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

RESUMEN

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.


Asunto(s)
Neoplasias Abdominales/epidemiología , Aneurisma de la Aorta Abdominal/cirugía , Aortografía/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada/efectos adversos , Procedimientos Endovasculares/efectos adversos , Neoplasias Inducidas por Radiación/epidemiología , Radiografía Intervencional/efectos adversos , Neoplasias Abdominales/diagnóstico , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/epidemiología , Bases de Datos Factuales , Inglaterra/epidemiología , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Neoplasias Inducidas por Radiación/diagnóstico , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
4.
Nature ; 559(7712): 146, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29970911
5.
Eur J Vasc Endovasc Surg ; 55(4): 492-502, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29307756

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Cooperación del Paciente , Complicaciones Posoperatorias/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Humanos , Estimación de Kaplan-Meier , Oportunidad Relativa , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Valor Predictivo de las Pruebas , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
6.
J Endovasc Ther ; 24(6): 764-772, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28895447

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/fisiopatología , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Europa (Continente) , Femenino , Humanos , Masculino , Nueva Zelanda , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
7.
Ann Surg ; 264(6): 1162-1167, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26813915

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Torácica/mortalidad , Aneurisma de la Aorta Torácica/cirugía , Causas de Muerte , Procedimientos Endovasculares/mortalidad , Anciano , Femenino , Humanos , Masculino , Estudios Prospectivos
8.
J Vasc Surg ; 63(6): 1428-1433.e1, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27005591

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Técnicas de Apoyo para la Decisión , Procedimientos Endovasculares/efectos adversos , Complicaciones Posoperatorias/cirugía , Reoperación , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Bélgica , Implantación de Prótesis Vascular/mortalidad , Supervivencia sin Enfermedad , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Países Bajos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Valor Predictivo de las Pruebas , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
9.
J Endovasc Ther ; 23(1): 7-20, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26564913

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Diagnóstico por Imagen/normas , Endofuga/diagnóstico , Procedimientos Endovasculares/instrumentación , Stents , Lesiones del Sistema Vascular/diagnóstico , Aneurisma de la Aorta Abdominal/diagnóstico , Aortografía/normas , Implantación de Prótesis Vascular/efectos adversos , Consenso , Diagnóstico por Imagen/métodos , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Humanos , Angiografía por Resonancia Magnética/normas , Valor Predictivo de las Pruebas , Diseño de Prótesis , Reproducibilidad de los Resultados , Factores de Tiempo , Tomografía Computarizada por Rayos X/normas , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex/normas , Lesiones del Sistema Vascular/etiología
10.
J Endovasc Ther ; 23(1): 21-8, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26620398

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico , Rotura de la Aorta/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Embolización Terapéutica , Endofuga/etiología , Endofuga/mortalidad , Endofuga/terapia , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Europa (Continente) , Estudios de Factibilidad , Femenino , Humanos , Masculino , Nueva Zelanda , Diseño de Prótesis , Sistema de Registros , Retratamiento , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
11.
J Endovasc Ther ; 23(5): 685-92, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-27555430

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/terapia , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aortografía , Femenino , Humanos , Masculino , Diseño de Prótesis , Sistema de Registros , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del Tratamiento
12.
Circulation ; 130(24): 2136-42, 2014 Dec 09.
Artículo en Inglés | MEDLINE | ID: mdl-25378548

RESUMEN

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.


Asunto(s)
Aneurisma Infectado/microbiología , Aneurisma Infectado/terapia , Aneurisma de la Aorta/microbiología , Aneurisma de la Aorta/terapia , Procedimientos Endovasculares/métodos , Adulto , Anciano , Anciano de 80 o más Años , Aneurisma Infectado/epidemiología , Antibacterianos/uso terapéutico , Aneurisma de la Aorta/epidemiología , Europa (Continente)/epidemiología , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Análisis de Regresión , Estudios Retrospectivos , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/microbiología , Infección de la Herida Quirúrgica/mortalidad , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento
13.
Kidney Int ; 87(2): 442-51, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25140912

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares/efectos adversos , Riñón/fisiopatología , Creatinina/sangre , Humanos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Insuficiencia Renal/etiología , Insuficiencia Renal/fisiopatología , Factores de Tiempo
14.
J Vasc Surg ; 62(2): 290-8, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-25953017

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/prevención & control , Procedimientos Endovasculares/instrumentación , Anciano , Anciano de 80 o más Años , Aneurisma Roto/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Radiografía , Reoperación , Estudios Retrospectivos , Stents
15.
J Endovasc Ther ; 22(3): 309-11, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25862364

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/cirugía , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/cirugía , Stents , Anciano de 80 o más Años , Angiografía de Substracción Digital , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Endofuga/diagnóstico , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Migración de Cuerpo Extraño/diagnóstico , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Diseño de Prótesis , Reoperación , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex
16.
J Endovasc Ther ; 22(3): 330-7, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25862366

RESUMEN

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.


Asunto(s)
Aneurisma/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Arteria Poplítea/cirugía , Stents , Anciano , Anciano de 80 o más Años , Aneurisma/diagnóstico , Aneurisma/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Estimación de Kaplan-Meier , Recuperación del Miembro , Masculino , Arteria Poplítea/fisiopatología , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
17.
Circulation ; 127(1): 24-32, 2013 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-23283856

RESUMEN

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.


Asunto(s)
Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/mortalidad , Aneurisma de la Aorta Torácica/cirugía , Procedimientos Endovasculares/mortalidad , Sistema de Registros/estadística & datos numéricos , Enfermedad Aguda , Adulto , Anciano , Anciano de 80 o más Años , Disección Aórtica/mortalidad , Disección Aórtica/patología , Disección Aórtica/cirugía , Aorta Torácica/patología , Aneurisma de la Aorta Torácica/patología , Enfermedad Crónica , Ensayos Clínicos como Asunto , Bases de Datos Factuales/estadística & datos numéricos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
19.
Ann Surg ; 260(2): 389-95, 2014 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-24441822

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Torácica/etiología , Aneurisma de la Aorta Torácica/cirugía , Disección Aórtica/etiología , Disección Aórtica/cirugía , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular , Humanos , Incidencia , Sistema de Registros , Reino Unido
20.
J Vasc Surg ; 59(1): 248-54, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24199764

RESUMEN

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.


Asunto(s)
Aorta Torácica/cirugía , Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Fístula Esofágica/cirugía , Fístula Vascular/cirugía , Antibacterianos/uso terapéutico , Enfermedades de la Aorta/diagnóstico , Enfermedades de la Aorta/mortalidad , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Distribución de Chi-Cuadrado , Remoción de Dispositivos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Fístula Esofágica/diagnóstico , Fístula Esofágica/mortalidad , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/cirugía , Recurrencia , Reoperación , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Fístula Vascular/diagnóstico , Fístula Vascular/mortalidad
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