Cardiac Implantable Electrical Devices Research Articles

AF burden is important - fact or fiction?

Asymptomatic atrial fibrillation (AF) is common and in view of its prognostic impact (the same as of clinically overt AF) knowledge of the overall AF burden (defined as the amount of time spent in AF) appears to be important, both for scientific and clinical reasons. Data collected on more than 12,000 patients indicate that cardiac implantable electrical devices (CIEDs) are validated tools for measuring AF burden and that AF burden is associated with an increased risk of stroke. A maximum daily AF burden of ≥1h carries important negative prognostic implications and may be a clinically relevant parameter for improving risk stratification for stroke. Decision-making should primarily consider the context in which asymptomatic, subclinical arrhythmias are detected (i.e. primary or secondary prevention of stroke and systemic embolism) and the risk profile of every individual patient with regard to thromboembolic and haemorrhagic risk, as well as patient preferences and values. Continuous monitoring using CIEDs with extensive data storage capabilities allow in-depth study of the temporal relationship between AF and ischaemic stroke. The relationships between AF and stroke are complex. AF is certainly a risk factor for cardioembolic stroke, with a cause-effect relationship between the arrhythmia and a thromboembolic event, the latter being related to atrial thrombi. However, AF can also be a simple 'marker of risk', with a non-causal association between the arrhythmia and stroke, the latter being possibly related to atheroemboli from the aorta, the carotid arteries or from other sources.

Postmarket surveillance of medical devices: current capabilities and future opportunities

Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide. Premarket evaluation of CIEDs cannot be expected to eliminate all performance defects. Robust postmarket surveillance systems are needed to promote patient safety and reduce harm. Challenges impacting existing surveillance mechanisms include underreporting of defects, low rates of return of explanted CIEDs, lack of integration of surveillance into normal workflow, underutilization of existing resources including registries, a lack of capacity of aging resources, multiple proprietary platforms that lack interoperability, and the unmet need for common data variables as well as newer methods to generate, synthesize, analyze, and interpret evidence in order to respond rapidly to safety signals. Long-term solutions include establishing a unique device identification system; promoting expanded use of registries for surveillance and post-approval studies; developing additional methods to combine evidence from diverse data sources; creating tools and implementing strategies for universal automatic, triggered electronic event reporting; and refining methods to rapidly identify and interpret safety signals. Protection from litigation and creation of financial and other incentives by legislators, regulators, payers, accreditation organizations, and licensing boards can be expanded to increase participation in device surveillance by clinicians and health care facilities. Research to evaluate the comparative effectiveness of surveillance strategies is needed. Interim solutions to improve CIED surveillance while new initiatives are launched and the system strengthened are also presented.

Requirements for Achieving and Maintaining Competency in the Implantation and Management of Cardiac Implantable Electrical Devices: A clinical competency statement by the Emirates Cardiac Society.

Requirements for Achieving and Maintaining Competency in the Implantation and Management of Cardiac Implantable Electrical Devices: A clinical competency statement by the Emirates Cardiac Society.

Deactivation of Pacemakers and Implantable Cardioverter-Defibrillators

Cardiac implantable electrical devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs), are the most effective treatment for life-threatening arrhythmias. Patients or their surrogates may request device deactivation to avoid prolongation of the dying process or in other settings, such as after device-related complications or with changes in health care goals. Despite published guidelines outlining theoretical and practical aspects of this common clinical scenario, significant uncertainty remains for both patients and health care providers regarding the ethical and legal status of CIED deactivation. This review outlines the ethical and legal principles supporting CIED deactivation, centered upon patient autonomy and authority over their own medical treatment. The empirical literature describing stakeholder views and experiences surrounding CIED deactivation is described, along with implications of these studies for future research surrounding the care of patients with CIEDs.

Cardiac implantable electronic device-related endocarditis: A 12-year single-centre experience

The incidence of cardiac implantable electrical device endocarditis (CIEDE) is increasing, but CIEDE remains a relatively poorly described infection. This case series describes our experience of the condition at a tertiary referral centre in London over a 12-y period. We identified cases using an endocarditis database containing prospectively collected clinical and microbiological information. We also used data recorded in an electronic database of all cardiac implantable electrical device-related procedures. Thirty cases of CIEDE were treated at our institution during the study period. Presentation was most commonly with fever, and 93% of our patients had positive blood cultures. Vegetations were identified on echocardiography in only 70% of patients, although a transoesophageal echocardiogram (TOE) was performed in only half of the cases. Sixty-seven percent of our cases were defined as definite endocarditis according to the modified Duke criteria for infective endocarditis. Twenty-three patients underwent percutaneous explantation of their infected CIED (including 6 patients with vegetations greater than 10 mm in diameter), while 5 underwent surgical explantation. The overall in-hospital mortality was 17%. Our data confirm the life-threatening nature of CIEDE in a UK population. In addition, our experience suggests that percutaneous extraction of devices with large adherent vegetations may be safe, and that the selective use of TOE may not compromise outcomes. Lastly, we show that the modified Duke criteria do not perform very well with this condition, suggesting a need for specific, validated criteria for diagnosing CIEDE.

Proton dose perturbations caused by high‐voltage leads from implanted cardioverter defibrillators

An increasing number of patients undergoing proton radiotherapy have cardiac implantable electrical devices (CIEDs). We recently encountered a situation in which a high‐voltage coil on a lead from an implanted cardiac defibrillator was located within the clinical treatment volume for a patient receiving proton radiotherapy for esophageal cancer. To study the effects of the lead on the dose delivery, we placed a high‐Z CIED lead at both the center and the distal edge of a clinical spread‐out Bragg peak (SOBP) in a water phantom, in both a stationary position and with the lead moving in a periodic pattern to simulate cardiorespiratory movement. We then calculated planned doses using a commercial proton treatment planning system (TPS), and compared them with the doses delivered in the phantom, measured using radiographic film. Dose profiles from TPS‐calculated and measured dose distributions showed large pertubrations in the delivered proton dose in the vicinity of the CIED lead when it was not moving. The TPS predicted perturbations up to 20% and measurements revealed perturbations up to 35%. However, the perturbations were less than 3% when the lead was moving. Greater dose perturbations were seen when the lead was placed at the distal edge of the SOBP than when it was placed in the center of the SOBP. We conclude that although cardiorespiratory motion of the lead mitigates some of the perturbations, the effects of the leads should be considered and steps taken to reduce these effects during the treatment planning process.PACS numbers: 87.55.D‐,87.55.ne, 87.85.M

PMD52 Workload in German Hospitals Caused by Routine Follow-up Services for Cardiac Implantable Electrical Devices (CIED)

Regular follow-up (FU) of CIED patients is mandatory to monitor device functionality and disease status. Demand for this highly specialised service increases continuously. However, most calendar based visits do not need further action and could safely be replaced by remote monitoring. This model aims 1) to quantify hospital workload associated with calendar based FU between 2011 and 2015, and 2) to identify opportunity costs if monitoring services would be performed remotely. The estimated number of prevalent CIED patients in Germany was combined with recently published data on healthcare personnel resource burden related to FU. Opportunity costs were identified considering 2011 DRG payments for frequent cardiology procedures. Assuming in-office FU twice annually for pacemaker patients, and four times annually for implantable cardioverter defibrillator or cardiac resynchronisation therapy patients, hospitals will have to provide about 2.23 mio FU services in 2015, to about 856,000 patients. These services will bind about 411,000 physician hours, 392,000 nurse hours and 280,000 technician hours, at total costs of EURO 44.8 mio to hospitals. Using remote monitoring to replace all but one in-office FU visit per year could free up to 126,700 physician hours (2015). In theory, this physician time would allow for about 50'600 bypass surgeries (worth EURO 596 mio), or 84,400 dual-chamber pacemaker implantations (EURO 434 mio), or 63,300 dual chamber ICD implantations (EURO 1.1 billion). Possible cost overestimation due to not considering unscheduled FU visits is explored in scenario analyses. The ability of BIOTRONIK Home Monitoring to safely replace in-office FU visits has been proven in clinical trials. While continuously monitoring all patients, it is possible to identify patients in need to attend in clinic FU in person. Remote monitoring technologies can support hospitals with focussing their available staff and room capacities and optimise operative income while providing patient care at potentially improved outcomes.

PMD66 Demand for Routine in office Follow-up Visits for Cardiac Implantable Electrical Devices (CIED) in Germany and the United Kingdom

PMD66 Demand for Routine in office Follow-up Visits for Cardiac Implantable Electrical Devices (CIED) in Germany and the United Kingdom

PMD71 Resource Use Caused by in-office Follow-up Visits for Cardiac Implantable Electrical Devices (CIED) in Germany and the United Kingdom

PMD71 Resource Use Caused by in-office Follow-up Visits for Cardiac Implantable Electrical Devices (CIED) in Germany and the United Kingdom

PMD15 Societal Costs of Routine Follow-up Services for Cardiac Implantable Electrical Devices in Germany and the United Kingdom - and the Impact of remote Monitoring

PMD15 Societal Costs of Routine Follow-up Services for Cardiac Implantable Electrical Devices in Germany and the United Kingdom - and the Impact of remote Monitoring

Informed Consent in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) for the treatment of heart failure (HF) raises complex problems for informed consent. CRT with and without defibrillator backup has been demonstrated in clinical trials to improve symptoms from HF and decrease mortality.1–4 A CRT pacemaker (CRT-P) may improve symptoms and reduce mortality in selected patients, even without offering the specific protection from malignant arrhythmias afforded by a CRT defibrillator (CRT-D). Further, CRT-P may prevent disease progression even in earlier stages of HF.4,5 Implantable cardioverter-defibrillators (ICDs) alone are effective in preventing sudden cardiac death (SCD) in selected patients.6,7 Although most patients eligible for CRT-P will similarly meet guidelines for an ICD, the decision to include ICD backup with a CRT implant may not be straightforward.8 The decision for CRT-P or CRT-D implantation includes not only the medical facts, but also the important considerations based on values and principles. Patients and physicians may wrestle with fundamental questions about quality and quantity of life and struggle to come together toward a truly informed consent process. There are no formal guidelines or standards that argue for specific content to be included in the informed consent process for CRT. This article examines 4 categories of questions regarding CRT based on an understanding of autonomy and shared decision-making as elements of informed consent: (1) control over the manner of death, (2) quality versus quantity of life, (3) therapeutic flexibility, and (4) clinical uncertainty. This article may help to guide clinicians and patients by clarifying the clinical and moral considerations and the principles behind particular treatment decisions. Autonomy refers to an understanding and knowledge of available options and the ability to choose between them through rational deliberation.9,10 Respect for patient autonomy is the foundation of modern bioethics and, in …

Suppression of Cautery-Induced Electromagnetic Interference of Cardiac Implantable Electrical Devices by Closely Spaced Bipolar Sensing

Electromagnetic interference (EMI) induced by electrocautery during surgery in patients with cardiac pacemakers or implanted cardioverter-defibrillators (ICDs) may inhibit pacing and cause inappropriate tachyarrhythmia oversensing. In particular, susceptibility to EMI may be enhanced in ICDs by frequently used wide interelectrode sensing (i.e., integrated bipolar sensing). Consequently, ICD function is usually disabled preoperatively and restored later by noninvasive programming. Because sensing by closely spaced electrodes (i.e., true bipolar) may be less susceptible to EMI, preoperative programming to a true bipolar mode may minimize the need for perioperative programming while preserving device function. Our study population consisted of 23 consecutive patients either receiving a new ICD or undergoing ICD pulse generator change. In each patient, electrocautery-induced EMI was initiated with the ICD in the closely spaced sensing configuration and again during widely spaced sensing. In comparing the 2 sensing modes, right ventricular electrogram amplitude was significantly greater and EMI noise amplitude tended to be greater with widely spaced bipolar sensing. Furthermore, widely spaced bipolar sensing was associated with ICD pacing inhibition in 22 of 23 patients and incorrect "ventricular fibrillation" detection in 17 of 23 patients. Conversely, closely spaced bipolar sensing was not accompanied by either pacing inhibition or incorrect ventricular fibrillation sensing. Closely spaced bipolar sensing (i.e., true bipolar) appropriately rejects electrocautery-induced EMI. Programming implanted devices to closely spaced bipolar sensing may minimize the need for perioperative reprogramming while preserving intraoperative device operation.

Contemporary Developments in the Pacemaker World

ICU leaders need to be current with recent technological advances related to cardiac implantable electrical devices (CIEDs). This update will review the following 4 topics: (1) an update on contemporary technology for CIED companies headquartered in the United States, (2) unique features of one CIED company headquartered in Europe, (3) ICU considerations for patients with CIEDs for whom do not resuscitate orders are in place, and (4) evaluation of patients admitted to the ICU with incomplete medical information about a visible medical device that may be a CIED. This discussion will provide valuable information for the care of ICU patients with CIED.

Device therapy and hospital reimbursement practices across European countries: a heterogeneous scenario

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

274 Arrhythmias in Patients with Cardiac Implantable Electrical Devices (CIED) Following Implantation of a Left Ventricular Assist Device (LVAD)

274 Arrhythmias in Patients with Cardiac Implantable Electrical Devices (CIED) Following Implantation of a Left Ventricular Assist Device (LVAD)

Healthcare personnel resource burden related to in-clinic follow-up of cardiovascular implantable electronic devices: a European Heart Rhythm Association and Eucomed joint survey

A pilot European survey was conducted to assess the cumulative time spent by healthcare personnel for in-office follow-up of cardiac implantable electrical devices (CIEDs), including cardiac pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy (CRT) devices. Resource use data were collected during a session of in-clinic follow-up. Among 407 visits, 93% were scheduled and 7% unscheduled. Visit duration (total cumulative time) lasted a mean of 27 min for scheduled visits, and was ∼30% longer for unscheduled visits. Independent determinants of visit duration were: unscheduled visit (+7.6 min, P = 0.01), the need for device reprogramming (+7.5 min, P < 0.001), and the type of device checked, with CRT devices needing 9.1 and 6.6 more minutes than single- (P < 0.001) and dual-chamber devices (P = 0.002), respectively. Most visits involved two different types of healthcare personnel (239 of 407, 59%), simultaneously. The most frequent combination was the involvement of both a cardiologist and a nurse (216 of 407 visits with both of them only, and 65 additional visits with also an internal technician, an external technician, or both). Overall, an external technician was involved in 18% of visits. In 'real-world' practice, the follow-up of CIEDs nowadays requires important resources in terms of time dedicated by specialized personnel, corresponding to cardiologists, nurses, internal technicians, and external, industry-employed technicians. These observations should be the basis for addressing clinical, organizational, financial, and policy initiatives targeted to optimize follow-up procedures in order to face the increase in the number of patients treated with CIEDs expected for the next years.

Ethical and Legal Views Regarding Deactivation of Cardiac Implantable Electrical Devices in Patients With Hypertrophic Cardiomyopathy

Little is known about patients' views surrounding the ethical and legal aspects of managing pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) near the end of life. Patients with hypertrophic cardiomyopathy (HC) are at heightened risk of sudden cardiac death and are common recipients of such devices. Patients with HC recruited from the membership of the Hypertrophic Cardiomyopathy Association were surveyed about their clinical histories, advance care planning, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy. The mean age of the 546 patients was 49.1 years, 47% were women, and 57% had ICDs. Only 46% of the respondents had completed an advance directive, only 51% had a healthcare proxy, and cardiac implantable electrical devices (CIEDs) were commonly not addressed in either (92% and 58%, respectively). Many patients characterized deactivating PMs or ICDs as euthanasia or physician-assisted suicide (29% for PMs and 17% for ICDs), and >50% expressed uncertainty regarding the legality of device deactivation. Patients viewed deactivation of ICDs and PMs as morally different from other life-sustaining therapies such as mechanical ventilation and dialysis, and these views varied substantially according to the CIED type (p <0.0001). The respondents expressed concerns regarding clinical conflicts related to religion, ethical and legal uncertainty, and informed consent. In conclusion, patients who have, or are eligible to receive, CIEDs might require improved advance care planning and education regarding the ethical and legal options for managing CIEDs at the end of life.

Management of cardiac electrical implantable devices in patients nearing the end of life or requesting withdrawal of therapy. Review of the Heart Rhythm Society 2010 consensus statement

Cardiac implantable electrical devices (CIEDs) are increasingly common interventions for a wide spectrum of cardiovascular diseases. Caring for patients with life-sustaining devices such as CIEDs at the end of life raises legal and ethical challenges. In 2010, the Heart Rhythm Society (HRS) published an expert consensus statement to review the principles and practice of CIED deactivation. This statement addressed a wide range of ethical and legal principles while providing guidance for communication, decision-making, and procedures in a variety of settings. In this article, we provide a summary of the HRS guidelines and highlight the most important features of CIED deactivation for the practicing clinician.

Curriculum und Sachkundekurse Herzschrittmacher- und ICD – Therapie

The curricula "Practice of Pacemaker Therapy" and "Practice of ICD Therapy" have been developed from practical experience with the first educational courses which are necessary to fulfill the German requirements of the medical products law which restricts the application of medical products to persons with the necessary education, knowledge and experience. The corresponding courses of competence under the auspices of the German Cardiac Society derive from this legal prerequisite. Competence refers to technical knowledge in cardiac implantable electrical devices (CIEDs) and understanding of possible dysfunctions as well as substantial knowledge on arrhythmia. The two curricula form the theoretical basis for the application of CIEDs. These courses represent an offer to cardiologists and all other physicians who wish to acquire and document competency in this field. A legal obligation to participate in these competency courses does not currently exist in Germany as long as evidence can be provided that this competency has been achieved by other means. Both curricula have proven to be comprehensive and practically highly useful and have been presented by highly committed specialists with expertise in this topic at a high level. Since 2005 some 2,000 physicians have been trained in courses on pacemaker therapy and more than 1,000 physicians in courses on ICD therapy with an ongoing high level demand to be expected in the future.

Physician Ethical and Legal Views Regarding Deactivation of Cardiac Implantable Electrical Devices

Physician Ethical and Legal Views Regarding Deactivation of Cardiac Implantable Electrical Devices