Transvenous extraction of implantable cardioverter-defibrillator leads under advisory—A comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads

doi:10.1016/j.hrthm.2013.06.021

Heart Rhythm

Volume 10, Issue 10, October 2013, Pages 1444-1450

https://doi.org/10.1016/j.hrthm.2013.06.021 Get rights and content

Background

Comparative safety and efficacy associated with transvenous lead extraction (TLE) of recalled and non-recalled implantable cardioverter-defibrillator (ICD) leads has not been well characterized.

Objectives

To compare the indications, techniques, and procedural outcomes of recalled vs non-recalled ICD lead extraction procedures.

Methods

TLE procedures performed at our institution from June 2002 to June 2012 in which Riata, Sprint Fidelis, or non-recalled ICD leads were extracted were included in the analysis.

Results

ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Sprint Fidelis, and 1 Riata and Sprint Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads. Overall, there was 96.8% complete procedural success, 99.1% clinical success, and 0.9% failure, with 3.9% minor complications and 1.5% major complications. Procedural outcomes for Riata and Sprint Fidelis TLE procedures were no different. Lead implant duration was significantly less in recalled than in non-recalled ICD lead TLE procedures. Complete procedural success was higher in recalled (424 of 430 [98.6%]) than in non-recalled (621 of 649 [95.7%]; P = .007) ICD lead TLE procedures. Minor complications were lower in recalled (10 of 430 [2.3%]) than in non-recalled (32 of 649 [5.0%]; P = .030) ICD lead TLE procedures. Rates of clinical success, failure, and major complications were no different in the recalled and non-recalled ICD lead TLE procedures.

Conclusion

In our experience, recalled ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads.

Introduction

Implantable cardioverter-defibrillator (ICD) systems provide valuable lifesaving therapies for patients with life-threatening tachyarrhythmias. Expanding indications for ICD therapy coupled with improving survival of patients with cardiovascular disease has resulted in millions of patients who rely on functioning ICD systems.1, 2 Failure of high-voltage leads can compromise ICD function, causing inappropriate shocks, loss of pacing, failure of defibrillation, fatal proarrhythmia, and even death.

The Sprint Fidelis (Medtronic, Minneapolis, MN; referred to as Fidelis hereafter) family of ICD leads have been found to be prone to conductor fracture and are a prototypical example of high- and low-voltage failure in ICD leads.³ Fidelis lead fracture may result in inappropriate shocks and loss of both brady- and tachyarrythmia therapy. In 2007, Medtronic voluntarily suspended distribution of Fidelis leads and the Food and Drug Administration (FDA) announced a class I device recall shortly thereafter.⁴

More recently, the Riata (8-F) and Riata ST (7-F) (St Jude Medical, Sylmar, CA; referred to as Riata hereafter) family of ICD leads have demonstrated a propensity for the conductor cables to wear through the silicone insulation from inside-out (externalized conductors [ECs]; Figure 1).⁵ Riata leads were removed from the market by St Jude Medical in 2010, and the FDA announced a class I device recall in 2011.⁶

The incidence of ECs detected by radiographic screening has ranged from 12% to 33% in case series5, 7, 8, 9, 10, 11, 12 and is higher in 8-F than in 7-F leads.5, 7, 13 Many of these leads, however, continue to function normally despite the presence of ECs. In addition, lead failures due to pace/sense or high-voltage conductor deterioration without ECs are seen, rendering the usefulness of radiographic screening, as suggested by the FDA, questionable.⁶

The transvenous lead extraction (TLE) outcomes of Fidelis leads in high-volume centers have been good,¹⁴ but other reports have been less reassuring.¹⁵ However, the safety and efficacy associated with TLE of Riata leads is not well described,13, 16, 17, 18 and the TLE outcomes of neither Riata nor Fidelis leads have been compared with those of non-recalled ICD leads. Our goal was to compare the indications, techniques, and procedural outcomes of recalled (Riata and Fidelis) and non-recalled ICD lead extraction procedures.

Section snippets

Methods

We retrospectively analyzed consecutive patients who underwent TLE of an ICD lead at the Cleveland Clinic between June 2002 and June 2012. The timeframe encompassed all Riata and Fidelis ICD lead extraction procedures through June 2012. Demographic, historical, and procedural data were obtained from the electronic medical record and institutional databases. The study was approved by the Institutional Review Board of the Cleveland Clinic.

Lead extraction was defined as removal of a lead implanted

Results

During the period from June 2002 to June 2012, ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Fidelis, and 1 Riata and Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads (Table 1). The first Riata lead was extracted in June 2002, and the first Fidelis lead was extracted in February 2005.

Baseline patient characteristics

Discussion

Our goal was to compare the indications, techniques, and procedural outcomes of recalled (Riata and Fidelis) and non-recalled ICD lead extraction procedures. TLE of Riata and Fidelis leads has been described.13, 14, 15, 16, 17, 18 However, TLE of Riata leads is not well characterized and procedural outcomes of neither Riata or Fidelis ICD leads have been compared with those of non-recalled ICD leads. It also remains to be determined whether Riata TLE may be more dangerous or difficult in the

Conclusions

The FDA and the HRS do not currently recommend prophylactic extraction of recalled Riata or Fidelis ICD leads because of the risks of lead explantation and the lack of data to determine whether such risks would outweigh the benefits. Our study contributes to the existing body of knowledge by showing that in our high-volume center, recalled Riata and Fidelis ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads.

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Cited by (54)

Predictors for adverse events during cardiac lead extraction – Experience from a large single centre
2023, International Journal of Cardiology
As the use of cardiac implantable electronic devices (CIED) has increased in recent years, the need for transvenous lead extraction (TLE) has also steadily increased. However, the TLE procedure could lead to serious complications and even death. Clinical decision-making tools are necessary for predicting these adverse events, but the appropriate tools have not yet been developed.
To explore the possible predictors and develop a clinical model to predict TLE related adverse events.
All the patients who were admitted to our cardiac center for TLE from January 2014 to January 2021 were included in this study. The patient information, device baseline characteristics, procedure-related information, complications and outcomes were recorded. Independent predictors of TLE related adverse events were identified by univariate, LASSO and multivariate analysis. A nomogram for predicting these adverse events was developed based on these independent predictors. Calibration and decision curve analysis were conducted to evaluate the nomogram.
One thousand and one hundred patients were included in this study, 778 (70.7%) were male and the median age was 68 years old. A total of 2,208 leads were extracted and 2.01±0.74 leads were extracted per procedure. Fifty-five patients (5%) developed adverse events including minor complications (2.4%), major complications (2.3%) and death (0.27%). Seven independent predictors for TLE related adverse events were identified and selected to establish the nomogram including BMI, female gender, hypoalbuminemia, number of extracted leads>3, longest dwell time of the extracted leads and manual traction. The area under the receiver operating characteristic (ROC) curve (AUC) for the prediction model was 0.774. Calibration curve and decision curve analysis showed that the nomogram had good prediction performance.
TLE related adverse events are some of the key issues that concern clinicians. We have identified seven independent factors and established a predictive model that may help clinicians identify at-risk patients and create better plans for lead extraction.
Open Chest Approach Lead Extraction in a Patient with a Large Vegetation: The Importance of Multidisciplinary Approach, Advanced Imaging, and Procedural Planning
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Predictors of perforation during lead extraction: Results of the Canadian Lead ExtrAction Risk (CLEAR) study
2022, Heart Rhythm
Citation Excerpt :
Over the past 30 years, TLE techniques have evolved significantly, moving from simple traction to the incorporation of sophisticated dedicated toolsets that have improved the clinical effectiveness and safety of TLE procedures, of which the excimer laser is one of the most common and effective tools.1 Depending on the series, the complete procedural success of extraction has been estimated at 95%–97% (“clinical success” of 98%–99% if partial extractions are included).2–4 As a counterbalance to the high procedural success is the realization that TLE carries a risk of significant complications.
Transvenous lead extraction can have serious adverse events, such as cardiac or vascular perforation. Risk factors have not been well characterized.
The purpose of this study was to identify factors associated with perforation and death, and to characterize lead extraction in a large contemporary population.
We performed a retrospective multicenter study examining patients undergoing lead extraction at 8 Canadian institutions from 1996 through 2016. Demographic and clinical data were used to identify variables associated with perforation and mortality using logistic regression modeling.
A total of 2325 consecutive patients (age 61.9 ±16.5 years) underwent extraction of 4527 leads. Perforation rate was 2.7% (63/2325) and 30-day mortality was 1.6% (38/2325), with mortality of 0.4% due to perforation (10/2325). Variables associated with perforation included no previous cardiac surgery (odds ratio [OR] 3.33; 95% confidence interval [CI] 1.54–7.19; P = .002), female sex (OR 3.27; 95% CI 1.91–5.60; P <.001); left ventricular ejection fraction ≥40% (OR 2.81; 95% CI 1.28–6.14; P = .010); lead age >8 years (OR 2.64; 95% CI 1.52–4.60; P <.001); ≥2 leads extracted (OR 2.49; 95% CI 1.23–5.04; P = .011); and diabetes (OR 2.12; 95% CI 1.16–3.86; P = .014). Variables associated with death included infection as indication for extraction (OR 3.85; 95% CI 1.38–10.73; P = .010); anemia (OR 3.14; 95% CI 1.38–6.61; P = .003), and patient age (OR 1.04; 95% CI 1.01–1.07; P = .012).
Risk factors associated with perforation in lead extraction include no history of cardiac surgery, female sex, preserved left ventricular ejection fraction, lead age >8 years, ≥2 leads extracted, and diabetes.
Algorithm for the analysis of pre-extraction computed tomographic images to evaluate implanted lead–lead interactions and lead–vascular attachments
2020, Heart Rhythm
The number of lead extractions is growing because of the greater population and increasing age of individuals with a cardiac implantable electronic device. Lead extraction procedures can be complex undertakings with risk of significant mortality, and vascular tears in the superior vena cava are of greatest concern.
The purpose of this study was to study whether a novel algorithm that analyzes pre-extraction computed tomographic (CT) images can determine the likelihood and location of lead–lead interactions and lead–vessel attachment within patients’ venous vasculatures. This information can be used to identify potential case challenges in the planning stages.
We developed an algorithm to estimate the presence and position of lead–lead interactions and lead–vessel adherences by tracking distance between the leads and distance between the lead and superior vena cava in a sample of 12 patients referred to the United Heart and Vascular Clinic for lead extractions due to infection (n = 5), lead failure (n = 5), and tricuspid regurgitation (n = 2).
Preliminary results indicate that the developed algorithm successfully identified lead–lead and lead–vascular attachments compared to review of CT images by medical experts.
With future validation and clinical implementation, this algorithm could aid physician preparedness by minimizing intraprocedural emergencies and may improve patient outcomes.
Lead extraction in non-cardiac surgery centers: Easier said than done
2020, International Journal of Cardiology
Outcomes of cardiac implantable electronic device transvenous lead extractions performed in centers without onsite cardiac surgery
2020, International Journal of Cardiology
Citation Excerpt :
Almost all contemporary studies that looked at outcomes of CIED lead extractions reported major complications [7,14–16]. However, the majority of outcomes data is generated from tertiary centers with higher operator skill and volume, and greater likelihood of on-site cardiac support, which is a recommendation in current HRS guidelines [5–8,17,18]. This leaves a gap in evidence on the differences in clinical characteristics and outcomes of patients undergoing CIED lead extractions between centers with and without on-site cardiac surgery facilities.
While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals' cardiac surgery (CS) facilities.
We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals' CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers.
In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p < 0.001) during the study period. In comparison to on-site CS group, patients admitted to off-site CS group were older, less comorbid, and experienced lower adjusted odds of major adverse cardiovascular events (0.72 [0.67, 0.77]), mortality (0.60 [0.52, 0.69]), procedure-related bleeding (0.48 [0.44, 0.54]) and complications (thoracic: 0.81 [0.75, 0.88]; cardiac: 0.45 [0.38, 0.54]) (p < 0.001 for all).
Our national analysis demonstrates that transvenous CIED lead extractions are being increasingly undertaken in centers with on-site CS surgery, in compliance with international guideline recommendations. Patients managed with lead extractions in on-site CS centers are more comorbid and critically ill compared to those admitted to off-site CS centers, and remain at a higher risk of procedure-related complications.

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: Dr Brunner, Dr Cronin, Dr Baranowski, and Dr Wilkoff designed the study. Dr Brunner, Dr Cronin, Dr Jacob, and Dr Duarte gathered the data. Dr Cronin and Dr Brunner performed statistical analysis. Dr Brunner drafted the manuscript. The additional authors critically revised the manuscript for important intellectual content and were involved in the transvenous lead extraction procedures.

: Dr Tarakji has received communication speaker’s honoraria from HMP. Dr Martin has received speaker’s honoraria from Medtronic. Dr Callahan has received speaker’s honoraria from Biotronik, Boston Scientific, and St Jude Medical. Dr Saliba and Dr Kanj have received speaker’s honoraria from Boston Scientific, Medtronic, and St Jude Medical. Dr Wilkoff has received physician advisory from Medtronic, St Jude Medical, and Spectranetics. All authors with disclosures reported compensation of less than $10,000 per year.

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Transvenous extraction of implantable cardioverter-defibrillator leads under advisory—A comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads

Background

Objectives

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Results

Discussion

Conclusions

J Am Coll Cardiol

Heart Rhythm

Heart Rhythm

Int J Cardiol

Heart Rhythm

J Am Coll Cardiol

Heart Rhythm

J Am Coll Cardiol

Implantable cardioverter-defibrillator utilization

Europace