Implantable Cardioverter-defibrillator Lead Research Articles

Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Defibrillator Lead Perforation Leading to Concerning Electrocardiogram Findings: Case Report

Introduction: Implantable cardioverter-defibrillator (ICD) lead perforation through the myocardium may result in chest pain and electrocardiogram (ECG) changes concerning for ST-segment elevation myocardial infarction. The clinical context of the ECG aids in appropriate management.Case Report: We report the case of a 71-year-old woman experiencing chest pain after an ICD placement two weeks earlier. On presentation, she exhibited ST-segment elevation on her ECG. Computed tomography confirmed ICD lead migration. The patient’s hemodynamics were normal, and she was discharged home after a five-day hospital stay following a lead revision.Conclusion: Although rare, ICD lead perforation is a potential cause of chest pain and ischemic ECG changes. Emergency physicians should consider lead perforation as a potential differential diagnosis when evaluating chest pain in patients with ICDs, taking into account the potential complications of coronary angiography.

Successful direct pacing of the left bundle branch area with ICD lead using steerable delivery sheath.

Recently, conduction system pacing has been performed in patients with impaired cardiac function. We report a case in which a DF4 implantable cardioverter defibrillator lead was screwed directly into the left bundle branch area with the support of a steerable delivery sheath.

Analysis of 1051 ICD Leads Extractions in Search of Factors Affecting Procedure Difficulty and Complications: Number of Coils, Tip Fixation and Position-Does It Matter?

Background: Implantable cardioverter-defibrillator (ICD) leads are considered a risk factor for major complications (MC) during transvenous lead extraction (TLE). Methods: We analyzed 3878 TLE procedures (including 1051 ICD lead extractions). Results: In patients with ICD lead removal, implant duration was almost half as long (69.69 vs. 114.0 months; p < 0.001), procedure complexity (duration of dilatation of all extracted leads, use of more advanced tools or additional venous access) (15.13% vs. 20.78%; p < 0.001) and MC (0.67% vs. 2.62%; p < 0.001) were significantly lower as compared to patients with pacing lead extraction. The procedural success rate was higher in these patients (98.29% vs. 94.04%; p < 0.001). Extraction of two or more ICD leads or additional superior vena cava (SVC) coil significantly prolonged procedure time, increased procedure complexity and use of auxiliary or advanced tools but did not influence the rate of MC. The type of ICD lead fixation and tip position did not affect TLE complexity, complications and clinical success although passive fixation reduces the likelihood of procedural success (OR = 0.297; p = 0.011). Multivariable regression analysis showed that ICD lead implant duration ≥120 months (OR = 2.956; p < 0.001) and the number of coils in targeted ICD lead(s) (OR = 2.123; p = 0.003) but not passive-fixation ICD leads (1.361; p = 0.149) or single coil ICD leads (OR = 1.540; p = 0.177) were predictors of higher procedure complexity, but had no influence on MC or clinical and procedural success. ICD lead implant duration was of crucial importance, similar to the number of leads. Lead dwell time >10 years is associated with a high level of procedure difficulty and complexity but not with MC and procedure-related deaths. Conclusions: The main factors affecting the transvenous removal of ICD leads are implant duration and the number of targeted ICD leads. Dual coil and passive fixation ICD leads are a bit more difficult to extract whereas fixation mechanism and tip position play a much less dominant role.

Left bundle branch pacing lead for sensing ventricular arrhythmias in implantable cardioverter-defibrillator: A pilot study (LBBP-ICD study)

BackgroundLeft bundle branch pacing (LBBP) has been suggested as an alternative modality for biventricular pacing in cardiac resynchronization therapy (CRT)–eligible patients. As it provides stable R-wave sensing, LBBP has been recently used to provide sensing of ventricular arrhythmia in patients receiving implantable cardioverter-defibrillator (ICD) with CRT. ObjectiveThe aim of this study was to analyze the long-term safety and efficacy of the LBBP lead for appropriate detection of ventricular arrhythmia and delivery of antitachycardia pacing (ATP) in patients requiring defibrillator therapy with CRT. MethodsCRT-eligible patients who underwent successful LBBP-optimized ICD and LBBP-optimized CRT with defibrillator were enrolled. The LBBP lead was connected to the right ventricular-P/S port after capping the IS-1 connector plug of the DF-1–ICD lead. LBBP-optimized ICD or LBBP-optimized CRT with defibrillator was decided on the basis of correction of conduction system disease. Documented arrhythmic episodes and therapy delivered were analyzed. ResultsThirty patients were enrolled. The mean age was 59.7 ± 10.5 years. LBBP resulted in an increase in left ventricular ejection fraction from 29.9% ± 4.6% to 43.9% ± 11.2% (P < .0001). During a mean follow-up of 22.9 ± 12.5 months, 254 ventricular arrhythmic events were documented. Appropriate events (n = 225 [89%]) included nonsustained ventricular tachycardia (VT) (n = 212 episodes [94%]), VT (n = 8 [3.5%]), and ventricular fibrillation (n = 5 [2.5%]). ATP efficacy in terminating VT was 75%. Eleven percent of episodes (n = 29) were inappropriately detected because of T-wave oversensing. Inappropriate therapy (ATP) was delivered for 14 episodes (5.5%). Three patients (10%) had worsening of tricuspid regurgitation. ConclusionSensing from the LBBP lead for arrhythmia detection is safe as ∼90% of the episodes were detected appropriately. Future studies with a dedicated LBBP-defibrillator lead along with algorithms to avoid oversensing can help in combining defibrillation with conduction system pacing.

Abstract 13663: 90-day Safety and Performance Outcomes With a Novel Extravascular ICD Lead

Introduction: Long-term transvenous implantable cardioverter defibrillator (ICD) leads have many pitfalls. There is in development a novel extravascular (EV) ICD lead for sensing and defibrillation of ventricular tachyarrhythmias (VT/VF) utilizing commercially available DF-4 ICD pulse generators. We evaluate here 90-day safety and performance outcomes for delivery, stability, sensing, and defibrillation using this prototype EV lead. Methods: 18 patients scheduled to undergo de novo or replacement ICD were enrolled in a prospective, nonrandomized study (SECURE-EV STUDY). Each subject was simultaneously implanted with EV ICD lead (AtaCor, SanClemente, CA) attached to a commercially available ICD pulse generator. Study lead was delivered with a designed tool into left parasternal anterior mediastinum via a selected 4th, 5th or 6th intercostal space. Over 90 days pts were evaluated intermittently for defibrillation energy requirements, matched sensing events between both devices, stability of lead position and adverse events. Results: 16/18 of enrolled subjects received study device. Lead failed implant in 2 due to (1) intercostal ossification and (1) mediastinal adhesions. Prior to 30-days, 4 subjects were withdrawn from study due to pneumothorax, wound dehiscence, death unrelated to IV-ICD implantation and early elective lead removal. Over 90-days of simultaneous sensing, 4 events of VT/VF in 3 pts were detected by both devices. There was 1 AF discrimination error &amp; 1 atrial oversensing event detected by both devices. There were 4 events of non-cardiac noise in 4 pts detected by EV-ICD only. 1 event of Twave oversensing was detected by TV-ICD. 23 conversion tests in 13 subjects were performed at energy (26 to 30 J delivered, 1 tested with 35J) at 30- and 90-day visits, with successful conversion in all 23. Mean time between fibrillation detection and shock delivery was 10.7 seconds. Conclusion: This study showed feasibility of sensing and defibrillating induced VT/VF with intercostal placed prototype extravascular ICD lead. Findings with ICD lead was consistent across 4 commercially available ICDs. Simultaneous sensing of VT/VF in ambulatory pts was matched. Non-cardiac inappropriate sensing with EV-ICD lead is being addressed in new prototype.

Abstract 16065: AICD Lead Endocarditis With Large Vegetation Complicated by Septic Pulmonary Embolism

Introduction: Infective endocarditis of an automatic implantable cardioverter-defibrillator (AICD) lead is a rare and serious complication. Less than 4% of AICD related endocarditis cases are caused by Enterococcus faecalis . Herein, we report a rare case of a patient with an infected AICD lead and a large vegetation caused by Enterococcus faecalis . Case Presentation: A 66-year-old male with a history of mitral valve replacement, heart failure with reduced ejection fraction status post AICD and hypertension presented with loss of appetite, subjective fevers and chills. Initial vitas were significant for tachycardia and tachypnea. Physical examination revealed lethargy and an irregular rate and rhythm. Initial labs showed an elevated WBC count, elevated C-reactive protein, elevated D-dimer, negative procalcitonin, negative High-sensitivity troponins and elevated BNP. Electrocardiogram showed atrial fibrillation. Echocardiogram showed an EF of 25-30% with a vegetation on the right ventricular lead. A CT angiogram chest was done and showed a right pulmonary artery embolism. Blood cultures were positive for Enterococcus faecalis . The patient was started on IV antibiotics, anticoagulation and he underwent open removal of the AICD along with multiple vegetations with the largest being 3.5cm. He recovered well post-operatively. Discussion: Cardiac device endocarditis is a difficult to manage condition that has been increasing in incidence over the years. Persistent infection is a problem faced when a patient has AICD endocarditis since these infections are typically resistant to many antibiotics necessitating surgical removal of the AICD. Patients that present with large vegetations larger than 2.5cm are at highest risk of complications. These complications include septic pulmonary emboli as seen in our patient, pulmonary abscess formation and pneumonia. Early diagnosis and lead extraction has been related to the highest reduction in mortality.

Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators.

This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs. This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used. Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed. This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.

Long term longevity of defibrillator leads: a prospective follow-up over 25 years

Abstract Funding Acknowledgements Type of funding sources: None. Background The implantable cardioverter defibrillator (ICD) lead is the most fragile part of the device. Several studies have focused on both the longevity of ICD and the factors associated with lead malfunction but long-term data (i.e., ≥ 10 years) are limited. Purpose We report our experience on the very long-term longevity of ICD leads. Methods Data from all patients ≥18 years implanted with an transvenous ICD at our university hospital between 1988 and May 2021 were prospectively collected and analyzed. Follow-up was censored in July 2022. Data included patient characteristics, lead characteristics and follow-up data. The primary endpoint of the study was the survival rate without lead failure defined by the 2017 HR consensus . Factors influencing longevity were analyzed. Results 2093 ICD leads were included in our study. During follow-up (mean = 72.6±56.9 months, range = 11-299), there were 84 lead dysfunction. Lead survival rate was 97% at 5 years, 92% at 10 years, 88% at 15 years and 85% at 24 years respectively. In the multivariate analysis, factors associated with a higher risk of lead dysfunction revealed were: younger age (p = 0.001), channelopathy (p = 0.037), Linox leads (p = 0.041), Riata leads (p = 0.022) and Fidelis leads (p = 0.001). On the other hand, polyurethane coated leads (p &amp;lt; 0.001), Durata leads (p = 0.036), Endotak reliance leads (p = 0.016) and Sprint quattro 6935 leads (p = 0.026) were associated with less lead dysfunction. Conclusion The survival rate of the leads decreased progressively between 1 and 24 years after implantation but the risk of lead rupture seems to be maximal within the first 10 years after implant with little increase thereafter.

Left Bundle Branch Area Defibrillator (LBBAD): A First-in-Human Feasibility Study

BackgroundLeft bundle branch area (LBBA) pacing is a promising pacing technique. LBBA implantable cardioverter-defibrillator (ICD) lead implantation reduces the number of leads in patients with both pacing and ICD indications, reducing cost and potentially increasing safety. LBBA positioning of ICD leads has not previously been described. ObjectivesThe goal of this study was to evaluate the safety and feasibility of implanting an LBBA ICD lead. MethodsThis prospective, single-center, feasibility study was conducted in patients with an ICD indication. LBBA ICD lead implantation was attempted. Acute pacing parameters and paced electrocardiography data were collected, and defibrillation testing was performed. ResultsLBBA defibrillator (LBBAD) implantation was attempted in 5 patients (mean age 57 ± 16.5 years; 20% female) and achieved in 3 (60%). Mean procedural and fluoroscopy duration were 170.0 ± 17.3 minutes and 28.8 ± 16.1 minutes, respectively. Left bundle capture was achieved in 2 patients (66%) and left septal capture in 1 patient. LBBA pacing exhibited a mean QRS duration and V6 R-wave peak time of 121.3 ± 8.3 milliseconds and 86.1 ± 10.0 milliseconds. In all 3 patients, defibrillation testing was successful with mean time to adequate shock delivery of 8.6 ± 2.6 seconds. Acute LBBA pacing threshold and R-wave amplitudes were 0.80 ± 0.60 V at 0.4 milliseconds and 7.0 ± 2.7 mV. No LBBA lead-related complications occurred. ConclusionsThis first-in-human evaluation showed the feasibility of LBBAD implantation in a small cohort of patients. With current tools, implantation remains complex and time-consuming. Considering the feasibility reported and the potential benefits, further technological development in this field is warranted with evaluation of long-term safety and performance.

Performance of an implantable cardioverter-defibrillator lead family.

Lead failure is the major limitation in implantable cardioverter-defibrillator (ICD) therapy. Long-term follow-up data for Biotronik Linox ICD leads are limited. Therefore, we analyzed the performance of all these leads implanted at our institution. All Linox and Linox Smart ICD leads implanted between 2006 and 2015 were identified. Lead failure was defined as electrical dysfunction (oversensing, abnormal impedance, exit block). Lead survival was described, according to Kaplan-Meier. Associations between lead failure and specific variables were examined. p < .05 was considered significant. We included 417 ICD leads. The median follow-up time for Linox (n = 205) was 81 months and for Linox Smart (n = 212) 75 months. During that follow-up time, 30 Linox (14.6%) and 16 Linox Smart leads (7.6%) showed a malfunction. The 5-year lead survival probability was 97.4% for Linox and 95.2% for Linox Smart (log-rank test, p = .19). The 6- and 8-year lead survival probability for Linox was 93.6% and 84.6%, and for Linox Smart 93% and 91.9%. The only factor significantly associated with lead failure was younger patient age at implantation (hazard ratio/year: 0.97, 95% CI: 0.94-0.99, p = .002). This relatively large study with a long follow-up period highlights a relevant failure rate of Biotronik Linox leads. The performance of Linox versus Linox Smart ICD leads was comparable. Although we show an acceptable 5-year lead survival probability, we observed a marked drop after just 1 more year of follow-up. In an era of improving heart failure survival probability, a prolonged follow-up of ICD leads is increasingly clinically relevant.

Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design.

Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability. The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

A case report of Enterobacter cloacae endocarditis in a patient with a history of cotton fever

BackgroundCotton fever is a self-limited, febrile syndrome occurring after the injection of trace amounts of drugs, in particular heroin, extracted from reused cotton filters. It is characterized by non-specific findings, such as fever, tachycardia, and leucocytosis. The leading pathophysiologic explanation suggests it is the result of direct inoculation of the bloodstream with endotoxins from Gram-negative bacilli of the genus Enterobacter, known to colonize all parts of the cotton plant. Only one prior case report has suggested cotton fever as a potential risk factor of infective endocarditis (IE).Case summaryWe describe a case of a 57-year-old patient with a history of intravenous heroin use complicated by self-reported episodes of cotton fever. His presentation was notable for Enterobacter cloacae IE with bilateral septic pulmonary emboli. Transthoracic echocardiography findings included new tricuspid regurgitation and two mobile echodensities on the right atrial implantable cardioverter defibrillator (ICD) lead. Despite broad antibiotic coverage and extraction of the ICD leads, the patient passed away from septic shock.DiscussionThe present case report is only the second published report of endocarditis in a patient with a history of cotton fever. In both cases, bacteria of the Enterobacter genus were isolated in patients’ blood cultures. This evidence supports the endotoxin theory as the leading pathophysiologic explanation for cotton fever and suggests cotton fever as a risk factor for Gram-negative IE. In the inpatient setting it informs proper antibiotic coverage, whereas in the outpatient setting it supports harm reduction interventions in the form of sterile cotton balls.

Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics.

Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure. The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts. A prespecified ancillary substudy, World-Wide Randomized Antibiotic Envelope Infection Prevention Trial, was conducted in patients with an ICD with all available alerts enabled. The investigators reported possible lead system events (LSEs), with or without an alert. An independent committee reviewed all data and classified events as lead failure, other LSE, or nonlead system events (NLEs). In 4942 patients who were followed for 19.4 ± 8.7 months, there were 124 alerts (65 LSEs, 59 NLEs) and 19 LSEs without an alert. Lead monitoring alerts had 100% sensitivity for the 48 adjudicated lead failures (95% confidence interval 92.6%-100%) and for 10 events adjudicated as either lead failure or connection issue. The positive predictive value of alerts forlead failure was 38.7% (48 of 124). For 34 pace-sense lead failures,an alert that incorporated oversensing was more sensitivethan thepacing impedance threshold alert (33 patients [97.1%] vs 9 patients[26.5%]; P < .0001). However, the sensitivity was only 13.6% for lead dislodgments or perforations. Inappropriate shocksoccurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs. In this first real-world prospective study, lead monitoring alerts had 100% sensitivity for identifying lead failures. Although their positive predictive value was modest, no false-positive alerts resulted in an unnecessary lead replacement. For the diagnosis of pace-sense lead failure, an alert for oversensing was more sensitive than a pacing impedance threshold alert. ClinicalTrials.gov identifier: NCT02277990.

682. Implantable Cardioverter-Defibrillator Lead Vegetation with Long-Standing Actinomyces neuii Bacteremia

BackgroundEndocarditis caused by Actinomyces species is uncommon with only 30 cases reported in contemporary literature. MethodsWe present a novel case of cardiovascular implantable electronic device (CIED) endocarditis secondary to infection by Actinomyces neuii – a unique non-branching member of the species that grows in both anaerobic and aerobic media.ResultsOur patient, a 51-year-old female, with a history of implantable cardioverter-defibrillator (ICD) placement 17 years prior for heart failure, presented with six weeks of fevers and rigors. She was referred to the infectious disease clinic for evaluation of pyrexia of unknown origin. Her examination was unremarkable, and the ICD pocket was uninflamed. Her initial labs revealed mildly elevated inflammatory markers and renal insufficiency. Blood cultures were positive for slow-growing non-branching gram-positive rods in both aerobic and anaerobic media. These were identified as Actinomyces neuii by mass spectrometry. Review of outside records showed positive blood cultures with Actinomyces neuii at another facility two weeks prior to our evaluation which were not acted upon and thought to be bacterial contamination. The patient was further evaluated with a transesophageal echocardiogram that demonstrated a 3.3 x 2.2cm mobile vegetation attached to the ICD lead. She subsequently underwent removal of her Saint Jude cardiac resynchronization therapy defibrillator and leads using laser and snaring techniques, but the tail end of the ventricular lead fractured and could not be retrieved. The ICD pocket was also found to be infected. A planned 6-week course of IV ampicillin was interrupted by 2 weeks of ceftriaxone for treatment of an intercurrent lower respiratory tract infection. The patient regained her baseline health and was discharged 2 weeks after ICD removal with a LifeVest. She is to complete 12 months of oral amoxicillin therapy after completion of IV antibiotics in view of retained lead fragment, and long standing Actinomyces bacteremia - consistent with published management strategies. Figure 1. Transesophageal echocardiogram demonstrating size of vegetation. Figure 2. Three-dimensional view demonstrating vegetation on the ICD lead.ConclusionHere we describe the first known case of Actinomyces neuii CIED endocarditis with a large lead vegetation and long-standing bacteremia, presenting as pyrexia of unknown origin.Disclosures All Authors: No reported disclosures

Prospective long-term follow-up of silicone-polyurethane–insulated implantable cardioverter-defibrillator leads

BackgroundSt Jude Medical (now Abbott) Optim-insulated implantable cardioverter-defibrillator (ICD) leads were expected to overcome problems with insulation abrasion and externalized conductors in earlier models. Long-term follow-up is essential to the evaluation of lead performance.ObjectiveTo determine, in a prospective cohort of Optim-insulated ICD leads, the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) and electrical dysfunction adjudicated as nonmechanical failure.MethodsAbbott established 3 prospective registries, enrolling 11,155 leads among 10,872 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reporting, and documentation of lead revision or inactivation, study withdrawal, and death or transplant. The Population Health Institute (McMaster University) reviewed database functions, adjudicated all potential mechanical lead failures, and conducted independent data analyses.ResultsDuring a median follow-up of 4.6 years, there were 171 mechanical failures (1.53%, 95.4% freedom from failure by 12 years). There were no significant differences in survival among Durata DF4 and DF1 and Riata ST Optim leads. The year-to-year rate of failure of leads increased over time. There were 69 electrical dysfunctions (0.62%, 98.8% freedom from failure by 12 years) adjudicated as nonmechanical failure.ConclusionDuring follow-up as long as 12 years (median 4.6 years), Optim-insulated leads had low rates of mechanical failure and electrical dysfunction. Independent analyses provide reliable data on the long-term outcomes essential to analyzing ICD lead performance.

Single lead implantable cardioverter-defibrillator (icd) system with a floating atrial sensing dipole: Long term follow up with limitations of the SMART algorithm

Single lead implantable cardioverter-defibrillator (icd) system with a floating atrial sensing dipole: Long term follow up with limitations of the SMART algorithm

Long-Term Follow-up of Standard and Small Diameter Implantable Cardioverter Leads

Background: Small-diameter implantable cardioverter-defibrillator (ICD) leads have been introduced into clinical practice to facilitate the implantation procedure. Despite their expected benefits, the reliability of these leads has proven to be questionable. The main purpose of our study is to investigate the impact of ICD lead diameter (≤8 F versus &gt;8 F) on long-term lead durability. Methods: Overall, 206 consecutive patients implanted with a right ventricular ICD lead in the Electrophysiology and Cardiac Pacing Unit of our department from January 2008 to December 2013 were included in this analysis. ICD leads were defined, according to their diameter, as small (≤8 F) and standard (&gt;8 F).The small-diameter leads (n=106) included Linox (Biotronik; n=58) and Durata (St. Jude Medical/Abbot; n=48). The standard-diameter ICD leads (n=100) consisted of Sprint Quattro (Medtronic; n=64) and Endotak (Boston Scientific; n=36). Results: After a median follow-up of 7.3 years, lead failure rate was significantly increased for small-diameter leads compared with standard-diameter leads (6.6% vs 1%; P=0.035). No difference in lead survival probability has been observed between Linox and Durata small-diameter leads (93% vs 92.7%; P=0.71). The majority of lead failures presented as noise (87.5%), without detectable abnormalities on fluoroscopic evaluation. Conclusion: Our single-centre study showed that both Linox and Durata small-diameter ICD are associated to be more susceptible to a greater risk of lead failure as compared to standard-diameter ICD leads. In this perspective, a comprehensive vigilance strategy including home monitoring is warranted for early detection of lead failure.

Long-Term Electrocardiographic and Echocardiographic Progression of Arrhythmogenic Right Ventricular Cardiomyopathy and Their Correlation With Ventricular Tachyarrhythmias.

Prior studies of structural and electrocardiographic changes in arrhythmogenic right ventricular (RV) cardiomyopathy and their role in predicting ventricular arrhythmias (ventricular tachycardia) have shown conflicting results. We reviewed 405 ECGs, 315 transthoracic echocardiographies, and 441 implantable cardioverter defibrillator interrogations in 64 arrhythmogenic RV cardiomyopathy patients (56% men, mean age [SD], 44.2 [14.6] years) over a mean follow-up of 10 (range, 2.3-19) years. Generalized estimating equations were used to identify the association between ECG abnormalities, clinical variables, and transthoracic echocardiographic measurements (>mild degree of tricuspid regurgitation, RV outflow tract diameter in parasternal long axis and short axis, RV end-diastolic area, fractional area change). There was a 4.65 (95% CI, 0.51%-8.8%) increase in RV end-diastolic area, a 3.75 (95% CI, 1.17%-6.34%) decrease in fractional area change, and 1.9 (95% CI, 1.3-2.8) higher odds (odds ratio) of RV wall motion abnormality with every 5-year increase in age after patients' first transthoracic echocardiography. >Mild tricuspid regurgitation was an independent predictor of RV enlargement and dysfunction (hazard ratio of >10% drop in fractional area change from baseline [95% CI], 3.51 [1.77-6.95] and hazard ratio of >10% increase in RV end-diastolic area from baseline [95% CI], 4.90 [2.52-9.52]). Patients with implantable cardioverter defibrillator were more likely to develop >mild tricuspid regurgitation and larger structural and functional disease progression. More pronounced increase in RV end-diastolic area was translated into higher rates of any ventricular tachycardia. Inferior T-wave inversions and sum of R waves (mm) in V1 to V3 were predictors of RV enlargement and dysfunction with the former also predicting risk of any ventricular tachycardia. Arrhythmogenic RV cardiomyopathy is a progressive disease. Tricuspid regurgitation is an independent predictor of structural disease progression, which may be exacerbated by use of a transvenous implantable cardioverter defibrillator lead.

Lead Abandonment and Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) Implantation in a Cohort of Patients With ICD Lead Malfunction.

Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction.Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD).Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29–3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49–9.24; P = 0.238).Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment.Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637