RESUMEN
Spin transfer in magnetic multilayers offers the possibility of ultrafast, low-power device operation. We report a study of spin pumping in spin valves, demonstrating that a strong anisotropy of spin pumping from the source layer can be induced by an angular dependence of the total Gilbert damping parameter, α, in the spin sink layer. Using lab- and synchrotron-based ferromagnetic resonance, we show that an in-plane variation of damping in a crystalline Co_{50}Fe_{50} layer leads to an anisotropic α in a polycrystalline Ni_{81}Fe_{19} layer. This anisotropy is suppressed above the spin diffusion length in Cr, which is found to be 8 nm, and is independent of static exchange coupling in the spin valve. These results offer a valuable insight into the transmission and absorption of spin currents, and a mechanism by which enhanced spin torques and angular control may be realized for next-generation spintronic devices.
RESUMEN
BACKGROUND: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath. METHODS AND RESULTS: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.
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Desfibriladores Implantables , Rayos Láser , Marcapaso Artificial , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Desfibriladores Implantables/efectos adversos , Electrodos Implantados/efectos adversos , Diseño de Equipo , Seguridad de Equipos , Femenino , Humanos , Rayos Láser/efectos adversos , Masculino , Persona de Mediana Edad , Marcapaso Artificial/efectos adversos , Estudios Prospectivos , Sistema de RegistrosRESUMEN
OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction. BACKGROUND: Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments. METHODS: A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS: Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.
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Angioplastia por Láser/instrumentación , Electrodos Implantados , Tecnología de Fibra Óptica/instrumentación , Marcapaso Artificial , Anciano , Anciano de 80 o más Años , Causas de Muerte , Diseño de Equipo , Falla de Equipo , Seguridad de Equipos , Femenino , Fibrosis/cirugía , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Estudios Prospectivos , Infecciones Relacionadas con Prótesis/cirugía , Resultado del Tratamiento , Venas/cirugíaRESUMEN
Adenosine appears to be an important mediator of hypotension and bradycardia in certain subsets of patients with vasodepressor syncope. Adenosine receptor blockage with methylxanthines may hypothetically prevent the vasodepressor spell. We studied the chronotropic, hemodynamic, and cardiac autonomic responses to head-up tilt in patients (mean age 40.7 +/- 18.1 years) with vasodepressor syncope before and after treatment with oral theophylline. At baseline, hypotension and syncope or near syncope were induced at 11.7 +/- 2.3 minutes of 60 degrees head-up tilt in all patients. Cardiac vagal and sympathetic tone showed biphasic and directionally opposite changes during tilt. Repeat tilt during oral theophylline therapy (6-12 mg/kg/day for 14 +/- 6 days) did not provoke symptomatic hypotension in 82% of patients. During 10.7 +/- 6.1 months of follow-up, seven patients had no recurrence of vasodepressor syncope and seven patients discontinued theophylline because of adverse reactions. Low-dose theophylline prevents tilt-induced vasodepressor syncope and may prevent spontaneous vasodepressor syncope in selected patients who can tolerate theophylline.
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Corazón/efectos de los fármacos , Postura , Síncope/tratamiento farmacológico , Teofilina/uso terapéutico , Administración Oral , Adulto , Sistema Nervioso Autónomo/efectos de los fármacos , Bradicardia/tratamiento farmacológico , Bradicardia/etiología , Bradicardia/fisiopatología , Femenino , Corazón/inervación , Corazón/fisiopatología , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Síncope/etiología , Síncope/fisiopatología , Teofilina/administración & dosificación , Teofilina/efectos adversosRESUMEN
Patients with an equivocal signal averaged electrocardiogram (SAECG) had less heart disease and better prognosis than patients with overtly abnormal SAECGs. An equivocal SAECG should not prompt further invasive diagnostic testing for ventricular tachycardia unless other clinical risk factors are present.
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Electrocardiografía , Sistema de Conducción Cardíaco/fisiopatología , Taquicardia Ventricular/diagnóstico , Disfunción Ventricular/diagnóstico , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Procesamiento de Señales Asistido por Computador , Taquicardia Ventricular/fisiopatología , Disfunción Ventricular/fisiopatologíaRESUMEN
Extraction of chronically implanted pacing leads involves a thorough understanding of the pathophysiology of lead maturation and the problems that may occur. It also requires specific knowledge of lead construction and the idiosyncrasies of individual lead models. Though we have evolved to use a standardized approach to lead extraction, each patient and lead removal is unique. The operator must be ready to adapt the technique and tools used to the situation at hand. The more experience and the more tools available to the operator, the more likely that there will be a safe and successful outcome to the procedure. Preparation for disaster is mandatory, such that when a complication does occur, one may respond quickly and therefore salvage the patient.
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Arritmias Cardíacas/terapia , Cateterismo Periférico , Desfibriladores Implantables , Migración de Cuerpo Extraño/cirugía , Marcapaso Artificial , Cateterismo Cardíaco , Ecocardiografía , Falla de Equipo , Migración de Cuerpo Extraño/diagnóstico , Migración de Cuerpo Extraño/etiología , Humanos , Resultado del TratamientoRESUMEN
The clinical evaluation of a new automatic sensitivity adjustment feature in the Cosmos II, Model #284-05 is described. This feature, designed to maintain a 2:1 safety margin for sensing intrinsic signals, was activated by way of special programmer software in ten patients at two centers. While the feature worked satisfactorily in some cases, it did not perform as expected, and undersensing in both chambers was observed. This may have been due to biasing the adjustment toward maximum rather than minimum electrograms. This study suggested that electrograms may vary by more than 100% which underscores the importance of this feature, and reinforces the need for continued development.
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Algoritmos , Marcapaso Artificial , Diseño de Software , Electrocardiografía Ambulatoria , Diseño de Equipo , Estudios de Evaluación como Asunto , Humanos , Microcomputadores , Validación de Programas de Computación , TeléfonoRESUMEN
A new pacemaker algorithm designed to automatically verify pacemaker capture and determine pacing threshold by detection of a stimulus evoked potential was studied in 20 patients undergoing permanent pacemaker implantation. To eliminate pacing stimulus afterpotential and detect an evoked response, a hardware feedback circuit and a software template matching algorithm were used to produce a triphasic charge-balanced pacing pulse. After charge balancing the pacing lead, a residual artifact is measured. A capture window is defined as the area integral of the first 24 msec of the evoked depolarization, and a capture threshold as one third the amplitude of the capture window. The maximum allowable residual artifact is one eighth the amplitude of the capture window. Once the stimulus afterpotential is eliminated and the evoked response detected, capture threshold is automatically and continuously determined and the algorithm adds a 0.8-V safety margin to the pacemaker output. This algorithm was run automatically and after simulated loss of capture, produced by manually decreasing pacer output below threshold, in the bipolar (13 patients) and unipolar (20 patients) pacing modes. In each patient loss of capture was immediately detected. The data were consistent (P = NS) between algorithm runs. During unipolar pacing the area integral of the first 24 msec of the evoked response was 412 +/- 137 versus 413 +/- 144 and the residual artifact 5.8 +/- 4.8 versus 8.1 +/- 7.5. The resulting ratio (signal/noise) of the two parameters was 150 +/- 141 versus 145 +/- 181. Automatically determined threshold was 0.69 +/- 0.43 V versus 0.69 +/- 0.42.(ABSTRACT TRUNCATED AT 250 WORDS)
Asunto(s)
Algoritmos , Estimulación Cardíaca Artificial/métodos , Bloqueo Cardíaco/terapia , Marcapaso Artificial , Síndrome del Seno Enfermo/terapia , Anciano , Electrodos Implantados , Diseño de Equipo , Potenciales Evocados , Femenino , Humanos , MasculinoRESUMEN
Antegrade activation of the His-Purkinje system (HPS) results in synchronized activation of the right ventricular (RV) and left ventricular (LV) endocardia forming normal, narrow QRS duration (QRSD). An alteration in septal activation and transseptal conduction time have been reported to be the causes for QRSD widening seen with bundle branch block. However, reduced synchronization of activation of RV and LV endocardia as another potential mechanism for QRSD widening has not been systematically studied. Fifteen consecutive patients underwent radiofrequency ablation (RFA) for treatment of supraventricular tachycardia. After RFA, mean QRSD in normal sinus rhythm was 86 +/- 8 ms with mean HV interval of 40 +/- 5 ms. Right atrial (RA), coronary sinus (CS), simultaneous (S) RA-CS, RV apex (RVA), LV apex (LVA), and SRVA-LVA pacing were performed. Mean QRSD with RA, CS, SRA-CS pacing was similar to normal sinus rhythm (87 +/- 7, 87 +/- 8 and 88 +/- 8 ms respectively). Mean QRSD was significantly longer with SRVA-LVA and either RVA or LVA pacing alone compared to normal sinus rhythm (106 +/- 8, 146 +/- 12 and 157 +/- 13 ms, respectively). However, QRSD was significantly shorter with SRVA-LVA pacing compared to either RVA or LVA pacing alone (P < 0.0001). We conclude that shorter QRSD with SRVA-LVA pacing compared to either RVA or LVA pacing alone is due to elimination of transseptal conduction delay; longer QRSD with SRVA-LVA pacing compared to sinus or atrial paced rhythm is due to reduced synchronization of endocardial activation secondary to ectopic entry of impulses into the HPS network and inability to take advantage of the branching structure of the HPS. Therefore, in addition to transseptal conduction delay, reduced synchronization of endocardial activation is another potential mechanism for QRSD widening.
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Electrocardiografía , Ventrículos Cardíacos/fisiopatología , Ramos Subendocárdicos/fisiopatología , Adolescente , Adulto , Bloqueo de Rama/complicaciones , Bloqueo de Rama/fisiopatología , Bloqueo de Rama/terapia , Estimulación Cardíaca Artificial , Ablación por Catéter , Femenino , Estudios de Seguimiento , Atrios Cardíacos/fisiopatología , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Ramos Subendocárdicos/cirugía , Taquicardia Supraventricular/complicaciones , Taquicardia Supraventricular/fisiopatología , Taquicardia Supraventricular/cirugíaRESUMEN
From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1,299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4-7 years, and 31% of leads 8-24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%, including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke).(ABSTRACT TRUNCATED AT 250 WORDS)
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Marcapaso Artificial/efectos adversos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , ReoperaciónRESUMEN
BACKGROUND: Despite using different electrode positions, "conventional" external DC cardioversion in patients with atrial fibrillation is ineffective in 6%-50% of cases. An alternative when DC cardioversion is not successful is low energy internal cardioversion, which is performed at increased risk. We tested the hypothesis that optimization of electrode pad position under fluoroscopy to encompass as much atrial muscle as possible might improve the success rate of external cardioversion and thus minimize the need for internal cardioversion. METHODS: Fifteen (9 males, 6 females) patients (age: 54 +/- 15 years, weight: 124 +/- 35 kg) with chronic atrial fibrillation (> 8 weeks) who had undergone unsuccessful conventional external cardioversion entered the study. Repeat conventional external cardioversion with electrodes in standard (right anterior and left posterior) positions was followed by "optimized" external cardioversion by positioning electrodes under fluoroscopy (using metallic markers). In case of failure, internal cardioversion was performed. RESULTS: All 15 patients had undergone unsuccessful conventional external cardioversion with 360-J shocks. Eight patients (group A) reverted to sinus rhythm with one or two 360-J shocks using fluoroscopy-guided pad placement (53%). Six of the remaining 7 (86%) patients (group B) had successful internal cardioversion with biphasic shocks (12 +/- 3 J). The body weight and body mass index were statistically lower in group A vs group B (106 +/- 27 vs 145 +/- 33 kg, p = 0.03 and 35 +/- 8 vs 45 +/- 8 kg/m2, P = 0.48, respectively). There was no statistically significant in age, height, body surface area, duration of atrial fibrillation, amiodarone therapy, ejection fraction, or underlying heart disease. CONCLUSION: Unsuccessful external DC cardioversion, in some patients, is in part due to suboptimal conventional positioning of electrode pads that can be improved under fluoroscopic guidance by achieving the best possible vector encompassing the right and left atria. The optimized external cardioversion technique may minimize the need for internal cardioversion, which remains an effective approach when external cardioversion fails.
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Fibrilación Atrial/terapia , Desfibriladores Implantables , Cardioversión Eléctrica/métodos , Atrios Cardíacos/diagnóstico por imagen , Adolescente , Adulto , Anciano , Amiodarona/uso terapéutico , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/fisiopatología , Cateterismo Cardíaco/métodos , Femenino , Fluoroscopía , Estudios de Seguimiento , Atrios Cardíacos/fisiopatología , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Volumen Sistólico , Resultado del TratamientoRESUMEN
Biphasic defibrillation waveforms have provided a reduction in defibrillation thresholds in transvenous ICD systems. Although a variety of biphasic waveforms have been tested, the optimal pulse durations and tilts have yet to be identified. A multicenter clinical study was conducted to evaluate the performance of a new ICD biphasic waveform and new RV active fixation steroid eluting lead system. Fifty-three patients were entered into the study. Mean age was 63 years with a mean ejection fraction of 36.8%. Primary indication for implantation was monomorphic ventricular tachycardia alone (54.7%). Forty-eight patients (90.6%) were implanted with an RV shocking lead and active can alone as the anodal contact. The ICD can was the cathode. In four cases (7.5%), an additional SVC or CS lead was used due to a high DFT with the RV lead alone. In an additional case, a chronic SVC lead was used although the RV-Can DFT was acceptable. DFT for all cases at implant was 9.8 +/- 3.7 J. Repeat testing at 3 months for a subset of patients showed a reduction in DFT (7.4 +/- 3.0 J), P value = 0.03. Sensing and pacing characteristics of the RV lead system remained excellent during the study period (acute 0.047 +/- 0.005 ms at 5.4 V and 9.9 +/- 6.2 mV R wave; chronic 0.067 +/- 0.11 ms at 5.4 V and 9.3 +/- 5.4 mV R wave). It is concluded that this lead system provides good acute and chronic sensing and pacing characteristics with good DFT values in combination with this waveform.
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Desfibriladores Implantables , Cardioversión Eléctrica/métodos , Gasto Cardíaco Bajo/complicaciones , Cardiomiopatías/complicaciones , Cardiotónicos/uso terapéutico , Enfermedad Coronaria/complicaciones , Diseño de Equipo , Estudios de Evaluación como Asunto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Taquicardia Ventricular/terapia , Fibrilación Ventricular/terapiaRESUMEN
At present the only method for measuring the high voltage system lead impedance in patients with an ICD is to deliver a low energy test shock. This is painful, requires sedation, and carries a risk of ventricular fibrillation induction. We sought to assess the shock lead and electrode function by calculating IMP using low voltage pacing pulses, and compared it to the measured impedance of a shock through the same lead. This was performed in both an intact and a modified lead system in order to mimic common clinical scenarios that alter lead system IMP (e.g., lead fracture). In an anesthesized canine model (n = 12) a standard (S) transvenous defibrillation lead (TDL), a modified (M) TDL (two-thirds of coil covered with heat-shrunk tubing), an active can (AC), and a M epicardial patch (EP) (two of four coils were disconnected) were used. Three configurations (C) were tested: C1:S/TDL-->AC, C2:M/TDL-->AC, and C3:M/TDL-->MEP. A measured IMP was obtained by an ICD using a 5-J shock as control. IMP was calculated using a 5-J shock, pacing pulses of 10-, 5-, 2-, and 1-V amplitude, as well as from a square wave drive train of low amplitude/high frequency signals (1 and 0.2 V, at 10 kHz) in all Cs. Ohm's law (V = IR) was utilized for measuring calculated IMP. As the surface area of the high voltage lead system decreased, the mean measured IMP (control) increased from C 1 to 3 (63 +/- 10, 95 +/- 4, and 127 +/- 20 omega, respectively). The correlation of calculated IMP from all Cs to measured impedance (control) remained high throughout the IMP range (range of correlation coefficient (r): 0.921-0.981). Calculated IMP using delivery of pacing pulses is highly correlated to IMP measured during shock delivery. This correlation remains high over a clinically significant range of high voltage lead system IMP changes. This study suggests that pacing pulses can be used to predict the IMP changes in the high voltage lead system which may occur clinically, reducing the need to deliver a shock for IMP measurement.
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Desfibriladores Implantables , Animales , Estimulación Cardíaca Artificial , Perros , Impedancia Eléctrica , Electrochoque , Falla de EquipoRESUMEN
Transvenous pacemaker lead extraction has become a commonly performed procedure that is associated with a small but significant risk. We report two cases where lead extraction was complicated by arteriovenous fistulae between branches of the aortic arch and the left brachiocephalic vein. Presenting signs and symptoms included severe chest or back pain, persistent or copious bleeding from the venous puncture site, unexplained hypotension or anemia, superior vena cava syndrome, and signs of central venous hypertension or acute heart failure. One patient whose injury was not recognized immediately and who did not undergo repair died rapidly, whereas the other patient who was diagnosed quickly underwent successful repair. Immediate diagnosis with arteriography and rapid intervention with surgery or percutaneous techniques are indicated and may prevent mortality.
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Aorta Torácica , Fístula Arteriovenosa/cirugía , Implantación de Prótesis Vascular , Venas Braquiocefálicas , Marcapaso Artificial , Anciano , Angiografía , Aorta Torácica/cirugía , Aortografía , Fístula Arteriovenosa/diagnóstico , Fístula Arteriovenosa/etiología , Venas Braquiocefálicas/cirugía , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Politetrafluoroetileno , Factores de TiempoRESUMEN
STUDY OBJECTIVE: The efficacy of a shock waveform for external defibrillation depends on the waveform characteristics. Recently, design principles based on cardiac electrophysiology have been developed to determine optimal waveform characteristics. The objective of this clinical trial was to evaluate the efficacy of principles-based monophasic and biphasic waveforms for external defibrillation. METHODS: A prospective, randomized, blinded, multicenter study of 118 patients undergoing electrophysiologic testing or receiving an implantable defibrillator was conducted. Ventricular fibrillation was induced, and defibrillation was attempted in each patient with a biphasic and a monophasic waveform. Patients were randomly placed into 2 groups: group 1 received shocks of escalating energy, and group 2 received only high-energy shocks. RESULTS: The biphasic waveform achieved a first-shock success rate of 100% in group 1 (95% confidence interval [CI] 95.1% to 100%) and group 2 (95% CI 94.6% to 100%), with average delivered energies of 201+/-17 J and 295+/-28 J, respectively. The monophasic waveform demonstrated a 96.7% (95% CI 89.1% to 100%) first-shock success rate and average delivered energy of 215+/-12 J for group 1 and a 98.2% (95% CI 91.7% to 100%) first-shock success rate and average delivered energy of 352+/-13 J for group 2. CONCLUSION: Using principles of electrophysiology, it is possible to design both biphasic and monophasic waveforms for external defibrillation that achieve a high first-shock efficacy.
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Cardioversión Eléctrica/métodos , Fibrilación Ventricular/terapia , Anciano , Intervalos de Confianza , Desfibriladores Implantables , Femenino , Humanos , Periodo Intraoperatorio , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Estados UnidosRESUMEN
The synthesis and biological activity of a series of benzofuro[3,2-c]pyridines and a benzothieno[3,2-c]pyridine are described. These compounds exhibit high affinity for the alpha 2-adrenoceptor, with high selectivity versus the alpha 1-receptor. Compound 1 also shows potent in vivo central activity and has been selected for further biological and clinical evaluation.
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Antagonistas Adrenérgicos alfa/síntesis química , Antagonistas Adrenérgicos alfa/farmacología , Antidepresivos/síntesis química , Antidepresivos/farmacología , Piridinas/síntesis química , Piridinas/farmacología , Receptores Adrenérgicos alfa 2/metabolismo , Agonistas alfa-Adrenérgicos/metabolismo , Agonistas alfa-Adrenérgicos/farmacología , Antagonistas Adrenérgicos alfa/metabolismo , Animales , Antidepresivos/metabolismo , Células CHO , Clonidina/metabolismo , Clonidina/farmacología , Cricetinae , Humanos , Masculino , Prazosina/metabolismo , Prazosina/farmacología , Piridinas/metabolismo , Ensayo de Unión Radioligante , Ratas , Xilazina/metabolismo , Xilazina/farmacología , Yohimbina/metabolismo , Yohimbina/farmacologíaRESUMEN
BACKGROUND: The Telectronics Accufix pacing leads were recalled in November 1994 after 2 deaths and 2 nonfatal injuries were reported. This multicenter clinical study (MCS) of patients with Accufix leads was designed to determine the rate of spontaneous injury related to the J retention wire and results of lead extraction. METHODS AND RESULTS: The MCS included 2589 patients with Accufix atrial pacing leads that were implanted at or who were followed up at 12 medical centers. Patients underwent cinefluoroscopic imaging of their lead every 6 months. The risk of J retention wire fracture was approximately 5.6%/y at 5 years and 4.7%/y at 10 years after implantation. The annual risk of protrusion was 1.5%. A total of 40 spontaneous injuries were reported to a worldwide registry (WWR) that included data from 34 672 patients (34 892 Accufix leads), including pericardial tamponade (n=19), pericardial effusion (n=5), atrial perforation (n=3), J retention wire embolization (n=4), and death (n=6). The risk of injury was 0.02%/y (95% CI, 0.0025 to 0. 072) in the MCS and 0.048%/y (95% CI, 0.035 to 0.067) in the WWR. A total of 5299 leads (13%) have been extracted worldwide. After recall in the WWR, fatal extraction complications occurred in 0.4% of intravascular procedures (16 of 4023), with life-threatening complications in 0.5% (n=21). Extraction complications increased with implant duration, female sex, and J retention wire protrusion. CONCLUSIONS: Accufix pacing leads pose a low, ongoing risk of injury. Extraction is associated with substantially higher risks, and a conservative management approach is indicated for most patients.
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Falla de Equipo/estadística & datos numéricos , Migración de Cuerpo Extraño/epidemiología , Marcapaso Artificial/efectos adversos , Sistema de Registros/estadística & datos numéricos , Medición de Riesgo , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Taponamiento Cardíaco/epidemiología , Taponamiento Cardíaco/etiología , Femenino , Válvulas Cardíacas/lesiones , Humanos , Masculino , Persona de Mediana Edad , Derrame Pericárdico/epidemiología , Derrame Pericárdico/etiología , Estudios Prospectivos , Embolia Pulmonar/epidemiología , Embolia Pulmonar/etiologíaRESUMEN
The procedure of lead removal has recently matured into a definable, teachable art with its own specific tools and techniques. It is now time to recognize and formalize the practice of lead removal according to the current methods of medicine and the health care industry. In addition, since at this time the only prospective scientific study of lead extraction is the PLEXES trial, we suggest that studies relating to the techniques of and indications for lead extraction be designed. Recommendations for a common set of definitions, for a framework of training and reviewing physicians in the art, for general methods of reimbursement, and for consistency among clinical trials have been made. Implementation of these recommendations will require additional effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry.
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Cateterismo Periférico , Desfibriladores Implantables , Marcapaso Artificial , Falla de Prótesis , Procedimientos Quirúrgicos Cardíacos , Cateterismo Periférico/métodos , Cateterismo Periférico/normas , Humanos , ReoperaciónRESUMEN
Of the 400,000-500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5-year period (1989-1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix or Encore leads (46%), or other causes (2%). Patients were 64+/-17 years of age (range 5-96); 59% were men, 41% women. Leads were implanted 47+/-41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P<0.0001), less experienced physicians (P<0.0001), ventricular leads (P<0.005), noninfected patients (P<0.0005), and younger patients (P<0.0001). Major complications were reported for 1.4% of patients (<1% at centers with >300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P<0.005) and with less experienced physicians (P<0.005); risk of major complications was higher for women (P<0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.