RESUMEN
(1) Background: Endovascular abdominal aneurysm repair (EVAR) is associated with a reduction in early morbidity and mortality compared with open repair. Procedures performed under hypnosis might represent an alternative to further reduce the risks related to general anesthesia (GA). This study aimed to assess the feasibility and safety of hypnosis and local anesthesia during EVAR. (2) Methods: All consecutive patients who underwent EVAR or fenestrated/branched EVAR (f/bEVAR) under hypnosis and local anesthesia (n = 28) between 2017 and 2019 were retrospectively studied and matched to control patients who underwent the same interventions under GA. (3) Results: There was neither a significant difference in the length of ICU stay (p = 0.06), nor in the occurrence of endoleaks, reintervention, and 30-day mortality rate (p = 1.00, 0.73, and 0.24, respectively). The hypnosis group had lower use of norepinephrine (maximum dose 0.04 ± 0.1 vs. 1.2 ± 4.0 mg·h-1, p < 0.001), shorter procedure duration (181.2 ± 71.4 vs. 214.3 ± 79.6 h, p = 0.04), and shorter length of stay (5.4 ± 3.2 vs. 8.4 ± 5.9 days, p = 0.002). (4) Conclusions: In this pioneering study, hypnosis during EVAR appears feasible and safe. It is associated with lower intraoperative use of norepinephrine, as well as procedure duration and length of in-hospital stay.
RESUMEN
Pre-op spinal arterial mapping is crucial for complex aortic repair. This study explores the utility of non-selective cone beam computed tomography (CBCT) for pre-operative spinal arterial mapping to identify the Adamkiewicz artery (AKA) in patients undergoing open or endovascular repair of the descending thoracic or thoracoabdominal aorta at risk of spinal cord ischemia. Pre-operative non-selective dual-phase CBCT after intra-aortic contrast injection was performed in the aortic segment to be treated. The origin of detected AKA was assessed based on image fusion between CBCT and pre-interventional computed tomography angiography. Then, the CBCT findings were compared with the incidence of postoperative spinal cord ischemia (SCI). Among 21 included patients (median age: 68 years, 20 men), AKA was detected in 67% within the explored field of view, predominantly from T7 to L1 intercostal and lumbar arteries. SCI occurred in 14%, but none when AKA was not detected (p < 0.01). Non-selective CBCT for AKA mapping is deemed safe and feasible, with potential predictive value for post-surgical spinal cord ischemia risk. The study concludes that non-selective aortic CBCT is a safe and feasible method for spinal arterial mapping, providing promising insights into predicting post-surgical SCI risk.
RESUMEN
Adjuvant radiotherapy for breast cancer may involve some incidental exposure of the ipsilateral internal mammary artery to ionizing radiation. However, the relevant evidence is limited and inconsistent. The dataset presented in this article contains the information used to assess the effects of accidental radiation exposure on the internal mammary artery in patients with unilateral total mastectomy followed radiotherapy for breast cancer. The study population consists of two groups: the irradiated group and the control group. The left and right internal mammary arteries were assessed through the second intercostal spaces using a computed sonography system (Vivid S6; GE, Tirat Carmel, Israel) equipped with a 5.5 - 11 MHz transducer. The recorded parameters were the diameter, time-averaged maximum velocity, and blood flow of the internal mammary artery. The dataset contains two files of data: a raw and an analyzed data. The raw data file contains the individual information of each participant, including demographic characteristics and the parameters of the internal mammary artery duplex ultrasound imaging. The analyzed data file was made up of R Markdown, a markup language of R. The results of data analysis were presented in the related research article which has been accepted for publication in the Annals of Vascular Surgery. The dataset presented in this article may be reused for further studies in which the internal mammary artery is considered as potential donor or recipient vessels for a vascular bypass or free flap anastomosis.
RESUMEN
BACKGROUND: The effects of incidental radiation exposure on internal mammary arteries remain unclear. The present study was designed to test the hypothesis by comparing diameter and blood flow of the irradiated and nonirradiated internal mammary arteries, using Duplex ultrasound imaging. METHODS: The study was designed as a single-center, transversal, comparative study. The main outcomes were diameter and volumetric blood flow of the internal mammary arteries. The Wilcoxon rank-sum test was used to assess the differences between the irradiated and nonirradiated internal mammary arteries with regard to the diameter and volumetric blood flow. RESULTS: The diameter (median [interquartile range]) of the irradiated internal mammary arteries (0.170 mm [0.160, 0.180]) was smaller than that of the contralateral nonirradiated ones (0.180 mm [0.170, 0.200], P < 0.0001) and that of the internal mammary arteries in the control group (0.180 mm [0.170, 0.190], P < 0.0001). Similarly, blood flow (median [interquartile range]) of the irradiated internal mammary arteries (52.4 ml/min [37.78, 65.57]) was smaller than that of the contralateral nonirradiated ones (62.7 ml/min [46.87, 84.17], P < 0.0001), as well as of the left (56.7 ml/min [46.88, 72.58], P = 0.02) and the right internal mammary arteries in the control group (61.0 ml/min [47.47, 74.52], P = 0 0.0009). CONCLUSIONS: The data indicate that the irradiated internal mammary arteries in patients with a history of total mastectomy followed by radiotherapy for breast cancer had significantly smaller diameter and blood flow compared to the nonirradiated internal mammary arteries.
Asunto(s)
Neoplasias de la Mama , Arterias Mamarias , Humanos , Femenino , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Arterias Mamarias/diagnóstico por imagen , Mastectomía Simple , Mastectomía , Resultado del TratamientoRESUMEN
OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.
Asunto(s)
Aneurisma , Aneurisma de la Aorta Torácica , Enfermedades de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Prótesis Vascular/efectos adversos , Reparación Endovascular de Aneurismas , Stents/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/complicaciones , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma/cirugía , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/cirugía , Enfermedades de la Aorta/complicaciones , Endofuga/etiología , Endofuga/cirugía , Accidente Cerebrovascular/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: The purpose of this study was to compare postoperative morbi-mortality and medium-term follow-up of fenestrated stent grafting and open repair (OR) for patients with juxtarenal aortic aneurysms (JRAAs). METHODS: All consecutive patients who underwent custom-made fenestrated endovascular aortic repair (FEVAR) or OR for complex abdominal aortic aneurysm between 2005 and 2017 in 2 tertiary centers were scrutinized. Patients with JRAA constituted the study group. Suprarenal and thoracoabdominal aortic aneurysms were excluded. The groups were made comparable through the use of a propensity score matching. RESULTS: 277 patients with JRAAs were included, 102 (36.8%) in the FEVAR group and 175 (63.2%) in the OR group, respectively. After propensity score matching, 54 FEVAR patients (52.9%) and 103 OR patients (58.9%) were included for analysis. In-hospital mortality rates were 1.9% (n = 1) in the FEVAR group versus 6.9% (n = 7) in the OR group (P = 0.483). Postoperative complications were less common in the FEVAR group (14.8% vs. 30.7%; P = 0.033). Mean follow-up was 42.1 months in the FEVAR group and 40 months in the OR group. Overall mortality rates at 12 and 36 months were 11.5% and 24.5% in the FEVAR group versus 9.1 % (P = 0.691) and 11.6% (P = 0.067) in the OR group. Late reinterventions were more frequent in the FEVAR group (11.3% vs. 2.9%; P = 0.047). However, freedom from reintervention rates were not significantly different at 12 months (FEVAR: 86% vs. OR: 90%; P = 0.560) and 36 months (FEVAR: 86% vs. OR: 88.4%, P = 0.690). In the FEVAR group, persistent endoleak during follow-up was identified in 11.3% of cases. CONCLUSIONS: In the present study, there was no statistical difference in terms of mortality in-hospital at 12 or 36 months between FEVAR and OR groups for JRAA. FEVAR for JRAA was associated with a significant reduction of overall postoperative major complications compared with OR. There were significantly more late reinterventions in the FEVAR group.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Implantación de Prótesis Vascular/efectos adversos , Puntaje de Propensión , Factores de Riesgo , Resultado del Tratamiento , Estudios Retrospectivos , Procedimientos Endovasculares/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapiaRESUMEN
BACKGROUND: To assess midterm results of physician-modified stent grafts (PMSG) for the treatment of emergent complex abdominal and thoracoabdominal aortic aneurysms (TAAA) in high-risk patients. METHODS: All consecutive patients with emergent complex abdominal or TAAA undergoing PMSG technique between January 2012 and July 2019 were retrospectively included. Indications for PMSG were symptomatic aneurysms and rapidly growing aneurysms >70 mm. Ruptured aneurysms were excluded. RESULTS: Thirty-three patients (mean age: 74 +/- 11 years) were included. The mean aneurysm diameter was 76 +- 20 mm. Patients presented with TAAA (n = 20, 61%), complex abdominal aortic aneurysms (CAAA, n = 9, 27%), type I endoleak after previous endovascular aneurysm repair (n = 3, 9%) and intramural aortic hematoma (n = 1, 3%). Chimney technique was performed in addition to PMSG in seven cases (21%). Intraoperative adverse events were recorded in seven cases (35%) in the TAAA group and one case (11%) in the CAAA group. In-hospital mortality rate was 15% (n = 3) in the TAAA group and 11% (n = 1) in the CAAA group. Moderate to severe complications were recorded in 45% of cases (n = 15). Spinal cord ischemia occurred in two cases (6%, one case without residual deficit and one with minor motor deficit). One (3%) patient required transient hemodialysis. One patient presented with early aortic rupture and required an open conversion. The mean follow-up duration was 31 months (1-79). Overall survival estimates were 81.4% (95% confidence interval [CI]: 63.1.-91.2) at 1 year and 71.6% (95% CI: 52.6-84.1) at 2 years. Freedom from reintervention rates at 1 and 2 years were 61.2% (95% CI: 41.7-75.9) and 57.4% (95% CI: 37.9-72.8). Target vessel primary patency rates at 1 and 2 years were 99.2% (95% CI: 94.2-99.9) and 97.7% (95% CI: 90.7-99.4). CONCLUSIONS: PMSG for high-risk patients with complex aneurysms provided acceptable technical success and excellent target vessel patency rates but were associated with a 12% in-hospital mortality rate. Reinterventions were frequent. This technique should be limited to selected high-risk patients for whom the risk of rupture in the short-term is deemed too high to wait for graft manufacturing of custom-made device.
Asunto(s)
Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta Toracoabdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Stents , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Diseño de Prótesis , Factores de TiempoRESUMEN
BACKGROUND: COVID-19 infection is associated not only with venous thromboses but also with arterial thromboses (COV-ATs) in relation with an endothelial dysfunction, a coagulopathy and rhythm disorders. The incidence, the topography, and the prognosis of COV-ATs remain poorly known. The objective of this study was to report the overall experience of the Greater Paris University Hospitals (Assistance Publique - Hopitaux de Paris, AP-HP) during the first pandemic wave of COVID-19 infection. METHODS: After approval by the ethics committee, a study using the AP-HP clinical data warehouse was carried out between March and May 2020. Overall, 124,609 patients had a polymerase chain reaction for COVID-19 in our hospitals, of which 25,345 were positive. From 20,710 exploitable stays, patients tested positive for COVID who presented an episode of acute COV-AT (except coronary and intracranial arteries) were selected on the basis of the French medical classification for clinical procedures codes. The data are presented as absolute values with percentages and/or means with standard deviation. RESULTS: Over the studied period, 60 patients (aged 71±14 years, 42 men) presented a COV-AT at the time of their hospitalization, an incidence of 0.2%. The arterial complication occurred 3±7 days after the COVID infection and was inaugural in 30% of the cases (n = 18). The sites of COV-AT were the lower extremities (n = 35%, 58%), the abdominal aorta (n = 10%, 17%), the thoracic aorta (n = 7%, 12%), the upper limbs (n = 7%, 12%), the cerebral arteries (n = 7%, 12%), the digestive arteries (n = 6%, 10%), the renal arteries (n = 2%, 3%), and the ophthalmic artery (n = 1%, 2%). Multiple COV-ATs were observed in 13 patients (22%). At the time of diagnosis, 20 (33%) patients were in intensive care, including six (10%) patients who were intubated. On computed tomography angiography, COVID lesions were classified as moderate and severe in 25 (42%) and 21 (35%) cases, respectively. Revascularization was attempted in 27 patients (45%), by open surgery in 16 cases, using endovascular techniques in 8 cases and with a hybrid approach in three cases. Six patients (22%) required reinterventions. The duration of hospitalization was 12±9 days. Early mortality (in-hospital or at 30 days) was 30% (n = 18). Nine (15%) patients presented severe nonlethal ischemic complications. CONCLUSIONS: Arterial involvement is rare during COVID-19 infection. The aorta and the arteries of the limbs are the privileged sites. The morbi-mortality of these patients is high. Future studies will have to determine if the systematization of anticoagulation therapy decreases the incidence and the severity of the condition.
Asunto(s)
COVID-19 , Trombosis , Masculino , Humanos , SARS-CoV-2 , Resultado del Tratamiento , Trombosis/diagnóstico por imagen , Trombosis/epidemiología , Trombosis/terapia , ArteriasAsunto(s)
Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Médicos , Humanos , Stents , Prótesis Vascular , Rayos Láser , Diseño de Prótesis , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/cirugíaRESUMEN
OBJECTIVE: Mycotic/infective native aortic aneurysms (INAA) are managed heterogeneously. In the context of disparate literature, this study aimed to assess the outcomes of INAA surgical management and provide comprehensive data in alignment with recent suggestions for reporting standards. METHODS: A retrospective review of patients presenting with INAA from September 2002 to March 2020 at two institutions was conducted. In hospital mortality, 90 day mortality, overall mortality, and infection related complications (IRCs) were the study endpoints. Overall survival and IRC free survival were estimated, and predictors of mortality tested using uni- and multivariable analyses. RESULTS: Seventy patients (60 men [86%], median age 68 years [range 59 - 76 years]) were included. Twenty (29%) were ruptured at presentation. INAA location was thoracic in 11 (16%) cases, thoraco-abdominal in seven (10%), and abdominal in 50 (71%). Half of the abdominal INAAs were suprarenal. Two INAAs were concomitantly abdominal and thoracic. Pathogens were identified in 83%. The bacterial spectrum was scattered, with rare Salmonella species (n = 6; 9%). Open surgical repair was performed in 66 (94%) patients, including five conversions of initially attempted endovascular grafts (EVAR), three hybrid procedures, and one palliative EVAR. Vascular substitutes were cryopreserved arterial allografts (n = 67; 96%), prosthesis (n = 2), or femoral veins (n = 1). Kaplan-Meier estimates of overall survival at 30 and 90 days were 87% (95% confidence interval [CI] 76.6 - 93.0) and 71.7% (95% CI 59.2 - 80.9), respectively. The overall in hospital mortality rate was 27.9% (95% CI 1.8 - 66.5). IRCs occurred in seven (10%) patients. The median follow up period was 26.5 months (range 13.0-66.0 months). Chronic kidney disease (CKD) was independently related to in hospital mortality (odds ratio [OR] 20.7, 95% CI 1.8 - 232.7). American Society of Anesthesiologists score of 3 (OR 6.0, 95% CI 1.1 - 33.9), 4 (OR 14.9, 95% CI 1.7 - 129.3), and CKD (OR 32.0, 95% CI 1.2 - 821.5) were related to 90 day mortality. CONCLUSION: Surgical INAA management has significant mortality and a low re-infection rate. EVAR necessitated secondary open repair, but its limited use in this report did not allow conclusions to be drawn.
Asunto(s)
Aneurisma Infectado , Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aloinjertos/cirugía , Aneurisma Infectado/microbiología , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim was to describe initial outcomes of physician modified stent grafts using antegrade laser fenestrations and image fusion guidance (LEVAR) and company manufactured custom made (CM) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs), thoraco-abdominal aortic aneurysms (TAAAs) and type I endoleaks (T1ELs). METHODS: This was a retrospective single centre study. All LEVAR and Zenith (Cook) CM stent graft procedures between 1 January 2012 and 31 December 2018 were reviewed. Endpoints included intra-operative adverse events (IOAEs), in hospital mortality, re-interventions, target vessel patency, and 12 month outcomes (overall survival, freedom from re-intervention, target vessel patency). Outcomes at 12 months were estimated using the Kaplan-Meier method. RESULTS: A hundred patients were identified and included in the study. All patients were deemed unfit for open repair. The cohort included 22 LEVAR and 78 CM stent grafts. LEVAR cases included painful aneurysms (n = 5), > 65 mm aneurysms (n = 10), anatomical constrains and/or presence of previous renal stents (n = 7) or cases declined by the manufacturer planning centre (n = 2). IOAEs were recorded in 41% of cases (n = 9) in the LEVAR group vs. 10% (n = 8, p = .002) in the CM group. The in hospital mortality rate in the LEVAR group was 9% (n = 2) vs. 4% (n = 3, p = .30) in the CM group. The median follow up duration was 22 months (7 - 38) in the LEVAR group and 28 months (11 - 78) in the CM group. The estimate of overall survival at one year was 91% in both groups. The freedom from re-intervention rate at one year was 58% in the LEVAR group vs. 87% in the CM group. The target vessel patency rates at one year were 95% in both groups. CONCLUSION: In high risk patients deemed unfit for open repair, LEVAR may provide satisfactory 12 month overall survival and target vessel patency rates, though reported IOAE, mortality, and re-interventions rates were high thus requiring close and extensive follow up.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Endofuga/cirugía , Procedimientos Endovasculares/instrumentación , Anciano , Anciano de 80 o más Años , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Tomografía Computarizada de Haz Cónico , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Femenino , Fluoroscopía , Mortalidad Hospitalaria , Humanos , Complicaciones Intraoperatorias/etiología , Terapia por Láser , Masculino , Persona de Mediana Edad , Imagen Multimodal , Complicaciones Posoperatorias/etiología , Reoperación , Estudios Retrospectivos , Stents/efectos adversos , Cirugía Asistida por Computador , Tasa de Supervivencia , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: We report a case of juxtarenal abdominal aortic aneurysm-anatomically unsuitable for conventional endovascular repair because of narrow distal aorta-successfully treated by endovascular repair facilitated by in situ laser fenestration. METHODS AND RESULTS: An aortic stent graft was inserted to exclude a juxtarenal aneurysm: under image fusion guidance, antegrade in situ laser fenestration allowed to perfuse superior mesenteric artery and both renal arteries. After complementary insertion of an extended aortouni-iliac stent graft, retrograde in situ laser fenestration was performed to perfuse the contralateral left iliac artery, in order to overcome a narrow distal aorta. Postoperative course was uneventful. Six month's CT showed an excluded aneurysm, patency of the inserted stents and the absence of endoleak. CONCLUSIONS: In situ laser fenestration seems to be an effective solution for endovascular therapy of complex juxtarenal aneurysms. In this case of narrow distal aorta it was a suitable alternative to overcome endovascular aneurysm repair anatomical restrictions and to prevent other additional open surgical interventions.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/fisiopatología , Humanos , Masculino , Diseño de Prótesis , Flujo Sanguíneo Regional , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. MATERIALS AND METHODS: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. RESULTS: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. CONCLUSIONS: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.
Asunto(s)
Procedimientos Endovasculares/instrumentación , Arteria Femoral/cirugía , Técnicas Hemostáticas/instrumentación , Dispositivos de Cierre Vascular , Anciano , Diseño de Equipo , Femenino , Humanos , Masculino , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019. METHODS: Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery. RESULTS: Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001). CONCLUSION: For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).
Asunto(s)
Aneurisma de la Aorta Abdominal/terapia , Implantación de Prótesis Vascular/métodos , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Reoperación/estadística & datos numéricos , Resultado del TratamientoAsunto(s)
Arterias/trasplante , Criopreservación , Enfermedad Arterial Periférica/cirugía , Infecciones Relacionadas con Prótesis/cirugía , Infecciones Estafilocócicas/cirugía , Anciano , Aloinjertos/microbiología , Aloinjertos/trasplante , Amputación Quirúrgica/estadística & datos numéricos , Arterias/microbiología , Prótesis Vascular/efectos adversos , Prótesis Vascular/microbiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/mortalidad , Reoperación/estadística & datos numéricos , Infecciones Estafilocócicas/microbiología , Infecciones Estafilocócicas/mortalidad , Staphylococcus aureus/aislamiento & purificación , Análisis de Supervivencia , Trasplante Homólogo , Resultado del TratamientoRESUMEN
BACKGROUND: Ischemic colitis (IC) is a severe emergency in gastrointestinal surgery. The aim of the present study was to identify the predictors of postoperative mortality after emergent open colectomy for IC treatment. Additionally, we compared postoperative outcomes of patients undergoing emergent colectomy due to aortic surgery-related IC (AS-IC group) vs. other IC etiologies (Other-IC group). METHODS: We analyzed records of consecutive patients who underwent emergency open colectomy for IC between 2008 and 2019. Logistic regression analysis was performed to identify clinical and operative parameters associated with postoperative mortality. The AS-IC and Other-IC groups were compared for mortality, morbidity, ICU stay, hospital stay, and survival. RESULTS: During the study period, 94 patients (mean age, 67.4 ± 13.7 years) underwent emergent open colectomy for IC. In the majority of cases, IC involved the entire colon (53.2%) and vasopressor agents were required preoperatively (63.8%) and/or intraoperatively (78.8%). Thirty-four patients underwent surgery due to AS-IC, whereas 60 due to Other-IC causes. In the AS-IC group, 9 patients had undergone endovascular aortic repair and 25 open aortic surgery; 61.8% of patients needed aortic surgery for ruptured abdominal aortic aneurism (AAA). Overall, 66 patients (70.2%) died within 90 days from surgery. The AS-IC and Other-IC groups showed similar operative outcomes and postoperative complication rates. However, the duration of the ICU stay (19 days vs. 11 days; p = 0.003) and of the total hospital stay (22 days vs. 16 days; p = 0.016) was significantly longer for the AS-IC group than for the Other-IC group. The rate of intestinal continuity restoration at 1 year after surgery was higher for the Other-IC group than for the AS-IC group (58.8% vs. 22.2%; p = 0.05). In the multivariate model, preoperative increased lactate levels, a delay between signs/symptoms' onset and surgery > 12 h, and the occurrence of postoperative acute kidney injury were statistically associated with postoperative mortality. Neither IC etiology (aortic surgery vs. other etiology) nor ruptured AAA was associated with postoperative mortality. CONCLUSION: Emergency open colectomy for IC is associated with high postoperative mortality, which appears to be unrelated to the IC etiology. Preoperative lactate levels, > 12-h delay to surgery, and postoperative acute kidney injury are independent predictors of postoperative mortality.
Asunto(s)
Lesión Renal Aguda/mortalidad , Colectomía/mortalidad , Colitis Isquémica/mortalidad , Colitis Isquémica/cirugía , Complicaciones Posoperatorias/mortalidad , Anciano , Biomarcadores/sangre , Urgencias Médicas , Femenino , Humanos , Masculino , Factores de Riesgo , Tiempo de TratamientoRESUMEN
Background Color-duplex ultrasonography (DUS) could be an alternative to computed tomography-aortography (CTA) in the lifelong surveillance of patients after endovascular aneurysm repair (EVAR), but there is currently no level 1 evidence. The aim of this study was to assess the diagnostic accuracy of DUS as an alternative to CTA for the follow-up of post-EVAR patients. Methods Between December 16, 2010, and June 12, 2015, we conducted a prospective, blinded, diagnostic-accuracy study, in 15 French university hospitals where EVAR was commonly performed. Participants were followed up using both DUS and CTA in a mutually blinded setup until the end of the study or until any major aneurysm-related morphological abnormality requiring reintervention or an amendment to the follow-up policy was revealed by CTA. Database was locked on October 2, 2017. Our main outcome measures were sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios of DUS against reference standard CTA. CIs are binomial 95% CI. Results This study recruited prospectively 659 post-EVAR patients of whom 539 (82%) were eligible for further analysis. Following the baseline inclusion visit, 940 additional follow-up visits were performed in the 539 patients. Major aneurysm-related morphological abnormalities were revealed by CTA in 103 patients (17.2/100 person-years [95% CI, 13.9-20.5]). DUS accurately identified 40 patients where a major aneurysm-related morphological abnormality was present (sensitivity, 39% [95% CI, 29-48]) and 403 of 436 patients with negative CTA (specificity, 92% [95% CI, 90-95]). The negative predictive value and positive predictive value of DUS were 92% (95% CI, 90-95) and 39% (95% CI, 27-50), respectively. The positive likelihood ratio was 4.87 (95% CI, 2.9-9.6). DUS sensitivity reached 73% (95% CI, 51-96) in patients requiring an effective reintervention. Conclusions DUS had an overall low sensitivity in the follow-up of patients after EVAR, but its performance improved meaningfully when the subset of patients requiring effective reinterventions was considered. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01230203.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares , Tomografía Computarizada Multidetector , Complicaciones Posoperatorias/diagnóstico por imagen , Ultrasonografía Doppler en Color , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Francia , Humanos , Masculino , Complicaciones Posoperatorias/terapia , Valor Predictivo de las Pruebas , Estudios Prospectivos , Reproducibilidad de los Resultados , Retratamiento , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions. BACKGROUND: No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions. METHODS: BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period. RESULTS: Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization. CONCLUSIONS: In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.