Cardiac Implantable Devices Research Articles

Risk of cardiac implantable device malfunction in cancer patients receiving proton therapy: an overview.

Age is a risk factor for both cardiovascular disease and cancer, and as such radiation oncologists frequently see a number of patients with cardiac implantable electronic devices (CIEDs) receiving proton therapy (PT). CIED malfunctions induced by PT are nonnegligible and can occur in both passive scattering and pencil beam scanning modes. In the absence of an evidence-based protocol, the authors emphasise that this patient cohort should be managed differently to electron- and photon- external beam radiation therapy (EBRT) patients due to distinct properties of proton beams. Given the lack of a PT-specific guideline for managing this cohort and limited studies on this important topic; the process was initiated by evaluating all PT-related CIED malfunctions to provide a baseline for future reporting and research. In this review, different modes of PT and their interactions with a variety of CIEDs and pacing leads are discussed. Effects of PT on CIEDs were classified into a variety of hardware and software malfunctions. Apart from secondary neutrons, cumulative radiation dose, dose rate, CIED model/manufacturer, distance from CIED to proton field, and materials used in CIEDs/pacing leads were all evaluated to determine the probability of malfunctions. The importance of proton beam arrangements is highlighted in this study. Manufacturers should specify recommended dose limits for patients undergoing PT. The establishment of an international multidisciplinary team dedicated to CIED-bearing patients receiving PT may be beneficial.

Cardiac device-related infective endocarditis need for lead extraction whatever the device according to the ESC EORP EURO-ENDO registry.

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. 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). 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.

Incidence of Complications in Implantable Cardiac Devices in a Single Centre

Incidence of Complications in Implantable Cardiac Devices in a Single Centre

Trends in cardiac implantable electronic device utilization in adults with congenital heart disease: a US nationwide analysis.

Adults with congenital heart disease (ACHD) have increased risk of arrhythmias warranting implantation of cardiac implantable electronic devices (CIEDs), which may parallel the observed increase in survival of ACHD patients over the past few decades. We sought to characterize the trends and outcomes of CIED implantation in the inpatient ACHD population across US from 2005 to 2019. A retrospective analysis of the Nationwide Inpatient Sample (NIS) identified 1,599,519 unique inpatient ACHD admissions (stratified as simple (85.1%), moderate (11.5%), and complex (3.4%)) using the International Classification of Diseases 9/10-CM codes. Hospitalizations for CIED implantation (pacemaker, ICD, CRT-p/CRT-d) were identified and the trends analyzed using regression analysis (2-tailed p < 0.05 was considered significant). A significant decrease in the hospitalizations for CIED implantation across the study period [3.3 (2.9-3.8)% in 2005 vs 2.4 (2.1-2.6)% in 2019, p < 0.001] was observed across all types of devices and CHD severities. Pacemaker implantation increased with each age decade, whereas ICD implantation rates decreased over 70years of age. Complex ACHD patients receiving CIED were younger with a lower prevalence of age-related comorbidities, however, had a greater prevalence of atrial/ventricular tachyarrhythmias and complete heart block. The observed inpatient mortality rate was 1.2%. In a nationwide analysis, we report a significant decline in CIED implantation between 2005 and 2019 in ACHD patients. This may either be due to a greater proportion of hospitalizations resulting from other complications of ACHD or reflect a declining need for CIED due to advances in medical/surgical therapies. Future prospective studies are needed to elucidate this trend further.

Prevention, diagnosis and treatment of cardiac implantable electronic device infections. Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

Frame-rate reduction to reduce radiation dose for cardiac device implantation is safe.

Radiation exposure to patient and surgeon during cardiac implantable electrical device (CIED) procedures remains a substantial health hazard to date. Advanced technical options for radiation dose reduction often pose considerable financial hurdles. We propose a near-zero cost, low-effort modification to a clinical x-ray system significantly reducing radiation dose during CIED implantation. We aim to evaluate a reduced frame rate protocol in CIED implantation for complication rates and reduction in radiation exposure. Starting May 2019, the frame rate during CIED implantations at our hospital was halved from 7.5 frames/s to 3.8 frames/s, and no further technical changes were made. During the following year, 264 patients were operated using this protocol and retrospectively compared with 231 cases implanted in the year before the protocol change, totaling 495 cases. Of these, 17%, 63%, and 19% were single-chamber, dual-chamber, or resynchronization devices, respectively. Incidence of complication prior to hospital discharge was considered the primary endpoint of the analysis. Radiation dose and procedural parameters were secondary endpoints. There was no increase in complications with the reduced frame rate protocol. Regression analysis further supported that the reduced frame rate radiation protocol was not associated with complication rates. Radiation exposure measured as dose area product was significantly reduced by ∼62% (median 369 [interquartile range 154-1207] cGy·cm2 via the reduced frame rate protocol vs median 970 [interquartile range 400-1906] cGy·cm2 with the standard frame rate; P < 0.01). A reduction of frame rate during CIED implantation is safe in terms of complication incidence and effective in terms of reducing radiation exposure.

ANATOMICAL FEATURES OF THE CARDIAC VENOUS SYSTEM, SIGNIFICANT FOR THE LEFT VENTRICULAR LEAD PLACEMENT: LITERATURE REVIEW AND EXPERIENCE

HighlightsThe article is a comprehensive literature review on anatomical variations and anomalies of cardiac veins. A classification of coronary venous anatomy and anomalies detailing clinical, anatomical and radiological features is proposed. Developing such classification is important for the field of left ventricular lead placement, as it would cover a variety of clinically significant anomalies of cardiac veins. AbstractWith the advancements in the cardiac resynchronization therapy, the role of cardiac vein anatomy has become vital due to the complications associated with poor left ventricle lead placement. The cardiac vein anatomy varies much more than the anatomy of the coronary arteries, thus making cardiac veins much harder to study. In this article we have analyzed different approaches to description and naming of cardiac veins, and have summarized venous anomalies and features described in literature or encountered in real clinical practice. All anatomical features described in the article have a clinical significance in the left ventricle lead placement. Moreover, we have analyzed the wide variety of suggestions to overcoming anatomical obstacles. As a result of the analysis, we have proposed a clinical classification of the coronary venous anomalies and features that can be used during the implantation of cardiac resynchronization therapy devices.

Ultrasound utilization for implantation of cardiac implantable electronic devices.

Ultrasound (US) guidance for implantation of cardiac implantable electronic devices (CIED) is currently not routine practice. This article sought to review published data on the use of ultrasound in each of the major surgical steps involved in implantation of CIEDs, including achieving anesthesia, obtaining venous access and implantation of leads. Aliterature review was performed, revealing atotal of 20peer-reviewed studies that assessed US guidance for CIED implantation; 3 of these were randomized trials while the remainder were mostly feasibility studies. The available data suggest that ultrasound can be useful in guiding implantation of CIEDs, with atrend towards less complication rates; however, more high-quality studies that compare US guidance to traditional techniques in CIED implantation are required.

#2674 ASSOCIATION BETWEEN SARCOPENIA, BODY COMPOSITION AND FRAILTY IN PERITONEAL DIALYSIS PATIENTS: A MULTI-CENTRIC STUDY

Abstract Background and Aims Patients with chronic kidney disease (CKD) have an increased risk of mortality due to many causes. One of them is sarcopenia, a progressive skeletal muscle disorder that increases adverse outcomes such as fractures, falls, and physical disability, and has been considered an independent risk factor for mortality. Sarcopenia could be defined as a muscle failure in which muscle strength is the most solid measure of muscle function and a better predictor of adverse events rather than muscle mass. Grip strength is considered a reliable surrogate for measures of arm and leg strength. The aim of this study was to evaluate the prevalence of probable sarcopenia in peritoneal dialysis (PD) patients and its association with body composition and several clinical variables. Method This retrospective multi-centric descriptive study was conducted at the Hospital de Santa Cruz (Lisboa) and Hospital Universitario de Badajoz (Badajoz). We performed a single evaluation of 62 patients on peritoneal dialysis from at least 3 months, aged &amp;gt;18 years in whom we measured muscle strength by handgrip strength using a dynamometer. We divided patients into two groups, using cut-off points to consider probable sarcopenia for men and women less than 27 kg and 16 kg, respectively. Patients with acute infection, amputated limbs, and implantable cardiac devices were excluded. The following data were analyzed: age, anthropometric variables, gender, duration, modality of PD, presence of hypertension, diabetes, and cardiovascular disease, obtained from electronic medical records. We also analyze data from body composition using a bioelectrical impedance device (overhydration, extracellular intracellular water ratio (E/I), lean and fat tissue index and phase angle), PD parameters (weekly urea Kt/v, nGFR, D/P Cr, nPCR, residual urine output) and measured serum concentrations of hemoglobin, PCR, NT-ProBNP, PTH, Ca-125, calcium, and phosphorus. We assessed patients for the Clinical Fragility Scale (CFS) and measured performance in activities of daily living using the Barthel Scale. Results Records of 62 patients, 61% male, mean age 57 ± 22 years, and body mass index 27.5 ± 5.1 kg/m2 were reviewed, with 15 (18.8%) classified as probable sarcopenic. Old age (p = 0.005), high CFS score (p = 0.005), E/I ratio (p &amp;lt; 0,001), and low values of lean tissue index (p &amp;lt; 0.031), mean phase angle (p &amp;lt; 0.001) and residual urine output (p &amp;lt; 0,018) were correlated with the presence of probable sarcopenia. In the multivariable analysis, age (HR 1.135; CI 95% 1.015 - 1.269), CFS score (HR 2.637; CI 1,008 - 6,900), and urine output (HR 0,996; CI 95% 0.993 - 0.999) were also related to probable sarcopenia. There was no association between the presence of anemia, cardiovascular disease, type of peritoneal transport, and clearance of small solutes. Conclusion This study reported a low prevalence of probable sarcopenia in PD patients. We corroborate the association between age and frailty in the sarcopenic group. The percentage of extracellular water, muscle mass, and phase angle measured by bioimpedance could be useful variables to identify sarcopenic or at-risk patients. In multivariate analysis, age, higher CFS score, and urine output have been associated with sarcopenia. Preservation of residual renal function seems to be associated with less sarcopenia, which reinforces the importance of preserving residual renal function in PD patients. It's also important to identify sarcopenic or at-risk patients in order to promote early detection and treatment.

The role of CT in arrhythmia management-treatment planning and post-procedural imaging surveillance.

Several interventional treatment options exist in patients with atrial and ventricular arrhythmia. Cardiac CT is routinely performed prior to occlusion of the left atrial appendage, pulmonary vein isolation, and cardiac device implantation. Besides the evaluation of coronary artery disease, cardiac CT provides isotropic, high-resolution CT images of the cardiac anatomy with the possibility of multiplanar reformations and three-dimensional reconstructions which are helpful to guide interventional treatment. In addition, cardiac CT is increasingly used to rapidly evaluate periprocedural complications and for the routine post-procedural imaging surveillance in patients after interventions. This review article will discuss current applications of pre- and post-interventional CT imaging in patients with arrhythmia.

RWD33 Cardiac Implantable Electronic Device Centers’ Landscape in the Brazilian Public Healthcare: A 12-Year Real World Data Analysis

Cardiac implantable electronic devices (CIED) implantation procedures, available in the Brazilian Public Health System (SUS) for more than 30 years, are performed only in tertiary care centers. This research aims to explore CIED implantation centers' landscape in the Brazilian Public Healthcare System.

20-Year Audit of Community Issued Automated External Defibrillators, Auckland City Hospital 2002–2022

Early community defibrillation has been shown to improve survival in patients with cardiac arrest. Providing home automated external defibrillators (AEDs) to patients who do not meet guidelines for an implantable cardioverter defibrillator (ICD) implant, have significant contraindications for an ICD implant, or do not wish to have an ICD implanted is a service delivered by some hospitals. This was a retrospective audit of patients issued an AED by Auckland City Hospital 2002–2022. A telephonic survey of active patients was undertaken. Over the 20-year period, 34 patients were issued AEDs. Mean age was 18.5 years with 58.5% aged ≤15 years at date of issue; 58.8% were NZ European and 14.7% Māori. The predominant cardiac diagnosis was Long QT syndrome (41.2%) followed by hypertrophic cardiomyopathy/hypertrophic obstructive cardiomyopathy (23.5%). Twenty-one patients still have AEDs. Of four patients who had multiple prior cardiac implantable electronic device (CIED) implants and lead extractions, one proceeded to a heart transplant, and one died. Six patients proceeded to CIED implants: three ICDs and three implantable loop recorders (ILRs). No surveyed patients required AED therapy. All surveyed patients/caregivers reported that home AED gives them peace of mind. Issuing of home AEDs is not standard clinical practice, but for specific patients who do not meet guidelines, are unwilling to have or have contraindications to an ICD, it provides peace of mind. No surveyed patients required AED therapy.

Does radiotherapy effect the voltage output of cardiac implantable electronic devices (CIEDs)?

Abstract Funding Acknowledgements Type of funding sources: None. Purpose Current guidelines for the management of patients undergoing radiotherapy with cardiac implantable electronic devices (CIEDs) were published in 1994. They recommend that the total dose received by the device should be estimated before treatment, devices should not be placed in the direct radiation beam and the cumulative dose should not exceed 2Gy to any part of a pacemaker (0.5Gy for ICDs). This is because radiotherapy can cause malfunctions in cardiac implantable devices. At doses higher than this, relocation of the device is recommended. Device malfunctions are suggested to correlate with a beam energy of ≥10MV. One malfunction that poses a high risk to patients is a change in voltage output amplitude. This study assessed if low-energy flattening filter and high energy flattening filter-free photon beam radiation caused a change in the voltage output amplitude of cardiac implantable devices. Method 40 cardiac implantable devices were divided into two treatment groups and irradiated in vitro with a cumulative 48Gy dose of 6MV radiation at 600MU/min in 8 fractions or a 48Gy dose of 10MV radiation at 2400MU/min. The voltage output amplitude of all devices was collected using an oscilloscope and an amplitude change of ≥25% was classed as a clinically significant malfunction. Results In the 6X treatment group, 0/19 devices showed a clinically significant change. No statistical significant difference was found between the median peak voltage output amplitude before fraction 1 and after fraction 8 (U = 149.5, p = 0.3733, n =19). In the 10MV treatment group, 2/21 devices showed a clinically significant change. These devices showed a voltage output amplitude increase of 28.07% and 36.97%. However, no statistical significant difference was found between the median peak voltage output amplitude before and after radiation (U = 149.5, P = 0.0746, n = 21). Although insignificant, there was clearly a larger change across all devices in the 10FFF group compared to the 6X group. Results were not statistically significant between manufacturers but defibrillators were statistically significantly more likely to malfunction than pacemakers. Conclusion The recommended dose of radiotherapy for patients with a CIED should be carefully considered on an individual basis. Due to neutron production and its effect on rapid access memory (RAM) and complementary metal oxide semiconductor (CMOS) circuitry, high-energy ≥10MV radiation can affect the voltage output amplitude, despite its statistical insignificance. Based on this limited report it is unlikely that the voltage output amplitude of CIEDs will be affected by clinically relevant doses of radiotherapy, but it may have long term implications on battery life. These results could eliminate the risk of increased infection due to relocation of devices, provide patients with optimised treatment and enable a more effective service for improved patient management.

Electric cars and high power chargers: Are they safe for patients with cardiac implantable electronic devices?

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Deutsche Stiftung für Herzforschung research grant Background Electromagnetic interference (EMI) poses a risk to patients with cardiac implantable devices (CIEDs) and can result in device malfunction including pacing inhibition or inappropriate shock therapy. Such EMI sources are ubiquitous in the modern world. Battery electric vehicles (BEVs) represent such a potential EMI source. We have previously investigated the EMI risk of driving eCars and found that the largest electromagnetic field is located along the charging cable. New high power chargers deliver higher currents (facilitating rapid recharging), potentially associated with greater electromagnetic fields and higher risk for clinically relevant EMI. This present study aims to evaluate this EMI-risk to address this clinically important question. Methods A consecutive group of 130 patients with a range of CIEDs were recruited to participate. After a complete device interrogation each had their device programmed to optimise EMI detection with ensured ventricular pacing and ICD therapies were disabled. Under continuous 6-lead ECG monitoring each patient then plugged in and charged four different BEVs (Porsche Taycan Turbo, VW ID3 pro, Tesla Model 3 and Audi e-tron 55 Quattro) in addition to a ‘dummy’ eCar (which permitted the maximal charging power flow of 350kW) with the charging cable placed directly over the device. During charging both the magnetic field and electric field was measured. A further complete device interrogation was then performed to evaluate for spontaneous reprogramming and tachycardia detection. Results In total 561 separate charging events were performed by 130 patients with the four eCars and one dummy car. The maximal magnetic field along the charging cable was 38.65µT and at the charging column was 77.9µT. There were no incidences of EMI, specifically there was no pacing inhibition due to oversensing, no spontaneous reprogramming and no tachycardia over-detection. This results in a patient-based risk of 0% (95% CI; 0% - 2.8%) and a charging event-based risk of 0% (95% CI; 0% - 0.6%). Conclusions and Discussion We found that there was no EMI induced during the use of high power charger technology for BEV despite device programming and charging cable placement being optimised for a worst-case scenario and maximising the chance of clinical EMI. Our study suggests that there is a very low risk, if any, posed by BEVs and the new high power chargers. CIED patients should reassured that their use is safe. We would still recommend not to place the charging cable directly above the CIED during use to maximise safety of high power charging.

Follow-up of implantable cardiac electronic devices during the Covid-19 pandemic: organizational model and results of a single center experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction During the SARS-CoV-2 COVID-19 pandemic, the global health system has had to review important processes involved in daily routines such as outpatient activities within the hospital, including follow-up visits of implantable cardiac electronic devices (CIEDs), pacemakers (PMs) and implantable defibrillators (ICDs) carried out in office. The aim of this study was to prospectively evaluate the success rate of remote transmissions of all devices followed by the CIED control clinic and verify the adopted organizational models. Methods All patients with remote monitoring system were considered in the study if automatic algorithm such as autocapture and autosensing were activated and well-functioning. Between January 2021 and November 2022, they were completely followed by remote monitoring and called for unscheduled in-office visit only because of remote yellow or red alarms. Patients were divided into two groups: Manual Transmission System (MTS) and Automatic Transmission System (ATS), based on the available technology. Organizational models shown in figures 1-2, were followed for the two groups. The technology of the ATS group, in addition to ensuring a daily transmission of any yellow or red alarms, allowed a control of missed communication at least every 14 days. The MTS group provided a manual transmission every 6 months. The ATS group was controlled at least once in the year, even if no alarms occurred. Results At the end of 2022 a total of 1193 patients were followed remotely by our center. Of these, 238 from the MTS group and 955 from the ATS group. 3314 remote transmission required medical intervention, which generated 182 unscheduled outpatient visits, mainly due to lack of transmission for prolonged periods, failure of the autocapture test and newly onset atrial fibrillation. 3496 transmissions were generated and 120 transmissions were missed; the overall success rate of transmissions with the organizational model adopted was 96.6% (connectivity index). On average, the monthly rate of unconnected manual devices was 5.1% while 3.5% for automatic devices. 2-year mortality was 12.7%. Conclusions By adopting an appropriate organizational model, it is possible to maintain high transmission success rates. The available technology allows you to change hospital outpatient habits in the cardiology field for CIED checks and move to a virtual clinic safely. The automatic transmission technology allows a more frequent control of patients with CIED, the impact on the patients' health must be assessed.

Comparison between thoracic ultrasound and chest x-ray in non-infective early complications detection after cardiac implantable electronic devices implantation procedures

Abstract Funding Acknowledgements Type of funding sources: None. Background In the immediate postoperative of cardiac implantable electronic devices (CIED) implantation procedures, literature and practice suggest the use of chest radiography as a gold standard diagnostic tool for early local complications such as pneumothorax, hemothorax and pericardial effusion. The introduction of bedside thoracic ultrasound into clinical practice guarantees a tool that is easy to use and highly appropriate for the early diagnosis of pleural pathologies. However, its use in the context of cardiac stimulation is not yet validated and is not mentioned in international consensus documents. Purpose The purpose of this study was to evaluate the rate of early mechanical complications in the post-implantation of cardiac stimulation devices and to compare the diagnostic power of the two methods. Methods 397 consecutive patients who underwent intracavitary device implantation or upgrade with the puncture of a central venous vessel were prospectively enrolled in a multicenter study from November 1, 2021, to September 30, 2022. In the two days following surgery, all patients underwent chest radiography, when possible in the supine position, and chest ultrasound at the patient's bed to detect early complications of the implantation. Results Acute mechanical complications following the implantation of CIED accounted for 5.3%, of which 13 were pneumothorax (3.3%), in over 92% of cases of mild degree. The diagnosis was made by chest ultrasound alone in 10 cases (77%), in 2 cases (15.3%) by radiography alone and in 1 case (7.7%) by both methods (p-value 0.006). In 3 patients it was necessary to place a pleural drainage, in 2 cases the diagnosis was made with ultrasound alone and in 1 case with radiography alone (p=ns). Eight pericardial effusions (2%) were also observed, all of a mild degree, diagnosed exclusively with ultrasound methods and did not require drainage. No cases of hemothorax were observed. Conclusion In our experience, thoracic ultrasound performed at the patient's bed following the implantation of a CIED has a diagnostic power superior to standard chest radiography in diagnosing early mechanical complications of the procedure, without subjecting the patient to early mobilization or ionizing radiation.

Impact of gender on the utilization of cardiac implantable devices and outcome: results from the German DEVICE registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are widely used in patients with life-threatening cardiac arrhythmias or systolic heart failure. Real world data regarding gender impact on ICD and CRT implantation and outcome is scarce. Purpose To investigate the impact of gender-specific differences on cardiac devices implantation and outcomes. Methods The German DEVICE registry is a nationwide prospective multicentre database of ICD and CRT devices implantation. A total of 5451 patients were prospectively enrolled in 44 centres between March 2007 and February 2014 and were monitored for a median of 17 months. Results A minority of patients in this registry was female 1050 (19.3%; mean age 64.4 ± 14.6 years; median BMI 27.2) while men represented 80.7% (mean age 65.5 ± 12.4 years; median BMI 26.8). Female patients were less likely to have a LVEF &amp;lt;35% (70.6% vs. 77.7%; p&amp;lt;0.0001) and more likely to have a LVEF &amp;gt;55% (13.3% vs. 6.6%; p&amp;lt;0.0001). Moreover, women were less likely to have coronary artery disease (42.3% vs. 64.7%; p&amp;lt;0.0001), history of myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft (p&amp;lt;0.0001 for all). The rate of CRTs was significantly higher in women than in men (33.4% vs. 28.7%; p=0.0036). In terms of secondary prevention implantations, women were more likely to have history of ventricular fibrillation (VF; 50.7% vs. 37.2%; p&amp;lt;0.0001) but less likely to have history of ventricular tachycardia (VT; 34.5% vs. 47.5%; p&amp;lt;0.0001). The rates of major periprocedural complications and in-hospital complications were higher in women (3.3% vs. 1.7%; p=0.002 and 5.6% vs. 3.7%; p=0.0208). The Kaplan-Meier estimated 1-year all-cause mortality was 5.4% for women and 7.4% for men, while the overall mortality during follow-up was 10% for women and 14% for men (p=0.0004), with no gender differences in terms of death cause. Significantly less women received device shocks (14.2% vs. 17.5%; p=0.0260), while more women needed device revision during follow-up (10.9 % vs. 8.2%; p=0.0246). Similar rates of primary and secondary prevention indication were noted for female and male patients (p=0.9717). There was no difference between the groups regarding the need of postprocedural system revision (p=0.7884), as well as in-hospital death, cardiac death, or sudden cardiac death. The non-fatal complications during follow-up were comparable for men and women. Moreover, similar rates and durations of all cause and cardiac rehospitalizations were found (p=0.1644 and p= 0.1816). Conclusion In this real-life patient cohort only a minority of female patients were enrolled. Female patients were more likely to undergo CRT implantation and had a higher risk for acute major periprocedural complications and in-hospital complications but a lower overall mortality in 1-year follow-up. However, the differences in baseline characteristics should be considered as potential confounders.

Blood stream infection in patients with implantable-cardioverter defibrillator admitted to non-cardiology units: incidence, diagnostic work-up and outcome

Abstract Funding Acknowledgements Type of funding sources: None. Background There is limited knowledge on the incidence of blood stream infections (BSI) in patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy devices (CRTs), as well as about the diagnostic work-up and outcome when these patients are admitted to non-cardiology units. Purpose We assessed the incidence of BSI in patients with an ICD or CRT, evaluated the diagnostic work-up performed, and investigated the outcome. Methods This is a single-center, retrospective cohort analysis of all 515 patients implanted with a de-novo ICD or CRT between 2012 and 2021 at our centre, and subsequently admitted to a non-cardiology unit of any public hospital in Canton Ticino with a BSI (≥ 2 positive blood cultures). Device infection was defined according to the 2019 International Cardiac Implantable Electronic Device (CIED) Infection Criteria. Results A total of 43 patients were diagnosed with BSI during a median follow-up of 48 months (IQR 24-78 months). Incidence rate for BSI was 19 (95%-CI 14 – 26) and 23 (95%-CI 14 – 35) per 1000 patient-years for ICDs and CRTs, respectively. The most common source for BSI was urinary tract infection (21%), which was mostly caused by gram positive pathogens (68%) with coagulase-negative staphylococci being the most frequent one (39%). Definite CIED infection rate in patients presenting with BSI was 11.6% (see table). The majority of patients (56%) had no cardiac imaging including transthoracic or transesophageal echocardiography; a PET-CT was performed in only 4 patients (9%). Nearly all patients (86%) were treated with short-term antibiotics; in contrast, system extraction (2.3%) and chronic antibiotic therapy (4.7%) were rarely performed. Throughout the entire follow-up period, patients with BSI had a 8-fold higher probability (HR 7.8, 95% CI 4.8-12.7; p&amp;lt;0.001) of all-cause mortality compared to those without BSI. Conclusions Awareness in non-cardiology units about possible device infection in patients with BSI is rather low leading to limited diagnostic work-up and ultimately to a high mortality rate of these patients.

Axillary vein puncture versus cephalic vein cutdown for cardiac implantable electronic device implantation: a meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Cephalic vein cutdown (CVC) and axillary vein puncture (AVP) are both recommended for transvenous implantation of leads for cardiac implantable electronic devices (CIEDs). Nonetheless, it is still debated which of the two techniques has a better safety and efficacy profile. Methods We systematically searched Medline, Embase and Cochrane electronic databases up to September 5th, 2022, for studies that evaluated the efficacy and safety of AVP and CVC reporting at least one clinical outcome of interest. The primary endpoint was acute procedural success. The effect size was estimated using a random-effect model as Risk Ratio (RR) and relative 95% Confidence Interval (CI). Results Overall, 8 studies were included, which enrolled 1926 patients and 3532 transvenous lead implants [66.3% (n=1277) males with an average age of 72.3±14.8 years]. Compared to CVC, AVP showed a significant increase in the primary endpoint (95.7 % vs 76.1 %; RR: 1.24; 95% CI: 1.09-1.40; p=0.001) (Figure 1). Total procedural time (Mean Difference [MD]: -8.25 min; 95%CI: -10.23- -6.27; p&amp;lt;0.0001; I2 =0%) and venous access time (MD: -6.24 min; 95%CI: -7.01- -5.47; p&amp;lt;0.0001; I2 =0%) were significantly shorter with AVP compared to CVC. No differences were found between AVP and CVC for incidence of pneumothorax (RR: 0.72; 95% CI: 0.13 - 4.0; p=0.71), lead failure (RR: 0.58; 95% CI: 0.23-1.48; p=0.26), pocket hematoma/bleeding (RR: 0.58; 95% CI: 0.15- 2.23; p=0.43), device infection (RR: 0.95; 95% CI: 0.14- 6.60; p=0.96) and fluoroscopy time (MD: -0.24 min; 95%CI: -0.75- 0.28; p=0.36). Conclusion Our meta-analysis suggests that AVP may improve procedural success and reduce total procedural time and venous access time compared to CVC.

Remote support during cardiac implantable electrical device follow-up: preliminary experience in clinical practice

Abstract Funding Acknowledgements Type of funding sources: None. Background Industry employed allied professionals (IEAPs) traditionally provide technical assistance to physicians during cardiac implantable electrical device (CIED) implantation, programming, troubleshooting, and follow-up, by operating the programmers under the supervision of the physician. The Heart Connect™ application is a data-sharing system intended to provide physicians with the means to establish an online meeting and share the display of the LATITUDE™ Programmer (Boston Scientific) with IEAPs in a remote location. Purpose We describe the preliminary experience of remote IEAP support during CIED follow-up in clinical practice. Methods The Heart Connect™ software was downloaded on the programmer and network connection was established and tested using both Wi-Fi and a 4G cellular adapter at 3 Italian medical centers. External headset and webcam have been connected to the programmer. After system setup, the staff was trained on how to use the application, and online meetings were established with IEAPs of the Remote Clinical Support team during consecutive CIED follow-up visits. Data and users’ feedback were collected on the training provided, the quality of the remote connection, the support at each meeting. Results All the professionals trained in the use of the system judged the information received to be clear and adequate, and felt confident in using the system. Online meetings were established during 34 follow-up visits (12 pacemakers and CRT-P, 13 single- or dual-chamber ICD, 9 CRT-D). The remote connection was successfully established in all cases. In all cases the communication remained stable for the entire duration of the visit, except for 2 cases (connected via 4G) in which a loss of connection occurred (not restored in 1 case). The sound and video quality during two-way communication were rated good or excellent in 31 (91%) cases. The mean duration of the online meeting was 7±3 minutes. Routine CIED checks were performed during the visits: battery status, pacing and sensing thresholds, impedances, current rhythm diagnosis, arrhythmias detected and therapies delivered, device counters and review of programmed parameters, alerts and clinical diagnostics. Programming changes were done during 7 (21%) visits: pacing and sensing parameters, tachycardia detection and therapies. The remote support allowed to successfully complete the visit in 33 (97%) cases, without requiring additional medical or technical support. In all these cases, the support was judged to be equally effective compared to the on-site support, without causing delays or organizational difficulties. Conclusions Remote support during CIED follow-up using Heart Connect™ seems feasible, effective and well accepted. Additional tests are ongoing to demonstrate the potential usefulness of this solution in standard clinical practice, and in the context of restrictions on access to healthcare facilities due to COVID-19 pandemic.