Lesson Learned with the Use of Iliac Branch Devices: Single Centre 10 Year Experience in 157 Consecutive Procedures.

OBJECTIVE/BACKGROUND: Absence of an adequate iliac seal rarely represents an absolute contraindication to endovascular abdominal aortic aneurysm repair. Iliac branch devices (IBD) are increasingly used in patients with extensive aorto-iliac aneurysmal disease, but few data are available on the long-term results of these procedures. METHODS: Between 2006 and 2016, 157 consecutive IBD procedures performed at a single centre were entered into a prospective database. Indications included unilateral or bilateral common iliac artery aneurysms combined or not with abdominal aortic aneurysms. Long-term results were reported according to the Kaplan-Meier method. RESULTS: During the study period 149 patients were treated with an iliac branched endograft. Isolated IBD was implanted in 17.8% of the cases; technical success rate was 97.5%. Peri-operative procedure failure occurred in seven patients, four during surgery and three within 30 days of the procedure. Presence of ipsilateral hypogastric aneurysm (p = .031; Exp [B] = 6.72) and intervention performed during the initial study period (p = .006; Exp [B] = 10.40) were predictive of early failure on multivariate analysis. After a mean follow-up of 44.2 months actuarial freedom from IBD related re-intervention was 97.4%, 95.6%, 94.0%, and 91.8% at 1, 3, 5, and 9 years, respectively. Hypogastric artery patency was 94.7%, 92.6%, and 90.4% at 1, 3, and 10 years, respectively. Presence of a hypogastric aneurysm was an independent predictor of target artery occlusion during follow-up on multivariate analysis (p = .007; Exp [B] = 5.93). CONCLUSION: Iliac branched endografting can now be performed with a high technical success rate; long-term freedom from re-intervention is comparable with patients treated with standard aortic endografting. IBD should be considered a first-option treatment in patients with adequate vascular anatomy unsuitable for standard endovascular aortic repair.

Arbitrary Palliation of Ruptured Abdominal Aortic Aneurysms in the Elderly is no Longer Warranted.

OBJECTIVE/BACKGROUND: A consistent number of elderly patients with ruptured abdominal aortic aneurysms (rAAAs) are deemed unfit for repair and excluded from any treatment. The objective of this study was to examine the impact on survival of endovascular repair and open surgery with restricted turndown in acute AAA repair. METHODS: A prospective database for patients treated for rAAA was established. None of the patients admitted alive with rAAA were denied treatment. Multivariate regression models, the predictive risk assessment Glasgow Aneurysm Score (GAS), and subgroup analyses in older patients were applied to identify indicators of excessive 30 day mortality risk that could affect the decision for turndown. RESULTS: From 2006 to 2015, 113 consecutive patients (93 males; mean age 77.2 years) with rAAAs were treated (69 open surgery; 44 EVAR). Overall peri-operative (30 day) mortality was 38.9% (44/113): 40.6% (28/69), and 36.4% (16/44) after open surgery and EVAR, respectively (p = .70). Multivariate logistic regression identified old age as an indicator of increased peri-operative mortality (odd ratio [OR] 1.2, 95% confidence interval [CI] 1.1-1.3; p = .001), as well as free aneurysm rupture (OR 5.0, 95% CI 1.3-19.9; p = .02). GAS was higher in patients who died (97.75 vs. 86.62), but the score failed to identify increased peri-operative mortality risk in adjusted analyses (OR 1.0; p = .06). Almost two thirds of the patients (n = 71) were older than 75 at the time of aneurysm rupture (48.6% octogenarians) and EVAR was more commonly applied than open surgery (86.4% vs. 47.8%; p < .0001). Peri-operative mortality in > 75 year old patients was 46.5% compared with 26.2% in younger patients (p = .05), with rates increased after open surgery (54.5% vs. 27.8%, p = .03) but not after EVAR (39.5% vs. 16.7%; p = .39). According to Kaplan-Meier estimates, mean survival was 39.7 ± 4.8 months. Patients older than 75 years of age survived for a mean of 23.0 ± 4.47 months after rupture. CONCLUSION: In this study aggressive treatment with a very restricted or no turndown strategy for any rAAA, also applied to older patients, allowed for an additional mean 40 months of survival after aneurysm rupture. In the contemporary endovascular era the decision to deny repair arbitrarily to older patients with rAAAs must be revisited.

Safety of chronic anticoagulation therapy after endovascular abdominal aneurysm repair (EVAR).

OBJECTIVE: Current data supporting the effect of anticoagulation drug use on aneurysm sealing and the durability of endovascular abdominal aneurysm repair (EVAR) are conflicting. This study assessed the safety of chronic anticoagulation therapy after EVAR. METHODS: Records of 1409 consecutive patients having elective EVAR during 1997-2011 who were prospectively followed were reviewed. Survival, reintervention, conversion, and endoleak rates were analyzed in patients with and without chronic anticoagulants. Cox proportional hazards models were used to estimate the effect of anticoagulation therapy on outcomes. RESULTS: One-hundred and three (7.3%) patients were on chronic anticoagulation drugs (80 on vitamin K antagonists) at the time of EVAR. An additional 46 patients started on anticoagulants after repair were identified. Patients on chronic anticoagulation therapy at repair (mean age 73.6 years; 91 males) had more frequent cardiac disease (74.8% vs. 44.2%; p < 00001), but no other differences in demographic and major baseline comorbidities with respect to the others. At baseline, mean abdominal aortic aneurysm (AAA) diameter was 56.43 mm vs. 54.65 mm (p = .076) and aortic neck length 26.54 mm vs. 25.21 mm (p = .26) in patients with and without anticoagulants, respectively. At 5 years, freedom from endoleak rates were 55.5% vs. 69.9% (p < .0001), and freedom from reintervention/conversion rates were 69.4% vs. 82.4% (p < .0001) in patients with (including those with delayed drug use) and without chronic anticoagulants, respectively. Controlling for covariates with the Cox regression method, at a mean follow-up of 64.3 ± 45.2 months after EVAR, use of anticoagulation drugs was independently associated with an increased risk of endoleak (odds ratio, OR 1.6; 95% confidence interval, CI: 1.23-2.07; p < .0001) and reintervention or late conversion rates (OR 1.8; 95% CI: 1.31-2.48; p < .0001). CONCLUSIONS: The safety of anticoagulation therapy after EVAR is debatable. Chronic anticoagulation drug use risks exposure to a poor long-term outcome. A critical and balanced decision-making approach should be applied to patients with AAA and cardiac disease who may require prolonged anticoagulation treatment.

Effect of stentgraft model on aneurysm shrinkage in 1,450 endovascular aortic repairs.

BACKGROUND: Regression of the aneurysmal sac after endovascular repair of abdominal aortic aneurysm (AAA) is an accepted indicator of aneurysm exclusion. This study evaluated the spontaneous decrease in sac diameter over a 10-year period in patients undergoing endovascular aneurysm repair (EVAR) with different stentgrafts. METHODS: 1,450 patients (mean age 73.1 ± 7.7 years; 1,325 male) undergoing EVAR and with a minimum of 1-year computed tomography (CT) imaging were included. Different implanted stentgrafts (n = 622 [42.9%] Zenith, n = 236 [16.3%] AneuRx, n = 179 [12.3%] Talent, n = 83 [5.7%] Endurant, n = 236 [16.3%] Excluder, n = 36 [2.5%] Fortron, 53 [3.7%] Anaconda, n = 5 [0.3%] others) were employed. "Persisting shrinkage" was measured as ≥ 5 mm AAA diameter regression spontaneously persisting or increasing until the end of follow-up without reintervention. Persisting shrinkage among devices was compared with survival and Cox regression analyses. RESULTS: During a median follow-up of 45 months (interquartile range, IQR, 21-79) persisting shrinkage was detected in 768 (53%) aneurysms. Kaplan-Meier estimates of persisting shrinkage were 25.8% at 1 year, 63% at 3 years and 72.6% at 10 years. Persisting shrinkage rates were significantly higher for Zenith (p < .0001), Endurant (p = .013) and new generation Excluder (p < .0001) devices. Cox analyses confirmed that persisting shrinkage rates were independently associated with Zenith (OR 1.33; 95% CI: 1.176-1.514) and Endurant (OR 1.52; 95% CI: 1.108-2.092) stentgrafts and negatively associated with the AneuRx (OR 0.57; 95% CI: 0.477-0.688) device. Survival rates were higher in the persisting shrinkage group: 84.1% vs. 77.8% at 3 years, and 53% vs. 38.1% at 10 years (p < .0001). Freedom from AAA-related-death rate was 100% at 3 years and 99.7% at 10 years in the persisting shrinkage group. CONCLUSIONS: Aneurysm diameter shrinkage can be achieved in most current EVARs with persisting effect at 10 years from repair and indicates the benefit and safety of treatment. Last generation devices seem to be important factors in inducing aneurysm sac shrinkage with similar clinically relevant effects among single models.

Safety of carotid stenting (CAS) is based on institutional training more than individual experience in large-volume centres.

BACKGROUND: Operator training is a key factor for the safety of carotid stenting (CAS). Whether institutional practice is associated with improved individual operator outcomes is debated. OBJECTIVE: To evaluate the effect of the institutional experience on outcomes of new trainees with CAS, a retrospective analysis of a prospectively held database was performed. METHODS: The overall study period, 2004-2012, was divided into two sequential time frames: 2004-April 2006 (leaders-team phase) and May 2006-2012 (expanded team phase). In the first frame, a single leader-operators team that first approached CAS and passed the original institutional learning curve, performed all the procedures; in the following expanded-team phase, five new trainees joined. Institutional CAS training for new trainees was based on a team-working approach including selection of patients, devices and techniques and collegial meetings with critical review and discussion of all procedural steps and imaging. RESULTS: A total of 431 CAS procedures were performed in the leaders-team phase and 1026 in the sequential expanded-team phase. Periprocedural complication rates in the two time frames were similar: stroke/death (3.0% vs. 2.1%; P = 0.35), stroke (2.8% vs. 2.1%; P = 0.45) major stroke (0.9% vs. 0.6%, P = 0.49), death (0.2% vs. 0%; P = 0.29) during the leaders-team and expanded-team phase, respectively. However, rates of CAS failure requiring surgical conversions (3.7% vs. 0.8%; P < 0.0001) and mean contrast use (91.6 vs. 71.1 ml; P = 0.0001) decreased in the expanded phase. In the expanded-team frame (May 2006-2012), there was no mortality, and stroke rates were comparable between the leader and new operator teams: 2.6% vs. 1.2%; P = 0.17. CONCLUSIONS: Institutional experience, including instruction on selection of patients and materials best suited for the procedure, is a primary factor driving outcomes of CAS. An effective team-working approach can reliably improve the training of new trainees preserving CAS safety and efficacy.

No benefit from carotid intervention in fatal stroke prevention for >80-year-old patients.

BACKGROUND: Invasive management of patients ≥80 years of age with carotid stenosis may be questionable. The higher likelihood of stroke needs to be balanced with the increased perioperative risk and the reduced life expectancy of this ageing population. The purpose of this study was to evaluate the clinical relevance of carotid stenosis revascularisation in octogenarians. METHODS: All patients ≥80 years of age who received carotid revascularisation in 2001-2010 were reviewed for perioperative and 5-year outcomes. The experience was comprehensive of carotid endarterectomy (CEA) and carotid stenting (CAS) performed during the training frame when age was not a contraindication for this procedure. Mortality rates were compared to those of octogenarians of the same geographical territory according to all-cause and stroke-related mortality national statistics datasets. RESULTS: A total of 348 procedures performed in ≥80-year-old patients (272 males) were reviewed: 162 (46.6%) were by CAS and 169 (48.6%) were for symptomatic disease. Perioperative stroke/death rate was 5.5% and was non-significantly higher for symptomatic disease (7.1% vs. 3.9% asymptomatic; p = 0.24), after CAS (6.2% vs. 4.8% CEA; p = 0.64) and in females (6.6% vs. 5.1% males; p = 0.57). At median follow-up of 36.18 months, 95 deaths and 21 new ischaemic strokes (12 fatal) occurred with 5-year Kaplan-Meier freedom from stroke of 84.8% (78.7%, symptomatic vs. 90.3% asymptomatic; p = 0.003). According to national datasets, in 80-85-year-old resident population 5-year mortality was 29.9% (23.4% females, 40.6% males) and ischaemic stroke-related mortality was 14.9% (16.8% females, 13.0% males). Corresponding figures from treated population showed a 5-year mortality of 49.4%, higher in males (39.5% females, 52.5% males) and ischaemic stroke-related mortality of 20.2%, higher in females (40.0% females, 15.6% males). Comparing data from the study population with residents' figures, ischaemic stroke-related mortality hazard was significantly higher in the study females: odds ratio (OR) 3.2, 95% confidence interval (CI) 1.16-9.17; p = 0.029 (for males: OR 0.97, 95%CI 0.89-1.10; p = 0.99). CONCLUSIONS: Despite perioperative stroke/death risks being lower compared with CAS, the benefit of surgical carotid revascularisation in old patients remains controversial due to limited life expectancy and high fatality of stroke in this ageing population. Invasive treatment of carotid stenosis may not be warranted in most patients ≥80 years of age with carotid stenosis, especially when female and asymptomatic.

Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial.

BACKGROUND: Randomised trials have failed to demonstrate benefit from early surgical repair of small abdominal aortic aneurysm (AAA) compared with surveillance. This study aimed to compare results after endovascular aortic aneurysm repair (EVAR) or surveillance in AAA <5.5 cm. METHODS: Patients (50-79 years) with AAA of 4.1-5.4 cm were randomly assigned, in a 1:1 ratio, to receive immediate EVAR or surveillance by ultrasound and computed tomography (CT) and repair only after a defined threshold (diameter ≥5.5 cm, enlargement >1 cm /year, symptoms) was achieved. The main end point was all-cause mortality. Recruitment is closed; results at a median follow-up of 32.4 months are here reported. RESULTS: Between 2004 and 2008, 360 patients (early EVAR = 182; surveillance = 178) were enrolled. One perioperative death after EVAR and two late ruptures (both in the surveillance group) occurred. At 54 months, there was no significant difference in the main end-point rate [hazard ratio (HR) 0.76; 95% confidence interval (CI) 0.30-1.93; p = 0.6] with Kaplan-Meier estimates of all-cause mortality of 14.5% in the EVAR and 10.1% in the surveillance group. Aneurysm-related mortality, aneurysm rupture and major morbidity rates were similar. Kaplan-Meier estimates of aneurysms growth ≥5 mm at 36 months were 8.4% in the EVAR group and 67.5% in the surveillance group (HR 10.49; 95% CI 6.88-15.96; p < 0.01). For aneurysms under surveillance, the probability of delayed repair was 59.7% at 36 months (84.5% at 54 months). The probability of receiving open repair at 36 months for EVAR feasibility loss was 16.4%. CONCLUSION: Mortality and rupture rates in AAA <5.5 cm are low and no clear advantage was shown between early or delayed EVAR strategy. However, within 36 months, three out of every five small aneurysms under surveillance might grow to require repair and one out of every six might lose feasibility for EVAR. Surveillance is safe for small AAA if close supervision is applied. Long-term data are needed to confirm these results. CLINICAL TRIAL REGISTRATION INFORMATION: This study is registered, NCT Identifier: NCT00118573.

Second-generation thienopyridine use is not associated with better early perioperative outcome during carotid stenting.

OBJECTIVE: Management of anti-platelet therapy during carotid artery stenting (CAS) is mainly based on indirect evidence from coronary stenting experience. There is common agreement on the use of thienopyridine (mainly second-generation) during CAS, but some patients are unsuitable for clopidogrel treatment and data on the benefit of its use in large CAS populations are lacking. The aim of this study was to investigate whether clopidogrel was associated with reduced perioperative morbidity in patients undergoing CAS. METHODS: Consecutive patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of clopidogrel and perioperative morbidity was assessed using multivariable analysis. RESULTS: A total of 1083 patients were treated (29% females, mean age 71.6 years); 825 (76%) patients were given clopidogrel starting before treatment. Clopidogrel use was associated with a non-significant reduction of perioperative stroke/death (4.3% vs. 2.4%; p = 0.13) and disabling stroke (1.2% vs. 1.0%; p = 1) rates. The non-significant stroke/death difference was similar in symptomatic (5.8% vs. 4.0%, p = 0.37) and asymptomatic (3.7% vs. 1.9%; p = 0.17) patients. After adjusting for demographics, co-morbidities and other therapies with multivariable analysis, clopidogrel use failed to show any significant independent association in decreasing operative risks. The only independent protective factor was use of statins (p = 0.010). The additional use of dual anti-platelet therapy did not add any advantage to the use of clopidogrel alone. CONCLUSIONS: The suggested benefit of clopidogrel in decreasing the incidence of complications in patients undergoing CAS may be overestimated due to the overlapping effect of other more relevant factors (e.g., pleiotropy and plaque stabilisation from statins). More data and level I evidence are needed to understand which is the best medical management of CAS that will help improve outcomes of the procedure.

Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial.

OBJECTIVE: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1-5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. METHODS: Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. RESULTS: Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (-3.9 in EVAR, -6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. CONCLUSIONS: Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.

Functional ability in patients with critical limb ischaemia is unaffected by successful revascularisation.

OBJECTIVE: Patient- and society-oriented measures of outcome have a critical role in determining the effectiveness of any treatment in patients with critical limb ischaemia (CLI). In particular, the impact of an intervention on patient's dependency and functional performance is relevant but is largely unknown. The aim of the study was to investigate whether the limitations encountered in the activities of daily living (ADLs) measured with the Katz Index (KI) in patients with CLI were changed by the treatment. METHODS: During the period 2006-2008, 248 consecutive patients undergoing repair for CLI were investigated with an ADL questionnaire for assessing KI before and after a mean of 16.19 months from treatment. Changes in KI were stratified by type of treatment and outcome. RESULTS: There were 165 males and 83 females, mean age 73.3 ± 8.3 years; 125 patients showed tissue loss and 123 rest pain alone, 98 received surgical bypass and 150 endovascular repair. Pre-operative KI mean was 10.42. At the post-operative assessment, there was significant worsening in patients' functional outcome (mean KI decreased to 9.78) despite relief of pain (81.5%), tissue healing (72%), good vessel patency (83.8%) and low amputation rate (9.7%). Deterioration of KI was not significantly higher in patients undergoing endovascular repair. Patients receiving major amputation started with worse pre-operative functional score (KI mean 9.42) and did further deteriorate (KI mean 7.71) after demolition surgery. However, patients who received successful revascularisation showed deterioration in the dependence index. CONCLUSIONS: Successful vascular treatment is not associated with improved functional ability in patients with CLI, especially when already highly dependent in their activities. Large nationwide preventive and educational programmes should be implemented to prevent irreversible and severe health deterioration in populations with CLI.

Is haemodynamic depression during carotid stenting a predictor of peri-procedural complications?

OBJECTIVE: The clinical significance of Haemodynamic Depression (HD) during carotid stenting (CAS) remains unclear. The aim of this study was to analyze the frequency and predictors of HD during CAS in a single centre experience. METHODS: A prospective protocol for CAS was applied in a 15-month interval. Patients with restenosis, on betablockers, or with arrhythmias were excluded. A standardized dose of atropine (0.4mg) was given prior to stent deployment. Changes in heart rate, blood pressure, and neurological status were monitored and recorded. HD was defined as systolic pressure <90mmHg and/or heart rate <50 beats/min. Fifteen potential predictors of HD (age, gender, hypertension, smoking, diabetes, coronary artery disease, previous myocardial infarction, symptoms, degree of carotid stenosis contralateral CEA or CAS, calcified/hyperechoic plaque, plaque length, stent oversizing and type of stent) were tested in multivariate analysis. RESULTS: Two hundred and twenty three consecutive patients were enrolled. HD occurred in 98 cases (44%): in 68 cases HD required additional pharmacological support. At 30 days, any stroke rate was 3.1% (3 major and 4 minor), TIA rate 1.8%, myocardial infarction rate 0.4%. No deaths were recorded. No difference in complication rates were found in patients with or without HD. From regression analysis only the presence of calcified plaque (HR 9.5; 95% CI 5.0 to 18.2; p<0.0001) and the plaque length (HR 1.77; 95% CI 1.03 to 3.06; p=0.038) were associated significantly with HD. CONCLUSIONS: HD during CAS is a common, relatively benign event, without increased risk of peri-operative complications. Careful pharmacological treatment is necessary to decrease HD and the potential complications, especially in patients with more severe calcified lesions. These results require confirmation in a separate, larger cohort.

Does iron cause bacterial infections in patients with end stage renal disease?

Anemia management using erythropoietin and intravenous iron supplementation has improved the lives of many patients with end stage renal disease (ESRD). However, because iron is an essential nutrient for microorganisms, it is plausible that iron supplementation may promote infection. This review examines the literature on the connection between iron and infection, with a focus on the relevance of these data to hemodialysis patients treated according to the National Kidney Foundation--Dialysis Outcomes Quality Initiative (NKF-DOQI) Guidelines for Anemia Management. The current evidence does not show a cause-and-effect relationship between intravenous iron administration and an increased susceptibility to infection in hemodialysis patients. Therefore, the author does not recommend changing current iron management practices in ESRD patients because of concern about infectious risk.