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INTRODUCTION: The treatment of chronic postdissection aneurysms of the aortic arch is a challenge. This study aims to describe false lumen management after aortic arch endovascular repair of post-type A dissection aneurysms treated with a branched endograft. METHODS: In this single-center retrospective observational study, all consecutive patients undergoing endovascular treatment of aneurysmal degeneration of chronic type A aortic dissections following open repair were enrolled. The primary endpoint was maximal aortic diameter evolution measured on computed tomography angiography (CTA) performed during follow-up. Secondary endpoints included procedural success, aortic re intervention, and remodeling during follow-up. RESULTS: Between January 2017 and June 2020, 22 patients underwent endovascular branched arch repair for post type A dissection aneurysms. Technical success was 100%. Thirteen patients (59%) had dissection involvement of at least 1 supra-aortic vessel. Midterm follow-up CTA was performed for 20 patients, 23.1 (±13.3) months after the procedure. Maximal aortic diameter at the level of the repair was decreasing in 13 (65%) patients, increasing in 2 (10%) patients, and no change was observed in 5 (25%) patients. During follow-up, 7 patients (35%) required aortic reintervention. Thoracic candy plugs were implanted for distal false lumen occlusion in 15 patients and associated with a high rate of complete remodeling (6/15 patients, 40%). CONCLUSION: Arch branch endografting of aneurysmal evolution of a post type A dissection aortic arch is a safe and feasible option in experienced hands. Candy plug use in favorable anatomies seems to be associated with accelerated remodeling of the aorta. CLINICAL IMPACT: There are currently no recommendations on dissected supra- aortic vessels management and the use of thoracic aorta false lumen occlusion devices during endovascular repair of chronic post dissection aneurysm of the aortic arch with branched endografts. Based on our clinical experience reported in the current manuscript, we propose a treatment algorithm for the management of the false lumen in this setting.
ABSTRACT
BACKGROUND: Surgical repair of aortic arch pathology is complex and associated with significant morbidity and mortality. Alternative approaches have been developed to reduce these risks, including the use of thoracic stent-grafts with fenestrations or in combination with bypass procedures to maintain supra-aortic trunk blood flow. Branched stent-grafts are a novel approach to treat aortic arch pathology. METHODS: Consecutive patients with aortic arch disease presenting to a single university hospital vascular centre were considered for branched stent-graft repair (October 2010 to January 2017). Patients were assessed in a multidisciplinary setting including a cardiologist, cardiac surgeon and vascular surgeon. All patients were considered prohibitively high risk for standard open surgical repair. The study used reporting standards for endovascular aortic repair and PROCESS (Preferred Reporting of Case Series in Surgery) guidelines. RESULTS: Some 30 patients (25 men) underwent attempted branch stent-graft repair. Mean age was 68 (range 37-84) years. Eighteen patients had chronic aortic dissection, 11 patients had an aneurysm and one had a penetrating ulcer. Fourteen patients had disease in aortic arch zone 0, six in zone 1 and ten in zone 2. Twenty-five patients had undergone previous aortic surgery and 24 required surgical revascularization of the left subclavian artery. Technical success was achieved in 27 of 30 patients. Four patients had an endoleak (type Ia, 1; type II, 3). The in-hospital mortality rate was three of 30. Mean length of follow-up was 12·0 (range 1·0-67·8) months, during which time 12 patients required an aortic-related reintervention. CONCLUSION: Repair of aortic arch pathology using branched stent-grafting appears feasible. Before widespread adoption of this technology, further studies are required to standardize the technique and identify which patients are most likely to benefit.
Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Stents , Adult , Aged , Aged, 80 and over , Aortic Diseases/mortality , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/instrumentation , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Treatment OutcomeABSTRACT
OBJECTIVE: The aim of this study was to evaluate a new 3D Workstation workflow (EVAR Assist, Advantage Windows, GE Healthcare, Chalfont, UK) (EA-AW) designed to simplify complex EVAR planning. PATIENTS AND METHODS: All pre-operative computed tomography (CT) scans of patients who underwent repair at our institution of a complex aortic aneurysm using fenestrated endovascular repair (f-EVAR) between January and September 2014, were reviewed. For each patient, imaging analysis (12 measures: aortic diameters and length and "clock position" of visceral artery) was performed on two different workstations: Aquarius (TeraRecon, San Mateo, CA, USA) and EA-AW. According to a standardized protocol, three endovascular surgeons experienced in aortic endograft planning, performed image analyses and data collection independently. We analyzed an internal assessment between observers (on the Aquarius 3DWS) and an external assessment comparing these results with the planning center (PC) data used to custom the fenestrated endograft of the patients enrolled in this study. Finally, we compared both 3DWS data to determine the accuracy and the reproducibility. A p-value < .05 was considered as statistically significant. Complete agreement between operators was defined as 1.0. RESULTS: Intra- and inter-observer variability (interclass correlation coefficients - ICC: 0.81-.091) was very low and confirmed the reliability of our planners. The ICC comparison between EA-AW and Aquarius was excellent (> 0.8 for both), thus confirming the reproducibility and reliability of the new EA-AW application. Aortic and iliac necks diameters and lengths were similarly reported with both workstations. In our study, the mean difference in distance and orientation evaluation of target vessels evaluated by the two workstations was marginal and has no impact on clinical practice in term of device manufacturing. CONCLUSIONS: We showed that complex EVAR planning can be performed with this new dedicated 3D workstation workflow with a good reproducibility.
Subject(s)
Aortic Aneurysm/diagnostic imaging , Blood Vessel Prosthesis Implantation , Imaging, Three-Dimensional/methods , Software/standards , Aged , Aged, 80 and over , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Female , Humans , Image Interpretation, Computer-Assisted , Male , Middle Aged , Observer Variation , Predictive Value of Tests , Reproducibility of Results , Retrospective Studies , Tomography, X-Ray ComputedABSTRACT
OBJECTIVE/BACKGROUND: Fenestrated endovascular repair (FEVAR) has been used to treat complex abdominal aortic aneurysms (AAAs). The risk of renal function deterioration compared with infrarenal endovascular aortic repair (EVAR) has not been determined. METHODS: Patients with preserved renal function (estimated glomerular filtration rate [eGFR] > 45 mL/minute) enrolled in two prospective, non-randomised studies evaluating Zenith fenestrated and AAA stent grafts were matched (1:2) by propensity scores for age, sex, hypertension, diabetes, and pre-operative eGFR. Sixty-seven patients were treated by FEVAR and 134 matched controls treated by EVAR. Mean follow-up was 30 ± 20 months. Outcomes included acute kidney injury (AKI) defined by RIFLE and changes in serum creatinine (sCr), eGFR, and chronic kidney disease (CKD) staging up to 5 years. RESULTS: AKI at 1 month was similar between groups, with > 25% decline in eGFR observed in 5% of FEVAR and 9% of EVAR patients (p = .39). There were no significant differences in > 25% decline in eGFR at 2 years (FEVAR 20% vs. EVAR 20%; p > .99) or 5 years (FEVAR 27% vs. EVAR 50%; p = .50). Progression to stage IV-V CKD was similar at 2 years (FEVAR 2% vs. EVAR 3%; p > .99) and 5 years (FEVAR 7% vs. EVAR 8%; p > .99), with similar sCr and eGFR up to 5 years. During follow-up, there were more renal artery stenosis/occlusions (15/67 [22%] vs. 3/134 [2%]; p < .001) and renal related re-interventions (12/67 [18%] vs. 4/134 [3%]; p < .001) in patients treated by FEVAR. Rate of progression to renal failure requiring dialysis was low and identical in both groups (1.5% vs. 1.5%; p > .99). CONCLUSION: Aortic repair with FEVAR and EVAR was associated with similar rates of renal function deterioration in patients with preserved pre-operative renal function. Renal related re-interventions were higher following FEVAR, although net changes in renal function were similar in both groups.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Kidney Diseases/etiology , Kidney/physiopathology , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Biomarkers/blood , Blood Vessel Prosthesis Implantation/adverse effects , Creatinine/blood , Disease Progression , Endovascular Procedures/adverse effects , Female , Glomerular Filtration Rate , Humans , Kidney Diseases/diagnosis , Kidney Diseases/physiopathology , Kidney Diseases/therapy , Male , Prospective Studies , Prosthesis Design , Renal Dialysis , Risk Factors , Time Factors , Treatment Outcome , United StatesSubject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Endovascular Procedures , Aorta, Thoracic/anatomy & histology , Aortic Diseases/complications , Aortic Diseases/diagnosis , Aortic Diseases/epidemiology , Endovascular Procedures/adverse effects , Humans , Postoperative Complications/prevention & controlABSTRACT
OBJECTIVE: To assess short- and long-term movement of renal arteries after fenestrated endovascular aortic repair (FEVAR). METHODS: Consecutive patients who underwent FEVAR at one institution with a custom-made device designed with fenestrations for the superior mesenteric (SMA) and renal arteries, a millimetric computed tomography angiography (CTA), and a minimum of 2 years' follow-up were included. Angulation between renal artery trunk and aorta, clock position of the origin of the renal arteries, distance between renal arteries and SMA, and target vessel occlusion were retrospectively collected and compared between the pre-operative, post-operative (<6 months), and last (>12 months) CTA. RESULTS: From October 2004 to January 2014, 100 patients met the inclusion criteria and 86% of imaging was available for accurate analysis. Median follow-up was 27.3 months (22.7-50.1). There were no renal occlusions. A significant change was found in the value of renal trunk angulation of both renal arteries on post-operative compared with pre-operative CTA (17° difference upward [7.5-29], p < .001), but no significant change thereafter (p = .5). Regarding renal clock positions (7.5° of change equivalent to 15 min of renal ostial movement): significant anterior change was found between post-operative and pre-operative CTA (15 min [0-30], p = .03 on the left and 15 min [15-30], p < .001 on the right), without significant change thereafter (15 min [0-30], p = .18 on the left and 15 min [0-15] on the right, p = .28). No changes were noted on the distance between renal and SMA ostia (difference of 1.65 mm [1-2.5], p = .63). CONCLUSION: The renal arteries demonstrate tolerance to permanent changes in angulation after FEVAR of approximately 17° upward trunk movement and of 15-30 min ostial movement without adverse consequences on patency after a median of more than 2 years' follow-up. The distance between the target vessels remained stable over time. These results may suggest accommodation to sizing errors and thus a compliance with off the shelf devices in favourable anatomies.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/instrumentation , Renal Artery/anatomy & histology , Renal Artery/diagnostic imaging , Stents , Aorta/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Computed Tomography Angiography , Endovascular Procedures/methods , Follow-Up Studies , Humans , Mesenteric Artery, Superior/diagnostic imaging , Prosthesis DesignABSTRACT
INTRODUCTION: Hyperhomocysteinemia is a biological marker that could be identified in the venous thrombotic events and rarely during acute arterial thrombotic events. The consequences can be serious. Effective diagnostic strategy is needed to optimize the management. CASE REPORT: Following bariatric surgery, a 40-year-old patient was admitted with an acute encephalopathy associated with peripheral lower limb arterial ischemia. The diagnostic work-up identified a major hyperhomocysteinemia whose causes were several. Surgical treatment and anticoagulation was associated with vitamins and trace elements supplementation. Correcting deficiencies allowed delirium and hyperhomocysteinemia improvement. Once treatment established, the patient did not present a recurrent thrombotic episode. CONCLUSION: Major hyperhomocysteinemia seems to be associated with an increased risk of acute arterial thrombosis. This marker might be considered in nutritional deficiency situations with appropriate support on the vascular, metabolic and nutrition level.
Subject(s)
Anticoagulants/therapeutic use , Hyperhomocysteinemia/complications , Thrombosis/etiology , Adult , Arteries/pathology , Dietary Supplements , Female , HumansABSTRACT
OBJECTIVE/BACKGROUND: The objective was to investigate renal outcomes following endovascular repair of thoraco-abdominal aortic aneurysms (TAAA) comparing fenestrations with branches for the renal arteries. METHODS: Renal outcomes following TAAA endovascular repair performed with renal branches were collected from five high volume European centers and compared with renal outcomes following TAAA endovascular repair performed with renal fenestrations at one center. Renal re-intervention and occlusion rates, and freedom from any renal outcome and death were analyzed by patient and target vessel. Estimated glomerular filtration rate (eGFR) was calculated and collected pre-operatively and at the last available follow up. RESULTS: In total, 449 patients were included in this retrospective study (235 treated with branched devices [BEVAR] and 214 with fenestrated devices [FEVAR]). Altogether, 856 renal vessels were analyzed (445 perfused by branches and 411 by fenestrations). Both groups were comparable except for sex and smoking habits. Technical success rates were 95% and 99%, respectively. Mean ± SD follow up was 19 ± 18 months after BEVAR and 24 ± 20 months after FEVAR. During follow up, renal re-intervention rates were similar in both groups (4.7% vs. 5.2%). The renal occlusion rate was significantly higher following BEVAR (9.6% vs. 2.3%; p < .01), and the 2 year freedom for renal occlusion rate was 90.4% (SE 85.8-95.3%) following BEVAR and 97.1% (SE 94.6-99.7%) following FEVAR (p < .01). During follow up, a 12% median decrease in eGFR was observed following BEVAR versus 9% following FEVAR (non-significant). The 2 year survival rates were 73.4% (SE 66.6-80.9%) and 81.8% (SE 76.1-87.9%) following BEVAR and FEVAR, respectively. CONCLUSION: Mid-term renal outcomes following endovascular repair of TAAA are satisfactory. Endograft designs incorporating renal fenestrations rather than renal branches are associated with significantly lower occlusion rates. A prospective trial is now required to confirm these results.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Kidney/physiopathology , Renal Artery/surgery , Aged , Angioplasty/methods , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis , Female , Glomerular Filtration Rate , Humans , Kidney/blood supply , Male , Renal Artery Obstruction/etiology , Retrospective Studies , Stents , Treatment Outcome , Vascular Grafting/methodsABSTRACT
OBJECTIVES: The use of branched stent grafts for the treatment of thoracoabdominal aneurysms [TAAA] is increasing, but mating stent graft choice has not been studied. This study combined experience of five high volume centres to assess a preferred mating stent. METHODS: Data from five centres were retrospectively combined. Patients were included if they underwent stent graft for treatment of TAAA that used only branches to mate with visceral and renal vessels. All patients with fenestrations in their device were excluded. Perioperative details, reintervention, occlusion, and death were recorded. Outcome of occlusion or reintervention, as well as a composite outcome of any death, occlusion, or reintervention was planned using a per-patient, and per-branch analysis. RESULTS: In 235 included patients, there were 940 vessels available for placement of mating stent. The average age of included patients was 70 years (SD 7.9), and 179 of the 235 were male. Medical comorbidities included diabetes in 29/234 (12.4%), current smoker in 81/233 (34.8%), and COPD in 77/234 (32.9%). The primary stent deployed was self-expanding in 556 branches, balloon expandable in 231 branches, and was unknown in 92 branches. After a mean of 20.7 months (SD 25) follow-up, there have been 44 incidents of occlusion or reintervention, of which 40 culprit stents are known. Where the stent placed is known, the event rate in renal branches (35/437, 8%) is higher than that of visceral branches (8/443, 1.8%). There is no difference in occlusion or reintervention between self-expanding and balloon expandable stents (HR 0.95, p = .91) but there is a statistically significant difference between renal and visceral artery occlusions (HR 3.51, p = 0.001). CONCLUSION: There appears to be no difference in occlusion or reintervention rate for branch vessels mated with balloon expandable compared with self-expanding stents. Renal events appear to outnumber visceral events in this population.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Europe , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
OBJECTIVES: The aim was to evaluate the current results of aortic arch aneurysm repair using inner branched endografts performed in three high volume aortic endovascular centers and to compare them to the pioneering global experience with this technology. METHODS: Included patients underwent repair of aortic arch aneurysms >55 mm in diameter using inner branched endograft technology between April 2013 and November 2014. All patients were deemed unfit for open surgery. Inner branches were designed to perfuse the brachiocephalic trunk and the left common carotid artery in all cases. A left subclavian artery (LSA) revascularization was performed prior to the arch endovascular repair. Data were collected retrospectively in an electronic database. Parameters included length of procedure, fluoroscopy time, contrast volume, technical success, presence of endoleaks, early and late complications, and mortality. RESULTS: Twenty-seven patients were included in the study. Technical success was achieved in all cases. No patients died during the 30 day post-operative period. Early neurologic events included two major strokes (7.4%) and one minor stroke (3.7%). Transient spinal cord ischemia with full recovery was observed in two patients (7.4%). Four patients (14.8%) underwent early (<30 day) re-interventions; these were for an access complication, an ischemic limb and exploration of the left ventricle through a sternotomy in two patients. During follow up (median 12 months), one patient (3.7%) died from a remote thoraco-abdominal aneurysm rupture. There were three Type 2 endoleaks (11.1%). Two re-interventions (7.4%) were performed, one to treat a Type 2 endoleak and one to treat a septic false aneurysm. A significant decrease in overall mortality was observed when comparing patients from the early experience with patients from the current report. CONCLUSIONS: The early outcomes associated with this technology are favorable. Branched endografting of aortic arch aneurysms should be considered in patients unfit for open surgery.
Subject(s)
Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Endovascular Procedures/methods , Vascular Grafting/methods , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: Outcomes are reported in management of post-dissection aneurysms involving the aortic arch and/or thoraco-abdominal segment (TAAA) treated with fenestrated and branched (complex) endografts. METHODS: This report includes all patients with chronic post-dissection aneurysms >55 mm in diameter, deemed unfit for open surgery, treated using complex endografts between October 2011 and March 2015. When appropriate, staged management strategies including left subclavian artery revascularization, thoracic endografting, dissection flap fenestration or tear enlargement, and other endovascular procedures were performed at least 3 weeks prior to definitive complex endovascular repair. The following outcome data were collected prospectively at discharge, 12 months and annually thereafter: technical success, endoleaks, target vessel patency, false lumen patency, aneurysm diameter, major and minor complications, re-interventions, and mortality. RESULTS: The cohort comprised 23 patients with a median age of 65 years. Staged procedures were performed in 14 patients (61%). Seven patients with dissections involving the arch were treated with inner branched endografts, and 16 TAAA patients were treated with fenestrated or branched endografts. The technical success rate was 71% following arch repair and 100% following TAAA repair. During early follow up, one of the arch group patients died and one in the TAAA group suffered spinal cord ischemia. The median follow up was 12 months (range 3-48), during which time one patient died of causes unrelated to aneurysm or treatment. Two early re-interventions were performed in the arch group to correct access vessel complications and there were a further two late re-interventions in the TAAA group to treat endoleaks. All target vessels (n = 72) remained patent. CONCLUSIONS: This experience indicates that complex endovascular repair of post-dissection aneurysms is a viable alternative to open repair in patients deemed unfit for open surgery. There are insufficient data to allow comparison with the outcome of open surgery in anatomically similar, but fit, patients.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Dissection/diagnosis , Aortic Dissection/mortality , Aortic Dissection/physiopathology , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Endoleak/etiology , Endoleak/therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , Humans , Male , Middle Aged , Patient Selection , Prospective Studies , Prosthesis Design , Retreatment , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , Vascular PatencyABSTRACT
BACKGROUND: Atherosclerosis is an inflammatory disease in which macrophages play a crucial role. Macrophages are present in different phenotypes, with at the extremes of the spectrum the classical M1 pro-inflammatory and the alternative M2 anti-inflammatory macrophages. The neuron-derived orphan receptor 1 (NOR1), together with Nur77 and Nurr1, are members of the NR4A orphan nuclear receptor family, expressed in human atherosclerotic lesion macrophages. However, the role of NOR1 in human macrophages has not been studied yet. OBJECTIVES: To determine the expression and the functions of NOR1 in human alternative macrophages. METHODS AND RESULTS: In vitro IL-4 polarization of primary monocytes into alternative M2 macrophages enhances NOR1 expression in human but not in mouse macrophages. Moreover, NOR1 expression is most abundant in CD68+MR+ alternative macrophage-enriched areas of human atherosclerotic plaques in vivo. Silencing NOR1 in human alternative macrophages decreases the expression of several M2 markers such as the Mannose Receptor (MR), Interleukin-1 Receptor antagonist (IL-1Ra), CD200 Receptor (CD200R), coagulation factor XIII A1 polypeptide (F13A1), Interleukin 10 (IL-10) and the Peroxisome Proliferator-Activated Receptor (PPAR)γ. Bioinformatical analysis identified F13A1, IL-1Ra, IL-10 and the Matrix Metalloproteinase-9 (MMP9) as potential target genes of NOR1 in human alternative macrophages. Moreover, expression and enzymatic activity of MMP9 are induced by silencing and repressed by NOR1 overexpression in M2 macrophages. CONCLUSIONS: These data identify NOR1 as a transcription factor induced during alternative differentiation of human macrophages and demonstrate that NOR1 modifies the alternative macrophage phenotype.
Subject(s)
Carotid Artery Diseases/metabolism , DNA-Binding Proteins/metabolism , Macrophage Activation , Macrophages/metabolism , Receptors, Steroid/metabolism , Receptors, Thyroid Hormone/metabolism , Animals , Biomarkers/metabolism , Carotid Artery Diseases/genetics , Carotid Artery Diseases/immunology , Carotid Artery Diseases/pathology , Cell Differentiation , Cells, Cultured , DNA-Binding Proteins/genetics , Gene Silencing , Humans , Interleukin 1 Receptor Antagonist Protein/genetics , Interleukin 1 Receptor Antagonist Protein/metabolism , Interleukin-10/genetics , Interleukin-10/metabolism , Interleukin-4/pharmacology , Macrophage Activation/drug effects , Macrophages/drug effects , Macrophages/immunology , Matrix Metalloproteinase 9/genetics , Matrix Metalloproteinase 9/metabolism , Mice, Inbred C57BL , Phenotype , Plaque, Atherosclerotic , Primary Cell Culture , RNA Interference , Receptors, Steroid/genetics , Receptors, Thyroid Hormone/genetics , STAT6 Transcription Factor/genetics , STAT6 Transcription Factor/metabolism , Signal Transduction , Time Factors , TransfectionABSTRACT
OBJECTIVES/BACKGROUND: ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms (rAIA) eligible for treatment by either endovascular (EVAR) or open surgical repair (OSR). Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture. METHODS: Randomization was done by week, synchronously in all centers. The primary end point was 30 day mortality. Secondary end points were post-operative morbidity, length of stay in the intensive care unit (ICU), amount of blood transfused (units) and 6 month mortality. RESULTS: From January 2008 to January 2013, 107 patients (97 men, 10 women; median age 74.4 years) were enrolled in 14 centers: 56 (52.3%) in the EVAR group and 51 (47.7%) in the OSR group. The groups were similar in terms of age, sex, consciousness, systolic blood pressure, Hardman index, IGSII score, type of rupture, use of endoclamping balloon, and levels of troponin, creatinine, and hemoglobin. Delay to treatment was higher in the EVAR group (2.9 vs. 1.3 hours; p < .005). Mortality at 30 days and 1 year were not different between the groups (18% in the EVAR group vs. 24% in the OSR group at 30 days, and 30% vs. 35%, respectively, at 1 year). Total respiratory support time was lower in the EVAR group than in the OSR group (59.3 hours vs. 180.3 hours; p = .007), as were pulmonary complications (15.4% vs. 41.5%, respectively; p = .050), total blood transfusion (6.8 vs. 10.9, respectively; p = .020), and duration of ICU stay (7 days vs. 11.9 days, respectively; p = .010). CONCLUSION: In this study, EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality. However, EVAR was associated with less severe complications and less consumption of hospital resources than OSR.
Subject(s)
Aneurysm, Ruptured/surgery , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Aneurysm/surgery , Aged , Aged, 80 and over , Aneurysm, Ruptured/diagnosis , Aneurysm, Ruptured/economics , Aneurysm, Ruptured/mortality , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/economics , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnosis , Aortic Rupture/economics , Aortic Rupture/mortality , Blood Transfusion , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/economics , Blood Vessel Prosthesis Implantation/mortality , Cost-Benefit Analysis , Endovascular Procedures/adverse effects , Endovascular Procedures/economics , Endovascular Procedures/mortality , Female , France , Hospital Costs , Hospital Mortality , Humans , Iliac Aneurysm/diagnosis , Iliac Aneurysm/economics , Iliac Aneurysm/mortality , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/therapy , Prospective Studies , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The purpose of this study was to analyze immediate and long-term renal outcomes (renal function and renal events) after fenestrated (FEVAR) and branched endovascular aortic aneurysm repair (BEVAR). METHODS: All FEVAR and BEVAR performed between October 2004 and October 2012 were included in this study. Post-operative acute renal failure (ARF) was defined according to the RIFLE criteria. Renal volume (calculated with a 3D workstation) and estimated glomerular filtration rate (GFR) (estimated with the Modification of Diet in Renal Disease [MDRD] formula) were evaluated before the procedure, before discharge, 12 months after, and yearly thereafter. Renal stent occlusion, dissection, fracture, stenosis, kink, renal stent related endoleak, and renal stent secondary intervention were all considered "renal composite events" and analyzed. A time to event analysis was performed for renal events and secondary renal interventions. RESULTS: 225 patients were treated with FEVAR and BEVAR. Renal target vessels (n = 427) were perfused by fenestrations (n = 374), or branches (n = 53). Median follow up was 3.1 years (2.9-3.3 years). Technical success was achieved in 95.5% of patients. Post-operative ARF was seen in 64 patients (29%). Mean total renal volume and eGFR at 1 year, 2 year, and 3 year follow up were significantly lower when compared with pre-operative levels (after BEVAR and FEVAR); the decrease at 3 years was 14.8% (6.7%; 22.2%) (p = .0006) for total renal volume and 14.3% (3.1%; 24.3%) (p = .02) for eGFR. The 30 day and 5 year freedom from renal composite event was 98.6% (95.8-99.6%) and 84.5% (76.5-89.9%) after FEVAR and BEVAR (NS). The 30 day and 5 year freedom from renal occlusion was 99.5% (96.7-99.9%) and 94.4% (89.3-97.1%) after FEVAR and BEVAR (NS). CONCLUSION: FEVAR and BEVAR are durable options for the treatment of complex aortic aneurysms and are associated with low renal morbidity, without differences between devices types. The clinical impact of decreasing renal volume over time in these patients is yet to be fully understood.