Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study.

AIMS: The aim of this study was to determine the long-term effects and determinants of success of cardiac pacing in patients affected by reflex syncope enrolled in the Syncope Unit Project 2 (SUP 2) study. Initial results have validated the effectiveness of a standardized guideline-based algorithm which can be used in clinical practice in order to select suitable candidates for cardiac pacing. METHODS AND RESULTS: In this prospective, multicentre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncope, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. Of 281 patients who met the inclusion criteria, 137 (49%) received a pacemaker and were followed up for a mean of 26 ± 11 months: syncope recurred in 25 (18%) of them. At 3 years, the actuarial syncope recurrence rate was 20% [95% confidence interval (CI) 12-30] and was significantly lower than in 142 patients who did not receive a pacemaker and were observed by means of an ILR [43% (95% CI 29-57), P = 0.01]. The 3-year recurrence rate was not different among 78 CSM+, 38 TT+, and 21 ILR+ patients, whereas it was lower in 20 patients with negative TT [5% (95% CI 0-15)] than in 61 patients with positive TT [24% (95% CI 10-38)]. CONCLUSION: The benefit of cardiac pacing is maintained at 3 years, irrespective of the index diagnostic test, and is maximum in patients with negative TT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.

Assessment of a standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncopes.

AIMS: Opinions differ regarding the effectiveness of cardiac pacing in patients affected by reflex syncope. We assessed a standardized guideline-based algorithm in different forms of reflex syncope. METHODS AND RESULTS: In this prospective, multi-centre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncopes, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. POPULATION: 253 patients, mean age 70 ± 12 years, median 4 (3-6) syncopes, 89% without or with short prodromes. Of these patients, 120 (47%) received a pacemaker and 106 were followed up for a mean of 13 ± 7 months: syncope recurred in 10 (9%). The recurrence rate was similar in 61 CSM+ (11%), 30 TT+ (7%), and 15 ILR+ (7%) patients. The actuarial total syncope recurrence rate was 9% (95% confidence interval (CI), 6-12) at 1 year and 15% (95% CI, 10-20) at 2 years and was significantly lower than that observed in the group of 124 patients with non-diagnostic tests who had received an ILR: i.e. 22% (95% CI, 18-26) at 1 year and 37% (95% CI, 30-43) at 2 years (P = 0.004). CONCLUSION: About half of older patients with severe recurrent syncopes without prodromes have an asystolic reflex for which cardiac pacing goes along with a low recurrence rate. The study supports the clinical utility of the algorithm for the selection of candidates to cardiac pacing in everyday clinical practice. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.

Optimizing remote heart failure management: First experiences with the HeartInsight score for implanted defibrillators.

We explored the results of two tests of the novel HeartInsight algorithm for heart failure (HF) prediction, reconstructing trends from historical cases. Results suggest potential extension of HeartInsight to implantable cardioverter defibrillators patients without history of HF and illustrate the importance of the baseline clinical profile in enhancing algorithm specificity.

Anaplastic Large Cell Lymphoma Growing in the Pacemaker Pocket.

An 88-year-old patient underwent pacemaker generator replacement. Shortly after the replacement, the pacemaker pocket became swollen and, assuming a hematoma, underwent percutaneous drainage. However, the swelling was due to an aggressive lymphoma located in the pocket. This is the first described case of T-cell lymphoma in a pacemaker pocket.

[Management strategies and choice of antithrombotic treatment in patients admitted with acute coronary syndrome--executive summary for clinical practice. Consensus Document of the Regional Chapters of the Italian National Association of Hospital Cardiologists (ANMCO) and of the Italian Society of Emergency Medicine (SIMEU)]. / Strategie Assistenziali e Scelta della Terapia Antitrombotica nei Pazienti Ricoverati con Diagnosi di Sindrome Coronarica Acuta--Sintesi Operativa per la Pratica Clinica. Documento congiunto delle Sezioni Regionali del Lazio dell'Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) e della Società Italiana di Medicina di Emergenza-Urgenza (SIMEU).

This document has been developed by the Lazio regional chapters of two scientific associations, the Italian National Association of Hospital Cardiologists (ANMCO) and the Italian Society of Emergency Medicine (SIMEU), whose members are actively involved in the everyday management of Acute Coronary Syndromes (ACS). The document is aimed at providing a specific, practical, evidence-based guideline for the effective management of antithrombotic treatment (antiplatelet and anticoagulant) in the complex and ever changing scenario of ACS. The document employs a synthetic approach which considers two main issues: the actual operative context of treatment delivery and the general management strategy.

[Artificial intelligence applied to the electrocardiogram.] / L'intelligenza artificiale applicata all'elettrocardiogramma.

Artificial intelligence is able to read and interpret Ecg traces quickly and precisely, increasing the diagnostic capacity and offering the possibility of anticipating preventive therapies. However, there is no evidence on the clinical utility and cost-effectiveness of certain practical applications. In fact, the literature shows the prognostic importance in favor of prevention, but clear evidence is not available that correcting strokes, embolisms, heart failure early improves quality and life span of patients.

Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario.

BACKGROUND: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). RESEARCH DESIGN AND METHODS: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. RESULTS: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. CONCLUSIONS: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

Diagnosis, management, and outcomes of patients with syncope and bundle branch block.

AIMS: Although patients with syncope and bundle branch block (BBB) are at high risk of developing atrio-ventricular block, syncope may be due to other aetiologies. We performed a prospective, observational study of the clinical outcomes of patients with syncope and BBB following a systematic diagnostic approach. METHODS AND RESULTS: Patients with ≥1 syncope in the last 6 months, with QRS duration ≥120 ms, were prospectively studied following a three-phase diagnostic strategy: Phase I, initial evaluation; Phase II, electrophysiological study (EPS); and Phase III, insertion of an implantable loop recorder (ILR). Overall, 323 patients (left ventricular ejection fraction 56 ± 12%) were studied. The aetiological diagnosis was established in 267 (82.7%) patients (102 at initial evaluation, 113 upon EPS, and 52 upon ILR) with the following aetiologies: bradyarrhythmia (202), carotid sinus syndrome (20), ventricular tachycardia (18), neurally mediated (9), orthostatic hypotension (4), drug-induced (3), secondary to cardiopulmonary disease (2), supraventricular tachycardia (1), bradycardia-tachycardia (1), and non-arrhythmic (7). A pacemaker was implanted in 220 (68.1%), an implantable cardioverter defibrillator in 19 (5.8%), and radiofrequency catheter ablation was performed in 3 patients. Twenty patients (6%) had died at an average follow-up of 19.2 ± 8.2 months. CONCLUSION: In patients with syncope, BBB, and mean left ventricular ejection fraction of 56 ± 12%, a systematic diagnostic approach achieves a high rate of aetiological diagnosis and allows to select specific treatment.

[e-Health, telemedicine and applications in cardiology: state of the art in Italy and experience of the cardiology unit of the G.B. Grassi Hospital of Rome]. / e-Health, telemedicina e applicazioni in Cardiologia: stato dell'arte in Italia ed esperienza dell'U.O.C. di Cardiologia dell'Ospedale G.B. Grassi di Roma.

e-Health (electronic health) refers to the use of information and communication technologies (ICT) to promote organizational change and facilitate new healthcare skills. In the last few years, several telemedicine services using ICT have been launched and the updating of related regulations has started, also for the increase in demand for services, their complexity and the need to offer adequate care to the patient. In cardiology, the experiences concern mainly patients suffering from heart failure or the carriers of cardiac implantable electronic devices (CIEDs), and few experiences are described in ischemic heart disease. In this article we present the design, the implementation and the results of the telemedicine service at the Cardiology Unit of the G.B. Grassi Hospital in Rome, concerning follow-up televisits for patients with heart failure, ischemic heart disease and for management of treatment plans, telemonitoring and telecontrol of CIEDs carriers and teleconsultation in ischemic heart disease. The considerations of this review, the experiences reported and the speed of digital evolution make the implementation of existing practices and the redesign of new pathways necessary.

Effectiveness of remote monitoring in the management of syncope and palpitations.

AIMS: Recently, the remote transmission of data detected by implantable loop recorders (ILRs) has become available. The aim of this study was to evaluate effectiveness and acceptance of remote monitoring in the clinical management of syncope and palpitations in patients with ILR. METHODS AND RESULTS: Consecutive patients implanted with ILR (Reveal DX/XT Medtronic, Inc.) and followed up by means of remote monitoring (CareLink(®)) were included. The patients were requested to transmit the data stored in the ILR every week, via the CareLink system, or more frequently during the first period. Patient acceptance of ILR was evaluated by means of a questionnaire concerning physical and mental components. Forty-seven patients (27 males, average age 64 ± 19 years) were enrolled and followed up for 20 ± 13 weeks. Thirty-two patients (68%) had at least one ECG recording of a true relevant event. The mean time from ILR implantation to the first true relevant ECG was 28 ± 49 days, which was 71 ± 17 days less than in the clinical practice of 3-monthly in-office follow-up examinations. Thirty-eight patients (81%) had at least one false arrhythmic event, mainly false asystole and false fast ventricular tachycardia. In the absence of Carelink transmission, at least one episode of memory saturation of ILR would have occurred in 21 patients (45%) that would have limited the diagnostic yield. Patient compliance was good even though one-fifth had some minor psychological concern regarding the ILR implant. CareLink was well accepted and judged easy to use. CONCLUSION: Remote monitoring enhances the diagnostic effectiveness of Reveal, limiting the risk of memory saturation due to the high number of false detections and reducing the time to diagnosis. Both ILR and CareLink were well accepted and well tolerated by the patients, as they were considered useful.

[50 years of electrophysiology and cardiac pacing]. / 50 anni di elettrofisiologia ed elettrostimolazione.

During the last 50 years a continuous improvement was observed in the field of cardiac pacing and electrophysiology as for as both technological and clinical aspects were concerned. We moved from the first recording of the His bundle electrogram to the identification of the various mechanisms and sites of supraventricular and ventricular tachyarrhythmias, to three-dimensional mapping and ablation of different reentry circuits and eventually to pulmonary vein isolation for the treatment of atrial fibrillation. As far as cardiac pacing is concerned, we moved from single chamber to dual chamber pacing, to ventricular pacing and implantable automatic defibrillators provided by sophisticated diagnostic and therapeutic algorithms and by remote control. Recently a family of leadless devices (loop recorders, endocavitary pacemakers, subcutaneous defibrillators) have become available for diagnostic and therapeutic purposes and brought a significant benefit in the reduction and management of many device-related troubles.

Prospective multicentre systematic guideline-based management of patients referred to the Syncope Units of general hospitals.

AIMS: Although an organizational model for syncope management facilities was proposed in the 2004 guidelines of the European Society of Cardiology (ESC), its implementation in clinical practice and its effectiveness are largely unknown. METHODS AND RESULTS: This prospective study enrolled 941 consecutive patients referred to the Syncope Units of nine general hospitals from 15 March 2008 to 15 September 2008. A median of 15 patients per month were examined in each unit, but the five older units had a two-fold higher volume of activity than the four newer ones (instituted <1 year before): 23 vs. 12, P = 0.02. These figures give an estimated volume of 163 and 60 patients per 100,000 inhabitants per year, respectively. Referrals: 60% from out-of-hospital services, 11% immediate and 13% delayed referrals from the Emergency Department, and 16% hospitalized patients. A diagnosis was established on initial evaluation in 191 (21%) patients and early by means of 2.9 +/- 1.6 tests in 541 (61%) patients. A likely reflex cause was established in 67%, orthostatic hypotension in 4%, cardiac in 6% and non-syncopal in 5% of the cases. The cause of syncope remained unexplained in 159 (18%) patients, despite a mean of 3.5 +/- 1.8 tests per patient. These latter patients were older, more frequently had structural heart disease or electrocardiographic abnormalities, unpredictable onset of syncope due to the lack of prodromes, and higher OESIL and EGSIS risk scores than the other groups of patients. The mean costs of diagnostic evaluation was 209 euro per outpatient and 1073 euro per inpatient. The median cost of hospital stay was 2990 euro per patient. CONCLUSION: We documented the current practice of syncope management in specialized facilities that have adopted the management model proposed by the ESC. The results are useful for those who wish to replicate this model in other hospitals. Syncope remains unexplained during in-hospital evaluation in more complex cases at higher risk.

ICD-measured heart sounds and their correlation with echocardiographic indexes of systolic and diastolic function.

BACKGROUND: Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD. METHODS: The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit. RESULTS: S3 amplitude inversely correlated with deceleration time of the E-wave (r = -0.32; 95% CI -0.46 - -0.17; P < 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03-0.30; P = 0.021). S3 > 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%-93%) sensitivity and 82% (95% CI 75%-88%) specificity, while S1 < 1.5 mG detected ejection fraction < 35% with 28% (95% CI 19%-40%) sensitivity and 88% (95% CI 80%-93%) specificity. CONCLUSION: ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.

Prospective evaluation of the multisensor HeartLogic algorithm for heart failure monitoring.

BACKGROUND: The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. HYPOTHESIS: We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert-based follow-up strategy. METHODS: The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In-office examinations were performed every 6 months or when deemed necessary. RESULTS: During a median follow-up of 13 (10-16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient-year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF-related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient-year, and the rate of hospitalizations not associated with an alert was 0.05/patient-year. Centers performed remote follow-up assessments of 1113 scheduled monthly transmissions (10.3/patient-year) and 100 alerts (0.93/patient-year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P < .001). CONCLUSIONS: HeartLogic allowed relevant HF-related clinical conditions to be identified remotely and enabled effective clinical actions to be taken; the rates of unexplained alerts and undetected HF events were low. An alert-based management strategy seemed more efficient than a scheduled monthly remote follow-up scheme.

Neuro-arrhythmology: a challenging field of action and research: a review from the Task Force of Neuro-arrhythmology of Italian Association of Arrhythmias and Cardiac Pacing.

: There is a growing interest in the study of the mechanisms of heart and brain interactions with the aim to improve the management of high-impact cardiac rhythm disorders, first of all atrial fibrillation. However, there are several topics to which the scientific interests of cardiologists and neurologists converge constituting the basis for enhancing the development of neuro-arrhythmology. This multidisciplinary field should cover a wide spectrum of diseases, even beyond the classical framework corresponding to stroke and atrial fibrillation and include the complex issues of seizures as well as loss of consciousness and syncope. The implications of a more focused interaction between neurologists and cardiologists in the field of neuro-arrhythmology should include in perspective the institution of research networks specifically devoted to investigate 'from bench to bedside' the complex pathophysiological links of the abovementioned diseases, with involvement of scientists in the field of biochemistry, genetics, molecular medicine, physiology, pathology and bioengineering. An investment in the field could have important implications in the perspectives of a more personalized approach to patients and diseases, in the context of 'precision'medicine. Large datasets and electronic medical records, with the approach typical of 'big data' could enhance the possibility of new findings with potentially important clinical implications. Finally, the interaction between neurologists and cardiologists involved in arrythmia management should have some organizational implications, with new models of healthcare delivery based on multidisciplinary assistance, similarly to that applied in the case of syncope units.

Preliminary experience with the multisensor HeartLogic algorithm for heart failure monitoring: a retrospective case series report.

AIMS: In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice. METHODS AND RESULTS: Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation. CONCLUSIONS: Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation.

Management of syncope: clinical and economic impact of a Syncope Unit.

AIMS: Aim of this observational study is to evaluate the clinical performance of a Syncope Unit, in order to assess whether the implemented organization really improves syncope management. METHODS AND RESULTS: The study enrolled patients with unexplained syncope who were consecutively referred to our Syncope Unit, either as outpatients or during hospitalization, in a 2-month period. The design of this observational study consists in three phases: a retrospective analysis of their clinical management in the 9 months prior to the first attendance at the Syncope Unit (phase one), their subsequent clinical management in the Syncope Unit (phase two) and a 9-month follow-up (phase three). The retrospective analysis of phase one showed that 25% of patients had already been hospitalized without diagnosis. After Syncope Unit evaluation, diagnosis was obtained in 82% of patients, with 15% of patients indicated to pacing. In the follow-up, 23% of patients experienced a syncopal recurrence. Our analysis indicated an 85% reduction of hospital costs in the follow-up period. CONCLUSION: The clinical and economic analysis of the three phases of our study demonstrates that a Syncope Unit allows an improved management of patients with syncope.

Preliminary experience with a novel Multisensor algorithm for heart failure monitoring: The HeartLogic index.

We report the first case of a patient in whom an implantable cardioverter-defibrillator (ICD) endowed with HeartLogic, a novel algorithm for heart failure (HF) monitoring, was implanted in clinical practice. The good temporal association between HeartLogic index threshold crossings and HF hospitalizations confirms the high sensitivity in detecting gradual worsening of HF.

[Appropriateness criteria for the management of anticoagulant therapy in complex patients with atrial fibrillation. The opinion of a group of expert Italian cardiologists]. / Criteri di appropriatezza nella gestione della terapia anticoagulante nel paziente complesso con fibrillazione atriale. L'opinione di un gruppo di esperti cardiologi italiani.

Atrial fibrillation (AF) is a common arrhythmia often associated with high thromboembolic risk. The purpose of this position paper is to provide clinicians with recommendations useful in managing some important issues regarding the use of anticoagulant therapy in patients with AF in particularly complex clinical situations.The RAND/UCLA appropriateness method, validated to combine the best available scientific evidence with the collective judgment of experts, was used to assess the judgment of an expert panel of cardiologists. To this purpose, the benefit-to-harm ratio of 37 clinical scenarios was rated. Each indication was classified as "appropriate", "uncertain", or "inappropriate" in accordance with the panelists' median score.The present document reports the results of this consensus process, which led to the development of recommendations for clinical practice on how to use anticoagulant therapy in patients with AF in complex clinical settings, including the presence of comorbidities, cardioversion, or ablation. Non-vitamin K oral anticoagulants are a valid alternative to vitamin K antagonists in preventing embolic events in patients with non-valvular AF, particularly in case of clinical complexity.

[Electromagnetic interference in the current era of cardiac implantable electronic devices designed for magnetic resonance environment]. / Le interferenze elettromagnetiche nell'era dei dispositivi elettronici cardiaci impiantabili compatibili con la risonanza magnetica.

In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.