Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population

Porterfield, Florence; Porterfield, F.H.R.S. Linda M.; Kuck, Karl Heinz; Corbisiero, Raffaele; Greenberg, Steven M.; Hindricks, Gerhard; Wazni, Oussama; Beau, Scott L.; Herre, John M.

doi:10.1111/j.1540-8167.2009.01651.x

Cited by 40 publications

(33 citation statements)

References 25 publications

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“…8,10 Compared with these data, the lead failure rate was 20-times to 100-times higher as reported by the manufacturer (0.63%) 7 and published in 2 performance articles of the Riata lead family (0.13% and 0.21%, respectively). 11,12 The main reason for this discrepancy could be explained by the definition of adverse events that were defined as those that required lead revision, extraction, or replacement. Without systematic fluoroscopically screening, the rate of conductor externalization was obviously underestimated.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Presentation of Externalized Conductors and Electrical Abnormalities in Riata Defibrillator Leads After Fluoroscopic Screening

Theuns

Elvan

Voogt

et al. 2012

Circ: Arrhythmia and Electrophysiology

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Background-The Riata family of implantable cardioverter-defibrillator (ICD) leads is prone to a specific insulation abrasion characterized by externalization of conductor cables. The objective of this study was to determine the prevalence of externalized conductors and electrical abnormalities in Riata ICD leads by fluoroscopic screening and standard ICD interrogation. Methods and Results-All ICD implantation centers were contacted by the Netherlands Heart Rhythm Association Device Advisory Committee to identify all patients with an active Riata ICD lead and to perform fluoroscopic screening of the lead. In addition, the electrical integrity of the lead was assessed. As of March 1, 2012, data for 1029 active Riata leads were available; 47% of these were 8-F Riata and 53% were 7-F Riata ST. Externalized conductors were observed in 147 leads (14.3%). Proportion of externalized conductors was higher in 8-F Riata compared with 7-F Riata ST (21.4% vs 8.0%; P<0.001). Median time from implantation to detection of externalized conductors was 65.3 months. The estimated rates of externalized conductors were 6.9% and 36.6% at 5 and 8 years after implantation, respectively. Of the 147 leads with externalized conductors, 10.9% had abnormal electrical parameters vs 3.5% in nonexternalized leads (P<0.001). Conclusions-The

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Section: Discussionmentioning

confidence: 99%

Prevalence and Presentation of Externalized Conductors and Electrical Abnormalities in Riata Defibrillator Leads After Fluoroscopic Screening

Theuns

Elvan

Voogt

et al. 2012

Circ: Arrhythmia and Electrophysiology

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“…Earlier studies reported a very low incidence of lead insulation damage at 0.16% in 6,405 patients with a median follow-up of 24 months [7]. Another large series involving 15,378 patients with a median follow-up period of 13.5 months reported insulation defects of the order of 0.21% [6]. These studies were limited by the way insulation defects were ascertained and no systematic fluoroscopy was used.…”

Section: Discussionmentioning

confidence: 99%

“…Prior studies have reported various electrical abnormalities associated with lead externalization such as pacing impedance rise, increased capture threshold or inappropriate ICD shocks due to noise [2,5]. Earlier studies have shown a low rate of lead insulation failure (< 1%) but these studies were limited due to the way insulation failure were analyzed (no consistent fluoroscopy) or shorter period of follow up [6,7]. A recent large study by Hauser et al [8] reported an alarming number of deaths in patients implanted with Riata ® and Riata ® ST leads primarily associated with failed defibrillation.…”

Section: Introductionmentioning

confidence: 99%

Fluoroscopic investigation of Riata® transvenous defibrillator leads

et al. 2015

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“…Riata leads have a unique multi-lumen design in which one or two coil conductors and a ring conductor are packed independently into each silicon cavity surrounding a tip conductor. Recently, some instances of insulation damage in the Riata family have been reported (1)(2)(3)(4). An information report from St. Jude Medical Co. indicated that externalized conductors may result from relative motion of conductor cables within the silicon insulation lumen, referred to as "inside-out" abrasion (5).…”

Section: Insulation Defects In Riata Leadsmentioning

confidence: 99%

“…Over 200,000 Riata and Riata ST ICD leads (St. Jude Medical, Sylmar, CA, USA) were implanted worldwide between 2002 and 2010. Recently, it has been announced that insulation defects are a special problem associated with these leads in Western countries, although the precise incidence and clinical details of the problems have not yet been clarified (1)(2)(3)(4). The conductor cables in the leads are prone to erode the silicone insulation and project outside of the lead body.…”

Section: Introductionmentioning

confidence: 99%

Insulation Defects in Riata Implantable Cardioverter-defibrillator Leads

et al. 2012

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Background The structures composing implantable cardioverter-defibrillator (ICD) leads have become more complicated and thinner with technological advances. Silicon insulation defects with and without clinically manifested electrical abnormalities have been reported in Riata leads (St. Jude Medical). Objective The aim of this study was to assess the incidence and clinical implications of insulation defects in Riata leads implanted at our hospital. Methods The subjects included 10 consecutive patients who received 8-French Riata ICD leads with dualcoil conductors (model 1580 or 1581) between 2006 and 2010 at our hospital. Operative records, chest Xrays and interrogation data were reviewed. Results In all cases, Atlas+ (St. Jude Medical) was used as an ICD generator and the Riata leads were implanted transvenously and fixed to the right ventricular apex. During a mean follow-up period of 52±9 (36-70) months, chest X-rays revealed insulation defects in Riata leads and conductor wires projecting from the bodies of the Riata leads in two of 10 (20%) patients. One of the patients received inappropriate ICD therapies due to T-wave oversensing based on attenuation of R waves and augmentation of T waves 41 months after implantation. In the other patient, an insulation defect without any clinically manifested electrical troubles was detected 50 months after implantation. Conclusion Riata leads have a high incidence of insulation defects, which may be occasionally accompanied by inappropriate ICD discharges. For patients with Riata leads, careful observation of any changes in the lead-electrical measurements and a routine chest X-ray follow-up are necessary.

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Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population

Abstract: During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable.

Cited by 40 publications

References 25 publications

Prevalence and Presentation of Externalized Conductors and Electrical Abnormalities in Riata Defibrillator Leads After Fluoroscopic Screening

Prevalence and Presentation of Externalized Conductors and Electrical Abnormalities in Riata Defibrillator Leads After Fluoroscopic Screening

Fluoroscopic investigation of Riata® transvenous defibrillator leads

Insulation Defects in Riata Implantable Cardioverter-defibrillator Leads

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