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OBJECTIVE: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians. SUMMARY BACKGROUND DATA: Few studies looking at octogenarian-specific outcomes with diverging results. METHODS: Retrospective, multicentre cohort study including consecutive patients undergoing elective FEVAR for cAAAs or type IV thoracoabdominal aortic aneurysms between 2007-2022 in eight high-volume centres. Octogenarians vs. non-octogenarians were compared. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival and reintervention rates. RESULTS: A total of 729 patients (median age of 74.8 years [IQR 69.2 - 79.14]) were included, 169 (23%) of which were octogenarians, with 316 (43.3%) patients undergoing juxta/pararenal aneurysm repair. Although octogenarians presented less complex but larger (61 mm vs. 58 mm) aneurysms, the number of fenestrations was similar across groups. No differences in in-hospital mortality (4.1 vs. 3.0%), MAE (16.6% vs 12.2%) or reintervention rates (11.2 vs. 10%) were found. Multivariable logistic regression of in-hospital mortality identified BMI (OR 0.66, 95% CI 0.51-0.95, P=0.003), chronic heart failure (OR 7.70, 95% CI 1.36-36.15, P=0.003) and GFR<45 ml/min/1.73 m2 (OR 5.25, 95% CI 1.20-22.86, P=0.027) as independent predictors. Median follow-up was 41 months. The 1, 2 and 5-year survival rates were 91.3%, 81.8% and 49.5% in octogenarians vs 90.6%, 86.5% and 68.8% in non-octogenarian patients (Log-rank: =0.001). Freedom from aortic-related death and freedom from reintervention at five-years were similar across groups (log-rank=0.94 and .76, respectively). Age>80 was not an independent predictor of 30-day or long-term mortality on multivariable and Cox regression analysis. CONCLUSIONS: Elective FEVAR in octogenarians appears to be safe, with similar outcomes as in younger patients. Future studies looking at improved patient selection methods to ensure long-term survival benefits in both octogenarians and younger patients are warranted.
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OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.
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OBJECTIVE: The management of cervical artery dissections (CADs) is poorly standardized given the scarce number of prospective studies comparing medical and interventional approach to CAD. The aim of the present study is to perform a systematic review and meta-analysis of studies on the treatments of CAD. METHODS: Systematic review and meta-analysis (pre-registered on PROSPERO [CRD42022297512] are performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses [PRISMA] guidelines searching in three different databases [PubMed, Embase and Cochrane Database]) of studies on medical or interventional approach to CAD. Only prospective studies were selected to reduce the risk of bias for the primary meta-analysis. Secondarily, retrospective studies were also included. The aim was to assess the rate of stroke and of stroke/death/bleeding (major or intracranial) by Der Simonian-Laird weights of random effects model. RESULTS: After screening 456 articles, 6 prospective and 22 retrospective studies were identified. Two randomized controlled trials and five retrospective studies comparing antiplatelet (APT) vs oral anticoagulant therapy (OAC) for CAD were identified, as well as four prospective and 17 retrospective single-arm studies evaluating stenting for CAD. In the meta-analysis of randomized controlled trials comparing APT vs OAC, 444 patients were considered, and a borderline significant association was identified in terms of stroke/death in the APT vs OAC groups (odds ratio [OR], 5.6; 95% confidence interval [CI], 0.94-33.38; P = .06; I2 = 0%). No differences were found for the stroke/death/bleeding outcome (OR, 1.25; 95% CI, 0.19-8.18; P = .81; I2 = 0%) between the two treatments. In the meta-analysis including also retrospective studies, overall risk of bias was considered "serious," and 4104 patients were included with no differences in APT vs OAC for stroke (OR, 1.06; 95% CI, 0.53-2.11; P = .29; I2 = 18%); no other comparisons were possible. The pooled meta-analysis of prospective studies on stenting for CAD included four series, for a total of 68 patients, in whom stenting was adopted primarily after failed medical therapy or after traumatic dissection. The pooled rate of stroke/death was 7% (95% CI, 3%-17%; I2 = 0%). The analysis of moderators identified a significant inverse association between the percentage of traumatic dissection and a reduction in postoperative stroke (Y = -1.60-2.02X; P = .03). The pooled rate of the composite endpoint of stroke/death/ or major bleeding was 8% (95% CI, 3%-18%; I2 = 0%). Secondarily, the meta-analysis also included 17 retrospective studies with overall 457 patients and showed a 2.1% pooled rate of stroke/death (95% CI, 1.0%-3.3%; I2 = 0%) and 3.2% stroke/death/bleeding (95% CI, 1.8%-4.7%; I2 = 0%). CONCLUSIONS: Few prospective studies on CAD treatment are present in literature. APT and OAC seem to have similar efficacy in reducing the recurrence of stroke after CAD. No definitive conclusion can be drawn for stenting, due to the low number of studies available. More prospective studies are necessary to evaluate its potential additional value over medical therapy alone in the early phase after CAD.
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Anticoagulantes , Procedimentos Endovasculares , Inibidores da Agregação Plaquetária , Stents , Acidente Vascular Cerebral , Humanos , Anticoagulantes/uso terapêutico , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Procedimentos Endovasculares/instrumentação , Inibidores da Agregação Plaquetária/uso terapêutico , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Dissecação da Artéria Vertebral/terapia , Dissecação da Artéria Vertebral/mortalidade , Dissecação da Artéria Vertebral/diagnóstico por imagemRESUMO
OBJECTIVE: Persistent type II endoleaks (pEL2s) are not uncommon after endovascular aneurysm repair and their impact on long-term outcomes is well-documented. However, their occurrence and natural history after fenestrated/branched endografting (F/B-EVAR) for juxtarenal and pararenal aneurysms (J/P-AAAs) have been scarcely investigated. Aim of this study was to report incidence, risk factors, and natural history of pEL2 after F/B-EVAR in J/P-AAAs. METHODS: Between 2016 and 2022, all J/P-AAAs undergoing F/B-EVAR were prospectively collected and retrospectively analyzed. EL2 were assessed at the completion angiography, at 30 days and after 6 months as primary outcomes. Preoperative risk factors for pEL2, follow-up survival, freedom from reinterventions (FFR) and aneurysm shrinkage (≥5 mm) were considered as secondary outcomes. RESULTS: Of 132 patients, there were 88 (67%) JAAAs and 44 (33%) PAAAs. Seventeen EL2 (13%) were detected at the completion angiography and 36 (27%) at 30-day computed tomography angiography. The mean follow-up was 28 ± 23 months. Eleven (31%) EL2 sealed spontaneously within 6 months and three new cases were detected, for an overall of 28 pEL2/107 patients (26%) with available radiological follow-up of ≥6 months. Preoperative antiplatelet therapy (odds ratio, 4.7; 95% confidence interval [CI[, 1-22.1; P = .05), aneurysm thrombus volume of ≤40% and six or more patent aneurysm afferent vessels (odds ratio, 7.2; 95% CI, 1.8-29.1; P = .005) were independent risk factors for pEL2. The estimated 3-year survival was 80%, with no difference between cases with and without pEL2 (78% vs 85%; P = .08). The estimated 3-year FFR was 86%, with no difference between cases with and without pEL2 (81% vs 87%; P = .41). Four cases (3%) of EL2-related reinterventions were performed. In 65 cases (49%), aneurysm shrinkage was detected. pEL2 was an independent risk factor for absence of aneurysm shrinkage during follow-up (hazard ratio, 3.2; 95% CI, 1.2-8.3; P = .014). Patients without shrinkage had lower follow-up survival (64% vs 86% at 3-year; P = .009) and FFR (74% vs 90% at 3 years; P = .014) than patients with shrinkage. CONCLUSIONS: PEL2 is not infrequent (26%) after F/B-EVAR for J/P-AAAs and is correlated with preoperative antiplatelet therapy, aneurysm thrombus volume of ≤40%, and six or more patent sac afferent vessels. Patients with pEL2 have a diminished aneurysm shrinkage, which is correlated with lower follow-up survival and FFR compared with patients with aneurysm shrinkage.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Prótese Vascular , Endoleak , Procedimentos Endovasculares , Humanos , Masculino , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Estudos Retrospectivos , Feminino , Fatores de Risco , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Idoso , Endoleak/etiologia , Endoleak/terapia , Endoleak/diagnóstico por imagem , Fatores de Tempo , Idoso de 80 Anos ou mais , Incidência , Medição de Risco , Resultado do Tratamento , Desenho de Prótese , StentsRESUMO
BACKGROUND: Endovascular repair of complex abdominal aortic aneurysms (CAAAa) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated and branched devices (F/BEVAR) represents the first-line treatment in old or unfit patients. Currently, the widespread diffusion of these techniques has led to a progressive increase of complex endovascular procedures also in younger and fitter patients, but the related results have been only minimally, reported without long-term data. We investigated the long-term results of F/BEVAR for CAAA and TAAA repair in young and fit patients. METHODS: All consecutive patients, aged ≤70 years, who underwent F/BEVAR for CAAA and TAAA over the last 13 years at two tertiary institutions were included in the study. All subjects presented a low to intermediate risk according to the Society for Vascular Surgery clinical comorbidity grading system. The primary end points were technical and clinical success and late overall and aortic-related survival. Major complications and specific target vessel-related outcomes were investigated as secondary end points. RESULTS: A total of 183 patients (155 males [84.7%]; mean age, 64.5 ± 5.7 years; range, 33-70 year5s) underwent F/BEVAR during the study period, for a total of 167 degenerative (91.3%) and 16 postdissection (8.7%) aneurysms, including 44 (24%) juxtarenal, 33 (18%) pararenal, and 106 (58%) TAAAs. Technical and clinical success were achieved in 176 patients (96.2%) and 171 patients (93.4%), respectively. Four patients (2.2%) died perioperatively, of which two (1.1%) operated in emergency. Postoperatively, five patients (2.7%) presented permanent grade 3 spinal cord injury and three (1.6%) renal failure needing permanent dialysis. The mean follow-up was 65.7 ± 39.6 months (range, 1-158 months). The estimated overall and aortic-related survival at 12, 60, and 120 months was 94.0%, 85.1%, 72.2%, and 97.8%, 97.8%, 96.2%, respectively, and reintervention and branch instability-free survival at the same time points were 84.4%, 71.8%, 71.8%, and 93.2%, 86.3%, 72.2%, respectively. An aneurysm growth of >5 mm was detected in six patients (3.3%), and a sac shrinkage of >5 mm was achieved in 118 cases (64.5%). The Cox regression analysis demonstrated the need for unplanned procedure as the only risk factor for overall mortality (odds ratio, 3.331; 95% confidence interval, 1.397-7.940; P < .01]. CONCLUSIONS: F/BEVAR in young and fit patients led to low perioperative mortality and major morbidity rates and a favorable overall survival rate in the long-term, making this technique particularly appealing in such a subgroup of patients. The availability of long-term data derived from the results of young patients, may additionally provide helpful information to redefine the indications for treatment and allow future targeted device and technique improvements.
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OBJECTIVE: To report outcomes of urgent juxtarenal/pararenal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch). METHODS: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter of >70 mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI), and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions, and target artery instability (TAI) were evaluated during follow-up. RESULTS: Overall, 197 patients (J-AAAs, n = 64 [33%]; P-AAAs, n = 95 [48%]; previous failed endovascular aneurysm repair (EVAR), n = 38 [19%]) were analyzed. The mean age and aneurysm diameter was 75 ± 8 years and 76 ± 4 mm, respectively. The American Society of Anesthesiologists score was 3 and 4 in 118 (60%) and 79 (40%) patients. Rupture, symptoms, and diameter of >70 mm were present in 51 (26%), 110 (56%), and 53 (27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28 cases (14%). The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154 ± 49 mm. Single-stage repair and cerebrospinal fluid drainage were reported in 144 (73%) and 53 (27%) cases, respectively. TS was achieved in 182 (92%) cases (rupture, 84% vs no rupture, 95%; P = .02). Failures consist of TA loss (11 [6%]: renal artery, 9; celiac trunk, 2), type I to III endoleaks (2 [1%]), and 24-h mortality (2 [1%]). Rupture was a risk factor for technical failure (P = .02; odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1-12.1). Overall, 15 patients (8%) had persistent SCI (rupture, 14% vs no rupture, 5%) with 11 (6%) , of paraplegia (rupture, 10% vs no rupture, 5%; P = .001). Rupture (P = .04; OR, 3.1; 95% CI, 1.1-8.9) and adjunctive proximal thoracic endograft (P = .01; OR, 4.1; 95% CI, 1.3-12.9) were risk-factors for SCI. Twenty-two patients (11%) died within 30 days or during a prolonged hospitalization. Previous failed EVAR (P = .04; OR, 3.6; 95% CI, 1.1-12.3), paraplegia (P < .001; OR, 9.9; 95% CI, 1.6-62.2) and postoperative mesenteric complications (P = .03; OR, 10.4; 95% CI, 1.2-93.3), as well as cardiac (P = .03; OR, 8.2; 95% CI, 2.0-33.0) and respiratory (P < .001; OR, 10.1; 95% CI, 2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19 ± 5 months. The estimated 3-year survival and freedom from reinterventions was 58% and 77%, respectively. TAI occurred in 27 patients (14%) (occlusion, 15; endoleak, 14) with an estimated 3-year freedom from TAI of 72%. CONCLUSIONS: Urgent repair of J/P-AAAs by T-branch is feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a non-negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed EVAR and postoperative mesenteric complications, as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and should be subjected to more research for the purposes of improving outcomes.
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OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi Consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A 3-Round Delphi Consensus document was produced with 44 experts on 6 pre-specified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44; 95.4%) agreed that a minimum case volume/year is essential (or probably essential) for a center to offer open/endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost-effective. Additionally, most panelists (36 of 44; 81.9%) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 (79.7%) participants thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi Consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved in some topics, highlighting the need for further research in those areas.
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PURPOSE: The purpose was to describe a technique to promote false lumen (FL) thrombosis in post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs) managed by fenestrated/branched endografting (F/B-EVAR). TECHNIQUE: A 5/6Fr-90 cm length sheath is advanced from the true lumen (TL) to FL through the most distal entry tear of the infrarenal aorta or iliac arteries. It is parked in the most cranial portion of the FL in the thoracic aorta. Aortic endografts are deployed in the TL excluding all the para-visceral/distal entry tears and target visceral vessels bridging stenting is performed. A selective FL angiography is performed through the 5/6Fr sheath to detect the origin of all segmentary arteries. Embolization of FL is performed from above to below by M-reye pushable coils, obtaining the packaging of FL. After completion angiography, the 5/6Fr sheath is retrieved in external iliac artery and molding ballooning of the distal segment of the aortic/iliac endograft is performed. Between 2019 and 2023, this technique was applied in 11cases with a median number of 73 (interquartile range [IQR=12) coils. Out of 8 (72%) patients with available radiological follow-up at 1 year, 7 exhibited complete FL thrombosis. CONCLUSIONS: The FL coiling in PD-TAAAs managed by F/B-EVAR is feasible, safe, and effective to promote the complete FL thrombosis. CLINICAL IMPACT: Preemptive false lumen embolization is a feasible, safe, and effective technique for preventing persistent type II endoleaks after fenestrated-branched endovascular repair of post-dissection thoracoabdominal aortic aneurysms. This technique may be routinely recommended to promote FL thrombosis and aortic remodeling after FB-EVAR in PD-TAAAs, thereby reducing the incidence of reinterventions during follow-up.
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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.
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Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Prótese Vascular , Resultado do Tratamento , Fatores de Risco , Complicações Pós-Operatórias/cirurgia , Desenho de Prótese , Estudos RetrospectivosRESUMO
OBJECTIVE: Numerous articles have reported an increased incidence of limb graft occlusion (LGO) with the Cook Zenith Alpha endograft compared with other endografts in endovascular aortic aneurysm repair (EVAR). The present study aimed to assess the rate of LGO after EVAR in particular with the Cook Zenith Alpha device when adhering to a standardised protocol designed to prevent limb related complications. METHODS: This was a non-sponsored retrospective study performed in two university vascular surgery centres employing the same protocol for limb complication prevention during EVAR from 2016 to 2019. The protocol encompassed: (1) angioplasty of any common or external iliac artery with > 50% stenosis before endograft navigation; (2) proximal sealing zone of limbs at the same level of the flow divider with minimum overlap, which is more restrictive than the Cook Zenith Alpha instructions for use; (3) semi-compliant kissing ballooning of limbs; (4) limb stenting for any residual tortuosity, kinking, or stenosis; and (5) adjunctive common and external iliac stenting for residual stenosis or dissection after EVAR. Patients enrolled in this study were treated with standard aortobi-iliac EVAR. Follow up was performed by clinical visit and duplex ultrasonography at discharge, six months, and yearly thereafter. The primary endpoint was to evaluate the LGO rate with different EVAR devices (Cook Zenith Alpha, Gore C3, and Medtronic Endurant) and to determine potential risk factors for LGO associated with the Zenith Alpha. RESULTS: In the study period, 547 EVARs were considered: 233 (42.6%) Cook Zenith Alpha, 196 (35.8%) Gore Excluder, and 118 (21.6%) Medtronic Endurant. The mean follow up was 44 ± 23 months, and the five year freedom from LGO was 97 ± 3%, without differences between groups (97 ± 2%, 95 ± 3%, and 100% with Cook Zenith Alpha, Medtronic Endurant, and Gore Excluder, respectively; p = .080). In the Zenith Alpha group, intra-operative adjunctive iliac artery angioplasty, iliac artery stenting, or iliac limb stenting was performed in 8%, 3.4%, and 9.7% of cases, respectively. Analysis of potential risk factors for LGO identified external iliac artery distal landing and large main bodies (ZIMB 32 - 36) to be independently associated with LGO during follow up (hazard ratio [HR] 18, 95% confidence interval [CI] 3 - 130, p = .004; and HR 12, 95% CI 1.2 - 130, p = .030, respectively). CONCLUSION: The present experience with a protocol for limb complication prevention allows achievement of a low rate of LGO at five years with Zenith Alpha endografts similar to other endografts. Specific risk factors for the Cook Zenith Alpha endograft are external iliac artery distal landing and the use of a large main body (ZIMB 32 - 36).
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BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic valve stenosis in patients at increased surgical risk. Percutaneous transfemoral (TF) is the access of choice due to its reduced invasiveness and perioperative morbidity/mortality compared with the trans-axillary, aortic, and apical routes. On the other hand, vascular access complications (VACs) of the TF access are associated with prolonged hospitalization, 30-day, and 1-year mortality. In addition, the concomitance of peripheral arterial disease may require associated endovascular management. A multidisciplinary team with Interventional Cardiologists and Vascular Surgeons may minimize the rate of VACs in patients with challenging femoral-iliac access or concomitant disease of other vascular districts, thus optimizing the outcome of TF-TAVI. The aim of this study was to evaluate the role of Vascular Surgeons in TF TAVI procedures. METHODS: We conducted a retrospective single-center review of all TF-TAVI procedures assisted by Vascular Surgeons between January 2016 and December 2020 in a high-volume tertiary hospital. Pre, intra, and postoperative data were analyzed by a dedicated group of Interventional Cardiologists and Vascular Surgeons. VACs were defined according with the Valve Academic Research Consortium (VARC) three guidelines. The outcomes of TF-TAVI procedures with Vascular Surgeons involvement were assessed as study's endpoints. RESULTS: Overall, 937 TAVI procedures were performed with a TF approach ranging between 78% (2016) and 98% (2020). Vascular Surgeons were involved in 67 (7%) procedures with the following indications: concomitant abdominal aortic aneurysm (EVAR + TAVI) - 3 (4%), carotid stenosis (TAVI + CAS) - 2 (3%), hostile femoral/iliac access, or VACs - 62 (93%). Balloon angioplasty of iliac artery pre-TAVI implantation was performed in 51 cases (conventional PTA: 38/51%-75%; conventional PTA + intravascular lithotripsy: 13/51%-25%; stenting: 5/51%-10%). TAVI procedure was successfully completed by percutaneous TF approach in all 62 cases with challenging femoral/iliac access. VACs necessitating interventions were 18/937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (17%) and 15/18 (83%) cases, respectively. Fifteen/18 (83%) VACs were treated during the index procedure. There was no procedure-related mortality or 30-day readmission. CONCLUSION: In our experience, Vascular Surgeon assistance in TAVI procedures was not infrequent and allowed safe and effective device introduction through challenging TF access. Similarly, the concomitant significant disease of other vascular districts could be safely addressed, potentially reducing postoperative related mortality and morbidity. The implementation of multidisciplinary team with interventional cardiologists and vascular surgeons should be encouraged whenever possible.
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INTRODUCTION: Carotid endarterectomy (CEA) in patients with asymptomatic carotid stenosis (ACAS) remains a subject of debate. Current recommendations are based on randomized trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of cerebral ischemic events (CIE). This study presents a mid-term analysis of results from an ongoing prospective observational study of ACAS patients to assess their CIE risk in a real-world setting. METHODS: This is a prospective observational cohort study of patients with ACAS >60 % (NASCET criteria) identified in a single duplex ultrasonography (DUS) vascular laboratory (trial registered: NCT04825080). Patients were not considered for CEA due to their short life expectancy (<3 year) or absence of signs of plaque vulnerability (ulceration, ipoechogenic core). Patient enrollment started in January 2019 and ended in March 2020 with a targeted sample size of 300 patients.A 5-year follow-up was scheduled. Clinical characteristics, risk factors, and medical therapies were documented, and, when necessary, the best medical therapy (BMT), involving antiplatelet agents, blood pressure control, and statins, was recommended during clinical visits. The primary endpoint was to asses CIEs (including strokes, transient ischemic attacks, amaurosis-fugax) ipsilateral to ACAS along with plaque progression rate and patients survival. Follow-up involved annual clinical visit and carotid DUS examination, complemented by telephone interviews at six-month intervals. RESULTS: The study included 307 patients, with an average age of 80 ± 7 years, of whom 55 % were male. Contralateral stenosis exceeding 60 % was present in 61 (20 %) patients. Seventy-seven percent of patients were on BMT. At a mean follow-up of 41±9 months, 7 ispilateral strokes and 9 TIAs occurred, resulting in 14 CIEs (2 patients experienced both TIA and stroke). According to Kaplan-Meier analysis, the 4-year CIE rate was 6±2 %, with an annual CIE rate of 1.5 %. Fifty-eight (19 %) patients had a stenosis progression which was associated with a higher 4-year estimated CIE rate compared to patients with stable plaque (10.3 % vs 3.2 %, P=.01). Similarly, a contralateral carotid stenosis >60 % was associated with a higher 4-year estimated CIE rate: 11.7 % vs 2.9 %, P=.002. These factors were independently associated with high risk for CIE at the multivariate COX analysis: Hazard Ratio (HR): 3.2; 95 % Confidence Interval: 1.1-9.2 and HR: 3.6; 95 % CI: 1.2-10.5. CONCLUSION: The mid-term results of this prospective study suggest that the incidence of CIE in ACAS patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs.
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Estenose das Carótidas , Endarterectomia das Carótidas , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Masculino , Idoso , Idoso de 80 Anos ou mais , Feminino , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/terapia , Constrição Patológica/complicações , Estudos Prospectivos , Estudos de Coortes , Progressão da Doença , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/complicações , Endarterectomia das Carótidas/efeitos adversos , Fatores de Risco , Ataque Isquêmico Transitório/diagnóstico por imagem , Ataque Isquêmico Transitório/epidemiologia , Ataque Isquêmico Transitório/etiologia , Resultado do TratamentoRESUMO
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 da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Prótese Vascular , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Endoleak/epidemiologia , Endoleak/cirurgia , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Fatores de Tempo , Fatores de Risco , Sistema de Registros , Estudos Retrospectivos , Desenho de PróteseRESUMO
OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.
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Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Correção Endovascular de Aneurisma , Implante de Prótese Vascular/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Fatores de Tempo , Estudos Retrospectivos , Prótese VascularRESUMO
BACKGROUND: Penetrating aortic ulcer (PAU) is determined by atherosclerotic degeneration of the tunica media with disruption of the intima. Usually it is detected in the thoracic aorta, with few series describing an abdominal location. The aim of the study was to report early and late outcomes of the endovascular repair of complicated infrarenal abdominal PAU (a-PAU) by aortobi-iliac endograft and embolization. METHODS: Data from all complicated a-PAU submitted to endovascular repair by aortobi-iliac endograft (Cook-Zenith Alpha) between 2016 and 2021 (February) were analyzed. The a-PAU coil embolization was performed to decrease the risk of persistent type II endoleak whenever possible. Complicated a-PAU were defined according with the presence of symptoms, aortic rupture, or saccular or pseudo-aneurysm. Technical success, 30-day morbidity and mortality, and reinterventions were assessed as early outcomes. Survival, endoleaks, and freedom from reinterventions were evaluated during follow-up. RESULTS: Of 1153 endovascular aortic procedures, 45 cases (4%) of complicated a-PAU were identified. Fourteen cases (31%) were managed in urgent setting (symptoms, n = 10 [22%]; shock, n = 4 [9%]). The median diameter of a-PAU was 49 mm (interquartile range, 14 mm). Thirteen patients (29%) had severe femoral or iliac access (angle >90°, circumferential calcification [>50%], hemodynamic iliac stenosis or obstruction, an external iliac artery diameter of less than 7 mm, or a previous femoral surgical graft). The a-PAU embolization was performed in 30 cases (67%). Technical success was achieved in all patients. Postoperative cardiac, pulmonary and renal morbidity occurred in one (2%), two (4%), and eight (18%) patients, respectively. Two patients (4%) required reintervention within 30 days for access related complications. The 30-day mortality was 2%. At a median follow-up of 24 months (interquartile range, 18 months), no type I or III endoleaks, iliac leg occlusion, or graft infection occurred and no patient required late reinterventions; the 36-month survival rate was 72%. No a-PAU enlarged or ruptured during follow-up. CONCLUSIONS: Endovascular repair of complicated a-PAU by a low-profile aortobi-iliac endograft and embolization is safe and effective. Excellent technical results are reported even in challenging anatomic features. Midterm clinical results are satisfactory in terms of aortic-related complications or mortality, freedom from reintervention, and survival.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/terapia , Úlcera/diagnóstico por imagem , Úlcera/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Resultado do Tratamento , Fatores de Risco , Prótese Vascular/efeitos adversos , Estudos RetrospectivosRESUMO
OBJECTIVE: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results. METHODS: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions. RESULTS: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively. CONCLUSIONS: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss.
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Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Prótese Vascular/efeitos adversos , Endoleak/etiologia , Correção Endovascular de Aneurisma , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/complicações , Constrição Patológica/etiologia , Fatores de Risco , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Resultado do Tratamento , Desenho de PróteseRESUMO
OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.
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Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/complicações , Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Procedimentos Endovasculares/efeitos adversos , Complicações Pós-Operatórias , Estudos Retrospectivos , Fatores de Risco , Stents/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.
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Aneurisma , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/etiologia , Implante de Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Prótese Vascular , Aneurisma/cirurgia , Estudos Retrospectivos , Desenho de PróteseRESUMO
INTRODUCTION: The aim of the study is to report a single-center experience with the Gore Excluder conformable endograft with active control system (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) in abdominal aortic aneurysms (AAAs) with severe infrarenal neck angulation. METHODS: All patients underwent EVAR with CEXC Device between September 2018 and 2020, were prospectively enrolled, and retrospectively analyzed. Anatomical details of the proximal aortic neck were evaluated. Early endpoints were the use of repositionability and angulation system, intraoperative unplanned cuff, technical success (TS), 30-day morbidity/mortality, and reintervention. Follow-up endpoints were type-I endoleaks, endograft migration, aortic neck dilatation, aneurismal sac shrinkage, survival (S), and freedom from reintervention (FFR). RESULTS: Twenty-five patients were enrolled (median age: 80 [range = 60-90] years, median AAA diameter: 60 [range = 52-90] mm). All patients had severe infrarenal neck angulation (beta angle ⧠60°), and 11 (44%) of those had neck beta angle ⧠90°. Median infrarenal neck angle, length, and diameter were 70° (range = 60°-90°), 22 (range = 13-42) mm and 22 (range = 18-31) mm, respectively. Endograft repositioning system was employed in 15 (60%) cases and the median number of repositioning maneuvers was 1 (range:0-4). Active angulation system was used in 17 (68%) patients. The median proximal diameter of the main-body and oversize were 28 (range = 23-36) mm and 28% (range = 21%-38%), respectively. Proximal cuff was positioned in 1 (4%) patient. Technical success was achieved in all cases. Intraoperative and perioperative morbidity and mortality were 12% and 0%, respectively. Perioperative type-I/III and II endoleaks were observed in 0 and 4 (16%) patients, respectively. The median follow-up was 12 months (range: 3-30). One patient died at 12-month for AAA-unrelated causes. Abdominal aortic aneurysm-sac shrinkage and stability were observed in 9 (36%) and 15 (60%) cases, respectively. No type-I/III endoleak and reintervention occurred during the follow-up. One persistent type-II endoleak was observed. Estimated survival at 24 months was 92%. CONCLUSION: According to the present data, the CEXC Device allows an excellent rate of TS in severe angulated aortic neck. This preliminary data, could increase the rate of patients eligible for EVAR.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Prótese Vascular/efeitos adversos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Fatores de Risco , Aortografia/efeitos adversos , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Desenho de PróteseRESUMO
PURPOSE: To report outcomes of endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) with currently-available endografts and identify predictors of technical/clinical failure. MATERIALS AND METHODS: Patients undergoing EVAR between 2012 and 2020 were prospectively collected and retrospectively analyzed. Technical success (TS: no type I-III endoleaks, renal/hypogastric arteries loss, iliac leg occlusion, conversion to open repair and mortality within 24 postoperative hour), proximal neck-related TS (nr-TS: no proximal type I endoleaks, unplanned renal arteries coverage), and 30-day mortality were assessed as early outcomes. Proximal type I endoleak (ELIa), survival and freedom from reinterventions (FFRs) were assessed during follow-up. Uni/multivariate analysis and Cox-regression were used to identified factors associated with early and follow-up outcomes; FFR and survival were assessed by Kaplan-Meier analysis. RESULTS: A total of 710 were included. Technical success and nr-TS were 692 (98%) and 700 (99%), respectively. The presence of ≥2 hostile anatomical infrarenal neck characteristics was associated with technical failure (odds ratio [OR]: 2.4; 95% confidence interval [CI]: 1.3-4.1; p: 0.007). Infrarenal neck angle >90° (OR: 2.88; 95% CI: 9.6-50.3; p: 0.004), barrel shape (OR: 2.33; 95% CI: 11.1-100.3; p: 0.02) or presence of ≥2 hostile anatomical infrarenal neck characteristics (OR: 2.16; 95% CI: 2.5-5.3; p: 0.03) were independent risk factors for neck-related technical failures. Six (0.8%) patients died within 30 postoperative days. Chronic obstructive pulmonary disease (OR: 16; 95% CI: 1.1-218.3; p: 0.04) and urgent repair (OR: 15; 95% CI: 1.8-119.6; p: 0.01) were independent risk factors for 30-day mortality. The mean follow-up was 53±13 months. There were 12 (1.7%) ELIa during follow-up. Infrarenal neck length <15 mm (hazard ratio [HR]: 2.8; 95% CI: 1.9-9.6; p: 0.005), diameter >28 mm (HR: 2.7; 95% CI: 1.6-9.5; p: 0.006), angle ≥90° (HR: 2.7; 95% CI: 8.3-50.1; p: 0.007), and persistent type II endoleak (HR: 2.9; 95% CI: 1.6-10.1; p: 0.004) were independent risk factors for ELIa. Freedom from reintervention was 91% at 5 years. The ELIa was an independent risk factor for reinterventions during follow-up (HR: 29.5; 95% CI: 1.4-1.6; p<0.001). Survival was 74% at 5 years with 2 cases (0.3%) of late aortic-related mortality. Peripheral arterial occlusive disease (HR: 1.9; 95% CI: 1.4-3.65; p: 0.03), aneurysm diameter ≥65 mm (HR: 2.2; 95% CI: 1.4-3.26; p<0.001), and infrarenal neck length <15 mm (HR: 1.7; 95% CI: 1.2-2.35; p: 0.04) were independent risk factors for mortality during follow-up. CONCLUSION: Endovascular repair with currently-available endografts has high TS and low 30-day mortality. Survival and FFRs were satisfactory at mid-term. Pre/postoperative risk factors for technical and clinical failure were identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome. CLINICAL IMPACT: Pre and postoperative risk factors for technical and clinical EVAR failure can be identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome.