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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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 |
format | Article |
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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 < 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 & 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 < 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 & 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 & 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 & 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 < 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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