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1.
Vascular ; : 17085381241262350, 2024 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-38872254

RESUMO

OBJECTIVES: A current and ongoing challenge is to reduce patient mortality after endovascular abdominal aortic repair (EVAR). This study aimed to assess the predictors of all-cause mortality after EVAR. METHODS: Data regarding the demographic characteristics, comorbidities, laboratory values, selected anatomical factors, post-EVAR treatment, surveillance and complications of patients who underwent elective EVAR for non-ruptured abdominal aortic aneurysm (AAA) between January 2010 and January 2021 were evaluated. Mortality was assessed until 10 October 2023. Multivariate analyses were performed after adjusting for age, hypertension, diabetes mellitus, dyslipidaemia, sex, smoking, number of lumbar arteries, patency of inferior mesenteric artery (IMA), IMA diameter and reinterventions. RESULTS: This study included 196 patients (183 men and 13 women) with a mean age of 72.4 ± 7.67 years. The overall mortality rate during a mean follow-up period of 5.75 ± 3.1 years was 50.0% (N = 98). The 2-, 5- and 10-year mortality rates were 9.7%, 32.0% and 66.6%, respectively. The mortality rates decreased by 59% in patients with reinterventions (hazard ratio [HR]: 0.41; 95% confidence interval [CI]: 0.23-0.73; p = .002) and by 59% in patients treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) (HR: 0.41; 95% CI: 0.26-0.66; p < .001). Chronic anticoagulation was associated with 2.09-fold higher mortality (HR: 2.09; 95% CI: 1.19-3.67; p = .010), and coronary artery disease (CAD) was associated with 1.74-fold higher mortality (HR: 1.74; 95% CI: 1.09-2.78; p = .021). Pre-EVAR AAA diameter and 1-year post-EVAR sac diameter were positively associated with mortality (HR: 1.05; 95% CI: 1.03-1.08; p < .001, and HR: 1.05; 95% CI: 1.03-1.07; p < .001, respectively), that is, an increase of pre-EVAR and/or 1-year post-EVAR AAA diameter by 1 mm was associated with a 5% higher risk of all-cause mortality. CONCLUSIONS: Reinterventions and treatment with ACE inhibitors or ARBs may be associated with decreased post-EVAR mortality. A greater pre-EVAR, a post-EVAR AAA diameter, CAD and chronic anticoagulation were associated with higher all-cause mortality post-EVAR.

2.
BMJ Case Rep ; 16(12)2023 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-38129080

RESUMO

The internal mammary artery has become the primary conduit for the surgical revascularisation of the left anterior descending artery. Large side branches of internal mammary artery are typically ligated during cardiac surgery to avoid a potential coronary steal phenomenon. However, ligation of side branches can be unsuccessful due to the technically difficult surgical exploration of internal mammary artery branches. In this article, we present a case of a man who suffered from exertion angina pectoris despite successful surgical revascularisation of occluded left anterior descending artery by the internal mammary artery bypass. The coronary steal syndrome caused by the mighty side branch of internal mammary artery, that is, lateral costal artery was concluded as the reason of exertional angina. The endovascular procedure was performed and the lateral costal artery was successfully occluded using vascular plug. The occlusion of lateral costal artery has led to a complete disappearance of the exertional angina.


Assuntos
Doença da Artéria Coronariana , Artéria Torácica Interna , Masculino , Humanos , Angina Pectoris/etiologia , Angina Pectoris/cirurgia , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/complicações , Artéria Torácica Interna/cirurgia , Anastomose de Artéria Torácica Interna-Coronária/efeitos adversos
3.
Vasa ; 52(5): 325-331, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37350324

RESUMO

Background: Knowledge of factors that influence all-cause mortality after endovascular abdominal aortic aneurysm repair (EVAR) could improve therapeutic strategies post-EVAR and thus patient prognosis. Our study aimed to evaluate the association between sociodemographic information, comorbidities, laboratory parameters, treatment, selected anatomical and genetic factors and all-cause mortality post-EVAR. Patients and methods: We reviewed all patients who had undergone elective EVAR for non-ruptured abdominal aortic aneurysm (AAA) between January 2010 and December 2019. AAA size (maximum diameter and volume) was measured using CT-angiography. Sac expansion was defined as at least 5 mm increase, sac regression as at least 5 mm decrease in the sac diameter determined at 36±3 months post-EVAR in relation to pre-EVAR AAA diameter. Adjustments were performed for age, hypertension, diabetes mellitus, dyslipidaemia, sex, smoking, number of lumbar arteries, patency of inferior mesenteric artery and number of reinterventions post-EVAR. Results: One hundred and sixty-two patients (150 men, 12 women) with a mean age of 72.6±7.3 years were included in the analysis. Pre-EVAR AAA diameter (HR 1.07; 95% CI 1.03 - 1.12; p=0.001), pre-EVAR AAA volume (HR 1.01; 95% CI 1.002 - 1.011; p=0.008), post-EVAR sac diameter (HR 1.06; 95% CI 1.03 - 1.10; p=0.000), post-EVAR sac volume (HR 1.01; 95% CI 1.002 - 1.011; p=0.006) and anticoagulation therapy (HR 2.46; 95% CI 1.18 - 5.14; p=0.019) were associated with higher mortality in multivariate analysis. Sac regression (HR 0.42; 95% CI 0.22 - 0.82; p=0.011), and treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) (HR 0.71; 95% CI 0.36 - 0.97; p=0.047) were associated with lower mortality. Conclusions: Greater pre- and post-EVAR diameter and volume, failure of sac regression and anticoagulation were associated with higher mortality post-EVAR. Reduced mortality was observed in patients treated with ACE inhibitors or ARBs, and in patients with AAA sac regression.


Assuntos
Aneurisma da Aorta Abdominal , Procedimentos Endovasculares , Idoso , Feminino , Humanos , Masculino , Antagonistas de Receptores de Angiotensina , Inibidores da Enzima Conversora de Angiotensina , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
4.
Turk J Emerg Med ; 23(2): 127-130, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37169034

RESUMO

Ventricular septal defect (VSD) is a known complication after myocardial infarction associated with high mortality. Extracorporeal membrane oxygenation (ECMO) is being successfully used in patients with VSD as a bridge to definitive surgical repair. Although often the only possibility to stabilize hemodynamics and oxygenation, ECMO has many potential complications, carrying significant morbidity and mortality. Here, the patient presented with a postinfarct VSD on peripheral venoarterial ECMO who developed a dissection of the common iliac artery (CIA) on the 5th day after ECMO implantation. As a result, a sudden drop in ECMO flow has become evident along with high pressures in the arterial cannula. After a definitive diagnosis of a CIA lesion obstructing the blood flow was made, trans-ECMO endovascular repair of CIA was performed. Four days after endovascular repair, we encountered the same problem of decreased blood flow associated with stent kinking and were approached with another endovascular repair to re-establishing full ECMO flow.

5.
Vnitr Lek ; 68(4): 221-226, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36220419

RESUMO

The increasing volume of the data and experience with direct oral anticoagulants (DOACS) in the primary and secondary prevention of venous thromboembolism in oncologic patients (CAVTE) has recently lead to changes in several international guidelines. We reflect these changes within the conditions in Slovak republic. In the primary prevention of CAVTE we recognise oncosurgical patients and nonsurgical patients: hospitalised and out patients. Low molecular weight heparins are still dominant in the primary prevention of CAVTE. Regarding the treatment and the secondary prevention of CAVTE, we recommend always to consider the possibility to use DOACs as they proved to be non inferior to LMWH. However, LMWH should be prefered over DOACs as well as over warfarin (VKA) in all patients who are in a clinically unstable condition with the high risk of bleeding and/or interaction with the systemic treatment. Primarily in the patients with intraluminal tumours of the upper part of the gastrointestinal tract and genitourinary tumours with the high risk of bleeding. As for the lack of data, LMWH are still preferd also in patients with primary tumours and metastatic disease of the central nervous system and in hemato oncology.


Assuntos
Neoplasias , Tromboembolia Venosa , Anticoagulantes/uso terapêutico , Consenso , Hemorragia/induzido quimicamente , Hemorragia/complicações , Hemorragia/prevenção & controle , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Varfarina
6.
Cardiovasc Intervent Radiol ; 45(7): 918-928, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35445317

RESUMO

PURPOSE: To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation. METHODS: The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention. RESULTS: Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2-89.9) and 90.4% (95% CI 86.5-93.3), and 92.3% (95% CI 89.9-94.1) and 92.9% (95% CI 89.7-95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4-15.3) in males and 11.9% (95% CI 8.6-16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9-11.9) in males and 4.0% (95% CI 2.3-7.0) in females. CONCLUSION: Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation. CLINICAL TRIAL REGISTRATION: NCT02276313. LEVEL OF EVIDENCE: Level 4.


Assuntos
Angioplastia com Balão , Fármacos Cardiovasculares , Doença Arterial Periférica , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Materiais Revestidos Biocompatíveis , Feminino , Artéria Femoral , Humanos , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/complicações , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Estudos Prospectivos , Sistema de Registros , Resultado do Tratamento , Grau de Desobstrução Vascular
7.
Int Angiol ; 41(4): 277-284, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35373941

RESUMO

BACKGROUND: Type II endoleaks are the most common complication occurring after endovascular abdominal aortic aneurysm repair (EVAR). The aims of our study were to evaluate the impact of persistent type II endoleak on sac dynamics post-EVAR, and to study the association between non-anatomical factors including polymorphisms associated with abdominal aortic aneurysm (AAA) and persistent type II endoleak. METHODS: The cohort comprises 210 patients undergoing EVAR between January 2010 and December 2018. A persistent type II endoleak was defined as any type II endoleak lasting longer than six months and included also a type II endoleak diagnosed after six months or more post-EVAR during the 36-month follow-up period confirmed with CT-angiography. Anteroposterior AAA maximum diameter and AAA volume were measured pre-EVAR and 36 months post-EVAR using CT-angiographic pictures. Sac progression was defined as at least 5 mm increase, sac regression as at least 5 mm decrease in the sac diameter in relation to the preprocedural diameter. Sociodemographic information, comorbidities, treatment, laboratory parameters, selected anatomical and genetic factors were all analyzed to determine their impact on persistent type II endoleak. The adjustments included age, hypertension, diabetes mellitus, dyslipidemia, sex, smoking in multivariate analyses. When postprocedural diameter and volume were evaluated, adjustments included also preprocedural diameter/volume. RESULTS: After exclusion, 178 patients with mean age 72.4±7.60 years remained for analysis. Persistent type II endoleak was found in 27.5% of patients (N.=49) and 2.94-times increased risk of sac progression in multivariate analysis (P=0.033). In multivariate analysis, AAA diameter in patients with persistent type II endoleak was 4.31 mm greater than in patients without (B=4.31; P=0.014); and its presence was also associated with 22.0 cm3 greater sac volume (B=22.0; P=0.034) compared to patients without persistent type II endoleak. Treatment with calcium channel blockers increased risk of persistent type II endoleak 2.11-times in multivariate analysis (OR=2.11; 95% CI: 1.05-4.25; P=0.037). No association between persistent type II endoleak and selected polymorphisms associated with AAA and other observed factors were found. CONCLUSIONS: Risk of persistent type II endoleak was more than doubled in patients taking calcium channel blockers. Patients with persistent type II endoleak had greater anteroposterior sac diameter and sac volume compared to patients without persistent type II endoleak.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aortografia , Implante de Prótese Vascular/efeitos adversos , Bloqueadores dos Canais de Cálcio , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
11.
Ann Vasc Surg ; 75: 237-252, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33831519

RESUMO

OBJECTIVES: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation. METHODS: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention. RESULTS: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class. CONCLUSION: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities. CLINICAL TRIAL REGISTRATION: NCT02276313.


Assuntos
Angioplastia com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Diabetes Mellitus , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Dispositivos de Acesso Vascular , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Ásia/epidemiologia , Austrália/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Multimorbidade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
12.
Cardiovasc Intervent Radiol ; 44(1): 10-18, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32964317

RESUMO

PURPOSE: The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups. MATERIALS AND METHODS: BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization) at 6 months and freedom from clinically driven target lesion revascularization (FfTLR) at 12 months. RESULTS: At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6 months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12 months. At 24 months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of - 2.9 ± 1.9, p < 0.0001) and an improvement in pain (mean improvement on Wong-Baker Faces Pain Scale of - 2.7 ± 2.9, p < 0.0001). CONCLUSIONS: In this real-world DCB registry, 24-month outcomes of Passeo-18 Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24 months. TRIAL REGISTRATION: NCT02276313.


Assuntos
Angioplastia com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Artéria Femoral/fisiopatologia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Artéria Poplítea/fisiopatologia , Sistema de Registros , Idoso , Desenho de Equipamento , Feminino , Humanos , Masculino , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
13.
Cardiovasc Intervent Radiol ; 44(2): 207-217, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33083853

RESUMO

PURPOSE: After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. METHODS: BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. RESULTS: 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. CONCLUSION: The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313).


Assuntos
Angioplastia com Balão/métodos , Procedimentos Endovasculares/métodos , Paclitaxel/uso terapêutico , Doença Arterial Periférica/cirurgia , Idoso , Materiais Revestidos Biocompatíveis , Estudos de Coortes , Desenho de Equipamento , Artéria Femoral/fisiopatologia , Artéria Femoral/cirurgia , Seguimentos , Humanos , Masculino , Artéria Poplítea/fisiopatologia , Artéria Poplítea/cirurgia , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento , Moduladores de Tubulina/uso terapêutico , Grau de Desobstrução Vascular
14.
JACC Cardiovasc Interv ; 13(19): 2289-2299, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-32950415

RESUMO

OBJECTIVES: The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon. BACKGROUND: Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices. METHODS: BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6. RESULTS: The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates. CONCLUSIONS: In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.


Assuntos
Paclitaxel/uso terapêutico , Doença Arterial Periférica , Idoso , Angioplastia com Balão , Fármacos Cardiovasculares , Materiais Revestidos Biocompatíveis , Humanos , Isquemia/tratamento farmacológico , Salvamento de Membro , Pessoa de Meia-Idade , Artéria Poplítea , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
15.
J Endovasc Ther ; 27(2): 304-315, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31989855

RESUMO

Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry (ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Idoso , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Ásia , Austrália , Fármacos Cardiovasculares/efeitos adversos , Desenho de Equipamento , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Intervalo Livre de Progressão , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Grau de Desobstrução Vascular
16.
Int Angiol ; 38(5): 410-417, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31566319

RESUMO

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.


Assuntos
Aorta Abdominal/anatomia & histologia , Aneurisma da Aorta Abdominal/sangue , Colágeno Tipo XVIII/sangue , Idoso , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/patologia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/patologia , Biomarcadores/sangue , Estudos Transversais , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Fatores de Risco , Ultrassonografia
17.
Vasa ; 48(4): 347-354, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30874486

RESUMO

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.


Assuntos
Aneurisma da Aorta Abdominal , Idoso , Aortografia , Implante de Prótese Vascular , Endoleak , Procedimentos Endovasculares , Fibrinogênio , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
18.
Int Angiol ; 36(4): 306-315, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27905692

RESUMO

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.


Assuntos
Angioplastia/efeitos adversos , Angioplastia/instrumentação , Isquemia Encefálica/etiologia , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/terapia , Stents , Acidente Vascular Cerebral/etiologia , Fatores Etários , Idoso , Angioplastia/mortalidade , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/mortalidade , Estenose das Carótidas/complicações , Estenose das Carótidas/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Eslováquia , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento
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