High-on-treatment platelet reactivity predicts adverse outcome after carotid artery stenting: A prospective study.

BACKGROUND AND PURPOSE: High-on-treatment platelet reactivity (HTPR) has been established as a predictor of major adverse cardiovascular events (MACE) in patients undergoing percutaneous coronary interventions on dual antiplatelet therapy (DAPT), but no data are available on its predictive value in patients on DAPT after carotid artery stenting (CAS). We aimed to evaluate the possible association between HTPR in patients on aspirin plus clopidogrel therapy after CAS and subsequent MACE. METHODS: All consecutive patients treated with CAS in a single institution were enrolled in a prospective clinical study. HTPR was evaluated with 5 different laboratory assays carried out just before CAS. MACE incidence (cerebral ischemia, myocardial infarction, stent thrombosis, acute limb ischemia and vascular death) was evaluated at 30 days and thereafter at yearly visits. RESULTS: A total of 300 patients were enrolled in the study, and eight were then excluded because blood samples resulted unsuitable for the laboratory testing or CAS aborted for technical problems. Median follow-up was 5.8 years and during this period 47 MACE occurred. HTPR detected by multiplate electronic aggregometry (MEA) and the VASP phosphorylation assay (VASP) were associated with a significantly enhanced risk of MACE (p = 0.048 and p = 0.038, respectively). However, HTPR to three tests (HTPR3) was more strongly predictive of increased risk of a vascular event at follow up (p = 0.005) at bivariate analysis and also at Cox regression multivariate analysis (p = 0.002). CONCLUSIONS: HTPR to three different assays (mainly to VASP + PFA P2Y+ VerifyNow) in patients on DAPT after CAS has predictive value for subsequent MACE. Prospective studies to assess whether platelet function testing-guided antiplatelet therapy is superior to standard DAPT in patient undergoing CAS should be considered.

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.

Current results of total endovascular repair of thoracoabdominal aortic aneurysms.

Minimally invasive surgical solutions for patients with extensive aortic disease are eagerly awaited, since open repair is often associated with high rates of morbidity and mortality. In the last decade, the development of fenestrated and branched aortic endografts has offered a therapeutic option to patients deemed unsuitable for major surgery. Preliminary studies showed promising early results, while mid- and long- term data are scarce. The aim of this paper was to review current results of total endovascular repair of thoracoabdominal aortic aneurysms (TAAA) with a single model of endograft in the published literature. A literature search was conducted, and our two-center experience with fenestrated and branched endografts in the treatment of TAAA, with the Cook Zenith endograft, is presented. Early results show perioperative mortality rates ranging from 0% to 21%, spinal cord ischemia from 0% to 33.3%. At a mean follow up ranging from 9 to 19 months, reinterventions are needed in 3.3% to 25% of the cases, with a mid term visceral branch patency of 90% to 100%. Current experiences with total endovascular TAAA repair show promising results, in selected centers with large experience in complex aortic endografting. With increasing follow- up times, need for reintervention is growing, while aneurysm-related deaths remain rare. Long-term results are still lacking, but these encouraging data and further technological developments will support wider adoption of the technique.

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.

Plaque debulking for femoro-popliteal occlusions: techniques and results.

Although currently there is a trend of using percutaneous transluminal angioplasty (PTA) and stenting for the treatment of long occlusions of superficial femoral artery, many studies reported comparable results in terms of mid- and long-term patency between PTA and stenting and plaque debulking techniques such as remote endarterectomy, directional atherectomy catheter atherectomy and laser guided atherectomy. A successful debulking procedure is strongly associated with patients comorbidities, length of lesions and clinical presentation. In the last decade many new devices have been proposed to improve debulking results. Despite encouraging data about technical feasibility and limb salvage rate, debulking is still associated with a low rate of long-term primary and secondary patency. However, randomized clinical trials are expected and can hopefully provide conclusions on the effective durability of these procedures.

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.

Results of the "endovascular treatment first" policy for infrapopliteal disease.

Even though differences between first-bypass vs. first-endovascular approach in below the knee (BTK) lesions have never been adequately compared, endovascular strategy first approach can be currently successfully used to treat BTK lesions in patients with critical limb ischemia (CLI). Success however is strongly associated with risk groups, severity of disease and degree of clinical presentation beside the method of revascularization. From available data, the best results of endovascular first approach for BTK lesions can be achieved with multivessel and tibial (more than peroneal alone) recanalization and Rutherford 4 or 5 ischemia changes, especially if the correct angiosome can be revascularized (direct flow to the feeding artery of the foot) and there is no renal failure. For patients in Rutherford class 6 and extensive gangrene/tissue loss, BTK endovascular strategy alone does not seem to provide ideal results. Outcomes of interventional therapy for BTK lesions are consistently better when applied in experienced centers with the use of more advanced technology and use of eluting materials. According to limited but randomized evidence, drug-eluting stent (DES) placement might be recommended in BTK lesions under 40 mm long since yields significantly better results than angioplasty alone or implantation of bare metal stents in this lesion subset. Nevertheless, this policy raises doubts on the efficacy of treatment due to limitations in generalizability of outcomes in common hospital settings and related costs. Furthermore, there are still no consistent numbers to provide the efficacy of this approach and long-term data are lacking. Waiting for the long-term results of ongoing trials and new researches, a more comprehensive analysis of outcomes with BTK endovascular first strategy can be provided in the next future.