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OBJECTIVE: To evaluate the performance of an artificial intelligence (AI) large language model, ChatGPT (version 4.0), for common retinal diseases, in accordance with the American Academy of Ophthalmology (AAO) Preferred Practice Pattern (PPP) guidelines. DESIGN: A cross-sectional survey study design was employed to compare the responses made by ChatGPT to established clinical guidelines. PARTICIPANTS: Responses by the AI were reviewed by a panel of three vitreoretinal specialists for evaluation. METHODS: To investigate ChatGPT's comprehension of clinical guidelines, we designed 130 questions covering a broad spectrum of topics within 12 AAO PPP domains of retinal disease These questions were crafted to encompass diagnostic criteria, treatment guidelines, and management strategies, including both medical and surgical aspects of retinal care. A panel of 3 retinal specialists independently evaluated responses on a Likert scale from 1 to 5 based on their relevance, accuracy, and adherence to AAO PPP guidelines. Response readability was evaluated using Flesch Readability Ease and Flesch-Kincaid grade level scores. RESULTS: ChatGPT achieved an overall average score of 4.9/5.0, suggesting high alignment with the AAO PPP guidelines. Scores varied across domains, with the lowest in the surgical management of disease. The responses had a low reading ease score and required a college-to-graduate level of comprehension. Identified errors were related to diagnostic criteria, treatment options, and methodological procedures. CONCLUSION: ChatGPT 4.0 demonstrated significant potential in generating guideline-concordant responses, particularly for common medical retinal diseases. However, its performance slightly decreased in surgical retina, highlighting the ongoing need for clinician input, further model refinement, and improved comprehensibility.
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Marfan syndrome is a rare inherited connective tissue disorder that can result in significant morbidity and mortality. We report a case of a 29-year-old pregnant woman presenting with an acute type B aortic dissection. Owing to cardiopulmonary decompensation and intestinal malperfusion, she underwent an emergency cesarean section followed by left subclavian to carotid transposition and thoracic endovascular aortic repair that was complicated by a retrograde type A aortic dissection and was managed surgically. Molecular testing confirmed the diagnosis of Marfan syndrome. This case highlights that multidisciplinary and hybrid management of challenging cases of acute aortic syndromes can result in a favorable outcome.
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Inteligencia Artificial , Valor Predictivo de las Pruebas , Humanos , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/cirugía , Aortografía , Angiografía por Tomografía Computarizada , Interpretación de Imagen Radiográfica Asistida por Computador , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagenRESUMEN
OBJECTIVE: To examine the perioperative, postoperative, and long-term outcomes of fenestrated/branched endovascular aneurysm repair (F/BEVAR) in octogenarians compared with nonoctogenarians. METHODS: A multicenter, retrospective cohort study was conducted using the Vascular Quality Improvement database, which prospectively captures information on patients who undergo vascular surgery across 1021 academic and community hospitals in North America. All patients who underwent F/BEVAR endovascular aortic repair from 2012 to 2022 were included. Patients were stratified into two groups: those aged <80 years and those aged ≥80 years at the time of the procedure. The preoperative, intraoperative, and postoperative factors were compared between the two groups. The primary outcome was long-term all-cause mortality; secondary outcomes included aortic-specific mortality and aortic-specific reintervention. RESULTS: A total of 6007 patients (aged <80 years, n = 4860; aged ≥80 years, n = 1147) who had undergone F/BEVAR procedures were included. No significant difference was found in technical success, postoperative length of stay, length of intensive care unit stay, postoperative bowel ischemia, and spinal cord ischemia. After adjustment for baseline covariates, octogenarians were more likely to suffer from a postoperative complication (odds ratio [OR]: 1.16; [95% confidence interval (CI): 0.98-1.37], P < .001) and be discharged to a rehabilitation center (OR: 1.60; [95% CI: 1.27-2.00], P < .001) or nursing home (OR: 2.23; [95% CI: 1.64-3.01], P < .001). Five-year survival was lower in octogenarians (83% vs 71%, hazard ratio [HR]: 1.70; [95% CI: 1.46-2.0], P < .0001). Multivariate Cox proportional hazard analysis demonstrated that age was associated with increased all-cause mortality (HR: 1.72, [95% CI: 1.39-2.12], P < .001) and aortic-specific mortality (HR: 1.92, [95% CI: 1.04-3.68], P = .038). Crawford extent II aortic disease was associated with an increase in all-cause mortality (HR 1.49; [95% CI: 1.01-2.19], P < .001), aortic-specific mortality (HR: 5.05; [95% CI: 1.35-18.9], P = .016), and aortic-specific reintervention (HR: 1.91; [95% CI: 1.24-2.93], P = .003). Functional dependence was associated with increased all-cause mortality (HR: 2.90; [95% CI: 1.87-4.51], P < .001) and aortic-specific mortality (HR: 4.93; [95% CI: 1.69-14.4], P = .004). CONCLUSIONS: Our findings suggest that octogenarians do have a mildly increased mortality rate and rate of adverse events after F/BEVAR procedures. Despite this, when adjusted for other risk factors, age is on par with other medical comorbidities and therefore should not be a strict exclusion criterion for F/BEVAR procedures, rather considered in the global context of patient's aortic anatomy, health, and functional status.
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Reparación Endovascular de Aneurismas , Complicaciones Posoperatorias , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Factores de Edad , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Bases de Datos Factuales , Reparación Endovascular de Aneurismas/efectos adversos , Reparación Endovascular de Aneurismas/mortalidad , América del Norte , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
Integrating large language models (LLMs) like GPT-4 into medical ethics is a novel concept, and understanding the effectiveness of these models in aiding ethicists with decision-making can have significant implications for the healthcare sector. Thus, the objective of this study was to evaluate the performance of GPT-4 in responding to complex medical ethical vignettes and to gauge its utility and limitations for aiding medical ethicists. Using a mixed-methods, cross-sectional survey approach, a panel of six ethicists assessed LLM-generated responses to eight ethical vignettes.The main outcomes measured were relevance, reasoning, depth, technical and non-technical clarity, as well as acceptability of GPT-4's responses. The readability of the responses was also assessed. Of the six metrics evaluating the effectiveness of GPT-4's responses, the overall mean score was 4.1/5. GPT-4 was rated highest in providing technical (4.7/5) and non-technical clarity (4.4/5), whereas the lowest rated metrics were depth (3.8/5) and acceptability (3.8/5). There was poor-to-moderate inter-rater reliability characterised by an intraclass coefficient of 0.54 (95% CI: 0.30 to 0.71). Based on panellist feedback, GPT-4 was able to identify and articulate key ethical issues but struggled to appreciate the nuanced aspects of ethical dilemmas and misapplied certain moral principles.This study reveals limitations in the ability of GPT-4 to appreciate the depth and nuanced acceptability of real-world ethical dilemmas, particularly those that require a thorough understanding of relational complexities and context-specific values. Ongoing evaluation of LLM capabilities within medical ethics remains paramount, and further refinement is needed before it can be used effectively in clinical settings.
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Eticistas , Ética Médica , Humanos , Estudios Transversales , Reproducibilidad de los Resultados , Solución de ProblemasRESUMEN
PURPOSE: To assess the accuracy and readability of responses generated by the artificial intelligence model, ChatGPT (version 4.0), to questions related to 10 essential domains of orbital and oculofacial disease. METHODS: A set of 100 questions related to the diagnosis, treatment, and interpretation of orbital and oculofacial diseases was posed to ChatGPT 4.0. Responses were evaluated by a panel of 7 experts based on appropriateness and accuracy, with performance scores measured on a 7-item Likert scale. Inter-rater reliability was determined via the intraclass correlation coefficient. RESULTS: The artificial intelligence model demonstrated accurate and consistent performance across all 10 domains of orbital and oculofacial disease, with an average appropriateness score of 5.3/6.0 ("mostly appropriate" to "completely appropriate"). Domains of cavernous sinus fistula, retrobulbar hemorrhage, and blepharospasm had the highest domain scores (average scores of 5.5 to 5.6), while the proptosis domain had the lowest (average score of 5.0/6.0). The intraclass correlation coefficient was 0.64 (95% CI: 0.52 to 0.74), reflecting moderate inter-rater reliability. The responses exhibited a high reading-level complexity, representing the comprehension levels of a college or graduate education. CONCLUSIONS: This study demonstrates the potential of ChatGPT 4.0 to provide accurate information in the field of ophthalmology, specifically orbital and oculofacial disease. However, challenges remain in ensuring accurate and comprehensive responses across all disease domains. Future improvements should focus on refining the model's correctness and eventually expanding the scope to visual data interpretation. Our results highlight the vast potential for artificial intelligence in educational and clinical ophthalmology contexts.
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Blefaroespasmo , Seno Cavernoso , Humanos , Inteligencia Artificial , Comprensión , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta Toracoabdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Reparación Endovascular de Aneurismas , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Factores de Tiempo , Estudios Retrospectivos , Prótesis VascularRESUMEN
Vascular Ehlers-Danlos syndrome is a rare inherited connective tissue disorder that can result in significant morbidity and mortality. This report details an iatrogenic aortic rupture during an endovascular approach in the management of critical limb ischemia in a 27-year-old woman who presented with acute onset of severe sensory deficit of the left leg. Conversion to open repair with a midline laparotomy and an aortic-left popliteal bypass was performed. In the endovascular era, we highlight that even minimally invasive therapeutic interventions can have devastating adverse events in patients with vascular Ehlers-Danlos syndrome.
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OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.
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Aneurisma , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta Toracoabdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/etiología , Implantación de Prótesis Vascular/efectos adversos , Reparación Endovascular de Aneurismas , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Prótesis Vascular , Aneurisma/cirugía , Estudios Retrospectivos , Diseño de PrótesisRESUMEN
PURPOSE: The aim of the study was to present the results in patients with a T4 thoracic tumor with aortic involvement who were treated with a thoracic endograft before surgical resection. DESCRIPTION: All consecutive patients undergoing a thoracic endograft procedure before an oncologic resection between January 2012 and December 2019 were reviewed in a single-center retrospective study. Included patients had either a T4 lung tumor or a mediastinal tumor invading the thoracic aorta. EVALUATION: Nine patients were included: 7 with T4 lung cancer, 1 with sarcoma, and 1 patient with thymoma. Median follow-up was 25 months (range, 22-47 months). There were no endograft-related complications. All but 1 patient had an R0 oncologic resection. Eight patients were alive and free from recurrence at the last follow-up. CONCLUSIONS: Use of thoracic stent grafting before surgical resection for patients with a thoracic tumor invading the aorta is a feasible option that obviates the need for extracorporeal circulation and its associated morbidity. This technique could be an alternative strategy in the treatment of tumors invading the thoracic aorta.
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Implantación de Prótesis Vascular , Neoplasias Pulmonares , Humanos , Estudios Retrospectivos , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Aorta/cirugía , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aorta Torácica/patología , Stents , Resultado del Tratamiento , Prótesis VascularRESUMEN
False lumen patency is a poor prognostic factor for favorable aortic remodeling in patients with chronic aortic dissection. Several endovascular techniques are available to obliterate the false lumen; however, they are not always successful. We present the case of a 55-year old male with a chronic type B dissection and a large descending thoracic aortic aneurysm with rapid growth, up to 90 mm, despite attempted control of the false lumen with several endovascular devices (thoracic aortic stent graft, Amplatzer device, glue and candy plug). Successful aneurysmal open repair was achieved by removing these devices during the procedure. This case demonstrates the technical challenges of explanting an aortic stent graft and multiple other devices during distal aortic repair.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Stents , Resultado del TratamientoRESUMEN
Challenges for data storage during drug development have become increasingly complex as the pharmaceutical industry expands in an environment that requires on-demand availability of data and resources for users across the globe. While the efficiency and relative low cost of cloud services have become increasingly attractive, hesitancy toward the use of cloud services has decreased and there has been a significant shift toward real-world implementation. Within GxP laboratories, the considerations for cloud storage of data include data integrity and security, as well as access control and usage for users around the globe. In this review, challenges and considerations when using cloud storage options for the storage of laboratory-based GxP data are discussed and best practices are defined.
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Nube Computacional/normas , Almacenamiento y Recuperación de la Información/métodos , Laboratorios/normas , HumanosRESUMEN
Purpose: To develop a mechanically realistic aortoiliac model to evaluate anatomic variables associated with stent-graft rotation and to assess common deployment techniques that may contribute to rotation. Materials and Methods: Idealized aortoiliac geometries were constructed either through direct 3-dimensional (3D) printing (rigid) or through casting with polyvinyl alcohol using 3D-printed molds (flexible). Flexible model bending rigidity was controlled by altering wall thickness. Three flexible patient-specific models were also created based on the preoperative computed tomography angiograms. Zenith infrarenal and fenestrated devices were used in this study. The models were pressurized to 100 mm Hg with normal saline. Deployments were performed under fluoroscopy at 37°C. Rotation was calculated by tracking the change in position of gold markers affixed to the devices. Results: In the rigid idealized models, stent-graft rotation increased with increasing torsion; torsion levels of 1.6, 2.6, and 3.6 mm-1 had mean rotations of 5.2°±0.03°, 11.2°±4.8°, and 27.6°±13.0°, respectively (p<0.001). In the flexible models, the highest rotation (58°±3.0°) was observed in models with high torsion and high rigidity (7.5 mm-1 net torsion and 254 N·m2 flexural rigidity). No rotation was observed in the absence of torsion. Applying torque to the device during insertion significantly increased stent-graft rotation by an average of 28° across all levels of torsion (p<0.01). Multiple device insertions prior to deployment did not change the observed device rotation. The patient-specific models accurately predicted the degree of rotation seen intraoperatively to within 5°. Conclusion: Insertion technique plays an important role in the degree of stent-graft rotation during deployment. Our model suggests that in vivo correction of device orientation can increase the observed rotation and supports the concept of fully removing the device, adjusting the orientation, and subsequently reinserting. Additionally, increasing iliac artery torsion in the presence of increased vessel rigidity results in stent-graft rotation.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/fisiopatología , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Análisis de Falla de Equipo , Hemodinámica , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Aneurisma Ilíaco/fisiopatología , Ensayo de Materiales , Modelos Anatómicos , Modelos Cardiovasculares , Modelación Específica para el Paciente , Impresión Tridimensional , Diseño de Prótesis , Falla de Prótesis , Stents , Estrés MecánicoRESUMEN
A mechanistic model of the immune response was evaluated for its ability to predict anti-drug antibody (ADA) and their impact on pharmacokinetics (PK) and pharmacodynamics (PD) for a biotherapeutic in a phase 1 clinical trial. Observed ADA incidence ranged from 33 to 67% after single doses and 27-50% after multiple doses. The model captured the single dose incidence well; however, there was overprediction after multiple dosing. The model was updated to include a T-regulatory (Treg) cell mediated tolerance, which reduced the overprediction (relative decrease in predicted incidence rate of 21.5-59.3% across multidose panels) without compromising the single dose predictions (relative decrease in predicted incidence rate of 0.6-13%). The Treg-adjusted model predicted no ADA impact on PK or PD, consistent with the observed data. A prospective phase 2 trial was simulated, including co-medication effects in the form of corticosteroid-induced immunosuppression. Predicted ADA incidences were 0-10%, depending on co-medication dosage. This work demonstrates the utility in applying an integrated, iterative modeling approach to predict ADA during different stages of clinical development.
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Anticuerpos/inmunología , Modelos Biológicos , Proteínas/administración & dosificación , Corticoesteroides/administración & dosificación , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Humanos , Sistema Inmunológico/inmunología , Estudios Prospectivos , Proteínas/farmacocinética , Proteínas/farmacología , Linfocitos T Reguladores/inmunologíaRESUMEN
INTRODUCTION: During endovascular aneurysm repair, the iliac artery typically serves as a conduit for device delivery. The degree of tortuosity and calcification in the iliac artery ultimately determines whether the device can successfully traverse the vessel. These 2 parameters can be assessed using qualitative approaches or calculated using quantitative methods based on the Society for Vascular Surgery (SVS) reporting standards. The objective of this study was to determine whether qualitative methods are sufficient to accurately assess iliac artery tortuosity and calcification by calculating interobserver variability and comparing them to the SVS Reporting Standards. METHODS: Three vascular surgeons reviewed preoperative computed tomography scans for 50 patients who underwent fenestrated endovascular aneurysm repair and qualitatively assessed left and right iliac artery tortuosity and calcification. Iliac artery geometries were segmented from these image sets. Tortuosity index and calcification length ratio were calculated and categorized based on the SVS Reporting Standards. RESULTS: Interobserver variability was calculated for the qualitative assessments using interclass correlation coefficients. For tortuosity index, among the 3 observers, good agreement was found for the left iliac artery and fair agreement was found for the right. For calcification length ratio, excellent agreement was found for both iliac arteries. When compared to the quantitative assessment, the qualitative assessments underpredicted tortuosity in 2.3% of cases, matched the quantitative values in 16.7% of cases, and overpredicted tortuosity in 81.0% of cases. The qualitative assessments underpredicted calcification in 46.3% of cases, matched the quantitative values in 49.3% of cases, and overpredicted calcification in 4.3% of cases. CONCLUSION: Qualitative assessment of iliac artery tortuosity showed fair-to-good interobserver agreement and poor agreement to SVS Reporting Standards. Qualitative assessment of iliac artery calcification showed excellent interobserver agreement and fair agreement to SVS Reporting Standards. These trends should be considered when qualitative reporting methodologies are used.
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Angiografía por Tomografía Computarizada , Arteria Ilíaca/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Calcificación Vascular/diagnóstico por imagen , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios Retrospectivos , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: In situ fenestration of aortic stent grafts for treatment of aortic arch aneurysms is a new option for endovascular aortic arch repair. So far, only few reports have shown perioperative and short-term results of in situ fenestrations for aortic arch diseases. We present the multicenter experience with the aortic arch in situ fenestration technique documented in the AARCHIF registry for treatment of aortic arch aneurysms or localized type A aortic dissections and analyzed perioperative outcome and midterm follow-up. METHODS: Patients with aortic arch pathologies treated by aortic arch in situ fenestration with proximal stent graft landing in aortic arch Ishimura zones 0 and 1 were included in the registry. Stent-graft in situ fenestrations were created using needles or radiofrequency or laser catheters and completed by implantation of covered connecting stent grafts. Single in situ fenestrations for the left subclavian artery (LSA) were excluded. RESULTS: Between 06/2009 and 03/2017, twenty-five patients were treated by in situ stent-graft fenestrations for aortic arch pathologies at 9 institutions in 7 different countries, 3 of them as bailout procedures for stent-graft malplacement. In situ fenestrations were performed for the brachiocephalic trunk (n = 20), the left common carotid artery (n = 21) and the LSA (n = 9). Technical success for intended in situ fenestrations was 94.0% (47/50), with additional supraaortic bypass procedures performed in 14 patients. Perioperative mortality occurred in 1 (4.0%) patient, treated as a bailout procedure and 3 (12.0%) perioperative strokes were observed. One proximal aortic stent-graft nonalignment and 4 type III endoleaks, 2 early and 2 late, required reeintervention. During follow-up (1-118 months), the diameter of aortic arch aneurysms decreased from 61.5 ± 4.1 mm to 48.4 ± 3.2 mm (P = 0.02) and, so far, 6 patients died from diseases unrelated to their aortic arch pathologies with a mean survival time of 79.5 months and 3 endovascular reinterventions for distal aortic expansion were performed. Cerebrovascular event (n = 4) was the most relevant prognostic factor for mortality during midterm follow-up (P = 0.003). CONCLUSIONS: The aortic arch in situ fenestration technique for endovascular aortic arch repair seems to be valuable treatment option for selected patients, although initial consideration of other treatment options is mandatory. Data about long-term durability are required.
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Aneurisma de la Aorta Torácica/cirugía , Disección Aórtica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Adulto , Anciano , Anciano de 80 o más Años , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/mortalidad , Disección Aórtica/fisiopatología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Aneurisma de la Aorta Torácica/fisiopatología , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: During fenestrated endovascular aneurysm repair (FEVAR), accurate alignment of the fenestration and the target artery is necessary to prevent complications. This study's objective is to determine the incidence of clinical outcomes following fenestration misalignment during FEVAR. METHODS: A single-center, retrospective chart review was performed for all elective FEVARs between January 2008 and April 2015. Data were gathered from patient records and intraoperative imaging. Native vessel angles were calculated using the vessel centerlines. Intraoperative stent graft orientation was determined by changing the angle of the image intensifier as the fenestration was profiled for cannulation. Vertical fenestration misalignment was defined as 4 mm or greater and is the distance from the center of the fenestration markers to the center of the target vessel ostium at the time of cannulation. Horizontal stent graft misalignment was defined as a difference between the native vessel angle and the intraoperative fenestration angle of 15° or more. Early and late clinical outcomes were analyzed with respect to the presence of either vertical or horizontal misalignment of the renal artery fenestrations. RESULTS: The study cohort includes 65 patients who underwent FEVAR during this study period. A horizontal misalignment of 15° or more occurred in 40% of patients (n = 26) and 30° or more in 9.2% of patients (n = 6). A vertical misalignment of 4 mm or greater occurred in 32.3% of patients (n = 21). The incidence of severe postoperative complications, defined as any in-hospital end-organ ischemia and/or death, was significantly greater for patients with stent graft misalignment-31% (n = 11) vs 3% (n = 1) in the aligned group. There was a trend toward higher rates of target vessel cannulation failure in patients with stent graft misalignment 3% (n = 99 fenestrations) vs 0% (n = 76 fenestrations). The combined incidence of any intraoperative target vessel complication was significantly higher in patients with misalignment, 8.1% (4, 15) vs 1.3% (0, 8). Long-term survival was significantly lower in patients with stent graft misalignment, which was primarily driven by high intraoperative and in-hospital mortality rates (P < .05). CONCLUSIONS: Intraoperative stent graft misalignment is associated with higher rates of procedural target vessel complications and severe postoperative adverse events. Patients with stent graft misalignment should be considered at high risk for early postoperative complications. These results highlight an important need for improved FEVAR planning.