Failure of implantable cardioverter-defibrillator leads: A matter of lead size?
Background Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. Objective To compare the incidence of failure of small-diameter (...
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| Veröffentlicht in: | Heart rhythm 2013-02, Vol.10 (2), p.184-190 |
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| creator | Rordorf, Roberto, MD Poggio, Luca, MD Savastano, Simone, MD Vicentini, Alessandro, MD Petracci, Barbara, MD Chieffo, Enrico, MD Klersy, Catherine, MD,MSc Landolina, Maurizio, MD |
| description | Background Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. Objective To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center. Methods From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center. Results During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P |
| doi_str_mv | 10.1016/j.hrthm.2012.10.017 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1287382374</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S1547527112012064</els_id><sourcerecordid>1287382374</sourcerecordid><originalsourceid>FETCH-LOGICAL-c620t-662b1dc86cded73c673f721b7b8f580f6c50c905572a7f0b414c2fb6e3fdefb83</originalsourceid><addsrcrecordid>eNqFkc1u1TAQhS1ERUvLEyChLNnkdmwndooEVVXRglSpi5a15Z-x6ouTXOykUnl6bG5hwYaVreNzZsbfEPKWwoYCFafbzUNaHsYNA8qKsgEqX5Aj2vei5YOkL-u9k23PJD0kr3PeArAzAfwVOWQcBO84HJHbKx3imrCZfRPGXdTTok3ExurkwvyIacHUOvTBpBCjXubURNQuf2gumlEv5bUmq9Tk8BPPT8iB1zHjm-fzmHy7-nx_-aW9ub3-enlx01rBYGmFYIY6Owjr0EluheReMmqkGXw_gBe2B3sGfS-Zlh5MRzvLvBHIfRnGDPyYvN_X3aX5x4p5UWPIFsuIE85rVpQNkg-My65Y-d5q05xzQq92KYw6PSkKqpJUW_WbpKokq1hIltS75warGdH9zfxBVwwf9wYs33wMmFS2ASeLLiS0i3Jz-E-DT__kbQxTsDp-xyfM23lNUyGoqMpMgbqry6y7pLUIiI7_Atctmo8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1287382374</pqid></control><display><type>article</type><title>Failure of implantable cardioverter-defibrillator leads: A matter of lead size?</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Rordorf, Roberto, MD ; Poggio, Luca, MD ; Savastano, Simone, MD ; Vicentini, Alessandro, MD ; Petracci, Barbara, MD ; Chieffo, Enrico, MD ; Klersy, Catherine, MD,MSc ; Landolina, Maurizio, MD</creator><creatorcontrib>Rordorf, Roberto, MD ; Poggio, Luca, MD ; Savastano, Simone, MD ; Vicentini, Alessandro, MD ; Petracci, Barbara, MD ; Chieffo, Enrico, MD ; Klersy, Catherine, MD,MSc ; Landolina, Maurizio, MD</creatorcontrib><description>Background Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. Objective To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center. Methods From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center. Results During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P <.001) and Riata/Riata ST (4.8%/year vs 2.6%/year; P = .03) leads. The incidence of lead failure in Riata/Riata ST leads proved significantly higher than in standard-diameter leads (2.6%/year vs 0.8%/year; P = .001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small-diameter (hazard ratio [HR] 5.03, 2.53–10.01, P <.001), Sprint Fidelis (HR 6.3, 3.1–13.3, P <.001), or Riata/Riata ST (HR 4.5, 1.9–10.5, P = .001) leads and age<60 years (HR 2.3, 1.3–4.3, P = .005) were found to independently increase the risk of lead failure. Conclusions Compared with standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at an increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group.</description><identifier>ISSN: 1547-5271</identifier><identifier>EISSN: 1556-3871</identifier><identifier>DOI: 10.1016/j.hrthm.2012.10.017</identifier><identifier>PMID: 23063430</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Analysis of Variance ; Arrhythmias, Cardiac - diagnosis ; Arrhythmias, Cardiac - mortality ; Arrhythmias, Cardiac - therapy ; Cardiovascular ; Cohort Studies ; Confidence Intervals ; Defibrillator ; Defibrillators, Implantable - adverse effects ; Durata lead ; Electrodes, Implanted - adverse effects ; Equipment Design ; Equipment Failure - statistics & numerical data ; Equipment Failure Analysis ; Female ; Follow-Up Studies ; Humans ; ICD lead ; Lead failure ; Lead size ; Male ; Middle Aged ; Multivariate Analysis ; Predictive Value of Tests ; Proportional Hazards Models ; Retrospective Studies ; Riata lead ; Risk Assessment ; Sprint Fidelis ; Survival Analysis ; Treatment Outcome</subject><ispartof>Heart rhythm, 2013-02, Vol.10 (2), p.184-190</ispartof><rights>Heart Rhythm Society</rights><rights>2013 Heart Rhythm Society</rights><rights>Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c620t-662b1dc86cded73c673f721b7b8f580f6c50c905572a7f0b414c2fb6e3fdefb83</citedby><cites>FETCH-LOGICAL-c620t-662b1dc86cded73c673f721b7b8f580f6c50c905572a7f0b414c2fb6e3fdefb83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.hrthm.2012.10.017$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23063430$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rordorf, Roberto, MD</creatorcontrib><creatorcontrib>Poggio, Luca, MD</creatorcontrib><creatorcontrib>Savastano, Simone, MD</creatorcontrib><creatorcontrib>Vicentini, Alessandro, MD</creatorcontrib><creatorcontrib>Petracci, Barbara, MD</creatorcontrib><creatorcontrib>Chieffo, Enrico, MD</creatorcontrib><creatorcontrib>Klersy, Catherine, MD,MSc</creatorcontrib><creatorcontrib>Landolina, Maurizio, MD</creatorcontrib><title>Failure of implantable cardioverter-defibrillator leads: A matter of lead size?</title><title>Heart rhythm</title><addtitle>Heart Rhythm</addtitle><description>Background Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. Objective To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center. Methods From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center. Results During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P <.001) and Riata/Riata ST (4.8%/year vs 2.6%/year; P = .03) leads. The incidence of lead failure in Riata/Riata ST leads proved significantly higher than in standard-diameter leads (2.6%/year vs 0.8%/year; P = .001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small-diameter (hazard ratio [HR] 5.03, 2.53–10.01, P <.001), Sprint Fidelis (HR 6.3, 3.1–13.3, P <.001), or Riata/Riata ST (HR 4.5, 1.9–10.5, P = .001) leads and age<60 years (HR 2.3, 1.3–4.3, P = .005) were found to independently increase the risk of lead failure. Conclusions Compared with standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at an increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group.</description><subject>Adult</subject><subject>Analysis of Variance</subject><subject>Arrhythmias, Cardiac - diagnosis</subject><subject>Arrhythmias, Cardiac - mortality</subject><subject>Arrhythmias, Cardiac - therapy</subject><subject>Cardiovascular</subject><subject>Cohort Studies</subject><subject>Confidence Intervals</subject><subject>Defibrillator</subject><subject>Defibrillators, Implantable - adverse effects</subject><subject>Durata lead</subject><subject>Electrodes, Implanted - adverse effects</subject><subject>Equipment Design</subject><subject>Equipment Failure - statistics & numerical data</subject><subject>Equipment Failure Analysis</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>ICD lead</subject><subject>Lead failure</subject><subject>Lead size</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Predictive Value of Tests</subject><subject>Proportional Hazards Models</subject><subject>Retrospective Studies</subject><subject>Riata lead</subject><subject>Risk Assessment</subject><subject>Sprint Fidelis</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>1547-5271</issn><issn>1556-3871</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1u1TAQhS1ERUvLEyChLNnkdmwndooEVVXRglSpi5a15Z-x6ouTXOykUnl6bG5hwYaVreNzZsbfEPKWwoYCFafbzUNaHsYNA8qKsgEqX5Aj2vei5YOkL-u9k23PJD0kr3PeArAzAfwVOWQcBO84HJHbKx3imrCZfRPGXdTTok3ExurkwvyIacHUOvTBpBCjXubURNQuf2gumlEv5bUmq9Tk8BPPT8iB1zHjm-fzmHy7-nx_-aW9ub3-enlx01rBYGmFYIY6Owjr0EluheReMmqkGXw_gBe2B3sGfS-Zlh5MRzvLvBHIfRnGDPyYvN_X3aX5x4p5UWPIFsuIE85rVpQNkg-My65Y-d5q05xzQq92KYw6PSkKqpJUW_WbpKokq1hIltS75warGdH9zfxBVwwf9wYs33wMmFS2ASeLLiS0i3Jz-E-DT__kbQxTsDp-xyfM23lNUyGoqMpMgbqry6y7pLUIiI7_Atctmo8</recordid><startdate>20130201</startdate><enddate>20130201</enddate><creator>Rordorf, Roberto, MD</creator><creator>Poggio, Luca, MD</creator><creator>Savastano, Simone, MD</creator><creator>Vicentini, Alessandro, MD</creator><creator>Petracci, Barbara, MD</creator><creator>Chieffo, Enrico, MD</creator><creator>Klersy, Catherine, MD,MSc</creator><creator>Landolina, Maurizio, MD</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>20130201</creationdate><title>Failure of implantable cardioverter-defibrillator leads: A matter of lead size?</title><author>Rordorf, Roberto, MD ; Poggio, Luca, MD ; Savastano, Simone, MD ; Vicentini, Alessandro, MD ; Petracci, Barbara, MD ; Chieffo, Enrico, MD ; Klersy, Catherine, MD,MSc ; Landolina, Maurizio, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c620t-662b1dc86cded73c673f721b7b8f580f6c50c905572a7f0b414c2fb6e3fdefb83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Analysis of Variance</topic><topic>Arrhythmias, Cardiac - diagnosis</topic><topic>Arrhythmias, Cardiac - mortality</topic><topic>Arrhythmias, Cardiac - therapy</topic><topic>Cardiovascular</topic><topic>Cohort Studies</topic><topic>Confidence Intervals</topic><topic>Defibrillator</topic><topic>Defibrillators, Implantable - adverse effects</topic><topic>Durata lead</topic><topic>Electrodes, Implanted - adverse effects</topic><topic>Equipment Design</topic><topic>Equipment Failure - statistics & numerical data</topic><topic>Equipment Failure Analysis</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>ICD lead</topic><topic>Lead failure</topic><topic>Lead size</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Predictive Value of Tests</topic><topic>Proportional Hazards Models</topic><topic>Retrospective Studies</topic><topic>Riata lead</topic><topic>Risk Assessment</topic><topic>Sprint Fidelis</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rordorf, Roberto, MD</creatorcontrib><creatorcontrib>Poggio, Luca, MD</creatorcontrib><creatorcontrib>Savastano, Simone, MD</creatorcontrib><creatorcontrib>Vicentini, Alessandro, MD</creatorcontrib><creatorcontrib>Petracci, Barbara, MD</creatorcontrib><creatorcontrib>Chieffo, Enrico, MD</creatorcontrib><creatorcontrib>Klersy, Catherine, MD,MSc</creatorcontrib><creatorcontrib>Landolina, Maurizio, MD</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>Heart rhythm</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rordorf, Roberto, MD</au><au>Poggio, Luca, MD</au><au>Savastano, Simone, MD</au><au>Vicentini, Alessandro, MD</au><au>Petracci, Barbara, MD</au><au>Chieffo, Enrico, MD</au><au>Klersy, Catherine, MD,MSc</au><au>Landolina, Maurizio, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Failure of implantable cardioverter-defibrillator leads: A matter of lead size?</atitle><jtitle>Heart rhythm</jtitle><addtitle>Heart Rhythm</addtitle><date>2013-02-01</date><risdate>2013</risdate><volume>10</volume><issue>2</issue><spage>184</spage><epage>190</epage><pages>184-190</pages><issn>1547-5271</issn><eissn>1556-3871</eissn><abstract>Background Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. Objective To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center. Methods From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center. Results During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P <.001) and Riata/Riata ST (4.8%/year vs 2.6%/year; P = .03) leads. The incidence of lead failure in Riata/Riata ST leads proved significantly higher than in standard-diameter leads (2.6%/year vs 0.8%/year; P = .001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small-diameter (hazard ratio [HR] 5.03, 2.53–10.01, P <.001), Sprint Fidelis (HR 6.3, 3.1–13.3, P <.001), or Riata/Riata ST (HR 4.5, 1.9–10.5, P = .001) leads and age<60 years (HR 2.3, 1.3–4.3, P = .005) were found to independently increase the risk of lead failure. Conclusions Compared with standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at an increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>23063430</pmid><doi>10.1016/j.hrthm.2012.10.017</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Analysis of Variance Arrhythmias, Cardiac - diagnosis Arrhythmias, Cardiac - mortality Arrhythmias, Cardiac - therapy Cardiovascular Cohort Studies Confidence Intervals Defibrillator Defibrillators, Implantable - adverse effects Durata lead Electrodes, Implanted - adverse effects Equipment Design Equipment Failure - statistics & numerical data Equipment Failure Analysis Female Follow-Up Studies Humans ICD lead Lead failure Lead size Male Middle Aged Multivariate Analysis Predictive Value of Tests Proportional Hazards Models Retrospective Studies Riata lead Risk Assessment Sprint Fidelis Survival Analysis Treatment Outcome |
| title | Failure of implantable cardioverter-defibrillator leads: A matter of lead size? |
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