Single‐Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre‐imaging, and Same‐day Expedited discharge (SOLO‐CLOSE): A comparison with conventional approach

Background Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. Aims We describe and compare SOLO‐CLOSE (single‐operator LAA occlusion utilizing conscious...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2024-08, Vol.104 (2), p.330-342
Hauptverfasser: Golzarian, Hafez, Pasley, Benjamin A., Shah, Sidra R., Thiel, Arielle M., Knous, Mallory, Kleman, Anna C., Saum, Jamie L., Hempfling, Gerri L., Otto, Michael, Otto, Todd, Racer, Lisa, Martz, Denise, Gemmel, David J., Laird, Amanda D., Cole, William C., Parsa, Prabhakar, Imm, Craig, Patel, Sandeep M.
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container_end_page 342
container_issue 2
container_start_page 330
container_title Catheterization and cardiovascular interventions
container_volume 104
creator Golzarian, Hafez
Pasley, Benjamin A.
Shah, Sidra R.
Thiel, Arielle M.
Knous, Mallory
Kleman, Anna C.
Saum, Jamie L.
Hempfling, Gerri L.
Otto, Michael
Otto, Todd
Racer, Lisa
Martz, Denise
Gemmel, David J.
Laird, Amanda D.
Cole, William C.
Parsa, Prabhakar
Imm, Craig
Patel, Sandeep M.
description Background Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. Aims We describe and compare SOLO‐CLOSE (single‐operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre‐imaging, and same‐day expedited discharge) with the conventional approach (CA). Methods A single‐center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO‐CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri‐device leak at time of closure. The primary safety endpoint was the composite incidence of all‐cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7‐day readmission rates, and cost analytics were collected as well. Results Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO‐CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO‐CLOSE (p 
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We sought to facilitate simplification of LAAO. Aims We describe and compare SOLO‐CLOSE (single‐operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre‐imaging, and same‐day expedited discharge) with the conventional approach (CA). Methods A single‐center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO‐CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri‐device leak at time of closure. The primary safety endpoint was the composite incidence of all‐cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7‐day readmission rates, and cost analytics were collected as well. Results Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO‐CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO‐CLOSE (p &lt; 0.01). Seven‐day readmissions for SOLO‐CLOSE was zero. After SOLO‐CLOSE implementation, there was a 188% increase in positive contribution margin per case. Conclusions The SOLO‐CLOSE methodology offers similar efficacy and safety when compared to the CA, while improving clinical efficiency, reducing procedural times, and increasing economic benefit.</description><identifier>ISSN: 1522-1946</identifier><identifier>ISSN: 1522-726X</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.31073</identifier><identifier>PMID: 38736248</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Aged ; Aged, 80 and over ; Anesthesia ; Atrial Appendage - diagnostic imaging ; Atrial Appendage - physiopathology ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - diagnostic imaging ; Atrial Fibrillation - physiopathology ; Atrial Fibrillation - therapy ; Cardiac Catheterization - adverse effects ; Cardiac Catheterization - instrumentation ; Congestive heart failure ; conscious sedation ; Conscious Sedation - adverse effects ; Cost-Benefit Analysis ; Echocardiography, Transesophageal ; Effusion ; Embolization ; Female ; Humans ; left atrial appendage occlusion ; Male ; Malignancy ; Middle Aged ; Occlusion ; Patient Discharge ; Patient Readmission ; Retrospective Studies ; Risk Factors ; same day discharge ; single operator ; Stroke ; TEE imaging ; Time Factors ; Treatment Outcome</subject><ispartof>Catheterization and cardiovascular interventions, 2024-08, Vol.104 (2), p.330-342</ispartof><rights>2024 The Authors. published by Wiley Periodicals LLC.</rights><rights>2024 The Authors. 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-c3483-c038f1777b65c361ca91f38d7fb11c8e10098aa49fa992e2fc76547a3db3d1a93</cites><orcidid>0000-0003-1912-943X ; 0000-0003-2932-6525 ; 0000-0001-6122-3484 ; 0000-0002-1681-4661</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.31073$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.31073$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38736248$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Golzarian, Hafez</creatorcontrib><creatorcontrib>Pasley, Benjamin A.</creatorcontrib><creatorcontrib>Shah, Sidra R.</creatorcontrib><creatorcontrib>Thiel, Arielle M.</creatorcontrib><creatorcontrib>Knous, Mallory</creatorcontrib><creatorcontrib>Kleman, Anna C.</creatorcontrib><creatorcontrib>Saum, Jamie L.</creatorcontrib><creatorcontrib>Hempfling, Gerri L.</creatorcontrib><creatorcontrib>Otto, Michael</creatorcontrib><creatorcontrib>Otto, Todd</creatorcontrib><creatorcontrib>Racer, Lisa</creatorcontrib><creatorcontrib>Martz, Denise</creatorcontrib><creatorcontrib>Gemmel, David J.</creatorcontrib><creatorcontrib>Laird, Amanda D.</creatorcontrib><creatorcontrib>Cole, William C.</creatorcontrib><creatorcontrib>Parsa, Prabhakar</creatorcontrib><creatorcontrib>Imm, Craig</creatorcontrib><creatorcontrib>Patel, Sandeep M.</creatorcontrib><title>Single‐Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre‐imaging, and Same‐day Expedited discharge (SOLO‐CLOSE): A comparison with conventional approach</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Background Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. Aims We describe and compare SOLO‐CLOSE (single‐operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre‐imaging, and same‐day expedited discharge) with the conventional approach (CA). Methods A single‐center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO‐CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri‐device leak at time of closure. The primary safety endpoint was the composite incidence of all‐cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7‐day readmission rates, and cost analytics were collected as well. Results Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO‐CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO‐CLOSE (p &lt; 0.01). Seven‐day readmissions for SOLO‐CLOSE was zero. After SOLO‐CLOSE implementation, there was a 188% increase in positive contribution margin per case. Conclusions The SOLO‐CLOSE methodology offers similar efficacy and safety when compared to the CA, while improving clinical efficiency, reducing procedural times, and increasing economic benefit.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anesthesia</subject><subject>Atrial Appendage - diagnostic imaging</subject><subject>Atrial Appendage - physiopathology</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - diagnostic imaging</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Atrial Fibrillation - therapy</subject><subject>Cardiac Catheterization - adverse effects</subject><subject>Cardiac Catheterization - instrumentation</subject><subject>Congestive heart failure</subject><subject>conscious sedation</subject><subject>Conscious Sedation - adverse effects</subject><subject>Cost-Benefit Analysis</subject><subject>Echocardiography, Transesophageal</subject><subject>Effusion</subject><subject>Embolization</subject><subject>Female</subject><subject>Humans</subject><subject>left atrial appendage occlusion</subject><subject>Male</subject><subject>Malignancy</subject><subject>Middle Aged</subject><subject>Occlusion</subject><subject>Patient Discharge</subject><subject>Patient Readmission</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><subject>same day discharge</subject><subject>single operator</subject><subject>Stroke</subject><subject>TEE imaging</subject><subject>Time Factors</subject><subject>Treatment Outcome</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>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAUhSMEoj-w4AWQJTat1GntOBPH7KoQfqRIWUyR2EV3bGfGJZOktkOZrngEHo1n4Em4IQMLJFa27_18ztU9UfSC0UtGaXyllL7kjAr-KDpmyzheiDj99PhwZzJJj6IT728ppTKN5dPoiGeCp3GSHUc_VrbbtObnt-_VYByE3pHSNIFAcBZaAsNgOg0bQyql2tHbviNjsK19wG8k7zuvbD964o2GMDVviuKClKA-k74h1RgGLJsukMFNHnYHG_x4QaDTZAW7qaZhT4qvg9E2GE209WoLDg3PVlVZYT8vq1Vx_ppcE9XvBnDWo829DVt8d19QG23nSV0PavssetJA683zw3kafXxb3OTvF2X17kN-XS4UTzK-UJRnDRNCrNOl4ilTIFnDMy2aNWMqM7hXmQEksgEpYxM3SqTLRADXa64ZSH4anc26aHs3Gh_qHY5u2hY6gxupOV0mCedCcERf_YPe9qPDoSdKYm40TSbqfKaU6713pqkHh_ty-5rReoq5xpjr3zEj-_KgOK53Rv8l_-SKwNUM3NvW7P-vVOf5m1nyFxB-t0I</recordid><startdate>20240801</startdate><enddate>20240801</enddate><creator>Golzarian, Hafez</creator><creator>Pasley, Benjamin A.</creator><creator>Shah, Sidra R.</creator><creator>Thiel, Arielle M.</creator><creator>Knous, Mallory</creator><creator>Kleman, Anna C.</creator><creator>Saum, Jamie L.</creator><creator>Hempfling, Gerri L.</creator><creator>Otto, Michael</creator><creator>Otto, Todd</creator><creator>Racer, Lisa</creator><creator>Martz, Denise</creator><creator>Gemmel, David J.</creator><creator>Laird, Amanda D.</creator><creator>Cole, William C.</creator><creator>Parsa, Prabhakar</creator><creator>Imm, Craig</creator><creator>Patel, Sandeep M.</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</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/0000-0003-1912-943X</orcidid><orcidid>https://orcid.org/0000-0003-2932-6525</orcidid><orcidid>https://orcid.org/0000-0001-6122-3484</orcidid><orcidid>https://orcid.org/0000-0002-1681-4661</orcidid></search><sort><creationdate>20240801</creationdate><title>Single‐Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre‐imaging, and Same‐day Expedited discharge (SOLO‐CLOSE): A comparison with conventional approach</title><author>Golzarian, Hafez ; Pasley, Benjamin A. ; Shah, Sidra R. ; Thiel, Arielle M. ; Knous, Mallory ; Kleman, Anna C. ; Saum, Jamie L. ; Hempfling, Gerri L. ; Otto, Michael ; Otto, Todd ; Racer, Lisa ; Martz, Denise ; Gemmel, David J. ; Laird, Amanda D. ; Cole, William C. ; Parsa, Prabhakar ; Imm, Craig ; Patel, Sandeep M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3483-c038f1777b65c361ca91f38d7fb11c8e10098aa49fa992e2fc76547a3db3d1a93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anesthesia</topic><topic>Atrial Appendage - diagnostic imaging</topic><topic>Atrial Appendage - physiopathology</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - diagnostic imaging</topic><topic>Atrial Fibrillation - physiopathology</topic><topic>Atrial Fibrillation - therapy</topic><topic>Cardiac Catheterization - adverse effects</topic><topic>Cardiac Catheterization - instrumentation</topic><topic>Congestive heart failure</topic><topic>conscious sedation</topic><topic>Conscious Sedation - adverse effects</topic><topic>Cost-Benefit Analysis</topic><topic>Echocardiography, Transesophageal</topic><topic>Effusion</topic><topic>Embolization</topic><topic>Female</topic><topic>Humans</topic><topic>left atrial appendage occlusion</topic><topic>Male</topic><topic>Malignancy</topic><topic>Middle Aged</topic><topic>Occlusion</topic><topic>Patient Discharge</topic><topic>Patient Readmission</topic><topic>Retrospective Studies</topic><topic>Risk Factors</topic><topic>same day discharge</topic><topic>single operator</topic><topic>Stroke</topic><topic>TEE imaging</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Golzarian, Hafez</creatorcontrib><creatorcontrib>Pasley, Benjamin A.</creatorcontrib><creatorcontrib>Shah, Sidra R.</creatorcontrib><creatorcontrib>Thiel, Arielle M.</creatorcontrib><creatorcontrib>Knous, Mallory</creatorcontrib><creatorcontrib>Kleman, Anna C.</creatorcontrib><creatorcontrib>Saum, Jamie L.</creatorcontrib><creatorcontrib>Hempfling, Gerri L.</creatorcontrib><creatorcontrib>Otto, Michael</creatorcontrib><creatorcontrib>Otto, Todd</creatorcontrib><creatorcontrib>Racer, Lisa</creatorcontrib><creatorcontrib>Martz, Denise</creatorcontrib><creatorcontrib>Gemmel, David J.</creatorcontrib><creatorcontrib>Laird, Amanda D.</creatorcontrib><creatorcontrib>Cole, William C.</creatorcontrib><creatorcontrib>Parsa, Prabhakar</creatorcontrib><creatorcontrib>Imm, Craig</creatorcontrib><creatorcontrib>Patel, Sandeep M.</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library Free Content</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>Golzarian, Hafez</au><au>Pasley, Benjamin A.</au><au>Shah, Sidra R.</au><au>Thiel, Arielle M.</au><au>Knous, Mallory</au><au>Kleman, Anna C.</au><au>Saum, Jamie L.</au><au>Hempfling, Gerri L.</au><au>Otto, Michael</au><au>Otto, Todd</au><au>Racer, Lisa</au><au>Martz, Denise</au><au>Gemmel, David J.</au><au>Laird, Amanda D.</au><au>Cole, William C.</au><au>Parsa, Prabhakar</au><au>Imm, Craig</au><au>Patel, Sandeep M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single‐Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre‐imaging, and Same‐day Expedited discharge (SOLO‐CLOSE): A comparison with conventional approach</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2024-08-01</date><risdate>2024</risdate><volume>104</volume><issue>2</issue><spage>330</spage><epage>342</epage><pages>330-342</pages><issn>1522-1946</issn><issn>1522-726X</issn><eissn>1522-726X</eissn><abstract>Background Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO. Aims We describe and compare SOLO‐CLOSE (single‐operator LAA occlusion utilizing conscious sedation TEE, lack of outpatient pre‐imaging, and same‐day expedited discharge) with the conventional approach (CA). Methods A single‐center retrospective analysis of 163 patients undergoing LAAO between January 2017 and April 2022 was conducted. The SOLO‐CLOSE protocol was enacted on December 1, 2020. Before this date, we utilized the CA. The primary efficacy endpoint was defined as successful LAAO with ≤5 mm peri‐device leak at time of closure. The primary safety endpoint was the composite incidence of all‐cause deaths, any cerebrovascular accident (CVA), device embolization, pericardial effusion, or major postprocedure bleeding within 7 days of the index procedure. Procedure times, 7‐day readmission rates, and cost analytics were collected as well. Results Baseline characteristics were similar in both cohorts. Congestive heart failure (37.5% vs. 11.1%) and malignancy (28.8% vs. 12.5%) were higher in SOLO‐CLOSE. Median CHA2D2SVASc score was 5 in both cohorts. The primary efficacy endpoint was met 100% in both cohorts. Primary safety endpoint was similar between cohorts (p = 0.078). Mean procedure time was 30 min shorter in SOLO‐CLOSE (p &lt; 0.01). Seven‐day readmissions for SOLO‐CLOSE was zero. After SOLO‐CLOSE implementation, there was a 188% increase in positive contribution margin per case. Conclusions The SOLO‐CLOSE methodology offers similar efficacy and safety when compared to the CA, while improving clinical efficiency, reducing procedural times, and increasing economic benefit.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>38736248</pmid><doi>10.1002/ccd.31073</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0003-1912-943X</orcidid><orcidid>https://orcid.org/0000-0003-2932-6525</orcidid><orcidid>https://orcid.org/0000-0001-6122-3484</orcidid><orcidid>https://orcid.org/0000-0002-1681-4661</orcidid><oa>free_for_read</oa></addata></record>
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subjects Aged
Aged, 80 and over
Anesthesia
Atrial Appendage - diagnostic imaging
Atrial Appendage - physiopathology
Atrial Fibrillation - diagnosis
Atrial Fibrillation - diagnostic imaging
Atrial Fibrillation - physiopathology
Atrial Fibrillation - therapy
Cardiac Catheterization - adverse effects
Cardiac Catheterization - instrumentation
Congestive heart failure
conscious sedation
Conscious Sedation - adverse effects
Cost-Benefit Analysis
Echocardiography, Transesophageal
Effusion
Embolization
Female
Humans
left atrial appendage occlusion
Male
Malignancy
Middle Aged
Occlusion
Patient Discharge
Patient Readmission
Retrospective Studies
Risk Factors
same day discharge
single operator
Stroke
TEE imaging
Time Factors
Treatment Outcome
title Single‐Operator Left atrial appendage Occlusion utilizing Conscious sedation TEE, Lack of Outpatient pre‐imaging, and Same‐day Expedited discharge (SOLO‐CLOSE): A comparison with conventional approach
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