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 |
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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 |
doi_str_mv | 10.1002/ccd.31073 |
format | Article |
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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 < 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 < 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 & 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 < 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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