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.

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.

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.

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.

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.

Amputation of the Unsalvageable Leg in Vascular Patients with Cancer.

OBJECTIVES: The aim of this study was to compare outcomes of major lower limb amputation (MLA) in patients with and without cancer and with cancer patients receiving palliation over amputation for their unsalvageable limb. METHODS: Cancer patients who underwent a major amputation or palliation between 2013 and 2018 were included. Comparison groups were cancer-MLA (active/managed cancers), non-cancer MLA (historic cancer or no cancer history) and cancer-palliation at presentation with unsalvageable limbs. Prospectively collected data was retrospectively analysed for outcomes including survival, postoperative complications, length of stay, suitability for rehabilitation and discharge destination. RESULTS: 262 (cancer and non-cancer) patients underwent MLA and 18 patients with cancer received palliation. Of those amputated, 26 (9.9%) had active or managed cancer, of which 12 were diagnosed in the 6 months before MLA. Cancer-MLA patients presented with more acute ischaemia compared to non-cancer patients. Median survival was significantly different between the cancer-MLA (14.1 [9.5 - 29.5, 95% CI] months), non-cancer MLA (57.7 [45 - 73.6, 95% CI] months) and cancer-palliation (.6 [.4 - 2.3, 95% CI] months) groups, P < .001. A significantly higher proportion of cancer-MLA patients (10/26, 38.5%) were deemed unsuitable for rehabilitation in post-operative assessment compared to non-cancer MLA (21/236, 8.9%) patients, P < .001. There was a variation in destinations of discharge, with a greater proportion of cancer-MLA patients (4/26, 15.4%) going to a nursing home compared to non-cancer MLA (10/236, 4.2%) patients, P = .016. CONCLUSION: Cancer is prevalent among vascular amputees, with a large proportion being occult diagnoses. Cancer is associated with poorer outcomes following amputation, but survival remains significantly better compared to palliation in cancer patients presenting with unsalvageable limbs.

A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat®, for the Management of Bleeding in Elective Carotid Artery Surgery.

Anastomotic bleeding in vascular surgery can be difficult to control. Patients, in particular those undergoing carotid surgery, have often been started on treatment with dual antiplatelet agents and receive systemic heparinization intraoperatively. The use of local hemostatic agents as an adjunct to conventional methods is widely reported. 3-D Matrix's absorbable hemostatic material RADA16 (PuraStat®), is a fully synthetic resorbable hemostatic agent. The aim of this study is to confirm the safety and performance of this agent when used to control intraoperative anastomotic bleeding during carotid endarterectomy (CEA). A prospective, single-arm, multicenter study involving 65 patients, undergoing CEA, in whom the hemostatic agent was applied to the suture line after removal of arterial clamps. Patients were followed up at 24 h, discharge, and one month after surgery. Time to hemostasis was measured as the primary endpoint. Secondary endpoints included hemostasis efficacy and safety outcomes, blood loss, intraoperative and postoperative administration of blood products, and incidence of reoperation for bleeding. A total of 65 cases (51 male and 14 female) undergoing CEA, utilizing patch reconstruction (90. 8%), eversion technique (6.1%), and direct closure (3.1%) were analyzed. All patients received dual antiplatelet therapy preoperatively and were administered systemic intravenous heparin intraoperatively, as per local protocol. The mean time to hemostasis was 83 s ± 105 s (95% CI: 55-110 s). Primary hemostatic efficacy was 90.8%. The mean volume of product used was 1.7 mL ± 1.1 mL. Hemostasis was achieved with a single application of the product in 49 patients (75.3%). Two patients required a transfusion of blood products intraoperatively. There were no blood product transfusions during the postoperative period. The intraoperative mean blood loss was 127 mL ± 111.4 mL and postoperatively, the total mean drainage volume was 49.0 mL ± 51.2 mL. The mean duration of surgery was 119 ± 35 min, and the mean clamp time was 35 min 12 s ± 19 min 59 s. In 90.8% of patients, there was no presence of hematoma at 24 h postoperatively. Three returned to theatre due to bleeding (2 in the first 24 h), however, none of these cases were considered product related. Overall, there were no device-related serious adverse events (SAE) or unanticipated device-related SAEs reported. Use of the hemostatic agent PuraStat® is associated with a high rate of hemostatic efficacy (90.8%) and a short time to hemostasis. The safety of the product for use on vascular anastomoses has been demonstrated.

Optimal periprocedural antithrombotic treatment in carotid interventions: An international, multispecialty, expert review and position statement.

BACKGROUND: The optimal antithrombotic (antiplatelet or anticoagulant) treatment of patients undergoing extracranial carotid artery interventions is a subject of debate. The aim of this multidisciplinary document was to critically review the recommendations of current guidelines, taking into consideration the results of recently published studies. METHODS: The various antithrombotic strategies reported were evaluated for asymptomatic and symptomatic patients undergoing extracranial carotid artery interventions (endarterectomy, transfemoral carotid artery stenting [CAS] or transcarotid artery revascularization [TCAR]). Based on a critical review, a series of recommendations were formulated by an international expert panel. RESULTS: For asymptomatic patients, we recommend low-dose aspirin (75-100 mg/day) or clopidogrel (75 mg/day) with the primary goal to reduce the risk of myocardial infarction and cardiovascular event rates rather than to reduce the risk of stroke. For symptomatic patients, we recommend dual antiplatelet treatment (DAPT) initiated within 24 h of the index event to reduce the risk of recurrent events. We suggest that following transfemoral CAS or TCAR, patients continue DAPT for 1 month after which a single antiplatelet agent is used. High level of evidence to support anticoagulant treatment for patients with carotid artery disease is lacking. CONCLUSIONS: The antithrombotic treatment offered to carotid patients should be individualized, taking into account the presence of symptoms, the type of intervention and the goal of the treatment. The duration and type of DAPT (ticagrelor instead of clopidogrel) should be evaluated in future trials.

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.

Benefits and drawbacks of statins and non-statin lipid lowering agents in carotid artery disease.

International guidelines strongly recommend statins alone or in combination with other lipid-lowering agents to lower low-density lipoprotein cholesterol (LDL-C) levels for patients with asymptomatic/symptomatic carotid stenosis (AsxCS/SCS). Lowering LDL-C levels is associated with significant reductions in transient ischemic attack, stroke, cardiovascular (CV) event and death rates. The aim of this multi-disciplinary overview is to summarize the benefits and risks associated with lowering LDL-C with statins or non-statin medications for Asx/SCS patients. The cerebrovascular and CV beneficial effects associated with statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statin lipid-lowering agents (e.g. fibrates, ezetimibe) are reviewed. The use of statins and PCSK9 inhibitors is associated with several beneficial effects for Asx/SCS patients, including carotid plaque stabilization and reduction of stroke rates. Ezetimibe and fibrates are associated with smaller reductions in stroke rates. The side-effects resulting from statin and PCSK9 inhibitor use are also highlighted. The benefits associated with lowering LDL-C with statins or non-statin lipid lowering agents (e.g. PCSK9 inhibitors) outweigh the risks and potential side-effects. Irrespective of their LDL-C levels, all Asx/SCS patients should receive high-dose statin treatment±ezetimibe or PCSK9 inhibitors for reduction not only of LDL-C levels, but also of stroke, cardiovascular mortality and coronary event rates.

Comparison of Recent Practice Guidelines for the Management of Patients With Asymptomatic Carotid Stenosis.

Despite the publication of several national/international guidelines, the optimal management of patients with asymptomatic carotid stenosis (AsxCS) remains controversial. This article compares 3 recently released guidelines (the 2020 German-Austrian, the 2021 European Stroke Organization [ESO], and the 2021 Society for Vascular Surgery [SVS] guidelines) vs the 2017 European Society for Vascular Surgery (ESVS) guidelines regarding the optimal management of AsxCS patients.The 2017 ESVS guidelines defined specific imaging/clinical parameters that may identify patient subgroups at high future stroke risk and recommended that carotid endarterectomy (CEA) should or carotid artery stenting (CAS) may be considered for these individuals. The 2020 German-Austrian guidelines provided similar recommendations with the 2017 ESVS Guidelines. The 2021 ESO Guidelines also recommended CEA for AsxCS patients at high risk for stroke on best medical treatment (BMT), but recommended against routine use of CAS in these patients. Finally, the SVS guidelines provided a strong recommendation for CEA+BMT vs BMT alone for low-surgical risk patients with >70% AsxCS. Thus, the ESVS, German-Austrian, and ESO guidelines concurred that all AsxCS patients should receive risk factor modification and BMT, but CEA should or CAS may also be considered for certain AsxCS patient subgroups at high risk for future ipsilateral ischemic stroke.