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1.
Pol J Radiol ; 89: e1-e5, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38371889

RESUMO

The year 2023 marks 60 years since the first pacemaker was implanted in Poland. The number of implantable cardiac electrotherapy devices (CIEDs), including pacemakers, cardioverter-defibrillators, and resynchronization therapy systems, has been systematically increasing in the subsequent decades. It is estimated that nearly 500,000 Poles have an implanted cardiac electrotherapy device, making optimal diagnostic imaging with the use of magnetic resonance imaging (MRI) a clinically and epidemiologically important issue. MRI has become a gold diagnostic standard in many disease states. In this situation, it is believed that 50-70% of patients who have a cardiac electrotherapy device may have indications for an MRI examination later in life. For many years, an implanted cardiac electrotherapy device was considered a definite contraindication to MRI. However, MRI has become possible in most patients with CIED if certain procedures and precautions are followed. In these guidelines, we describe the basic rules that should be followed in order to perform a safe MRI examination in patients with different CIEDs. Despite all the risks and organizational factors described in the text, it seems that for many MRI departments, MRI in patients with CIEDs is achievable and should be implemented immediately. A second important issue is the need for dedicated financial support for these procedures from public health insurance.

2.
Europace ; 22(5): 769-776, 2020 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-32304216

RESUMO

AIMS: The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions. METHODS AND RESULTS: The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045). CONCLUSION: Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225).


Assuntos
Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Insuficiência Cardíaca , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Hospitalização , Humanos , Estudos Prospectivos , Resultado do Tratamento
4.
J Cardiovasc Electrophysiol ; 28(4): 425-431, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28176442

RESUMO

BACKGROUND: Randomized controlled trials demonstrate that remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) may improve quality of care and prognosis in heart failure (HF) patients. However, the impact of RM on long-term mortality in a real-world cohort is still not well examined. METHODS AND RESULTS: This study was designed as a matched cohort study based on the COMMIT-HF trial--a single-center, ongoing prospective observational registry (NCT02536443). Complete patient demographics, medical history, in-hospital results, hospitalizations, and mortality data were collected based on institutional registries and healthcare providers' records. Patients were divided into 2 groups based on RM presence and matched by means of propensity scores according to clinical characteristics. The primary endpoint of this study was the long-term all-cause mortality. Out of 1,429 consecutive patients, 822 patients with a first implantation of an ICD/CRT-D were included in the analysis. The final matched study population contained 574 patients in RM and in a control group. Although demographic and echocardiographic parameters as well as pharmacological treatments were similar in both groups, a significantly lower 1-year mortality was detected in the RM group (2.1% vs. 11.5%, P < 0.0001). This was also maintained during a 3-year follow-up (4.9% vs. 22.3%, P < 0.0001). Multivariate analysis showed that RM was associated with an improved prognosis (hazard ratio 0.187, 95% confidence interval 0.075-0.467, P = 0.0003). CONCLUSION: RM of HF patients with ICDs/CRT-Ds significantly reduced long-term mortality in a real-world clinical condition.


Assuntos
Insuficiência Cardíaca/diagnóstico , Telemedicina/métodos , Telemetria , Idoso , Terapia de Ressincronização Cardíaca , Dispositivos de Terapia de Ressincronização Cardíaca , Distribuição de Qui-Quadrado , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Prognóstico , Pontuação de Propensão , Modelos de Riscos Proporcionais , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo
5.
Artigo em Inglês | MEDLINE | ID: mdl-28019051

RESUMO

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225).


Assuntos
Desfibriladores Implantáveis/estatística & dados numéricos , Insuficiência Cardíaca/terapia , Hospitalização/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Projetos de Pesquisa , Telemedicina/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
6.
J Cardiovasc Electrophysiol ; 27(10): 1247-1251, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27325433

RESUMO

Cardiac implantable electronic devices (CIEDs) have been in use for over 50 years and their therapeutic value is undisputable. With the rapidly aging population, it is estimated that the number of CIEDs will grow dramatically over the next 2 decades. Given these predictions, the topic of management of concomitant conditions associated with older age becomes more relevant than ever. In particular, the number of patients with an implanted CIED diagnosed with cancer is expected to rise by about 70%, from 14 million in 2012 to 22 million within the next 2 decades. Treatment of most of these tumors and tumor metastases requires radiation therapy. However, the necessary high doses of radiation can potentially interact with the function, longevity, and integrity of the CIEDs and/or cause harm to the patient. The impact of an absence of clear therapeutic guidelines for oncology patients with CIEDs who should undergo radiation therapy is vast; and due to the fear of possible complications related to device failure, many of these patients may not be treated adequately to their needs, which can strongly affect their prognosis. This article summarizes the available data on the management of patients with CIEDs undergoing radiotherapy. It systematically presents possible causes and consequences of direct and scattered radiation on CIEDs, highlights possible complications that may occur during this kind of treatment, and provides practical guidance for this challenging real life clinical setting.


Assuntos
Desfibriladores Implantáveis , Neoplasias/radioterapia , Marca-Passo Artificial , Dosagem Radioterapêutica , Desfibriladores Implantáveis/efeitos adversos , Humanos , Marca-Passo Artificial/efeitos adversos , Guias de Prática Clínica como Assunto , Desenho de Prótese , Falha de Prótese , Radioterapia/efeitos adversos , Fatores de Risco , Espalhamento de Radiação , Resultado do Tratamento
7.
Cardiology ; 131(1): 41-50, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25832492

RESUMO

BACKGROUND: The no-reflow (NR) phenomenon exists despite percutaneous coronary intervention (PCI), and is especially prevalent in diabetics. The causes(s) of NR are not fully elucidated, but may be associated with impaired residual platelet and inflammatory reactivity during dual-antiplatelet therapy. OBJECTIVE: To assess the relationship between dual-antiplatelet therapy, NR and conventional biomarkers suggestive of platelet and inflammatory response in diabetics following ST-segment elevation myocardial infarction (STEMI) treated with PCI. METHODS: Sixty diabetics with (n = 27) and without NR (n = 33) were prospectively enrolled. All patients were treated with clopidogrel and aspirin. Platelet and inflammatory biomarkers were assessed serially in the peripheral blood and right atrium before and after PCI and then at 24 h, 7 days and 30 days. RESULTS: Arachidonic acid (AA)-induced platelet aggregation and the serum thromboxane B2 level before and after PCI (in the peripheral and right atrium blood) were significantly higher in the NR patients than in those with no NR. AA-induced aggregation >100 (AUC*min) before PCI predicted NR in diabetic patients with 96.2% sensitivity and 38.5% specificity (AUC 0.66; 95% CI 0.52-0.71; p = 0.029). There were no other correlations between NR and platelet reactivity (collagen, adenosine diphosphate, thrombin receptor agonist peptide-induced aggregation, vasodilator-stimulated phosphoprotein platelet reactivity index, soluble P-selectin, soluble CD40 ligand, platelet-derived growth factor AB and the level of platelet-monocyte aggregates) or between NR and inflammatory indices (i.e. high-sensitivity C-reactive protein, interleukin 6 and interleukin 10). CONCLUSION: An inadequate response to aspirin, but not to clopidogrel, may be associated with the occurrence of the NR phenomenon in diabetics with STEMI who have been treated with primary PCI.


Assuntos
Complicações do Diabetes/etiologia , Infarto do Miocárdio/complicações , Fenômeno de não Refluxo/etiologia , Inibidores da Agregação Plaquetária/uso terapêutico , Agregação Plaquetária , Idoso , Aspirina/uso terapêutico , Biomarcadores/sangue , Clopidogrel , Complicações do Diabetes/sangue , Resistência a Medicamentos , Feminino , Humanos , Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Fenômeno de não Refluxo/sangue , Intervenção Coronária Percutânea , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico
8.
Kardiol Pol ; 82(2): 166-174, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38493472

RESUMO

BACKGROUND: Notwithstanding readily available revascularization, significant advancements in mechanical circulatory support, and pharmacological progress, cardiogenic shock (CS) secondary to unprotected left main culprit lesion-related acute myocardial infarction (ULMCL-related AMI) is associated with very high mortality. In this population, chronic total occlusion (CTO) is relatively frequent. AIMS: This study sought to assess the association between the presence of CTO and 12-month mortality in patients with CS due to ULMCL-related AMI. RESULTS: The study included consecutive patients admitted for AMI-related CS with ULMCL who underwent percutaneous coronary intervention (PCI) and were enrolled in the prospective Polish Registry of Acute Coronary Syndromes (PL-ACS) between January 2017 and December 2021. The patients were stratified into two groups based on the presence of at least one CTO. The primary endpoint was all-cause death at 12 months. Of the 250 included patients, 60 (24%) patients had one or more CTOs of a major coronary artery (+CTO), and in 190 (76%) patients, the presence of CTO was not observed (-CTO). The 12-month mortality rates for the +CTO and -CTO patients were 85% and 69.8%, respectively (P log-rank = 0.03). After multivariable adjustment for differences in the baseline characteristics, the presence of CTO remained significantly associated with higher 12-month mortality (hazard ratio, 1.423; 95% CI, 1.027-1.973; P = 0.034). CONCLUSIONS: Our analysis showed that in patients with CS due to ULMCL-related AMI treated with PCI, the presence of CTO is associated with worse 12-month prognosis.


Assuntos
Síndrome Coronariana Aguda , Oclusão Coronária , Intervenção Coronária Percutânea , Humanos , Choque Cardiogênico/etiologia , Oclusão Coronária/complicações , Oclusão Coronária/cirurgia , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/cirurgia , Resultado do Tratamento , Estudos Prospectivos , Vasos Coronários , Polônia , Prognóstico , Sistema de Registros , Doença Crônica
9.
Clin Res Cardiol ; 2024 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-39387937

RESUMO

BACKGROUND: Atrial fibrillation (AF) is common in cardiac resynchronization therapy (CRT) recipients. It is a marker of impaired CRT response mainly mediated by the reduction of effectively captured biventricular paced beats (BiVp). There are no randomized trials comparing strategies to maintain high BiVp percentage. OBJECTIVE: To compare the efficacy of rhythm vs rate control strategies in CRT recipients with long-standing persistent AF. METHODS: We performed a randomized trial including CRT recipients with persistent AF resulting in low BiVp%. All patients received amiodarone, the rhythm control group received external electrical cardioversion (EC), and the rate control group received atrioventricular node ablation, if needed. The primary end-point was 12-month BiVp% (NCT). RESULTS: 43 patients were included in the analysis. The mean age was 68.4 (SD: ± 8.3) years and the mean BiVp% 82.4% ± 9.7%. AF lasted 25 ± 19 months. The mean baseline left ventricular ejection fraction (LVEF), left atrium area, and the maximal oxygen uptake (VO2max) were: 30 ± 8%, 33 ± 7 cm2, and 14 ± 5 mL/(kg*min), respectively. The EC success rate was 58%. 38% patients remained in sinus rhythm (SR) after 12 months. BiVp% increased similarly in both arms reaching 99% [95% CI 97.3-99.8] and 98% [94.0-99.0], P = 0.14 in rhythm and rate control groups, respectively. LVEF raised significantly only in the rhythm control group (ΔLVEF 4.1 (± 7.3), P = 0,018) which was driven by the patients who maintained SR. No differences in VO2max, QoL, clinical and safety end-points were observed. CONCLUSION: Despite comparable BiVp% in both groups, only restoration of SR led to improved left ventricular ejection fraction in CRT patients with long-standing AF. TRIAL REGISTRATION: NCT01850277 registered on 22/04/2013.

10.
Cardiol J ; 30(1): 117-124, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-33843044

RESUMO

BACKGROUND: Recent data regarding the comparison of implantable cardioverter-defibrillator (ICD) therapy and optimal medical treatment in patients with non-ischemic cardiomyopathy has indicated no mortality benefit as a result of ICD therapy. Although the recommendations for ICD implantation did not change, it is worth noting that these findings significantly affected the daily practice of ICD implantation in Europe. METHODS: To assess the effect of ICD implantation in comparison to pharmacotherapy in the non- -ischemic cardiomyopathy heart failure population through a systematic review and meta-analysis of the available carefully designed prospective randomized controlled trials. Only prospective randomized controlled trials comparing ICD implantation in primary prevention vs. optimal pharmacological therapy or placebo and reporting mortality results were included in the meta-analysis. The authors have chosen to include the following trials: CAT, AMIOVIRT, DEFINITE, and DANISH. RESULTS: A meta-analysis of pooled hazard ratios (HR) from all trials conducted on a total of 1789 patients found that ICD therapy decreased all-cause mortality in comparison to optimal pharmacological treatment, with a HR of 0.48 (95% confidence interval [CI] 0.67-1.01); p = 0.06. The data from the AMIOVIRT, DANISH, and DEFINITE trials, with a total of 1677 participants, showed a significant reduction of sudden cardiac deaths as a result of ICD implantation, with a HR of 0.48 (95% CI 0.31-0.67); p < 0.001. CONCLUSIONS: In comparison with optimal medical treatment, ICD implantation in patients with heart failure improves the long-term prognosis in terms of sudden cardiac death, with a strong tendency towards all-cause mortality reduction.


Assuntos
Cardiomiopatias , Desfibriladores Implantáveis , Insuficiência Cardíaca , Isquemia Miocárdica , Humanos , Desfibriladores Implantáveis/efeitos adversos , Cardiomiopatias/complicações , Cardiomiopatias/diagnóstico , Cardiomiopatias/terapia , Estudos Prospectivos , Prevenção Primária/métodos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Isquemia Miocárdica/complicações , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle
11.
Kardiol Pol ; 81(7-8): 746-753, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37270830

RESUMO

BACKGROUND: Current guidelines recommend coronary catheterization in patients with non-ST- -segment elevation myocardial infarction (NSTEMI) within 24 hours of hospital admission. However, whether there is a stepwise relationship between the time to percutaneous coronary intervention (PCI) and long-term mortality in patients with NSTEMI treated invasively within 24 hours of admission has not been established yet. AIMS: The study aimed to evaluate the association between door-to-PCI time and all-cause mortality at 12 and 36 months in NSTEMI patients presenting directly to a PCI-capable center who underwent PCI within the first 24 hours of hospitalization. METHODS: We analyzed data of patients hospitalized for NSTEMI between 2007-2019, included in the nationwide registry of acute coronary syndromes. Patients were stratified into twelve groups based on 2-hour intervals of door-to-PCI time. The mortality rates of patients within those groups were adjusted for 33 confounding variables by the propensity score weighting method using overlap weights. RESULTS: A total of 37 589 patients were included in the study. The median age of included patients was 66.7 (interquartile range [IQR], 59.0-75.8) years; 66.7% were male, and the median GRACE (Global Registry of Acute Coronary Events) score was 115 (98-133). There were increased 12-month and 36-month mortality rates in consecutive groups of patients stratified by 2-hour door-to-PCI time intervals. After adjustment for patient characteristics, there was a significant positive correlation between the time to PCI and the mortality rates (rs = 0.61; P = 0.04 and rs = 0.65; P = 0.02 for 12-month and 36-month mortality, respectively). CONCLUSIONS: The longer the door-to-PCI time, the higher were 12-month and 36-month all-cause mortality rates in NSTEMI patients.


Assuntos
Infarto do Miocárdio sem Supradesnível do Segmento ST , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Infarto do Miocárdio sem Supradesnível do Segmento ST/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Sistema de Registros
12.
Kardiol Pol ; 81(7-8): 818-823, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37489830

RESUMO

Cardiovascular diseases account for 43% of deaths in Poland. The COVID-19 pandemic increased the number of cardiovascular deaths by as much as 16.7%. Lipid metabolism disorders are observed in about 20 million Poles. Lipid disorders are usually asymptomatic, they cause a significant increase in the risk of cardiovascular diseases. Up to 20% of patients who experience an acute coronary syndrome (ACS) may experience a recurrence of a cardiovascular event within a year, and up to 40% of these patients may be re-hospitalized. Within 5 years after a myocardial infarction, 18% of patients suffer a second ACS and 13% have got a stroke. Lipid-lowering therapy is an extremely important element of comprehensive management, both in primary and secondary prevention, and its main goal is to prevent or extend the time to the onset of heart or vascular disease and reduce the risk of cardiovascular events. A patient with a history of ACS belongs to the group of a very high risk of a cardiovascular event due to atherosclerosis. In this group of patients, low-density lipoprotein cholesterol levels should be aimed below 55 mg/dl (1.4 mmol/l). Many scientific guidelines define the extreme risk group, which includes not only patients with two cardiovascular events within two years, but also patients with a history of ACS and additional clinical factors: peripheral vascular disease, multivessel disease (multilevel atherosclerosis), or multivessel coronary disease, or familial hypercholesterolemia, or diabetes with at least one additional risk factor: elevated Lp(a) >50 mg/dl or hsCRP >3 mg/l, or chronic kidney disease (eGFR <60 ml/min/1.73 m²). In this group of patients, the LDL-C level should be aimed at below 40 mg/dl (1.0 mmol/l). Achieving therapeutic goals in patients after ACS should occur as soon as possible. For this purpose, a high-dose potent statin should be added to the therapy at the time of diagnosis, and ezetimibe should be added if the goal is not achieved after 4-6 weeks. Combination therapy may be considered in selected patients from the beginning. After 4-6 weeks of combination therapy, if the goal is still not achieved, adding a proprotein convertase subtilisin/kexin type 9 protein inhibitor or inclisiran should be considered. In order to increase compliance with the recommendations, Polish Cardiac Society and Polish Lipid Society propose to attach in the patient's discharge letter a statement clearly specifying what drugs should be used and what LDL-C values should be achieved. It is necessary to cooperate between the patient and the doctor, to follow the recommendations and take medicines regularly, to achieve and maintain therapeutic goals.


Assuntos
Síndrome Coronariana Aguda , Anticolesterolemiantes , Aterosclerose , COVID-19 , Inibidores de Hidroximetilglutaril-CoA Redutases , Infarto do Miocárdio , Humanos , LDL-Colesterol , Polônia , Prevenção Secundária , Pandemias , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Aterosclerose/tratamento farmacológico , Anticolesterolemiantes/uso terapêutico , Pró-Proteína Convertase 9/uso terapêutico
13.
ESC Heart Fail ; 10(5): 3174-3183, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37449716

RESUMO

AIMS: In recent years, survival in patients with breast cancer has increased. Despite the improvement in outcomes of those patients, the risk of treatment-related cardiotoxicity remains high, and its presence has been associated with a higher risk of treatment termination and thus lower therapeutic efficacy. Prior trials demonstrated that a preventive initiation of heart failure drugs, including the renin-angiotensin-aldosterone inhibitors, might reduce the risk of treatment-related cardiotoxicity. However, to date, no study investigated the efficacy of sacubitril/valsartan, a novel antineurohormonal drug shown to be superior to the previous therapies, in the prevention of cardiotoxicity in patients with early-stage breast cancer, which is the aim of the trial. METHODS AND RESULTS: MAINSTREAM is a randomized, placebo-controlled, double-blind, multicentre, clinical trial. After the run-in period, a total of 480 patients with early breast cancer undergoing treatment with anthracyclines and/or anti-human epidermal growth factor receptor 2 drugs will be randomized to the highest tolerated dose of sacubitril/valsartan, being preferably 97/103 mg twice daily or placebo in 1:1 ratio. The patients will be monitored, including routine transthoracic echocardiography (TTE) and laboratory biomarker monitoring, for 24 months. The primary endpoint of the trial will be the occurrence of a decrease in left ventricular ejection fraction by ≥5% in TTE within 24 months. The key secondary endpoints will be the composite endpoint of death from any cause or hospitalization for heart failure, as well as other imaging, laboratory, and clinical outcomes, including the occurrence of the cancer therapy-related cardiac dysfunction resulting in the necessity to initiate treatment. The first patients are expected to be recruited in the coming months, and the estimated completion of the study and publication of the results are expected in December 2027, pending recruitment. CONCLUSIONS: The MAINSTREAM trial will determine the efficacy and safety of treatment with sacubitril/valsartan as a prevention of cardiotoxicity in patients with early breast cancer (ClinicalTrials.gov number: NCT05465031).

14.
Kardiol Pol ; 81(5): 455-462, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36871295

RESUMO

BACKGROUND: The use of subcutaneous implantable cardioverter-defibrillators (S-ICD) has been growing in Poland since 2014. The Polish Registry of S-ICD Implantations was run by the Heart Rhythm Section of the Polish Cardiac Society between May 2020 and September 2022 to monitor the implementation of that therapy in Poland. AIMS: To investigate and present the state-of-the-art of S-ICD implantation in Poland. METHODS: Implanting centers reported clinical data of patients undergoing S-ICD implantations and replacements, including age, sex, height, weight, underlying disease, history of pacemaker and defibrillator implantations, indications for S-ICD, electrocardiographical parameters, procedural techniques, and complications. RESULTS: Four hundred and forty patients undergoing S-ICD implantation (411) or replacement (29) were reported by 16 centers. Most patients were in New York Heart Association class II (218 patients, 53%) or I (150 patients, 36.5%). Left ventricular ejection fraction was 10%-80%, median (IQR) was 33% (25%-55%). Primary prevention indications were present in 273 patients (66.4%). Non-ischemic cardiomyopathy was reported in 194 patients (47.2%). The main reason for the choice of S-ICD were: young age (309, 75.2%), risk of infectious complications (46, 11.2%), prior infective endocarditis (36, 8.8%), hemodialysis (23, 5.6%), and immunosuppressive therapy (7, 1.7%). Electrocardiographic screening was performed in 90% of patients. The rate of adverse events was low (1.7%). No surgical complications were observed.


Assuntos
Desfibriladores Implantáveis , Humanos , Polônia , Desfibriladores Implantáveis/efeitos adversos , Volume Sistólico , Função Ventricular Esquerda , Sistema de Registros , Morte Súbita Cardíaca/prevenção & controle
15.
Cardiol J ; 2023 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-37183538

RESUMO

Out-of-hospital cardiac arrest (OHCA) remains a leading cause of global mortality, while survivors are burdened with long-term neurological and cardiovascular complications. OHCA management at the hospital level remains challenging, due to heterogeneity of OHCA presentation, the critical status of OHCA patients reaching the return of spontaneous circulation (ROSC), and the demands of post ROSC treatment. The validity and optimal timing for coronary angiography is one important, yet not fully defined, component of OHCA management. Guidelines state clear recommendations for coronary angiography in OHCA patients with shockable rhythms, cardiogenic shock, or in patients with ST-segment elevation observed in electrocardiography after ROSC. However, there is no established consensus on the angiographic management in other clinical settings. While coronary angiography may accelerate the diagnostic and therapeutic process (provided OHCA was a consequence of coronary artery disease), it might come at the cost of impaired post-resuscitation care quality due to postponing of intensive care management. The aim of the current statement paper is to discuss clinical strategies for the management of OHCA including the stratification to invasive procedures and the rationale behind the risk-benefit ratio of coronary angiography, especially with patients in critical condition.

16.
Kardiol Pol ; 80(3): 286-292, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35040485

RESUMO

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices (CIED) allows for a regular analysis of the occurrence of arrhythmias and functioning of the devices. AIMS: To date, no study investigated the characteristics of the alert-triggered ultimate transmissions before death, which was the aim of the present analysis. METHODS: Patients monitored remotely in our center, whose baseline characteristics were obtained from the COMMIT-HF Registry (NCT02536443) were analyzed and divided according to the occurrence of alert transmissions during the RM. In patients who had an alert transmission, the last transmission was analyzed. All RM data were obtained from the software provided by four RM manufacturers. RESULTS: Of 1271 patients with CIEDs which transmitted at least one message to the RM center, 198 (15.6%) had no alert transmissions, while 1073 (84.4%) had at least one alert transmission. Respective mortality in patients with and without alerts during RM was 29.7% and 12.6%, respectively. In patients who had ever an alert, the last recorded transmission before death was scheduled in 166 patients and alert-triggered in 152 patients. The most frequent alert-triggered last transmissions were atrial fibrillation/flutter (39.4%) and ventricular tachyarrhythmias (26.8%). The median period from the last alert-triggered transmission to death was 10 days. CONCLUSION: This is the first analysis of the ultimate RM transmissions delivered by CIEDs before death. In approximately 85% of RM patients with CIEDs, at least one alert transmission occurred during the RM, and in patients who had ever an alert, almost half of the last transmissions before death were alert-triggered.


Assuntos
Fibrilação Atrial , Desfibriladores Implantáveis , Insuficiência Cardíaca , Taquicardia Ventricular , Insuficiência Cardíaca/terapia , Humanos , Monitorização Fisiológica
17.
Cardiol J ; 29(1): 27-32, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34931693

RESUMO

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic disorganised healthcare systems and has caused a reduction in the number of hospitalizations and procedures. Cardiac implantable electronic device (CIED) procedure rates and clinical characteristics of their recipients were compared in corresponding weeks of 2019 and 2020 were analyzed. METHODS: The database of the National Health Fund (NHF) in Poland was retrospectively analyzed. 3206 patients who underwent CIED implantation in the Silesia - a region in Southern Poland comprising an adult population of 3.8 million between 12th and 31st week of 2020. Patients were classified into groups: the recipient of an implantable cardioverter-defibrillator or cardiac resynchronization therapy group (ICD/CRT) or pacemaker group (PM). RESULTS: During the pandemic a reduction of 39.38% of implantations was observed compared to the same period in 2019 (1210 vs. 1996 patients) and had impacted both groups. Two phases lasting 10 weeks each could be distinguished: total lockdown (maximal reduction) and the recovery phase with growing numbers of procedures. Patient baseline characteristics (sex, age, comorbidities) who were implanted during the COVID-19 pandemic did not differ from the 2019 period. The rate of peri-procedural mortality was also similar. CONCLUSIONS: During COVID-19 pandemic period a reduction in CIED implantations of all types was observed. Despite the decreased number of performed CIED implants, no differences in baseline patient characteristics were observed.


Assuntos
COVID-19 , Desfibriladores Implantáveis , Adulto , COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Eletrônica , Humanos , Pandemias , Polônia , Estudos Retrospectivos , SARS-CoV-2
18.
Kardiol Pol ; 80(1): 64-71, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34668179

RESUMO

BACKGROUND: Scant data exist on long-term outcomes, including death, in patients with complica-tions related to transvenous lead extractions (TLE). AIMS: We sought to characterize the population and examine the outcomes including risk factors for in-hospital complications and 12-month mortality and morbidity related to the complications in a large administrative database of patients undergoing TLE. RESULTS: From the database of patients hospitalized for cardiovascular diseases and included in the Silesian Cardiovascular Database (SILCARD) registry, we selected the admissions of those who underwent TLE according to the appropriate ICD-9 codes. The patients were divided into two groups based on whether they did or did not manifest any complications during their hospitalization for the TLE procedure. Between 2007 and 2019, we found a total of 835 patients who underwent TLE. TLE-related complications occurred in 56 patients (6.7%) of the Complications-Yes group while no complications were recorded in 779 (93.3%) patients of the Complications-No group. A significant difference in the rate of all-cause mortality (23.9% vs. 6.5%; P <0.001) and major adverse cardiac events (MACE) (58.7% vs. 39.4%; P = 0.01) between the Complications-Yes and Complications-No groups were recorded. Multivariable analysis of the entire study population revealed that prior dialysis, chronic kidney disease, and ventricular tachycardia were independent factors of a higher risk of TLE-related in-hospital complications. Multivariable analysis of the patients discharged from the hospital after the TLE procedure showed that TLE-related complications, a history of heart failure, and older age independently affected 12-month mortality. CONCLUSIONS: The presence of TLE-related in-hospital complications increased 12-month mortality.


Assuntos
Desfibriladores Implantáveis , Marca-Passo Artificial , Arritmias Cardíacas/etiologia , Desfibriladores Implantáveis/efeitos adversos , Remoção de Dispositivo/efeitos adversos , Humanos , Marca-Passo Artificial/efeitos adversos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
19.
Kardiol Pol ; 79(2): 139-146, 2021 02 25.
Artigo em Inglês | MEDLINE | ID: mdl-33146505

RESUMO

BACKGROUND: Cardiovascular diseases are the most common factor affecting prognosis in cancer survivors. Cardio­oncology (CO) services have been developed to solve this issue. The outcomes regarding patient demographics and clinical findings are limited and the available data include CO services evaluating patients undergoing only chemotherapy as opposed to those also undergoing radiation therapy. AIMS: We aimed to show initial experiences of the CO service implemented in a tertiary oncology center. METHODS: The CO service was designed to include 2 major domains, general CO and electrotherapy consultations. This observational study included patients referred to the CO service with the following data: baseline demographics, cancer type, reasons for referral, cardiac evaluation, and initial clinical outcomes. RESULTS: All patients with cancer referred to our CO service between March 2016 and December 2019 were included in the study. A total of 2762 patients (77% women) at the mean (SD) age of 62 (12) years were referred (63% on an out­patient basis) for general consultations. The most frequent diagnosis was breast cancer (66%). A total of 18% of patients were referred to the CO service due to cardiovascular complications related to cancer treatment. The CO-cardiac implantable electronic device (CIED) team evaluated 652 patients (515 patients with CIEDs who were qualified for radiotherapy, 48 patients with CIEDs who were assessed with magnetic resonance imaging, and 89 patients with CIEDs who underwent cancer surgery). In the total of 5872 radiotherapy sessions, there were 2 harmful interactions; no other complications during magnetic resonance imaging and surgery were recorded. CONCLUSIONS: The CO­service established within the cancer center seems to be safe and feasible.


Assuntos
Desfibriladores Implantáveis , Cardiopatias , Neoplasias , Marca-Passo Artificial , Radioterapia (Especialidade) , Feminino , Cardiopatias/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/terapia
20.
Nutrients ; 13(11)2021 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-34836249

RESUMO

Low spot urinary creatinine concentration (SUCR) is a marker of muscle wasting and clinical outcome. The risk factors for low SUCR in heart failure (HF) remain poorly understood. We explored the risk factors for low SUCR related to poor outcomes. In 721 HF patients (age: 52.3 ± 11 years, female: 14%, NYHA: 2.7 ± 0.7) SUCR and Dexa body composition scans were performed. BMI prior HF-onset, weight loss, and appendicular muscle mass were obtained. Each patient was classified as malnutrition or normal by GLIM criteria and three other biochemical indices (CONUT, PNI, and GRNI). Sarcopenia index (SI) as creatinine to cystatin C ratio was also calculated. Within 1 year, 80 (11.1%) patients died. In ROC curve we identified a SUCR value of 0.628 g/L as optimally discriminating surviving from dead. In low SUCR group more advanced HF, higher weight loss and catabolic components of weight trajectory (CCWT), more frequent under-nutrition by GLIM, and lower SI were observed. In multivariate analysis the independent predictors of low SUCR were SI, CCWT, and GNRI score. In conclusion: the risk of low SUCR was associated with a worse outcome. Low SUCR was associated with greater catabolism and sarcopenia but not with biochemical indices of malnutrition.


Assuntos
Creatinina/urina , Insuficiência Cardíaca/urina , Estado Nutricional , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Curva ROC
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