Clinical Outcome of Implantable Cardioverter Defibrillators With Recalled and Non-Recalled Leads in Japanese Patients

Inden, Yasuya; Shimano, Masayuki; Yoshida, Naoki; Inoue, Hiroshi; Fujita, Masatoshi; Ohguchi, Shiou; Ishikawa, Shinya; Kato, Hiroyuki; Okumura, Satoshi; Miyoshi, Akio; Nagao, Tomoyuki; Yamamoto, Toshihiko; Hirai, Makoto; Murohara, Toyoaki

doi:10.1253/circj.cj-13-1040

Cited by 5 publications

(11 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Of these, 776 were excluded because they either were duplicates or were deemed unsuitable for the purpose of this meta‐analysis (editorials, letters, reviews, or case reports). The remaining 63 results were carefully screened, and after analysis of the full text (in case of journal articles), 17 studies were considered adequate for the purpose of our meta‐analysis. The selection process is illustrated in Figure .…”

Section: Resultsmentioning

confidence: 99%

“…The Durata family had shorter follow-up (6716 lead-years). Mean follow-up in the included studies was usually %2 to 3 years, shown in 13 of the17 selected studies [23][24][25][26][27][28][29][32][33][34][35][36] (Table 1). None of the included studies presented >6 years of median follow-up; the longest was 6.4 years (95% CI 6.0-6.6).…”

Section: Performance Of the Different Lead Familiesmentioning

confidence: 99%

See 1 more Smart Citation

Transvenous Implantable Cardioverter‐Defibrillator (ICD) Lead Performance: A Meta‐Analysis of Observational Studies

Providência

Kramer

Pimenta

et al. 2015

JAHA

View full text Add to dashboard Cite

BackgroundDespite the widespread use of implantable cardioverter‐defibrillators (ICDs) in clinical practice, concerns exist regarding ICD lead durability. The performance of specific lead designs and factors determining this in large populations need clarification.Methods and ResultsThe Medline, Embase, and Cochrane Collaboration databases were searched for studies including ≥2 of the most commonly implanted leads. The Mantel‐Haenszel random‐effects model was used. Seventeen studies were selected, including a total of 49 871 patients—5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)—with follow‐up of 136 509 lead‐years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%–0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per‐year increase) and Sprint Fidelis (>2.0% per‐year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.ConclusionsEndotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long‐term follow‐up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Performance Of the Different Lead Familiesmentioning

confidence: 99%

Transvenous Implantable Cardioverter‐Defibrillator (ICD) Lead Performance: A Meta‐Analysis of Observational Studies

Providência

Kramer

Pimenta

et al. 2015

JAHA

View full text Add to dashboard Cite

show abstract

“…A previous report revealed that the ICD lead survival rate at 5 years was 85% 3 . After reporting the early failure of Riata and Fidelis leads, 4–7 several technological improvements were invented, 8 contributing to the durability of the ICD leads, and the ICD lead survival rate improved to 99%−100% 9,15 . This study demonstrated a 99.3% survival rate, which was a drastic improvement from the historical studies.…”

Section: Discussionmentioning

confidence: 57%

“…The Sprint Fidelis and Riata leads are prone to early failure 4–7 . After reports of these lead recalls, several technological improvements have been invented and the durability of the ICD leads has improved 8,9 . The incidence of lead failures has decreased compared to that in a previous study 10 .…”

Section: Introductionmentioning

confidence: 99%

Transvenous lead performance of implantable cardioverter‐defibrillators and pacemakers

Mori

Kato

Ikeda

et al. 2021

Pacing Clinical Electrophis

View full text Add to dashboard Cite

Background After the reports of recalled leads, several technological improvements have been introduced and the durability of implantable cardioverter defibrillator (ICD) leads has improved. The incidence of lead failures is now less than in the previous studies. However, there are few reports that have shown the long‐term durability of ICD leads as compared to pacemaker (PM) leads. This study analyzed the medium to long‐term performance of transvenous ICD leads as compared to PM leads. Methods We retrospectively studied 1227 cases from April 2007 to December 2017 who underwent an initial transvenous ICD or PM implantation. The number of lead failures and patient background characteristics were analyzed. Results During a median 3–3.5 years follow up period, 1 (0.3%) ICD lead and 18 (2.4%) PM leads failed. The incidence of lead failures was significantly higher in the PM group than ICD group (p = .019). Males were associated with a higher incidence of lead failures in the PM group. Conclusion Since the era of recalled ICD leads, the durability of ICD leads has remarkably improved and the incidence of lead failures with non‐recalled ICD leads has been less than that for PM leads.

show abstract

“…However, contemporary evidence showed that lead failure rate was increasing over the years. The failure rate of this recalled lead reached up to 4.5% per year in long-term follow-up [5]. Given the aging population of our cardiac patients and the increasing dwell-time of leads, the failure rate of non-recall leads would be expected to increase as well.…”

Section: Should We Monitor Patients With Low Bmi or Highly Active Patmentioning

confidence: 99%

Whom to further monitor in remote monitoring?

Barake

Deshmukh

2019

Indian Pacing and Electrophysiology Journal

View full text Add to dashboard Cite

Clinical Outcome of Implantable Cardioverter Defibrillators With Recalled and Non-Recalled Leads in Japanese Patients

Abstract: The rate of Sprint Fidelis lead failure continues to increase over time in Japanese patients.

Cited by 5 publications

References 25 publications

Transvenous Implantable Cardioverter‐Defibrillator (ICD) Lead Performance: A Meta‐Analysis of Observational Studies

Transvenous Implantable Cardioverter‐Defibrillator (ICD) Lead Performance: A Meta‐Analysis of Observational Studies

Transvenous lead performance of implantable cardioverter‐defibrillators and pacemakers

Whom to further monitor in remote monitoring?

Contact Info

Product

Resources

About