One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

OBJECTIVE: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. METHODS: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. RESULTS: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. CONCLUSION: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

Could prior endovascular interventions affect the results of lower extremity below the knee autologous vein bypasses?

BACKGROUND: Performing a non-selective primary endovascular approach involves risk of performing ineffective procedures and could compromise future treatments. The objective of this research is to determine if previous failed endovascular intervention could affect bypass results. METHODS: Retrospective cohort study including 77 below the knee (BTK) bypasses with great saphenous vein (GSV) in patients with critical limb ischemia, carried out between 2008-2018. Primary bypasses (P-BP) were compared with bypasses with history of previous failed endovascular intervention (Secondary bypasses [S-BP]). Primary outcomes included: primary, primary-assisted, and secondary patency, and major amputation-free survival (AFS). The quality of GSV used was evaluated as a potential confounding factor. RESULTS: Forty-six procedures were P-BP (59.7%) and 31 S-BP (40.3%). The mean follow-up was 35.4 (SD: 31) and 28 (DS: 30) months respectively. Univariate results showed an increased risk of loss of primary patency (HR=2.7), primary-assisted patency (HR=3.1) and secondary patency (HR=3.26) in S-BP (P<0.05). This group also presented a trend towards an increased risk of major amputation (HR=1.6; P>0.05). Suboptimal GSV was used in 29% of S-BP and 15% of P-BP. This factor was identified as confounding partially, as it decreased the influence assumed by the history of prior endovascular intervention in the analyzed variables. CONCLUSIONS: Secondary bypasses show inferior results to primary bypasses in our series. Although the cause could be a prior failed endovascular intervention, the frequent use of suboptimal GSV in this type of patients may also contribute to this effect.

Tratamiento endovascular con dispositivos ramificados ilíacos: estudio multicéntrico / Endovascular treatment with iliac branch devices: multicenter study

INTRODUCCIÓN: se estima que entre 18 y un 39 % de los pacientes con aneurismas del sector aortoilíaco sometidos a tratamiento endovascular presentan zonas no aptas para el sellado distal en arterias ilíacas comunes. Tradicionalmente, una de las opciones disponibles para abordar dicha situación consiste en realizar un sellado distal a nivel de las arterias ilíacas externas, ocluyendo las arterias hipogástricas. Sin embargo, esto conlleva la aparición de manifestaciones clínicas derivadas de la isquémica pélvica en el 28-55 % de los casos. La utilización de dispositivos ramificados ilíacos (DRI) permite mantener el flujo anterógrado a las arterias hipogástricas, lo que evita este tipo de complicaciones. El objetivo de nuestro estudio es analizar los resultados a medio plazo de la exclusión endovascular de aneurismas del sector aortoilíaco utilizando DRI. MÉTODOS: estudio descriptivo retrospectivo multicéntrico que incluye los DRI utilizados para el tratamiento endovascular de aneurismas de aorta con afectación del sector aortoilíaco entre enero de 2008 y julio de 2019. Se recogieron datos demográficos, anatómicos, intra- y perioperatorios y de seguimiento en tres centros. Las variables de interés analizadas fueron: éxito técnico, mortalidad perioperatoria, incidencia de isquemia pélvica, permeabilidad primaria de rama hipogástrica y rama ilíaca externa, reintervención relacionada con DRI y mortalidad relacionada con el aneurisma. RESULTADOS: se incluyeron 80 DRI implantados en 61 pacientes: 28 (35 %) Gore(R) Excluder(R) Iliac Branch Endoprosthesis y 52 (65 %) Cook(R) Zenith(R) Branch Endovascular Graft. Se implantaron DRI bilaterales en 18 casos (29,5 %). La tasa de éxito técnico fue del 95 % sin que existieran casos de muertes en el periodo perioperatorio. El seguimiento medio fue de 30,1 meses (± 26,3). Se presentaron seis casos de isquemia pélvica durante el seguimiento. La permeabilidad de la rama hipogástrica fue del 97,5 %, del 94,5 % y del 90,6 % a los 6, 12 y 24 meses, respectivamente. La permeabilidad de la rama ilíaca externa fue del 100 %, del 97,3 % y del 95,5 % a los 6, 12 y 24 meses, respectivamente. La tasa libre de reintervención secundaria al DRI fue del 100 %, del 96,8 % y del 94,7 % a los 6, 12 y 24 meses, respectivamente. Se produjo un caso de muerte relacionada con el aneurisma durante el seguimiento. CONCLUSIONES: en nuestra experiencia, los DRI presentan buenos resultados a medio plazo en la exclusión endovascular de aneurismas con afectación del sector aortoilíaco. Estos dispositivos permiten mantener la permeabilidad de las arterias hipogástricas, minimizando la incidencia de isquemia pélvica. A pesar de las escasas complicaciones tardías y la baja tasa de reintervenciones, es necesario realizar un seguimiento a largo plazo para mantener el éxito técnico

INTRODUCTION: it is estimated that between 18-39 % of patients with aorto-iliac aneurysms undergoing endovascular treatment have a no suitable zone for distal sealing in common iliac arteries. Traditionally, one of the options is to perform a distal seal at the external iliac arteries occluding the hypogastric arteries. However, this can lead to complications derived from pelvic ischemia in 28-55 % of cases. The use of iliac branched devices (IBD) allow to maintain the antegrade flow to the hypogastric arteries, avoiding these complications. The objective of our study is to analyze the medium-term results of endovascular exclusion of aorto-iliac aneurysms using IBD. METHODS: a descriptive multicenter retrospective study including the IBD for the endovascular treatment of aneurysms with involvement of the aorto-iliac sector was conducted between January 2008 and July 2019. Demographic, anatomical, intra-perioperative and follow-up data was collected at 3 centers. The variables of interest analyzed were: technical success, perioperative mortality, incidence of pelvic ischemia, primary patency of the hypogastric branch and external iliac branch, DRI-related reoperation, and aneurysm-related mortality. RESULTS: eighty IBDs were included from 61 patients: 28 (35 %) Gore(R) Excluder(R) Iliac Branch Endoprosthesis, and 52 (65 %) Cook(R) Zenith(R) Branch Endovascular Graft. Bilateral IBDs were implanted in 18 cases (29.5 %). The technical success was achieved in 95 % of cases, with no perioperative deaths. The mean follow-up was 30.1 (± 26.3) months. 6 patients presented pelvic ischemia during follow-up. The patency of the hypogastric side branch was 97.5 %, 94.5 %, and 90.6 %, at 6, 12, and 24 months, respectively. The patency of the external iliac side branch was 100 %, 97.3 %, and 95.5 %, at 6, 12, 24 months, respectively. Freedom from reintervention rate secondary to IBD was 100 %, 96.8 %, and 94.7 %, at 6, 12, and 24 months, respectively. There was 1 case of aneurysm-related death during follow-up. CONCLUSIONS: in our experience, IBDs show good medium-term results in endovascular treatment of aorto-iliac aneurysms. These devices allow to maintain the perfusion of the hypogastric arteries, minimizing the incidence of pelvic ischemia. Although the appearance of late complications and the need for reinterventions is low, a long-term follow-up should be carried out to maintain the success of the procedure

National Diagnostic Reference Levels for Endovascular Aneurysm Repair and Optimisation Strategies.

OBJECTIVE: The International Commission on Radiological Protection (ICRP) has highlighted the large number of medical specialties using fluoroscopy outside imaging departments without programmes of radiation protection (RP) for patients and staff. Vascular surgery is one of these specialties and endovascular aneurysm repair (EVAR) is one of the most challenging procedures requiring RP guidance and optimisation actions. The recent European Directive on Basic Safety Standards requires the use and regular update of diagnostic reference levels (DRL) for interventional procedures. The objective of the study was to know the doses of patients undergoing EVAR with mobile Xray systems and with hybrid rooms (fixed Xray systems), to obtain national DRLs and suggest optimisation actions. METHODS: The Spanish Chapter of Endovascular Surgery launched a national survey that involved hospitals for 10 autonomous communities representing the 77% of the Spanish population (46.7 million inhabitants). Patient dose values from mobile Xray systems were available from nine hospitals (sample of 165 EVAR procedures) and data from hybrid rooms, from seven hospitals, with dosimetric data from 123 procedures. The initial national DRLs have been obtained, as the third quartile of the median values from the different centres involved in the survey. RESULTS: The proposed national DRLs are 278 Gy cm2 for hybrid rooms and 87 Gy cm2 for mobile Xray systems, and for cumulative air kerma (cumulative AK) at the patient entrance reference point, 1403 mGy for hybrid rooms, and 292 mGy for mobile systems. CONCLUSION: An audit of patient doses for EVAR procedures to identify optimised imaging protocol strategies is needed. It is also appropriate to evaluate the diagnostic information required for EVAR procedures. The increase by a factor of 3.2 (for kerma area product) and 4.8 (for cumulative AK) in the DRLs needs to be justified when the procedures are performed in the hybrid rooms rather than with mobile Xray systems.

Fenestrated and chimney endovascular aneurysm repair versus open surgery for complex abdominal aortic aneurysms.

BACKGROUND: Many patients with complex abdominal aortic aneurysms are unfit for open repair. New endovascular technologies and bailout techniques are being used for managing these complex anatomies. The purpose of this study is to compare the results obtained with advanced endovascular aneurysm repair (a-EVAR) techniques (fenestrated and chimney endografts) to those obtained with open repair for the treatment of complex abdominal aortic aneurysms not anatomically suitable for standard endovascular exclusion (infrarenal neck <10 mm, juxtarenal, suprarenal and Crawford's type IV thoracoabdominal aneurysms). METHODS: All patients that underwent open surgery (OS cohort; historical, January 1994-December 2015) or a-EVAR (a-EVAR cohort; prospective, January 2006-December 2015) at our institution for complex abdominal aortic aneurysms that meet the anatomical criteria described above on the preoperatory contrast-enhanced computed tomography scan were included. Vascular Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (V-POSSUM) was employed for risk-assessment. RESULTS: A total of 108 patients were included, all of them male: 56 in the OS cohort and 52 in the a-EVAR cohort (mean age: 67.5±6.7 vs. 72.65±6.4 years, respectively; P=0.000). V-POSSUM predicted 4 deaths for the OS cohort and 3 deaths for the a-EVAR cohorts within the postoperative period and morbidity rates of 57% and a 44.4%, respectively. All-cause 30-day mortality rates were 9 patients (16%) for the OS cohort and 2 patients (3.8%) for the a-EVAR cohort (P=0.038). Thirty-day morbidity rates were 59% for the OS cohort and 44% for the a-EVAR cohort (P=0.09). Mean cost of treatment was € 15,707 per patient for the OS cohort (median: € 11,516; inter-quartilic range [IQR]: € 7901; min-max: € 5069-11,0052) and € 33,457 per patient for the a-EVAR cohort (median: € 29,663; IQR: € 5979; min-max: € 13,865-19,3536), P=0.000. CONCLUSIONS: A-EVAR is a feasible alternative to open surgery for complex abdominal aortic aneurysms at our institution, with lower 30-day mortality rates, yet increasing double the amount the total cost of the therapy.

Development of an individualized scoring system to predict mid-term survival after carotid endarterectomy.

BACKGROUND: Carotid endarterectomy (CEA) is a prophylactic surgery focused in preventing stroke in the mid-long term. The purpose of this study was to analyze mid-term mortality in patients undergoing CEA, identify predictors of 3-year mortality and design a score to estimate individual risk of mortality in this population. METHODS: A retrospective single-center study including consecutive patients undergoing CEA between 1997-2010. Demographic data and comorbidities, postoperative results and patient follow-up data were registered and evaluated. Kaplan Meier analysis was used to analyze survival. After multivariable COX regression analysis, a score based on the calculated Hazards Ratios (HR) was designed. The sum of all points performed the individual score for each patient for estimating 3-years mortality. Population was stratified into four groups according to percentiles of score obtained: Group A (-7 to 4 points), Group B (5-8 points), Group C (9-10 points), Group D (score greater than 11 points). RESULTS: A total of 453 patients with a mean follow-up of 53.4 months were included in the study. Overall 3-year survival was 88.4%. On the univariate analysis the variables associated with significant increasing in 3-year mortality were: female gender (OR 2.32), diabetes mellitus (OR 2.28), COPD (OR 2.98), ischemic heart disease (OR 2.29), critical carotid stenosis >90% (OR 2.16) and antiplatelet therapy as a protective factor (OR 0,23). Factors associated with mortality in multivariate analysis were age (HR 1.14 P=0.001), diabetes mellitus (HR 1.62, P=0.031), COPD (HR 1.88 P=0.022), ischemic heart disease (HR 1.59 P=0.05), critical stenosis >90% (HR 1.70 P=0.015) and antiplatelet therapy as a protective factor (HR 0.23 P=0.027). The scoring system includes the following items: female gender (+2 points), age (50-69 years +7 points, 70-79 years +12 points, >80 years +15 points), diabetes (+4 points), COPD (+5 points), ischemic heart disease (+4 points), carotid stenosis> 90% (+4 points). Antiplatelet (-7 points). The score range from -7 to 26 points. The 3-year mortality range was 5.6% (group A) versus 25.5% (group D). The incidence of stroke at 3-year folllow-up was not correlated with the score (99%, 100%, 97% and 94.5%, respectively groups A-D, P=0.11) CONCLUSIONS: The score developed based on the risk factors of mortality allows individualized risk prediction of 3-year mortality in patients with carotid stenosis. This represents a useful and practical tool for decision-making in the indication of the CEA, allowing surgeons to identify high-risk patients who would benefit from medical treatment due to their limited life expectancy, mainly in asymptomatic patients.

Endograft-assisted coil embolization of a celiac trunk aneurysm.

BACKGROUND: Celiac trunk aneurysms are rare but potential life-threatening lesions. Endovascular techniques are more often used for their treatment because of low rates of morbidity and mortality. CASE REPORT: We describe a modification of stent-assisted coil embolization technique more commonly used in the treatment of intracranial aneurysm, to exclude a 50-mm diameter celiac trunk aneurysm. The patient was a 67-year-old man who had a previous exclusion of a symptomatic aortic aneurysm, with occlusion of the inferior mesenteric and both hypogastric arteries. Anatomic features of the celiac trunk aneurysm and its branches do not allow treatment with a straight endograft or maintain direct flow to the hepatic artery. We then performed an endograft-assisted coil embolization of the aneurysm, with a straight flow line to the splenic artery. CONCLUSION: Endograft-assisted coil embolization is a feasible and safe technique to allow selective embolization of the sac and the presence of direct flow to the splenic artery and indirect flow to the hepatic artery.

Popliteal artery aneurysm in patient with Klippel--Trénaunay--Weber syndrome.

BACKGROUND: The association of Klippel-Trénaunay-Weber syndrome (KTWS) with artery aneurysms is very rare. METHODS AND RESULTS: A 61-year-old man, diagnosed with left lower limb KTWS, presented with a venous ulcer and a popliteal aneurysm measuring 3.5 cm in diameter in the same limb. Endovascular treatment with covered stent was applied with good morphological and clinical results. CONCLUSION: We report a singular case of the association of a popliteal aneurysm with KTWS and its endovascular treatment. This treatment enabled exclusion of the popliteal artery aneurysm with safety and effectiveness and reduced the number of arteriovenous fistulas.