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BACKGROUND: The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIEs) in aortoiliac aneurysms treated with iliac branch devices (IBDs). METHODS: Patients with pre-IBD and post-IBD computed tomography imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pretreatment and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pretreatment to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD. RESULTS: We analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -0.20 [-0.22 to -0.18] vs. -0.09 [-0.12 to -0.06], P < 0.0001 and -19.6° [-22.4° to -16.9°] vs. -11.2° [-15.3° to -7.0°], P = 0.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and 5 device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (nAIE, nitinol = 8). CONCLUSIONS: Purpose-built IBDs effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at 4 years. Anatomic predictors of AIE are limited.
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OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.
Assuntos
Procedimentos Endovasculares , Aneurisma Ilíaco , Humanos , Masculino , Feminino , Aneurisma Ilíaco/cirurgia , Aneurisma Ilíaco/diagnóstico por imagem , Idoso , Procedimentos Endovasculares/métodos , Pessoa de Meia-Idade , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/patologia , Artéria Ilíaca/diagnóstico por imagem , Implante de Prótese Vascular/métodos , Idoso de 80 Anos ou mais , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
OBJECTIVE: The ideal mating stent for target vessel revascularization in fenestrated endovascular aneurysm repair (FEVAR) of juxtarenal and thoracoabdominal aortic aneurysms remains unknown. The objective of this study was to assess the outcomes associated with use of different stent types and configurations mated with reinforced fenestrations during FEVAR. METHODS: Clinical data from patients undergoing FEVAR for juxtarenal and thoracoabdominal aortic aneurysms in a prospective physician-sponsored investigational device exemption trial were analyzed. Outcomes for two different balloon-expandable covered stents (BECSs) mated with reinforced fenestrations were assessed along with the impact of distal extension with a self-expanding stent (SES). Primary patency, branch-related endoleak, and reintervention rates were determined. Cox proportional hazards model was used for time-to-event analysis. RESULTS: From 2001 to 2016, there were 918 patients who underwent fenestrated or branched endograft repair of complex aortic aneurysms; 1604 renal arteries (RAs), 714 superior mesenteric arteries (SMAs), and 333 celiac arteries (CAs) were mated with reinforced fenestrations using JOMED (n = 2014; Abbott Vascular, Santa Clara, Calif) or iCAST (n = 637; Atrium Medical, Hudson, NH) BECSs. The type of BECS did not affect short-term or long-term patency, branch-related endoleaks, or reintervention rates in the RA, SMA, or CA. Twenty-five percent (402/1604) of RAs, 84% (598/714) of SMAs, and 8% (27/333) of CAs underwent distal SES extension at the index operation. RAs with a distal SES in addition to the BECS had a higher likelihood of an occlusion event (hazard ratio, 2.791; 95% confidence interval, 1.42-5.48; P = .003) and reinterventions (P = .036) compared with those without an SES. Addition of a distal SES to the BECS in the SMA or CA did not have an impact on patency or reintervention rates. CONCLUSIONS: BECS choice does not appear to have an impact on branch durability after FEVAR. Selective distal SES placement in RAs with high-risk anatomy does not appear to significantly protect against an occlusion event or to prevent secondary interventions. Routine addition of a distal SES does not improve SMA fenestration durability.
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Angioplastia com Balão/instrumentação , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Desenho de Prótese , Stents , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Endoleak/terapia , Feminino , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/terapia , Humanos , Masculino , Ohio , Estudos Prospectivos , Retratamento , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: This study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts. METHODS: Data from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis. RESULTS: IAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA. CONCLUSIONS: IAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Aneurisma Ilíaco/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Isquemia do Cordão Espinal/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Torácica/complicações , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/estatística & dados numéricos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/estatística & dados numéricos , Feminino , Humanos , Aneurisma Ilíaco/etiologia , Aneurisma Ilíaco/cirurgia , Artéria Ilíaca/cirurgia , Incidência , Masculino , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Isquemia do Cordão Espinal/etiologia , Stents/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVE: The incidence of failed endovascular aneurysm repair (EVAR) is increasing, and understanding the different methods of management and repair is paramount. The objective of this study was to evaluate the clinical management and rescue of failed EVAR by either explantation or fenestrated-branched EVAR (F/B-EVAR). METHODS: A retrospective analysis (1999-2016) of 247 patients who underwent either explantation (n = 162) or F/B-EVAR (n = 85) for failed EVAR was performed. F/B-EVAR was performed under a physician-sponsored investigational device exemption. Demographics of the patients, clinical presentation and failure etiology, perioperative management, rate of reinterventions, morbidity, and mortality were analyzed. Those undergoing surgical explantation were compared with those undergoing F/B-EVAR conversion. Statistical analysis included multivariable logistic regressions, Fisher exact test, and χ2 test. RESULTS: The majority of patients were male (n = 216 [87%]), with a mean age of 75 years (range, 50-93 years). The mean time from primary EVAR was higher in F/B-EVAR (46 ± 7 months vs 69 ± 41 months; P < .001). Graft manufacturer did not differ between those requiring explantation and those having endovascular rescue (P = .170). All emergencies (n = 24 [10%]) and infections (n = 28 [11%]) were treated with open conversion. Endoleak was the most common reason for failure in both explantation and F/B-EVAR groups (75% vs 64%, respectively; P = .052). Type I endoleak was the most common endoleak reported in both groups, occurring more frequently in F/B-EVAR (64% vs 40%; P < .001); type II endoleak was more common in those undergoing open repair (28% vs 2%; P < .001). Graft migration (12% vs 26%; P = .005) and neck degeneration/disease progression (14% vs 59%; P < .001) were more prevalent in F/B-EVAR, but aneurysm enlargement was more common in explantation (68% vs 33%; P < .001). Thirty-day reintervention rates did not differ between F/B-EVAR and explantation (odds ratio, 0.6258; 95% confidence interval, 0.2-1.86; P = .4115); however, 30-day mortality was lower in the F/B-EVAR group (5% vs 10%; P = .0192). Similarly, aneurysm-related mortality was also lower in the F/B-EVAR group (hazard ratio, 0.0683; 95% confidence interval, 0.01-0.44; P = .0048). A subset analysis excluding emergencies and infections did not alter the lack of difference in terms of freedom from reinterventions (P = .1175), 30-day mortality (P = .6329), or aneurysm-related mortality (P = .7849). CONCLUSIONS: Explantation and F/B-EVAR are necessary options in treating patients with failed EVAR, and both techniques have competitive results. Different modes of failure may point to a preferred method of treatment; consequently, rescue of failed EVAR should be individualized according to each patient's presentation and resources available.
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Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Remoção de Dispositivo , Procedimentos Endovasculares/instrumentação , Complicações Pós-Operatórias/cirurgia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/fisiopatologia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Falha de TratamentoRESUMO
OBJECTIVE: Repair options for complex abdominal and thoracoabdominal aortic aneurysms (TAAAs) are evolving with increased experience and availability of less invasive endovascular techniques. Identifying risk factors for mortality after fenestrated and branched endovascular aortic repair (F/B-EVAR) could improve patient selection and facilitate decision making regarding who may benefit from prophylactic F/B-EVAR. METHODS: We evaluated 1091 patients in a prospective investigational device exemption trial who underwent F/B-EVAR from August 2001 to June 2015 for complex aortic aneurysms (CAAs). Multivariable analysis of risk factors for death was performed using a nonproportional hazards model and a nonparametric analysis using random survival forest technology. RESULTS: Operative mortality after F/B-EVAR was low (3.7%), with high CAA-related survival at 30 day and 5 years (96.8% and 94.0%, respectively). All-cause 5-year survival, however, was 46.2% and older age, heart failure, chronic obstructive pulmonary disease, renal disease, anemia, and coagulation disorders were risk factors. Risk was highest for those undergoing type I/II TAAA repairs and those with larger aneurysms. CONCLUSIONS: Patients with multiple comorbidities and those undergoing type I or II TAAA repair are at greatest risk of mortality; however, in this high-risk population, F/B-EVAR offers greater survival compared with that reported for the natural history of untreated aneurysms. Operative and early mortality is lower than the best-reported open repair outcomes, even in this high-risk population, suggesting a potential benefit in extending the use of F/B-EVAR to low-to-average risk CAA patients.
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Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular , Tomada de Decisão Clínica , Técnicas de Apoio para a Decisão , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Ensaios Clínicos como Assunto , Comorbidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Ohio , Seleção de Pacientes , Complicações Pós-Operatórias/mortalidade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Long-term data regarding the safety and durability of thoracic endovascular aortic repair (TEVAR) are limited. The study objective was to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology. METHODS: High-risk patients were treated with thoracic endografts (2001-2011) under a prospective, physician-sponsored, investigational device exemption trial. Three-dimensional reconstructions and measurements were performed on computed tomography scans acquired before discharge, at 1, 6, and 12 months, and then yearly thereafter. RESULTS: The study included 200 patients, of whom 171 were treated for thoracic aneurysm, 28 for chronic dissection, and 1 for aortobronchial fistula. Patients were monitored for an average of 4.8 ± 3.3 years, and 93 (46.5%) were monitored for >5 years. Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94.0%, 85.8%, 55.6%, and 31.4%, and freedom from aneurysm-related death was 94.0%, 92.4%, 91.7%, 91.7%, respectively. Sixty-one endoleaks occurred in 54 patients (28%). Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention at 30 days, 1, 5, and 9 years was 87.9%, 82.9%, 75.5%, and 64.0%, respectively. Forty-seven reinterventions (70%) were thoracic aneurysm-related, 35 (74%) of which were endovascular procedures. Thirty of these were to correct endoleaks at a median of 1.4 years (interquartile range, 0.2-5.0 years). CONCLUSIONS: TEVAR is durable and associated with high long-term aneurysm-related survival. Long-term imaging follow-up remains critical to identify endoleaks or rare device durability issues, most of which can be monitored or managed with endovascular therapies.
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Aorta Torácica/cirurgia , Doenças da Aorta/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Aorta Torácica/diagnóstico por imagem , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/mortalidade , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Angiografia por Tomografia Computadorizada , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Imageamento Tridimensional , Estimativa de Kaplan-Meier , Masculino , Ohio , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Estudos Prospectivos , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Retratamento , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: This study evaluated and compared the long-term clinical outcomes of endovascular repair of infrarenal aortoiliac aneurysms (EVAR) vs EVAR with preservation of antegrade internal iliac artery (IIA) perfusion using iliac branched devices (EVAR-IBDs). METHODS: From October 1998 to August 2015, patients with infrarenal aortoiliac aneurysmal (AIA) disease at high risk for conventional open surgery were enrolled in a prospective physician-sponsored investigational device exemption trial. Clinical data of 75 patients treated with EVAR-IBD and 255 with standard EVAR were analyzed. Technical success, perioperative outcomes, mortality, device patency, endoleak rates, and reinterventions during a follow-up of 10 years were analyzed. RESULTS: There were 87 IBDs deployed in 75 patients. Technical success rate was 97%. Mortality at 30 days was 1.3%. Freedom from aneurysm-related mortality at 3, 5, and 10 years was 99%. Freedom from a type I or III endoleak at 3, 5, and 10 years was 99%. Freedom from secondary reinterventions at 3, 5, and 10 years was 86%, 81%, and 81%, respectively. Primary patency of the IBDs at 3, 5, and 10 years was 94%, 94%, and 77%, respectively. Twenty-four percent of patients underwent EVAR for concomitant AIA disease (EVAR-AIA), and 78% were managed by staged IIA embolization before EVAR. No statistically significant difference in freedom from aneurysm-related mortality, limb occlusions, or endoleak rates was identified in patients with EVAR-AIA vs EVAR-IBD (P > .05). There were significantly more secondary reinterventions in the EVAR-AIA group compared with the EVAR-IBD group (hazard ratio, 0.476, 95% confidence interval, 0.226-1.001; P = .045). CONCLUSIONS: EVAR of infrarenal AIAs with preservation of antegrade flow to the IIA using IBDs is feasible with long-term sustained durability. Serious considerations should be given to the use of IBDs in patients with infrarenal AIAs meeting appropriate anatomic criteria.
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Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Endovasculares/métodos , Aneurisma Ilíaco/cirurgia , Artéria Ilíaca/cirurgia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/fisiopatologia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Estudos de Viabilidade , Feminino , Humanos , Aneurisma Ilíaco/diagnóstico por imagem , Aneurisma Ilíaco/mortalidade , Aneurisma Ilíaco/fisiopatologia , Artéria Ilíaca/diagnóstico por imagem , Artéria Ilíaca/fisiopatologia , Estimativa de Kaplan-Meier , Masculino , Ohio , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Estudos Prospectivos , Desenho de Prótese , Fluxo Sanguíneo Regional , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: Advances in endovascular aneurysm repair now allow surgeons to treat high-risk patients with complex aortic aneurysms. Stringent selection criteria for repair exist from an anatomic and technical perspective; however, there is a paucity of literature examining frailty in patients being evaluated for fenestrated and branched endovascular aortic repair (FEVAR). As a marker of frailty well supported in the literature, we hypothesized that preoperative hypoalbuminemia would increase risk for short-term mortality after endovascular juxtarenal and thoracoabdominal aortic aneurysm repair. METHODS: One thousand eighty nine consecutive patients with juxtarenal and thoracoabdominal aortic aneurysms considered high risk for open surgery from a single institution who underwent FEVAR from 2001 to 2014 were included in the study. Risk factors for all-cause mortality were identified via a Cox regression model on time to death. RESULTS: The patients with severe hypoalbuminemia (albumin <2.4 g/dL) had significantly increased 30-day mortality (P = 0.025, odds ratio [OR]: 4.967 (95% CI: 1.385-17.814, normal versus severe) and 2-year mortality P = 0.006, OR: 2.4, 95% CI: 1.05-5.73, normal versus severe), as well as increased 30-day complication rates P = 0.026, OR: 1.91, 95% CI: 0.9-4.17, normal versus severe). A univariate analysis for 30-day mortality revealed no significant difference in median age: 75.1 vs. 72.5 years (alive at 30 days (Q1, Q3: 69.8, 80.1) versus expired (Q1, Q3: 69.3, 77.8), P = 0.24. CONCLUSIONS: Patients with hypoalbuminemia have significantly increased mortality risk. Albumin level is regulated by nutritional intake and inflammation due to chronic disease, which make it a useful part of a preoperative frailty assessment. Further studies are needed to identify whether optimizing nutrition status will affect albumin levels or decrease mortality.
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Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/mortalidade , Hipoalbuminemia/mortalidade , Albumina Sérica Humana/metabolismo , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Biomarcadores/sangue , Implante de Prótese Vascular/efeitos adversos , Regulação para Baixo , Procedimentos Endovasculares/efeitos adversos , Feminino , Fragilidade/diagnóstico , Fragilidade/mortalidade , Avaliação Geriátrica , Humanos , Hipoalbuminemia/sangue , Hipoalbuminemia/diagnóstico , Estimativa de Kaplan-Meier , Masculino , Avaliação Nutricional , Razão de Chances , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Thoracoabdominal aortic aneurysm (TAAA) repair remains a challenging clinical pathology. Endovascular technology, in particular the evolution of fenestrated and branched (F/B) endografts used in endovascular aneurysm repair (EVAR) has provided a less invasive method of treating these complex aneurysms. This study evaluated the technical and clinical outcomes of F/B-EVAR for extensive type II and III TAAA. METHODS: Data from 354 high-risk patients enrolled in a physician-sponsored investigational device exemption trial (2004-2013) undergoing F/B-EVAR for type II and III TAAA were evaluated. Technical success, perioperative clinical outcomes, and midterm outcomes (36 months) for branch patency, reintervention, aneurysm-related death, and all-cause mortality were analyzed. Data are presented as mean ± standard deviation and were assessed using Kaplan-Meier, univariate, and multivariate analysis. RESULTS: F/B-EVARs incorporating 1305 fenestration/branches were implanted with 96% of target vessels successfully stented. Completion aortography showed 2.8% patients had a type I or III endoleak. Procedure duration (6.0 ± 1.7 vs 5.5 ± 1.6 hours; P < .01) and hospital stay (13.1 ± 10.1 vs 10.2 ± 7.4 days; P < .01) were longer for type II TAAA. Perioperative mortality was greater in type II repairs (7.0% vs 3.5%; P < .001). Permanent spinal cord ischemia occurred in 4% and renal failure requiring hemodialysis occurred in 2.8% of patients. Twenty-seven branches (7.6%) required reintervention for stenosis or occlusion; and celiac artery, superior mesenteric artery, and renal artery secondary patency at 36 months was 96% (95% confidence interval [CI], 0.93-0.99), 98% (95% CI, 0.97-1.0), and 98% (95% CI, 0.96-1.0), respectively. Eighty endoleak repairs were performed in 67 patients, including 55 branch-related endoleaks, 4 type Ia, 5 type Ib, and 15 type II endoleaks. At 36 months, freedom from aneurysm-related death was 91% (95% CI, 0.88-0.95), and freedom from all-cause mortality was 57% (95% CI, 0.50-0.63). The treatment of type II TAAA (P < .01), age (P < .01), and chronic obstructive pulmonary disease (P < .05) negatively affected survival. CONCLUSIONS: F/B-EVAR is a robust treatment option for patients at increased risk for conventional repair of extensive TAAAs. Technical success and branch patency are excellent, but some patients will require reintervention for branch-related endoleak. Aneurysm extent portends a higher risk of perioperative and long-term morbidity and mortality. Additional efforts are needed to improve outcomes and understand the utility of this treatment option in the general TAAA population.
Assuntos
Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/fisiopatologia , Aortografia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Distribuição de Qui-Quadrado , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Ohio , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Estudos Prospectivos , Desenho de Prótese , Retratamento , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
OBJECTIVE: The aim of this study was to evaluate curvature and its effect on the durability of visceral and renal branches in patients undergoing endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) with fenestrated/branched endovascular aneurysm repair (F/B-EVAR). METHODS: Quantitative branch vessel curvature assessment on branches arising from reinforced fenestrations was performed for 168 patients undergoing F/B-EVAR for type II and type III TAAAs. Preoperative and postoperative centerline coordinates were obtained using iNtuition (TeraRecon, Foster City, Calif) and exported into MATLAB (The MathWorks, Inc, Natick, Mass) based on thin-slice computed tomography imaging. Spline interpolation was applied to the centerline coordinates and resampled at 100 equally spaced points, and curvature calculations (κ, mm(-1)) were applied. Global and maximal curvatures for each of the target vessels were measured and categorized by severity. Categories for curvature were 0 to 0.05 mm(-1) (low), 0.05 to 0.1 mm(-1) (medium), 0.1 to 0.15 mm(-1) (high), and >0.15 mm(-1) (extreme) for global curvature and 0 to 0.2 mm(-1), 0.2 to 0.4 mm(-1), 0.4 to 0.6 mm(-1), and >0.6 mm(-1), respectively, for maximum curvature. Curvature variances were assessed for an association with vessel patency and need for reintervention. RESULTS: There were 558 vessels that underwent analysis based on repairs involving 650 vessels, whereby 92 vessels were excluded as they were treated with an external helical branch (58 celiac arteries and 34 superior mesenteric arteries). There was a significant difference found before and after F/B-EVAR for the global celiac artery curvature (median difference, -0.01; P < .001), global left renal artery curvature (median, -0.01; P = .014), maximum left renal artery curvature (median, 0.05; P < .001), and maximum right renal artery curvature (median, 0.03; P = .009). Maximum artery curvature was found to have shifted distally in all vessels postoperatively; 37 adverse events (AEs) were observed in 30 patients (6 branched occlusions and 31 reinterventions [24 type III endoleaks, 5 vessel stenoses, and 2 vessel occlusions]). The majority of AEs (>70%) occurred within the range of low to medium curvature. Univariate analysis found gender to be a dependent variable associated with high (maximum) preoperative curvature (odds ratio, 0.395; P = .02). The use of self-expanding stents (vs balloon-expandable stents alone) in vessels with high preoperative curvature (>0.6 mm(-1)) was significant in the right renal artery (P = .044). CONCLUSIONS: This study did not show a significant relationship between the severity of artery curvature or changes in curvature and AEs found for visceral or renal branches after F/B-EVAR for extensive TAAA. Surprisingly, the majority of AEs occurred in low- and medium-curved vessels. This study is limited in that it does not take into account other factors that may affect AEs, like motion, which would be valuable in future studies.
Assuntos
Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Artéria Renal/cirurgia , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aortografia/métodos , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Distribuição de Qui-Quadrado , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Razão de Chances , Complicações Pós-Operatórias/etiologia , Valor Preditivo dos Testes , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Artéria Renal/diagnóstico por imagem , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: The practice of using fenestrated endografts to treat juxtarenal and group IV thoracoabdominal aortic aneurysms (TAAAs) has become more accepted, but long-term outcomes are still unknown. We report long-term survival, complications, and branch-related outcomes from a single-center experience. METHODS: The study included consecutive patients enrolled prospectively into a physician-sponsored investigational device exemption classified as undergoing group IV TAAA or juxtarenal aneurysm repair by the treating surgeon using fenestrated endografts. Device morphology was used to subclassify this group of patients. Long-term survival and a composite outcome of secondary intervention, branch occlusion, stent migration, endoleak, aneurysm growth, or spinal cord injury were calculated. Descriptive analysis of branch-related outcomes and need for any reintervention was performed. Univariate and multivariate analysis of mortality and the composite outcome was performed to determine associative risks. RESULTS: Long-term survival for patients with juxtarenal and group IV TAAA aneurysms treated with fenestrated stent grafts was 20% at 8 years. Multivariate analysis showed long-term survival for this patient population was negatively associated with increasing age, congestive heart failure, cancer, and previous aneurysm repair. The risk of spinal cord ischemia (SCI) in this group was 1.2% and of aortic-related mortality was 2%. The risk of a spinal event increased with coverage above the celiac artery (52 mm of coverage above the celiac artery in patients with SCI vs 33 mm without SCI; P = .099). More complex device configurations were more likely to require an increased rate of reinterventions, and patients with celiac fenestrations were more likely to experience celiac occlusion over time (3.5% vs 0.5%; P = .019). However, less complex designs were complicated by an increased risk of type I endoleak over time (10.4% for renal fenestrations only vs 1.9% for others; P < .01). As experience evolved, there was a trend to increase the number of fenestrations in devices treating the same anatomy. CONCLUSIONS: The use of fenestrated devices to treat juxtarenal and group IV TAAA is safe and effective in long-term follow-up. Mortality in this patient population is largely not aortic-related. Devices designed for fenestrated repair of juxtarenal and group IV thoracoabdominal aneurysms within a physician sponsored investigational device exemption have changed over time. Further research is needed to determine the best configuration to treat aneurysms requiring coverage proximal to the celiac artery.
Assuntos
Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Torácica/diagnóstico , Aneurisma da Aorta Torácica/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Curva de Aprendizado , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Ohio , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Endovascular options for the treatment of proximal thoracic and arch disease have evolved over the years. In this manuscript, we review the midterm results of fenestrated compared with chimney configurations for proximal aortic aneurysm disease. METHODS: We performed an analysis of all patients with chimney grafts or custom fenestrated endografts used for treatment of proximal thoracic aneurysm disease (involving the supra-aortic trunk vessels) presenting to our institution between 2004 and 2013. Patients were identified by retrospective chart review and through the prospective database (National Institutes of Health study number NCT00583050). Details of devices placed, intraoperative details, and measurements from postoperative imaging were included in the analysis. The primary outcomes of interest were long-term freedom from branch stent complications and freedom from proximal endoleak, but we also included perioperative events, in-hospital mortality, and requirement for secondary interventions in our review. The log-rank test (Mantel-Cox) was used to compare survival data. Student t-test (two tailed) and Fisher exact test (two tailed) were used for continuous and categorical data, respectively. RESULTS: Of 767 patients who underwent thoracic endovascular repair from January 2004 to February 2013, 33 satisfied the inclusion criteria (4%): 18 of 33 noncustom and 15 of 33 custom graft designs. Overall, the rate of technical success was 97%. There were four branch stent-related problems in the follow-up period, one of 15 (7%) in the custom group and three of 18 (17%) in the noncustom group. There were three proximal sealing failures in the immediate postoperative and follow-up period, one of 15 (7%) in the custom group and two of 18 (11%) in the noncustom group. Overall, 10 patients underwent secondary procedures, four of 15 (27%) in the custom group and six of 18 (33%) in the noncustom group. CONCLUSIONS: Although they are technically feasible, both custom fenestrated endografts and chimney repairs for proximal thoracic disease involving the supra-aortic trunk vessels suffer from failures in intermediate follow-up, with a trend toward better long-term outcomes for custom devices. More work is needed to develop durable devices for this anatomic territory in the future.
Assuntos
Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Prótese Vascular , Procedimentos Endovasculares/métodos , Stents , Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/diagnóstico por imagem , Endoleak/prevenção & controle , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Ohio/epidemiologia , Desenho de Prótese , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
BACKGROUND: Multisegment thoracic aortic disease typically requires total aortic arch replacement, affects a heterogenous population, and carries a high risk even at centers of excellence. Risk has been associated with the duration of operation and complexity of repair. A novel branched stented anastomosis frozen elephant trunk repair (B-SAFER) technique has been developed at our center and is currently being studied as a physician-sponsored investigation device exemption (PS-IDE). OBJECTIVE: This study aimed to assess the early safety of using this investigational technique to treat the proximal aorta in subjects with aortic disease involving multiple segments. METHODS: This prospective, single center, nonrandomized study enrolled patients undergoing B-SAFER for acute aortic syndrome (n = 73), aortic aneurysm with chronic aortic dissection (n = 68), degenerative aortic aneurysm (n = 33), or congenital aortic arch disease (n = 4). Devices are delivered antegrade under hypothermic circulatory arrest, and the arch reconstruction is performed as a single anastomosis single stent (SASS; n = 70), single anastomosis multiple stent (SAMA; n = 68), multiple anastomosis single stent (MASS; n = 21), or multiple anastomosis multiple stent (MAMS; n = 16) reconstruction. The primary safety endpoints were operative mortality, disabling stroke, and paraparesis/paralysis. RESULTS: Between May 27, 2021, and December 31, 2022, 178 patients underwent B-SAFER in the configurations and for the indications as described above. The median patient age was 65 years (range, 21 to 85 years), and 52 (29%) were female. The median cardiopulmonary bypass time was 188 minutes (interquartile range [IQR], 155 to 226 minutes), and 97% of the patients underwent repair with antegrade brain perfusion for a median of 46 minutes (IQR, 38 to 61 minutes). Operative mortality occurred in 10 patients (5.6%, including 6 [8.2%] with acute dissection, 2 [2.9%] with chronic dissection, 2 [6.1%] with degenerative aneurysm, and 0 with a congenital disorder), disabling stroke in 5 patients (2.9%), and paraparesis in 1 patient. Other serious complications included respiratory failure (n = 20; 11.4%) and acute kidney injury (n = 18; 10%). Thirty-two patients (18%) had undergone second-stage repairs (28 endovascular and 4 open), with 1 operative mortality after that procedure due to distal rupture. Estimated survival was 95% at 30 days, 88% at 90 days, 84% at 6 months, and 79% at 1 year. One-year survival differed by indication (72% for acute dissection, 91% for chronic dissection, 71% for degenerative aneurysm, and 100% for congenital disorders). CONCLUSIONS: The B-SAFER technique for total arch replacement in a complex cohort of patients with various indications for surgery is a safe and reproducible operation, as demonstrated by the early results from a very inclusive PS-IDE study. Further follow-up and analysis will help refine the technique. Novel devices to perform this procedure should be developed.
RESUMO
The Nile tilapia, Oreochromis niloticus, is a gonochoristic teleost fish with an XX/XY genetic system and is an excellent model for gonadal sex differentiation. In the present study, we screened novel genes that were expressed predominantly in either XY or XX undifferentiated gonads during the critical period for differentiation of gonads into ovaries or testes using microarray screening. We focused on one of the isolated 12 candidate genes, #9475, which was an ortholog of gsdf (gonadal soma-derived factor), a member of the transforming growth factor-beta superfamily. #9475/gsdf showed sexual dimorphism in expression in XY gonads before any other testis differentiation-related genes identified in this species thus far. We also overexpressed the #9475/gsdf gene in XX tilapia, and XX tilapia bearing the #9475/gsdf gene showed normal testis development, which suggests that #9475/gsdf plays an important role in male determination and/or differentiation in tilapia.