Implantable Devices Research Articles

Increased fluid accumulation, reduced physical activity and heart rate variability during national holidays in patients with cardiac implantable electronic devices.

The higher incidence of myocardial infarction during national holidays could be caused by overindulgence of food and beverages, potentially straining the heart of vulnerable individuals. Monitoring decreased thoracic impedance by cardiac implantable electronic devices (CIED) can be used for detection of fluid accumulation. We aimed to assess the relationship between cardiac metrics and national holidays in patients with CIED. Patients with CIED-based impedance monitoring at a tertiary care hospital in Sweden were screened. Patients were included if they had data for at least one holiday (Christmas, New Year or Midsummer) between June 2015 and January 2020. Thoracic impedance, heart rate variability and activity during the holiday were compared with baseline values, defined as the average of three days preceding Christmas and Midsummer. Clinical characteristics were obtained from medical records. In total, 96 patients (82 % men, age 69±10 years, 92 % ICD, 78 % CRT, 72 % with LVEF<40%) were included, which provided data for 649 patient-holidays. During Christmas Day, New Years Day and Midsummer Day combined, impedance decreased by a mean of 1.1 Ohm [95% CI 0.7-1.6, p< 0.001], heart rate variability decreased by a mean of 8.0 ms [4.9-11.2, p >0.001] and daily activity by a mean of 40 minutes [35-45, p<0.001]. One ventricular tachycardia event requiring shock therapy was documented during the holiday. A transient decrease in thoracic impedance, heart rate variability and physical activity was observed during national holidays, potentially contributing to the higher incidence of myocardial infarction during holidays.

Evaluating the Characteristics of the Totally Implantable Venous Access Device in Cancer Patients Using Fluorodeoxyglucose-PET/CT in the Absence of Suspected Catheter-Related Infections

Evaluating the Characteristics of the Totally Implantable Venous Access Device in Cancer Patients Using Fluorodeoxyglucose-PET/CT in the Absence of Suspected Catheter-Related Infections

Multicentric Experience With the Use of Short 13Fr Mechanical Rotating Dilator Sheath for Transvenous Lead Extraction.

The need for transvenous lead extraction (TLE) is increasing worldwide. Since the course of the subclavian vein until the junction with the superior vena cava is a frequent place of lead adherences, we aim to assess the safety and efficacy of a short 13Fr bidirectional rotational mechanical sheath as first choice. In this multicentric study, 202 carriers of a cardiac implantable electronic device (CIED) undergoing TLE using a short 13 Fr bidirectional rotational mechanical sheath were prospectively enrolled. All procedures were performed using a stepwise approach. The indication for TLE were infection (62%), malfunction (32%), and upgrade (6%). Overall, 471 leads were extracted: 65% pacing leads, 20% defibrillator leads, 9% coronary sinus leads, and 6% abandoned leads. Clinical success and complete lead extraction have been achieved in 97% and 95% of cases, respectively. The short sheath was always effective in gaining venous access at the start of the procedure and was sufficient for complete TLE in 67% of cases. Lead dwell time, defibrillator lead, number of leads per patient, and lead malfunction were predicting factors of long bidirectional rotational mechanical sheath use. There were no cases of intraprocedural death, and major complications were reported in 2% of patients. Overall survival was 97% at 1-year follow-up. This multicentric experience using a short 13Fr bidirectional rotational mechanical sheath reported high safety and efficacy, demonstrating the utility of routine use of short extraction sheaths of higher caliper as the first choice.

Executive Summary: State-of-the-Art Review: Complexities in Cardiac Implantable Electronic Device Infections: A Contemporary Practical Approach.

Cardiac implantable electronic device infections (CIEDIs) present substantial challenges for infectious diseases specialists, encompassing diagnosis, management, and complex decision-making involving patients, families, and multidisciplinary teams. This review, guided by a common clinical case presentation encountered in daily practice, navigates through the diagnostic process, management strategies in unique scenarios, long-term follow-up, and critical discussions required for CIEDIs.

State-of-the-Art Review: Complexities in Cardiac Implantable Electronic Device Infections: A Contemporary Practical Approach.

Cardiac implantable electronic device infections (CIEDIs) present substantial challenges for infectious diseases specialists, encompassing diagnosis, management, and complex decision making involving patients, families, and multidisciplinary teams. This review, guided by a common clinical case presentation encountered in daily practice, navigates through the diagnostic process, management strategies in unique scenarios, long-term follow-up, and critical discussions required for CIEDIs.

Approach to joint wireless powering and communication with electronic implantable medical devices based on near-infrared light

This paper proposes what we believe to be a novel approach using near-infrared (NIR) light to jointly provide wireless communication and energy transfer to electronic implantable medical devices (IMDs). The proof-of-concept was implemented on a test bed constructed with commercially available components, including a single-beam 810 nm NIR LED, a monocrystalline photovoltaic cell (PV), a power management integrated circuit (PMIC), a photodetector amplifier (PDA), and a supercapacitor for energy storage. Three different experiments were conducted using a 1 cm thickness optical phantom mimicking the human soft tissue. First, we demonstrated optical power transfer capability. Second, we demonstrated data transmission capability utilizing Gaussian minimum shift keying (GMSK) modulation to carry the data. Third, we demonstrated joint data and power to IMDs. In terms of wireless energy transfer, the result shows that the supercapacitor achieves a full charge in approximately five hours with a constant NIR light exposure of 200 mW/cm2 across the optical phantom. Concerning wireless data transfer, data rates of approximately 100 kb/s are achieved. We show that combining wireless power transfer and data communication through a single beam NIR LED is feasible. Our approach aims to significantly enhance clinical applications and patient care in the field of biomedical engineering, especially in the context of providing secure and safe wireless communication links and power transfer techniques for IMDs.

PLACE: Multicenter Study for Right Ventricular Failure on Mechanical Cardiocirculatory Supports.

Isolated acute right ventricular failure (aRVF) is associated with poor prognosis in different scenarios. In severe conditions, temporary mechanical cardiocirculatory support (tMCS) is required. PLACE is an international, retrospective, multicenter registry including 17 centers that investigated patients affected by isolated aRVF and treated with various types of tMCS from January 2000 to December 2020. The registry included 644 (69.6% males, mean age: 55 years) patients. The most frequent etiologies were post-left ventricular assist device implantation (LVAD) and postcardiotomy shock. These patients received mostly mechanical circulatory support (MCS) and veno-arterial extracorporeal membrane oxygenation. Mean tMCS duration was 9 days, weaning was achieved in 70.5% of the patients, and the major cause of death on support was multiorgan failure (50.5%). The mortality rate was 45 and 48.4% in-hospital and at 3 month follow-up, respectively. Multivariable logistic regression analysis identified age, aRVF due to acute pulmonary hypertension, bilirubin level, and oliguria or anuria at tMCS implantation as risk factors for in-hospital mortality. Conversely, aRVF after LVAD was found to be associated with a lower risk of early mortality. In-hospital and 3 months mortality occurred in less than half of the aRVF-supported subjects. Furthermore, several preimplant aspects such as age, organ function, and type of tMCS are independently associated with in-hospital and 3 month mortality.

Angiology in rhythmology: What should Iknow about vascular complications?

Both the performance of electrophysiological examinations and the implantation of cardiac devices (pacemakers, implantable cardioverter-defibrillator [ICDs], and cardiac resynchronization therapy defibrillator [CRT-D] systems) are associated with vascular punctures. This article provides an overview of possible vascular complications and their management from the perspective of angiology. The most common access site for invasive electrophysiological procedures is usually via the femoral veins and/or arteries. Puncture of the brachial vessels is apossible but rarely used alternative. For implantation of transvenous cardiac devices, access via the cephalic vein or axillary vein is used. The electrodes located in the venous vascular system represent aforeign material and increase the risk of thrombus formation in the affected vein. Punctures of the femoral vessels can lead to bleeding, thrombosis and the formation of arteriovenous fistulas or pseudoaneurysms (aneurysma spurium). Venous thromboses can occur postprocedurally. The correct puncture technique is essential to avoid complications. Ultrasound-guided puncture also significantly reduces the rate of vascular complications.

Sex Differences in the In-Hospital Outcomes of Left Ventricular Assist Device Implantation: A Population-Based National Inpatient Sample Study From 2015 to 2021.

Left ventricular assist device (LVAD) implantation can be used to manage advanced heart failure. Debates over sex differences in postoperative outcomes of LVAD implantation remain contentious; there is limited evidence available from the continuous-flow era, particularly following the introduction of third-generation devices. This study aimed to conduct a comprehensive, contemporary, and population-based analysis of the sex difference in the in-hospital outcomes following LVAD implantations. Patients who underwent LVAD implantation were selected from National Inpatient Sample from Q4 2015-2021. Multivariable logistic regression was used to compare in-hospital outcomes between females and males, where demographics, socioeconomic status, primary payer status, hospital characteristics, comorbidities, and transfer/admission status were adjusted. There were 1201 (23.6%) female and 3881 (76.4%) male patients who underwent LVAD implantation. Females and males had comparable in-hospital mortality, MACE, and stroke. However, females had higher diaphragmatic paralysis (aOR = 7.94, 95 CI = 1.46-43.48, p = 0.02). Meanwhile, females had lower cardiogenic shock (aOR = 0.85, 95 CI = 0.73-0.98, p = 0.02), renal complications (aOR = 0.72, 95 CI = 0.62-0.84, p < 0.01), and infection (aOR = 0.70, 95 CI = 0.58-0.86, p < 0.01). Females also had longer hospital length of stay (44.1 ± 40.0 vs. 38.8 ± 30.6 days, p = 0.01) and higher total hospital charges (1293779.0 ± 1182139.0 vs. 1172780.0 ± 917544.0 US dollars, p = 0.04). In the contemporary era with the introduction of third-generation devices, in-hospital mortality and stroke after LVAD implantation continued to decrease and were comparable in both sexes. However, there are still notable sex-based differences in the complications of LVAD implantation, which underscores the need for sex-specific preoperative risk assessments and tailored perioperative management.

Insights from serial cardiovascular magnetic resonance imaging show early progress in diastolic dysfunction relates to impaired right ventricular deformation

Latent pulmonary vascular disease is a distinct feature already in the early pathophysiology of masked heart failure with preserved ejection fraction (HFpEF) and associated with reduced right ventricular (RV) functional reserve. We hypothesized that serial real-time cardiovascular magnetic resonance (CMR) imaging at rest and during exercise-stress may detect early progress in pathophysiological alterations in HFpEF. Patients presenting with exertional dyspnoea and signs of diastolic dysfunction (E/e’>8, left ventricular (LV) ejection fraction > 50%) were prospectively enrolled in the HFpEF Stress Trial (NCT03260621). Rest and exercise-stress echocardiography, CMR and right heart catheterisation were performed at baseline. Pulmonary capillary wedge pressure (PCWP) was used for classification of HFpEF (≥ 15/25mmHg at rest/during exercise-stress) and non-cardiac dyspnoea (NCD). Repeat rest and exercise-stress CMR was performed in median 2.94 years after recruitment during which timeframe some HFpEF patients had undergone interatrial shunt device (IASD) implantation. Cardiovascular events were assessed after 4 years.Serial CMR scans were available for NCD n = 10, HFpEF n = 10 and HFpEF with IASD implantation following baseline diagnosis n = 6. RV long axis strain at rest and during exercise-stress decreased in HFpEF (p = 0.007 for both) but neither in NCD nor HFpEF with IASD. In contrast, in NCD, an improvement in LA LAS during exercise-stress (p = 0.028) was noted. There were no functional alterations in HFpEF patients who had undergone IASD implantation. RV functional deterioration may be a pathophysiological feature during early-stage disease progress in HFpEF. In this observational study RV functional deterioration was detected in HFpEF patients only but not patients with NCD and patients with HFpEF that were treated with IASD placement. These findings should next be explored in adequately powered future research trials. Clinicaltrials.gov: NCT03260621 (First posted date 24/08/2017).

Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices

The aim was to identify the experiences of Notified Bodies (NBs) in Europe in applying restrictions or limitations to certificates for high-risk medical devices. A survey examining NB practices regarding restrictions or limitations applied to Class III and IIb implantable medical devices was conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU.

Effect of atrial high-rate episodes (AHREs) on functional status and quality of life (QoL) in heart failure—cardiac resynchronization therapy population

BackgroundNew type of arrhythmia called atrial high-rate episodes (AHREs) has been discovered thanks to the ability of cardiac electronic implantable devices to track, record, and analyze complex arrhythmias. The aim is to determine factors associated with AHRE in HFrEF/CRT patients and the effect of AHRE on functional capacity and quality of life (QoL).ResultsWe interrogated 100 patients' devices to gauge the incidence and burden of AHRE, then assessed their functional capacity using the standard 6-min walk test (6MWT), and evaluated their QoL using the Minnesota Living with HF questionnaire (MLHFQ) score. 34% of patients had AHRE, and 91.2% of them had AF. By multivariate logistic regression analysis, smoking (OR 9.426, 95% CI [1.33, 66.65], P 0.025), higher BMI (OR 1.336, 95% CI [1.09, 1.635], P 0.005), and increased LAVI (OR 1.16, 95% CI [1.063, 1.262], P < 0.001) are independent predictors for AHRE. There was a significant correlation between AHRE and the distance walked during 6MWT when compared to the distance expected for an equivalent healthy individual (82.02 ± 17.22% in the non-AHRE group vs. 75.15 ± 15.78% in the AHRE group, P < 0.001). It was found that AHRE was statistically linked to a higher total MLHFQ score (46.76 ± 9.82 in the AHRE group vs. 36.97 ± 7.76 in the non-AHRE group, P 0.032), with higher physical scores in the AHRE group.ConclusionAHRE significantly reduces functional status and perceived quality of life in HFrEF patients receiving CRT. Longer than five minutes of AHRE was associated with a higher MLHFQ score and worse performance on the 6MWT. In that patient population, smoking, obesity, and elevated LAVI were independent predictors of AHRE.

The Heart of the Matter: Exploring a Veteran's Wish for Pacemaker Deactivation.

Individuals living with serious illness might request deactivation of a cardiac implantable electronic device for a variety of reasons. Discontinuation of implantable cardiac defibrillators and pacemakers are considered to be ethically sound procedures. However, healthcare professional comfort with discontinuation of different types of devices might vary. In this case we describe a veteran's request for pacemaker deactivation and our interdisciplinary team's response to this request, including evaluation of total suffering, ethical considerations, and mood symptoms at end-of-life.

The Reconstructed Individual Patient Data from Kaplan–Meier (IPDfromKM) Method for Non-Inferiority Analyses: A New Potential Application

The IPDfromKM method, or Shiny method, is an artificial intelligence tool that enables indirect comparisons between studies by reconstructing individual patient data (IPD) from Kaplan–Meier (KM) curves. The IPDfromKM method is generally used for superiority analyses, but a further application could be represented by non-inferiority analyses. However, there are no studies supporting this methodological hypothesis. The aim of this work was to validate the IPDfromKM method for non-inferiority analyses by “exploiting” the well-described non-inferiority of implantable devices occluding the left atrial appendage compared to oral anticoagulants in patients with atrial fibrillation. We performed a systematic review searching for randomized controlled trials (RCTs) in the PubMed database and found five studies. The R software (version 4.3.3) was used to perform a standard survival analysis comparing Watchman and Amlet devices with warfarin. The hazard ratio (HR), with 95% confidence interval (CI), was the main parameter of our analysis. The results confirmed the non-inferiority of Amlet and Watchman compared to warfarin (HR of Watchman vs. warfarin: 1.23, 95% CI 0.80 to 1.9; HR of Amlet vs. warfarin: 1.05, 95% CI 0.61 to 1.80). Therefore, we proposed a new application of the IPDfromKM method that could be potentially relevant in decision-making for the management of this common cardiac arrhythmia and a wide range of other pathological conditions.

HSPICE simulation and analysis of current reused operational transconductance amplifiers for biomedical applications

The proposed work focuses on the design of a current-reused biomedical amplifier; it is a microwatt-level electrocardiogram (ECG) analog circuit design that addresses low power consumption and noise efficiency. As implantable devices require unobtrusiveness and longevity, the current reuse technique in this circuit effectively enhances power and noise efficiencies. Using 90 nm technology enables efficient circuit implementation, yielding promising simulation results. At 100 Hz, the noise performance reaches 62.095 nV/√Hz, while the power consumption is only 8.3797 µW. These advancements are pivotal for next-generation implantable devices, ensuring reliable operation and reducing frequent battery replacements, improving patient convenience. Moreover, the high noise efficiency ensures that ECG signals are captured with high fidelity, crucial for accurate monitoring and diagnosis. This research addresses the challenges in implantable ECG analog circuit design and sets a benchmark for future developments. The techniques employed can be adapted for other bio signal monitoring devices, broadening the impact on healthcare technology. Ultimately, this advancement contributes to more efficient, reliable, and long-lasting medical devices, enhancing patient monitoring and healthcare on a broader scale.

Safety and Feasibility of 3D Intracardiac Echocardiography in Guiding Left AtrialAppendage Occlusion With WATCHMAN FLX.

Intracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice. This prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips). A total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak<5mm) at 45days. The safety endpoint was the incidence of major complications at 7 and 45days. Physician experience and imaging quality scores were collected (1=lowest, 5=highest). The mean age was 77.0±8.1years, and 39 (39%) were women. CHA2DS2-VASc score was 4.8±1.5 and HAS-BLED score was 3.2±1.1. Total procedural time was 54±25minutes. Mean contrast volume was 41±46ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5mm at 45days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7days with no other major complications. Physicians' rating of overall ICE imaging quality was 4.6±0.6. The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.

2021 European Society of Cardiology guidelines on cardiac pacing and cardiac resynchronisation therapy : Statement of endorsement by the NVVC.

The European Society of Cardiology (ESC) has updated its guidelines on cardiac pacing and cardiac resynchronisation. As the majority are classII recommendations (61%) and based on expert opinion (59%), acritical appraisal for the Dutch situation was warranted. Aworking group has been established, consisting of specialists in cardiology, cardiothoracic surgery, geriatrics, allied professionals in cardiac pacing, and patient organisations with support from the Knowledge Institute of the Dutch Association of Medical Specialists. They assessed the evidence leading to the recommendations and the suitability for daily Dutch practice. Several recommendations have been amended or omitted altogether if aconflicting Dutch guideline has recently been published, such as aguideline on performing magnetic resonance imaging in patients with cardiac implantable electronic devices. The recent Dutch guideline on implantable cardioverter defibrillator implantation in patients with non-ischaemic cardiomyopathy has recommended implanting cardiac resynchronisation therapy devices without adefibrillator function. Shared decision making has received amore prominent role in the ESC guidelines and is discussed in more detail in this document. The recommendations given in this document are intended for health care professionals involved in the care of patients with an indication for cardiac pacing and are approved by the participating professional societies and the patient organisation Harteraad.

Implantable Cardioverter Defibrillator Generator Replacement and Breast Implant Revision-A Combined Case.

Physicians are increasingly likely to encounter patients with both cardiac implantable electronic devices (CIED) and breast implants insitu. Our case indicates the importance of appropriate planning and multidisciplinary input for CIED procedures in patients with breast implants or vice versa. When planning the procedure, the aesthetic outcome needs to be considered.

Protection from sudden cardiac death using a new extravascular implantable cardioverter-defibrillator device: a literature review and a case series from a high-volume single center

The extravascular implantable cardioverter-defibrillator (EV-ICD, Aurora, Medtronic, Minneapolis, MN, USA) has recently been validated as a new device for preventing arrhythmic death with the aim of reducing vascular and mechanical complications of transvenous ICDs and overcoming the limitations of subcutaneous ICDs. A dedicated learning program is required and, in addition to the electrophysiologist, the implantation procedure must be performed with the assistance of an anesthesiologist for general anesthesia induction and, especially in the early stages of training, a cardiothoracic surgeon for assistance during access to the retrosternal space where the lead should be placed. The objective of this case series is to describe the experience at our high-volume hospital where we treated the first 10 patients with the Aurora EV-ICD device over a period of 8 months.

Ventricular assist device implantation in children with a mechanical valve: An ACTION registry analysis

Ventricular assist device implantation in children with a mechanical valve: An ACTION registry analysis