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 |
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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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fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2376733596</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2376733596</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4199-a1f068797097ace457be2731299c51f1343418cbc9af61238af73a54b5b413883</originalsourceid><addsrcrecordid>eNp1kc-OFCEQh4nRuOvowRcwJF700LvQQNN420zWf9lEjXruVNOQZcLALNCj7bP4sLL26sFELkUqX32p1A-hp5Sc0frOd9qcUc6ZuodOqeCk6Wkn79c_4aJhvWQn6FHOO0Io64h4iE5YS7tWCnmKfn40yca0h6ANjhYDDvFoPAZd3NFg675DcTHgmxmm5A7RQ8Le2IKPJpTk9Lw2YMLVgjWkyYHGyeQl6OsUg_uxzpdrk-CwvMIXpYAL-HOB0XlXFvypmvHWu-A0-Nqfp-V2fvYlP0YPLPhsntzVDfr6-vLL9m1z9eHNu-3FVaM5VaoBaknXSyWJkqANF3I0rWS0VUoLainjjNNej1qB7WjLerCSgeCjGDllfc826MXqPaR4M5tchr3L2ngPwcQ5Dy2TnWRMqK6iz_9Bd3FOoW5XKSUFbXm99wa9XCmdYs7J2OGQ3B7SMlAy3EY21MiG35FV9tmdcR73ZvpL_smoAucr8M15s_zfNLzfXq7KX6ZdofQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2397512487</pqid></control><display><type>article</type><title>Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><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.</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 & 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>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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