Epidemiological analysis of lower limb revascularization for peripheral arterial disease over 12 years on the public healthcare system in Brazil / Análise epidemiológica da revascularização de membros inferiores para doença arterial periférica em 12 anos no sistema público de saúde do Brasil

Abstract Background Worldwide, peripheral arterial disease (PAD) is a disorder with high morbidity, affecting more than 200 million people. Objectives Our objective was to analyze surgical treatment for PAD provided on the Brazilian Public Healthcare System over 12 years using publicly available data. Methods The study was conducted with analysis of data available on the Brazilian Health Ministry's database platform, assessing distributions of procedures and techniques over the years and their associated mortality and costs. Results A total of 129,424 procedures were analyzed (performed either for claudication or critical ischemia, proportion unknown). The vast majority of procedures were endovascular (65.49%) and this disproportion exhibited a rising trend (p<0.001). There were 3,306 in-hospital deaths (mortality of 2.55%), with lower mortality in the endovascular group (1.2% vs. 5.0%, p=0.008). The overall governmental expenditure on these procedures was U$ 238,010,096.51, and endovascular procedures were on average significantly more expensive than open surgery (U$ 1,932.27 vs. U$ 1,517.32; p=0.016). Conclusions Lower limb revascularizations were performed on the Brazilian Public Healthcare System with gradually increasing frequency from 2008 to 2019. Endovascular procedures were vastly more common and were associated with lower in-hospital mortality rates, but higher procedure costs.

Resumo Contexto A doença arterial periférica (DAP) é uma doença com alta morbidade global, afetando mais de 200 milhões de pessoas. Objetivos Neste estudo, analisamos o tratamento cirúrgico para DAP no sistema público de saúde do Brasil no período de 12 anos, com base em dados publicamente disponíveis. Métodos O estudo foi conduzido a partir da análise de dados disponíveis na plataforma do Departamento de Informática do Sistema Único de Saúde (DATASUS), do Ministério da Saúde, avaliando a distribuição da técnica cirúrgica utilizada, a mortalidade e o custo ao longo dos anos. Resultados Um total de 129.424 procedimentos foram analisados (para claudicantes e isquemia crítica, em proporção desconhecida). A maiora dos procedimentos foi via endovascular (65,49%), com tendência de aumento nessa desproporção (p < 0,001). Houve 3.306 mortes intra-hospitalares (mortalidade de 2,55%) com menor mortalidade no grupo endovascular (1,2% vs. 5,0%; p = 0,008). O investimento governamental total para esses procedimentos foi de US$ 238.010.096,51, e os procedimentos endovasculares foram significativamente mais caros que a cirurgia aberta convencional (US$ 1.932,27 vs. US$ 1.517,32; p = 0,016). Conclusões No sistema público de saúde brasileiro, as revascularizações de membros inferiores ocorreram com frequência crescente entre 2008 e 2019. Os procedimentos endovasculares foram mais comuns e relacionados a menor mortalidade intra-hospitalar, mas a maiores custos.

Doença arterial obstrutiva periférica: um estudo comparativo entre revascularizações abertas e endovasculares realizadas em caráter de urgência no sistema público de saúde do Brasil entre 2010 e 2020 / Peripheral artery disease: a comparison of urgent open and endovascular revascularizations on the public health system in Brazil, from 2010 to 2020

RESUMO Contexto A doença arterial obstrutiva periférica apresenta alta prevalência, sendo associada a elevado risco de eventos cardiovasculares. A intervenção cirúrgica ou endovascular faz-se necessária na isquemia crítica do membro. Objetivos Avaliar a distribuição de realização de revascularizações abertas e endovasculares nas diferentes regiões do Brasil, analisando os custos para o sistema de saúde e a mortalidade relacionada a esses procedimentos. Métodos Foi realizado um estudo epidemiológico observacional transversal descritivo para avaliar as cirurgias abertas e endovasculares realizadas no sistema público de saúde do Brasil entre 2010 e 2020. Os dados foram coletados através do Departamento de Informática do SUS (Datasus). Resultados No período analisado, foram registradas 83.218 internações para realização de cirurgias abertas e endovasculares, com um custo total de R$ 333.989.523,17. Houve predominância das internações para os procedimentos percutâneos (56.132) em relação aos cirúrgicos convencionais (27.086). As Regiões Sudeste e Sul concentraram a maior parte do total de procedimentos realizados no país (83%), enquanto a Região Norte foi a que apresentou a menor taxa de internação. Observou-se uma tendência decrescente para os procedimentos abertos, e uma tendência crescente para os endovasculares. A média de permanência hospitalar foi menor nos procedimentos endovasculares (5,3 dias) em relação aos abertos (10,2 dias). Além disso, notou-se uma maior taxa de mortalidade hospitalar relacionada à revascularização aberta em relação à endovascular (5,24% versus 1,56%). Conclusões As técnicas endovasculares consistiram em uma abordagem dominante no tratamento cirúrgico da isquemia crítica, apresentando menor taxa de mortalidade hospitalar e menor tempo de internação quando comparada às cirurgias abertas.

ABSTRACT Background Peripheral artery disease (PAD) has high prevalence and is associated with high risk of cardiovascular events. Surgical or endovascular intervention is necessary in chronic limb-threatening ischemia. Objectives To evaluate the distribution of open and endovascular revascularizations in different regions of Brazil, analyzing the health system costs and mortality related to these procedures. Methods A descriptive, cross-sectional, observational, epidemiological study was carried out to evaluate open and endovascular surgeries performed on the SUS public healthcare system in Brazil, from 2010 to 2020. Data were collected from the SUS Department of Informatics (Datasus). Results Over the period analyzed, 83,218 admissions for open and endovascular surgeries were registered, with a total cost of R$ 333,989,523.17. There were more hospital admissions for percutaneous procedures (56,132) than for conventional surgery (27,086). Most of the procedures (83%) were performed in the country's Southeast and South regions, while the North region had the lowest number of procedures. Over the period evaluated, there was a decreasing trend for open procedures and an increasing trend for endovascular procedures. The average hospital stay was shorter for endovascular procedures (5.3 days) than for open surgery (10.2 days). The analysis of mortality related to these procedures revealed a higher rate of in-hospital mortality associated with open revascularization than with endovascular (5.24% vs. 1.56%). Conclusions Endovascular techniques constituted the primary approach for revascularization treatment in critical limb-threatening ischemia, with a lower in-hospital mortality rate and shorter hospital stay when compared to open surgeries.

Two-year clinical outcomes following lower limb endovascular revascularisation for chronic limb-threatening ischaemia at a tertiary Asian vascular centre in Singapore

INTRODUCTION@#Percutaneous transluminal angioplasty (PTA) is commonly used to treat patients with chronic limb-threatening ischaemia (CLTI). This study aimed to examine the mortality and functional outcomes of patients with CLTI who predominantly had diabetes mellitus in a multi-ethnic Asian population in Singapore.@*METHODS@#Patients with CLTI who underwent PTA between January 2015 and March 2017 at the Vascular Unit at Singapore General Hospital, Singapore, were studied. Primary outcome measures were 30-day unplanned readmission, two-year major lower extremity amputation (LEA), mortality rates, and ambulation status at one, six and 12 months.@*RESULTS@#A total of 221 procedures were performed on 207 patients, of whom 184 (88.9%) were diabetics. The one-, six- and 12-month mortality rate was 7.7%, 16.4% and 21.7%, respectively. The two-year LEA rate was 30.0%. At six and 12 months, only 96 (46.4%) and 93 (44.9%) patients were ambulant, respectively. Multivariate analysis revealed that preoperative ambulatory status, haemoglobin, Wound Ischaemia and foot Infection (WIfI) score, and end-stage renal failure (ESRF) were independent predictors of one-year ambulatory status. Predictors of mortality at one, six and 12 months were ESRF, preoperative albumin level, impaired functional status and employment status.@*CONCLUSION@#PTA for CLTI was associated with low one-year mortality and two-year LEA rates but did not significantly improve ambulation status. ESRF and hypoalbuminaemia were independent predictors of mortality. ESRF/CKD and WIfI score were independent predictors of loss of ambulation at six months and one year. We need better risk stratification for patients with CLTI to decide between initial revascularisation and an immediate LEA policy.

Aneurisma verdadeiro isolado de artéria femoral profunda associado a doença arterial periférica: relato de caso / True isolated deep femoral artery aneurysm associated with peripheral artery disease: case report

Resumo Os aneurismas verdadeiros de artéria femoral profunda são extremamente raros, representando cerca de 0,5% do total dos aneurismas periféricos. Neste relato, descrevemos um paciente de 79 anos de idade, sexo masculino, com histórico de abordagem cirúrgica prévia convencional devido a aneurisma de aorta abdominal, que deu entrada no Serviço de Cirurgia Vascular do Hospital das Clínicas com quadro de claudicação intermitente de membros inferiores. Foi realizado eco-Doppler colorido arterial do membro inferior direito, que revelou doença arterial periférica femoro-poplítea e infrapatelar. A angiotomografia computadorizada identificou oclusão aortoilíaca e do enxerto bifurcado desde o segmento infrarrenal da aorta, além de aneurisma de artéria femoral profunda de 3,7 x 3,5 cm de diâmetro com 7 cm de extensão. Procedeu-se com a ressecção do aneurisma e revascularização da artéria femoral profunda por interposição de prótese de Dacron® e reimplante de artéria femoral superficial na prótese. Portanto, nos casos de aneurisma de artéria femoral profunda concomitante a doença arterial periférica, deve-se atentar para revascularização e perfusão adequada do membro inferior.

Abstract True deep femoral artery aneurysms are extremely rare, accounting for about 0.5% of all peripheral aneurysms. In this report, we describe a 79-year-old male patient with a history of prior abdominal aortic aneurysm surgery via a conventional approach who was admitted to the vascular surgery service at the Hospital das Clínicas with intermittent claudication of the lower limbs. Arterial color-Doppler ultrasonography of the right lower limb was performed, revealing peripheral arterial disease of the femoral--popliteal and infrapatellar segments. Computed tomography angiography identified aortoiliac and bifurcated graft occlusion from the infrarenal segment of the aorta, in addition to a deep femoral artery aneurysm with diameters of 3.7 cm x 3.5 cm and length of 7 cm. Resection of the aneurysm was followed by revascularization of the deep femoral artery by interposition of a Dacron® graft and reimplantation of the superficial femoral artery into the graft. In cases of deep femoral artery aneurysms with concomitant peripheral arterial disease, it is important to ensure revascularization and adequate perfusion of the lower limb.

Manejo endovascular de la isquemia crítica distal: análisis de una serie contemporánea

Background: Chronic limb ischemia can lead to high rates of limb loss and mortality. Open surgery is the gold standard for treatment of distal disease. Endovascular surgery should have less complications with similar outcomes. Aim: To report a cohort of patients with distal arterial disease treated with endovascular surgery at our institution. Material and Methods: Review of angioplasty records of patients undergoing distal lower extremity endovascular procedures between 2016 and 2019. Demographics, comorbidities, form of presentation, type of intervention, perioperative complications, and length of stay were analyzed. The primary outcomes were wound healing, reinterventions and freedom from major amputation. Secondary outcomes were overall survival and amputation-free survival. Results: Forty-eight limbs of 41 patients with a mean age 75 years (78% males) were treated. Ninety-three percent had hypertension, 88% diabetes, 30% chronic kidney disease. 73% presented with major wounds. Plain balloon and drug coated balloon angioplasties were carried out in 65 and 31% of procedures respectively, with no difference in results. In 46% of the cases, only chronic total occlusions were treated. Wound healing was achieved in 85% of procedures and 90% of patients were free from amputation at one year of follow up. Complications were observed in 18% of procedures, perioperative mortality was 2% and one-year survival was 76%. Conclusions: Endovascular therapy achieves high rates of wound healing and freedom from amputation with low perioperative mortality and moderate complication rates.

Tipos de cirugías arteriales en pacientes diabéticos / Types of arterial surgeries in diabetic patients

Introducción: Las cirugías arteriales en los pacientes diabéticos permiten disminuir las frecuencias de amputaciones que se realizan en estos pacientes. Objetivo: Exponer los principales tipos de cirugías arteriales en los miembros inferiores que se realizan en pacientes diabéticos y sus resultados. Métodos: Estudio de búsqueda y síntesis bibliográfica en el que consultaron y tamizaron 162 documentos (artículos, registros médicos y tesis) publicados en las bases de datos de sistemas referativos MEDLINE, PubMed y SciELO e indexadas en la Web of Sciencies, Scopus, Redalyc y Latindex, con la utilización de descriptores: cirugía revascularizadora, permeabilidad arterial, pie diabético, cirugía endovascular, endarterectomía, angioplastia transluminal percutánea. Esto generó que se seleccionara 43 artículos y tres registros médicos. Resultados: La técnica en la revascularización del sector aortoiliaco incluye la cirugía derivativa anatómica [by-passaorto-femoral (bi o uni)]y la extraanatómica [by-pass (axilo-femoral, fémoro-femoral), la endarterectomía y la cirugía endovascular en el sector iliaco. Las técnicas quirúrgicas a aplicar en el sector femoropoplíteo y distal son el by-pass secuencial, endarterectomía, simpatectomía, tratamiento endovascular. Es importante tener en cuenta las características de los pacientes por separado para la decisión del tipo de cirugía. Conclusiones: Las cirugías arteriales en el paciente diabético son diversas y para su éxito es necesario valorar siempre el riesgo quirúrgico y la anatomía de las lesiones de cada paciente(AU)

Introduction: Arterial surgeries in diabetic patients allow reducing the frequency of amputations that are performed in these patients. Objective: To show the main types of arterial surgery in the lower limbs performed in diabetic patients and their results. Methods: Bibliographic search and synthesis study in which 162 materials (articles, medical records and theses) published in the MEDLINE, PubMed and SciELO reference databases were searched and indexed in the Web of Sciencies, Scopus, Redalyc and Latindex, using as descriptors: revascularization surgery, arterial permeability, diabetic foot, endovascular surgery, endarterectomy, percutaneous transluminal angioplasty. This led to the quoting of 43 articles and three medical records. Results: The technique in the revascularization of the aorto iliac sector includes the anatomical derivative surgery [aorto-femoral by-pass (bi or uni)] and extra-anatomical [by-pass (axillo-femoral, femoro-femoral), endarterectomy and endovascular surgery in the iliac sector. The surgical techniques to be applied in the femoro popliteal and distal sectors are the sequential by-pass, endarterectomy, sympathectomy, and endovascular treatment. It is important to consider the characteristics of patients separately to decide the type of surgery. Conclusions: The arterial surgeries in the diabetic patient are diverse and for the success of them it is necessary to always assess the surgical risk and the anatomy of the lesions of each patient(AU)

Impact of arterial procedures on coagulation and fibrinolysis - a pilot study

Abstract Objective: The main goal of our study was to assess the impact of vascular procedures on the activity of hemostatic and fibrinolytic pathways. Methods: We enrolled 38 patients with ≥ 45 years old undergoing surgery for abdominal aortic aneurysm or peripheral artery disease under general or regional anesthesia and who were hospitalized at least one night after the procedure. Patients undergoing carotid artery surgery and those who had acute bypass graft thrombosis, cancer, renal failure defined as estimated glomerular filtration rate < 30 ml/min/1.73m2, venous thromboembolism three months prior to surgery, or acute infection were excluded from the study. We measured levels of markers of hemostasis (factor VIII, von Willebrand factor:ristocetin cofactor [vWF:CoR], antithrombin), fibrinolysis (D-dimer, tissue plasminogen activator [tPA], plasmin-antiplasmin complexes), and soluble cluster of differentiation 40 ligand (sCD40L) before and 6-12h after vascular procedure. Results: Significant differences between preoperative and postoperative levels of factor VIII (158.0 vs. 103.3, P<0.001), antithrombin (92.1 vs. 74.8, P<0.001), D-dimer (938.0 vs. 2406.0, P=0.005), tPA (10.1 vs. 12.8, P=0.002), and sCD40L (9092.9 vs. 1249.6, P<0.001) were observed. There were no significant differences between pre- and postoperative levels of vWF:CoR (140.6 vs. 162.8, P=0.17) and plasmin-antiplasmin complexes (749.6 vs. 863.7, P=0.21). Conclusion: Vascular surgery leads to significant alterations in hemostatic and fibrinolytic systems. However, the direction of these changes in both pathways remains unclear and seems to be different depending on the type of surgery. A study utilizing dynamic methods of coagulation and fibrinolysis assessment performed on a larger population is warranted.

Single-center study comparing short and mid-term results of evar in old and young populations

Abstract Objective: The purpose of this study was to compare the operative mortality rate and outcomes of endovascular aneurysm repair (EVAR) between young and geriatric people in a single center. Methods: Eighty-five patients with abdominal aortic aneurysms who underwent EVAR between January 2012 and September 2016 were included. Outcomes were compared between two groups: the young (aged < 65 years) and the geriatric (aged ≥ 65 years). The primary study outcome was technical success; the secondary endpoints were mortality and secondary interventions. The mean follow-up time was 36 months (3-60 months). Results: The study included 72 males and 13 females with a mean age of 71.08±8.6 years (range 49-85 years). Of the 85 patients analyzed, 18 (21.2%) were under 65 years old and 67 patients (78.8%) were over 65 years old. There was no statistically significant correlation between chronic disease and age. We found no statistically significant difference between aneurysm diameter, neck angle, neck length, or right and left iliac angles. The secondary intervention rate was 7% (six patients). The conversion to open surgery was necessary for only one patient and only three deaths were reported (3.5%). There was no statistically significant difference in the mortality and reintervention rates between the age groups. The three deaths occurred only in the geriatric group and two died secondary to rupture. Kidney failure was observed in three patients in the geriatric group (4.5%). Conclusion: Our single-center experience shows that EVAR can be used safely in both young and geriatric patients.

Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment / Experiência real com balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas: resultados após 12 meses do primeiro ano de seleção de pacientes para o registro BIOLUX P-III

Abstract Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

Resumo Contexto O manejo endovascular de artérias infrainguinais ateroscleróticas recentemente tem mudado para dispositivos farmacológicos, desenhados para impedir localmente o processo de reestenose. Numerosos estudos clínicos descrevem uma vantagem da angioplastia com uso de balões farmacológicos sobre os balões convencionais no tratamento de doença arterial periférica dos membros inferiores. No entanto, considerando que as plataformas do revestimento farmacológico e dos balões são diferentes, cada dispositivo requer avaliações clínicas específicas. Objetivo Fazer investigação adicional sobre a segurança e eficácia de um balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas em um cenário de mundo real. Métodos 203 pacientes de uma amostra final de 882 pacientes foram incluídos neste registro prospectivo observacional multicêntrico de inclusão sequencial, durante os primeiros 12 meses. Os desfechos primários foram eventos adversos maiores (definidos como morte relacionada ao procedimento ou ao dispositivo em até 30 dias após o procedimento-índice, necessidade de revascularização da lesão-alvo ou amputação significativa do membro-alvo) em 6 meses e ausência de de revascularização da lesão-alvo em 12 meses. Ambos os desfechos foram adjudicados por um comitê de eventos clínicos. Resultados A idade média foi 70,2±10,4 anos (60,1% sexo masculino). 47,3% dos pacientes eram diabéticos, e 67,5% tinham história de tabagismo. Claudicação severa foi relatada em 37,4%, e 40% apresentava isquemia crítica de membro. 257 lesões, incluindo 13,2% em território infrapoplíteo, foram tratadas com o balão Passeo-18 Lux (comprimento médio das lesões 75,1 mm±69,4, 20% oclusões, 76,3% calcificadas). Aos 6 meses, a taxa de eventos adversos maiores foi de 5,5% (95%CI 3,1-9,7). A ausência de revascularização da lesão-alvo aos 12 meses foi de 93,2% (95%CI 89,1-95,8). Mortalidade por todas as causas foi de 6,5% (95%CI 3,8-11,0) e a taxa geral de amputação foi de 4,2% (95%CI 2,1-8,3) aos 12 meses. Conclusão Em um cenário de mundo real, os resultados preliminares do registro BIOLUX P-III confirmam a segurança e eficácia do balão revestido com paclitaxel Passeo-18 Lux como opção de tratamento único para artérias infrainguinais ateroscleróticas.

Doença cística adventicial da artéria poplítea: causa infrequente de claudicação intermitente / Cystic adventitial disease of the popliteal artery: an infrequent cause of intermittent claudication

A claudicação intermitente está frequentemente associada à doença aterosclerótica, mas diagnósticos diferenciais devem ser pesquisados em pacientes sem fatores de risco tradicionais. A doença cística adventicial, de etiologia incerta, acomete em maior proporção a artéria poplítea e, eventualmente, apresenta-se como claudicação intermitente. Apresentamos um caso da doença e seu manejo cirúrgico, e discutimos a etiopatogenia, os aspectos diagnósticos e terapêuticos da enfermidade.

Intermittent claudication is frequently associated with atherosclerotic disease, but differential diagnosis must be sought in patients with no traditional risk factors. Cystic adventitial disease, of unknown etiology, most frequently affects the popliteal artery, and occasionally presents as intermittent claudication. We report a case of this disease and the surgical treatment, and discuss some aspects related to etiopathogenesis, diagnosis and treatment of this condition.