{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T19:18:59Z","timestamp":1761765539566},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2012,4,1]],"date-time":"2012-04-01T00:00:00Z","timestamp":1333238400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pacing Clinical Electrophis"],"published-print":{"date-parts":[[2012,6]]},"abstract":"<jats:p><jats:italic>\n            <jats:bold>Background:<\/jats:bold> The Medtronic Sprint Fidelis (Medtronic Inc., Minneapolis, MN, USA) lead family is associated with an unacceptable incidence of premature lead failure. There are limited data on risk factors for lead fracture. We hypothesized that factors leading to potential increased forces on the lead related to device implantation or technique may be associated with premature lead failure.<\/jats:italic><\/jats:p><jats:p><jats:italic>\n            <jats:bold>Methods:<\/jats:bold> We reviewed the implant data from our group and identified 176 patients who received active fixation Medtronic Fidelis (Model 6931, single coil and Model 6949, dual coil) leads. Implant data, including age, sex, venous access site, implant side, implant location, and number of venous leads were reviewed. Hospital, pacemaker clinic, and Medtronic registration databases were reviewed for evidence of lead failure, replacement, or abandonment. Data was evaluated in univariate and multivariate regression analyses.<\/jats:italic><\/jats:p><jats:p><jats:bold>\n            <jats:italic>Results:<\/jats:italic>\n          <\/jats:bold>\n          <jats:italic>Of the 176 leads implanted, 10 (5.7%) were noted to develop malfunction. This presented as inappropriate shocks from sensed noise or elevated impedance measurements. Of the above noted implant features, only right\u2010sided (vs left\u2010sided) implant (hazard ratio [HR] 18.8, 95% confidence intervals [CI] 3.8, 93.3), and subpectoral implant (vs prepectoral; HR 14.31, 95% CI 3.2, 64.0) were predictive of lead failure in maximally adjusted models.<\/jats:italic><\/jats:p><jats:p><jats:italic>\n            <jats:bold>Conclusions:<\/jats:bold> We have identified both right\u2010sided implantation and subpectoral generator positioning as factors associated with premature lead malfunction in Fidelis active fixation leads. Clinical decisions regarding patient management should incorporate these findings in regard to lead replacement in high\u2010risk patients. (PACE 2012; 35:659\u2013664)<\/jats:italic><\/jats:p>","DOI":"10.1111\/j.1540-8159.2012.03357.x","type":"journal-article","created":{"date-parts":[[2012,4,3]],"date-time":"2012-04-03T12:42:06Z","timestamp":1333456926000},"page":"659-664","source":"Crossref","is-referenced-by-count":9,"title":["Right\u2010Sided Implantation and Subpectoral Position are Predisposing Factors for Fracture of a 6.6 French ICD Lead"],"prefix":"10.1111","volume":"35","author":[{"given":"NEIL E.","family":"BERNSTEIN","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"EDMUND T.","family":"KARAM","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"ANTHONY","family":"AIZER","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"BRIAN C.","family":"WONG","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"DOUGLAS S.","family":"HOLMES","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"SCOTT A.","family":"BERNSTEIN","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"LARRY A.","family":"CHINITZ","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,4]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2007.03.041"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8167.2006.00692.x"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2009.02.024"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.2005.40003.x"},{"key":"e_1_2_6_6_2","first-page":"12","article-title":"Characteristics of Sprint Fidelis lead failure","volume":"16","author":"Beukema RJ","year":"2010","journal-title":"Neth Heart J"},{"key":"e_1_2_6_7_2","unstructured":"GrovesR. 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Physician Letter: Sprint Fidelis Lead Patient Management Recommendations Update Models 6949 6948 6931 6930 and Appendix Medtronic April 2011."},{"key":"e_1_2_6_18_2","first-page":"S242","article-title":"The incidence and clinical predictors of Fidelis lead fractures","volume":"5","author":"Cuoco FA","year":"2008","journal-title":"Heart Rhythm"},{"key":"e_1_2_6_19_2","first-page":"S290","article-title":"The effect of venous access technique and body surface area on transvenous defibrillator lead failure","volume":"5","author":"Gleva MJ","year":"2008","journal-title":"Heart Rhythm"},{"key":"e_1_2_6_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1542-474X.2005.00063.x"}],"container-title":["Pacing and Clinical Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1540-8159.2012.03357.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1540-8159.2012.03357.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T06:38:40Z","timestamp":1698647920000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1540-8159.2012.03357.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,4]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2012,6]]}},"alternative-id":["10.1111\/j.1540-8159.2012.03357.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1540-8159.2012.03357.x","archive":["Portico"],"relation":{},"ISSN":["0147-8389","1540-8159"],"issn-type":[{"value":"0147-8389","type":"print"},{"value":"1540-8159","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,4]]}}}