Pub Date : 2025-01-02DOI: 10.1001/jamasurg.2024.6489
{"title":"Error in Byline and Open Access Status.","authors":"","doi":"10.1001/jamasurg.2024.6489","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.6489","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914682","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}
Pub Date : 2025-01-01DOI: 10.1001/jamasurg.2024.5024
Paul C M Andel, Iris W J M van Goor, Simone Augustinus, Frederik Berrevoet, Marc G Besselink, Rajesh Bhojwani, Ugo Boggi, Stefan A W Bouwense, Geert A Cirkel, Jacob L van Dam, Angela Djanani, Dimitri Dorcaratto, Stephan Dreyer, Marcel den Dulk, Isabella Frigerio, Poya Ghorbani, Mara R Goetz, Bas Groot Koerkamp, Filip Gryspeerdt, Camila Hidalgo Salinas, Martijn Intven, Jakob R Izbicki, Rosa Jorba Martin, Emanuele F Kauffmann, Reinhold Klug, Mike S L Liem, Misha D P Luyer, Manuel Maglione, Elena Martin-Perez, Mark Meerdink, Vincent E de Meijer, Vincent B Nieuwenhuijs, Andrej Nikov, Vitor Nunes, Elizabeth Pando, Dejan Radenkovic, Geert Roeyen, Francisco Sanchez-Bueno, Alejandro Serrablo, Ernesto Sparrelid, Konstantinos Tepetes, Rohan G Thakkar, George N Tzimas, Robert C Verdonk, Meike Ten Winkel, Alessandro Zerbi, Vincent P Groot, I Quintus Molenaar, Lois A Daamen, Hjalmar C van Santvoort
Importance: International guidelines lack consistency in their recommendations regarding routine imaging in the follow-up after pancreatic resection for pancreatic ductal adenocarcinoma (PDAC). Consequently, follow-up strategies differ between centers worldwide.
Objective: To compare clinical outcomes, including recurrence-focused treatment and survival, in patients with PDAC recurrence who received symptomatic follow-up or routine imaging after pancreatic resection in international centers affiliated with the European-African Hepato-Pancreato-Biliary Association (E-AHPBA).
Design, setting, and participants: This was a prospective, international, cross-sectional study. Patients from a total of 33 E-AHPBA centers from 13 countries were included between 2020 and 2021. According to the predefined study protocol, patients who underwent PDAC resection and were diagnosed with disease recurrence were prospectively included. Patients were stratified according to postoperative follow-up strategy: symptomatic follow-up (ie, without routine imaging) or routine imaging.
Exposures: Symptomatic follow-up or routine imaging in patients who underwent PDAC resection.
Main outcomes and measures: Overall survival (OS) was estimated with Kaplan-Meier curves and compared using the log-rank test. To adjust for potential confounders, multivariable logistic regression was used to evaluate the association between follow-up strategy and recurrence-focused treatment. Multivariable Cox proportional hazard analysis was used to study the independent association between follow-up strategy and OS.
Results: Overall, 333 patients (mean [SD] age, 65 [11] years; 184 male [55%]) with PDAC recurrence were included. Median (IQR) follow-up at time of analysis 2 years after inclusion of the last patient was 40 (30-58) months. Of the total cohort, 98 patients (29%) received symptomatic follow-up, and 235 patients (71%) received routine imaging. OS was 23 months (95% CI, 19-29 months) vs 28 months (95% CI, 24-30 months) in the groups who received symptomatic follow-up vs routine imaging, respectively (P = .01). Routine imaging was associated with receiving recurrence-focused treatment (adjusted odds ratio, 2.57; 95% CI, 1.22-5.41; P = .01) and prolonged OS (adjusted hazard ratio, 0.75; 95% CI, 0.56-.99; P = .04).
Conclusion and relevance: In this international, prospective, cross-sectional study, routine follow-up imaging after pancreatic resection for PDAC was independently associated with receiving recurrence-focused treatment and prolonged OS.
{"title":"Routine Imaging or Symptomatic Follow-Up After Resection of Pancreatic Adenocarcinoma.","authors":"Paul C M Andel, Iris W J M van Goor, Simone Augustinus, Frederik Berrevoet, Marc G Besselink, Rajesh Bhojwani, Ugo Boggi, Stefan A W Bouwense, Geert A Cirkel, Jacob L van Dam, Angela Djanani, Dimitri Dorcaratto, Stephan Dreyer, Marcel den Dulk, Isabella Frigerio, Poya Ghorbani, Mara R Goetz, Bas Groot Koerkamp, Filip Gryspeerdt, Camila Hidalgo Salinas, Martijn Intven, Jakob R Izbicki, Rosa Jorba Martin, Emanuele F Kauffmann, Reinhold Klug, Mike S L Liem, Misha D P Luyer, Manuel Maglione, Elena Martin-Perez, Mark Meerdink, Vincent E de Meijer, Vincent B Nieuwenhuijs, Andrej Nikov, Vitor Nunes, Elizabeth Pando, Dejan Radenkovic, Geert Roeyen, Francisco Sanchez-Bueno, Alejandro Serrablo, Ernesto Sparrelid, Konstantinos Tepetes, Rohan G Thakkar, George N Tzimas, Robert C Verdonk, Meike Ten Winkel, Alessandro Zerbi, Vincent P Groot, I Quintus Molenaar, Lois A Daamen, Hjalmar C van Santvoort","doi":"10.1001/jamasurg.2024.5024","DOIUrl":"10.1001/jamasurg.2024.5024","url":null,"abstract":"<p><strong>Importance: </strong>International guidelines lack consistency in their recommendations regarding routine imaging in the follow-up after pancreatic resection for pancreatic ductal adenocarcinoma (PDAC). Consequently, follow-up strategies differ between centers worldwide.</p><p><strong>Objective: </strong>To compare clinical outcomes, including recurrence-focused treatment and survival, in patients with PDAC recurrence who received symptomatic follow-up or routine imaging after pancreatic resection in international centers affiliated with the European-African Hepato-Pancreato-Biliary Association (E-AHPBA).</p><p><strong>Design, setting, and participants: </strong>This was a prospective, international, cross-sectional study. Patients from a total of 33 E-AHPBA centers from 13 countries were included between 2020 and 2021. According to the predefined study protocol, patients who underwent PDAC resection and were diagnosed with disease recurrence were prospectively included. Patients were stratified according to postoperative follow-up strategy: symptomatic follow-up (ie, without routine imaging) or routine imaging.</p><p><strong>Exposures: </strong>Symptomatic follow-up or routine imaging in patients who underwent PDAC resection.</p><p><strong>Main outcomes and measures: </strong>Overall survival (OS) was estimated with Kaplan-Meier curves and compared using the log-rank test. To adjust for potential confounders, multivariable logistic regression was used to evaluate the association between follow-up strategy and recurrence-focused treatment. Multivariable Cox proportional hazard analysis was used to study the independent association between follow-up strategy and OS.</p><p><strong>Results: </strong>Overall, 333 patients (mean [SD] age, 65 [11] years; 184 male [55%]) with PDAC recurrence were included. Median (IQR) follow-up at time of analysis 2 years after inclusion of the last patient was 40 (30-58) months. Of the total cohort, 98 patients (29%) received symptomatic follow-up, and 235 patients (71%) received routine imaging. OS was 23 months (95% CI, 19-29 months) vs 28 months (95% CI, 24-30 months) in the groups who received symptomatic follow-up vs routine imaging, respectively (P = .01). Routine imaging was associated with receiving recurrence-focused treatment (adjusted odds ratio, 2.57; 95% CI, 1.22-5.41; P = .01) and prolonged OS (adjusted hazard ratio, 0.75; 95% CI, 0.56-.99; P = .04).</p><p><strong>Conclusion and relevance: </strong>In this international, prospective, cross-sectional study, routine follow-up imaging after pancreatic resection for PDAC was independently associated with receiving recurrence-focused treatment and prolonged OS.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"74-84"},"PeriodicalIF":15.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Importance: </strong>Physical biomarkers for stratifying patients with lung cancer into subtypes suggestive of outcomes are underexplored.</p><p><strong>Objective: </strong>To investigate the clinical utility of respiratory sarcopenia for optimizing postoperative risk stratification in patients with non-small cell lung cancer (NSCLC).</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study reviewed consecutive patients undergoing lobectomy and mediastinal lymph node dissection for NSCLC at 2 institutions in Tokyo, Japan, between 2009 and 2018. Eligible patients underwent electronic computed tomography image analysis. Follow-up began at the date of surgery and continued until death, the last contact, or March 2022. Data analysis was performed from April 2022 to March 2023.</p><p><strong>Main outcomes and measures: </strong>Respiratory sarcopenia was identified by poor respiratory strength (peak expiratory flow rate) and was confirmed by a low pectoralis muscle index (PMI; pectoralis muscle area/body mass index). Patients with poor peak expiratory flow rate but normal PMI received a diagnosis of pre-respiratory sarcopenia. Short-term and long-term postoperative outcomes were compared among patients with a normal status, pre-respiratory sarcopenia, and respiratory sarcopenia. Group differences were analyzed using the Kruskal-Wallis test and Pearson χ2 test for continuous and categorical data, respectively. Survival differences were compared using the log-rank test. Univariable and multivariable analyses were conducted using the Cox proportional hazards model.</p><p><strong>Results: </strong>Of a total of 1016 patients, 806 (497 men [61.7%]; median [IQR] age, 69 [64-76] years) were eligible for electronic computed tomography image analysis. The median (IQR) duration of follow-up for survival was 5.2 (3.6-6.4) years. Respiratory strength was more closely correlated with PMI than pectoralis muscle radiodensity (Pearson r2, 0.58 vs 0.29). Respiratory strength and PMI declined with aging simultaneously (both P for trend < .001). Pre-respiratory sarcopenia was present in 177 patients (22.0%), and respiratory sarcopenia was present in 130 patients (16.1%). The risk of postoperative complications escalated from 82 patients (16.4%) with normal status to 39 patients (22.0%) with pre-respiratory sarcopenia to 39 patients (30.0%) with respiratory sarcopenia (P for trend < .001), as did the risk of delayed recovery after surgery (P for trend < .001). Compared with patients with normal status or pre-respiratory sarcopenia, patients with respiratory sarcopenia exhibited worse 5-year overall survival (438 patients [87.2%] vs 133 patients [72.9%] vs 85 patients [62.5%]; P for trend < .001). Multivariable analysis identified respiratory sarcopenia as a factor independently associated with increased risk of mortality (hazard ratio, 1.83; 95% CI, 1.15-2.89; P = .01) after adjustment for sex, age, smoking status, performance
{"title":"Diagnosis of Respiratory Sarcopenia for Stratifying Postoperative Risk in Non-Small Cell Lung Cancer.","authors":"Changbo Sun, Yoshifumi Hirata, Takuya Kawahara, Mitsuaki Kawashima, Masaaki Sato, Jun Nakajima, Masaki Anraku","doi":"10.1001/jamasurg.2024.4800","DOIUrl":"10.1001/jamasurg.2024.4800","url":null,"abstract":"<p><strong>Importance: </strong>Physical biomarkers for stratifying patients with lung cancer into subtypes suggestive of outcomes are underexplored.</p><p><strong>Objective: </strong>To investigate the clinical utility of respiratory sarcopenia for optimizing postoperative risk stratification in patients with non-small cell lung cancer (NSCLC).</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study reviewed consecutive patients undergoing lobectomy and mediastinal lymph node dissection for NSCLC at 2 institutions in Tokyo, Japan, between 2009 and 2018. Eligible patients underwent electronic computed tomography image analysis. Follow-up began at the date of surgery and continued until death, the last contact, or March 2022. Data analysis was performed from April 2022 to March 2023.</p><p><strong>Main outcomes and measures: </strong>Respiratory sarcopenia was identified by poor respiratory strength (peak expiratory flow rate) and was confirmed by a low pectoralis muscle index (PMI; pectoralis muscle area/body mass index). Patients with poor peak expiratory flow rate but normal PMI received a diagnosis of pre-respiratory sarcopenia. Short-term and long-term postoperative outcomes were compared among patients with a normal status, pre-respiratory sarcopenia, and respiratory sarcopenia. Group differences were analyzed using the Kruskal-Wallis test and Pearson χ2 test for continuous and categorical data, respectively. Survival differences were compared using the log-rank test. Univariable and multivariable analyses were conducted using the Cox proportional hazards model.</p><p><strong>Results: </strong>Of a total of 1016 patients, 806 (497 men [61.7%]; median [IQR] age, 69 [64-76] years) were eligible for electronic computed tomography image analysis. The median (IQR) duration of follow-up for survival was 5.2 (3.6-6.4) years. Respiratory strength was more closely correlated with PMI than pectoralis muscle radiodensity (Pearson r2, 0.58 vs 0.29). Respiratory strength and PMI declined with aging simultaneously (both P for trend < .001). Pre-respiratory sarcopenia was present in 177 patients (22.0%), and respiratory sarcopenia was present in 130 patients (16.1%). The risk of postoperative complications escalated from 82 patients (16.4%) with normal status to 39 patients (22.0%) with pre-respiratory sarcopenia to 39 patients (30.0%) with respiratory sarcopenia (P for trend < .001), as did the risk of delayed recovery after surgery (P for trend < .001). Compared with patients with normal status or pre-respiratory sarcopenia, patients with respiratory sarcopenia exhibited worse 5-year overall survival (438 patients [87.2%] vs 133 patients [72.9%] vs 85 patients [62.5%]; P for trend < .001). Multivariable analysis identified respiratory sarcopenia as a factor independently associated with increased risk of mortality (hazard ratio, 1.83; 95% CI, 1.15-2.89; P = .01) after adjustment for sex, age, smoking status, performance ","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"66-73"},"PeriodicalIF":15.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1001/jamasurg.2024.4683
Laurent G Glance, Karen E Joynt Maddox, Sabu Thomas, Mark J Sorbero, Lee A Fleisher, Stewart J Lustik, Heather L Lander, Jingjing Shang, Patricia W Stone, Michael P Eaton, Marjorie S Gloff, Andrew W Dick
<p><strong>Importance: </strong>Delaying elective noncardiac surgery after a recent acute myocardial infarction is associated with better outcomes, but current American Heart Association recommendations are based on data that are more than 20 years old.</p><p><strong>Objective: </strong>To examine the association between the time since a non-ST-segment elevation myocardial infarction (NSTEMI) and the risk of postoperative major adverse cardiovascular and cerebrovascular events (MACCE).</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study examined Medicare claims data between 2015 and 2020 for patients 67 years or older who had major noncardiac surgery. Data were analyzed from September 21, 2023, to February 1, 2024.</p><p><strong>Exposure: </strong>Time elapsed between a prior NSTEMI and surgery.</p><p><strong>Main outcomes and measures: </strong>MACCE (30-day mortality, in-hospital myocardial infarction, heart failure, or stroke) and all-cause 30-day mortality. Multivariable logistic regression was used to estimate the association between outcomes and time since a prior NSTEMI.</p><p><strong>Results: </strong>The sample included 5 227 473 surgeries. The mean (SD) age was 75.7 (6.6) years; 2 981 239 (57.0%) were female, and 2 246 234 (43%) were male. There were 42 278 patients (0.81%) with a previous NSTEMI. Compared with patients without a prior NSTEMI, patients with an NSTEMI within 30 days of elective surgery had higher odds of MACCE, regardless of whether they had undergone coronary revascularization (adjusted odds ratio [aOR], 2.15; 95% CI, 1.09-4.23; P = .03) or not (aOR, 2.04; 95% CI, 1.31-3.16; P = .001). The odds of postoperative MACCE leveled off after 30 days in patients who had undergone any coronary revascularization procedure (and after 90 days in patients with drug-eluting stents) and then increased after 180 days (any revascularization at 181-365 days: aOR, 1.46; 95% CI, 1.25-1.71; P < .001; patients with drug-eluting stents at 181-365 days: aOR, 1.73; 95% CI, 1.42-2.12; P < .001). The odds of MACCE did not level off for patients who did not have revascularization. Findings for all-cause 30-day mortality were similar to those for MACCE, except that the odds of mortality in patients with previous NSTEMI who had revascularization leveled off after 60 days in elective surgeries and 90 days for nonelective surgeries (elective 30-day: aOR, 2.88; 95% CI, 1.30-6.36; P = .009; elective 61- to 90-day: aOR, 1.03; 95% CI, 0.57-1.86; P = .92; nonelective 30-day: aOR, 1.91; 95% CI, 1.52-2.40; P < .001; nonelective 91- to 120-day: aOR, 1.00; 95% CI, 0.73-1.37; P = .99).</p><p><strong>Conclusions and relevance: </strong>This study found that among older patients undergoing noncardiac surgery who had revascularization, the odds of postoperative MACCE and mortality leveled off between 30 and 90 days and then increased after 180 days. The odds did not level off for patients who did not have revascularization. Delayin
{"title":"Time Since Prior NSTEMI and Major Adverse Cardiovascular and Cerebrovascular Events After Noncardiac Surgery.","authors":"Laurent G Glance, Karen E Joynt Maddox, Sabu Thomas, Mark J Sorbero, Lee A Fleisher, Stewart J Lustik, Heather L Lander, Jingjing Shang, Patricia W Stone, Michael P Eaton, Marjorie S Gloff, Andrew W Dick","doi":"10.1001/jamasurg.2024.4683","DOIUrl":"10.1001/jamasurg.2024.4683","url":null,"abstract":"<p><strong>Importance: </strong>Delaying elective noncardiac surgery after a recent acute myocardial infarction is associated with better outcomes, but current American Heart Association recommendations are based on data that are more than 20 years old.</p><p><strong>Objective: </strong>To examine the association between the time since a non-ST-segment elevation myocardial infarction (NSTEMI) and the risk of postoperative major adverse cardiovascular and cerebrovascular events (MACCE).</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study examined Medicare claims data between 2015 and 2020 for patients 67 years or older who had major noncardiac surgery. Data were analyzed from September 21, 2023, to February 1, 2024.</p><p><strong>Exposure: </strong>Time elapsed between a prior NSTEMI and surgery.</p><p><strong>Main outcomes and measures: </strong>MACCE (30-day mortality, in-hospital myocardial infarction, heart failure, or stroke) and all-cause 30-day mortality. Multivariable logistic regression was used to estimate the association between outcomes and time since a prior NSTEMI.</p><p><strong>Results: </strong>The sample included 5 227 473 surgeries. The mean (SD) age was 75.7 (6.6) years; 2 981 239 (57.0%) were female, and 2 246 234 (43%) were male. There were 42 278 patients (0.81%) with a previous NSTEMI. Compared with patients without a prior NSTEMI, patients with an NSTEMI within 30 days of elective surgery had higher odds of MACCE, regardless of whether they had undergone coronary revascularization (adjusted odds ratio [aOR], 2.15; 95% CI, 1.09-4.23; P = .03) or not (aOR, 2.04; 95% CI, 1.31-3.16; P = .001). The odds of postoperative MACCE leveled off after 30 days in patients who had undergone any coronary revascularization procedure (and after 90 days in patients with drug-eluting stents) and then increased after 180 days (any revascularization at 181-365 days: aOR, 1.46; 95% CI, 1.25-1.71; P < .001; patients with drug-eluting stents at 181-365 days: aOR, 1.73; 95% CI, 1.42-2.12; P < .001). The odds of MACCE did not level off for patients who did not have revascularization. Findings for all-cause 30-day mortality were similar to those for MACCE, except that the odds of mortality in patients with previous NSTEMI who had revascularization leveled off after 60 days in elective surgeries and 90 days for nonelective surgeries (elective 30-day: aOR, 2.88; 95% CI, 1.30-6.36; P = .009; elective 61- to 90-day: aOR, 1.03; 95% CI, 0.57-1.86; P = .92; nonelective 30-day: aOR, 1.91; 95% CI, 1.52-2.40; P < .001; nonelective 91- to 120-day: aOR, 1.00; 95% CI, 0.73-1.37; P = .99).</p><p><strong>Conclusions and relevance: </strong>This study found that among older patients undergoing noncardiac surgery who had revascularization, the odds of postoperative MACCE and mortality leveled off between 30 and 90 days and then increased after 180 days. The odds did not level off for patients who did not have revascularization. Delayin","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"45-54"},"PeriodicalIF":15.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1001/jamasurg.2024.6210
{"title":"Error in Author Affiliation and Name.","authors":"","doi":"10.1001/jamasurg.2024.6210","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.6210","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":"160 1","pages":"115"},"PeriodicalIF":15.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949217","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}
Pub Date : 2024-12-23DOI: 10.1001/jamasurg.2024.5788
Clayton C Petro, Ryan C Ellis, Sara M Maskal, Sam J Zolin, Chao Tu, Adele Costanzo, Lucas R A Beffa, David M Krpata, Diya Alaedeen, Ajita S Prabhu, Benjamin T Miller, Kevin F Baier, Alisan Fathalizadeh, John Rodriguez, Michael J Rosen
<p><strong>Importance: </strong>Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair-an anterior gastropexy-may reduce recurrence, but this adjunct is currently not the standard of care.</p><p><strong>Objective: </strong>To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR.</p><p><strong>Design, setting, and participants: </strong>This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024.</p><p><strong>Intervention: </strong>Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121).</p><p><strong>Main outcome: </strong>The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year.</p><p><strong>Results: </strong>A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups.</p><p><strong>Conclusions and relevance: </strong>This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identif
{"title":"Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial.","authors":"Clayton C Petro, Ryan C Ellis, Sara M Maskal, Sam J Zolin, Chao Tu, Adele Costanzo, Lucas R A Beffa, David M Krpata, Diya Alaedeen, Ajita S Prabhu, Benjamin T Miller, Kevin F Baier, Alisan Fathalizadeh, John Rodriguez, Michael J Rosen","doi":"10.1001/jamasurg.2024.5788","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.5788","url":null,"abstract":"<p><strong>Importance: </strong>Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair-an anterior gastropexy-may reduce recurrence, but this adjunct is currently not the standard of care.</p><p><strong>Objective: </strong>To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR.</p><p><strong>Design, setting, and participants: </strong>This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024.</p><p><strong>Intervention: </strong>Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121).</p><p><strong>Main outcome: </strong>The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year.</p><p><strong>Results: </strong>A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups.</p><p><strong>Conclusions and relevance: </strong>This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identif","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877043","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}
Pub Date : 2024-12-23DOI: 10.1001/jamasurg.2024.5711
Shernaz S Dossabhoy, Laura A Graham, Aditi Kashikar, Elizabeth L George, Carolyn D Seib, Manjula Kurella Tamura, Todd H Wagner, Mary T Hawn, Shipra Arya
<p><strong>Importance: </strong>Surgical quality improvement efforts have largely focused on 30-day outcomes, such as readmissions and complications. Surgery may have a sustained impact on the health and quality of life of patients considered frail, yet data are lacking on the long-term health care utilization of patients with frailty following surgery.</p><p><strong>Objective: </strong>To examine the independent association of preoperative frailty on long-term health care utilization (up to 24 months) following surgery.</p><p><strong>Design, setting, and participants: </strong>This retrospective, observational cohort study included patients undergoing elective general and vascular surgery performed in the Veterans Affairs (VA) Surgical Quality Improvement Program with study entry from October 1, 2013, to September 30, 2018. Patients were followed up for 24 months. Patients with nursing home visits prior to surgery, emergent cases, and in-hospital deaths were excluded. Data analysis was conducted from September 2022 to May 2024.</p><p><strong>Exposures: </strong>Preoperative frailty as assessed by the Risk Analysis Index (RAI-A) score: robust, less than 20; normal, 20 to 29; frail, 30 to 39; and very frail, 40 or more.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was health care utilization through 24 months, defined as inpatient admissions, outpatient visits, emergency department (ED) visits, and nursing home or rehabilitation services collected via Corporate Data Warehouse and Centers for Medicare & Medicaid Services data. χ2 Tests and analysis of variance were used to assess preoperative frailty status, and a Cox proportional hazards model was used to calculate the adjusted association of preoperative frailty on each postdischarge health care utilization outcome.</p><p><strong>Results: </strong>This study identified 183 343 elective general (80.5%) and vascular (19.5%) procedures (mean [SD] age, 62 [12.7] years; 12 915 females [7.0%]; 28 671 Black patients [16.0]; 138 323 White patients [77.3%]; 94 451 Medicare enrollees [51.5%]) with mean (SD) RAI-A score of 22.2 (7.0). After adjustment for baseline characteristics and preoperative use of health care services, frailty was associated with higher inpatient admissions (frail: hazard ratio [HR], 1.75; 95% CI, 1.70-1.79; very frail: HR, 2.33; 95% CI, 2.25-2.42), ED visits (frail: HR, 1.39; 95% CI, 1.36-1.41; very frail: HR, 1.70; 95% CI, 1.65-1.75), and nursing home or rehabilitation encounters (frail: HR, 4.97; 95% CI, 4.36-5.67; very frail: HR, 7.44; 95% CI, 6.34-8.73). For patients considered frail and very frail, health care utilization was higher after surgery and remained significant through 24 months for all outcomes (using piecewise Cox proportional hazards modeling).</p><p><strong>Conclusions and relevance: </strong>In this study, frailty was a significant risk factor for high long-term health care utilization after surgery. This may have quality of life implicat
{"title":"Frailty and Long-Term Health Care Utilization After Elective General and Vascular Surgery.","authors":"Shernaz S Dossabhoy, Laura A Graham, Aditi Kashikar, Elizabeth L George, Carolyn D Seib, Manjula Kurella Tamura, Todd H Wagner, Mary T Hawn, Shipra Arya","doi":"10.1001/jamasurg.2024.5711","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.5711","url":null,"abstract":"<p><strong>Importance: </strong>Surgical quality improvement efforts have largely focused on 30-day outcomes, such as readmissions and complications. Surgery may have a sustained impact on the health and quality of life of patients considered frail, yet data are lacking on the long-term health care utilization of patients with frailty following surgery.</p><p><strong>Objective: </strong>To examine the independent association of preoperative frailty on long-term health care utilization (up to 24 months) following surgery.</p><p><strong>Design, setting, and participants: </strong>This retrospective, observational cohort study included patients undergoing elective general and vascular surgery performed in the Veterans Affairs (VA) Surgical Quality Improvement Program with study entry from October 1, 2013, to September 30, 2018. Patients were followed up for 24 months. Patients with nursing home visits prior to surgery, emergent cases, and in-hospital deaths were excluded. Data analysis was conducted from September 2022 to May 2024.</p><p><strong>Exposures: </strong>Preoperative frailty as assessed by the Risk Analysis Index (RAI-A) score: robust, less than 20; normal, 20 to 29; frail, 30 to 39; and very frail, 40 or more.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was health care utilization through 24 months, defined as inpatient admissions, outpatient visits, emergency department (ED) visits, and nursing home or rehabilitation services collected via Corporate Data Warehouse and Centers for Medicare & Medicaid Services data. χ2 Tests and analysis of variance were used to assess preoperative frailty status, and a Cox proportional hazards model was used to calculate the adjusted association of preoperative frailty on each postdischarge health care utilization outcome.</p><p><strong>Results: </strong>This study identified 183 343 elective general (80.5%) and vascular (19.5%) procedures (mean [SD] age, 62 [12.7] years; 12 915 females [7.0%]; 28 671 Black patients [16.0]; 138 323 White patients [77.3%]; 94 451 Medicare enrollees [51.5%]) with mean (SD) RAI-A score of 22.2 (7.0). After adjustment for baseline characteristics and preoperative use of health care services, frailty was associated with higher inpatient admissions (frail: hazard ratio [HR], 1.75; 95% CI, 1.70-1.79; very frail: HR, 2.33; 95% CI, 2.25-2.42), ED visits (frail: HR, 1.39; 95% CI, 1.36-1.41; very frail: HR, 1.70; 95% CI, 1.65-1.75), and nursing home or rehabilitation encounters (frail: HR, 4.97; 95% CI, 4.36-5.67; very frail: HR, 7.44; 95% CI, 6.34-8.73). For patients considered frail and very frail, health care utilization was higher after surgery and remained significant through 24 months for all outcomes (using piecewise Cox proportional hazards modeling).</p><p><strong>Conclusions and relevance: </strong>In this study, frailty was a significant risk factor for high long-term health care utilization after surgery. This may have quality of life implicat","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877056","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}
Pub Date : 2024-12-23DOI: 10.1001/jamasurg.2024.5664
Juliet Blakeslee Carter, Adam W Beck
{"title":"The Investigational Device Exemption Effect-More Than Just Volume.","authors":"Juliet Blakeslee Carter, Adam W Beck","doi":"10.1001/jamasurg.2024.5664","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.5664","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877168","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}