup>11</sup> vector genomes [vg] per kilogram of body weight [in two participants]; intermediate-dose: 6×10<sup>11</sup> vg per kilogram [in two]; or high-dose: 2×10<sup>12</sup> vg per kilogram [in six]). Efficacy outcomes included factor IX activity, the annualized bleeding rate, and factor IX concentrate use. Safety assessments included clinical events, liver function, and imaging.</p><p><strong>Results: </strong>Participants were followed for a median of 13.0 years (range, 11.1 to 13.8). Factor IX activity remained stable across the dose cohorts, with mean factor IX levels of 1.7 IU per deciliter in the low-dose group, 2.3 IU per deciliter in the intermediate-dose group, and 4.8 IU per deciliter in the high-dose group. Seven of the 10 participants did not receive prophylaxis. The median annualized bleeding rate decreased from 14.0 episodes (interquartile range, 12.0 to 21.5) to 1.5 episodes (interquartile range, 0.7 to 2.2), which represented a reduction by a factor of 9.7. Use of factor IX concentrate decreased by a factor of 12.4 (interquartile range, 2.2 to 27.1). A total of 15 vector-related adverse events occurred, primarily transient elevations in aminotransferase levels. Factor IX inhibitor, thrombosis, or chronic liver injury did not develop in any participant. Two cancers were identified but were deemed by the investigators, together with an expert multidisciplinary team, as being unrelated to the vector. A liver biopsy that was conducted in 1 participant 10 years after the infusion revealed transcriptionally active transgene expression in hepatocytes without fibrosis or dysplasia. Levels of neutralizing antibodies to AAV8 remained high throughout follow-up, thus indicating potential barriers to readministration of the vector.</p><p><strong>Conclusions: </strong>A single administration of scAAV2/8-LP1-hFIXco gene therapy resulted in durable factor IX expression, sustained clinical benefit, and no late-onset safety concerns over a period of 13 years. These data support the long-term efficacy and safety of AAV gene therapy for severe hemophilia B. (Funded by the U.K. Medical Research Council and others; ClinicalTrials.gov number, NCT00979238; EudraCT number, 2005-005711-17.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 22","pages":"2226-2234"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lauralyn McIntyre, Dean Fergusson, Tracy McArdle, Shane English, Deborah J Cook, Alison E Fox-Robichaud, Claudio Martin, John Marshall, Michael Pugliese, Kusum Menon, Kednapa Thavorn, Ian D Graham, Steven Hawken, Akshai Iyengar, Kwadwo Kyeremanteng, Raphael Saginur, Andrew J E Seely, Ian G Stiell, Daniel Bainbridge, Charles Weijer, Monica Taljaard
{"title":"A Crossover Trial of Hospital-Wide Lactated Ringer's Solution versus Normal Saline.","authors":"Lauralyn McIntyre, Dean Fergusson, Tracy McArdle, Shane English, Deborah J Cook, Alison E Fox-Robichaud, Claudio Martin, John Marshall, Michael Pugliese, Kusum Menon, Kednapa Thavorn, Ian D Graham, Steven Hawken, Akshai Iyengar, Kwadwo Kyeremanteng, Raphael Saginur, Andrew J E Seely, Ian G Stiell, Daniel Bainbridge, Charles Weijer, Monica Taljaard","doi":"10.1056/NEJMoa2416761","DOIUrl":"https://doi.org/10.1056/NEJMoa2416761","url":null,"abstract":"<p><strong>Background: </strong>Whether lactated Ringer's solution is clinically superior to normal saline for routine intravenous administration of fluids is uncertain.</p><p><strong>Methods: </strong>In an open-label, two-period, two-sequence, cross-sectional, cluster-randomized, crossover trial, we assigned hospitals in Ontario, Canada, to use either lactated Ringer's solution or normal saline hospital-wide for a period of 12 weeks. After a washout period, hospitals switched to the other fluid for 12 weeks. The primary outcome was a composite of death or readmission to the hospital within 90 days after the index admission. Secondary outcomes were the individual components of the primary outcome, as well as the length of stay in the hospital, initiation of dialysis within 90 days after the index admission, a visit to the emergency department within 90 days, and discharge to a facility other than home. Data on outcomes were obtained from health administrative databases. The analyses were conducted at the hospital level, and the primary estimand was the effect of the use of lactated Ringer's solution as compared with normal saline averaged across all participating hospitals.</p><p><strong>Results: </strong>Seven hospitals completed both 12-week periods before the trial was interrupted owing to the coronavirus disease 2019 pandemic. Data on the primary outcome were available for 43,626 eligible patients. The mean (±SD) incidence of the composite of death or readmission to the hospital within 90 days after the index admission was 20.3±3.5% with lactated Ringer's solution and 21.4±3.3% with normal saline (adjusted difference, -0.53 percentage points; 95% confidence interval, -1.85 to 0.79; P = 0.35). Results for all secondary outcomes were consistent with those for the primary outcome. No serious adverse events were reported.</p><p><strong>Conclusions: </strong>A hospital-wide policy to administer lactated Ringer's solution rather than normal saline did not result in a significantly lower incidence of death or readmission to the hospital within 90 days after the index admission. (Funded by the Canadian Institutes of Health Research and the Ottawa Hospital Academic Medical Organization; FLUID ClinicalTrials.gov number, NCT04512950.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-Term Effects of Empagliflozin in Chronic Kidney Disease.","authors":"Jacob Ilany","doi":"10.1056/NEJMc2504181","DOIUrl":"https://doi.org/10.1056/NEJMc2504181","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 22","pages":"2284-2285"},"PeriodicalIF":96.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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