Predictors of outcome events and 6-year mortality after carotid endarterectomy and carotid stenting in patients with carotid artery stenosis.

AIM: The aim of our study was to evaluate the results of CEA and CAS in patients with carotid artery stenosis, and their effect on long-term mortality and morbidity, as well as to identify predictors of long-term mortality in a single-centre observational study. CLINICAL RATIONALE: While data on short-term morbidity and mortality after carotid endarterectomy (CEA) and carotid stenting (CAS) is robust, there is only a limited amount of literature on long-term mortality and its predictors five years-plus post these procedures. MATERIAL AND METHODS: Consecutive patients with symptomatic and asymptomatic internal carotid artery stenosis treated with CEA or CAS in a single centre in eastern Slovakia between 2012 and 2014 were included. We recorded basic sociodemographic data, the presence of co-morbidities and periprocedural complications. Clinical and sonographic follow-up was performed three and 12 months after the procedures. Patient survival data and any stroke data was obtained at the end of a six-year follow-up. RESULTS: We included 259 patients after CEA (mean age 67.4 ± 8.5, 64.5% men) and 321 after CAS (mean age 66.9 ± 8.4, 73.5% men). We did not identify a statistically significant difference in short-term or long-term mortality, survival times, or the presence of short-term or long-term complications between the CEA and CAS groups. Predictors of long-term mortality included age and diabetes mellitus in both cohorts. Repeated interventions were related to increased mortality only in the CAS cohort. CONCLUSIONS: The results of our study show that long-term mortality does not differ between CEA and CAS.

Positive association between abdominal aortic diameter and serum collagen XVIII levels.

BACKGROUND: The identification of abdominal aortic aneurysm (AAA) biomarker offers a perspective to determine disease progress and rupture risk. The aim of our study was to evaluate the association between selected circulating biomarkers and diameter of abdominal aorta. METHODS: One hundred and two patients (88 men and 14 women) with mean age 70.0±8.7 years were included in a single center cross-sectional study conducted between February 2016 and October, 2018. AAA was defined as subrenal aortic dilatation ≥3 cm. Serum biomarker concentrations (insulin-like growth factor-1, peroxiredoxin-1, collagen IV, collagen XVIII) were measured by an enzyme-linked immunosorbent assay (ELISA). Adjustments including variables with different baseline distribution at univariate level with P<0.1 (age, body mass index, coronary artery disease, fibrinogen) were performed in multivariate models. RESULTS: Higher collagen XVIII was found in AAA patients in comparison with the control group of patients (39.5 vs. 25.0 ng/mL; P=0.002). Diameter of abdominal aorta was positively associated with collagen XVIII levels in univariate (B=0.16; P=0.004), and in multivariate analysis (B=0.14; P=0.027), i.e. increase in collagen XVIII by 1 ng/mL corresponded to an increase in abdominal aortic diameter by 0.14 mm. Patients with serum collagen XVIII levels in the third tertile (˃47 ng/mL) had 4.23 times higher risk of AAA compared to patients with collagen XVIII levels in the first and second tertiles (OR 4.23; 95% CI 1.42-11.6; P=0.020). No association was found between other examined biomarkers and abdominal aortic diameter. CONCLUSIONS: Diameter of abdominal aorta was positively associated with serum collagen XVIII level.

Higher preprocedural fibrinogen levels are associated with aneurysm sac regression after EVAR.

Background: The aim of our study was to determine the diameter of the aneurysm sac 24 months after endovascular abdominal aortic aneurysm repair (EVAR); to identify factors associated with sac regression, and to determine the impact of sac regression on all-cause mortality during long-term follow-up. Patients and methods: We conducted a retrospective review of prospectively collected data from patients treated with EVAR between January, 2010 and July, 2016. Sac regression was defined as at least 5 mm decrease in aneurysm diameter in relation to the preprocedural diameter seen on computed tomography angiography. Sociodemographic information, comorbidities, treatment, laboratory parameters, selected anatomical and genetic factors were all analysed to determine their impact on sac regression. Results: During the study period, 124 patients with mean age of 71.2 ± 7.2 years met the inclusion criteria. Sac regression was found in 45.2% of patients. Higher preprocedural fibrinogen was found in patients with sac regression in comparison with patients with stable sac or sac expansion (3.84 g/l vs 3.47 g/l; p = 0.028). In multivariate analysis after adjustment for age, hypertension, sex, smoking, dyslipidaemia, volume and percentage of intraluminal thrombus higher fibrinogen was associated with an increased probability of sac regression (OR 2.47; 95% CI 1.29-4.72; p = 0.006). Persistent type II endoleak was associated with significantly lower probability of sac regression in univariate and multivariate analysis after adjustment for age, hypertension, sex, smoking and dyslipidaemia (OR 0.26; 95% CI 0.10-0.66; p = 0.004). Higher age was a significant predictor of sac regression in multivariate analysis after adjustment for hypertension, sex, smoking and dyslipidaemia (OR 1.07; 95% CI 1.02-1.14; p = 0.012). No difference was found between patient subgroups with and without sac regression in all-cause mortality during follow-up. Conclusions: Higher preprocedural fibrinogen, absence of persistent type II endoleak and higher age were predictive factors of aneurysm sac regression post-EVAR.

Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort.

OBJECTIVES: This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated. METHODS: The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period. RESULTS: A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate. CONCLUSIONS: Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset.

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.

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.

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.

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.

Remote pre-procedural ischemic stroke as the greatest risk in carotid­stenting­associated stroke and death: a single center's experience.

BACKGROUND: The goal of carotid artery stenting (CAS) is to decrease the stroke risk in patients with carotid stenosis. This procedure carries an immediate risk of stroke and death and many patients do not benefit from it, especially asymptomatic patients. It is crucial to accurately select the patients who would benefit from carotid procedure, and to rule out those for whom the procedure might be hazardous. Remote ischemic stroke is a known risk factor for stroke recurrence during surgery. The aim of our study was to determine the periprocedural complication risk (within 30 days after CAS) associated with carotid stenting (stroke, death) in patients with and without remote pre-procedural ischemic stroke, to analyze periprocedural risk in other specific patient subgroups treated with CAS, and to determine the impact of observed variables on all-cause mortality during long-term follow-up. METHODS: We conducted a retrospective review of prospectively collected data from all patients treated with protected CAS between June 20, 2008 and December 31, 2015. Patient age, gender, type of carotid stenosis (symptomatic versus asymptomatic), side of stenosis (right or left carotid artery), type of cerebral protection (proximal versus distal), presence of comorbidities (remote ischemic pre-procedural ischemic stroke, coronary artery disease, diabetes mellitus, peripheral artery disease), previous ipsilateral carotid endarterectomy (CEA), contralateral carotid occlusion (CCO) and previous contralateral CAS/CEA were analyzed to identify higher CAS risk and to determine the impact of these variables on all-cause mortality during follow-up. Survival data were obtained from the Health Care Surveillance Authority registry. Mean follow-up was 1054 days (interquartile range 547.3; 1454.8). Remote pre-procedural ischemic stroke was defined as any-territory ischemic stroke >6 months prior to CAS. RESULTS: Primary periprocedural endpoint incidence (stroke/death) in 502 patients was 3.8% (N.=19) of all patients, 5.4% (N.=10) of symptomatic patients and 2.8% (N.=9) of asymptomatic patients. The risk of periprocedural stroke/death was 3.4 times higher in patients with (N.=198) compared to patients without remote ischemic stroke (N.=304) (6.6% versus 2.0% of patients without remote ischemic stroke; P=0.008). Periprocedural stroke/death in symptomatic patients (N.=186) was non-significantly higher in patients with remote ischemic stroke (N.=76) compared with patients without remote ischemic stroke (N.=110) (7.9% versus 3.6%; P=0.206). Asymptomatic patients with remote ischemic stroke (N.=122) had a 5.6-time-higher periprocedural risk of stroke/death compared with asymptomatic patients without remote ischemic stroke (N.=194) (5.7% versus 1.0%; P=0.014). Patients ≥75 years (N.=83) had a 3.0-time-higher periprocedural risk of stroke/death compared with younger patients (N.=419) (8.4% versus 2.9%; P=0.015); a non-significant increase of periprocedural stroke/death was found in both symptomatic (N.=35) and asymptomatic (N.=48) elderly patients (11.4% versus 4.0%, P=0.078; and 6.3% versus 2.4%, P=0.124, respectively). Increased periprocedural risk of stroke/death was not documented in other analyzed patient subgroups. During long-term follow-up, a 1.5-time-higher mortality risk was found in patients with remote ischemic stroke compared with patients without remote ischemic stroke in multivariable analysis; other patient subgroups (except older versus younger patients) did not differ in long-term mortality following carotid stenting. CONCLUSIONS: In our experience, all patients with remote pre-procedural any-territory ischemic stroke belong to risky subgroup for periprocedural stroke death after CAS. All asymptomatic patients with remote ischemic stroke should not be treated with CAS. Remote ischemic stroke increases all-cause mortality in long-term follow-up after carotid stenting. Patients aged ≥75 years also have increased risk of periprocedural stroke and death after CAS. These factors should help us to be more selective when planning carotid procedures.

[Traumatic pseudoaneurysm of descendent thoracic aorta solved by aortal stentgraft repair followed by development of fatal aortoesophageal fistula]. / Traumatická pseudoaneuryzma descendentnej torakálnej aorty riesená aortálnym stentgraftom s následnou fatálnou aortoezofageálnou fistulou.

Traumatic pseudoaneurysms are relatively frequently mentioned in textbooks of pathology and forensic medicine but their incidence in pathological reports is seldom documented. Our described case presented a patient who suffered from chronic alcoholism and who was repeatedly hospitalised because of various injuries including epidural and subdural hematomas. We present a case of a 69-year-old man who was hospitalised after nonspecific blunt chest injury with chest pain and dysphagia. By computed tomography the traumatic pseudoaneurysm of the descendent thoracic aorta was diagnosed pressing the oesophageal wall which was solved by implantation of aortal stent graft (TEVAR - thoracic endovascular aortic/aneurysm repair). Since after the implantation there was no blood leak, no progression of the lesion, he was soon discharged from hospital. The patient was hospitalised again after two months for newly developed haemoptysis. On suspicion of bleeding from aortal arch a carotid-carotid bypass from right to left side was performed and then re-TEVAR was implanted proximally to the first one. The man died two days following the implantation after a massive bleeding from oesophagus due to aortoesophageal fistula. The presented case deals with the etiology of the development of pseudoaneurysms, histomorphological picture of pseudoaneurysm resembling not only an isolated thoracic aortitis but slightly also the Takayashu disease. We suppose that in this case the most probable cause of necrosis and perforation of aortal wall was a decubital necrosis caused by stent graft which led to the fatal aortoesophageal necrosis. Aortoesophageal fistula belongs to the most common lethal complications of the TEVAR.

"V" aortoplasty of the proximal descending aorta in the elephant trunk procedure.

Complex pathology of the aorta, especially in patients presenting an aneurysm involving the entire aortic arch and proximal descending aorta has been approached in one or two stages. Surgical management of those with an extremely wide diameter of the proximal descending aorta is not yet well defined. The patient in this case was an asymptomatic 47-year-old female with systemic lupus erythematosus (SLE) associated with aneurysm of the ascending aorta, whose aortic arch and descending aorta had presented only overall weakness (examination by inspection and palpation without histological verification). The imaging identified a giant aorta arising at the level of the sinotubular junction (STJ), ending up immediately below the diaphragm. In the first stage she underwent surgical replacement of the entire ascending aorta, aortic arch and proximal part of the descending aorta by combining the elephant trunk with a new type of aortoplasty. In the second stage an endovascular stent graft was inserted into the elephant trunk in the descending aorta. The patient continues to do well 20 months following the repair. In this manuscript type we describe a novel technique of "V" aortoplasty of the proximal descending aorta in order to facilitate the performing of anastomosis between the Dacron graft and aortic aneurysm.