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BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
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BACKGROUND: Despite significant advances in surgical techniques and perioperative care, people undertaking cardiac surgery due to cardiovascular disease are more prone to the development of postoperative adverse events. Statins (5-hydroxy-3-methylglutaryl-co-enzyme A (HMG-CoA) reductase inhibitors) are well-known for their anti-inflammatory and antioxidant effects and are established for primary and secondary prevention of coronary artery disease. In addition, statins are thought to have clinical benefits in perioperative outcomes in people undergoing cardiac surgery. This review is an update of a review that was first published in 2012 and updated in 2015. OBJECTIVES: To evaluate the benefits and harms of preoperative statin therapy in adults undergoing cardiac surgery compared to standard of care or placebo. SEARCH METHODS: We performed a search of the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 9, 2023), Ovid MEDLINE (1980 to 14 September 2023), and Ovid Embase (1980 to 2023 (week 36)). We applied no language restrictions. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing any statin treatment before cardiac surgery, for any given duration and dose, versus no preoperative statin therapy (standard of care) or placebo. We excluded trials without a registered trial protocol and trials without approval by an institutional ethics committee. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. Primary outcomes were short-term mortality and major adverse cardiovascular events. Secondary outcomes were myocardial infarction, atrial fibrillation, stroke, renal failure, length of intensive care unit (ICU) stay, length of hospital stay and adverse effects related to statin therapy. We reported effect measures as risk ratios (RRs) or mean differences (MDs) with corresponding 95% confidence intervals (CIs). We used the RoB 1 tool to assess the risk of bias in included trials, and GRADE to assess the certainty of the evidence. MAIN RESULTS: We identified eight RCTs (five new to this review) including 5592 participants. Pooled analysis showed that statin treatment before surgery may result in little to no difference in the risk of postoperative short-term mortality (RR 1.36, 95% CI 0.72 to 2.59; I2 = 0%; 6 RCTs, 5260 participants; low-certainty evidence; note 2 RCTs reported 0 events in both groups so RR calculated from 4 RCTs with 5143 participants). We are very uncertain about the effect of statins on major adverse cardiovascular events (RR 0.93, 95% CI 0.77 to 1.13; 1 RCT, 2406 participants; very low-certainty evidence). Statins probably result in little to no difference in myocardial infarction (RR 0.88, 95% CI 0.73 to 1.06; I2 = 0%; 5 RCTs, 4645 participants; moderate-certainty evidence), may result in little to no difference in atrial fibrillation (RR 0.87, 95% CI 0.72 to 1.05; I2 = 60%; 8 RCTs, 5592 participants; low-certainty evidence), and may result in little to no difference in stroke (RR 1.47, 95% CI 0.90 to 2.40; I2 = 0%; 4 RCTs, 5143 participants; low-certainty evidence). We are very uncertain about the effect of statins on renal failure (RR 1.04, 95% CI 0.80 to 1.34; I2 = 57%; 4 RCTs, 4728 participants; very low-certainty evidence). Additionally, statins probably result in little to no difference in length of ICU stay (MD 1.40 hours, 95% CI -1.62 to 4.41; I2 = 43%; 3 RCTs, 4528 participants; moderate-certainty evidence) and overall hospital stay (MD -0.31 days, 95% CI -0.64 to 0.03; I2 = 84%; 5 RCTs, 4788 participants; moderate-certainty evidence). No study had any individual risk of bias domain classified as high. However, two studies were at high risk of bias overall given the classification of unclear risk of bias in three domains. AUTHORS' CONCLUSIONS: In this updated Cochrane review, we found no evidence that statin use in the perioperative period of elective cardiac surgery was associated with any clinical benefit or worsening, when compared with placebo or standard of care. Compared with placebo or standard of care, statin use probably results in little to no difference in MIs, length of ICU stay and overall hospital stay; and may make little to no difference to mortality, atrial fibrillation and stroke. We are very uncertain about the effects of statins on major harmful cardiac events and renal failure. The certainty of the evidence validating this finding varied from moderate to very low, depending on the outcome. Future trials should focus on assessing the impact of statin therapy on mortality and major adverse cardiovascular events.
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Procedimentos Cirúrgicos Cardíacos , Inibidores de Hidroximetilglutaril-CoA Redutases , Complicações Pós-Operatórias , Cuidados Pré-Operatórios , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/mortalidade , Cuidados Pré-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Infarto do Miocárdio/prevenção & controle , Tempo de Internação , Adulto , Viés , Acidente Vascular Cerebral/prevenção & controleRESUMO
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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PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.
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Stents Farmacológicos , Procedimentos Endovasculares , Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Calcificação Vascular , Humanos , Masculino , Feminino , Idoso , Artéria Poplítea/diagnóstico por imagem , Artéria Femoral/diagnóstico por imagem , Estudos Retrospectivos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico por imagem , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Grau de Desobstrução Vascular , Polímeros , Pessoa de Meia-Idade , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: While endovascular aneurysm repair has become a first-line strategy in many centers, open surgical repair (OSR) of abdominal aortic aneurysms (AAAs) is still the best option for certain patients. A significant number of patients who are offered OSR for AAA have been previously submitted to other open abdominal surgeries (PAS). It is unclear, however, how this may impact their outcomes. The purpose of this study was to determine if there is an association between PAS and outcomes of OSR of AAA. METHODS: This is a retrospective cohort study based on clinical data from the American College of Surgeons National Surgical Quality Improvement Program database, including all patients undergoing elective OSR for AAA between 2011 and 2017. Excluded were patients with missing data on prior abdominal surgery, supramesenteric clamping, or urgent repairs. Patients with prior abdominal surgery (PAS) and patients without prior abdominal surgeries (nonPAS) were compared. The primary outcome was 30-day postoperative mortality. Secondary outcomes were operating time, ischemic colitis, postoperative complications, and lengths of hospital stay. RESULTS: Of the 2034 patients included, 27% had previous open abdominal surgery and 73% did not. Overall, the median age was 71(interquartile range 65-76), 72% of patients were male, 44% were smokers, and the average body mass index was 27 kg/m2. Univariate analysis showed no difference in postoperative 30-day mortality (4.0% PAS vs. 4.1% nonPAS, P = 0.91) or overall postoperative complication rates (33% PAS vs. 29% nonPAS, P = 0.07). Previous open abdominal surgery was significantly associated with longer operating times (P = 0.032) and an almost doubled rate of ischemic colitis (4.7% PAS vs. 2.6% nonPAS, P = 0.02). Postoperative intensive care unit and hospitalization were also significantly longer in patients with prior abdominal surgery (P = 0.005 and P = 0.014, respectively). Finally, there were significantly less patients discharged home, as opposed to institutionalized care (75.7% PAS down from 82.4% nonPAS, P = 0.001). Despite these initial univariate analysis results, on multivariate analysis, PAS actually did not prove to be a statistically significant independent risk factor for 30-day mortality, ischemic colitis, or longer operating times. CONCLUSIONS: This study suggests that patients who have undergone PAS may have some disadvantages in OSR of AAA. However, these negative trends do not go so far as to statistically significantly identify PAS as an independent risk factor for 30-day mortality, ischemic colitis, or longer operating times. As such, we suggest that a history of previous open abdominal surgery, in and of its own, should not exclude patients from consideration for open aortic abdominal aneurysm repair.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Colite Isquêmica , Procedimentos Endovasculares , Humanos , Masculino , Idoso , Feminino , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Implante de Prótese Vascular/efeitos adversos , Estudos Retrospectivos , Colite Isquêmica/etiologia , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Complicações Pós-OperatóriasRESUMO
OBJECTIVE: To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes. DATA SOURCES: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases. REVIEW METHODS: Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404). RESULTS: Of 8 717 titles identified, 43 studies and 28 277 patients were included: 1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 - 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 - 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 - 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 - 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 - 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 - 2.32; GRADE = high). CONCLUSION: This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable to demonstrate any clinically meaningful AAA growth rate reduction concomitant with changed AAA epidemiology. This suggests that the RESCAN recommendations on small AAA surveillance are still valid. However, sub-analysis results from RCTs and high quality study data indicate potential lower AAA growth rates of 1.88 - 2.09 mm/year, findings that should be validated in a high quality prospective registry.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Exposição à Radiação , Humanos , Correção Endovascular de Aneurisma , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/efeitos adversos , Resultado do TratamentoRESUMO
INTRODUCTION: Statins are highly used in cardiovascular prevention. Statin intolerance is the most significant cause of decreased adherence, translating into a higher cardiovascular risk. This systematic review aims to estimate the incidence of muscle adverse events in patients with a history of statin intolerance receiving placebo. METHODS: Database search was performed in CENTRAL, MEDLINE, and EMBASE until March 2023. This systematic review included blinded randomized control trials enrolling patients with a history of statin intolerance who received a placebo. A random-effects meta-analysis was performed. Results were presented in percentages, with 95% confidence intervals (95% CI). RESULTS: Overall, eight studies with 8095 patients with a history of statin intolerance receiving placebo were included. The muscle adverse events incidence rate was 21.34% (95% CI 13.26-30.63%, 8 studies), and discontinuation due to adverse muscle events was 6.12% (95% CI 1.22-13.70%, 3 studies). The incidence was higher in subcutaneous placebo/sham (41.67%, 1 study) compared to oral placebo studies (22.95%, 6 studies). CONCLUSION: In patients previously labeled as statin-intolerant, about a fifth of the patients exhibited muscle symptoms when receiving a placebo. This highlights the importance of ruling out non-statin-related symptoms to further optimize statin therapy for cardiovascular risk improvement.
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Inibidores de Hidroximetilglutaril-CoA Redutases , Humanos , Braço , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Incidência , MúsculosRESUMO
Late aortic and graft-related complications after open aortic repair are not infrequent and a significant number of them are missed, diagnosed at a very late stage, or present as urgent complications such as aortic rupture or aorto-enteric fistula. Once a late complication is diagnosed and reintervention is necessary, both open and endovascular strategies are possible. Open reintervention is complex and usually associated with very high rates of morbidity and mortality. Endovascular techniques may offer several solutions for these cases, which may be tailored to the patient and specific complication. In this review, we aim to summarize current indications, options, and strategies for endovascular salvage after failed or complicated open surgical repair.
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Oxidation of PUFAs in LDLs trapped in the arterial intima plays a critical role in atherosclerosis. Though there have been many studies on the atherogenicity of oxidized derivatives of PUFA-esters of cholesterol, the effects of cholesteryl hemiesters (ChEs), the oxidation end products of these esters, have not been studied. Through lipidomics analyses, we identified and quantified two ChE types in the plasma of CVD patients and identified four ChE types in human endarterectomy specimens. Cholesteryl hemiazelate (ChA), the ChE of azelaic acid (n-nonane-1,9-dioic acid), was the most prevalent ChE identified in both cases. Importantly, human monocytes, monocyte-derived macrophages, and neutrophils exhibit inflammatory features when exposed to subtoxic concentrations of ChA in vitro. ChA increases the secretion of proinflammatory cytokines such as interleukin-1ß and interleukin-6 and modulates the surface-marker profile of monocytes and monocyte-derived macrophage. In vivo, when zebrafish larvae were fed with a ChA-enriched diet, they exhibited neutrophil and macrophage accumulation in the vasculature in a caspase 1- and cathepsin B-dependent manner. ChA also triggered lipid accumulation at the bifurcation sites of the vasculature of the zebrafish larvae and negatively impacted their life expectancy. We conclude that ChA behaves as an endogenous damage-associated molecular pattern with inflammatory and proatherogenic properties.
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Aterosclerose , Peixe-Zebra , Animais , Humanos , Ésteres do Colesterol , Monócitos , Inflamação , ÉsteresRESUMO
Objective: The optimal degree of proximal thoracic endograft oversizing when aiming for durable sealing in prosthetic grafts is unknown. The aim of the present study was to create an in vitro model for testing different oversized thoracic endografts in a reproducible and standardized manner and, subsequently, determine the optimal oversizing range when planning procedures with a proximal landing in prosthetic zones in the descending thoracic aorta or aortic arch. Methods: An in vitro model consisting of a fixed 24-mm polyethylene terephthalate (Dacron; DuPont) graft sutured proximally and distally to two specifically designed 40-mm rings, with four force sensing resistors attached at four equally distant positions and a USB camera attached proximally for photographic and video documentation was used for deployment of Zenith TX2 (Cook Medical Inc) dissection platform endografts with diameters between 24 and 36 mm. After deployment, ballooning with a 32-mm compliant balloon was performed to simulate real-life conditions. The assessment of oversizing included visual inspection, calculation of the valley areas created between the prosthetic wall and the stent graft fabric, distance between the stent graft peaks, the radial force exerted by the proximal sealing stent, and the pull-out force necessary for endograft extraction. Results: A total of 70 endografts were deployed with the oversizing ranging from 0% to 50%: 10 × 24 mm, 10 × 26 mm, 10 × 28 mm, 10 × 30 mm, 10 × 32 mm, 10 × 34 mm, and 10 × 36 mm. Two cases of infolding occurred with 50% oversizing. The valley areas increased from 8.79 ± 0.23 mm2 with 16.7% oversizing to 14.26 ± 0.45 mm2 with 50% oversizing (P < .001). A significant difference was found in the pull-out force required for endografts with <10% oversizing vs ≥10% oversizing (P < .001). The difference reached a plateau at â¼4 N with oversizing of >15%. The mean radial force of the proximal sealing stent was greater after remodeling with a compliant balloon (0.55 ± 0.02 N vs 0.60 ± 0.02 N after ballooning; P < .001). However, greater oversizing did not lead to an increase in the radial force exerted by the proximal sealing stent. Conclusions: The findings from the present study offer additional insight into the mechanics of oversized stent grafts in surgical grafts. In endografts with the Zenith stent design (TX2), oversizing of <16.7% resulted in reduced resistance to displacement forces, and oversizing of >50% was associated with major infolding in 20% of cases. Long-term in vitro and in vivo testing is required to understand how these mechanical properties affect the clinical outcomes of oversizing.
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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
OBJECTIVES: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. MATERIALS AND METHODS: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. RESULTS: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. CONCLUSION: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. CLINICAL IMPACT: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.
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OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.
Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Masculino , Idoso , Feminino , Prótese Vascular , Correção Endovascular de Aneurisma , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Estudos Retrospectivos , Estudos de Coortes , Resultado do Tratamento , Fatores de Tempo , Desenho de PróteseRESUMO
Objective: We evaluated the patency of the spinal arteries (intercostal and lumbar) after the STABILISE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) technique. Methods: A retrospective analysis of all patients with aortic dissection treated with the STABILISE technique between April 2018 and July 2021 was performed. Imaging analysis of the spinal cord vascular supply was accomplished using multiplanar and maximum intensity projection reconstructed images of pre- and postoperative computed tomography angiograms at 1 month, 12 months, and annually thereafter. Results: Twelve patients were treated for complicated aortic dissection. Primary technical success was 100% and mid-term clinical success, at a mean follow-up of 27 ± 12 months, was 90%. No cases of spinal cord ischemia were identified. One patient died after 1 year (non-aortic related), and one patient was lost to follow-up. A significant decrease was found in the mean number of patent spinal arteries in the stent graft area at 1 month (P < .001), 1 year (P < .001), and 2 years (P = .004). However, no significant reduction was found in the number of spinal arteries in either the bare metal stented or nonstented aorta (P > .05). Conclusions: Use of the STABILISE technique decreased intercostal artery patency in the thoracic stent graft area, but spinal artery patency was not significantly affected by the bare metal stent nor its aggressive ballooning. These findings constitute a step toward a better understanding of the safety of this technique.