Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure

doi:10.1016/j.hrthm.2009.02.024

Heart Rhythm

Volume 6, Issue 5, May 2009, Pages 605-610

https://doi.org/10.1016/j.hrthm.2009.02.024 Get rights and content

Background

The Medtronic Sprint Fidelis defibrillator lead is prone to fracture and was recalled in 2007 after 665 failures and five reported deaths. Approximately 150,000 patients at risk for sudden death in the United States have Sprint Fidelis leads. The rate of Sprint Fidelis lead failure may be increasing, and physicians are confronted with the decision to replace the lead prophylactically.

Objective

The purpose of this study was to determine if the hazard of Sprint Fidelis lead failure is changing and to compare its performance to other contemporary implantable cardioverter-defibrillator (ICD) leads.

Methods

Transvenous ICD leads implanted and followed at our two tertiary-care referral centers between January 2004 and December 2008 were included in the study. Lead failure data were entered prospectively by both centers via the Multicenter Registry. Clinical data were collected prospectively by each center and merged for the purpose of this study.

Results

During 5,700 implant years of follow-up (average 1.9 ± 1.3 years), 94 of 3,037 defibrillator leads failed (1.65%/year), including 72 (8.5%) of 848 Sprint Fidelis leads. The cumulative hazard of Sprint Fidelis failure was significantly greater compared to 2,189 other defibrillator leads (P <.0001), and the hazard of Sprint Fidelis failure accelerated after the first year and continued to increase during the study. In contrast to other defibrillator leads, the Sprint Fidelis failure rate was significantly higher (3.75%/year vs 0.58%/year) and the 3-year estimated survival was significantly lower (87.9% [95% CI 84.8, 90.9] vs 98.5% [95% CI 97.8, 99.3]; P <.0001). The chance that a Sprint Fidelis lead would survive another year decreased progressively during the study. Most Sprint Fidelis failures were caused by pace-sense conductor fracture (n = 63 [87.5%]), which caused inappropriate shocks in 36 of 72 patients.

Conclusion

The hazard of Sprint Fidelis lead failure is increasing, whereas the failure rates of other defibrillator leads are low and stable. Physicians should consider these data when managing patients who have Sprint Fidelis leads.

Introduction

The Medtronic Sprint Fidelis implantable cardioverter-defibrillator (ICD) high-voltage lead is prone to fracture.1, 2 The manufacturer voluntarily removed the lead from the market in October 2007 after 665 confirmed fractures and five reported deaths.³ Medtronic currently estimates that 150,000 patients at high risk for sudden cardiac death in the United States have Fidelis leads.⁴ Although initial reports suggested failure rates less than 2%,1, 2 recent evidence suggests that the risk of Fidelis lead fracture is increasing with time.⁵ Moreover, the manufacturer's clinical studies show a downward trend in Fidelis survival.⁶

At issue is whether the manufacturer's current recommendations regarding patient management are appropriate for the majority of patients, namely, to monitor the Fidelis lead for signs of fracture and to not replace it unless a defect is identified.⁷ However, prophylactic replacement of Fidelis leads in selected patients may be reasonable if the benefits clearly outweigh the risks. Patients who have received an ICD for secondary prevention of sudden cardiac death, who have been rescued by the ICD, or who are pacemaker dependent (asystolic) may benefit from prophylactic Fidelis replacement. Nevertheless, lead replacement with or without extraction of a chronic lead is associated with known complications, including infection, pericardial tamponade, and death. However, these major adverse events may be mitigated if Fidelis lead replacement is performed at the time of pulse generator change by experienced operators in high-volume centers. Although the procedural risks are specific to individual patients, operators, and hospitals,⁸ the device risks depend on the chance of a Fidelis failing over time, the potential clinical consequences of Fidelis failure for an individual patient, and the reliability of the replacement lead. Therefore, we sought to examine the performance of Fidelis leads at our two centers to determine if the hazard of Fidelis failure is changing and to compare the Fidelis failure rate and survival to those of other ICD lead models implanted at our hospitals during the same period.

Section snippets

Study design

Transvenous ICD lead failure data were entered prospectively into the Multicenter Registry database.⁹ Implant and follow-up data were collected prospectively by each center and merged for the purposes of the study.

Study population

All transvenous leads that were implanted and followed at the Minneapolis Heart Institute (Minneapolis, MN, USA) and the Mayo Clinic (Rochester, MN, USA) for a minimum of 1 month between January 2004 and December 2008 were included in the study.

Implant techniques and follow-up

Leads were inserted via left-sided or

Results

During the study, 3,037 leads were implanted and followed by the two centers. Of these, 2,318 (75.8%) were active as of December 2008, 94 (3.0%) had failed, 272 (9.3%) had been removed from service due to patient death, 176 (6.3%) were abandoned or explanted for reasons unrelated to lead performance, and 177 (5.7%) patients were lost to follow-up more than 90 days after implant. Leads were implanted an average of 22.5 ± 15.3 months (median 19.8 months; range 31 days to 57.9 months).

Discussion

The results of this prospective two-center study show that the hazard of Sprint Fidelis failure is increasing significantly compared to other contemporary defibrillator leads. Furthermore, the rate of Fidelis failure appeared to accelerate after the first implant year and showed no sign of abating. The chance that a Fidelis lead would survive another year decreased progressively during the study. These findings are timely and important because physicians are increasingly confronted with the

Conclusion

The hazard of Sprint Fidelis defibrillator lead fracture appears to be accelerating. In contrast, the failure rates of other contemporary leads are low and stable. These data should be considered when physicians decide whether a normally functioning Fidelis lead should be replaced at the time of pulse generator change. However, the results of this study do not justify routine prophylactic replacement of normally functioning Fidelis leads. Such a decision should be based on the indication for

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Implantable cardioverter-defibrillators (ICDs) represent transformational technology, arguably the most significant advance in cardiovascular medicine in 50 years. The vision and determination of pioneers Mirowski and Mower was fundamental to this monumental achievement, working with limited resources and confronted by skepticism/criticism from medical establishment. The inventors were followed >35 years in which a multitude of innovative clinical scientists and engineers introduced technological advances leading to the sophisticated devices in practice today. A pivotal patient experiment with automated termination of ventricular fibrillation (1980) led to U.S. Food and Drug Administration approval. Transvenous lead systems converted ICDs from thoracotomy-based secondary prevention to primary prevention of sudden death devices in countless patients worldwide. ICD acceptance was solidified by prospective randomized controlled trials showing reduced mortality superior to antiarrhythmic drugs. ICDs eventually expanded from coronary disease to inherited arrhythmia conditions (eg, hypertrophic cardiomyopathy). The ICD breakthrough story demonstrates how significant progress is possible in medicine against all odds, given fearless imagination to pursue novel ideas that conflict with accepted wisdom.
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Chronic kidney disease (CKD) and hemodialysis increase the risk of sudden cardiac death (SCD) in heart failure (HF); however, national trends in utilization and outcomes of implantable cardioverter-defibrillator (ICD) in this population remain unknown. We sought to evaluate the utilization and outcomes of ICD therapy in HF patients with CKD and end-stage renal disease (ESRD) using the National Inpatient Sample from 2009 to 2018. Hospitalizations with a discharge diagnosis of systolic HF and ICD implantation were identified and stratified by stages of kidney disease. A total of 281,219 systolic HF hospitalizations who underwent ICD implantation were included. A significant decrease in inpatient ICD implantation was observed over the past decade (3.7% in 2009 to 1.1% in 2018) regardless of renal impairment. In-hospital mortality was highest in ESRD, followed by CKD compared with patients with no CKD. Length of hospital stay and hospitalization costs were also significantly higher in patients with CKD and ESRD. The overall utilization of inpatient ICD implantation has decreased in systolic HF patients and inpatient ICD placement in CKD is associated with an increased risk of mortality and adverse clinical outcomes. This indicates that patients with renal impairment and HF represent a sicker cohort than the general HF population.
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Citation Excerpt :
If TV-ICD–related infection rates may vary between 0.67% and 1.49% over a 3- to 12-month follow-up period,3 lead failure rates significantly differ according to the lead type, the year of implantation (with older leads more likely to fail), and the follow-up duration. Indeed, if the Riata4 and Fidelis5 leads have shown the highest rates of lead failure (up to 25%) and they have thereby been recalled, when assessing the most used leads (Durata, Endotak Reliance, Sprint Quattro Secure, and Linox), the estimated rates of freedom from lead failure at 5 years ranged from 97.7% to 98.9%.6 In this analysis, the authors used lead replacement as a surrogate for lead failure, which may indeed have led to an underestimation of total lead failure events.
Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion.
The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort.
Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.
A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191–3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P = .001) were protective factors.
The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
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To determine the outcome of high-risk patients with inherited arrhythmia syndromes and genetic cardiomyopathies comparing two defibrillator technologies.
Between 2010 and 2018, 183 consecutive patients from two large German tertiary care centers were enrolled in the study. The majority of patients (83%) had either cardiac channelopathies or idiopathic ventricular fibrillation without cardiac structural abnormalities, while the remaining 17% had a genetic cardiomyopathy (HCM/ARVC). Eighty-six patients (47%) received a transvenous ICD (TV-ICD), while a subcutaneous ICD (S-ICD) was implanted in another 97 patients (53%).
During a mean follow-up of 4.3 years, 30 patients had an appropriate ICD therapy (annual rate 3.8%). Fifteen patients experienced an inappropriate shock (annual rate 1.9%). Lead failure occurred in 17 (9%) patients and was less frequent in the S-ICD group (OR 0.48, 95%CI 0.38–0.62). Adverse defibrillator events, defined as a composite of inappropriate shocks and lead failure requiring surgical revision were significantly lower in the S-ICD group as compared to the TV-ICD group (OR 0.55, 95%CI 0.41–0.72). There was a non-significant trend towards lower appropriate shocks in the S-ICD group, that in combination with all-cause shocks yielded in a significantly higher freedom of any shock in the S-ICD group (RR 39%, p = 0.003). No deaths occurred during follow-up.
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: Dr. Hayes has received honoraria from Medtronic, Boston Scientific [Guidant], St. Jude Medical, Sorin/ELA, and Blackwell/Wiley; has served and/or is serving on an Advisory Board of Boston Scientific (Guidant), St. Jude Medical, Sorin/ELA, and AI-Semi; serves on a Steering Committee of St. Jude (DSMB); and has received royalties from Blackwell/Futura.

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Original-clinicalDeviceIncreasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Study design

Study population

Implant techniques and follow-up

Results

Discussion

Conclusion

Heart Rhythm

Heart Rhythm

Heart Rhythm

Heart Rhythm

Heart Rhythm

Heart Rhythm

Urgent Medical Device Information: Sprint Fidelis Lead Patient Management Recommendations

Original-clinical
Device
Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure