RESUMO
BACKGROUND: To measure the impact of the COVID-19 pandemic on the management of patients with carotid artery stenosis. METHODS: We prospectively collected data from 25 centers (19 centers in the United States and 6 centers internationally) on postponed carotid artery operations between March 2020 and January 2022. We describe the characteristics of these patients and their planned operations, along with outcomes including mortality and neurological deterioration during the period of operative delay due to the COVID-19 pandemic. RESULTS: A total of 1,220 vascular operations were postponed during the pandemic, of them 96 patients presented with significant carotid stenosis (median stenosis of 71%; interquartile range; 70-80) and 80% of them were planned for carotid endarterectomy. Most patients were asymptomatic (69%), and 31% of patients were symptomatic (16% of patients had a stroke, 15% of patients had a transient ischemic attack, and 1% of patients experienced amaurosis fugax). The median length of surgical delay was 71 days (interquartile range: 45.5, 115.5). At the data entry time, 62% of patients had their carotid operations postponed and successfully completed. Most postponements (72%) were due to institutional policies aimed at resource conservation. During the delay, no patient decompensated or required an urgent operation. A total of 5 patients (5%) with carotid stenosis died while awaiting operations due to COVID-19. CONCLUSIONS: Our study of a cohort of patients with carotid artery stenosis who underwent a median delay of 71 days during the COVID-19 pandemic showed a disparate operation delay between US regions and internationally, most postponements were due to hospital policy, and none of the patients deteriorated or required an emergency surgery during the delay.
Assuntos
COVID-19 , Estenose das Carótidas , Endarterectomia das Carótidas , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Estenose das Carótidas/epidemiologia , Pandemias , Resultado do Tratamento , Endarterectomia das Carótidas/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Artérias CarótidasRESUMO
BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.
Assuntos
Infarto do Miocárdio , Doença Arterial Periférica , Humanos , Rivaroxabana/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Aspirina/uso terapêutico , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Hemorragia/induzido quimicamente , Infarto do Miocárdio/tratamento farmacológico , Isquemia/diagnóstico por imagem , Isquemia/tratamento farmacológico , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Resultado do TratamentoRESUMO
Vascular research questions can be answered using various study designs. Observational studies are used frequently to address a wide range of clinical questions when randomized clinical trials are not feasible or practical. One of the powerful vascular research tools is the cohort study. The cohort study is a reliable observational study design in which individuals who share a common characteristic (a cohort) are followed over time and their outcomes are assessed at various intervals. This review focuses on the essential characteristics, design, implementation, bias, validity, and clinical significance of cohort studies and provides illustrative examples. A cohort study can be either a prospective or a retrospective study, depending on whether the outcome occurred before or after the enrollment of the cohort. Each type has its advantages and disadvantages. Confounding, selection, and information biases can all occur in cohort studies. Applications of the cohort study design include studying the natural history of a disease, describing a condition's frequency, and investigating multiple outcomes simultaneously.
Assuntos
Projetos de Pesquisa , Procedimentos Cirúrgicos Vasculares , Humanos , Estudos de Coortes , Estudos Retrospectivos , Estudos Prospectivos , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Estudos Observacionais como AssuntoRESUMO
Quality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.
Assuntos
Pesquisa Biomédica/estatística & dados numéricos , COVID-19/epidemiologia , Sistema de Registros , Procedimentos Cirúrgicos Vasculares/estatística & dados numéricos , COVID-19/prevenção & controle , COVID-19/transmissão , Ensaios Clínicos como Assunto , Humanos , Utilização de Procedimentos e Técnicas , Melhoria de QualidadeRESUMO
OBJECTIVE: Vascular surgeons treating patients with ruptured abdominal aortic aneurysm must make rapid treatment decisions and sometimes lack immediate access to endovascular devices meeting the anatomic specifications of the patient at hand. We hypothesized that endovascular treatment of ruptured abdominal aortic aneurysm (rEVAR) outside manufacturer instructions-for-use (IFU) guidelines would have similar in-hospital mortality compared to patients treated on-IFU or with an infrarenal clamp during open repair (ruptured open aortic aneurysm repair [rOAR]). METHODS: Vascular Quality Initiative datasets for endovascular and open aortic repair were queried for patients presenting with ruptured infrarenal AAA between 2013-2018. Graft-specific IFU criteria were correlated with case-specific proximal neck dimension data to classify rEVAR cases as on- or off-IFU. Univariate comparisons between the on- and off-IFU groups were performed for demographic, operative and in-hospital outcome variables. To investigate mortality differences between rEVAR and rOAR approaches, coarsened exact matching was used to match patients receiving off-IFU rEVAR with those receiving complex rEVAR (requiring at least one visceral stent or scallop) or rOAR with infrarenal, suprarenal or supraceliac clamps. A multivariable logistic regression was used to identify factors independently associated with in-hospital mortality. RESULTS: 621 patients were treated with rEVAR, with 65% classified as on-IFU and 35% off-IFU. The off-IFU group was more frequently female (25% vs. 18%, Pâ¯=â¯0.05) and had larger aneurysms (76 vs. 72 mm, P= 0.01) but otherwise was not statistically different from the on-IFU cohort. In-hospital mortality was significantly higher in patients treated off-IFU vs. on-IFU (22% vs. 14%, P= 0.02). Off-IFU rEVAR was associated with longer operative times (135 min vs. 120 min, P= 0.004) and increased intraoperative blood product utilization (2 units vs. 1 unit, P= 0.002). When off-IFU patients were matched to complex rEVAR and rOAR patients, no baseline differences were found between the groups. Overall in-hospital complications associated with off-IFU were reduced compared to more complex strategies (43% vs. 60-81%, P< 0.001) and in-hospital mortality was significantly lower for off-IFU rEVAR patients compared to the supraceliac clamp group (18% vs. 38%, P= 0.006). However, there was no significantly increased mortality associated with complex rEVAR, infrarenal rOAR or suprarenal rOAR compared to off-IFU rEVAR (all P> 0.05). This finding persisted in a multivariate logistic regression. CONCLUSIONS: Off-IFU rEVAR yields inferior in-hospital survival compared to on-IFU rEVAR but remains associated with reduced in-hospital complications when compared with more complex repair strategies. When compared with matched patients undergoing rOAR with an infrarenal or suprarenal clamp, survival was no different from off-IFU rEVAR. Taken together with the growing available evidence suggesting reduced long-term durability of off-IFU EVAR, these data suggest that a patient's comorbidity burden should be key in making the decision to pursue off-IFU rEVAR over a more complex repair when proximal neck violations are anticipated preoperatively.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/mortalidade , Mortalidade Hospitalar , Complicações Pós-Operatórias/mortalidade , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/mortalidade , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Tomada de Decisão Clínica , Comorbidade , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Fidelidade a Diretrizes , Humanos , Masculino , Guias de Prática Clínica como Assunto , Rotulagem de Produtos , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The COVID-19 pandemic has made a significant impact on all spheres of society. The objective of this study was to examine the impact of COVID-19 on the practices, finances, and social aspects of Brazilian vascular surgeons' lives. METHODS: This is a descriptive analysis of the responses from Brazilian vascular surgeons to the cross-sectional anonymous Society for Vascular Surgery Wellness Task Force Pandemic Practice, Anxiety, Coping, and Support Survey for Vascular Surgeons disseminated 14-24 April 2020. Survey dissemination in Brazil occurred mainly via the Brazilian Society of Angiology and Vascular Surgery (SBACV) and social media. The survey evaluated the impact of the COVID-19 pandemic on vascular surgeons' lives by assessing COVID-19-related stressors, anxiety using theGeneral Anxiety Disorder (GAD)-7 scale, and coping strategies using the Brief Coping Orientation to Problems Experienced (Brief-COPE) inventory. RESULTS: A total of 452 responses were recorded from Brazil, with 335 (74%) respondents completing the entire survey. The majority of respondents were males (N = 301, 67%) and practiced in an urban hospitals. The majority of respondents considered themselves at high risk to be infected with COVID-19 (N = 251, 55.8%), and just over half the respondents noted that they had adequate PPE at their primary hospital (N = 171, 54%). One hundred and nine (35%) surgeons confirmed that their hospitals followed professional surgical society guidelines for prioritizing surgeries during the pandemic. At the time of the survey, only 33 (10%) surgeons stated they have pre-operative testing of patients for COVID-19 available at their hospital. Academic vascular surgeons reported being redeployed more often to help with other non-vascular duties compared to community-based or solo practitioners (43% vs. 30% vs. 21% respectively, P = .01). Severe anxiety due to pandemic-related financial concerns was similar in those surgeons practicing solo compared to those in community- or academic-based/group practice (46% vs. 38% vs. 22%; P = .54). The respondents reported their anxiety levels as mild based on the stressors investigated instead of moderate-severe (54% vs. 46%; P = .04). Social media was utilized heavily during the pandemic, with video gatherings being the most commonly used tool (76%). Self-distraction (60%) and situational acceptance (81%) were the most frequently reported coping mechanisms used among Brazilian vascular surgeons. CONCLUSION: The COVID pandemic has greatly affected healthcare providers around the world. At the time of this survey, Brazilian vascular surgeons are reporting low anxiety levels during this time and are using mostly active coping mechanisms.
Assuntos
COVID-19/epidemiologia , SARS-CoV-2/patogenicidade , Procedimentos Cirúrgicos Vasculares , Adulto , Brasil , Estudos Transversais , Feminino , Humanos , Masculino , Cirurgiões , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Symptomatic peripheral artery disease of the lower extremity rarely affects young adults and, when present, typically has a nonatherosclerotic etiology. Anatomical variants have manifested as symptomatic foot ischemia in four cases in the literature. We describe the case of a 17-year-old girl presenting with foot pain upon plantar flexion due to dynamic dorsalis pedis (DP) artery entrapment by fibrous bands and the extensor hallucis brevis (EHB) tendon. METHODS: The patient was a 17-year-old girl who presented with right foot pain upon plantar flexion, which resolved upon returning to the neutral position. The potential site of compression was identified on MRI where the DP artery ran deep to the EHB tendon near the first and second tarsometatarsal joints. On diagnostic arteriogram, there was notching of the dorsalis pedis over the talus bone. The dorsalis pedis Doppler signal was obliterated upon plantar flexion. A longitudinal incision was made over the artery in the area of compression. The flexor retinaculum was incised. Abnormal fibrous bands were identified, which were lysed anterior to the artery. The EHB tendon was released and transferred distally to the extensor hallucis longus tendon. RESULTS: A completion angiogram showed a persistently patent dorsalis pedis artery with plantar flexion. She was discharged one day postoperatively without issues. On follow-up, the patient was ambulatory with complete resolution of her pain. Arterial duplex demonstrated normal velocities through the dorsalis pedis in all positions. CONCLUSIONS: Symptomatic peripheral artery disease is a rare presentation in young adults and is usually due to nonatherosclerotic pathophysiology. We present a rare case of dorsalis pedis artery entrapment syndrome. Given the mechanical nature of obstruction, surgical correction was an effective treatment.
Assuntos
Pé/irrigação sanguínea , Claudicação Intermitente/etiologia , Doença Arterial Periférica/etiologia , Corrida , Tendões/fisiopatologia , Adolescente , Fenômenos Biomecânicos , Descompressão Cirúrgica , Feminino , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Claudicação Intermitente/cirurgia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/cirurgia , Resistência Física , Recuperação de Função Fisiológica , Transferência Tendinosa , Tendões/diagnóstico por imagem , Tendões/cirurgia , Tenotomia , Resultado do TratamentoRESUMO
BACKGROUND: Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely. We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA). METHODS: This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival. RESULTS: One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2-11), TEG: 4.5 (2-8)] (P = 0.317), but more plasma units [CCA: 2.0 (0-4), TEG: 0.0 (0-3)] (P = 0.022), and more platelets units [CCA: 0.0 (0-1), TEG: 0.0 (0-0)] (P = 0.041) in the first 2 hours of resuscitation. CONCLUSIONS: Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation.