RESUMEN
OBJECTIVE: The aim of this study was to evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8 × 6 mm) and 2 (6 × 6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: A total of 796 patients were included in this study, 71.7% male, with a mean age of 73.3 ± 8.1 years. The mean follow-up was 30.0 ± 20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8 × 6 mm, and 52.4% were 6 × 6 mm. At the 30-day landmark, primary patency (99.9% vs 98.0%; P value < .001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%; P value < .001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%; P value = .022 for groups 1 and 2, respectively) were higher in 8 × 6 compared with 6 × 6 fenestrations, and the incidence of acute kidney injury was similar across the groups (92.6% vs 92.7%; P value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8 × 6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, P values = .010 and .021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6 × 6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, P value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3% and 1.6% for 8 × 6 and 6 × 6mm fenestrations, respectively, P = .689). The 6 × 6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8 × 6 fenestrations (7.6%) at 5 years (P < .001). The risk of type IIIc endoleak was significantly higher among 8 × 6 fenestrations at 5 years (4.9% and 2% for 8 × 6 and 6 × 6 mm fenestrations, respectively; P = .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857; P < .001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929; P < .001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921; P = .034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979; P < .001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948; P = .572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938; P = .036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8 × 6 small fenestrations have better patency at 30 days, 1 year, and 5 years, whereas 6 × 6 small fenestrations are associated with lower rates of SIs, primarily due to a lower incidence of type IIIc endoleaks. FG ≥5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak, and 5-year patency independently of the fenestration size or vessel diameter.
RESUMEN
OBJECTIVE: The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. METHODS: Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. RESULTS: During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. CONCLUSIONS: This initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.
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Angioplastia de Balón/instrumentación , Aorta Torácica/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Stents , Anciano , Angioplastia de Balón/efectos adversos , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/fisiopatología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/fisiopatología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Ensayos Clínicos como Asunto , Bases de Datos Factuales , Endofuga/etiología , Femenino , Oclusión de Injerto Vascular/etiología , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: To describe changes in renal volumes (RV) and renal function after fenestrated-branched endovascular repair (F-BEVAR) for complex aortic aneurysms. METHODS: The data from patients enrolled in a physician-sponsored investigational device exemption clinical trial for endovascular treatment of complex aortic aneurysms from July 2012 to April 2017 were retrospectively analyzed. Descriptive statistics were calculated using the mean ± standard deviation. The mean estimated glomerular filtration rate (eGFR) and RV were calculated at baseline and 6, 12, and 18 months after F-BEVAR. Variable distributions were evaluated for skewness, and all models required log-transformation. Linear models using generalized estimating equations were used to assess the association between the RV and eGFR over time after adjustment for relevant covariates. We used Kaplan-Meier life-table analysis to calculate survival and branch patency. RESULTS: A total of 139 patients were followed up for 18 months or until death. The mean age was 71 ± 8 years (70% male). The most common risk factor was hypertension (92%). Chronic kidney disease (CKD; eGFR <60 mL/min) was present in 56 patients (40%). Thirty-one patients (22%) had ≥1 accessory renal artery. Of these 31 accessory arteries, 27 (87%) were embolized or covered. On average, the eGFR had decreased over time compared with baseline, with a median change of -4.4 mL/min (interquartile range [IQR], -11.4 to 4.9 mL/min), -2.6 mL/min (IQR, -11.9 to 6.5 mL/min), and -3.4 mL/min (IQR, -11.9 to 5.5 mL/min) at 6, 12, and 18 months postoperatively, respectively. Similarly, the RV had decreased from baseline by 8% ± 17%, 10% ± 17%, and 11% ± 22% at 6, 12, and 18 months, respectively. An increase in the baseline patient age of 5 years was estimated to be associated with a 3% (95% confidence interval [CI], 0.2%-6.0%) decrease in the mean eGFR during the follow-up period, collapsing over time. This change is similar to the natural history of renal deterioration with age. We estimated that an increase in the log-RV of 1 U would be associated with an estimated 26% (95% CI, 3%-52%) increase in the mean eGFR. Preexisting CKD did not affect the average change in RV. Of the 56 patients with previous CKD, 9 (16.1%) showed improvement in the eGFR to >60 mL/min. The median follow-up period was 17.9 months (IQR, 6.3-24.8). The Kaplan-Meier survival rate at 1 and 2 years was 84.7% (95% CI, 78.3%-91.1%) and 78.8% (95% CI, 71.0%- 86.6%), respectively. CONCLUSIONS: The RV and eGFR decreased in patients undergoing repair at the rates expected for patients with complex aortic disease. The eGFR correlated with the RV. Most of the decline in renal function occurred within the first 6 months postoperatively, after which, the renal function had stabilized.
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Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Tasa de Filtración Glomerular , Riñón/fisiopatología , Insuficiencia Renal Crónica/fisiopatología , Stents , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Aneurisma de la Aorta Torácica/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Ensayos Clínicos como Asunto , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Diseño de Prótesis , Recuperación de la Función , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Pre-prostatic artery embolization (PAE) cone-beam computed tomography (CT) angiograms (n = 31; mean age: 62.4 ± 9.75 years) and conventional CT angiograms (n = 32; mean age: 62.5 ± 7.2 years) were retrospectively compared. Mean signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), radiation exposure, and prostatic artery (PA) identification scores (0-4) for cone-beam CT angiogram and conventional CT angiogram were 33.19 (± 14.31) and 18.13 (± 5.38) (P < .01); 27.42 (± 13.39) and 14.78 (± 4.92) (P < .01); 14.57 mSv (±2.5) and 19.25 mSv (±3.7) (P < .01); 3.36 (± 0.89) and 3.16 (± 0.95) (P = .08), respectively. Pre-PAE cone-beam CT angiogram allows for PA identification with improved SNR and CNR and less radiation dose compared to conventional CT angiogram.
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Arterias/diagnóstico por imagen , Angiografía por Tomografía Computarizada/métodos , Tomografía Computarizada de Haz Cónico/métodos , Embolización Terapéutica , Próstata/irrigación sanguínea , Adulto , Anciano , Anciano de 80 o más Años , Angiografía de Substracción Digital , Medios de Contraste , Fluoroscopía , Humanos , Yohexol , Masculino , Persona de Mediana Edad , Dosis de Radiación , Estudios Retrospectivos , Relación Señal-RuidoRESUMEN
The double-barrel stenting (DBS) is a technique in which 2 parallel stents are simultaneously deployed through the same reinforced fenestration, into 2 adjacent target vessels. Prior reports describe the application of this technique for the treatment of superior mesenteric artery dissection with aneurysmal degeneration, coronary artery bifurcations, aortic arch branches, and intracranial aneurysms. The DBS technique is particularly useful in the context of fenestrated repair (FEVAR) of complex anatomy aortic aneurysms when the origin of visceral arteries branch off the aorta very close to each other or present early branches. We herein describe a case series including 7 patients who underwent a FEVAR procedure for thoracoabdominal and juxtarenal aortic aneurysms in which the presence of accessory renal arteries (ARA) or early renal branches was the reason for the application of this technique. Technical success was 100% and all stents were patent in the last follow-up CT scan (follow-up range: 1.8-62.8 months). There was only 1 small endoleak from indetermined source potentially related to the DBS, but the aneurysm sac decreased in size during follow-up and no secondary intervention was needed. Therefore, the DBS technique is a viable option for the incorporation of ARA or early renal branches to a fenestrated repair of aortic aneurysms with complex anatomy.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Arteria Renal/diagnóstico por imagen , Arteria Renal/cirugía , Reparación Endovascular de Aneurismas , Resultado del Tratamiento , Factores de Riesgo , Stents , Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares/efectos adversos , Diseño de Prótesis , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugíaRESUMEN
A 29-year-old woman underwent esophageal stent placement after developing esophageal stenosis in the setting of tracheoesophageal fistula repair in childhood. The patient developed hemoptysis from an esophageal to aberrant right subclavian artery fistula; this was managed with several staged procedures involving arterial stent placement, carotid-to-subclavian bypass, and aberrant subclavian artery ligation. The patient then underwent pericardial patch repair of her perforated esophagus. This case illustrates the importance of understanding congenital anatomy and frequent associations, such as tracheoesophageal fistula and aberrant right subclavian artery; furthermore, it demonstrates the importance of multidisciplinary care for complex cases.