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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EThe observational CREDO study of Riata silicone endocardial defibrillation leads demonstrates that the average rate of electrical failure for 7 French and 8 French Riata leads was 5.9% over a mean follow-up of 7.5 years, with a trend toward a higher failure rate with cable externalization with 8 Fr leads.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecable externalization\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECREDO\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eelectrical failure\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERiata leads\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiac implantable electronic devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003ERatika Parkash, MD, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada, presented results of the Canadian Registry of Cardiac Implantable Electronic Device Outcomes (CREDO) study, demonstrating that over a mean follow-up of 7.5 years, the rate of electrical failure was similar for 7 French (Fr) and 8 Fr Riata leads, with an average failure rate of 5.9%.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECable externalization and insulation abrasion are known to occur with Riata silicone endocardial defibrillation leads. The electrical and structural failure rates have been described, but the current rates are not known. Also, the relationship of cable externalization to electrical failure is not well described.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ECREDO was a prospective, observational cohort study that involved 15 Canadian centers. The overall objective was to perform an observational study of Riata leads under advisory in Canada. The specific objectives were to determine the electrical and structural failure rates of the leads over time and to determine the predictors of such failure.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe patient population included patients with a St Jude Medical Riata model implanted under advisory in Canada. Patients were followed as per Canadian guidelines for device follow-up. Radiographic screening was not mandated and was left up to the discretion of each center. The end points were death attributable to lead malfunction, incidence of cable externalization, and incidence of electric lead failure.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EA total of 2707 patients were observed (mean age 63.2 years; 19.3% women) with a mean follow-up time of 7.47 years. Across all centers, 8 Fr leads were used in 70.2% of cases and 7 Fr leads were used in 29.8% of cases.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EOn average, 8 Fr leads had a longer follow-up and the 10-year failure rate of 8 Fr leads was 5.9%, while an 8-year failure rate of 7 Fr leads was 5.1% (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The difference was not statistically significant, and the average failure rate was 5.9% over a mean follow-up of 7.5 years.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/12\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Cumulative Incidence of Electrical FailureFr, French.Reproduced with permission from R Parkash, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1713832920\u0022 data-figure-caption=\u0022Cumulative Incidence of Electrical FailureFr, French.Reproduced with permission from R Parkash, MD.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/12\/14\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/12\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/12\/14\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16702\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ECumulative Incidence of Electrical Failure\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EFr, French.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EReproduced with permission from R Parkash, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003ECable externalization occurred at a rate of 7.4% in 8 Fr leads vs 4.9% in 7 Fr leads, mainly occurring after 4 years of follow-up. Among patients who underwent radiographic screening (n\u2005=\u20051187), cable externalization occurred in 6.7% of all patients. A total of 10.1% of patients experienced cable externalization with electrical failure (9.4% with 8 Fr leads vs 13.3% with 7 Fr leads).\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EMultivariate predictors of lead failure were younger age (HR, 0.84; 95% CI, 0.75 to 0.95; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01; per 10 years) and higher left ventricular ejection fraction grouped into 10% deciles (HR, 1.26; 95% CI, 1.10 to 1.45; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01).\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe risk of major complications in lead revisions was 6.32%. Complications included infection, pneumothorax, death, lead dislodgement, reoperation, and hematoma.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EDr Parkash concluded that over a mean follow-up of 7.5 years, the rate of electrical failure was similar for 7 Fr and 8 Fr Riata leads. There was a trend toward a higher failure rate with cable externalization with 8 Fr leads. The risk of major complications in lead revisions at 6.3% was similar to the rate of electrical failure (5.9%). Finally, Dr Parkash stressed that isolated lead revision or extraction due to advisory is not warranted.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/12\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzljdp\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzljdp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}