Cardiac Pacing Devices Research Articles

Scalable networks of wireless bioelectronics using magnetoelectrics.

Networks of miniature bioelectronic implants would enable precise measurement and manipulation of the complex and distributed physiological systems in the body. For example, sensing and stimulation nodes throughout the heart, brain, or peripheral nervous system would more accurately track and treat disease or support prosthetic technologies with many degrees of freedom. A main challenge to creating this type of in-body bioelectronic network is the fact that wireless power and data transfer are often inefficient when communicating through biological tissues. This challenge is typically compounded as one increases the number of implants within the network. Here, we show that magnetoelectric wireless data and power transfer enable a network of millimeter-sized bioelectronic implants where the power transfer efficiency of the system improves as the number of implanted devices increases. Using this property, we demonstrate networks of wireless battery-free bioelectronics ranging from 1 to 6 implants where the wireless power transfer efficiency for the system increases from 0.2% to 1.3%, with each node in the network receiving 2.2 mW at a distance of 1 cm. We use this system for efficient and robust wireless data and power transfer to demonstrate proof-of-concept networks of miniature spinal cord stimulators and cardiac pacing devices in large animals. The scalability of this network architecture enabled by magnetoelectric wireless power transfer provides a platform for building wireless closed-loop networks of bioelectronic implants for next-generation electronic medicine.

Guide to identify specific characteristics in cardiac pacing devices by radiological figure

Guide to identify specific characteristics in cardiac pacing devices by radiological figure

Impact of clinical frailty on the outcome of pacing for bradyarrhythmias in a district general hospital population

Abstract Background and Aims There is good evidence for mortality with increasing age, heart disease, peripheral vascular disease, pulmonary disease and renal disease in implantable cardiac defibrillators. And while multimorbid states and fragility are considered in decision to offer for more complex cardiac electronic device implants1,2 we aimed to characterise how much frailty and co-morbidities impact mortality in patients receiving simple bradyarrhythmia cardiac pacing device implants. Methods Retrospective examination of 700 consecutive novel standard bradyarrhythmia cardiac device implants (DDD, VVI, AAI) at Walsall Manor Hospital between 01/01/2016 to 28/02/2021 was undertaken through the electronic patient record. Patients’ frailty was calculated with Rockwood Frailty Score (RFS) and comorbidities at the time of implant recorded.3 Prospective follow up until 14/02/2023 was conducted, allowing at least a 2 year follow-up for all surviving patients. Results were analysed with Kaplan-Meier survival curves and Hazard Ratios (HR) and Risk Ratios (RR). Results Mean age of implant was 78.4±10.3 with mortality rate of 87/700 (12.4%) at one year and total 282/700 (40.3%). Overall, a RFS of 5 or more was associated with death overall HR 2.05 (95% CI 1.61-2.60) and 3.42 (95% CI 2.23-5.24) within 1 year (Fig. 1). Heart failure (OR 2.38, 95% CI 1.59-3.57), valvular heart disease (OR 3.19, 95% CI 2.08-4.89), atrial fibrillation/flutter (OR 1.44, 95% CI 1.09-1.91), chronic kidney disease (OR 1.89, 95% CI 1.296-1.72), malignancy (OR 1.91, 95% CI 1.08-3.36) were important co-morbidities of death within one year of implant. Ischemic heart disease and cognitive impairment including dementia demonstrated a trend towards worse mortality but did not reach significance (Fig. 2). Conclusion High frailty score as well as comorbidities including heart failure, valvular heart disease, atrial fibrillation, chronic kidney disease and malignancy indicate increased risk of early death after novel implant of bradycardia cardiac pacing device implants. Although advanced age alone is not a barrier to offer pacing, consideration should be given to advanced frailty and multimorbid states which may detract from any perceived benefit bradyarrhythmia correction may offer. These data have impacted our shared decision making during the consent process with our patients and in our multidisciplinary team discussions.Figure 1Figure 2

Complications according to intrathoracic versus extrathoracic venous access for cardiac device implantation: results from the PLACE (Planning Lead Access for Cardiac Electrostimulation) study

Abstract Background and Aims The choice of the vascular access for cardiac pacing devices (CIED) implant may impact on patients outcome. Recent studies and consensus documents encourage the use of an extra-thoracic access to prevent adverse events. In this large, multicenter, retrospective study we report the impact of leads access on post-procedural outcome. Methods Consecutive patients receiving a CIED from 2008 to 2019 in 4 high-volume Italian hospitals were enrolled. Short- and long-term complications (i.e. pneumothorax, cardiac tamponade, pocket decubitus, pocket hematoma, lead dislodgement, lead failure) were collected and their relationship with the type of vascular access (extra- vs intra-thoracic, i.e. cephalic vein/extra-thoracic axillary vein vs subclavian vein puncture) was analyzed. Primary endpoint was the occurrence of at least one complication during follow-up. Results A total of 4,443 patients were enrolled; 3,374 (75.9%) received a pacemaker (PM) and 1,069 (24.1%) an implantable cardioverter defibrillator (ICD). Mean follow-up was 1,630±1,010 days. At least one complication occurred in 7.6% of patients. At multivariate Cox regression analysis, adjusted for baseline confounders, the presence of structural heart disease (HR 1.59, 95%CI 1.21-2.10; p=0.001), anticoagulant therapy at implantation [HR 1.31, 95%CI 1.0004-1.71; p=0.05) and female gender (HR 0.78, 95%CI 0.63-0.98; p=0.03) were associated with the primary outcome measure. Extra-thoracic access did not reduce the risk of complications compared to intra-thoracic access (HR 0.97, 95%CI 0.76-1.25 p=0.81). The use of both accesses in the same patient conferred a significant increase in the risk of complications (HR vs single approach:1.95, 95%CI 1.41-2.69; p <0.001). Conclusions The choice of a different vascular access (intra- vs extra-thoracic) does not impact on post-procedural complications in patients receiving CIED. In particular, the intra-thoracic subclavian vein puncture by experienced operators is not related to a poorer outcome. The need for both types of access in the same patient (i.e. increased procedure complexity) increases the risk of post-procedural complications.Graphical abstract

Extracción percutánea con vainas mecánicas en las infecciones de dispositivos de electro estimulación cardiaca

The treatment of choice for infections of cardiac pacing devices is currently percutaneous endovascular traction with mechanical or laser dissection sheaths, which in experienced hands has a success rate of almost 98% and a mortality rate of less than 1%.The success of the procedure depends mainly on the experience of the operator and the characteristics of the device itself (pacemaker/defibrillator, side and time of implantation, type, number and condition of the electrodes). Safe extraction with mechanical sheaths requires knowledge of the tools used in the procedure, a systematic approach (including all possible precautions), and a good understanding of the possible complications that may arise. It is also necessary to have the means available for early diagnosis and treatment.Throughout this review we will answer many questions: What to do before we start? How do we perform the extraction? Why use mechanical sheaths and what are their advantages over laser sheaths? Where to start and how to finish?

Guide to identify specific characteristics in cardiac pacing devices by radiological figure.

This guide provides help for medical doctors systematically identifying each commercial brand of pacemakers by thoracic radiography through their electronic components (electrode connectors, logic circuit, and battery); this is crucial for watching the pacemaker after being implanted. We aimed to describe the different cardiac stimulation devices, electrodes, and programming modes more frequently used.

PO-619-04 MIMIC HEART RATE VARIABILITY ALGORITHMS FOR PACEMAKERS

Heart rate variability (HRV) is the physiological variation in the duration of cardiac cycles. HRV is a complex signal composed of multiple frequencies that give it chaotic characteristics. These characteristics are not taken into account in current cardiac pacing devices, whose operation is fundamentally periodic, with variations according to the level of activity.

Long-term impact of transient atrioventricular block during atrioventricular nodal re-entrant tachycardia ablation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Ablation of atrioventricular nodal re-entrant tachycardia (AVNRT) is an extremely safe procedure, being complete atrioventricular (AV) block the most feared complication. Transient AV or ventriculoatrial (VA) block during ablation is considered a risk marker of immediate AV permanent block. Purpose To study whether TB (transient block) during AVNRT ablation is associated with a higher risk of AV permanent block and pacemaker implantation during long term follow-up. Methods Retrospective analysis of all patients who underwent ablation for AVNRT in our center and had a minimum five years follow-up. Patients carrying a cardiac pacing device were excluded. Data was extracted from electronic medical records and follow-up was performed by telephone contact. TB was defined as AV or VA loss of conduction of at least 1 beat during energy delivery. Results We included 689 patients who underwent AVNRT ablation from March 1995 to December 2015: mean age 52.6 ± 18.6 years; 240 (34.8%) male; 677 radiofrequency and 12 cryotherapy ablations. TB was observed in 106 (15,4%) patients. Baseline characteristics are described in Table 1. Within the TB group, 44 (41.5%) patients presented with AV block, 60 (56.6%) with VA block, and 2 patients presented with both. TB concerned more than one beat in 65 (61.9%) cases and persisted after cessation of energy delivery in 15 (14.2%) cases. Two patients did not recover AV conduction, requiring pacemaker implantation before discharge. During a median 12.5 years follow-up (IQR 9.5-16.6), 3 of the remaining 104 TB patients required pacemaker implantation due to AV block. All 3 had presented AV TB and had undergone radiofrequency ablation; they were not significantly older (67.0 ± 9.3 vs 48.8 ± 19.8, p = 0.12) but presented longer basal PR (237.0 ± 115.2 vs 152.6 ± 26.5, p < 0.001) and HV (57.3 ± 6.7 vs 44.2 ± 7.6, p = 0.004) intervals. When compared to the non-TB group, there were no differences in pacemaker implantation due to AV block during follow-up (7 (1.2%) p = 0.19). However, median time to pacemaker implantation was shorter in TB patients than in non-TB: 0.7 [0.1-1.4] vs 13.7 [5.2-22.0], p = 0.02. Conclusion Long term incidence of permanent AV block did not differ between TB and non-TB groups, however AV block occurred significantly earlier in TB patients. Non-TB group(n = 583) TB group(n = 106) p Age (mean ± SD) 53.2 ± 18.3 49.3 ± 19.8 0.05 PR (mean ± SD) 153.0 ± 28.4 155.0 ± 33.8 0.54 AH (mean ± SD) 83.3 ± 23.6 82.1 ± 22.2 0.64 HV (mean ± SD) 44.4 ± 7.8 44.6 ± 7.9 0.76

Atrial pacing as a new predictor for atrial high rate episodes in patients with dual-chamber pacemaker

Introduction and objectivesAtrial and ventricular pacing (AP/VP) have been related to a higher risk of clinical atrial fibrillation (AF). Subclinical AF (SCAF) is detected as atrial high rate episodes by cardiac pacing devices. We aimed to determine whether the percentage of AP/VP is related with the development of SCAF. MethodsFrom February 2012 to September 2015 we recruited consecutive patients with dual chamber pacemakers and no history of AF. SCAF (atrial high rate episodes), clinical AF (electrocardiographically documented) and cardiovascular events were registered. ResultsA total of 249 patients (57% men; 75±9 years) were included. After a mean follow-up of 33±11 months, 38.5% developed SCAF and 10.4% AF. Patients with AP ≥ 50% presented higher risk of SCAF (62.5% vs 32.3%; OR, 3.48; 95%CI, 1.93-6.4; P<.01) and AF (18.7% vs 8.6%; OR, 2.4; 95%CI, 1.05-5.52; P <.05). Patients with VP ≥ 50% had higher risk of SCAF (46.4% vs 31.6%; OR, 1.87; 95%CI, 1.10-3.24; P <.05) and AF (25.9% vs 9.7%; OR, 2.7; 95%CI, 1.13-7.72; P <.05). AP ≥ 50% was an independent predictor for SCAF (HR, 2.44; 95%CI, 1.20-4.97; P=.014). ConclusionsAtrial and ventricular pacing are related with higher risk of developing subclinical and clinical AF in patients with dual-chamber pacemakers and no history of previous AF. Our data suggest, that patients presenting a high percentage of AP should be closely followed during routinely pacemaker check-ups assessing for SCAF.

Work-up of an inflammatory cardiomyopathy

Abstract A 72-year-old woman was admitted for acute heart failure. The echocardiography revealed moderate depression of the left ventricular ejection fraction. Coronary disease was excluded by coronarography. Cardiac magnetic resonance showed predominantly left ventricular septal hypertrophy and severe depression of the left ventricular systolic function. There was also a bright, multifocal and patchy late gadolinium enhancement with subendocardial, mesocardial and subepicardial involvement, suggestive of sarcoidosis. Biochemical study, thoracic computed tomography and positron emission tomography were inconclusive for extra-cardiac sarcoidosis. Therefore, an endomyocardial biopsy was performed. The procedure was complicated by the development of complete atrioventricular block, requiring implantation of a cardiac resynchronization pacing device. A few days after device implantation, the patient developed fever. The echocardiography revealed extensive vegetations, and thus the diagnosis of a device-associated infective endocarditis was made. Even though antibiotic therapy was promptly started, the patient ended up dying. Biopsy results revealed lymphocytic myocarditis. This case is paradigmatic because it shows how the etiologic diagnosis of dilated cardiomyopathy can be challenging. Non-invasive diagnostic exams may not provide a definite diagnosis, requiring an endomyocardial biopsy. However, the benefits versus risks of such procedure must always be carefully weighted.

Acute and Long-Term Outcomes of Transvenous Cardiac Pacing Device Implantation in Patients With Congenital Heart Disease.

Background: Little is known about the acute/long-term outcomes of implantation of cardiac implantable electronic devices (CIED) using a transvenous approach for patients with congenital heart disease (CHD).Methods and Results: We retrospectively investigated the acute/long-term results and complications associated with transvenous CIED implantation in 140 patients with CHD. We implanted 77 pacemakers, 51 implantable cardioverter defibrillators (ICD), and 12 cardiac resynchronization therapy (CRT) devices. Although we successfully implanted pacemakers and ICD in all patients, we could not place a coronary sinus (CS) lead in 25% of the patients requiring CRT devices due to coronary vein anomalies associated with corrected transposition of the great arteries (cTGA). Overall complication rate, lead failure rate, and incidence of device infection were 16%, 9%, and 0.7%, respectively. There was no significant difference in overall complication rates between the simple (n=22) and complex CHD (n=118) groups (14% vs. 16%). The 10-year lead survival for the ICD leads (77%) was significantly lower than for the pacemaker leads (91%, P=0.0065).Conclusions: The outcomes of transvenous CIED in patients with CHD seemed acceptable, although there was a relatively high incidence of complications. CS lead placement for cTGA may be hindered by coronary vein anomalies. Lead survival tended to be lower for ICD than for pacemakers in these patients.

Clinical experience of magnetic resonance imaging in patients with cardiac pacing devices: unrestricted patient population.

Magnetic resonance imaging (MRI) in patients with cardiac pacing devices has become available despite previously being considered absolutely contraindicated. However, most institutional safety protocols have included several limitations on patient selection, leaving MRI unavailable for many patients. To evaluate the first 1000 MRI examinations conducted on patients with cardiac pacing devices at Helsinki University Hospital for any potential safety hazards and also to evaluate the long-term functionality of the safety protocol in “real-life” clinical practice. A total of 1000 clinically indicated MRI scans were performed with a 1.5-T MRI scanner according to the safety protocol. The following information was collected from the electronic medical record (EMR): patients’ date of birth; sex; pacing device generator model; date of MRI scan; date of the latest pacing device generator implantation; and the body region scanned. The EMR of these patients was checked and especially searched for any pacing device related safety hazards or adverse outcomes during or after the MRI scan. Only one potentially dangerous adverse event was noted in our study group. In addition, patients with abandoned leads, temporary pacing devices, and newly implanted pacing device generators were scanned successfully and safely. MRI scans can be performed safely in patients with cardiac pacing devices if the dedicated safety protocol is followed.

Salvage of Threatened Cardiovascular Implantable Electronic Devices: Case Series and Review of Literature.

The treatment of infected or exposed cardiac pacing and defibrillator devices is controversial. The conservative and widely accepted management calls for removal of the device and leads with immediate or delayed replacement of new components in a new site. Lead extraction carries a 2% major complication risk. In this article, we describe our experience with device salvage techniques and review the current literature. This is a retrospective case series of consecutive patients with infected, exposed, or at-risk implanted cardiac devices that were treated with aggressive surgical debridement, local pocket irrigation, and revision. A comprehensive review of the literature regarding device infection management was performed. Ten patients with threatened devices were identified. Surgical revision with the aim to salvage the device was successful in 8 (80%) of 10 cases. Seventeen retrospective publications were reviewed. All indicate success with attempted salvage surgery, but heterogeneity of data limits formal meta-analysis and prevents management recommendations. Cardiac pacing and defibrillator devices with low-grade infection or threatened exposure may be salvaged without explantation. Despite the lack of clear management guidelines or data, plastic surgeons may be asked to assist in the management of threatened cardiac devices. Further prospective trials are required to evaluate the safety, efficacy, and cost-effectiveness of attempted implant salvage.

Leadless pacemaker extraction from a single-center perspective.

Leadless pacemaker can be considered as a technical revolution in cardiac pacing devices, with clear advantages over conventional pacemakers in overcoming all lead-related complications. However, the management of these devices once they reach the end of life (EOL) of the battery is still controversial. In the next years, there will be an increase in the need to define a clear strategy in the management of leadless PM once they reach their EOL. Safe extraction of these devices will define in a great manner this strategy METHODS: We performed the extraction of three functioning Nanostim leadless pacemaker prophylactically in two females and one male patients as part of the Nanostim battery depletion field action recommendation. All patients had a prior transesophageal 3D echocardiography to determine the device intracardiac mobility and the extent of possible endothelialization. For the extractions, we used the Nanostim Retrieval Catheter S1RSIN (St. Jude Medical, St. Paul, MN, USA), which is a proprietary catheter provided by the manufacturing company based on a lasso. Complete extraction of the devices was achieved in all patients using a relatively short fluoroscopic time (16, 19, and 12 minutes). The extraction of leadless pacemakers can be considered as a safe and feasible procedure using the tools provided by the manufacturer and designed for the extraction. However, a very low threshold must be maintained to avoid any risk to the patients. Our extraction time ranges are between 983 and 1,070 days, nevertheless it is necessary to gather more long-term data to assess the feasibility and safety of these procedures.

Safely Preserving the Breast in Patients With Cardiac Pacing Devices

Safely Preserving the Breast in Patients With Cardiac Pacing Devices

Cardiac Pacing and Defibrillation Devices: Cost and Effectiveness.

Implantable cardiac pacing and defibrillation devices are effective and commonly used therapies for patients with cardiac rhythm disorders. Because device implantation is not easily reversible, as well as the high healthcare costs inherent in device use, a clear understanding of the clinical benefits relative to costs is essential for both appropriate clinical use and rational policy making. Cardiac implantable electronic devices (CIEDs) have been among the best-investigated therapies in medicine; these devices have been the topic of numerous clinical and economic evaluations during the past 30 years. However, many important questions remain unclarified. We review the evidence supporting the clinical benefits of CIEDs, including effectiveness in extending survival as well as improving quality of life. We also summarize the economic studies that have investigated costs associated with these devices and their overall cost effectiveness, and we highlight important potential areas for future research.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high.

56 The Influence of Chronotropic Incompetence on Exercise Capacity in Chronic Heart Failure

IntroductionIncreased cardiac output during exercise is the result of greater stroke volume and an increase in heart rate. It is therefore assumed that a limitation to heart rate rise (HRR)...

Procedimiento de actuación de enfermería en la extracción de dispositivos de estimulación cardiaca

The need of the extraction of an artificial cardiac pacing device is not exempt from complications, and may involve an increase in morbidity and mortality, even in expert hands, despite the improvement in the technological performance of these devices.The state of leads is the main obstacle for an effective and safe extraction of implants (more adherence, greater difficulty). The extraction is, therefore, advised to be carried out by experienced health professionals.We describe the nursing intervention procedure on the extraction of artificial cardiac pacing devices in the operating room of Cardiac surgery (Virgen del Rocio University Hospital Seville).

Deterioration of left ventricular ejection fraction and contraction synchrony during right ventricular pacing in patients with left bundle branch block

Electrocardiographic left bundle branch block (LBBB) may be intrinsic, due to ventricular conduction system disease, or induced by right ventricular pacing. Prior reports clearly delineate the derogatory impact of LBBB on left ventricular (LV) mechanical synchrony and global function, and suggest that the intrinsic and induced varieties are equivalent. This study sought to determine the difference in LV synchrony and global function between intrinsic LBBB and right ventricular apical pacing induced LBBB. Ten patients with heart failure, diminished ejection fraction (EF) (33±11%), intrinsic LBBB and an implanted cardiac pacing device were studied. In each patient, separate gated SPECT acquisitions were performed during intrinsic ventricular activation (atrial pacing) and during induced LBBB (atrial and right ventricular pacing). During each condition, LVEF, contraction synchrony (phase standard deviation, PSD), and spatial pattern of activation were measured. Compared to intrinsic, induced LBBB was associated with decreased EF (30±11% vs 33±11%, P=.007), contraction synchrony (PSD 49.7±23.2° vs 41.6±19.8, P=.02), and a disparate spatial pattern of activation. Induced LBBB is associated with significantly worse global and regional LV mechanical function than intrinsic LBBB.