To Extract or not To Extract? Navigating Lead Failure in Cardiac Devices.

Implantable cardioverter-defibrillators (ICDs) have revolutionized the treatment of patients at risk for sudden cardiac death. In the nearly 3 decades since the first human ICD implant,1 millions of devices have been implanted worldwide and innumerable lives have been saved. Successful resuscitation of a potentially lethal ventricular arrhythmia by an ICD system depends on successful arrhythmia detection and timely delivery of therapy. Both the ICD generator and the ICD lead are critical components of this system. The lead, in particular, is literally a lifeline whose purpose is to convey critical information about the heart’s rhythm to the ICD generator and, in turn, to deliver life-sustaining therapy when needed. Failure of an ICD lead may result in significant clinical events, including failure to pace, failure to defibrillate, inappropriate shocks, and even death. Article p 2727 ICD leads, like many medical technologies, have undergone a remarkable transformation. Epicardial leads, which necessitated a thoracotomy for lead placement, have given way to transvenous leads, which are easier to implant, less costly, and associated with decreased morbidity and mortality.2 Important advances in transvenous lead technology, such as the development of steroid elution, smaller diameter leads, novel insulations, and multipolar leads, have translated into meaningful clinical benefits for patients. Although modern ICD leads consist primarily of electrodes, conductors, insulation, and a fixation mechanism to attach the lead to the myocardium, lead design and performance vary from model to model. Indeed, monitoring of performance is critical not only to identify products with increased failure rates but also to provide physicians and patients with realistic expectations of device performance. In the current issue of Circulation , Eckstein et al add to our understanding of ICD lead performance.3 The investigators conducted a retrospective analysis of 1317 consecutive patients who received ICD systems (including 38 different ICD lead …

Surgically implanted cardiac devices play an important role in the treatment of heart disease. In the 50 years since the first pacemaker was implanted, technology has improved dramatically, and these devices have saved or improved the quality of countless lives. Pacemakers treat slow heart rhythms by increasing the heart rate or by coordinating the heart's contraction for some heart failure patients.1 Implantable cardioverter defibrillators stop dangerous rapid heart rhythms by delivering an electric shock.2 As the range of applications widens, the number of patients with cardiac devices continues to increase. Approximately 400 000 devices are implanted each year in the United States, and there >3 million patients with implanted cardiac devices currently. Occasionally, pacemaker and implantable cardioverter defibrillator systems must be removed. The removal of such systems is potentially a high-risk procedure. With the increasing number of implanted devices, removal is required more frequently. To ensure patient safety, the Heart Rhythm Society has published guidelines for safe lead removal or extraction. These guidelines outline the indications for lead extraction, physician qualifications and training, and the tools and techniques used in the procedure.3 One part of the system is the pulse generator, a metal can that contains electric circuits and a battery, usually placed under the skin on the chest wall beneath the collarbone. To replace the battery, the pulse generator must be changed by a simple surgical procedure every 5 to 10 years. The other parts are the wires, or leads, which run between the pulse generator and the heart. In a pacemaker, these leads allow the device to increase the heart rate by delivering small bursts of electric energy to make it beat faster. In a defibrillator, the lead has special coils to allow the device to deliver a high-energy shock and convert dangerous rapid rhythms …

The influence of prolonged antibiotic treatment before lead extraction procedures on the outcomes of device reimplantation in cardiac implantable electronic device infections

Heart Rythm Society expert consensus statement on electrophysiology laboratory standards: process, protocols, equipment, personnel, and safety.

ObjectivesComplete extraction the cardiac implantable electronic devices (CIED) lead systems remains a complex procedure. This retrospective study was conducted to describe the safety and effectiveness of a modified extracting transvenous...

Complete lead extraction is strongly recommended for managing cardiac implantable electronic device (CIED) infections. However, actual practices and associated patient outcomes in real-world settings are not well documented. This study aims to quantify use of lead extraction among Australian patients with CIED infections. In this retrospective cohort study, we analyzed linked hospital and mortality data from New South Wales (July 2008 to September 2022). We included patients aged ≥18 years diagnosed with CIED infections, identified using diagnosis codes T82.71 (from July 2017 onwards) and T82.7 with relevant supplementary codes prior to July 2017. We quantified the association between lead extraction and 1-year mortality using time-varying Cox proportional hazards regression models. We included 2,339 patients (mean age 72.5 years, 31.5% female) who were hospitalized with CIED infections, of which 24.0% (n = 561) underwent lead extraction within 30 days. The likelihood of lead extraction was higher among those with sepsis, endocarditis, Staphylococcus aureus infection, prior revision/replacement CIED procedures, and patients admitted to private hospitals. In contrast, older patients (aged 75+ years), female patients, and those with chronic kidney disease were less likely to undergo lead extraction. Lead extraction was associated with reduced 1-year mortality rate (adjusted-HR = 0.64, 95% CI: 0.51 to 0.81), with evidence of greater survival benefit in patients with sepsis and lesser benefit in older patients and females. In conclusion, utilization of lead extraction was limited among patients with CIED infections. Lead extraction was linked to significantly reduced mortality rate, highlighting the importance of improving adherence to recommended management for patients with CIED infections.

Although surgical approaches for infected or failing cardiac implantable electronic device (CIED) leads are more invasive than transvenous approaches, they are still required for patients considered unsuitable for transvenous procedures. In this study, surgical management with transvenous equipment for CIED complications was examined in patients unsuitable for transvenous lead extraction.Methods and Results: We retrospectively examined 152 consecutive patients who underwent CIED extraction between April 2009 and December 2021 at the Department of Cardiovascular Surgery, Nippon Medical School. Nine patients (5.9%; mean [±SD] age 61.7±16.7 years) who underwent open heart surgery were identified as unsuitable for the isolated transvenous approach. CIED types included 5 pacemakers and 4 implantable cardioverter-defibrillators; the mean [±SD] lead age was 19.5±7.0 years. Indications for surgical management according to Heart Rhythm Society guidelines included failed prior to transvenous CIED extraction (n=6), intracardiac vegetation (n=2), and severe lead adhesion (n=1). Transvenous CIED extraction tools were used in all patients during or before surgery. Additional surgical procedures with CIED extraction included epicardial lead implantation (n=4) and tricuspid valve repair (n=3). All patients were discharged; during the follow-up period (mean 5.7±3.7 years), only 1 patient died (non-cardiac cause). Surgical procedures and transvenous extraction tools were combined in the removal strategy for efficacious surgical management of CIED leads. Intensive surgical procedures were safely performed in patients unsuitable for transvenous extraction.

Some patients with cardiac implantable electronic devices (CIEDs) require atrial fibrillation (AF) ablation, and the superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein foci of AF. This study aimed to investigate the interaction between SVC isolation (SVCI) and CIED leads implanted through the SVC. We studied 34 patients with CIEDs who had undergone SVCI as part of AF ablation (CIED group), involving a total of 71 CIED leads. A similar number of age-, sex-, and AF type-matched patients without CIEDs formed a control group (non-CIED group). Patients' background and procedural characteristics were compared between the groups. In the CIED group, lead parameters before and after AF ablation were compared, and lead failure after AF ablation was also examined in detail. Procedural characteristics other than fluoroscopic time were similar in both groups. The success rate of SVCI after the final ablation procedure was 91.2% in the CIED group and 100% in the non-CIED group; however, these differences were not statistically significant. Lead parameters before and after the AF ablation did not significantly differ between the two groups. Lead failure was observed in three patients, with a sensing noise in one patient and an impedance increase in two patients after SVCI. SVCI was achievable without lead failure and significant change in lead parameters in most patients with CIEDs; however, it should be noted that lead failure was observed in 8.8% of the study patients after SVCI.

BackgroundCardiac implantable electronic device (CIED) implantation rate has been increasing worldwide. Despite proper surgical technique and preincisional intravenous antibiotics, the incidence of infected CIED remains high and leads to serious complications. When encountered with CIED infection, complete CIED system removal is indicated. Several lead extraction approaches have shown a high success rate. However, the facilities are limited in Thailand. In our current practice, we perform lead extraction using the Dotter basket snare femoral approach as our primary method. There are no prior data on this countertraction‐assisted transfemoral technique. Therefore, we aim to study the procedural outcome of countertraction‐assisted transfemoral lead removal technique of CIED infection in Thai patients.MethodsPatients diagnosed with CIED infection and with a history of device infection were retrospectively included. Simple manual removal was performed. In case of failure, we proceeded with the modified countertraction‐assisted transfemoral technique.ResultsThere were 35 patients in the study. The success rate was 94.3%. Most of the leads, 62.8%, were removed by simple manual traction. In the 37.1% who required further femoral approach lead extractions, procedural failure was observed in 5.7% and procedure‐related adverse events in 5.6%. CIED infection‐related death accounted for 5.7% and nosocomial infection‐related death, 2.8%.ConclusionThe success rate of CIED infection lead explant and countertraction‐assisted transfemoral lead extraction technique was high with small complications and can be performed without advanced facilities. However, the procedure required a main center with a cardiovascular thoracic surgery support team.

There is an increasing prevalence of cardiac implantable electronic devices (CIEDs) due to expanding adoption and availability of these evidence-based therapies. With the increased prevalence of these life-saving devices, there has also been an increased demand for lead removal and lead extraction. Understanding the specific subgroups of patients at high risk for complications during and after lead extraction has become imperative to properly manage endovascular CIED leads. There have been multiple published studies describing clinical variables that predict adverse outcomes in CIED system extractions; however, the risk of complications in leads placed after cardiac transplantation has not specifically been addressed to date. We present four cases of transvenous extraction and removal of pacing leads placed after cardiac transplantation. There were no major complications related to extraction in these four cases; however, three of the four patients died within one year after the procedure. While the etiology of death in these cases seemed to be unrelated to the extraction procedure, the indications for extraction (infection in the setting of immunosuppression and calcineurin-associated ESRD and poor sensing/capture possibly secondary to chronic rejection and/or frequent right heart biopsies) likely contributed at least indirectly to the subsequent death.

AimsThree Tesla (T) magnetic resonance imaging (MRI) provides critical imaging information for many conditions. Owing to potential interactions of the magnetic field, it is largely withheld from patients with cardiac implantable electronic devices (CIEDs). Therefore, we assessed the safety of 3T MRI in patients with ‘3T MRI-conditional’ and ‘non-3T MRI-conditional’ CIEDs.Methods and resultsWe performed a retrospective single-centre analysis of clinically indicated 3T MRI examinations in patients with conventional pacemakers, cardiac resynchronization devices, and implanted defibrillators from April 2020 to May 2022. All CIEDs were interrogated and programmed before and after scanning. Adverse events included all-cause death, arrhythmias, loss of capture, inappropriate anti-tachycardia therapies, electrical reset, and lead or generator failure during or shortly after MRI. Changes in signal amplitude and lead impedance were systematically assessed. Statistics included median and interquartile range. A total of 132 MRI examinations were performed on a 3T scanner in 97 patients. Thirty-five examinations were performed in patients with ‘non-3T MRI-conditional’ CIEDs. Twenty-six scans were performed in pacemaker-dependent patients. No adverse events occurred during or shortly after MRI. P-wave or R-wave reductions ≥ 50 and ≥ 25%, respectively, were noted after three (2.3%) scans, all in patients with ‘3T MRI-conditional’ CIEDs. Pacing and shock impedance changed by ± 30% in one case (0.7%). Battery voltage and stimulation thresholds did not relevantly change after MRI.ConclusionPending verification in independent series, our data suggest that clinically indicated MRI scans at 3T field strength should not be withheld from patients with cardiac pacemakers or defibrillators.

Subclavian versus axillary vein puncture for implantation of cardiac electronic devices. A meta-analysis

Incidence and outcomes of cardiovascular implantable electronic device infections in patients with end-stage kidney disease

First-in-man implantation of a gold-coated biventricular defibrillator: Difficult differential diagnosis of metal hypersensitivity reaction vs chronic device infection

Many patients awaiting heart transplantation (HTX) have a cardiac implantable electronic device (CIED). Lead removal is often still a part of the HTX procedure. Abandoned lead fragments carry a risk for infections and prohibit magnetic resonance imaging (MRI) imaging. This study evaluated the concept of an elective lead management algorithm after HTX. Between 2009 and 2018, 102 consecutive patients with previously implanted CIED underwent HTX. Lead removal by manual traction during HTX was performed in 74 patients until December 2014. Afterward, treatment strategy was changed and 28 patients received elective lead extraction procedures in a hybridoperating room (OR) using specialized extraction tools. Total of74 patients with 157 leads underwent lead extraction by manual traction during HTX. The mean lead age was 32.3 ± 38.7 months. Postoperative X-ray revealed abandoned intravascular lead fragments in 31(41.9%) patients, resulting in a complete lead extraction rate of only 58.1%. The high rate of unsuccessful lead extractions led to the change in the extraction strategy in 2015. Since then, HTX was performed in 28 CIED patients. In those patients, 64 leads with a mean lead age of 53.8 ± 42.8 months were treated in an elective lead extraction procedure. No major or minor complications occurred during lead extraction. All leads could be removed completely, resulting in a procedural success rate of 100%. Our results demonstrate that chronically implanted leads should be removed in an elective procedure, using appropriate extraction tools. This enables complete lead extraction, which reduces the infection risk in this patient population with the necessity for permanent immunosuppressive therapy and allows further MRI surveillance.