Background: Cardiovascular disease remains the leading cause of death and the use of percutaneous coronary intervention (PCI) is steadily increasing. Current guidelines advocate the use of the fractional flow reserve (FFR) to assess coronary stenosis and treatment strategies; however, invasive FFR has some limitations. Angiography-derived FFR is a potential alternative for calculating FFR from two-dimensional (2D) angiographic images, thereby reducing invasiveness and complications. A novel artificial intelligence (AI)-based angiography-derived FFR, named "MPFFR," offers automated operator-independent hemodynamic calculations; this phase 3 trial aims to validate its diagnostic performance against 2D-quantitative coronary angiography (QCA).
Methods and analysis: This pivotal MPFFR trial is a prospective, multicenter, single-blind study. This trial involves patients with coronary artery disease (CAD) from eight cardiovascular centers. Invasive FFR will be performed according to standard guidelines and defined as the reference standard. Angiography-derived FFR will be computed using a proprietary method and 2D-QCA will be performed using validated software. The primary endpoint is the area under the curve for identifying physiologically significant coronary stenosis (FFR ≤0.80), with secondary endpoints including diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and correlations between angiography-derived and invasive FFR. This study is designed to demonstrate the superiority of angiography-derived FFR over 2D-QCA and is powered to achieve this with a sample size of 240 patients. Medipixel Inc. supports the trial and is not involved in the data analysis or management.
{"title":"Diagnostic performance of angiography-derived fractional flow reserve compared to pressure wire-derived fractional flow reserve: Rationale and design of MPFFR pivotal trial.","authors":"Hyun-Wook Chu, Chang-Hwan Yoon, Donghoon Han, Won-Woo Seo, Sang-Don Park, Joon Hyung Doh, Chang-Wook Nam, Eun-Seok Shin, Bon-Kwon Koo, In-Ho Chae, Tae-Jin Youn","doi":"10.1016/j.carrev.2024.09.015","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.015","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease remains the leading cause of death and the use of percutaneous coronary intervention (PCI) is steadily increasing. Current guidelines advocate the use of the fractional flow reserve (FFR) to assess coronary stenosis and treatment strategies; however, invasive FFR has some limitations. Angiography-derived FFR is a potential alternative for calculating FFR from two-dimensional (2D) angiographic images, thereby reducing invasiveness and complications. A novel artificial intelligence (AI)-based angiography-derived FFR, named \"MPFFR,\" offers automated operator-independent hemodynamic calculations; this phase 3 trial aims to validate its diagnostic performance against 2D-quantitative coronary angiography (QCA).</p><p><strong>Methods and analysis: </strong>This pivotal MPFFR trial is a prospective, multicenter, single-blind study. This trial involves patients with coronary artery disease (CAD) from eight cardiovascular centers. Invasive FFR will be performed according to standard guidelines and defined as the reference standard. Angiography-derived FFR will be computed using a proprietary method and 2D-QCA will be performed using validated software. The primary endpoint is the area under the curve for identifying physiologically significant coronary stenosis (FFR ≤0.80), with secondary endpoints including diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and correlations between angiography-derived and invasive FFR. This study is designed to demonstrate the superiority of angiography-derived FFR over 2D-QCA and is powered to achieve this with a sample size of 240 patients. Medipixel Inc. supports the trial and is not involved in the data analysis or management.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366958","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 : 2024-09-24DOI: 10.1016/j.carrev.2024.09.014
Lis Victória Ravani, Henrique Barbosa Ribeiro, Pedro Calomeni, Fábio Sandoli de Brito, Fernando Bernardi, Pedro Lemos, Fausto Feres, Dimytri Alexandre Siqueira, Ricardo Costa, Rogério Sarmento-Leite, Fernanda Mangione, José Armando Mangione, Luiz Eduardo Koenig São Thiago, Valter Correia de Lima, Adriano Dias Dourado Oliveira, Marcos Antônio Marino, Carlos José Francisco Cardoso, Paulo Ricardo Avancini Caramori, Rogério Tadeu Tumelero, Antenor Lages Fortes Portela, Maurício Lopes Prudente, Leônidas Alvarenga Henriques, Fabio Solano de Freitas Souza, Cristiano Guedes Bezerra, Guy Fernandes de Almeida Prado Junior, Leandro Zacarias Figueiredo de Freitas, Ederlon Ferreira Nogueira, George César Ximenes Meirelle, Renato Bastos Pope, Ênio Eduardo Guérios, Pedro Beraldo de Andrade, Luciano de Moura Santos, Mauricio Felippi de Sá Marchi, Vinicius Borges Cardozo Esteves, Alexandre Abizaid
Background: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain.
Methods: The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated.
Results: We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality.
Conclusions: Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.
{"title":"Clinical impact of sex differences and procedural setting in transcatheter aortic valve implantation.","authors":"Lis Victória Ravani, Henrique Barbosa Ribeiro, Pedro Calomeni, Fábio Sandoli de Brito, Fernando Bernardi, Pedro Lemos, Fausto Feres, Dimytri Alexandre Siqueira, Ricardo Costa, Rogério Sarmento-Leite, Fernanda Mangione, José Armando Mangione, Luiz Eduardo Koenig São Thiago, Valter Correia de Lima, Adriano Dias Dourado Oliveira, Marcos Antônio Marino, Carlos José Francisco Cardoso, Paulo Ricardo Avancini Caramori, Rogério Tadeu Tumelero, Antenor Lages Fortes Portela, Maurício Lopes Prudente, Leônidas Alvarenga Henriques, Fabio Solano de Freitas Souza, Cristiano Guedes Bezerra, Guy Fernandes de Almeida Prado Junior, Leandro Zacarias Figueiredo de Freitas, Ederlon Ferreira Nogueira, George César Ximenes Meirelle, Renato Bastos Pope, Ênio Eduardo Guérios, Pedro Beraldo de Andrade, Luciano de Moura Santos, Mauricio Felippi de Sá Marchi, Vinicius Borges Cardozo Esteves, Alexandre Abizaid","doi":"10.1016/j.carrev.2024.09.014","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.014","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain.</p><p><strong>Methods: </strong>The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated.</p><p><strong>Results: </strong>We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality.</p><p><strong>Conclusions: </strong>Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142373248","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}
Lately, a large number of stable ischemic patients, with no obstructed coronary arteries are being diagnosed. Despite this condition, which is being described as angina with no obstructive coronary arteries (ANOCA), was thought to be benign, recent evidence report that it is associated with increased risk for adverse cardiovascular outcomes. ANOCA is more frequent in women and, pathophysiologically, it is predominantly related with microvascular dysfunction, while other factors, such as endothelial dysfunction, inflammation and autonomic nervous system seem to also play a major role to its development, while other studies implicate ANOCA and microvascular dysfunction in the pathogenesis of heart failure with preserved ejection fraction. For establishing an ANOCA diagnosis, measurement including coronary flow reserve (CFR), microvascular resistance (IMR) and hyperemic microvascular resistance (HMR) are mostly used in clinical practice. In addition, new modalities, such as optical coherence tomography (OCT) are being tested and show promising results for future diagnostic use. Regarding management, pharmacotherapy consists of a wide selection of drugs, according to the respected pathophysiology of the disease (vasospastic angina or microvascular dysfunction), while research for new treatment options including interventional techniques, is currently ongoing. This review, therefore, aims to provide a comprehensive analysis of all aspects related to ANOCA, from pathophysiology to clinical managements, as well as clinical implications and suggestions for future research efforts, which will help advance our understanding of the syndrome and establish more, evidence-based, therapies.
{"title":"ANOCA updated: From pathophysiology to modern clinical practice.","authors":"Kyriakos Dimitriadis, Nikolaos Pyrpyris, Athanasios Sakalidis, Eirini Dri, Panagiotis Iliakis, Panagiotis Tsioufis, Fotis Tatakis, Eirini Beneki, Christos Fragkoulis, Konstantinos Aznaouridis, Konstantinos Tsioufis","doi":"10.1016/j.carrev.2024.09.010","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.010","url":null,"abstract":"<p><p>Lately, a large number of stable ischemic patients, with no obstructed coronary arteries are being diagnosed. Despite this condition, which is being described as angina with no obstructive coronary arteries (ANOCA), was thought to be benign, recent evidence report that it is associated with increased risk for adverse cardiovascular outcomes. ANOCA is more frequent in women and, pathophysiologically, it is predominantly related with microvascular dysfunction, while other factors, such as endothelial dysfunction, inflammation and autonomic nervous system seem to also play a major role to its development, while other studies implicate ANOCA and microvascular dysfunction in the pathogenesis of heart failure with preserved ejection fraction. For establishing an ANOCA diagnosis, measurement including coronary flow reserve (CFR), microvascular resistance (IMR) and hyperemic microvascular resistance (HMR) are mostly used in clinical practice. In addition, new modalities, such as optical coherence tomography (OCT) are being tested and show promising results for future diagnostic use. Regarding management, pharmacotherapy consists of a wide selection of drugs, according to the respected pathophysiology of the disease (vasospastic angina or microvascular dysfunction), while research for new treatment options including interventional techniques, is currently ongoing. This review, therefore, aims to provide a comprehensive analysis of all aspects related to ANOCA, from pathophysiology to clinical managements, as well as clinical implications and suggestions for future research efforts, which will help advance our understanding of the syndrome and establish more, evidence-based, therapies.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336978","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 : 2024-09-21DOI: 10.1016/j.carrev.2024.09.011
Ramy Sedhom, Adeba Mohammad, Mohamed Khedr, Michael Megaly, Carly Waldman, Aditya S Bharadwaj, Ofer Kobo, Ahmed Sayed, Dmitry Abramov
Objective: To examine the characteristics and outcomes of acute myocardial infarction (AMI) in patients with bleeding and/or hypercoagulable disorders.
Background: Studies examining the outcomes of AMI in bleeding/hypercoagulable disorders are scarce.
Methods: The Nationwide Readmissions Database was utilized to identify hospitalizations with AMI from 2016 to 2020. The study cohort was divided into 4 groups: (1) MI without bleeding or hypercoagulable disorders, (2) MI with bleeding disorders, (3) MI with hypercoagulable disorders and (4) MI with mixed disorders. The main outcome was all-cause in-hospital mortality.
Results: A total of 4,206,005 weighted hospitalizations with AMI were identified during the study period, of which 382,118 (9.1 %) had underlying bleeding or hypercoagulable disorders. The utilization of invasive strategies for the management of MI was highest in patients without bleeding or hypercoagulable disorders (62.6 %) and lowest in patients with mixed disorders (39.3 %). In-hospital mortality was higher among patients with bleeding (adjusted odds ratio [OR] 1.22; 95 % confidence interval [CI] 1.21, 1.24) and mixed disorders (aOR 3.38; 95 % CI 3.27, 3.49) compared with patients without bleeding or hypercoagulable disorders. Among patients with any bleeding or hypercoagulable disorder, those who underwent invasive strategy had lower adjusted odds of in-hospital mortality (aOR 0.28; 95 % CI 0.27, 0.30), ischemic stroke (aOR 0.60; 95 % CI 0.56, 0.64), bleeding (aOR 0.63; 95 % CI 0.61, 0.65), blood transfusion (aOR 0.95; 95 % CI 0.91, 0.99) and 30-day urgent readmissions (aOR 0.70; 95 % CI 0.68, 0.72).
Conclusions: The inpatient management and outcomes of AMI in patients with bleeding/hypercoagulable disorders differ from patients without those disorders. Revascularization in the setting of AMI was associated with lower in-hospital mortality, which suggests that patients with bleeding/hypercoagulable disorders can be evaluated for standard approaches to managing AMI; however, confounding by indication may be a concern.
摘要研究出血和/或高凝状态患者急性心肌梗死(AMI)的特征和预后:研究出血/高凝状态下急性心肌梗死预后的研究很少:方法:利用全国再入院数据库来识别 2016 年至 2020 年的急性心肌梗死住院患者。研究队列分为 4 组:(1) 无出血或高凝障碍的急性心肌梗死;(2) 伴有出血障碍的急性心肌梗死;(3) 伴有高凝障碍的急性心肌梗死;(4) 伴有混合障碍的急性心肌梗死。主要结果是全因住院死亡率:研究期间共发现 4,206,005 例急性心肌梗死加权住院病例,其中 382,118 例(9.1%)有潜在的出血或高凝障碍。无出血或高凝状态的患者采用侵入性方法治疗心肌梗死的比例最高(62.6%),混合型患者的比例最低(39.3%)。与无出血或高凝状态的患者相比,有出血(调整后的几率比 [OR] 1.22;95% 置信区间 [CI] 1.21,1.24)和混合型疾病(aOR 3.38;95% CI 3.27,3.49)的患者的院内死亡率更高。在有任何出血或高凝障碍的患者中,接受侵入性策略的患者院内死亡率(aOR 0.28;95 % CI 0.27,0.30)、缺血性中风(aOR 0.60; 95 % CI 0.56, 0.64)、出血(aOR 0.63; 95 % CI 0.61, 0.65)、输血(aOR 0.95; 95 % CI 0.91, 0.99)和30天紧急再入院(aOR 0.70; 95 % CI 0.68, 0.72):有出血/高凝状态的急性心肌梗死患者与无出血/高凝状态的急性心肌梗死患者的住院管理和预后不同。在AMI的情况下进行血管重建与较低的院内死亡率相关,这表明出血/高凝状态患者可接受标准方法评估,以管理AMI;然而,适应症的混淆可能是一个问题。
{"title":"Characteristics and outcomes of myocardial infarction among patients with bleeding or hypercoagulable disorders: A nationwide analysis.","authors":"Ramy Sedhom, Adeba Mohammad, Mohamed Khedr, Michael Megaly, Carly Waldman, Aditya S Bharadwaj, Ofer Kobo, Ahmed Sayed, Dmitry Abramov","doi":"10.1016/j.carrev.2024.09.011","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.011","url":null,"abstract":"<p><strong>Objective: </strong>To examine the characteristics and outcomes of acute myocardial infarction (AMI) in patients with bleeding and/or hypercoagulable disorders.</p><p><strong>Background: </strong>Studies examining the outcomes of AMI in bleeding/hypercoagulable disorders are scarce.</p><p><strong>Methods: </strong>The Nationwide Readmissions Database was utilized to identify hospitalizations with AMI from 2016 to 2020. The study cohort was divided into 4 groups: (1) MI without bleeding or hypercoagulable disorders, (2) MI with bleeding disorders, (3) MI with hypercoagulable disorders and (4) MI with mixed disorders. The main outcome was all-cause in-hospital mortality.</p><p><strong>Results: </strong>A total of 4,206,005 weighted hospitalizations with AMI were identified during the study period, of which 382,118 (9.1 %) had underlying bleeding or hypercoagulable disorders. The utilization of invasive strategies for the management of MI was highest in patients without bleeding or hypercoagulable disorders (62.6 %) and lowest in patients with mixed disorders (39.3 %). In-hospital mortality was higher among patients with bleeding (adjusted odds ratio [OR] 1.22; 95 % confidence interval [CI] 1.21, 1.24) and mixed disorders (aOR 3.38; 95 % CI 3.27, 3.49) compared with patients without bleeding or hypercoagulable disorders. Among patients with any bleeding or hypercoagulable disorder, those who underwent invasive strategy had lower adjusted odds of in-hospital mortality (aOR 0.28; 95 % CI 0.27, 0.30), ischemic stroke (aOR 0.60; 95 % CI 0.56, 0.64), bleeding (aOR 0.63; 95 % CI 0.61, 0.65), blood transfusion (aOR 0.95; 95 % CI 0.91, 0.99) and 30-day urgent readmissions (aOR 0.70; 95 % CI 0.68, 0.72).</p><p><strong>Conclusions: </strong>The inpatient management and outcomes of AMI in patients with bleeding/hypercoagulable disorders differ from patients without those disorders. Revascularization in the setting of AMI was associated with lower in-hospital mortality, which suggests that patients with bleeding/hypercoagulable disorders can be evaluated for standard approaches to managing AMI; however, confounding by indication may be a concern.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336979","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 : 2024-09-21DOI: 10.1016/j.carrev.2024.09.008
Ulver Spangsberg Lorenzen, Henrik Arendrup, Pär Ingemar Johansson, Janus Christian Jakobsen
Introduction: Coronary artery bypass graft surgery has considerable effects on patient haemostasis. Heparins as thromboprophylaxis may be beneficial but may also increase the risk of bleeding complications.
Objectives: To assess the effects of heparins on haemostasis in post-coronary artery bypass graft patients.
Methods: Across one year, we randomised 60 participants scheduled for an elective coronary artery bypass graft-procedure with or without aortic valve replacement. The trial was a prospective, open-label (though blinded for the laboratory), randomised, single-centre trial with three intervention groups (n = 20 in each): group 1 received acetylsalicylic acid, group 2 received subcutaneous low molecular weight heparin and acetylsalicylic acid, and group 3 received intravenous unfractionated heparin and acetylsalicylic acid. Primary outcomes were platelet activation (Multiplate® ASPI-test) and time to clot initiation (TEG® R-time). We secondly assessed several additional Multiplate® and TEG® parameters.
Results: Group 3 (intravenous unfractionated heparin) compared with group 1 (acetylsalicylic acid alone) showed evidence of 1) increased clot initiation time (R-time + 0.9 min; 95 % CI: +0.4 to +1.4 min; P = 0.009), and 2) decreased 30-min lysis (-1.3 %; 95 % CI: -2.1 to -0.5 %; P = 0.02). The remaining analyses of primary and secondary outcomes showed no evidence of a difference between the three groups.
Discussion: Intravenous unfractionated heparins may increase the clot initiation time post-operatively after coronary artery bypass graft surgery and reduce lysis. Otherwise, there seems to be no effect of low molecular weight or unfractionated heparin on haemostatic parameters after coronary artery bypass surgery patients.
{"title":"Acetylsalicylic acid alone or in combination with either enoxaparin or unfractionated heparin for postoperative thromboprophylaxis in coronary artery bypass surgery patients. A randomised clinical trial assessing surrogate outcomes.","authors":"Ulver Spangsberg Lorenzen, Henrik Arendrup, Pär Ingemar Johansson, Janus Christian Jakobsen","doi":"10.1016/j.carrev.2024.09.008","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.008","url":null,"abstract":"<p><strong>Introduction: </strong>Coronary artery bypass graft surgery has considerable effects on patient haemostasis. Heparins as thromboprophylaxis may be beneficial but may also increase the risk of bleeding complications.</p><p><strong>Objectives: </strong>To assess the effects of heparins on haemostasis in post-coronary artery bypass graft patients.</p><p><strong>Methods: </strong>Across one year, we randomised 60 participants scheduled for an elective coronary artery bypass graft-procedure with or without aortic valve replacement. The trial was a prospective, open-label (though blinded for the laboratory), randomised, single-centre trial with three intervention groups (n = 20 in each): group 1 received acetylsalicylic acid, group 2 received subcutaneous low molecular weight heparin and acetylsalicylic acid, and group 3 received intravenous unfractionated heparin and acetylsalicylic acid. Primary outcomes were platelet activation (Multiplate® ASPI-test) and time to clot initiation (TEG® R-time). We secondly assessed several additional Multiplate® and TEG® parameters.</p><p><strong>Results: </strong>Group 3 (intravenous unfractionated heparin) compared with group 1 (acetylsalicylic acid alone) showed evidence of 1) increased clot initiation time (R-time + 0.9 min; 95 % CI: +0.4 to +1.4 min; P = 0.009), and 2) decreased 30-min lysis (-1.3 %; 95 % CI: -2.1 to -0.5 %; P = 0.02). The remaining analyses of primary and secondary outcomes showed no evidence of a difference between the three groups.</p><p><strong>Discussion: </strong>Intravenous unfractionated heparins may increase the clot initiation time post-operatively after coronary artery bypass graft surgery and reduce lysis. Otherwise, there seems to be no effect of low molecular weight or unfractionated heparin on haemostatic parameters after coronary artery bypass surgery patients.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336977","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 : 2024-09-19DOI: 10.1016/j.carrev.2024.09.007
Michael Yang, Grace C Bloomfield, Brian C Case, Lowell F Satler, Ron Waksman, Itsik Ben-Dor
Background: Anomalous coronary arteries (ACA) are seen in 1-5 % of patients undergoing coronary angiography, and their presence may increase procedural difficulty. We aimed to compare procedural outcomes of coronary angiography in ACA patients by anatomy and prior knowledge of the ACA.
Methods: This was a single-center review of ACA patients undergoing coronary angiography between October 2013 and February 2022. Primary endpoints were contrast volume, fluoroscopy dose, time, and dose-area product (DAP). Comparisons were made between groups based on ACA anatomy and based on prior knowledge of the ACA.
Results: We found 176 diagnostic coronary angiograms among ACA patients. Anomalies of the right coronary artery (RCA) comprised 77 %, followed by left circumflex (LCX) at 16 % and left main or left anterior descending (LMCA/LAD) at 7 %. There was significantly more contrast use among patients with RCA (mean 110.5 mL) or LMCA/LAD (115.6 mL) anomalies than LCX (76.2 mL; p = 0.01). There was no difference in fluoroscopy dose, time, or DAP. Prior knowledge of the anomaly was recorded in 61 (35 %) cases. Contrast volume (mean difference 27.1 mL, 95 % confidence interval: 12.5-41.8) and all fluoroscopy measures decreased if the ACA was previously known to the operators.
Conclusion: Different types of ACAs are associated with increased contrast use but not fluoroscopy exposure. Prior knowledge of ACA is associated with decreased contrast use and fluoroscopy exposure. Thorough review of prior catheterizations and knowledge of catheter selection is important for reducing contrast use and fluoroscopy exposure in patients with ACA.
{"title":"Procedural characteristics of coronary angiography in patients with anomalous aortic origin of a coronary artery.","authors":"Michael Yang, Grace C Bloomfield, Brian C Case, Lowell F Satler, Ron Waksman, Itsik Ben-Dor","doi":"10.1016/j.carrev.2024.09.007","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.007","url":null,"abstract":"<p><strong>Background: </strong>Anomalous coronary arteries (ACA) are seen in 1-5 % of patients undergoing coronary angiography, and their presence may increase procedural difficulty. We aimed to compare procedural outcomes of coronary angiography in ACA patients by anatomy and prior knowledge of the ACA.</p><p><strong>Methods: </strong>This was a single-center review of ACA patients undergoing coronary angiography between October 2013 and February 2022. Primary endpoints were contrast volume, fluoroscopy dose, time, and dose-area product (DAP). Comparisons were made between groups based on ACA anatomy and based on prior knowledge of the ACA.</p><p><strong>Results: </strong>We found 176 diagnostic coronary angiograms among ACA patients. Anomalies of the right coronary artery (RCA) comprised 77 %, followed by left circumflex (LCX) at 16 % and left main or left anterior descending (LMCA/LAD) at 7 %. There was significantly more contrast use among patients with RCA (mean 110.5 mL) or LMCA/LAD (115.6 mL) anomalies than LCX (76.2 mL; p = 0.01). There was no difference in fluoroscopy dose, time, or DAP. Prior knowledge of the anomaly was recorded in 61 (35 %) cases. Contrast volume (mean difference 27.1 mL, 95 % confidence interval: 12.5-41.8) and all fluoroscopy measures decreased if the ACA was previously known to the operators.</p><p><strong>Conclusion: </strong>Different types of ACAs are associated with increased contrast use but not fluoroscopy exposure. Prior knowledge of ACA is associated with decreased contrast use and fluoroscopy exposure. Thorough review of prior catheterizations and knowledge of catheter selection is important for reducing contrast use and fluoroscopy exposure in patients with ACA.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336996","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 : 2024-09-19DOI: 10.1016/j.carrev.2024.09.009
Reza Masoomi, Lorenzo Azzalini, Kathleen E Kearney, William L Lombardi
{"title":"Rota-Sesame technique for chronic total occlusion percutaneous coronary intervention.","authors":"Reza Masoomi, Lorenzo Azzalini, Kathleen E Kearney, William L Lombardi","doi":"10.1016/j.carrev.2024.09.009","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.009","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336997","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 : 2024-09-19DOI: 10.1016/j.carrev.2024.09.004
A Di Molfetta, V Cusimano, M Cesario, P Mollo, G Di Ruzza, M Menichelli
Background: Literature reports a 20 % discordance between hyperemic (FFR) and non-hyperemic indexes (NHi) of coronary stenosis lesions. This work aims to develop and test clinically, a formula relating FFR and NHi (including iFR, RFR and Pd/Pa) to study their discordance.
Methods: We conducted a prospective, single-center, clinical study enrolling all patients undergoing full coronary physiology assessment with Coroventis CoroFlow Cardiovascular System (Abbott Vascular, St. Paul, Minnesota) to validate the developed formula: [Formula: see text] where IMR(BMR) is the hyperemic (basal) microvascular resistance and HSR(BSR) is the hyperemic (basal) stenosis resistance.
Results: A total of 51 patients were enrolled, 72 % male, average age 67.4 ± 8.9. Mean hemodynamic data were: FFR 0.87 ± 0.07, iFR 0.93 ± 0.05, RFR 0.91 ± 0.05, Pd/Pa 0.92 ± 0.05, BMR 76.6 ± 51.6 mmHg*s, IMR 28.4 ± 22.8 mmHg*s, BSR 5.5 ± 4.7 mmHg, HSR 3.8 ± 2.9 mmHg*s, coronary flow reserve (CFR) 2.9 ± 1.6, resistive reserve ratio (RRR) 3.3 ± 2.0. Lin's Concordance and Bland Altman analysis showed an optimal correlation between measured and estimated data. Sensitivity analysis showed that: (1) FFR can underestimate epicardial stenosis severity leading to FFR- vs NHi + discordance in case of elevated IMR, (2) NHi can overestimate epicardial stenosis severity leading to FFR- vs NHi + in the case of low BMR, (3) if BSR > HSR, FFR- vs NHi + discordance can occur, while if BSR < HSR, FFR+ vs NHi- discordance can occur.
Conclusion: (1) NHi can be more reliable in case of elevated IMR; (2) FFR-CFR combination can be more reliable for low BMR occurring to compensate an epicardial stenosis; (3) NHi-CFR combination can be more reliable when BSR > HSR, while FFR-CFR combination can be more reliable when BSR < HSR. The combination between pressure and flow indexes (FFR-CFR or NHi-CFR) is more reliable when compensatory mechanisms occur.
{"title":"Hyperemic vs non-hyperemic indexes discordance: Role of epicardial and microvascular resistance (HyperDisco Study).","authors":"A Di Molfetta, V Cusimano, M Cesario, P Mollo, G Di Ruzza, M Menichelli","doi":"10.1016/j.carrev.2024.09.004","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.004","url":null,"abstract":"<p><strong>Background: </strong>Literature reports a 20 % discordance between hyperemic (FFR) and non-hyperemic indexes (NHi) of coronary stenosis lesions. This work aims to develop and test clinically, a formula relating FFR and NHi (including iFR, RFR and Pd/Pa) to study their discordance.</p><p><strong>Methods: </strong>We conducted a prospective, single-center, clinical study enrolling all patients undergoing full coronary physiology assessment with Coroventis CoroFlow Cardiovascular System (Abbott Vascular, St. Paul, Minnesota) to validate the developed formula: [Formula: see text] where IMR(BMR) is the hyperemic (basal) microvascular resistance and HSR(BSR) is the hyperemic (basal) stenosis resistance.</p><p><strong>Results: </strong>A total of 51 patients were enrolled, 72 % male, average age 67.4 ± 8.9. Mean hemodynamic data were: FFR 0.87 ± 0.07, iFR 0.93 ± 0.05, RFR 0.91 ± 0.05, Pd/Pa 0.92 ± 0.05, BMR 76.6 ± 51.6 mmHg*s, IMR 28.4 ± 22.8 mmHg*s, BSR 5.5 ± 4.7 mmHg, HSR 3.8 ± 2.9 mmHg*s, coronary flow reserve (CFR) 2.9 ± 1.6, resistive reserve ratio (RRR) 3.3 ± 2.0. Lin's Concordance and Bland Altman analysis showed an optimal correlation between measured and estimated data. Sensitivity analysis showed that: (1) FFR can underestimate epicardial stenosis severity leading to FFR- vs NHi + discordance in case of elevated IMR, (2) NHi can overestimate epicardial stenosis severity leading to FFR- vs NHi + in the case of low BMR, (3) if BSR > HSR, FFR- vs NHi + discordance can occur, while if BSR < HSR, FFR+ vs NHi- discordance can occur.</p><p><strong>Conclusion: </strong>(1) NHi can be more reliable in case of elevated IMR; (2) FFR-CFR combination can be more reliable for low BMR occurring to compensate an epicardial stenosis; (3) NHi-CFR combination can be more reliable when BSR > HSR, while FFR-CFR combination can be more reliable when BSR < HSR. The combination between pressure and flow indexes (FFR-CFR or NHi-CFR) is more reliable when compensatory mechanisms occur.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336994","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}
Background: Few randomized clinical trials have evaluated the safety and efficacy of abbreviated ticagrelor based dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS); however, these trials were underpowered to detect differences in hard clinical outcomes.
Methods: A systematic search of MEDLINE, Cochrane, and Scopus databases was performed through June 2024, for trials that compared abbreviated (≤3-months) versus standard 12-months ticagrelor based DAPT in ACS. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and major bleeding. Endpoints were measured at 12-months after DAPT initiation. Data were pooled using random-effects model. Effect measure utilized was risk ratio (RR). Heterogeneity was assessed via Chi-squared and Higgin's I2 test. RevMan 5.0 (Cochrane Collaboration, Oxford, United Kingdom) was utilized to perform statistical analysis.
Results: Five trials were included in this analysis with 21,407 patients assessed. ULTIMATE-DAPT, T-PASS, and GLOBAL LEADERS-ACS assessed 1-month DAPT duration while TICO and TWILIGHT-ACS assessed 3-months DAPT duration. The average age was 62.7 years and 22.7 % were women. ACS presentations included non-ST elevation myocardial infarction (40.1 %), unstable angina (35.2 %), and ST-segment elevation myocardial infarction (31.5 %). Abbreviated ticagrelor based DAPT was associated with lower risk of all-cause mortality (RR 0.78; 95 % Confidence Interval (CI) 0.62-0.98, I2 = 0 %) compared with standard duration DAPT. There was no difference between groups in cardiovascular death (RR 0.65; 95 % CI 0.41-1.03, I2 = 0 %), myocardial infarction (RR 1.04; 95 % CI 0.85-1.27, I2 = 0 %), stent thrombosis (RR 0.97; 95 % CI 0.64-1.45, I2 = 0 %), or ischemic stroke (RR 0.90; 95 % CI 0.62-1.30, I2 = 0 %). Abbreviated DAPT was associated with lower risk of major bleeding (RR 0.50; 95 % CI 0.38-0.66, I2 = 46 %).
Conclusion: Our analysis includes the totality of randomized data evaluating the merits of abbreviated ticagrelor based DAPT after ACS. The salient study finding was the observed reduced risk of all-cause mortality and major bleeding with abbreviated DAPT approach.
{"title":"Abbreviated ticagrelor based dual antiplatelet therapy in acute coronary syndrome: A systematic review and meta-analysis.","authors":"Wissam Harmouch, Ravi Thakker, Mirza Umair Khalid, Wissam Khalife, Neal Kleiman, Umamahesh Rangasetty, Waleed Tallat Kayani, Hani Jneid, Bashar Al-Hemyari, Ayman Elbadawi","doi":"10.1016/j.carrev.2024.09.005","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.005","url":null,"abstract":"<p><strong>Background: </strong>Few randomized clinical trials have evaluated the safety and efficacy of abbreviated ticagrelor based dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS); however, these trials were underpowered to detect differences in hard clinical outcomes.</p><p><strong>Methods: </strong>A systematic search of MEDLINE, Cochrane, and Scopus databases was performed through June 2024, for trials that compared abbreviated (≤3-months) versus standard 12-months ticagrelor based DAPT in ACS. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and major bleeding. Endpoints were measured at 12-months after DAPT initiation. Data were pooled using random-effects model. Effect measure utilized was risk ratio (RR). Heterogeneity was assessed via Chi-squared and Higgin's I<sup>2</sup> test. RevMan 5.0 (Cochrane Collaboration, Oxford, United Kingdom) was utilized to perform statistical analysis.</p><p><strong>Results: </strong>Five trials were included in this analysis with 21,407 patients assessed. ULTIMATE-DAPT, T-PASS, and GLOBAL LEADERS-ACS assessed 1-month DAPT duration while TICO and TWILIGHT-ACS assessed 3-months DAPT duration. The average age was 62.7 years and 22.7 % were women. ACS presentations included non-ST elevation myocardial infarction (40.1 %), unstable angina (35.2 %), and ST-segment elevation myocardial infarction (31.5 %). Abbreviated ticagrelor based DAPT was associated with lower risk of all-cause mortality (RR 0.78; 95 % Confidence Interval (CI) 0.62-0.98, I<sup>2</sup> = 0 %) compared with standard duration DAPT. There was no difference between groups in cardiovascular death (RR 0.65; 95 % CI 0.41-1.03, I<sup>2</sup> = 0 %), myocardial infarction (RR 1.04; 95 % CI 0.85-1.27, I<sup>2</sup> = 0 %), stent thrombosis (RR 0.97; 95 % CI 0.64-1.45, I<sup>2</sup> = 0 %), or ischemic stroke (RR 0.90; 95 % CI 0.62-1.30, I<sup>2</sup> = 0 %). Abbreviated DAPT was associated with lower risk of major bleeding (RR 0.50; 95 % CI 0.38-0.66, I<sup>2</sup> = 46 %).</p><p><strong>Conclusion: </strong>Our analysis includes the totality of randomized data evaluating the merits of abbreviated ticagrelor based DAPT after ACS. The salient study finding was the observed reduced risk of all-cause mortality and major bleeding with abbreviated DAPT approach.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142336976","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 : 2024-09-18DOI: 10.1016/j.carrev.2024.09.002
Robert S Zhang, Norma Keller, Eugene Yuriditsky, Eric Bailey, Lindsay Elbaum, Orly Leiva, Allison A Greco, Radu Postelnicu, Vincent Li, Kerry M Hena, Vikramjit Mukherjee, Sylvie F Hall, Carlos L Alviar, Sripal Bangalore
Introduction: This study explores the implementation and outcomes of catheter-based thrombectomy (CBT) for acute pulmonary embolism (PE) within a safety-net hospital (SNH), addressing a critical gap in the literature concerning CBT in underserved and vulnerable populations.
Methods: This is a retrospective study of patients undergoing CBT between October 2020 and January 2024 at a SNH. The primary outcome was 30-day all-cause mortality.
Results: A total of 107 patients (47.6 % female, mean age 58.4 years) underwent CBT for acute PE, with 23 (21.5 %) high-risk and 84 (78.5 %) intermediate-risk PE. Demographically, 64 % identified as Black, 10 % White, 19 % Hispanic or Latino, and 5 % Asian. In terms of insurance coverage, 50 % had private insurance or Medicare, 36 % had Medicaid, and 14 % were uninsured. Notably, 67 % of the patients resided in high poverty rate zip codes and 11 % were non-citizen non-residents. Over a median follow up period of 30 days, 6 (5.6 %) patients expired (all high-risk PE), 3 of whom presented with cardiac arrest. No patients who presented with intermediate-risk PE died at 30 days. There was no difference in 30-day mortality based on race, insurance type, poverty level or citizenship status.
Conclusion: Our study findings reveal no disparities in access or outcomes to CBT at our SNH, emphasizing the feasibility and success of implementing PERT and CBT at a SNH, offering a potential model to address healthcare disparities in acute PE on a broader scale.
{"title":"Mitigating health disparities by improving access to catheter-based therapies for vulnerable patients with acute pulmonary embolism.","authors":"Robert S Zhang, Norma Keller, Eugene Yuriditsky, Eric Bailey, Lindsay Elbaum, Orly Leiva, Allison A Greco, Radu Postelnicu, Vincent Li, Kerry M Hena, Vikramjit Mukherjee, Sylvie F Hall, Carlos L Alviar, Sripal Bangalore","doi":"10.1016/j.carrev.2024.09.002","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.09.002","url":null,"abstract":"<p><strong>Introduction: </strong>This study explores the implementation and outcomes of catheter-based thrombectomy (CBT) for acute pulmonary embolism (PE) within a safety-net hospital (SNH), addressing a critical gap in the literature concerning CBT in underserved and vulnerable populations.</p><p><strong>Methods: </strong>This is a retrospective study of patients undergoing CBT between October 2020 and January 2024 at a SNH. The primary outcome was 30-day all-cause mortality.</p><p><strong>Results: </strong>A total of 107 patients (47.6 % female, mean age 58.4 years) underwent CBT for acute PE, with 23 (21.5 %) high-risk and 84 (78.5 %) intermediate-risk PE. Demographically, 64 % identified as Black, 10 % White, 19 % Hispanic or Latino, and 5 % Asian. In terms of insurance coverage, 50 % had private insurance or Medicare, 36 % had Medicaid, and 14 % were uninsured. Notably, 67 % of the patients resided in high poverty rate zip codes and 11 % were non-citizen non-residents. Over a median follow up period of 30 days, 6 (5.6 %) patients expired (all high-risk PE), 3 of whom presented with cardiac arrest. No patients who presented with intermediate-risk PE died at 30 days. There was no difference in 30-day mortality based on race, insurance type, poverty level or citizenship status.</p><p><strong>Conclusion: </strong>Our study findings reveal no disparities in access or outcomes to CBT at our SNH, emphasizing the feasibility and success of implementing PERT and CBT at a SNH, offering a potential model to address healthcare disparities in acute PE on a broader scale.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366959","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}