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On-pump techniques are the methods of choice for organ protection and heart support during thoracoabdominal aortic aneurysm surgical repair. We present a case of a patient with a symptomatic saccular aneurysm of the visceral segment of a severe atheromatous aorta requiring a surgical type IV aortic repair during which we adopted a temporary passive arterial shunt from the left axillary artery to ensure visceral and distal aortic perfusion. The old-fashioned technique of passive shunting to ensure visceral and distal aortic perfusion seems to offer an appealing alternative to on-pump techniques in selected patients.
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PURPOSE: The role of carotid artery disease (CAD) in the development of various types of ocular arterial occlusive disorders has often been reported. This systematic review aims to evaluate and review the current evidence regarding the role of CAD and the subsequent carotid artery hemodynamic alterations in the development of non-arteritic anterior (NA-AION) and posterior (NA-PION) ischemic optic neuropathy. METHODS: We systematically reviewed studies following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. We systematically searched PubMed, Embase, and Scopus databases for relevant studies that clearly assessed the role of CAD and the subsequent carotid artery hemodynamic alterations in the development of NA-AION and NA-PION. All studies that examined the associations between CAD and the development of NA-AION and NA-PION in adults aged 18 years or older were synthesized. Quality assessment using the Newcastle-Ottawa Scale (NOS), and Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Case Reports and Case-Series were also conducted. RESULTS: Our search identified 1933 manuscripts published in the English language. The number of participants with non-arteritic ischemic optic neuropathy (NA-ION) ranged from 1 to 191, with a total of 478 patients experiencing either NA-AION (410 out of 478), NA-PION (13 out of 478), or a combination of thereof (1 out of 478). The number of participants with NA-ION due to atherosclerosis ranged from 1 to 191, with a total of 376 patients. CONCLUSIONS: Although carotid artery disease may rarely contribute to the development of NA-ION, it should be considered as a possible cause of NA-ION.
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We report the case of a 65-year-old male patient who was deemed unfit for open surgery and underwent zone 0 endovascular repair with a physician-modified fenestrated endograft for a symptomatic penetrating ulcer. A thoracic stent graft was modified creating a large fenestration for the innominate artery and the left common carotid artery, and a second small fenestration for the left subclavian artery and the left vertebral artery, which had a common origin. No bridging stent was used for the left subclavian artery to avoid coverage of the left vertebral artery. The postoperative course was uneventful, and no leaks nor other complications were detected on postoperative computed tomography angiography. Although long-term durability needs to be better assessed, our experience suggests that physician-modified fenestrated endografts are a feasible option for the emergent treatment of aortic arch lesions in unfit patients and provide satisfactory results in the short term.
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OBJECTIVE: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.
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Aorta Torácica , Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Desenho de Prótese , Stents , Humanos , Masculino , Idoso , Feminino , Pessoa de Meia-Idade , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Idoso de 80 Anos ou mais , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Adulto , Resultado do Tratamento , Aorta Torácica/cirurgia , Aorta Torácica/diagnóstico por imagem , Itália , Estudos Retrospectivos , Fatores de Tempo , Adulto Jovem , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Doenças da Aorta/cirurgia , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/mortalidade , Fatores de RiscoRESUMO
OBJECTIVE: In treatment of aneurysms (SAAs) and pseudoaneurysms (SAPs) of the splenic artery, endovascular coil embolization is the approach most commonly used as it is minimally invasive and safe. However, it carries a significant rate of primary failure (up to 30%) and might be complicated by splenic infarction. The use of stent grafts might represent a valuable alternative when specific anatomical criteria are respected. We report a comprehensive review on technical and clinical outcomes achieved in this setting. Methods: We performed a comprehensive review of the literature through the MedLine and Cochrane databases (from January 2000 to December 2023) on reported cases of stenting for SAAs and SAPs. Outcomes of interest were clinical and technical success and related complications. The durability of the procedure in the long-term was also investigated. Results: Eighteen papers were included in the analysis, totalling 41 patients (n = 20 male 48.8%, mean age 55.5, range 32-82 years; n = 31, 75.6% SAAs). Mean aneurysm diameter in non-ruptured cases was 35 mm (range 20-67 mm), and most lesions were detected at the proximal third of the splenic artery. Stent grafting was performed in an emergent setting in n = 10 (24.3%) cases, achieving immediate clinical and technical success rate in 90.2% (n = 37) of patients regardless of the type of stent-graft used. There were no procedure-related deaths, but one patient died in-hospital from septic shock and n = 2 (4.9%) patients experienced splenic infarction. At the last available follow-up, the complete exclusion of the aneurysm was confirmed in 87.8% of cases (n = 36/41), while no cases of aneurysm growing nor endoleak were reported. None of the patients required re-intervention during follow-up. Conclusions: When specific anatomical criteria are respected, endovascular repair of SAAs and SAAPs using stent grafts appears to be safe and effective, and seems to display a potential advantage in respect to simple coil embolization, preserving the patient from the risk of end-organ ischemia.
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Aneurisma da Aorta Torácica , Dissecção Aórtica , Tratamento Conservador , Humanos , Dissecção Aórtica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Tratamento Conservador/métodos , Implante de Prótese Vascular/métodos , Masculino , Aorta Torácica/cirurgia , Aorta Torácica/diagnóstico por imagem , Idoso , Procedimentos Endovasculares/métodos , Complicações Pós-Operatórias/cirurgia , Tomografia Computadorizada por Raios X , Pessoa de Meia-Idade , Aneurisma do Arco AórticoRESUMO
BACKGROUND: The use of biological grafts provides acceptable mid- and long-term results in native or prosthetic vascular infections. Several reports describe the successful use of bovine pericardium in case of vascular infections, mainly as a large patch to be sutured as a tubular graft. Recently, a novel prefabricated bovine pericardium graft (Biointegral Surgical No-React® Inc, Mississauga, ON, Canada) has been introduced in clinical practice with promising results. In this study, we report our preliminary experience utilizing Biointegral Surgical graft in case of native and or prosthetic aorto-iliac and infrainguinal infection. METHODS: We retrospectively analyzed data from 20 patients with native or prosthetic aorto-iliac and infrainguinal infection who underwent in situ reconstruction (ISR) with a Biointegral Surgical No-React bovine pericardium prosthesis between October 2020 and February 2023 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario Gemelli - IRCCS in Rome, Italy. All patients followed a standardized protocol including postoperative anticoagulation and long-term intravenous antibiotics. RESULTS: The indication for surgery was: mycotic aortic aneurysm in 4 patients (20%), graft infection after abdominal aortic repair in 11 patients (55%), peripheral graft infection in 5 patients (25%). Complete excision of the infected aorta or prosthetic graft, surgical debridement and ISR were performed in all patients. Hospital mortality rate was 5% (n = 1) and graft-related mortality of 0%. During follow-up (median 13 months, range 6-34 months), reinfection was 5.2% and primary graft patency 94.7%. CONCLUSIONS: The use of prefabricated bovine pericardial grafts represents a promising option for the treatment of native and prosthetic aorto-iliac and infrainguinal infections. The application of this biological graft with a standardized postoperative protocol has been associated with a satisfactory patency and reinfection rate without increased bleeding complications.
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Bioprótese , Implante de Prótese Vascular , Prótese Vascular , Pericárdio , Desenho de Prótese , Infecções Relacionadas à Prótese , Humanos , Infecções Relacionadas à Prótese/cirurgia , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/mortalidade , Prótese Vascular/efeitos adversos , Estudos Retrospectivos , Pericárdio/transplante , Masculino , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Idoso , Resultado do Tratamento , Feminino , Pessoa de Meia-Idade , Animais , Bovinos , Fatores de Tempo , Xenoenxertos , Idoso de 80 Anos ou mais , Artéria Ilíaca/cirurgia , Antibacterianos/administração & dosagem , Fatores de Risco , Grau de Desobstrução Vascular , Aneurisma Infectado/cirurgia , Aneurisma Infectado/microbiologia , Aneurisma Infectado/mortalidade , Aneurisma Infectado/diagnóstico por imagem , ReoperaçãoRESUMO
OBJECTIVE: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. METHODS: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. RESULTS: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. CONCLUSIONS: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.
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Aneurisma da Aorta Abdominal , Consenso , Técnica Delphi , Correção Endovascular de Aneurisma , Humanos , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/normas , Angiografia por Tomografia Computadorizada/normas , Correção Endovascular de Aneurisma/efeitos adversos , Correção Endovascular de Aneurisma/normas , Valor Preditivo dos Testes , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Myocardial injury is prevalent among patients hospitalized for COVID-19. However, the role of COVID-19 vaccines in modifying the risk of myocardial injury is unknown. OBJECTIVES: To assess the role of vaccines in modifying the risk of myocardial injury in COVID-19. METHODS: We enrolled COVID-19 patients admitted from March 2021 to February 2022 with known vaccination status and ≥1 assessment of hs-cTnI within 30 days from the admission. The primary endpoint was the occurrence of myocardial injury (hs-cTnI levels >99th percentile upper reference limit). RESULTS: 1019 patients were included (mean age 67.7±14.8 years, 60.8% male, 34.5% vaccinated against COVID-19). Myocardial injury occurred in 145 (14.2%) patients. At multivariate logistic regression analysis, advanced age, chronic kidney disease and hypertension, but not vaccination status, were independent predictors of myocardial injury. In the analysis according to age tertiles distribution, myocardial injury occurred more frequently in the III tertile (≥76 years) compared to other tertiles (I tertile:≤60 years;II tertile:61-75 years) (p<0.001). Moreover, in the III tertile, vaccination was protective against myocardial injury (OR 0.57, CI 95% 0.34-0.94; p=0.03), while a previous history of coronary artery disease was an independent positive predictor. In contrast, in the I tertile, chronic kidney disease (OR 6.94, 95% CI 1.31-36.79, p=0.02) and vaccination (OR 4.44, 95% CI 1.28-15.34, p=0.02) were independent positive predictors of myocardial injury. CONCLUSIONS: In patients ≥76 years, COVID-19 vaccines were protective for the occurrence of myocardial injury, while in patients ≤60 years, myocardial injury was associated with previous COVID-19 vaccination. Further studies are warranted to clarify the underlying mechanisms.
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PURPOSE: This retrospective study aimed to assess the safety and technical efficacy of preoperative direct puncture embolization using a nonadhesive ethylene vinyl alcohol (EVOH) copolymer-based liquid embolic agent (LEA) combined with balloon occlusion at the origin of the external carotid artery for head and neck paragangliomas (HNP). METHODS: We conducted a review of all consecutive cases of HNPs treated with direct puncture embolization using EVOH-based LEAs between 2017 and 2022 in 2 tertiary high-volume hospitals. RESULTS: A total of 25 cases of HNPs in 24 patients underwent direct puncture embolization (12 males, 12 females, mean age 50.9⯱ 15.6 years). The average lesion volume was 299.95â¯mm3. The mean procedure time was 139.11â¯min, and the mean volume of EVOHs used per case was 19.38â¯mL. Successful complete devascularization was achieved in all cases, with a homogeneous and deep penetration of the embolic agent into the tumor vessel bed regardless of the LEA type. CONCLUSION: Preoperative embolization of HNPs using a direct puncture technique and EVOHs is a safe, efficient, and feasible treatment option with a low risk of complications. This procedure facilitates surgery by transforming tumors into avascular masses that are well-delineated against the surrounding normal tissue.
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Despite the technical innovations introduced in the previous decades, open thoracoabdominal aortic aneurysm repair still represents an enormous challenge for patients and surgeons. Logically, the systemic inflammatory response resulting from these massive operations appears considerable; however, the response has never been thoroughly investigated. In addition, intraoperative adjuncts to modulate the postoperative activation of the immune system have not yet been introduced into clinical practice. We report a case of intraoperative hemadsorption during open repair of a thoracoabdominal aortic aneurysm through the introduction of a CytoSorb device (CytoSorbents Corp) in the left heart bypass circuit. The technique appeared feasible and safe and probably contributed to the good clinical outcomes.
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We evaluated the use of autologus bone marrow stem cells transplantation in patients with critical limb ischaemia (CLI) not eligible for revascularization. Eighty consecutive patients candidate to amputation were enrolled in a single-centre retrospective study. The primary endpoint was defined as the amputation-free rate from stem cells transplantation. Secondary endpoints were the evaluation of transcutaneous oximetry and its predictive potential for probability of amputation and the evaluation of rest pain. Ankle brachial index, transcutaneous oxygen (TcpO2) and radiological imaging were performed at the enrolment and during the follow-up times. All patients were treated with auto transplant of bone marrow stem cells. Two patients died due to acute renal and acute respiratory failures. 19 patients were amputated from the thigh or leg. In total, 59 of 80 patients intended to thigh amputation saved the limb, preserving the plantar support. TcpO2 was found a predictive metric with an AUC equal to .763, and a threshold for a risk of amputation of 10% and 5% at the values ≤22.7 and ≤26.9 mmHg, respectively. Auto transplant of bone marrow stem cells seems to be a safe and an efficient option for CLI not eligible to revascularizzation.
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The chimney endovascular aneurysm repair (Ch-EVAR) technique has progressively increased in popularity in the treatment of complex aortic aneurysms. However, the long-term results of this technique still must be assessed, especially in comparison to custom-made solutions. The patency of chimney grafts has always been one of the important issues with the Ch-EVAR technique. However, interactions between nonstented aortic side branches and chimney stent grafts have rarely been discussed. In the present case report, we describe a rare case of mesenteric ischemia due to superior mesenteric artery ostium coverage by the misalignment of a renal stent graft in a Ch-EVAR.
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Severe surgical site infections (SSIs) are a frequent nosocomial complication after vascular interventions, an important cause of postoperative morbidity, and a substantial burden to the health care system. Patients undergoing arterial interventions are at elevated risk of SSIs, possibly because of the presence of several risk factors in this patient population. In this review, we examined the available clinical evidence for the prevention, treatment, and prognostication of postoperative severe SSIs after vascular exposure in the groin and other body areas. Results from studies evaluating preoperative, intraoperative, and postoperative preventive strategies and several treatment options are reviewed. In addition, risk factors for surgical wound infections are analyzed in detail and related evidence from the literature is highlighted. Although several measures have been implemented over the time to prevent them, SSIs continue to pose a substantial health care and socioeconomic challenge. Therefore, strategies to decrease the risk and improve the treatment of SSIs for the high-risk vascular patient population should be the focus of continuing improvement and critical review. This review aimed at identifying and reviewing the current evidence for preventing, treating, and performing stratification according to the prognosis of postoperative severe SSIs after vascular exposure in the groin and other body areas.
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Virilha , Infecção da Ferida Cirúrgica , Humanos , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/prevenção & controle , Prognóstico , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Fatores de RiscoRESUMO
BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch. METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions. RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change. CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.
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Transtornos de Deglutição , Divertículo , Cardiopatias Congênitas , Doenças Vasculares , Adolescente , Humanos , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/anormalidades , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/cirurgia , Divertículo/diagnóstico por imagem , Divertículo/cirurgia , Divertículo/complicações , Cardiopatias Congênitas/complicações , Artéria Subclávia/diagnóstico por imagem , Artéria Subclávia/cirurgia , Artéria Subclávia/anormalidades , Resultado do Tratamento , Doenças Vasculares/complicações , Adulto , Pessoa de Meia-IdadeRESUMO
An extracranial carotid artery aneurysm (ECAA) is a rare condition. The major complications are rupture and thromboembolism. Therefore, treatment is generally recommended. We report the case of a young woman affected by an ECAA, with a cervical pulsatile mass. A multidisciplinary evaluation was performed to ensure the best treatment in terms of safety and efficacy, and the patient underwent hybrid treatment. The 6-month computed tomography angiogram revealed patency of the carotid artery stents and the venous graft, in the absence of any relevant complications. An ECAA is a serious clinical condition. The treatment is challenging, and a multidisciplinary evaluation and precise planning are recommended.
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BACKGROUND: Pre-operative embolization prior to surgical resection of carotid body tumors was meant to decrease intraoperative blood loss and operative time. Yet, potential confounders such as different Shamblin classes have never been analyzed. Aim of our meta-analysis was to investigate effectiveness of a pre-operative embolization according to different Shamblin classes. METHODS: Five studies comprising 245 patients were included. A random effects model meta-analysis was conducted, and the I2 statistic was used to assessment for heterogeneity. RESULTS: Pre-operative embolization was associated with a significant reduction in blood loss (WM: 276.4 mL; 95% CI, 201.9-378.3, p < 0.01); an absolute mean reduction, though not statistically significant, was observed in both Shamblin 2 and 3 classes. No difference in operative time was found between the two strategies (WM: 192.0 min; 95% CI, 157.7-234.1, p = 1.0). CONCLUSIONS: Embolization proved an overall significant reduction in perioperative bleeding, which did not reach threshold for statistical significance when Shamblin classes were singularly considered.
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Tumor do Corpo Carotídeo , Embolização Terapêutica , Humanos , Tumor do Corpo Carotídeo/cirurgia , Procedimentos Cirúrgicos Vasculares , Estudos Retrospectivos , Perda Sanguínea Cirúrgica , Resultado do TratamentoRESUMO
PURPOSE: This study investigated the long-term outcomes of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for complex abdominal aortic aneurysms (c-AAAs). Complex abdominal aortic aneurysms are defined as aneurysms that involve the renal or mesenteric arteries and extend up to the level of the celiac axis or diaphragmatic hiatus but do not extend into the thoracic aorta. This study compares with a propensity-score matching the outcome of these procedures from 2 high-volume aortic centers. MATERIALS AND METHODS: All patients with c-AAAs undergoing repair at 2 centers between January 2010 and June 2016 were included. The long-term imaging follow-up consisted in a yearly computed tomography angiography (CTA) in the F-BEVAR group. Yearly abdominal ultrasound examination and 5-year CTA were performed in the OSR group. The primary endpoints were long-term mortality, aneurysm-related mortality, and chronic renal decline (CRD), defined as estimated glomerular filtration rate reduction to <60 mL/min/1.73 m2 or >20%/de novo dependence on permanent dialysis in patients with normal or abnormal preoperative renal function, respectively. Secondary endpoints included aortic-related reinterventions, target vessel occlusion, proximal aorta degeneration, access-related complications, graft infection, and the composite endpoint of clinical failure during follow-up. RESULTS: After 1:1 propensity matching, 102 consecutive patients who underwent F-BEVAR and OSR, respectively, were included. The median follow-up was 67 months. There was no significant difference in long-term overall mortality (40.2% vs 36.3%; p=0.40) and aneurysm-related mortality (6.8% vs 5.8%; p=0.30), in the F-BEVAR and OSR groups, respectively. During follow-up, late renal function decline occurred in 27 (27.8%) versus 46 patients (47.4%) in the F-BEVAR and OSR groups, respectively (p<0.01). During follow-up, 23 reinterventions (23.5%) were performed in the F-BEVAR group, and 5 (5.1%) in the OSR group (p<0.01). CONCLUSIONS: No differences in overall and aneurysm-related mortality were observed. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the F-BEVAR group. These long-term results reflect the outcomes of a complex procedure performed by a single experienced operator in 2 high-volume centers, and followed with a strict surveillance imaging follow-up. CLINICAL IMPACT: Nowadays, F-BEVAR and OSR are considered two established techniques for the treatment of c-AAA. However, long-term comparative outcomes are not well studied, and concerns may rise in terms of durability of the repair, risk of reinterventions and late chronic renal decline. The present study showed, with a median follow-up > 5 years, no differences in overall and aneurysm-related mortality. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the endovascular group. To achieve the best possible long-term outcomes, both techniques should be performed in high volume aortic centres, tailored to the patient, and with an adequate surveillance imaging.
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OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.