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1.
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.

2.
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.

3.
ESC Heart Fail ; 6(1): 182-193, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30299600

RESUMO

AIMS: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. METHODS AND RESULTS: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. CONCLUSIONS: The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.


Assuntos
Cardiomiopatia Dilatada/terapia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Prevenção Primária/métodos , Medição de Risco , Cardiomiopatia Dilatada/complicações , Cardiomiopatia Dilatada/mortalidade , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Eletrocardiografia , Europa (Continente)/epidemiologia , Seguimentos , Humanos , Seleção de Pacientes , Estudos Prospectivos , Qualidade de Vida , Taxa de Sobrevida/tendências , Resultado do Tratamento
4.
Int J Vasc Med ; 2012: 757501, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22500235

RESUMO

Treatment of symptom recurrence after initially successful alcohol septal ablation (ASA) in hypertrophic obstructive cardiomyopathy (HOCM) when accompanied by relapse of intracavitary left ventricular pressure gradient (LVG) is guided by the underlying mechanism. We describe our experience with permanent pacing in three patients with relapse of both LVG and symptoms 7 to 12 months after successful ASA. Even though pressure gradient recurrence was observed at midventricular level, we were able to achieve symptomatic improvement and LVG reduction after right ventricular apex pacing in all three cases. The effect on symptoms was long lasting-the 6-month followup echo-stress tests confirmed good exercise capacity and lack of provocable LVG. We found pacing to be a safe and effective treatment option in this clinical scenario. Based on our overall observations, we propose pacing as a niche treatment for patients with recurrence of LVG at midventricular level after ASA.

5.
J Thromb Thrombolysis ; 34(1): 85-90, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22249353

RESUMO

Multiple studies have shown a correlation between high on-treatment platelet reactivity (HPR) and ischemic complications after percutaneous coronary interventions (PCI); however, the role of platelet reactivity testing in order to adjust clopidogrel dose is debated. We sought to determine whether a strategy incorporating platelet reactivity testing with the Multiplate analyzer to tailor the dose of clopidogrel is superior to standard clopidogrel treatment after PCI. Between May 2008 and June 2009, 192 consecutive patients undergoing PCI were randomized to a tailored treatment strategy using the Multiplate analyzer or to uniform administration of 75 mg clopidogrel. In the tailored group, platelet function was assessed 24 h after clopidogrel loading, and patients with HPR (>46 U) received an additional 600 mg loading dose and 150 mg clopidogrel thereafter for one month. The primary endpoint was the composite of cardiac death, myocardial infarction, ischemic stroke or definite/probable stent thrombosis during six months. In the tailored group, a repeated loading dose of 600 mg clopidogrel significantly decreased platelet reactivity in patients with HPR (61.0 U [IQR: 52.5-71.5] vs. 21.5 U [15.8-30.5]; P < 0.0001) that remained unchanged during the maintenance phase on 150 mg clopidogrel (25.0 U [IQR: 19.8-27.0]; P = 0.20). The incidence of the primary endpoint was significantly higher in the standard clopidogrel group as compared to the Multiplate-tailored arm (5.3% vs. 0%, P = 0.03). In parallel, MACCE-free survival significantly improved in patients with Multiplate-tailored therapy (Kaplan-Meier log-rank: P = 0.02). Increasing the dose of clopidogrel according to the Multiplate assay may reduce ischemic complications in patients on clopidogrel after PCI.


Assuntos
Síndrome Coronariana Aguda/terapia , Angina Pectoris/terapia , Angioplastia Coronária com Balão , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/mortalidade , Idoso , Angina Pectoris/mortalidade , Clopidogrel , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes de Função Plaquetária , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Fatores de Tempo
6.
Int J Cardiol ; 138(3): 314-6, 2010 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-18778860

RESUMO

Two patients presenting with huge pericardial effusion were treated with pericardiotomy, using an Inoue balloon dilating catheter, to prevent recurrences and achieve symptoms relief. The procedure is a modification of an original technique reported by Palacios et al. gaining advantage of the Inoue balloon self positioning abilities and low profile. No early recurrence was observed. In both cases the effect was excellent and lead to quick ambulation sparing the patients the risk of more aggressive surgical procedure and general anesthesia. It is concluded that percutaneous balloon pericardiotomy supported by the Inoue balloon unique versatility is a simple and safe way to drain massive pericardial effusions.


Assuntos
Cateterismo/métodos , Derrame Pericárdico/cirurgia , Derrame Pericárdico/terapia , Pericardiectomia/métodos , Cateterismo/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pericardiectomia/instrumentação , Índice de Gravidade de Doença
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