Cardiac Implantable Electronic Devices Patients Research Articles

A novel score predictor for atrial fibrillation in cardiac implantable electronic device patients

Abstract Background Atrial fibrillation (AF) in individuals with cardiac implantable electronic devices is associated with heightened risks of adverse outcomes. Despite this, risk stratification for AF development in this patient cohort remains unexplored. Consequently, we present the development and validation of a simplified multi-parameter risk-based scoring system for predicting AF in patients with cardiac implantable electronic devices. Methods and Results A cohort of 226 consecutive patients with cardiac implantable electronic devices at Rajavithi Hospital underwent comprehensive follow-up to observe AF development, defined by 12-lead EKG evidence of AF. Analysis encompassed risk factors and AF incidence. The resulting V-DASH score integrated a History of vascular disease, including coronary artery disease (CAD) and peripheral arterial disease (PAD) (1.5 points), Diabetes (1 point), Apical lead position (1 point), Sex (female gender (1.5 points)), and Hypertension (1 point). Predictive value assessment revealed that Diabetes, Female gender, and a history of vascular disease were significantly associated with AF incidence. Apical lead position and Hypertension emerged as robust risk factors for AF development. Over a median follow-up duration of 13 months, 8 (3.53%) patients developed AF. The incidence of AF exhibited a noteworthy escalation in correlation with the V-DASH score (4.68 times higher risk per point increase). Among patients with a V-DASH score ≥4, the probability of AF occurrence was 97.34%. The V-DASH score demonstrated exceptional predictive capability (area under the curve, 0.90; 95% CI, 0.79–1.00), calibration ability (Hosmer-Lemeshow goodness-of-fit P=0.552), and accuracy (sensitivity 87.50% and specificity 83.94%), surpassing other clinical scores such as the C2HEST score. Conclusions The V-DASH score emerged as a robust predictor of AF incidence in patients with cardiac implantable electronic devices, with the highest risk observed in those with a V-DASH score ≥4. The potential clinical utility of the V-DASH score in this patient population warrants further investigation.ROC curve for predicting AFPerformance calibration plot

Cardiac Implantable Electronic Device (CIED) Infections, Associated Risk Factors and Optimization in Reducing CIED Infections; An Experience of Tertiary Care Hospital of Pakistan

Objective: To determine the frequency of infections in cardiac implantable Electronic device patients, identify risk factors, and look for optimization in reducing Cardiac Implantable Electronic Device infections, with a resultant decrease in mortality and morbidity, decrease in hospital stay, and total expenditure. Study Design: Cross-sectional study. Place and Duration of Study: Electrophysiology Department of National Institute of Cardiovascular Diseases, Karachi Pakistan, from Jul 2019 to Jun 2020. Methodology: The study was conducted on the patients with cardiac implantable devices. Adult patients of either genderwith cardiac implantable Electronic device and infection were included. Epicardial leads and surgical site infections within six weeks were excluded. Results: One thousand and forty-six (1046) patients were enrolled in the study. There were 596(57%) male patients. 385(36.8%) patients were implanted with single chamber pacemakers, 390(37.3%) with dual chamber pacemakers, 146(14%) single chamber ICD (implantable cardiac defibrillator), 67(6.4%) dual-chamber cardiac implantable Electronic device, 46(4.4%) CRT-D, 12(1.1%) TPM, 134(12.8%) Re-do, 114(10.9%), 114(10.9%) generator change, 20(1.9%) leads revision, 26(2.5%) patients had extraction. The rate of CIED infection was 34(2.1%). The association of the study parameters with infection rate revealed that type of device (p=0.002), extraction, suture type, and post-procedure hematoma (p<0.001) had a statistically significant relationship with infection rate.Conclusion: The Cardiac Implantable Electronic Device infection rate was 2.1%. Hypertension and diabetes were common risk factors, and left ventricular dysfunction was common in high-energy devices with multiple leads and repeated procedures.

Factors of mortality in patients with cardiac implantable electronic device: 5-year experience.

The use of cardiac implantable electronic devices has increased in recent years. It has also brought some issues. Among these, the complications of cardiac implantable electronic devices infection and pocket hematoma are difficult to manage. It can be fatal with the contribution of patient-related risk factors. In this study, we aimed to find mortality rates in patients who developed cardiac implantable electronic devices infection and pocket hematoma over 5 years. We also investigated the risk factors affecting mortality in patients with cardiac implantable electronic devices. A total of 288 cardiac implantable electronic devices patients were evaluated. Demographic details, history, and clinical data of all patients were recorded. Cardiac implantable electronic devices infection was defined according to the modified Duke criteria. The national registry was used to ascertain the mortality status of the patients. The patients were divided into two groups (exitus and survival groups). In addition, the pocket hematoma was defined as significant bleeding at the pocket site after cardiac implantable electronic devices placement. The cardiac implantable electronic devices infection was similar in both groups (p=0.919), and the pocket hematoma was higher in the exitus group (p=0.019). The exitus group had higher usage of P2Y12 inhibitors (p≤0.001) and novel oral anticoagulants (p=0.031). The Cox regression analysis, including mortality-related factors, revealed that renal failure is the most significant risk factor for mortality. Renal failure was linked to a 2.78-fold higher risk of death. No correlation was observed between cardiac implantable electronic devices infection and mortality, whereas pocket hematoma was associated with mortality. Furthermore, renal failure was the cause of the highest mortality rate in patients with cardiac implantable electronic devices.

Prevalence and Predictors of Venous Stenosis Following First Transvenous Cardiac Implantable Electronic Device Implantation.

Very few studies have been done on Venous stenosis following the first transvenous cardiac device implantation. We aimed to assess the prevalence and predictors of Venous stenosis/Occlusion following the first transvenous cardiac device implantation with venous angiography at one year of follow-up. This study was a single-center prospective, observational study. Demographic, clinical, procedural, and device data was collected. All patients underwent a preimplant contrast and repeated venography at twelve months to look for upper limb venous anatomy, obstruction, or collaterals. A total of 146 patients were included in the final analysis. 60 (41 %) patients developed some degree of venous stenosis. Most patients had mild to moderate stenosis, and almost all were asymptomatic. Among patient-related factors increasing age (64.66 ± 10.07 vs 60.91 ± 11.94 years p = 0.04), presence of hypertension (50.5 % vs 19.6 % p = 0.0004), diabetes (73 % vs 29.6 % p = 0.000) and dyslipidemia (66.7 % vs 36.3 p = 0.009) were significantly associated with Venous stenosis/occlusion. Among procedure-related factors, larger total lead diameter (3.88 ± 1.09 vs. 3.50 ± 1.03 mm p = 0.03) and implantation of biventricular devices (p = 0.0037) seem to be significantly associated with venous obstruction. In logistic regression analysis, hypertension (p = 0.018), total lead diameter (p = 0.024), and use of CRT-P/CRTD/ICD (p = 0.03) remained significant predictors of severe venous stenosis. Our study demonstrates venous obstruction in 40 % of cardiac implantable electronic device patients at one-year follow-up. Most patients have mild to moderate stenosis, and almost all are asymptomatic. Increasing age, hypertension, diabetes, dyslipidemia, larger total lead diameter, and implantation of biventricular devices are significantly associated with venous obstruction.

Using technology to improve reconnection to remote monitoring in cardiac implantable electronic device patients

Remote monitoring (RM) of cardiac implantable electronic device (CIED) patients is now considered standard of care. However, a fundamental requirement of RM is continuous connectivity between the patient's implanted device and the CIED manufacturer's central server. This study examined the rate of RM disconnections in CIED recipients and the impact of short message service (SMS) to facilitate reconnections. Using a platform that collects RM data from CIED manufacturers, we retrospectively examined the disconnection and reconnection events in 6085 patients from 20 medical centers. Each medical center reported their usual practice regarding RM disconnections, which consisted of either an automatic SMS from the platform to patients who were disconnected for 2 weeks or the standard of care (SC) of a phone call to patients. During a 1-year period, 43% of patients had at least 1 disconnection. Half of these patients experienced multiple disconnections. The use of SMS reduced the time to reconnection by 43% in comparison to SC. The median time to reconnect a disconnected patient was 11.0 [3.2, 29.0] days for SC vs 6.3 [1.3, 22.0] days for SMS (P < .0001). Furthermore, there was a high rate of reconnections within the first 48 hours of the SMS message, which was nearly double that in the SC arm. This study demonstrates the feasibility of an automatic system to deliver an SMS to patients with a disconnected CIED to facilitate early reconnection to RM.

Cardiac surgery in cardiac implantable electronic device patients and risk of device infections: a nationwide nested case-control study

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen’s Foundation Background Cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) has been associated with a higher risk of infective endocarditis, but how it influences risk of CIED-specific infections is not known. Purpose To examine risk of systemic CIED infections after cardiac surgery in patients with CIEDs. Methods Based on data obtained from Danish administrative registries and the Danish Pacemaker and ICD Register, we conducted a case-control study nested within a nationwide cohort of patients who underwent a de novo CIED implantation in Denmark between 1998-2017. Patients entered the study at six months after implantation. We defined cases as incident systemic CIED infections resulting in device system extraction. Controls were sampled 1:100 on age, sex and follow-up time using risk set sampling. Exposure was defined as coronary artery bypass graft (CABG)-, or cardiac heart valve replacement- or repair surgery. Results From a study cohort comprising 67,621 patients, we identified 170 cases and 16,966 controls. In the minimally adjusted model, the incidence rate ratio (IRR) for systemic CIED infection was 6.4 (95% confidence interval (CI) 3.9-17.1) with cardiac surgery, and after confounder adjustment, 7.0 (95% CI 4.1-11.9). IRRs were higher when exposure was restricted to heart valve replacement surgery (adjusted IRR (aIRR) 9.7, 95% CI 5.2-17.8), and when limiting our exposure time window to one year (aIRR 12.7, 95% CI 5.8-27.8). Conclusion Cardiac surgery in patients with de novo CIEDs was associated with a high risk of systemic CIED infections. Highest risk was observed after heart valve replacement surgery, and within the first year of surgery.

No substantial excess all-cause mortality among cardiac implantable electronic device patients during the first COVID‑19 lockdown in the Leiden area.

In the Netherlands, the coronavirus disease 2019 (COVID‑19) pandemic has resulted in excess mortality nationwide. Chronic heart disease patients are at risk for a complicated COVID‑19 course. The current study investigates all-cause mortality among cardiac implantable electronic device (CIED) patients during the first peak of the pandemic and compares the data to the statistics for the corresponding period in the two previous years. Data of adult CIED patients undergoing follow-up at the Leiden University Medical Centre were analysed. All-cause mortality between 1 March and 31 May 2020 was evaluated and compared to the data for the same period in 2019 and 2018. At the beginning of the first peak of the pandemic, 3,171 CIED patients (median age 70 years; 68% male; 41% ischaemic aetiology) were alive. Baseline characteristics of the 2019 (n = 3,216) and 2018 (n = 3,169) cohorts were comparable. All-cause mortality during the peak of the pandemic was 1.4% compared to 1.6% and 1.4% in the same period in 2019 and 2018, respectively (p = 0.84). During the first peak of the COVID‑19 pandemic, there was no substantial excess mortality among CIED patients in the Leiden area, despite the fact that this is group at high risk for a complicated course of a COVID‑19 infection. Strict adherence to the preventive measures may have prevented substantial excess mortality in these vulnerable patients.Supplementary InformationThe online version of this article (10.1007/s12471-021-01650-y) contains supplementary material, which is available to authorized users.

Electromagnetic Field Associated With Dermoscope Magnets May Affect the Safety of Cardiac Implanted Electronic Devices Patients.

Dermoscopy is currently used as an auxiliary tool in general dermatology. Since some commercially available dermoscopes have built-in magnets, electromagnetic interference (EMI) may occur when examining cardiac implantable electronic devices (CIED) patients. The aim of the study was to create maps of electromagnetic fields defining a safe distance in terms of EMI. The study was performed in laboratory conditions using measuring equipment specially designed for this purpose. The following dermoscopes have been tested: Illuco IDS-1100, Visiomed Luminis, Visiomed Luminis 2, Heine NC2 with and without a contact plate, DermLite DL4, and DermLite Handyscope. Measurements were made for the following set of lift-off distances: 5, 10, 20, 30, 40, 50, and 150 mm. Each 2D scan consisted of 10-line scans shifted from each other by 10 mm. The strength of the magnetic field decreased with the distance from the faceplate. The distribution of the magnetic field differed depending on the position of the magnets. The highest magnetic field was recorded in the center of the Heine NC2 faceplate (up to 8 mT). In most cases, at a distance of 10 mm, the magnetic field strength was measured below 1 mT, with the exception of Heine NC2 and Heine NC2 with a contact plate. All tested dermoscopes generated a magnetic field of <1 mT at the distance of 20 mm. The use of dermoscopes with built-in magnets may affect the functioning of CIEDs, and the impact may vary depending on the type of dermoscope.

Clinic time required to manage cardiac implantable electronic device patients: a time and motion workflow evaluation

Abstract Background The population with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage these patients. However, the CIED follow-up workflow is poorly understood. This study sought to characterize the workflow and staff time for CIED patient management. Methods A time and motion workflow evaluation was performed in 6 U.S. CIED clinics, which manage an average of 4,217 patients. Each task involved in CIED management was repeatedly timed, including all manufacturers, during 1 business week at each clinic. Mean staff time for a remote transmission and an in-person visit were calculated, including all clinical and administrative (e.g: scheduling, documentation) activities related to the encounter. Annual staff time for follow-up of 1 patient was modeled using CIED transmission data for the 6 clinics, guidelines for CIED follow-up, and published literature. Results 124 clinic visits and 1,374 remote monitoring activities were observed. Staff time required per remote transmission ranged from 12.1–13.4 minutes (depending on the CIED type), and time per visit was 43.4–51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively (Table 1). Conclusion CIED clinic workflow is complex and requires significant staff time. Remote monitoring is an efficient complement to in-office visits, allowing for continuous follow-up of patients. Future research should examine heterogeneity in clinic processes to identify the most efficient workflow. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

Managing cardiac implantable electronic device patients during a health care crisis: Practical guidance.

Our world is faced with a global pandemic that threatens to overwhelm many national health care systems for a prolonged period. Consequently, the elective long-term cardiac implantable electronic device (CIED) management of millions of patients is potentially compromised, raising the likelihood of patients experiencing major adverse events owing to loss of CIED therapy. This review gives practical guidance to health care providers to help promptly recognize the requirement for expert consultation for urgent interrogation and/or surgery in CIED patients.

Occult bacteraemia in cardiac implantable electronic device patients: a review of diagnostic workflow and mandatory therapy.

: Cardiac implantable electronic device (CIED) implantation has greatly increased, with an associated exponential increase in CIED infections (CDIs). Cardiac device related infective endocarditis (CDRIE) has high morbidity and mortality: approximately 10-21%. Therefore, a prompt diagnosis and radical treatment of CDRIE are needed; transvenous lead extraction (TLE) is the mainstay for the complete healing, even if associated with wide logistic problems, high therapeutic costs and high mortality risk for patients. Some criticisms about the value of Duke criteria and their limitations for the diagnosis of CDRIE are known. The significance of classic laboratory data, transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE), considered in the Duke score, are reviewed and critically discussed in this article, with regard to the specific field of the diagnosis of CDI. The need for new techniques for achieving the diagnostic reliability has been well perceived by physicians, and additional techniques have been introduced in the new European Society of Cardiology (ESC) and British Heart Rhythm Society (BHRS) guidelines on infective endocarditis. These suggested techniques, such as 18-Fluorodeoxyglucose PET/computed tomography (FDG-PET/CT), white blood cell PET (WBC PET) and lung multislice CT (MSCT), are also discussed in the study. This short review is intended as an extensive summary of the diagnostic workflow in cases of CDI and will be useful for readers who want to know more about this issue.

Магнитно-резонансная томография у пациентов с имплантированными устройствами для лечения нарушений сердечного ритма: обзор текущей ситуации

The question of the possibility of MRI scanning in patients with cardiac implantable electronic devices (CIED) appeared simultaneously with the introduction of MRI in clinical practice. A lot of in-vitro, in-vivo and clinical researches were performed to estimate wat going on with CIED in strong magnetic field and is it possible to perform some unified protocol of safe MRI-scanning for these patients. Recommendations were provided, but not for the wide practice. MRI remained strongly contraindicated for CIED patient. To meet the clinical need CIEM manufacturers changed the design of devices to made them MRI-compatible, including reducing of ferromagnetic components, additional filters, new software. Lead coil design was changed as well to minimize lead heating and electrical current induction. Now all leaders of CIED industry have in their portfolio all types of MRI-conditional implanted cardiac rhythm management devices (pacemakers, ICDs, CRTs). "Conditional" means MRI scanning can be done only under specific condition. For MRI device and lead in one system have to be from the same manufacturer. Now, if you need to implant the device, you must proceed from the fact that the patient is more likely to need an MRI in the future and choose the appropriate model, not forgetting that the electrodes should also be MRI-compatible.

Dosimetric review of cardiac implantable electronic device patients receiving radiotherapy.

A formal communication process was established and evaluated for the management of patients with cardiac implantable electronic devices (CIEDs) receiving radiation therapy (RT). Methods to estimate dose to the CIED were evaluated for their appropriateness in the management of these patients. A retrospective, institutional review board (IRB) approved study of 69 patients with CIEDs treated with RT between 2005 and 2011 was performed. The treatment sites, techniques, and the estimated doses to the CIEDs were analyzed and compared to estimates from published peripheral dose (PD) data and three treatment planning systems (TPSs) — UMPlan, Eclipse's AAA and Acuros algorithms. When measurements were indicated, radiation doses to the CIEDs ranged from 0.01–5.06 Gy. Total peripheral dose estimates based on publications differed from TLD measurements by an average of 0.94 Gy (0.05–4.49 Gy) and 0.51 Gy (0–2.74 Gy) for CIEDs within 2.5 cm and between 2.5 and 10 cm of the treatment field edge, respectively. Total peripheral dose estimates based on three TPSs differed from measurements by an average of 0.69 Gy (0.02–3.72 Gy) for CIEDs within 2.5 cm of the field edge. Of the 69 patients evaluated in this study, only two with defibrillators experienced a partial reset of their device during treatment. Based on this study, few CIED‐related events were observed during RT. The only noted correlation with treatment parameters for these two events was beam energy, as both patients were treated with high‐energy photon beams (16 MV). Differences in estimated and measured CIED doses were observed when using published PD data and TPS calculations. As such, we continue to follow conservative guidelines and measure CIED doses when the device is within 10 cm of the field or the estimated dose is greater than 2 Gy for pacemakers or 1 Gy for defibrillators.PACS number: 87.55.N‐

New Technology for Implantable Cardioverter Defibrillators

The DF-4 lead connector offers the advantage of a smaller, less complex header, requiring only a single set screw to connect all high and low voltage terminals. It reduces the possibility of lead/ connector failure at the cost of decreased flexibility to selectively replace or substitute individual components of the implantable cardioverter defibrillator (ICD) lead. New floating atrial bipole single-lead ICD systems offer the benefits of dual-chamber sensing, including atrial tachyarrhythmia detection and improved supra ventricular tachycardia (SVT) discrimination, avoiding the disadvantages of an additional atrial lead. They are not suitable for atrial pacing. Novel shock reduction strategies include sophisticated T-wave discrimination algorithms, advanced lead integrity monitoring, and enhanced lead noise discrimination; they are further enhanced by remote ICD monitoring. Remote monitoring of ICD devices has been associated with a reduction in office visits and hospitalizations, improved battery life, and reduction in inappropriate ICD shocks. The subcutaneous ICD is a new effective alternative for patients who lack vascular access or when it seems beneficial to avoid transvenous lead placement. Up to 75% of cardiac implantable electronic device patients will need a magnetic resonance imaging scan (MRI) at some point in their life. MRI conditional ICD and cardiac resynchronization therapy (CRT) devices are under clinical investigation.