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1.
J Interv Card Electrophysiol ; 59(2): 307-313, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32350745

RESUMO

COVID-19 is a rapidly evolving public health emergency that has largely impacted the provision of healthcare services around the world. The challenge for electrophysiology teams is double; on one side preventing disease spread by limiting all nonessential face-to-face interactions, but at the same time ensuring continued care for patients who need it. These guidelines contain recommendations regarding triaging in order to define what procedures, device checks and clinic visits can be postponed during the pandemic. We also discuss best practices to protect patients and healthcare workers and provide guidance for the management of COVID-19 patients with arrhythmic conditions.


Assuntos
Arritmias Cardíacas/cirurgia , Ablação por Cateter/estatística & dados numéricos , Infecções por Coronavirus/prevenção & controle , Assistência à Saúde , Técnicas Eletrofisiológicas Cardíacas/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Guias de Prática Clínica como Assunto , Argentina , Arritmias Cardíacas/diagnóstico , Brasil , Eletrofisiologia Cardíaca/organização & administração , Ablação por Cateter/normas , Colômbia , Infecções por Coronavirus/epidemiologia , Procedimentos Cirúrgicos Eletivos/normas , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Técnicas Eletrofisiológicas Cardíacas/estatística & dados numéricos , Feminino , Humanos , Controle de Infecções/organização & administração , América Latina , Masculino , México , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Gestão da Segurança/normas , Sociedades Médicas
2.
Arch Cardiovasc Dis ; 113(8-9): 492-502, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32461091

RESUMO

The population of patients with congenital heart disease (CHD) is continuously increasing, and a significant proportion of these patients will experience arrhythmias because of the underlying congenital heart defect itself or as a consequence of interventional or surgical treatment. Arrhythmias are a leading cause of mortality, morbidity and impaired quality of life in adults with CHD. Arrhythmias may also occur in children with or without CHD. In light of the unique issues, challenges and considerations involved in managing arrhythmias in this growing, ageing and heterogeneous patient population and in children, it appears both timely and essential to critically appraise and synthesize optimal treatment strategies. The introduction of catheter ablation techniques has greatly improved the treatment of cardiac arrhythmias. However, catheter ablation in adults or children with CHD and in children without CHD is more technically demanding, potentially causing various complications, and thus requires a high level of expertise to maximize success rates and minimize complication rates. As French recommendations regarding required technical competence and equipment are lacking in this situation, the Working Group of Pacing and Electrophysiology of the French Society of Cardiology and the Affiliate Group of Paediatric and Adult Congenital Cardiology have decided to produce a common position paper compiled from expert opinions from cardiac electrophysiology and paediatric cardiology. The paper details the features of an interventional cardiac electrophysiology centre that are required for ablation procedures in adults with CHD and in children, the importance of being able to diagnose, monitor and manage complications associated with ablations in these patients and the supplemental hospital-based resources required, such as anaesthesia, surgical back-up, intensive care, haemodynamic assistance and imaging. Lastly, the need for quality evaluations and French registries of ablations in these populations is discussed. The purpose of this consensus statement is therefore to define optimal conditions for the delivery of invasive care regarding ablation of arrhythmias in adults with CHD and in children, and to provide expert and - when possible - evidence-based recommendations on best practice for catheter-based ablation procedures in these specific populations.


Assuntos
Arritmias Cardíacas/cirurgia , Procedimentos Cirúrgicos Cardíacos , Cardiologistas/normas , Serviço Hospitalar de Cardiologia/normas , Ablação por Cateter/normas , Competência Clínica/normas , Criocirurgia/normas , Cardiopatias Congênitas/cirurgia , Adolescente , Adulto , Fatores Etários , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/fisiopatologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/mortalidade , Ablação por Cateter/efeitos adversos , Ablação por Cateter/mortalidade , Criança , Pré-Escolar , Consenso , Criocirurgia/efeitos adversos , Criocirurgia/mortalidade , Técnicas Eletrofisiológicas Cardíacas/normas , Cardiopatias Congênitas/diagnóstico por imagem , Cardiopatias Congênitas/mortalidade , Cardiopatias Congênitas/fisiopatologia , Frequência Cardíaca , Humanos , Lactente , Recém-Nascido , Fatores de Risco , Sobreviventes , Resultado do Tratamento , Adulto Jovem
3.
G Ital Cardiol (Rome) ; 21(5): 336-340, 2020 05.
Artigo em Italiano | MEDLINE | ID: mdl-32310918
4.
JACC Clin Electrophysiol ; 5(5): 626-634, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31122386

RESUMO

OBJECTIVES: This study sought to determine whether a radiation safety time-out reduces radiation exposure in electrophysiology procedures. BACKGROUND: Time-outs are integral to improving quality and safety. The authors hypothesized that a radiation safety time-out would reduce radiation exposure levels for patients and the health care team members. METHODS: The study was performed at the New York University Langone Health Electrophysiology Lab. Baseline data were collected for 6 months prior to the time-out. On implementation of the time-out, data were collected prospectively with analyses to be performed every 3 months. The primary endpoint was dose area product. The secondary endpoints included reference point dose, fluoroscopy time, use of additional shielding, and use of alternative imaging such as intracardiac and intravascular ultrasound. RESULTS: A total of 1,040 patient cases were included. The median dose area product prior to time-out was 18.7 Gy∙cm2, and the median during the time-out was 14.7 Gy∙cm2, representing a 21% reduction (p = 0.007). The median reference point dose prior to time-out was 163 mGy, and during the time-out was 122 mGy (p = 0.011). The use of sterile disposable protective shields and ultrasound imaging for access increased significantly during the time-out. CONCLUSIONS: A radiation safety time-out significantly reduces radiation exposure in electrophysiology procedures. Electrophysiology laboratories, as well as other areas of cardiovascular medicine using fluoroscopy, should strongly consider the use of radiation safety time-outs to reduce radiation exposure and improve safety.


Assuntos
Técnicas Eletrofisiológicas Cardíacas , Segurança do Paciente , Doses de Radiação , Exposição à Radiação , Idoso , Idoso de 80 Anos ou mais , Técnicas Eletrofisiológicas Cardíacas/métodos , Técnicas Eletrofisiológicas Cardíacas/normas , Feminino , Fluoroscopia/normas , Humanos , Masculino , Estudos Prospectivos , Exposição à Radiação/prevenção & controle , Exposição à Radiação/normas , Exposição à Radiação/estatística & dados numéricos , Fatores de Tempo
5.
J Interv Card Electrophysiol ; 56(2): 199-203, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29858762

RESUMO

PURPOSE: Audit has played a key role in monitoring and improving clinical practice. However, audit often fails to drive change as summative institutional data alone may be insufficient to do so. We hypothesised that the practice of attributed audit, wherein each individual's procedural performance is presented will have a greater impact on clinical practice. This hypothesis was tested in an observational study evaluating improvement in fluoroscopy times for AF ablation. METHODS: Retrospective analyses of fluoroscopy times in AF ablations at the Barts Heart Centre (BHC) from 2012-2017. Fluoroscopy times were compared pre- and post- the introduction of attributed audit in 2012 at St Bartholomew's Hospital (SBH). In order to test the hypothesis, this concept was introduced to a second group of experienced operators from the Heart Hospital (HH) as part of a merger of the two institutions in 2015 and change in fluoroscopy times recorded. RESULTS: A significant drop in fluoroscopy times (33.3 ± 9.14 to 8.95 ± 2.50, p < 0.0001) from 2012-2014 was noted after the introduction of attributed audit. At the time of merger, a significant difference in fluoroscopy times between operators from the two centres was seen in 2015. Each operator's procedural performance was shared openly at the audit meeting. Subsequent audits showed a steady decrease in fluoroscopy times for each operator with the fluoroscopy time (min, mean±SD) decreasing from 13.29 ± 7.3 in 2015 to 8.84 ± 4.8 (p < 0.0001) in 2017 across the entire group. CONCLUSIONS: Systematic improvement in fluoroscopy times for AF ablation procedures was noted byevaluating individual operators' performance. Attributing data to physicians in attributed audit can promptsignificant improvement and hence should be adopted in clinical practice.


Assuntos
Fibrilação Atrial/cirurgia , Técnicas Eletrofisiológicas Cardíacas/normas , Auditoria Médica , Ablação por Cateter , Estudos Transversais , Feminino , Fluoroscopia , Humanos , Londres , Masculino , Duração da Cirurgia , Melhoria de Qualidade , Radiografia Intervencionista , Estudos Retrospectivos
6.
Heart Rhythm ; 16(6): 905-912, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30576876

RESUMO

BACKGROUND: Patients with syncope and bundle branch block (BBB) are at risk for atrioventricular block (AVB). Electrophysiological study (EPS) can help in identifying patients at higher risk for AVB, but the false-negative rate is remarkable. Few data on the predictors of the need for pacemaker implantation during follow-up have been reported. OBJECTIVE: The purpose of this study was to analyze the rate of patients who need pacemaker implantation after negative EPS and predictive factors. METHODS: A single-center prospective study of 159 consecutive patients (73.9 ± 12.1 years; male 64.9%) with syncope and BBB (January 2012-December 2016) and negative EPS was conducted. An implantable loop recorder was implanted. RESULTS: After 27.9 ± 10.8 months of follow-up, 39 patients (24.8%) underwent pacemaker implantation because of bradyarrhythmia. In the univariate analysis, bifascicular (right BBB + left fascicular block) block, bifascicular block + long PR interval, conduction disturbance different from isolated right BBB, HV ≥60 ms, and HV ≥70 ms after class I drug challenge were predictors of pacemaker implantation. In the multivariate analysis, only bifascicular block (hazard ratio 2.5; 95% confidence interval 1.4-4.8; P = .04) and HV interval ≥60 ms (hazard ratio 3.5; 95% confidence interval 1.8-6.2; P <.001) were statistically significant. A risk score according to the multivariate model identified 3 levels of pacemaker implantation rate (13.5%, 32.7%, and 66.7%; P <.001). No death or severe trauma related to bradyarrhythmia occurred. CONCLUSION: The strategy of an implantable loop recorder in patients with syncope and BBB is safe after negative EPS, but some patients might need pacemaker implantation during follow-up. A risk score based on HV ≥60 ms and bifascicular block can be useful in identifying patients at risk for advanced AVB after negative EPS.


Assuntos
Bloqueio Atrioventricular , Bloqueio de Ramo , Estimulação Cardíaca Artificial , Técnicas Eletrofisiológicas Cardíacas , Marca-Passo Artificial/estatística & dados numéricos , Medição de Risco , Síncope , Idoso , Bloqueio Atrioventricular/etiologia , Bloqueio Atrioventricular/fisiopatologia , Bloqueio Atrioventricular/prevenção & controle , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/fisiopatologia , Bloqueio de Ramo/cirurgia , Estimulação Cardíaca Artificial/métodos , Estimulação Cardíaca Artificial/estatística & dados numéricos , Técnicas Eletrofisiológicas Cardíacas/métodos , Técnicas Eletrofisiológicas Cardíacas/normas , Reações Falso-Negativas , Feminino , Seguimentos , Sistema de Condução Cardíaco/fisiopatologia , Sistema de Condução Cardíaco/cirurgia , Humanos , Masculino , Valor Preditivo dos Testes , Prognóstico , Medição de Risco/métodos , Medição de Risco/estatística & dados numéricos , Síncope/diagnóstico , Síncope/etiologia , Síncope/prevenção & controle
7.
JACC Clin Electrophysiol ; 4(12): 1541-1552, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30573117

RESUMO

OBJECTIVES: This study aimed: 1) to determine the voltage correlation between sinus rhythm (SR) and atrial fibrillation (AF)/atrial flutter (AFL) using multielectrode fast automated mapping; 2) to identify a bipolar voltage cutoff for scar and/or low voltage areas (LVAs); and 3) to examine the reproducibility of voltage mapping in AF. BACKGROUND: It is unclear if bipolar voltage cutoffs should be adjusted depending on the rhythm and/or area being mapped. METHODS: High-density mapping was performed first in SR and afterward in induced AF/AFL. In some patients, 2 maps were performed during AF. Maps were combined to create a new one. Points of <1 mm difference were analyzed. Correlation was explored with scatterplots and agreement analysis was assessed with Bland-Altman plots. The generalized additive model was also applied. RESULTS: A total of 2,002 paired-points were obtained. A cutoff of 0.35 mV in AFL predicted a sinus voltage of 0.5 mV (95% confidence interval [CI]: 0.12 to 2.02) and of 0.24 mV in AF (95% CI: 0.11 to 2.18; specificity [SP]: 0.94 and 0.96; sensitivity [SE]: 0.85 and 0.75, respectively). When generalized additive models were used, a cutoff of 0.38 mV was used for AFL for predicting a minimum value of 0.5 mV in SR (95% CI: 0.5 to 1.6; SP: 0.94, SE: 0.88) and of 0.31 mV for AF (95% CI: 0.5 to 1.2; SP: 0.95, SE: 0.82). With regard to AF maps, there was no change in the classification of any left atrial region other than the roof. CONCLUSIONS: It is possible to establish new cutoffs for AFL and/or AF with acceptable validity in predicting a sinus voltage of <0.5 mV. Multielectrode fast automated mapping in AFL and/or AF seems to be reliable and reproducible when classifying LVAs. These observations have clinical implications for left atrial voltage distribution and in procedures in which scar distribution is used to guide pulmonary vein isolation and/or re-isolation.


Assuntos
Fibrilação Atrial/diagnóstico , Técnicas Eletrofisiológicas Cardíacas/métodos , Técnicas Eletrofisiológicas Cardíacas/normas , Idoso , Flutter Atrial/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes
8.
Sensors (Basel) ; 18(5)2018 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-29724033

RESUMO

The intracardiac electrical activation maps are commonly used as a guide in the ablation of cardiac arrhythmias. The use of catheters with force sensors has been proposed in order to know if the electrode is in contact with the tissue during the registration of intracardiac electrograms (EGM). Although threshold criteria on force signals are often used to determine the catheter contact, this may be a limited criterion due to the complexity of the heart dynamics and cardiac vorticity. The present paper is devoted to determining the criteria and force signal profiles that guarantee the contact of the electrode with the tissue. In this study, we analyzed 1391 force signals and their associated EGM recorded during 2 and 8 s, respectively, in 17 patients (82 ± 60 points per patient). We aimed to establish a contact pattern by first visually examining and classifying the signals, according to their likely-contact joint profile and following the suggestions from experts in the doubtful cases. First, we used Principal Component Analysis to scrutinize the force signal dynamics by analyzing the main eigen-directions, first globally and then grouped according to the certainty of their tissue-catheter contact. Second, we used two different linear classifiers (Fisher discriminant and support vector machines) to identify the most relevant components of the previous signal models. We obtained three main types of eigenvectors, namely, pulsatile relevant, non-pulsatile relevant, and irrelevant components. The classifiers reached a moderate to sufficient discrimination capacity (areas under the curve between 0.84 and 0.95 depending on the contact certainty and on the classifier), which allowed us to analyze the relevant properties in the force signals. We conclude that the catheter-tissue contact profiles in force recordings are complex and do not depend only on the signal intensity being above a threshold at a single time instant, but also on time pulsatility and trends. These findings pave the way towards a subsystem which can be included in current intracardiac navigation systems assisted by force contact sensors, and it can provide the clinician with an estimate of the reliability on the tissue-catheter contact in the point-by-point EGM acquisition procedure.


Assuntos
Arritmias Cardíacas/terapia , Ablação por Cateter/métodos , Técnicas Eletrofisiológicas Cardíacas/normas , Humanos , Reprodutibilidade dos Testes
9.
J Cardiovasc Electrophysiol ; 29(7): 990-997, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29660191

RESUMO

INTRODUCTION: The unipolar electrogram (UEG) provides local measures of cardiac activation and repolarization and is an important translational link between patient and laboratory. A simple theoretical model of the UEG was previously proposed and tested in silico. METHOD AND RESULTS: The aim of this study was to use epicardial sock-mapping data to validate the simple model's predictions of unipolar electrogram morphology in the in vivo human heart. The simple model conceptualizes the UEG as the difference between a local cardiac action potential and a position-independent component representing remote activity, which is defined as the average of all action potentials. UEGs were recorded in 18 patients using a multielectrode sock containing 240 electrodes and activation (AT) and repolarization time (RT) were measured using standard definitions. For each cardiac site, a simulated local action potential was generated by adjusting a stylized action potential to fit AT and RT measured in vivo. The correlation coefficient (cc) measuring the morphological similarity between 13,637 recorded and simulated UEGs was cc  =  0.89 (0.72-0.95), median (Q1 -Q3 ), for the entire UEG, cc  =  0.90 (0.76-0.95) for QRS complexes, and cc  =  0.83 (0.58-0.92) for T-waves. QRS and T-wave areas from recorded and simulated UEGs showed cc> 0.89 and cc> 0.84, respectively, indicating good agreement between voltage isochrones maps. Simulated UEGs accurately reproduced the interaction between AT and QRS morphology and between RT and T-wave morphology observed in vivo. CONCLUSIONS: Human in vivo whole heart data support the validity of the simple model, which provides a framework for improving the understanding of the UEG and its clinical utility.


Assuntos
Eletrocardiografia/normas , Técnicas Eletrofisiológicas Cardíacas/normas , Sistema de Condução Cardíaco/fisiologia , Modelos Cardiovasculares , Eletrocardiografia/instrumentação , Eletrocardiografia/métodos , Eletrodos/normas , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Técnicas Eletrofisiológicas Cardíacas/métodos , Humanos , Reprodutibilidade dos Testes
10.
J Cardiothorac Vasc Anesth ; 32(4): 1892-1910, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29422281

RESUMO

As the complexity and duration of cardiac ablation procedures increase, there is a growing demand for anesthesiologist involvement in the electrophysiology suites for sedation and anesthesia provision, hemodynamic and neuromonitoring, and procedural guidance through transesophageal echocardiography. To deliver high-quality perioperative care, it is important that the anesthesiologist is intimately familiar with the evolving techniques and technologies, the anesthetic options and ventilation strategies, and the anticipated postprocedural complications.


Assuntos
Anestesia/métodos , Anestesiologistas , Ablação por Cateter/métodos , Cuidados Intraoperatórios/métodos , Anestesia/normas , Anestesiologistas/normas , Ablação por Cateter/normas , Técnicas Eletrofisiológicas Cardíacas/métodos , Técnicas Eletrofisiológicas Cardíacas/normas , Humanos , Cuidados Intraoperatórios/normas
12.
Europace ; 19(12): 1909-1922, 2017 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29126278
15.
J Interv Card Electrophysiol ; 49(1): 3-9, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28168447

RESUMO

PURPOSE: Bedside vascular ultrasound machines are increasingly available. They are used to facilitate safer vascular access across a number of different specialties. In the electrophysiology laboratory however, where patients are frequently anticoagulated and require the insertion of multiple venous sheaths, anatomical landmark techniques predominate. Despite the high number of vascular complications associated with electrophysiological procedures and the increasing evidence to support its use in electrophysiology, ultrasound remains underutilised. A new standard of care is required. A comprehensive technical report, providing a detailed explanation of this important technique, will provide other electrophysiology centres with the knowledge and justification for adopting ultrasound guidance as their standard practice. METHOD: We review the increasing body of evidence which demonstrates that routine ultrasound usage can substantially improve the safety of femoral venous access in the electrophysiology laboratory. We offer a comprehensive technical report to guide operators through the process of ultrasound-guided venous access, with a specific focus on the electrophysiology laboratory. Additionally, we detail a novel technique which utilises real-time colour Doppler ultrasound to accurately identify needle tip location during venous puncture. CONCLUSIONS: The use of vascular ultrasound to guide femoral venous cannulation is rapid, inexpensive and easily learnt. Ultrasound is readily available and offers the potential to significantly reduce vascular complications in the unique setting of the electrophysiology laboratory. Ultrasound guidance to achieve femoral venous access should be the new standard of care in electrophysiology.


Assuntos
Cateteres Venosos Centrais/normas , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Técnicas Eletrofisiológicas Cardíacas/normas , Veia Femoral/diagnóstico por imagem , Guias de Prática Clínica como Assunto , Ultrassonografia de Intervenção/instrumentação , Ultrassonografia de Intervenção/normas , Técnicas Eletrofisiológicas Cardíacas/métodos , Humanos , Laboratórios/normas , Ultrassonografia de Intervenção/métodos , Reino Unido
16.
J Cardiovasc Electrophysiol ; 28(1): 109-114, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27653802

RESUMO

BACKGROUND: Contact-force (CF) sensing catheters are increasingly used in electrophysiological procedures due to their efficacy and safety profile. As data about the accuracy of fiberoptic CF technology are scarce, we sought to quantify it using in vitro experiments. METHODS AND RESULTS: A force sensor was built with a flexible membrane to allow exact reference force measurements for each set of experiments. A TactiCath Quartz (TCQ) ablation catheter was brought in contact with the force sensor membrane in order to compare the TCQ force measurements to sensor reference force measurements. Measurements were performed at different tip angles (0°/perpendicular contact, 45°, 90°/parallel contact), with fluid irrigation, different degrees of catheter deflection, and using a sheath. The accuracy of the TCQ force measurements was 0.9 ± 0.9 g (0°), 0.8 ± 0.8 g (45°) and 1.2 ± 1.3 g (90°), 0.8 ± 0.7 g (irrigation), 0.8 ± 0.8 g (deflection), and 0.8 ± 0.9 g (sheath); this was not significantly different among all experimental conditions. The precision was ≤3.8%. CONCLUSION: CF measurements using a fiberoptic sensing technology show a high level of accuracy and precision, without being significantly influenced by tip angle, fluid irrigation, catheter deflection or use of a sheath.


Assuntos
Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Tecnologia de Fibra Óptica/instrumentação , Transdutores de Pressão , Calibragem , Cateterismo Cardíaco/normas , Cateteres Cardíacos/normas , Técnicas Eletrofisiológicas Cardíacas/normas , Desenho de Equipamento , Tecnologia de Fibra Óptica/normas , Teste de Materiais , Padrões de Referência , Reprodutibilidade dos Testes , Irrigação Terapêutica , Transdutores de Pressão/normas
17.
Int J Cardiol ; 225: 4-8, 2016 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-27694034

RESUMO

BACKGROUND: The atrioventricular (AV) dissociation, which is frequently used in differential diagnosis of wide QRS complex tachycardia (WQCT), is the most specific finding of ventricular tachycardia (VT) with lower sensitivity. Herein, we aimed to show the importance of Lewis lead ECG records to detect 'visible p waves' during WQCT. METHOD: A total of 21 consecutive patients who underwent electrophysiologic study (EPS) were included in the study. During EPS, by using a quadripolar diagnostic catheter directed to the right ventricular apex, a fixed stimulus was given and the ventriculoatrial (VA) Wenkebach point was found, and a VT was simulated by a RV apical stimulus at 300ms. The standard and Lewis lead ECG records were taken during this procedure. RESULT: We detected 'visible p waves' in 7 (33.3%) and 14 (66.7%) patients in the standard and Lewis lead ECG groups, respectively. In terms of the 'visible p waves', there was a statistically significant difference between groups (p=0.022). The sensitivity of standard and Lewis lead ECG in determination of the visible p waves was 33.3% and 66.7%, respectively. CONCLUSION: The Lewis lead ECG can be more informative about AV dissociation than the standard 12 lead ECG. As a result, we could suggest the assessment of the Lewis lead ECG recording in addition to the standard 12 lead ECG in differential diagnosis of VT in patients with WQCT.


Assuntos
Eletrocardiografia/normas , Bloqueio Cardíaco/diagnóstico , Bloqueio Cardíaco/fisiopatologia , Frequência Cardíaca/fisiologia , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/fisiopatologia , Adulto , Idoso , Eletrocardiografia/instrumentação , Eletrodos/normas , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Técnicas Eletrofisiológicas Cardíacas/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
18.
J Interv Card Electrophysiol ; 47(1): 19-27, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27565971

RESUMO

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.


Assuntos
Aprovação de Equipamentos/normas , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Técnicas Eletrofisiológicas Cardíacas/normas , Vigilância de Produtos Comercializados/normas , Avaliação da Tecnologia Biomédica/normas , United States Food and Drug Administration/normas , Biotecnologia/instrumentação , Biotecnologia/normas , Aprovação de Equipamentos/legislação & jurisprudência , Guias como Assunto , Marketing de Serviços de Saúde/normas , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Estados Unidos
19.
J Am Heart Assoc ; 5(6)2016 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-27317349

RESUMO

BACKGROUND: Drug safety precautions recommend monitoring of the corrected QT interval. To determine which QT correction formula to use in an automated QT-monitoring algorithm in our electronic medical record, we studied rate correction performance of different QT correction formulae and their impact on risk assessment for mortality. METHODS AND RESULTS: All electrocardiograms (ECGs) in patients >18 years with sinus rhythm, normal QRS duration and rate <90 beats per minute (bpm) in the University Hospitals of Leuven (Leuven, Belgium) during a 2-month period were included. QT correction was performed with Bazett, Fridericia, Framingham, Hodges, and Rautaharju formulae. In total, 6609 patients were included (age, 59.8±16.2 years; 53.6% male and heart rate 68.8±10.6 bpm). Optimal rate correction was observed using Fridericia and Framingham; Bazett performed worst. A healthy subset showed 99% upper limits of normal for Bazett above current clinical standards: men 472 ms (95% CI, 464-478 ms) and women 482 ms (95% CI 474-490 ms). Multivariate Cox regression, including age, heart rate, and prolonged QTc, identified Framingham (hazard ratio [HR], 7.31; 95% CI, 4.10-13.05) and Fridericia (HR, 5.95; 95% CI, 3.34-10.60) as significantly better predictors of 30-day all-cause mortality than Bazett (HR, 4.49; 95% CI, 2.31-8.74). In a point-prevalence study with haloperidol, the number of patients classified to be at risk for possibly harmful QT prolongation could be reduced by 50% using optimal QT rate correction. CONCLUSIONS: Fridericia and Framingham correction formulae showed the best rate correction and significantly improved prediction of 30-day and 1-year mortality. With current clinical standards, Bazett overestimated the number of patients with potential dangerous QTc prolongation, which could lead to unnecessary safety measurements as withholding the patient of first-choice medication.


Assuntos
Arritmias Cardíacas/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Arritmias Cardíacas/induzido quimicamente , Arritmias Cardíacas/fisiopatologia , Eletrocardiografia/normas , Técnicas Eletrofisiológicas Cardíacas/normas , Feminino , Frequência Cardíaca/fisiologia , Humanos , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/diagnóstico , Síndrome do QT Longo/fisiopatologia , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Medição de Risco
20.
J Interv Card Electrophysiol ; 47(1): 11-18, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27020440

RESUMO

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.


Assuntos
Aprovação de Equipamentos/normas , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Técnicas Eletrofisiológicas Cardíacas/normas , Vigilância de Produtos Comercializados/normas , Avaliação da Tecnologia Biomédica/normas , United States Food and Drug Administration/normas , Aprovação de Equipamentos/legislação & jurisprudência , Guias como Assunto , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Estados Unidos
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