Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads

Raed H. Abdelhadi, Samir F. Saba, Christopher R. Ellis, Pamela K. Mason, Daniel B. Kramer, Paul Andrew Friedman, Melanie T. Gura, John P. Dimarco, Andrew S. Mugglin, Matthew R. Reynolds, Raveen R. Bazaz, Linda Kallinen Retel, David L. Hayes, Robert G. Hauser

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. Methods: The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. Results: From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2±2.4 years vs 3.3±1.7 years; P<.0001). During the study, 67 leads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P =.422). Conclusions: The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.

Original languageEnglish (US)
Pages (from-to)361-365
Number of pages5
JournalHeart Rhythm
Volume10
Issue number3
DOIs
StatePublished - Mar 2013

Fingerprint

Implantable Defibrillators
Multicenter Studies
Survival
Retrospective Studies
Lead

Keywords

  • Complication
  • Failure
  • Implantable cardioverter-defibrillator
  • Insulation
  • Lead

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Abdelhadi, R. H., Saba, S. F., Ellis, C. R., Mason, P. K., Kramer, D. B., Friedman, P. A., ... Hauser, R. G. (2013). Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm, 10(3), 361-365. https://doi.org/10.1016/j.hrthm.2012.10.045

Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. / Abdelhadi, Raed H.; Saba, Samir F.; Ellis, Christopher R.; Mason, Pamela K.; Kramer, Daniel B.; Friedman, Paul Andrew; Gura, Melanie T.; Dimarco, John P.; Mugglin, Andrew S.; Reynolds, Matthew R.; Bazaz, Raveen R.; Retel, Linda Kallinen; Hayes, David L.; Hauser, Robert G.

In: Heart Rhythm, Vol. 10, No. 3, 03.2013, p. 361-365.

Research output: Contribution to journalArticle

Abdelhadi, RH, Saba, SF, Ellis, CR, Mason, PK, Kramer, DB, Friedman, PA, Gura, MT, Dimarco, JP, Mugglin, AS, Reynolds, MR, Bazaz, RR, Retel, LK, Hayes, DL & Hauser, RG 2013, 'Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads', Heart Rhythm, vol. 10, no. 3, pp. 361-365. https://doi.org/10.1016/j.hrthm.2012.10.045
Abdelhadi, Raed H. ; Saba, Samir F. ; Ellis, Christopher R. ; Mason, Pamela K. ; Kramer, Daniel B. ; Friedman, Paul Andrew ; Gura, Melanie T. ; Dimarco, John P. ; Mugglin, Andrew S. ; Reynolds, Matthew R. ; Bazaz, Raveen R. ; Retel, Linda Kallinen ; Hayes, David L. ; Hauser, Robert G. / Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. In: Heart Rhythm. 2013 ; Vol. 10, No. 3. pp. 361-365.
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abstract = "Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. Methods: The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. Results: From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2±2.4 years vs 3.3±1.7 years; P<.0001). During the study, 67 leads failed (6.2{\%}), including 62 of 774 Riata (8.0{\%}) and 5 of 307 Riata ST (1.6{\%}) leads. Forty-seven of 67 lead failures (70.1{\%}) were caused by electrical malfunction, and 20 lead failures (29.9{\%}) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32{\%}) and 1 of 29 Riata ST (3.4{\%}) leads. Of 26 Riata leads with ECs, 7 (27{\%}) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P =.422). Conclusions: The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.",
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AU - Abdelhadi, Raed H.

AU - Saba, Samir F.

AU - Ellis, Christopher R.

AU - Mason, Pamela K.

AU - Kramer, Daniel B.

AU - Friedman, Paul Andrew

AU - Gura, Melanie T.

AU - Dimarco, John P.

AU - Mugglin, Andrew S.

AU - Reynolds, Matthew R.

AU - Bazaz, Raveen R.

AU - Retel, Linda Kallinen

AU - Hayes, David L.

AU - Hauser, Robert G.

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N2 - Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. Methods: The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. Results: From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2±2.4 years vs 3.3±1.7 years; P<.0001). During the study, 67 leads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P =.422). Conclusions: The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.

AB - Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance. Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers. Methods: The study included adults who received St Jude Medical Riata or Riata ST leads. Data for Quattro Secure leads were obtained from an earlier study. Results: From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2±2.4 years vs 3.3±1.7 years; P<.0001). During the study, 67 leads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P =.422). Conclusions: The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.

KW - Complication

KW - Failure

KW - Implantable cardioverter-defibrillator

KW - Insulation

KW - Lead

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