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BACKGROUND: During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take up to 12 weeks. During this awaiting period, the aortic related mortality is being increased. To overcome this limitation, off-the shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAA). Our aim was to systematically evaluate all the published studies of off-the shelf endografts for the treatment of pararenal and thoracoabdominal aortic aneurysms. METHODS: We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel (TVV) instability, major adverse events and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs). RESULTS: A total of 1605 study titles were identified by the initial search strategy, of which 13 (8=t-Branch/ 3=E-nside/1=We-Flow/1=TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer-multibranched group (OMG); 6.1% inner-multibranched group (IMG) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95%, CI, 83.8-96.4%) and 96.9% (95%, CI, 92.5-98.8%) for the outer- and inner-multibranched endograft, respectively. The pooled 30-day mortality was 10.4 % (95%, CI, 6.6-16.1%,) and 4.2% (95%, CI, 2.0-8.6%) for the outer and inner branched group respectively. The pooled 30-day and late TVV instability for the outer-branched group was 3.5% (95%, CI, 2.0-6.1%) and 6.2% (95%, CI, 4.7-8.0%) and for the inner branched group 10.4% (95%, CI, 4.5-22.5%) and 1.6% (95%, CI, 0.7-3.3%) respectively. CONCLUSIONS: This pooled analysis indicated good technical success and mortality rate, for both devices despite the high rate of urgent procedures. Pararenal and thoracoabdominal aortic aneurysms can be safely treated using the included devices. However, further studies are required to draw additional conclusions for the inner group due to the small sample size.
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BACKGROUND: The INCRAFT stent graft system is an ultra-low-profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze mid-term outcomes of a real-world patient cohort treated with the INCRAFT endograft. METHODS: Consecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm. RESULTS: Eighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use. Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up (FU) was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3, and 5 years of 84%, 66%, and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in 3 patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during FU and 4 open conversions (5%) were necessary. No known risk factors, including treatment outside instruction for use, were predictive for reinterventions. CONCLUSIONS: Treatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during FU to maintain endograft patency and prevent aneurysm growth.
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BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.
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Aneurisma de la Aorta Abdominal , Prótesis Vascular , Conversión a Cirugía Abierta , Reparación Endovascular de Aneurismas , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Conversión a Cirugía Abierta/efectos adversos , Endofuga/etiología , Endofuga/cirugía , Endofuga/mortalidad , Reparación Endovascular de Aneurismas/efectos adversos , Reparación Endovascular de Aneurismas/instrumentación , Reparación Endovascular de Aneurismas/mortalidad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Prótesis Vascular , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Reparación Endovascular de Aneurismas , Endofuga/epidemiología , Endofuga/cirugía , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Factores de Tiempo , Factores de Riesgo , Sistema de Registros , Estudios Retrospectivos , Diseño de PrótesisRESUMEN
OBJECTIVE: To describe mid-term outcomes of the use of EndoAnchors as an adjunct for arch and thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective multicentre series from nine centres using the Heli-FX EndoAnchor System (Medtronic Inc, Minneapolis, USA) at TEVAR over May 2014-May 2019 is presented. The study is registered at ClinicalTrials.gov with number NCT04100499. The primary outcome was freedom from Type I endoleak at EndoAnchors deployments; secondary outcomes included evaluation of aortic wall penetration (AWP) at first computed tomography scan, EndoAnchor-related issues and mortality. RESULTS: 54 high-risk patients (35 males/19 females, age 73 ± 11 years) with arch, thoracic and thoracoabdominal aneurysmal disease (3 chronic post-dissection and one patch pseudoaneurysm), with a mean neck length 19.7 ± 6.6 mm that were treated with multiple hybrid and endovascular techniques were included. A total of 329 EndoAnchors were used with a mean of 6.1 ± 2.5 per patient. Overall adequate AWP was 86%, whereas arch (Ishimaru's zones 0-2) deployments achieved 80.6% when compared to 87.3% in descending thoracic aorta (dTA); although there was no statistical significance. Freedom from type I endoleaks was 88% at 2 year follow-up, due to 4 type IA endoleaks, two of them successfully treated, one with conservative treatment due to complexity of repair and remaining patient died 1 year later due to endograft infection. There were reported five EndoAnchor-related issues; four losses and one renal stent-graft was crushed due to catheter deflection solved with balloon reinflation. None of the losses had clinical significance. Overall mortality is described for 7 (9.5%) patients, one of them aneurysm-related. CONCLUSIONS: The adjunctive use of EndoAnchors in TEVAR and complex TEVAR procedures achieved acceptable outcomes at midterm in a high-risk series with hostile seal zones. Still, they should be still judiciously used as there is lack of data to suggest a more liberal use; therefore, the landing zone should not be compromised in favour of their use.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Femenino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Reparación Endovascular de Aneurismas , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/etiologíaRESUMEN
OBJECTIVE: We performed a systematic review and meta-analysis to assess the stroke rates after thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysms and/or dissections. METHODS: A systematic search of all the literature reported until September 2021 was performed according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The pooled perioperative stroke rates and corresponding 95% confidence intervals (CIs) were estimated using fixed or random effect methods. RESULTS: A total of 878 study titles were identified by the initial search strategy, of which 43 were considered eligible for inclusion in the meta-analysis. A total of 5764 patients (63.5% male) were identified among the eligible studies. The pooled any stroke rate was 4.4% (95% CI, 3.60%-5.28%). However, after procedures without left subclavian artery (LSA) ostial coverage (eg, TEVAR deployed within or distal to zone ≥3), the stroke rate was 3.15% (95% CI, 2.21%-4.22%). For the patients with LSA coverage, the pooled stroke rate was 2.8% (95% CI, 1.69%-4.14%) for patients receiving left subclavian artery revascularization. However, the patients without LSA revascularization had a pooled estimated stroke incidence of 11.8% (95% CI, 5.85%-19.12%). CONCLUSIONS: Stroke has been a common finding after TEVAR, especially with LSA coverage without revascularization, validating current clinical practice guidelines recommending routine revascularization, when feasible. Additional studies with larger patient numbers that provide separate data regarding the aortic pathology treated, the anatomic location of the stroke and their association with functional recovery and survival are needed.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Accidente Cerebrovascular , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Femenino , Humanos , Masculino , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Arteria Subclavia/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe the outcome of open thoracoabdominal aortic aneurysm (TAAA) repair following previous aortic arch repair including elephant trunk (ET) or frozen elephant trunk (FET) for acute and chronic pathologies. METHODS: This was a retrospective, observational, multicenter study including 32 patients treated between 2006 and 2019 in two aortic centers using identical surgical protocols. Assessment focused on perioperative and long-term outcome, namely in-hospital morbidity and mortality, as well as procedure-related reintervention rate and aortic-related mortality rate. Kaplan-Meier curves with 95% confidence intervals were used to analyze the overall survival after surgery within the cohort. RESULTS: Thirty-two patients (mean age, 45.0 ± 13.6 years; 20 males [62.5%]) were treated because of acute (34.38% [n = 11]) or chronic (65.62% [n = 21]) aortic pathologies, including residual dissection following acute, symptomatic type A dissection (n = 7) and symptomatic mega aortic syndrome (n = 4), as well as post-dissection TAAA (n = 18) and asymptomatic mega aortic syndrome (n = 3). Twenty-eight patients (87.5%) received type II repair, and 4 patients (12.5%) received type III repair after previous ascending aorta and arch repair including ET/FET. Concomitant infrarenal and iliac vessel repair was performed in 38.7% (n = 12) and 29.4% (n = 10), respectively. The in-hospital mortality rate was 18.75% (n = 6). Spinal cord ischemia occurred in two cases, both after one-stage emergency procedure with one case of permanent paraplegia. Temporary acute kidney injury occurred in 41.94% (n = 13). The estimated 1-year survival rate was 78.1% (95% confidence interval, 63.9%-95.6%), with a median follow-up time of 1.29 years (interquartile range, 0.26-3.88 years). No procedure-related reinterventions and one case of aortic-related mortality, namely sepsis because of graft infection, was observed. CONCLUSIONS: Open TAAA repair following aortic arch repair including ET or FET because of acute or chronic aortic pathologies is associated with a relevant perioperative morbidity and mortality rate. During follow-up, a low aortic-related mortality rate and procedure-related reintervention rate were observed.
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Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Adulto , Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: This study reports on open TAAA repair comparing short and long term patient outcome according to the type of repair defined by the Crawford classification and elective vs. emergency repair. Endpoints were death, acute kidney injury (AKI), sepsis, spinal cord ischaemia (SCI), and re-intervention rate. METHODS: This was a retrospective study reporting the outcomes of 255 patients (between 2006 and 2019), designed according to the STROBE criteria. RESULTS: The TAAA distribution was type I 25%, type II 26%, type III 23%, type IV 18%, and type V 7%. Fifty-one (20%) patients had an emergency procedure. Of all the patients, 51% had a history of aortic surgery, 58% suffered from post-dissection TAAA, and 26% had connective tissue disease. The in hospital mortality rate among electively treated patients was 16% (n = 33) vs. 35% (n = 18) in the emergency subgroup; the total mortality rate was 20% (n = 51). The adjusted odds ratio for in hospital death following emergency repair compared with elective repair was 2.52 (95% confidence interval [CI] 1.15 - 5.48). Temporary renal replacement therapy because of AKI was required in 29% (n = 74) of all patients, sepsis from different cause was observed in 37% (n = 94), and SCI in 7% (n = 18, 10 patients suffering from paraplegia and eight from paraparesis). The mean follow up time was 3.0 years (median 1.5, range 0 - 12.8 years). Aortic related re-intervention was required in 2.8%. The total mortality rate during follow up was 22.5% (n = 46); 5.3% (n = 11) of all patients died because of aortic related events. CONCLUSION: Open TAAA repair is associated with an important morbidity and mortality rate, yet the incidence of spinal cord ischaemia may be favourably low if a neuromonitoring protocol is applied. The aortic related re-intervention and aortic related mortality rate during follow up are low.
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Lesión Renal Aguda , Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Sepsis , Isquemia de la Médula Espinal , Lesión Renal Aguda/etiología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/etiología , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/etiología , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/efectos adversos , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Estudios Retrospectivos , Factores de Riesgo , Sepsis/etiología , Isquemia de la Médula Espinal/etiología , Isquemia de la Médula Espinal/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: To collect and analyse the available evidence in the outcomes of patients treated with fenestrated endovascular aortic repair (f-EVAR) technique focusing specifically on visceral vessel outcomes. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the studies reporting the f-EVAR technique for the management of degenerative pararenal and/or type IV thoracoabdominal aortic aneurysms (TAAA) were considered eligible for inclusion in the study. The main study outcomes (technical success, type I endoleaks, fracture or occlusion of the bridging stents, overall aneurysm-related mortality, and the reintervention rate) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Fourteen studies with a total of 1804 patients were included in a pooled analysis. The technical success of the procedure was 95.97% (95%CI = 92.35-98.60). Intraoperatively, the pooled proportion of reported type I endoleak was 7.6% (95%CI = 2.52-14.60) while during a median follow-up of 41 months (range 11-96) follow-up period the pooled rate of fracture and occlusion of the bridging stents was 2.79% (95%CI = 0.00-8.52) and 4.46% (95%CI = 1.93-7.77), respectively. The overall aneurysm-related mortality was detected to be 0.63% (95%CI = 0.04-1.63), and the pooled estimate for re-intervention rate was 15.69%. CONCLUSIONS: Fenestrated endovascular repair for p-AAA is an effective and safe treatment. Target vessel complications and endoleaks remain the two most important concerns for fenestrated endovascular procedures, contributing to most of the secondary interventions. The lack of computed tomography angiography follow-up evaluation does not allow us to draw robust conclusions about the complication rates for the superior mesenteric artery during f-EVAR. Due to the potential implications of SMA complications on aneurysm-related mortality, standardized reporting of short- and long-term target visceral vessel outcomes is required.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/etiología , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Análisis de Datos , Endofuga/etiología , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Humanos , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.
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Aneurisma de la Aorta , Catéteres , Procedimientos Endovasculares , Catéteres/efectos adversos , Humanos , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Background: Ruptured juxtarenal aortic aneurysms (RJAAA) represent a special challenge in clinical practice, but the evidence to guide therapeutic decision-making is scarce. The aim of this study was to present two different approaches, open surgical (OAR) and chimney endovascular repair (CHEVAR), for treating patients with RJAAA. Patients and methods: This retrospective two-center study included all patients per center undergoing OAR or CHEVAR for RJAAA between February 2008 and January 2020. Juxtarenal aortic aneurysms were defined as having an infrarenal neck of 2-5 mm, measured after three-dimensional reconstruction of the computed tomography angiography scan. Results: 12 OAR patients (10 male, median age 73 years [58-90 years]) and 6 CHEVAR patients (all male, median age 74 years [59-83 years]) were included. In the OAR group, the proximal aortic clamping was suprarenal in 7 and interrenal in 5 patients. Cold renal perfusion was used in 4 patients, in 2 with suprarenal aortic clamping and in 2 with interrenal aortic clamping. 3 CHEVAR patients received a single renal chimney, the other 3 received double renal chimneys. Technical success was 12/12 in the OAR group 5/6 in the CHEVAR group. In-hospital mortality and 30-day mortality were 3/12 after OAR and 0/6 after CHEVAR. 2 OAR patients required transient dialysis. Median in-hospital stay was 14 (10-63) and 8 (6-21) days and median follow-up (FU) was 20 (3-37) and 30 (7-101) months, respectively. No further deaths occurred during FU. One OAR patient and 4 CHEVAR patients required aortic reinterventions. Conclusions: RJAAAs are rare. Both OAR and CHEVAR can represent adequate treatments for RJAAAs. OAR is the traditional approach, but CHEVAR has - in a high-volume center - promising early results with nonetheless a need for continuous FU to prevent reinterventions. Defining the studied aortic pathology precisely is essential for future research in order to draw valid conclusions.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aorta Abdominal , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Humanos , Masculino , Complicaciones Posoperatorias , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Background: Acute kidney injury (AKI) as complication after open and endovascular repair of thoracoabdominal aortic aneurysm (TAAA) is one major predictor of mortality and postoperative complications. We evaluated tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor-binding protein 7 (IGFBP7) as combined early biomarker for AKI detection and predictor of patients' outcome. Patients and methods: Between 2014 and 2015, 52 patients have been enrolled in this observational study, of whom 29 (55.8%) underwent elective open repair and 23 (44.2%) endovascular repair. TIMP2 × IGFBP7 were measured until 48 hours after admission on intensive-care unit (ICU) and were analyzed regarding their predictive ability for AKI (defined according to the KDIGO criteria) requiring temporary renal replacement therapy (RRT) and 90-day mortality using ROC curves. Results: Mean patient age was 64.5 years (Min: 43, Max: 85), endovascular treated patients were older (p <0.0001). 40.4% (n = 21) developed AKI, and 21.2% (n = 11) required renal replacement therapy. In-hospital and total mortality rates were 7.7% (n = 4) and 9.6% (n = 5), respectively. At no time a significant difference in TIMP2 × IGFB7 levels between patients undergoing open or endovascular surgery was observed. The predictive quality of the TIMP2 × IGFBP7 value on ICU admission was sound regarding AKI requiring temporary renal replacement therapy (sensitivity: 55.56% [38.1-72.1%], specificity: 90.91% [58.7-99.8%] with an area under the curve [AUC]: 0.694 [0.543-0.820]). Mean follow-up was 13.2 months (Min: 2, Max: 20), regarding the 90-day mortality, the predictive property of the TIMP2 × IGFBP7 value was not sufficient (sensitivity: 80% [28.4-99.5%], specificity: 52.38% [36.4-68%], and AUC: 0.607 [0.454-0.746]). Conclusions: TIMP2 × IGFBP7 level measured 6-12 hrs postoperatively may be useful as an early detectable biomarker for AKI requiring temporary renal replacement therapy. It seems not suited to predict patients' outcome following complex thoracoabdominal aortic surgery, regardless if performed by open or endovascular repair.
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Lesión Renal Aguda , Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Lesión Renal Aguda/terapia , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Biomarcadores , Humanos , Persona de Mediana Edad , Terapia de Reemplazo Renal , Inhibidor Tisular de Metaloproteinasa-2RESUMEN
OBJECTIVE: The aim of this pilot study was to evaluate intraoperative contrast-enhanced ultrasound (iCEUS) examination for endoleak (EL) detection after complex endovascular aortic repairs (EVAR) in comparison with the standard angiographic completion control. METHODS: Twenty-one patients (16 male; median age, 73 years [range, 54-81 years]) who underwent single-stage EVARs at our center between October 2016 and October 2018 were included prospectively. The procedures comprised fenestrated and/or branched EVAR (n = 14; 66%), infrarenal EVAR (n = 5; 24%), infrarenal EVAR with bilateral iliac side branch implantation (n = 1; 5%), and infrarenal EVAR with occluder implantation into the internal iliac artery (n = 1; 5%). The used endografts included 14 custom made devices (Cook, Australia Pty Ltd, Brisbane, Australia, n = 6; Vascutek Terumo, Glasgow, Scotland, n = 8) and seven standard infrarenal endografts (Medtronic Inc, Santa Rosa, Calif, n = 5; Vascutek Terumo, Glasgow, Scotland, n = 1; Cook, n = 1). All patients underwent an angiographic completion control for EL detection followed by iCEUS examination. The iCEUS examination was performed by the same examiner who was blinded to the angiography result. In addition to the comparison of the angiographic results to iCEUS examination, iCEUS examination was also compared with the computed tomography angiography (CTA) before discharge (median time to CTA, 5 days [range, 1-7 days]). RESULTS: Angiography detected eight type II EL, defining the EL origin in four cases. In addition to detecting all of those eight EL, iCEUS examination revealed eight more type II EL not seen on angiography (P = .002) and allowed a definition of the EL origin in all cases. CTA before discharge showed a persistence of only 5 of the 16 type II EL detected by iCEUS examination (31%, P = .002). CONCLUSIONS: An iCEUS examination can be used as another adjunct to decrease exposure to contrast agent and radiation during EVAR, including complex procedures. A replacement of the completion angiography by iCEUS examination is conceivable for infrarenal EVAR, but also for endovascular type IV or type V repairs. Future studies with larger patient numbers will help to further validate iCEUS examination during complex EVAR.
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Aneurisma de la Aorta Abdominal/cirugía , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares , Complicaciones Posoperatorias/diagnóstico por imagen , Ultrasonografía/métodos , Anciano , Anciano de 80 o más Años , Angiografía , Medios de Contraste , Femenino , Humanos , Periodo Intraoperatorio , Masculino , Persona de Mediana Edad , Proyectos PilotoRESUMEN
Purpose: To analyze the changes in target vessel (TV) anatomy after fenestrated endovascular aneurysm repair (fEVAR) during midterm follow-up. Materials and Methods: A retrospective single-center study analyzed 56 patients (mean age 71±7 years; 49 men) who underwent fEVAR using custom-made stent-grafts (22 Zenith and 34 Anaconda) between June 2010 and July 2016. Advanta V12 (V12; 74, 53%) and BeGraft (BeG; 66, 47%) stent-grafts were used to bridge to the 140 TVs. Measurements of the TV deviation at the aortic origin, the vessel shift distal to the bridging stent-graft (BSG), and the outer and inner BSG curve lengths were performed after 3-dimensional reconstruction of the serial computed tomography angiography scans. The results of the measurements for the main devices, the TVs, and the bridging stent-grafts were compared using univariable and multivariable analysis. Results: Of the 140 BSGs examined (74 V12s and 66 BeGs), 393 measurements (38 celiac trunks, 102 superior mesenteric arteries, 121 left renal arteries, and 132 right renal arteries) were analyzed. The outer/inner BSG curve length ratio was larger after implantation of Zenith devices compared with Anaconda (p<0.001). The vessel shift distal to the BSG was significantly associated with the interaction of the TV and type of BSG only in the univariable analysis (p=0.001). There were no significant changes of the TV deviation at the aortic origin. Only the outer BSG curve length was significantly associated with TV complications (p=0.033). Median follow-up was 24 months (range 2-61). The BSG curve length ratio showed a significant increase over time (p<0.001) but did not differ between the BeG and V12 (p=0.381). Conclusion: No difference was found between the V12 and the BeG stent-grafts regarding anatomical TV changes during midterm follow-up after fEVAR. Both stent-grafts adapt to the TV anatomy over time, and moderate anatomical changes seem to be tolerated without increasing the risk for TV complications. The type of main device also influences the TV anatomy.
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Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Arteria Celíaca/cirugía , Procedimientos Endovasculares/instrumentación , Arteria Mesentérica Superior/cirugía , Arteria Renal/cirugía , Stents , Remodelación Vascular , Anciano , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Arteria Celíaca/diagnóstico por imagen , Arteria Celíaca/fisiopatología , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Arteria Mesentérica Superior/diagnóstico por imagen , Arteria Mesentérica Superior/fisiopatología , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Diseño de Prótesis , Arteria Renal/diagnóstico por imagen , Arteria Renal/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions. MATERIALS AND METHODS: A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter. RESULTS: Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%. CONCLUSIONS: Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.
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Procedimientos Endovasculares/instrumentación , Vena Ilíaca , Stents Metálicos Autoexpandibles , Enfermedades Vasculares/terapia , Vena Cava Inferior , Adolescente , Adulto , Anciano , Aleaciones , Enfermedad Crónica , Constricción Patológica , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/fisiopatología , Grado de Desobstrucción Vascular , Vena Cava Inferior/diagnóstico por imagen , Vena Cava Inferior/fisiopatología , Adulto JovenRESUMEN
BACKGROUND: Despite all efforts, spinal cord ischemia (SCI) is a relevant and feared complication after open and endovascular thoracoabdominal aortic aneurysm (TAAA) repair. Besides the established correlation of motor evoked potentials (MEPs) and SCI, the usage of biomarkers for early detection of SCI intraoperatively and postoperatively after TAAA surgery is scarcely described in literature. METHODS: The methods include retrospective assessment of 33 patients (48.48% male) undergoing open and endovascular TAAA repair between January 2017 and January 2018. Levels of the biomarkers neurone-specific enolase (NSE), glial fibrillary acidic protein (GFAP), and S100 B were correlated with a decrease of the amplitude of the MEPs of more than 50%, indicating SCI. Linear mixed models were applied to test for differences in the biomarker levels between open and endovascular surgery and between different times of measurement. Post hoc analyses were performed using Tukey's multiple comparisons test. Logistic regression models were used to investigate the association between GFAP, NSE, and S100 B levels at different times and a significant decrease in MEP or in-hospital mortality. RESULTS: Altogether, 19 patients were treated by endovascular repair; 14 patients were treated by open repair; 5 patients were treated because of a type I TAAA; 7 received treatment because of a type II TAAA; 7, 10, and 4 patients received type III, IV, or V TAAA repair, respectively. In-hospital mortality was 18.18% (n = 6); 5 of these patients were treated because of symptomatic TAAA. MEP decrease could be observed in 18 cases (54.5%), with 16 (48.4%) recovering during the intervention. SCI could be observed in 9.09% (n = 3), 2 endovascular repairs leading to paraplegia and one open repair leading to paraparesis. All biomarkers showed increasing levels over time, with no statistically significant difference between open and endovascular repair. The difference in NSE and S100 B levels between the different times of measurements was statistically significant (P < 0.0001, P = 0.0017, respectively). In a univariable logistic regression analysis, no correlation with the end points "significant decrease in MEP" or "in-hospital mortality" was observed for any of the assessed biomarkers. CONCLUSIONS: SCI-related biomarkers, namely NSE and S100 B, show a relevant increase directly after open and endovascular TAAA surgery, while no clear association between these biomarker levels and an intraoperatively measurable indicator for SCI could be observed.
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Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Proteína Ácida Fibrilar de la Glía/sangre , Fosfopiruvato Hidratasa/sangre , Subunidad beta de la Proteína de Unión al Calcio S100/sangre , Isquemia de la Médula Espinal/sangre , Adulto , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Torácica/sangre , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Biomarcadores/sangre , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/mortalidad , Potenciales Evocados Motores , Femenino , Mortalidad Hospitalaria , Humanos , Monitorización Neurofisiológica Intraoperatoria , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Isquemia de la Médula Espinal/diagnóstico , Isquemia de la Médula Espinal/etiología , Isquemia de la Médula Espinal/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Aortic aneurysms in the viscerorenal-segment are nowadays treatable by endovascular means. Previously, new endograft techniques were only tested in healthy animals. We aimed to establish a new large animal model for testing complex endovascular stent techniques preclinically. METHODS: In sheep, four juxtarenal and two type IV thoracoabdominal aortic aneurysms were surgically created via a retroperitoneal approach. Two pieces out of a 10 × 15-cm bovine pericardial patch were sewn with the healthy aorta longitudinally. The viscerorenal segment was clamped, and the aorta was incised longitudinally. Then, the patches were longitudinally sewn together. In the meantime, antegrade flow through the native part of the aorta was already established by tangential clamping. Computed tomography angiography was performed after 4, 8, and 52 wk. RESULTS: Technical success was 100%. The median surgical procedure time was 3 h, the median blood loss was 210 mL, and the viscerorenal-segment clamping time was 2-4 min. The animals started drinking 1 h after arousal from anesthesia. One animal died after 1 wk because of delayed bleeding and another died after 1 y because of aneurysm rupture by a secondary bacterial infection. Four animals survived. The proximal landing zone diameter and the clock position of the vessel were stable over 52 wk. CONCLUSIONS: Surgical creation of an aortic aneurysm in the viscerorenal-segment in sheep was successful, without an ischemia/reperfusion injury. This animal model offers a new platform for evaluating innovative endovascular therapy options in vivo.
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Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/métodos , Modelos Animales de Enfermedad , Animales , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada , Femenino , Humanos , Ovinos , Resultado del TratamientoRESUMEN
OBJECTIVE: This study compared the outcomes of open one stage with open two stage repair of type II thoraco-abdominal aortic aneurysms (TAAA). METHODS: This retrospective study included 94 patients (68 men) with a mean ± SD age of 54.5 ± 14 years who underwent open type II TAAA repair from March 2006 to January 2016. The mean aneurysm diameter was 65 ± 14.4 mm. The median follow up was 42 months (range 12-96). Seventy-six patients received one stage open repair and 18 patients were treated in two steps: 12 received two open procedures (thoracic and abdominal) and six received hybrid repair (one open and one endovascular procedure). This study focused on the comparison of open one stage and open two stage TAAA repair. The median time between the two steps was 31.5 days (range 1-169). RESULTS: In hospital mortality after open one stage repair versus open two stage type II repair was 22.4% versus 0% (odds ratio 7.352, 95% confidence interval [CI] 0.884-959.1]; p = .19). The one year survival rate after one stage repair versus open two stage repair was 74.7% (95% CI 62.7-83.3) versus 90.9% (95% CI 50.8-98.7 [p = .225]). The five year survival rate after one stage repair versus open two stage repair was 53.0% (95% CI 37.2-66.5) versus 90.9% (95% CI 50.8-98.7 [p = .141]). The hazard ratio for survival after one stage repair and after open two stage repair was 4.563 (95% CI 96.9-81.4 [p = .137]). Paraplegia was observed after open one stage repair versus open two stage in 10.5% vs. 8% (p = 1). Acute kidney injury requiring permanent dialysis and myocardial infarction were assessed for after open one stage repair and open two stage and were seen in 3.9% vs. 0% (p = 1) and in 5.3% vs. 0% (p = 1), respectively. CONCLUSION: Open two stage repair may be recommended as a treatment option for type II TAAAs if anatomically feasible, as it has a lower mortality and similar complication rates to one stage repair.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Adulto , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Retrospectivos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Fenestrated endovascular aortic aneurysm repair (FEVAR) is a standard procedure for the treatment of complex aortic aneurysm. More than 4 fenestrations are still randomly used, even in case of complex aneurysm anatomy involving accessory renal arteries. METHODS: We are presenting the case of a 62-year-old male patient suffering from 63-mm juxtarenal aortic aneurysm. Because of his medical history and an ongoing immunosuppressive medication an endovascular approach was conducted. Using a 6-fold fenestrated endograft, 4 renal arteries as well as the superior mesenteric artery and the celiac trunk have been cannulated and stented successfully. RESULTS: No perioperative complications such as impairment of renal function could be observed. After 12 months, still a nonhampered renal function could be assessed. Furthermore, the endoprosthesis showed a good fit without detection of endoleaks, patent fenestrations, and a decreasing aneurysm diameter after 12 months of follow-up. Coverage of accessory renal arteries has been described as an established and necessary technique during endovascular repair of juxtarenal aortic aneurysm; yet coverage of these vessels may be related to renal infarction and an impaired renal function during follow-up. Based on current technical developments the implantation of a 6-fold FEVAR may be conducted with promising results. CONCLUSIONS: Six-fold fenestrated stent-graft prosthesis for the treatment of juxtarenal aortic aneurysm involving accessory renal arteries may be a feasible treatment option related to an appropriate 12-month patency.
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Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Grado de Desobstrucción Vascular , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) has been described as a potential biomarker of acute kidney injury (AKI) in different settings, but its behaviour under influence of open and endovascular repair of thoraco-abdominal aortic aneurysms (TAAA) has not been assessed yet. In this study, the course of NGAL was observed and differences of serum- (sNGAL) and urine-NGAL (uNGAL) levels following TAAA repair, especially with regard to AKI, were evaluated. PATIENTS AND METHODS: In this retrospective single centre study, 52 patients (mean age 64.5 years, [43-85 years]), including 39 (75 %) men, were enrolled (2014-2015, 13.2 months mean follow-up). Levels of sNGAL and uNGAL were measured perioperatively for 48 hours on intensive care unit. Twenty-three patients were treated by endovascular and 29 by open TAAA-repair. RESULTS: Logistic regression revealed an increase in NGAL (sNGAL p = 0.0263, uNGAL p = 0.0080) corresponding with an increase in serum creatinine within the first 48 hours. Fourteen patients (26.9 %) developed AKI and 11 (21.1 %) required dialysis. The course of NGAL differed significantly (uNGAL p < .0001, sNGAL p = 0.0002) between patients suffering from AKI requiring dialysis and patients without AKI. The predictive power of uNGAL was three times higher than that of sNGAL (estimate of the regression slope 0.1382 vs. 0.0460). No significant difference between patients undergoing open or endovascular TAAA repair regarding the perioperative course of sNGAL and uNGAL was observed. CONCLUSION: serum-NGAL and urine-NGAL correlate with serum creatinine levels and AKI requiring dialysis. Furthermore, the postoperative course of sNGAL and uNGAL after open and endovascular TAAA repair is not significantly different. Taken together, the results indicate that uNGAL and, to a lesser extent, sNGAL could be considered biomarkers for early detection of perioperative AKI after open and endovascular TAAA surgery.