Pub Date : 2020-01-01DOI: 10.1177/1753944720924255
Kassandra Marsh, David Green, Veronica Raco, John Papadopoulos, Tania Ahuja
Background: Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline.
Methods: We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy.
Results: A total of 63 patients [pediatric (n = 6), adult (n = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered.
Conclusion: Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.
{"title":"Antithrombotic and hemostatic stewardship: evaluation of clinical outcomes and adverse events of recombinant factor VIIa (Novoseven<sup>®</sup>) utilization at a large academic medical center.","authors":"Kassandra Marsh, David Green, Veronica Raco, John Papadopoulos, Tania Ahuja","doi":"10.1177/1753944720924255","DOIUrl":"10.1177/1753944720924255","url":null,"abstract":"<p><strong>Background: </strong>Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline.</p><p><strong>Methods: </strong>We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy.</p><p><strong>Results: </strong>A total of 63 patients [pediatric (<i>n</i> = 6), adult (<i>n</i> = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered.</p><p><strong>Conclusion: </strong>Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720924255"},"PeriodicalIF":2.6,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f7/1f/10.1177_1753944720924255.PMC7249557.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37972465","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}
Ivabradine is a pure heart-rate lowering drug that is nowadays used, accordingly to the last ESC Guidelines, to reduce mortality and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction and in symptomatic patiens with inappropriate sinus tachycardia. Moreover, interesting effect of ivabradine on endothelial and myocardial function and on oxidative stress and inflamation pathways are progressively emerging. The aim of this paper is to highlight newer evidences about ivabradine effect (and consequently possible future application of the drug) in pathological settings different from guidelines-based clinical practice.
{"title":"Ivabradine and endothelium: an update.","authors":"Lucia Dallapellegrina, Edoardo Sciatti, Enrico Vizzardi","doi":"10.1177/1753944720934937","DOIUrl":"https://doi.org/10.1177/1753944720934937","url":null,"abstract":"<p><p>Ivabradine is a pure heart-rate lowering drug that is nowadays used, accordingly to the last ESC Guidelines, to reduce mortality and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction and in symptomatic patiens with inappropriate sinus tachycardia. Moreover, interesting effect of ivabradine on endothelial and myocardial function and on oxidative stress and inflamation pathways are progressively emerging. The aim of this paper is to highlight newer evidences about ivabradine effect (and consequently possible future application of the drug) in pathological settings different from guidelines-based clinical practice.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720934937"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720934937","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38107331","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 : 2020-01-01DOI: 10.1177/1753944720956752
{"title":"Corrigendum to <i>DUSP-1</i> gene expression is not regulated by promoter methylation in diabetes-associated cardiac hypertrophy.","authors":"","doi":"10.1177/1753944720956752","DOIUrl":"https://doi.org/10.1177/1753944720956752","url":null,"abstract":"","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720956752"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720956752","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38398882","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 : 2020-01-01DOI: 10.1177/1753944720924254
Gustavo Neves de Araujo, Tiago Luiz Luz Leiria, Mariana Vargas Furtado, Bruno da Silva Matte, Guilherme Pinheiro Machado, Ana Maria Krepsky, Luiz Carlos Corsetti Bergoli, Sandro Cadaval Goncalves, Marco Vugman Wainstein, Carisi Anne Polanczyk
Background: Despite the complexity of SYNTAX score (SS), guidelines recommend this tool to help choosing between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with left main of three-vessel coronary artery disease. The aim of this study was to compare the inter-observer variation in SS performed by clinical cardiologists (CC), interventional cardiologists (IC), and cardiac surgeons (CS).
Methods: Seven coronary angiographies from patients with left main and/or three-vessel disease chosen by a heart team were analyzed by 10 CC, 10 IC and 10 CS. SS was calculated via SYNTAX website.
Results: Kappa concordance was very low between CC and CS (k = 0.176), moderate between CS and IC (k = 0.563), and moderate between CC and IC (0.553). There was a statistically significant difference between CC, who classified more cases as low complexity (70%), and CS, who classified more cases as moderate complexity (80%) (p = 0.041).
Conclusion: Concordance between SS analyzed by CC, CS and IC is low. The usefulness of SS in decision-making of revascularization strategy is undeniable and evidence supports its use. However, this study highlights the importance of well-trained professionals on calculating the SS. It could avoid misclassification of borderline cases.
{"title":"Inter-observer variation of Syntax score among cardiac surgeons, clinical and interventional cardiologists.","authors":"Gustavo Neves de Araujo, Tiago Luiz Luz Leiria, Mariana Vargas Furtado, Bruno da Silva Matte, Guilherme Pinheiro Machado, Ana Maria Krepsky, Luiz Carlos Corsetti Bergoli, Sandro Cadaval Goncalves, Marco Vugman Wainstein, Carisi Anne Polanczyk","doi":"10.1177/1753944720924254","DOIUrl":"https://doi.org/10.1177/1753944720924254","url":null,"abstract":"<p><strong>Background: </strong>Despite the complexity of SYNTAX score (SS), guidelines recommend this tool to help choosing between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with left main of three-vessel coronary artery disease. The aim of this study was to compare the inter-observer variation in SS performed by clinical cardiologists (CC), interventional cardiologists (IC), and cardiac surgeons (CS).</p><p><strong>Methods: </strong>Seven coronary angiographies from patients with left main and/or three-vessel disease chosen by a heart team were analyzed by 10 CC, 10 IC and 10 CS. SS was calculated <i>via</i> SYNTAX website.</p><p><strong>Results: </strong>Kappa concordance was very low between CC and CS (k = 0.176), moderate between CS and IC (k = 0.563), and moderate between CC and IC (0.553). There was a statistically significant difference between CC, who classified more cases as low complexity (70%), and CS, who classified more cases as moderate complexity (80%) (<i>p</i> = 0.041).</p><p><strong>Conclusion: </strong>Concordance between SS analyzed by CC, CS and IC is low. The usefulness of SS in decision-making of revascularization strategy is undeniable and evidence supports its use. However, this study highlights the importance of well-trained professionals on calculating the SS. It could avoid misclassification of borderline cases.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720924254"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720924254","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37963232","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 : 2020-01-01DOI: 10.1177/1753944720931637
Gani Nuredini, Alec Saunders, Chakravarthi Rajkumar, Michael Okorie
White coat hypertension (WCH) is characterised by an elevated clinic blood pressure (BP) with normal ambulatory or home BP. It is well recognised in clinical practice and occurs in approximately one-third of untreated patients with elevated clinic BP. Current evidence suggests that WCH is associated with cardiovascular risk factors, including the development of sustained hypertension and the presence of target organ damage. However, its effects on cardiovascular outcomes remain a matter of debate. There is also insufficient evidence from randomised controlled trials to determine whether WCH warrants treatment. This narrative review aims to provide an update on the current understanding of WCH. It focuses on the clinical characteristics and potential implications of WCH, its relationship to cardiovascular risk and the evidence regarding treatment. Gaps in existing research are also highlighted.
{"title":"Current status of white coat hypertension: where are we?","authors":"Gani Nuredini, Alec Saunders, Chakravarthi Rajkumar, Michael Okorie","doi":"10.1177/1753944720931637","DOIUrl":"10.1177/1753944720931637","url":null,"abstract":"<p><p>White coat hypertension (WCH) is characterised by an elevated clinic blood pressure (BP) with normal ambulatory or home BP. It is well recognised in clinical practice and occurs in approximately one-third of untreated patients with elevated clinic BP. Current evidence suggests that WCH is associated with cardiovascular risk factors, including the development of sustained hypertension and the presence of target organ damage. However, its effects on cardiovascular outcomes remain a matter of debate. There is also insufficient evidence from randomised controlled trials to determine whether WCH warrants treatment. This narrative review aims to provide an update on the current understanding of WCH. It focuses on the clinical characteristics and potential implications of WCH, its relationship to cardiovascular risk and the evidence regarding treatment. Gaps in existing research are also highlighted.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720931637"},"PeriodicalIF":2.6,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/58/43/10.1177_1753944720931637.PMC7318827.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38086205","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 : 2020-01-01DOI: 10.1177/1753944720977732
Neil Ruparelia, Vasileios Panoulas
Aims: To determine whether the number of patients presenting with acute coronary syndromes has reduced during the COVID-19 pandemic.
Methods: Numbers of primary percutaneous coronary intervention (PPCI) activations, ST elevation myocardial infarctions (STEMIs) and non-ST elevation myocardial infarctions (NSTEMIs) in a large tertiary Greater London centre and a large district general hospital, both of which have on-site heart attack centres, were collected. We compared the number of PPCI activations, STEMI, NSTEMIs and all MIs prior to the COVID-19 era (January to third week of February 2020), after the start of some COVID-19 restrictions taking place (fourth week of February 2020) and after formal instruction by the United Kingdom Government that all citizens were to observe strict social distancing measures (20 March 2020). We further obtained data for the corresponding weekly figures from 2019.
Results: The average weekly figure of all myocardial infarction in 2020, prior to the COVID-19 social distancing restrictions/awareness in the UK (beginning of January to third week of February), did not differ when compared with corresponding weeks in 2019 (23.3 ± 5.4 in 2019 versus 21.13 ± 3.5, p = 0.411).With increased media reporting and associated public awareness of the threat of COVID-19 (last week of February), there was a significant reduction in all myocardial infarction (27.1 ± 4.7 in 2019 versus 15.9 ± 3.6 in 2020, p < 0.001). Following official governmental instruction that mandated strict social distancing and the 'stay at home' campaign, the weekly figures of STEMI (15 ± 3.5 in 2019 versus 10 ± 4.4 in 2020, p = 0.013), NSTEMI (13 ± 2.6 in 2019 versus 4.7 ± 2.3 in 2020, p = 0.038) and all myocardial infarction (28 ± 6.1 in 2019 versus 14.7 ± 5.7 in 2020, p = 0.008) have remained significantly reduced.
Conclusion: We have observed an unexpected major decline in presentations (and treatment) of the entire spectrum of acute coronary syndromes following the beginning of the COVID-19 pandemic and nationwide public-health measures that have promoted the importance of strict social distancing and self-quarantine.
{"title":"The missing acute coronary syndromes in the COVID-19 era.","authors":"Neil Ruparelia, Vasileios Panoulas","doi":"10.1177/1753944720977732","DOIUrl":"https://doi.org/10.1177/1753944720977732","url":null,"abstract":"<p><strong>Aims: </strong>To determine whether the number of patients presenting with acute coronary syndromes has reduced during the COVID-19 pandemic.</p><p><strong>Methods: </strong>Numbers of primary percutaneous coronary intervention (PPCI) activations, ST elevation myocardial infarctions (STEMIs) and non-ST elevation myocardial infarctions (NSTEMIs) in a large tertiary Greater London centre and a large district general hospital, both of which have on-site heart attack centres, were collected. We compared the number of PPCI activations, STEMI, NSTEMIs and all MIs prior to the COVID-19 era (January to third week of February 2020), after the start of some COVID-19 restrictions taking place (fourth week of February 2020) and after formal instruction by the United Kingdom Government that all citizens were to observe strict social distancing measures (20 March 2020). We further obtained data for the corresponding weekly figures from 2019.</p><p><strong>Results: </strong>The average weekly figure of all myocardial infarction in 2020, prior to the COVID-19 social distancing restrictions/awareness in the UK (beginning of January to third week of February), did not differ when compared with corresponding weeks in 2019 (23.3 ± 5.4 in 2019 <i>versus</i> 21.13 ± 3.5, <i>p</i> = 0.411).With increased media reporting and associated public awareness of the threat of COVID-19 (last week of February), there was a significant reduction in all myocardial infarction (27.1 ± 4.7 in 2019 <i>versus</i> 15.9 ± 3.6 in 2020, <i>p</i> < 0.001). Following official governmental instruction that mandated strict social distancing and the 'stay at home' campaign, the weekly figures of STEMI (15 ± 3.5 in 2019 <i>versus</i> 10 ± 4.4 in 2020, <i>p</i> = 0.013), NSTEMI (13 ± 2.6 in 2019 <i>versus</i> 4.7 ± 2.3 in 2020, <i>p</i> = 0.038) and all myocardial infarction (28 ± 6.1 in 2019 <i>versus</i> 14.7 ± 5.7 in 2020, <i>p</i> = 0.008) have remained significantly reduced.</p><p><strong>Conclusion: </strong>We have observed an unexpected major decline in presentations (and treatment) of the entire spectrum of acute coronary syndromes following the beginning of the COVID-19 pandemic and nationwide public-health measures that have promoted the importance of strict social distancing and self-quarantine.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720977732"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720977732","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38334346","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 : 2020-01-01DOI: 10.1177/1753944720919577
Christina Paitazoglou, Martin W Bergmann
{"title":"The atrial flow regulator: current overview on technique and first experience.","authors":"Christina Paitazoglou, Martin W Bergmann","doi":"10.1177/1753944720919577","DOIUrl":"https://doi.org/10.1177/1753944720919577","url":null,"abstract":"","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720919577"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720919577","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38418682","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 : 2020-01-01DOI: 10.1177/1753944720939383
Motoaki Sano
This review focuses on the pathogenic role of sodium glucose cotransporter (SGLT)-2 in the development of renal dysfunction and heart failure in patients with diabetes, by emphasizing the concept of reno-cardiac syndrome (kidney injury worsens cardiac condition) and by substantiating the deleterious effect of sympathetic overdrive in this context. Furthermore, the review proposes a mechanistic hypothesis to explain the benefits of SGLT2 inhibitors, specifically that SGLT-2 inhibitors reduce sympathetic activation at the renal level. To illustrate this point, several examples from both animal experiments and clinical observations are introduced. The bidirectional interaction of the heart and kidney were deeply implicated as an exacerbator of heart failure and renal failure without diabetes. Renal cortical ischemia and abnormal glucose metabolism of tubular epithelial cells are likely to exist as common pathologies in nondiabetic heart failure patients. It is no wonder why SGLT-2 inhibitors are specifically being studied even in the absence of diabetes, both for heart failure and also for renal failure.
{"title":"Sodium glucose cotransporter (SGLT)-2 inhibitors alleviate the renal stress responsible for sympathetic activation.","authors":"Motoaki Sano","doi":"10.1177/1753944720939383","DOIUrl":"https://doi.org/10.1177/1753944720939383","url":null,"abstract":"<p><p>This review focuses on the pathogenic role of sodium glucose cotransporter (SGLT)-2 in the development of renal dysfunction and heart failure in patients with diabetes, by emphasizing the concept of reno-cardiac syndrome (kidney injury worsens cardiac condition) and by substantiating the deleterious effect of sympathetic overdrive in this context. Furthermore, the review proposes a mechanistic hypothesis to explain the benefits of SGLT2 inhibitors, specifically that SGLT-2 inhibitors reduce sympathetic activation at the renal level. To illustrate this point, several examples from both animal experiments and clinical observations are introduced. The bidirectional interaction of the heart and kidney were deeply implicated as an exacerbator of heart failure and renal failure without diabetes. Renal cortical ischemia and abnormal glucose metabolism of tubular epithelial cells are likely to exist as common pathologies in nondiabetic heart failure patients. It is no wonder why SGLT-2 inhibitors are specifically being studied even in the absence of diabetes, both for heart failure and also for renal failure.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720939383"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944720939383","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38197154","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 : 2020-01-01DOI: 10.1177/1753944720912071
Javier Mariani, Andrés Rosende, Maximiliano De Abreu, Gabriel Gonzalez Villa Monte, Heraldo D'Imperio, Laura Antonietti, Gabriela Lemonnier, Alejandra de Bonis, Carlos Tajer
Background: Adherence to treatment after a myocardial infarction (MI) is poor, even in the early postinfarction period. Combining evidence-based drugs into a multicap could improve adherence in this population. No previous randomized trial assessing fixed-dose combination therapy has included patients early after a MI. We aimed to assess if a multicap containing four secondary prevention drugs increases adherence to treatment at 6 months after MI hospitalization. The study was designed as a randomized, parallel, open-label, controlled trial.
Methods: Patients were randomized within 7 days of a MI to either multicap or control group. The multicap group received a capsule containing aspirin, atenolol, ramipril, and simvastatin. The control group received each drug in separate pills. The primary outcome was adherence at 6 months. We also measured blood pressure, heart rate, serum cholesterol levels, C-reactive protein, and platelet aggregation.
Results: The study was stopped prematurely when 100 patients were included for futility. At 6 months, 92 (95.8%) patients were adherent to medical treatment: 98.0% in the multicap group and 93.5% in the control group [relative risk (RR) 1.05; 95% confidence interval (CI) 0.96-1.14; p = 0.347]. There were no differences between groups in systolic blood pressure (p = 0.662), diastolic blood pressure (p = 0.784), heart rate (p = 0.533), total cholesterol (p = 0.760), LDL-c (p = 0.979), C-reactive protein (p = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition (p = 0.600).
Conclusions: The study did not find any improvement in the adherence at 6 months after a MI with a multicap-based strategy (Multicap for Increase Adherence After Acute Myocardial Infarction; [ ClinicalTrials.gov identifier: NCT02271178]).
{"title":"Multicap to improve adherence after acute coronary syndromes: results of a randomized controlled clinical trial.","authors":"Javier Mariani, Andrés Rosende, Maximiliano De Abreu, Gabriel Gonzalez Villa Monte, Heraldo D'Imperio, Laura Antonietti, Gabriela Lemonnier, Alejandra de Bonis, Carlos Tajer","doi":"10.1177/1753944720912071","DOIUrl":"10.1177/1753944720912071","url":null,"abstract":"<p><strong>Background: </strong>Adherence to treatment after a myocardial infarction (MI) is poor, even in the early postinfarction period. Combining evidence-based drugs into a multicap could improve adherence in this population. No previous randomized trial assessing fixed-dose combination therapy has included patients early after a MI. We aimed to assess if a multicap containing four secondary prevention drugs increases adherence to treatment at 6 months after MI hospitalization. The study was designed as a randomized, parallel, open-label, controlled trial.</p><p><strong>Methods: </strong>Patients were randomized within 7 days of a MI to either multicap or control group. The multicap group received a capsule containing aspirin, atenolol, ramipril, and simvastatin. The control group received each drug in separate pills. The primary outcome was adherence at 6 months. We also measured blood pressure, heart rate, serum cholesterol levels, C-reactive protein, and platelet aggregation.</p><p><strong>Results: </strong>The study was stopped prematurely when 100 patients were included for futility. At 6 months, 92 (95.8%) patients were adherent to medical treatment: 98.0% in the multicap group and 93.5% in the control group [relative risk (RR) 1.05; 95% confidence interval (CI) 0.96-1.14; <i>p</i> = 0.347]. There were no differences between groups in systolic blood pressure (<i>p</i> = 0.662), diastolic blood pressure (<i>p</i> = 0.784), heart rate (<i>p</i> = 0.533), total cholesterol (<i>p</i> = 0.760), LDL-c (<i>p</i> = 0.979), C-reactive protein (<i>p</i> = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition (<i>p</i> = 0.600).</p><p><strong>Conclusions: </strong>The study did not find any improvement in the adherence at 6 months after a MI with a multicap-based strategy (Multicap for Increase Adherence After Acute Myocardial Infarction; [ ClinicalTrials.gov identifier: NCT02271178]).</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944720912071"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/11/52/10.1177_1753944720912071.PMC7081461.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37748631","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 : 2020-01-01DOI: 10.1177/1753944719895902
Markus W Ferrari, P Christian Schulze, Daniel Kretzschmar
Acute right heart failure is associated with impaired prognosis in cardiogenic shock. Since most pharmacological therapies are not evaluated for the failing right ventricle, or even contraindicated, there is a need for rapid minimal invasive circulatory right heart support. The PERKAT RV is such a device for acute therapy in congestive heart failure. It reduces the central venous pooling by pumping blood from the inferior vena cava into the pulmonary artery with flow rates of up to 4 litres/min. The device was evaluated in an animal model of acute pulmonary embolism after careful in vitro tests. PERKAT RV increased cardiac output by 59% in sheep suffering from acute right heart failure. We await the first human implantation in the near future. Based on the PERKAT concept, future devolvement will also focus on left heart support.
{"title":"Acute right heart failure: future perspective with the PERKAT RV pulsatile right ventricular support device.","authors":"Markus W Ferrari, P Christian Schulze, Daniel Kretzschmar","doi":"10.1177/1753944719895902","DOIUrl":"https://doi.org/10.1177/1753944719895902","url":null,"abstract":"<p><p>Acute right heart failure is associated with impaired prognosis in cardiogenic shock. Since most pharmacological therapies are not evaluated for the failing right ventricle, or even contraindicated, there is a need for rapid minimal invasive circulatory right heart support. The PERKAT RV is such a device for acute therapy in congestive heart failure. It reduces the central venous pooling by pumping blood from the inferior vena cava into the pulmonary artery with flow rates of up to 4 litres/min. The device was evaluated in an animal model of acute pulmonary embolism after careful <i>in vitro</i> tests. PERKAT RV increased cardiac output by 59% in sheep suffering from acute right heart failure. We await the first human implantation in the near future. Based on the PERKAT concept, future devolvement will also focus on left heart support.</p>","PeriodicalId":23035,"journal":{"name":"Therapeutic Advances in Cardiovascular Disease","volume":"14 ","pages":"1753944719895902"},"PeriodicalIF":2.3,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1753944719895902","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37527341","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}