Hamid Y Hassen, Steven Abrams, G. Musinguzi, Imogen Rogers, Alfred Dusabimana, P. Mphekgwana, H. Bastiaens, H. Bastiaens, Hamid Y Hassen, N. Aerts, S. Anthierens, Kathleen Van Royen, Caroline Masquillier, Jean Yves Le Reste, D. Le Goff, G. Perraud, Harm van Marwijk, Elisabeth Ford, Tom Grice-Jackson, Imogen Rogers, P. Nahar, Linda Gibson, M. Bowyer, Almighty Nkengateh, G. Musinguzi, R. Ndejjo, Fred Nuwaha, T. Sodi, P. Mphekgwana, Nancy Malema, Nancy Kgatla, T. Mothiba
Accurate prediction of a person’s risk of cardiovascular disease (CVD) is vital to initiate appropriate intervention. The non-laboratory INTERHEART risk score (NL-IHRS) is among the tools to estimate future risk of CVD. However, measurement disparities of the tool across contexts are not well documented. Thus, we investigated variation in NL-IHRS and components in selected sub-Saharan African and European countries. We used data from a multi-country study involving 9309 participants, i.e., 4941 in Europe, 3371 in South Africa and 997 in Uganda. Disparities in total NL-IHRS score, specific subcomponents, subcategories, and their contribution to the total score was investigated. The variation in the adjusted total and component scores were compared across contexts using analysis of variance. The adjusted mean NL-IHRS was higher in South Africa (10.2) and Europe (10.0) compared to Uganda (8.2) and the difference was statistically significant (p<0.001). The prevalence and percent contribution of diabetes mellitus and high blood pressure were lowest in Uganda. Score contribution of non-modifiable factors was lower in Uganda and South Africa, entailing 11.5% and 8.0% of the total score respectively. Contribution of behavioral factors to the total score was highest in both sub-Saharan African countries. In particular, adjusted scores related to unhealthy dietary patterns were highest in South Africa (3.21) compared to Uganda (1.66) and Europe (1.09). Whereas contribution of metabolic factors was highest in Europe (30.6%) compared with Uganda (20.8%) and South Africa (22.6%). The total risk score, subcomponents, categories, and their contribution to total score greatly varies across contexts, which could be due to disparities in risk burden and/or self-reporting bias in resource limited settings. Therefore, primary preventive initiatives should identify risk factor burden across contexts and intervention activities need to be customized accordingly. Furthermore, contextualizing the risk assessment tool and evaluating its usefulness in different settings is recommended.
{"title":"Disparities in the non-laboratory INTERHEART risk score and its components in selected countries of Europe and sub-Saharan Africa: Analysis from the SPICES multi-country project","authors":"Hamid Y Hassen, Steven Abrams, G. Musinguzi, Imogen Rogers, Alfred Dusabimana, P. Mphekgwana, H. Bastiaens, H. Bastiaens, Hamid Y Hassen, N. Aerts, S. Anthierens, Kathleen Van Royen, Caroline Masquillier, Jean Yves Le Reste, D. Le Goff, G. Perraud, Harm van Marwijk, Elisabeth Ford, Tom Grice-Jackson, Imogen Rogers, P. Nahar, Linda Gibson, M. Bowyer, Almighty Nkengateh, G. Musinguzi, R. Ndejjo, Fred Nuwaha, T. Sodi, P. Mphekgwana, Nancy Malema, Nancy Kgatla, T. Mothiba","doi":"10.1093/ehjopen/oead131","DOIUrl":"https://doi.org/10.1093/ehjopen/oead131","url":null,"abstract":"\u0000 \u0000 \u0000 Accurate prediction of a person’s risk of cardiovascular disease (CVD) is vital to initiate appropriate intervention. The non-laboratory INTERHEART risk score (NL-IHRS) is among the tools to estimate future risk of CVD. However, measurement disparities of the tool across contexts are not well documented. Thus, we investigated variation in NL-IHRS and components in selected sub-Saharan African and European countries.\u0000 \u0000 \u0000 \u0000 We used data from a multi-country study involving 9309 participants, i.e., 4941 in Europe, 3371 in South Africa and 997 in Uganda. Disparities in total NL-IHRS score, specific subcomponents, subcategories, and their contribution to the total score was investigated. The variation in the adjusted total and component scores were compared across contexts using analysis of variance.\u0000 \u0000 \u0000 \u0000 The adjusted mean NL-IHRS was higher in South Africa (10.2) and Europe (10.0) compared to Uganda (8.2) and the difference was statistically significant (p<0.001). The prevalence and percent contribution of diabetes mellitus and high blood pressure were lowest in Uganda. Score contribution of non-modifiable factors was lower in Uganda and South Africa, entailing 11.5% and 8.0% of the total score respectively. Contribution of behavioral factors to the total score was highest in both sub-Saharan African countries. In particular, adjusted scores related to unhealthy dietary patterns were highest in South Africa (3.21) compared to Uganda (1.66) and Europe (1.09). Whereas contribution of metabolic factors was highest in Europe (30.6%) compared with Uganda (20.8%) and South Africa (22.6%).\u0000 \u0000 \u0000 \u0000 The total risk score, subcomponents, categories, and their contribution to total score greatly varies across contexts, which could be due to disparities in risk burden and/or self-reporting bias in resource limited settings. Therefore, primary preventive initiatives should identify risk factor burden across contexts and intervention activities need to be customized accordingly. Furthermore, contextualizing the risk assessment tool and evaluating its usefulness in different settings is recommended.\u0000","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138599551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I. Dykun, A. A. Mahabadi, Stefanie Jehn, Ankur Kalra, T. Isogai, O. Wazni, Mohamad Kanj, A. Krishnaswamy, G. Reed, James J Yun, Matthias Totzeck, R. Jánosi, Alexander Y Lind, Samir R Kapadia, T. Rassaf, R. Puri
Conduction abnormalities necessitating permanent pacemaker (PPM) implantation remains the most frequent complication post-TAVI, yet reliance on PPM function varies. We evaluated the association of right-ventricular (RV)-stimulation rate post-TAVI with 1-year MACE (all-cause mortality and heart failure hospitalization). This retrospective cohort study of patients undergoing TAVI in 2 high-volume centers included patients with existing PPM pre-TAVI or new PPM post-TAVI. There was a bimodal distribution of RV-stimulation rates stratifying patients into 2 groups of either low [≤10%: 1.0 (0.0, 3.6)] or high [>10%: 96.0 (54.0, 99.9)] RV-stimulation rate post-TAVI. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated comparing MACE in patients with high vs. low RV-stimulation rates post-TAVI. From 4659 patients, 408 patients (8.6%) had an existing PPM pre-TAVI and 361 patients (7.7%) underwent PPM implantation post-TAVI. Mean age was 82.3 ± 8.1 years, 39% were women. A high RV-stimulation rate (>10%) development post-TAVI associated with a 2-fold increased risk for MACE [1.97 (1.20, 3.25), p = 0.008]. Valve implantation depth was an independent predictor of high RV-stimulation rate [odds ratio (95% CI): 1.58 (1.21, 2.06), p=<0.001] and itself associated with MACE [1.27 (1.00, 1.59), p = 0.047]. Greater RV-stimulation rates post-TAVI correlates with increased 1-year MACE in patients with new PPM post-TAVI or in those with existing PPM but low RV-stimulation rates pre-TAVI. A shallower valve implantation depth reduces the risk of greater RV-stimulation rates post-TAVI, correlating with improved patient outcomes. These data highlight the importance of a meticulous implant technique even in TAVI recipients with pre-existing PPMs.
{"title":"The Degree of Permanent Pacemaker Dependence and Clinical Outcomes Following TAVI: Implications for Procedural Technique","authors":"I. Dykun, A. A. Mahabadi, Stefanie Jehn, Ankur Kalra, T. Isogai, O. Wazni, Mohamad Kanj, A. Krishnaswamy, G. Reed, James J Yun, Matthias Totzeck, R. Jánosi, Alexander Y Lind, Samir R Kapadia, T. Rassaf, R. Puri","doi":"10.1093/ehjopen/oead127","DOIUrl":"https://doi.org/10.1093/ehjopen/oead127","url":null,"abstract":"\u0000 \u0000 \u0000 Conduction abnormalities necessitating permanent pacemaker (PPM) implantation remains the most frequent complication post-TAVI, yet reliance on PPM function varies. We evaluated the association of right-ventricular (RV)-stimulation rate post-TAVI with 1-year MACE (all-cause mortality and heart failure hospitalization).\u0000 \u0000 \u0000 \u0000 This retrospective cohort study of patients undergoing TAVI in 2 high-volume centers included patients with existing PPM pre-TAVI or new PPM post-TAVI. There was a bimodal distribution of RV-stimulation rates stratifying patients into 2 groups of either low [≤10%: 1.0 (0.0, 3.6)] or high [>10%: 96.0 (54.0, 99.9)] RV-stimulation rate post-TAVI. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated comparing MACE in patients with high vs. low RV-stimulation rates post-TAVI.\u0000 \u0000 \u0000 \u0000 From 4659 patients, 408 patients (8.6%) had an existing PPM pre-TAVI and 361 patients (7.7%) underwent PPM implantation post-TAVI. Mean age was 82.3 ± 8.1 years, 39% were women. A high RV-stimulation rate (>10%) development post-TAVI associated with a 2-fold increased risk for MACE [1.97 (1.20, 3.25), p = 0.008]. Valve implantation depth was an independent predictor of high RV-stimulation rate [odds ratio (95% CI): 1.58 (1.21, 2.06), p=<0.001] and itself associated with MACE [1.27 (1.00, 1.59), p = 0.047].\u0000 \u0000 \u0000 \u0000 Greater RV-stimulation rates post-TAVI correlates with increased 1-year MACE in patients with new PPM post-TAVI or in those with existing PPM but low RV-stimulation rates pre-TAVI. A shallower valve implantation depth reduces the risk of greater RV-stimulation rates post-TAVI, correlating with improved patient outcomes. These data highlight the importance of a meticulous implant technique even in TAVI recipients with pre-existing PPMs.\u0000","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138603910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-27eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead121
Alexander E Sullivan, Tara A Holder, Joshua A Beckman, Cynthia L Green, Manesh R Patel, Terry A Fortin, W Schuyler Jones
{"title":"Utility of electrocardiographic findings in acute pulmonary embolism.","authors":"Alexander E Sullivan, Tara A Holder, Joshua A Beckman, Cynthia L Green, Manesh R Patel, Terry A Fortin, W Schuyler Jones","doi":"10.1093/ehjopen/oead121","DOIUrl":"10.1093/ehjopen/oead121","url":null,"abstract":"","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10724117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-24eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead122
Salvatore De Rosa, Margarita Brida, Julia Grapsa, Laura Dos Subira, Magnus Bäck, Alaide Chieffo
{"title":"Women in Cardiology.","authors":"Salvatore De Rosa, Margarita Brida, Julia Grapsa, Laura Dos Subira, Magnus Bäck, Alaide Chieffo","doi":"10.1093/ehjopen/oead122","DOIUrl":"10.1093/ehjopen/oead122","url":null,"abstract":"","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10724110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-21eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead120
Ioannis Katsoularis, Hanna Jerndal, Sebastian Kalucza, Krister Lindmark, Osvaldo Fonseca-Rodríguez, Anne-Marie Fors Connolly
Aims: COVID-19 increases the risk of cardiovascular disease, especially thrombotic complications. There is less knowledge on the risk of arrhythmias after COVID-19. In this study, we aimed to quantify the risk of arrhythmias following COVID-19.
Methods and results: This study was based on national register data on all individuals in Sweden who tested positive for SARS-CoV-2 between 1 February 2020 and 25 May 2021. The outcome was incident cardiac arrhythmias, defined as international classification of diseases (10th revision) codes in the registers as follows: atrial arrhythmias; paroxysmal supraventricular tachycardias; bradyarrhythmias; and ventricular arrhythmias. A self-controlled case series study and a matched cohort study, using conditional Poisson regression, were performed to determine the incidence rate ratio and risk ratio, respectively, for an arrhythmia event following COVID-19.A total of 1 057 174 exposed (COVID-19) individuals were included in the study as well as 4 074 844 matched unexposed individuals. The incidence rate ratio of atrial tachycardias, paroxysmal supraventricular tachycardias, and bradyarrhythmias was significantly increased up to 60, 180, and 14 days after COVID-19, respectively. In the matched cohort study, the risk ratio during Days 1-30 following COVID-19/index date was 12.28 (10.79-13.96), 5.26 (3.74-7.42), and 3.36 (2.42-4.68), respectively, for the three outcomes. The risks were generally higher in older individuals, in unvaccinated individuals, and in individuals with more severe COVID-19. The risk of ventricular arrhythmias was not increased.
Conclusion: There is an increased risk of cardiac arrhythmias following COVID-19, and particularly increased in elderly vulnerable individuals, as well as in individuals with severe COVID-19.
{"title":"Risk of arrhythmias following COVID-19: nationwide self-controlled case series and matched cohort study.","authors":"Ioannis Katsoularis, Hanna Jerndal, Sebastian Kalucza, Krister Lindmark, Osvaldo Fonseca-Rodríguez, Anne-Marie Fors Connolly","doi":"10.1093/ehjopen/oead120","DOIUrl":"https://doi.org/10.1093/ehjopen/oead120","url":null,"abstract":"<p><strong>Aims: </strong>COVID-19 increases the risk of cardiovascular disease, especially thrombotic complications. There is less knowledge on the risk of arrhythmias after COVID-19. In this study, we aimed to quantify the risk of arrhythmias following COVID-19.</p><p><strong>Methods and results: </strong>This study was based on national register data on all individuals in Sweden who tested positive for SARS-CoV-2 between 1 February 2020 and 25 May 2021. The outcome was incident cardiac arrhythmias, defined as international classification of diseases (10th revision) codes in the registers as follows: atrial arrhythmias; paroxysmal supraventricular tachycardias; bradyarrhythmias; and ventricular arrhythmias. A self-controlled case series study and a matched cohort study, using conditional Poisson regression, were performed to determine the incidence rate ratio and risk ratio, respectively, for an arrhythmia event following COVID-19.A total of 1 057 174 exposed (COVID-19) individuals were included in the study as well as 4 074 844 matched unexposed individuals. The incidence rate ratio of atrial tachycardias, paroxysmal supraventricular tachycardias, and bradyarrhythmias was significantly increased up to 60, 180, and 14 days after COVID-19, respectively. In the matched cohort study, the risk ratio during Days 1-30 following COVID-19/index date was 12.28 (10.79-13.96), 5.26 (3.74-7.42), and 3.36 (2.42-4.68), respectively, for the three outcomes. The risks were generally higher in older individuals, in unvaccinated individuals, and in individuals with more severe COVID-19. The risk of ventricular arrhythmias was not increased.</p><p><strong>Conclusion: </strong>There is an increased risk of cardiac arrhythmias following COVID-19, and particularly increased in elderly vulnerable individuals, as well as in individuals with severe COVID-19.</p>","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10711544/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-19eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead119
Bente Halvorsen, Pål Aukrust, Tuva Børresdatter Dahl, Ida Gregersen
{"title":"Increased cardiovascular mortality during the COVID-19 pandemic: do not neglect causality.","authors":"Bente Halvorsen, Pål Aukrust, Tuva Børresdatter Dahl, Ida Gregersen","doi":"10.1093/ehjopen/oead119","DOIUrl":"https://doi.org/10.1093/ehjopen/oead119","url":null,"abstract":"","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10711536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-17eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead118
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
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.
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。
{"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":"10.1093/ehjopen/oead118","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":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-15eCollection Date: 2023-11-01DOI: 10.1093/ehjopen/oead117
Bart J J Velders, Michiel D Vriesendorp, Rolf H H Groenwold
We thank Diab and colleagues for raising awareness for immortal time bias (ITB) in studies on cardiosurgical treatments in the European Heart Journal. 1 The authors elaborate on ITB in research on infective endocarditis (IE) and tricuspid regurgitation (TR), stating that a prospective, intention-to-treat design is the only practical way to detect and avoid ITB. In this letter, we elaborate on the causes of ITB and outline additional methods to prevent this bias in observational studies. ITB is introduced when researchers deviate from basic principles of study design. At the start of follow-up (i.e. ‘time-zero’), treatment status should be determined and eligibility criteria should be met for all participants. For a fair comparison, time-zero
{"title":"Preventing immortal time bias in observational studies: a matter of design.","authors":"Bart J J Velders, Michiel D Vriesendorp, Rolf H H Groenwold","doi":"10.1093/ehjopen/oead117","DOIUrl":"10.1093/ehjopen/oead117","url":null,"abstract":"We thank Diab and colleagues for raising awareness for immortal time bias (ITB) in studies on cardiosurgical treatments in the European Heart Journal. 1 The authors elaborate on ITB in research on infective endocarditis (IE) and tricuspid regurgitation (TR), stating that a prospective, intention-to-treat design is the only practical way to detect and avoid ITB. In this letter, we elaborate on the causes of ITB and outline additional methods to prevent this bias in observational studies. ITB is introduced when researchers deviate from basic principles of study design. At the start of follow-up (i.e. ‘time-zero’), treatment status should be determined and eligibility criteria should be met for all participants. For a fair comparison, time-zero","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10683033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Background Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is used to reduce periprocedural complications. However, its effectiveness and safety for patients on dialysis are not well established. Aims We aimed to investigate the association of TRI with in-hospital complications in dialysis patients undergoing PCI. Methods We included 44,462 patients on dialysis who underwent PCI using Japanese nationwide PCI registry data (2019–2021) regardless of acute or chronic coronary syndrome. Patients were categorized based on access site: TRI, transfemoral intervention (TFI). Periprocedural access site bleeding complication requiring transfusion was the primary outcome and in-hospital death and other periprocedural complications were the secondary outcomes. Matched weighted analysis was performed for TRI and TFI. Results Here, 8,267 (18.6%) underwent TRI, 36,195 (81.4%) underwent TFI, . Patients who received TRI were older and had lower rates of comorbidities than those who received TFI. Access site bleeding rate and in-hospital death were significantly lower in the TRI group (0.1% versus 0.7%, P < 0.001; 1.8% versus 3.2%, P < 0.001, respectively). After adjustment, TRI was associated with a lower risk of access site bleeding (odds ratio [OR] [95% confidence interval (CI)]: 0.19 [0.099–0.38]; P < 0.001) and in-hospital death (OR [95% CI]: 0.79 [0.65–0.96]; P = 0.02). Other periprocedural complications between TRI and TFI were not significantly different. Conclusions In patients undergoing dialysis and PCI, TRI had a lower risk of access site bleeding and in-hospital death than TFI. This suggests that TRI may be safer for this patient population.
背景经桡动脉介入治疗(TRI)用于经皮冠状动脉介入治疗(PCI)可减少围手术期并发症。然而，其对透析患者的有效性和安全性尚未得到很好的证实。目的探讨行PCI的透析患者TRI与院内并发症的关系。方法:采用日本全国PCI登记数据(2019-2021)纳入44,462例接受PCI治疗的透析患者，无论急性或慢性冠状动脉综合征。根据入路位置对患者进行分类:TRI、经股介入(TFI)。围手术期通路出血并发症是主要结局，院内死亡和其他围手术期并发症是次要结局。对TRI和TFI进行匹配加权分析。结果8267例(18.6%)行TRI, 36195例(81.4%)行TFI。与接受TFI的患者相比，接受TRI的患者年龄更大，合并症发生率更低。TRI组通路部位出血率和院内死亡率显著降低(0.1% vs 0.7%， P <0.001;1.8%对3.2%，P <分别为0.001)。调整后，TRI与较低的通路部位出血风险相关(优势比[OR][95%可信区间(CI)]: 0.19 [0.099-0.38];P, lt;0.001)和院内死亡(OR [95% CI]: 0.79 [0.65-0.96];P = 0.02)。其他围手术期并发症在TRI和TFI之间无显著差异。结论在接受透析和PCI治疗的患者中，TRI发生通路部位出血和院内死亡的风险低于TFI。这表明TRI可能对这类患者更安全。
{"title":"Transradial Intervention in Dialysis Patients Undergoing Percutaneous Coronary Intervention: A Japanese Nationwide Registry Study","authors":"Toshiki Kuno, Kyohei Yamaji, Tadao Aikawa, Mitsuaki Sawano, Tomo Ando, Yohei Numasawa, Hideki Wada, Tetsuya Amano, Ken Kozuma, Shun Kohsaka","doi":"10.1093/ehjopen/oead116","DOIUrl":"https://doi.org/10.1093/ehjopen/oead116","url":null,"abstract":"Abstract Background Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is used to reduce periprocedural complications. However, its effectiveness and safety for patients on dialysis are not well established. Aims We aimed to investigate the association of TRI with in-hospital complications in dialysis patients undergoing PCI. Methods We included 44,462 patients on dialysis who underwent PCI using Japanese nationwide PCI registry data (2019–2021) regardless of acute or chronic coronary syndrome. Patients were categorized based on access site: TRI, transfemoral intervention (TFI). Periprocedural access site bleeding complication requiring transfusion was the primary outcome and in-hospital death and other periprocedural complications were the secondary outcomes. Matched weighted analysis was performed for TRI and TFI. Results Here, 8,267 (18.6%) underwent TRI, 36,195 (81.4%) underwent TFI, . Patients who received TRI were older and had lower rates of comorbidities than those who received TFI. Access site bleeding rate and in-hospital death were significantly lower in the TRI group (0.1% versus 0.7%, P &lt; 0.001; 1.8% versus 3.2%, P &lt; 0.001, respectively). After adjustment, TRI was associated with a lower risk of access site bleeding (odds ratio [OR] [95% confidence interval (CI)]: 0.19 [0.099–0.38]; P &lt; 0.001) and in-hospital death (OR [95% CI]: 0.79 [0.65–0.96]; P = 0.02). Other periprocedural complications between TRI and TFI were not significantly different. Conclusions In patients undergoing dialysis and PCI, TRI had a lower risk of access site bleeding and in-hospital death than TFI. This suggests that TRI may be safer for this patient population.","PeriodicalId":93995,"journal":{"name":"European heart journal open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134957612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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