Impact of Perioperative Levosimendan Administration on Risk of Bleeding After Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials

Background Levosimendan, a calcium sensitizer and potassium channel opener, has been demonstrated to improve myocardial function without increasing oxygen consumption and to show protective effects in other organs. Recently, a prospective, randomized controlled trial (RCT) revealed an association be...

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Veröffentlicht in:American journal of cardiovascular drugs : drugs, devices, and other interventions devices, and other interventions, 2020-04, Vol.20 (2), p.149-160
Hauptverfasser: Yan, Sen-bo, Wang, Xiao-yan, Shang, Guo-kai, Wang, Zhi-hao, Deng, Qi-ming, Song, Jia-wen, Sai, Wen-wen, Song, Ming, Zhong, Ming, Zhang, Wei
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container_issue 2
container_start_page 149
container_title American journal of cardiovascular drugs : drugs, devices, and other interventions
container_volume 20
creator Yan, Sen-bo
Wang, Xiao-yan
Shang, Guo-kai
Wang, Zhi-hao
Deng, Qi-ming
Song, Jia-wen
Sai, Wen-wen
Song, Ming
Zhong, Ming
Zhang, Wei
description Background Levosimendan, a calcium sensitizer and potassium channel opener, has been demonstrated to improve myocardial function without increasing oxygen consumption and to show protective effects in other organs. Recently, a prospective, randomized controlled trial (RCT) revealed an association between levosimendan use and a possible increased risk of bleeding postoperatively. Levosimendan’s anti-platelet effects have been shown in in vitro studies. Current studies do not provide sufficient data to support a relation between perioperative levosimendan administration and increased bleeding risk. Purpose Our goal was to investigate the relation between perioperative levosimendan administration and increased bleeding risk using a meta-analysis study design. Methods The PubMed, Ovid, EMBASE and Cochrane Library databases were searched for relevant RCTs before July 1, 2019. The outcome parameters included reoperation secondary to increased bleeding in the postoperative period, the amount of postoperative recorded blood loss, and the need for transfusion of packed red blood cells (RBCs) and other blood products. Results A total of 1160 patients in nine RCTs (576 in the levosimendan group and 584 in the control group) were included according to our inclusion criteria. Analysis showed that perioperative levosimendan administration neither increased the rate of reoperation secondary to bleeding nor increased the amount of postoperative chest tube drainage when compared with the control group. In terms of blood product transfusion, levosimendan did not influence the requirement for RBC transfusion, platelet transfusion nor fresh frozen plasma (FFP) transfusion. Levosimendan also did not shorten or prolong the aortic cross-clamp time or the cardiopulmonary bypass time. Conclusion The analyzed parameters, including reoperations due to bleeding, postoperative chest drainage and the requirement for blood products, revealed that levosimendan did not increase postoperative bleeding risk. More studies with a larger sample size are needed to address a more reliable conclusion due to study limitations.
doi_str_mv 10.1007/s40256-019-00372-2
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Recently, a prospective, randomized controlled trial (RCT) revealed an association between levosimendan use and a possible increased risk of bleeding postoperatively. Levosimendan’s anti-platelet effects have been shown in in vitro studies. Current studies do not provide sufficient data to support a relation between perioperative levosimendan administration and increased bleeding risk. Purpose Our goal was to investigate the relation between perioperative levosimendan administration and increased bleeding risk using a meta-analysis study design. Methods The PubMed, Ovid, EMBASE and Cochrane Library databases were searched for relevant RCTs before July 1, 2019. The outcome parameters included reoperation secondary to increased bleeding in the postoperative period, the amount of postoperative recorded blood loss, and the need for transfusion of packed red blood cells (RBCs) and other blood products. Results A total of 1160 patients in nine RCTs (576 in the levosimendan group and 584 in the control group) were included according to our inclusion criteria. Analysis showed that perioperative levosimendan administration neither increased the rate of reoperation secondary to bleeding nor increased the amount of postoperative chest tube drainage when compared with the control group. In terms of blood product transfusion, levosimendan did not influence the requirement for RBC transfusion, platelet transfusion nor fresh frozen plasma (FFP) transfusion. Levosimendan also did not shorten or prolong the aortic cross-clamp time or the cardiopulmonary bypass time. Conclusion The analyzed parameters, including reoperations due to bleeding, postoperative chest drainage and the requirement for blood products, revealed that levosimendan did not increase postoperative bleeding risk. More studies with a larger sample size are needed to address a more reliable conclusion due to study limitations.</description><identifier>ISSN: 1175-3277</identifier><identifier>EISSN: 1179-187X</identifier><identifier>DOI: 10.1007/s40256-019-00372-2</identifier><identifier>PMID: 31523760</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Bias ; Blood platelets ; Blood products ; Blood Transfusion ; Blood transfusions ; Cardiac Surgical Procedures - methods ; Cardiology ; Cardiotonic Agents - administration &amp; dosage ; Cardiotonic Agents - adverse effects ; Clinical trials ; Heart surgery ; Humans ; Medicine ; Medicine &amp; Public Health ; Meta-analysis ; Perioperative Care - methods ; Pharmacology/Toxicology ; Pharmacotherapy ; Postoperative Hemorrhage - epidemiology ; Randomized Controlled Trials as Topic ; Risk ; Simendan - administration &amp; dosage ; Simendan - adverse effects ; Studies ; Systematic Review</subject><ispartof>American journal of cardiovascular drugs : drugs, devices, and other interventions, 2020-04, Vol.20 (2), p.149-160</ispartof><rights>Springer Nature Switzerland AG 2019</rights><rights>Copyright Springer Nature B.V. 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Recently, a prospective, randomized controlled trial (RCT) revealed an association between levosimendan use and a possible increased risk of bleeding postoperatively. Levosimendan’s anti-platelet effects have been shown in in vitro studies. Current studies do not provide sufficient data to support a relation between perioperative levosimendan administration and increased bleeding risk. Purpose Our goal was to investigate the relation between perioperative levosimendan administration and increased bleeding risk using a meta-analysis study design. Methods The PubMed, Ovid, EMBASE and Cochrane Library databases were searched for relevant RCTs before July 1, 2019. The outcome parameters included reoperation secondary to increased bleeding in the postoperative period, the amount of postoperative recorded blood loss, and the need for transfusion of packed red blood cells (RBCs) and other blood products. Results A total of 1160 patients in nine RCTs (576 in the levosimendan group and 584 in the control group) were included according to our inclusion criteria. Analysis showed that perioperative levosimendan administration neither increased the rate of reoperation secondary to bleeding nor increased the amount of postoperative chest tube drainage when compared with the control group. In terms of blood product transfusion, levosimendan did not influence the requirement for RBC transfusion, platelet transfusion nor fresh frozen plasma (FFP) transfusion. Levosimendan also did not shorten or prolong the aortic cross-clamp time or the cardiopulmonary bypass time. Conclusion The analyzed parameters, including reoperations due to bleeding, postoperative chest drainage and the requirement for blood products, revealed that levosimendan did not increase postoperative bleeding risk. 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Recently, a prospective, randomized controlled trial (RCT) revealed an association between levosimendan use and a possible increased risk of bleeding postoperatively. Levosimendan’s anti-platelet effects have been shown in in vitro studies. Current studies do not provide sufficient data to support a relation between perioperative levosimendan administration and increased bleeding risk. Purpose Our goal was to investigate the relation between perioperative levosimendan administration and increased bleeding risk using a meta-analysis study design. Methods The PubMed, Ovid, EMBASE and Cochrane Library databases were searched for relevant RCTs before July 1, 2019. The outcome parameters included reoperation secondary to increased bleeding in the postoperative period, the amount of postoperative recorded blood loss, and the need for transfusion of packed red blood cells (RBCs) and other blood products. Results A total of 1160 patients in nine RCTs (576 in the levosimendan group and 584 in the control group) were included according to our inclusion criteria. Analysis showed that perioperative levosimendan administration neither increased the rate of reoperation secondary to bleeding nor increased the amount of postoperative chest tube drainage when compared with the control group. In terms of blood product transfusion, levosimendan did not influence the requirement for RBC transfusion, platelet transfusion nor fresh frozen plasma (FFP) transfusion. Levosimendan also did not shorten or prolong the aortic cross-clamp time or the cardiopulmonary bypass time. Conclusion The analyzed parameters, including reoperations due to bleeding, postoperative chest drainage and the requirement for blood products, revealed that levosimendan did not increase postoperative bleeding risk. More studies with a larger sample size are needed to address a more reliable conclusion due to study limitations.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>31523760</pmid><doi>10.1007/s40256-019-00372-2</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-5681-7843</orcidid></addata></record>
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subjects Bias
Blood platelets
Blood products
Blood Transfusion
Blood transfusions
Cardiac Surgical Procedures - methods
Cardiology
Cardiotonic Agents - administration & dosage
Cardiotonic Agents - adverse effects
Clinical trials
Heart surgery
Humans
Medicine
Medicine & Public Health
Meta-analysis
Perioperative Care - methods
Pharmacology/Toxicology
Pharmacotherapy
Postoperative Hemorrhage - epidemiology
Randomized Controlled Trials as Topic
Risk
Simendan - administration & dosage
Simendan - adverse effects
Studies
Systematic Review
title Impact of Perioperative Levosimendan Administration on Risk of Bleeding After Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials
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