Effects of Implantable Cardioverter-Defibrillator Leads on the Tricuspid Valve and Right Ventricle: A Randomized Trial.

BACKGROUND: There are no randomized data to inform the extent to which transvenous cardiac leads cause tricuspid regurgitation (TR). OBJECTIVES: This study sought to determine the effect of a transvenous implantable cardioverter-defibrillator (TV-ICD) on TR severity, and secondarily, on right ventricular (RV) size and function. METHODS: We evaluated TR severity before and 6 months after implantable cardioverter-defibrillator insertion in a post hoc analysis of adults randomized to receive a transvenous (n = 252) or subcutaneous implantable cardioverter-defibrillator (S-ICD) (n = 251) device. TR and RV size and systolic function were assessed by echocardiographic images analyzed in a core laboratory. RESULTS: At baseline, at least mild TR was present in 30% of individuals. At 6 months, the proportion of participants with any TR in the TV-ICD group was 42% vs 19% in the S-ICD group (P < 0.001). The proportion with moderate or severe TR was 7% in the TV-ICD group vs 2% in the S-ICD group (P = 0.021). At 6 months, the OR of at least 1 grade worsening of TR in the TV-ICD group as compared with the S-ICD group was 7.2 (95% CI: 3.3-15.8; P < 0.001). There were no differences between groups with respect to RV size or systolic function. CONCLUSIONS: Six months following TV-ICD insertion, there was a 7-fold increase in the risk of at least 1 grade worsening of TR, with 7% of individuals having TR that was moderate or severe. There was no detectable difference in RV size or function; however, longer follow-up is needed.

Interference voltage measurement and analysis of cardiac implants exposed to electric fields at extremely low frequency.

Objective.The possibility of interference by electromagnetic fields in the workplaces with cardiac implants is a concern for both individuals and employers. This article presents an analysis of the interference to which cardiac implants are subjected under high-intensity electric field at the power frequency.Approach.Evaluations of interference were conducted by studying the induced voltages at the device input in the real case study and the substitute study, and establishing an association between them with the equivalence factorF. A funnel-shaped phantom, designed forin vitrotesting and representing the electrical characteristics of the locations where cardiac implants are installed, was used in the substitute study. A measuring system was implemented to measure the induced voltage at the device input under high intensity electric fields.Main results.The induced voltages obtained in the experimental measurements align with the findings of the numerical study in the phantom. By applying the equivalence factors derived between the real case study and the substitute study (2.39 for unipolar sensing; 3.64 for bipolar sensing), the induced voltages on the cardiac implants can be determined for the real case using the substitute experimental set-up.Significance.The interference voltages on the cardiac implants under electric field exposures at low frequency were experimentally measured with detailed description. The findings provide evidence for an analysis method to systematically study the electromagnetic interference on the cardiac implants at low frequency.

Arrhythmic manifestations and outcomes of definite and probable cardiac sarcoidosis.

BACKGROUND: The 2014 Heart Rhythm Society consensus statement defines histological (definite) and clinical (probable) diagnostic categories of cardiac sarcoidosis (CS), but few studies have compared their arrhythmic phenotypes and outcomes. OBJECTIVE: The purpose of this study was to evaluate the electrophysiological/arrhythmic phenotype and outcomes of patients with definite and probable CS. METHODS: We analyzed the arrhythmic/electrophysiological phenotype in a single-center North American cohort of 388 patients (median age 56 years; 39% female, n = 151) diagnosed with definite (n = 58) or probable (n = 330) CS (2000-2022). The primary composite outcome was survival to first ventricular tachycardia/fibrillation (VT/VF) event or sudden cardiac death. Key secondary outcomes were also assessed. RESULTS: At index evaluation, in situ cardiac implantable electronic devices and antiarrhythmic drug use were more common in definite CS. At a median follow-up of 3.1 years, the primary outcome occurred in 22 patients with definite CS (38%) and 127 patients with probable CS (38%) (log-rank, P = .55). In multivariable analysis, only a higher ratio of the 18F-fluorodeoxyglucose maximum standardized uptake value of the myocardium to the maximum standardized uptake value of the blood pool (hazard ratio 1.09; 95% confidence interval 1.03-1.15; P = .003, per 1 unit increase) was associated with the primary outcome. During follow-up, patients with definite CS had a higher burden of device-treated VT/VF events (mean 2.86 events per patient-year vs 1.56 events per patient-year) and a higher rate of progression to heart transplant/left ventricular assist device implantation but no difference in all-cause mortality compared with patients with probable CS. CONCLUSION: Patients with definite and probable CS had similarly high risks of first sustained VT/VF/sudden cardiac death and all-cause mortality, though patients with definite CS had a higher overall arrhythmia burden. Both CS diagnostic groups as defined by the 2014 Heart Rhythm Society criteria require an aggressive approach to prevent arrhythmic complications.

Light-sensitive PEG hydrogel with antibacterial performance for pacemaker pocket infection prevention.

Prevention of cardiovascular implantable electronic devices (CIED) infection is crucial for successful outcomes. In this study, we report an adhesive and antibacterial hydrogel coating for CIED infection treatment, by immobilizing polyethylene glycol (PEG) and 2'-O-hydroxypropyl trimethyl ammonium chloride chitosan (HAC) on Ti surface. Initial alkali and APTES treatment caused the formation of -NH2 to enhance the adhesion of the hydrogel coating to Ti implants, followed by immobilizing a photo-cross-linkable PEG/2'-O-HTACCS hydrogel on Ti/OH/NH2 surface. Surface characterization of Ti/OH/NH2 sample and adhesion testing of hydrogel on Ti/OH/NH2 surface confirm successful immobilization of hydrogel onto the Ti/OH/NH2 surface. In vitro and in vivo antimicrobial results exhibited that the photo-cross-linkable PEG/HAC composite hydrogel has excellent antimicrobial capabilities against both Grampositive (S. aureus and S. epidermidis) and Gram-negative (P. aeruginosa and E. coli) bacteria. The outcome of this study demonstrates the photo-cross linked PEG/HAC coating hydrogels can be easily formed on the Ti implants, and has great potential in preventing CIED pocket infection.

Study on the relationship between atrial high-rate episode and left atrial strain in patients with cardiac implantable electronic device.

Background: Although atrial high-rate episode (AHRE) and atrial fibrillation (AF) cannot entirely be identical, recent studies suggest AHRE is linked to AF development and shares some characteristics with AF regarding thromboembolism. At present, there is still lack of predictive indicators for AHRE and diagnostic methods and clinical indicators for AHRE in patients without cardiac implantable electronic device (CIED). The aim of this study was thus to explore the relationship between AHRE and left atrial (LA) strain parameters with the goal of identifying high-risk populations of AHRE by LA strain characteristics. Methods: From February 2022 to May 2023, a total of 105 CIED patients were enrolled and divided into two groups based on whether AHRE had occurred: AHRE (-) group (n=65) and AHRE (+) group (n=40). Real-time three-dimensional echocardiography (RT-3DE) technique was used to obtain the LA time-volume curve. The collected dynamic images were analyzed on the Echopac 204 workstation to obtain the parameters of LA. The four-dimensional automatic LA quantitative analysis (4D Auto LAQ) technology was used to analyze the LA strain parameters: LA reservoir longitudinal strain (LASr), LA conduit longitudinal strain (LAScd), LA contraction longitudinal strain (LASct), LA reservoir circumferential strain (LASr-c), LA conduit circumferential strain (LAScd-c), LA contraction circumferential strain (LASct-c). Correlation analysis was carried out using Binary logistic regression analysis. The area under the receiver operating characteristic (ROC) curve (AUC) was used to evaluate the diagnostic performance of LASct in AHRE. Results: Body surface area (BSA) [odds ratio (OR) =8.34, 95% confidence interval (CI): 1.32-72.30, P=0.037], LASct (OR =1.20, 95% CI: 1.05-1.39, P=0.013) and LA end-systolic volume (LAESV) (OR =1.02, 95% CI: 1.00-1.04, P=0.023) were the influencing factors of AHRE. Only LASct (OR =1.18, 95% CI: 1.01-1.38, P=0.041) was found to be an independent influencing factor of AHRE. This result remained significant after adjusting for age, sex, hypertension, diabetes, and stroke history. The ROC curve showed that the cut-off for predicting AHRE was LASct =-4.125% with sensitivity of 37.5% and specificity of 87.7%. Conclusions: This cross-sectional study found that decreased LASct (absolute value) is an independent risk factor for the AHRE and has diagnostic efficacy in certain degree for the occurrence of AHRE.

Fundamental Electrophysiology Principles Related to Perioperative Management of Cardiovascular Implantable Electronic Devices.

An increasing number of patients undergoing elective or emergency surgery in the United States have a cardiovascular implantable electronic device. Practice advisories and consensus statements have been issued by the American Society of Anesthesiologists and the Heart Rhythm Society, advocating a multidisciplinary approach. Unfortunately, anesthesia providers often find themselves in a situation in which they are left to manage these devices independently. At the University of Washington Medical Center, an anesthesiology-based service to manage these devices has existed for more than a decade. Many problems with devices have been observed, including confusing rhythms, failure of magnets to provide the desired change in device function, and actual device malfunction. With these clinical case examples taken from the authors' collective experience, this article provides an in-depth understanding of some key electrophysiology principles relevant to cardiovascular implantable electronic device function and appropriate perioperative management.

Contemporary Features and Management of Endocarditis.

Infective endocarditis is a rare but devastating disease. Morbidity and mortality rates have failed to improve despite new technological advances. The disease has evolved over time with new significant populations at risk-most notably those with prosthetic valves or implantable cardiovascular devices. These devices pose new challenges for achieving a timely and accurate diagnosis of infection. While the modified Duke criteria is accepted as the gold standard for diagnosing native valve endocarditis, it has been shown to have significantly inferior sensitivity when it comes to identifying infections related to right-heart endocarditis, prosthetic valves, and indwelling cardiac devices. Additionally, prosthetic valves and cardiovascular implantable electronic devices can exhibit shadowing and artifact, rendering transthoracic echocardiography and transesophageal echocardiography results inconclusive or even normal. Having a keen awareness of the varying clinical presentations, as well as emerging valvular imaging modalities such as F-fluorodeoxyglucose cardiac positron-emission tomography plus computed tomography, promises to improve the evaluation and diagnosis of infective endocarditis. However, indications for appropriate use of these studies and guidance on modern clinical management are still needed.

Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices.

INTRODUCTION: The automobile passive keyless entry (PKE) system is a potential source of electromagnetic interference (EMI). We aim to determine the incidence and significance of EMI from automobile PKE system in cardiovascular implantable electronic device (CIED) patients. METHODS: This was a single-center cross-sectional study conducted at Maharaj Nakorn Chiang Mai hospital, Thailand. Patients with CIED were instructed to lock and unlock two automobiles using the PKE system. Any EMI or arrhythmias were detected by CIED interrogation and single-lead electrocardiogram event recorder. We also used a spectrum analyzer to identify the automobiles working frequency bandwidth. RESULTS: There was a total of 102 CIED patients. Device types included 48.0% defibrillators, 37.3% permanent pacemakers, and 14.7% cardiac resynchronization therapy device. Both interrogated data from device and event monitor revealed no incidence of EMI during the PKE activation. We failed to identify the working frequency bandwidth of the two studied cars due to very low signal strength, thus blended in with the background noise. CONCLUSIONS: Automobile PKE systems transmitted very low power signals. Therefore, under normal circumstances, CIED patients can use automobile PKE system safely without any EMI regardless of key fob positions in relation to the CIED pulse generator. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (https://clinicaltrials.gov), and the identification number is NCT03016390.

Anesthetic Choice for Cardiovascular Implantable Electronic Device Placement and Lead Removal: A National Anesthesia Clinical Outcomes Registry Analysis.

OBJECTIVE: The authors evaluated the anesthetic approach for cardiovascular implantable electronic device (CIED) placement and transvenous lead removal, hypothesizing that monitored anesthesia care is used more frequently than general anesthesia. DESIGN: A retrospective study. SETTING: National Anesthesia Clinical Outcomes Registry data. PARTICIPANTS: Adult patients who underwent CIED (permanent cardiac pacemaker or implantable cardioverter-defibrillator [ICD]) placement or transvenous lead removal between 2010 and 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Covariates were selected a priori within multivariate models to assess predictors of anesthetic type. A total of 87,530 patients underwent pacemaker placement, 76,140 had ICD placement, 2,568 had pacemaker transvenous lead removal, and 4,861 had ICD transvenous lead extraction; 51.2%, 45.64%, 16.82%, and 45.64% received monitored anesthesia care, respectively. A 2%, 1% (both p < 0.0001), and 2% (p = 0.0003) increase in monitored anesthesia care occurred for each 1-year increase in age for pacemaker placement, ICD placement, and pacemaker transvenous lead removal, respectively. American Society of Anesthesiologists (ASA) physical status ≤III for pacemaker placement, ASA ≥IV for ICD placement, and ASA ≤III for pacemaker transvenous lead removal were 7% (p = 0.0013), 5% (p = 0.0144), and 27% (p = 0.0247) more likely to receive monitored anesthesia care, respectively. Patients treated in the Northeast were more likely to receive monitored anesthesia care than in the West for all groups analyzed (p < 0.0024). Male patients were 24% less likely to receive monitored anesthesia care for pacemaker transvenous lead removal (p = 0.0378). For every additional 10 pacemaker or ICD lead removals performed in a year, a 2% decrease in monitored anesthesia care was evident (p = 0.0271, p < 0.0001, respectively). CONCLUSIONS: General anesthesia still has a strong presence in the anesthetic management of both CIED placement and transvenous lead removal. Anesthetic choice, however, varies with patient demographics, hospital characteristics, and geographic region.

Candidemia in Patients With Cardiovascular Implantable Electronic Devices: Uncertainty in Management Based on Current International Guidelines.

Background: In contrast to bloodstream infection due to a variety of bacteria in patients with cardiovascular implantable electronic devices (CIED), there are limited data regarding candidemia and risk of CIED infection. Methods: All patients with candidemia and a CIED at Mayo Clinic Rochester between 2012 and 2019 were reviewed. Cardiovascular implantable electronic device infection was defined by (1) clinical signs of pocket site infection or (2) echocardiographic evidence of lead vegetations. Results: A total of 23 patients with candidemia had underlying CIED; 9 (39.1%) cases were community onset. None of the patients had pocket site infection. The duration between CIED placement and candidemia was prolonged (median 3.5 years; interquartile range, 2.0-6.5). Only 7 (30.4%) patients underwent transesophageal echocardiography and 2 of 7 (28.6%) had lead masses. Only the 2 patients with lead masses underwent CIED extraction, but device cultures were negative for Candida species. Two (33.3%) of 6 other patients who were managed as candidemia without device infection subsequently developed relapsing candidemia. Cardiovascular implantable electronic device removal was done in both patients and device cultures grew Candida species. Although 17.4% of patients were ultimately confirmed to have CIED infection, CIED infection status was undefined in 52.2%. Overall, 17 (73.9%) patients died within 90 days of diagnosis of candidemia. Conclusions: Although current international guidelines recommend CIED removal in patients with candidemia, the optimal management strategy remains undefined. This is problematic because candidemia alone is associated with increased morbidity and mortality as seen in this cohort. Moreover, inappropriate device removal or retention can both result in increased patient morbidity and mortality.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

Single center experience with the novel rotating dilator sheath TightRailTM Sub-C in transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction has become a frequent procedure in the context of device lead management and various tools are available. The aim of this study was to investigate the efficacy and safety of the novel short rotating dilator sheath TightRailTM Sub-C (Sub-C) in transvenous lead extraction. METHODS: For this retrospective single-center analysis, we included consecutive patients undergoing transvenous lead extraction using the Sub-C from January 2018 until February 2020 at the University Heart Center Zurich. RESULTS: A total of 87 leads were extracted within 45 patients using the Sub-C extraction sheath. The mean dwell time of the leads was 112 ± 9.1 months. Complete procedural success was achieved in 95.6% (43/45) and clinical procedural success in 97.8% (44/45). Two major complications (4.4%, 2/45) occurred, but neither was directly related to the Sub-C. CONCLUSION: This retrospective single-center analysis suggests that transvenous lead extraction with a routine use of the TightRailTM Sub-C extraction sheath is a safe strategy resulting in high success rates that may offer useful theoretical benefits. Future studies are needed to evaluate the incremental benefit of a routine use of short extraction sheaths including the Sub-C during TLE procedures.

Abandoned Intracardiac Electrodes in an Oncological Patient.

Cardiological and oncological patients comprise the majority of patients admitted to the emergency unit with chronic or acute conditions that are the dominant cause of death worldwide. However, electrotherapy and implantable devices (pacemakers and cardioverters) improve the prognosis of cardiological patients. We present the case report of a patient who, in the past, had a pacemaker implanted due to symptomatic sick sinus syndrome (SSS) without removing the two remaining leads. Echocardiography revealed severe tricuspid valve regurgitation. The tricuspid valve septal cusp was in a restricting position due to the two ventricular leads passing through the valve. A few years later, she was diagnosed with breast cancer. We present a 65-year-old female admitted to the department due to right ventricular failure. The patient manifested symptoms of right heart failure, predominated by ascites and lower extremity edema, despite increasing doses of diuretics. The patient underwent a mastectomy two years ago due to breast cancer and was qualified for thorax radiotherapy. A new pacemaker system was implanted in the right subclavian area as the pacemaker generator occupied the radiotherapy field. In the case of right ventricular lead removal and the need for pacing and resynchronization therapy, guidelines allow a coronary sinus for LV pacing to avoid passing the leads through the tricuspid valve. We facilitated this approach in our patient, suggesting that the percentage of ventricular pacing was very low.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

Predictors of cardiovascular implantable electronic device dependence at long-term follow-up after alcohol septal ablation in hypertrophic cardiomyopathy patients.

BACKGROUND: The most common complication of alcohol septal ablation (ASA) is transient periprocedural high-grade AV block (HGAVB). To date, no long-term follow-up of cardiovascular implantable electronic device (CIED) utilization after ASA has been reported. We hypothesized that CIED dependence on long-term follow-up can be predicted by ECG or procedural characteristics. METHODS: We analyzed all patients with HCM who underwent ASA from December 1998 to December 2019 and received their first CIED within 30 days after ASA for HGAVB. All follow-up interrogations were reviewed. CIED dependence was defined as ventricular pacing of ≥ 5%. RESULTS: A total of 138 patients with HCM underwent ASA. Of these, 35 had a prior device and were excluded. Of the remaining 103 patients, 25 patients received a CIED for HGAVB within 30 days after ASA. Average follow-up duration was 10.1 years. On long-term follow-up, 16 patients (64%) were found to be CIED-dependent. Baseline characteristics, including pre- and post-ASA ECG, were not significantly different between dependent and non-dependent patients. The only predictor for CIED dependence was > 1 ml of alcohol injected (OR 6.0, p = 0.031). CONCLUSIONS: CIED implantation after ASA is common. Almost two thirds of patients who received a CIED for post-procedural HGAVB were CIED-dependent on long-term follow-up. CIED dependence can be predicted by the amount of injected alcohol > 1 ml.

Safety of magnetic resonance imaging in patients with surgically implanted permanent epicardial leads.

BACKGROUND: Magnetic resonance imaging (MRI) safety in patients with an epicardial cardiac implantable electronic device (CIED) is uncertain. OBJECTIVE: The purpose of this study was to assess the safety and adverse effects of MRI in patients who had surgically implanted epicardial CIED. METHODS: Patients with surgically implanted CIEDs who underwent MRI with an appropriate cardiology-radiology collaborative protocol between January 2008 and January 2021 were prospectively studied in 2 clinical centers. All patients underwent close cardiac monitoring through MRI procedures. Outcomes were compared between the epicardial CIED group and the matched non-MRI-conditional transvenous CIED group. RESULTS: Twenty-nine consecutive patients with epicardial CIED (41.4% male; mean age 43 years) underwent 52 MRIs in 57 anatomic regions. Sixteen patients had a pacemaker, 9 had a cardiac defibrillator or cardiac resynchronization therapy-defibrillator, and 4 had no device generator. No significant adverse events occurred in the epicardial or transvenous CIED groups. Battery life, pacing, sensing thresholds, lead impedance, and cardiac biomarkers were not significantly changed, except 1 patient had a transient decrease in atrial lead sensing function. CONCLUSION: MRI of CIEDs with epicardially implanted leads does not represent a greater risk than transvenous CIEDs when performed with a multidisciplinary collaborative protocol centered on patient safety.