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1.
J Endovasc Ther ; 30(3): 449-460, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-35297713

RESUMEN

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Reparación Endovascular de Aneurismas , Técnica Delphi , Consenso , Testimonio de Experto , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Factores de Riesgo , Estudios Retrospectivos , Prótesis Vascular
2.
Eur J Vasc Endovasc Surg ; 66(6): 849-854, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37659740

RESUMEN

OBJECTIVE: Inflow arterial aneurysms are a rare but serious complication after long term arteriovenous fistulae (AVF), probably due to arterial wall remodelling after an increase in flow and shear stress, and kidney transplantation with immunosuppressive therapy. This study aimed to describe the outcomes of surgical treatment and long term follow up in a large cohort. METHODS: This prospective cohort study collected data from patients with a true inflow artery aneurysm after AVF creation that was surgically repaired between 2010 and 2022. Anastomotic and infected aneurysms or post-puncture pseudoaneurysms were excluded. Demographic data, access characteristics, symptoms, treatment strategies, and long term follow up were recorded; patency was estimated using Kaplan-Meier survival analysis. RESULTS: During the study period, 28 patients (64% men, mean age 60.1 years) were treated surgically for aneurysmal degeneration of the axillary or brachial (n = 23) or radial (n = 5) artery after an AVF (10 distal, 18 proximal) performed a mean of 18.3 ± SD 7.9 years previously. Most AVFs were ligated or thrombosed, while all patients except one had previously received kidney transplants. Most of the cases (n = 18) were symptomatic: 13 with pain or swelling, four with distal embolisation, and one rupture. They were repaired by aneurysm partial excision and graft interposition (11 great saphenous vein, six ipsilateral basilic vein, three cephalic vein, and two PTFE graft), ligation (n = 3), or direct end to end anastomosis (n = 3). No major complications occurred before discharge, after a mean hospital stay of 2.4 days. After a mean follow up of 4.8 ± 3.3 years, three cases presented complications: two recurrent proximal brachial aneurysms were repaired with an additional proximal interposition graft (one with further late infected pseudoaneurysm) and an asymptomatic post-traumatic graft thrombosis. Five year primary and secondary patency was 84% and 96%, respectively. CONCLUSION: Aneurysmal degeneration of the inflow artery is an unusual complication during long term follow up of AVFs. Aneurysm excision and, in general, autogenous graft interposition using the saphenous or ipsilateral arm vein is a safe and effective strategy.


Asunto(s)
Aneurisma , Fístula Arteriovenosa , Derivación Arteriovenosa Quirúrgica , Masculino , Humanos , Persona de Mediana Edad , Femenino , Derivación Arteriovenosa Quirúrgica/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento , Diálisis Renal/efectos adversos , Aneurisma/diagnóstico por imagen , Aneurisma/etiología , Aneurisma/cirugía , Arterias/cirugía , Vena Safena/cirugía , Grado de Desobstrucción Vascular , Estudios Retrospectivos , Arteria Braquial/cirugía
3.
Ann Vasc Surg ; 75: 29-44, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33831530

RESUMEN

OBJECTIVE: Branched and fenestrated endografts (fEVAR/bEVAR) are complex techniques used to treat thoracic aorta pathologies involving the aortic arch. This systematic review aims to determine all the reported results regarding these techniques in the aortic arch, in order to describe their clinical outcomes. METHODS: A systematic review of the literature was performed, considering all articles published until October 2019. PubMed, Cochrane database resources were used. The protocol of the study was previously registered in the Prospero database (CRD42020147037). Primary exclusion criteria included opinion articles, merely technique descriptions, articles without the follow-up of at least 1 month, studies conducted on animals, mixed treatments, and ongoing trials without published data. Included variables were study design, aortic pathology, type of endovascular technique (fEVAR/bEVAR), endograft manufacturing, number of fenestrations/branches and type of bridge stents. Technical success, complications during surgery and follow-up were also described. RESULTS: From a total of 164 articles, 29 (28 retrospective, 1 prospective) were analyzed with a total of 693 cases (341 fEVAR and 352 bEVAR). The most common indications for repair were aneurysm (54.8%) and dissection (40%). Only fEVAR and bEVAR were considered, but different endograft materials and techniques were used and, therefore, reported upon in the current review. Zenith Alpha Thoracic Endovascular Graft was the most representative (24% of cases). Custom made, off-the-shelf, physician modified and in situ fenestrated endografts were also used in 39%, 22.4%, 18.6% and 18.9% of cases, respectively. Bridge stents were implanted in the 50.5% of cases. Technical success rate was 96%. The main intraoperative complication was the endoleak (5.2%) followed by stroke (4.8%). The in-hospital mortality was 2.5%. The mean follow-up was 18.5 months. The mortality related to the main operation during follow-up was 3.2% and not directly related to the main operation was 11.3%. During the follow-up, 92 cases (13.3%) in total had to undergo through a reintervention, 46.7% with endovascular repair and 26.1% with open surgical repair (the rest were not specified). CONCLUSION: published experience with bEVAR and fEVAR in the aortic arch showed acceptable short-term effectiveness and safety. More well-conducted prospective clinical studies with long term follow-up, combined with comparative meta-analysis, are needed to elucidate the real benefit of those endovascular techniques in the aortic arch pathology.


Asunto(s)
Aorta Torácica/cirugía , Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Aorta Torácica/diagnóstico por imagen , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Diseño de Prótesis , Retratamiento , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
4.
Ann Vasc Surg ; 77: e7-e13, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34454017

RESUMEN

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.


Asunto(s)
Angiopatías Diabéticas/cirugía , Educación de Postgrado en Medicina , Internado y Residencia , Enfermedad Arterial Periférica/cirugía , Cirujanos/educación , Procedimientos Quirúrgicos Vasculares/educación , Competencia Clínica , Curriculum , Angiopatías Diabéticas/diagnóstico , Angiopatías Diabéticas/epidemiología , Humanos , Curva de Aprendizaje , Región Mediterránea/epidemiología , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/epidemiología , Evaluación de Programas y Proyectos de Salud , Especialización
5.
Vascular ; 29(5): 661-666, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33377825

RESUMEN

INTRODUCTION: To report total endovascular treatment for a rare case of Crawford extent IV thoraco-abdominal aortic aneurysm (TAAA) using custom-designed branched device in a patient with Behçet's disease. METHODS: A 50 years' old man with history of BD was accidentally diagnosed Crawford extent IV TAAA during computed tomography follow-up after left nephrectomy of renal carcinoma. The aneurysm extended from descending aorta to right common iliac artery with a maximum diameter of 6.2 cm. RESULTS: The endovascular procedure wassuccessfully performed using custom-designed branched component to cannulate visceral arteries, bifurcated endograft and iliac legs to exclude the aneurysm sac in abdominal aorta and an iliac branched device to preserve the right internal iliac artery. The patient was discharged without any complication. Computed tomography angiogram at one month after endovascular repair demonstrated total exclusion of the aneurysm, patent visceral branches and right internal iliac artery. No complication occurred to six-month follow-up. CONCLUSION: Endovascular treatment of stable TAAA in patients with Behc?et's disease using custom-designed branched device is feasible, microinvasive and safe. The long-term efficacy needs to be observed.


Asunto(s)
Aneurisma de la Aorta Torácica/cirugía , Síndrome de Behçet/complicaciones , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Adulto , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/etiología , Síndrome de Behçet/diagnóstico , Síndrome de Behçet/tratamiento farmacológico , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Inmunosupresores/uso terapéutico , Hallazgos Incidentales , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Stents , Resultado del Tratamiento , Adulto Joven
6.
J Vasc Surg ; 71(1): 329-341, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31327598

RESUMEN

BACKGROUND: Carotid artery atherosclerotic stenosis is a preventable major cause of stroke, but there is still a need for definition of high-risk plaque in asymptomatic patients who might benefit from interventional therapies. Several image markers are recommended to characterize unstable plaques. The measurement of serum biomarkers is a promising method to assist in decision making, but the lack of robust evidence in the carotid environment burdens their potential as a standard of care. The goal of this review was to offer an updated state-of-the-art study of available serum biomarkers with clinical implications, with focus on those that may predict carotid symptom development. METHODS: The Cochrane Library and MEDLINE databases were searched (all until September 2018) for studies on carotid plaque and serum biomarkers of atherosclerosis. Nonhuman, basic science, and histology studies were excluded, focusing on clinical studies. Selected abstracts were screened to include the most relevant articles on atherosclerotic plaque presence, progression, instability or symptom development. RESULTS: Some well-established biomarkers for coronary disease are not relevant to carotid atherosclerosis and other inflammatory biomarkers, lipids, interleukins, homocysteine, and adipokines may be useful in quantifying carotid disease-related risk. Some serum biomarkers combined with image features may assist vascular specialists in selecting patients at high risk for stroke and in need of intervention. CONCLUSIONS: Prospective studies applying a combination of biomarkers are essential to prove clinical usefulness.


Asunto(s)
Biomarcadores/sangre , Enfermedades de las Arterias Carótidas/sangre , Accidente Cerebrovascular/epidemiología , Enfermedades de las Arterias Carótidas/diagnóstico , Enfermedades de las Arterias Carótidas/epidemiología , Enfermedades de las Arterias Carótidas/terapia , Humanos , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Pronóstico , Medición de Riesgo , Factores de Riesgo , Rotura Espontánea , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/prevención & control
7.
Eur J Vasc Endovasc Surg ; 60(2): 194-200, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32571654

RESUMEN

OBJECTIVE: There is controversy about the role of pre-emptive thoracic endovascular aortic repair (TEVAR) in uncomplicated type B aortic dissection (TBAD). The aim was to understand expert opinions and the factors influencing decision making. METHODS: In 2018, surgeons from Australia/New Zealand (ANZ) and Europe (EUR) were contacted to participate in an online survey which comprised questions about preferences for pre-emptive TEVAR, followed by five case scenarios, and two ranking questions for anatomical and technical risk factors respectively. Case 1 was designed to favour TEVAR in a hypertensive patient with partial false lumen thrombosis and large diameter (aortic ≥ 40 mm, false lumen ≥ 22 mm). Case 2 had no risk factors mandating TEVAR, according to current evidence. Cases 3, 4, and 5 were designed to test one risk factor respectively, large entry tear on the inner aortic curvature (≥10 mm), partial false lumen thrombosis, and large diameter alone. RESULTS: There were 75 responses, 42 from EUR and 33 from ANZ. Almost half of surgeons (49.3%) endorsed pre-emptive TEVAR with 82.3% preferring to perform TEVAR in the subacute phase. In Case 1 and 5, 58.3% and 52.8% of surgeons respectively chose TEVAR, the highest rates obtained in the survey. Cases 1 and 5 included large diameters ≥40 mm, which were ranked the highest in importance when surgeons considered anatomical risk factors. Surgeons who recommend pre-emptive TEVAR were more likely to choose TEVAR in both Case 1 (83.3% vs. 33.3%, p < .001, 95% CI 27.6%-65.8%) and Case 5 (69.4% vs. 38.2%, p = .008, 95% CI 8.2%-50.0%). CONCLUSION: In this survey about uncomplicated TBAD, about half of surgeons recommended pre-emptive TEVAR in selected cases. The surgeon's predisposition towards intervention and large diameters appear to be the most influential factors in decision making. These findings underline the uncertainty in today's practice and emphasise the need for better predictive tools.


Asunto(s)
Aneurisma de la Aorta Torácica/cirugía , Disección Aórtica/cirugía , Implantación de Prótesis Vascular , Toma de Decisiones Clínicas , Procedimientos Endovasculares , Pautas de la Práctica en Medicina , Cirujanos , Disección Aórtica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Australia , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Europa (Continente) , Encuestas de Atención de la Salud , Estado de Salud , Disparidades en Atención de Salud , Humanos , Nueva Zelanda , Selección de Paciente , Factores de Riesgo , Stents , Resultado del Tratamiento
8.
Vasc Med ; 25(5): 443-449, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32644915

RESUMEN

Our aim is to examine the effects of climatic conditions on the incidence of ruptured abdominal aortic aneurysms (rAAA) in Catalonia, Spain. We combined clinical data from the Public Health official registries in Catalonia, Spain (HD-MBDS) of all rAAA with local climatic data obtained from the closest meteorological station (69 stations, National Meteorological Service: MeteoCat) from 2008 to 2017. We analyzed the median, maximum, minimum, and variability of atmospheric pressure (hPa) and air temperature (°C), solar irradiation (MJ/m2), humidity (%), accumulated precipitation (mm), median wind, and maximum flaw direction and velocity (°, m/s), recorded on the days of events, the previous day, and mean results for 3, 7, and 30 days before, as well as seasonality. Seventy-five control days were randomly selected in a 1-year period around every rAAA day at the same meteorological station, and compared. A total of 717 days and locations with rAAA were identified, and 53,775 controls were randomly selected. For the rAAA days, there were significantly lower temperatures, lower solar global irradiation, and higher mean humidity levels in all time periods (p < 0.001, p < 0.001, p < 0.05); higher atmospheric pressure variability during 1 week and 1 month before (p = 0.011, p = 0.007); and they often occurred during autumn/winter (57.6%, p < 0.001). Logistic regression identified low mean temperatures on the days of ruptures and high mean humidity the week before as independent rupture predictors. In conclusion, low median temperatures the same day and high humidity during 1 week before were identified as independent predictors of rAAA occurrence. The role of climate on pathophysiologic mechanisms may require further investigation.


Asunto(s)
Aneurisma de la Aorta Abdominal/epidemiología , Rotura de la Aorta/epidemiología , Clima , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Rotura de la Aorta/diagnóstico por imagen , Presión Atmosférica , Bases de Datos Factuales , Femenino , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , España/epidemiología , Factores de Tiempo , Tiempo (Meteorología)
9.
Ann Vasc Surg ; 64: 80-87, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31629131

RESUMEN

BACKGROUND: Ruptured abdominal aortic aneurysms (rAAAs) represent a life-threatening emergency and carry a high community and in-hospital mortality, despite treatment and protocol advances. Identifying prognostic factors like the presence of on-call vascular surgery teams at first hospital admissions or times of hospital admissions can modify hospital protocols and mechanisms to ameliorate general outcomes. The aim of this study is to analyze the influence of on-call vascular surgery teams and off-hour admissions on survival after rAAAs in Catalonia, Spain. METHODS: We used data from public health official registries (based on registration of the minimum basic data set) to collect diagnosed cases of rAAAs (ICD-9-CM [International Classification of Diseases, Ninth Revision, Clinical Modification] 441.3) between January 2008 and December 2017. Variables included patient comorbidities, aneurysm treatment and type (endovascular treatment: ICD-9-CM 39.7 or open surgery: ICD-9-CM 398.44 and 39.25), in-hospital mortality, initial hospital admissions and transfers, days and times of admission, and final treatment received. We compared intervention rates and mortalities in all samples and operated cases, in patients initially admitted into tertiary vascular centers (with on-call vascular surgery teams) and community centers (without on-call vascular surgery teams), and the "off-hour effect" (night [22:00 hr to 8:00 hr] or weekend admissions [Friday to Sunday]) in mortality and type of surgery (open or endovascular repair). RESULTS: Of 717 patients with rAAAs (92% men), 561 (78.2%) were initially admitted into tertiary vascular centers and 156 (21.8%) into community centers. The rate of operated cases and global mortality was higher when cases were initially admitted into tertiary vascular centers (388, 69.2% vs. 46, 29.5%; P < 0.001 and 63.6% vs. 88.5%, P < 0.001, respectively), but when surgery was performed (excluding palliative nonoperated cases), the postoperative mortality in both groups was comparable (47.4% vs. 60.9%, P = 0.085), in both univariate and multivariate analysis. On the other hand, patients admitted during night hours (210, 29.3%) did not reveal noteworthy differences in the overall mortality (68.6% vs. 69.2%, P = 0.860) or postoperative mortality compared to those admitted during day hours (61.0% vs. 60.4%, P = 0.880). Weekend admissions neither showed worse results (280, 39.1%, admitted during weekend: overall mortality 70.4% vs. 68.2%, P = 0.541 and postoperative mortality 51.2% vs. 47.3%, P = 0.436). No significant dissimilarities were seen either in the use of endovascular or open repair at night (42.2% vs. 46.1%, P = 0.457) or weekend (41.8% vs. 47%, P = 0.287). CONCLUSIONS: Patients with rAAAs initially admitted into tertiary vascular centers have better overall survival rates than those initially admitted into community centers, mainly because of higher rates of rejected cases in community centers. No differences were seen in terms of mortality or type of surgery in the off-hour admitted cases (night hours or during weekends).


Asunto(s)
Atención Posterior , Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/cirugía , Grupo de Atención al Paciente , Procedimientos Quirúrgicos Vasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/mortalidad , Centros Comunitarios de Salud , Bases de Datos Factuales , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Complicaciones Posoperatorias/mortalidad , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , España , Centros de Atención Terciaria , Factores de Tiempo , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares/efectos adversos , Procedimientos Quirúrgicos Vasculares/mortalidad
10.
Clin Trials ; 16(5): 490-501, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31184490

RESUMEN

BACKGROUND: The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal. METHODS: Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies. We review the literature to assess different definitions and the role of registries in the hierarchy of scientific evidence. We analyze common characteristics affecting registry design, implementation, and governance as well as safety reporting and off-label use while describing the experience of setting up an international, prospective registry for an endovascular device used to treat abdominal aortic aneurysms. RESULTS: Key areas in which to distinguish registries from trials are as follows: eligibility, setting (patients and institutions), device configurations and iterations, the use of design and quality "spaces," a focus on systematic quality checks (rather than source data monitoring), open-ended follow-up, flexibility in the definition of end points and sample sizes, data sharing, and publishing commitments. CONCLUSION: Both clinical trials and registries are essential and complementary research methods and the strengths and weaknesses of each need to be recognized. The specific characteristics of registry research deserve to be acknowledged and safeguarded in the regulations governing clinical investigations with medical devices.


Asunto(s)
Equipos y Suministros , Sistema de Registros/normas , Ensayos Clínicos como Asunto , Humanos , Vigilancia de Productos Comercializados/normas
11.
Ann Vasc Surg ; 56: 216-223, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30500645

RESUMEN

BACKGROUND: Aortic arch curvature can be straightened by endograft placement. However, different measurement methods with dissimilar follow-up and endografts have been published. The aim of this study was to corroborate, for the first time, the pliability of the Conformable Gore TAG Thoracic Endoprosthesis (W.L. Gore and Associates, Flagstaff, AZ, USA) into the aortic arch, using different image vector analysis. MATERIAL AND METHODS: We, retrospectively, analyzed patients primarily treated for thoracic aortic aneurysms and blunt traumatic aortic injuries by means of a Conformable Gore TAG Thoracic Endoprosthesis endograft proximally sealed into the aortic arch (zones Z1-Z3) in five different Spanish centers, between 2010 and 2017. The preoperative, one-month and six-month postoperative, computed tomography angiographies (CTAs) were obtained, creating accurate 3D center lumen line and external lumen line from the aortic valve to the renal arteries. Three different image analysis methods were used to compare modifications of the aortic curvature: first, segment analysis (angulations of the center lumen line when divided into seven precise segments, examining anterior-posterior, right-left, and cranial-caudal displacement), second, center lumen line analysis (bending of the center lumen line itself in seven definite points), and third, expected behavior (length of the endograft in the external lumen line). Two independent observers performed a blind analysis of all CTAs. Changes between preoperative and postoperative CTAs at one and six months are compared, and differences are viewed between cases sealed proximally (Z1-Z2) and distally (Z3) into the aortic arch. RESULTS: We analyzed 37 cases. At 1- and 6-month follow-ups, minimal changes occurred first in segment analysis (only a slight decrease of -2.0° in the XY plane at 10 cm from the brachiocephalic trunk at six-month follow-up was seen, P = 0.027). Second, center lumen line analysis again only showed negligible aortic curvature straightening (+3.5° at 10 cm from the brachiocephalic trunk at one month, P = 0.006, disappearing at six-month follow-up). Finally, good device length predictability was shown (interclass correlation coefficients: 0.995 and 0.994 at one and six months, P > 0.001). No differences were seen between cases proximally sealed into the proximal and distal aortic arch. CONCLUSIONS: Conformable Gore TAG Thoracic Endoprosthesis thoracic endograft showed a good pliability into the aortic arch and proximal thoracic aorta, with minimal changes in the aortic curvature after endograft placement in the short-term follow-up (up to six months). In addition, final endograft length into outer aortic curvature is highly predictable.


Asunto(s)
Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Angiografía por Tomografía Computarizada/métodos , Procedimientos Endovasculares/instrumentación , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/cirugía , Anciano , Anciano de 80 o más Años , Aorta Torácica/lesiones , Aorta Torácica/fisiopatología , Aneurisma de la Aorta Torácica/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Diseño de Prótesis , Estudios Retrospectivos , España , Factores de Tiempo , Resultado del Tratamiento , Remodelación Vascular , Lesiones del Sistema Vascular/fisiopatología
12.
J Endovasc Ther ; 25(6): 726-734, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30280649

RESUMEN

PURPOSE:: To evaluate the safety and performance of the Treovance stent-graft. METHODS:: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. RESULTS:: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. CONCLUSION:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , 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 , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Vigilancia de Productos Comercializados , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
13.
J Vasc Surg ; 66(4): 1227-1235, 2017 10.
Artículo en Inglés | MEDLINE | ID: mdl-28662925

RESUMEN

OBJECTIVE: The aim of this study is to identify which endograft-parallel stent combinations and which degree of oversizing result in the most adequate fit in a juxtarenal abdominal aneurysmal neck, when using a double or triple parallel-stent (chimney) technique. METHODS: In vitro silicon, juxtarenal, abdominal aortic aneurysmal neck models of different diameters, with two and three side-branches (simulating both the renal and superior mesenteric arteries), were constructed. Two different endografts of three diameters each, with two or three parallel stents (of 6 mm and 6 mm; or 6 mm, 6 mm, and 8 mm) were tested (Endurant-II endograft [Medtronic Inc, Santa Rosa, Calif] with balloon-expandable BeGraft stent [Bentley InnoMed, Hechingen, Germany] and an Excluder endograft [W. L. Gore and Associates, Flagstaff, Ariz] with self-expanding Viabahn stent [W. L. Gore and Associates]), applying three endograft-oversizing degrees: recommended (15%), excessive (30%), and over-excessive (40%). After remodeling, using the kissing-balloon technique at 37°C (98.6°F), 36 endograft-stent-oversizing models were scanned by computed tomography. The area of the gutters, parallel-stent compression, and main endograft infolding were recorded. RESULTS: Increasing oversizing (15%, 30%, and 40%) revealed a nonsignificant propensity toward smaller gutters and similar parallel-stent compression, but it significantly augmented infolding, more in three parallel-stent models (0%, 0%, 67% and 0%, 33%, 83% of cases; P = .015 and .018, for two and three parallel-stent models; n = 36) and mainly for the Excluder-Viabahn combination. The Excluder-Viabahn showed significantly smaller gutters, but with higher stent compression, than Endurant-BeGraft combinations for both two and three parallel stents (8.2 mm2, 22.6 mm2; P = .002 and 14.4 mm2, 23.3 mm2; P = .009 gutter area; and 18%, 2%; P < .001 and 15%, 2%; P = .007 relative stent area compression, respectively). CONCLUSIONS: Better endograft stent apposition was usually attained when using 30% oversizing during two and three parallel-stent techniques. Higher oversizing was related to nonsignificant smaller gutters but higher rates of infolding. Smaller gutters, but higher stent compression and risk of infolding, were achieved with the Excluder-Viabahn than with the Endurant-BeGraft combination.


Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Aorta Abdominal/diagnóstico por imagen , Aorta Abdominal/patología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/patología , Aortografía , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Humanos , Modelos Anatómicos , Modelos Cardiovasculares , Diseño de Prótesis , Silicio
14.
Ann Vasc Surg ; 44: 221-228, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28483625

RESUMEN

BACKGROUND: The aim of the study was to identify the best conditions in iliac sandwich procedure for hypogastric artery preservation during endovascular aneurysm repair, testing different devices, different oversizing (OS) degrees as well as different methods to measure it. METHODS: Four external iliac devices (16-mm Endurant and 12-mm Aorfix limb extensions; 11- and 13-mm Viabahn endografts) were tested with 2 distinct internal iliac stent grafts (8-mm Advanta V12 and 8-mm Viabahn) inside different proximal silicon iliac limb models (10, 12, 14, 16, and 18 mm), simulating an iliac sandwich procedure for hypogastric preservation. After remodeling all devices in a saline bath at 37°C, the combinations were computed tomography scanned. Gutter size, parallel-stent compression, and inadequate parallel-stent deployment or infolding were recorded. Oversizing between both parallel stents and the iliac limb models were examined in terms of added diameter, perimeter, and area being additionally compared. RESULTS: All three sizing methods (diameter, perimeter, and area) were highly correlated (diameter OS to perimeter and area OS correlation coefficient 0.998 and 0.997, respectively, P < 0.001 for both); thus, diameter OS was used for further comparisons. Increasing diameter OS (< 30%, 30-55%, 55-75%, and > 75%) showed a significant tendency toward smaller gutters (38.9, 12.2, 5.4, and 2.6 mm2, respectively, P < 0.001) but also increasing parallel-stent compression (13.5%, 28.9%, 43.9%, and 55.1%, P < 0.001) and infolding (0%, 0%, 38%, and 60%, P < 0.001). There were no significant differences between the analyzed devices. CONCLUSIONS: In iliac sandwich procedures, better apposition is usually achieved when using 30-55% diameter OS; higher OS is related to smaller gutters but higher rates of malpositioning and parallel-stent compression. No clear recommendations in material selection can be performed. All sizing methods are highly correlated and predictable.


Asunto(s)
Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Arteria Ilíaca/cirugía , Stents , Aneurisma de la Aorta/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/métodos , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Humanos , Arteria Ilíaca/diagnóstico por imagen , Modelos Anatómicos , Modelos Cardiovasculares , Tomografía Computarizada Multidetector
15.
Ann Vasc Surg ; 38: 233-241, 2017 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-27522975

RESUMEN

BACKGROUND: The objective of this study was to analyze the original curvature of the aortic arch and thoracic aorta, and how it is modified after the placement of a thoracic endograft. METHODS: We retrospectively analyzed all patients primarily treated for thoracic aortic aneurysms and blunt traumatic aortic injuries by means of an endograft sealed into the aortic arch (zones, Z1-Z3) in 2 different centers (Vascular Surgery Division, Hospital Clinic, UB; and Vascular and Endovascular Surgery Department, Hospital Vall d'Hebron, UAB; Barcelona, Spain), between 2010 and 2015. The last preoperative and early (1-month) postoperative computed tomography angiography (CTA) was obtained for all cases, and an accurate 3-dimensional (3D) center lumen line was created, from the aortic valve to the renal arteries. Angles in 2-dimensional (2D; XY-plane) and 3D (referred to cranial-caudal Z-axis) were analyzed in: the distal ascending aorta, aortic arch, and thoracic aorta (at 5, 10, 15, and 20 cm from the brachiocephalic trunk [BCT]) and celiac trunk (CT). Changes in preoperative-postoperative CTA were compared independently for both diseases. Thirty-six cases were included (20 aneurysms, 16 blunt traumatic injuries; mean age, 69.5 and 42.5 years). RESULTS: After placement of an aortic endograft (sealed in Z1-Z2 in 30% of aneurysms and 75% of traumatic injuries; mean endograft length: 22.6 cm and 11.3 cm, respectively), a global left anterior displacement of the ascending aorta was observed (2D examination: -13.1° and -7.5°, P = 0.049 and 0.041, respectively). The 3D examination showed an average increase of the aortic angle at 5 and 10 cm from the BCT in the whole sample (+4.0°, +4.9° in reference to the vertical; P = 0.017, 0.001), softening the curvature of the proximal descending thoracic aorta. In addition, in traumatic injuries, a decrease in the aortic arch angle was observed (-3.5°, P = 0.030). CONCLUSIONS: Placement of an endograft into the aortic arch and proximal thoracic aorta engenders a softening of the proximal descending thoracic aorta curvature, increasing its angle from the vertical. In blunt traumatic aortic injuries (with shorter and more proximally sealed endografts), an additional decrease of the aortic arch angle (3.5° more vertical), was observed.


Asunto(s)
Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Remodelación Vascular , Lesiones del Sistema Vascular/cirugía , Adulto , Anciano , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/lesiones , Aorta Torácica/fisiopatología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/fisiopatología , Aortografía/métodos , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Imagenología Tridimensional , Masculino , Persona de Mediana Edad , Interpretación de Imagen Radiográfica Asistida por Computador , Estudios Retrospectivos , España , Factores de Tiempo , Resultado del Tratamiento , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/fisiopatología
16.
Rev Port Cir Cardiotorac Vasc ; 24(3-4): 113, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-29701346

RESUMEN

INTRODUCTION: The suitability of the proximal and distal landing zones remains one of the main limitations to thoracic endovascular aortic repair. The advent of custom-made scalloped stent grafts widened the endovascular options in some challenging anatomies. METHODS: The authors present three cases of thoracic aortic aneurysm (TAA), with three different hostile anatomies, successfully treated with custom-made scalloped stent grafts. RESULTS: Case1: Male patient, 47 years old, no relevant medical history. Angio-CT revealed a 54mm post- traumatic TAA, extending distally from the origin of the left subclavian artery. Inadequate sealing in Ishimaru zone 2 was evident. The patient was sequentially treated by means of a carotid-subclavian bypass followed by TEVAR with proximal scallop to the left common carotid artery. Proper proximal sealing was obtained. Case2: Male patient, 76 years old, diagnosed with a 65mm diameter TAA, involving the origin of the left subclavian artery. Presence of a bovine trunk, and inadequate landing zone distally to it, were noted. The patient was sequentially treated by means of a carotid-subclavian bypass followed by TEVAR with proximal scallop to the bovine trunk. Proper sealing in Ishimaru zone 2 was granted. Case3: Male patient, 77 years old, multiple comorbidities. Angio-CT revealed a 59,3mm saccular aneurysm of the distal thoracic descending aorta, extending proximally from the origin of the celiac trunk. Good collateralization was observed after celiac trunk occlusion test. Proper distal seal was obtained by means of selective embolization of the celiac trunk followed by TEVAR with distal scallop to the superior mesenteric artery. All procedures were uneventful, with no reported endoleaks, birdbeaks, migrations or re- interventions. There are no reported complications at 1-year follow-up. CONCLUSION: Custom-made scalloped thoracic stentgrafts are an accessible, reproducible and safe therapeutic option when dealing with hostile descending thoracic anatomies, and should be considered as a minimally-invasive effective solution in selected cases.


Asunto(s)
Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Animales , Aneurisma de la Aorta Torácica/terapia , Aortografía , Prótesis Vascular , Bovinos , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Stents , Resultado del Tratamiento
19.
Eur J Cardiothorac Surg ; 65(5)2024 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-38733578

RESUMEN

OBJECTIVES: The goal of this multicentre retrospective cohort study was to evaluate technical success and early and late outcomes of thoracic endovascular repair (TEVAR) with grafts deployed upside down through antegrade access, to treat thoracic aortic diseases. METHODS: Antegrade TEVAR operations performed between January 2010 and December 2021 were collected and analysed. Both elective and urgent procedures were included. Exclusion criteria were endografts deployed in previous or concomitant surgical or endovascular repairs. RESULTS: Fourteen patients were enrolled; 13 were males (94%) with a mean age of 71 years (interquartile range 62; 78). Five patients underwent urgent procedures (2 ruptured aortas and 3 symptomatic patients). Indications for treatment were 8 (57%) aneurysms/pseudoaneurysms, 3 (21%) dissections and 3 (21%) penetrating aortic ulcers. Technical success was achieved in all procedures. Early mortality occurred in 4 (28%) cases, all urgent procedures. Median follow-up was 13 months (interquartile range 1; 44). Late deaths occurred in 2 (20%) patients, both operated on in elective settings. The first died at 19 months of aortic-related reintervention; the second died at 34 months of a non-aortic-related cause. Two patients (14%) underwent aortic-related reinterventions for late type I endoleak. The survival rate of those having the elective procedures was 100%, 84% and 67% at 12, 24 and 36 months, respectively. Freedom from reintervention was 92%, 56% and 56% at 12, 24 and 36 months, respectively. CONCLUSIONS: Antegrade TEVAR can seldom be considered an alternative when traditional retrograde approach is not feasible. Despite good technical success and few access-site complications, this study demonstrates high rates of late type I endoleak and aortic-related reinterventions.


Asunto(s)
Aorta Torácica , Enfermedades de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Masculino , Procedimientos Endovasculares/métodos , Anciano , Femenino , Estudios Retrospectivos , Aorta Torácica/cirugía , Persona de Mediana Edad , Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular/métodos , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/mortalidad , Complicaciones Posoperatorias/epidemiología , Prótesis Vascular , Reparación Endovascular de Aneurismas
20.
JAMA Surg ; 158(8): 832-839, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-37314760

RESUMEN

Importance: Endovascular treatment is not recommended for aortic pathologies in patients with connective tissue diseases (CTDs) other than in redo operations and as bridging procedures in emergencies. However, recent developments in endovascular technology may challenge this dogma. Objective: To assess the midterm outcomes of endovascular aortic repair in patients with CTD. Design, Setting, and Participants: For this descriptive retrospective study, data on demographics, interventions, and short-term and midterm outcomes were collected from 18 aortic centers in Europe, Asia, North America, and New Zealand. Patients with CTD who had undergone endovascular aortic repair from 2005 to 2020 were included. Data were analyzed from December 2021 to November 2022. Exposure: All principal endovascular aortic repairs, including redo surgery and complex repairs of the aortic arch and visceral aorta. Main Outcomes and Measures: Short-term and midterm survival, rates of secondary procedures, and conversion to open repair. Results: In total, 171 patients were included: 142 with Marfan syndrome, 17 with Loeys-Dietz syndrome, and 12 with vascular Ehlers-Danlos syndrome (vEDS). Median (IQR) age was 49.9 years (37.9-59.0), and 107 patients (62.6%) were male. One hundred fifty-two (88.9%) were treated for aortic dissections and 19 (11.1%) for degenerative aneurysms. One hundred thirty-six patients (79.5%) had undergone open aortic surgery before the index endovascular repair. In 74 patients (43.3%), arch and/or visceral branches were included in the repair. Primary technical success was achieved in 168 patients (98.2%), and 30-day mortality was 2.9% (5 patients). Survival at 1 and 5 years was 96.2% and 80.6% for Marfan syndrome, 93.8% and 85.2% for Loeys-Dietz syndrome, and 75.0% and 43.8% for vEDS, respectively. After a median (IQR) follow-up of 4.7 years (1.9-9.2), 91 patients (53.2%) had undergone secondary procedures, of which 14 (8.2%) were open conversions. Conclusions and Relevance: This study found that endovascular aortic interventions, including redo procedures and complex repairs of the aortic arch and visceral aorta, in patients with CTD had a high rate of early technical success, low perioperative mortality, and a midterm survival rate comparable with reports of open aortic surgery in patients with CTD. The rate of secondary procedures was high, but few patients required conversion to open repair. Improvements in devices and techniques, as well as ongoing follow-up, may result in endovascular treatment for patients with CTD being included in guideline recommendations.


Asunto(s)
Aneurisma de la Aorta Torácica , Enfermedades del Tejido Conjuntivo , Síndrome de Ehlers-Danlos Tipo IV , Procedimientos Endovasculares , Síndrome de Loeys-Dietz , Síndrome de Marfan , Humanos , Masculino , Persona de Mediana Edad , Femenino , Síndrome de Marfan/complicaciones , Síndrome de Marfan/cirugía , Síndrome de Loeys-Dietz/complicaciones , Estudios Retrospectivos , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Enfermedades del Tejido Conjuntivo/complicaciones , Enfermedades del Tejido Conjuntivo/cirugía , Aorta
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