Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population

The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an E...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:JACC. Clinical electrophysiology 2024-08, Vol.10 (8), p.1896-1912
Hauptverfasser: Swerdlow, Charles, Gillberg, Jeff, Boersma, Lucas V.A., Manlucu, Jaimie, Zhang, Xusheng, Zhang, Yan, Hernandez, Alfonso Aranda, Bhatia, Varun, Murgatroyd, Francis
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 1912
container_issue 8
container_start_page 1896
container_title JACC. Clinical electrophysiology
container_volume 10
creator Swerdlow, Charles
Gillberg, Jeff
Boersma, Lucas V.A.
Manlucu, Jaimie
Zhang, Xusheng
Zhang, Yan
Hernandez, Alfonso Aranda
Bhatia, Varun
Murgatroyd, Francis
description The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P < 0.0001) and correlated with low R-wave amplitude (P < 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P = 0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P < 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680) [Display omitted]
doi_str_mv 10.1016/j.jacep.2024.02.033
format Article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3055892718</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S2405500X24001816</els_id><sourcerecordid>3055892718</sourcerecordid><originalsourceid>FETCH-LOGICAL-c239t-d7220ccc84f0102b1b61347598878e246d1d4432b73b14536d9cbf26139106633</originalsourceid><addsrcrecordid>eNp9kEtr3DAQgEVpaUKaX1AoOvZiZ_SwLR96KJsnLLTQBHoTeowXLV7LlbxL---rzaY59jQD883rI-Qjg5oBa6-29dY4nGsOXNbAaxDiDTnnEpqqAabevubw84xc5rwFANZwxZl8T86E6hret-ycbG5-L8kcTHb70ST6sJtHMy3GjkhXJvkQD5gWTNU1DsGmMI5miYn-wCmHaUPN5Ok1LuiWECcaJmro2qQN0rsxWjPS73EuY4_FD-TdYMaMly_xgjzd3jyu7qv1t7uH1dd15bjol8p3nINzTskBGHDLbMuE7JpeqU4hl61nXkrBbScsk41ofe_swAvUM2hbIS7I59PcOcVfe8yL3oXssNw9YdxnLaBpVM87pgoqTqhLMeeEg55T2Jn0RzPQR8l6q58l66NkDVwXyaXr08uCvd2hf-35p7QAX04AljcPAZPOLuDk0IdURGkfw38X_AUHvo2x</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3055892718</pqid></control><display><type>article</type><title>Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Swerdlow, Charles ; Gillberg, Jeff ; Boersma, Lucas V.A. ; Manlucu, Jaimie ; Zhang, Xusheng ; Zhang, Yan ; Hernandez, Alfonso Aranda ; Bhatia, Varun ; Murgatroyd, Francis</creator><creatorcontrib>Swerdlow, Charles ; Gillberg, Jeff ; Boersma, Lucas V.A. ; Manlucu, Jaimie ; Zhang, Xusheng ; Zhang, Yan ; Hernandez, Alfonso Aranda ; Bhatia, Varun ; Murgatroyd, Francis</creatorcontrib><description>The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P &lt; 0.0001) and correlated with low R-wave amplitude (P &lt; 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P = 0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P &lt; 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680) [Display omitted]</description><identifier>ISSN: 2405-500X</identifier><identifier>ISSN: 2405-5018</identifier><identifier>EISSN: 2405-5018</identifier><identifier>DOI: 10.1016/j.jacep.2024.02.033</identifier><identifier>PMID: 38752961</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Defibrillators, Implantable ; detection ; Electrocardiography ; extravascular ; Female ; Humans ; implantable cardioverter-defibrillator ; Male ; Middle Aged ; Prospective Studies ; sensing ; Tachycardia, Ventricular - diagnosis ; Tachycardia, Ventricular - physiopathology ; Tachycardia, Ventricular - therapy ; Ventricular Fibrillation - diagnosis ; Ventricular Fibrillation - therapy</subject><ispartof>JACC. Clinical electrophysiology, 2024-08, Vol.10 (8), p.1896-1912</ispartof><rights>2024 American College of Cardiology Foundation</rights><rights>Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c239t-d7220ccc84f0102b1b61347598878e246d1d4432b73b14536d9cbf26139106633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38752961$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Swerdlow, Charles</creatorcontrib><creatorcontrib>Gillberg, Jeff</creatorcontrib><creatorcontrib>Boersma, Lucas V.A.</creatorcontrib><creatorcontrib>Manlucu, Jaimie</creatorcontrib><creatorcontrib>Zhang, Xusheng</creatorcontrib><creatorcontrib>Zhang, Yan</creatorcontrib><creatorcontrib>Hernandez, Alfonso Aranda</creatorcontrib><creatorcontrib>Bhatia, Varun</creatorcontrib><creatorcontrib>Murgatroyd, Francis</creatorcontrib><title>Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population</title><title>JACC. Clinical electrophysiology</title><addtitle>JACC Clin Electrophysiol</addtitle><description>The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P &lt; 0.0001) and correlated with low R-wave amplitude (P &lt; 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P = 0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P &lt; 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680) [Display omitted]</description><subject>Aged</subject><subject>Defibrillators, Implantable</subject><subject>detection</subject><subject>Electrocardiography</subject><subject>extravascular</subject><subject>Female</subject><subject>Humans</subject><subject>implantable cardioverter-defibrillator</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>sensing</subject><subject>Tachycardia, Ventricular - diagnosis</subject><subject>Tachycardia, Ventricular - physiopathology</subject><subject>Tachycardia, Ventricular - therapy</subject><subject>Ventricular Fibrillation - diagnosis</subject><subject>Ventricular Fibrillation - therapy</subject><issn>2405-500X</issn><issn>2405-5018</issn><issn>2405-5018</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtr3DAQgEVpaUKaX1AoOvZiZ_SwLR96KJsnLLTQBHoTeowXLV7LlbxL---rzaY59jQD883rI-Qjg5oBa6-29dY4nGsOXNbAaxDiDTnnEpqqAabevubw84xc5rwFANZwxZl8T86E6hret-ycbG5-L8kcTHb70ST6sJtHMy3GjkhXJvkQD5gWTNU1DsGmMI5miYn-wCmHaUPN5Ok1LuiWECcaJmro2qQN0rsxWjPS73EuY4_FD-TdYMaMly_xgjzd3jyu7qv1t7uH1dd15bjol8p3nINzTskBGHDLbMuE7JpeqU4hl61nXkrBbScsk41ofe_swAvUM2hbIS7I59PcOcVfe8yL3oXssNw9YdxnLaBpVM87pgoqTqhLMeeEg55T2Jn0RzPQR8l6q58l66NkDVwXyaXr08uCvd2hf-35p7QAX04AljcPAZPOLuDk0IdURGkfw38X_AUHvo2x</recordid><startdate>202408</startdate><enddate>202408</enddate><creator>Swerdlow, Charles</creator><creator>Gillberg, Jeff</creator><creator>Boersma, Lucas V.A.</creator><creator>Manlucu, Jaimie</creator><creator>Zhang, Xusheng</creator><creator>Zhang, Yan</creator><creator>Hernandez, Alfonso Aranda</creator><creator>Bhatia, Varun</creator><creator>Murgatroyd, Francis</creator><general>Elsevier Inc</general><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>7X8</scope></search><sort><creationdate>202408</creationdate><title>Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population</title><author>Swerdlow, Charles ; Gillberg, Jeff ; Boersma, Lucas V.A. ; Manlucu, Jaimie ; Zhang, Xusheng ; Zhang, Yan ; Hernandez, Alfonso Aranda ; Bhatia, Varun ; Murgatroyd, Francis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c239t-d7220ccc84f0102b1b61347598878e246d1d4432b73b14536d9cbf26139106633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Aged</topic><topic>Defibrillators, Implantable</topic><topic>detection</topic><topic>Electrocardiography</topic><topic>extravascular</topic><topic>Female</topic><topic>Humans</topic><topic>implantable cardioverter-defibrillator</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>sensing</topic><topic>Tachycardia, Ventricular - diagnosis</topic><topic>Tachycardia, Ventricular - physiopathology</topic><topic>Tachycardia, Ventricular - therapy</topic><topic>Ventricular Fibrillation - diagnosis</topic><topic>Ventricular Fibrillation - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Swerdlow, Charles</creatorcontrib><creatorcontrib>Gillberg, Jeff</creatorcontrib><creatorcontrib>Boersma, Lucas V.A.</creatorcontrib><creatorcontrib>Manlucu, Jaimie</creatorcontrib><creatorcontrib>Zhang, Xusheng</creatorcontrib><creatorcontrib>Zhang, Yan</creatorcontrib><creatorcontrib>Hernandez, Alfonso Aranda</creatorcontrib><creatorcontrib>Bhatia, Varun</creatorcontrib><creatorcontrib>Murgatroyd, Francis</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Clinical electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Swerdlow, Charles</au><au>Gillberg, Jeff</au><au>Boersma, Lucas V.A.</au><au>Manlucu, Jaimie</au><au>Zhang, Xusheng</au><au>Zhang, Yan</au><au>Hernandez, Alfonso Aranda</au><au>Bhatia, Varun</au><au>Murgatroyd, Francis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population</atitle><jtitle>JACC. Clinical electrophysiology</jtitle><addtitle>JACC Clin Electrophysiol</addtitle><date>2024-08</date><risdate>2024</risdate><volume>10</volume><issue>8</issue><spage>1896</spage><epage>1912</epage><pages>1896-1912</pages><issn>2405-500X</issn><issn>2405-5018</issn><eissn>2405-5018</eissn><abstract>The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P &lt; 0.0001) and correlated with low R-wave amplitude (P &lt; 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P = 0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P &lt; 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680) [Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38752961</pmid><doi>10.1016/j.jacep.2024.02.033</doi><tpages>17</tpages></addata></record>
fulltext fulltext
identifier ISSN: 2405-500X
ispartof JACC. Clinical electrophysiology, 2024-08, Vol.10 (8), p.1896-1912
issn 2405-500X
2405-5018
2405-5018
language eng
recordid cdi_proquest_miscellaneous_3055892718
source MEDLINE; Alma/SFX Local Collection
subjects Aged
Defibrillators, Implantable
detection
Electrocardiography
extravascular
Female
Humans
implantable cardioverter-defibrillator
Male
Middle Aged
Prospective Studies
sensing
Tachycardia, Ventricular - diagnosis
Tachycardia, Ventricular - physiopathology
Tachycardia, Ventricular - therapy
Ventricular Fibrillation - diagnosis
Ventricular Fibrillation - therapy
title Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-11T05%3A01%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Extravascular%20Implantable%20Cardioverter-Defibrillator%20Sensing%20and%20Detection%20in%20a%20Large%20Global%20Population&rft.jtitle=JACC.%20Clinical%20electrophysiology&rft.au=Swerdlow,%20Charles&rft.date=2024-08&rft.volume=10&rft.issue=8&rft.spage=1896&rft.epage=1912&rft.pages=1896-1912&rft.issn=2405-500X&rft.eissn=2405-5018&rft_id=info:doi/10.1016/j.jacep.2024.02.033&rft_dat=%3Cproquest_cross%3E3055892718%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3055892718&rft_id=info:pmid/38752961&rft_els_id=S2405500X24001816&rfr_iscdi=true