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In 2020, the UK environmental regulators and food safety agencies, published the 25th edition of the Radioactivity in Food and the Environment (RIFE) report. This marks a quarter of a century since the landmark RIFE report was first published by the Ministry of Agriculture, Fisheries and Food in 1996, which represented the first joint monitoring and assessment report for the United Kingdom. This paper provides a summary of the RIFE report, how it has evolved and presents some case studies from over the 25 year period.
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Inocuidad de los Alimentos , Reino UnidoRESUMEN
Twiddler syndrome is an uncommon yet dangerous phenomenon usually resulting in lead displacement with loss of capture of cardiac implantable electronic devices. In this case report, we present an interesting case of Twiddler syndrome without lead dislodgment which was detected by an alert triggered by an increase in impedance on remote monitoring.
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Background: Apical hypertrophic cardiomyopathy (aHCM) is thought to have a more benign clinical course compared to septal HCM (sHCM), but most data have been derived from Asian cohorts. Comparative data on clinical outcome in Caucasian aHCM cohorts are scarce, and the results are conflicting. The aim of this study was to estimate the prevalence and outcome of aHCM in French-Canadians of Caucasian descent. Methods and results: We conducted a retrospective, single-center cohort study. The primary endpoint was a composite of documented sustained ventricular arrhythmia (VA), appropriate ICD therapy, arrhythmogenic syncope, cardiac arrest, or all-cause mortality. A total of 301 HCM patients (65% males) were enrolled including 80/301 (27%) with aHCM and 221/301 (73%) with sHCM. Maximal wall thickness was similar in both groups. Left ventricular apical aneurysm was significantly more common in aHCM (10 vs. 0.5%; p < 0.001). The proportion of patients with myocardial fibrosis ≥ 15% of the left ventricular mass was similar between aHCM and sHCM (21 vs. 24%; p = 0.68). Secondary prevention ICDs were more often implanted in aHCM patients (16 vs. 7%; p = 0.02). The primary endpoint occurred in 26% of aHCM and 10.4% of sHCM patients (p = 0.001) and was driven by an increased incidence of sustained VA (10 vs. 2.3%; p = 0.01). Multivariate analysis identified apical aneurysm and a phenotype of aHCM as independent predictors of the primary endpoint and the occurrence of sustained ventricular tachycardia. Unexplained syncope and a family history of sudden cardiac death were additional predictors for sustained VA. Apical HCM was associated with an increased risk of ventricular arrhythmia even when excluding patients with apical aneurysm. Conclusions: The phenotype of apical HCM is much more common in French-Canadians (27%) of Caucasian descent compared to other Caucasian HCM populations. Apical HCM in French-Canadians is associated with an increased risk for ventricular arrhythmia.
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BACKGROUND: Monitoring of cardiac implantable electronic devices was highly impacted by the COVID-19 pandemic considering the high volume of in-person visits for regular follow-up. Recent recommendations highlight the important role of remote monitoring to prevent exposure to the virus. This study compared remote monitoring of implantable cardioverter defibrillators (ICDs) in patients whose in-person annual visit was substituted for a remote monitoring session with patients who were already scheduled for a remote monitoring session. METHODS: This was a cross-sectional observational study of 329 consecutive patients between 20 March and 24 April 2020. Group 1 included 131 patients whose in-person annual visit was substituted for a remote monitoring session. Group 2 included 198 patients who underwent a remote monitoring session as scheduled in their usual device follow-up. The time interval since the last in-person visit was 13.3 ± 3.2 months in group 1 and 5.9 ± 1.7 months in group 2 (P < .01). RESULTS: In group 1, 15 patients (11.5%) experienced a clinical event compared to 15 patients (7.6%) in group 2 (P = .25). Nineteen patients (14.5%) required a physician intervention in group 1 compared to 19 patients (9.6%) in group 2 (P = .22). Two patients (1.5%) in group 1 and four patients (2.0%) in group 2 required an early in-person follow-up visit during the pandemic (P > .99). CONCLUSION: Remote monitoring of ICDs is useful to identify clinical events and allows physicians to treat patients appropriately during the COVID-19 pandemic regardless of the time interval since their last in-person visit. It reduces significantly in-person visit for regular follow-up.
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Desfibriladores Implantables , Telemetría , Anciano , COVID-19/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodosRESUMEN
BACKGROUND: Current guidelines recommend 4 weeks of private driving restriction after implantation of a primary-prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. Advances in medical treatment and ICD programming have lowered the overall rate of device therapies. The objective of this study was to assess the incidence of ICD therapies at 30, 60, and 180 days after implantation. METHODS: Driving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) was a retrospective cohort study conducted at 2 Canadian university centres enrolling patients with new implantation of a primary-prevention ICD. Device programming was standardised according to current guidelines. A total of 803 patients were enrolled. RESULTS: The cumulative rates of appropriate ICD therapies at 30, 60, and 180 days were 0.12%, 0.50%, and 0.75%, respectively. There was no syncope during the first 6 months. The median duration to the first appropriate ICD therapy was 208 (range 23-1109) days after implantation. The rate of inappropriate ICD therapies at 30 days was only 0.2%. Overall, < 13.6% of all appropriate ICD therapies occurred within the first 6 months after implantation. CONCLUSIONS: The rate of appropriate ICD therapies within the first 30 days after device insertion is extremely low in contemporary primary prevention cohorts with guideline-concordant device programming. There was no increased risk for ventricular arrhythmia early after ICD insertion. The results of DREAM-ICD suggest the need for a revision of the existing driving restrictions for primary-prevention ICD recipients.
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Arritmias Cardíacas/prevención & control , Conducción de Automóvil , Desfibriladores Implantables , Cardioversión Eléctrica/métodos , Prevención Primaria/métodos , Adulto , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/epidemiología , Canadá/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Adulto JovenRESUMEN
BACKGROUND: Cardiostat™ is a single lead ambulatory ECG monitor. Recording is made through 2 electrodes positioned in a lead 1-like configuration. We first validated its accuracy for atrial fibrillation detection compared to a 12-lead ECG. In the second phase of the study, arrhythmia detection accuracy was compared between Cardiostat™ ambulatory ECG and a standard 24â¯h Holter ECG monitoring. METHOD/RESULTS: Phase one of the study included patients undergoing cardioversion for atrial fibrillation (AF) or atrial flutter. Cardiostat™ tracings were compared with standard 12-lead ECG. In the second phase, patients undergoing 24â¯h ambulatory Holter ECG monitoring for control or suspicion of atrial fibrillation (AF) were included. Simultaneous Holter monitoring and Cardiostat™ ECG recordings were performed. Tracings were analysed and compared. Two hundred twelve monitoring were compared. AF was diagnosed in 73 patients. Agreement between Cardiostat™ ECG and standard Holter monitoring was 99% for AF detection with kappaâ¯=â¯0.99. Kappa correlation for atrial flutter detection was only moderate at 0.51. AF burden was similar in both recordings. Noise hindered analysis in a greater proportion with Cardiostat™ compared to Holter ambulatory ECG (8.5 vs 3.8%). CONCLUSION: Cardiostat™ ambulatory ECG device showed excellent correlation with the standard Holter ECG monitoring for AF detection. Holter monitoring was however superior to discriminate premature atrial and ventricular beats and to qualify the morphology of PVCs since it has more vectors for analysis. Added value of Cardiostat™ includes longer monitoring duration, less cumbersome installation and water resistance.
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Fibrilación Atrial/diagnóstico , Aleteo Atrial/diagnóstico , Electrocardiografía Ambulatoria/instrumentación , Anciano , Diseño de Equipo , Femenino , Humanos , MasculinoRESUMEN
Diagnosis of arrhythmic disorders is challenging because of their short-lasting, intermittent character. Conventional technologies of noninvasive ambulatory rhythm monitoring are limited by modest sensitivity. We present a novel form of wearable electrocardiogram (ECG) sensors providing an alternative tool for long-term rhythm monitoring with the potential of increased sensitivity to detect intermittent or subclinical arrhythmia. The objective was to assess the signal quality and R-R coverage of a wearable ECG sensor system compared to a standard 3-lead Holter. In this phase-1 trial, healthy individuals underwent 24-h simultaneous rhythm monitoring using the OMsignal system together with a 3-lead Holter recording. The OMsignal system consists of a garment (bra or shirt) with integrated sensors recording a single-lead ECG and an acquisition module for data storage and processing. Head-to-head signal quality was assessed regarding adequate P-QRS-T distinction and was performed by three electrophysiologists blinded to the recording technology. The accuracy of signal coverage was assessed using Bland-Altman analysis. Fifteen individuals underwent simultaneous 24-h recording. Signal quality and accuracy of the OMgaments was equivalent to Holter-monitoring (84% vs 93% electrophysiologists rating, p = 0.06). Signal coverage of R-R intervals showed a very close overlay between the OMsignal system and Holter signals, mean difference in heart rate of 2 5 bpm. The noise level of OMgarments was comparable to Holter recording. OMgarments provide high signal quality for adequate rhythm analysis, representing a promising novel technology for long-term non-invasive ECG monitoring.
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Electrocardiografía Ambulatoria/métodos , Frecuencia Cardíaca , Dispositivos Electrónicos Vestibles , Adulto , Arritmias Cardíacas/fisiopatología , Electrocardiografía Ambulatoria/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Procesamiento de Señales Asistido por Computador , TelemedicinaRESUMEN
BACKGROUND: Infections of cardiac implantable electronic devices (CIED) are associated with significant morbidity and mortality. Despite many preventive measures, this condition is associated with significant costs for the health care system. METHODS: We retrospectively analyzed all infection cases referred for lead extraction at a single university hospital over 1 year (2015-2016). We then calculated all costs related to the infection episode per patient using hospital databases and charts review. RESULTS: Thirty-eight patients with CIED infections (29% women-mean age 71 ± 14 years) were referred for lead extraction (27 pocket infections, 11 endocarditis). Devices were mainly pacemakers (60%). When the pathogen was identified, Staphylococcus aureus methicillin sensitive was the main cause. Extraction was performed in all but 3 cases (92%). One death occurred in the nonextracted group. Respective durations of hospitalization and intravenous and antibiotic administration for patients undergoing extraction were 21 and 36 days. The calculated mean total cost for CIED infection management was CAD$29,907 (median: 26,879; range: CAD$4,827-$62,585). Mean hospital charges were CAD$12,291, accounting for 41% of the total costs. CONCLUSIONS: This study represents the first analysis of the direct costs associated with lead extraction in Canada. Device infections are associated with significant costs and increased morbidity. Any preventive measure will have a significant impact on the economic burden of the health care system and patient outcome after lead extraction.
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Desfibriladores Implantables/efectos adversos , Remoción de Dispositivos/economía , Costos de la Atención en Salud , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Anciano , Análisis Costo-Beneficio , Desfibriladores Implantables/economía , Femenino , Humanos , Incidencia , Masculino , Marcapaso Artificial/economía , Infecciones Relacionadas con Prótesis/economía , Quebec/epidemiología , Estudios Retrospectivos , Tasa de Supervivencia/tendenciasRESUMEN
INTRODUCTION: Implantable cardioverter-defibrillator (ICD) DF-4 connectors have been introduced to facilitate defibrillator lead connection and to reduce the size of device header. There are limited data regarding the overall performance of those leads and no comparison between different ICD DF-4 leads. METHODS: This is a cohort study of consecutive patients implanted with ICD DF-4 lead system at one University Centre between October 2010 and February 2015. A historical control group of patients with ICD DF-1 lead implantation was used for comparison. The following ICD DF-4 leads were evaluated: St. Jude Medical Durata 7122Q (St. Jude Medical, St. Paul, MN, USA), Medtronic Sprint Quattro Secure 6935 M (Medtronic Inc., Minneapolis, MN, USA), Boston Scientific Endotak Reliance 4-Site 0293 (Boston Scientific, Marlborough, MA, USA), and Boston Scientific Reliance 4-Front 0693. This study evaluated the acute and mid-term performances of those leads as well as complications. RESULTS: A total of 812 patients (age 63 ± 12 years, 80% male, left ventricular ejection fraction 31 ± 12%) underwent implantation of an ICD DF-4 lead. Acute and follow-up R-wave sensing and threshold were excellent. Compared to implantation, intrinsic R waves were higher at follow-up for Boston Scientific and Medtronic leads, and pacing lead impedances were lower for all leads at first follow-up (P < 0.001). The number of lead dislodgement or failure was similar between all leads. The estimated lead survival rates at 3 years were 95.6% for Boston Scientific Endotak 4-Site, 97.1% for Boston Scientific 4-Front, 97.7% for Medtronic Sprint Quattro, and 97.5% for St. Jude Durata (P = 0.553). CONCLUSION: All ICD DF-4 leads had excellent acute and mid-term electrical performances. Longer follow-up will be necessary to confirm their sustained performance.
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BACKGROUND: Subcutaneous implantable cardioverter-defibrillators provide an alternative to transvenous defibrillation but require higher shock outputs and offer no antitachycardia pacing. The Substernal Pacing Acute Clinical Evaluation (SPACE) study evaluated the feasibility of pacing from an extravascular substernal location. OBJECTIVES: The primary purpose of the SPACE study was to characterize pacing from the substernal space. Secondary objectives included evaluating extracardiac stimulation and recording electrograms. METHODS: The SPACE study prospectively evaluated the feasibility of pacing with a commercially available electrophysiology catheter acutely implanted in the substernal space via minimally invasive subxiphoid access. Pacing data were collected in ≥7 vectors using constant current stimulation up to 20 mA and pulse width up to 10 ms. RESULTS: Catheter placement was successful in all 26 patients who underwent the procedure, with a mean placement time of 11.7 ± 10.1 minutes. Eighteen patients (69%) had successful ventricular capture in ≥1 tested vector. The mean pacing threshold at a pulse width of 10 ms was 7.3 ± 4.2 mA across all vectors (5.8 ± 4.4 V). Failed capture was generally associated with suboptimal catheter placement or presumed air ingression. A low level of extracardiac stimulation was observed in 1 patient. The mean R-wave amplitude ranged from 2.98 to 4.11 mV in the unipolar configuration and from 0.83 to 3.95 mV in the bipolar configuration. CONCLUSION: The data from the SPACE study demonstrate that pacing is feasible from the extravascular substernal location. A substernal electrode configuration has the potential to provide pacing in a future extravascular device without need for intracardiac hardware placement.
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Arritmias Cardíacas/terapia , Desfibriladores Implantables , Técnicas Electrofisiológicas Cardíacas , Frecuencia Cardíaca/fisiología , Ventrículos Cardíacos/fisiopatología , Enfermedad Aguda , Arritmias Cardíacas/fisiopatología , Cateterismo Cardíaco/métodos , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Curva ROC , Factores de TiempoRESUMEN
Radiological exposures due to naturally occurring radioactive material (NORM) can occur during a wide range of work-related activities in the mineral processing and chemical industries. However, evaluation of such exposures in industrial settings remains a difficult exercise owing inter alia to the large number of personnel, operations and plants affected; assumptions that often have to be made concerning the actual duration and frequency of exposures; the complex chemistry and radioactive disequilibria involved and typically, the paucity of historical data. In our study, the challenges associated with assessing chronic exposure to fugitive dust enriched in 210Pb and 210Po and the determination of the associated internal dose by inhalation and ingestion are described by reference to a case study undertaken at an iron ore sintering plant between June 2013 and July 2015. The applicability of default dose coefficients and biokinetic models provided by the International Commission for Radiological Protection (ICRP) was verified by combining air and dust monitoring with information on the characteristics of the aerosols and in-vitro solubility experiments. The disparity between particulate matter 100 microns or less in diameter (PM100), particulate matter 10 microns or less in diameter (PM10) and 210Pb/210Po activity concentrations observed over the different monitoring campaigns and sampling locations confirmed that use of positional short-term monitoring surveys to extrapolate intake over a year was not appropriate and could lead to unrealistic intake and dose figures. Personal air sampling is more appropriate for estimating the dose in such situations, though it is not always practical and may collect insufficient quantities of material for radiochemical analysis; this is an important constraint when dealing with low specific activity materials.
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Radiological exposures due to naturally occurring radioactive material (NORM) can occur during a wide range of work-related activities in the mineral processing and chemical industries. However, evaluation of such exposures in industrial settings remains a difficult exercise owing inter alia to the large number of personnel, operations and plants affected; assumptions that often have to be made concerning the actual duration and frequency of exposures; the complex chemistry and radioactive disequilibria involved and typically, the paucity of historical data. In our study, the challenges associated with assessing chronic exposure to fugitive dust enriched in 210Pb and 210Po and the determination of the associated internal dose by inhalation and ingestion are described by reference to a case study undertaken at an iron ore sintering plant between June 2013 and July 2015. The applicability of default dose coefficients and biokinetic models provided by the International Commission for Radiological Protection was verified by combining air and dust monitoring with information on the characteristics of the aerosols and in-vitro solubility experiments. The disparity between particulate matter 100 microns or less in diameter (PM100), particulate matter 10 microns or less in diameter (PM10) and 210Pb/210Po activity concentrations observed over the different monitoring campaigns and sampling locations confirmed that use positional short-term monitoring surveys to extrapolate intake over a year was not appropriate and could lead to unrealistic intake and dose figures. Personal air sampling is more appropriate for estimating the dose in such situations, though it is not always practical and may collect insufficient quantities of material for radiochemical analysis; this is an important constraint when dealing with low specific activity materials.
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Contaminantes Ocupacionales del Aire/análisis , Contaminantes Radiactivos del Aire/análisis , Hierro , Exposición Profesional/análisis , Monitoreo de Radiación/métodos , Aerosoles/análisis , Polvo/análisis , Ingestión de Alimentos , Humanos , Industrias , Exposición por Inhalación , Material Particulado/análisis , Protección RadiológicaRESUMEN
Sudden cardiac death is a major public health issue in Canada. However, despite the overwhelming evidence to support the use of implantable cardioverter defibrillators (ICDs) in the prevention of cardiac death there remains significant variability in implantation rates across Canada. Since the most recent Canadian Cardiovascular Society position statement on ICD use in Canada in 2005, there has been a plethora of new scientific information to assist physicians in their discussions with patients considered for ICD implantation to prevent sudden cardiac death due to ventricular arrhythmias. We have reviewed, critically appraised, and synthesized the pertinent evidence to develop recommendations regarding: (1) ICD implantation in the primary and secondary prevention of sudden cardiac death in patients with and without ischemic heart disease; (2) when it is reasonable to withhold ICD implantation on the basis of comorbidities; (3) ICD implantation in patients listed for heart transplantation; (4) implantation of a single- vs dual-chamber ICD; (5) implantation of single- vs dual-coil ICD leads; (6) the role of subcutaneous ICDs; and (7) ICD implantation infection prevention strategies. We expect that this document, in combination with the companion article that addresses the implementation of these guidelines, will assist all medical professionals with the care of patients who have had or at risk of sudden cardiac death.
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Arritmias Cardíacas/terapia , Cardiología , Muerte Súbita Cardíaca/prevención & control , Desfibriladores Implantables/normas , Prevención Secundaria/normas , Sociedades Médicas , Arritmias Cardíacas/complicaciones , Muerte Súbita Cardíaca/etiología , Humanos , Prevención Secundaria/métodosAsunto(s)
Bloqueo Atrioventricular , Terapia de Resincronización Cardíaca/métodos , Muerte Súbita Cardíaca/prevención & control , Insuficiencia Cardíaca , Ventrículos Cardíacos , Infarto del Miocardio , Marcapaso Artificial/efectos adversos , Falla de Prótesis , Implantación de Prótesis/efectos adversos , Bloqueo Atrioventricular/complicaciones , Bloqueo Atrioventricular/terapia , Muerte Súbita Cardíaca/etiología , Análisis de Falla de Equipo , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Ventrículos Cardíacos/diagnóstico por imagen , Ventrículos Cardíacos/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/fisiopatología , Flebografía/métodos , Cuidados Preoperatorios/métodos , Falla de Prótesis/efectos adversos , Falla de Prótesis/etiología , Implantación de Prótesis/métodos , Tomografía Computarizada por Rayos X/métodos , Vena Cava Superior/diagnóstico por imagenRESUMEN
AIMS: This multicenter acute clinical study was designed to verify novel three-dimensional (3D) quadripolar lead designs that can achieve ≤2.5 V average pacing capture threshold (PCT) not only at the apex, but also at the base of the left ventricle with phrenic nerve stimulation (PNS) avoidance for cardiac resynchronization. METHODS: During the implant procedure, up to two different left ventricular investigational leads were introduced and tested in the same target coronary vein based on the coronary sinus venogram in a wedged and unwedged position. Adverse events were collected in 30 days following the procedure. RESULTS: Eighty-seven leads were tested in 50 patients. When the best performing spiral electrode was chosen from each lead testing, the average of the best PCT on spiral in a wedged position was similar to the unwedged position (1.7 ± 1.5 V vs 1.9 ± 1.5 V, P = ns) and was similar to the wedged tip electrode average PCT (1.7 ± 1.5 V vs 1.6 ± 1.6 V, P = ns). In the majority of patients (89-96%), pacing was achievable in a mid-basal ventricular location without PNS. CONCLUSIONS: This acute study demonstrated that a 3D quadripolar spiral lead design can achieve acceptable PCTs and avoid PNS without repositioning the lead at implant in the vast majority of patients. It also demonstrated that this lead design can achieve mid-basal ventricular stimulation with low PCT and good acute stability.
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Dispositivos de Terapia de Resincronización Cardíaca , Electrodos Implantados , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/prevención & control , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/prevención & control , Anciano , Diseño de Equipo , Análisis de Falla de Equipo , Femenino , Insuficiencia Cardíaca/diagnóstico , Humanos , Internacionalidad , Masculino , Resultado del Tratamiento , Disfunción Ventricular Izquierda/diagnósticoRESUMEN
BACKGROUND: Riata™ and Riata ST defibrillation leads (St. Jude Medical, Sylmar, CA, USA) are susceptible to insulation defects with conductor externalization. Cine-fluoroscopy is considered to be the gold standard for the documentation of insulation defects, but similar detection rates have been reported for posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming. OBJECTIVE: Prospective single-center study to assess the diagnostic equivalence of a PA/lateral CXR with zooming for the detection of Riata insulation defects in a direct comparison to cine-fluoroscopy. METHODS: Seventy-eight consecutive patients underwent 3-view cine-fluoroscopy and a PA/lateral CXR. All CXRs and cine-fluoroscopy images were reviewed by blinded electrophysiologists and staff radiologists. RESULTS: Forty-four of 78 patients had an abnormal cine-fluoroscopy (56%). The diagnostic correlation between PA/lateral CXR and cine-fluoroscopy was excellent (κ = 0.90; 95% confidence interval 0.80-1.00). PA/lateral CXR was equivalent to cine-fluoroscopy for the detection of conductor externalization showing a sensitivity of 97.7% and a specificity of 91.2%. The mean radiation effective dose of CXR was significantly lower compared to cine-fluoroscopy (0.09 millisievert [mSV] vs 0.85 ± 0.47 mSv; P < 0.001). Also, CXR was significantly less expensive. CONCLUSION: PA/lateral CXR with zooming is equivalent to cine-fluoroscopy for the detection of Riata insulation defects and should be considered as the preferred screening method.
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Cinerradiografía , Desfibriladores Implantables , Radiografía Torácica , Anciano , Femenino , Fluoroscopía , Humanos , Masculino , Estudios Prospectivos , Radiografía Torácica/métodosRESUMEN
BACKGROUND AND PURPOSE: Riata(TM) defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in Riata(TM) leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure. METHODS: A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed. RESULTS: The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy. CONCLUSION: The annual incidence of new insulation defects in Riata(TM) leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in Riata(TM) leads is also much higher than reported and is associated with conductor externalization.
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Desfibriladores Implantables/estadística & datos numéricos , Electrodos Implantados/estadística & datos numéricos , Falla de Equipo/estadística & datos numéricos , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/prevención & control , Distribución por Edad , Anciano , Análisis de Falla de Equipo/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Estudios Longitudinales , Masculino , Estudios Prospectivos , Quebec/epidemiología , Factores de Riesgo , Distribución por SexoRESUMEN
INTRODUCTION: A purely subcutaneous implantable cardioverter defibrillator (ICD) requires higher energy but may be an effective alternative to transvenous ICDs to deliver lifesaving therapies. OBJECTIVE: To identify combinations of anteroposterior subcutaneous shock pathways and waveforms with defibrillation efficacy comparable to transvenous ICDs. METHODS: Defibrillation testing was performed in 141 patients temporarily implanted with an active can emulator and subcutaneous coil electrodes. The patients were subdivided into 5 groups within 2 study phases. In all groups, a posterior electrode was positioned with its tip close to the spine. In the first study phase, 2 different can locations were evaluated: (1) an inframammary pocket (IM-1-750), or (2) a conventional infraclavicular pocket (IC-1-750). In both cases, a 70 J biphasic shock was used (peak voltage 750 V; 270 µF capacitance). In the second phase, configuration IC-1-750 was enhanced by the addition of a second (parasternal) subcutaneous electrode (IC-2-750). Furthermore, the effects of a different 70 J shock waveform (1,000 V, 160 µF) were evaluated for configurations IM-1-750 and IC-2-750 (becoming IM-1-1000 and IC-2-1000). RESULTS: The proportion of patients satisfying a defibrillation safety margin test of 2 consecutive successes at ≤50 J was 74%, 11%, and 44%, respectively, for the IM-1-750, IC-1-750, and IC-2-750 configurations, and 93% and 86% for the IM-1-1000 and IC-2-1000 configurations. CONCLUSIONS: Defibrillation efficacy comparable to that of a transvenous system was achieved with an anteroposterior subcutaneous ICD configuration, with 160 µF capacitance, 1,000 V, and 70 J output. An infraclavicular pocket location becomes feasible if a parasternal subcutaneous coil is added.
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Desfibriladores Implantables/normas , Cardioversión Eléctrica/métodos , Cardioversión Eléctrica/normas , Tejido Subcutáneo , Anciano , Cardioversión Eléctrica/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tejido Subcutáneo/fisiologíaRESUMEN
Accurate sensing of malignant arrhythmia is critical for the appropriate delivery of therapy from implantable cardioverter defibrillators, and undersensing of ventricular tachyarrhythmias can have catastrophic consequences. Here, we present an unusual case of ventricular fibrillation undersensing from the right ventricular lead at multiple different implantation sites because of very low amplitude voltage signals during induced ventricular fibrillation. A left ventricular sensing electrode was implanted to allow correct sensing and therapy delivery.