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1.
N Engl J Med ; 384(21): 1981-1990, 2021 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-33999548

RESUMO

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).


Assuntos
Aspirina/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Inibidores da Agregação Plaquetária/administração & dosagem , Idoso , Aspirina/efeitos adversos , Aterosclerose/tratamento farmacológico , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Feminino , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/efeitos adversos , Prevenção Secundária , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle
2.
Eur J Clin Invest ; 54(6): e14178, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38348627

RESUMO

BACKGROUND: Given the limited access to invasive vasospastic reactivity testing in Western Countries, there is a need to further develop alternative non-invasive diagnostic methods for vasospastic angina (VSA). Hyperventilation testing (HVT) is defined as a class IIa recommendation to diagnose VSA by the Japanese Society of Cardiology. METHODS: In this systematic review and meta-analysis reported according to the PRISMA statement, we review the mechanisms, methods, modalities and diagnostic accuracy of non-invasive HVT for the diagnostic of VSA. RESULTS: A total of 106 articles published between 1980 and 2022 about VSA and HVT were included in the systematic review, among which 16 were included in the meta-analysis for diagnostic accuracy. Twelve electrocardiogram-HVT studies including 804 patients showed a pooled sensitivity of 54% (95% confidence intervals [CI]; 30%-76%) and a pooled specificity of 99% (95% CI; 88%-100%). Four transthoracic echocardiography-HVT studies including 197 patients revealed a pooled sensitivity of 90% (95% CI; 82%-94%) and a pooled specificity of 98% (95% CI; 86%-100%). Six myocardial perfusion imaging-HVT studies including 112 patients yielded a pooled sensitivity of 95% (95% CI; 63%-100%) and a pooled specificity of 78% (95% CI; 19%-98%). Non-invasive HVT resulted in a low rate of adverse events, ventricular arrhythmias being the most frequently reported, and were resolved with the administration of nitroglycerin. CONCLUSIONS: Non-invasive HVT offers a safe alternative with high diagnostic accuracy to diagnose VSA in patients with otherwise undiagnosed causes of chest pain.


Assuntos
Vasoespasmo Coronário , Ecocardiografia , Eletrocardiografia , Hiperventilação , Humanos , Hiperventilação/diagnóstico , Hiperventilação/fisiopatologia , Vasoespasmo Coronário/diagnóstico , Vasoespasmo Coronário/fisiopatologia , Angina Pectoris/diagnóstico , Angina Pectoris/fisiopatologia , Sensibilidade e Especificidade , Imagem de Perfusão do Miocárdio
3.
Clin Trials ; 20(1): 31-35, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35999816

RESUMO

BACKGROUND/AIMS: Actively engaging patient partners in the conduct of trials is crucial to ensure the studies answer genuine, patient-centered, unmet clinical needs, and to facilitate participant recruitment and retention. The aim of this article is to demonstrate the feasibility of patient engagement within a large pragmatic multicenter randomized controlled trial, specifically for the purposes of dissemination of study information/updates and to favorize recruitment and retention. METHODS: In the patient-centric, pragmatic ADAPTABLE randomized trial, transparent and timely dissemination of information on the study updates to the trial participants was undertaken to create meaningful engagement and to facilitate retention. A national panel of patient partners, the Adaptors, were directly involved in this information dissemination strategy, and study participants were engaged both nationally and locally to design recruitment methods iteratively during the conduct of the trial. All Adaptors had a lived experience with cardiovascular disease. RESULTS: Adaptors attended bi-weekly meetings facilitated by the director of the study's patient-powered research network. They drafted and/or edited newsletters and ad hoc educational information written in a lay-friendly manner for study participants, which were regularly distributed to the ADAPTABLE community, in addition to online forums where participants could share their experience of their involvement in ADAPTABLE. To spur recruitment, a patient-driven initiative was to draft letters sharing their story, which were distributed by the local study teams. Patient partners thought that using patients' voice to provide their perspectives on why they believed this project was important would be more engaging for prospective participants than traditional approaches. CONCLUSIONS: ADAPTABLE's experience has demonstrated the feasibility of engaging patients as partners in the conduct of a large-scale, multi-center, pragmatic randomized controlled trial. Future trials should embrace and iteratively improve this model by engaging patient partners as early as study protocol development and funding applications, and quantify its impact on the effectiveness and value of the trial.


Assuntos
Participação do Paciente , Projetos de Pesquisa , Humanos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Disseminação de Informação
4.
Acta Radiol ; 64(5): 1912-1918, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36760078

RESUMO

BACKGROUND: Percutaneous vertebroplasty (PVP) is an effective measure for painful metastases or impending pathological fractures of the spine with cement leakages being the most frequent complication. Posterior extrusion of cement into the spinal canal may result in neurological symptoms and deficits. PURPOSE: To compare the occurrence of intraspinal canal cement leakage between vertebrae with posterior wall disruption and vertebrae without posterior wall disruption. MATERIAL AND METHODS: A single-center retrospective study was conducted of all PVP for spine metastases between June 2020 and November 2021. All leaks were analyzed by a postprocedural computed tomography scan or cone-beam computed tomography. RESULTS: A total of 77 patients with 143 vertebrae treated by PVP were included. Posterior wall disruption was observed in 64 (44.8%) vertebrae while 79 (55.2%) had a complete posterior wall. Spinal canal cement leakage occurred in 36 (25.2%) vertebrae and was comparable in both groups, occurring in 16 (25.0%) vertebrae with posterior wall disruption and 20 (25.3%) vertebrae without posterior wall disruption (P = 1). No risk factors for spinal canal leakage were found in the univariate and multivariate analyses. One spinal leak was symptomatic with intercostal neuralgia. CONCLUSION: Our results suggest that an incomplete vertebral posterior wall does not increase the rate of spinal canal cement leakage during PVP.


Assuntos
Fraturas por Compressão , Fraturas por Osteoporose , Fraturas da Coluna Vertebral , Neoplasias da Coluna Vertebral , Vertebroplastia , Humanos , Estudos Retrospectivos , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/cirurgia , Neoplasias da Coluna Vertebral/diagnóstico por imagem , Neoplasias da Coluna Vertebral/cirurgia , Fraturas por Compressão/cirurgia , Vertebroplastia/efeitos adversos , Cimentos Ósseos/efeitos adversos , Dor no Peito/etiologia , Fraturas por Osteoporose/cirurgia , Resultado do Tratamento
5.
Acta Radiol ; 64(4): 1381-1389, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36802809

RESUMO

BACKGROUND: Hemoptysis is a severe complication of cystic fibrosis (CF) for which bronchial artery embolization (BAE) is an efficient primary therapeutic option. However, recurrence is more frequent than for other etiologies of hemoptysis. PURPOSE: To assess the safety and efficacy of BAE in patients with CF and hemoptysis and predictive factors for recurrent hemoptysis. MATERIAL AND METHODS: This retrospective study reviewed all adult patients with CF treated by BAE for hemoptysis in our center from 2004 to 2021. The primary endpoint was the recurrence of hemoptysis after bronchial artery embolization. Secondary endpoints were overall survival and complications. We introduced the vascular burden (VB) defined as the sum of all bronchial artery diameters measured on pre-procedural enhanced computed tomography (CT) scans. RESULTS: A total of 48 BAE were performed in 31 patients. A total of 19 recurrences occurred with a median recurrence-free survival of 3.9 years. In univariate analyzes, percentage of unembolized VB (%UVB) (hazard ratio [HR] = 1.034, 95% confidence interval [CI=1.016-1.052; P < 0.001) and %UVB vascularizing the suspected bleeding lung (%UVB-lat) (HR = 1.024, 95% CI=1.012-1.037; P < 0.001) were associated with recurrence. In multivariate analyzes, only %UVB-lat remained significantly associated with recurrence (HR = 1.020, 95% CI=1.002-1.038; P = 0.030). One patient died during follow-up. No complication of grade 3 or higher was reported according to the CIRSE classification system for complications. CONCLUSION: When possible, unilateral BAE seems sufficient in patients with CF with hemoptysis even in such a diffuse disease involving both lungs. The efficiency of BAE could be improved by thoroughly targeting all arteries vascularizing the bleeding lung.


Assuntos
Fibrose Cística , Embolização Terapêutica , Hemoptise , Humanos , Adulto , Fibrose Cística/complicações , Hemoptise/terapia , Artérias Brônquicas , Embolização Terapêutica/métodos , Estudos Retrospectivos , Resultado do Tratamento , Masculino , Feminino , Pessoa de Meia-Idade
6.
Circulation ; 143(23): 2229-2240, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-33619968

RESUMO

BACKGROUND: Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. METHODS: We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. RESULTS: Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses. CONCLUSIONS: In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Dispositivos de Proteção Embólica/efeitos adversos , Acidente Vascular Cerebral/patologia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Razão de Chances , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do Tratamento
7.
Curr Opin Cardiol ; 37(6): 474-480, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-36094455

RESUMO

PURPOSE OF REVIEW: Coronary artery disease (CAD) is responsible for >50% of heart failures cases. Patients with ischemic left ventricular systolic dysfunction (iLVSD) are known to have poorer outcomes after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) compared to patients with a normal ejection fraction. Nevertheless, <1% of patients in coronary revascularization trials to date had iLVSD. The purpose of this review is to describe coronary revascularization modalities in patients with iLVSD and highlight the need for randomized controlled trial evidence comparing these treatments in this patient population. RECENT FINDINGS: Network meta-analytic findings of observational studies suggest that PCI is associated with higher rates of mortality, cardiac death, myocardial infarction, and repeat revascularization but not stroke compared to CABG in iLVSD. In recent years, outcomes for patients undergoing PCI have improved as a result of advances in technologies and techniques. SUMMARY: The optimal coronary revascularization modality in patients with iLVSD remains unknown. In observational studies, CABG appears superior to PCI; however, direct randomized evidence is absent and developments in PCI techniques have improved post-PCI outcomes in recent years. The Surgical Treatment for Ischemic Heart Failure 3.0 consortium of trials will seek to address the clinical equipoise in coronary revascularization in patients with iLVSD.


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Disfunção Ventricular Esquerda , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Disfunção Ventricular Esquerda/cirurgia
8.
J Nucl Cardiol ; 29(6): 3281-3290, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35199279

RESUMO

OBJECTIVE: Evaluate the impact of 82-Rubidium positron emission tomography (PET) myocardial perfusion imaging (MPI) availability on patient management presenting at the emergency department (ED) with chest pain (CP). METHODS: This is a single-center retrospective study of clinical databases. Patients presenting with CP with a non-definitive suspicion of acute coronary syndrome (ACS) at the ED between April 2016 and February 2020 were divided into 2 groups based on PET availability. The proportion of invasive coronary angiography (ICA) without significant coronary artery disease (CAD), length of stay (LoS), and additional downstream testing were evaluated. RESULTS: There were 21,242 ED visits for CP without definitive ACS: 5,492 when PET is not available and 15,750 when PET is available. When PET is available, proportion of patients undergoing a MPI study was greater (20.7% vs 17.6%, P<0.0001), proportion of ICA without significant CAD was similar (18.5% vs 21.4%, P=0.24), and median ED LoS was shorter (16.6 vs 18.1 hours, P=0.03). Patients undergoing SPECT MPI had significantly more downstream testing (8.9% vs 6.4%, P=0.003) and a higher rate of coronary angiogram without significant CAD (21.2% vs 14.2%, P=0.09) compared to those who underwent PET MPI. CONCLUSION: Availability of PET MPI was associated with an increased number of MPI referral from the ED, similar rates of ICA without significant CAD, decreased LoS, and fewer downstream testing.


OBJETIVO: Evaluar el impacto de la tomografía por emisión de positrones (PET) con 82-Rubidio y la disponibilidad de imágenes de perfusión miocárdica (MPI) en el manejo de los pacientes que se presentan en el servicio de urgencias (ED) con dolor torácico (CP). MéTODOS: Este es un estudio retrospectivo de bases de datos clínicas de un solo centro. Pacientes que presentaron CP con sospecha no definitiva de síndrome coronario agudo (ACS) en el ED entre abril de 2016 y febrero de 2020, se dividieron en 2 grupos según la disponibilidad de PET. Se evaluó la proporción de angiografía coronaria invasiva (ICA) sin enfermedad arterial coronaria (CAD) significativa, la duración de la estancia (LoS) y las pruebas posteriores adicionales. RESULTADOS: Hubo 21,242 visitas al ED por CP sin ACS definitivo: 5,492 cuando no se dispone de PET y 15.750 cuando se dispone de PET. Cuando se dispone de PET, la proporción de pacientes sometidos a estudio de MPI fue mayor (20.7% vs 17.6%, p=0.03). Los pacientes que se sometieron a SPECT MPI tuvieron significativamente más pruebas posteriores (8.9 % frente a 6.4 %, p = 0.003) y una tasa más alta de angiografía coronaria sin CAD significativa (21.2 % frente a 14.2 %, p = 0.09) en comparación con los que se sometieron a PET MPI. CONCLUSIóN: La disponibilidad de PET MPI se asoció con un mayor número de referencias de MPI desde el ED, tasas similares de ICA sin CAD significativa, disminución de LoS y menos pruebas posteriores.


Assuntos
Síndrome Coronariana Aguda , Doença da Artéria Coronariana , Imagem de Perfusão do Miocárdio , Humanos , Rubídio , Angiografia Coronária/métodos , Estudos Retrospectivos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/complicações , Dor no Peito/diagnóstico por imagem , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Tomografia por Emissão de Pósitrons/métodos , Radioisótopos de Rubídio , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Imagem de Perfusão do Miocárdio/métodos
9.
Clin Trials ; 18(4): 449-456, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33541120

RESUMO

BACKGROUND: ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) is a pragmatic clinical trial examining high-dose versus low-dose aspirin among patients with cardiovascular disease. ADAPTABLE is leveraging novel approaches for clinical trial conduct to expedite study completion and reduce costs. One pivotal aspect of the trial conduct is maximizing clinician engagement. METHODS/RESULTS: Clinician engagement can be diminished by barriers including time limitations, insufficient research infrastructure, lack of research training, inadequate compensation for research activities, and clinician beliefs. We used several key approaches to boost clinician engagement such as empowering clinician champions, including a variety of clinicians, nurses and advanced practice providers, periodic newsletters and coordinated team celebrations, and deploying novel technological solutions. Specifically, some centers generated electronic health records-based best practice advisories and research dashboards. Future large pragmatic trials will benefit from standardization of the various clinician engagement strategies especially studies leveraging electronic health records-based approaches like research dashboards. Financial or academic "credit" for clinician engagement in clinical research may boost participation rates in clinical studies. CONCLUSION: Maximizing clinician engagement is important for the success of clinical trials; the strategies employed in the ADAPTABLE trial may serve as a template for future pragmatic studies.


Assuntos
Aspirina , Doenças Cardiovasculares , Ensaios Clínicos Pragmáticos como Assunto , Projetos de Pesquisa , Aspirina/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/prevenção & controle , Registros Eletrônicos de Saúde , Humanos , Assistência Centrada no Paciente , Pesquisadores
10.
Circulation ; 140(13): 1115-1124, 2019 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-31545683

RESUMO

Aspirin is the cornerstone of the antithrombotic management of patients with established atherosclerotic cardiovascular disease, but major guidelines provide conflicting recommendations for its use in primary prevention. Findings from recent randomized trials totaling >47 000 patients called into question the net clinical benefits of aspirin in primary prevention for 3 key populations: patients with diabetes mellitus, community-dwelling elderly individuals, and patients without diabetes mellitus who are at intermediate risk for atherosclerotic events. In the context of increasing emphasis on the use of other treatments for primary prevention in patients with moderate-high future risk of developing atherosclerotic cardiovascular disease, the efficacy and safety of aspirin for primary prevention has become uncertain. Key unresolved questions regarding the role of aspirin in primary prevention include the optimal drug formulation, dosing schedule, weight-based dose selection, and interplay between sex and treatment response. In the current era, most patients without established atherosclerotic cardiovascular disease should not be prescribed aspirin. Rather, aggressive management of comorbidities tailored to the expected cardiovascular risk needs to be emphasized. In this context, informed shared decision making between clinicians and patients regarding the use of aspirin for primary prevention of cardiovascular events is a suitable and laudable approach. In this article, we revisit the role of aspirin for the primary prevention of cardiovascular diseases by critically reviewing the key scientific literature, highlight key areas of uncertainties for future research, and propose a decisional framework for clinicians to support prescription of aspirin in primary prevention.


Assuntos
Aspirina/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Fibrinolíticos/uso terapêutico , Idoso , Tomada de Decisão Clínica , Protocolos Clínicos , Ensaios Clínicos como Assunto , Cálculos da Dosagem de Medicamento , Humanos , Prevenção Primária , Risco , Fatores de Risco
11.
Circulation ; 140(17): 1426-1436, 2019 10 22.
Artigo em Inglês | MEDLINE | ID: mdl-31634011

RESUMO

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.


Assuntos
Ensaios Clínicos como Assunto , Registros Eletrônicos de Saúde , Aplicativos Móveis , Dispositivos Eletrônicos Vestíveis , Humanos , Projetos de Pesquisa
12.
Catheter Cardiovasc Interv ; 95(5): 924-931, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-31435999

RESUMO

In this review, we report a contemporary appraisal of the available evidence focusing on adjunctive antithrombotic therapy and technical aspects of percutaneous coronary interventions (PCI) in patients with acute myocardial infarction and cardiogenic shock (AMICS). Only few randomized trials have been conducted to evaluate the optimal arterial access choice, antithrombotic therapy, stent type, or the role of aspiration thrombectomy in this population. Observational data suggest that a transradial approach should be preferred for experienced operators, although knowledge and experience of transfemoral access is required to place any mechanical support device. In the absence of high-quality evidence to guide choice of the adjunctive antithrombotic drugs to support PCI in patients with AMICS, knowledge of the altered pharmacokinetics and pharmacodynamics in shock is required to inform decisions. Drug-eluting stents should be favored over bare-metal stents, and routine thrombectomy is not encouraged. Owing to the challenges inherent to the conduct of randomized trials in this acutely ill patient population, concerted multicenter, and international efforts are paramount to orchestrate the development of high-quality evidence to guide clinical practice.


Assuntos
Doença da Artéria Coronariana/terapia , Trombose Coronária/terapia , Fibrinolíticos/uso terapêutico , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Choque Cardiogênico/terapia , Trombectomia , Tomada de Decisão Clínica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/mortalidade , Trombose Coronária/fisiopatologia , Stents Farmacológicos , Fibrinolíticos/efeitos adversos , Hemodinâmica , Humanos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Medição de Risco , Fatores de Risco , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/mortalidade , Choque Cardiogênico/fisiopatologia , Trombectomia/efeitos adversos , Trombectomia/instrumentação , Trombectomia/mortalidade , Resultado do Tratamento
13.
Eur Radiol ; 30(2): 943-949, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31478088

RESUMO

PURPOSE: To evaluate electromagnetic navigation system (ENS) for percutaneous fixation by internal cemented screw (FICS) under CT guidance. BACKGROUND: FICS is a recently developed modality that consists in inserting screws, under imaging guidance, into bone through a minimal skin incision. FICS recently showed good efficacy for the palliation or prevention of pathologic fractures of the pelvic ring and femoral neck. MATERIALS AND METHODS: In this single-center retrospective study, we reviewed all consecutive cancer patients treated with percutaneous FICS under ENS-assisted CT guidance for the prevention or palliation of pelvic or femoral neck fractures. The primary endpoint was technical success. Secondary endpoints were screw placement accuracy (defined by proximal deviation p, distal deviation d, and angle deviation θ), radiation dose exposure, number of CT acquisitions, duration of procedures, and complications. RESULTS: Mean duration of FICS procedures was 111 ± 51 min. Mean post-procedure hospitalization length was 2.1 days. Technical success was achieved in 48 cases (96%) with a total of 76 screws inserted. Mean distance p, mean distance d, and mean angle θ were respectively 8.0 ± 4.5 mm, 7.5 ± 4.4 mm, and 5.4 ± 2°. Angle θ accuracy was higher for screws with a craniocaudal angulation of less than 20° (4.4° vs 6.4°, p = 0.02). The mean number of CT acquisitions during procedures was 6.4 ± 3.0. The mean dose length product was 1524 ± 953 mGy cm and the mean dose area product was 12 ± 8 Gy cm2. Five complications occurred in 4 patients. CONCLUSION: CT guidance assisted by ENS is an effective approach for percutaneous FICS. KEY POINTS: • ENS-assisted CT enables screw insertion in the pelvic ring and femoral neck, with a wide range of trajectories, even when a significant craniocaudal angulation is required. • ENS-assisted CT can be used as an alternative to CBCT guidance for percutaneous fixation by internal cemented screw. • ENS-assisted CT provides high technical success rate with excellent placement accuracy.


Assuntos
Parafusos Ósseos , Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas/métodos , Fraturas Espontâneas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Cimentos Ósseos/uso terapêutico , Fenômenos Eletromagnéticos , Feminino , Neoplasias Femorais/secundário , Neoplasias Femorais/cirurgia , Fluoroscopia/métodos , Fixação Interna de Fraturas/instrumentação , Humanos , Masculino , Pessoa de Meia-Idade , Pelve/cirurgia , Estudos Retrospectivos , Cirurgia Assistida por Computador/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto Jovem
14.
J Vasc Interv Radiol ; 31(10): 1683-1689.e1, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32921566

RESUMO

PURPOSE: To assess the safety and efficacy of multilevel thoracolumbar vertebroplasty in the simultaneous treatment of ≥ 6 painful pathologic compression fractures. MATERIALS AND METHODS: Retrospective review was conducted of 50 consecutive patients treated with vertebroplasty for ≥ 6 pathologic compression fractures in a single session for pain palliation at a tertiary single cancer center from 2015 to 2019. Outcomes measured included procedural safety according to Common Terminology Criteria for Adverse Events (CTCAE), change in 4-week postprocedure back pain by numeric rating scale (NRS), comparison of daily opioid medication consumption, and development of skeletal-related events. RESULTS: A total of 397 pathologic compression fractures were treated during 50 sessions (mean, 7.9 per patient ± 1.5). Mean procedure duration was 162 minutes ± 35, mean postoperative hospitalization duration was 1.6 days ± 0.9, and mean follow-up duration was 401 days ± 297. Seven complications were recorded, including 1 case of symptomatic polymethyl methacrylate pulmonary embolism. No major complications (CTCAE grade 4/5) were reported. NRS pain score was significantly decreased (5.0 ± 1.8 vs 1.7 ± 1.4; P < .0001), with a mean score decrease of 3.3 points (66%). Opioid agent use decreased significantly (76 mg/24 h ± 42 vs 45 mg/24 h ± 37; P = .0003), with a mean decrease of 30 mg/24 h (39%). Skeletal-related events occurred in 7 patients (14%). CONCLUSIONS: Multilevel vertebroplasty for ≥ 6 pathologic compression fractures is safe and provides significant palliative benefit when performed simultaneously.


Assuntos
Dor nas Costas/prevenção & controle , Fraturas por Compressão/terapia , Fraturas Múltiplas/terapia , Fraturas Espontâneas/terapia , Vértebras Lombares/lesões , Cuidados Paliativos , Fraturas da Coluna Vertebral/terapia , Vértebras Torácicas/lesões , Vertebroplastia , Idoso , Dor nas Costas/diagnóstico , Dor nas Costas/etiologia , Feminino , Fraturas por Compressão/complicações , Fraturas por Compressão/diagnóstico por imagem , Fraturas Múltiplas/complicações , Fraturas Múltiplas/diagnóstico por imagem , Fraturas Espontâneas/complicações , Fraturas Espontâneas/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fraturas da Coluna Vertebral/complicações , Fraturas da Coluna Vertebral/diagnóstico por imagem , Vértebras Torácicas/diagnóstico por imagem , Resultado do Tratamento , Vertebroplastia/efeitos adversos
15.
Heart Vessels ; 35(4): 537-543, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31560110

RESUMO

Although apical and midventricular Takotsubo cardiomyopathies (TTCs) share common triggers and pathophysiological features, little is known about the potential differences in left ventricular (LV) mechanistic properties between these TTC phenotypes. We sought to investigate whether LV systolic and/or diastolic function, as assessed invasively by left heart catheterization (LHC), differ according to ballooning patterns in the acute phase of TTC. One hundred and fourteen TTC patients were retrospectively identified between January 2009 and December 2015 at the University Hospital of Strasbourg, France. A comprehensive list of LV quantitative parameters was derived from LHC analysis for each patient. We examined 2 groups of patients according to ballooning patterns in the acute phase of TTC: patients with apical ballooning ("Apical group"; n = 76) and those with midventricular ballooning ("Midventricular group"; n = 38). LV minimal diastolic pressure (8.72 ± 6.72 vs. 5.02 ± 6.08 mmHg; p = 0.004), LV end diastolic pressure (23.11 ± 8.32 vs. 18.84 ± 8.06 mmHg; p = 0.01), and LV diastolic stiffness (LV stiffness 1: 0.29 ± 0.23 vs. 18.84 ± 8.06 mmHg/mL; p = 0.04-LV stiffness 2: 0.16 ± 0.08 vs. 0.12 ± 0.05 mmHg/mL; p = 0.005) were significantly higher in patients with apical TTC than in the midventricular group. Concomitantly, these findings were associated with significantly higher BNP levels in the apical group (923.91 ± 1164.53 vs. 418.71 ± 557.75 pg/mL; p = 0.004) than in the midventricular group. In the acute phase of stress cardiomyopathy, the classic apical form of TTC is associated with poorer diastolic function compared to the midventricular ballooning variant, as assessed through direct invasive hemodynamic measurements using LHC.


Assuntos
Ventrículos do Coração/diagnóstico por imagem , Cardiomiopatia de Takotsubo/diagnóstico por imagem , Disfunção Ventricular Esquerda/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Ecocardiografia , Feminino , França , Ventrículos do Coração/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Cardiomiopatia de Takotsubo/patologia , Disfunção Ventricular Esquerda/patologia
16.
Radiology ; 290(2): 418-425, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30422090

RESUMO

Purpose To evaluate the safety and efficacy of palliative treatment of patients with pathologic pelvic by using fluoroscopy and cone-beam CT needle guidance software to perform percutaneous fixation by internal cemented screw (FICS). Materials and Methods This single-center study involved retrospective analysis of 100 consecutive patients with cancer with pathologic pelvic fractures managed with percutaneous FICS. Image guidance was performed with fluoroscopy and cone-beam CT needle guidance software. Pain palliative outcomes and opioid use after FICS were compared by means of paired-sample t test. Results A total of 107 percutaneous FICS procedures were performed from 2010 to 2017 to palliate 141 pathologic fractures in 100 patients (mean age, 65.0 years ± 17.6 [standard deviation; female age, 66.3 years ± 18.0; mean, 63.7 years ± 17.2]). Of 107 procedures, 104 (97.2%) were technically successful, with mean postprocedure hospitalization of 2 days ± 3. Complications occurred in 14 patients: focal pain at procedure site for longer than 48 hours (n = 5), hematoma (n = 3), progressive fracture despite fixation (n = 2), infection (n = 1), tumor track seeding (n = 1), and screw displacement (n = 2). In the 88 patients who completed early follow-up, mean numeric rating scale pain score was significantly improved at 6 weeks from 6.1 ± 2.5 to 2.1 ± 3.0 (P < .001). Opioid use was reduced at 6 weeks (preprocedure vs postprocedure, 91.3 g ± 121 vs 64.6 g ± 124, respectively; P = .04). Conclusion Fluoroscopy and cone-beam CT-guided percutaneous fixation of pathologic pelvis fractures by internal cemented screw is a safe and effective approach that can reduce pain and opioid use. © RSNA, 2018.


Assuntos
Tomografia Computadorizada de Feixe Cônico/métodos , Fluoroscopia/métodos , Fixação Interna de Fraturas/métodos , Fraturas Espontâneas , Idoso , Idoso de 80 Anos ou mais , Parafusos Ósseos , Feminino , Fraturas Espontâneas/diagnóstico por imagem , Fraturas Espontâneas/etiologia , Fraturas Espontâneas/cirurgia , Humanos , Masculino , Neoplasias/complicações , Ossos Pélvicos/diagnóstico por imagem , Ossos Pélvicos/cirurgia , Estudos Retrospectivos
17.
J Neurol Neurosurg Psychiatry ; 90(1): 68-74, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30257967

RESUMO

OBJECTIVE: Our aim was to compare the clinical outcome of patients with ischaemic stroke with anterior large vessel occlusion treated with stent retrievers and/or contact aspiration mechanical thrombectomy (MT) under general anaesthesia (GA) or conscious sedation non-GA through a systematic review and meta-analysis. METHODS: The literature was searched using PubMed, Embase and Cochrane databases to identify studies reporting on anaesthesia and MT. Using fixed or random weighted effect, we evaluated the following outcomes: 3-month mortality, modified Rankin Score (mRs) 0-2, recanalisation success (thrombolysis in cerebral infarction (TICI) ≥2b) and symptomatic intracerebral haemorrhagic (sICH) transformation. RESULTS: We identified seven cohorts (including three dedicated randomised controlled trials), totalling 1929 patients (932 with GA). Over the entire sample, mortality, mRs 0-2, TICI≥2b and sICH rates were, respectively 17.5% (99% CI 9.7% to 29.6%; Q-value: 60.1; I2: 93%, 1717 patients), 42.1% (99% CI 33.3% to 51.7%; Q-value: 41.3; I2: 87.9%), 82.9% (99% CI 74.0% to 89.1%; Q-value: 20.7; I2: 80.6%, 1006 patients) and 5.5% (99% CI 2.8% to 10.8%; Q-value: 18.6; I2: 78.5%). MT performed in non-GA patients was associated with better 3-month functional outcome (pooled OR, 1.35; 99% CI 1.04 to 1.76; Q-value: 24.0; I2: 9.2%, 1845 patients) and lower 3-month mortality rate (pooled OR, 0.70; 99% CI 0.49 to 0.98; Q-value: 1.4; I2: 0%, 1717 patients; fixed weighted effect model) compared with GA. MT performed under conscious sedation non-GA had significantly shorter onset-to-recanalisation and onset-to-groin delay compared with GA, and recanalisation success and sICH were similar. CONCLUSION: Non-GA during MT for anterior acute ischaemic stroke with current-generation stent retriever/aspiration devices is associated with better 3-month functional outcome and lower mortality rates. These unadjusted estimates are subject to biases and should be interpreted with caution.


Assuntos
Anestesia Geral/métodos , Isquemia Encefálica/cirurgia , Hemorragia Cerebral/epidemiologia , Sedação Consciente/métodos , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Humanos , Mortalidade , Resultado do Tratamento
18.
Eur Radiol ; 29(10): 5655-5663, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30877460

RESUMO

OBJECTIVES: To evaluate post-ablation MRI for the detection of incompletely treated spinal osseous metastases (SOM) after cryoablation and to propose a post-ablation imaging classification. METHODS: After IRB consent, all patients treated with cryoablation of SOM between 2011 and 2017 having at least 1-year minimum follow-up and a spine MRI within 4 months after cryoablation were retrospectively included. A classification of MRI images into four types was set up. The primary endpoint of our study was to assess the diagnostic performance of the post-ablation MRI. The secondary endpoints were the 1-year complete treatment rate (CTR) and complications. RESULTS: Fifty-four SOMs in 39 patients were evaluated. Post-ablation MRI was performed with a median delay of 25 days after cryoablation. Images were evaluated by two independent readers according to the pre-established image classification. Sensitivity and specificity for the detection of residual tumor were 77.3% (95%CI = 62.2-88.5) and 85.9% (95%CI = 75.0-93.4), respectively. Types I, II, III, and IV of the classification were associated with a 1-year complete treatment in 100%, 83.3%, 35.7%, and 10% of cases, respectively. The 1-year CTR was 59.3% for all 54 metastases, and 95.8% for metastases measuring less than 25 mm and at least 2 mm or more away from the spinal canal. Two grade 3 and two grade 2 adverse events according to the CTCAE were reported. CONCLUSIONS: MRI after cryoablation is useful for the evaluation of the ablation efficacy. The classification of post-cryoablation MRI provides reliable clues for the prediction of complete treatment at 1 year. KEY POINTS: • MRI performed 25 days after cryoablation is useful to evaluate the efficacy. • The proposed classification provides a reliable clue for complete cryoablation. • Percutaneous cryoablation of spinal metastases is highly effective for lesions less than 25 mm in diameter and of at least 2 mm away from the spinal canal.


Assuntos
Vértebras Cervicais , Criocirurgia/métodos , Detecção Precoce de Câncer/métodos , Vértebras Lombares , Imageamento por Ressonância Magnética/métodos , Neoplasias da Coluna Vertebral/diagnóstico , Vértebras Torácicas , Adulto , Idoso , Tomografia Computadorizada de Feixe Cônico , Feminino , Fluoroscopia , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Estudos Retrospectivos , Neoplasias da Coluna Vertebral/secundário , Neoplasias da Coluna Vertebral/cirurgia , Cirurgia Assistida por Computador/métodos , Resultado do Tratamento , Adulto Jovem
19.
CMAJ ; 191(11): E299-E307, 2019 03 18.
Artigo em Inglês | MEDLINE | ID: mdl-30885968

RESUMO

BACKGROUND: Comorbidity indexes derived from administrative databases are essential tools of research in global health. We sought to develop and validate a novel cardiac-specific comorbidity index, and to compare its accuracy with the generic Charlson-Deyo and Elixhauser comorbidity indexes. METHODS: We derived the cardiac-specific comorbidity index from consecutive patients who were admitted to hospital at a tertiary-care cardiology hospital in Quebec. We used logistic regression analysis and incorporated age, sex and 22 clinically relevant comorbidities to build the index. We compared the cardiac-specific comorbidity index with refitted Charlson-Deyo and Elixhauser comorbidity indexes using the C-statistic and net reclassification improvement to predict in-hospital death, and the Akaike information criterion to predict length of stay. We validated our findings externally in an independent cohort obtained from a provincial registry of coronary disease in Alberta. RESULTS: The novel cardiac-specific comorbidity index outperformed the refitted generic Charlson-Deyo and Elixhauser comorbidity indexes for predicting in-hospital mortality in the derivation population (n = 10 137): C-statistic 0.95 (95% confidence interval [CI] 0.94-0.9) v. 0.81 (95% CI 0.77-0.84) and 0.86 (95% CI 0.82-0.89), respectively. In the validation population (n = 17 877), the cardiac-specific comorbidity index was similarly better: C-statistic 0.92 (95% CI 0.89-0.94) v. 0.76 (95% CI 0.71-0.81) and 0.82 (95% CI 0.78-0.86), respectively, and also numerically outperformed the Charlson-Deyo and Elixhauser comorbidity indexes for predicting 1-year mortality (C-statistic 0.78 [95% CI 0.76-0.80] v. 0.75 [95% CI 0.73-0.77] and 0.77 [95% CI 0.75-0.79], respectively). Similarly, the cardiac-specific comorbidity index showed better fit for the prediction of length of stay. The net reclassification improvement using the cardiac-specific comorbidity index for the prediction of death was 0.290 compared with the Charlson-Deyo comorbidity index and 0.192 compared with the Elixhauser comorbidity index. INTERPRETATION: The cardiac-specific comorbidity index predicted in-hospital and 1-year death and length of stay in cardiovascular populations better than existing generic models. This novel index may be useful for research of cardiology outcomes performed with large administrative databases.


Assuntos
Comorbidade , Cardiopatias/mortalidade , Mortalidade Hospitalar , Tempo de Internação/estatística & dados numéricos , Medição de Risco/métodos , Idoso , Estudos de Coortes , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Quebeque/epidemiologia , Centros de Atenção Terciária
20.
J Interv Cardiol ; 31(4): 496-503, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29372578

RESUMO

OBJECTIVES: The objective was to assess the effect of ultrasound (US)-guidance compared to the anatomical landmark (AL) approach in patients requiring femoral artery (FA) access for coronary angiography/percutaneous coronary interventions (PCI). BACKGROUND: US-guidance has been proposed as a strategy to optimize FA access, potentially leading to decreased vascular complications. METHODS: Patients requiring FA access for coronary angiography/PCI were randomized to the US-guided or AL approaches. The primary endpoint was a composite of immediate procedural vascular outcomes, and access-site outcomes at day one. Results were subsequently pooled in a study-level meta-analysis of randomized trials comparing US-guided FA access to another strategy. RESULTS: A total of 129 patients were randomized (64 US-guided group; 65 AL group). The primary endpoint occurred in 30 patients (47%) with US, and in 39 patients (62%) with AL (P = 0.09). Four additional studies met the inclusion criteria and were included in the meta-analysis (1553 patients). Following data pooling, bleeding events (OR = 0.41; 95%CI 0.20-0.83; P = 0.01), venipunctures (OR = 0.18; 95%CI: 0.11-0.29; P < 0.0001), and multiple puncture attempts (OR = 0.24; 95%CI: 0.19-0.31; P < 0.0001) were significantly improved with US-guidance, but not successful common FA cannulation (OR = 0.84; 95%CI: 0.60-1.17; P = 0.29). CONCLUSION: Our study did not show significant benefits for the use of US to guide arterial femoral access compared to the anatomical landmark approach, but pooled analysis of five randomized trials showed decreased rates of bleeding events and venipunctures, and improved first-pass success. The clinical impact of these findings is uncertain, and do not warrant a systematic use of US-guidance in this clinical setting.


Assuntos
Perda Sanguínea Cirúrgica/estatística & dados numéricos , Cateterismo Periférico , Angiografia Coronária , Artéria Femoral , Intervenção Coronária Percutânea , Ultrassonografia de Intervenção/métodos , Idoso , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Angiografia Coronária/efeitos adversos , Angiografia Coronária/métodos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento
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