Elsevier

Heart Rhythm

Volume 11, Issue 9, September 2014, Pages 1613-1618
Heart Rhythm

Multicenter experience with extraction of the Riata/Riata ST ICD lead

https://doi.org/10.1016/j.hrthm.2014.05.014Get rights and content

Background

In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial.

Objective

Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.

Methods

We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.

Results

Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0–124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P < .0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).

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.

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.

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      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.

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    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.

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