Ana Fernandez-Bustamante, Robert A Parker, Gyorgy Frendl, Jae Woo Lee, Alexander Nagrebetsky, Loreta Grecu, David Amar, Pedro Tanaka, Juraj Sprung, Ravindra A Gupta, Balachundhar Subramanian, Jadelis Giquel, Matthias Eikermann, Guido Musch, Jacob W Nadler, Marcelo Gama de Abreu, Karsten Bartels, Meera Grover, Lee-Lynn Chen, Jamie Sparling, Marcos F. Vidal Melo
{"title":"Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial","authors":"Ana Fernandez-Bustamante, Robert A Parker, Gyorgy Frendl, Jae Woo Lee, Alexander Nagrebetsky, Loreta Grecu, David Amar, Pedro Tanaka, Juraj Sprung, Ravindra A Gupta, Balachundhar Subramanian, Jadelis Giquel, Matthias Eikermann, Guido Musch, Jacob W Nadler, Marcelo Gama de Abreu, Karsten Bartels, Meera Grover, Lee-Lynn Chen, Jamie Sparling, Marcos F. Vidal Melo","doi":"10.1016/s2213-2600(25)00040-2","DOIUrl":"https://doi.org/10.1016/s2213-2600(25)00040-2","url":null,"abstract":"<h3>Background</h3>Postoperative pulmonary complications (PPCs) are a leading cause of morbidity, death, and increased use of health-care resources. We aimed to determine whether a perioperative lung expansion bundle including individualised intraoperative management reduces PPC severity in patients undergoing major open abdominal surgery compared with usual care.<h3>Methods</h3>In this multicentre, randomised controlled phase 3 trial (PRIME-AIR), we enrolled adult patients (age ≥18 years) scheduled for an elective open abdominal surgery that would last at least 2 h, who were at intermediate or high risk for PPCs on the basis of their Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score (a score of ≥26), and who had a BMI below 35 kg/m<sup>2</sup> at 17 academic hospitals across ten states in the USA. Participants were randomly assigned (1:1), using permuted block randomisation (a mixture of blocks sizes of 2 and 4; in a 1:2 ratio), stratified by centre, to either usual care or a lung expansion bundle. The bundle comprised preoperative education on PPCs, intraoperative protective ventilation with individualised positive end-expiratory pressure (PEEP) to maximise respiratory system compliance, intraoperative neuromuscular blockade administration and reversal based on patient's weight and neuromuscular transmission monitoring, and postoperative supervised incentive spirometry and mobilisation encouragement. Anaesthesiologists at each site were also randomly assigned to either the intervention bundle group or usual care group, and at each site, at least one unmasked and one masked investigator was designated for each participant. Assessors were masked to treatment assignment. The primary outcome was the highest severity (grade 0–4) of a composite of PPCs by postoperative day 7, including hypoxaemia, respiratory symptoms, atelectasis, bronchospasm, respiratory infection, hypercapnia, pneumonia, pleural effusion, pneumothorax, and ventilatory dependence. The primary endpoint and safety were assessed in the modified intention-to-treat (mITT) population (ie, all participants randomly assigned to treatment who received surgery, and did not withdraw consent or verbal agreement, and excluded those found to be ineligible after randomisation, or for whom consent was not obtained for other reasons). This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT04108130</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and is now complete.<h3>Findings</h3>Between Jan 24, 2020, and April 5, 2023, we screened 1462 patients, of whom 794 were enrolled and rando","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"27 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143486456","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 outcomes and the future of extracorporeal care","authors":"J W Awori Hayanga, Heather Kaiser Hayanga","doi":"10.1016/s2213-2600(24)00416-8","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00416-8","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"65 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143477536","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}
Maria Elena De Piero, Silvia Mariani, Bas C T van Bussel, Dominik Jarczak, Niklas Krenner, Enrique Perez de la Sota, Pedro E Silva, Magdalena Roemmer, Mariusz Kowalewski, Simone Carelli, Lars Mikael Broman, Alain Vuylsteke, Philip Fortuna, Francesco Alessandri, Gennaro Martucci, Brijesh V Patel, Gosta Lotz, Udo Boeken, Sven Maier, Bursa Filip, Robert Loveridge
{"title":"In-hospital outcomes and 6-month follow-up results of patients supported with extracorporeal membrane oxygenation for COVID-19 from the second wave to the end of the pandemic (EuroECMO-COVID): a prospective, international, multicentre, observational study","authors":"Maria Elena De Piero, Silvia Mariani, Bas C T van Bussel, Dominik Jarczak, Niklas Krenner, Enrique Perez de la Sota, Pedro E Silva, Magdalena Roemmer, Mariusz Kowalewski, Simone Carelli, Lars Mikael Broman, Alain Vuylsteke, Philip Fortuna, Francesco Alessandri, Gennaro Martucci, Brijesh V Patel, Gosta Lotz, Udo Boeken, Sven Maier, Bursa Filip, Robert Loveridge","doi":"10.1016/s2213-2600(24)00369-2","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00369-2","url":null,"abstract":"<h3>Background</h3>Extracorporeal membrane oxygenation (ECMO) for COVID-19 was thoroughly assessed during the first pandemic wave, but data on subsequent waves are limited. We aimed to investigate in-hospital and 6-month survival of patients with COVID-19 supported with ECMO from the second pandemic wave (Sept 15, 2020) until the end of the pandemic (March 21, 2023, announced by WHO).<h3>Methods</h3>EuroECMO-COVID is a prospective, observational study including adults (aged ≥16 years) requiring ECMO respiratory support for COVID-19 from 98 centres in 21 countries. We compared patient characteristics and outcomes between in-hospital survivors and non-survivors. Mixed-effects multivariable logistic regressions were used to investigate factors linked to in-hospital mortality. 6-month survival and overall patient status were determined via patient contact or chart review. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT04366921</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and is complete.<h3>Findings</h3>We included 3860 patients (2687 [69·7%] were male and 1169 [30·3%] were female; median age 51 years [SD 11]) from 98 centres in 21 countries. In-hospital mortality was 55·9% (n=2158), with 81·2% (n=1752) deaths occurring during ECMO support. More non-survivors had diabetes, hypertension, cardiovascular disease, and renal failure, and required more pre-ECMO inotropes and vasopressors compared with survivors. Median support duration was 18 days (IQR 10–31) for both groups. Factors linked to in-hospital mortality included older age, pre-ECMO renal failure, pre-ECMO vasopressors use, longer time from intubation to ECMO initiation, and complications, including neurological events, sepsis, bowel ischaemia, renal failure, and bleeding. Of the 1702 (44·1%) in-hospital survivors, 99·7% (n=1697) were alive at 6 months follow-up. Many patients at 6 months follow-up had dyspnoea (501 [32·0%] of 1568 patients), cardiac (122 [7·8%] of 1568 patients), or neurocognitive (168 [10·7%] of 1567 patients) symptoms.<h3>Interpretation</h3>Our data for patients undergoing ECMO support for respiratory distress from the second COVID-19 wave onwards confirmed most findings from the first wave regarding patient characteristics and factors correlated to in-hospital mortality. Nevertheless, in-hospital mortality was higher than during the initial pandemic wave while 6-month post-discharge survival remained favourable (99·7%). Persisting post-discharge symptoms confirmed the need for post-ECMO patient follow-up programmes.<h3>Funding</h3>None.","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"4 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143477535","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}
Franck F Rahaghi, Marc Humbert, Marius M Hoeper, R James White, Robert P Frantz, Paul M Hassoun, Anna R Hemnes, Steven M Kawut, Vallerie V McLaughlin, Gergely Meszaros, Peter G M Mol, Steven D Nathan, Mitchel A Psotka, Farbod N Rahaghi, Olivier Sitbon, Norman Stockbridge, Jason Weatherald, Faiez Zannad, Sandeep Sahay
{"title":"Future treatment paradigms in pulmonary arterial hypertension: a personal view from physicians, health authorities, and patients","authors":"Franck F Rahaghi, Marc Humbert, Marius M Hoeper, R James White, Robert P Frantz, Paul M Hassoun, Anna R Hemnes, Steven M Kawut, Vallerie V McLaughlin, Gergely Meszaros, Peter G M Mol, Steven D Nathan, Mitchel A Psotka, Farbod N Rahaghi, Olivier Sitbon, Norman Stockbridge, Jason Weatherald, Faiez Zannad, Sandeep Sahay","doi":"10.1016/s2213-2600(24)00425-9","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00425-9","url":null,"abstract":"Novel treatments in pulmonary arterial hypertension (PAH) with significant pathophysiological and clinical responses have generated renewed interest in changing the course of the disease and achieving long-term disease control. Historically, the term disease modification was coined in rheumatological conditions with therapies that managed to treat the underlying condition as opposed to just alleviating symptoms. With the advent of novel therapies, the term disease modification was introduced in our discussions. Last year, a group of experts discussed this concept in PAH and proposed clinical trial designs to show disease modification in PAH. Taking a step further we convened a group of international experts at the 20th Global CardioVascular Clinical Trialists Forum, patients' representatives, and members of global regulatory agencies to discuss future treatment objectives and trial designs in PAH. The deliberations revealed the difficulty with securely defining disease modification, in that there are no pathophysiological biomarkers that reflect disease activity and studies are not designed or performed in a way that would support such designation. Regulatory agencies indicated they are going away from making this designation a priority in PAH. They declared interest in encouraging trials that advance interventions with significant pathophysiological effect, in particular showing reverse pulmonary vascular remodelling, which is likely to bring about more potent clinical response, partial or complete remission, and perhaps cure. In this Personal View, we provide a review of our understanding of defining disease modification in PAH along with providing definitions of what might constitute a partial or full remission in PAH.","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"22 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143462473","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":"Use of lung-cancer trends for global and public health priorities","authors":"Eunji Choi, Julie A Barta","doi":"10.1016/s2213-2600(25)00042-6","DOIUrl":"https://doi.org/10.1016/s2213-2600(25)00042-6","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"270 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143417390","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":"Patient in her 70s with COPD and asthma improving significantly since using monoclonal antibody dupilumab","authors":"Tony Kirby","doi":"10.1016/s2213-2600(25)00038-4","DOIUrl":"https://doi.org/10.1016/s2213-2600(25)00038-4","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"184 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143417389","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}