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1.
Coron Artery Dis ; 2024 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-38742995

RESUMO

BACKGROUND: The prevalence and location of coronary artery disease (CAD) in anomalous aortic origin of a coronary artery (AAOCA) remain poorly documented in adults. We sought to assess the presence of CAD in proximal (or ectopic) and distal (or nonectopic) segments of AAOCA. We hypothesized that the representation of CAD may differ among the different courses of AAOCA. METHODS: The presence of CAD was analyzed on coronary angiography and/or coronary computed tomography angiography in 390 patients (median age 64 years; 73% male) with AAOCA included in the anomalous coronary arteries multicentric registry. RESULTS: AAOCA mainly involved circumflex artery (54.4%) and right coronary artery (RCA) (31.3%). All circumflex arteries had a retroaortic course; RCA mostly an interarterial course (98.4%). No CAD was found in the proximal segment of interarterial AAOCA, whereas 43.8% of retroaortic AAOCA, 28% of prepulmonic AAOCA and 20.8% subpulmonic AAOCA had CAD in their proximal segments (P < 0.001). CAD was more prevalent in proximal than in distal segments of retroaortic AAOCA (OR: 3.1, 95% CI: 1.8-5.4, P < 0.001). On multivariate analysis, a retroaortic course was associated with an increased prevalence of CAD in the proximal segment (adjusted OR 3.4, 95% CI: 1.3-10.7, P = 0.022). CONCLUSION: Increased prevalence of CAD was found in the proximal segment of retroaortic AAOCA compared to the proximal segments of other AAOCA, whereas no CAD was observed in the proximal segment of interarterial AAOCA. The mechanisms underlying these differences are not yet clearly identified.

3.
Ann Cardiol Angeiol (Paris) ; 71(6): 391-398, 2022 Dec.
Artigo em Francês | MEDLINE | ID: mdl-36241480

RESUMO

Coronary aneurysms are rare and of various etiologies in adults. Natural history, modalities of management and clinical monitoring remain poorly known due to the lack of large studies and homogeneous diagnostic and follow-up criteria in the published data. Coronary angiography is, so far, the most common diagnostic tool but can overlook some partially thrombosed aneurysmal. Intracoronary imaging, particularly intravascular ultrasound, can differentiate aneurysms from pseudoaneurysms considered by some to be at greater risk of events, requiring a curative treatment. Intracoronary imaging can also help with etiological assessment and percutaneous treatment. With its growing use in the search for coronary atheromatous disease, coronary CT angiography has become a major diagnostic tool for coronary aneurysms. In addition, that it can incidentally detect coronary aneurysms, coronary CT angiography is particularly useful for giant aneurysms poorly visualized on coronary angiography or less well evaluated by intracoronary imaging. It specifies their relationship with adjacent anatomical structures. It is also a non-invasive modality of monitoring. These three imaging tools are currently the most relevant in current practice pending large studies evaluating the natural history of coronary aneurysms, with the identification of possible risk factors that could modify the management.


Assuntos
Aneurisma Coronário , Humanos , Adulto , Aneurisma Coronário/diagnóstico por imagem , Angiografia Coronária/efeitos adversos , Tomografia Computadorizada por Raios X , Angiografia por Tomografia Computadorizada/efeitos adversos , Ultrassonografia
4.
Ann Cardiol Angeiol (Paris) ; 71(5): 283-289, 2022 Nov.
Artigo em Francês | MEDLINE | ID: mdl-36115720

RESUMO

BACKGROUND: Despite an often favorable risk/benefit ratio, patients with severe chronic kidney disease are sometimes declined for interventional coronary procedures, due to the risk of acute kidney injury post-contrast (AKI-PC). A large preventive supply of intravenous fluid may be problematic in this population. The RenalGuard® system allows hyperhydration by maintaining a stable volemia through an enhanced diuresis. METHODS AND RESULTS: This work reports the evaluation of the RenalGuard® system in 25 consecutive patients with chronic kidney disease (glomerular filtration rate < 40 mL/min/1.73 m²) requiring an interventional coronary procedure (coronary angiography and/or percutaneous coronary intervention) and at high risk of IRA-PC. An increase in serum creatinine ≥ 26.5 µmol/L at 48-72 hours (AKI-PC definition) was observed in 4 patients (16%). The mean glomerular filtration rate was 26 ± 8 mL/min/1.73 m² at 48-72 hours versus 25 ± 8 mL/min/1.73 m² at baseline. No patient presented with an increase in serum creatinine ≥ 1.5 from baseline, stage 2 or 3 AKI, or acute pulmonary edema. No renal replacement therapy was necessary. One death unrelated to AKI-PC occurred during hospital stay. CONCLUSIONS: This single-center observational study suggests that the RenalGuard® system, allowing diuresis-adjusted hyperhydration, is safe and useful for patients at high risk of AKI-PC after an interventional coronary procedure.


Assuntos
Injúria Renal Aguda , Intervenção Coronária Percutânea , Insuficiência Renal Crônica , Humanos , Creatinina , Meios de Contraste/efeitos adversos , Fatores de Risco , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Angiografia Coronária/efeitos adversos
5.
Arch Med Sci ; 18(4): 839-854, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35832705

RESUMO

Introduction: Long-term follow-up after an acute coronary syndrome (ACS) presents a crucial challenge due to the high residual cardiovascular risk and the potential for major bleeding events. Although several treatment strategies are available, this article focuses on patients who have undergone percutaneous coronary intervention (PCI) for ACS, which is a frequent clinical situation. This position paper aims to support physicians in daily practice to improve the management of ACS patients. Material and methods: A group of recognized international and French experts in the field provides an overview of current evidence-based recommendations - supplemented by expert opinion where such evidence is lacking - and a practical guide for the management of patients with ACS after hospital discharge. Results: The International Collaborative Group underlines the need of a shared collaborative approach, and a care plan individualized to the patient's risk profile for both ischaemia and bleeding. Each follow-up appointment should be viewed as an opportunity to optimize the personalized approach, to reduce adverse clinical outcomes and improve quality of life. As risks - both ischaemic and haemorrhagic - evolve over time, the risk-benefit balance should be assessed in an ongoing dynamic process to ensure that patients are given the most suitable treatment at each time point. Conclusions: This Expert Opinion aims to help clinicians with a practical guide underlying the proven strategies and the remaining gaps of evidence to optimize the management of coronary patients.

6.
Eur Heart J ; 43(29): 2783-2797, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35583186

RESUMO

AIMS: The respective roles of oral anticoagulation or antiplatelet therapy following transcatheter aortic valve implantation (TAVI) remain debated. ATLANTIS is an international, randomized, open-label, superiority trial comparing apixaban to the standard of care. METHODS AND RESULTS: After successful TAVI, 1500 patients were randomized (1:1) to receive apixaban 5 mg (2.5 mg if impaired renal function or concomitant antiplatelet therapy) (n = 749) twice daily, or standard of care (n = 751). Randomization was stratified by the need for chronic anticoagulation therapy. Standard-of-care patients received a vitamin K antagonist (VKA) (Stratum 1) or antiplatelet therapy (Stratum 2) if there was an indication for anticoagulation or not, respectively. The primary endpoint was the composite of death, myocardial infarction, stroke or transient ischaemic attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding over 1-year follow-up. The primary safety endpoint was major, disabling, or life-threatening bleeding. The primary outcome occurred in 138 (18.4%) and 151 (20.1%) patients receiving apixaban or standard of care, respectively [hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.73-1.16] and there was no evidence of interaction between treatment and stratum (Pinteraction = 0.57). The primary safety endpoint was similar in both groups (HR 1.02; 95% CI 0.72-1.44). In Stratum 1 (n = 451), an exploratory analysis showed no difference for all endpoints between apixaban and VKA. In Stratum 2 (n = 1049), the primary outcome and primary safety endpoint did not differ, but obstructive valve thrombosis was reduced with apixaban vs. antiplatelet therapy (HR 0.19; 95% CI 0.08-0.46), while a signal of higher non-cardiovascular mortality was observed with apixaban. CONCLUSION: After TAVI, apixaban was not superior to the standard of care, irrespective of an indication for oral anticoagulation.


Assuntos
Trombose , Substituição da Valva Aórtica Transcateter , Anticoagulantes/uso terapêutico , Valva Aórtica/cirurgia , Fibrinolíticos , Hemorragia/induzido quimicamente , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Padrão de Cuidado , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
7.
Int J Cardiol Heart Vasc ; 34: 100790, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34124338

RESUMO

Preventing sudden cardiac death (SCD) in athletes is a primary duty of sports cardiologists. Current recommendations for detecting high-risk cardiovascular conditions (hr-CVCs) are history and physical examination (H&P)-based. We discuss the effectiveness of H&P-based screening versus more-modern and accurate methods. In this position paper, we review current authoritative statements and suggest a novel alternative: screening MRI (s-MRI), supported by evidence from a preliminary population-based study (completed in 2018), and a prospective, controlled study in military recruits (in development). We present: 1. Literature-Based Comparisons (for diagnosing hr-CVCs): Two recent studies using traditional methods to identify hr-CVCs in >3,000 young athletes are compared with our s-MRI-based study of 5,169 adolescents. 2. Critical Review of Previous Results: The reported incidence of SCD in athletes is presently based on retrospective, observational, and incomplete studies. H&P's screening value seems minimal for structural heart disease, versus echocardiography (which improves diagnosis for high-risk cardiomyopathies) and s-MRI (which also identifies high-risk coronary artery anomalies). Electrocardiography is valuable in screening for potentially high-risk electrophysiological anomalies. 3. Proposed Project : We propose a prospective, controlled study (2 comparable large cohorts: one historical, one prospective) to compare: (1) diagnostic accuracy and resulting mortality-prevention performance of traditional screening methods versus questionnaire/electrocardiography/s-MRI, during 2-month periods of intense, structured exercise (in military recruits, in advanced state of preparation); (2) global costs and cost/efficiency between these two methods. This study should contribute significantly toward a comprehensive understanding of the incidence and causes of exercise-related mortality (including establishing a definition of hr-CVCs) while aiming to reduce mortality.

8.
Eur J Neurol ; 28(8): 2700-2707, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33938088

RESUMO

BACKGROUND AND PURPOSE: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial. METHODS: This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists. RESULTS: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up. CONCLUSIONS: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.


Assuntos
Isquemia Encefálica , Forame Oval Patente , Transtornos de Enxaqueca , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Adulto , Feminino , Forame Oval Patente/complicações , Forame Oval Patente/cirurgia , Humanos , Pessoa de Meia-Idade , Transtornos de Enxaqueca/complicações , Transtornos de Enxaqueca/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
9.
Eur J Prev Cardiol ; 28(6): 679-686, 2021 05 22.
Artigo em Inglês | MEDLINE | ID: mdl-34021577

RESUMO

AIMS: Limited data exist regarding the incidence and aetiology of life-threatening events such as major cardiac events or exertional heat stroke during long-distance races. We aimed to provide an updated incidence, etiology and prognosis of life-threatening events during long-distance races. METHODS: The prospective RACE PARIS registry recorded all life-threatening events/fatal events occurring during 46 marathons, half-marathons and other long-distance races in the Paris area between 2006 and 2016, comprising 1,073,722 runners. Event characteristics were determined by review of medical records and interviews with survivors. RESULTS: The incidence of life-threatening events, exertional heat stroke and major cardiac events was 3.35 per 100,000, 1.02 per 100,000 and 2.33 per 100,000, respectively, including 18 sudden cardiac arrests (1.67 per 100,000). The main aetiology of sudden cardiac arrest was myocardial ischaemia (11/18), due to acute coronary thrombosis (6/11), stable atherosclerotic coronary artery disease (2/11), coronary dissection (1/11), anomalous connection (1/11) or myocardial bridging (1/11). A third of participants with ischaemia-related major cardiac events presented with pre-race clinical symptoms. Major cardiac events were more frequent in the case of a high pollution index (6.78 per 100,000 vs. 2.07 per 100,000, odds ratio 3.27, 95% confidence interval 1.12-9.54). Case fatality was low (0.19 per 100,000). Similarly, we report in a meta-analysis of eight long-distance race registries comprising 16,223,866 runners a low incidence of long-distance race-related sudden cardiac arrest (0.82 per 100,000) and fatality (0.39 per 100,000). Death following sudden cardiac arrest was strongly associated with initial asystole or pulseless rhythm. CONCLUSION: Long-distance race-related life-threatening events remain rare although serious events. Better information for runners on the risk of pre-race clinical symptoms, outside air pollution and temperature may reduce their incidence.


Assuntos
Parada Cardíaca , Corrida , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Humanos , Estudos Prospectivos , Sistema de Registros
10.
J Am Heart Assoc ; 10(7): e018593, 2021 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-33728970

RESUMO

Background With the emergence of coronary computed tomography (CT) angiography, anomalous aortic origin of a coronary artery (ANOCOR) is more frequently diagnosed. Fractional flow reserve derived from CT (FFRCT) is a noninvasive functional test providing anatomical and functional evaluation of the overall coronary tree. These unique features of anatomical and functional evaluation derived from CT could help for the management of patients with ANOCOR. We aimed to retrospectively evaluate the physiological and clinical impact of FFRCT analysis in the ANOCOR registry population. Methods and Results The ANOCOR registry included patients with ANOCOR detected during invasive coronary angiography or coronary CT angiography between January 2010 and January 2013, with a planned 5-year follow-up. We retrospectively performed FFRCT analysis in patients with coronary CT angiography of adequate quality. Follow-up was performed with a clinical composite end point (cardiac death, myocardial infarction, and unplanned revascularization). We obtained successful FFRCT analyses and 5-year clinical follow-up in 54 patients (average age, 60±13 years). Thirty-eight (70%) patients had conservative treatment, and 16 (30%) patients had coronary revascularization after coronary CT angiography. The presence of an ANOCOR course was associated with a moderate reduction of FFRCT value from 1.0 at the ostium to 0.90±0.10 downstream the ectopic course and 0.82±0.11 distally. No significant difference in FFRCT values was identified between at-risk and not at-risk ANOCOR. After a 5-year follow-up, only one unplanned percutaneous revascularization was reported. Conclusions The presence of ANOCOR was associated with a moderate hemodynamic decrease of FFRCT values and associated with a low risk of cardiovascular events after a 5-year follow-up in this middle-aged population.


Assuntos
Aorta Torácica/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Anomalias dos Vasos Coronários/fisiopatologia , Vasos Coronários/fisiopatologia , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Tomografia Computadorizada por Raios X/métodos , Anomalias dos Vasos Coronários/diagnóstico , Vasos Coronários/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de Doença
11.
J Invasive Cardiol ; 33(4): E269-E274, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33723087

RESUMO

OBJECTIVES: Anomalous origin of the right coronary artery (ARCA) represents the most common form of abnormal coronary origin and may potentially increase the risk for sudden cardiac death. Morphological and functional evaluation of ARCA in adult patients referred for invasive coronary angiogram (ICA) is challenging. Quantitative flow ratio (QFR) is an available method able to virtually calculate fractional flow reserve using 3-dimensional quantitative coronary angiography (3D-QCA) based on ICA. We aimed to evaluate the feasibility of QFR analysis in patients with ARCA and its clinical impact. METHODS: Using the registry of proximal anomalous connections of coronary arteries (ANOCOR registry), a multicenter observational registry including 472 adult patients with ANOCOR between 2010 and 2013, we retrospectively performed QFR analysis from ICA and evaluated the rate of death, myocardial infarction, and unplanned revascularization at 5 years. RESULTS: Among 128 patients with ARCA, 41 (32%) could have QFR analysis with median clinical follow-up of 8.3 years. The mean QFR value was 0.90 ± 0.10, and 3D-QCA analysis showed preserved lumen area despite the elliptical shape of the proximal part of the ARCA, which in the worst cases appeared on ICA as a significant narrowing. The event rate was 12.2% (n = 5), including 3 deaths (1 due to cancer, 1 due to stroke, and 1 cause unknown) and 2 unplanned revascularizations at 5 years. No myocardial infarctions were reported. CONCLUSIONS: When QFR analysis of ARCA is feasible, non-significant QFR values are associated with good clinical outcome at 5 years.


Assuntos
Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Adulto , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Estudos de Viabilidade , Seguimentos , Humanos , Imageamento Tridimensional , Estudos Retrospectivos
13.
Front Cardiovasc Med ; 7: 596018, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33614737

RESUMO

Few patients with an anomalous aortic origin of a coronary artery (AAOCA) require a correction of this congenital anomaly. Current recommendations offer surgical repair as a first line therapy to prevent a sudden cardiac death as a main objective. However, these guidelines are focused on children and not based on randomized controlled studies. Furthermore, decision-making should be different in an adult population less exposed to the risk of sudden cardiac death. Current practices showed reluctance to offer a surgical treatment for right AAOCA associated with ischemic symptoms or myocardial ischemia. Our aim in this review is to expose the rationale for percutaneous coronary intervention in right AAOCA with interarterial course and to present the published results.

15.
Catheter Cardiovasc Interv ; 93(2): 181-188, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30280482

RESUMO

OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Desenho de Equipamento , Europa (Continente) , Feminino , Humanos , Malásia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
17.
Resuscitation ; 128: 126-131, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29746987

RESUMO

BACKGROUND: Little is known about the association between provision of post-resuscitation care and prognosis of out-of-hospital cardiac arrest (OHCA) in elderly patients. Previous studies have suggested futility after 65 years of age. OBJECTIVES: We aimed to evaluate the association of early coronary angiogram (CAG) followed if necessary by percutaneous coronary intervention (PCI), with favorable outcome after OHCA among elderly patients, compared to younger patients. METHODS: Using a large French registry, we included all OHCA patients with an initial shockable rhythm, transported to hospital from 2011 to 2015. Favorable outcome was defined as hospital discharge with Cerebral Performance Category (CPC) 1 or 2. and were evaluated by multivariate logistic regression. Subgroup analyses were performed according to age groups: <65, 65-75 and >75 years. RESULTS: Among 1502 included patients, 31% were older than 65 and 12% older than 75 years. An early CAG was performed in 79%, 88% and 76% of patients below 65, between 65 and 75 and above 75, respectively (P = 0.002). The rate of patients discharged with CPC1 or 2 was 42% below 65, 38% between 65 and 75 and 24% above 75 (P < 0.001). Among the whole population, early CAG (OR = 6.4, 95% CI = 3.9-10.5, P < 0.001) was associated with favorable outcome. In subgroups analysis, CAG was associated with favorable outcome among patients <65 and 65-75. In patients >75, there was a trend towards a favorable outcome (OR2.9, 95CI = 0.9-9.1). CONCLUSIONS: In a large registry of OHCA survivors, the early CAG use was associated with a better prognosis. This benefit was persistent up to 75 years of age, suggesting that age alone should not guide the decision for early invasive strategy.


Assuntos
Fatores Etários , Angiografia Coronária/estatística & dados numéricos , Parada Cardíaca Extra-Hospitalar/mortalidade , Intervenção Coronária Percutânea/estatística & dados numéricos , Idoso , Reanimação Cardiopulmonar/mortalidade , Angiografia Coronária/métodos , Feminino , Humanos , Modelos Logísticos , Masculino , Parada Cardíaca Extra-Hospitalar/diagnóstico por imagem , Parada Cardíaca Extra-Hospitalar/terapia , Intervenção Coronária Percutânea/métodos , Sistema de Registros , Fatores de Tempo
18.
J Clin Epidemiol ; 91: 111-120, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28728922

RESUMO

OBJECTIVES: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. STUDY DESIGN AND SETTING: A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. RESULTS: Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. CONCLUSION: To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.


Assuntos
Próteses e Implantes/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Relatório de Pesquisa/normas , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
19.
Congenit Heart Dis ; 12(6): 726-732, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28639359

RESUMO

OBJECTIVE: The diagnosis of anomalous connections of the coronary arteries (ANOCOR) requires an appropriate identification for the management of the patients involved. We studied the observer variability in the description and classification of ANOCOR between a nonexpert group of physicians and a group of expert physicians, using the ANOCOR cohort. PATIENTS AND DESIGN: Consecutive patients identified by 71 referring cardiologists were included in the ANOCOR cohort. Anomalous connection was diagnosed by invasive and/or computed tomography coronary angiography. Angiographic images were reviewed by an angiographic committee with experience in this field. Both investigators and angiographic committee filled out a questionnaire to classify each anomaly with the type of coronary artery involved, the site of anomalous connection, and the initial course. Observer variability between investigators and angiographic committee was assessed by κ statistics. Anomalous connection with a preaortic course was defined as at-risk. RESULTS: Among 472 patients of the ANOCOR cohort, 496 abnormalities were identified with a preaortic course present in 31%. The agreement for the type of artery was excellent (κ = 0.92, 95% CI = 0.86-0.98, P < .05), while the agreement for the site of anomalous connection was moderate (κ = 0.50, 95% CI = 0.42-0.58, P < .05), and the agreement for the initial course was only fair (κ = 0.32, 95% CI = 0.28-0.37, P < .05). Observer agreement for the identification of at-risk forms was moderate (κ = 0.497, 95% CI = 0.40-0.59, P < .05). CONCLUSIONS: Observer variability in the assessment of anomalous connection of the coronary arteries between nonexperienced and experienced physicians can be significant. We found that expert physicians provide a more robust classification in comparison with nonexpert physicians. Therefore, referral to physicians with a relevant experience should be considered, especially if an anomaly at-risk is suspected.


Assuntos
Angiografia Coronária/métodos , Anomalias dos Vasos Coronários/classificação , Vasos Coronários/diagnóstico por imagem , Sistema de Registros , Tomografia Computadorizada por Raios X/métodos , Anomalias dos Vasos Coronários/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Estudos Retrospectivos
20.
BMC Nephrol ; 17(1): 167, 2016 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-27821094

RESUMO

BACKGROUND: Despite the use of low-osmolar contrast media that have significantly reduced the occurrence of severe adverse reactions, contrast-induced (CI) acute kidney injury (AKI) remains the third cause of AKI in hospitals. We sought to estimate the frequency of CI-AKI among hospitalized patients undergoing image-guided cardiovascular procedures, to quantify the effect of risk factors on the development of this complication and to assess relative organizational and economic burden in healthcare. METHODS: A retrospective cross-sectional population-based study using the extensive French hospital discharge database (PMSI) was carried out. Hospitalizations with image-guided cardiovascular procedures using a contrast media were identified in adults over a 2-year period (2012-2013). Suspected CI-AKI was defined as the presence, during hospitalization, of a diagnostic code of AKI (International Classification of Diseases, 10th revision [ICD-10] codes: N141, 142, N144, N990, N17, N19 or R392) or a code of renal replacement therapy procedure (Classification Commune des Actes Médicaux [CCAM] codes: JVJB001, JVJF002-005 and JVJF008) as creatinine criteria were not available. RESULTS: During 1,047,329 hospitalizations studied, 32,308 suspected CI-AKI were observed, yielding a frequency of 3.1 %. By multivariate analysis, factors that significantly increased the risk of suspected CI-AKI included cardiogenic shock (odds ratio [OR] = 20.5, 95 % confidence interval [95 % CI] [18.7; 22.5]), acute heart failure (OR = 2.5, 95 % CI [2.4; 2.6]) and chronic kidney disease (OR = 2.3, 95 % CI [2.2; 2.3]. Renal replacement therapy was initiated during 6,335 (0.6 %) hospitalizations. The mean length of stay and cost of hospitalizations associated with suspected CI-AKI was higher than in hospitalizations without suspected CI-AKI (20.5 vs 4.7 days, p < 0.00001 and €15,765 vs €3,352, p < 0.0001, respectively). CONCLUSIONS: This is the first large-scale population-based study to estimate frequency and health burden of suspected CI-AKI occurring after image-guided cardiovascular procedures, and the first available data in a French population. We showed that this iatrogenic complication remains of high concern despite prevention efforts and contrast media product improvement. From our results, suspected CI-AKI is associated with particularly high mortality, significantly extends hospitalizations, and leads to additional costs reaching a total of €200M per year.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/epidemiologia , Meios de Contraste/efeitos adversos , Custos de Cuidados de Saúde , Hospitalização/economia , Compostos de Iodo/efeitos adversos , Doença Aguda , Injúria Renal Aguda/economia , Injúria Renal Aguda/terapia , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardiovasculares/estatística & dados numéricos , Estudos Transversais , Diabetes Mellitus/epidemiologia , Feminino , França/epidemiologia , Insuficiência Cardíaca/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Radiologia Intervencionista , Insuficiência Renal Crônica/epidemiologia , Terapia de Substituição Renal , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/epidemiologia
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