Cable Externalization Research Articles

Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up

AimsRiata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. MethodsThis single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8-month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. ResultsDuring a mean follow-up of 10.2 ± 2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years post-implantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. ConclusionThe incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.

Canadian Registry of Implantable Electronic Device Outcomes: Longer-term follow-up of the Riata lead under advisory

The Riata lead advisory was announced in 2011 and has posed unique management challenges because of cable externalization and insulation abrasion, in some cases leading to sudden loss of defibrillation. The purpose of this study was to provide further data on the rate of electrical failure in a population of patients with a Riata lead under advisory. Using the Canadian Registry of Electronic Device Outcomes, prospective follow-up data were collected on 1352 Riata leads under advisory in 17 implantable cardioverter-defibrillator (ICD) implantation centers in Canada. Data on electrical and structural failure were collected, as well as periprocedural complications related to lead revision (abandonment or extraction). Of the 1352 leads included in this 12-month follow-up cohort, 110 leads were revised. Mean follow-up time was 10.4 ± 1.5 years. The 12-year rate of electrical failure for the 8Fr lead was 9.45%, whereas the 10-year failure rate for the 7Fr lead was 7.25% and was not found to be accelerating. Of the leads revised because of advisory only (patient preference, advisory related, electrical or structural failure), the majority were abandoned (n = 54 [76.0%]), whereas 17 (24.0%) were extracted using power tools. The rate of major complications in each group was 5.6% and 5.9%, respectively. This report provides further data on the risk of electrical lead failure over a long lead dwell time. The risk of failure exceeds the risk of periprocedural major complications, indicating that the risk-to-benefit ratio is favorable to revise the lead in appropriate clinical scenarios.

Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of the Riata Lead Under Advisory.

The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead. This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5.2% at 8 years, with no difference between 7-French and 8-French lead models. Cable externalization was found to be more common in the 8-French model (12.3% versus 5.2%, P<0.0001) and was associated with a higher risk of electrical failure. Predictors of electrical lead failure included cable externalization, higher left ventricular ejection fraction, younger age, higher body mass index, and a passive fixation lead. One patient died due to electrical failure, a further 2 patients survived an event where the device failed to deliver high-voltage therapy. Major complications because of lead extraction were higher when compared with lead abandonment, no difference among lead model observed. Two deaths occurred as a consequence of lead extraction, in the context of an underlying infection. The Riata lead under advisory has a steady electrical failure rate over time. There are identifiable predictors of lead failure that can assist with clinical decisions as to whether lead revision should be performed prophylactically.

Cable externalization at the proximal portion of the superior vena cava coil in Riata implantable cardioverter defibrillator leads

Many Riata (St. Jude Medical, St. Paul, MN, USA) implantable cardioverter defibrillator (ICD) leads have reportedly developed cable externalization. The most likely cause of cable externalization is insulation abrasion, which often occurs at the can or between the right ventricular coil and superior vena cava (SVC) coil. We report a rare case of an adult male whose ICD lead cable was externalized at the proximal portion of the SVC coil. This lead became fixed to the wall at the subclavian vein and SVC and became bent between these adhesions. Furthermore, the motion of this lead was affected by pulsation of the aortic arch. The ICD lead might develop inside-out abrasion due to mechanical stress evoked by pulsation of the aortic arch at this site.<Learning objective: Cable externalization of the implantable cardioverter defibrillator lead at the proximal portion of the superior vena cava (SVC) coil has rarely been reported. Externalization might be the result of deformation of the left brachiocephalic vein and the anatomical relationship with the aortic arch. The anatomical pathway of the lead should be carefully considered during the procedure, especially when a dual-coil lead is selected. Moreover, possible cable externalization at both the proximal and distal portions of the SVC coil should be kept in mind during follow-up.>

Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis.

The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates of cable externalization (CE) and electrical failure (EF). The overall rates of these complications remain unknown. The purpose of this study was to systematically search the literature for rates of Riata lead failure and to perform a meta-analysis to estimate failure rates. We conducted a meta-analysis of observational studies examining the rates of EF, CE, and the interaction of the two. We identified 23 English language manuscripts addressing 1 or more of these questions. Across 23 studies, the overall CE rate was 23.1% (95% confidence interval [CI] 19.0%-27.6%). The overall EF rate was 6.3% (95% CI 4.7%-8.2%). The presence of CE was associated with a more than 6-fold increase in the rate of EF compared to no CE (17.3% [95% CI 11.2%-25.9%] vs 2.7% [95% CI 1.4%-5.2%], respectively). The rate of CE was 3-fold higher for 8Fr leads compared to 7Fr leads, but rates of EF were similar (4.6%; 95% CI 3.2-6.6] and 3.9%; 95% CI 2.4-6.1], respectively). Rates of both CE and EF were higher in dual coil vs single coil leads, but confidence intervals overlapped. In clinical practice, rates of CE in Riata leads are substantial. While CE is associated with a significant increase in the risk of EF, the incidence of EF without externalization is not trivial.

Insight into the mechanism of failure of the Riata lead under advisory.

Cable externalization and insulation abrasion are known to occur with the St Jude Medical Riata leads under advisory. The distribution of these abnormalities and how they relate to clinical presentation have not been well described. In this study, we sought to determine the relationship between structural lead failure and clinical presentation by using the analysis of returned Riata products in Canada. The analyses of returned Riata products in Canada were obtained from St Jude Medical, Sylmar, CA. These data were correlated with the clinical presentation of patients just before lead removal from service. As of May 1, 2013, there were 263 returned Riata leads in Canada. Of these, 43 (16.8%) were found to have insulation abrasion that was due to either lead-can or lead-other device interaction (70%) or inside-out abrasion (27.9%). The predilection of lead-to-can abrasion was seen in the Riata 7-F leads (84.2% vs 58.4%; P = .07), while inside-out abrasion was more common in the Riata 8-F leads (37.5% vs 15.8%; P = .12). Electrical abnormalities were frequent (20 of 31 [65.4%]) and most often due to electrical noise (45.2%), although inappropriate shocks were present (25.8%). Death occurred in 1 of 43 (2.3%) of those patients with an insulation defect in the lead-can abrasion group. Lead-can abrasion is the most common form of insulation defect in the Riata group of leads under advisory. Management of this group of leads under advisory should not neglect the issue of lead-can abrasion, in addition to detection of cable externalization.

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

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. Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. 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%). 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.

Shock-induced failure of a Riata lead with normal electrical lead parameters and a normal fluoroscopic appearance: A case report

An 81-year-old man was scheduled for an elective implantable cardioverter defibrillator (ICD) generator exchange because of battery depletion. The Atlas™+ DR ICD (St. Jude Medical, Sylmar, CA) had been implanted in February 2007 for primary prevention. The ICD lead (Riata 1570, St. Jude Medical, Sylmar, CA) had been positioned via the left cephalic vein at the right ventricular apex. Prior to the ICD generator exchange, which took place 70 months after the initial implantation, all routine device interrogations revealed normal electrical lead parameters, and cine-fluoroscopy of the lead showed normal appearance without any apparent fracture. We attempted to conduct high-voltage shock testing, as there was concern about the possibility of silent lead malfunction. Following delivery of the first high-voltage shock, the device declared “possibility of output circuit damage.” Subsequent shocks could not be delivered. Nonetheless, other lead parameters remained stable, and high-voltage lead impedance was <20Ω. The following day, the failed generator was replaced with a new ICD generator and connected with a new ICD lead. We then tested the new device by inducing ventricular fibrillation, which was defibrillated successfully. Although electric screening in asymptomatic patients with the Riata ICD lead remains controversial, it should be remembered that there are patients with or without detected cable externalization in whom only high-voltage shock testing can disclose lead malfunction. Issues with Riata leads have not yet been elucidated in full detail.

Riata and Riata ST defibrillator leads failure: cable externalization is one problem, but other electrical failures seem more preoccupant

Purpose: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are recalled insulation failure and cable externalization since 2010. The consequences of this insulation damage are not yet established. We aimed to determine the overall failures and their mechanism in 2 tertiary centres. Methods: All patients with Riata and Riata ST leads implanted and followed between 2003 and 2012, were evaluated with an annual biplane chest x-ray and ICD interrogation every 3 months. Results: 181 patients have been implanted with Riata (94 single-coil and 46 double-coil) and Riata ST (36 single-coil and 5 double-coil) leads. 86 patients have completed a follow-up of 74 months, 22 had heart transplant, 41 died, and 34 patients were referred to other centres or lost. Overall failure rate was 32.5% (28 patients); all were observed in 8-French leads except for one patient. We report 10 oversensing including 5 related to insulation damages and 5 without, none of them have shown cable externalization, 8 conductor fractures, 7 conductor externalizations without electrical abnormality, and 3 other isolated electrical problem such as impedance increase (11.6%, 9.3%, 8.1%, and 3.5% respectively). Mean time to failure was 62 months. Conclusions: Riata lead failure mostly concerns 8-French leads. Attention is especially paid to conductor externalization risk, but global failure rate with electrical complications seems more preoccupant and needs to be emphasised.

Transvenous removal of recalled ICD leads: riata vs sprint fidelis

Introduction: Sprint Fidelis (S) and Riata (R) ICD leads were recalled by the Food and Drug Administration because of an increased rate of failure due to conductor fracture (S) or insulation abrasion (R). Treatment options include intensifying monitoring and intervening replacing recalled lead, with or without extraction. However, because of its mechanical separation, R leads may be challenging to extract. Aim of this study is a comparison between S and R lead extraction. Methods: Since January 1997 to June 2012, we managed 513 consecutive patients with 545 ventricular ICD leads; among these, 45 were S and 94 R. There were no significative difference in patients and lead characteristics in the two groups. Indications to removal were infective in the majority of cases (73%). Mean pacing period was 39.1±22.1 months in S group and 36.1±23.4 months in R group. 91% of ICD leads in both groups were dual coil. In case of manual traction failure, we performed mechanical dilatation using a single polypropylene sheath technique (Cook Vascular - Leechburg PA, USA) and if necessary, other intravascular tools (Catchers and Lassos, Osypka, Grentzig-Whylen, G); an Approach through the Internal Jugular Vein (JA) was performed in case of failure of the standard approach. Results: Success rate was achieved in all 45 (100%) S leads and in 93/94 (98.9%) R leads. No major complications occurred. Manual traction effectiveness was higher in S leads (9 vs 2%) while JA was required more frequently in R leads (8 vs 2%) (p<0.01). Extraction time and mean sheath size used were significantly higher in R group. Comparing binding sites locations, R leads exhibited higher incidence in superior vena cava, right atrium and tricuspid valve as compared to S leads (p<0.01). In R group presence of cable externalization was a predictor of difficult procedure and need for JA. Conclusions: Our experience shows that the extraction of recalled S and R ICD leads is feasible and effective. However, extraction of R leads is more complex than F leads. Lack of coil backfilling and cable externalization in R group may account for these differences. The decision to extract or not to extract R leads should be individualized.

Differential Lead Component Pulling as a Possible Mechanism of Inside‐Out Abrasion and Conductor Cable Externalization

Conductor cable externalization with protrusion (CCE*) is highly prevalent among the Riata 8F and ST 7F defibrillation (DF) leads and infrequently present in the QuickSite and the QuickFlex coronary sinus (CS) leads (St. Jude Medical, Sylmar, CA, USA). A model for CCE* based on differential lead component pulling and conjugate extension with reciprocal compression-bending was developed. Extension of a proximal lead body segment by pectoral or cardiac movements causes reciprocal compression-bending of a distal lead body segment mediated by inextensible conductor cables running down a lead body fixed at various points by fibrous adhesions. The "sawing" action of these cables under tension causes inside-out abrasion of insulation leading to CCE*. DF leads from different manufacturers and the QuickFlex and QuickFlex μ CS leads were subjected to simulated differential pulling. Restitution from differential pulling followed three patterns: complete, partial without escalation, and incomplete with escalation. Only the last pattern (only shown by the Riata 8F and ST 7F leads) was associated with an increased risk to CCE*. For CS leads, deformation concentrated on the more flexible segment when the lead body did not have a uniform construction. The Durata, Riata ST Optim, QuickFlex μ, and Quartet leads should be relatively immune to CCE*. The Durata leads are extremely resistant to longitudinal deformation and probably cause mediastinal displacement rather than differential pulling in response to pectoral movements in vivo. Implantation techniques and lead designs can be used to minimize the risk of CCE*. A bench test for CCE* can be constructed.

Extraction of defibrillator leads recalled for cable externalization and failure

The Riata implantable cardioverter-defibrillator lead was recalled by the Food and Drug Administration because of an increased rate of failure associated with cable externalization. Because of its mechanical separation, the Riata lead may be challenging to extract. We therefore examined the experience with Riata lead extractions at our institution. All patients implanted with the Riata lead underwent detailed review of their electronic medical records and operative notes. Procedural complications were ascertained by reviewing the medical records up to 30 days after Riata extraction. From a total of 627 patients implanted with the Riata lead at our institution, 20 patients (age at time of extraction, 57 ± 11 years; 85 % men; lead dwell time, 48 ± 27 months) underwent lead extraction. Extraction was successful in 19 of 20 (95 %) patients and required the use of laser-powered sheaths in 18 (90 %) patients. Over a 30-day follow-up period, 1 of 20 (5 %) patients had a minor procedure-related complication consisting of a new pericardial effusion that did not require drainage. Extraction of the Riata lead seems to be successful and safe and frequently requires the use of powered sheaths.

Standard X‐Ray Is Inadequate for the Identification of Conductor Cable Externalization in Riata Leads

Journal of Cardiovascular ElectrophysiologyVolume 24, Issue 4 p. 471-471 EP Image Standard X-Ray Is Inadequate for the Identification of Conductor Cable Externalization in Riata Leads MARTA PACHÓN M.D., MARTA PACHÓN M.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorMIGUEL A. ARIAS M.D., Ph.D., MIGUEL A. ARIAS M.D., Ph.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorRAUL NADAL R.N., RAUL NADAL R.N. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorJESÚS JIMÉNEZ-LÓPEZ M.D., JESÚS JIMÉNEZ-LÓPEZ M.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this author MARTA PACHÓN M.D., MARTA PACHÓN M.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorMIGUEL A. ARIAS M.D., Ph.D., MIGUEL A. ARIAS M.D., Ph.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorRAUL NADAL R.N., RAUL NADAL R.N. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this authorJESÚS JIMÉNEZ-LÓPEZ M.D., JESÚS JIMÉNEZ-LÓPEZ M.D. Cardiac Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hospital Virgen de la Salud, Toledo, SpainSearch for more papers by this author First published: 29 August 2012 https://doi.org/10.1111/jce.12002Citations: 1 Miguel A. Arias, M.D., Ph.D., Unidad de Arritmias y Electrofisiología Cardiaca, Hospital Virgen de la Salud, Avda. Barber 30, Planta Semisótano 45004, Toledo, Spain. Fax: +34 925265492; E-mail: [email protected] J Cardiovasc Electrophysiol, Vol. 24, p. 471, April 2013. No disclosures. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume24, Issue4April 2013Pages 471-471 RelatedInformation

Fluoroscopic Screening of Asymptomatic Patients Implanted With the Recalled Riata Lead Family

The Food and Drug Administration recently issued a class I recall of the St. Jude Medical Riata implantable cardioverter-defibrillator lead presumably because of increased risk of electric failure and mechanical separation via inside-out abrasion. We sought to examine the incidence and time dependence of inside-out abrasion in asymptomatic patients implanted with the Riata lead. Asymptomatic patients implanted with the Riata lead at our institution were offered voluntary fluoroscopic screening in 3 views. Electric testing of the Riata lead with provocative isometric muscle contraction was performed at the time of fluoroscopic screening. Of the 245 patients undergoing fluoroscopic screening, 53 (21.6%) patients showed clear evidence of lead separation. Of these externalized leads, 0%, 13%, and 26% had a dwell time of <3 years, 3 to 5 years, and >5 years, respectively (P=0.037). Externalized leads had a significantly pronounced decrease in R-wave amplitude (-1.7±2.9 mV versus +0.35±2.5 mV; P<0.001), and more patients with externalized leads had ≥25% decrease in R-wave amplitude from baseline (28.0% versus 8.1%; P=0.018). One patient with externalization exhibited new noise on near-field electrogram. The Riata lead exhibits time-dependent high rates of cable externalization exceeding 20% at >5 years of dwell time. Externalized leads are associated with a more pronounced decrease in R-wave amplitude, which may be an early marker of future electric failure. The use of fluoroscopic and electric screening of asymptomatic patients with the Riata lead remains controversial in the management of patients affected by the recent Food and Drug Administration recall.