Effective and rapid sealing of coronary, aortic and atrial suture lines †.
Identifieur interne : 000256 ( PubMed/Curation ); précédent : 000255; suivant : 000257Effective and rapid sealing of coronary, aortic and atrial suture lines †.
Auteurs : Jiri Skorpil [République tchèque] ; Alexandros Paraforos [Allemagne] ; Jiri Mandak [République tchèque] ; William E. Cohn [États-Unis] ; Tomas Hajek [République tchèque] ; Ivan Friedrich [Allemagne]Source :
- Interactive cardiovascular and thoracic surgery [ 1569-9285 ] ; 2015.
Descripteurs français
- Wicri :
- geographic : République tchèque, Allemagne.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Aortic Valve (surgery), Biocompatible Materials, Blood Loss, Surgical (prevention & control), Coronary Artery Bypass (adverse effects), Coronary Artery Bypass (mortality), Coronary Vasospasm (etiology), Czech Republic, Female, Germany, Heart Arrest (etiology), Heart Valve Prosthesis Implantation (adverse effects), Heart Valve Prosthesis Implantation (mortality), Humans, Male, Middle Aged, Postoperative Hemorrhage (prevention & control), Prospective Studies, Surgical Wound Infection (etiology), Suture Techniques (adverse effects), Suture Techniques (mortality), Time Factors, Tissue Adhesives (adverse effects), Tissue Adhesives (therapeutic use), Treatment Outcome.
- MESH :
- chemical , adverse effects : Tissue Adhesives.
- chemical , therapeutic use : Tissue Adhesives.
- chemical : Biocompatible Materials.
- geographic : Czech Republic, Germany.
- adverse effects : Coronary Artery Bypass, Heart Valve Prosthesis Implantation, Suture Techniques.
- etiology : Coronary Vasospasm, Heart Arrest, Surgical Wound Infection.
- mortality : Coronary Artery Bypass, Heart Valve Prosthesis Implantation, Suture Techniques.
- prevention & control : Blood Loss, Surgical, Postoperative Hemorrhage.
- surgery : Aortic Valve.
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome.
Abstract
Cardiac surgical procedures carry a high risk of perioperative bleeding. Surgical sealants are often used to prevent suture line bleeding. PreveLeak™ is a surgical sealant composed of bovine serum albumin, a polyaldehyde cross-linker, and other components that forms a soft, flexible, water-tight, mechanical seal that is biocompatible and bioresorbable.
DOI: 10.1093/icvts/ivv061
PubMed: 25810290
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Cohn</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Hajek, Tomas" sort="Hajek, Tomas" uniqKey="Hajek T" first="Tomas" last="Hajek">Tomas Hajek</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen</wicri:regionArea></affiliation></author><author><name sortKey="Friedrich, Ivan" sort="Friedrich, Ivan" uniqKey="Friedrich I" first="Ivan" last="Friedrich">Ivan Friedrich</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25810290</idno><idno type="pmid">25810290</idno><idno type="doi">10.1093/icvts/ivv061</idno><idno type="wicri:Area/PubMed/Corpus">000256</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000256</idno><idno type="wicri:Area/PubMed/Curation">000256</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000256</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Effective and rapid sealing of coronary, aortic and atrial suture lines †.</title><author><name sortKey="Skorpil, Jiri" sort="Skorpil, Jiri" uniqKey="Skorpil J" first="Jiri" last="Skorpil">Jiri Skorpil</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic skorpilj@fnplzen.cz.</nlm:affiliation><country wicri:rule="url">République tchèque</country><wicri:regionArea>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen</wicri:regionArea></affiliation></author><author><name sortKey="Paraforos, Alexandros" sort="Paraforos, Alexandros" uniqKey="Paraforos A" first="Alexandros" last="Paraforos">Alexandros Paraforos</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier</wicri:regionArea></affiliation></author><author><name sortKey="Mandak, Jiri" sort="Mandak, Jiri" uniqKey="Mandak J" first="Jiri" last="Mandak">Jiri Mandak</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, University Hospital of Hradec Kralove, Hradec Kralove, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Cardiac Surgery, University Hospital of Hradec Kralove, Hradec Kralove</wicri:regionArea></affiliation></author><author><name sortKey="Cohn, William E" sort="Cohn, William E" uniqKey="Cohn W" first="William E" last="Cohn">William E. Cohn</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Hajek, Tomas" sort="Hajek, Tomas" uniqKey="Hajek T" first="Tomas" last="Hajek">Tomas Hajek</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen</wicri:regionArea></affiliation></author><author><name sortKey="Friedrich, Ivan" sort="Friedrich, Ivan" uniqKey="Friedrich I" first="Ivan" last="Friedrich">Ivan Friedrich</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier</wicri:regionArea></affiliation></author></analytic><series><title level="j">Interactive cardiovascular and thoracic surgery</title><idno type="eISSN">1569-9285</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Aortic Valve (surgery)</term><term>Biocompatible Materials</term><term>Blood Loss, Surgical (prevention & control)</term><term>Coronary Artery Bypass (adverse effects)</term><term>Coronary Artery Bypass (mortality)</term><term>Coronary Vasospasm (etiology)</term><term>Czech Republic</term><term>Female</term><term>Germany</term><term>Heart Arrest (etiology)</term><term>Heart Valve Prosthesis Implantation (adverse effects)</term><term>Heart Valve Prosthesis Implantation (mortality)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Postoperative Hemorrhage (prevention & control)</term><term>Prospective Studies</term><term>Surgical Wound Infection (etiology)</term><term>Suture Techniques (adverse effects)</term><term>Suture Techniques (mortality)</term><term>Time Factors</term><term>Tissue Adhesives (adverse effects)</term><term>Tissue Adhesives (therapeutic use)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Tissue Adhesives</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Tissue Adhesives</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Biocompatible Materials</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Czech Republic</term><term>Germany</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Coronary Artery Bypass</term><term>Heart Valve Prosthesis Implantation</term><term>Suture Techniques</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Coronary Vasospasm</term><term>Heart Arrest</term><term>Surgical Wound Infection</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Coronary Artery Bypass</term><term>Heart Valve Prosthesis Implantation</term><term>Suture Techniques</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Blood Loss, Surgical</term><term>Postoperative Hemorrhage</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Aortic Valve</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>République tchèque</term><term>Allemagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Cardiac surgical procedures carry a high risk of perioperative bleeding. Surgical sealants are often used to prevent suture line bleeding. PreveLeak™ is a surgical sealant composed of bovine serum albumin, a polyaldehyde cross-linker, and other components that forms a soft, flexible, water-tight, mechanical seal that is biocompatible and bioresorbable.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25810290</PMID><DateCreated><Year>2015</Year><Month>05</Month><Day>29</Day></DateCreated><DateCompleted><Year>2016</Year><Month>03</Month><Day>10</Day></DateCompleted><DateRevised><Year>2015</Year><Month>05</Month><Day>29</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1569-9285</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>6</Issue><PubDate><Year>2015</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Interactive cardiovascular and thoracic surgery</Title><ISOAbbreviation>Interact Cardiovasc Thorac Surg</ISOAbbreviation></Journal><ArticleTitle>Effective and rapid sealing of coronary, aortic and atrial suture lines †.</ArticleTitle><Pagination><MedlinePgn>720-4; discussion 724</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/icvts/ivv061</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Cardiac surgical procedures carry a high risk of perioperative bleeding. Surgical sealants are often used to prevent suture line bleeding. PreveLeak™ is a surgical sealant composed of bovine serum albumin, a polyaldehyde cross-linker, and other components that forms a soft, flexible, water-tight, mechanical seal that is biocompatible and bioresorbable.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A prospective, multicentre study evaluated PreveLeak use in 44 subjects undergoing 63 cardiac procedures, primarily coronary artery bypass grafting (n = 23/63, 36.5%) and aortic valve replacement (n = 19/63, 30.2%). PreveLeak was applied to 127 suture lines and the time to sealing evaluated upon clamp release. The primary safety endpoint was the incidence of significant bleeding, infections, neurological deficits and immune/inflammatory allergic responses within 6 weeks post-treatment; subjects were followed for 3 months.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Immediate sealing was achieved at all sites in 42 of 44 subjects (95.5%) and 125 of 127 treatment sites (98.4%). There were nine primary safety events: eight infections and one transient neurological deficit. Most adverse events were mild (n = 46/71, 64.8%) or moderate (n = 18/71, 25.4%) in severity. One adverse event (transient vasospasm) was considered possibly sealant-related. One death occurred due to a cardiac arrest.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">PreveLeak prevented bleeding at 98.4% of treated sites and was well tolerated; adverse events were consistent with those commonly observed in subjects undergoing surgical procedures. These results compared favourably with published studies of other sealants. The observed prevention of bleeding is clinically important in cardiac surgical patients. A randomized, comparative study is justified to further evaluate PreveLeak and confirm the findings from this study.</AbstractText><CopyrightInformation>© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Skorpil</LastName><ForeName>Jiri</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic skorpilj@fnplzen.cz.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paraforos</LastName><ForeName>Alexandros</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mandak</LastName><ForeName>Jiri</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Cardiac Surgery, University Hospital of Hradec Kralove, Hradec Kralove, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cohn</LastName><ForeName>William E</ForeName><Initials>WE</Initials><AffiliationInfo><Affiliation>Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hajek</LastName><ForeName>Tomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Friedrich</LastName><ForeName>Ivan</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>03</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Interact Cardiovasc Thorac Surg</MedlineTA><NlmUniqueID>101158399</NlmUniqueID><ISSNLinking>1569-9285</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001672">Biocompatible Materials</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014014">Tissue Adhesives</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001021" MajorTopicYN="N">Aortic Valve</DescriptorName><QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001672" MajorTopicYN="Y">Biocompatible Materials</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016063" MajorTopicYN="N">Blood Loss, Surgical</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001026" MajorTopicYN="Y">Coronary Artery Bypass</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003329" MajorTopicYN="N">Coronary Vasospasm</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018153" MajorTopicYN="N" Type="Geographic">Czech Republic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005858" MajorTopicYN="N" Type="Geographic">Germany</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006323" MajorTopicYN="N">Heart Arrest</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019918" MajorTopicYN="Y">Heart Valve Prosthesis Implantation</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019106" MajorTopicYN="N">Postoperative Hemorrhage</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013530" MajorTopicYN="N">Surgical Wound Infection</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013536" MajorTopicYN="Y">Suture Techniques</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014014" MajorTopicYN="N">Tissue Adhesives</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Cardiac surgical procedures</Keyword><Keyword MajorTopicYN="N">Coronary artery bypass grafting</Keyword><Keyword MajorTopicYN="N">Sealing</Keyword><Keyword MajorTopicYN="N">Surgical sealant</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>09</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>02</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>3</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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