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1.
N Engl J Med ; 389(13): 1167-1179, 2023 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-37622677

RESUMO

BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year). CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).


Assuntos
Anticoagulantes , Arritmias Cardíacas , Embolia , Inibidores do Fator Xa , Idoso , Feminino , Humanos , Masculino , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Embolia/tratamento farmacológico , Embolia/etiologia , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Hemorragia/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Eletrodos Implantados , Método Duplo-Cego , Arritmias Cardíacas/complicações , Arritmias Cardíacas/diagnóstico , Fatores de Risco
2.
Eur Heart J ; 45(10): 837-849, 2024 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-37956458

RESUMO

BACKGROUND AND AIMS: Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. METHODS: This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. RESULTS: Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001). CONCLUSIONS: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.


Assuntos
Fibrilação Atrial , Piridinas , Acidente Vascular Cerebral , Tiazóis , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/diagnóstico , Átrios do Coração , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/diagnóstico , Anticoagulantes/uso terapêutico
3.
Europace ; 25(7)2023 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-37345804

RESUMO

Atrial high-rate episodes (AHRE) are atrial tachyarrhythmias detected by continuous rhythm monitoring by pacemakers, defibrillators, or implantable cardiac monitors. Atrial high-rate episodes occur in 10-30% of elderly patients without atrial fibrillation. However, it remains unclear whether the presence of these arrhythmias has therapeutic consequences. The presence of AHRE increases the risk of stroke compared with patients without AHRE. Oral anticoagulation would have the potential to reduce the risk of stroke in patients with AHRE but is also associated with a rate of major bleeding of ∼2%/year. The stroke rate in patients with AHRE appears to be lower than the stroke rate in patients with atrial fibrillation. Wearables like smart-watches will increase the absolute number of patients in whom atrial arrhythmias are detected. It remains unclear whether anticoagulation is effective and, equally important, safe in patients with AHRE. Two randomized clinical trials, NOAH-AFNET6 and ARTESiA, are expected to report soon. They will provide much-needed information on the efficacy and safety of oral anticoagulation in patients with AHRE.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fatores de Risco , Anticoagulantes/uso terapêutico , Átrios do Coração , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
4.
Eur Heart J ; 41(36): 3437-3447, 2020 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-32372094

RESUMO

AIMS: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. METHODS AND RESULTS: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537-0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class

Assuntos
Desfibriladores Implantáveis , Idoso , Estudos de Coortes , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Europa (Continente) , Humanos , Prevenção Primária , Estudos Prospectivos , Fatores de Risco , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
6.
Europace ; 21(10): 1459-1467, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31377792

RESUMO

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/epidemiologia , Átrios do Coração/fisiopatologia , Frequência Cardíaca/fisiologia , Medição de Risco/métodos , Acidente Vascular Cerebral/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Saúde Global , Humanos , Prevalência , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
7.
Med Sci Monit ; 25: 3316-3320, 2019 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-31055590

RESUMO

BACKGROUND Catheter radiofrequency ablation for typical atrial flutter is considered to be safe and effective. However, atrial fibrillation (AF) following cavotricuspid isthmus ablation for atrial flutter has been reported in patients without a previous history of AF, which has implications for the decision to use oral anticoagulation. This retrospective study at a single center aimed to evaluate the occurrence of AF in patients after successful cavotricuspid isthmus ablation of typical atrial flutter and to determine the incidence and associations with AF during follow-up. MATERIAL AND METHODS Between January 2011 and July 2017, of 110 consecutive patients who underwent cavotricuspid isthmus ablation for typical atrial flutter, 67 patients had no previous history of AF, of which 40 patients underwent follow-up. The 40 patients included in this retrospective clinical study included 34 men and 6 women, with a mean age of 67±10 years. RESULTS Forty patients underwent post-ablation follow-up for 46±23 months, and 12 patients (30%) developed AF; six patients (15%) experienced recurrent of atrial flutter. More than half of the patients with post-ablation AF were asymptomatic with a European Heart Rhythm Association (EHRA) score of 1, and univariate analysis showed the absence of variables associated with the prevalence of AF. CONCLUSIONS Following cavotricuspid isthmus ablation for atrial flutter, recurrence of atrial flutter was found in 15% of cases, and asymptomatic AF occurred in 30%. These findings have implications for the use of post-ablation oral anticoagulation treatment, which is often discontinued following ablation therapy and before patient follow-up.


Assuntos
Fibrilação Atrial/etiologia , Flutter Atrial/cirurgia , Ablação por Cateter/métodos , Valva Tricúspide/cirurgia , Idoso , Idoso de 80 Anos ou mais , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
8.
J Electrocardiol ; 57S: S34-S39, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31526572

RESUMO

BACKGROUND: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. SUMMARY: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12­lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. CONCLUSION: The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.


Assuntos
Pesquisa Comparativa da Efetividade , Morte Súbita Cardíaca , Desfibriladores Implantáveis , Morte Súbita Cardíaca/prevenção & controle , Eletrocardiografia , Europa (Continente) , Humanos , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Estudos Prospectivos , Resultado do Tratamento
9.
Europace ; 20(6): 963-970, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29016784

RESUMO

Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials. Methods and results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002). Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Cardioversão Elétrica , Fatores Sexuais , Idoso , Arritmias Cardíacas/complicações , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/métodos , Falha de Equipamento/estatística & dados numéricos , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Prevenção Primária/métodos , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos
10.
Cardiovasc Drugs Ther ; 32(2): 169-173, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29623481

RESUMO

PURPOSE: Antazoline is a first-generation antihistaminic agent with additional anticholinergic properties and antiarrhythmic potential. Recent data shows its high effectiveness in sinus rhythm restoration among patients with paroxysmal atrial fibrillation. The effect of antazoline on electrophysiological parameters of the heart in vivo has not yet been examined. The aim of this study was to evaluate changes in electrophysiological parameters of the heart muscle and conduction system as a response to increasing doses of antazoline. METHODS: After successful ablation of supraventricular arrhythmias, the electrophysiological parameters: sinus rhythm cycle length (SRCL), AH, HV, QRS, QT, QTc intervals, Wenckebach point (WP), sinus node recovery period (SNRT), intra- (hRA-CSos) and interatrial conduction time (hRA-CSd), right and left atrium refractory period (RA-; LA-ERP), and atrioventricular node refractory period (AVN-ERP) were assessed initially and after 100, 200, and 300 mg of antazoline given intravenously. RESULTS: Fifteen patients (8 males, 19-72 years old) undergoing EPS and RF ablation were enrolled. After 100 mg bolus, a significant reduction in SRCL was noticed. After antazoline administration, significant prolongation of HV, QRS, QTc, hRA-CSos, hRA-CSd intervals, RA- and LA-ERP and reduction of SRCL were observed. After a total dose of 300 mg, QT interval prolonged significantly. Increasing the dose of antazoline had no impact on AH, Wenckebach point, AVN-ERP, and SNRT. CONCLUSION: Antazoline has an effect on electrophysiological parameters of the atrial muscle and has rapid onset of action. No negative effect on sinus node function and atrioventricular conduction in a unique property among antiarrhythmic drugs.


Assuntos
Potenciais de Ação/efeitos dos fármacos , Antazolina/administração & dosagem , Antiarrítmicos/administração & dosagem , Flutter Atrial/tratamento farmacológico , Átrios do Coração/efeitos dos fármacos , Sistema de Condução Cardíaco/efeitos dos fármacos , Frequência Cardíaca/efeitos dos fármacos , Músculos Papilares/efeitos dos fármacos , Taquicardia por Reentrada no Nó Atrioventricular/tratamento farmacológico , Adulto , Idoso , Flutter Atrial/diagnóstico , Flutter Atrial/fisiopatologia , Flutter Atrial/cirurgia , Ablação por Cateter , Relação Dose-Resposta a Droga , Feminino , Átrios do Coração/fisiopatologia , Átrios do Coração/cirurgia , Sistema de Condução Cardíaco/fisiopatologia , Sistema de Condução Cardíaco/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Músculos Papilares/fisiopatologia , Músculos Papilares/cirurgia , Taquicardia por Reentrada no Nó Atrioventricular/diagnóstico , Taquicardia por Reentrada no Nó Atrioventricular/fisiopatologia , Taquicardia por Reentrada no Nó Atrioventricular/cirurgia , Resultado do Tratamento , Adulto Jovem
11.
Pol Merkur Lekarski ; 39(233): 277-80, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26637091

RESUMO

UNLABELLED: Cardiovascular autonomic neuropathy (CAN) is one of the most common chronic complications of diabetes. It is defined as an impaired control of the cardiovascular system by the autonomic nervous system. The gold standard in detecting it is the Ewing test suite. The usefulness of other methods is still a subject of research. AIM: The aim of this study was to assess the clinical usefulness of baroreflex sensitivity (BRS) test in the detection of CAN in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: The study included diabetic patients: 24 with CAN, diagnosed through the Ewing tests (the mean age 58 ± 7 years, BMI 33.6 ± 5 kg*m⁻², HbA1c% 8.3 ± 3, duration of diabetes 13.3 ± 7 years), and 24 without CAN (56 ± 8 years, BMI 32.2 ± 5 kg*m-2, HbA1c% 9.1 ± 2, 9.3 ± 9 years, respectively). The control group consisted of 12 patients without diabetes, homogeneous regarding gender and age. BRS was assessed in the supine (L-BRS), and in the standing position (S-BRS). RESULTS: L-BRS was lower in the group with CAN vs the non-CAN group (6.2 ± 4 vs 9.6 ± 4 ms/mmHg; p=0,009); S-BRS respectively (4.4 ± 3 vs 6.9 ± 4 ms/mmHg; p=0.02). BRS well differentiates patients with and without polyneuropathy. The highest sensitivity of L-BRS and SBRS for detecting CAN is by cutoff ≤ 7 ms/mmHg. CONCLUSIONS: The study confirms the value of baroreflex sensitivity in the early detection of CAN among patients with type 2 diabetes. We recommended cutoff points for BRS to detect CAN among patients with type 2 diabetes mellitus.


Assuntos
Arritmias Cardíacas/diagnóstico , Barorreflexo , Diabetes Mellitus Tipo 2/complicações , Cardiomiopatias Diabéticas/diagnóstico , Neuropatias Diabéticas/diagnóstico , Arritmias Cardíacas/etiologia , Cardiomiopatias Diabéticas/etiologia , Neuropatias Diabéticas/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
12.
Europace ; 15(10): 1453-62, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23696624

RESUMO

AIMS: To determine the long-term costs of extending device longevity in four patient populations requiring a single-chamber implantable cardioverter-defibrillator (ICD) or requiring cardiac resynchronization therapy with defibrillation (CRT-D) device over a 15-year time window. METHODS AND RESULTS: We considered patient populations with an accepted indication for a single-chamber ICD for prevention of sudden cardiac death in the context of preserved (Population A) or impaired (Population B) left ventricular function; or with indication for a CRT-D device in the context of heart failure in New York Heart Association class II (Population C) or III (Population D). Expected patient survival and a cost analysis, including the cost of complications, was undertaken from a hospital perspective. Extended device longevity of 5 vs. 9 years for ICDs (Populations A and B); 4 vs. 7 years for CRT-Ds (Populations C and D) were considered. Over a 15-year time horizon, total, yearly, and per diem savings, per patient, from extending ICD longevity to 9 years were €10 926.91, €728.46, and €1.99 for Population A, and €7661.32, €510.75, and €1.40 for Population B. Total, yearly, and per diem savings from extending CRT-D longevity to 7 years were €13 630.38, €908.69, and €2.49 for Population C, and €10 968.29, €731.22, and €2.00 for Population D. Avoidance of a generator replacement amounted up to 46.6-62.5% of the saving. CONCLUSION: Extending device longevity has an important effect on the long-term cost of device therapy, both for ICD and CRT-D. This has important implications for device choice.


Assuntos
Arritmias Cardíacas/terapia , Dispositivos de Terapia de Ressincronização Cardíaca/economia , Terapia de Ressincronização Cardíaca/economia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/economia , Cardioversão Elétrica/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/terapia , Prevenção Primária/economia , Arritmias Cardíacas/complicações , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Orçamentos , Redução de Custos , Análise Custo-Benefício , Morte Súbita Cardíaca/etiologia , Cardioversão Elétrica/instrumentação , Desenho de Equipamento , Falha de Equipamento/economia , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Modelos Econômicos , Prevenção Primária/instrumentação , Desenho de Prótese , Falha de Prótese , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
13.
Cardiol J ; 30(3): 473-482, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36908162

RESUMO

Flecainide, similar to encainide and propafenone, is IC class antiarrhythmic, inhibiting Nav1.5 sodium channels in heart muscle cells and modulates cardiac conduction. Despite its over 40-year presence in clinical practice, strong evidence and well-known safety profile, flecainide distribution in Europe has not always been equal. In Poland, the drug has been available in pharmacies only since October this year, and previously it had to be imported on request. Flecainide can be used successfully in both the acute and chronic treatment of cardiac arrhythmias. The main indication for flecainide is the treatment of paroxysmal supraventricular tachycardias, including atrial fibrillation, atrioventricular nodal re-entrant tachycardia, atrioventricular re-entrant tachycardia and ventricular arrhythmias in patients without structural heart disease. Beyond that, it may be used in some supraventricular tachycardia in children and for sustained fetal tachycardia. Many studies indicate its efficacy comparable to or better than previously used drugs such as propafenone and amiodarone, depending on the indication. This review aims to highlight the most important clinical uses of flecainide in the light of the latest scientific evidence and to provide an overview of the practical aspects of treatment, including indications, off-label use, contraindications, areas of use, monitoring of treatment and most common complications, taking into account special populations: children and pregnant women.


Assuntos
Fibrilação Atrial , Taquicardia Ventricular , Gravidez , Criança , Humanos , Feminino , Flecainida/efeitos adversos , Propafenona/efeitos adversos , Antiarrítmicos/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico
14.
N Engl J Med ; 361(15): 1427-36, 2009 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-19812399

RESUMO

BACKGROUND: The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)


Assuntos
Desfibriladores Implantáveis , Infarto do Miocárdio/terapia , Idoso , Causas de Morte , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Modelos de Riscos Proporcionais , Sistema de Registros , Risco , Taxa de Sobrevida , Fatores de Tempo
15.
Europace ; 13 Suppl 2: ii18-20, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21518743

RESUMO

Although clinical trial results and the implementation of current guidelines appear to have encouraged progress in the treatment of arrhythmias, great discrepancies still exist between European Society of Cardiology (ESC) member countries. Guidelines are not adhered to for a variety of reasons. This cannot be explained only by economic factors, although these obviously play a substantial role. Other factors responsible for adequate guideline implementation appear to be the lack of trained personnel, the lack of infrastructure, or different health insurance systems. In this complex scenario, the data based on European registries are useful for creating standards and harmonizing the treatment of arrhythmias. Moreover, a summary of registry data, such as presented in the European Heart Rhythm Association (EHRA) White Book, can provide the opportunity to share and exchange information among ESC member countries on specific needs for improvements, reimbursement policy, and training issues.


Assuntos
Arritmias Cardíacas/prevenção & controle , Terapia por Estimulação Elétrica/estatística & dados numéricos , Medicina Baseada em Evidências/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/métodos , Padrões de Prática Médica/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Atitude do Pessoal de Saúde , Pesquisa Biomédica/tendências , Cardiologia/estatística & dados numéricos , Europa (Continente)/epidemiologia , Humanos
16.
Europace ; 13(5): 654-62, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21454333

RESUMO

AIMS: Sudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization. METHODS AND RESULTS: This study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres. CONCLUSION: There are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.


Assuntos
Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/prevenção & controle , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/estatística & dados numéricos , Arritmias Cardíacas/economia , Desfibriladores Implantáveis/economia , Europa (Continente)/epidemiologia , Geografia , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Mecanismo de Reembolso/economia
17.
Europace ; 13 Suppl 2: ii59-65, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21518752

RESUMO

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.


Assuntos
Arritmias Cardíacas/economia , Arritmias Cardíacas/prevenção & controle , Dispositivos de Terapia de Ressincronização Cardíaca/economia , Grupos Diagnósticos Relacionados/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Reembolso de Seguro de Saúde/economia , Análise Custo-Benefício , Atenção à Saúde/economia , Europa (Continente)/epidemiologia , Humanos
18.
Med Sci Monit ; 17(2): CR73-7, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21278691

RESUMO

BACKGROUND: Endothelial dysfunction is an independent predictor of future cardiac events. MATERIAL/METHODS: We evaluated the relationship between flow-mediated dilation (FMD) in brachial artery and coronary risk factors in 93 patients (70 males, mean age: 62 ± 8 years) with ACS treated with primary angioplasty (PCI). The patients were divided into 2 subgroups: 43 patients with diabetes mellitus type 2 (DM) and 50 non-diabetics (non-DM). Patients were examined on the 3rd day after ACS and after 6 months. FMD on the 3rd day were significantly lower in DM than in non-DM (5.8 ± 2.2% vs. 8.8 ± 4.9%, p=0.0007) and after 6 months (6.2 ± 2.6% vs. 9.4 ± 4.4%, p<0.0001). It was also observed that the improvement of FMD in both groups after a 6-month follow-up inversely correlated with the increase of left ventricular end-diastolic volume (LVEDV) (r=-0.41, p<0.001). RESULTS: There was an inverse relationship between FMD and age (r=-0.26, p<0.01), BMI (r=-0.26, p<0,005), total cholesterol (r=-0.56, p<0.001) and LDL cholesterol (r=-0.53, p<0.001). There was no relationship between triglycerides, hypertension and history of smoking. In the DM group, FMD negatively correlated with HbA1c (r=-0.68, p<0.001). Restenosis rate was significantly higher in the DM group (19% vs. 6%, p<0.001) but there was no relationship between FMD and restenosis. CONCLUSIONS: Impaired FMD is more significant in diabetics than in non-diabetic patients with ACS. Lack of improvement of FMD after acute coronary syndrome can be a predictor of detrimental left ventricular remodeling in patients with ACS.


Assuntos
Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/fisiopatologia , Complicações do Diabetes/complicações , Complicações do Diabetes/fisiopatologia , Endotélio Vascular/fisiopatologia , Remodelação Ventricular/fisiologia , Idoso , Angioplastia Coronária com Balão , Circulação Coronária/fisiologia , Reestenose Coronária/complicações , Reestenose Coronária/fisiopatologia , Vasos Coronários/fisiopatologia , Demografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vasodilatação/fisiologia
19.
JMIR Mhealth Uhealth ; 9(8): e23425, 2021 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-34448723

RESUMO

Atrial fibrillation is the most commonly reported arrhythmia and, if undiagnosed or untreated, may lead to thromboembolic events. It is therefore desirable to provide screening to patients in order to detect atrial arrhythmias. Specific mobile apps and accessory devices, such as smartphones and smartwatches, may play a significant role in monitoring heart rhythm in populations at high risk of arrhythmia. These apps are becoming increasingly common among patients and professionals as a part of mobile health. The rapid development of mobile health solutions may revolutionize approaches to arrhythmia screening. In this viewpoint paper, we assess the availability of smartphone and smartwatch apps and evaluate their efficacy for monitoring heart rhythm and arrhythmia detection. The findings obtained so far suggest they are on the right track to improving the efficacy of early detection of atrial fibrillation, thus lowering the risk of stroke and reducing the economic burden placed on public health.


Assuntos
Fibrilação Atrial , Smartphone , Fibrilação Atrial/diagnóstico , Eletrocardiografia , Acessibilidade aos Serviços de Saúde , Humanos , Fotopletismografia
20.
Curr Vasc Pharmacol ; 19(4): 403-410, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32286948

RESUMO

BACKGROUND: Although cardiac resynchronisation therapy (CRT) is an important player in the treatment of patients with heart failure (HF), the proportion of CRT patients with no improvement in either echocardiographic or clinical parameters remains consistently high and accounts for about 30% despite meeting CRT implantation criteria. Furthermore, in patients suffering from HF, renal dysfunction accounts for as many as 30-60%. Accordingly, CRT may improve renal function inducing a systemic haemodynamic benefit leading to increased renal blood flow. OBJECTIVES: The aim of the present study was to evaluate the importance of renal function in response to resynchronisation therapy during a 12-month follow-up period. MATERIALS AND METHODS: The study consisted of 46 HF patients qualified for implantation of cardiac resynchronisation therapy defibrillator (CRT-D). A CRT responder is defined as a person without chronic HF exacerbations during observation whose physical efficiency has improved owing to the New York Heart Association (NYHA) class improvement ≥1. RESULTS: A statistically significant difference was noted between responders and non-responders regarding creatinine level at the 3rd month (p=0.04) and, particularly, at the 12th month (p=0.02) of follow-up (100±23 vs 139±78 µmol/l). Moreover, there was a remarkable difference between both study groups with regard to GFR CKD-EPI (glomerular filtration rate (GFR) assessed using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) at the 6th (p=0.03) and 12th month (p=0.01) of follow-up. The reference values for initial creatinine concentrations (101 µmol/l) as well as GFR CKDEPI (63 ml/min/1.73m2) were empirically evaluated to predict favourable therapeutic CRT response. CONCLUSION: Predictive value of GFR CKD-EPI and creatinine concentration for a positive response to CRT was found relevant.


Assuntos
Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Rim , Insuficiência Cardíaca/terapia , Humanos , Rim/fisiologia , Resultado do Tratamento
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