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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. (J Am Coll Cardiol EP 2022;8:101-111) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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, Graphical Abstract

The mortality benefit of implantable cardioverter defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) has been well-established, but ICD therapy remains globally underutilized. The results of the Improve SCA study showed a 49% relative risk reduction in all-cause mortality among ICD patients with 1.5 primary prevention (1.5PP) characteristics (patients with one or more risk factors,We used a published Markov model that compares costs and outcomes of ICD to no ICD therapy from local payers' perspective and included country-specific and disease-specific inputs from the Improve SCA study and current literature. We used WHO-recommended willingness-to-pay (WTP) thresholds to assess cost-effectiveness and compared model outcomes between countries.Incremental costs per QALY (quality-adjusted life year) saved by ICD compared to no ICD therapy are Colombian Pesos COP$46,729,026 in Colombia, Mexican Pesos MXN$246,016 in Mexico, and Uruguayan Pesos UYU$1,213,614 in Uruguay in the base case scenario; all three figures are between 1-3-times GDP per capita for each country. One-way and probabilistic sensitivity analyses confirm the base case scenario results. Non-cardiac accumulated deaths are lower in Mexico, resulting in a comparatively increased cost-effective ICD therapy.The Improve SCA study was not randomized, so clinical results could be biased; however, measures were taken to reduce this bias. Costs and benefits were modelled beyond the timeline of direct observation in the Improve SCA study.ICD therapy is cost-effective in Mexico and Uruguay and potentially cost-effective in Colombia for a 1.5PP population. Variability in ICER estimates by country can be explained by differences in non-cardiac deaths and cost inputs.

Pacemaker-related infections remain a constant concern due to increased risk of patient morbidity and mortality. Although transvenous pacemakers are expected to have an infection rate ranging from 0.77% to 2.08%, no cases of leadless pacemaker infection have been reported in clinical trials enrolling more than 3000 patients. Many potential reasons why leadless pacemakers may be resistant to infection include the absence of a subcutaneous pocket and leads, reduced skin and glove contact, size, location, and device material. This review summarizes the current state of evidence regarding the apparent infection resistance of leadless pacemakers.

INTRODUCTION Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. METHODS Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. RESULTS The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P

The volume of atrial fibrillation (AF) catheter ablation procedures has increased to address the growing patient population with AF; however, the impact of cryoballoon ablation on electrophysiology (EP) lab throughput is under-studied when treating patients with persistent AF (PsAF).To assess EP lab utilization associated with cryoballoon ablation for the treatment of patients with PsAF and to evaluate mechanisms that optimize hospital resources.Procedural data derived from the STOP Persistent AF trial were input into a discrete event simulation to assess EP lab utilization during AF ablation procedures. Patient and physician delays and lab occupancy times were modeled in a nominal and efficient EP lab setting over 1000 days. Accounting for variation in procedural times, we evaluated the number of days in which preplanned pulmonary vein isolation (PVI) cases resulted in overtime or excess time for non-ablation EP cases within a given lab day. A sensitivity analysis determined the parameters that most strongly influenced EP lab throughput.Lab occupancy times for the Nominal Use (NU) case included 165 procedures, and the High-Efficiency Use (HEU) case was derived from 69 procedures conducted at sites with faster procedure times than average. The HEU case had shorter lab occupancy times than the NU case (158 ± 32 minutes vs 188 ± 51 minutes, respectively). In the NU case, a total of 2000 procedures were conducted, with 28 lab days (2.8%) extending into overtime and 900 lab days (90%) exhibiting excess time for a non-ablation EP case. In the HEU case, a total of 3000 procedures were conducted, with 87 lab days (8.7%) extending into overtime and 635 lab days (63.5%) exhibiting excess time for a non-ablation EP case. The model was most sensitive to lab occupancy duration and the time of day that overtime started.Cryoballoon ablation for the treatment of patients with PsAF confers EP lab efficiencies that can support 3 PVI cases in a lab day.

This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures.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.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 (appeared10 times) across 100 iterations of imputed data were deemed significant.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.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.

Automated optimization algorithm (AdaptivCRT; Medtronic, Mounds View, MN, USA) allowing automated optimization of cardiac resynchronization therapy (CRT), has been introduced. However, little is known concerning its cost-effectiveness. This study aims to evaluate the potential economic benefits of AdaptivCRT of CRT.Markov modelling was informed by empirical data sourced from the AdaptivCRT Clinical Trial. Published meta-analyses were used to derive the impact of increasing response to hospitalization and mortality risks. Response was assessed via the clinical composite score.Deterministic results suggested a mean survival of 10.97 years with adaptive algorithms against 10.5 years without (+0.47 in favour of novel algorithms). Heart failure hospitalization costs were modelled to ¥1,382,753 (US $12,686) with novel devices against ¥1,524,747 (US $13,989) with previous technology models. Sensitivity analyses show CRT with Adaptive algorithm was projected to provide cost savings in all scenarios.The use of AdaptivCRT was projected to improve average patient survival and avoid costs in a Japanese healthcare setting.

Background: Implantable cardiac defibrillators (ICDs) therapy for primary prevention (PP) of sudden cardiac arrest (SCA) is well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP), based on PP patients with the presence of documented risk factors: non-sustained ventricular tachycardia, frequent premature ventricular contractions, left ventricular ejection fraction < 25%, and pre-syncope or syncope. Objective: This study evaluated the cost-effectiveness of ICD therapy compared to no ICD among 1.5PP patients in the Brazilian public healthcare system. Methods: Modified inputs to a published Markov model were applied to compare costs and outcomes of ICD therapy to no ICD therapy from the Brazilian payer’s perspective. Mortality and utility estimates were obtained from the IMPROVE SCA trial. Additional effectiveness inputs were sourced from the literature. Cost inputs were obtained from the Brazilian Unified Health System and the Ministry of Health. Costs were discounted at 4.7%; quality-adjusted life years (QALYs) were discounted at 1.45%. This study applied a willingness-to-pay (WTP) value of three times Brazil’s gross domestic product (GDP) in 2017, R$105,723 (Brazilian Real). Results: The total discounted lifetime costs for ICD therapy were R$100,920 compared to R$43,866 for no ICD therapy. Total discounted QALYs for ICD therapy and no ICD therapy were 9.85 and 7.15, respectively. The incremental cost effectiveness ratio was R$21,156 per QALY and less than the R$105,723 WTP threshold. Results from sensitivity analyses were consistent with base case results. Conclusions: ICD therapy compared to no ICD therapy is cost-effective in the 1.5PP population in Brazil. (Int J Cardiovasc Sci. 2021; [online].ahead print, PP.0-0)

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.

Supplemental Digital Content is available in the text., 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.

Funding Acknowledgements This work was supported by Medtronic Background/Introduction: The increasing number of cardiac implantable electronic device (CIED) infections has led to increased interest in the identification of patients who may benefit from additional infection prevention measures. Purpose The purpose of this evaluation was to validate the predictive value of the Prevention of Arrhythmia Device Infection Trial (PADIT) risk score to identify patients at increased risk of CIED infection using a U.S. health claims data set. Methods A retrospective analysis using the Optum® Clinformatics® claims database was conducted to create a dataset of index procedures which either did or did not result in an infection. The study population included both commercial and Medicare Advantage patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014. Major CIED infections, defined as an infection associated with system removal, invasive procedure without system removal, or death attributable to infection, were identified through diagnosis and procedure codes. The dataset was randomized (stratified by PADIT score, which included prior procedures, age, depressed renal function, immunocompromised, and procedure type) into a Development Dataset (60%) and a Validation dataset (40%). A frailty model allowing multiple procedures per patient was fit using the Development Dataset, with PADIT score as the only predictor, excluding patients with prior infection. Prior CIED infection, which was not available in the original PADIT data, was examined for additional predictive value. Results The data extraction resulted in a dataset of 53,554 index procedures among 51,583 patients, with 30,950 patients randomized to the Development Dataset. The distribution of procedures was pacemakers (52%), ICD (20%), CRT (12%), and Revision/Upgrade (16%), while prior procedures were none (62%), 1 (37%), and 2 (1%). Among patients with no history of prior CIED infection, the frailty model showed that a 1 unit increase in the PADIT score predicts higher infection risk (20%) in the U.S. claims data set (Table 1). Prior CIED infection was associated with strong additional predictive value (HR 4.77, p Conclusion In the largest external validation of a CIED risk score, the PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that can benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection brings additional predictive value to the PADIT score.

Supplemental Digital Content is available in the text., 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

Objective Implantable cardiac defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) are well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP) based on PP patients with the presence of certain risk factors. We evaluated the cost-effectiveness of ICD therapy compared to no ICD among the PP population and the subset of 1.5PP patients in Taiwan. Methods A Markov model was run over a lifetime time horizon from the Taiwan payer perspective. Mortality and utility estimates were obtained from the literature (PP) and the IMPROVE SCA trial (1.5PP). Cost inputs were obtained from the Taiwan National Health Insurance Administration (NHIA), Ministry of Health and Welfare. We used a willingness-to-pay (WTP) threshold of NT$2,100,000, as established through standard WTP research methods and in alignment with World Health Organization recommendations. Results The total discounted costs for ICD therapy and no ICD therapy were NT$1,664,259 and NT$646,396 respectively for PP, while they were NT$2,410,603 and NT$905,881 respectively for 1.5PP. Total discounted QALYs for ICD therapy and no ICD therapy were 6.48 and 4.98 respectively for PP, while they were 10.78 and 7.71 respectively for 1.5PP. The incremental cost effectiveness ratio was NT$708,711 for PP and NT$441,153 for 1.5PP, therefore ICD therapy should be considered cost effective for PP and highly cost effective for 1.5PP. Conclusions ICD therapy compared to no ICD therapy is cost-effective in the whole PP population and highly cost-effective in the subset 1.5PP population in Taiwan.

Background The Micra clinical trials have enrolled more than 2500 patients without any reported device-related infections that required removal during follow-up. Leadless pacemakers might be more resistant to bacterial seeding due to smaller surface area and a greater tendency for encapsulation. Objective To analyze the incidence and outcomes of serious infectious events (SIEs: bacteremia or endocarditis) that developed during follow-up in patients with history of Micra leadless pacemaker implantation. Methods SIE and outcomes were characterized based upon adverse event reports. Among 720 patients implanted with Micra in the investigational device exemption trial, we identified 16 patients who had documented 21 SIEs during follow-up. Results Among patients with SIEs, mean age was 71.9 ± 11.7 years. SIEs occurred at a mean 4.8 ± 4.5 months after implant and patients were followed for 13.1 ± 9.1 months after documentation of SIE. All events were adjudicated as unrelated to the Micra device or procedure. Bacteremia was documented to be related to a gram-positive organism in 13 events (seven Staphylococcus, three Streptococcus, two Enterococcus, and one uncharacterized gram-positive bacteria), and gram-negative organisms in three events. In five events, the type of organism was not characterized (two patients with endocarditis). No persistent cases of bacteremia after antibiotic cessation were seen over the duration of follow-up CONCLUSION: In this small series of Micra patients who developed SIEs postimplant, the occurrence of bacteremia and/or endocarditis did not appear to lead to persistent bacteremia off antibiotics; most events resolved with antibiotic treatment.

Risk factors for CIED infection are not well defined and procedural techniques to minimize infection lack supportive evidence. WRAP-IT was a large randomized trial assessing the efficacy of an antibiotic envelope to reduce CIED infections. Machine learning techniques enhance the ability to identify

Background This study sought to assess payer costs following cryoballoon or radiofrequency current ( RFC ) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. Methods and Results A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC ) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [ $ ]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country‐specific diagnosis‐related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow‐up were €640, £364, and $ 925 in favor of cryoballoon ablation ( P =0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $ 355 000. Conclusions When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Identifier: NCT01490814.

a Cardiology Department, Kuwait Cardiac Center, Kuwait b Cardiology Department, P. Stradins Clinical University Hospital, Riga, Latvia c Cardiology Department, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia d Cardiology Department, Eugene Marais Hospital, Pretoria, South Africa e Department of Internal Medicine—Cardiology, University Hospital Brno, Brno, Czech Republic f Cardiology Department, Hospital General de Ciudad Real, Ciudad Real, Spain g Cardiology Department, Karlovarska Krajska Nemocnice a.s., Karlovy Vary, Czech Republic h Cardiology Department, Care Institute of Medical Sciences, CIMS Hospital, Gujarat, India i Cardiology Department, Hospital Carlos Arvelo, Caracas, Venezuela j Medtronic Bakken Research Center, Maastricht, The Netherlands k Medtronic, Inc., Minneapolis, USA l Cardiology Department, Christiaan Barnard Memorial Hospital, Cape Town, South Africa

BackgroundThe PANORAMA study was designed to collect concurrent data on subjects from different worldwide regions implanted with CRM devices.MethodsIn this prospective, multi-center study, we analyzed baseline data on 8586 subjects implanted with CRM devices with no additional selection criteria (66% pacemaker (IPG), 16% implantable cardiac defibrillators (ICD), 17% cardiac resynchronization therapy (CRT) and < 1% Internal Loop Recorder) from 156 hospitals across 6 geographical regions between 2005 and 2011.ResultsRegardless of the device implanted, subjects from the Middle East and India often had more diabetes than other regions. Eastern and Western Europe had higher rates of atrial fibrillation reported, and men were more likely to smoke than women (46% vs 11%, p < 0.001). Within the CRT cohort there was significant variation in the proportion of males receiving a device, ranging from 55% in India to 83% in Eastern Europe.ConclusionsWe provide comprehensive descriptive data on patients receiving CRM devices from a range of geographies that are not typically reported in literature. We found significant variations in clinical characteristics and implant practices. Long term follow-up data will help evaluate if these variations require adjustments to outcome expectations.

Background Remote monitoring (RM) of defibrillators (implantable cardioverter defibrillators [ICDs]) and cardiac resynchronization therapy devices (CRTDs) has been shown to be cost effective, convenient, and associated with reduced mortality and a reduction in the time to physician intervention for actionable events. However, patient compliance with monitoring over time and what factors might influence such compliance have not been well described. This study sought to identify factors contributing to patient noncompliance with RM of ICDs and CRTDs in a large real-world population. Methods Deidentified data on U.S. patients enrolled in the Medtronic CareLink RM system were used to compare patients with no (noncompliant, n = 14,848) and with ≥2 RM transmissions (compliant, n = 103,284) during a 14-month period. Results Overall noncompliance with RM was 21%. Younger age (≤40), female sex, wanded device, Medicare Census Division, and small clinic size all predicted patient noncompliance (P 100 patients), OR 4.38 (3.92–4.91). Conclusions There is room for improvement in RM usage among enrolled patients. Younger patients, smaller clinics, and certain geographic areas may be targets for research into interventions to further improve the use of RM

The VALUE PVI study demonstrated that atrial fibrillation (AF) ablation procedures and electrophysiology laboratory (EP lab) occupancy times were reduced for the cryoballoon compared with focal radiofrequency (RF) ablation. However, the economic impact associated with the cryoballoon procedure for hospitals has not been determined.Assess the economic value associated with shorter AF ablation procedure times based on VALUE PVI data.A model was formulated from data from the VALUE PVI study. This model used a discrete event simulation to translate procedural efficiencies into metrics utilized by hospital administrators. A 1000-day period was simulated to determine the accrued impact of procedure time on an institution's EP lab when considering staff and hospital resources. The simulation demonstrated that procedures performed with the cryoballoon catheter resulted in several efficiencies, including: (1) a reduction of 36.2% in days with overtime (422 days RF vs 60 days cryoballoon); (2) 92.7% less cumulative overtime hours (370 hours RF vs 27 hours cryoballoon); and (3) an increase of 46.7% in days with time for an additional EP lab usage (186 days RF vs 653 days cryoballoon). Importantly, the added EP lab utilization could not support the time required for an additional AF ablation procedure.The discrete event simulation of the VALUE PVI data demonstrates the potential positive economic value of AF ablation procedures using the cryoballoon. These benefits include more days where overtime is avoided, fewer cumulative overtime hours, and more days with time left for additional usage of EP lab resources.

Background: Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and “intermittent” AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy. Methods and Results: The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up. Conclusions: The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.

The clinical application of atrial tachyarrhythmia (AT) episode data stored by implantable devices is presently limited by the high proportion of inappropriate detection. We quantified the percentage of inappropriate AT detection in two implantable devices with AT diagnostics and therapies via meta-analysis of stored AT episodes from a number of clinical trials. The AT500 and GEM III AT, contain dual chamber logic to discriminate AT from ventricular tachycardia and far-field R wave (FFRW) oversensing using dual chamber bipolar electrograms. A subset of data from four clinical trials of 1,142 patients was considered. Manual analysis was performed on 21,553 stored episodes with atrial EGM and marker channel from 409 patients with stored episodes and the market-released device detection configuration. The percentage of episodes with inappropriate detection and termination was evaluated and compared between septal and nonseptal lead locations. The percentage of inappropriately detected episodes receiving ATP therapy was also determined. The percentage of episodes appropriately detected and the percentage of net episode duration (i.e., burden) recorded by the device were also determined from a separate analysis of 24-hour Holter recordings from a subset of 40 patients from one trial. Adjusted estimates of the percentage of appropriate [corrected] detection were 95.3% (93.5-96.7; 95% CI) for AT500 and 95.7% (84.3-98.9) for GEM III AT. Inappropriate detection was primarily due to FFRW oversensing or brief runs of premature atrial contractions (PACs). The device detected 100% of the sustained atrial arrhythmia episodes and 95.3% (range 76.1-99.9) of the net AT duration observed on the Holter recordings. AT detection was not influenced by atrial lead location. Appropriate detection of normal sinus rhythm at episode termination was 83.7% (80.7-86.3) for AT500 and 92.1% (84.5-96.2) for GEM III AT. Accurate detection and discrimination of FFRWs validates the reliability of AT diagnostic data and decreases the risk of inappropriate device therapy.

Introduction: The combined role of atrial septal lead location and atrial pacing algorithms in the prevention of atrial tachyarrhythmias (AT/AF), including both atrial fibrillation and flutter, is unknown. We tested the hypothesis that atrial prevention pacing algorithms could decrease AT/AF frequency in patients with atrial septal leads, bradycardia, and paroxysmal AT/AF. Methods and Results: A total of 298 patients (age 70 ± 10 years; 61% male) from 35 centers were implanted with a DDDRP pacing system including three AT/AF prevention pacing algorithms. Lead site was randomized at implant to right atrial septal or nonseptal. Patients were randomized 1 month postimplant to AT/AF prevention ON or OFF for 3 months and then crossed over for 3 months. Patients logged symptomatic AT/AF episodes via a manual activator. Prevention efficacy was evaluated based on intention-to-treat in 277 patients (138 septal) with complete follow-up. No changes in device-recorded AT/AF frequency or burden were observed with algorithms OFF versus ON or between patients randomized to septal versus nonseptal lead location. Analysis of other secondary outcomes revealed that AT/AF prevention pacing resulted in decreased atrial premature contractions in both the septal (1.9 [0.2–8.7] vs 3.3 [0.3–10.6]× 103/day; P < 0.01) and nonseptal groups (0.9 [0.2–3.3] vs 1.3 [0.3–5.5]× 103/day; P < 0.001). Patients with septal leads had fewer symptomatic AT/AF episodes ON versus OFF (1.4 ± 3.0 vs 2.5 ± 5.2/month, P = 0.01). Conclusion: The combination of three atrial prevention pacing algorithms did not decrease device classified atrial tachyarrhythmia frequency or burden during a 3-month cross-over period in bradycardic patients and septal or nonseptal atrial pacing leads. Prevention pacing was associated with decreased frequency of premature atrial contractions and with decreased symptomatic atrial tachyarrhythmia frequency in patients with atrial septal leads. (J Cardiovasc Electrophysiol, Vol. 14, pp. 1189-1195, November 2003)