Cardiovascular Implantable Electronic Devices Research Articles

Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke

ObjectiveImplantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation...

Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.

Value of Extended Arrhythmia Screening in Adult Congenital Heart Disease Patients

The European Society of Cardiology guidelines for the management of adult congenital heart disease patients recommend screening for arrhythmias and bradycardias in symptomatic patients, often being done by means of an ambulatory 24–48-hour Holter or implantable loop recorder (ILR). However, nowadays non-invasive instruments, such as patches, smartwatches and smartphones based on single-lead ECGs that perform extended monitoring, are also available. The aim of this narrative review was to assess whether these instruments, when they detect arrhythmias and bradycardias in patients with adult congenital heart disease, will lead to meaningful changes in clinical care. Clinically meaningful changes include adjustment of medication, cardioversion, electrophysiology study, ablation or implantation of a cardiovascular implantable electronic device. The following monitoring instruments are discussed: cumulative Holter, 2-week continuous monitor, smartwatch- and smartphone-based single-lead ECG, and ILR. The diagnostic yield of extended rhythm monitoring is high, and varies between 18% (smartphone-based single-lead ECG) and 41% with ILR. In conclusion, contemporary arrhythmia screening includes various new non-invasive technologies that are promising new tools as an alternative to Holter monitoring or ILR. However, the optimal mode of detection is still unclear due to the lack of head-to-head comparisons.

Reinfection Rates Following Cardiovascular Implantable Electronic Device Reimplementation Post-device Primary Infection

Cardiovascular implantable electronic device (CIED) infections have become an increasing problem around the world, affecting one in 20 patients within 3 years of device implementation. Prevention of reinfection following CIED reimplantation is a prominent challenge. One of the most difficult aspects of managing CIED infections is the complexities of their diagnosis: with the complexities of many infections, timely and correct diagnosis becomes complicated, frequently causing delays in commencing proper therapy, and worsening disease severity. As patients receiving CIED therapy are now older, and possess significant comorbidities, they are at a higher risk of infection. The American Heart Association (AHA) has issued a statement to educate clinicians about CIED infections, and the required care for those with suspected or diagnosed infections. To prevent an infection from spreading, it is important to isolate the causative pathogen and perform testing for susceptibility, which is required for crucial choices, including routes and duration of antimicrobial therapy. This review aims to serve as a valuable resource for healthcare professionals, by synthesising current knowledge and best practices; and providing insights into preventive measures, diagnostic challenges, therapeutic strategies, and evidence-based approaches to diagnose and improve the management of CIED infections in an ageing and medically complex patient population.

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

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

Superior vena cava obstruction and cardiovascular implantable electronic devices-a new era of leadless devices.

Cardiovascular implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators require the placement of a transvenous lead through the superior vena cava (SVC), which can be difficult if there is stenosis or obstruction of the SVC. Moreover, SVC syndrome may occur after the lead is inserted even if the SVC was intact before the implantation. Therefore, there is need of an appropriate strategy for handling stenosis or obstruction of SVC during lead placement. In addition, advances are being made in CIEDs that do not require transvenous leads, and thus CIEDs without a transvenous lead should be considered depending on the indications and urgency of the particular case. This manuscript is divided into (I) device therapy for patients with SVC obstruction and (II) therapeutic strategy for SVC obstruction after lead implantation. In patients with SVC syndrome, treatment of the SVC occlusion should be based on the individual pathophysiology, and depending on the indications and urgency of the case, treatment with CIEDs that do not require transvenous leads should be considered. Further data must be accumulated to clarify the long-term prognosis of device implantation after treatment of SVC occlusion. In addition, transvenous lead extraction is now widely used for device-related SVC obstruction, and this procedure also merits further accumulation of data.

Hematoma Prevention Using Tachosil (Fibrin Sealant) Patch during Insertion of Cardiovascular Implantable Electronic Devices without Suspending Antithrombotics: Three Case Reports

Patients undergoing insertion of cardiac implantable electronic devices often exhibit perioperative hemorrhagic complications. Perioperative antithrombotic management, which balances the risk of acute thrombosis and postoperative bleeding, is therefore important for these patients. In this case report, we present three cases of cardiovascular implantable electronic device (CIED) insertion. While the three patients each had different reasons for not discontinuing antithrombotic medications, they all needed CIEDs. During the CIED implantation procedures, a small incision was made on the pectoralis muscle region to obtain a small subcutaneous pocket, and Tachosil, a fibrin sealant patch, was inserted below and above the inserted device. The patients showed no pocket hematoma formation or any hemorrhagic complications. We thus concluded the application of a fibrin sealant patch could be an option for perioperative anticoagulation management without interruption of anticoagulants and antiplatelets.

Trends in the 30-year span of noninfectious cardiovascular implantable electronic device complications in Olmsted County

Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends. We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County. The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed. A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years. Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

Automated electronic alert for the detection of infected cardiovascular implantable electronic devices in patients with bacteremia

Automated electronic alert for the detection of infected cardiovascular implantable electronic devices in patients with bacteremia

Prognosis of pacing-dependent patients with cardiovascular implantable electronic devices.

Data on the prognostic significance of pacing dependency in patients with cardiovascular implantable electronic devices (CIEDs) are sparse. The prognostic significance of pacing dependency defined as absence of an intrinsic rhythm ≥ 30 bpm was determined in 786 patients with CIEDs at the authors' institution using univariate and multivariate regression analysis to identify predictors of all-cause mortality. During 49months median follow-up, death occurred in 63 of 130 patients with pacing dependency compared to 241 of 656 patients without pacing dependency (48% versus 37%, hazard ratio [HR] 1.34; 95% confidence interval [CI]: 1.02-1.78, P = 0.04). Using multivariate regression analysis, predictors of all-cause mortality included age (HR 1.07; 95% CI: 1.05-1.08, P < 0.01), history of atrial fibrillation (HR 1.32, 95% CI: 1.03-1.69, P < 0.01), chronic kidney disease (HR 1.28; 95% CI: 1.00-1.63, P = 0.048) and New York Heart Association (NYHA) class ≥ III (HR 2.00; 95% CI: 1.52-2.62, P < 0.01), but not pacing dependency (HR 1.15; 95% CI: 0.86-1.54, P = 0.35). In contrast to age, atrial fibrillation, chronic kidney disease and heart failure severity as indexed by NYHA functional classIII orIV, pacing dependency does not appear to be an independent predictor of all-cause mortality in patients with CIEDs.

Percutaneous mechanical aspiration in patients with right-sided infective endocarditis: An analysis of thenational inpatient sample database-2016-2020.

Given the challenges of conventional therapies in managing right-sided infective endocarditis (RSIE), percutaneous mechanical aspiration (PMA) of vegetations has emerged as a novel treatment option. Data on trends, characteristics, and outcomes of PMA, however, have largely been limited to case reports and case series. The aim of the current investigation was to provide a descriptive analysis of PMA in the United States and to profile the frequency of PMA with a temporal analysis and the patient cohort. The International Classification of Diseases, 10th Revision codes were used to identify patients with RSIE in the national (nationwide) inpatient sample (NIS) database between 2016 and 2020. The clinical characteristics and temporal trends of RSIE hospitalizations in patients who underwent PMA was profiled. An estimated 117,955 RSIE-related hospital admissions in the United States over the 5-year study period were estimated and 1675 of them included PMA. Remarkably, the rate of PMA for RSIE increased 4.7-fold from 2016 (0.56%) to 2020 (2.62%). Patients identified with RSIE who had undergone PMA were young (medial age 36.5 years) and had few comorbid conditions (median Charlson Comorbidity Index, 0.6). Of note, 36.1% of patients had a history of hepatitis C infection, while only 9.9% of patients had a cardiovascular implantable electronic device. Staphylococcus aureus was the predominant (61.8%) pathogen. Concomitant transvenous lead extraction and cardiac valve surgery during the PMA hospitalization were performed in 18.2% and 8.4% of admissions, respectively. The median hospital stay was 19.0 days, with 6.0% in-hospital mortality. The marked increase in the number of PMA procedures in the United States suggests that this novel treatment option has been embraced as a useful tool in select cases of RSIE. More work is needed to better define indications for the procedure and its efficacy and safety.

Clinician Perspectives on Risks and Benefits of Sharing Cardiovascular Implanted Electronic Device (CIED) Data with Patients

Background and Objective: Cardiovascular implantable electronic devices (CIEDs) are critical, life-saving devices that are essential for the clinical decision-making process due to the data they collect. Because not all patients have ready access to their device data, there may be a clinical care gap where the CIED data are not being used most effectively in the care of patients with CIEDs. However, sharing CIED data may risk harming clinician-patient relationships and necessitates further study into clinician’s perspectives on CIED data sharing. The objective of this study was to explore clinicians’ perspectives on sharing CIED data with their patients and explore the perceived benefits and concerns.&#x0D; Methods: Clinicians involved in CIED care in the United States were recruited for semi-structured phone interviews. Participants were asked questions regarding their experiences and perspectives in sharing CIED data, and were presented scenarios to assess how they would leverage the CIED data in particular situations. Responses from the participants were analyzed by one researcher using thematic analysis.&#x0D; Results: Of the 28 clinicians interviewed in this study, the majority were white (85.7%) and located in the midwestern United States (67.9%). Participants included cardiac device clinic nurses and electrophysiology nurses (28.6%), electrophysiologists (25%), electrophysiology advanced practice providers (APPs) (17.9%), cardiologists (14.3%), and cardiology APPs (14.3%). The following themes were identified: (1) Patient engagement with healthcare, (2) Patient selfadvocacy, (3) Patients cannot interpret CIED data, (4) One size does not fit all.&#x0D; Conclusion and Potential Impact: Clinicians perceived both potential benefits and harms from CIED data sharing. Clinicians noted that CIED data sharing has the potential to increase patient participation in their healthcare, but it also can cause increased patient anxiety due to insufficient patient education. This study demonstrated some of the ways CIED data sharing may affect clinical practice involving CIEDs and the challenge of sharing complex data elements with patients.

ESC guidelines 2023 on the management of endocarditis : What is new?

In August 2023 the new European guidelines on the management of infective endocarditis were published by the European Society of Cardiology (ESC). Numerous recommendations were revised and supplemented by new ones. This review article outlines the essential modifications of the current ESC guidelines focusing on the prevention including antibiotic prophylaxis, the role of the endocarditis team, the revision of the diagnostic criteria, the paradigm shift towards oral antibiotic treatment, the timing and the indications for surgical treatment as well as the relevance of infections of cardiovascular implantable electronic devices.

Continuous in situ targeted antibiotics for late cardiovascular implantable electronic device pocket perforation

Continuous in situ targeted antibiotics for late cardiovascular implantable electronic device pocket perforation

Safety Implications in Catheter Ablation Based Procedures After Cardiovascular Implantable Electronic Devices - Single Centre Experience

Safety Implications in Catheter Ablation Based Procedures After Cardiovascular Implantable Electronic Devices - Single Centre Experience

A mutually communicable external system resource in remote monitoring for cardiovascular implantable electronic devices.

Using third-party resources to manage remote monitoring (RM) data from implantable cardiac electronic devices (CIEDs) can assist in device clinic workflows. However, each hospital-acquired data is not used for further analysis as big data. We developed a real-time and automatically centralized system of CIED information from multiple hospitals. If the extensive data-based analysis suggests individual problems, it can be returned to each hospital. To show its feasibility, we prospectively analyzed data from six hospitals. For example, unexpected abnormal battery levels were easily illustrated without recall information. The centralized RM system could be a new platform that promotes the utilization of device data as big data, and that information could be used for each patient's practice.

Update on Cardiovascular Implantable Electronic Device Infections and Their Prevention, Diagnosis, and Management: A Scientific Statement From the American Heart Association: Endorsed by the International Society for Cardiovascular Infectious Diseases.

The American Heart Association sponsored the first iteration of a scientific statement that addressed all aspects of cardiovascular implantable electronic device infection in 2010. Major advances in the prevention, diagnosis, and management of these infections have occurred since then, necessitating a scientific statement update. An 11-member writing group was identified and included recognized experts in cardiology and infectious diseases, with a career focus on cardiovascular infections. The group initially met in October 2022 to develop a scientific statement that was drafted with front-line clinicians in mind and focused on providing updated clinical information to enhance outcomes of patients with cardiovascular implantable electronic device infection. The current scientific statement highlights recent advances in prevention, diagnosis, and management, and how they may be incorporated in the complex care of patients with cardiovascular implantable electronic device infection.

Managing ventricular arrhythmias and implantable cardiac defibrillator shocks after left ventricular assist device implantation.

Continuous flow left ventricular assist devices (CF-LVADs) have been shown to reduce mortality and morbidity in patients with advanced heart failure with reduced ejection fraction. However, ventricular arrhythmias (VA) are common, are mostly secondary to underlying myocardial scar, and have a higher incidence in patients with pre-LVAD VA. Sustained VA is well tolerated in the LVAD patient but can result in implantable defibrillator (ICD) shocks, right ventricular failure, hospitalizations, and reduced quality of life. There is limited data regarding best practices for the medical management of VA as well as the role for procedural interventions in patients with uncontrolled VA and/or ICD shocks. Vast majority of CF-LVAD patients have a preexisting cardiovascular implantable electronic device (CIED) and ICD and/or cardiac resynchronization therapies are continued in many. Several questions, however, remain regarding the efficacy of ICD and CRT following CF-LVAD. Moreover, optimal CIED programming after CF-LVAD implantation. Therefore, the primary objective of this review article is to provide the most up-to-date evidence and to provide guidance on the clinical significance, pathogenesis, predictors, and management strategies for VA and ICD therapies in the CF-LVAD population. We also discuss knowledge gaps as well as areas for future research.

A Patient-Centered Intervention Reduces Disparities in Remote Monitoring in Patients With Implanted Cardiac Devices

BackgroundRemote monitoring (RM) is recommended for patients with cardiovascular implantable electronic devices, yet many individuals, especially those living in underserved communities, fail to receive this guideline-directed care. Multilevel interventions that target patient and clinic-level barriers to RM care may be beneficial. ObjectivesThis study sought to evaluate a remotely delivered, patient-centered intervention to improve RM activation and adherence and reduce disparities in RM care. MethodsThe intervention provides home delivery of remote monitor, phone-based education, monitor setup, and facilitation of first transmission. A retrospective cohort analysis was performed using RM data from 190,643 patients (71.6 ± 12.7 years of age, 40.5% female) implanted with a pacemaker or defibrillator at 4,195 U.S. clinics between October 2015 and October 2019. Outcomes included RM activation (12 weeks and 1-year postimplantation) and adherence to clinic-scheduled transmissions. Patients receiving a cardiovascular implantable electronic deviceimplant 0 to 730 days before (control group, n = 95,861) and after (intervention group, n = 94,782) intervention launch were compared using logistic regression and generalized estimating equations. Multivariable models included patient, clinic, and neighborhood socioeconomic characteristics. ResultsThe odds of achieving guideline-recommended activation were significantly higher in the intervention group at 12 weeks (OR: 2.99; 76.7% vs 60.9%; P < 0.001) and 1 year (OR: 3.05; 88.2% vs 79.3%; P < 0.001). Adherence to scheduled transmissions was also higher in the intervention group compared with the control group (OR: 2.18; 89.1% vs 81.9%; P < 0.001). Preintervention disparities in RM activation and adherence were reduced in underserved groups following the intervention. ConclusionsA remotely delivered patient-centered intervention was associated with earlier activation and improved adherence to RM while reducing disparities in RM care.

Barriers and Facilitators Associated With Remote Monitoring Adherence Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators: Qualitative Cross-Sectional Study.

The Heart Rhythm Society strongly recommends remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) because of the clinical outcome benefits to patients. However, many patients do not adhere to RM and, thus, do not achieve these benefits. There has been limited study of patient-level barriers and facilitators to RM adherence; understanding patient perspectives is essential to developing solutions to improve adherence. We sought to identify barriers and facilitators associated with adherence to RM among veterans with CIEDs followed by the Veterans Health Administration. We interviewed 40 veterans with CIEDs regarding their experiences with RM. Veterans were stratified into 3 groups based on their adherence to scheduled RM transmissions over the past 2 years: 6 fully adherent (≥95%), 25 partially adherent (≥65% but <95%), and 9 nonadherent (<65%). As the focus was to understand challenges with RM adherence, partially adherent and nonadherent veterans were preferentially weighted for selection. Veterans were mailed a letter stating they would be called to understand their experiences and perspectives of RM and possible barriers, and then contacted beginning 1 week after the letter was mailed. Interviews were structured (some questions allowing for open-ended responses to dive deeper into themes) and focused on 4 predetermined domains: knowledge of RM, satisfaction with RM, reasons for nonadherence, and preferences for health care engagement. Of the 44 veterans contacted, 40 (91%) agreed to participate. The mean veteran age was 75.3 (SD 7.6) years, and 98% (39/40) were men. Veterans had been implanted with their current CIED for an average of 4.4 (SD 2.8) years. A total of 58% (23/40) of veterans recalled a discussion of home monitoring, and 45% (18/40) reported a good understanding of RM; however, when asked to describe RM, their understanding was sometimes incomplete or not correct. Among the 31 fully or partially adherent veterans, nearly all were satisfied with RM. Approximately one-third recalled ever being told the results of a remote transmission. Among partially or nonadherent veterans, only one-fourth reported being contacted by a Department of Veterans Affairs health care professional regarding not having sent a remote transmission; among those who had troubleshooted to ensure they could send remote transmissions, they often relied on the CIED manufacturer for help (this experience was nearly always positive). Most nonadherent veterans felt more comfortable engaging in RM if they received more information or education. Most veterans were interested in being notified of a successful remote transmission and learning the results of their remote transmissions. Veterans with CIEDs often had limited knowledge about RM and did not recall being contacted about nonadherence. When they were contacted and troubleshooted, the experience was positive. These findings provide opportunities to optimize strategies for educating and engaging patients in RM.