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Background: Implant site hematoma is a known complication of cardiac device procedures and can lead to major consequences., Objectives: To evaluate risk factors for hematoma and further understand the relationship between anticoagulant (AC), antiplatelet (AP) use, and hematoma development., Methods: We included 6800 patients from the WRAP-IT trial. To assess baseline and procedural characteristics associated with hematoma within the first 30 days postprocedure, a stepwise Cox regression model was implemented with minimal Akaike information criterion. Cox regressions were also used to evaluate AC/AP use and hematoma risk., Results: The overall rate of hematoma was 2.2%. The model identified 11 baseline and procedural characteristics associated with hematoma risk. AC use (hazard ratio [HR]: 2.44, P < .001), lower body mass index (HR: 1.06, P < .001), and history of valve surgery (HR: 2.11, P < .001) were associated with the highest risk. AP use, male sex, history of coronary artery disease, existing pocket, history of nonischemic cardiomyopathy, number of previous cardiac implantable electronic device (CIED) procedures, procedure time, and lead revision were associated with moderate risk. Antithrombotic use was high overall (86%) and AC+AP use was highly predictive of hematoma risk. Regardless of AC status, AP use was associated with an almost doubling of risk vs no AP (HR = 1.85, P = .0006) in the general cohort. Interruption of AC was associated with the lowest hematoma risk (HR = 2.35) while heparin bridging (HR = 4.98) and AP use vs no AP use (HR = 1.85) was associated with the highest hematoma risk., Conclusion: The results of this analysis highlight risk factors associated with the development of hematoma in patients undergoing CIED procedures and can inform antithrombotic management., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Objectives: This study sought to examine the effect of the return electrode's surface area on bipolar RFA lesion size., Background: Bipolar radiofrequency ablation (RFA) is typically performed between 2 3.5-mm tip catheters serving as active and return electrodes. We hypothesized that increasing the surface area of the return electrode would increase lesion dimensions by reducing the circuit impedance, thus increasing the current into a larger tissue volume enclosed between the electrodes., Methods: In step 1, ex vivo bipolar RFA was performed between 3.5-mm and custom-made return electrodes with increasing surface areas (20, 80, 180 mm 2 ). In step 2, ex vivo bipolar RFA was performed between 3.5-mm and 3.5-mm or 8-mm electrode catheters positioned perpendicular or parallel to the tissue. In step 3, in vivo bipolar RFA was performed between 3.5-mm and either 3.5-mm or 8-mm parallel electrode at the: 1) left ventricular summit; 2) interventricular septum; and 3) healed anterior infarction., Results: In step 1, increasing the surface area of the return electrode resulted in lower circuit impedance (R = -0.65; P < 0.001), higher current (R = +0.80; P < 0.001), and larger lesion volume (R = +0.88; P < 0.001). In step 2, an 8-mm return electrode parallel to tissue produced larger and deeper lesions compared with a 3.5-mm return electrode (P = 0.014 and P = 0.02). Similarly, in step 3, compared with a 3.5-mm, bipolar RFA with an 8-mm return electrode produced larger (volume: 1,525 ± 871 mm 3 vs 306 ± 310 mm 3 , respectively; P < 0.001) and more transmural lesions (88% vs 0%; P < 0.001)., Conclusions: Bipolar RFA using an 8-mm return electrode positioned parallel to the tissue produces larger lesions in comparison with a 3.5-mm return electrode., Competing Interests: Funding Support and Author Disclosures Mr Bubar is an employee of Biosense Webster. Dr Tarakji receives consultation fees from AliveCor, Medtronic, Janssen, and Pfizer. Dr Anter has received research grants and speaking honoraria from Biosense Webster, Boston Scientific, Affera Inc, and Itamar Medical; and holds stock options in Affera Inc. Dr Koruth has received research grants from Affera Inc, Farapulse, Cardiofocus, Biosense, Acutus, Kardium; has equity in Affera Inc; and serves as a consultant to Farapulse and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console., Objective: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods., Methods: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless)., Results: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber)., Conclusion: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)

This collaborative statement from the Digital Health Committee of the Heart Rhythm Society provides everyday clinical scenarios in which wearables may be utilized by patients for cardiovascular health and arrhythmia management. We describe herein the spectrum of wearables that are commercially available for patients, and their benefits, shortcomings and areas for technological improvement. Although wearables for rhythm diagnosis and management have not been examined in large randomized clinical trials, undoubtedly the usage of wearables has quickly escalated in clinical practice. This document is the first of a planned series in which we will update information on wearables as they are revised and released to consumers., (© 2021 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

Background: Direct-to-consumer devices allow patients to record electrocardiograms (ECG) and detect atrial fibrillation (AF). Clinical adoption of these devices has been limited owing to the lack of efficient workflow., Objective: To assess a new care model for following patients after AF ablation that uses a smartphone ECG coupled with a novel cloud-based platform., Methods: This was a pilot study to describe AF detection, healthcare utilization, use of additional ECGs and cardiac monitors, and changes in anxiety after AF ablation. Patients presenting 3-4 months after early successful AF ablation were randomized into a control group with standard clinical follow-up or a self-monitoring group using smartphone ECG (Kardia Mobile, KM) coupled with a cloud-based platform (KardiaPro, KP) that alerted the physician when AF was detected and followed for 6 months., Results: A total of 100 patients were randomized: 51 to the KM/KP group and 48 to the control group (1 withdrew). AF was detected in 18 patients (18.2%), 11 (21.6%) in the KM/KP group and 7 (14.6%) in the control group ( P = .42). AF detection occurred at a median of 68 and 91 days in the KM/KP and control groups, respectively ( P = .93). These differences were not statistically significant. Healthcare utilization and changes in anxiety were similar between the groups. More patients required additional ECGs or cardiac monitors in the control group (27.1%) compared to the KM/KP group (5.9%) ( P = .004)., Conclusions: Smartphone ECG with a cloud-based platform can be incorporated into the care of post-AF ablation patients without increasing anxiety and with less need for additional traditional monitors., (© 2021 Heart Rhythm Society.)

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.)

Objectives: This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges., Background: CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation., Methods: All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique., Results: Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p < 0.01), with a male predominance (75% vs. 66%; p < 0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p = 0.28) or 90-day complications (5.1% vs. 4.6%; p = 0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p < 0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p = 1.0)., Conclusions: Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies., Competing Interests: Author Disclosures Dr. Wilkoff has received honoraria/consultant fees from Medtronic, Abbott, and Philips Healthcare. Dr. Rickard has received honoraria/consultant fees from Abbott and Medtronic. Dr. Tarakji has received honoraria/consultant fees from Medtronic and AliveCor. Dr. Varma has received honoraria/consultant fees from St. Jude Medical, Boston Scientific, Biotronik, and Medtronic. Drs. Hussein and Wazni have received honoraria/consultant fees from Biosense Webster and Boston Scientific. Dr. Cantillon has received honoraria/consultant fees from Abbott and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to assess outcomes of pulmonary vein isolation (PVI) performed on athletes at a tertiary care center and to characterize its efficacy and physiological effects., Background: The incidence of atrial fibrillation (AF) is increased in highly trained athletes and poses unique management challenges., Methods: Athletes were identified through a database of patients undergoing PVI from January 2000 through October 2015. Outcomes of AF ablation were defined in accordance with published guidelines. Available electrocardiographic, echocardiographic, and exercise treadmill testing data were also analyzed., Results: The study population included 144 athletes (93% men; mean age 50.4 ± 8.6 years; 97 paroxysmal, 38 persistent, and 9 long-standing persistent) with median follow-up of 3 years. Single-procedure freedom from arrhythmia was 75%, 68%, and 33% at 1 year for paroxysmal, persistent, and long-standing persistent AF, respectively. Multiple-procedure freedom from arrhythmia off antiarrhythmic drugs was 86%, 76%, and 56% in respective groups at the end of follow-up (mean 1.4 ± 0.7 ablations per athlete). Compared with a matched cohort of nonathletes who underwent PVI, there was no difference in arrhythmia recurrence (log-rank p = 0.23). Excluding long-standing persistent AF, longer diagnosis-to-ablation time was the only variable in Cox proportional hazards analyses associated with arrhythmia recurrence (adjusted heart rate per log increase: 1.92; 95% confidence interval: 1.40 to 2.73; p < 0.0001), and PVI within 2 years of diagnosis was notably associated with successful outcomes (log-rank p = 0.002). Sinus rate increased following the index ablation (mean 54 beats/min vs. 64 beats/min at >1 year; p < 0.0001), but maximum metabolic equivalents on exercise treadmill testing were unchanged (13.1 ± 1.2 vs. 12.7 ± 1.4; p = 0.44)., Conclusions: PVI is an effective therapy in athletes with paroxysmal and persistent AF, and arrhythmia recurrence was no different from that among matched nonathletes. Early ablation was associated with improved success rates. Sustained cardioautonomic effects were observed following ablation, but exercise capacity was preserved., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Many digital health technologies capable of atrial fibrillation (AF) detection are directly available to patients. However, adaptation into clinical practice by heart rhythm healthcare practitioners (HCPs) is unclear., Objective: To examine HCP perspectives on use of commercial technologies for AF detection and management., Methods: We created an electronic survey for HCPs assessing practice demographics and perspectives on digital devices for AF detection and management. The survey was distributed electronically to all members of 3 heart rhythm professional societies., Results: We received 1601 responses out of 73,563 e-mails sent, with 43.6% from cardiac electrophysiologists, 12.8% from fellows, and 11.6% from advanced practice practitioners. Most respondents (62.3%) reported having recommended patient use of a digital device for AF detection. Those who did not had concerns about their accuracy (29.6%), clinical utility of results (22.8%), and integration into electronic health records (19.8%). Results from a 30-second single-lead electrocardiogram were sufficient for 42.7% of HCPs to recommend oral anticoagulation for patients at high risk for stroke. Respondents wanted more data comparing the accuracy of digital devices to conventional devices for AF monitoring (64.9%). A quarter (27.3%) of HCPs had no reservations recommending digital devices for AF detection, and most (53.4%) wanted guidelines from their professional societies providing guidance on their optimal use., Conclusion: Many HCPs have already integrated digital devices into their clinical practice. However, HCPs reported facing challenges when using digital technologies for AF detection, and professional society recommendations on their use are needed., (© 2020 The Authors.)

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.)

Objectives: This study sought to assess the incidence and outcomes of life-threatening complications from atrial fibrillation ablations in a high volume center., Background: With increasing rates of atrial fibrillation ablation procedures, an increase in life-threatening procedure-related complications has been reported despite improvements in technology and ablation strategies., Methods: Between 2000 and 2015, 10,378 patients underwent atrial fibrillation ablation at our institution and were enrolled in a prospectively maintained data registry. We identified all patients who had life-threatening cardiac, neurological, respiratory, or vascular complications to the ablation resulting in death or requiring emergent intervention., Results: Major life-threatening complications occurred in 100 patients (0.9%). The most common was pericardial effusion requiring pericardiocentesis (0.5%), with 7 (0.07%) requiring emergent surgical repair for cardiac perforation. Stroke occurred in 27 patients (0.3%) with a vast majority having an ischemic stroke (93%) followed by hemorrhagic (3.5%) and ischemic stroke with hemorrhagic conversion (3.5%). The yearly incidence of stroke decreased from an average of 1.1% per year in the first tertile (2000 to 2004) to 0.2% per year in the last 2 tertiles (2005 to 2015). Permanent neurological deficits occurred in 23 patients. Vascular complications causing hemorrhagic shock occurred in 7 patients (0.06%), 5 of whom required urgent surgical intervention. Acute coronary syndrome requiring urgent percutaneous coronary revascularization occurred in 2 patients whereas 1 developed a right coronary artery air embolus. No procedural death or atrio-esophageal fistulae occurred., Conclusions: In a large quaternary care center, the incidence of life-threatening complications is low. Experienced operators, high volume, continuous quality improvement initiatives, and efficient back-up support have allowed exemplary safety profiles and 0 procedure-related deaths over 16 years., (Copyright © 2019 American College of Cardiology Foundation. Published by 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.)

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.)

Objectives: This study reports a high-volume tertiary care center experience with the microbiology of cardiac implantable electronic devices (CIED) infections with assessment of temporal trends and profiles of late versus early infections., Background: The rates of CIED infections have been increasing. With changing demographics, patient and device characteristics, prophylactic measures, and the wide use of broad-spectrum antibiotics, there is need for updated contemporary data on the microbiology of CIED infections., Methods: The study included 816 consecutive patients with confirmed CIED infections who underwent transvenous lead extraction at our institution between the years 2000 and 2011. Blood cultures were obtained in addition of pocket swabs, pocket capsule, and leads., Results: Staphylococcal species remained the most common pathogens in CIED infections (68.4%), especially coagulase-negative species (37.6%). Methicillin-resistant staphylococci were the pathogens in 33.8% of all CIED infections and accounted for 49.4% of all staphylococcal infections. Gram-negative pathogens were identified in 8.9% of cases, whereas 13.2% were with negative cultures. CIED infections related to streptococci (2.5%), enterococci (4.2%), anaerobes (1.6%), fungi (0.9%), and mycobacteria species (0.2%) were less common. Of pocket infections, 49.5% occurred more than 1 year after pocket manipulation, and 53.6% of these were related to coagulase-negative staphylococci. In contrast, most endovascular infections were related to Staphylococcus aureus. The proportions of culture negative infections have increased (p < 0.0001)., Conclusions: The study provides contemporary data on the microbiology of CIED infections. The rates of methicillin resistance seem to be greater than those reported from the preceding decade., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Rhythm control with antiarrhythmic drugs (AADs) is not superior to rate control in patients with heart failure (HF) and atrial fibrillation (AF), but AF ablation may be more successful at achieving rhythm control than AADs. However, risks for both ablation and AADs are likely higher and success rates lower in patients with HF., Objective: To compare rate control versus AF catheter ablation strategies in patients with AF and HF., Methods: We conducted a meta-analysis of trials which randomized HF patients (LVEF<50%) with AF to a rate control or AF catheter ablation strategy and reported change in LVEF, quality of life, 6-minute walk test, or peak oxygen consumption. Study quality and heterogenity were assessed using Jadad scores and Cochran's Q statistics, respectively. Mantel Haenszel relative risks and mean differences were calculated using random effect models., Results: Four trials (N=224) met inclusion criteria; 82.5% (n=185) had persistent AF. AF ablation was associated with an increase in LVEF (mean difference 8.5%; 95%CI 6.4,10.7%; P<0.001) compared to rate control. AF ablation was superior in improving quality of life by Minnesota Living with Heart Failure (MLWHF) questionnaire scores (mean difference -11.9; 95%CI -17.1, -6.6; P<0.001). Peak oxygen consumption and 6-minute walk distance increased in AF ablation compared to rate control patients (mean difference 3.2; 95%CI 1.1,5.2; P=0.003; mean difference 34.8; 95%CI 2.9, 66.7; P = 0.03, respectively). In the persistent AF subgroup LVEF and MLWHF were significantly improved with AF ablation. Major adverse event rates (RR 1.3; 95% CI, 0.4, 3.9; p=0.64) were not significantly different. No significant heterogeneity was evident., Conclusions: In patients with HF and AF, AF catheter ablation is superior to rate control in improving LVEF, quality of life and functional capacity. Prior to accepting a rate control strategy in HF patients with persistent or drug refractory AF, consideration should be given to AF ablation.