Multicenter experience with extraction of the Riata/Riata ST ICD lead
Introduction
Approximately 227,000 Riata and Riata ST leads (St Jude Medical, St Paul MN) have been distributed worldwide since the initial introduction of the Riata family of leads in June 2001. The initial reports of lead failure due to externalization of the lead conductors began to appear in 2008.1 Subsequently, more reports of insulation failure and conductor externalization have surfaced, with a prevalence ranging from 8% to 33%.2, 3, 4, 5, 6, 7, 8, 9 Structural failure has been frequently observed in the absence of electrical abnormalities, a finding attributed to the ethylene tetrafluoroethylene coating on the high-voltage and pace-sense cables. The survivability of the ethylene tetrafluoroethylene coating in externalized conductors is unknown, and several groups have reported on the electrical failure of the Riata/Riata ST lead.10, 11, 12, 13 In addition, it appears that there is an incidence of electrical failure that is discrete from insulation failure.3, 6, 7, 14, 15 Management recommendations regarding the recall have remained controversial. Data regarding the safety and feasibility of extraction of the Riata/Riata ST lead are limited. This study examined the experience at 11 extraction referral centers with regard to extraction of the Riata/Riata ST lead and assessment of the morbidity and mortality of this procedure when performed by experienced operators at high-volume centers.
Section snippets
Methods
We identified a cohort of consecutive patients undergoing Riata/Riata ST leads at 11 high-volume centers between July 2003 and April 2013 and retrospectively analyzed patient and lead characteristics, procedural outcomes, and complications. The lead extraction technique applied was the decision of the operator. All operators are highly skilled and well versed in all extraction modalities with a large volume of experience (>75 lead extractions per year). Patient characteristics along with the
Results
Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients. The mean patient age at the time of the procedure was 60 ± 16 years (median 64 years; IQR 52–73 years), and 78% were men (Table 1). The mean left ventricular ejection fraction was 34% ± 14%. Riata and dual-coil leads predominated (84% and 88%, respectively). The majority (53.0%) of leads were removed for infectious indications (36% systemic infections). More than one-third of the leads were removed for
Discussion
We provide the first multicenter, large-scale data regarding the safety and feasibility of transvenous extraction of the Riata/Riata ST lead. In our experience of 577 Riata/Riata ST leads, we observed complete procedural success in 99.1% of cases, with a 0.87% major complication rate and 1 procedure-related death. There was no difference in TLE indication, success, or complications between Riata and Riata ST leads. Riata leads as compared with Riata ST leads had significantly longer implant
Conclusion
Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data, but clinical management decisions should remain individualized on a case-by-case basis.
References (35)
- et al.
Implantable cardioverter-defibrillator lead disintegration at the level of the tricuspid valve
Heart Rhythm
(2008) - et al.
Unusual failure of a multilumen, small-diameter implantable cardioverter-defibrillator lead
Heart Rhythm
(2010) - et al.
High prevalence of insulation failure with externalized cables in St. Jude Medical Riata family ICD leads: fluoroscopic grading scale and correlation to extracted leads
Heart Rhythm
(2012) - et al.
Prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata(R) and Riata(R) ST implantable cardioverter-defibrillator leads
Int J Cardiol
(2013 Jul 15) - et al.
Riata implantable cardioverter-defibrillator lead failure: analysis of explanted leads with a unique insulation defect
Heart Rhythm
(2012) - et al.
Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads
Heart Rhythm
(2012) - et al.
Failure rate of the Riata lead under advisory: a report from the CHRS Device Committee
Heart Rhythm
(2013) - et al.
Nationwide fluoroscopic screening of recalled Riata defibrillator leads in Denmark
Heart Rhythm
(2013 Jun) - et al.
Transvenous lead extraction: Heart Rhythm Society Expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA)
Heart Rhythm
(2009) - et al.
Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead
J Am Coll Cardiol
(2010)
Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier
J Am Coll Cardiol
Transvenous extraction of implantable cardioverter-defibrillator leads under advisory—a comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads
Heart Rhythm
Effectiveness of implantable cardioverter-defibrillator lead coil treatments in facilitating ease of extraction
Heart Rhythm
Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads
Heart Rhythm
Riata lead failure: a report from Northern Ireland Riata lead screening programme [abstract]
Eur Heart J
Insulation defects of thin high-voltage ICD leads: an underestimated problem?
J Cardiovasc Electrophysiol
Conductor externalization of the Riata internal cardioverter-defibrillator lead: tip of the iceberg? Report of three cases and review of literature
Europace
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2019, JACC: Clinical ElectrophysiologyTransvenous extraction of advisory implantable cardioverter defibrillator leads with a relatively long implant duration
2018, Journal of CardiologyCitation Excerpt :These data suggest that there was no significant technical difference in these two leads regarding the extraction. However, Maytin et al. [7] suggested that an extraction of the Riata lead might require a specific technique because of the externalized conductors. Furthermore, intravascular thrombus formation adherent to externalized conductors [16] and extreme externalization of the conductors reaching to the pulmonary artery [17] have been reported.
Safety and Efficacy of Transvenous Lead Extraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience
2018, JACC: Clinical Electrophysiology
Dr Maytin has received research grants from Medtronic and Spectranetics and is a consultant for St Jude Medical. Dr Wilkoff has received research grants from Biotronik, Boston Scientific, LifeWatch, Medtronic, Spectranetics, and St Jude Medical and is a consultant for Boston Scientific, LifeWatch, Medtronic, Spectranetics, and St Jude Medical. Dr Love has received research grants from Biotronik, Boston Scientific, Medtronic, and St Jude Medical and is a consultant for Biotronik, Boston Scientific, Cook Vascular, Medtronic, Sorin/ELA, St Jude Medical, Spectranetics, and TyRx. Dr Fischer is currently a paid employee of St Jude Medical. Dr Carrillo is a consultant for Medtronic, Sorin/ELA, Spectranetics, and St Jude Medical. Dr Mittal has received fellowship and research support from and is a consultant for Bard, Biosense Webster, Biotronik, Boehringer, Boston Scientific, Medtronic, Spectranetics, and St Jude Medical. Dr John participates in industry-sponsored research with Biosense Webster, Medtronic, and Thermedical and is a consultant for St Jude Medical. Dr Epstein has received research grants from and is a consultant for Boston Scientific, Medtronic, Spectranetics, and St Jude Medical; he has equity in and served as a board member for Carrot Medical.