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OBJECTIVE: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR. METHODS: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. RESULTS: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm2 (IQR, 105-194 mGy∗cm2). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. CONCLUSIONS: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices.

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OBJECTIVE: To evaluate the impact of celiac artery (CA) compression by median arcuate ligament (MAL) on technical metrics and long-term CA patency in patients with complex aortic aneurysms undergoing fenestrated/branched endograft repairs (F/B-EVARs). METHODS: Single-center, retrospective review of patients undergoing fenestrated/branched endovascular aortic aneurysm repairs and requiring incorporation of the CA between 2013 and 2023. Patients were divided into two groups-those with (MAL+) and without (MAL-) CA compression-based on preoperative computed tomography angiography findings. MAL was classified in three grades (A, B, and C) based on the degree and length of stenosis. Patients with MAL grade A had ≤50% CA stenosis measuring ≤3 mm in length. Those with grade B had 50% to 80% CA stenosis measuring 3 to 8 mm long, whereas those with grade C had >80% stenosis measuring >8 mm in length. End points included device integrity, CA patency and technical success-defined as successful implantation of the fenestrated/branched device with perfusion of CA and no endoleak. RESULTS: One hundred and eighty patients with complex aortic aneurysms (pararenal, 128; thoracoabdominal, 52) required incorporation of the CA during fenestrated/branched endovascular aortic aneurysm repair. Majority (73%) were male, with a median age of 76 years (interquartile range [IQR], 69-81 years) and aneurysm size of 62 mm (IQR, 57-69 mm). Seventy-eight patients (43%) had MAL+ anatomy, including 33 patients with MAL grade A, 32 with grade B, and 13 with grade C compression. The median length of CA stenosis was 7.0 mm (IQR, 5.0-10.0 mm). CA was incorporated using fenestrations in 177 (98%) patients. Increased complexity led to failure in CA bridging stent placement in four MAL+ patients, but completion angiography showed CA perfusion and no endoleak, accounting for a technical success of 100%. MAL+ patients were more likely to require bare metal stenting in addition to covered stents (P = .004). Estimated blood loss, median operating room time, contrast volume, fluoroscopy dose and time were higher (P < .001) in MAL+ group. Thirty-day mortality was 3.3%, higher (5.1%) in MAL+ patients compared with MAL- patients (2.0 %). At a median follow-up of 770 days (IQR, 198-1525 days), endograft integrity was observed in all patients and CA events-kinking (n = 7), thrombosis (n = 1) and endoleak (n = 2) -occurred in 10 patients (5.6%). However, only two patients required reinterventions. MAL+ patients had overall lower long-term survival. CONCLUSIONS: CA compression by MAL is a predictor of increased procedural complexity during fenestrated/branched device implantation. However, technical success, long-term device integrity and CA patency are similar to that of patients with MAL- anatomy.

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OBJECTIVE: Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) of the aortic arch is a viable approach in patients unsuitable for open repair. The aim was to summarise the published results of manufactured F/B-TEVAR devices for partial and total repair of the aortic arch, and to compare fenestrated with branched configurations. DATA SOURCES: PubMed, Scopus and The Cochrane Library were searched for articles (2018 - 2021) about patients with elective, urgent, or emergency aortic requiring a proximal landing zone in the aortic arch (zone 0 - 1 - 2) and treated by F/B-TEVAR. REVIEW METHODS: The systematic review and meta-analysis were performed according to the PRISMA guidelines. Open repair, supra-aortic trunk (SAT) debranching + standard TEVAR, and in situ physician modified and parallel grafts were excluded. Primary outcomes were technical success and 30 day mortality rate. Secondary outcomes were 30 day major adverse events, and overall survival and procedure related endpoints during follow up. RESULTS: Of 458 articles screened, 18 articles involving 571 patients were selected. Indications for intervention were chronic dissections (50.1%), degenerative aneurysms (39.6%), penetrating aortic ulcers (7.4%), and pseudoaneurysms (2%). F-TEVAR, B-TEVAR, and F+B-TEVAR were used in 38.4%, 54.1%, and 7.5% of patients, respectively. Overall, technical success was 95.9% (95% confidence interval [CI] 0.93 - 0.97; I2 = 0%; p for heterogeneity (Het) = .77) and the 30 day mortality rate was 6.7% (95% CI 0.05 - 0.09; I2 = 0%; p Het = .66). No statistical differences were found comparing fenestrated with branched endografts, except for a higher rate of type I - III endoleaks in F-TEVAR (9.8% vs. 2.6%; p = .034). The overall survival rate and freedom from aortic related death at the one year follow up ranged between 82 - 96.4% and 94 - 94.7%, respectively. Thirteen and five studies were considered at moderate and high risk of bias, respectively. CONCLUSION: F/B-TEVAR for the treatment of the aortic arch, according to experience in dedicated centres, now enjoys a satisfactory level of technical success together with a progressively reduced early mortality rate. There are several limitations, and further studies are needed to reach clearer conclusions.

Asunto(s)

Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Prótesis Vascular , Resultado del Tratamiento , Factores de Riesgo , Complicaciones Posoperatorias/cirugía , Diseño de Prótesis , Estudios Retrospectivos

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Objective: Left subclavian artery (LSA)-branched endografts with retrograde inner branch configuration (thoracic branch endoprosthesis [TBE]) offer a complete endovascular solution when LSA preservation is required during zone 2 thoracic endovascular aortic repair. However, the hemodynamic consequences of the TBE have not been well-investigated. We compared near-wall hemodynamic parameters before and after the TBE implantation using computational fluid dynamic simulations. Methods: Eleven patients who had undergone TBE implantation were included. Three-dimensional aortic arch geometries were constructed from the pre- and post-TBE implantation computed tomography images. The resulting 22 three-dimensional aortic arch geometries were then discretized into finite element meshes for computational fluid dynamic simulations. Inflow boundary conditions were prescribed using normal physiological pulsatile circulation. Outlet boundary conditions consisted of Windkessel models with previously published values. Blood flow, modeled as Newtonian fluid, simulations were performed with rigid wall assumptions using SimVascular's incompressible Navier-Stokes solver. We compared well-established hemodynamic descriptors: pressure, flow rate, time-averaged wall shear stress (TAWSS), the oscillatory shear index (OSI), and percent area with an OSI of >0.2. Data were presented on the stented portion of the LSA. Results: TBE implantation was associated with a small decrease in peak LSA pressure (153 mm Hg; interquartile range [IQR], 151-154 mm Hg vs 159 mm Hg; IQR, 158-160 mm Hg; P = .005). No difference was observed in peak LSA flow rates before and after implantation: 40.4 cm3/ (IQR, 39.5-41.6 cm3/s) vs 41.3 cm3/s (IQR, 37.2-44.8 cm3/s; P = .59). There was a significant postimplantation increase in TAWSS (15.2 dynes/cm2 [IQR, 12.2-17.7 dynes/cm2] vs 6.2 dynes/cm2 [IQR, 5.7-10.3 dynes/cm2]; P = .003), leading to decreases in both the OSI (0.088 [IQR, 0.063 to -0.099] vs 0.1 [IQR, 0.096-0.16]; P = .03) and percentage of area with an OSI of >0.2 (10.4 [IQR, 5.8-15.8] vs 15.7 [IQR, 10.7-31.9]; P = .13). Neither LSA side branch angulation (median, 81°, IQR, 77°-109°) nor moderate compression (16%-58%) seemed to have an impact on the pressure, flow rate, TAWSS, or percentage of area with an OSI of >0.2 in the stented LSA. Conclusions: The implantation of TBE produces modest hemodynamic disturbances that are unlikely to result in clinically relevant changes.

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PURPOSE: Ascending aortic replacement is a common emergency procedure for treating acute type A aortic dissection. Secondary open or endovascular interventions for residual arch pathologies is difficult because of adhesions, short prosthetic grafts, and distorted anatomies. Aortic arch branched stent grafts have emerged as a potential solution for these patients if they have suitable anatomical conditions. This study aimed to evaluate the theoretical anatomical and technical feasibility of 2 currently used aortic arch branch endografts in patients who had prior replacement of the ascending aorta. MATERIALS AND METHODS: All patients who had a prosthetic ascending aortic or hemiarch replacement for acute type A dissection in a single institution between January 2013 and December 2018 were included. Contrast computed tomography images on the most recent follow-up were analyzed on a 3-dimensional workstation. Morphological parameters were measured individually for the ascending aorta, aortic arch, supra-aortic branches, and access iliac arteries. The computed tomography scan of each patient was individually evaluated for anatomical suitability for the arch branched and double-branch devices according to set selection criteria. RESULTS: Computed tomography images of 56 patients (median age of 57 years, 45 males) were reviewed. Based on our evaluation, 26 patients (46.4%) were good candidates for an endovascular arch branched device. It would be feasible for 13 patients (23.2%), but prudent preoperative planning was required due to complicated anatomy. The other 17 patients (30.4%) were unsuitable because they met at least 1 exclusion criterion. Short prosthetic grafts, extreme graft angulations, and extensive dissections in the supra-aortic branches were the main reasons for exclusion. CONCLUSION: Endovascular repair using arch branched endografts is feasible in patients with prior ascending aortic arch or hemiarch replacement for acute type A aortic dissection. The most common anatomical conditions that may influence the feasibility of the arch branched endograft procedure include insufficient proximal seal length, severe angulation of the graft, and extensive aortic dissection within the supra-aortic vessels.

Asunto(s)

Aneurisma de la Aorta Torácica , Disección Aórtica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Persona de Mediana Edad , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/etiología , Estudios de Factibilidad , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Diseño de Prótesis , Estudios Retrospectivos , Stents , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/cirugía , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía

RESUMEN

OBJECTIVES: We devised a novel physician-modified endograft (PMEG) with hydrogel-reinforced fenestrations to provide a more secure connection with the bridging graft than fenestrations alone. We applied this novel PMEG in a clinical setting and evaluated the clinical and technical results. METHODS: In this study, patients with complex thoraco-abdominal aortic pathologies involving the renal, superior mesenteric or coeliac artery were included. However, patients with pararenal abdominal aneurysm were excluded. Regardless of anatomical suitability, all patients referred to our hospital were enrolled. All patients were treated via compassionate use of PMEG. All PMEGs were used following the same procedure using hydrogel-reinforced fenestrations. A retrospective analysis was conducted on consecutive patients who were treated between October 2018 and April 2021. RESULTS: Out of 40 patients, 29 and 11 were men and women, respectively. The median patient age was 73.6 (range: 49-87) years. Among the patients, 36 (90%) had true aneurysms, whereas the others had false lumen aneurysms and penetrating atherosclerotic ulcer. Despite anatomical challenges, all branches were successfully reconstructed. The mean operative time was 333 (standard deviation 98) min. Postoperative computed tomography angiography did not reveal type I and IIIc endoleaks from the hydrogel-reinforced fenestrations. The 30-day survival rate was 97.5%. One patient died due to brain haemorrhage on postoperative day 5. During follow-up, computed tomography revealed no migration of any bridging graft. CONCLUSIONS: We confirmed the effectiveness of the hydrogel as a sealing material and the secure connection between hydrogel-reinforced fenestrations and side branches in vivo. CLINICAL TRIAL REGISTRATION NUMBER: 5287.

Asunto(s)

Aneurisma de la Aorta Torácica , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Torácica/cirugía , Procedimientos Endovasculares/métodos , Femenino , Humanos , Hidrogeles/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Stents , Resultado del Tratamiento

RESUMEN

OBJECTIVE: The objective of this prospective single centre study was to assess whether branches and fenestrations have different outcomes on renal function in the early phase. METHODS: From March 2018 to June 2019, 67 patients who underwent elective fenestrated and branched endovascular aneurysm repair (F/BEVAR) procedures were enrolled in this study. The patients were divided into two groups according to the renal bridging component configuration (fenestration vs. branch). All of them underwent dynamic renal scintigraphy with 99mTc diethylenetriaminepentaacetic acid (DTPA), two weeks pre-operatively, and three months and one year post-operatively. The primary end points were peri-procedural technical success, 30 day major adverse events, differences in glomerular filtration rate (GFR) between the branch and fenestration configurations, and variations between the pre-operative and the post-operative dynamic renal scintigraphy. RESULTS: Overall, 135 kidneys were analysed: 63 in the 32 patients treated with fenestrations, and 72 in the 35 patients treated with branches; the mean GFR on baseline scintigraphy was 58.4 ± 30.9 mL/min in the fenestration group, and 65.1 ± 29.2 mL/min in the branch group. Only kidneys associated with a patent fenestration/branch were included in the split GFR final analysis. The mean total GFR at three month scintigraphy decreased by 6.0 ± 2.9 mL/min in the fenestration group and by 23.4 ± 6.4 mL/min in the branch group. The split GFR decreased by 3.5 ± 0.6 mL/min in the fenestration group, and by 15.4 ± 5.4 mL/min in the branch group. The GFR decrease remained stable at one year. CONCLUSION: In this study, the use of branches for renal arteries during F/BEVAR resulted in a greater decrease in the GFR than in those patients who were treated with fenestrations alone. The scintigraphic alterations were evident at an early phase.

Asunto(s)

Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Enfermedades Renales/diagnóstico por imagen , Cintigrafía , Arteria Renal/cirugía , 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 , Procedimientos Endovasculares/efectos adversos , Femenino , Tasa de Filtración Glomerular , Humanos , Enfermedades Renales/etiología , Enfermedades Renales/fisiopatología , Masculino , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Radiofármacos/administración & dosificación , Arteria Renal/diagnóstico por imagen , Arteria Renal/fisiopatología , Pentetato de Tecnecio Tc 99m/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

BACKGROUND: Endovascular rescue of failed infrarenal repair (EVAR) has emerged as an attractive option to stent graft explantation. The procedure, however, is underutilized due to limited devices accessibility and the challenges associated with their implantation in this patient population. The purpose of this study was to report our outcomes and discuss our approach to rescuing previously failed infrarenal endovascular aneurysm repairs (EVAR) with fenestrated/branched endografts (f/b-EVAR). METHODS: A retrospective analysis of prospectively collected data of consecutive patients with failed EVAR rescued with f/b-EVAR at our institution from November 2013 to March 2019 was conducted. The study primary end point was technical success; defined as the implantation of the device with no type I a/b or type III endoleak or conversion to open repair. Secondary endpoints included major adverse events (MAEs), graft patency and reintervention rates. RESULTS: During this time, 202 patients with complex aortic aneurysms were treated with f/b-EVAR. Of these, 19 patients (Male: 17, mean age 79 ± 7 years) underwent repair for failed EVAR. The median time from failed repair to f/b-EVAR was 48 (30, 60) months. Treatment failure was attributed to stent graft migration in 9 (47.4%) patients, disease progression in 5 (26.3%), short initial neck in 3 (15.8%) and unable to be determined in 2 (10.5%). Three patients were treated urgently with surgeon modified stent graft. Technical success was achieved in 18 patients (95%), including two who had undergone emergent repair for rupture. Seventy-two targeted vessels (97.3%) were successfully incorporated. Sixteen (84.2%) patients required a thoracoabdominal repair to achieve a durable seal. Major adverse events (MAEs) occurred in 3 patients (15.7%) including paralysis and death in one (5.3%), compartment syndrome and temporary dialysis in another and laparotomy with snorkeling of one renal and bypass of the other in the third patient. Median (IQR) hospital length of stay was 3 (2, 4) days. Late reintervention, primary target vessel patency and primary assisted patency rates were 5.3%, 98.6% and 100%, respectively. CONCLUSION: Implantation of f/b-EVAR in patients with failed previous EVAR is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.