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Background: Systolic heart failure treatment now includes cardiac resynchronization therapy (CRT) as a necessary element. CRT has been shown to have advantageous impacts on mortality, hospitalization rates, and quality of life. Approximately 30% of patients fail to respond to traditional CRT implantation. Aims and Objectives: This study aimed to compare the outcome of dual resynchronization by placing the right ventricular pacing lead at His bundle or left bundle branch area against conventional CRT. Materials and Methods: This longitudinal follow-up study of a total of 35 patients undergoing CRT device placement for assessment of safety, efficacy, and feasibility of the procedure and post-procedural complications and correlation with parameters obtained from electrocardiogram and echocardiography parameters in a tertiary care set up in India. Results: Among this matched population (mean age 64 years) there was a higher responder rate with the newer technique of dual resynchronization compared to conventional CRT (83% vs. 70%). Conclusion: Dual resynchronization therapy is feasible and safe and provides better electrical resynchronization compared to conventional CRT and could be a better alternative, especially when suboptimal electrical resynchronization is obtained.

Background: Systolic heart failure treatment now includes cardiac resynchronization therapy (CRT) as a necessary element. CRT has been shown to have advantageous impacts on mortality, hospitalization rates, and quality of life. Approximately 30% of patients fail to respond to traditional CRT implantation. Aims and Objectives: This study aimed to compare the outcome of dual resynchronization by placing the right ventricular pacing lead at His bundle or left bundle branch area against conventional CRT. Materials and Methods: This longitudinal follow-up study of a total of 35 patients undergoing CRT device placement for assessment of safety, efficacy, and feasibility of the procedure and post-procedural complications and correlation with parameters obtained from electrocardiogram and echocardiography parameters in a tertiary care set up in India. Results: Among this matched population (mean age 64 years) there was a higher responder rate with the newer technique of dual resynchronization compared to conventional CRT (83% vs. 70%). Conclusion: Dual resynchronization therapy is feasible and safe and provides better electrical resynchronization compared to conventional CRT and could be a better alternative, especially when suboptimal electrical resynchronization is obtained. [ABSTRACT FROM AUTHOR]

The use of cardiac electronic devices has increased over the last decades, which has generated an increase in the number of electrode extraction procedures, as a greater number of patients with multiple comorbidities undergo cardiac electronic device implantation. Currently, the percutaneous technique is preferable in most patients, given its excellent clinical results and lower morbidity and mortality compared to surgical extraction. Nonetheless, some clinical scenarios increase procedural difficulty, including anatomical variants, or the need to extract passive fixation leads. We present a case of a patient with pacemaker due to complete atrioventricular block, with diaphragmatic stimulation caused by a passive fixation ventricular electrode that was implanted in a posterolateral vein of the coronary sinus through a persistent left superior vena cava, who underwent successful transvenous lead extraction. [ABSTRACT FROM AUTHOR]

Background: Cardiac electronic device implantation may be associated with complications. Case Summary: This is a report of inadvertent implantation of implantable cardioverter-defibrillator lead through an unrecognized sinus venosus atrial septal defect into the left ventricle that was not diagnosed early after implantation. Six months later chest x-ray showed an abnormal lead course that was confirmed with echocardiography as to be in the left ventricle. Surgical removal of the implantable cardioverter-defibrillator lead, repair of atrial septal defect, and correction of abnormal pulmonary venous connections were performed. Meanwhile, follow-up of the patient receiving a new dual chamber permanent pacemaker from the contralateral side and discussion of the aforementioned complication are addressed. Conclusion: Early diagnosis of device implantation complication is of paramount importance and prevents potential catastrophic complications. This is a report of a middle-aged woman who received a heart battery (pacemaker) without proper initial indication and faced unnecessary consequences/complications. The wire was supposed to be implanted in the right side of the heart, but due to the congenital heart disease of the patient (that was not diagnosed), the wire was erroneously passed through the congenital defect to the left side of the heart. After the diagnosis of the problem, we referred her to a heart surgeon to correct the congenital heart defect and also pull the wire out. After open surgery, a new pacemaker (with two wires) was implanted in the patient without any additional complications. Article highlights Transient loss of consciousness (syncope) may be related to cardiac causes. Adherence to guidelines-directed indications for cardiac implantable electronic devices (CIED) implantation is recommended and may obviate the need for unnecessary interventions. Venous or congenital cardiac defects may pose the physician with some challenges during the implantation of CIED. Adherence to protocols for follow-up of patients with CIED is necessary. Implantation of leads into the left side of the heart although rare should be kept in mind. This problem may remain asymptomatic or be diagnosed after a systemic embolism. Transvenous or surgical lead extraction is needed for the removal of lead erroneously implanted in the left side of the heart. Early diagnosis of complications prevents probable catastrophic complications. [ABSTRACT FROM AUTHOR]

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Breast implants whether used for cosmetic or reconstructive purposes can be placed in pockets either above or below the pectoralis major muscle, depending on clinical circumstances such as subcutaneous tissue volume, history of radiation, and patient preference. Likewise, cardiac implantable electronic devices (CIEDs) can be placed above or below the pectoralis major muscle. When a patient has both devices, knowledge of the pocket location is important for procedural planning and for durability of device placement and performance. Here, we report a patient who previously failed subcutaneous CIED placement due to incision manipulation with prior threatened device exposure requiring plane change to subpectoral pocket. Her course was complicated by submuscular migration of the CIED into her breast implant periprosthetic pocket. With subcutaneous plane change being inadvisable due to patient noncompliance, soft tissue support of subpectoral CIED placement with an acellular biologic matrix (ABM) was performed. Similar to soft tissue support used for breast implants, submuscular CIED neo-pocket creation with ABM was performed with durable CIED device positioning confirmed at 9 months postprocedure.

Aims: Cardiac device–related infective endocarditis (CDRIE) is a severe complication of cardiac device (CD) implantation and is usually treated by antibiotic therapy and percutaneous device extraction. Few studies report the management and prognosis of CDRIE in real life. In particular, the rate of device extraction in clinical practice and the management of patients with left heart infective endocarditis (LHIE) and an apparently non-infected CD (LHIE+CDRIE−) are not well described. Methods and results: We sought to study in EURO-ENDO, the characteristics, prognosis, and management of 483 patients with a CD included in the European Society of Cardiology EurObservational Research Programme EURO-ENDO registry. Three populations were compared: 280 isolated CDRIE (66.7 ± 14.3 years), 157 patients with LHIE and an apparently non-infected CD (LHIE+CDRIE−) (71.1 ± 13.6), and 46 patients with both LHIE and CDRIE (LHIE+CDRIE+) (70.2 ± 10.1). Echocardiography was not always transoesophageal echography (TOE); it was transthoracic echography (TTE) for isolated CDRIE in 88.4% (TOE = 67.6%), for LHIE+CDRIE− TTE = 93.0% (TOE = 58.6%), and for CDRIE+LHIE+ TTE = 87.0% (TOE = 63.0%). Nuclear imaging was performed in 135 patients (positive for 75.6%). In-hospital mortality was lower in isolated CDRIE 13.2% vs. 22.3% and 30.4% for LHIE+CDRIE− and LHIE+CDRIE+ (P = 0004). Device extraction was performed in 62.1% patients with isolated CDRIE, 10.2% of LHIE+CDRIE− patients, and 45.7% of CDRIE+LHIE+ patients. Device extraction was associated with a better prognosis [hazard ratio 0.59 (0.40–0.87), P = 0.0068] even in the LHIE+CDRIE− group (P = 0.047). Conclusion: Prognosis of endocarditis in patients with a CD remains poor, particularly in the presence of an associated LHIE. Although recommended by guidelines, device extraction is not always performed. Device removal was associated with better prognosis, even in the LHIE+CDRIE− group. Infective endocarditis associated with the presence of a cardiac device remains a serious disease and should be treated with device extraction, even in patients with left heart infective endocarditis and an apparently non-infected device. Graphical abstract [ABSTRACT FROM AUTHOR]

Breast implants whether used for cosmetic or reconstructive purposes can be placed in pockets either above or below the pectoralis major muscle, depending on clinical circumstances such as subcutaneous tissue volume, history of radiation, and patient preference. Likewise, cardiac implantable electronic devices (CIEDs) can be placed above or below the pectoralis major muscle. When a patient has both devices, knowledge of the pocket location is important for procedural planning and for durability of device placement and performance. Here, we report a patient who previously failed subcutaneous CIED placement due to incision manipulation with prior threatened device exposure requiring plane change to subpectoral pocket. Her course was complicated by submuscular migration of the CIED into her breast implant periprosthetic pocket. With subcutaneous plane change being inadvisable due to patient noncompliance, soft tissue support of subpectoral CIED placement with an acellular biologic matrix (ABM) was performed. Similar to soft tissue support used for breast implants, submuscular CIED neo-pocket creation with ABM was performed with durable CIED device positioning confirmed at 9 months postprocedure. [ABSTRACT FROM AUTHOR]

Aims/background: The number of cardiac devices implanted increases year on year, as does the complexity of the patients being managed. A large proportion of this patient group have an indication for anticoagulation, and this raises challenges around the perioperative management of these agents. Method: A quality improvement project was conducted to review current practice, understand local experience and improve patient care. Results: Following the initial review, local guidelines were updated, the postoperative anticoagulation decision escalated to the responsible clinician and a clearer pathway for communicating the decision created. Conclusions: The implemented changes have shown an overall improvement in junior doctor feedback and also clinical documentation in the electronic patient records. [ABSTRACT FROM AUTHOR]

• Clearance rates of new moderate risk cardiac devices by the F.D.A has decreased significantly. • Meanwhile, recall rates of such cardiac devices have increased. • The majority of these recalls were of a high risk nature: F.D.A. Class I and II recalls. Medical device expenditures have increased in the 21st century, with cardiac devices comprising an outsized portion of the market. Meanwhile, the disproportionate share of FDA recalls of cardiac devices is often overshadowed. Using the FDA 510(k) premarket notification pathway and FDA recalls issued from 2000 to 2020, this project seeks to engage our understanding of innovation and recalls in the cardiac device space. 510(k) premarket notification submission dates, outcomes, and recalls from 1/1/2000 to 12/31/2019 were obtained from publicly available FDA data as a function of cardiac device innovation. We compared the annual number of 510(k) premarket clearances and FDA recalls from 1/1/2000 to 12/31/2009 to 1/1/2010 to 12/31/2019. We found 343 moderate risk cardiac medical devices cleared for sale between the years 2000 and 2020. Comparing the last 10 years of the study period to the first, the yearly number of cleared devices decreased 39.7 %, from 21.4 to just 12.9 (p = 0.0019), defying positive trends in U.S. GDP and healthcare expenditures. Meanwhile, the number of FDA recalls issued for these devices increased 94.5 % from 7.3 to 14.2 recalls per year (p = 0.031). 215 device recalls were issued; 78 % Class II and 16 % Class I which constitute serious, potentially fatal recalls. While United States healthcare spending continues to trend upward, there was a distinct decrease in the number of new and updated cardiac devices entering the market between 2000 and 2020. Meanwhile, recalls of these devices have uncomfortably increased. Together, these trends suggest cardiac device innovation has become risk averse. [ABSTRACT FROM AUTHOR]

Introduction: We evaluated time efficiency and patient satisfaction of a "car park clinic" (CPC) compared to traditional face‐to‐face (F2F) during the COVID‐19 pandemic. Methods: Consecutive patients attending CPC between September 2020 and November 2021 were surveyed. CPC time was recorded by staff. F2F time was reported by patients and administrative data. Results: A total of 591 patients attended the CPC. A total of 176 responses were collected for F2F clinic. Regarding satisfaction, 90% of CPC patients responded "happy" or "very happy." 96% reported feeling "safe" or "very safe." Patients spent significantly less time in CPC compared to F2F (17 ± 8 vs. 50 ± 24 min, p <.001). Conclusion: CPC had excellent patient satisfaction and superior time efficiency compared to F2F. [ABSTRACT FROM AUTHOR]

Infections are important complications of cardiac implantable electronic devices (CIED), with a high prognostic impact. Several risk factors for CIED infections are known. Different studies have been published proposing different risk scores, in order to preoperatively assess the individual likelihood of developing a CIED infection. Among the different scores, large heterogeneity exists and there is no consensus or convergence on a single score finding large applicability in global practice. The aim of this review is to comprehensively present and analyze all the available risk scores for CIED infection, with particular regard to the evidence of comparison studies. [ABSTRACT FROM AUTHOR]

Infective endocarditis and infection of cardiac devices are conditions characterized by high morbidity and mortality, thus requiring a prompt diagnosis. Advanced imaging modalities are often required in the management of infectious endocarditis according to guidelines. The aim of this review is to collect and describe evidence-based knowledge about the diagnostic role and clinical usefulness of [ 18 F]FDG PET/CT in endocarditis and cardiac device infections based on published systematic reviews and meta-analyses on this topic and on recent guidelines. [ 18 F]FDG PET/CT is recommended only in selected cases. This imaging method has good diagnostic accuracy in detecting prosthetic valve endocarditis and cardiac device infection. Furthermore, it can identify extra-cardiac infectious foci changing the clinical management in a significant percentage of cases., (© 2024 Wiley Periodicals LLC.)

Infective endocarditis (IE) is a life-threatening microbial infection of native and prosthetic heart valves, endocardial surface, and/or indwelling cardiac device. Prevalence of IE is increasing and mortality has not significantly improved despite technological advances. This review provides an updated overview using recent literature on the clinical presentation, diagnosis, imaging, causative pathogens, treatment, and outcomes in native valve, prosthetic valve, and cardiac device-related IE. In addition, the experimental approaches used in IE research to improve the understanding of disease mechanisms and the current diagnostic pipelines are discussed, as well as potential innovative diagnostic and therapeutic strategies. This will ultimately help towards deriving better diagnostic tools and treatments to improve IE patient outcomes.

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The epidemiology of infective endocarditis (IE) in this millennium has changed with emergence of new risk factors and reemergence of others. This, coupled with modifications in national guidelines in the setting of a pandemic, prompted an address of the topic. Our goal is to provide a contemporary review of IE epidemiology considering changing incidence of rheumatic heart disease (RHD), cardiac device implantation, and injection drug use (IDU), with SARS-CoV-2 pandemic as the backdrop. PubMed and Google Scholar were used to identify studies of interest. Our experience over the past two decades verifies the notion that there is not one 'textbook' profile of IE. Multiple factors have dramatically impacted IE epidemiology, and these factors differ, based, in part on geography. RHD has declined in many areas of the world, whereas implanted cardiovascular devices-related IE has grown exponentially. Perhaps the most influential, at least in areas of the United States, is injection drug use complicating the opioid epidemic. Healthy younger individuals contracting a potentially life-threatening infection has been tragic. In the past year, epidemiological changes due to the COVID-19 pandemic have also occurred. No doubt, changes will characterize IE in the future and serial review of the topic is warranted. [ABSTRACT FROM AUTHOR]

Competing Interests: Disclosures The authors have no conflicts to disclose.

Background: Increasing use of cardiovascular implantable electronic devices (CIED), as permanent pacemakers (PPM), implantable cardioverter defibrillators (ICD), or cardiac resynchronization therapy (CRT), is associated with the emergence of CIED-related infective endocarditis (CIED-IE). We aimed to characterize CIED-IE profile, temporal trends, and prognostic factors. Methods: CIED-IE diagnosed at Rennes University Hospital during years 1992–2017 were identified through computerized database, and included if they presented all of the following: (1) clinical signs of infection; (2) microbiological documentation through blood and/or CIED lead cultures; (3) lead or valve vegetation, or definite IE according to Duke criteria. Data were retrospectively extracted from medical charts. The cohort was categorized in three periods: 1992–1999, 2000–2008, and 2009–2017. Results: We included 199 patients (51 women, 148 men, median age 73 years [interquartile range, 64–79]), with CIED-IE: 158 PPMs (79%), 24 ICD (12%), and 17 CRT (9%). Main pathogens were coagulase-negative staphylococci (CoNS: n = 86, 43%), Staphylococcus aureus (n = 60, 30%), and other Gram-positive cocci (n = 28, 14%). Temporal trends were remarkable for the decline in CoNS (P = 0.002), and the emergence of S. aureus as the primary cause of CIED-IE (24/63 in 2009–2017, 38%). Factors independently associated with one-year mortality were chronic obstructive pulmonary disease (COPD: hazard ratio 3.84 [1.03–6.02], P = 0.03), left-sided endocarditis (HR 2.25 [1.09–4.65], P = 0.03), pathogens other than CoNS (HR 3.16 [1.19–8.39], P = 0.02), and CIED removal/reimplantation (HR 0.41 [0.20–0.83], P = 0.01). Conclusions: S. aureus has emerged as the primary cause of CIED-IE. Left-sided endocarditis, COPD, pathogens other than CoNS, and no CIED removal/reimplantation are independent risk factors for one-year mortality. [ABSTRACT FROM AUTHOR]

Cardiac devices are frequently used in different cardiovascular conditions for the purpose of morbidity or mortality prevention. These include cardiac implantable electronic devices (CIED) like permanent pacemakers and implantable cardiac defibrillators, ventricular assistance devices (VADs), left atrial appendage occlusion (LAAO) devices like the Watchman™, atrial and ventricular septal occluders like the Amplatzer™, among others. In the past years, there has been an increase in the development of these devices as a result of a rise in the number of indications for implantation, paired with the aging and more medically complex patient population. This has led to an increase in the incidence of cardiac device-related infections, one of the most feared and serious complications which is associated with significant morbidity, mortality and financial burden. Accurate diagnosis of cardiac device-related infections is essential given the management implications which often involve removal of the infected device, removal of other prosthetic material and long-term antimicrobial therapy. Clinical and laboratory data are useful diagnostic tools but multimodality imaging is often necessary. The recently published 2020 European Heart Rhythm Association International Consensus document, which is endorsed by many expert societies, has recommended the use of multimodality imaging for the diagnosis of CIED infections. (1) This allows better disease characterization by identifying abnormal fluid collections and guiding aspiration for both diagnostic and therapeutic purposes (i.e. soft tissue ultrasound and computed tomography), evaluation for local extent of disease (i.e. transesophageal echocardiogram to evaluate for concomitant infective endocarditis), embolic manifestation of disease (i.e. computed tomography and magnetic resonance imaging) and metabolic tissue characterization (positron emission tomography and tagged white blood cell scan). (2) In addition, computed tomography (CT) allows for pre-procedural planning which has shown to be associated with better procedural outcomes.

The implantation of cardiac devices significantly reduces morbidity and mortality in patients with cardiac arrhythmias. Arrhythmias as well as therapy delivered by the device may impact quality of life of patients concerned considerably. Therefore we aimed at conducting a systematic search and meta-analysis of trials examining the impact of the implantation of cardiac devices, namely implantable cardioverter-defibrillators (ICD), pacemakers and left-ventricular assist devices (LVAD) on quality of life. After pre-registering the trial with the PROSPERO database, we searched Medline, PsycINFO, Web of Science and the Cochrane databases for relevant publications. Study quality was assessed by two independent reviewers using standardized protocols. A total of 37 trials met our inclusion criteria. Of these, 31 trials were cohort trials while 6 trials used a randomized controlled design. We found large pre-post effect sizes for positive associations between quality of life and all types of devices. The effect sizes for LVAD, pacemaker and ICD patients were g = 1.64, g = 1.32 and g = 0.64, respectively. There was a lack of trials examining the effect of implantation on quality of life relative to control conditions. Trials assessing quality of life in patients with cardiac devices are still scarce. Yet, the existing data suggest beneficial effects of cardiac devices on quality of life. We recommend that clinical trials on cardiac devices routinely assess quality of life or other parameters of psychological well-being as a decisive study endpoint. Furthermore, improvements in psychological well-being should influence decisions about implantations of cardiac devices and be part of patient education and may impact shared decision-making.

Introduction: Tricuspid regurgitation (TR) is a known complication of cardiac implantable electronic devices (CIED). A better understanding of the patient population affected by this complication and their outcomes is needed. The aims of our study were to: 1) describe the incidence of CIED-related tricuspid regurgitation; 2) identify patient characteristics conferring risk; 3) assess the long-term risk of hospitalisation for heart failure and mortality in patients with this complication.Methods: This was a retrospective cohort study of 2,265 patients that had a de novo device implantation at a tertiary referral centre between January 2010 and December 2017. Patients with echocardiograms prior to and at least 3 months after device implantation were included. Patients with moderate or severe TR at baseline were excluded.Results: Following screening of medical records, 165 patients were analysed. Forty-four (44) (27%) patients developed new-onset moderate or severe device-related TR, without a significant difference between patients with permanent pacemaker (PPM) and implantable cardioverter-defibrillator (ICD). Patients with CIED-related tricuspid regurgitation had a higher rate of hospitalisation for heart failure than those without (63.6% vs 34.7%, p=0.001) during a median follow-up of 29 months (IQR 13-60 months). Subsequent analyses showed that the association between CIED-related TR and heart failure hospitalisation only became significant in the period beyond 12 months following CIED implantation. Piecewise Cox regression analysis stratified at 12 months of follow-up showed that CIED-related TR was associated with an increased risk of heart failure hospitalisation beyond 12 months after adjustment for differences in baseline characteristics (HR 1.99, 95% CI 1.05-3.76, p=0.03). There was a higher mortality rate in the group with CIED-related TR; however, this did not reach significance (36.3% vs 22.3%, p=0.09).Conclusion: CIED-related TR is common and clinically significant with serious implications for long-term outcomes, especially congestive heart failure. [ABSTRACT FROM AUTHOR]

Background: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment., Objective: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives., Methods: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist., Results: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03)., Conclusions: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers' income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective., Trial Registration: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr., (©Sarah Raes, Andrea Prezzi, Rik Willems, Hein Heidbuchel, Lieven Annemans. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.04.2024.)

Background: Cardiovascular implantable electronic device (CIED) infections are a common indication for device extraction. Early diagnosis and complete system removal are crucial to reduce morbidity and mortality. The lack of clear infectious symptoms makes the diagnosis of pocket infections challenging and may delay referral for extraction., Objective: We aimed to determine if inflammatory biomarkers can help diagnose CIED isolated pocket infection., Methods: We performed a retrospective analysis of all patients undergoing transvenous lead extraction for CIED infection at the University of California San Diego from 2012 to 2022 (N = 156). Patients were classified as systemic infection (n = 88) or isolated pocket infection (n = 68). Prospectively collected preoperative procalcitonin (PCT), C-reactive protein, and white blood cell count were compared between groups., Results: Pairwise comparisons revealed that the systemic infection group had a higher PCT than the control group ( P < .001) and the pocket infection group ( P = .009). However, there was no significant difference in PCT value between control subjects and isolated pocket infection subjects. Higher white blood cell count was only associated with systemic infection when compared with our control group ( P = .018)., Conclusion: In patients diagnosed with CIED infections requiring extraction, inflammatory biomarkers were not elevated in isolated pocket infection. Inflammatory markers are not predictive of the diagnosis of pocket infections, which ultimately requires a high level of clinical suspicion., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)

This subanalysis of the Euro-CRT survey II specifically focus on Belgian practice for CRT implantation. It explores Belgian adherence with the guidelines but also benchmark CRT practice in Belgium against the other European countries. Overall, Belgian management of CRT implantation is performed with great agreement with guidelines. This report could be used to provide guidance for both practical and economical approaches. [ABSTRACT FROM AUTHOR]

The healing process, occurring after intra-cardiac and intra-vascular device implantation, starts with fibrin condensation and attraction of inflammatory cells, followed by the formation of fibrous tissue that slowly covers the device. The duration of this process is variable and may be incomplete, which can lead to thrombus formation, dislodgement of the device or stenosis. To better understand this process and the neotissue formation, animal models were developed: small (rats and rabbits) and large (sheep, pigs, dogs and baboons) animal models for intra-vascular device implantation; sheep and pigs for intra-cardiac device implantation. After intra-vascular and intra-cardiac device implantation in these animal models, in vitro techniques, i.e. histology, which is the gold standard and scanning electron microscopy, were used to assess the device coverage, characterize the cell constitution and detect complications such as thrombosis. In humans, optical coherence tomography and intra-vascular ultrasounds are both invasive modalities used after stent implantation to assess the structure of the vessels, atheroma plaque and complications. Non-invasive techniques (computed tomography and magnetic resonance imaging) are in development in humans and animal models for tissue characterization (fibrosis), device remodeling evaluation and device implantation complications (thrombosis and stenosis). This review aims to (1) present the experimental models used to study this process on cardiac devices; (2) focus on the in vitro techniques and invasive modalities used currently in humans for intra-vascular and intra-cardiac devices and (3) assess the future developments of non-invasive techniques in animal models and humans for intra-cardiac devices. [ABSTRACT FROM AUTHOR]

Purpose: Approximately 5.7 million people in the US are affected by congestive heart failure. This study aimed to quantitatively evaluate cardiothoracic morphology and variability within a cohort of heart failure patients for the purpose of optimally engineering cardiac devices for a variety of heart failure patients. Methods: Co-registered cardiac-gated and non-gated chest computed tomography (CT) scans were analyzed from 20 heart failure patients (12 males; 8 females) who were primarily older adults (79.5 ± 8.8 years). Twelve cardiothoracic measurements were collected and compared to study sex and left ventricular (LV) ejection fraction (EF) type differences in cardiothoracic morphology. Results: Four measures were significantly greater in males compared to females: LV long-axis length, LV end diastolic diameter (LVEDD) at 50% length of the LV long-axis, the minimal distance between the sternum and heart, and the angle between the LV long-axis and coronal plane. Four measures were significantly greater in patients with reduced EF compared to preserved LV: LV long-axis length, LVEDD at 50% length of the LV long-axis, left ventricular volume normalized by body surface area, and the angle between the mitral valve plane and LV long-axis. Conclusions: These cardiothoracic morphology measurements are important to consider in the design of cardiac devices for heart failure management (e.g. cardiac pacemakers, ventricular assist devices, and implantable defibrillators), since morphology differs by sex and ejection fraction. [ABSTRACT FROM AUTHOR]

Background: Cardiac device therapy is likely to affect different aspects of patients' psychological well-being, such as their quality of life. The aim of this study was to examine the mental health status, specifically the conditions of depression and anxiety regarding implantable cardiac device patients., Methods: A cross-sectional retrospective study was conducted in January 2022. This study was conducted at King Abdul-Aziz University Hospital in Jeddah, Saudi Arabia. All patients aged more than 18 years old who underwent heart device implantation for six months or more formed the study population. A total of 30 implantable cardioverter defibrillator (ICD) subtypes were used in our patients (45.8%), including cardiac resynchronization therapy device (CRT-D) in seven patients (14.6%) and one subcutaneous ICD (2.1%). A pacemaker was used in 18 patients (37.5%). Binary logistic regression analysis was conducted to identify the association between type of cardiac implantation device and the likelihood of having abnormal depression and anxiety score., Results: A total of 48 patients participated in this study. Hypertension was the most frequently associated risk factor in our sample (64.6%; n=31). In comparison between ICD users and pacemaker users in terms of the SF-36 general health survey, a marginally significant difference was noted in the role of limitations due to emotional health (63 ± 28.6) for ICD patients compared to pacemaker patients (81.8 ± 28.1), (p=0.050). However, pacemaker patients showed a significant favourable social functioning score (90.1 ± 17.7) compared to ICD patients (71.5 ± 19), (p=0.001). There is no significant difference noted regarding the other domains. Binary logistic regression analysis identified that patients who are using ICD were seven times more likely to have abnormal anxiety score (odds ratio: 7.00 (95% confidence interval: 1.36-35.9) (p=0.020)., Conclusion: This study identified a potential association between cardiac devices and the anxiety and quality of life of patients. Nonetheless, further investigation is warranted to assess the psychological and physiological effects of cardiac device therapy on patients, in addition to examining the effects of implantation and follow-up on cardiac function and cardiac symptoms., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Alshoaibi et al.)

Atrial high-rate episodes (AHRE) are atrial tachyarrhythmias that are identified by the use of continuous rhythm monitoring devices such as pacemakers, defibrillators, or implantable cardiac monitors. Nevertheless, the therapeutic implications of these rhythm disturbances remain uncertain. The presence of AHRE is associated with an increased risk of stroke as compared to patients who do not exhibit AHRE. The utilisation of oral anticoagulation has the ability to mitigate the likelihood of stroke occurrence in patients with AHRE. However, it is important to note that this treatment approach is also linked to a severe bleeding rate of approximately 2% per year. The stroke rate among individuals diagnosed with AHRE appears to be comparatively lower when compared to patients diagnosed with atrial fibrillation. The efficacy and safety of anticoagulation in patients with AHRE have yet to be definitively established. Further research is required to provide a comprehensive understanding of the effectiveness and safety of oral anticoagulation in individuals with AHRE., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Use of an implantable cardioverter defibrillator (ICD) is an established therapy for the prevention of sudden cardiac death. However, at the end of life, these devices can prolong the dying experience, causing physical and psychological trauma. Patients are often unaware of their options regarding ICD management at the end of their life, which highlights the need for health professionals to have these discussions with patients. This study aimed to identify patients' knowledge and opinions about their ICD and the factors influencing their knowledge and opinions. Of the 30 participants in this study, 59% had sufficient knowledge about ICDs. There was no relationship between knowledge and time since implantation (p=0.11). A relationship existed between knowledge and age; those that were older were better informed (p=0.008). The authors conclude that patient education and communication are essential for patients with ICDs to enhance decision-making about ICD management at the end of life. [ABSTRACT FROM AUTHOR]

Introduction: Heart failure (HF) is a common finding in patients with pacemakers implanted for bradycardia, with cross-sectional and longitudinal studies contributing to the growing consensus that right ventricular pacing can cause adverse cardiac remodeling and left ventricular systolic dysfunction increasing the risk of hospitalization and death. An unselected approach using cardiac resynchronization therapy from the time of first implant in patients with heart block has produced equivocal results. Contemporary research has therefore begun to focus on the stratification of patients' risk of pacemaker-associated impairment to permit focused, personalized management. Areas covered: The present review will describe the incidence and relevance of HF in the pacemaker population and discuss current management options for such patients. Expert commentary: At present there are few contemporary data to guide the identification of patients with and at risk of pacemaker-associated cardiac remodeling and dysfunction. Emphasis must be placed on precise and personalized treatment approaches which currently remain under-investigated due to a number of challenges, for example, small sample sizes, limited clarity on programmed settings, and short follow-up periods. [ABSTRACT FROM AUTHOR]

Many Americans rely on cardiac surgical procedures and devices such as pacemakers and thrombolytic catheters to treat or manage their cardiovascular diseases. However, the failure of these cardiac devices and procedures could have grave consequences. One reason cardiac devices tended to fail was due to physician error; there is a learning effect for the physician or operator to come up to speed in skillfully implanting devices and conducting procedures. In order to better understand these learning effects, we had previously modeled the resulting learning curve effects in simulations a hierarchical setting with physicians clustered within institutions using our unique methodology (see the work of Govindarajulu et al 2017). Previously, we had employed these in hierarchical linear modeling and also in generalized estimating equations. In this setting, we have demonstrated how to apply similar methodology but revised in a survival analytic framework or time‐to‐event analyses. Through simulations and real dataset applications, we found that, out of the three shapes modeled to fit the learning curve, the logarithmic shape tended to have the best fit, similar to previous work (see the work of Govindarajulu et al 2017). However, as seen before, modeling the learning rate can be dataset specific and one shape may be better than another. We learned that modeling the learning rate could also be applied in the survival analysis setting through this new methodology. The goal of this paper is to model cardiac device and procedure learning curve effects in a time‐to‐event setting so that this knowledge may allow for the improvement of both short and long‐term patient survival. [ABSTRACT FROM AUTHOR]

The number of infections related to cardiac implantable electronic devices (CIEDs) has increased as the number of devices implanted around the world has grown exponentially in recent years. CIED complications can sometimes be difficult to diagnose and manage, as in the case of lead-related infective endocarditis. We present the case of a 48-year-old male diagnosed with Staphylococcus aureus device-related infective endocarditis, 12 years after the implant of a single chamber pacemaker. A recent history of the patient includes two urinary catheterizations due to obstructive uropathy in the context of a prostatic adenoma, 2 months previously, both without antibiotic prophylaxis; no other possible entry sites were found and no history of other invasive procedures. After initiation of antibiotic therapy according to antibiotic susceptibility testing, we decided to remove the right ventricular passive fixation lead along with the vegetation and pacemaker generator; because of severe lead adhesions in the costoclavicular region, and especially in the right ventricle, we needed mechanical sheaths to remove the abundant fibrous tissue that encompassed the lead. After a difficult, but successful, lead extraction along with a large vegetation and 6 weeks’ antibiotic therapy, the clinical and biological evolution was favorable, without reappearance of symptoms. While very late lead endocarditis is a rarity, late lead-related infective endocarditis (more than 12 months elapsed since implant) is not an exception; this is why we find that endocarditis prophylaxis should be reconsidered in certain patient categories, our patient being proof that procedures with neglectable endocarditis risk according to the guidelines can lead to bacterial endocarditis.

The imaging appearance of implantable loop recorders (ILR's) have been described in literature (Steinberger and Margolies, 2017; Mayo and Leung, 2017; Tsau and Berger, 2004) 1–3 ; however, the mammographic appearance of the BioMonitor ILR produced by BIOTRONIK has not been described. It is important for radiologists interpreting breast imaging to become familiar with the appearance of different implantable cardiac devices on mammograms in order to create accurate reports and adjust imaging protocols to improve imaging quality and lessen patient discomfort as needed. • Mammographic appearance of the BioMonitor implantable loop recorder • Multidisciplinary care in breast cancer patients • Incidentally identified foreign objects on mammography [ABSTRACT FROM AUTHOR]

The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC)Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM)

Background: Cefazolin is used as standard preoperative prophylaxis for a variety of surgical procedures that involve the skin. In contrast, vancomycin is recommended for a minority of patients, specifically those with an IgE‐mediated allergy to beta‐lactams and considered in patients with known colonization with methicillin‐resistant Staphylococcus aureus or at high risk for such. Vancomycin, however, has been overprescribed, has nephrotoxicity risk, and may be less effective due to its inferior coverage of methicillin‐susceptible S. aureus and lack of Gram‐negative coverage. This study was performed to assess whether vancomycin use was associated with an increased incidence of cardiovascular implantable electronic device infection (CIEDI) as compared to that of cefazolin or other antistaphylococcal beta‐lactam antibiotics. Methods: The VA Informatics and Computing Infrastructure database, which included all veterans who underwent CIED placement or revision between 2008 and 2015, was used. A logistic regression model was constructed to estimate the adjusted odds of CIEDI. Results: Overall, 10,454 CIED procedures were included, and 98% of them were performed in men with a mean age of 71 ± 12 years. The logistic regression analysis showed that vancomycin use alone or in combination with other antibiotics was associated with an increased risk of CIEDI (odds ratio 2.99 [1.76–5.06], P‐value < 0.001), after controlling for other effects. Conclusions: Our study revealed that among patients who received surgical site infection prophylaxis for CIED placement or revision, there was: (1) an unanticipated high rate of vancomycin use, and (2) a threefold increase in the incidence of subsequent CIEDI among vancomycin recipient [ABSTRACT FROM AUTHOR]

Background: Implantable hypoglossal nerve upper airway stimulation (HNS) is a novel strategy approved by the US Food and Drug Administration for the management of moderate-to-severe obstructive sleep apnea (OSA) in patients with continuous positive airway pressure therapy intolerance or failure. Because of the proximity of a cardiac implantable electronic device (CIED) to this stimulator, interaction between these devices is theoretically possible.Objective: The purpose of this study was to assess interactions between an implantable HNS device and a CIED.Methods: We retrospectively analyzed 14 ad hoc patients with continuous positive airway pressure-intolerant, moderate-to-severe OSA and pre-existing transvenous CIEDs undergoing HNS implantation (Inspire II, Inspire Medical Systems). We assessed these devices for their pre and postimplant OSA outcomes and for possible device-device interaction. All patients were followed up for 1 year.Results: Of the 14 patients, 9 had a pacemaker (8 dual-chamber, 1 single-chamber), 4 had an implantable cardioverter-defibrillator (2 dual-chamber, 1 single-chamber), and 1 had a cardiac resynchronization therapy device. All the HNS devices were implanted on the opposite side of the CIED. All CIEDs were programmed bipolar. HNS were programmed either unipolar or bipolar. During implant, intraoperative testing was performed to confirm that bipolar and unipolar HNS stimulation did not impact CIED sensing. During the follow-up period, no oversensing episodes were noted on the CIEDs.Conclusion: In this early experience, simultaneous use of a novel hypoglossal nerve upper airway stimulation device with transvenous CIEDs seems to be safe, effective, and without any device-device interactions. [ABSTRACT FROM AUTHOR]

Abstract: Although thought to be a rare event, permanent pacemakers and implantable cardioverter‐defibrillators with right ventricular intracardiac leads have the potential to induce tricuspid valve dysfunction. Adverse lead‐valve interactions can take place through a variety of mechanisms including damage at the time of implantation, leaflet pinning, or long‐term fibrosis encapsulating the leaflet tissue. Clinical manifestations can display a wide range of severity, as well as a highly variable time span between implantation and hemodynamic deterioration. This review aims to describe the potential pathophysiologic effects of intracardiac device leads on the tricuspid valve, with a focus on ideal diagnostic strategies and treatment options once lead‐induced valvular dysfunction is suspected. [ABSTRACT FROM AUTHOR]

Abstract: Background: The rate of cardiovascular implantable electronic device infection (CIEDI) has increased, despite the use of perioperative antibiotics at the time of device placement or revision. This is due, in part, to the presence of multiple comorbid conditions in an elderly population, in general, who require CIED. Statins may have an antibacterial effect, although there is currently no evidence that the likelihood of CIEDI has been impacted by statin use. Methods: A retrospective cohort study was performed to assess whether statins are associated with a reduced risk of CIEDI. The VA Informatics and Computing Infrastructure (VINCI) database, which includes all veterans who underwent CIED placement between 2008 and 2015, was used. A logistic regression model was constructed to estimate the adjusted risk of CIEDI among patients who were receiving statins after adjusting for confounding factors. Results: Overall, 18,970 CIED procedures were included, and 98% of them were performed in men with a mean age of 71 ± 11 years. The rate of diabetes mellitus, heart failure, advanced chronic kidney diseases, CIEDI, positive methicillin‐resistant Staphylococcus aureus nasal colonization, and statin use were 23%, 15.7%, 3.3%, 1.14%, 12.6%, and 56%, respectively. The logistic regression analysis showed that statins were significantly associated with a reduced risk of CIEDI; after controlling for other effects, the reduction was 66% (odds ratio 0.34 [0.2–0.59], P‐value < 0.001). The effect of statins was confirmed by propensity score analysis. Conclusions: Our study showed that among patients receiving statins who had undergone CIED placement, there was a 66% reduction in subsequent CIEDI. [ABSTRACT FROM AUTHOR]