An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Quality Assessment of Elective Abdominal Aortic Aneurysm Repair Patient Information on the Internet Using the Modified Ensuring Quality Information for Patients Tool.

OBJECTIVE: This study aimed to assess the quality of patient information material regarding elective abdominal aortic aneurysm (AAA) repair on the internet using the Modified Ensuring Quality Information for Patients (MEQIP) tool. METHODS: A qualitative assessment of internet based patient information was performed. The 12 most used search terms relating to AAA repair were identified using Google Trends, with the first 10 pages of websites retrieved for each term searched. Duplicates were removed, and information for patients undergoing elective AAA were selected. Further exclusion criteria were marketing material, academic journals, videos, and non-English language sites. The remaining websites were then MEQIP scored independently by two reviewers, producing a final score by consensus. RESULTS: A total of 1 297 websites were identified, with 235 (18.1%) eligible for analysis. The median MEQIP score was 18 (interquartile range [IQR] 14, 21) out of a possible 36. The highest score was 33. The 99th percentile MEQIP scoring websites scored > 27, with four of these six sites representing online copies of hospital patient information leaflets, however hospital sites overall had lower median MEQIP scores than most other institution types. MEQIP subdomain median scores were: content, 8 (IQR 6, 11); identification, 3 (IQR 1, 3); and structure, 7 (IQR 6, 9). Of the analysed websites, 77.9% originated from the USA (median score 17) and 12.8% originated in the UK (median score 22). Search engine ranking was related to website institution type but had no correlation with MEQIP. CONCLUSION: When assessed by the MEQIP tool, most websites regarding elective AAA repair are of questionable quality. This is in keeping with studies in other surgical and medical fields. Search engine ranking is not a reliable measure of quality of patient information material regarding elective AAA repair. Health practitioners should be aware of this issue as well as the whereabouts of high quality material to which patients can be directed.

Long Term Outcomes and Durability of Fenestrated Endovascular Aneurysm Repair: A Meta-analysis of Time to Event Data.

OBJECTIVE: Despite widespread use, long term outcomes for fenestrated endovascular aneurysm repair (FEVAR) are uncertain. This meta-analysis reports long term survival, freedom from re-intervention, target vessel patency, and one year sac regression after FEVAR. DATA SOURCES: Systematic review and meta-analysis to pool time to event data according to PRISMA guidelines. The study was registered with the international prospective register of systematic reviews (PROSPERO) (ID: CRD42023401468). REVIEW METHODS: Medline, Embase, and Cochrane databases were searched from 1992 - 2023; articles were independently screened by two authors. Publication of complete time to event data for any outcome of interest was an inclusion criterion. Raw Kaplan-Meier probabilities were directly extracted from published curves and pooled by random effects. Risk of bias was assessed using ROBINS I and certainty with GRADE. RESULTS: A total of 3 569 records were retrieved, 2 869 screened after duplicate removal, yielding 37 included studies (n = 4 371). The pooled mean age was 73.2 years (interquartile range [IQR] 72.2, 73.7) and 87.4% were male (95% confidence interval [CI] 85.8 - 88.9). Pooled Kaplan-Meier estimated probabilities of survival (n = 34 studies, n = 4 192 patients) at one, three, and five years were 91.6% (95% CI 90.2 - 92.9), 80.8% (95% CI 78.0 - 83.2), and 65.1% (95% CI 60.9 - 69.1). For freedom from re-intervention (n = 24, n = 3 211 patients) at one, three, and five years these were 90.2% (95% CI 87.3 - 92.7), 80.9% (95% CI 76.5 - 84.9), and 73.8% (95% CI 67.1 - 79.6). For target vessel patency (n = 13, n = 5805 target vessels) at one, three, and five years, these were 96.6% (95% CI 94.9 - 98.0), 94.5% (95% CI 91.7 - 96.7), and 93.1% (95% CI 89.3 - 96.0). Pooled estimate of sac regression (n = 8, n = 560) at one year was 40.2% (95% CI 28.9 - 52.7). Risk of bias was judged as moderate in 11 studies and low for the remaining 26. CONCLUSION: There are moderate to low certainty data supporting reasonable long term outcome estimates following fenestrated endovascular aneurysm repair. Beyond five years there is a lack of data in the literature.

The Effect of One Year Aneurysm Sac Dynamics on Five Year Mortality and Continued Aneurysm Sac Evolution.

OBJECTIVE: One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with greater risk of all-cause mortality in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. METHODS: A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated from one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was rate of five year all-cause mortality. Kaplan-Meier estimates for freedom from all-cause mortality were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all-cause mortality. RESULTS: At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, five year all-cause mortality was 20%, compared with 28% for stable sac (p = .007) and 37% for the sac expansion (p = .010) cohorts. After adjustment, sac expansion and stable sac cohorts were associated with greater all-cause mortality (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p = .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p = .019). CONCLUSION: In the ENGAGE Global Registry, one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings utilising data from vascular registries. Sac regression could become the new standard for success after EVAR.

The Fate of Patients Opportunistically Screened for Abdominal Aortic Aneurysms During Echocardiogram or Arterial Duplex Scans.

OBJECTIVE: To evaluate the long term outcomes of individuals who attended for transthoracic echocardiograms (TTEs) or lower limb arterial duplex scans (LLADS) and were opportunistically screened for abdominal aortic aneurysms (AAA). METHODS: Follow up of a prospective single centre pilot cohort study conducted between December 2012 and September 2014 at a tertiary vascular centre in the United Kingdom. Men and Women aged 65 and over were invited to undergo AAA screening when attending hospital for TTE or LLADS. Screening was performed by ultrasonographic examination of the abdomen at the end of their planned scans. AAA was defined as an abdominal aorta outer wall to outer wall anteroposterior diameter of 30 mm or more. Patients were excluded if they had a known AAA or previous abdominal aorta intervention. Follow up outcomes were evaluated in December 2020. RESULTS: 762 patients were enrolled in this study; 486 had TTE and 276 patients had LLADS. The overall incidence of AAA was 54 (7.1%) in the combined cohort, 25 (5.1%) in the TTE group, and 29 (10.5%) in the LLADS group. After a median 7.6 years, two of the 54 AAAs received intervention in the form of endovascular repair. Three others reached treatment threshold but were managed conservatively. The overall intervention rate was 3.7% of detected AAAs. Adjusted mortality rates in those with AAA vs. without was 64.8% and 36%, respectively (hazard ratio [HR] 2.02, p < .001). Diabetes (HR 1.35, p = .015) and older age (HR 1.18, p = .17) were the other factors associated with death. CONCLUSION: AAA is associated with a significantly increased mortality rate. Populations attending hospital for TTE or LLADS demonstrate a higher prevalence of AAA than population based screening; however, the proportion offered AAA intervention was low. Further research into opportunistic screening should target those more likely to undergo AAA repair, unless other interventions are demonstrated, to reduce the general increased mortality in AAA patients.

Predicting Prosthetic Mobility at Discharge From Rehabilitation Following Major Amputation in Vascular Surgery.

OBJECTIVE: This study aimed to construct a decision aid to estimate the likelihood of independence with a prosthesis following rehabilitation for limb loss secondary to advanced ischaemia (acute or chronic limb threatening ischaemia) or diabetic foot disease (DFD). A secondary aim was to determine whether prosthetic independence is a surrogate marker of long term survival. METHODS: A retrospective cohort study of a prospectively maintained database of unilateral amputations due to ischaemia or DFD entering rehabilitation between 2007 and 2020 was performed. Predictors of independent prosthetic mobility (IPM) were used in construction of the IPM prediction model, which underwent bootstrap internal and criterion validation through correlation with predictors of other measures of function: Timed Up and Go (TUG) and two minute walk test. Kaplan-Meier and Cox regression analyses were performed to address the secondary aim. RESULTS: Of the 771 patients included, only 49.9% of amputees achieved IPM. Independent negative predictors of IPM were age > 75 years, female sex, higher amputation level, active malignancy, cerebrovascular disease, end stage renal disease, and cognitive impairment. The model yielded high discrimination (C statistic 0.778), and internal validation was demonstrated with bootstrapping (C statistic 0.778), confirming no over optimism. There was a strong correlation between IPM, TUG, and two minute distance and their predictors, confirming strong criterion validity. The IPM group had a median survival of 93.7 (80.7, 105) months, whereas the non-IPM group fared worse with a median survival of 56.6 (48.5, 66.7) months (p < .001). CONCLUSION: An internally validated decision aid for estimating the likelihood of independence with a prosthesis after major amputation was constructed. A strong association between female sex and poorer prosthetic mobility was observed. Prosthetic function was shown to be a surrogate marker of long term survival. Future research will involve external validation studies to confirm the generalisability of the decision aid in clinical practice.

Association between statin-use and mobility and long-term survival after major lower limb amputation.

AIM: The aim of this study was to determine if there is an association between statin-use and prosthetic mobility and long-term survival in patients receiving rehabilitation after major amputation for lower limb arterial disease. METHODS: A retrospective analysis of prospectively maintained data (2008-2020) from a centre for rehabilitation was performed. Patients were grouped by statin-use status and sub-grouped by the combination of statin and antithrombotic drugs (antiplatelets or anticoagulants). Outcomes were prosthetic mobility (SIGAM score, timed-up-go and 2-min walking distance) and long-term survival. Regression, Kaplan-Meier and Cox-proportional hazard analyses were performed to test associations adjusted to confounders. RESULTS: Of 771 patients, 499 (64.7%) were on a statin before amputation or prescribed a statin peri-operatively. Rate of statin-use was significantly lower among female (53.3%) compared to male (68.2%) patients, P < 0.001. Statin-use was associated with significantly better prosthetic independence (53.1% vs 44.1%, P = 0.017), timed-up-go (mean difference of 4 s, P = 0.04) and long-term survival HR 0.59 (0.48-0.72, P < 0.001). Significance persisted after adjusting for confounding factors and in subgroup analyses. The combination of statin with antiplatelet was associated with the most superior survival, HR 0.51 (0.40-0.65, P < 0.001). Sensitivity analysis (exclusion of non-users of prosthesis) showed that statin-use remained a significant indicator of longer survival, maximally when combined with antiplatelet use HR 0.52 (0.39-0.68, P < 0.001). CONCLUSIONS: Statin-use is associated with better mobility and long-term survival in rehabilitees after limb loss, particularly when used in combination with antiplatelets. Significantly lower rates of statin-use were observed in female patients. Further research is warranted on gender disparities in statin-use and causality in their association with improved mobility and survival.

Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Multicenter Randomized Phase II Trial.

BACKGROUND: Patients with symptomatic internal carotid artery (ICA) stenosis are at high risk of recurrent ischemic stroke and require early interventional treatment and antiplatelet therapy. Increased bleeding rates might counterbalance the periprocedural efficacy of intensified platelet inhibition. We aim to investigate, whether Revacept, a competitive antagonist of glycoprotein VI, adjunct to standard antiplatelet therapy reduces the occurrence of ischemic lesions in patients with symptomatic ICA stenosis. METHODS: International, multicenter (16 sites), 3-arm, randomized (1:1:1), double-blind, and placebo-controlled study with parallel groups, including patients with symptomatic ICA stenosis. A single infusion over 20 minutes of either placebo, 40 mg or 120 mg Revacept in addition to guideline-conform antiplatelet therapy was evaluated with regard to the exploratory efficacy end point: Number of new ischemic lesions on diffusion-weighted magnetic resonance imaging after treatment initiation. Main clinical outcome was the combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up. RESULTS: Out of 160 randomized patients, 158 patients (68±10.1 years, 24% female) received study medication (51 patients placebo, 54 patients 40 mg Revacept and 53 patients 120 mg Revacept) and were followed for 11.2±2.3 months. A total of 1.16 (95% CI, 0.88-1.53)/1.05 (95% CI, 0.78-1.42; P=0.629)/0.63 (95% CI, 0.43-0.93) new diffusion-weighted magnetic resonance imaging lesions per patient were detected in the placebo/40 mg/120 mg Revacept groups, without statistical evidence of a difference. A reduction of the combined safety and efficacy end point during the study period was observed in patients who received 120 mg (HR, 0.46 [95% CI, 0.21-0.99]; P=0.047), but not 40 mg Revacept compared with placebo (HR, 0.72 [95% CI, 0.37-1.42]; P=0.343). CONCLUSIONS: Revacept 120 mg reduced the combined safety and efficacy end point in patients with symptomatic ICA stenosis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT01645306.

Optimal Management of Asymptomatic Carotid Stenosis in 2021: The Jury is Still Out. An International, Multispecialty, Expert Review and Position Statement.

OBJECTIVES: The recommendations of international guidelines for the management of asymptomatic carotid stenosis (ACS) often vary considerably and extend from a conservative approach with risk factor modification and best medical treatment (BMT) alone, to a more aggressive approach with a carotid intervention plus BMT. The aim of the current multispecialty position statement is to reconcile the conflicting views on the topic. MATERIALS AND METHODS: A literature review was performed with a focus on data from recent studies. RESULTS: Several clinical and imaging high-risk features have been identified that are associated with an increased long-term ipsilateral ischemic stroke risk in patients with ACS. Such high-risk clinical/imaging features include intraplaque hemorrhage, impaired cerebrovascular reserve, carotid plaque echolucency/ulceration/ neovascularization, a lipid-rich necrotic core, a thin or ruptured fibrous cap, silent brain infarction, a contralateral transient ischemic attack/stroke episode, male patients < 75 years and microembolic signals on transcranial Doppler. There is growing evidence that 80-99% ACS indicate a higher stroke risk than 50-79% stenoses. CONCLUSIONS: Although aggressive risk factor control and BMT should be implemented in all ACS patients, several high-risk features that may increase the risk of a future cerebrovascular event are now documented. Consequently, some guidelines recommend a prophylactic carotid intervention in high-risk patients to prevent future cerebrovascular events. Until the results of the much-anticipated randomized controlled trials emerge, the jury is still out regarding the optimal management of ACS patients.

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing.

BACKGROUND: Endovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS. METHODS: Data were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates. RESULTS: There were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n = 185), juxtarenal and suprarenal (n = 73), ruptured (n = 18), and iliac (n = 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years). Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture. CONCLUSIONS: EVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.

Editor's Choice - Assessment of Correlation Between Mean Size of Infrarenal Abdominal Aortic Aneurysm at Time of Intact Repair Against Repair and Rupture Rate in Nine Countries.

OBJECTIVE: This study aimed to analyse the mean abdominal aortic aneurysm (AAA) diameter for repair in nine countries, and to determine variation in mean AAA diameter for elective AAA repair and its relationship to rupture AAA repair rates and aneurysm related mortality in corresponding populations. METHODS: Data on intact (iAAA) and ruptured infrarenal AAA (rAAA) repair for the years 2010-2012 were collected from Denmark, England, Finland, Germany, Hungary, New Zealand, Norway, Sweden, and the USA. The rate of iAAA repair and rAAA per 100 000 inhabitants above 59 years old, mean AAA diameter for iAAA repair and rAAA repair, and the national rates of rAAA were assessed. National cause of death statistics were used to estimate aneurysm related mortality. Direct standardisation methods were applied to the national mortality data. Logistic regression and analysis of variance model adjustments were made for age groups, sex, and year. RESULTS: There was a variation in the mean diameter of iAAA repair (n = 34 566; range Germany = 57 mm, Denmark = 68 mm). The standardised iAAA repair rate per 100000 inhabitants varied from 10.4 (Hungary) to 66.5 (Norway), p<.01, and the standardised rAAA repair rate per 100 000 from 5.8 (USA) to 16.9 (England), p<.01. Overall, there was no significant correlation between mean diameter of iAAA repair and standardised iAAA rate (r2 = 0.04, p = .3). There was no significant correlation between rAAA repair rate (n = 12 628) with mean diameter of iAAA repair (r2 = 0.2, p = .1). CONCLUSION: Despite recommendations from learned society guidelines, data indicate variations in mean diameter for AAA repair. There was no significant correlation between mean diameter of AAA repair and rates of iAAA repair and rAAA repair. These analyses are subject to differences in disease prevalence, uncertainties in rupture rates, validations of vascular registries, causes of death and registrations.

Improving 1-Year Outcomes of Infrainguinal Limb Revascularization: Population-Based Cohort Study of 104 000 Patients in England.

BACKGROUND: The availability and diversity of lower limb revascularization procedures have increased in England in the past decade. We investigated whether these developments in care have translated to improvements in patient pathways and outcomes. METHODS: Individual-patient records from Hospital Episode Statistics were used to identify 103 934 patients who underwent endovascular (angioplasty) or surgical (endarterectomy, profundaplasty, or bypass) lower limb revascularization for infrainguinal peripheral artery disease in England between January 2006 and December 2015. Major lower limb amputations and deaths within 1 year after revascularization were ascertained from Hospital Episode Statistics and Office for National Statistics mortality records. Competing risks regression was used to estimate the cumulative incidence of major amputation and death, adjusted for patient age, sex, comorbidity score, indication for the intervention (intermittent claudication, severe limb ischemia without record of tissue loss, severe limb ischemia with a record of ulceration, severe limb ischemia with a record of gangrene/osteomyelitis), and comorbid diabetes mellitus. RESULTS: The estimated 1-year risk of major amputation decreased from 5.7% (in 2006-2007) to 3.9% (in 2014-2015) following endovascular revascularization, and from 11.2% (2006-2007) to 6.6% (2014-2015) following surgical procedures. The risk of death after both types of revascularization also decreased. These trends were observed for all indication categories, with the largest reductions found in patients with severe limb ischemia with ulceration or gangrene. Overall, morbidity increased over the study period, and a larger proportion of patients was treated for the severe end of the peripheral artery disease spectrum using less invasive procedures. CONCLUSIONS: Our findings show that from 2006 to 2015, the overall survival increased and the risk of major lower limb amputation decreased following revascularization. These observations suggest that patient outcomes after lower limb revascularization have improved during a period of centralization and specialization of vascular services in the United Kingdom.

Changing Patterns of Carotid Endarterectomy Between 2011 and 2017 in England.

Background and Purpose- Carotid endarterectomy (CEA) reduces the risk of stroke in recently symptomatic patients and less so in asymptomatic patients. Recent evidence suggests that the number of CEAs may be declining. The aim of this study was to investigate annual patterns of CEA in asymptomatic and symptomatic patients in England from 2011 to 2017. Methods- Data from the National Vascular Registry were used to describe (1) the number of CEA procedures in England and its 9 geographic regions from 2011 to 2017, (2) the characteristics of patients undergoing CEA, and (3) whether rates of CEA correlated with the number of vascular arterial units within each region. Annual stroke incidence for each region was derived from official population figures and the number of index stroke admissions per year. Results- The overall number of CEAs performed in England fell from 4992 in 2011 to 3482 in 2017, a 30% decline. Among symptomatic patients, there was a 25% decline, the number of CEAs falling from 4270 to 3217. In asymptomatic patients, there were 722 CEAs performed in 2011 and 265 in 2017, a 63% decline. CEAs per 100 000 adults within all regions declined over time but the size of change varied across the regions (range, 1.7-5.5 per 100 000). The regional numbers of CEAs per year were associated with changes in the regional stroke incidence, the proportion of CEAs performed in asymptomatic patients, and the number of hospitals performing CEA. Conclusions- This population-based study revealed a 63% decline in CEAs among asymptomatic patients between 2011 and 2017, possibly because of changing attitudes in the role of CEA. Reasons for the 25% decline in CEAs among symptomatic patients are unclear as UK guidelines on CEA have not changed for these patients. Whether the proportion of symptomatic patients with 50% to 99% ipsilateral stenosis has changed requires investigation.

Thresholds for Abdominal Aortic Aneurysm Repair in England and the United States.

BACKGROUND: Thresholds for repair of abdominal aortic aneurysms vary considerably among countries. METHODS: We examined differences between England and the United States in the frequency of aneurysm repair, the mean aneurysm diameter at the time of the procedure, and rates of aneurysm rupture and aneurysm-related death. Data on the frequency of repair of intact (nonruptured) abdominal aortic aneurysms, in-hospital mortality among patients who had undergone aneurysm repair, and rates of aneurysm rupture during the period from 2005 through 2012 were extracted from the Hospital Episode Statistics database in England and the U.S. Nationwide Inpatient Sample. Data on the aneurysm diameter at the time of repair were extracted from the U.K. National Vascular Registry (2014 data) and from the U.S. National Surgical Quality Improvement Program (2013 data). Aneurysm-related mortality during the period from 2005 through 2012 was determined from data obtained from the Centers for Disease Control and Prevention and the U.K. Office of National Statistics. Data were adjusted with the use of direct standardization or conditional logistic regression for differences between England and the United States with respect to population age and sex. RESULTS: During the period from 2005 through 2012, a total of 29,300 patients in England and 278,921 patients in the United States underwent repair of intact abdominal aortic aneurysms. Aneurysm repair was less common in England than in the United States (odds ratio, 0.49; 95% confidence interval [CI], 0.48 to 0.49; P<0.001), and aneurysm-related death was more common in England than in the United States (odds ratio, 3.60; 95% CI, 3.55 to 3.64; P<0.001). Hospitalization due to an aneurysm rupture occurred more frequently in England than in the United States (odds ratio, 2.23; 95% CI, 2.19 to 2.27; P<0.001), and the mean aneurysm diameter at the time of repair was larger in England (63.7 mm vs. 58.3 mm, P<0.001). CONCLUSIONS: We found a lower rate of repair of abdominal aortic aneurysms and a larger mean aneurysm diameter at the time of repair in England than in the United States and lower rates of aneurysm rupture and aneurysm-related death in the United States than in England. (Funded by the Circulation Foundation and others.).

Early results of endovascular aneurysm sealing with chimney grafts to treat juxtarenal and suprarenal abdominal aortic aneurysms.

BACKGROUND: The treatment of juxtarenal abdominal aortic aneurysms is challenging. Open surgical repair is not a viable option for many patients. The use of endovascular aneurysm sealing (EVAS) with chimney grafts (Ch-EVAS) has been proposed as an immediately available, off-the-shelf option for individuals with juxtarenal aneurysms who require urgent treatment or are unsuitable for fenestrated or branched devices. This study reports the outcomes from our first patients to undergo this procedure. METHODS: Data were collected prospectively for 62 consecutive patients undergoing Ch-EVAS at our institution. The procedures were undertaken for intact juxtarenal or suprarenal aneurysms in patients who were unfit for open repair or needed urgent treatment or when the aneurysm morphology was unsuitable for treatment with fenestrated or branched endografts. RESULTS: Between July 2013 and June 2016, there were 62 patients who were treated with Ch-EVAS; 77.4% were male, and the mean age was 73.9 years. Median aneurysm diameter was 64.5 mm. Eight suprarenal aneurysms were treated, with three chimney grafts. Of 54 juxtarenal aneurysms treated, 21 cases used two chimney grafts and 33 cases used one chimney graft. Median follow-up was 407 days. Eleven patients underwent reintervention. There were five type IA endoleaks, all successfully treated. One type IB and one type II endoleak occurred, neither requiring treatment. There were four minor strokes. Chimney patency is 97%. CONCLUSIONS: These results in a group of high-risk patients suggest that Ch-EVAS is a viable alternative to custom-made devices in patients who are unfit for open surgery. Longer term follow-up and data from the international registry will determine the widespread applicability and durability of this technique.

Midterm results of endovascular aneurysm sealing to treat abdominal aortic aneurysm.

BACKGROUND: Endovascular aneurysm sealing (EVAS) represents a novel approach to the treatment of abdominal aortic aneurysms. It uses polymer technology to achieve an anatomic seal within the sac of the aneurysm. This cohort study reports the early clinical outcomes, technical refinements, and learning curve during the initial EVAS experience at a single institution. METHODS: Results from 150 consecutive EVAS cases for intact, infrarenal abdominal aortic aneurysms are reported here. These cases were undertaken between March 2013 and July 2015. Preoperative, perioperative, and postoperative data were collected for each patient prospectively. RESULTS: The median age of the cohort was 76.6 years (interquartile range, 70.2-80.9 years), and 87.3% were male. Median aneurysm diameter was 62.0 mm (IQR, 58.0-69.0 mm). Adverse neck morphology was seen in 69 (46.0%) patients, including aneurysm neck length <10 mm (17.3%), neck diameter >32 mm or <18 mm (8.7%), and neck angulation >60 degrees (15.3%). Median follow-up was 687 days (IQR, 463-897 days); 37 patients (24.7%) underwent reintervention. The rates of unresolved endoleak are 1.3% type IA, 0.7% type IB, and 2.7% type I. There were no type III endoleaks. There have been seven secondary ruptures in this cohort; all but one of these patients survived after reintervention. Only one rupture occurred in an aneurysm that had been treated within the manufacturer's instructions for use (IFU). CONCLUSIONS: The rate of unresolved endoleaks is satisfactorily low. The incidence of secondary rupture is of concern; however, when the IFU are adhered to, the rate is very low. The results of this study suggest that working within the IFU yields better clinical results.

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

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.