A randomized comparison of modified subcutaneous “Z”‐stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal

Objectives To compare subcutaneous “Z”‐stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. Background Structural interventions increasingly require large caliber venous access, for which convenient, safe, and ef...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2018-01, Vol.91 (1), p.105-112
Hauptverfasser: Pracon, Radoslaw, Bangalore, Sripal, Henzel, Jan, Cendrowska‐Demkow, Iwona, Pregowska‐Chwala, Barbara, Tarnowska, Agnieszka, Dzielinska, Zofia, Chmielak, Zbigniew, Witkowski, Adam, Demkow, Marcin
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container_title Catheterization and cardiovascular interventions
container_volume 91
creator Pracon, Radoslaw
Bangalore, Sripal
Henzel, Jan
Cendrowska‐Demkow, Iwona
Pregowska‐Chwala, Barbara
Tarnowska, Agnieszka
Dzielinska, Zofia
Chmielak, Zbigniew
Witkowski, Adam
Demkow, Marcin
description Objectives To compare subcutaneous “Z”‐stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. Background Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. “Z”‐stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. Methods This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the “Z”‐stitch or manual compression for hemostasis in a 2:1 fashion. There were three co‐primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler‐Duplex was performed with the stitch in place and after its removal. Results 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10–22 F). Patients randomized to “Z”‐stitch achieved hemostasis quicker [
doi_str_mv 10.1002/ccd.27003
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Background Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. “Z”‐stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. Methods This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the “Z”‐stitch or manual compression for hemostasis in a 2:1 fashion. There were three co‐primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler‐Duplex was performed with the stitch in place and after its removal. Results 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10–22 F). Patients randomized to “Z”‐stitch achieved hemostasis quicker [&lt;1 min vs. 12.0 (IQR 10.0–15.0) min, P &lt; 0.001] and ambulated sooner [7.0 (IQR 4.0–12.0) vs. 16.0 (IQR 11.8–20.3) hr post procedure, P &lt; 0.001] when compared with manual compression alone. The “Z”‐stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09–0.76, P = 0.01). All imaged veins were patent before and after stitch removal. Conclusions The “Z”‐stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. © 2017 Wiley Periodicals, Inc.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.27003</identifier><identifier>PMID: 28303670</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; bleeding ; Catheterization, Peripheral - adverse effects ; Catheterization, Peripheral - instrumentation ; Catheters ; Comparative Effectiveness Research ; Complications ; Compression ; Compression therapy ; Equipment Design ; Female ; Femoral Vein - diagnostic imaging ; Femoral Vein - physiopathology ; Femur ; Hemorrhage ; Hemorrhage - etiology ; Hemorrhage - prevention &amp; control ; Hemostasis ; Hemostatic Techniques - adverse effects ; Hemostatics ; Humans ; Male ; Middle Aged ; Poland ; Pressure ; Prospective Studies ; Punctures ; Randomization ; Sheaths ; structural heart disease intervention ; Suture Techniques - adverse effects ; Time Factors ; Treatment Outcome ; vascular access ; Vascular Access Devices ; Vascular Patency</subject><ispartof>Catheterization and cardiovascular interventions, 2018-01, Vol.91 (1), p.105-112</ispartof><rights>2017 Wiley Periodicals, Inc.</rights><rights>2018 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3533-150336c2fea192510e9d89e391bccdd35479f7e878c1feaf6ccc4d81941bf7733</citedby><cites>FETCH-LOGICAL-c3533-150336c2fea192510e9d89e391bccdd35479f7e878c1feaf6ccc4d81941bf7733</cites><orcidid>0000-0001-7519-0003</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.27003$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.27003$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28303670$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pracon, Radoslaw</creatorcontrib><creatorcontrib>Bangalore, Sripal</creatorcontrib><creatorcontrib>Henzel, Jan</creatorcontrib><creatorcontrib>Cendrowska‐Demkow, Iwona</creatorcontrib><creatorcontrib>Pregowska‐Chwala, Barbara</creatorcontrib><creatorcontrib>Tarnowska, Agnieszka</creatorcontrib><creatorcontrib>Dzielinska, Zofia</creatorcontrib><creatorcontrib>Chmielak, Zbigniew</creatorcontrib><creatorcontrib>Witkowski, Adam</creatorcontrib><creatorcontrib>Demkow, Marcin</creatorcontrib><title>A randomized comparison of modified subcutaneous “Z”‐stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives To compare subcutaneous “Z”‐stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. Background Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. “Z”‐stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. Methods This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the “Z”‐stitch or manual compression for hemostasis in a 2:1 fashion. There were three co‐primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler‐Duplex was performed with the stitch in place and after its removal. Results 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10–22 F). Patients randomized to “Z”‐stitch achieved hemostasis quicker [&lt;1 min vs. 12.0 (IQR 10.0–15.0) min, P &lt; 0.001] and ambulated sooner [7.0 (IQR 4.0–12.0) vs. 16.0 (IQR 11.8–20.3) hr post procedure, P &lt; 0.001] when compared with manual compression alone. The “Z”‐stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09–0.76, P = 0.01). All imaged veins were patent before and after stitch removal. Conclusions The “Z”‐stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. © 2017 Wiley Periodicals, Inc.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>bleeding</subject><subject>Catheterization, Peripheral - adverse effects</subject><subject>Catheterization, Peripheral - instrumentation</subject><subject>Catheters</subject><subject>Comparative Effectiveness Research</subject><subject>Complications</subject><subject>Compression</subject><subject>Compression therapy</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Femoral Vein - diagnostic imaging</subject><subject>Femoral Vein - physiopathology</subject><subject>Femur</subject><subject>Hemorrhage</subject><subject>Hemorrhage - etiology</subject><subject>Hemorrhage - prevention &amp; 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Bangalore, Sripal ; Henzel, Jan ; Cendrowska‐Demkow, Iwona ; Pregowska‐Chwala, Barbara ; Tarnowska, Agnieszka ; Dzielinska, Zofia ; Chmielak, Zbigniew ; Witkowski, Adam ; Demkow, Marcin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3533-150336c2fea192510e9d89e391bccdd35479f7e878c1feaf6ccc4d81941bf7733</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>bleeding</topic><topic>Catheterization, Peripheral - adverse effects</topic><topic>Catheterization, Peripheral - instrumentation</topic><topic>Catheters</topic><topic>Comparative Effectiveness Research</topic><topic>Complications</topic><topic>Compression</topic><topic>Compression therapy</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Femoral Vein - diagnostic imaging</topic><topic>Femoral Vein - physiopathology</topic><topic>Femur</topic><topic>Hemorrhage</topic><topic>Hemorrhage - etiology</topic><topic>Hemorrhage - prevention &amp; control</topic><topic>Hemostasis</topic><topic>Hemostatic Techniques - adverse effects</topic><topic>Hemostatics</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Poland</topic><topic>Pressure</topic><topic>Prospective Studies</topic><topic>Punctures</topic><topic>Randomization</topic><topic>Sheaths</topic><topic>structural heart disease intervention</topic><topic>Suture Techniques - adverse effects</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>vascular access</topic><topic>Vascular Access Devices</topic><topic>Vascular Patency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pracon, Radoslaw</creatorcontrib><creatorcontrib>Bangalore, Sripal</creatorcontrib><creatorcontrib>Henzel, Jan</creatorcontrib><creatorcontrib>Cendrowska‐Demkow, Iwona</creatorcontrib><creatorcontrib>Pregowska‐Chwala, Barbara</creatorcontrib><creatorcontrib>Tarnowska, Agnieszka</creatorcontrib><creatorcontrib>Dzielinska, Zofia</creatorcontrib><creatorcontrib>Chmielak, Zbigniew</creatorcontrib><creatorcontrib>Witkowski, Adam</creatorcontrib><creatorcontrib>Demkow, Marcin</creatorcontrib><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>Pracon, Radoslaw</au><au>Bangalore, Sripal</au><au>Henzel, Jan</au><au>Cendrowska‐Demkow, Iwona</au><au>Pregowska‐Chwala, Barbara</au><au>Tarnowska, Agnieszka</au><au>Dzielinska, Zofia</au><au>Chmielak, Zbigniew</au><au>Witkowski, Adam</au><au>Demkow, Marcin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized comparison of modified subcutaneous “Z”‐stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2018-01-01</date><risdate>2018</risdate><volume>91</volume><issue>1</issue><spage>105</spage><epage>112</epage><pages>105-112</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives To compare subcutaneous “Z”‐stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. Background Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. “Z”‐stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. Methods This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the “Z”‐stitch or manual compression for hemostasis in a 2:1 fashion. There were three co‐primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler‐Duplex was performed with the stitch in place and after its removal. Results 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10–22 F). Patients randomized to “Z”‐stitch achieved hemostasis quicker [&lt;1 min vs. 12.0 (IQR 10.0–15.0) min, P &lt; 0.001] and ambulated sooner [7.0 (IQR 4.0–12.0) vs. 16.0 (IQR 11.8–20.3) hr post procedure, P &lt; 0.001] when compared with manual compression alone. The “Z”‐stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09–0.76, P = 0.01). All imaged veins were patent before and after stitch removal. Conclusions The “Z”‐stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. © 2017 Wiley Periodicals, Inc.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28303670</pmid><doi>10.1002/ccd.27003</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-7519-0003</orcidid></addata></record>
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subjects Adult
Aged
Aged, 80 and over
bleeding
Catheterization, Peripheral - adverse effects
Catheterization, Peripheral - instrumentation
Catheters
Comparative Effectiveness Research
Complications
Compression
Compression therapy
Equipment Design
Female
Femoral Vein - diagnostic imaging
Femoral Vein - physiopathology
Femur
Hemorrhage
Hemorrhage - etiology
Hemorrhage - prevention & control
Hemostasis
Hemostatic Techniques - adverse effects
Hemostatics
Humans
Male
Middle Aged
Poland
Pressure
Prospective Studies
Punctures
Randomization
Sheaths
structural heart disease intervention
Suture Techniques - adverse effects
Time Factors
Treatment Outcome
vascular access
Vascular Access Devices
Vascular Patency
title A randomized comparison of modified subcutaneous “Z”‐stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal
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