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1.
Nature ; 2021 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-34707266
2.
Nature ; 2020 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-34193987
3.
J Vasc Surg ; 69(6): 1776-1785.e2, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30583890

RESUMO

OBJECTIVE: Endovascular aneurysm repair (EVAR) has increasingly been used as the primary treatment approach for abdominal aortic aneurysm (AAA). This study examined the hypothesis that EVAR leads to an increased risk of abdominal cancer within the radiation field compared with open AAA repair. METHODS: The nationwide English Hospital Episode Statistics database was used to identify all patients older than 50 years who received an AAA repair in 2005 to 2013. EVAR and open AAA repair groups were compared for the incidence of postoperative cancer using inverse probability weights and G-computation formula to adjust for selection bias and confounding. RESULTS: Among 14,150 patients who underwent EVAR and 24,645 patients who underwent open AAA repair, follow-up was up to 7 years. EVAR was associated with an increased risk of postoperative abdominal cancer (hazard ratio [HR], 1.14; 95% confidence interval [CI], 1.03-1.27) and all cancers (HR, 1.09; 95% CI, 1.02-1.17). However, there was no difference between the groups in the risk of lung cancer (HR, 1.04; 95% CI, 0.92-1.18) or obesity-related nonabdominal cancer (HR, 1.12; 95% CI, 0.69-1.83). Within the EVAR group, use of computed tomography surveillance was not associated with any increased risk of abdominal cancer (HR, 0.94; 95% CI, 0.71-1.23) or all cancers (HR, 0.97; 95% CI, 0.81-1.17). CONCLUSIONS: This study suggests an increased risk of abdominal cancer after EVAR compared with open AAA repair. The differential cancer risk should be further explored in alternative national populations, and radiation exposure during EVAR should be measured as a quality metric in the assessment of EVAR centers.


Assuntos
Neoplasias Abdominais/epidemiologia , Aneurisma da Aorta Abdominal/cirurgia , Aortografia/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Angiografia por Tomografia Computadorizada/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Neoplasias Induzidas por Radiação/epidemiologia , Radiografia Intervencionista/efeitos adversos , Neoplasias Abdominais/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/epidemiologia , Bases de Dados Factuais , Inglaterra/epidemiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias Induzidas por Radiação/diagnóstico , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
4.
Nature ; 559(7712): 146, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29970911
5.
Eur J Vasc Endovasc Surg ; 55(4): 492-502, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29307756

RESUMO

OBJECTIVE/BACKGROUND: Increasingly, reports show that compliance rates with endovascular aneurysm repair (EVAR) surveillance are often suboptimal. The aim of this study was to determine the safety implications of non-compliance with surveillance. METHODS: The study was carried out according to the Preferred Items for Reporting of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. An electronic search was undertaken by two independent authors using Embase, MEDLINE, Cochrane, and Web of Science databases from 1990 to July 2017. Only studies that analysed infrarenal EVAR and had a definition of non-compliance described as weeks or months without imaging surveillance were analysed. Meta-analysis was carried out using the random-effects model and restricted maximum likelihood estimation. RESULTS: Thirteen articles (40,730 patients) were eligible for systematic review; of these, seven studies (14,311 patients) were appropriate for comparative meta-analyses of mortality rates. Three studies (8316 patients) were eligible for the comparative meta-analyses of re-intervention rates after EVAR and four studies (12,995 patients) eligible for meta-analysis for abdominal aortic aneurysm related mortality (ARM). The estimated average non-compliance rate was 42.0% (95% confidence interval [CI] 28-56%). Although there is some evidence that non-compliant patients have better survival rates, there was no statistically significant difference in all cause mortality rates (year 1: odds ratio [OR] 5.77, 95% CI 0.74-45.14; year 3: OR 2.28, 95% CI 0.92-5.66; year 5: OR 1.81, 95% CI 0.88-3.74) and ARM (OR 1.47, 95% CI 0.99-2.19) between compliant and non-compliant patients in the first 5 years after EVAR. The re-intervention rate was statistically significantly higher in compliant patients from 3 to 5 years after EVAR (year 1: OR 6.36, 95% CI 0.23-172.73; year 3: OR 3.94, 85% CI 1.46-10.69; year 5: OR 5.34, 95% CI 1.87-15.29). CONCLUSION: This systematic review and meta-analysis suggests that patients compliant with EVAR surveillance programmes may have an increased re-intervention rate but do not appear to have better survival rates than non-compliant patients.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Cooperação do Paciente , Complicações Pós-Operatórias/diagnóstico por imagem , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Humanos , Estimativa de Kaplan-Meier , Razão de Chances , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Valor Preditivo dos Testes , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
6.
J Endovasc Ther ; 24(6): 764-772, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28895447

RESUMO

PURPOSE: To report the results of the ASCEND Registry of cases involving endovascular aneurysm sealing (EVAS) in combination with chimney grafts (chEVAS) for the treatment of para- and juxtarenal aortic aneurysms (AAA). METHODS: A retrospective, multicenter registry established in 8 vascular centers between 2013 and 2016 recorded the treatment results and follow-up of chEVAS procedures for nonruptured AAAs; data were analyzed using standardized outcome measures. In the observation period, 154 patients (mean age 72.3±7.7 years; 124 men) underwent elective treatment for de novo juxtarenal and pararenal aneurysms and formed the study group. RESULTS: Sixty-two (40.3%) of the cohort were treated using a single parallel graft, 54 (35.1%) with double chimneys, 27 (17.5%) with triple chimneys, and 11 (7.1%) with 4 chimneys. The 30-day mortality was 2.8%, and there were 4 perioperative strokes (1 fatal). At 1 year, the freedom from all-cause mortality was 89.8% and the freedom from aneurysm-related mortality was 94.3%. There were 3 endoleaks within 90 days of the procedure, one type Ia and 2 type Ib. The freedom from type Ia endoleaks was 95.7% at 1 year. There were no types II or III endoleaks in this series; the freedom from all endoleaks was 94.2% at 1 year. Freedom from reintervention at 1 year was 89.2%. Target vessel patency rates at 1 year were 97.7%, 99.3%, 100%, and 100% for the left renal, right renal, superior mesenteric artery, and celiac axis stents, respectively. CONCLUSION: The ASCEND Registry supports a proof of concept for the use of polymer technology and EVAS with parallel grafts in managing patients with complex aortic disease. The future role of chEVAS will be defined by studies that assess mid- to long-term durability.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/fisiopatologia , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Angiografia por Tomografia Computadorizada , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Europa (Continente) , Feminino , Humanos , Masculino , Nova Zelândia , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
7.
Ann Surg ; 264(6): 1162-1167, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26813915

RESUMO

INTRODUCTION: All-cause mortality in patients after repair of aortic aneurysms of the descending thoracic aorta thoracic endovascular aortic repair (TEVAR) is relatively high at mid-term follow-up. The aim of this study was to derive and validate a system that could predict all-cause mortality after TEVAR to aid with patient selection. METHODS: The MOTHER database contained 625 patients that underwent elective surgery for descending thoracic aortic aneurysms. Univariate analysis identified preoperative factors associated with mid-term all-cause mortality, and a Cox proportional hazards model was developed. The model was internally validated using Kaplan-Meier comparison of observed vs predicted mortality. External validation was performed using a data set from the University of Florida College of Medicine. RESULTS: There were 625 patients that underwent TEVAR for descending thoracic aortic aneurysm in the MOTHER database and 231 in the University of Florida College of Medicine validation set. The mid-term mortality rate at 6 years of follow-up was 34.4% and 34%, respectively. The all-cause mortality risk score was calculated using 0.0398 × (age) + 0.516 × (renal insufficiency) + 0.46 × (previous cerebrovascular disease) + 0.352 × (prior tobacco use) + 0.376 × (number of devices >2) + 0.016 × (maximum aneurysm diameter). Using this score, low-, medium-, and high-risk groups were defined, with predicted survival at 5 years of 80%, 60%, and 40%. Patients at high risk of mid-term all-cause death were identified in the validation cohort using the prediction rule. CONCLUSIONS: Identifying patients with a limited life expectancy after TEVAR is possible using a preoperative risk-stratification system. This information can be used to inform decision making regarding when and whether to proceed with TEVAR.


Assuntos
Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/cirurgia , Causas de Morte , Procedimentos Endovasculares/mortalidade , Idoso , Feminino , Humanos , Masculino , Estudos Prospectivos
8.
J Vasc Surg ; 63(6): 1428-1433.e1, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27005591

RESUMO

BACKGROUND: Identifying patients at risk for aneurysm rupture and sac expansion after open and endovascular abdominal aortic aneurysm (AAA) repair (EVAR) may help to attenuate this risk by intensifying follow-up and early detection of problems. The goal of this study was to validate the St George's Vascular Institute (SGVI) score to identify patients at risk for a secondary intervention after elective aneurysm repair. METHODS: A post hoc on-treatment analysis of a randomized trial comparing open AAA repair and EVAR was performed. In this multicenter trial, 351 patients were randomly assigned to undergo open AAA repair or EVAR. Information on survival and reinterventions was available for all patients at 5 years postoperatively, for 79% at 6 years, and for 53% at 7 years. Open repair was completed in 173 patients and EVAR in 171, based on an on-treatment analysis. Because 17 patients had incomplete anatomic data, 327 patients (157 open repair and 170 EVAR) were available for analysis. During 6 years of follow-up, 78 patients underwent at least one reintervention. The SGVI score, which is calculated from preoperative AAA morphology using aneurysm and iliac diameter, predictively dichotomized patients into groups at high-risk or low-risk for a secondary intervention. The observed freedom from reintervention was compared between groups at predicted high-risk and predicted low-risk. RESULTS: The 20 patients in the high-risk group were indeed at higher risk for a secondary intervention compared with the 307 patients predicted to be at low risk (hazard ratio [HR], 3.82; 95% confidence interval [CI], 2.05-7.11; P < .001). Discrimination between high-risk and low-risk groups was valid for EVAR (HR, 4.06; 95% CI, 1.93-8.51; P < .001) and for open repair (HR, 3.41; 95% CI, 1.02-11.4; P = .033). CONCLUSIONS: The SGVI score appears to be a useful tool to predict reintervention risk in patients after open repair and EVAR.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Técnicas de Apoio para a Decisão , Procedimentos Endovasculares/efeitos adversos , Complicações Pós-Operatórias/cirurgia , Reoperação , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Bélgica , Implante de Prótese Vascular/mortalidade , Intervalo Livre de Doença , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Países Baixos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
9.
J Endovasc Ther ; 23(1): 7-20, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26564913

RESUMO

Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Diagnóstico por Imagem/normas , Endoleak/diagnóstico , Procedimentos Endovasculares/instrumentação , Stents , Lesões do Sistema Vascular/diagnóstico , Aneurisma da Aorta Abdominal/diagnóstico , Aortografia/normas , Implante de Prótese Vascular/efeitos adversos , Consenso , Diagnóstico por Imagem/métodos , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Humanos , Angiografia por Ressonância Magnética/normas , Valor Preditivo dos Testes , Desenho de Prótese , Reprodutibilidade dos Testes , Fatores de Tempo , Tomografia Computadorizada por Raios X/normas , Resultado do Tratamento , Ultrassonografia Doppler Dupla/normas , Lesões do Sistema Vascular/etiologia
10.
J Endovasc Ther ; 23(1): 21-8, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26620398

RESUMO

PURPOSE: To assess the feasibility and safety of the endovascular aneurysm sealing (EVAS) technique in the treatment of acute abdominal aortic aneurysm (AAA). METHODS: A retrospective, multicenter, observational study was conducted at 8 centers (7 European and 1 in New Zealand) experienced with EVAS in the elective setting. From February 2013 to April 2015, 58 patients (mean age 74±9 years; 46 men) with an acute AAA were treated (28 ruptured and 30 symptomatic). The primary endpoint of the study was 30-day mortality; secondary endpoints included endoleak, reinterventions, and 30-day morbidity. RESULTS: The overall intensive care unit and hospital stays were 2.2±6.6 days and 9.7±11.4 days, respectively. Thirty-day mortality rates were 32% (9/28) for the ruptured group and 7% (2/30) for the symptomatic group, with morbidity rates of 57% and 17%, respectively. Early endoleak was present in only 2 (3%) patients, one in each group; both leaks were type Ia. Reinterventions within 30 days were performed in 8 patients in the ruptured group; in the symptomatic patients, the only perioperative reintervention was embolization a type Ia endoleak. The mean follow-up was 9.3±3.1 months in the ruptured group and 12.4±5.4 months in the symptomatic group. The mean aneurysm diameter at 30-day follow-up was 71.8±16.0 mm compared with 74.7±15.7 mm preoperatively in the ruptured group and 66.1±13.5 mm compared with 65.8±13.0 mm in the symptomatic group. CONCLUSION: EVAS in the acute setting appears safe and feasible and concordant with the literature for endovascular aneurysm repair. More robust prospective and comparative data are required to establish the position of the technique in the treatment algorithm of acute AAA.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico , Aneurisma da Aorta Abdominal/mortalidade , Ruptura Aórtica/diagnóstico , Ruptura Aórtica/mortalidade , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Embolização Terapêutica , Endoleak/etiologia , Endoleak/mortalidade , Endoleak/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Europa (Continente) , Estudos de Viabilidade , Feminino , Humanos , Masculino , Nova Zelândia , Desenho de Prótese , Sistema de Registros , Retratamento , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
11.
J Endovasc Ther ; 23(5): 685-92, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27555430

RESUMO

PURPOSE: To report the early and 12-month results of a global registry of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic aneurysms (AAAs). METHODS: The EVAS FORWARD Global Registry was a postmarket, multicenter, open-label, single-arm registry that enrolled 277 patients (mean age 75 years; 228 men) treated with the Nellix EVAS system for nonruptured AAAs at 18 sites over a 1-year period. The cohort had challenging aortic anatomy, with 17% having a proximal aortic neck length <10 mm, 8% a neck angulation >60°, and 20% an iliac diameter >25 mm. Baseline and follow-up computed tomography images were assessed by an independent core laboratory, and major adverse events were reviewed by an independent safety committee. RESULTS: Three patients died within 30 days of the procedure (none device-related). There were 13 endoleaks recorded in this time frame: 8 type Ia, 1 type Ib, and 5 type II. Root cause analysis demonstrated that the majority of type Ia endoleaks were due to technical error (low device placement and underfilling of the endobags). Between 30 days and 1 year, there were 4 new type Ia endoleaks; all were treated. There was also 1 type III endoleak between a Nellix device and a distal extension limb. At 1 year, the persistent endoleak rate was 0.7% (1 type Ia and 1 type II). The Kaplan-Meier estimates of freedom from types I and II endoleak at 12-month follow-up were 96% and 98%, respectively. The estimate of freedom from open conversion (n=7) was 98% at 12 months and the rate of freedom from any reintervention was 92%. The need for secondary intervention was associated with aortic morphology; for patients meeting the requirements of the instructions for use (IFU), the freedom from reintervention at 12 months was 98% compared with 86% when the implant was outside the IFU (p=0.009). At 1 year, the estimates of freedom from aortic-related and all-cause mortality were 98% and 95%, respectively. CONCLUSION: The EVAS FORWARD Global Registry documents the 12-month outcome of EVAS in an unselected group of patients with challenging aortic morphology. The results at present appear acceptable with regard to perioperative outcomes and complications. The type II endoleak rate is low. The place of EVAS in the armamentarium of techniques to treat AAAs will be defined by durability data in the longer term.


Assuntos
Aneurisma da Aorta Abdominal/terapia , Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Idoso , Aortografia , Feminino , Humanos , Masculino , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
12.
Circulation ; 130(24): 2136-42, 2014 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-25378548

RESUMO

BACKGROUND: Mycotic aortic aneurysm (MAA) is a rare and life-threatening disease. The aim of this European multicenter collaboration was to study the durability of endovascular aortic repair (EVAR) of MAA, by assessing late infection-related complications and long-term survival. METHODS AND RESULTS: All EVAR treated MAAs, between 1999 and 2013 at 16 European centers, were retrospectively reviewed. One hundred twenty-three patients with 130 MAAs were identified. Mean age was 69 years (range 39-86), 87 (71%) were men, 58 (47%) had immunodeficiency, and 47 (38%) presented with rupture. Anatomic locations were ascending/arch (n=4), descending (n=34), paravisceral (n=15), infrarenal aorta (n=63), and multiple (n=7). Treatments were thoracic EVAR (n=43), fenestrated/branched EVAR (n=9), and infrarenal EVAR (n=71). Antibiotic was administered for mean 30 weeks. Mean follow-up was 35 months (range 1 week to 149 months). Six patients (5%) were converted to open repair during follow-up. Survival was 91% (95% confidence interval, 86% to 96%), 75% (67% to 83%), 55% (44% to 66%), and 41% (28% to 54%) after 1, 12, 60, and 120 months, respectively. Infection-related death occurred in 23 patients (19%), 9 after discontinuation of antibiotic treatment. A Cox regression analysis demonstrated non-Salmonella-positive culture as predictors for late infection-related death. CONCLUSIONS: Endovascular treatment of MAA is feasible and for most patients a durable treatment option. Late infections do occur, are often lethal, and warrant long-term antibiotic treatment and follow-up. Patients with non-Salmonella-positive blood cultures were more likely to die from late infection.


Assuntos
Aneurisma Infectado/microbiologia , Aneurisma Infectado/terapia , Aneurisma Aórtico/microbiologia , Aneurisma Aórtico/terapia , Procedimentos Endovasculares/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Infectado/epidemiologia , Antibacterianos/uso terapêutico , Aneurisma Aórtico/epidemiologia , Europa (Continente)/epidemiologia , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/microbiologia , Infecção da Ferida Cirúrgica/mortalidade , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento
13.
Kidney Int ; 87(2): 442-51, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25140912

RESUMO

Deterioration in renal function has been described after endovascular repair of abdominal aortic aneurysms (EVRs). The etiology is multifactorial and represents an important therapeutic target. A need exists to quantitatively summarize incidence and severity of renal dysfunction after EVR to allow better-informed attempts to preserve renal function and improve life expectancy. Here a systematic search was performed using Medline and Embase for renal function after EVR applying PRISMA statements. Univariate and multivariate random-effects meta-analyses were performed to estimate pooled postoperative changes in serum creatinine and creatinine clearance at four time points after EVR. Clinically relevant deterioration in renal function was also estimated at 1 year or more after EVR. Pooled probability of clinically relevant deterioration in renal function at 1 year or more was 18% (95% confidence interval of 14-23%, I2 of 82.5%). Serum creatinine increased after EVR by 0.05 mg/dl at 30 days/1 month, 0.09 mg/dl at 1 month to 1 year, and 0.11 mg/dl at 1 year or more (all significant). Creatinine clearance decreased after EVR by 5.65 ml/min at 1 month-1 year and by 6.58 ml/min at 1 year or more (both significant). Thus, renal dysfunction after EVR is common and merits attention.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/efeitos adversos , Rim/fisiopatologia , Creatinina/sangue , Humanos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/fisiopatologia , Insuficiência Renal/etiologia , Insuficiência Renal/fisiopatologia , Fatores de Tempo
14.
J Vasc Surg ; 62(2): 290-8, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25953017

RESUMO

OBJECTIVE: Despite improvements in endograft devices, operator technique, and patient selection, endovascular repair has not achieved the long-term durability of open surgical aneurysm repair. Persistent or recurrent aneurysm sac flow from failed proximal sealing, component failure, or branch vessel flow underpins a significant rate of reintervention after endovascular repair. The Nellix device (Endologix, Irvine, Calif) employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow. This retrospective analysis represents the initial experience in consecutive patients treated with the device in real-world practice. METHODS: This study was performed at six clinical centers in Europe and one in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with computed tomography and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. Clinical and imaging end points included technical success (successful device deployment and absence of any endoleak at completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and reintervention. RESULTS: During a 17-month period, 171 patients with abdominal aortic aneurysms were treated with the Nellix device and observed for a median of 5 months (range, 0-14 months). The 153 male and 18 female patients with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infrarenal neck length of 28 ± 15 mm and infrarenal angulation of 37 ± 22 degrees. Technical success was achieved in all but two patients (99%); one patient had a type Ib endoleak and another had a type II endoleak. Through the last available follow-up, type Ia endoleak was observed in five patients (3%), type Ib endoleak in four patients (2%), and type II endoleak in four patients (2%). There were eight limb occlusions (5%), among which seven were evident at the 1-month follow-up visit. Aneurysm-related reinterventions were performed in 15 patients (9%). There were no aneurysm ruptures or open surgical conversions. CONCLUSIONS: This first multicenter postmarket report of the Nellix device for infrarenal abdominal aortic aneurysm repair demonstrates satisfactory results during the initial learning phase of this new technology. The rate of aneurysm exclusion was high, and frequency of complications was low. More definitive conclusions on the value of this novel device await the results of the ongoing Nellix EVAS FORWARD Global Registry and the EVAS FORWARD investigational device exemption trial.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Endoleak/prevenção & controle , Procedimentos Endovasculares/instrumentação , Idoso , Idoso de 80 Anos ou mais , Aneurisma Roto/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Endoleak/cirurgia , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Radiografia , Reoperação , Estudos Retrospectivos , Stents
15.
J Endovasc Ther ; 22(3): 309-11, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25862364

RESUMO

PURPOSE: To report the application of the Nellix endovascular aneurysm sealing (EVAS) device, including two chimney grafts, to successfully treat a type Ia endoleak. CASE REPORT: An 87-year-old man had an asymptomatic 7.6-cm infrarenal abdominal aortic aneurysm (AAA) and a 4.5-cm right internal iliac artery aneurysm treated using an aortouni-iliac stent-graft. Two years after the index endovascular repair, an asymptomatic type Ia endoleak was detected on duplex ultrasound; the computed tomographic angiogram (CTA) demonstrated significant sac enlargement and stent-graft migration. Initial attempts to treat the leak with 2 aortic cuffs only reduced the size of the endoleak. Another procedure was undertaken using the Nellix device with chimney grafts to increase the proximal sealing zone above the existing stent-graft. Imaging postoperatively demonstrated successful resolution of the endoleak and continuing patency of both renal artery chimney stent-grafts. CTA at 6 months demonstrated persistent sealing of the endoleak. CONCLUSION: The use of the EVAS system may represent another endovascular solution that can be added to the clinician's repertoire for treating type Ia endoleak after conventional endovascular repair of infrarenal AAA.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Endoleak/cirurgia , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/cirurgia , Stents , Idoso de 80 Anos ou mais , Angiografia Digital , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Endoleak/diagnóstico , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/diagnóstico , Migração de Corpo Estranho/etiologia , Humanos , Masculino , Desenho de Prótese , Reoperação , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Ultrassonografia Doppler Dupla
16.
J Endovasc Ther ; 22(3): 330-7, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25862366

RESUMO

PURPOSE: To perform an evidence synthesis study to assess outcomes of endovascular repair of popliteal artery aneurysms (PAAs) using the Hemobahn or Viabahn stent-graft. METHODS: A systematic literature review was conducted conforming to established standards to identify articles published between 1996 (the date of introduction of the Hemobahn stent-graft) and 2013 reporting stent-graft repair of PAAs in at least 10 patients. The data were pooled for Kaplan-Meier analysis of primary and secondary patency rates [presented with 95% confidence intervals (CIs)] as the primary outcomes. Random effects meta-analysis was performed for secondary outcomes that included rates of reintervention, endoleak, stent-graft fracture, and limb salvage. RESULTS: Fourteen studies reported outcomes for 514 PAAs. There was considerable heterogeneity in reporting standards among studies. Pooled primary and secondary patency rates were 69.4% (95% CI 63.3% to 76.2%) and 77.4% (95% CI 70.1% to 85.3%), respectively, at 5 years. Five studies (including only one randomized controlled trial) compared surgical to endovascular repair; no difference was found in primary patency on evidence synthesis (hazard ratio 1.30, 95% CI 0.79 to 12.14, p=0.189). CONCLUSION: Stent-graft repair provides a feasible treatment option for anatomically suitable PAAs. Further studies are required to optimize both patient selection and follow-up protocols.


Assuntos
Aneurisma/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Artéria Poplítea/cirurgia , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma/diagnóstico , Aneurisma/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Artéria Poplítea/fisiopatologia , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
17.
Circulation ; 127(1): 24-32, 2013 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-23283856

RESUMO

BACKGROUND: Endovascular repair of the thoracic aorta has become an increasingly utilized therapy. Although the short-term mortality advantage over open surgery is well documented, late mortality and the impact of presenting pathology on long-term outcomes remain poorly reported. METHODS AND RESULTS: A database was built from 5 prospective studies and a single institutional series. Rates of perioperative adverse events were calculated, as were midterm death and reintervention rates. Multivariate analysis was performed with the use of logistic regression modeling. Kaplan-Meier survival curves were drawn for midterm outcomes. The database contained 1010 patients: 670 patients with thoracic aortic aneurysm, 195 with chronic type B aortic dissection, and 114 with acute type B aortic dissection. Lower elective mortality was observed in patients with chronic dissections (3%) compared with patients with aneurysms (5%). Multivariate analysis identified age, mode of admission, American Society of Anesthesiologists grade, and pathology as independent predictors of 30-day death (P < 0.05). In the midterm, the all-cause mortality rate was 8, 4.9, and 3.2 deaths per 100 patient-years for thoracic aortic aneurysm, acute type B aortic dissection, and chronic type B aortic dissection, respectively. The rates of aortic-related death were 0.6, 1.2, and 0.4 deaths per 100 patient-years for thoracic aortic aneurysm, acute type B aortic dissection, and chronic type B aortic dissection, respectively. CONCLUSIONS: This study indicated that the midterm outcomes of endovascular repair of the thoracic aorta are defined by presenting pathology, associated comorbidities, and mode of admission. Nonaortic mortality is high in the midterm for patients with thoracic aortic aneurysm, and managing modifiable risk factors appears vital. Endovascular repair of the thoracic aorta results in excellent midterm protection from aortic-related mortality, regardless of presenting pathology.


Assuntos
Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/cirurgia , Procedimentos Endovasculares/mortalidade , Sistema de Registros/estatística & dados numéricos , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Dissecção Aórtica/mortalidade , Dissecção Aórtica/patologia , Dissecção Aórtica/cirurgia , Aorta Torácica/patologia , Aneurisma da Aorta Torácica/patologia , Doença Crônica , Ensaios Clínicos como Assunto , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
19.
Ann Surg ; 260(2): 389-95, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24441822

RESUMO

OBJECTIVE: To provide data regarding the etiology and timing of retrograde type A aortic dissection (RTAD) after thoracic endovascular aortic repair (TEVAR). METHODS: Details of patients who had RTAD after TEVAR were obtained from the MOTHER Registry supplemented by data from a systematic review of the literature. Univariate analysis and binary logistic regression analysis of patient or technical factors was performed. RESULTS: In MOTHER, RTAD developed in 16 of the 1010 patients (1.6%). Binary logistic regression demonstrated that an indication of TEVAR for aortic dissection (acute P = 0.000212; chronic P = 0.006) and device oversizing (OR 1.14 per 1% increase in oversizing above 9%, P < 0.0001) were significantly more frequent in patients with RTAD. Data from the systematic review was pooled with MOTHER data and demonstrated that RTAD occurred in 1.7% (168/9894). Most of RTAD occurred in the immediate postoperative (58%) period and was associated with a high mortality rate (33.6%). The odds ratio of RTAD for an acute aortic dissection was 10.0 (CI: 4.7-21.9) and 3.4 (CI: 1.3-8.8) for chronic aortic dissection. The incidence of RTAD was not significantly different for endografts with proximal bare stent (2.8%) or nonbare stent (1.9%) (P = 0.1298). CONCLUSIONS: Although RTAD after TEVAR is an uncommon complication, it has a high mortality rate. RTAD is significantly more frequent in patients treated for acute and chronic type B dissection, and when the endograft is significantly oversized. The proximal endograft configuration was not associated with any difference in the incidence of RTAD.


Assuntos
Aneurisma da Aorta Torácica/etiologia , Aneurisma da Aorta Torácica/cirurgia , Dissecção Aórtica/etiologia , Dissecção Aórtica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Prótese Vascular , Humanos , Incidência , Sistema de Registros , Reino Unido
20.
J Vasc Surg ; 59(1): 248-54, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24199764

RESUMO

OBJECTIVE: To provide a systematic review of the outcomes of thoracic endovascular aortic repair (TEVAR) for aortoesophageal fistula (AEF) and to identify prognostic factors associated with poor outcomes. METHODS: Literature searches of the Embase, Medline, and Cochrane databases identified relevant articles reporting results of TEVAR for AEF. The main outcome measure was the composite of aortic mortality, recurrence of the AEF, and stent graft explantation. The secondary outcome measure was aortic-related mortality. RESULTS: Fifty-five articles were integrated after a literature search identified 72 patients treated by TEVAR for AEFs. The technical success rate of TEVAR was 87.3%. The overall 30-day mortality was 19.4%. Prolonged antibiotics (>4 weeks) were administered in 80% of patients. Concomitant or staged resection or repair of the esophagus was performed in 44.4% of patients. Stent graft explantation was performed within the first month after TEVAR as a planned treatment in 11.1%. After a mean follow-up of 7.4 months (range, 1-33 months), the all-cause mortality was 40.2%, and the aortic-related mortality was 33.3. Prolonged antibiotic treatment (P = .001) and repair of AEFs due to a foreign body (P = .038) were associated with a significant lower aortic mortality. On univariate analysis, TEVAR and concomitant or staged adjunctive procedures (resection, repair of the esophagus, or a planned stent graft explantation) were associated with a significantly lower incidence of aortic-related mortality (P = .0121). When entered into a binary logistic regression analysis, prolonged antibiotic treatment was the only factor associated with a significant lower incidence of the endpoint (P = .003). CONCLUSIONS: Late infection or recurrence of the AEF and associated mortality rates are high when TEVAR is used as a sole therapeutic strategy. Prolonged antibiotic treatment has a strong negative association with mortality. A strategy of a temporizing endovascular procedure to stabilize the patient in extremis, and upon recovery, an open surgical esophageal repair with or without stent graft explantation is advocated.


Assuntos
Aorta Torácica/cirurgia , Doenças da Aorta/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Fístula Esofágica/cirurgia , Fístula Vascular/cirurgia , Antibacterianos/uso terapêutico , Doenças da Aorta/diagnóstico , Doenças da Aorta/mortalidade , Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Distribuição de Qui-Quadrado , Remoção de Dispositivo , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Fístula Esofágica/diagnóstico , Fístula Esofágica/mortalidade , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Infecções Relacionadas à Prótese/etiologia , Infecções Relacionadas à Prótese/cirurgia , Recidiva , Reoperação , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Fístula Vascular/diagnóstico , Fístula Vascular/mortalidade
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