Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device

Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous acc...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2024-10, Vol.104 (4), p.820-828
Hauptverfasser: Ali, Mahmoud, Masood, Faisal, Erickson, Lynn, Adefisoye, James, Kanani, Jim, Walczak, Sara, Ajam, Tarek, Kieu, Andy, Premjee, Mohammed, Jan, M. Fuad, Allaqaband, Suhail Q., Bajwa, Tanvir, Khitha, Jayant, Zilinski, Jodi, Jahangir, Arshad, Djelmami‐Hani, Mohamed, Sra, Jasbir, Niazi, Imran, Mortada, M. Eyman
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container_title Catheterization and cardiovascular interventions
container_volume 104
creator Ali, Mahmoud
Masood, Faisal
Erickson, Lynn
Adefisoye, James
Kanani, Jim
Walczak, Sara
Ajam, Tarek
Kieu, Andy
Premjee, Mohammed
Jan, M. Fuad
Allaqaband, Suhail Q.
Bajwa, Tanvir
Khitha, Jayant
Zilinski, Jodi
Jahangir, Arshad
Djelmami‐Hani, Mohamed
Sra, Jasbir
Niazi, Imran
Mortada, M. Eyman
description Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods In this physician‐initiated, randomized, single‐center study [clinicaltrials.gov ID: NCT04632641], single‐stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular‐related complications and mortality. Wilcoxon rank‐sum test was used to compare TTH, TTA, and TTD. Results TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p 
doi_str_mv 10.1002/ccd.31173
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Fuad ; Allaqaband, Suhail Q. ; Bajwa, Tanvir ; Khitha, Jayant ; Zilinski, Jodi ; Jahangir, Arshad ; Djelmami‐Hani, Mohamed ; Sra, Jasbir ; Niazi, Imran ; Mortada, M. Eyman</creator><creatorcontrib>Ali, Mahmoud ; Masood, Faisal ; Erickson, Lynn ; Adefisoye, James ; Kanani, Jim ; Walczak, Sara ; Ajam, Tarek ; Kieu, Andy ; Premjee, Mohammed ; Jan, M. Fuad ; Allaqaband, Suhail Q. ; Bajwa, Tanvir ; Khitha, Jayant ; Zilinski, Jodi ; Jahangir, Arshad ; Djelmami‐Hani, Mohamed ; Sra, Jasbir ; Niazi, Imran ; Mortada, M. Eyman</creatorcontrib><description>Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods In this physician‐initiated, randomized, single‐center study [clinicaltrials.gov ID: NCT04632641], single‐stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular‐related complications and mortality. Wilcoxon rank‐sum test was used to compare TTH, TTA, and TTD. Results TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p &lt; 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. Conclusion PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same‐day discharge in these patients.</description><identifier>ISSN: 1522-1946</identifier><identifier>ISSN: 1522-726X</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.31173</identifier><identifier>PMID: 39087741</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>ablation ; Aged ; Catheterization, Peripheral - adverse effects ; closure device ; Equipment Design ; Female ; Hematoma ; Hemorrhage - etiology ; Hemorrhage - prevention &amp; control ; Hemostasis ; Hemostatic Techniques - adverse effects ; Hemostatic Techniques - instrumentation ; Humans ; large bore venous access ; Length of Stay ; Male ; Middle Aged ; Mortality ; perclose proglide ; Prospective Studies ; Punctures ; Risk Factors ; SMC ; Suture Techniques - adverse effects ; Suture Techniques - instrumentation ; Sutures ; Time Factors ; Treatment Outcome ; Ultrasonography, Interventional ; Vascular Closure Devices ; Venous access</subject><ispartof>Catheterization and cardiovascular interventions, 2024-10, Vol.104 (4), p.820-828</ispartof><rights>2024 The Author(s). published by Wiley Periodicals LLC.</rights><rights>2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2783-5a748a483063c4337bdaf356088ffd68f468d3bf6ba7b6b749fb66de0c232a813</cites><orcidid>0000-0002-6067-0212 ; 0000-0002-0720-0879 ; 0000-0002-1039-9110 ; 0000-0002-0183-1063</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.31173$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.31173$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39087741$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ali, Mahmoud</creatorcontrib><creatorcontrib>Masood, Faisal</creatorcontrib><creatorcontrib>Erickson, Lynn</creatorcontrib><creatorcontrib>Adefisoye, James</creatorcontrib><creatorcontrib>Kanani, Jim</creatorcontrib><creatorcontrib>Walczak, Sara</creatorcontrib><creatorcontrib>Ajam, Tarek</creatorcontrib><creatorcontrib>Kieu, Andy</creatorcontrib><creatorcontrib>Premjee, Mohammed</creatorcontrib><creatorcontrib>Jan, M. Fuad</creatorcontrib><creatorcontrib>Allaqaband, Suhail Q.</creatorcontrib><creatorcontrib>Bajwa, Tanvir</creatorcontrib><creatorcontrib>Khitha, Jayant</creatorcontrib><creatorcontrib>Zilinski, Jodi</creatorcontrib><creatorcontrib>Jahangir, Arshad</creatorcontrib><creatorcontrib>Djelmami‐Hani, Mohamed</creatorcontrib><creatorcontrib>Sra, Jasbir</creatorcontrib><creatorcontrib>Niazi, Imran</creatorcontrib><creatorcontrib>Mortada, M. Eyman</creatorcontrib><title>Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods In this physician‐initiated, randomized, single‐center study [clinicaltrials.gov ID: NCT04632641], single‐stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular‐related complications and mortality. Wilcoxon rank‐sum test was used to compare TTH, TTA, and TTD. Results TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p &lt; 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. Conclusion PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same‐day discharge in these patients.</description><subject>ablation</subject><subject>Aged</subject><subject>Catheterization, Peripheral - adverse effects</subject><subject>closure device</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Hematoma</subject><subject>Hemorrhage - etiology</subject><subject>Hemorrhage - prevention &amp; control</subject><subject>Hemostasis</subject><subject>Hemostatic Techniques - adverse effects</subject><subject>Hemostatic Techniques - instrumentation</subject><subject>Humans</subject><subject>large bore venous access</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>perclose proglide</subject><subject>Prospective Studies</subject><subject>Punctures</subject><subject>Risk Factors</subject><subject>SMC</subject><subject>Suture Techniques - adverse effects</subject><subject>Suture Techniques - instrumentation</subject><subject>Sutures</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ultrasonography, Interventional</subject><subject>Vascular Closure Devices</subject><subject>Venous access</subject><issn>1522-1946</issn><issn>1522-726X</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc9OGzEQxq0KVP60B14AWeICUgP-F9vLLQpJQUL0QEG9WV57TBdtdoO9GxROfYKqz9gnwZDAoVJPM5r56ZtP8yG0R8kxJYSdOOePOaWKf0DbdMjYQDH5Y2Pd00LILbST0j0hpJCs-Ii2eEG0UoJuo9_XfddHwK5u00sdTbtJxLWNd4DLNg8WUDXYOgcp4cPr0XTy99ef28nF1dEpHuFoG9_OqifwX_A8tmkOrqsWgFPX-yVuA-5-AoYQKmfdEmcYJxuge10toGn79H7Yw6Jy8AltBlsn-Lyuu-hmOvk-Ph9cfvt6MR5dDhxTmg-GVgltheZEcic4V6W3gQ8l0ToEL3UQUnteBllaVcpSiSKUUnogjnFmNeW76HClm10_9JA6M6uSg7q2DWRXhhMti6EUWmT04B_0vu1jk92Z_HPBKJVCZepoRbn8hhQhmHmsZjYuDSXmJSSTQzKvIWV2f63YlzPw7-RbKhk4WQGPVQ3L_yuZ8fhsJfkMTQ6bhA</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Ali, Mahmoud</creator><creator>Masood, Faisal</creator><creator>Erickson, Lynn</creator><creator>Adefisoye, James</creator><creator>Kanani, Jim</creator><creator>Walczak, Sara</creator><creator>Ajam, Tarek</creator><creator>Kieu, Andy</creator><creator>Premjee, Mohammed</creator><creator>Jan, M. Fuad</creator><creator>Allaqaband, Suhail Q.</creator><creator>Bajwa, Tanvir</creator><creator>Khitha, Jayant</creator><creator>Zilinski, Jodi</creator><creator>Jahangir, Arshad</creator><creator>Djelmami‐Hani, Mohamed</creator><creator>Sra, Jasbir</creator><creator>Niazi, Imran</creator><creator>Mortada, M. Eyman</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6067-0212</orcidid><orcidid>https://orcid.org/0000-0002-0720-0879</orcidid><orcidid>https://orcid.org/0000-0002-1039-9110</orcidid><orcidid>https://orcid.org/0000-0002-0183-1063</orcidid></search><sort><creationdate>20241001</creationdate><title>Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device</title><author>Ali, Mahmoud ; Masood, Faisal ; Erickson, Lynn ; Adefisoye, James ; Kanani, Jim ; Walczak, Sara ; Ajam, Tarek ; Kieu, Andy ; Premjee, Mohammed ; Jan, M. Fuad ; Allaqaband, Suhail Q. ; Bajwa, Tanvir ; Khitha, Jayant ; Zilinski, Jodi ; Jahangir, Arshad ; Djelmami‐Hani, Mohamed ; Sra, Jasbir ; Niazi, Imran ; Mortada, M. Eyman</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2783-5a748a483063c4337bdaf356088ffd68f468d3bf6ba7b6b749fb66de0c232a813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>ablation</topic><topic>Aged</topic><topic>Catheterization, Peripheral - adverse effects</topic><topic>closure device</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Hematoma</topic><topic>Hemorrhage - etiology</topic><topic>Hemorrhage - prevention &amp; control</topic><topic>Hemostasis</topic><topic>Hemostatic Techniques - adverse effects</topic><topic>Hemostatic Techniques - instrumentation</topic><topic>Humans</topic><topic>large bore venous access</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>perclose proglide</topic><topic>Prospective Studies</topic><topic>Punctures</topic><topic>Risk Factors</topic><topic>SMC</topic><topic>Suture Techniques - adverse effects</topic><topic>Suture Techniques - instrumentation</topic><topic>Sutures</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ultrasonography, Interventional</topic><topic>Vascular Closure Devices</topic><topic>Venous access</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ali, Mahmoud</creatorcontrib><creatorcontrib>Masood, Faisal</creatorcontrib><creatorcontrib>Erickson, Lynn</creatorcontrib><creatorcontrib>Adefisoye, James</creatorcontrib><creatorcontrib>Kanani, Jim</creatorcontrib><creatorcontrib>Walczak, Sara</creatorcontrib><creatorcontrib>Ajam, Tarek</creatorcontrib><creatorcontrib>Kieu, Andy</creatorcontrib><creatorcontrib>Premjee, Mohammed</creatorcontrib><creatorcontrib>Jan, M. Fuad</creatorcontrib><creatorcontrib>Allaqaband, Suhail Q.</creatorcontrib><creatorcontrib>Bajwa, Tanvir</creatorcontrib><creatorcontrib>Khitha, Jayant</creatorcontrib><creatorcontrib>Zilinski, Jodi</creatorcontrib><creatorcontrib>Jahangir, Arshad</creatorcontrib><creatorcontrib>Djelmami‐Hani, Mohamed</creatorcontrib><creatorcontrib>Sra, Jasbir</creatorcontrib><creatorcontrib>Niazi, Imran</creatorcontrib><creatorcontrib>Mortada, M. Eyman</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ali, Mahmoud</au><au>Masood, Faisal</au><au>Erickson, Lynn</au><au>Adefisoye, James</au><au>Kanani, Jim</au><au>Walczak, Sara</au><au>Ajam, Tarek</au><au>Kieu, Andy</au><au>Premjee, Mohammed</au><au>Jan, M. Fuad</au><au>Allaqaband, Suhail Q.</au><au>Bajwa, Tanvir</au><au>Khitha, Jayant</au><au>Zilinski, Jodi</au><au>Jahangir, Arshad</au><au>Djelmami‐Hani, Mohamed</au><au>Sra, Jasbir</au><au>Niazi, Imran</au><au>Mortada, M. Eyman</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>104</volume><issue>4</issue><spage>820</spage><epage>828</epage><pages>820-828</pages><issn>1522-1946</issn><issn>1522-726X</issn><eissn>1522-726X</eissn><abstract>Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods In this physician‐initiated, randomized, single‐center study [clinicaltrials.gov ID: NCT04632641], single‐stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular‐related complications and mortality. Wilcoxon rank‐sum test was used to compare TTH, TTA, and TTD. Results TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p &lt; 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. Conclusion PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same‐day discharge in these patients.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>39087741</pmid><doi>10.1002/ccd.31173</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-6067-0212</orcidid><orcidid>https://orcid.org/0000-0002-0720-0879</orcidid><orcidid>https://orcid.org/0000-0002-1039-9110</orcidid><orcidid>https://orcid.org/0000-0002-0183-1063</orcidid><oa>free_for_read</oa></addata></record>
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subjects ablation
Aged
Catheterization, Peripheral - adverse effects
closure device
Equipment Design
Female
Hematoma
Hemorrhage - etiology
Hemorrhage - prevention & control
Hemostasis
Hemostatic Techniques - adverse effects
Hemostatic Techniques - instrumentation
Humans
large bore venous access
Length of Stay
Male
Middle Aged
Mortality
perclose proglide
Prospective Studies
Punctures
Risk Factors
SMC
Suture Techniques - adverse effects
Suture Techniques - instrumentation
Sutures
Time Factors
Treatment Outcome
Ultrasonography, Interventional
Vascular Closure Devices
Venous access
title Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device
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