Passive-fixation lead failure rates and long-term patient mortality in subjects implanted with Sprint Fidelis electrodes

2014 | journal article; research paper. A publication with affiliation to the University of Göttingen.

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​Passive-fixation lead failure rates and long-term patient mortality in subjects implanted with Sprint Fidelis electrodes​
Vollmann, D.; Woronowicz, S.; Kmiec, L.; Jung, K. ; Zenker, D. ; Seegers, J. & Sossalla, S.  et al.​ (2014) 
EP Europace16(2) pp. 258​-264​.​ DOI: https://doi.org/10.1093/europace/eut185 

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Authors
Vollmann, Dirk; Woronowicz, Sandra; Kmiec, Lukasz; Jung, Klaus ; Zenker, Dieter ; Seegers, Joachim; Sossalla, Samuel ; Dorenkamp, Marc; Sohns, Christian; Luethje, Lars ; Hasenfuß, Gerd ; Zabel, Markus 
Abstract
To evaluate passive-fixation lead failure rates and long-term patient survival in subjects implanted with Sprint Fidelis electrodes. We identified 748 subjects who received a Sprint Fidelis (n 429; Medtronic models 6948: 94.8, 6949: 2.6, 6930: 1.9, 6931: 0.7) or a Sprint non-Fidelis implantable cardioverter defibrillator lead (n 319, Medtronic models 6944: 68.6, 6947: 17.9, 6942: 7.8, 6943: 3.4, 6945: 2.2) at our centre between 1998 and 2008. KaplanMeier patient survival was lower in the Fidelis group than in the Control cohort (68.4 vs. 77.0 at 5 years, P 0.0061), but multivariate analyses revealed no significant association between mortality and implanted lead type. Passive-fixation lead failure rate at 5 years was 14.4 (95 confidence interval (CI) [9.2, 19.3]) in the Fidelis (n 414) group and 1.8 (95 CI [0.03.8]) in the Control (n 241) cohort (P 0.001 upon multivariate comparison). Failure rates of passive-fixation Sprint Fidelis leads are increased and similar to those previously reported for active-fixation Fidelis electrodes. Despite the elevated risk for lead failure and its potential sequelae, the Sprint Fidelis has no obvious impact on long-term mortality.
Issue Date
2014
Journal
EP Europace 
ISSN
1099-5129
eISSN
1532-2092

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