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Background: 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., Methods and Results: 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., Conclusion: 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., (© 2022 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes., Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group., Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study., Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03772704.

Background: Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure., Objective: The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts., Methods: 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)., Results: 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 for lead failure was 38.7% (48 of 124). For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing 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 shocks occurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs., Conclusion: 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., Trial Registration: ClinicalTrials.gov identifier: NCT02277990., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Chemotherapy-induced cardiomyopathy has been increasingly recognised as patients are living longer with more effective treatments for their malignancies. Anthracyclines are known to cause left ventricular (LV) dysfunction. While heart failure medications are frequently used, some patients may need consideration for device-based therapies such as cardiac resynchronisation therapy (CRT). However, the role of CRT in anthracycline-induced cardiomyopathy (AIC) is not well understood., Methods: We performed a retrospective review of all patients undergoing CRT implantation at our centre from 2003 to 2019 with a diagnosis of AIC. The LV remodelling and survival outcomes of this population were obtained and then compared with consecutive patients with other aetiologies of non-ischaemic cardiomyopathy (NICM)., Results: A total of 34 patients underwent CRT implantation with a diagnosis of AIC with a mean age of 60.5±12.7 years, left ventricular ejection fraction (LVEF) of 21.7%±7.4%, and 11.3±7.5 years and 10.2±7.4 years from cancer diagnosis and last anthracycline exposure, respectively. At 9.6±8.1 months after CRT implantation, there was an increase of LVEF from 21.8%±7.6% to 30.4%±13.0% (p<0.001). Patients whose LVEF increased by at least 10% post-CRT implant (42.5% of cohort) survived significantly longer than patients who failed to improve their LVEF by that amount (p=0.01). A propensity matched analysis between patients with AIC and 369 consecutive patients with other aetiologies of NICM who underwent CRT implantation during the same period revealed no significant differences in improvement in LVEF or long-term survival., Conclusions: Patients with AIC undergo LV remodelling with CRT at rates similar to other aetiologies of NICM. Furthermore, AIC post-CRT responders have a favourable long-term mortality compared with non-responders., Competing Interests: Competing interests: TC: consultant, Biotronik. KGT: consulting and honoraria from Medtronic and Spectranetics Corporation; advisory board, Medtronic and AliveCor. DC: consultant, Abbott and Boston Scientific. OW: Honoraria Spectranetics. NV: consultant/honoraria from St. Jude Medical, Boston Scientific, Biotronik and Medtronic. BLW: honoraria/consultant fees from Abbott, Medtronic and Philipps. JR: honoraria/consultant fees from Abbott and Medtronic. All other authors have no disclosures to report., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures., Background: Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies., Methods: This analysis included 2,803 control patients from the WRAP-IT trial who received standard preoperative antibiotics but not the envelope (44 patients with major infections through all follow-up). A multivariate least absolute shrinkage and selection operator machine learning model, controlling for patient characteristics and procedural variables, was used for risk factor selection and identification. Risk factors consistently retaining predictive value in the model (appeared >10 times) across 100 iterations of imputed data were deemed significant., Results: Of the 81 variables screened, 17 were identified as risk factors with 6 being patient/device-related (nonmodifiable) and 11 begin procedure-related (potentially modifiable). Patient/device-related factors included higher number of previous CIED procedures, history of atrial arrhythmia, geography (outside North America and Europe), device type, and lower body mass index. Procedural factors associated with increased risk included longer procedure time, implant location (non-left pectoral subcutaneous), perioperative glycopeptide antibiotic versus nonglycopeptide, anticoagulant, and/or antiplatelet use, and capsulectomy. Factors associated with decreased risk of infection included chlorhexidine skin preparation and antibiotic pocket wash., Conclusions: In WRAP-IT patients, we observed that several procedural risk factors correlated with infection risk. These results can help guide infection prevention strategies to minimize infections associated with secondary CIED procedures., Competing Interests: Funding Support and Author Disclosures Supported by Medtronic, Inc. Dr Tarakiji has received honoraria/consultant fees from AliveCor and Medtronic outside the submitted work. Dr Krahn has received honoraria/consultant fees from Medtronic outside the submitted work. Dr Poole has received honoraria/consultant fees from Boston Scientific, EBR Solutions, Kestra, and Medtronic outside the submitted work. Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic outside the submitted work. Dr Kennergren has received honoraria/consultant fees from Biotronik, Boston Scientific, Medtronic, and Philips outside the submitted work. Dr Biffi has received honoraria/consultant fees from Boston Scientific, Biotronik, and Medtronic outside the submitted work. Drs Korantzopoulos and Dallaglio have received honoraria/consultant fees from Medtronic outside the submitted work. Drs Lexcen and Lande and Mrs Hilleren and Holbrook have received personal fees from Medtronic. Dr Wilkoff has received honoraria/consultant fees from Abbott, Medtronic, and Philips outside the submitted work., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well understood., Objective: The purpose of this study was to evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients., Methods: All 6800 study patients were included in this analysis (control 3429; envelope 3371). Hematomas occurring within 30 days postprocedure (acute) were characterized and grouped by study treatment and evaluated for subsequent infection risk. Data were analyzed using Cox proportional hazard regression modeling., Results: Acute hematoma incidence was 2.2% at 30 days, with no significant difference between treatment groups (envelope vs control hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.84-1.58; P = .39). Through all follow-up, the risk of major infection was significantly higher among control patients with hematoma vs those without (13.1% vs 1.6%; HR 11.3; 95% CI 5.5-23.2; P <.001). The risk of major infection was significantly lower in the envelope vs control patients with hematoma (2.5% vs 13.1%; HR 0.18; 95% CI 0.04-0.85; P = .03)., Conclusion: The risk of hematoma was 2.2% among WRAP-IT patients. Among control patients, hematoma carried a >11-fold risk of developing a major CIED infection. This risk was significantly mitigated with antibacterial envelope use, with an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aim: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims., Methods and Results: Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76., Conclusion: The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited., Objective: The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event., Methods: We evaluated patients enrolled in WRAP-IT (Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial) undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement. All adverse events were adjudicated by an independent physician committee. Data were analyzed using Cox proportional hazard regression modeling., Results: In total, 5641 patients underwent device revision/upgrade/replacement. Electrocautery was used in 5205 patients (92.3%) (mean age 70.6 ± 12.7 years; 28.8% female), and low-temperature electrocautery was used in 1866 patients (35.9%). Compared to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure- or lead-related adverse event through 3 years of follow up (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.65-0.91; P = .002). After controlling for the number of active leads, degree of capsulectomy, degree of lead dissection, and renal dysfunction, low-temperature electrocautery was associated with a 32% lower risk of lead-related adverse events (HR 0.68; 95% CI 0.52-0.89; P = .004). These effects were consistent across a spectrum of lead-related adverse event types., Conclusion: This study represents one of the largest assessments of electrocautery use in patients undergoing CIED revision, upgrade, or replacement procedures. Compared to standard electrocautery, low-temperature electrocautery significantly reduces adverse effects from these procedures., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

[Figure: see text].

Objectives: This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study., Background: The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management., Methods: A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis. Patient characteristics, infection manifestation (pocket vs. systemic), and infection microbiology were evaluated through all follow-up (36 months). Data were analyzed using Cox proportional hazards regression., Results: A total of 3,371 patients received an envelope, and 3,429 patients were control subjects. Major CIED infection occurred in 32 patients who received an envelope and 51 control subjects (36-month Kaplan-Meier estimated event rate, 1.3% and 1.9%, respectively; p = 0.046). A 61% reduction in major pocket infection was observed within 12 months of the procedure in the envelope group (hazard ratio: 0.39, 95% confidence interval: 0.21 to 0.73; p = 0.003). Among 76 patients with major infections who had a sample taken, causative pathogens were identified in 47 patients. Staphylococcus species were the predominate pathogen (n = 31) and envelope use resulted in a 76% reduction in Staphylococcus-related pocket infections (n = 4 vs. 17; p = 0.010). Envelope use was not associated with delayed onset of pocket infections and did not affect the presentation of infections., Conclusions: Antibacterial envelope use resulted in a significant reduction of major CIED pocket infections and was particularly effective against Staphylococcus species, the predominant cause of pocket infections. (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial [WRAP-IT]; NCT02277990)., Competing Interests: Author Disclosures This work was supported by Medtronic, Inc. Dr. Sohail has received honoraria/consultant fees from Medtronic and Aziyo Biologics, outside the submitted work. Dr. Corey has received honoraria/consultant fees from Medtronic, Arsanis, Basilea, Bayer, Contrafect, Melinta, Motif, Paratek, Pfizer, Quintiles, Tetraphase, The Medicines Company, Theravance, Bio2 Medical, Cempra, Meiji Seika Pharm Co., Novella, Regeneron, and SC Pharma. Dr. Wilkoff has received honoraria/consultant fees from Medtronic, Abbott, and Philips, outside the submitted work. Dr. Poole has received honoraria/consultant fees from Medtronic, Boston Scientific, Kestra, and EBR Solutions, outside the submitted work. Dr. Mittal has received honoraria/consultant fees from Medtronic, Abbott, and Boston Scientific, outside the submitted work. Dr. Kennergren has received honoraria/consultant fees from Medtronic, outside the submitted work. Dr. Greenspon has received honoraria, consultant fees, and a research grant from Medtronic; and has received honoraria from Boston Scientific, outside the submitted work. Dr. Tarakji has received honoraria/consultant fees from Medtronic and AliveCor, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures., Objective: The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures., Methods: All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined., Results: Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P <.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates., Conclusion: Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system., Methods: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature., Results: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost., Conclusions: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Background: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN)., Objective: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications., Methods: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling., Results: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics)., Conclusion: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system., Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets., Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage., Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Background: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important., Methods: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED., Results: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%)., Conclusion: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study sought to retrospectively investigate outcomes of lead extraction by using pre-operative computed tomography (CT) scans to identify risk of complicated lead extraction to aid in pre-procedural planning., Background: Transvenous lead extractions remain high-risk procedures requiring specialized operators, equipment, and surgical backup. Data are lacking for how to identify difficult lead extractions. CT scans, which can illustrate the proximity of the lead to adherent venous structures can potentially aid in identifying difficult lead extractions., Methods: All cases of patients who were undergoing transvenous lead extractions at the authors' institution between 2015 and 2018, who had a pre-operative CT scan prior to lead extraction, were reviewed. The images were retrospectively reviewed to examine adherence of leads to the surrounding vein and obtained procedural outcomes., Results: A total of 203 cases were reviewed of patients undergoing transvenous lead extraction who had a pre-operative CT scan, and scans were separated based on lead location in the superior vena cava, as assessed by CT imaging. Scans were divided into 3 groups: those in a central location or <1 cm adherence (n = 28); those that had at least 1 lead with tip adherent >1 cm (n = 137); or those that had at least 1 lead outside the vein contour (n = 38). Although there was only 1 serious complication requiring vascular surgery intervention, patients with at least 1 lead outside the vein contour required significantly longer procedural time (190.8 ± 86.6 min vs. 158.1 ± 73.7 min vs. 142.8 ± 52.2 min; p = 0.019) and fluoroscopy time (33.1 ± 24.2 min vs. 19.6 ± 18.4 min vs. 18.3 ± 16.4 min; p = 0.0006) than those with leads adhering >1 cm and centrally located leads, respectively., Conclusions: Pre-operative CT scanning can identify difficult lead extractions prior to performing the procedure. This information may aid electrophysiologists in the planning of extraction procedures. Future prospective studies are needed to confirm these findings., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to evaluate the effectiveness and safety of transvenous lead extraction (TLE) in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC)., Background: ARVC is an increasingly diagnosed cardiomyopathy that often requires device implantation to prevent sudden death. Little is known about TLE in this setting, which has potential challenges and risks, primarily due to right ventricular (RV) wall thinning and fragility., Methods: All consecutive patients with ARVC who underwent TLE at our institution between 1996 and 2016 were included. When extraction tools were used, sheaths were advanced to the RV with countertraction at the lead tip. Success and complications were defined in concordance with Heart Rhythm Society guidelines., Results: Twenty-two TLE procedures in patients with ARVC involved extraction of 27 leads (22 defibrillators and 5 pacemakers). TLEs were performed due to evidence of lead malfunction (n = 17; 77%) or device infection (n = 5; 23%). Twenty-four leads (89%) were RV, and 3 leads (11%) were right atrial. The median age of the oldest extracted lead was 1,691 days (interquartile range [IQR]: 1,168 to 2,726 days). Specialized extraction tools were required in 20 procedures (91%). None required the use of a snare or a femoral workstation. The median procedural and fluoroscopic times were 152 min (IQR: 129 to 185 min) and 11 min (IQR: 6 to 18 min), respectively. Complete procedural success with removal of all leads was achieved in all cases. There were no major complications., Conclusions: In a high-volume center, TLE in patients with ARVC was associated with a high success rate and a low rate of complications when guideline-established techniques and tools were used., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections., Methods: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months., Results: A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (±SD) duration of follow-up was 20.7±8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98)., Conclusions: Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.)., (Copyright © 2019 Massachusetts Medical Society.)

The number of implanted cardiovascular implantable electronic devices (CIEDs) has increased significantly in the last 30 years, which has led to an upsurge in CIED complications, such as infection and lead malfunction requiring CIED extraction. The decision-making process of CIED reimplantation requires meticulous planning that includes careful consideration of several aspects: the reason for extraction, the indication for CIED reimplantation, patients' wishes, timing of reimplantation, the need for a bridging device, and the type and location of device to be reimplanted. In this article, the authors review this decision-making process and the necessary steps to achieve optimal patient outcomes., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to detect and quantify acute increases in tricuspid regurgitation (TR) severity following transvenous lead extraction (TLE) and to evaluate the associated risk factors., Background: Although established as a safe and effective method for lead removal, TLE is sometimes complicated by TR., Methods: In 208 consecutive patients undergoing TLE, acute changes in TR severity were assessed by transesophageal echocardiography. A significant acute TR increase (TRI) was defined as a ≥1 grade increase in TR severity and post-extraction TR severity that was moderate or greater., Results: Overall, 266 ventricular leads (mean lead age, 11.8 ± 7.3 years) were extracted from the 208 patients. A significant acute TRI was observed in 24 (11.5%) of these patients. Acute TRI was associated with longer lead implant duration, extraction of pacemaker rather than defibrillator leads, anatomic injury to the tricuspid valve (TV), and longer post-extraction hospital stays. Multivariate analysis yielded only lead implant duration as an independent predictor of TLE-related acute TRI (odds ratio: 1.05; 95% confidence interval: 1.01 to 1.11; p = 0.046). When the patients were divided into 4 subgroups according to quartiles of lead age, there was a graded elevation in the rates of acute TRI (p trend = 0.048) and TV injury (p trend = 0.009) with lead implant duration., Conclusions: Following TLE, TV damage and acute TRI were commonly detected by transesophageal echocardiography, particularly in patients with advanced lead age. Lead abandonment strategies, which prolong implantation duration of future leads requiring extraction, should consider the potential long-term deleterious impact on TV function., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Subcutaneous shocking coils (SQC) have been used to lower defibrillation thresholds in certain patient populations. There are limited data regarding the extraction complexity of these leads. The goal of this study is to describe our SQC extraction experience and identify challenges that may be of importance with the increase in utilization and extraction of fully subcutaneous defibrillator systems., Methods: We studied consecutive patients who underwent lead removal at our institution during which a Medtronic 6996SQ (Medtronic plc, Minneapolis, MN, USA) was removed RESULTS: Twenty-one patients (54.5 ± 14 years, 85.7% male) underwent procedures where at least one lead removed was a SQC. Mean ejection fraction was 27.7% and 11 patients had prior ventricular arrhythmia. Median SQC age was 177 days and the age of the oldest SQC removed was 3,041 days. Infection was the indication for removal in 14 patients. One removal was performed surgically and 20 were completed percutaneously. Three procedures required additional incisions beyond the device pocket and tie-down sleeve to complete the SQC lead removal due to dense adhesions. One removal procedure required the use of a laser sheath to relieve fibrosis. Complications in this group did not appear related to SQC removal., Conclusions: Drawing from our SQC removal experience, there may be a need for additional incisions and extra tools to complete removal of older subcutaneous implantable cardioverter defibrillator leads., (© 2018 Wiley Periodicals, Inc.)

Cardiac implantable electronic devices (CIEDs) including pacemakers, implantable cardioverter defibrillators and loop recorders have become widespread adjuncts in the care of patients with cardiovascular disease. CIEDs provide increased diagnostic yield, better quality of life and improved longevity. While there are obvious benefits with these devices, the mere fact that these therapies involve implantation of a foreign device within the body leads to certain risks. The most feared complication associated with CIED use is infection. While the incidence of CIED infection is relatively low for first-time implants, the consequences are serious and involve increased morbidity and mortality despite optimal management. In this review, we discuss preventive practices including a new antimicrobial envelope aimed at reducing the risk of CIED infections.

Background: The major complication rate of transvenous lead extraction (TLE) is estimated to be 1%-2%. Laceration of the central veins can be fatal., Objectives: To define the incidence and extent of venous injuries on a microscopic level after TLE and compare these data with those of clinically documented events of venous laceration., Methods: We studied all patients who underwent TLE at our tertiary center within 30 months via a variety of techniques. Extracted leads and tissue around them were fixed in formalin. Pathologic examination was standardized to examine the leads identifying the areas covered by tissue cuffs along the length of the lead. The cuffs were removed and sectioned transversely to their longitudinal axis. Microscopic examination was performed using hematoxylin and eosin stains and Movat stains to identify the presence of vein tissue., Results: In all, 861 leads (585 pacemaker and 272 defibrillator leads) were extracted from 461 patients (median age 63 years, standard deviation 15 years), with an average of 1.9 leads per patient and a median lead age of 2546 days. On microscopic review, 80 leads (9.3%) in 72 of 461 patients (15.6%) showed segments of vein, most of which were transmural (venous tissue including adventitia). Despite this finding, only 5 catastrophic complications (1.1%) occurred that required emergent surgical intervention. Risk factors for venous injury included implantable cardioverter defibrillator lead, age of lead, and the use of laser sheath., Conclusions: Microscopic venous injuries during lead extraction are common but often not recognized clinically., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac implantable electronic device infections have been on the rise. A high-risk population is that with renal disease, especially dialysis. We aimed to assess procedural profiles and clinical outcomes of transvenous lead extraction for cardiac implantable electronic device infection based on renal disease status., Methods and Results: In 1420 consecutive patients undergoing transvenous lead extraction of infected cardiac implantable electronic devices (1996-2012), we assessed procedural profiles and clinical outcomes in 3 groups: normal renal function (group 1, n=1159), renal dysfunction not requiring dialysis (group 2, n=163), and dialysis (group 3, n=98). A total of 3182 infected leads were extracted. Dialysis patients had shorter lead dwell times and were less likely to require transvenous lead extraction tools but as likely to require femoral workstations. There were higher overall rates of procedure-related complications in dialysis patients (12% versus ≈6% in nondialysis) with no difference in the major complication rates ( P =not significant). Complete procedural success rates were 94%, 96%, and 94% in groups 1, 2, and 3, respectively ( P =not significant). There were 4 intraprocedural deaths in group 1 versus none in groups 2 and 3. Mortality rates were significantly higher in dialysis patients both at 1 and 6 months ( P <0.0001 for both). In multivariable analyses, dialysis status was independently associated with increased mortality risk at 1 and 6 months. Other factors associated with mortality were lead material retention, functional (New York Heart Association) class, and occurrence of procedural complications., Conclusions: In patients with cardiac implantable electronic device infection, dialysis status did not seem to add complexity to transvenous lead extraction but was independently associated with increased mortality at 1 and 6 months., (© 2018 American Heart Association, Inc.)

Increasing numbers of patients with cardiac disease have improved quality of life and longevity as a result of cardiac implantable electronic devices (CIEDs). CIED infections can involve the generator pocket, bloodstream, or cardiac structures and occur in about 0.5% of de novo CIED implants and approximately 2% of CIED replacements. Prompt diagnosis of CIED infection is beneficial to the success of antibiotic therapy and subsequent device removal to resolve the infection. Measures to prevent CIED infections include assessment of the indication and patient status, strict sterile surgical techniques, preoperative antibiotics, and adequate homeostasis. New surgical methods and CIED devices may also lead to reduction in CIED infections. Further research is needed to better quantify the incidence of CIED, risk factors, and efficacy of surgical techniques to prevent infections., (Copyright © 2017 Cleveland Clinic.)

Aims: The incidence, indications, and risk factors for cardiac implantable electronic device (CIED) implantation after cardiac surgery in an era with an aging population are not well described. There are limited data about the survival of these patients compared with a non-device group. We aimed to evaluate the incidence, indications, and risk factors for postoperative CIED implantation. We also assessed survival of these patients compared with a non-device group., Methods: We included all patients without prior CIED implantation who underwent cardiac surgery at our institution from 1996 to 2008. Characteristics associated with CIED implantation were identified by multivariable logistic regression. A propensity model was constructed to compare survival., Results: A total of 39 546 patients were included in the study of which 1608 patients (4.1%) underwent postoperative CIED implantation. Conduction disease accounted for most devices, but 371 patients underwent CIED implantation for secondary prevention of ventricular arrhythmias. Risk factors associated with implantation included older age, valvular disease, atrial fibrillation, and prior surgery. The propensity-adjusted risk of early death (within 1 year) was significantly less in the device group (hazard ratio [HR] 0.38; 95% confidence interval [CI] 0.22-0.65; P = 0.0004). However, the propensity-adjusted risk of late death was significantly greater in the device group (HR 1.3; 95% CI 1.2-1.5; P = <0.0001)., Conclusion: Despite an aging population, the incidence of CIED implantation after cardiac surgery remains low and varies by the type of operation. Follow-up suggests increased early survival but decreased late survival in patients who undergo CIED implantation compared with a non-device group., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: This study sought to assess the impact of previously abandoned leads on the clinical management of cardiac device infections, notably transvenous lead extraction and subsequent clinical course., Background: The population of patients with cardiac implantable electronic devices continues to grow with a disproportionate increase in device infections, which are invariably life threatening. A potentially complicating issue is the widely practiced strategy of device lead abandonment at the time of system revision, change, or upgrade, which is affecting an increasing number of patients., Methods: The study assessed the impact of previously abandoned leads in a prospectively maintained registry of consecutive patients undergoing percutaneous extraction of infected cardiac devices at the Cleveland Clinic between August 1996 and September 2012. The primary clinical endpoint was complete procedural and clinical success defined as the successful removal of the device and all lead material from the vascular space, in the absence of a major complication., Results: Of 1,386 patients with infected cardiac devices, 323 (23.3%) had previously abandoned leads. Failure to achieve the primary endpoint occurred more frequently in patients with abandoned leads (13.0% vs. 3.7%; p < 0.0001). This was primarily due to retention of lead material (11.5% vs. 2.9%; p < 0.0001), which was associated with poor clinical outcomes including higher rates of 1-month mortality (7.4% vs. 3.5% in those without lead remnants). Lead extraction procedures in patients with previously abandoned leads were longer (p < 0.0001), with longer fluoroscopy times (p < 0.0001), and more likely to require specialized extraction tools (94.4% vs. 81.8%; p < 0.0001) or adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Procedural complications occurred more frequently in patients with previously abandoned leads (11.5% vs. 5.6%; p = 0.0003), which was true for both major (3.7% vs. 1.4%; p = 0.009) and minor complications (7.7% vs. 4.4%; p = 0.02)., Conclusions: Previously abandoned leads complicate the management of cardiac device infections, leading to worse clinical outcomes., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with significant morbidity and mortality. The aim of this study is to determine whether Medtronic TYRX absorbable envelope reduces the risk of CIED infection through 12 months of follow-up post procedure., Methods: WRAP-IT is a randomized, prospective, multi center, international, single-blinded study. Up to 7,764 subjects who are undergoing CIED generator replacement, upgrade, or revision, or a de novo CRT-D implant, will be enrolled and randomized (1:1) to receive the TYRX envelope or not. The primary endpoint is major CIED infection throughout 12 months of follow up after the procedure. Data will be analyzed with an intention to treat approach. WRAP-IT will also assess the performance of Medtronic's lead monitoring algorithms in subjects whose CIED includes a transvenous right ventricular defibrillation system., Conclusions: WRAP-IT is a large randomized clinical trial that will assess the efficacy of TYRX absorbable envelope in reducing CIED infection, define its cost effectiveness, and will also provide a unique opportunity to better understand the pathophysiology and risk factors for CIED infection., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: For each clinical circumstance, the benefits of transvenous lead extraction (TLE) need to be weighed against the risks. Clinical decision-making tools for predicting mortality after TLE are lacking., Objective: To create a preoperative risk score for prediction of 30-day all-cause mortality after TLE of pacemaker and defibrillator leads., Methods: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. A risk nomogram for predicting 30-day all-cause mortality was developed using baseline clinical variables and multivariable logistic regression modeling. Discrimination and calibration were assessed by using bootstrapping for internal validation. Continuous data are presented as median (25th, 75th percentile); categorical data are presented as number (percentage)., Results: A total of 5521 (4137 [74.9%] pacemaker and 1384 [25.1%] defibrillator) leads were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years and 2.0 (1.0, 2.0) leads were extracted per procedure. Sixty-seven patients (2.2%) had died by 30 days after TLE. Variables with the highest predictive value for 30-day all-cause mortality included age, body mass index, hemoglobin, end-stage renal disease, left ventricular ejection fraction, New York Heart Association functional class, extraction for infection, number of prior lead extractions performed by the operator, and extraction of a dual-coil defibrillator lead. These variables were used to create a nomogram with a bootstrap-corrected concordance index value of 0.867., Conclusions: Thirty-day all-cause mortality after TLE can be assessed with good discriminative power using readily available clinical information., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with increased morbidity and mortality. Recent data suggested a relationship between the antiseptic agent used for skin preparation at time of CIED procedure and risk for infection., Methods: On April 30, 2011, we changed the antiseptic agent used for skin preparation at our tertiary care facility from chlorhexidine-alcohol to povidone-iodine for all CIED procedures. We retrospectively reviewed records of all patients who underwent CIED procedure 1 year before and after the change. CIED infection was defined as pocket or endovascular systemic infection that required removal within 1 year of the index procedure. We examined if the change affected the risk of CIED infection., Results: A total of 2,792 patients underwent 2,840 CIED procedures; 1,748 (61.5%) had implantable cardioverter defibrillator procedures and 1,092 (38.4%) had permanent pacemaker procedures. Chlorhexidine-alcohol agent was used in 1,450 (51.1%) procedures, and povidone-iodine agent was used in 1,390 (48.9%). After 1 year of follow-up, 31 patients (1.09%) developed CIED infection that required system removal. The 1-year infection rate was 1.1% among both antiseptic agent groups and there were no significant differences in the infection presentations among both groups (P = 0.950). Multivariate Cox proportional hazards regression model showed that risk factors for infection within 1 year included age, diabetes, and African American race., Conclusion: In one large cohort of patients undergoing CIED procedures, the antiseptic agent used for skin preparation (chlorhexidine-alcohol vs povidone-iodine) was not associated with increased risk of developing CIED infection., (©2014 Wiley Periodicals, Inc.)

Aims: Infections of cardiac implantable electronic devices (CIEDs) are infrequent but carry significant morbidity and mortality. We aimed to assess risk factors for 1-year mortality among patients with CIED infection and to evaluate if the type of infection and the presence of vegetation affect survival., Methods and Results: We reviewed records of all patients with infected CIEDs who underwent transvenous lead extraction at our tertiary care centre between 2002 and 2008. Patients who presented with infection involving the device pocket were classified as 'pocket infection', and those who presented with bacteraemia with or without vegetation and a pocket that looked benign were classified as 'endovascular infection' (EVI). One-year mortality was examined using the social security death index. Five hundred and two patients were identified (68.5 ± 15 years); 289 (58%) had pocket infection and 213 (42%) had EVI. One-year mortality rate was 20%. Using multivariable Cox regression model, EVI was associated with significantly higher 1-year mortality (hazard ratio 2.1, P-value 0.0008). Among patients with EVI, 100 patients had vegetation on transoesophageal echo; however, there was no difference in 1-year mortality between patients with EVI and vegetation compared with patients with EVI and no vegetation (27, 27 vs. 40, 35%; P-value 0.188). Risk factors for 1-year mortality among patients with EVI included renal failure, worse functional class, and bleeding requiring transfusion. The presence of vegetation was not associated with increased 1-year mortality., Conclusion: One-year mortality is higher among patients with EVI compared with patients with pocket infection; this increased mortality does not seem to be related to the presence of vegetations., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: It is difficult to predict adverse patient outcomes associated with transvenous lead extraction (TLE) procedures., Objective: The purpose of this study was to examine the safety and efficacy of chronic endovascular pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction and risk factors associated with adverse patient outcomes., Methods: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. Univariate and multivariable logistic regression analyses were performed to evaluate for associations with outcomes. Continuous data are given as median (25th, 75th percentile). Categorical data are given as number (percentage)., Results: In total, 5521 leads (4137 [74.9%] pacemaker, 1384 [25.1%] ICD) were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 74.9% of procedures. Overall, there was 95.1% complete procedural success, 98.9% clinical success, and 1.1% failure, with 3.6% minor complications and 1.8% major complications. All-cause mortality within 30 days of TLE was 2.2%. Multivariable predictors of major complications included cerebrovascular disease, ejection fraction ≤15%, lower platelet count, international normalized ratio ≥1.2, mechanical sheaths, and powered sheaths. Multivariable predictors of all-cause mortality within 30 days of TLE included body mass index <25 kg/m(2), end-stage renal disease, higher New York Heart Association functional class, lower hemoglobin, higher international normalized ratio, lead extraction for infection, and extraction of a dual-coil ICD lead., Conclusion: TLE in this single-center experience was highly successful. Risk factors associated with adverse patient outcomes were identified., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The outcomes of patients requiring emergent surgical or endovascular intervention during transvenous lead extraction (TLE) have not been well characterized., Objectives: To evaluate the incidence of catastrophic complications requiring emergent surgical or endovascular intervention during TLE, to describe the injuries, and to review patient management and outcomes., Methods: Consecutive patients undergoing TLE of pacemaker and implantable cardioverter-defibrillator (ICD) leads at the Cleveland Clinic between August 1996 and September 2012 were included in the analysis., Results: A total of 5973 (4436 [74.3%] pacemaker and 1537 [25.7%] ICD) leads were extracted during 3258 TLE procedures (median [25th, 75th percentile] patient age 67.0 [55.0, 76.1] years; 69.2% men). The median (25th, 75th percentile) lead implant duration was 4.9 (2.4, 8.4) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 2369 (72.7%) procedures. Twenty-five (0.8%) patients experienced catastrophic complications requiring emergent surgical or endovascular intervention. Twenty patients (0.6%) required either sternotomy (n = 18) or thoracotomy (n = 2) for superior vena cava laceration (n = 15) and right atrial (n = 2) or ventricular (n = 3) perforation. Two patients required vascular repair at the procedural access site for either subclavian vein or artery laceration. Three patients were managed with an endovascular approach for superior vena cava laceration, left axillary artery laceration, and brachiocephalic vein and artery fistula. In-hospital mortality was 36.0% (6 procedural/operative deaths and 3 deaths during the same hospitalization)., Conclusions: Major vascular injury or cardiac perforation requiring emergent surgical or endovascular intervention during TLE is uncommon but carries significant in-hospital mortality. Despite high mortality, nearly two-thirds of these patients were rescued with immediate response and surgical or endovascular intervention., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Comparative safety and efficacy associated with transvenous lead extraction (TLE) of recalled and non-recalled implantable cardioverter-defibrillator (ICD) leads has not been well characterized., Objectives: To compare the indications, techniques, and procedural outcomes of recalled vs non-recalled ICD lead extraction procedures., Methods: TLE procedures performed at our institution from June 2002 to June 2012 in which Riata, Sprint Fidelis, or non-recalled ICD leads were extracted were included in the analysis., Results: ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Sprint Fidelis, and 1 Riata and Sprint Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads. Overall, there was 96.8% complete procedural success, 99.1% clinical success, and 0.9% failure, with 3.9% minor complications and 1.5% major complications. Procedural outcomes for Riata and Sprint Fidelis TLE procedures were no different. Lead implant duration was significantly less in recalled than in non-recalled ICD lead TLE procedures. Complete procedural success was higher in recalled (424 of 430 [98.6%]) than in non-recalled (621 of 649 [95.7%]; P = .007) ICD lead TLE procedures. Minor complications were lower in recalled (10 of 430 [2.3%]) than in non-recalled (32 of 649 [5.0%]; P = .030) ICD lead TLE procedures. Rates of clinical success, failure, and major complications were no different in the recalled and non-recalled ICD lead TLE procedures., Conclusion: In our experience, recalled ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads., (© 2013 Heart Rhythm Society. All rights reserved.)

The indications for cardiac implantable electronic devices (CIEDs) have increased significantly over the last two decades. This has led to a surge in device implants in an expanding cohort of recipients who are in general older and who have more comorbidities. Implantation of CIED is carried out under sterile techniques and with the use of perioperative antibiotics; however, despite all these preventive measures, CIED infection remains a significant complication. Many recent reports and data from national registries have suggested an increased rate of CIED infection. However, our understanding of its true incidence remains limited due to the lack of a clear denominator as the number of patients living with CIEDs continues to expand and the pool of patients who are at risk for developing infection is growing. The importance of CIED infection has been emphasized in many recent studies that have also suggested significant morbidity and mortality risk associated with this complication that spans beyond the extraction procedure of the infected device.

Background: Indications for cardiac implantable electronic devices (CIEDs) are increasing. Although CIED infections occur infrequently, the impact of this outcome is expected to be substantial., Objective: The purpose of this study was to the evaluate the outcome of patients undergoing removal of infected CIEDs., Methods: A retrospective study was conducted of all patients with proven or suspected infected CIEDs who were referred to the Cleveland Clinic for system removal from January 2002 through March 2007., Results: A total of 412 patients (age 68 +/- 15 years) were included in the study. The majority of patients (241 [59%]) presented with localized infection involving the device pocket. The remaining 171 patients (41%) presented with endovascular infection but no evidence of inflammation of the device pocket. Of the total 414 pathogens isolated, 366 (88%) were aerobic gram-positive organisms, of which 90% were Staphylococcus species, and almost half of these were methicillin resistant. In-hospital mortality was 4.6% (19 patients). Only 2 deaths were extraction related. One-year mortality was 17%. Among the total cohort, 8 (1.9%) patients had relapsing infection within the first year. Among patients who had device replacement during the same hospitalization, 6 (2.6%) had relapsing infections within 1 year of reimplantation; 5 of these patients had systemic symptoms and were bacteremic upon initial presentation., Conclusion: CIED infections are most often caused by Staphylococcus species, half of which are methicillin resistant. Percutaneous lead and device removal along with antibiotic therapy are effective as primary interventions. The overall relapse rate is 1.9%, and the relapse rate among patients who had reimplantation during the same hospitalization is 2.6%., (Copyright 2010 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Ventricular tachyarrhythmia events (VTE) are common among refractory heart failure patients requiring ventricular assist device (VAD) support. It is unknown whether implantable cardioverter-defibrillator (ICD) detection and therapy can extend survival in the VAD population., Objective: The purpose of this study was to evaluate the survival experience of refractory heart failure patients requiring VAD support with and without a concomitant ICD., Methods: Multivariable analysis of the Cleveland Clinic registry of consecutive patients with and without an ICD who underwent VAD placement between 1991 and 2008 using traditional and propensity-matched methods. The primary endpoint was all-cause mortality., Results: Among 478 VAD recipients (age 53.5 +/- 12.0 years, 80% male), 90 patients (18.8%) had an ICD at the time of VAD placement. VTE occurred in 26 patients (28.9%) at a mean of 32.4 +/- 47.1 days, with appropriate treatment in 24 patients (75% initial shock, 25% successful antitachycardia pacing). A concomitant ICD during VAD support was associated with a significant reduction in mortality (hazard ratio [HR] 0.55 [confidence interval 0.32-0.94]; P = .028) after adjustment for age, gender, left ventricular ejection fraction, VAD type, year placed, diagnosis and duration, complications, dialysis-dependent renal failure, and extended survival (median survival 295 vs. 226 days; P = .024). A propensity-matched analysis of 134 patients with and without ICD also demonstrated that a concomitant ICD was associated with lower all-cause mortality (odds ratio 0.42 [confidence interval 0.19-0.95]; P = .04)., Conclusion: A concomitant ICD among VAD recipients is associated with extended survival., (Copyright 2010 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)