No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Performance of the St. Jude Medical Riata Leads
Abstract
Recent attention has been focused on the performance of high-voltage implantable cardioverter-defibrillator (ICD) leads. Lead-related adverse events can be caused by several factors, including patient characteristics, concomitant therapies, implantation technique, access site, and lead design. Few studies have included the number of patients and the follow-up duration necessary to characterize accurately the lead performance and the incidence of lead-related adverse events.
This study sought to define the incidence of lead-related adverse events including conductor fracture, insulation damage, perforation, and dislodgement of St. Jude Medical Riata ICD leads.
Data from the Advancements in ICD Therapy, OPTIM Lead InsUlation Material (OPTIMUM), Resynchronization HemodYnamic Treatment for Heart Failure Management (RHYTHM), and Post Approval Study (PAS) registries provided data from 7,497 patients with Riata leads. Patients were followed up for a median of 22 months. Adverse events, defined as those that required lead revision, extraction, or replacement, were recorded.
Conductor fracture occurred in 0.09%, insulation damage in 0.13%, dislodgement in 0.88%, and perforation in 0.31% of patients, respectively.
During more than 22 months of follow-up of over 7,000 Riata leads in 4 prospective registries and clinical trials, the incidence of lead-related adverse events including conductor fracture, insulation damage, dislodgement, and perforation necessitating lead revision, extraction, or replacement is rare.
... In consistent with the previous reports, 19,25 the use of the recalled lead was a risk of the lead failure in our population ( ...
Background
As the transvenous defibrillator lead is fragile and its failure may cause a life‐threatening event, reliable insertion techniques are required. While the extrathoracic puncture has been introduced to avoid subclavian crush syndrome, the reports on the long‐term defibrillator lead survival using this approach, especially the comparison with the cephalic cutdown (CD), remain scarce. We aimed to evaluate the long‐term survival of the transvenous defibrillator lead inserted by the extrathoracic subclavian puncture (ESCP) compared with CD.
Methods
Between 1998 and 2011, 324 consecutive patients who underwent an implantable cardioverter‐defibrillator (ICD) implantation in Hokkaido University Hospital were included. ICD leads were inserted by CD from 1998 to 2003 and by contrast venography‐guided ESCP thereafter. Lead failure was defined as a nonphysiologic high‐rate oversensing with abnormal lead impedance or highly elevated sensing and pacing threshold.
Results
Of 324 patients, CD was used in 37 (11%) and ESCP in 287 patients (89%). During the median follow‐up of 6.2 years (IQR:3.2‐8.3), 7 leads (2 in CD and 5 leads in ESCP group) failed. All patients with lead failure in ESCP group were implanted with either SJM Riata (n = 1) or Medtronic Fidelis lead (n = 4). Five‐year lead survival was 93.8% (CI95%:77.3‐98.4%) in CD compared with 99.1% (CI95%:96.6‐99.8%) in ESCP group (P = 0.903). Univariate Cox regression analysis showed that the use of Fidelis or Riata lead was the strong predictor of the ICD lead failure (HR 13.8, CI95%:2.9‐96.5; P = 0.001).
Conclusions
Contrast venography‐guided extrathoracic puncture ensures the reliable long‐term survival in the transvenous defibrillator leads.
... Wilkoff et al. [23] analysed over 96,000 Optim high-voltage leads and 138,000 silicone ICD leads, and presented a significant reduction of full-thickness abrasion-related failures at 44 months post implant — no cases of externalised conductors were noticed. The first acknowledgement of Optim insulated leads from 2008 concerned 1093 ICD leads observed for 22 months without insulation failure or conductor externalisation [24]. Hauser et al. [25] searched the FDA's Manufacturers and User Device Experience (MAUDE) for Optim insulated lead abrasion and found 52 reports documenting that Optim does not prevent insulation abrasions developing as a result of friction with an ICD can or another device. ...
... Active fixation leads also provide the added convenience of possible lead extraction 9,10 . With an increasing number of pacemaker implantations and senior populations 11 , active-fixation pacing leads, have played a dominant role in Europe and the U.S. The right ventricular outflow tract (RVOT) is the most widely used pacing site other than the apex. With screwable fixation locating the distal part of the pacing leads, physicians can pace in either the septum or the free wall of the RVOT. ...
Active-fixation pacing leads allow the use of selective pacing sites. We evaluated their long-term performance versus passive-fixation leads in 199 newly implanted patients (n = 100 active and n = 99 passive). Postoperative pacing thresholds in the active group were higher than in the passive group (0.85 ± 0.31 V vs. 0.53 ± 0.21 V at baseline, P < 0.001). The active thresholds fell to 0.72 ± 0.23 V at 5 years with a significant drop at one month (0.68 ± 0.53 V, P = 0.003). The passive thresholds slightly increased to 0.72 ± 0.31 V at five years. Differences between groups were significant until three years (all P < 0.05). Active impedances were generally lower than passive impedances (600.44 ± 94.31Ω vs. 683.14 ± 110.98Ω at baseline), and both showed significant reductions at one month to 537.96 ± 147.43Ω in the active group, and after three months to 643.85 ± 82.40Ω in the passive group (both P < 0.01 vs. baseline). Impedance differences between groups were significant until four years (all P < 0.05). Adverse events included thresholds over 1 V, 5 of 6 active and 2 of 5 passive leads returned to below 1 V. One active left ventricular lead dislodged. One passive left subclavian lead insulation fracture occurred. Thus Active fixation pacing leads are stable in a five-year long-term follow up. There was no difference between active and passive leads in terms of electrical performance.
... More recently, clinicians have become aware of performance defects associated with the St. Jude Medical Riata transvenous defibrillation lead. A 2009 report by Epstein and colleagues, based on their analysis of data from four registries with median follow-up of 22 months, had concluded that the percentage of Riata leads with conductor fractures (0.09 %) and insulation damage (0.13 %) was very low [13]. However, the lead was removed from the market in November 2010 because of reports that conductor cables were wearing through the insulation that covered them [14]. ...
Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide. Premarket evaluation of CIEDs cannot be expected to eliminate all performance defects. Robust postmarket surveillance systems are needed to promote patient safety and reduce harm. Challenges impacting existing surveillance mechanisms include underreporting of defects, low rates of return of explanted CIEDs, lack of integration of surveillance into normal workflow, underutilization of existing resources including registries, a lack of capacity of aging resources, multiple proprietary platforms that lack interoperability, and the unmet need for common data variables as well as newer methods to generate, synthesize, analyze, and interpret evidence in order to respond rapidly to safety signals. Long-term solutions include establishing a unique device identification system; promoting expanded use of registries for surveillance and post-approval studies; developing additional methods to combine evidence from diverse data sources; creating tools and implementing strategies for universal automatic, triggered electronic event reporting; and refining methods to rapidly identify and interpret safety signals. Protection from litigation and creation of financial and other incentives by legislators, regulators, payers, accreditation organizations, and licensing boards can be expanded to increase participation in device surveillance by clinicians and health care facilities. Research to evaluate the comparative effectiveness of surveillance strategies is needed. Interim solutions to improve CIED surveillance while new initiatives are launched and the system strengthened are also presented.
... Implantable cardioverter defibrillators (ICDs) are an effective treatment option in selected patients for primary and secondary prevention of sudden cardiac death. 1 -6 Adverse effects of ICD therapy may include among others a decrease in quality of life, 7 complications during implantation, 8 inappropriate shocks, 9 lead failure, 10 and recalls. Overall, lead failure is a rare complication, 11 but has potential serious sequelae for the affected patient (failure to defibrillate; inappropriate discharge due to noise sensing). ...
AimsIn 2007, the Medtronic™ Sprint Fidelis® lead was withdrawn from the market due to elevated failure rates. Since then, several studies were published with failure rates between 1.3 and 3.75/year. However, they included a very high percentage of active fixation leads. Data in a population with passive leads are missing.Methods and resultsAll 166 patients who received a Fidelis lead between December 2004 and October 2007 in two teaching hospitals were identified. We excluded nine patients with incomplete data and 18 with active fixation leads. The study population thus consists of 139 patients with passive leads. Pacing and high-voltage impedance values were systematically collected at implant and in intervals of 6 months. Follow-up was 49 ± 15 months. All leads were 6948 models. During a follow-up of 41 ± 15 months, nine leads (6.5) failed. Annual failure rate was 1.9/year (95 CI 0.4-4.2), cumulative 5-year survival 95.8. There were no differences between leads used in resynchronization and non-resynchronization devices (8.9 and 5.3, P value 0.47).Conclusion
In a population with only passive leads, the Fidelis lead exhibited an impaired long-term survival, but performance was better than in previous studies in which >90 of leads were active models. © 2012 Published on behalf of the European Society of Cardiology.
... The sample size calculation was based on the assumption of the primary end point occurrence. RV lead-related events are expected to occur in 10% of the control group patients within the first 3 months after ICD/CRT-D implantation (high defibrillation threshold >25 J in 2% of patients, poor pacing/sensing measurements in 6% of patients, and lead dislodgement in 2% of patients)141516 . With a significance level of 5%, an 80% power, an estimated dropout rate of 16%, and an equivalence margin of 10% for the confidence intervals, a minimum sample size of 286 patients (143 patients in each group) is needed to detect non-inferiority between the two groups. ...
Detrimental effects of right ventricular apical pacing have prompted the search for alternative pacing sites. Data from pacemaker studies suggest that the mid-septum may be a hemodynamically favorable pacing site within the right ventricle. However, data on the safety of implantable cardioverter defibrillator (ICD) lead placement in this location are limited. The aim of the SPICE study is to ascertain that implantation of a ventricular ICD lead at the mid-septum is not inferior to the traditional apical site in terms of feasibility and safety.
In total, 286 patients with the indication for ICD implantation will be included in the study and stratified in a 1:1 ratio to have the lead placed in the right ventricular apex or the mid-septum. Primary outcome measure of this randomized, prospective study is the event-free survival of lead-related complications at 3 months. The combined end point includes the feasibility to reach the randomized pacing site in combination with the achievement of adequate pacing, sensing, and defibrillation thresholds. Data analysis and sample size calculation are based on a non-inferiority design.
This trial will primarily assess the feasibility, safety, and efficacy of right ventricular ICD lead positioning in the mid-septum compared to the traditional apical position. Documentation of non-inferiority of the novel lead position in terms of applicability and safety will be the prerequisite for potential further trials that may evaluate long-term clinical effects associated with mid-septal lead positions.
Introduction
The implantable cardioverter-defibrillator (ICD) was designed to detect and treat ventricular arrhythmias, which account for nearly half of all cardiovascular fatalities. Transvenous ICD (TV-ICD) complications were reduced by introducing subcutaneous ICD (S-ICD). S-ICD can be implanted using a three (3IT)- or two (2IT)-incision technique. This systematic review and meta-analysis was conducted to compare the 3IT to the 2IT.
Methods
We searched medical electronic databases of Cochrane Central, Embase, PubMed, Scopus, and Web of Science (WOS) from the study's inception until March 8, 2023. We compared 2IT and 3IT techniques of S-ICDs in terms of procedural, safety, and efficacy outcomes. We used Review Manager software for the statistical analysis. We calculated the risk ratio (RR) with its 95% confidence interval (CI) for dichotomous variables; and the mean difference with its 95% CI for continuous variables. We measured the heterogeneity using the chi-squared and I-squared tests. If the data were heterogeneous, the random-effect (RE) model was applied; otherwise, the fixed-effect model (FE) was used.
Results
We included three retrospective observational studies of 2076 patients, 1209 in the 2IT group and 867 in the 3IT. There was no statistically significant difference in erosion after S-ICD when 2IT compared with 3IT (RR = 0.27, 95% CI: [0.07, 1.02]; P = .05) (I2 = 0%, P = .90). There was no difference in risk of infection, lead dislocation, or inappropriate shock with either incision technique (RR = 0.78, 95% CI: [0.48, 1.29]; P = .34) (I2 = 0%, P = .71) and (RR = 0.37, 95% CI: [0.02, 8.14]; P = .53) (I2 = 66%, P = .05) respectively. Our meta-analysis showed that the efficacy of both techniques is comparable; Appropriate shock (RR = 0.94, 95% CI: [0.78, 1.12]; P = .48) (I2 = 0%, P = .81) and first shock efficacy (RR = 0.89, 95% CI: [0.44, 1.82]; P = .76) (I2 = 0%, P = .87).
Conclusion
2IT and 3IT of S-ICD have comparable efficacy and complication rates; however, the 3IT exposes patients to an additional incision without any additional benefits. These findings may provide clinicians with a simpler method for subcutaneous ICD implantation and likely result in improved cosmetic outcomes. Before the 2IT technique can be considered the standard of care, randomized controlled trials (RCTs) must be conducted to assess its long-term safety and efficacy.
The use of implantable cardioverter defibrillators (ICD) has been shown to improve survival in patients at risk of sudden cardiac death; however, due to the continuous risk of sudden loss of consciousness during arrhythmia or ICD intervention, they pose a potential risk to other road users while driving. A large number of opinions and recommendations from authorities and medical societies all over the world exist regarding driving restrictions after ICD implantation. This analysis provides an overview of the recommendations on driving restrictions from several countries. Furthermore, the use of the wearable and the subcutaneous ICD are taken into account.
Background
The long term performance of the Riata family of leads has recently come under increasing scrutiny. We aimed to determine the long term performance of the Riata 1580 leads compared with Endotak 0158 leads.
Methods
All patients with Riata 1580 or Endotak 0158 leads implanted from 2003–2008 at the Heart Hospital, UCLH were analysed.
Significant electrical changes were: threshold increase >1V at a set pulse width between pacing checks, persistent R wave fall to < 2mV or reduction in R wave >50%, noise, pacing impedance change to <300Ω or >1500 Ω, HV change to < 20Ω or > 200Ω, HV change ± 15Ω, pacing impedance change > 400Ω over 12 months.
Results
333 Riata and 356 Endotak leads were implanted. Median follow up time + interquartile range, after exclusion of censored events including loss to follow up: Riata 3652 + 655 days, Endotak 3730 + 810 days. A total of 51 (15.9%) Riata leads and 21 (6.3%) Endotak leads were affected.
A greater risk of failure was found for the Riata lead compared with the Endotak lead (p = 0.0001). An additional time‐dependent effect was found, with the Riata lead 1.9 times more likely to fail in the first 6 years following lead implantation and 5.3 times more likely to fail after 6 years.
Conclusions
Riata leads have a higher risk of failure compared to Endotak leads over time. The importance of careful ongoing performance surveillance late in the leads’ lifetime is reflected in this ten year follow up study.
This article is protected by copyright. All rights reserved
In 1986, the European Society of Biomaterials Consensus Conference gave a simplified definition of biomaterials as “a non-viable material used in a medical device intended to interact with biological systems”. This seems to be more appropriate when we look into the versatility of applications of biomaterials in the health sector, especially in cardiovascular practice. This field has expanded exponentially in every direction, with multifunctional capability. Heart valves have undergone an evolution in biomaterials and design. Patches and conduits have been developed to correct anatomical deficits, and solutions have been found for narrowing or ballooning of the arteries. Research is ongoing to find replacements for every part of this system by creating replicas made of various materials. To investigate problems pertaining to the cardiovascular system, catheters have undergone an astounding leap in material optimization. In these three sectors, the trends, successes, and failures are worth discussing. This review mainly focuses on the types of biomaterial used for making cardiovascular devices and their advantages and limitations.
The indications for implantation of an implantable cardioverter-defibrillator (ICD) in the pediatric population and in adults with congenital heart disease (CHD) have expanded in the 3 decades since the introduction of this technology. Application of ICD technology in all children and adults with CHD is characterized by both unique anatomic and size considerations. This chapter reviews published guidelines for current indications for ICD implantation in children and young adults with CHD, and novel ICD indications in the inheritable arrhythmias and structural and functional cardiac disease. Appropriate device and lead choices and programming strategies unique to these patients are also discussed.
The implantable cardiac pacemaker (PM)/defibrillator is a technically sophisticated system composed of a generator connected to one or more leads. Pacemaker/defibrillator leads play a pivotal role for system function, delivering the output pulse or the endocardial shock from the generator to the myocardium and acquiring spontaneous intracardiac electrogram from the heart to the device. Leads are also the most frequently involved component in case of system malfunction, and when a generator-pocket infection is present, their extraction — always necessary to guarantee complete resolution — is a challenge. The success of lead extraction is highly influenced by lead characteristics; for that reason, this chapter is dedicated to lead technology, i.e., polarity, electrodes, fixation mechanisms, electrode-tissue interaction, conductors, insulators, and connectors, with particular attention to aspects that may interfere with the extraction procedure. We discuss separately cardiac PM and defibrillator leads to emphasize their different technology.
Right ventricular perforation is a rare but serious complication of permanent pacemaker and implantable cardioverter-defibrillator implantation, with a reported prevalence rate of 0.1–6%. Generally, there is a high incidence of asymptomatic lead perforation with otherwise normal function. Some patients present with a stabbing chest pain and shortness of breath or pacemaker malfunction. However, in some cases, tamponade or adjacent tissue injury may be seen. The exact risk factors for lead perforation are not yet clear. Furthermore, there are many controversies in the management of lead perforation. Extraction of an asymptomatic, incidentally detected, chronically perforating lead does not seem to be necessary. Patients with symptoms or device malfunction will require treatment appropriate for their problem.
Introduction:
Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads.
Methods and results:
ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (p = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%).
Conclusions:
Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads. This article is protected by copyright. All rights reserved.
Extraction of cardiovascular implantable electronic device leads is the removal of a lead that has been implanted for >1 year or that requires more than a standard stylet. The number of these procedures has greatly increased over the past few decades owing to the growing demand for primary and secondary implantations in ageing populations, and an accompanying rise in revisions for complications, infections, and lead advisory safety alerts. In this Review, we present the most common indications and techniques used for extraction. Particular consideration is given to the extraction of leads with large vegetations, recalled leads, stented leads, and those placed in the coronary sinus. We also summarize the most relevant and contemporary data on safety, efficacy, and outcomes of lead extraction.
The totally subcutaneous implantable cardioverter and defibrillator (S-ICD) represents the most innovative development in implantable cardioverter and defibrillator therapy in the last 15 years. Its development arose out of concern for the long-term complications of transvenous devices. Clinical trials have shown that it is a safe and effective device for patients at risk of sudden cardiac death. The lack of transvenous and intracardiac components makes it an attractive choice for young patients, those with limited vascular access and increased infectious risk. Despite these advantages, the current S-ICD system has limitations, including the inability to deliver cardiac pacing. Future programming and technologic advancements have the opportunity to dramatically improve the efficacy and broaden the patient population treated with the S-ICD.
Background:
As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers.
Methods and results:
We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up.
Conclusions:
Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
Modern day pacemakers serve the primary function of either maintaining a minimum heart rate to avoid symptomatic or potentially life-threatening bradyarrhythmias, or offering resynchronization between the left and right ventricles in the setting of heart failure. However, multiple advances in device design, programming, sensor technology, and materials science have afforded the ability to offer an ever-widening range of devices with a variety of specialized features. In this chapter, we focus on the basic principles underlying cardiac pacing and then touch on several aspects of lead, device, and algorithm design.
Cable externalization and insulation abrasion are known to occur with the St. Jude Riata leads under advisory. The distribution of these abnormalities and how they relate to clinical presentation have not been well described.
Using the analysis of returned Riata products in Canada, we sought to determine the relationship between structural lead failure and clinical presentation.
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 prior to 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 either due to 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 7Fr leads (84.2% vs 58.4%, p=0.07), while inside-out abrasion was more common in the Riata 8Fr models (37.5% vs 15.8%, p=0.12). Electrical abnormalities were frequent (20/31, 65.4%) and most often due to electrical noise (45.2%), although inappropriate shocks were present (25.8%). Death occurred in 1/43 (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.
Copyright © 2014. Published by Elsevier Inc.
Background
Insulation defects resulting in conductor externalization (CE) have been reported in the Riata family of implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA). The aim of this study was to identify, prospectively, the rate of CE and outcomes following this, within a group of patients with a Riata ICD lead. Methods
Patients with a Riata ICD lead attended for fluoroscopic screening and electrical assessment of the lead at yearly intervals between 2010 and 2012. ResultsOne hundred and forty patients had no or borderline evidence of CE on initial assessment in 2010. These patients were prospectively followed for 3 years (304.6 patient-years). During this time, 11 patients developed definite CE, equating to an event rate of 3.6 (95% confidence intervals: 1.8-6.5) per 100 patient-years of follow-up. Of those patients developing definite CE, one patient had the ICD lead explanted (for reasons unrelated to CE) and no patients died. CE was not associated with any electrical abnormalities of the ICD lead. ConclusionsCE was observed at a rate of 3.6 per 100 patient-years of follow-up, in 140 individuals with a Riata ICD lead and no definite evidence of CE at baseline.
In December 2010 St. Jude Medical informed about higher incidence of silicone insulation abrasion in implantable cardioverter-defibrillator leads Riata/Riata ST. The manifestation of this phenomenon is the externalisation of conductors outside the body of the lead, which is visible in a fluoroscopy. The abrasion could also involve an insulation under high-voltage coil and in the worst case could result in a short circuit within high voltage part of the system. The incidence of this phenomenon varies from part of to several dozen percent according to published papers and becomes higher in a longer follow-up. The highest probability of malfunction in 8 F single coil and the lowest in 7 F dual-coil leads is observed. For the needs of this guidelines all Riata/Riata ST leads were divided into: functioning, damaged but active (visible externalisation but electrically functioning), malfunctioning. In the last case the lead should be removed and a new one implanted (class of indication I) ,although only implantation of a new lead with abandoning malfunctioning one is allowed and should be considered (IIa). In patients with functioning lead extraction with a new lead implantation may be considered during elective replacement only in high risk patients (IIb). In case of damaged but active lead its extraction with the implantation of a new lead during elective replacement of the device should be considered in high risk population (IIa) and may be considered in other patients (IIb). The final decision related to Riata/Riata ST should be individualised and undertaken in co-operation with the patient after detailed assessment of the risk related to each treatment option.
Aim
Riata implantable cardioverter-defibrillator leads are prone to failure by conductor externalization and/or electrical dysfunction. The objectives of this study were to determine the predictors of the Riata lead failure, to assess the association of conductor externalization and electrical lead failure, and to analyse the rates of lead failure over time.
Methods and results
Of 273 implanted Riata leads in our centre, 197 were investigated according to the Riata recall protocol, including electrical measurements by device interrogation and annually fluoroscopy. During a mean follow-up period of 5.6 ± 1.4 years, Riata lead failure was 18.8% (37 of 197) for externalization and 17.3% (34 of 197) for electrical lead failure. Electrical lead failure was correlated with time after implant. Externalization and electrical dysfunction co-existed in only 6 of 197 (3%) patients and were not related (Phi's coefficient −0.013, P = 0.85). During the second annual screening, 145 (73.6%) patients underwent fluoroscopy and 9 patients had novel externalizations resulting in an incidence of 6.72%/patient/year which was higher than expected based on cross-sectional analysis. Besides, there was a significant increase in the extent of externalization (17.65 ± 11.14 mm vs. 21.77 ± 11.95 mm, P = 0.001). In multivariate Cox regression analysis, non-ischaemic cardiomyopathy and impaired LVEF were independent predictors of externalization, and 7 Fr lead was a predictor of electrical lead failure.
Conclusion
Riata leads show progressive and high externalization rates without correlation between externalization and electrical lead failure. Non-ischaemic cardiomyopathy and impaired LVEF are independent predictors of structural lead failure in cross-sectional analysis, whereas 7 Fr lead is a predictor of electrical lead failure.
Background:
Implantable cardioverter-defibrillator leads from Riata® family (St. Jude Medical Inc., Sylmar, CA, USA) have been recently recalled by Food and Drug Administration for concerns of a unique type of "inside-out" insulation failure leading to conductor externalization. The objective of this study was to evaluate the prevalence and predictors of conductor externalization in patients implanted with Riata 8 French (Fr) and 7 Fr leads.
Methods:
Patients implanted with Riata® and Riata ST® who were actively followed up in our institution were scheduled for high resolution 3 view fluoroscopy and device interrogation including high voltage (HV) lead impedance testing. Fluoroscopic images were graded as presence of externalization or no externalization.
Results:
Of the 90 patients who underwent screening fluoroscopy, majority had dual coil leads (62.5%) and median duration from the implant time to screening was 79.5 months. Twenty four (26.7%) patients exhibited evidence of lead externalization with 10 (41.6%) of these showing electrical abnormalities at the time of screening. No externalization was seen in the 7 Fr leads. Pacing thresholds were significantly elevated in the externalized cohort compared to non-externalized group (1.42 ± 1.23 vs. 0.93 ± 0.53; p = 0.01). Time since lead implant and lead diameter emerged as significant predictors of lead externalization on univariate analysis with only lead diameter being significant on multivariate analysis (odds ratio 30.68; 4.95-∞, p = 0.001).
Conclusions:
Prevalence of insulation failure exhibiting as conductor externalization is high (26.7%) among the large diameter 8 Fr Riata® leads with a significant proportion of patients manifesting electrical failure. High resolution 3 view fluoroscopy is a reasonable approach to screen for this unique type of insulation failure.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a new therapeutic option for patients at risk of sudden cardiac arrest. The device uses a pulse generator implanted in the lateral thoracic region and a tunneled subcutaneous electrode. Benefits of this configuration include the preservation of venous access and reduction in the risk of systemic infection, vascular injury, and lead failure. Clinical trials suggest that the device effectively senses, discriminates, and converts both spontaneous and induced ventricular tachycardia and ventricular fibrillation episodes with minimal complications. The S-ICD represents a novel implantable cardioverter-defibrillator configuration that may provide reliably effective therapy for malignant tachyarrhythmias.
The evolution of implantable cardioverter defibrillator (ICD) technology for the past 3 decades has been nothing short of explosive, incorporating progressively transvenous leads, multizone programming, dual chamber antibradycardia pacing, antitachycardia pacing (ATP), sophisticated single- and dual-chamber discrimination algorithms, cardiac resynchronization therapy (CRT), and programmable options numbering into the thousands. As a consequence, ICDs have been used to treat patients with a variety of clinical needs, including those with a known history of ventricular tachycardia (VT), survivors of out of hospital cardiac arrest, patients with requirements for pacing or resynchronization with concomitant indications for an ICD, and patients who do not fit within these categories but are at risk for sudden cardiac death (SCD).
Response by Rav Acha and Milan on p 1244
Typically, the efficacy of most cardiac therapies is assessed initially on the sickest patients or those at highest risk. Such was the case for the ICD that was initially approved only for patients who had survived cardiac arrest. These early systems had epicardial leads and no pacing capabilities. Subsequently, transvenous lead systems and other advances were made in ICD technology, as noted above. However, these devices were approved and used based on the demonstration of the ability to detect and to terminate VT and ventricular fibrillation (VF). In fact, more complex therapies are not always better for patient outcomes. The Dual Chamber and VVI Implantable Defibrillator (DAVID) trial showed that indiscriminate right ventricular pacing is associated with increased risk of heart failure hospitalization and death, and more recent analyses continue to question the overuse of dual chamber devices.1,2 Similarly, CRT may be associated with more heart failure hospitalization among patients without QRS prolongation.3
The landmark prospective randomized trials showed a mortality benefit of ICDs for both primary and secondary prevention of SCD. The early …
Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients.METHODS AND RESULTS: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant.CONCLUSION: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.
The St. Jude Medical Riata family of implantable cardioverter defibrillator (ICD) leads has demonstrated a high rate of externalized conductors and electrical failure.
Given similar design elements to Riata, we sought to assess the rate of failure of the Riata-ST-Optim and Durata lead families in Canada.
All Canadian ICD-implanting centres were invited to submit follow-up information on all Optim-coated ICD leads implanted. Electrical failure was defined as a rapid change in impedance or pacing capture threshold leading to lead revision, or over-sensing due to noise. Externalized conductors were defined as appearance of conductor wires outside the lead body. Systematic fluoroscopic screening for externalized conductors was not performed.
As of December 1, 2012, fifteen of 25 centres provided data on 3981 leads (44% of those sold in Canada during the same timeframe); 3477 Durata and 504 Riata-ST-Optim leads. The most common model numbers were 7122 (1516 leads; 38%), 7121 (707 leads; 18%) and 7120 (622 leads; 16%). The mean follow up duration from implant to December 1, 2012 was 4.47± 0.48 years for Riata-ST-Optim leads and 2.00±1.10 years for Durata leads. The annual rate of lead failure was 0.27%/year for Riata-ST-Optim leads and 0.24%/year for Durata leads. There were no instances of externalized conductors identified in the failed leads. No deaths were attributed to lead failure; however, 2 patients experienced inappropriate shocks due to lead failure.
The overall electrical failure rate of the Riata-ST-Optim and Durata leads appears low, and no instances of externalized conductors were observed.
The implantable cardioverter defibrillator (ICD) lead is critical to the function of the ICD system. The mortality reduction associated with ICDs implanted for primary prevention indications has been made possible by the development of effective and reliable transvenous ICD leads. Mortality rates for implantation of transvenous ICD lead systems are currently less than 0.5%. The reliability and functional characteristics of a lead are often not known until it has been in widespread use. An understanding of the mechanism of lead failure is essential for proper patient management. This article describes the design and construction of ICD leads, discusses lead failure, and reviews subsequent management of patients.
Surgery involves the repair, resection, replacement, or improvement of body parts and functions and in numerous ways, surgery should be considered human engineering. There are many areas in which surgical materials could be improved, but surgeons are generally unaware of materials available for use, while materials scientists do not know what surgeons require. This article will review some of the areas where surgeons and materials scientists have interacted in the past and will discuss some of the most pressing problems which remain to be solved. These include better implant materials for hernia repair, breast reconstruction, the treatment of diabetes, vascular stenting and reconstruction, and electrical pacing devices. The combination of tissue engineering and nanomaterials has great potential for application to nearly every aspect of surgery. Tissue engineering will allow cells or artificial organs to be grown for specific uses while nanotechnology will help to ensure maximal biocompatibility. Biosensors will be combined with improved electrodes and pacing devices to control impaired neurological functions. WIREs Nanomed Nanobiotechnol 2013, 5:299–319. doi: 10.1002/wnan.1220
This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants
Implantable Materials and Surgical Technologies > Nanotechnology in Tissue Repair and Replacement
Implantable Materials and Surgical Technologies > Nanoscale Tools and Techniques in Surgery
AimsIncreased rates of structural abnormalities including externalized conductors have been reported in the Riata family of implantable cardioverter-defibrillator leads (St Jude Medical). Little is known about their reliability and the time lag for emergence of functional or structural abnormalities.Methods and resultsThirty-six patients who received small-caliber leads of the Riata family and who completed face-profile flouroscopies, repeated at every 6 months were included. We assessed the prevalence of conductors' externalization and its relation to abnormal electrical parameters or adverse events. Thirty-six patients, mean age = 64 ± 10 years, with at least 7-month completed fluoroscopy follow-up were included in the analysis. Externalized conductors were identified in 12 (33%) patients after a 53-month (13-114) mean delay. A higher left ventricular ejection fraction (LVEF): 47 ± 13 vs. 33 ± 12%, P = 0.04, and a progressive decrease (≥30% of the initial value) in amplitude of ventricular electrogram 9/12 (75%) vs. 4/24 (17%), P = 0.03 were independently associated with the fluoroscopic failures. Detection of the conductors' externalization was preceded by an electrical lead abnormality in 10 (83%) patients.Conclusion
Repeated face-profile fluoroscopies allowed detection of conductors' externalization in 33% of patients implanted with Riata leads. Better LVEF and a progressive decrease in amplitude of intracardiac ventricular electrogram were independently associated with externalized conductors. The structural abnormality was preceded by an electrical lead dysfunction 83% of patients. Published on behalf of the European Society of Cardiology. All rights reserved.
Objective
Safety concerns about the Riata ICD shock lead were recently raised, with insulation failure due to conductor externalisation. Its incidence and presentation were assessed, and predictors of insulation failure and lead survival of the Riata 1580–1582 were studied, retrospectively, before the official recall.
Methods
All 374 patients at the Erasmus Medical Center between July 2003 and December 2007 with a 1580, 1581 or 1582 shock lead.
Results
The majority of the patients were male (78 %), with a median age of 60 years (IQR 52–70); primary prevention in 61 %. Median follow-up was 60.3 months (IQR 35.5–73.2), with 117 (31 %) patients dying. Electrical abnormalities (mainly noise, 65 %) were observed in 20/257 patients (7.8 %). Definite conductor externalisation was confirmed with fluoroscopy or chest X-ray in 16 patients, and in one after extraction. One patient presented with a drop in the high-voltage impedance trend with a short circuit of the ICD system during defibrillation testing, and needed to be shocked externally. In 8 more patients, conductor externalisation was found during an elective procedure. No predictors of externalisation could be found, except for the use of single coil (p = 0.02). Median time to conductor externalisation was 5 years (IQR 3.1–6.2). Lead externalisation was observed in 5.4 % (95 % CI 3.1–9.3) at 5 years and 22.7 % (95 % CI 13.6–36.6) at 8 years.
Conclusion
A high incidence of insulation defects associated with conductor externalisation in the Riata ICD lead family is observed. The mode of presentation is diverse. This type of insulation failure can lead to failure of therapy delivery.
Background/objectives:
Sprint Fidelis and Riata defibrillator leads are prone to early failure. Few data exist on the comparative failure rates and mortality related to lead failure. The aims of this study were to determine the failure rate of Sprint Fidelis and Riata leads, and to compare failure rates and mortality rates in both groups.
Methods:
Patients implanted with Sprint Fidelis leads and Riata leads at a single centre were identified and in July 2012, records were reviewed to ascertain lead failures, deaths, and relationship to device/lead problems.
Results:
113 patients had Sprint Fidelis leads implanted between June 2005 and September 2007; Riata leads were implanted in 106 patients between January 2003 and February 2008. During 53.0 ± 22.3 months of follow-up there were 13 Sprint Fidelis lead failures (11.5%, 2.60% per year) and 25 deaths. Mean time to failure was 45.1 ± 15.5 months. In the Riata lead cohort there were 32 deaths, and 13 lead failures (11.3%, 2.71% per year) over 54.8 ± 26.3 months follow-up with a mean time to failure of 53.5 ± 24.5 months. There were no significant differences in the lead failure-free Kaplan-Meier survival curve (p=0.77), deaths overall (p=0.17), or deaths categorised as sudden/cause unknown (p=0.54).
Conclusions:
Sprint Fidelis and Riata leads have a significant but comparable failure rate at 2.60% per year and 2.71% per year of follow-up respectively. The number of deaths in both groups is similar and no deaths have been identified as being related to lead failure in either cohort.
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 prevalence of externalized conductors in Riata leads is significantly high (14.3%) using fluoroscopic screening. The majority of externalized conductors are not detectable with standard ICD interrogation. Screening with fluoroscopy is reasonable.
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 dual-coil conductors (model 1580 or 1581) between 2006 and 2010 at our hospital. Operative records, chest X-rays 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.
Introduction:
Insulation defects with externalized conductors have been reported in the St. Jude Riata(®) family of defibrillation leads (St. Jude Medical, Sylmar, CA, USA). The objective of the Northern Ireland Riata(®) lead screening program was to identify insulation defects and externalized conductors by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of patients. We sought to estimate the prevalence, identify risk factors, and determine the natural history of this abnormality.
Methods:
All patients with a Riata(®) lead under follow-up at the Royal Victoria Hospital were invited for fluoroscopic imaging and implantable cardioverter-defibrillator lead parameter checks. Fluoroscopic images were read independently by two cardiologists and the presence of externalized conductors was classified as positive, negative, or borderline.
Results:
One hundred and sixty-five of 212 patients with a Riata lead were evaluated by fluoroscopy and lead parameter measurements. The mean duration after implantation was 3.98+/-1.43 years. After screening 25 (15%) patients were classified as positive, 137 (83%) negative, and three (1.8%) borderline. Time since implantation (P = 0.001), presence of a single coil lead (P = 0.042), and patient age (P = 0.034) were significantly associated with externalized conductors. The observed rate of externalized conductors was 26.9% for 8-French and 4.7% for 7-French leads. No leads that were identified prospectively with externalized conductors had electrical abnormalities. Seven of 25 (28%) patients had a defective lead extracted by the end of this screening period.
Conclusion:
A significant proportion (15%) of patients with a Riata lead had an insulation breach 4 years after implantation. High-resolution fluoroscopic imaging in at least two orthogonal views is required to identify this abnormality.
Aim
The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure.
Methods and results
We searched the US Food and Drug Administration's (FDA's) Manufacturers and User Device Experience (MAUDE) database on 13 April 2012 using the simple search terms ‘Riata ST Optim™ abrasion analysis’ and ‘Durata abrasion analysis’. Lead implant time was estimated by subtracting 3 months from the reported lead age. The MAUDE search returned 15 reports for Riata ST Optim™ and 37 reports for Durata leads, which were submitted by SJM based on its analyses of returned leads for clinical events that occurred between December 2007 and January 2012. Riata ST Optim™ leads had been implanted 29.1 ± 11.7 months. Eight of 15 leads had can abrasions and three abrasions were caused by friction with another device, most likely another lead. Four of these abrasions resulted in high-voltage failures and one death. One failure was caused by an internal insulation defect. Durata leads had been implanted 22.2 ± 10.6 months. Twelve Durata leads had can abrasions, and six leads had abrasions caused by friction with another device. Of these 18 can and other device abrasions, 13 (72%) had electrical abnormalities. Low impedances identified three internal insulation abrasions.
Conclusions
Riata ST Optim™ and Durata ICD leads have failed due to insulation abrasions. Optim™ did not prevent these abrasions, which developed ≤4 years after implant. Studies are needed to determine the incidence of these failures and their clinical implications.
Background:
A medical device advisory issued by St Jude Medical in November 2011 estimated 0.63% all-cause abrasion rate on their Riata and Riata ST silicone high-voltage lead families (Riata/ST), leading to Food and Drug Administration class I recall. We performed an independent comparative, long-term electrical survival analysis of Riata/ST and 3 other high-voltage lead families in a large national cohort of patients.
Objective:
To evaluate long-term electrical survival of Riata/ST leads relative to other commonly evaluated high-voltage leads.
Methods:
Failure rates of Riata/ST, Sprint Quattro Secure (Quattro), Sprint Fidelis (Fidelis), and Endotak Reliance G/SG (Endotak) leads from the Veterans Administration's National Cardiac Device Surveillance Center database, consisting of 24,145 patients with remote transmissions since 2003, were analyzed. Survival Probabilities were determined with Kaplan-Meier survival analysis and compared using the log-rank test.
Results:
Of 1,403 Riata/ST, 6,091 Quattro, 5,073 Fidelis, and 2,401 Endotak leads identified, 5-year survival probability of Riata/ST leads (97.5%) was significantly lower than that of Quattro (99.3%) and Endotak (99.4%) leads (P <.0001) but higher than that of Fidelis leads (89.6%) (P <.0001). Riata ST leads showed a 5-year survival of 95.5% (95% confidence interval 92.4-97.4) compared to 98.4% (95% confidence interval 97.1-99.1) in Riata leads (P = .003).
Conclusions:
There is decreased survival probability of Riata/ST leads compared to other contemporary high-voltage leads, with decreased survival of Riata ST silicone compared to Riata lead series. Careful long-term follow-up should be maintained in patients with Riata/ST leads in order to prevent inappropriate shocks or failed device interventions. Our results were determined in advance of Food and Drug Administration class I recall, which suggested that large-scale remote monitoring may be an effective tool for continued implantable cardioverter-defibrillator system surveillance.
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.
Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population. Objective: The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs).
Background: A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs.
Methods: Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement.
Results: The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied.
Conclusions: 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. (J Cardiovasc Electrophysiol, Vol. 21, pp. 551-556, May 2010)
Inside-out abrasion with externalization of sensing ring or high-voltage cables in St Jude Medical Riata implantable cardioverter-defibrillator leads has been reported. The prevalence of extruded cables, rate of electrical abnormalities, and predictors of failure in Riata leads are unknown.
To estimate the incidence of lead failure in the St Jude Medical Riata implantable cardioverter-defibrillator leads and to propose a standard for the fluoroscopic assessment of insulation breakdown.
Patients undergoing cine-fluoroscopy on Riata implantable cardioverter-defibrillator leads at our institution before January 25, 2012, were included (n = 87). Leads were graded as types 0-3 (0 = normal, 1 = abnormal conductor spacing, 2 ≤1 cm cable extrusion, 3 = >1 cm length extrusion). Comparison to extracted leads (n = 15) was documented. Device interrogation data were used for electrical analysis.
The mean time from implant was 5.9 ± 3.45 years. Structural lead failure with externalized cables was seen in 33.3% (29 of 87) of the patients. Thirty-one percent (9 of 29) of the leads with exposed cables showed electrical failure, and 29.7% (19 of 64) of the leads with normal electrical data contained externalized cables. Time from implant ≥5 years predicted structural lead failure (P < 0.05). X-ray grade compared with extracted leads demonstrated a sensitivity and specificity of 86% and 100%, respectively.
Cine-fluoroscopy using a simple scale correlated with the structural integrity of extracted Riata leads. A high percentage of leads with extrusion showed electrical failure. Leads ≥5 years from implant showed a high rate of externalized cables. A large independent multicenter study to determine the prevalence and clinical sequelae of Riata lead failures is warranted.
The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4-5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0-18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population.
The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
Background:
Recently, several cases of symptomatic and/or electrically detectable intracardiac inside-out abrasions in silicon-coated Riata® and Riata® ST leads have been described. However, the prevalence in asymptomatic patients with unremarkable implantable cardioverter defibrillator (ICD) interrogation is unknown. The aim of this study was to determine the prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata® and Riata® ST leads.
Methods:
All 52 patients with an active silicone-coated Riata® and Riata® ST lead followed up in our outpatient clinic were scheduled for a premature ICD interrogation and a biplane chest radiograph. When an intracardiac inside-out abrasion was suspected, this finding was confirmed by fluoroscopy.
Results:
Mean time since implantation was 71 ± 18 months. An intracardiac inside-out abrasion was confirmed by fluoroscopy in 6 patients (11.5%). Mean time from lead implantation to detection of intracardiac inside-out abrasion was 79 ± 14 months. In all patients with an intracardiac inside-out abrasion, ICD interrogation showed normal and stable electrical parameters. Retrospectively, in 4 of these 6 patients, a coronary angiography performed 25 ± 18 months before diagnosis of intracardiac inside-out abrasion already showed the defect. Despite undetected intracardiac inside-out abrasion, 2 of these 4 patients experienced adequate antitachycardia pacing and ICD-shocks. ICD leads were replaced in all 6 patients.
Conclusions:
The prevalence of asymptomatic intracardiac inside-out abrasion in silicon-coated Riata® and Riata® ST leads is higher than 10% when assessed by fluoroscopy, and most intracardiac inside-out abrasions are not detectable by ICD interrogation.
Recently, concerns about St Jude's Riata lead family have come to light. We present three cases of patients with Riata internal cardioverter defibrillator (ICD) leads with externalized conductors.
All patients had the same insulation defect, with externalized conductors, but differed in presentation and symptoms. These cases, which form 3 of 179 (1.68%) of our total Riata lead population, presented four or more years after implantation. This may be an indication that the problem with the Riata lead may well be greater than reported in the recent St Jude Medical device advisory letter.
The management of the Riata lead problem is discussed as, up until now, management of patients with an implanted Riata lead has been based on detecting electric abnormalities on regular ICD interrogation only.
Long-term lead failure is a known complication of ICD therapy. The precise incidence and sequelae of insulation defects at the tricuspid level, however, are not well characterized. Objective: This study determined the risk of lead failure, with particular emphasis on insulation defects at the level of the tricuspid valve, in a large series of consecutive ICD recipients.
Data from 357 consecutive patients, who had received transvenous 7 and 8 French ICD-leads (St. Jude Medical, Riata family) and were followed at our center, formed the basis of this study.
During a mean follow-up of 42 ± 24 months, 30 of 357 (8%) patients required surgical intervention due to lead failure. For overall lead defects, lead access via the subclavian vein and subpectoral device placement were independent predictors of overall lead failure (OR 3.47, 95% CI 1.38-8.72, P = 0.013 and OR 3.83, 95% CI 1.77-8.27, P = 0.001, respectively). Lead insulation defects at the level of the tricuspid valve accounted for 20% of all lead failures. Diagnosis of this specific insulation defect could only be established by fluoroscopy, while electrical parameters were within normal limits in all of these patients. On univariate but not on multivariate analysis the presence of nonischemic cardiomyopathy was a predictor of this lead complication (OR 8.2, CI 1.5-46.1, P = 0.02).
Insulation defects of 7 and 8 French ICD leads at the tricuspid level represent an important complication of device therapy. Even moderate changes in lead impedance within the normal limits at follow-up should prompt careful fluoroscopic evaluation to avoid spurious shocks.
An increased risk of delayed cardiac perforation (DCP) with active-fixation small-diameter ICD leads has recently been reported, especially with regard to the St. Jude Riata lead (St. Jude Medical, Sylmar, CA, USA). Few data on the risk of DCP in small versus standard-diameter leads implanted in a single high-volume center are available. Moreover, no data on the performances of St. Jude's new small-diameter Durata lead are as yet available. The aim of this study was to assess the incidence of DCP in small versus standard-diameter leads implanted in our center.
Between January 2003 and October 2009, 437 small-diameter leads (190 Medtronic Sprint Fidelis [Medtronic Inc., Minneapolis, MN, USA], 196 Riata, 51 Durata) and 421 standard-diameter (>8 Fr) leads were implanted.
After a median follow-up of 421 days seven of 858 (0.8%) patients experienced DCP. The incidence of DCP was higher in patients with small-diameter leads than in those with standard-diameter leads (1.6% vs 0%, P = 0.01). No cases of DCP occurred among 371 passive-fixation leads versus 1.4% of events among active-fixation leads (P = 0.02). The incidence of DCP was 2.5% in Riata, 1% in Sprint Fidelis, 0% in Durata, and 0% in standard-diameter leads (P < 0.01 for Riata vs standard-diameter leads).
Small-diameter active-fixation ICD leads are at increased risk of DCP, a finding mostly due to the higher incidence of events in the Riata family. By contrast, passive-fixation small-diameter leads and standard-diameter leads appear to be safe enough regarding the risk of DCP. Our preliminary data suggest that the new Durata lead is not associated with an increased risk of DCP.
The intervals of the driving restrictions after an implantable cardioverter defibrillator (ICD) replacement vary across the different countries around the world. However, little is known regarding the appropriate duration for driving restrictions after an ICD replacement. The aim of this study was to investigate the clinical effect of ICD replacements and to elucidate when to resume driving an automobile after an ICD replacement.
The study reviewed 139 consecutive patients with an ICD replacement in order to evaluate the incidence of ICD therapies before and after ICD replacements, and to assess the time-dependence of the ICD therapies after the ICD replacement. There was no significant difference in the incidence of ICD therapies delivered during durations of 3 months and 6 months before and after the ICD replacement (P=0.28, and 1.0, respectively). ICD therapies after the replacements were observed in 8.6% of the patients who were legally eligible to drive according to the Japanese guidelines at 1 year, and that was associated with a relatively low annual risk of death or injury to others.
Implantable cardioverter defibrillator replacements did not affect the future ICD therapies under similar algorithms. The appropriate interval for driving restrictions after an ICD replacement is recommended to be a week or so, with a system integrity check performed before resumption of driving.
Implantable cardioverter-defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system.
First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients.
The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean (+/-SD) energy requirement (36.6+/-19.8 J vs. 11.1+/-8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Induced ventricular fibrillation was converted twice in 58 of 59 patients (98%) with the delivery of 65-J shocks in two consecutive tests. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10+/-1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia.
In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted ventricular fibrillation induced during electrophysiological testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. (ClinicalTrials.gov numbers, NCT00399217 and NCT00853645.)
The indications for ICD implantation continue to expand; however, these devices are associated with complications related to the implantation procedure itself and morbidity caused by the normal and abnormal functioning of the components comprising the system. Several factors need to be considered when embarking on initiating ICD implantation. Special consideration should be given to implantation technique and choice of operator to decrease acute complications. After implantation, the device should be appropriately programmed to minimize unnecessary pacing and decrease the likelihood of inappropriate shocks. Therapy should, in most cases, be painless and can be achieved by adhering to simple programming recommendations. A well-established and efficient follow-up program, ideally incorporating remote monitoring, is very important to ensure compliance and to monitor therapy and the integrity of the various device components-particularly given the possibility of device or lead malfunction.
Assisted reproductive technologies (ART) to treat infertility have been available for nearly three decades. There have been a number of systematic comparisons of the health and development of ART-conceived with spontaneously-conceived (SC) children. Data are equivocal, some finding no differences and others that there are more health and developmental problems in the ART group. It is agreed that perinatal mortality and morbidity are worse after assisted than spontaneous conception and the impact of the hormonally altered intrauterine environment on puberty and later fertility of offspring are unknown. To date however, there has been no investigation of the health and development of ART-conceived young adults, including from the world's few prospective cohorts of ART conceived children. Obtaining these data requires contact to be made with people at least twenty years after discharge from the treating service. Given the ethical difficulties of approaching families to participate in research up to two decades after cessation of treatment, the aim of this exploratory qualitative investigation was to assess the feasibility and acceptability of approaching mothers treated for infertility prior to 1988, and their recall of the health and development of their ART-conceived young adult children.
Mothers treated for infertility at the Royal Women's Hospital Reproductive Biology Unit in Melbourne, Australia prior to 1988 were approached by a senior clinician and invited to participate in individual semi-structured interviews which could include their partners and/or young adult children if they wished. Recruitment continued until theoretic saturation had been reached.
Ten mothers, two of their husbands and five young adults participated in interviews, and the health and development of 15 ART-conceived young adults were described. The experience of conception, pregnancy, birth and the health and development of the children were recalled vividly and in detail. Families were pleased to have been approached and supported the need for systematic data collection. Mode of conception had been disclosed from childhood to all the offspring.
With careful and sensitive recruitment strategies it is feasible and acceptable to contact women treated for infertility at least two decades ago and their families, to assess the health and development of ART-conceived young adults.
Implantation of transvenous implantable cardioverter defibrillators (ICDs) by use of a nonthoracotomy approach has become routine therapy for survivors of life-threatening tachyarrhythmias. The purpose of this study was to identify and prospectively characterize the frequency of lead- and ICD-related complications from the Antiarrhythmics versus Implantable Defibrillators (AVID) Trial.
Between June 1, 1993, and April 7, 1997, 539 patients received nonthoracotomy ICDs either as initial treatment assignment (477) or as crossover from medical management (62). A total of 62 first complications occurred. The subclavian route of insertion resulted in more complications than the cephalic vein route, 46 of 339 (14%) versus 6 of 135 (4%), P = .005, as did the abdominal versus pectoral generator site, 31 of 238 (13%) versus 17 of 291 (6%), P<.02. Most dislodgements and system infections tended to occur in the 3 months after implantation, whereas lead fractures continued to occur throughout follow-up. Failure to use perioperative antibiotics was a predictor of system infection (P = .001).
These data suggest that cephalic vein access and pectoral generator site may result in fewer complications. The continued occurrence of lead fractures and the need for premature system revision supports the practice of close routine ICD system surveillance.
Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population.
To determine the complication rate associated with ICD generator replacement for the current ICD advisories.
Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005.
Complications associated with elective ICD generator replacement for current device advisories.
At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences.
ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.
Limited information exists to direct clinical management after an implantable device has been put under advisory. A better understanding of the risks and benefits of device replacement compared with continued clinical follow-up would be helpful to clinicians.
Using the tools of decision analysis, to determine the best management approach (immediate device replacement vs continued monitoring) in the setting of a device advisory.
A decision model was constructed to evaluate the risks and benefits associated with immediate device replacement compared with continued monitoring.
Variables considered included indications for device implantation, anticipated course following device failure, device failure rates from the advisory ranging from 0.0001% to 1.0% per year, and device replacement mortality rates ranging from 0.10% to 1.00% per procedure. Device replacement was preferred to continued follow-up when replacement led to greater patient survival.
The decision to replace a recalled device depends primarily on the advisory's estimated device failure rate and the likely effects of device failure on mortality. Procedural mortality is an important secondary factor, while patient age and remaining generator life have the least influence on the decision. For pacemaker-dependent patients, advisory device failure rates exceeding 0.3% warrant device replacement in most situations. In patients with implantable cardioverter-defibrillators for primary or secondary prevention, a failure rate associated with an advisory of 3.0% is needed to favor replacement in most cases, decreasing to close to 1.0% as procedural mortality rates decrease to 0.1% or risk of fatal arrhythmias increase to near 20% per year. In cases of pacemaker implantation for non-life-threatening situations (eg, carotid sinus hypersensitivity), most device advisories do not warrant device replacement.
The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.
Defibrillator lead malfunction is a potential long-term complication in patients with an implantable cardioverter-defibrillator (ICD). The aim of this study was to determine the incidence and causes of lead malfunction necessitating surgical revision and to evaluate 2 approaches to treat lead malfunction.
We included 1317 consecutive patients with an ICD implanted at 3 European centers between 1993 and 2004. The types and causes of lead malfunction were recorded. If the integrity of the high-voltage part of the lead could be ascertained, an additional pace/sense lead was implanted. Otherwise, the patients received a new ICD lead. Of the 1317 patients, 38 experienced lead malfunction requiring surgical revision and 315 died during a median follow-up of 6.4 years. At 5 years, the cumulative incidence was 2.5% (95% confidence interval, 1.5 to 3.6). Lead malfunction resulted in inappropriate ICD therapies in 76% of the cases. Implantation of a pace/sense lead was feasible in 63%. Both lead revision strategies were similar with regard to lead malfunction recurrence (P=0.8). However, the cumulative incidence of recurrence was high (20% at 5 years; 95% confidence interval, 1.7 to 37.7).
ICD lead malfunction necessitating surgical revision becomes a clinically relevant problem in 2.5% of ICD recipients within 5 years. In selected cases, simple implantation of an additional pace/sense lead is feasible. Regardless of the chosen approach, the incidence of recurrent ICD lead-related problems after lead revision is 8-fold higher in this population.
We describe how a single defect in a new model transvenous lead for an implantable curdiuverter defibrillator can result in malfunction of the sensing and defibrillation circuits. The patient had received shocks during atrial fibrillation without premonitory symptoms. At least one shock was delivered and not fell by the patient. In addition, late in the course, a shock was delivered during atrial fibrillation documented to be with a slow ventricular response. In the transvenous lead, a distal spring functions as the anode for rate sensing and the cathode for defibrillation. The wire from this spring bifurcates near the proximal end of the catheter. One wire from the bifurcation leads to the positive (anode) rate-sensing socket of the pulse generator, and the other wire leads to the negative (cathode) high voltage output socket of the defibrillator for defibrillation and cardioversion. After the inappropriate and unperceived shocks were documented, intraoperative and postoperative electrical testing indicated that intermittent discontinuity of the distal spring system within the proximal yoke of the catheter caused faulty sensing and potentially unreliable defibrillation. This dual malfunction was possible because the distal spring of the lead functions in the high-voitage output and the rate-sensing iow-vollage input circuits of the implantable defibrillator.
The intraoperative and early postoperative mechanical complications of a procedure combining an atrial screw-in lead and a ventricular screw-in lead insertion were prospectively evaluated. The procedure was performed in 119 consecutive patients (mean age 69 ± 8 years), at first implant in 100 patients and at reoperation in 19. Nine patients had previously undergone cardiac surgery and three underwent transvenous ventricular defibrillator implantation. The double sets of leads were introduced through 2 separate veins in 5 cases, through a single venous route in 114 cases, using a percutaneous approach in 75 cases and a venous cutdown in 49, and a guidewire procedure following the venotomy in 19. The screw was mannitol coated in 102 cases, exposed in 111, and extendable/retractable in 25. The fixation of the ventricular lead was performed at the apex in 108 cases, at the outflow tract in 11, and was followed by the fixation of the atrial lead at the appendage in 112 cases and at the lateral wall in 7 cases. The lead positioning and fixation were successful at first attempt in 103 cases and after repeated lead manipulation in 19 cases. The rotational torque could be transferred to the helix in all cases except in one patient who required a second vein puncture. Unintentional fixation in the ventricular chamber with subsequent failure to remove the lead occurred in one patient. Reoperation for lead dislodgment was required in two patients. In one patient, symptomatic pericarditis with pericardial effusion was observed 1 day after the procedure and resolved spontaneously. Dual active fixation is feasible with a low incidence of mechanical complications.
The rapid evolution of implantable cardioverter-defibrillator (ICD) leads has resulted in thinner active fixation leads. While these advances have made the leads more versatile, new configurations may be associated with unforeseen complications.
The purpose of this study was to determine the incidence of perforation and dislodgement of defibrillator leads in a single center in the year 2005.
All patients who underwent percutaneous ICD implantation at the Massachusetts General Hospital using an endocardial right ventricular lead were included in this study. The specific leads analyzed were the Riata (1580/1581 and 1590/1591, St. Jude Medical, St Paul, Minnesota, USA;) and Sprint Fidelis (6949-65, Medtronic, Minneapolis, Minnesota, USA.). Information was collected retrospectively.
A total of 130 Riata leads and 111 Sprint Fidelis leads were implanted at the Massachusetts General Hospital during this time period. A total of five lead perforations occurred in patients implanted with the Riata lead as compared with none with the Sprint Fidelis lead (3.8% vs. 0%, respectively; P <.05). Two of the five patients with perforation required pericardiocentesis for tamponade. Clinical symptoms of perforation developed 1-10 days after implant. Moreover, there were five additional lead revisions in the Riata group, which were likely due to dislodgement and/or microperforation, as compared with none in the Sprint Fidelis group (7.7% vs. 0%, respectively; P <.005).
In 2005, at one institution, there were significantly more cardiac perforations and lead revisions with the Riata lead as compared with the Sprint Fidelis right ventricular defibrillator lead. Further data are required to determine whether certain lead characteristics are responsible for this observation.
Increased rates of complications related to the use of small-diameter implantable cardioverter-defibrillator (ICD) leads have been reported. Lead design and engineering aimed at reducing ICD lead diameter may increase associated subacute complications, including cardiac perforation, lead dislodgement, or lead failure.
The purpose of this study was to determine whether lead caliber altered the risk of perforation, lead dislodgement, or lead failure in a single center.
All patients with right ventricular (RV) ICD lead implantation at Vanderbilt University and VA-Nashville Medical Center between January 1, 2007, and August 31, 2007, were included in this study. Leads implanted during this period were the Riata 1580, Riata ST 7000 (St. Jude Medical, St. Paul, MN), Sprint Fidelis 6949, and Sprint Quattro 6947 (Medtronic, Minneapolis, MN). Information was collected retrospectively.
A total of 305 ICD leads were implanted (138 small diameter, 167 standard diameter) during the study period. Failure was defined as development of high pacing threshold, marked sensing change, cardiac perforation, or development of extracardiac stimulation. A total of 11 lead failures occurred in the small-diameter lead group, versus one in the standard group. Implantation of a small-diameter lead (Riata 1580, Riata ST 7000, or Sprint Fidelis 6949) was associated with a significant increase in failure rate, 8.0% versus 0.6% (P = .0008) compared with standard-size leads (Sprint Quattro 6947).
Subacute lead-related complications were more likely with use of small-diameter ICD leads (Riata 1580, Riata ST 7000, Sprint Fidelis 6949) than with with standard-caliber ICD leads (Sprint Quattro 6947).
A retrospective study on complications especially related to operative or postoperative management was carried out in 1000 pacemaker implantations in 717 patients between September, 1972 and December, 1986. In 33 of our series (4.8%), 24 pacing failure occurred within two weeks of implantation. Flange-type leads had the highest incidence of complications. Wedging the electrode close to the longitudinal axis of the heart was found to be the best placing, assuming that the tip of the electrode and the section immediately adjacent were pointing downward. There were 6 cases of diaphragmatic pacing which could not be corrected through programming. No relation with the position of the electrode could be found. We recommend using bipolar pacing to lower the incidence of diaphragmatic pacing. We also had 9 patients with lead fractures (1.3%); these included 3 cases with silicone insulation breaks and 6 cases with wire fractures which occurred closely proximal to the area where the lead was fixed to the vessels. No relationship between the ratio of lead fractures and their brand was found. Five patients developed infections, all of them late postoperatively, over a period of 8 months to 5 years postop. Of these, there were 3 cases with postoperative prolonged hematoma at the pocket site, and 4 cases which had required lead repositioning because of pacing failure. The incidence of infection in our series was low when compared to previous reports, probably due to local use of one gram of Kanamycin during the operation and active chemotherapy performed short term postoperatively. To manage infection of the skin pocket, the pacemaker was removed and a new pacemaker was implanted in the opposite side. There was 7 early postoperative deaths. One of them due to cardiac tamponade caused by perforation of the cardiac wall by temporary electrode lead. The resustation was unsuccessful.
Unlabelled:
Implantable cardioverter defibrillators (ICDs) are increasingly being implanted without the need for thoracotomy. Long-term lead performance and stability were evaluated in 150 consecutive patients in whom 1 of 3 nonthoracotomy ICD lead systems was implanted over a 3-year period from September 1990.
Results:
Twelve (8%) patients (7 males, 5 females) experienced 13 lead complications during a follow-up period of 12 +/- 10 months. Complications were related to intracardiac leads in 7 (4 dislodgments, 2 fractures, 1 right ventricular perforation) and patch leads in 6 (2 folding, 1 fracture, 1 erosion, and 2 hematomas) cases. Freedom from lead related complications at 1 year was 92% (95% confidence interval, 86%-95%). A significant difference in freedom from lead complications between the two most frequently implanted lead systems was observed (P = 0.02). Complication rates were similar in the initial 75 and the more recent 75 implants (P = 0.5). The median time between lead implant and detection of complications was 37 days (range 3-1,147). Complications were diagnosed before hospital discharge in only two cases. In five patients, complications were asymptomatic and in three of these, reoperation was required due to inadequate defibrillation thresholds. Reoperation was necessary in 9 of 12 patients.
Conclusions:
Nonthoracotomy ICD lead systems are associated with a low complication rate. Complications may or may not cause symptoms, usually occur after hospital discharge, and require reoperation. Complications are not related to a "learning curve." There is a significant difference in performance between different lead systems.
A series of 78 consecutive implants of the transvene PCD (Medtronic, Inc.) defibrillator system is presented and the occurrence of right ventricular perforation in 4 patients reported (5.2%). Diagnosis of perforation is made using four signs: (1) decrease in arterial blood pressure without any other explanation; (2) decrease in pulsatility of the cardiac silhouette as monitored by fluoroscopy; (3) increased size of the cardiac silhouette; and (4) abnormal position of the transvenous lead too far out toward the left ventricle along the pericardial outline. Perforation causes rapid and dramatic cardiac tamponade due to the large diameter and stiffness of the coil carrier lead. Immediate drainage of the hemopericardium must be carried out using the transxiphoid approach. The use of a thin blue-coded lead stylet (0.014-inch gauge) is recommended over the stiffer maroon-coded stylet. Since treatment must be carried out immediately, it is advised that a surgeon either perform, assist, or be immediately available whenever one of these systems is implanted.
A 58-year-old patient with dilated cardiomyopathy underwent implantable cardioverter defibrillator (ICD) implantation. The postoperative course was complicated by perforation of the right ventricular free wall by the active fixation transvenous ICD lead. The type of ICD lead and the type of organic heart disease are apparently important risk factors for perforation.
Delayed lead perforation (occurring more than 1 month after implantation) is a rare complication. Its pathophysiology and optimal management are currently unclear.
Three cases of delayed lead perforation (6-10 month) were identified in patients with low-profile active fixation leads.
All cases presented in a subacute fashion with pleuritic chest pain with confirmatory chest x-ray and device interrogation. Given the potential complications of a perforated lead, all cases had the lead extracted under TEE observation with cardiac surgery backup in the operating room. All patients tolerated extraction without complication.
Based on these cases, we recommend a management scheme for patients who present with delayed lead perforation.
Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity.
The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls.
ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory.
From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P <.001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P <.001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P <.0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11).
Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.
PACE 2006; 29:653–669Original publication
Pacemakers and implantable cardiac defibrillators (ICDs) are widely used for the management of cardiac arrhythmias and congestive heart failure (CHF). Acute implantation complication rates range from 3% to 7%. The aim of this study is to describe the incidence of lead perforation on computed tomography (CT), and correlate these findings with electrophysiologic data.
Images of 100 consecutive patients with permanent pacemakers (n = 72) or ICDs (n = 28) who underwent multidetector CTs of the chest were identified. Cases were reviewed by 2 cardiothoracic radiologists, and a third if there was disagreement. Each CT was reviewed for device and fixation type, tip position, and presence of pericardial effusion. Results were correlated with lead impedance and pacing threshold, when available [79% (79/100)]. A cardiac electrophysiologist interpreted device data.
All 100 patients had right ventricular leads (58 passive, 42 active) and 61 had right atrial leads (12 passive, 49 active). 15% (15/100) of patients had a lead perforation. Perforation rates were 15% (9/61) for atrial and 6% (6/100) for ventricular leads (P < 0.05, chi square). Four of 28 (14%) right ventricular ICD leads and 2 of 72 (3%)right ventricular pacemaker leads were perforated (P < 0.05, chi square). 12% (6/49) of active right atrial leads, and 25% (3/12) of passive right atrial leads perforated (P = NS, chi square). 7% (3/42) of active right ventricular leads, and 5% (3/58) of passive ventricular leads perforated (P = NS, chi square). Electrophysiologic parameters did not differ significantly between perforated and nonperforated leads.
Asymptomatic perforation is a common phenomenon and rarely resulting in electrophysiologic consequences. Atrial leads perforated more frequently than ventricular leads, and ventricular ICD leads perforated more frequently than ventricular pacemaker leads.
The number of patients with longer follow-up after implantation of an implantable cardioverter-defibrillator is increasing continuously. Defibrillation lead failure is a typical long-term complication. Therefore, the long-term reliability of implantable cardioverter-defibrillator leads has become an increasing concern. The aim of the present study was to assess the annual rate of transvenous defibrillation lead defects related to follow-up time after lead implantation.
A total of 990 consecutive patients who underwent first implantation of an implantable cardioverter-defibrillator between 1992 and May 2005 were analyzed. Median follow-up time was 934 days (interquartile range, 368 to 1870). Overall, 148 defibrillation leads (15%) failed during the follow-up. The estimated lead survival rates at 5 and 8 years after implantation were 85% and 60%, respectively. The annual failure rate increased progressively with time after implantation and reached 20% in 10-year-old leads (P<0.001). Lead defects affected newer as well as older models. Patients with lead defects were 3 years younger at implantation and more often female. Multiple lead implantation was associated with a trend to a higher rate of defibrillation lead defects (P=0.06). The major lead complications were insulation defects (56%), lead fractures (12%), loss of ventricular capture (11%), abnormal lead impedance (10%), and sensing failure (10%).
An increasing annual lead failure rate is noted primarily during long-term follow-up and reached 20% in 10-year-old leads. Patients with lead defects are younger and more often female.
Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates.
We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure.
Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence.
Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices.
We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice.
The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads.
The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models.
The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor.
The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified.
Delayed intracardiac lead perforation has been defined as migration and perforation after one month of implantation. It is a rare complication; pathophysiology and optimal management are currently unclear. Recognition of these cases becomes important with increasing use of these devices. We describe such a case of delayed lead perforation.
A 71-year-old woman underwent routine implantable cardioverter defibrillator implantation. On a predischarge check the next day, electrical signals and thresholds were excellent and similar to those at implant. The chest X-ray was unremarkable and showed good lead position at the right ventricular apex (RVA). At a routine one-month postimplant visit, electrograms were found to be miniscule, and pacing could not be achieved. Chest X-ray and fluoroscopy suggested perforation, then this was confirmed by computed tomography scan. The tip of the lead was estimated to be within 7 mm of the surface of the skin. The system was removed surgically, and the patient continued to do well.
The authors present two cases of patients with perforation of the right ventricular wall by the implantable cardioverter defibrillator (ICD) lead. The complication was resolved by cardiosurgical revision and epicardial leads stitched onto the diaphragmatic wall of the heart. The perforation was identified by electrical parameter changes of the leads, echocardiography, and computed tomography. Both patients had satisfactory values of electrical parameters and ICD function with epicardial leads. The importance of regular follow-up and a check of the lead parameters are emphasized.
The potential advantages of using a 4Fr lumenless pacing lead (3830 SelectSecure, Medtronic Inc, Minneapolis, MN, USA) in children are largely negated due to the large size of the delivery system. Here we describe an innovative, sheath guided, delivery technique using conventional 5F sheaths.
Transvenous access was obtained via the left cephalic or axillary vein. A 5Fr introducer set with a 45 degrees curved tip (CheckFlo Performer Introducer Set with the Children's Hospital Boston Modification, Cook Medical Inc, Bloomington, IN, USA) was placed over a wire into the right atrium (RA) or right ventricle (RV). The sheath was modified by cutting off the valved end and a SelectSecuretrade mark lead was introduced through the sheath. Rotating the sheath provided steerability and allowed for precise placement of the lead. After successful lead placement, the sheath was removed with a universal sheath splitter.
We placed seven atrial and six ventricular leads in eight patients during nine separate cases with this method. Patient ages and weights ranged from 5 to 16 years and 16 to -59 kg respectively. Pacing thresholds were excellent at implant. Leads were placed successfully in all attempts. There were no procedural complications. One patient had leads placed twice; both lead systems were removed for suspected infection. Over short-term follow-up in five patients, lead position and characteristics have remained stable.
Delivery of the SelectSecure lead in children can be successfully and precisely performed using a modified 5Fr sheath obviating the need for a large steerable delivery system.
The Medtronic Sprint Fidelis family of leads has recently been the subject of a widespread advisory. Lead failure rates are estimated at 2.3% at 30 months, 2.6 times the failure rate of the reference Medtronic 6947 lead.
The purpose of this study was to contact pediatric and adult implantable cardioverter-defibrillator (ICD) implant centers across Canada to determine the short-term response to the October 15, 2007 Medtronic Fidelis lead advisory.
All centers completed an 11-part survey to assess the frequency and presentation of lead failure, operator characteristics, and center's response.
Lead failure was noted in 80 (1.29%) of 6,181 patients at 21.0 months, with inappropriate shocks experienced in 45 (56%) of the 80 patients (overall risk 0.73%). No deaths were attributed to lead failure. Sensing was the primary form of failure, seen in 60 leads (75%), with pacing failure in 10 (13%), and high-voltage failure in 15 (19%). Assessment of the previous routine ICD interrogation prior to the advisory or lead failure demonstrated evidence of altered lead performance in only 8 (10%) of the 80 leads. Inappropriate shocks typically were multiple (median 7, range 1-122), with a single shock seen in only 5 patients. Lead failure was noted in 18 of 23 centers, representing 89.8% of leads implanted, with at least one failure noted in 15 of 16 centers that implanted more than 200 leads. Forty-seven of the 135 operators in the 23 institutions implanted the 80 leads that subsequently failed. Only 16 operators were involved in more than a single lead that subsequently failed; seven operators participated in three or more leads that subsequently failed. Seven centers planned to replace leads in most pacing-dependent patients, and two centers planned to replace leads in patients unable to hear the alert tone.
This national experience suggests a Fidelis lead failure rate of 1.29% at 21 months, most often presenting with multiple inappropriate shocks without evidence of impending failure from routine lead follow-up. Lead failure did not appear to cluster around specific operators or around high-volume or low-volume implant centers.
Recently, the performance and safety of smaller diameter implantable cardioverter defibrillator (ICD) leads has been questioned. The purpose of this analysis was to determine the impact of size on lead performance and perforation rates by comparing the performance of 7 French (7F) and 8 French (8F) leads with similar design characteristics implanted by a single operator.
Patients implanted with a Riata 1580 (8F) or 7000 (7F) series leads (St. Jude Medical, Sylmar, CA, USA) over a 2-year period were evaluated to compare performance and perforation rates.
There were 357 Riata 8F leads and 357 Riata 7F leads implanted in 714 patients. Follow-up ranged from 1 to 24 months. The 8F leads were implanted in the right ventricular apex more often than were 7F leads (129 or 37% vs 72 or 20%, P < 0.0001). Oversensing that did not result in therapy occurred in 2 pts (0.56%) with 8F leads and 1 pt. (0.28%) with a 7F lead (P = 0.56). Oversensing with therapy occurred once in both groups (0.28%, P = NS). One perforation occurred in each group (0.28%, P = NS). Both occurred in leads that were implanted in the right ventricular apex (P = 0.02).
The performance of St. Jude Medical 7F and 8F Riata leads was similar. The incidence of lead-related adverse events was within or below the low end of published acceptable ranges for ICD lead perforation and sensing anomalies. Perforations were less likely to occur in leads that were implanted in nonapical positions.
Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Working Group on Device Advisories
- Krahn Ad
- J Champagne
- Healey
- Js
Krahn AD, Champagne J, Healey JS, et al. Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Working Group on Device Advisories. Heart Rhythm 2008;5: 639 – 642.
Sub-acute lead complications with small caliber implant-able cardioverter-defibrillator (ICD) leads
- Ellis Cr Jn
Ellis CR, Rottman JN. Sub-acute lead complications with small caliber implant-able cardioverter-defibrillator (ICD) leads. Heart Rhythm 2008;5:S341.
Models 7020 and 7021 User's Manual. St. Jude Medical Cardiac Rhythm Management Division
- Riata St
Riata ST Optim Models 7020 and 7021 User's Manual. St. Jude Medical Cardiac Rhythm Management Division, 2007, Sylmar, CA.
Are 7 French leads safe?
- Han Jk N Joshi
- Z Feliciano
Han JK, Joshi N, Feliciano Z, et al. Are 7 French leads safe? Europace 2008;10:i64.
Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines
- Carlson Md
- Wilkoff Bl
- Wh
Carlson MD, Wilkoff BL, Maisel WH, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. Heart Rhythm 2006;3:1250 –1273.
Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator
- Danik
- Sb
- M Mansour
- J Singh
Danik SB, Mansour M, Singh J, et al. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm 2007;4:439 – 442.
Alabama 35294-0006. E-mail ad-dress: aepstein@uab
- Epstein
Epstein, Division of Cardiovascular Disease, Department of Medicine, The University of Alabama at Birmingham, Tinsley Harrison Tower 321L, 1530 3rd Avenue South, Birmingham, Alabama 35294-0006. E-mail ad-dress: aepstein@uab.edu. (Received August 29, 2008; accepted October 22, 2008.) 1547-5271/$ -see front matter © 2009 Heart Rhythm Society. All rights reserved. doi:10.1016/j.hrthm.2008.10.030 References
for the Writing Committee: NASPE Policy Statement. Report of the policy conference of NASPE on device/lead perfor-mance and the development of a postmarket surveillance database
- Maloney
- Hayes Dl Jd
- Gc
Maloney JD, Hayes DL, Timmis GC, for the Writing Committee: NASPE Policy Statement. Report of the policy conference of NASPE on device/lead perfor-mance and the development of a postmarket surveillance database. PACE 1993;16:1945–1952.
Performance of Riata ICD LEADS
- K H Kuck
- R Corbisiero
- S Greenberg
Kuck KH, Corbisiero R, Greenberg S, et al. Performance of Riata ICD LEADS. Italian J Cardiol (XIII International Symposium on Progress in Clinical Pacing, 2008), in press. Figure 1 Time to perforation.
Are 7 French leads safe?
- Han
Does size really matter?
- Corbisiero