A new transseptal solution for enabling left atrial access of large delivery sheaths
Background Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to suppo...
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| Veröffentlicht in: | Journal of cardiovascular electrophysiology 2021-03, Vol.32 (3), p.729-734 |
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| container_title | Journal of cardiovascular electrophysiology |
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| creator | Inohara, Taku Gilhofer, Thomas Al‐Dujaili, Saja Leung, Linus Yeung, Darwin Tsang, Michael Saw, Jacqueline |
| description | Background
Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing.
Methods
This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures.
Results
In a benchtop septum model (N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p |
| doi_str_mv | 10.1111/jce.14903 |
| format | Article |
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Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing.
Methods
This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures.
Results
In a benchtop septum model (N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p < .001) and overall work (17.3 ± 1.2 mJ vs. 28.0 ± 1.9 mJ; p < .001) were required to advance ExpanSure relative to a conventional SL1 transseptal sheath and dilator system. Peak force (2.34 ± 0.24 N vs. 2.65 ± 0.21 N; p < .003) and overall work (28.5 ± 3.9 mJ vs. 35.4 ± 2.1 mJ; p < .001) to advance a WATCHMAN sheath were also significantly lower after using ExpanSure than after using a conventional transseptal system. In 19 LAAC procedures, ExpanSure crossed the septum smoothly and integrated readily, which enabled efficient procedure completion (mean total procedure time 37.6 ± 13.5 min), with 100% success and no procedure‐related complications.
Conclusion
Experimental force measurements, combined with early clinical experience using ExpanSure, suggest that the tapered design with smooth transition without dilator–sheath step‐up and the larger diameter, both facilitated ease and efficiency of interatrial crossing.</description><identifier>ISSN: 1045-3873</identifier><identifier>EISSN: 1540-8167</identifier><identifier>DOI: 10.1111/jce.14903</identifier><identifier>PMID: 33476450</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>atrial fibrillation ; Early experience ; ExpanSure ; left atrial appendage closure ; Septum ; Sheaths ; transseptal puncture</subject><ispartof>Journal of cardiovascular electrophysiology, 2021-03, Vol.32 (3), p.729-734</ispartof><rights>2021 Wiley Periodicals LLC</rights><rights>2021 Wiley Periodicals LLC.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3533-6f7c46758ead14e8ddd33535a303e71de444927d39e5e4a78aa41a1ac40095e13</citedby><cites>FETCH-LOGICAL-c3533-6f7c46758ead14e8ddd33535a303e71de444927d39e5e4a78aa41a1ac40095e13</cites><orcidid>0000-0002-7027-984X ; 0000-0002-7889-2083</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjce.14903$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjce.14903$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33476450$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Inohara, Taku</creatorcontrib><creatorcontrib>Gilhofer, Thomas</creatorcontrib><creatorcontrib>Al‐Dujaili, Saja</creatorcontrib><creatorcontrib>Leung, Linus</creatorcontrib><creatorcontrib>Yeung, Darwin</creatorcontrib><creatorcontrib>Tsang, Michael</creatorcontrib><creatorcontrib>Saw, Jacqueline</creatorcontrib><title>A new transseptal solution for enabling left atrial access of large delivery sheaths</title><title>Journal of cardiovascular electrophysiology</title><addtitle>J Cardiovasc Electrophysiol</addtitle><description>Background
Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing.
Methods
This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures.
Results
In a benchtop septum model (N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p < .001) and overall work (17.3 ± 1.2 mJ vs. 28.0 ± 1.9 mJ; p < .001) were required to advance ExpanSure relative to a conventional SL1 transseptal sheath and dilator system. Peak force (2.34 ± 0.24 N vs. 2.65 ± 0.21 N; p < .003) and overall work (28.5 ± 3.9 mJ vs. 35.4 ± 2.1 mJ; p < .001) to advance a WATCHMAN sheath were also significantly lower after using ExpanSure than after using a conventional transseptal system. In 19 LAAC procedures, ExpanSure crossed the septum smoothly and integrated readily, which enabled efficient procedure completion (mean total procedure time 37.6 ± 13.5 min), with 100% success and no procedure‐related complications.
Conclusion
Experimental force measurements, combined with early clinical experience using ExpanSure, suggest that the tapered design with smooth transition without dilator–sheath step‐up and the larger diameter, both facilitated ease and efficiency of interatrial crossing.</description><subject>atrial fibrillation</subject><subject>Early experience</subject><subject>ExpanSure</subject><subject>left atrial appendage closure</subject><subject>Septum</subject><subject>Sheaths</subject><subject>transseptal puncture</subject><issn>1045-3873</issn><issn>1540-8167</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp10M9LwzAUB_AgipvTg_-ABLzooVuyJE1zHGP-YuBlnstb-7p1ZO1MWsf-e6OdHgTfJQ_y4cvjS8g1Z0MeZrTJcMilYeKE9LmSLEp4rE_DzqSKRKJFj1x4v2GMi5ipc9ITQupYKtYniwmtcE8bB5X3uGvAUl_btinriha1o1jB0pbVilosGgqNK4OALEPvaV1QC26FNEdbfqA7UL9GaNb-kpwVYD1eHd8BeXuYLaZP0fz18Xk6mUeZUEJEcaEzGWuVIORcYpLnuQgfCgQTqHmOUkoz1rkwqFCCTgAkBw6ZZMwo5GJA7rrcnavfW_RNui19htZChXXr07FM2NgIE8tAb__QTd26KlwXlDGxMjqcNCD3ncpc7b3DIt25cgvukHKWflWdhqrT76qDvTkmtsst5r_yp9sARh3YlxYP_yelL9NZF_kJzlaGxA</recordid><startdate>202103</startdate><enddate>202103</enddate><creator>Inohara, Taku</creator><creator>Gilhofer, Thomas</creator><creator>Al‐Dujaili, Saja</creator><creator>Leung, Linus</creator><creator>Yeung, Darwin</creator><creator>Tsang, Michael</creator><creator>Saw, Jacqueline</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7027-984X</orcidid><orcidid>https://orcid.org/0000-0002-7889-2083</orcidid></search><sort><creationdate>202103</creationdate><title>A new transseptal solution for enabling left atrial access of large delivery sheaths</title><author>Inohara, Taku ; Gilhofer, Thomas ; Al‐Dujaili, Saja ; Leung, Linus ; Yeung, Darwin ; Tsang, Michael ; Saw, Jacqueline</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3533-6f7c46758ead14e8ddd33535a303e71de444927d39e5e4a78aa41a1ac40095e13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>atrial fibrillation</topic><topic>Early experience</topic><topic>ExpanSure</topic><topic>left atrial appendage closure</topic><topic>Septum</topic><topic>Sheaths</topic><topic>transseptal puncture</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Inohara, Taku</creatorcontrib><creatorcontrib>Gilhofer, Thomas</creatorcontrib><creatorcontrib>Al‐Dujaili, Saja</creatorcontrib><creatorcontrib>Leung, Linus</creatorcontrib><creatorcontrib>Yeung, Darwin</creatorcontrib><creatorcontrib>Tsang, Michael</creatorcontrib><creatorcontrib>Saw, Jacqueline</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of cardiovascular electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Inohara, Taku</au><au>Gilhofer, Thomas</au><au>Al‐Dujaili, Saja</au><au>Leung, Linus</au><au>Yeung, Darwin</au><au>Tsang, Michael</au><au>Saw, Jacqueline</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A new transseptal solution for enabling left atrial access of large delivery sheaths</atitle><jtitle>Journal of cardiovascular electrophysiology</jtitle><addtitle>J Cardiovasc Electrophysiol</addtitle><date>2021-03</date><risdate>2021</risdate><volume>32</volume><issue>3</issue><spage>729</spage><epage>734</epage><pages>729-734</pages><issn>1045-3873</issn><eissn>1540-8167</eissn><abstract>Background
Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath–dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath–dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing.
Methods
This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures.
Results
In a benchtop septum model (N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p < .001) and overall work (17.3 ± 1.2 mJ vs. 28.0 ± 1.9 mJ; p < .001) were required to advance ExpanSure relative to a conventional SL1 transseptal sheath and dilator system. Peak force (2.34 ± 0.24 N vs. 2.65 ± 0.21 N; p < .003) and overall work (28.5 ± 3.9 mJ vs. 35.4 ± 2.1 mJ; p < .001) to advance a WATCHMAN sheath were also significantly lower after using ExpanSure than after using a conventional transseptal system. In 19 LAAC procedures, ExpanSure crossed the septum smoothly and integrated readily, which enabled efficient procedure completion (mean total procedure time 37.6 ± 13.5 min), with 100% success and no procedure‐related complications.
Conclusion
Experimental force measurements, combined with early clinical experience using ExpanSure, suggest that the tapered design with smooth transition without dilator–sheath step‐up and the larger diameter, both facilitated ease and efficiency of interatrial crossing.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33476450</pmid><doi>10.1111/jce.14903</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-7027-984X</orcidid><orcidid>https://orcid.org/0000-0002-7889-2083</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | atrial fibrillation Early experience ExpanSure left atrial appendage closure Septum Sheaths transseptal puncture |
| title | A new transseptal solution for enabling left atrial access of large delivery sheaths |
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