RESUMEN
BACKGROUND: Adoption and outcomes for conduction system pacing (CSP), which includes His bundle pacing (HBP) or left bundle branch area pacing (LBBAP), in real-world settings are incompletely understood. We sought to describe real-world adoption of CSP lead implantation and subsequent outcomes. METHODS: We performed an online cross-sectional survey on the implantation and outcomes associated with CSP, between November 15, 2020, and February 15, 2021. We described survey responses and reported HBP and LBBAP outcomes for bradycardia pacing and cardiac resynchronization CRT indications, separately. RESULTS: The analysis cohort included 140 institutions, located on 5 continents, who contributed data to the worldwide survey on CSP. Of these, 127 institutions (90.7%) reported experience implanting CSP leads. CSP and overall device implantation volumes were reported by 84 institutions. In 2019, the median proportion of device implants with CSP, HBP, and/or LBBAP leads attempted were 4.4% (interquartile range [IQR], 1.9-12.5%; range, 0.4-100%), 3.3% (IQR, 1.3-7.1%; range, 0.2-87.0%), and 2.5% (IQR, 0.5-24.0%; range, 0.1-55.6%), respectively. For bradycardia pacing indications, HBP leads, as compared to LBBAP leads, had higher reported implant threshold (median [IQR]: 1.5 V [1.3-2.0 V] vs 0.8 V [0.6-1.0 V], p = 0.0008) and lower ventricular sensing (median [IQR]: 4.0 mV [3.0-5.0 mV] vs. 10.0 mV [7.0-12.0 mV], p < 0.0001). CONCLUSION: In conclusion, CSP lead implantation has been broadly adopted but has yet to become the default approach at most surveyed institutions. As the indications and data for CSP continue to evolve, strategies to educate and promote CSP lead implantation at institutions without CSP lead implantation experience would be necessary.
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Bradicardia , Fascículo Atrioventricular , Humanos , Bradicardia/terapia , Estudios Transversales , Sistema de Conducción Cardíaco , Trastorno del Sistema de Conducción Cardíaco , Electrocardiografía , Estimulación Cardíaca Artificial , Resultado del TratamientoRESUMEN
BACKGROUND: Criteria for successful left bundle area pacing (LBAP) are in flux and currently guided by lead tip measurements. Lead ring measurements during LBAP have not been well studied. OBJECTIVE: The purpose of this study was to investigate dynamics in pacing parameters during successful and unsuccessful lead implant attempts. METHODS: SelectSecure 3830 pacing leads (Medtronic, Inc) guided by C315 sheaths for LBAP were placed for standard pacing indications in 73 patients. Retrospective review of procedural, echocardiographic, and standard pacing data were performed. Depth and lead-septal angle of implanted electrodes were determined from fluoroscopy with septal contrast delineation. Depth was graded in 4 categories according to the degree of ring penetration into the septum. Successful implant was defined by the ability to advance the lead deep into the septum and achieve LBAP criteria (ventricular activation time, QRS width/shape). RESULTS: Ring impedance increased stepwise during successful attempts as opposed to unsuccessful attempts (P = .039). A wider lead-septal angle at implant position correlated with higher ring impedance (P = .036), whereas no association was found with tip impedance. Unipolar ring threshold correlated with depth of lead implant (P = .029). Tip impedance measurements at implant position were less predictive of lead depth and did not correlate with septal thickness. CONCLUSION: Ring pacing parameters are more predictive of lead progress than tip measurements. Lead depth and lead-septal angle can be determined from ring impedance measurements. These measurements may provide determination of lead depth and could obviate the need for contrast injection.
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Estimulación Cardíaca Artificial , Electrocardiografía , Humanos , Ecocardiografía , Electrodos Implantados , Ventrículos Cardíacos , Fascículo AtrioventricularRESUMEN
BACKGROUND: A high incidence of asymptomatic atrial tachycardia and atrial fibrillation (AT/AF) has been recognized in patients with cardiac implantable devices (CIED). The clinical significance of these AT/AF episodes remains unclear. Some "device-detected AT/AF" was previously shown to be triggered by competitive atrial pacing (CAP). OBJECTIVE: To investigate and characterize a potential association between CAP and AT/AF in the largest series of observations to date. METHODS: RATE, a multicenter registry, included 5379 patients with CIEDs followed for approximately 2 years. Electrograms (EGMs) from 1352 patients with AT/AF, CAP, or both were analyzed by experienced adjudicators to assess a causal relationship between AT/AF and CAP onset, duration, and morphology. RESULTS: In 225 patients, 1394 episodes of both AT/AF and CAP were present in the same tracing. CAP and AT/AF were strongly associated (P ≤ .02). AT/AF occurred during the course of the study in 71% of patients with CAP. In 62% of the episodes, expert adjudication concluded that CAP triggered AT/AF. The duration and morphology of triggered and spontaneous AT/AF episodes differed. Spontaneous AT/AF episodes were associated with constant EGM morphology, and were either long or extremely short. CAP-triggered AT/AF more often had variable and shorter cycle length EGMs. The incidence of short AT/AF events was higher among triggered episodes (25% vs 12.8%, P < .002). CONCLUSION: Device-triggered AT/AF due to CAP is likely more common than previously recognized. This AT/AF entity differs from spontaneous AT/AF in duration and morphology. Clinical implications of spontaneous and device-triggered AT/AF may be different.
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Fibrilación Atrial/terapia , Estimulación Cardíaca Artificial/métodos , Técnicas Electrofisiológicas Cardíacas/métodos , Frecuencia Cardíaca/fisiología , Sistema de Registros , Fibrilación Atrial/epidemiología , Fibrilación Atrial/fisiopatología , Estudios de Seguimiento , Humanos , Incidencia , Estudios Prospectivos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: To characterize 3D electroanatomical mapping (EAM) of the His bundle (HB) region. BACKGROUND: Visualization of selective (S) and nonselective (NS) HB capture areas by EAM has not been described and may help guide HB pacing (HBP). METHODS: EAM was performed via NavX system in 17 patients (pts) undergoing HBP. HB cloud, S-HB, NS-HB, and right bundle (RB) capture areas were mapped. RESULTS: S-HBP areas were identified in 11, NS-HBP in 14, and RB in 11 pts. Two NS-HBP areas (upper and lower) either separated by S-HBP (8 pts) or almost contiguous (5 pts) were observed. S-HBP area measured: 1.1 ± 0.9 cm2 , NS upper: -1.2 ± 0.9 cm2 , NS lower: -1.2 ± 0.9 cm2 , RB: -1.7 ± 1.3 cm2 , total His cloud: -4.1 ± 2.7 cm2 . Electrocardiogram (ECG) pacemaps were different between upper and lower NS-HBP areas in 13/14 pts (p = .006). ECG differences between NS clouds were present in inferior leads in 9 pts (more negative QRS complex from lower NS area) and in precordial leads in 5 pts. There was no correlation between HBP lead location and capture threshold. R-wave amplitude was higher at more distal locations on HB cloud (p = .02). CONCLUSION: (1) Pacemapping identifies distinct regions that may correspond to HB anatomy. (2) A linear S-HBP area is typically surrounded by two separate NS areas. (3) Pace-map ECGs from upper and lower NS-HBP areas have different morphologies. (4) These EAM features and pace-mapping may be helpful to the implanter.
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Fascículo Atrioventricular , Estimulación Cardíaca Artificial , Electrocardiografía , Humanos , Resultado del TratamientoRESUMEN
BACKGROUND: Synergistic interactions between neprilysin inhibition (NEPi) with sacubitril and angiotensin receptor type1 blockade (ARB) with valsartan have been implicated in improvement of left ventricular (LV) contractility, relaxation, exercise tolerance, and fibrosis in preexisting heart failure (HF) induced by aortic valve insufficiency (AVI). It is not known whether this pharmacologic synergy can prevent cardiovascular pathology in a similar AVI model. Our aim was to investigate the pharmacology of sacubitril/valsartan in an experimental setting with therapy beginning immediately after creation of AVI. METHODS: HF was induced through partial disruption of the aortic valve in rats. Therapy began 3 hours after valve disruption and lasted 8 weeks. Sacubitril/valsartan (68 mg/kg), valsartan (31 mg/kg), sacubitril (31 mg/kg), or vehicle were administered daily via oral gavage (N=8 in each group). Hemodynamic assessments were conducted using Millar technology, and an exercise tolerance test was conducted using a rodent treadmill. RESULTS: Only sacubitril/valsartan increased total arterial compliance and ejection fraction (EF). Therapies with sacubitril/valsartan and valsartan similarly improved load-dependent (dP/dtmax) and load independent indices (Ees) of LV contractility, and exercise tolerance, whereas sacubitril did not. None of the therapies improved LV relaxation (dP/dtmin), whereas all reduced myocardial fibrosis. CONCLUSIONS: 1) The synergistic interaction between NEPi and ARB in early therapy with sacubitril/valsartan leads to increased total arterial compliance and EF. 2) Improvement in indices of LV contractility, and exercise tolerance with sacubitril/valsartan is likely because of ARB effect of valsartan. 3) All three therapies provided antifibrotic effects, suggesting both ARB and NEPi are capable of reducing myocardial fibrosis.
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Aminobutiratos/administración & dosificación , Antagonistas de Receptores de Angiotensina/administración & dosificación , Insuficiencia de la Válvula Aórtica/tratamiento farmacológico , Insuficiencia Cardíaca/tratamiento farmacológico , Tetrazoles/administración & dosificación , Valsartán/administración & dosificación , Aminobutiratos/metabolismo , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/metabolismo , Antagonistas de Receptores de Angiotensina/metabolismo , Animales , Insuficiencia de la Válvula Aórtica/metabolismo , Compuestos de Bifenilo , Combinación de Medicamentos , Interacciones Farmacológicas/fisiología , Sinergismo Farmacológico , Tolerancia al Ejercicio/efectos de los fármacos , Tolerancia al Ejercicio/fisiología , Insuficiencia Cardíaca/metabolismo , Masculino , Ratas , Ratas Sprague-Dawley , Volumen Sistólico/efectos de los fármacos , Volumen Sistólico/fisiología , Tetrazoles/metabolismo , Valsartán/metabolismoRESUMEN
BACKGROUND: The use of coronary sinus (CS) sheaths to deliver stylet-driven leads (SDLs) for His-bundle pacing (HBP) has not been described. Conventionally, HBP is achieved using a stylet-less lead delivered through a customized catheter. OBJECTIVE: The purpose of this study was to characterize the acute and early-term HBP experience with stylet-driven, active-fixation leads delivered through CS sheaths compared to the conventional approach. METHODS: Delivery of Medtronic 4471 and 7742 SDLs was attempted in 27 patients. Delivery was facilitated using CS guide catheters and custom-shaped stylets. Procedural characteristics and lead performance were compared to those of a group of 17 patients in whom delivery of 3830 lumen-less leads (LLLs) was attempted. Patients had heterogeneous pacing indications. RESULTS: HBP with SDL was successful in 24 of 27 patients(89%) compared to 15 of 17 patients (88%) in the LLL group. Mean procedural and fluoroscopy times in the SDL and LLL groups were 129 ± 43 minutes vs 104 ± 43 minutes and 9.6 ± 5.2 minutes vs 8.3 ± 5.0 minutes, respectively (both P = NS). There was a significant difference in procedure and fluoroscopy times within the SDL group between the first and second halves of the series, probably secondary to a learning curve. Acute HBP thresholds were higher with SDL than with LLL (2.6 ± 1.5 V vs 1.5 ± 1.2 V; P = .02) and remained stable at 8.4 ± 5.3 months. Both SDLs exhibited similar pacing thresholds. Two crossovers between groups occurred (1 in each group). Four patients with SDL and 1 patient with LLL exhibited high thresholds during follow-up. CONCLUSION: Permanent HBP using stylet-driven, active-fixation leads delivered through conventional CS sheaths is feasible. Procedural characteristics and lead performance were clinically acceptable.
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Fascículo Atrioventricular/fisiopatología , Cateterismo Cardíaco , Estimulación Cardíaca Artificial , Seno Coronario/cirugía , Retención de la Prótesis/métodos , Anciano , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/métodos , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/métodos , Electrocardiografía/métodos , Femenino , Fluoroscopía/estadística & datos numéricos , Bloqueo Cardíaco/terapia , Humanos , Masculino , Tempo Operativo , Marcapaso Artificial , Resultado del TratamientoRESUMEN
BACKGROUND: His bundle pacing (HBP) remains technically challenging and is currently guided by electrograms and 2-dimensional fluoroscopy. Our objective was to describe a new technique for HBP directly guided by electroanatomic mapping (EAM). METHODS: Twenty-eight patients were included. The atrioventricular septum was mapped via EAM, and His bundle (HB) electrograms, selective, and nonselective HB capture sites were tagged. Pacing leads were connected to EAM, navigated to tagged HB target sites and deployed. Intracardiac electrograms and pacing parameters were recorded. Lead location was tagged on the cloud of HB sites, which was divided into 3 arbitrary segments. In 5 patients, atrioventricular nodal ablation was performed with direct visualization of the HBP lead by EAM. RESULTS: Reproducible navigation of the pacing lead to predetermined HBP locations guided by EAM was achieved in all patients. The lead was successfully deployed in 25 patients. HB cloud area was 360 (212) mm2. There was no correlation between HBP threshold and lead location on the His cloud. The intracardiac electrograms atrial/ventricular ratio at the lead deployment site correlated with its EAM position on the His cloud ( P=0.045). Procedure, fluoroscopy, and mapping times were 116.0 (38.8), 8.6 (6.3), and 9.0 (11.4) minutes, respectively. HBP threshold at implant was 1.5 (2.3) V at 1.5 (1.0) ms. Distance between HB lead and ablation sites was 10.0 (1.3) mm in patients undergoing atrioventricular nodal ablation. CONCLUSIONS: Direct guidance of HBP by EAM allows for direct visualization of the pacing lead on the HB cloud and reproducible navigation to predetermined HB capture sites. Intracardiac electrograms atrial/ventricular ratio at the lead deployment site correlates with His cloud location. EAM can be applied during standard HBP procedures or combined with atrioventricular nodal ablation.
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Potenciales de Acción , Arritmias Cardíacas/terapia , Fascículo Atrioventricular/fisiopatología , Estimulación Cardíaca Artificial/métodos , Técnicas Electrofisiológicas Cardíacas , Insuficiencia Cardíaca/terapia , Imagenología Tridimensional , Procesamiento de Señales Asistido por Computador , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Simultaneous neprilysin inhibition (NEPi) and angiotensin receptor blockade (ARB) with sacubitril/valsartan improves cardiac function and exercise tolerance in patients with heart failure. However, it is not known whether these therapeutic benefits are primarily due to NEPi with sacubitril or ARB with valsartan or their combination. Therefore, the aim of the present study was to investigate the potential contribution of sacubitril and valsartan to the benefits of the combination therapy on left ventricular (LV) function and exercise tolerance. Heart failure was induced by volume overload via partial disruption of the aortic valve in rats. Therapy began 4 wk after valve disruption and lasted through 8 wk. Drugs were administered daily via oral gavage [sacubitril/valsartan (68 mg/kg), valsartan (31 mg/kg), and sacubitril (31 mg/kg)]. Hemodynamic assessments were conducted using Millar technology, and an exercise tolerance test was conducted using a rodent treadmill. Therapy with sacubitril/valsartan improved load-dependent indexes of LV contractility (dP/d tmax) and relaxation (dP/d tmin), exercise tolerance, and mitigated myocardial fibrosis, whereas monotherapies with valsartan, or sacubitril did not. Both sacubitril/valsartan and valsartan similarly improved a load-independent index of contractility [slope of the end-systolic pressure-volume relationship ( Ees)]. Sacubitril did not improve Ees. First, synergy of NEPi with sacubitril and ARB with valsartan leads to the improvement of load-dependent LV contractility and relaxation, exercise tolerance, and reduction of myocardial collagen content. Second, the improvement in load-independent LV contractility with sacubitril/valsartan appears to be solely due to ARB with valsartan constituent. NEW & NOTEWORTHY Our data suggest the following explanation for the effects of sacubitril/valsartan: 1) synergy of sacubitril and valsartan leads to the improvement of load-dependent left ventricular contractility and relaxation, exercise tolerance, and reduction of myocardial fibrosis and 2) improvement in load-independent left ventricular contractility is solely due to the valsartan constituent. The findings offer a better understanding of the outcomes observed in clinical studies and might facilitate the continuing development of the next generations of angiotensin receptor neprilysin inhibitors.
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Aminobutiratos/farmacología , Antagonistas de Receptores de Angiotensina/farmacología , Tolerancia al Ejercicio , Insuficiencia Cardíaca/tratamiento farmacológico , Hemodinámica , Tetrazoles/farmacología , Valsartán/farmacología , Aminobutiratos/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Animales , Compuestos de Bifenilo , Combinación de Medicamentos , Sinergismo Farmacológico , Fibrosis , Corazón/efectos de los fármacos , Insuficiencia Cardíaca/patología , Insuficiencia Cardíaca/fisiopatología , Masculino , Contracción Miocárdica , Ratas , Ratas Sprague-Dawley , Tetrazoles/uso terapéutico , Valsartán/uso terapéuticoRESUMEN
BACKGROUND: Simultaneous angiotensin receptor (AT1) blockade and neprilysin inhibition with the use of sacubitril/valsartan has been recently approved to treat patients with heart failure (HF). Therapeutic benefits of this therapy have been attributed to natriuretic peptide elevation and AT1 receptor blockade. However, that pharmacologic picture may not be complete. The aims of this study were to investigate the pharmacology of sacubitril/valsartan compared with sacubitril and valsartan alone and to examine their impact on peptides up-regulated by neprilysin inhibition, such as beta-endorphin. METHODS AND RESULTS: An HF model was induced by pressure overload via constriction of the suprarenal abdominal aorta in rats. Sacubitril/valsartan (68 mg/kg), valsartan (31 mg/kg), sacubitril (31 mg/kg), or placebo was administered by daily oral gavage (starting 4 weeks after pressure overload onset and continued for 4 additional weeks; nâ¯=â¯8 in each group). Exercise tolerance testing was conducted using a rodent treadmill and hemodynamic assessments were conducted under anesthesia with the use of Millar left ventricular (LV) conductance technology. Pressure overload led to exercise intolerance by 4 weeks and to hypertension and LV dysfunction and remodeling by 8 weeks. Both sacubitril/valsartan and sacubitril elevated beta-endorphin levels, by 40% and 54%, respectively, and improved exercise tolerance, by 93% and 112%, whereas valsartan did not. Indices of LV dysfunction persisted with the use of sacubitril/valsartan and valsartan therapies and even deteriorated in sacubitril group. CONCLUSIONS: When added to valsartan, sacubitril increases beta-endorphin concentrations and improves exercise tolerance. These data suggest beta-endorphin elevation as a potential mechanism of action leading to improvement in exercise tolerance that is seen with sacubitril/valsartan. This therapeutic benefit is potentially independent from LV function.
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Aminobutiratos , Tolerancia al Ejercicio , Insuficiencia Cardíaca , Volumen Sistólico , Tetrazoles , Función Ventricular Izquierda , betaendorfina , Animales , Masculino , Ratas , Aminobutiratos/farmacología , Antagonistas de Receptores de Angiotensina/farmacología , betaendorfina/sangre , Compuestos de Bifenilo , Modelos Animales de Enfermedad , Progresión de la Enfermedad , Combinación de Medicamentos , Tolerancia al Ejercicio/efectos de los fármacos , Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/fisiopatología , Condicionamiento Físico Animal , Distribución Aleatoria , Ratas Sprague-Dawley , Volumen Sistólico/efectos de los fármacos , Tetrazoles/farmacología , Valsartán , Función Ventricular Izquierda/efectos de los fármacosRESUMEN
BACKGROUND: The RATE Registry (Registry of Atrial Tachycardia and Atrial Fibrillation Episodes) is a prospective, outcomes-oriented registry designed to document the prevalence of atrial tachycardia and/or fibrillation (AT/AF) of any duration in patients with pacemakers and implantable cardioverter defibrillators (ICDs) and evaluate associations between rigorously adjudicated AT/AF and predefined clinical events, including stroke. The appropriate clinical response to brief episodes of AT/AF remains unclear. METHODS: Rigorously adjudicated electrogram (EGM) data were correlated with adjudicated clinical events with logistic regression and Cox models. Long episodes of AT/AF were defined as episodes in which the onset and/or offset of AT/AF was not present within a single EGM recording. Short episodes of AT/AF were defined as episodes in which both the onset and offset of AT/AF were present within a single EGM recording. RESULTS: We enrolled 5379 patients with pacemakers (N=3141) or ICDs (N=2238) at 225 US sites (median follow-up 22.9 months). There were 359 deaths. There were 478 hospitalizations among 342 patients for clinical events. We adjudicated 37 531 EGMs; 50% of patients had at least one episode of AT/AF. Patients with clinical events were more likely than those without to have long AT/AF (31.9% vs. 22.1% for pacemaker patients and 28.7% vs. 20.2% for ICD patients; P<0.05 for both groups). Only short episodes of AT/AF were documented in 9% of pacemaker patients and 16% of ICD patients. Patients with clinical events were no more likely than those without to have short AT/AF (5.1% vs. 7.9% for pacemaker patients and 11.5% vs. 10.4% for ICD patients; P=0.21 and 0.66, respectively). CONCLUSIONS: In the RATE Registry, rigorously adjudicated short episodes of AT/AF, as defined, were not associated with increased risk of clinical events compared with patients without documented AT/AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00837798.
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Desfibriladores Implantables , Marcapaso Artificial , Taquicardia/epidemiología , Taquicardia/etiología , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/etiología , Fibrilación Atrial/terapia , Estudios de Casos y Controles , Comorbilidad , Manejo de la Enfermedad , Progresión de la Enfermedad , Electrocardiografía Ambulatoria , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Mortalidad , Oportunidad Relativa , Vigilancia de la Población , Sistema de Registros , Taquicardia/diagnóstico , Taquicardia/terapia , Estados UnidosRESUMEN
BACKGROUND: Tachycardia diagnoses from implantable device recordings ultimately depend on the analysis of captured electrograms (EGMs). The degree to which atrial EGMs improve tachycardia discrimination, dependent on the level of expertise of the medical professional involved, remains uncertain. OBJECTIVE: The purpose of this article was to determine whether atrial EGM recordings improve tachycardia discrimination and whether this improvement, if any, varies for professionals with different levels of training. METHODS: Expert-adjudicated supraventricular tachycardia (SVT) and ventricular tachycardia (VT) dual-chamber EGMs (DEGMs) from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes in the Cardiac Rhythm Management Device Population were provided to electrophysiology specialists, electrophysiology fellows (EPF), and nurse practitioners or physician assistants (NPPA). Each participant diagnosed 112 EGM episodes presented in random sequence (61 VTs and 51 SVTs) and independently categorized each as "SVT," "VT," or "uncertain" in 2 stages. First, participants analyzed ventricular EGMs (VEGMs) alone (atrial channel covered). Second, the tracings were randomized and reanalyzed with atrial EGMs exposed. The diagnostic accuracy of VEGMs alone vs DEGMs was assessed for each group. RESULTS: For all 3 groups, diagnostic accuracy improved significantly (>20% for VTs and >15% for SVTs; P < .01 for all) when DEGMs were provided. Electrophysiology specialists diagnosed VTs more accurately than did EPF and NPPA (VEGM: 73.1%±7.6% vs 58.7%±15.5% and 56.1%±14.1%; P < .01; DEGM: 98.0%±2.7% vs 90.8%±16.0% and 80.3%±7.4%; P < .01). EPF diagnosed VTs more accurately than did NPPA only when DEGMs were provided. There was no significant intergroup difference in SVT diagnoses. CONCLUSION: DEGMs are superior to VEGMs alone for tachycardia discrimination at all levels of expertise. The level of training affects diagnostic accuracy with and without atrial EGMs.
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Competencia Clínica/normas , Técnicas Electrofisiológicas Cardíacas/métodos , Taquicardia Supraventricular/diagnóstico , Taquicardia Ventricular/diagnóstico , California , Desfibriladores Implantables/estadística & datos numéricos , Diagnóstico Diferencial , Encuestas de Atención de la Salud , Personal de Salud/clasificación , Personal de Salud/normas , Humanos , Marcapaso Artificial/estadística & datos numéricos , Sistema de RegistrosRESUMEN
INTRODUCTION: Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads. METHODS AND RESULTS: ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%). CONCLUSIONS: Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.
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Arritmias Cardíacas/terapia , Desfibriladores Implantables , Cardioversión Eléctrica/instrumentación , Anciano , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , Cardioversión Eléctrica/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Falla de Prótesis , Sistema de Registros , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Función Ventricular IzquierdaRESUMEN
PURPOSE: To compare the efficacy and accuracy of rotational angiography with three-dimensional reconstruction (3DATG) image merged with electro-anatomical mapping (EAM) vs. CT-EAM. METHODS: A prospective, randomized, parallel, two-center study conducted in 36 patients (25 men, age 65 ± 10 years) undergoing AF ablation (33 % paroxysmal, 67 % persistent) guided by 3DATG (group 1) vs. CT (group 2) image fusion with EAM. 3DATG was performed on the Philips Allura Xper FD 10 system. Procedural characteristics including time, radiation exposure, outcome, and navigation accuracy were compared between two groups. RESULTS: There was no significant difference between the groups in total procedure duration or time spent for various procedural steps. Minor differences in procedural characteristics were present between two centers. Segmentation and fusion time for 3DATG or CT-EAM was short and similar between both centers. Accuracy of navigation guided by either method was high and did not depend on left atrial size. Maintenance of sinus rhythm between the two groups was no different up to 24 months of follow-up. CONCLUSION: This study did not find superiority of 3DATG-EAM image merge to guide AF ablation when compared to CT-EAM fusion. Both merging techniques result in similar navigation accuracy.
Asunto(s)
Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Mapeo del Potencial de Superficie Corporal/estadística & datos numéricos , Ablación por Catéter/mortalidad , Imagenología Tridimensional/estadística & datos numéricos , Tomografía Computarizada por Rayos X/estadística & datos numéricos , Anciano , Fibrilación Atrial/mortalidad , Ablación por Catéter/métodos , Angiografía Coronaria/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Imagen Multimodal/estadística & datos numéricos , Tempo Operativo , Prevalencia , Estudios Prospectivos , Reproducibilidad de los Resultados , Factores de Riesgo , Rotación , Sensibilidad y Especificidad , Cirugía Asistida por Computador/estadística & datos numéricos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Specific respiratory patterns and periodic breathing have been associated with heart failure. Less is known regarding changes in tidal volume (TV) and minute ventilation (MV) as a result of early heart failure (HF) decompensation. METHODS AND RESULTS: Twelve adult Yucatan minipigs were implanted with a biventricular pacemaker and a left ventricular pressure sensor. HF was induced using high-rate pacing at 240 paces per minute for 2-4 weeks, followed by 2 weeks of recovery. Left ventricular pressure measurements and weekly echocardiograms verified the development of HF. The right and left ventricular intrathoracic impedance (RVITI and LVITI, respectively) signals were used to determine the respiratory parameters of rate, TV, and MV. Compared to baseline (BL), during HF, the TV dropped 68% for RVITI and 61% for LVITI (P < 0.0001 for both). Correspondingly, MV dropped 34% for RVITI and 27% for LVITI (P < 0.0001 for both). The daily medians of the respiratory rate (RR) and the longest breath interval (LBI) did not change significantly from BL to HF and recovery. However, circadian variation of the RR and the LBI became blunted during HF development. All derived respiratory parameters showed the reverse trend during the recovery period. CONCLUSION: TV and MV change independently from the RR in early HF decompensation. Tracking the changes of TV and MV with an implantable device may provide an additional method for early HF detection and assessment of the response to therapy.
Asunto(s)
Espectroscopía Dieléctrica/instrumentación , Espectroscopía Dieléctrica/métodos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Marcapaso Artificial , Animales , Humanos , Ventilación Pulmonar , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Porcinos , Porcinos Enanos , Volumen de Ventilación PulmonarRESUMEN
Rotors of two different left atrial flutters were mapped using focal impulse and rotor modulation and 3D-MRI overlayed on live fluoroscopy and were successfully ablated in a patient with two prior left-atrium ablation procedures for recurrent atrial fibrillation.