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PURPOSE: Tier 1 of the International RIsk Stratification in EndoVascular Aneurysm Repair (IRIS-EVAR) project aimed to identify important risk factors for adverse events following endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Initially, the steering committee proposed a number of risk factors for adverse events following EVAR. A Delphi consensus was performed as expert panelists were presented with risk factors and provided the opportunity to propose additional risk factors during the process. Experts in EVAR completed an online survey via 3 structured rounds. The first round opened in July 2022, and the third round closed in December 2022. Panelists rated risk factors using a 4-point Likert scale. Consensus was defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a statement in each round. RESULTS: Thirty-five panelists from 12 countries completed the 3 rounds of surveys. Of a total of 64 individual risk factors assessed by the panelists, 37 (58%) had consensus that they were important for adverse events following EVAR. Risk factors were stratified in 4 domains: 14 (38%) were related to preoperative anatomy, 3 (8%) related to the aortic device selection, 8 (22%) related to the procedure performance, and 12 (32%) related to postoperative surveillance. Factors with the highest consensus in each domain were as follows: proximal aortic neck length <15 mm (98% consensus), anatomy non-compliant with instructions for use (94% consensus), length of achieved proximal aortic neck post implantation <10 mm (98% consensus), and non-satisfactory seal at landing or overlapping zones/sac expansion/kink or stenosis (100% consensus each), respectively. CONCLUSIONS: Clinically important risk factors for adverse events after EVAR were identified via expert consensus. These factors will be used to develop an expert consensus-informed risk stratification and surveillance strategies. CLINICAL IMPACT: This is the first study to apply an in-depth Delphi methodology to achieve an expert consensus on risk factors for adverse events after endovascular aneurysm repair (EVAR). Important risk factors were stratified in 4 domains: preoperative anatomy (14 factors), aortic device (3 factors), EVAR procedure (8 factors), and postoperative surveillance (12 factors). This study will potentially influence future clinical practice by providing evidence informed by experts regarding predictors of adverse events following EVAR that can be taken into account during decision making and developing post-EVAR surveillance strategies. These findings will inform a risk stratification tool for everyday use by vascular surgeons.
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OBJECTIVE: To examine the management of distal aortic disease after total arch replacement with the frozen elephant trunk (TAR + FET) in patients with chronic thoracic aortic disease. METHODS: Two centre retrospective study of consecutive patients treated between January 2010 and December 2019. The primary endpoint was 30 day or in hospital death. The secondary endpoint was midterm survival. Data are presented as median (interquartile range [IQR]). The χ2 or Fisher's exact test was used as appropriate. Estimated survival (standard error) was assessed by calculating the Kaplan-Meier product limit estimator with right censoring of survival data. A p value of < .050 was considered statistically significant. STROBE guidelines were followed. RESULTS: A total of 158 patients (72 men; median age 70 years, IQR 64, 75; median distal aortic diameter 58 mm, IQR 46, 68; 127 aneurysmal disease, 31 chronic dissection) underwent TAR + FET. The peri-operative mortality rate was 10.1% (9/107 elective, 7/51 non-elective). Of 74 (46.8%) patients with a primary distal seal, seven (9.5%) died peri-operatively, the distal seal was maintained during follow up in 51, nine underwent late distal repair (two planned, seven unplanned; one open, eight endovascular; one peri-operative death) with a median interval to unplanned repair of 777 days (IQR 462, 1480), and seven with loss of seal had no intervention. Distal seal failed in 2/28 (7%) patients with a distal seal length > 30 mm and device oversizing > 10%, compared with 12/39 (31%) patients who did not meet these criteria (p = .031). In 84 patients without a primary distal seal, nine (10.7%) died peri-operatively, the distal aorta remained below the size threshold for repair during follow up in 12 patients, 44 had distal repair (median aortic diameter 64 mm, IQR 60, 75; eight open, one hybrid, 35 endovascular repairs; no deaths) at a median of 256 days (IQR 135, 740), and 19 did not have distal repair at the end of the follow up period: six died before planned repair at a median interval of 115 days (IQR 85, 120); eight were considered unfit; one was assessed as fit but declined; and four patients were awaiting assessment. Median follow up was 46 months (IQR 26, 75): no patients were lost to follow up. Estimated ± standard error five year survival was 61.5 ± 4.1%: elective 70.6 ± 4.7%, non-elective 43.2 ± 7.2%. CONCLUSION: TAR + FET achieved primary distal seal in 47% of patients, but late failure occurred in 21%. Distal repair was ultimately indicated in 84% of survivors without a primary distal seal and of these 70% underwent repair, almost 10% died before planned repair, and 13% were considered unfit. Earlier distal endovascular repair and better assessment of patient fitness may improve midterm outcomes.
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Aorta Torácica , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Humanos , Masculino , Femenino , Anciano , Estudios Retrospectivos , Persona de Mediana Edad , Aorta Torácica/cirugía , Aorta Torácica/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/instrumentación , Resultado del Tratamiento , Enfermedad Crónica , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/mortalidad , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Disección Aórtica/cirugía , Disección Aórtica/mortalidad , Disección Aórtica/diagnóstico por imagen , Prótesis Vascular , Mortalidad Hospitalaria , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Factores de Tiempo , Factores de RiesgoRESUMEN
OBJECTIVE: To compare the survival of patients who attended surveillance after endovascular aneurysm repair (EVAR) with those who were non-compliant. DATA SOURCES: MEDLINE and Embase were searched using the Ovid interface. REVIEW METHODS: A systematic review was conducted complying with the PRISMA guidelines. Eligible studies compared survival in EVAR surveillance compliant patients with non-compliant patients. Non-compliance was defined as failure to attend at least one post-EVAR follow up. The risk of bias was assessed with the Newcastle-Ottawa scale, and the certainty of evidence using the GRADE framework. Primary outcomes were survival and aneurysm related death. Effect measures were the hazard ratio (HR) or odds ratio (OR) and 95% confidence interval (CI) calculated using the inverse variance or Mantel-Haenszel statistical method and random effects models. RESULTS: Thirteen cohort studies with a total of 22 762 patients were included. Eight studies were deemed high risk of bias. The pooled proportion of patients who were non-compliant with EVAR surveillance was 43% (95% CI 36 - 51). No statistically significant difference was found in the hazard of all cause mortality (HR 1.04, 95% CI 0.61 - 1.77), aneurysm related mortality (HR 1.80, 95% CI 0.85-3.80), or secondary intervention (HR 0.66, 95% CI 0.31 - 1.41) between patients who had incomplete and complete follow up after EVAR. The odds of aneurysm rupture were lower in non-compliant patients (OR 0.63, 95% CI 0.39 - 1.01). The certainty of evidence was very low for all outcomes. Subgroup analysis for patients who had no surveillance vs. those with complete surveillance showed no significant difference in all cause mortality (HR 1.10, 95% CI 0.43 - 2.80). CONCLUSION: Patients who were non-compliant with EVAR surveillance had similar survival to those who were compliant. These findings question the value of intense surveillance in all patients post-EVAR and highlight the need for further research on individualised or risk adjusted surveillance.
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PURPOSE: Endoleaks are common following endovascular aneurysm repair (EVAR), and the liquid embolic material Onyx has been widely used in their treatment. We report our experience of long-term morphological changes of Onyx casts on surveillance imaging. MATERIALS AND METHODS: We identified 10 patients over 10 years who underwent Onyx embolization in our institution. Morphological changes of Onyx casts were assessed on surveillance radiographs and computed tomography (CT) scans. Relevant outcome data and sequelae were obtained via electronic patient records. RESULTS: Twelve procedures were performed on 10 cases, 9 for type 2, and 1 for a type 1a endoleak. Five cases showed evidence of Onyx fragmentation on follow-up imaging ranging from a single fracture to gross fragmentation with migration of fragments. Of these 5, 3 had achieved primary success but 2 went on to develop recurrence of endoleak. Onyx volume ranged from 4 to 46.5 ml (median 10.5 ml) per patient with larger volumes demonstrating the most marked fragmentation on follow-up. Follow-up ranged from 9 months to 8 years (median 2.25 years). CONCLUSION: To our knowledge, this is the first report of Onyx fragmentation after endoleak embolization. If long-term morphological stability of the Onyx cast is necessary to maintain aneurysm seal, then Onyx may not offer a permanent solution to some patients with post-EVAR endoleaks. Our study cannot ascertain whether the observed changes were the cause or the effect of ongoing aneurysm growth, persistent endoleak, and/or other forces acting on the solidified polymer, but it raises important questions on the use of Onyx in this setting.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/terapia , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Humanos , Polivinilos/efectos adversos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. METHODS: This is an international, retrospective, observational cohort study including data from 8 European institutions. RESULTS: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5-89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. CONCLUSION: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Humanos , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Stents , Resultado del TratamientoRESUMEN
OBJECTIVE: To report our outcomes and identify predictors of mortality after open descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysm (TAAA) repair in a specialist aortic center. METHODS: This retrospective observational cohort study included consecutive patients who underwent surgery at our institution between October 1998 and December 2019. The main outcome measures were mortality and major morbidities. A multivariate analysis was used to identify predictors of mortality. RESULTS: There were 430 patients who underwent DTA (n = 157) and TAA (n = 273) repair; 151 underwent surgery nonelectively. Forty-eight patients (11%) died within 30 days of surgery. The 30-day mortality was lower after elective surgery (3.1% after DTA repair and 9.9% after TAAA repair), whereas nonelective surgery had a 30-day mortality of 17.9%. Fourteen additional patients died in hospital after 30 days, one after nonelective DTA repair and 13 after TAAA repair (10 elective), all but one extent II. In-hospital mortality for the whole cohort improved over time, as the activity volume increased, except for patients undergoing extent II TAAA repair. Predictors of in-hospital mortality were age ≥70 years (odds ratio [OR], 3.36; 95% confidence interval [CI], 1.79-6.32; P < .001), extent II repair (OR, 4.39; 95% CI, 2.34-8.21; P < .001), nonelective surgery (OR, 2.72; 95% CI, 1.44, 5.12; P = .002), out-of-hours surgery (OR, 8.17; 95% CI, 2.16-30.95; P = .002), a left ventricular ejection fraction of <30% (OR, 9.86; 95% CI, 1.91-50.86; P < .006), and surgery for a degenerative aneurysm (OR, 2.20; 95% CI, 1.12-4.31; P = .02). The incidence of stroke and paraplegia was 7.1% and 0% after DTA repair and 9.9% and 3.3% after TAAA repair. Hemodialysis was necessary in 5.1% of cases after DTA repair and 22.7% after TAAA repair. CONCLUSIONS: Open thoracoabdominal aortic surgery carries significant risk to life, which is related to age, extent of aortic replacement, timing of surgery, and left ventricular function. Morbidity is considerable. Understanding these risks is fundamental for patient selection and the consent process of potential candidates for surgery, particularly in the elderly.
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Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular , Anciano , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Inglaterra , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
The emergence of severe acute respiratory syndrome coronavirus 2 in December 2019, presumed from the city of Wuhan, Hubei province in China, and the subsequent declaration of the disease as a pandemic by the World Health Organization as coronavirus disease 2019 (COVID-19) in March 2020, had a significant impact on health care systems globally. Each country responded to this disease in different ways, however this was done broadly by fortifying and prioritizing health care provision as well as introducing social lockdown aiming to contain the infection and minimizing the risk of transmission. In the United Kingdom, a lockdown was introduced by the government on March 23, 2020 and all health care services were focussed to challenge the impact of COVID-19. To do so, the United Kingdom National Health Service had to undergo widespread service reconfigurations and the so-called "Nightingale Hospitals" were created de novo to bolster bed provision, and industries were asked to direct efforts to the production of ventilators. A government-led public health campaign was publicized under the slogan of: "Stay home, Protect the NHS (National Health Service), Save lives." The approach had a significant impact on the delivery of all surgical services but particularly cardiac surgery with its inherent critical care bed capacity. This paper describes the impact on provision for elective and emergency cardiac surgery in the United Kingdom, with a focus on aortovascular disease. We describe our aortovascular activity and outcomes during the period of UK lockdown and present a patient survey of attitudes to aortic surgery during COVID-19 pandemic.
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COVID-19 , Procedimientos Quirúrgicos Cardíacos , China/epidemiología , Control de Enfermedades Transmisibles , Humanos , Pandemias , SARS-CoV-2 , Medicina Estatal , Reino Unido/epidemiologíaRESUMEN
Purpose: To investigate whether patients who develop aneurysm sac shrinkage following endovascular aneurysm repair (EVAR) have better outcomes than patients with a stable or increased aneurysm sac. Materials and Methods: The Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence was used to interrogate MEDLINE and EMBASE. Thesaurus headings were adapted accordingly. Case-control studies were identified comparing outcomes in patients demonstrating aneurysm sac shrinkage after EVAR with those of patients with a stable or expanded aneurysm sac. Pooled estimates of dichotomous outcome data were calculated using the odds ratio (OR) and 95% confidence interval (CI). Meta-analysis of time-to-event data was conducted using the inverse-variance method; the results are reported as a summary hazard ratio (HR) and 95% CI. Summary outcome estimates were calculated using random-effects models. Results: Eight studies were included in quantitative synthesis reporting a total of 17,096 patients (8518 patients with sac shrinkage and 8578 patients without sac shrinkage). The pooled incidence of sac shrinkage at 12 months was 48% (95% CI 40% to 56%). Patients with aneurysm sac shrinkage had a significantly lower hazard of death (HR 0.73, 95% CI 0.60 to 0.87), secondary interventions (HR 0.42, 95% CI 0.29 to 0.62), and late complications (HR 0.37, 95% CI 0.24 to 0.56) than patients with a stable or increased aneurysm sac. Furthermore, their odds of rupture were significantly lower than those in patients without shrinkage (OR 0.09, 95% CI 0.02 to 0.36). Conclusion: Sac regression is correlated to improved survival and a reduced rate of secondary interventions and EVAR-related complications. The prognostic significance of sac regression should be considered in surveillance strategies. Intensified surveillance should be applied in patients who fail to achieve sac regression following EVAR.
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Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/mortalidad , Aneurisma de la Aorta/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective was to investigate whether endovascular aneurysm repair (EVAR) has better peri-operative and late clinical outcomes than open repair for non-ruptured abdominal aortic aneurysm. METHODS: Electronic bibliographic sources (MEDLINE, EMBASE, and CENTRAL) were searched up to July 2019 using a combination of thesaurus and free text terms to identify randomised controlled trials (RCTs) comparing the outcomes of EVAR and open repair. The systematic review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI). A time to event data meta-analysis was performed using the inverse variance method and the results were reported as summary hazard ratio (HR) and 95% CI. RESULTS: Seven RCTs reporting a total of 2 983 patients were included in quantitative synthesis. Three of the trials reported long term follow up that extended to 15.8 years, 14.2 years, and 12.5 years. Meta-analysis found significantly lower odds of 30 day (OR, 0.36; 95% CI 0.20-0.66) and in hospital mortality with EVAR (RD -0.03; 95% CI -0.04 to -0.02). Meta-analysis of the three trials reporting long term follow up found no significant difference in all cause mortality at any time between EVAR and open repair (HR 1.02; 95% CI 0.93-1.13; p = .62). The hazard of all cause (HR 0.62; 95% CI 0.42-0.91) and aneurysm related death within six months (HR 0.42; 95% CI 0.24-0.75) was significantly lower in patients who underwent EVAR, but with further follow up, the pooled hazard estimate moved in favour of open surgery; in the long term (>8 years) the hazard of aneurysm related mortality was significantly higher after EVAR (HR 5.12; 95% CI 1.59-16.44). The risk of secondary intervention (HR 2.13; 95% CI 1.69-2.68), aneurysm rupture (OR, 5.08; 95% CI 1.11-23.31), and death due to rupture (OR, 3.57; 95% CI 1.87-6.80) was significantly higher after EVAR, but the risk of death due to cancer was not significantly different between EVAR and open repair (OR, 1.03; 95% CI 0.84-1.25). CONCLUSION: Compared with open surgery, EVAR results in a better outcome during the first six months but carries an increased risk of aneurysm related mortality after eight years.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Humanos , Complicaciones Posoperatorias/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim was to compare peri-operative and late outcomes of patients with acute and subacute uncomplicated type B aortic dissection (uTBAD) treated by thoracic endovascular aortic repair (TEVAR) or best medical therapy (BMT). METHODS: This was a Systematic review and meta-analysis of observational studies and randomised controlled trials (RCTs). The review was undertaken according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and registered with the International Prospective Register of Systematic Reviews (number: CRD42018094607). Multiple electronic databases were searched to identify relevant articles. The methodological quality of the included studies was assessed. The primary outcome measures were early mortality and re-intervention, late all cause and aorta related mortality, and re-intervention. Meta-analysis was used to produce pooled odds ratios (OR) or risk difference (RD) for peri-operative outcomes. Random effects models were applied. For late outcomes a time to event meta-analysis was conducted using the inverse variance model, reporting the results as hazard ratios (HR). RESULTS: Eight original articles from six studies encompassing 14 706 patients (1 066 TEVARs) were eligible for inclusion. There were no statistically significant differences between TEVAR and BMT with regards to inpatient mortality (RD 0.01, 95% CI -0.01-0.02, p = .46), early re-intervention by TEVAR (RD 0.02, 95% CI -0.01-0.04, p = .19) or surgery (RD 0.00, 95% CI -0.01-0.01, p = 1.0). BMT was associated with a significantly lower risk of early stroke (OR 0.64, 95% CI 0.48-0.85, p = .002), whereas the risk of late all cause (HR 1.54, 95% CI 1.27-1.86, p < .001) and aorta related mortality (HR 2.71, 95% CI 1.49-4.94, p = .001) was significantly higher than with TEVAR. No suitable data regarding late aortic re-intervention was found for meta-analysis. CONCLUSION: Given the limited number and quality of suitable studies it remains uncertain whether TEVAR is beneficial in the management of acute/subacute uTBAD. Further research is required to understand which dissections would benefit from pre-emptive treatment.
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Aneurisma de la Aorta/terapia , Disección Aórtica/terapia , Enfermedad Aguda , Disección Aórtica/cirugía , Aneurisma de la Aorta/cirugía , Procedimientos Endovasculares , Humanos , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim of this study was to measure the incidence of post endovascular aneurysm sealing (EVAS) abdominal aortic aneurysm (AAA) growth, and its association with stent migration, in a cohort of patients with differing compliance to old and new Instructions For Use (IFU). METHODS: A retrospective single centre study was conducted to review the computed tomography (CT) and clinical data of elective, infrarenal EVAS cases, performed as a primary intervention, between December 2013 and March 2018. All included patients had a baseline post-operative CT scan at one month and at least one year follow up. The primary outcome measure was the incidence of AAA growth and its association with stent migration. AAA growth was defined as a ≥5% increase in aortic volume between the lowermost renal artery and the aortic bifurcation post EVAS at any time during follow up, in comparison to the baseline CT scan. Migration was defined according to the ESVS guidelines, as > 10 mm downward movement of either Nellix stent frame in the proximal zone. RESULTS: Seventy-six patients were eligible for inclusion in the study (mean age 76 ± 7.4 years; 58 men). AAA growth was identified in 50 of 76 patients (66%); adherence to IFU did not affect its incidence (mean growth within IFU-2016 compliant cohort vs. non-compliant: 16% vs. 13%, p = .33). Over time, the incidence of AAA growth increased, from 32% at one year to 100% at four years. AAA growth by volume was progressive (p < .001), as its extent increased over time. Migration was detected in 16 patients and there was a statistically significant association with AAA growth (13 patients displayed migration and AAA growth, p = .036). CONCLUSION: Patients treated with EVAS are prone to AAA growth, irrespective of whether their aortic anatomy is IFU compliant. AAA growth by volume is associated with stent migration. Clinicians should continue close surveillance post EVAS, regardless of whether patients are treated within IFU.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Quirúrgicos Electivos/efectos adversos , Procedimientos Endovasculares/efectos adversos , Complicaciones Posoperatorias/epidemiología , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aorta Abdominal/patología , Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/patología , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Progresión de la Enfermedad , Procedimientos Quirúrgicos Electivos/instrumentación , Procedimientos Endovasculares/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Cooperación del Paciente , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Stents/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Secondary open aortic procedures (SOAP) treat complications of endovascular aneurysm repair, when further endovascular options are exhausted. We aimed at depicting the state of the art of SOAP with high-level evidence. METHODS: A systematic review of the SOAP literature, with a meta-analysis of its outcomes (primary outcome operative mortality; secondary outcome major morbidity) and metaregression of risk factors for mortality (PROSPERO 42017075631). RESULTS: Twenty-eight studies (1093 patients) were elected for analysis. SOAP was performed within the same hospitalization of or 30 days from domestic endovascular aneurysm repair (early SOAP) in 0.2% of the patients (85/40,256), and in a nonelective setting in 24.3% (95% confidence interval, 21.8-26.9). Most frequent indications were endoleak (44.4%; 95% confidence interval, 41.4-47.3) and rupture (12.7%; 95% confidence interval, 10.4-15.1). The most common procedures were infrarenal aortic replacement (85.2%; 95% confidence interval, 82.6-87.7) with high use of supravisceral clamping (suprarenal, 25% [95% confidence interval, 21.9-28.1] and supraceliac, 20.7% [95% confidence interval, 17.8-23.6]), and axillobifemoral bypass with stent explant (6.9%; 95% confidence interval, 5.1-8.7). Operative mortality (in-hospital or 30-day) was 10.9% (95% confidence interval, 8.7-13.5). The most frequent morbidities were respiratory (11.4%; 95% confidence interval, 8.1-15.9) and renal (9.5%; 95% confidence interval, 8.1-15.9). Risk factors for mortality were supravisceral clamping (Z = 3.007; Q = 9.044; P = .003) and nonelective status (Z = 3.382; Q = 11.440; P = .001). CONCLUSIONS: Endoleak is the main indication for SOAP, which mostly consists of infrarenal aortic replacement. Risk factors for operative mortality are nonelective status and supravisceral clamping.
Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Endofuga/cirugía , Procedimientos Endovasculares , Reoperación , Anciano , Aorta Abdominal/fisiopatología , Aneurisma de la Aorta Abdominal/fisiopatología , Endofuga/etiología , Endofuga/mortalidad , Endofuga/fisiopatología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Reoperación/efectos adversos , Reoperación/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/cirugía , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/cirugía , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Progresión de la Enfermedad , Procedimientos Quirúrgicos Electivos , Urgencias Médicas , Endofuga/diagnóstico por imagen , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Europa (Continente) , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Nueva Zelanda , Datos Preliminares , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Insuficiencia del TratamientoRESUMEN
PURPOSE: To investigate the incidence and extent of stent frame movement after endovascular aneurysm sealing (EVAS) in the abdominal aorta and its relationships to aneurysm growth and the instructions for use (IFU) of the Nellix endograft. METHODS: A retrospective single-center study was conducted to review the clinical data and computed tomography (CT) images of 75 patients (mean age 76±7.6 years; 57 men) who underwent infrarenal EVAS and had a minimum 1-year follow-up. The first postoperative CT scan at 1 month and the subsequent scans were used to measure the distances between the proximal end of the stent frames and a reference visceral vessel using a previously validated technique. Device migration was based on the Society of Vascular Surgery definition of >10-mm downward movement of either Nellix stent frame in the proximal landing zone; a more conservative proximal displacement measure (downward movement ⩾4 mm) was also recorded. Patients were categorized according to adherence to the old (2013) or new (2016) Nellix IFU. Aneurysm diameter was measured for each scan; a change ⩾5 mm was deemed indicative of aneurysm growth. RESULTS: Over a median follow-up of 24 months (range 12-48), proximal displacement ⩾4 mm occurred in 42 (56%) patients and migration >10 mm in 16 (21%), with similar incidences in the right and left stent frames. Proximal displacement was significantly more frequent among patients whose anatomy did not conform to any IFU (p=0.025). Presence of aneurysm growth ⩾5 mm was observed in 14 (19%) patients and was significantly associated with proximal displacement ⩾4 mm (p=0.03). CONCLUSION: Infrarenal EVAS may be complicated by proximal displacement and migration, particularly when performed outside the IFU. The definition of migration used for endovascular aneurysm repair may be inappropriate for EVAS; a new consensus on definition and measurement technique is necessary.
Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/etiología , Stents , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Progresión de la Enfermedad , Endofuga/etiología , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Humanos , Masculino , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE/BACKGROUND: Low psoas muscle mass is associated with increased mortality and morbidity after surgery. Recent evidence has linked low psoas muscle mass with survival after abdominal aortic aneurysm (AAA) repair. The aim of this study was to investigate the prognostic role of low skeletal muscle mass in survival of patients with AAA undergoing open or endovascular aneurysm repair (EVAR). METHODS: A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration number: CRD42018107793). The prognostic factor of interest was degenerative loss of skeletal muscle. A time-to-event data meta-analysis was performed for all cause mortality using the inverse variance method and the results were reported as summary hazard ratio (HR) and 95% confidence interval (CI). Pooled estimates of peri-operative outcome data were calculated using the odds ratio (OR) or risk difference (RD) and 95% CI. Random-effects models of meta-analysis were applied. RESULTS: Seven observational cohort studies reporting a total of 1,440 patients were eligible for quantitative synthesis. Patients with low skeletal muscle mass had a significantly higher hazard of mortality than those without low skeletal muscle mass (HR 1.66, 95% CI 1.15-2.40; p = .007). Subgroup analysis including only patients who underwent EVAR showed a marginal survival benefit for patients without low skeletal muscle mass (HR 1.86, 95% CI 1.00-3.43; p = .05). Meta-analysis of two studies found no significant difference in peri-operative mortality (RD 0.04, 95% CI -0.13 to 0.21) and morbidity (OR 1.58, 95% CI 0.90-2.76; p = .11) between patients with and without low skeletal muscle mass. CONCLUSION: There is a significant link between low skeletal muscle mass and mortality in patients undergoing AAA repair. Prospective studies validating the use of body composition for risk prediction after aortic surgery are required before this tool can be used to support decision making and patient selection.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/mortalidad , Composición Corporal , Procedimientos Endovasculares/mortalidad , Fragilidad/mortalidad , Músculo Esquelético/fisiopatología , Sarcopenia/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Fragilidad/diagnóstico por imagen , Fragilidad/fisiopatología , Estado de Salud , Humanos , Músculo Esquelético/diagnóstico por imagen , Medición de Riesgo , Factores de Riesgo , Sarcopenia/diagnóstico por imagen , Sarcopenia/fisiopatología , Resultado del TratamientoRESUMEN
BACKGROUND: Analytic morphometry is a novel concept in perioperative risk assessment. Low core muscle mass assessed by morphometry is associated with frailty and has been demonstrated to be an independent predictor of postoperative complications and mortality in oncologic, transplant, and aneurysm surgery. We aimed to study associations between core muscle mass and complication rates, length of hospital stay, and survival after surgical lower limb revascularization. METHODS: In this retrospective cohort study, 263 patients considered for surgical lower limb revascularization between January 2013 and December 2014 underwent cross-sectional imaging. Total psoas area (TPA) was measured on computed tomography angiograms at the level of the fourth lumbar vertebra by two independent observers blinded to clinical details. Clinical information was collected from patients' notes and the electronic medical record. Cox and logistic regression analyses were used to estimate the effect of clinical factors and psoas muscle area on survival, complication rates, and prolonged hospital stay after surgical lower limb revascularization. RESULTS: Data from 263 patients were analyzed. The American Society of Anesthesiologists score (hazard ratio [HR], 3.05; confidence interval [CI], 1.69-5.50; P < .001), emergency status (HR, 2.26; CI, 1.21-4.22; P = .011), lowest TPA quartile (HR, 1.89; CI, 1.07-3.35; P = .028), and Fontaine stage (HR, 1.63; CI, 1.04-2.53; P = .031) were found to be independent predictors of survival. Low TPA was not associated with increased rate of postoperative complications or prolonged hospital stay. CONCLUSIONS: Psoas muscle area may help identify patients with a shorter life expectancy after lower limb revascularization, but its role in predicting postoperative complications or length of hospital admission seems to be limited.
Asunto(s)
Angiografía por Tomografía Computarizada , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/cirugía , Músculos Psoas/diagnóstico por imagen , Injerto Vascular/mortalidad , Anciano , Distribución de Chi-Cuadrado , Registros Electrónicos de Salud , Femenino , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Esperanza de Vida , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Enfermedad Arterial Periférica/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Injerto Vascular/efectos adversosRESUMEN
PURPOSE: To explore whether or not there are temporal changes in the abdominal aortic aneurysm (AAA) and intraluminal thrombus (ILT) volumes between planning and implantation of the endovascular aneurysm sealing (EVAS) device and how these changes influence lumen volume. METHODS: A retrospective review was conducted of 51 AAA patients (mean age 76±7.1 years; 36 men) in whom 2 serial preoperative computed tomography angiograms (CTAs) had been performed within 1 to 18 months before fenestrated endovascular repair. The 2 preoperative CTAs were analyzed to identify changes in total sac, ILT, and lumen volumes. RESULTS: Over a median 7.0 months (interquartile range 4, 10), 46 (90%) of 51 AAAs increased in volume between the 2 CTAs. ILT volume increased in 44 aneurysms. In contrast, lumen volume increased in 31 and decreased in 20 AAAs. There was a strong correlation between changes in AAA volume and ILT volume (rs=0.859, p<0.001), which remained significant after adjustment for initial volumes (rs=0.815; p<0.001). There was no correlation between the time interval separating the 2 CTAs and changes in AAA volume (rs=0.115; p=0.421), changes in ILT volume (rs=0.084; p=0.599), or changes in lumen volume (rs=0.060; p=0.676). The AAA growth rate (defined as the change in AAA size/days between CTAs) showed a weak correlation with ILT volume (rs=0.272, p=0.054), which disappeared after adjustment for initial AAA size (rs=-0.002, p=0.991). Between the 2 CTAs, 12 aneurysms crossed the new <1.4 Nellix maximum aorta/lumen diameter ratio. CONCLUSION: As AAAs grow, the increase in aortic volume is largely occupied by additional ILT formation, with minimal change in lumen volume. These changes may alter the suitability of the aneurysm for the Nellix device and could have implications for EVAS planning and device deployment.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares , Trombosis/diagnóstico por imagen , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Progresión de la Enfermedad , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Selección de Paciente , Valor Predictivo de las Pruebas , Diseño de Prótesis , Estudios Retrospectivos , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The optimum timing of carotid intervention for symptomatic carotid stenosis remains unclear. The objective was to investigate outcomes of very urgent (< 48 h from neurological event) in comparison to urgent (≥ 48 h from neurological event) carotid intervention for symptomatic carotid disease. METHODS: A systematic literature review was carried out of randomised control trials (RCTs) and observational studies reporting peri-procedural outcomes of carotid intervention in relation to the length of time since the neurological event (PROSPERO registration number: CRD 42017075766). Ipsilateral stroke and death were defined as the primary outcome endpoints. Transient ischaemic attack (TIA) and myocardial infarction (MI) were secondary outcome parameters. Comparative outcomes were calculated and reported as dichotomous outcome measures using the odds ratio (OR) and associated 95% confidence interval (CI) for very urgent (< 48 h since neurological event) versus urgent (≥ 48 h) intervention. The combined overall effect size was calculated using a random effects model. RESULTS: Twelve observational studies and one RCT representing 5751 interventions, 5385 carotid endarterectomies (CEAs) and 366 carotid artery stenting (CAS) procedures, were included in quantitative synthesis. Very urgent carotid intervention was associated with increased risk of stroke within 30 days of treatment compared with urgent carotid intervention (OR 2.19, 95% CI 1.46-3.26, p < .001). No significant difference was found in mortality (OR 1.55, 95% CI 0.81-2.96, p = .19), TIA (OR 1.33, 95% CI 0.55-3.19, p = .52) or MI (OR 1.33, 95% CI 0.41-4.33, p = .64). CONCLUSIONS: Very urgent carotid intervention was found to be associated with increased risk of stroke.
Asunto(s)
Estenosis Carotídea/cirugía , Endarterectomía Carotidea , Infarto del Miocardio/cirugía , Accidente Cerebrovascular/cirugía , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Doppler ultrasound (DUS) and computed tomography angiography (CTA) are the most commonly used imaging modalities for carotid disease. The aim of this study was to test the accuracy and reproducibility of CTA-derived measurements of carotid stenosis and compare them with those obtained by DUS. METHODS: Images of 100 carotid arteries of patients who underwent carotid DUS at our unit and CTA of the carotids within a 28-day period were identified retrospectively from multidisciplinary team meeting records. CTAs were assessed by 2 investigators, each using a manual and a semi-automated method. With both methods, the degree of stenosis was calculated using the North American Symptomatic Carotid Endarterectomy Trial equation and graded as mild (0-49%), moderate (50-69%), or severe (70-99%). Cohen's kappa and specificity and sensitivity for ≥50% stenosis were calculated. RESULTS: The interobserver agreement was moderate (κ 0.407, weighted-κ 0.517) for the manual method and good (κ 0.786, weighted-κ 0.842) for the semi-automated method. Using DUS as the gold standard, the semi-automated method had greater sensitivity (75%) and specificity (91%) in detecting clinically significant carotid artery stenosis (≥50%) than the manual one (63% and 86%, respectively). Agreement between DUS and the semi-automated method of CTA reporting was moderate (κ 0.453, 95% confidence interval [CI]: 0.320-0.586, weighted-κ 0.598, 95% CI: 0.486-0.710), whereas DUS and the manual method of CTA reporting had only fair agreement (κ 0.344, 95% CI: 0.209-0.478, weighted-κ 0.446, 95% CI: 0.315-0.577). CONCLUSIONS: CTA tends to underestimate the degree of stenosis when compared with DUS. The semi-automated method of CTA reporting has greater reproducibility and greater agreement with DUS. These findings have practical implications when CTA is used to measure the degree of carotid stenosis in clinical practice.
Asunto(s)
Arterias Carótidas/diagnóstico por imagen , Estenosis Carotídea/diagnóstico por imagen , Angiografía por Tomografía Computarizada , Tomografía Computarizada Multidetector , Ultrasonografía Doppler , Anciano , Anciano de 80 o más Años , Área Bajo la Curva , Automatización , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Curva ROC , Interpretación de Imagen Radiográfica Asistida por Computador , Reproducibilidad de los Resultados , Estudios Retrospectivos , Índice de Severidad de la EnfermedadRESUMEN
The aim of this review was to investigate presentation, aetiology, management, and outcomes of bowel ischaemia following EVAR. We present a case report and searched electronic bibliographic databases to identify published reports of bowel ischaemia following elective infra-renal EVAR not involving hypogastric artery coverage or iliac branch devices. We conducted our review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement standards. In total, five cohort studies and three case reports were included. These studies detailed some 6,184 infra-renal elective EVARs, without procedure-related occlusion of the hypogastric arteries, performed between 1996 and 2014. Bowel ischaemia in this setting is uncommon with an incidence ranging from 0.5 to 2.8 % and includes a spectrum of severity from mucosal to transmural ischaemia. Due to varying reporting standards, an overall proportion of patients requiring bowel resection could not be ascertained. In the larger series, mortality ranged from 35 to 80 %. Atheroembolization, hypotension, and inferior mesenteric artery occlusion were reported as potential causative factors. Elderly patients and those undergoing prolonged procedures appear at higher risk. Bowel ischaemia is a rare but potentially devastating complication following elective infra-renal EVAR and can occur in the setting of patent mesenteric vessels and hypogastric arteries. Mortality ranges from 35 to 80 %. Further research is required to identify risk factors and establish prophylactic measures in patients that have an increased risk of developing bowel ischaemia after standard infra-renal EVAR.