Management of Cardiac Implantable Electrical Devices in Patients Undergoing Radiofrequency Ablation for Spine Pain: Physician Survey and Review of Guidelines.

BACKGROUND: More patients with cardiac implantable electrical devices (CIEDs) are presenting to spine and pain practices for radiofrequency ablation (RFA) procedures for chronic pain. Although the potential for electromagnetic interference (EMI) affecting CIED function is known with RFA procedures, available guidelines do not specifically address CIED management for percutaneous RFA for zygapophyseal (z-joint) joint pain, and thus physician practice may vary. OBJECTIVES: To better understand current practices of physicians who perform RFA for chronic z-joint pain with respect to management of CIEDs. Perioperative CIED management guidelines are also reviewed to specifically address risk mitigation strategies for potential EMI created by ambulatory percutaneous spine RFA procedures. STUDY DESIGN: Web-based provider survey and narrative review. SETTING: Multispecialty pain clinic, academic medical center. METHODS: A web-based survey was created using Research Electronic Data Capture (REDCap). A survey link was provided via e-mail to active members of the Spine Intervention Society (SIS), American Society of Regional Anesthesia and Pain Medicine, as well as distributed freely to community Pain Physicians and any receptive academic departments of PM&R or Anesthesiology. The narrative review summarizes pertinent case series, review articles, a SIS recommendation statement, and multi-specialty peri-operative guidelines as they relate specifically to spine RFA procedures. RESULTS: A total of 197 clinicians participated in the survey from diverse clinical backgrounds, including anesthesiology, physical medicine and rehabilitation, radiology, neurosurgery, and neurology, with 81% reporting fellowship training. Survey responses indicate wide variability in provider management of CIEDs before, during, and after RFA for z-joint pain. Respondents indicated they would like more specific guidelines to aid in management and decision-making around CIEDs and spine RFA procedures. Literature review yielded several practice guidelines related to perioperative management of CIEDs, but no specific guideline for percutaneous spine RFA procedures. However, combining the risk mitigation strategies provided in these guidelines, with interventional pain physician clinical experience allows for reasonable management recommendations to aid in decision-making. LIMITATIONS: Although this manuscript can serve as a review of CIEDs and aid in management decisions in patients with CIEDs, it is not a clinical practice guideline. CONCLUSIONS: Practice patterns vary regarding CIED management in ambulatory spine RFA procedures. CIED presence is not a contraindication for spine RFA but does increase the complexity of a spine RFA procedure and necessitates some added precautions. KEY WORDS: Radiofrequency ablation, neurotomy, cardiac implantable electrical device, zygapophyseal joint, spondylosis, neck pain, low back pain, chronic pain.

A Strategy of Lead Abandonment in a Large Cohort of Patients With Sprint Fidelis Leads.

OBJECTIVES: This study sought to examine outcomes of our approach to managing a large cohort of patients with Sprint Fidelis (Medtronic, Minneapolis, Minnesota) leads. BACKGROUND: The optimal management approach for patients with leads under advisory is unknown. Concerns regarding the risk of device infection and complications associated with delaying lead extraction have recently been suggested to argue against abandoning leads under advisory. METHODS: All patients with a Sprint Fidelis lead implanted at our institute were included. Lead management options were discussed with patients who presented for device surgery at the time of device upgrade, lead fracture, or elective replacement indicator. Implantation of a new lead with abandonment of the Sprint Fidelis lead was the recommended strategy. Patients were subsequently followed at the device clinic at 6-month intervals and were enrolled prospectively in a longitudinal registry. RESULTS: A total of 520 patients had Sprint Fidelis leads implanted between December 2003 and October 2007 at the study center; 217 patients underwent lead replacement (213 underwent a lead abandonment strategy and 4 underwent a lead extraction strategy). Mean follow-up after lead replacement was 55 ± 33 months. In patients undergoing lead abandonment, 10 of 213 (4.7%) had a procedural complication and 3 of 213 (1.4%) developed subsequent device infection requiring system extraction. CONCLUSIONS: In patients with a Sprint Fidelis lead, implanting a new lead without prophylactic extraction may be a feasible and safe strategy but requires longer follow-up.

Assessment of the 2017 AHA/ACC/HRS Guideline Recommendations for Implantable Cardioverter-Defibrillator Implantation in Cardiac Sarcoidosis.

BACKGROUND: Implantable cardioverter-defibrillators are used to prevent sudden cardiac death in patients with cardiac sarcoidosis. The most recent recommendations for implantable cardioverter-defibrillator implantation in these patients are in the 2017 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. These recommendations, based on observational studies or expert opinion, have not been assessed. We aimed to assess them. METHODS: We performed a large retrospective cohort study of patients with biopsy-proven sarcoidosis and known or suspected cardiac sarcoidosis that underwent cardiovascular magnetic resonance imaging. Patients were followed for a composite end point of significant ventricular arrhythmia or sudden cardiac death. The discriminatory performance of the Guideline recommendations was tested using time-dependent receiver operating characteristic analyses. The optimal cutoff for the extent of late gadolinium enhancement predictive of the composite end point was determined using the Youden index. RESULTS: In 290 patients, the class I and IIa recommendations identified all patients who experienced the composite end point during a median follow-up of 3.0 years. Patients meeting class I recommendations had a significantly higher incidence of the composite end point than those meeting class IIa recommendations. Left ventricular ejection fraction (LVEF) >35% with >5.7% late gadolinium enhancement on cardiovascular magnetic resonance imaging was as sensitive as and significantly more specific than LVEF >35% with any late gadolinium enhancement. Patients meeting 2 class IIa recommendations, LVEF >35% with the need for a permanent pacemaker and LVEF >35% with late gadolinium enhancement >5.7%, had high annualized event rates. Excluding 2 class IIa recommendations, LVEF >35% with syncope and LVEF >35% with inducible ventricular arrhythmia, resulted in improved discrimination for the composite end point. CONCLUSIONS: We assessed the Guideline recommendations for implantable cardioverter-defibrillator implantation in patients with known or suspected cardiac sarcoidosis and identified topics for future research.

Lessons Learned From the First Human Low-Field MRI Guided Radiation Therapy of the Heart in the Presence of an Implantable Cardiac Defibrillator.

Magnetic resonance imaging (MRI) guided radiation therapy is reported for the first time in a patient with an implantable cardioverter defibrillator (ICD) and cardiac fibroma in the left ventricle. Stereotactic body radiation therapy was delivered in 5 fractions at a dose of 700 cGy/fraction using a 0.35 T MRI-linear accelerator with real-time tumor tracking and beam gating. The average treatment time per fraction was 12.13 minutes, including gating dead time and gantry rotation, and the average duty cycle was 56.8%. Lessons learned included the need for MRI safety workflows that address the ICD and are tailored to the radiation oncology environment, selection of a suitable tracking target to ensure satisfactory duty cycle, and the presence of null band artifacts within the tracking target caused by ferrous components in the ICD.

Electromagnetic Interference with Protocolized Electrosurgery Dispersive Electrode Positioning in Patients with Implantable Cardioverter Defibrillators.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Electromagnetic interference from monopolar electrosurgery may disrupt implantable cardioverter defibrillators.Current management recommendations by the American Society of Anesthesiologists and Heart Rhythm Society are based on expert clinical opinion since there is a paucity of data regarding the risk of electromagnetic interference to implantable cardioverter defibrillators during surgery. WHAT THIS ARTICLE TELLS US THAT IS NEW: With protocolized electrosurgery dispersive electrode positioning in patients with implantable cardioverter defibrillators, the risk of clinically meaningful electromagnetic interference was 7% in above-the-umbilicus noncardiac surgery and 0% in below-the-umbilicus surgery. In cardiac surgery, clinically meaningful electromagnetic interference with use of an underbody dispersive electrode was 29%.Despite protocolized dispersive electrode positioning, the risk of electromagnetic interference in above-the-umbilicus surgery is high, supporting recommendations to suspend antitachycardia therapy when monopolar electrosurgery is used above the umbilicus.With protocolized dispersive electrode positioning, the risk of electromagnetic interference in below-the-umbilicus surgery is negligible, implying that suspending antitachycardia therapy might be unnecessary in these cases.With an underbody dispersive electrode, the risk of electromagnetic interference in cardiac surgery is high. BACKGROUND: The goal of this study was to determine the occurrence of intraoperative electromagnetic interference from monopolar electrosurgery in patients with an implantable cardioverter defibrillator undergoing surgery. A protocolized approach was used to position the dispersive electrode. METHODS: This was a prospective cohort study including 144 patients with implantable cardioverter defibrillators undergoing surgery between May 2012 and September 2016 at an academic medical center. The primary objectives were to determine the occurrences of electromagnetic interference and clinically meaningful electromagnetic interference (interference that would have resulted in delivery of inappropriate antitachycardia therapy had the antitachycardia therapy not been programmed off) in noncardiac surgeries above the umbilicus, noncardiac surgeries at or below the umbilicus, and cardiac surgeries with the use of an underbody dispersive electrode. RESULTS: The risks of electromagnetic interference and clinically meaningful electromagnetic interference were 14 of 70 (20%) and 5 of 70 (7%) in above-the-umbilicus surgery, 1 of 40 (2.5%) and 0 of 40 (0%) in below-the-umbilicus surgery, and 23 of 34 (68%) and 10 of 34 (29%) in cardiac surgery. Had conservative programming strategies intended to reduce the risk of inappropriate antitachycardia therapy been employed, the occurrence of clinically meaningful electromagnetic interference would have been 2 of 70 (2.9%) in above-the-umbilicus surgery and 3 of 34 (8.8%) in cardiac surgery. CONCLUSIONS: Despite protocolized dispersive electrode positioning, the risks of electromagnetic interference and clinically meaningful electromagnetic interference with surgery above the umbilicus were high, supporting published recommendations to suspend antitachycardia therapy whenever monopolar electrosurgery is used above the umbilicus. For surgery below the umbilicus, these risks were negligible, implying that suspending antitachycardia therapy is likely unnecessary in these patients. For cardiac surgery, the risks of electromagnetic interference and clinically meaningful electromagnetic interference with an underbody dispersive electrode were high. Conservative programming strategies would not have eliminated the risk of clinically meaningful electromagnetic interference in either noncardiac surgery above the umbilicus or cardiac surgery.

Evaluation of the safety of users of active implantable medical devices (AIMD) in the working environment in terms of exposure to electromagnetic fields - Practical approach to the requirements of European Directive 2013/35/EU.

OBJECTIVES: Electromagnetic fields (EMF) may cause malfunctions in electronic devices, in particular in active implantable medical devices (AIMD), along with discomfort or health hazards to users. The use of AIMD by workers is increasing (especially cardiac pacemakers, implantable cardioverter defibrillators and wearable insulin infusion pumps). Electromagnetic fields may be much stronger in the working environment than applied in basic immunity tests of AIMD (based on EN 60601- 1-2:2015 and EN 50527-1:2016). European Directive 2013/35/EU regarding the safety of workers exposed to EMF considered the AIMD users to be "workers at particular risk" who need an individual evaluation of EMF hazards. The study aimed at evaluating the safety of users of AIMD in medical and industrial working environments exposed to EMF. MATERIAL AND METHODS: Near the common sources of strong EMF applied in medical and industrial use, the "standard safety distances" (SSD) for AIMD users were evaluated (i.e., distances from the EMF source, where exposure drops below limits from Recommendation 1999/519/EC and AIMD safety may be expected). The analysis is based on the results of measurements of magnetic and electric field strengths near 127 typical devices, in their normal use. RESULTS: The longest electric field related SSD was identified near dielectric sealers (up to 180 cm), and the longest magnetic field related SSD - near induction heaters (up to 450 cm). CONCLUSIONS: Electromagnetic fields related AIMD malfunctions need to be considered up to several meters from EMF sources. The "individual safety distance," that is sufficient to ensure the safety of a particular AIMD user may be significantly different (usually shorter) from the presented SSD, but needs to be considered in the context of detailed safety data from the AIMD manufacturer (if available). The labelling indicating the location of the area of a strong EMF increases safety of AIMD users in the work environment. Int J Occup Med Environ Health 2018;31(6):795-808.

Management of cardiac implantable devices in patients undergoing radiotherapy.

The delivery of radiotherapy to patients with a cardiac implantable electronic device (CIED) is not an infrequent event. Consideration of the potential issues for patients is an important part of their care. An overview of CIEDs is provided, including the potential problems encountered and the steps that can be taken to mitigate this risk.

Evaluation of a novel automatic screening tool for determining eligibility for a subcutaneous implantable cardioverter-defibrillator.

BACKGROUND: The manufacturer has developed a new ECG screening tool to determine eligibility for the subcutaneous ICD (S-ICD), the "automatic screening tool" (AST), which may render manual ECG-screening unnecessary. The aim of the study was to determine the eligibility for the S-ICD using two methods (manual ECG-screening versus AST) in different patient categories including patients with cardiomyopathy, congenital heart disease and inherited primary arrhythmia syndrome. METHODS: We prospectively evaluated the ECG suitability for an S-ICD in consecutive patients at our outpatient clinic between February and June 2017. The primary endpoint of the study was ECG eligibility defined as at least 1 successful vector in both supine and sitting postures. RESULTS: A total of 254 patients (167 men; mean age 45 ±â€¯16 years) were screened using both methods. Overall, there was a high ECG eligibility using either method (93% versus 92%, P = 0.45). Overall agreement between both methods was 94%. Patients with hypertrophic cardiomyopathy (HCM) more often had a failed screening test using either test in comparison to the patients without HCM (manual: odds ratio [OR] 3.3, 95% confidence interval [CI] 1.2-9.3, P = 0.02; AST: OR 3.0, 95% CI 1.2-7.6, P = 0.02). CONCLUSION: AST showed a high agreement with manual ECG-screening for S-ICD. Overall there was a high ECG eligibility for S-ICD, although patients with HCM had a lower passing rate irrespective of the screening method.

Direct comparison of the novel automated screening tool (AST) versus the manual screening tool (MST) in patients with already implanted subcutaneous ICD.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has evolved as a valuable alternative to the transvenous ICD, especially in young patients. Unfortunately, some of these patients are ineligible for S-ICD implantation due to specific electrocardiographic features. So far, these patients were identified by mandatory pre-implantation screening using the manual screening tool (MST), which lacks objective value. Therefore, a novel automated screening tool (AST) has been introduced recently for objective screening, which has not been evaluated yet. METHODS/RESULTS: We here first investigate the novel AST, in direct comparison to MST, in 33 consecutive patients with already implanted S-ICD system to compare predicted eligibility by screening tools with true sensing of the S-ICD system. Both screening tools reliably predicted true ineligible single vectors, but also suggested overall ineligibility in a similar fraction of patients (MST: 3.0%; AST: 6.1%), albeit the implanted S-ICD worked flawlessly in these patients. AST did not predict the finally selected sensing vector better than MST. There was a surprising mismatch between AST and MST for the predicted eligibility of single vectors; only in 49% of patients did both screening tools predict eligibility for the same vectors. CONCLUSIONS: The novel AST predicted overall eligibility approximately similar to MST. Both tools predicted ineligibility in a few patients, who were actually eligible. There was a striking mismatch between both screening tools when eligibility of single vectors was predicted. Thus, the AST seems to be a valuable advance, due to its standardized and objective process, but it still lacks specificity.

Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from Associazione Italiana Aritmologia e Cardiostimolazione (AIAC), Associazione Italiana Radioterapia Oncologica (AIRO), Associazione Italiana Fisica Medica (AIFM).

The management of patients with a cardiac implanted electronic device (CIED) receiving radiotherapy (RT) is challenging and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, radiation oncologists and physicists in order to stratify the risk of patients with CIED requiring RT and approaching RT sessions appropriately. When high radiation doses and beam energy higher than 6MV are used, CIED malfunctions can occur during treatment. In our document, we reviewed the different types of RT and CIED behavior in the presence of ionizing radiations and electromagnetic interferences, from the cardiologist's, radiation oncologist's and medical physicist's point of view. We also reviewed in vitro and in vivo literature data and other national published guidelines on this issue so far. On the basis of literature data and consensus of experts, a detailed approach based on risk stratification and appropriate management of RT patients with CIEDs is suggested, with important implications for clinical practice.

Long-Term Efficacy of Implantable Cardioverter Defibrillator in Repaired Tetralogy of Fallot　- Role of Anti-tachycardia Pacing.

BACKGROUND: Tetralogy of Fallot (TOF) is one of the common congenital heart diseases (CHD) in implantable cardioverter defibrillator (ICD) recipients, but few studies have reported the long-term outcomes of and the anti-tachycardia pacing (ATP) efficacy in repaired TOF.Methods and Results:Twenty-one repaired TOF patients with an ICD implanted between April 2003 and March 2015 were investigated retrospectively. ICD therapy and clinical outcome were analyzed. Mean patient age was 39±11 years; 62% were male; and mean age at repair surgery was 9.4±6.8 years. During a median follow-up of 5.6 years (range, 2.6-8.4 years), no patients died. Appropriate ATP were delivered in 11 patients (52%), with appropriate shocks in 5 patients (24%) and inappropriate shocks in 5 patients (24%). The success rate of ATP was 98% for fast ventricular tachycardia (VT; cycle length ≤320 ms) and 98% for slow VT (cycle length >320 ms). ATP effectiveness increased from 81.5% with the first ATP attempt to 93.7% with the second ATP attempt, to 97.5% with the third ATP attempt, and to 98.6% with the fourth or successive ATP attempt (P<0.0001, Cochran-Armitage trend test). CONCLUSIONS: ATP was highly effective in repaired TOF regardless of VT cycle length. Multiple ATP attempts could have an important role in VT termination, and the novel subcutaneous ICD without ATP capability should be used carefully.

Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre.

PURPOSE: Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a "real-world" setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients. METHODS: We analysed 270 consecutive ICD recipients implanted in a single centre-135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death. RESULTS: At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group, n = 31 vs. standardised group, n = 16). There was a 47 % risk reduction in any device therapy (p = 0.04) and an 86 % risk reduction in inappropriate therapy (p = 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (p = 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death. CONCLUSIONS: In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.

Cardiovascular implanted electronic devices in people towards the end of life, during cardiopulmonary resuscitation and after death: guidance from the Resuscitation Council (UK), British Cardiovascular Society and National Council for Palliative Care.

The Resuscitation Council (UK), the British Cardiovascular Society (including the British Heart Rhythm Society and the British Society for Heart Failure) and the National Council for Palliative Care recognise the importance of providing clear and consistent guidance on management of cardiovascular implanted electronic devices (CIEDs) towards the end of life, during cardiorespiratory arrest and after death. This document has been developed to provide guidance for the full range of healthcare professionals who may encounter people with CIEDs in the situations described and for healthcare managers and commissioners. The authors recognise that some patients and people close to patients may also wish to refer to this document. It is intended as an initial step to help to ensure that people who have CIEDs, or are considering implantation of one, receive explanation of and understand the practical implications and decisions that this entails; to promote a good standard of care and service provision for people in the UK with CIEDs in the circumstances described; to offer relevant ethical and legal guidance on this topic; to offer guidance on the delivery of services in relation to deactivation of CIEDs where appropriate; to offer guidance on whether any special measures are needed when a person with a CIED receives cardiopulmonary resuscitation; and to offer guidance on the actions needed when a person with a CIED dies.

Radiotherapy in patients with pacemakers and implantable cardioverter defibrillators: a literature review.

An increasing number of patients with implantable cardiac rhythm devices undergo radiotherapy (RT) for cancer and are thereby exposed to the risk of device failure. Current safety recommendations seem to have limitations by not accounting for the risk of pacemakers and implantable cardioverter defibrillators malfunctioning at low radiation doses. Besides scant knowledge about optimal safety measures, only little is known about the exact prevalence of patients with devices undergoing RT. In this review, we provide a short overview of the principles of RT and present the current evidence on the predictors and mechanisms of device malfunctions during RT. We also summarize practical recommendations from recent publications and from the industry. Strongly associated with beam energy of photon RT, device malfunctions occur at ∼3% of RT courses, posing a substantial issue in clinical practice. Malfunctions described in the literature typically consist of transient software disturbances and only seldom manifest as a permanent damage of the device. Through close cooperation between cardiologists and oncologists, a tailored individualized approach might be necessary in this patient group in waiting time for updated international guidelines in the field.

Initial Experience of an Anesthesiology-based Service for Perioperative Management of Pacemakers and Implantable Cardioverter Defibrillators.

BACKGROUND: Management of cardiovascular implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators, for surgical procedures is challenging due to the increasing number of patients with CIEDs and limited availability of trained providers. At the authors' institution, a small group of anesthesiologists were trained to interrogate CIEDs, devise a management plan, and perform preoperative and postoperative programming and device testing whenever necessary. METHODS: Patients undergoing surgery between October 1, 2009 and June 30, 2013 at the University of Washington Medical Center were included in a retrospective chart review to determine the number of devices actively managed by the Electrophysiology/Cardiology Service (EPCS) versus the Anesthesiology Device Service (ADS), changes in workload over time, surgical case delays due to device management, and errors and problems encountered in device programming. RESULTS: The EPCS managed 254 CIEDs, the ADS managed 548, and 227 by neither service. Over time, the ADS providers managed an increasing percentage of devices with decreasing supervision from the EPCS. Only two CIEDs managed by the ADS required immediate assistance from the EPCS. Patients who were unstable postoperatively were referred to the EPCS. Although numerous issues in programming were encountered, primarily when restoring demand pacing after programming asynchronous pacing for surgery, no patient harm resulted from ADS or EPCS management of CIEDs. CONCLUSIONS: An ADS can provide safe CIED management for surgery, but it requires specialized provider training and strong support from the EPCS. Due to the complexity of CIED management, an ADS will likely only be feasible in high-volume settings.

The use of 1.5 T magnetic resonance imaging for therapeutic decisions in patients with cardiac implantable electronic devices and significant neurological, neurosurgical and neuro-oncology diagnostic indications.

UNLABELLED: Between September 2009 and May 2014 the classification of 36 patients with cardiac implantable electronic devices (CIEDs) in terms of the feasibility of MRI scanning due to strong clinical indications was carried out. Finally MRI examinations were performed in 20 patients, of whom 27 studies were conducted and a total number of 35 anatomical regions were scanned. Neurological, neurosurgical and neuro-oncology indications for MRI were reported in 19 patients (95%) in whom 26 MRI studies (96.3%) were performed, and 34 anatomical regions (97.1%) were scanned. One patient had indications for MRI in the field of cardiology. Medical information obtained from 27 MRI studies allowed decisions to be made regarding the treatment in all patients. After 8 studies (29.6%), patients were classified into 9 different neurosurgical procedures. In the case of the remaining 19 studies (70.4%), there were no indications for surgical treatment and the decisions to implement conservative treatment were made. There were no complications related to the implanted CIEDs observed: neither immediate nor in the follow-up.