Multicenter experience with extraction of the Riata/Riata ST ICD lead

Melanie Maytin, Bruce L. Wilkoff, Michael Brunner, Edmond Cronin, Charles J. Love, Maria Grazia Bongiorni, Luca Segreti, Roger Carrillo, Juan D. Garisto, Steven Kutalek, Faiz Subzposh, Avi Fischer, James O. Coffey, Sandeep R. Gangireddy, Samir Saba, Suneet Mittal, Aysha Arshad, Ryan Michael O'Keefe, Charles A. Henrikson, Peter BelottRoy M. John, Laurence M. Epstein

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

Original languageEnglish
Pages (from-to)1613-1618
Number of pages6
JournalHeart Rhythm
Volume11
Issue number9
DOIs
StatePublished - Jan 1 2014

Fingerprint

Implantable Defibrillators
Superior Vena Cava
Pericardial Effusion
United States Food and Drug Administration
Stroke Volume
Drainage
Lasers
Retrospective Studies
Safety
Infection
Lead

Keywords

  • ICD
  • Lead extraction
  • Lead management

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Maytin, M., Wilkoff, B. L., Brunner, M., Cronin, E., Love, C. J., Grazia Bongiorni, M., ... Epstein, L. M. (2014). Multicenter experience with extraction of the Riata/Riata ST ICD lead. Heart Rhythm, 11(9), 1613-1618. https://doi.org/10.1016/j.hrthm.2014.05.014

Multicenter experience with extraction of the Riata/Riata ST ICD lead. / Maytin, Melanie; Wilkoff, Bruce L.; Brunner, Michael; Cronin, Edmond; Love, Charles J.; Grazia Bongiorni, Maria; Segreti, Luca; Carrillo, Roger; Garisto, Juan D.; Kutalek, Steven; Subzposh, Faiz; Fischer, Avi; Coffey, James O.; Gangireddy, Sandeep R.; Saba, Samir; Mittal, Suneet; Arshad, Aysha; O'Keefe, Ryan Michael; Henrikson, Charles A.; Belott, Peter; John, Roy M.; Epstein, Laurence M.

In: Heart Rhythm, Vol. 11, No. 9, 01.01.2014, p. 1613-1618.

Research output: Contribution to journalArticle

Maytin, M, Wilkoff, BL, Brunner, M, Cronin, E, Love, CJ, Grazia Bongiorni, M, Segreti, L, Carrillo, R, Garisto, JD, Kutalek, S, Subzposh, F, Fischer, A, Coffey, JO, Gangireddy, SR, Saba, S, Mittal, S, Arshad, A, O'Keefe, RM, Henrikson, CA, Belott, P, John, RM & Epstein, LM 2014, 'Multicenter experience with extraction of the Riata/Riata ST ICD lead', Heart Rhythm, vol. 11, no. 9, pp. 1613-1618. https://doi.org/10.1016/j.hrthm.2014.05.014
Maytin M, Wilkoff BL, Brunner M, Cronin E, Love CJ, Grazia Bongiorni M et al. Multicenter experience with extraction of the Riata/Riata ST ICD lead. Heart Rhythm. 2014 Jan 1;11(9):1613-1618. https://doi.org/10.1016/j.hrthm.2014.05.014
Maytin, Melanie ; Wilkoff, Bruce L. ; Brunner, Michael ; Cronin, Edmond ; Love, Charles J. ; Grazia Bongiorni, Maria ; Segreti, Luca ; Carrillo, Roger ; Garisto, Juan D. ; Kutalek, Steven ; Subzposh, Faiz ; Fischer, Avi ; Coffey, James O. ; Gangireddy, Sandeep R. ; Saba, Samir ; Mittal, Suneet ; Arshad, Aysha ; O'Keefe, Ryan Michael ; Henrikson, Charles A. ; Belott, Peter ; John, Roy M. ; Epstein, Laurence M. / Multicenter experience with extraction of the Riata/Riata ST ICD lead. In: Heart Rhythm. 2014 ; Vol. 11, No. 9. pp. 1613-1618.
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abstract = "Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84{\%}]; Riata ST 89, [16{\%}]). Complete procedural success achieved in 99.1{\%}. The cohort was 78{\%} men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34{\%} ± 14{\%}. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0{\%}]) and 220 (35.7{\%}) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9{\%} were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7{\%} vs 17.7{\%} failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87{\%}). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.",
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author = "Melanie Maytin and Wilkoff, {Bruce L.} and Michael Brunner and Edmond Cronin and Love, {Charles J.} and {Grazia Bongiorni}, Maria and Luca Segreti and Roger Carrillo and Garisto, {Juan D.} and Steven Kutalek and Faiz Subzposh and Avi Fischer and Coffey, {James O.} and Gangireddy, {Sandeep R.} and Samir Saba and Suneet Mittal and Aysha Arshad and O'Keefe, {Ryan Michael} and Henrikson, {Charles A.} and Peter Belott and John, {Roy M.} and Epstein, {Laurence M.}",
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T1 - Multicenter experience with extraction of the Riata/Riata ST ICD lead

AU - Maytin, Melanie

AU - Wilkoff, Bruce L.

AU - Brunner, Michael

AU - Cronin, Edmond

AU - Love, Charles J.

AU - Grazia Bongiorni, Maria

AU - Segreti, Luca

AU - Carrillo, Roger

AU - Garisto, Juan D.

AU - Kutalek, Steven

AU - Subzposh, Faiz

AU - Fischer, Avi

AU - Coffey, James O.

AU - Gangireddy, Sandeep R.

AU - Saba, Samir

AU - Mittal, Suneet

AU - Arshad, Aysha

AU - O'Keefe, Ryan Michael

AU - Henrikson, Charles A.

AU - Belott, Peter

AU - John, Roy M.

AU - Epstein, Laurence M.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

AB - Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

KW - ICD

KW - Lead extraction

KW - Lead management

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