Mario Gaudino, Lamia Harik, Bjorn Redfors, Sigrid Sandner, John H Alexander, Antonino Di Franco, Arnaldo Dimagli, Jonathon Weinsaft, Roberto Perezgrovas-Olaria, Giovanni Jr Soletti, Christopher Lau, Charles Mack, Leonard Girardi
{"title":"后路心包切开术对心脏手术后房颤发生率的影响——延长随访研究(PALACS-EF):理论基础和设计。","authors":"Mario Gaudino, Lamia Harik, Bjorn Redfors, Sigrid Sandner, John H Alexander, Antonino Di Franco, Arnaldo Dimagli, Jonathon Weinsaft, Roberto Perezgrovas-Olaria, Giovanni Jr Soletti, Christopher Lau, Charles Mack, Leonard Girardi","doi":"10.1093/ehjopen/oead118","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery and has been associated with increased postoperative morbidity and hospital costs. The Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery (PALACS) trial found that posterior pericardiotomy significantly reduced the incidence of POAF (17% vs. 32%, <i>P</i> < 0.001). We present the protocol for The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): a prospective, extended follow-up of the original PALACS trial. The aim of PALACS-EF is to gain more data regarding the effect of posterior pericardiotomy on postdischarge clinical outcomes. The primary outcome is the time to the first occurrence of the composite of all-cause mortality or hospital cardiovascular readmission. The key secondary outcome is the time to the first occurrence of the composite of all-cause mortality and all-cause hospital readmission. Hospital readmission, myocardial infarction, stroke, transient ischaemic attack, heart failure, systemic embolism, or new arrhythmias with onset since 30-day follow-up will also be recorded.</p><p><strong>Methods and results: </strong>All 420 patients enrolled in the PALACS trial will be included; extended follow-up will be conducted via telephone by blinded research personnel utilizing a standardized script to ensure uniformity and completeness of follow-up. If an event has occurred, documentation will be obtained, and an independent adjudication committee blinded to group assignment will adjudicate outcome events. Results will be reported when a median follow-up of 5 years is achieved.</p><p><strong>Conclusion: </strong>PALACS-EF will provide data to answer the question of whether posterior pericardiotomy improves postdischarge outcomes in patients undergoing cardiac surgery, and it will provide information on the relationship between POAF and adverse postdischarge outcomes including mortality, hospitalization, heart failure, and stroke.</p><p><strong>Registration: </strong>PALACS: NCT02875405, PALACS-EF: NCT05903222.</p>","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":"3 6","pages":"oead118"},"PeriodicalIF":0.0000,"publicationDate":"2023-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684294/pdf/","citationCount":"0","resultStr":"{\"title\":\"The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): rationale and design.\",\"authors\":\"Mario Gaudino, Lamia Harik, Bjorn Redfors, Sigrid Sandner, John H Alexander, Antonino Di Franco, Arnaldo Dimagli, Jonathon Weinsaft, Roberto Perezgrovas-Olaria, Giovanni Jr Soletti, Christopher Lau, Charles Mack, Leonard Girardi\",\"doi\":\"10.1093/ehjopen/oead118\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery and has been associated with increased postoperative morbidity and hospital costs. The Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery (PALACS) trial found that posterior pericardiotomy significantly reduced the incidence of POAF (17% vs. 32%, <i>P</i> < 0.001). We present the protocol for The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): a prospective, extended follow-up of the original PALACS trial. The aim of PALACS-EF is to gain more data regarding the effect of posterior pericardiotomy on postdischarge clinical outcomes. The primary outcome is the time to the first occurrence of the composite of all-cause mortality or hospital cardiovascular readmission. The key secondary outcome is the time to the first occurrence of the composite of all-cause mortality and all-cause hospital readmission. Hospital readmission, myocardial infarction, stroke, transient ischaemic attack, heart failure, systemic embolism, or new arrhythmias with onset since 30-day follow-up will also be recorded.</p><p><strong>Methods and results: </strong>All 420 patients enrolled in the PALACS trial will be included; extended follow-up will be conducted via telephone by blinded research personnel utilizing a standardized script to ensure uniformity and completeness of follow-up. If an event has occurred, documentation will be obtained, and an independent adjudication committee blinded to group assignment will adjudicate outcome events. Results will be reported when a median follow-up of 5 years is achieved.</p><p><strong>Conclusion: </strong>PALACS-EF will provide data to answer the question of whether posterior pericardiotomy improves postdischarge outcomes in patients undergoing cardiac surgery, and it will provide information on the relationship between POAF and adverse postdischarge outcomes including mortality, hospitalization, heart failure, and stroke.</p><p><strong>Registration: </strong>PALACS: NCT02875405, PALACS-EF: NCT05903222.</p>\",\"PeriodicalId\":93995,\"journal\":{\"name\":\"European heart journal open\",\"volume\":\"3 6\",\"pages\":\"oead118\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-11-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684294/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European heart journal open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/ehjopen/oead118\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/11/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European heart journal open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/ehjopen/oead118","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的:术后心房颤动(POAF)是心脏手术最常见的并发症，与术后发病率和住院费用增加有关。心外科手术后左后路心包切开术预防房颤(PALACS)试验发现，后路心包切开术可显著降低POAF的发生率(17% vs. 32%， P < 0.001)。我们提出了后路心包切开术对心脏手术后房颤发生率的影响的方案-延长随访研究(PALACS- ef):一项对原始PALACS试验的前瞻性延长随访。PALACS-EF的目的是获得更多关于后路心包切开术对出院后临床结果影响的数据。主要转归是首次发生全因死亡率或医院心血管疾病再入院的时间。关键的次要结局是首次发生全因死亡率和全因再入院的时间。再次入院、心肌梗死、中风、短暂性缺血性发作、心力衰竭、全体性栓塞或30天随访后新发心律失常也将被记录。方法和结果:纳入PALACS试验的所有420例患者;为确保随访的统一性和完整性，盲法研究人员将通过电话进行延长随访。如果一个事件已经发生，将获得文件，并由一个不受小组分配影响的独立裁决委员会对结果事件进行裁决。中位随访5年后报告结果。结论:PALACS-EF将提供数据来回答后路心包切开术是否改善心脏手术患者的出院后结局，并将提供POAF与不良出院后结局(包括死亡率、住院率、心力衰竭和卒中)之间的关系。注册:PALACS: NCT02875405, PALACS- ef: NCT05903222。
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): rationale and design.
Aims: Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery and has been associated with increased postoperative morbidity and hospital costs. The Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery (PALACS) trial found that posterior pericardiotomy significantly reduced the incidence of POAF (17% vs. 32%, P < 0.001). We present the protocol for The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): a prospective, extended follow-up of the original PALACS trial. The aim of PALACS-EF is to gain more data regarding the effect of posterior pericardiotomy on postdischarge clinical outcomes. The primary outcome is the time to the first occurrence of the composite of all-cause mortality or hospital cardiovascular readmission. The key secondary outcome is the time to the first occurrence of the composite of all-cause mortality and all-cause hospital readmission. Hospital readmission, myocardial infarction, stroke, transient ischaemic attack, heart failure, systemic embolism, or new arrhythmias with onset since 30-day follow-up will also be recorded.
Methods and results: All 420 patients enrolled in the PALACS trial will be included; extended follow-up will be conducted via telephone by blinded research personnel utilizing a standardized script to ensure uniformity and completeness of follow-up. If an event has occurred, documentation will be obtained, and an independent adjudication committee blinded to group assignment will adjudicate outcome events. Results will be reported when a median follow-up of 5 years is achieved.
Conclusion: PALACS-EF will provide data to answer the question of whether posterior pericardiotomy improves postdischarge outcomes in patients undergoing cardiac surgery, and it will provide information on the relationship between POAF and adverse postdischarge outcomes including mortality, hospitalization, heart failure, and stroke.
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