Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results

Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and eff...

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Veröffentlicht in:Journal of cardiovascular electrophysiology 2020-05, Vol.31 (5), p.1147-1154
Hauptverfasser: Jackson, Kevin P., Faerestrand, Svein, Philippon, Francois, Yee, Raymond, Kong, Melissa H., Kloppe, Axel, Bongiorni, Maria Grazia, Lee, Scott F., Canby, Robert C., Pouliot, Erika, Ginneken, Mireille M. E., Crossley, George H.
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container_end_page 1154
container_issue 5
container_start_page 1147
container_title Journal of cardiovascular electrophysiology
container_volume 31
creator Jackson, Kevin P.
Faerestrand, Svein
Philippon, Francois
Yee, Raymond
Kong, Melissa H.
Kloppe, Axel
Bongiorni, Maria Grazia
Lee, Scott F.
Canby, Robert C.
Pouliot, Erika
Ginneken, Mireille M. E.
Crossley, George H.
description Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. Methods Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post‐implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow‐up and adverse events (AEs) were recorded upon occurrence. Results Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead‐related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6‐month follow‐up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. Conclusions This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.
doi_str_mv 10.1111/jce.14439
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E. ; Crossley, George H.</creator><creatorcontrib>Jackson, Kevin P. ; Faerestrand, Svein ; Philippon, Francois ; Yee, Raymond ; Kong, Melissa H. ; Kloppe, Axel ; Bongiorni, Maria Grazia ; Lee, Scott F. ; Canby, Robert C. ; Pouliot, Erika ; Ginneken, Mireille M. E. ; Crossley, George H.</creatorcontrib><description>Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. Methods Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post‐implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow‐up and adverse events (AEs) were recorded upon occurrence. Results Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead‐related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6‐month follow‐up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. Conclusions This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.</description><identifier>ISSN: 1045-3873</identifier><identifier>EISSN: 1540-8167</identifier><identifier>DOI: 10.1111/jce.14439</identifier><identifier>PMID: 32162757</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>active fixation ; Aged ; Aged, 80 and over ; cardiac resynchronization therapy ; Cardiac Resynchronization Therapy - adverse effects ; Cardiac Resynchronization Therapy Devices ; Equipment Design ; Female ; Heart ; Heart Failure - diagnosis ; Heart Failure - physiopathology ; Heart Failure - therapy ; Humans ; lead dislodgement ; LV lead ; Male ; Middle Aged ; Prospective Studies ; quadripolar lead ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; Ventricle ; Ventricular Function, Left</subject><ispartof>Journal of cardiovascular electrophysiology, 2020-05, Vol.31 (5), p.1147-1154</ispartof><rights>2020 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4199-a1f068797097ace457be2731299c51f1343418cbc9af61238af73a54b5b413883</citedby><cites>FETCH-LOGICAL-c4199-a1f068797097ace457be2731299c51f1343418cbc9af61238af73a54b5b413883</cites><orcidid>0000-0003-0096-8401 ; 0000-0002-2948-1333</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.14439$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjce.14439$$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/32162757$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jackson, Kevin P.</creatorcontrib><creatorcontrib>Faerestrand, Svein</creatorcontrib><creatorcontrib>Philippon, Francois</creatorcontrib><creatorcontrib>Yee, Raymond</creatorcontrib><creatorcontrib>Kong, Melissa H.</creatorcontrib><creatorcontrib>Kloppe, Axel</creatorcontrib><creatorcontrib>Bongiorni, Maria Grazia</creatorcontrib><creatorcontrib>Lee, Scott F.</creatorcontrib><creatorcontrib>Canby, Robert C.</creatorcontrib><creatorcontrib>Pouliot, Erika</creatorcontrib><creatorcontrib>Ginneken, Mireille M. E.</creatorcontrib><creatorcontrib>Crossley, George H.</creatorcontrib><title>Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results</title><title>Journal of cardiovascular electrophysiology</title><addtitle>J Cardiovasc Electrophysiol</addtitle><description>Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. Methods Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post‐implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow‐up and adverse events (AEs) were recorded upon occurrence. Results Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead‐related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6‐month follow‐up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. Conclusions This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.</description><subject>active fixation</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>cardiac resynchronization therapy</subject><subject>Cardiac Resynchronization Therapy - adverse effects</subject><subject>Cardiac Resynchronization Therapy Devices</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Heart</subject><subject>Heart Failure - diagnosis</subject><subject>Heart Failure - physiopathology</subject><subject>Heart Failure - therapy</subject><subject>Humans</subject><subject>lead dislodgement</subject><subject>LV lead</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>quadripolar lead</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ventricle</subject><subject>Ventricular Function, Left</subject><issn>1045-3873</issn><issn>1540-8167</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc-OFCEQh4nRuOvowRcwJF700LvQQNN420zWf9lEjXruVNOQZcLALNCj7bP4sLL26sFELkUqX32p1A-hp5Sc0frOd9qcUc6ZuodOqeCk6Wkn79c_4aJhvWQn6FHOO0Io64h4iE5YS7tWCnmKfn40yca0h6ANjhYDDvFoPAZd3NFg675DcTHgmxmm5A7RQ8Le2IKPJpTk9Lw2YMLVgjWkyYHGyeQl6OsUg_uxzpdrk-CwvMIXpYAL-HOB0XlXFvypmvHWu-A0-Nqfp-V2fvYlP0YPLPhsntzVDfr6-vLL9m1z9eHNu-3FVaM5VaoBaknXSyWJkqANF3I0rWS0VUoLainjjNNej1qB7WjLerCSgeCjGDllfc826MXqPaR4M5tchr3L2ngPwcQ5Dy2TnWRMqK6iz_9Bd3FOoW5XKSUFbXm99wa9XCmdYs7J2OGQ3B7SMlAy3EY21MiG35FV9tmdcR73ZvpL_smoAucr8M15s_zfNLzfXq7KX6ZdofQ</recordid><startdate>202005</startdate><enddate>202005</enddate><creator>Jackson, Kevin P.</creator><creator>Faerestrand, Svein</creator><creator>Philippon, Francois</creator><creator>Yee, Raymond</creator><creator>Kong, Melissa H.</creator><creator>Kloppe, Axel</creator><creator>Bongiorni, Maria Grazia</creator><creator>Lee, Scott F.</creator><creator>Canby, Robert C.</creator><creator>Pouliot, Erika</creator><creator>Ginneken, Mireille M. E.</creator><creator>Crossley, George H.</creator><general>Wiley Subscription Services, 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>7QP</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0096-8401</orcidid><orcidid>https://orcid.org/0000-0002-2948-1333</orcidid></search><sort><creationdate>202005</creationdate><title>Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results</title><author>Jackson, Kevin P. ; Faerestrand, Svein ; Philippon, Francois ; Yee, Raymond ; Kong, Melissa H. ; Kloppe, Axel ; Bongiorni, Maria Grazia ; Lee, Scott F. ; Canby, Robert C. ; Pouliot, Erika ; Ginneken, Mireille M. E. ; Crossley, George H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4199-a1f068797097ace457be2731299c51f1343418cbc9af61238af73a54b5b413883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>active fixation</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>cardiac resynchronization therapy</topic><topic>Cardiac Resynchronization Therapy - adverse effects</topic><topic>Cardiac Resynchronization Therapy Devices</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Heart</topic><topic>Heart Failure - diagnosis</topic><topic>Heart Failure - physiopathology</topic><topic>Heart Failure - therapy</topic><topic>Humans</topic><topic>lead dislodgement</topic><topic>LV lead</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>quadripolar lead</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ventricle</topic><topic>Ventricular Function, Left</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jackson, Kevin P.</creatorcontrib><creatorcontrib>Faerestrand, Svein</creatorcontrib><creatorcontrib>Philippon, Francois</creatorcontrib><creatorcontrib>Yee, Raymond</creatorcontrib><creatorcontrib>Kong, Melissa H.</creatorcontrib><creatorcontrib>Kloppe, Axel</creatorcontrib><creatorcontrib>Bongiorni, Maria Grazia</creatorcontrib><creatorcontrib>Lee, Scott F.</creatorcontrib><creatorcontrib>Canby, Robert C.</creatorcontrib><creatorcontrib>Pouliot, Erika</creatorcontrib><creatorcontrib>Ginneken, Mireille M. E.</creatorcontrib><creatorcontrib>Crossley, George H.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>ProQuest Health &amp; 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>Jackson, Kevin P.</au><au>Faerestrand, Svein</au><au>Philippon, Francois</au><au>Yee, Raymond</au><au>Kong, Melissa H.</au><au>Kloppe, Axel</au><au>Bongiorni, Maria Grazia</au><au>Lee, Scott F.</au><au>Canby, Robert C.</au><au>Pouliot, Erika</au><au>Ginneken, Mireille M. E.</au><au>Crossley, George H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results</atitle><jtitle>Journal of cardiovascular electrophysiology</jtitle><addtitle>J Cardiovasc Electrophysiol</addtitle><date>2020-05</date><risdate>2020</risdate><volume>31</volume><issue>5</issue><spage>1147</spage><epage>1154</epage><pages>1147-1154</pages><issn>1045-3873</issn><eissn>1540-8167</eissn><abstract>Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. Methods Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post‐implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow‐up and adverse events (AEs) were recorded upon occurrence. Results Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead‐related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6‐month follow‐up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. Conclusions This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32162757</pmid><doi>10.1111/jce.14439</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-0096-8401</orcidid><orcidid>https://orcid.org/0000-0002-2948-1333</orcidid></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects active fixation
Aged
Aged, 80 and over
cardiac resynchronization therapy
Cardiac Resynchronization Therapy - adverse effects
Cardiac Resynchronization Therapy Devices
Equipment Design
Female
Heart
Heart Failure - diagnosis
Heart Failure - physiopathology
Heart Failure - therapy
Humans
lead dislodgement
LV lead
Male
Middle Aged
Prospective Studies
quadripolar lead
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Ventricle
Ventricular Function, Left
title Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results
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