Chronic performance of Riata 1580 and Endotak 0158 ICD leads: A single center 10-year experience.

BACKGROUND: The long-term performance of the Riata family of leads has recently come under increasing scrutiny. We aimed to determine the long-term performance of the Riata 1580 leads compared with Endotak 0158 leads. METHODS: All patients with Riata 1580 or Endotak 0158 leads implanted from 2003 to 2008 at the Heart Hospital, UCLH were analyzed. Significant electrical changes were as follows: threshold increase >1 V at a set pulse width between pacing checks, persistent R wave fall to <2 mV or reduction in R wave >50%, noise, pacing impedance change to <300 Ω or >1500 Ω, high voltage (HV) change to <20 Ω or >200 Ω, HV change ± 15 Ω, pacing impedance change >400 Ω over 12 months. RESULTS: 333 Riata and 356 Endotak leads were implanted. Median follow-up time + interquartile range were calculated, after exclusion of censored events including loss to follow-up: Riata 3652 + 655 days, Endotak 3730 + 810 days. A total of 51 (15.9%) Riata leads and 21 (6.3%) Endotak leads were affected. A greater risk of failure was found for the Riata lead compared with the Endotak lead (P = .0001). An additional time-dependent effect was found, with the Riata lead 1.9 times more likely to fail in the first 6 years following lead implantation and 5.3 times more likely to fail after 6 years. CONCLUSIONS: Riata leads have a higher risk of failure compared to Endotak leads over time. The importance of careful ongoing performance surveillance late in the leads' lifetime is reflected in this 10-year follow-up study.

Analysis of early failure of Biotronik Linox Smart implantable cardioverter-defibrillator leads: A comparative study of three defibrillator leads.

BACKGROUND AND OBJECTIVES: Early failure of Biotronik Linox and Linox Smart leads (Biotronik, Berlin, Germany) has been reported in numerous recent publications. The aim of this study was to assess the performance of this lead compared with that of two other contemporary leads. METHODS: We conducted an ambispective study of all consecutive first implantations of defibrillator leads carried out in our center: Endotak (model 148, 158, Boston Scientific, Marlborough, MA, USA) (n = 173), Sprint Quattro (model 6644, 6947, Medtronic, Dublin, Ireland) (n = 145), and Linox Smart (Biotronik, model SD 65/16) (n = 120). RESULTS: During a median follow-up of 4.6 ± 2.1 years, failure occurred in nine Linox Smart (7.5%), one Endotak Reliance (0.6%), and no Sprint Quattro leads. The survival probability of the Linox Smart group was significantly lower than that of the Endotak and Sprint Quattro groups measured by the log-rank test (Linox vs Endotak; P < 0.001 and Linox vs Sprint Quattro; P < 0.001). Nonphysiological signals not due to external interference were observed in all Linox Smart leads, with normal parameters and without visible anomalies on chest x-ray. CONCLUSIONS: In this single-center experience, the survival rate of Linox Smart leads was 88% at 5 years of follow-up, which was significantly lower than that of the other leads. Comprehensive vigilance of Linox Smart leads, including home monitoring, may be advisable to facilitate early detection of lead failure and avoid inappropriate shocks.

Long-term single-center comparison of ICD lead survival: Evidence for premature Linox lead failure.

INTRODUCTION: ICD lead failure is a potential source of significant morbidity and mortality. This study investigates the survival rates of Sprint Quattro, Endotak Reliance, and Linox ICD leads. METHODS AND RESULTS: A retrospective cohort study of all patients with an ICD implanted between January 2007 and December 2012 from the Wellington Hospital region, New Zealand, a tertiary referral center. Lead and patient details were established by review of clinical notes and the PaceArt Optima database. We analyzed a total of 287 implants using Sprint Quattro (n  =  92), Endotak Reliance (n  =  37), Linox (n  =  151), Riata (n  =  4), and Sprint Fidelis (n  =  2) leads. Median follow-up was 61.6 (26.0-81.6) months for Sprint Quattro leads, 66.7 (53.3-88.8) months for Linox leads, and 82.9 (45.9-107.4) months for Endotak Reliance leads. There were 20 cases of lead failure of which 19 were in Linox leads. The 4-, 6-, and 8-year survival for Linox leads was 97% (92.6-99.1), 93% (85.5-96.5), and 76% (62.3-85.5), respectively. The predominant abnormality was detection of nonphysiological electrical signals. Linox lead failure was associated with a younger age of patient (49.2 vs. 57.7 years, P  =  0.007). CONCLUSIONS: The 7-year survival of Linox leads was significantly worse than shown in Biotronik surveillance reports, but in line with other single-center studies from around the world.

Comparison of longevity and clinical outcomes of implantable cardioverter-defibrillator leads among manufacturers.

BACKGROUND: An early failure of the Biotronik Linox S/SD implantable cardioverter-defibrillator (ICD) lead has been reported. We have also experienced several cases with early failure of Linox leads. OBJECTIVE: Our aim was to assess the longevity of Linox S/SD (Biotronik, Berlin, Germany) compared with Sprint Fidelis (Medtronic, Minneapolis, MN), Sprint Quattro (Medtronic), and Endotak Reliance (Boston Scientific, Natick, Massachusetts) leads. METHODS: We retrospectively reviewed patients who had undergone implantation of Linox S/SD (n = 90), Sprint Fidelis (n = 37), Sprint Quattro (n = 27), or Endotak Reliance (n = 50) leads between June 2000 and December 2013 at our hospital. Variables associated with lead failure were assessed by the Kaplan-Meier method and Cox survival modeling. RESULTS: Failure rates of Linox, Sprint Fidelis, and Endotak leads were 3.2%/year (7-year survival rate, 81.0%), 3.4%/year (7-year survival rate, 77.2%), and 0.61%/year (7-year survival rate, 95.8%), respectively. No lead failure was found with Sprint Quattro leads. The survival probability of Linox leads was significantly lower than that of Endotak leads (P = .049) and comparable to that of Sprint Fidelis leads (P = .69). In univariate analysis, age was the only predictor of Linox lead failure. Patients <58 years old were at significantly increased risk of lead failure compared with patients ≥58 years old (hazard ratio, 9.0; 95% confidence interval, 1.13-71.3; P = .037). CONCLUSION: In our single-center experience, the survival rate of Linox leads was unacceptably low. The only predictor of Linox lead failure was age at implantation. This is the first description of a lower survival rate for Linox leads in an Asian population.

Comparative study of the failure rates among 3 implantable defibrillator leads.

BACKGROUND: After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed. OBJECTIVE: The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads. METHODS: We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference. RESULTS: During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%). CONCLUSION: This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.

Failure rate and conductor externalization in the Biotronik Linox/Sorin Vigila implantable cardioverter-defibrillator lead.

BACKGROUND: We observed a case of conductor externalization in a Biotronik Linox lead. OBJECTIVE: The purpose of this study was to investigate lead performance of the Linox lead and the identical Sorin Vigila lead and prevalence of conductor externalization. METHODS: We compared lead performance of all Linox and Vigila leads implanted at our center (BL group; n = 93) with that of all Boston Scientific Endotak Reliance leads (ER group; n = 190) and Medtronic Sprint Quattro leads (SQ group; n = 202) implanted during the same period. We screened all patients in the BL group for conductor externalization. RESULTS: We identified 8 cases of lead failures in the BL group (index case of conductor externalization, 6 cases of nonphysiological high-rate sensing, and 1 case of high-voltage conductor fracture). Prospective fluoroscopic screening of 98% of all active BL group cases revealed 1 additional case of conductor externalization. The median follow-up was 41, 27, and 29 months for the BL group, ER group, and SQ group, respectively; lead survival was 94.9%, 99.2%, and 100% at 3 years and 88%, 97.5%, and 100% at 5 years (P = .038 for BL group vs ER group and P = .007 for BL group vs SQ group using the log-rank test). Younger age at implant was an independent predictor of lead failure in the BL group (adjusted hazard ratio 0.85; 95% confidence interval 0.77-0.94; P = .001). CONCLUSION: At our center, survival of the Linox lead is 88% at 5 years and significantly worse than that of other leads. Conductor externalization is present in a minority of failed Linox leads. Younger age at implant is an independent predictor of Linox lead failure.