Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead

Melanie Maytin, Charles J. Love, Avi Fischer, Roger Carrillo, Juan D. Garisto, Maria Grazia Bongiorni, Luca Segreti, Roy M. John, Gregory F. Michaud, Christine M. Albert, Laurence M. Epstein

Research output: Contribution to journalArticle

66 Citations (Scopus)

Abstract

Objectives: This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. Background: The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. Methods: We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. Results: Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths. Conclusions: Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.

Original languageEnglish
Pages (from-to)645-650
Number of pages6
JournalJournal of the American College of Cardiology
Volume56
Issue number8
DOIs
StatePublished - Aug 17 2010

Fingerprint

Implantable Defibrillators
Logistic Models
Safety
Defibrillators
Traction
Cohort Studies
Retrospective Studies
Odds Ratio
Lead
Guidelines
Confidence Intervals
Infection

Keywords

  • countertraction sheath assistance
  • CTS
  • ICD
  • implantable cardioverter- defibrillator
  • interquartile range
  • IQR

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Maytin, M., Love, C. J., Fischer, A., Carrillo, R., Garisto, J. D., Bongiorni, M. G., ... Epstein, L. M. (2010). Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. Journal of the American College of Cardiology, 56(8), 645-650. https://doi.org/10.1016/j.jacc.2010.03.058

Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. / Maytin, Melanie; Love, Charles J.; Fischer, Avi; Carrillo, Roger; Garisto, Juan D.; Bongiorni, Maria Grazia; Segreti, Luca; John, Roy M.; Michaud, Gregory F.; Albert, Christine M.; Epstein, Laurence M.

In: Journal of the American College of Cardiology, Vol. 56, No. 8, 17.08.2010, p. 645-650.

Research output: Contribution to journalArticle

Maytin, M, Love, CJ, Fischer, A, Carrillo, R, Garisto, JD, Bongiorni, MG, Segreti, L, John, RM, Michaud, GF, Albert, CM & Epstein, LM 2010, 'Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead', Journal of the American College of Cardiology, vol. 56, no. 8, pp. 645-650. https://doi.org/10.1016/j.jacc.2010.03.058
Maytin, Melanie ; Love, Charles J. ; Fischer, Avi ; Carrillo, Roger ; Garisto, Juan D. ; Bongiorni, Maria Grazia ; Segreti, Luca ; John, Roy M. ; Michaud, Gregory F. ; Albert, Christine M. ; Epstein, Laurence M. / Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. In: Journal of the American College of Cardiology. 2010 ; Vol. 56, No. 8. pp. 645-650.
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abstract = "Objectives: This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. Background: The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4{\%} and 7.3{\%}. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. Methods: We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. Results: Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4{\%}), and 26.5{\%} were extracted prophylactically. The other major indication for extraction was infection (22.8{\%}). Extraction was achieved with simple traction in 49.4{\%} leads; CTS assistance was required in 174 cases (50.6{\%}). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95{\%} confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths. Conclusions: Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.",
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AU - Maytin, Melanie

AU - Love, Charles J.

AU - Fischer, Avi

AU - Carrillo, Roger

AU - Garisto, Juan D.

AU - Bongiorni, Maria Grazia

AU - Segreti, Luca

AU - John, Roy M.

AU - Michaud, Gregory F.

AU - Albert, Christine M.

AU - Epstein, Laurence M.

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N2 - Objectives: This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. Background: The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. Methods: We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. Results: Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths. Conclusions: Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.

AB - Objectives: This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. Background: The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. Methods: We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. Results: Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths. Conclusions: Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.

KW - countertraction sheath assistance

KW - CTS

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KW - implantable cardioverter- defibrillator

KW - interquartile range

KW - IQR

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