Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

PURPOSE: The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). MATERIALS AND METHODS: This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. RESULTS: A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. CONCLUSION: In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. CLINICAL IMPACT: The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Prevalence, risk factors, and clinical effect of coronary artery disease in patients with asymptomatic bilateral carotid stenosis.

OBJECTIVE: In the present report, we have described the prevalence, risk factors, and clinical effects of coronary artery disease (CAD) for patients with asymptomatic bilateral carotid stenosis. METHODS: We conducted a single-center, retrospective cohort study of consecutive patients referred for bilateral carotid stenosis >70% (2014-2021). All the patients had undergone systematic coronary angiography. Depending on the anatomic and clinical characteristics, the patients had undergone combined carotid endarterectomy (CEA) plus coronary artery bypass grafting, coronary percutaneous intervention followed by CEA or carotid artery stenting (CAS), or staged bilateral CEA with cardiac best medical therapy. The cumulative 30-day stroke/myocardial infarction (MI) rate after cardiac and bilateral carotid interventions and long-term survival and freedom from cardiovascular mortality were assessed. RESULTS: A total of 167 patients with bilateral carotid stenosis >70% had undergone preoperative coronary angiography, identifying severe CAD in 108 patients (65.1%). Echocardiographic abnormalities (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.03-5.78; P = .04) and prior coronary intervention (OR, 11.94; 95% CI, 2.99-63.81; P = .001) were significantly associated with severe CAD. CAD was treatable in 91 patients (84%) and untreatable in 17 (16%). The cumulative MI rate was 4.8%; 5.6% for the patients with severe CAD and 1.7% for those without severe CAD (P = .262). The cumulative stroke rate was 1.8%; 1.8% for those with severe CAD and 1.7% for those without severe CAD (P = 1.00). The overall stroke/MI rate was 6.6%; 8.3% for those with severe CAD and 3.3% for patients without severe CAD (P = .33). Patients with severe CAD deemed untreatable for coronary bypass or percutaneous intervention had a higher risk of perioperative stroke/MI (OR, 1.24; 95% CI, 1.00-2.83; P = .04). At 10 years, overall survival was 67.1% (95% CI, 57%-79%), and freedom from cardiovascular mortality was 78.5% (95% CI, 69%-89%). Patients with untreatable CAD maintained a higher risk of 10-year mortality (hazard ratio, 5.5; 95% CI, 1.6-19.9; P < .01). CONCLUSIONS: In the present study, the prevalence of CAD in patients with bilateral carotid stenosis was high, especially for those with abnormal echocardiographic findings. CAD was potentially treatable in 80% of patients, and staged or simultaneous CAD treatment was performed with an acceptable stroke/MI complication rate for these patients. The presence of untreatable CAD was associated with worsened early and long-term outcomes, questioning the benefit of carotid interventions for this subset of patients.

Emergent In Situ Fenestration in the Ascending Aorta for the Endovascular Repair of a Large Pseudoaneurysm: A Technical Note.

PURPOSE: The purpose of this article is to describe an emergent in situ fenestration (ISF) technique in the ascending aorta for the endovascular repair of a large pseudoaneurysm using a trans-septal needle device through direct right common carotid artery access, in a patient with left ventricular assist device (LVAD). TECHNIQUE: We performed, in a multidisciplinary team-work approach, an emergent ISF to correct the displacement of a physician-modified thoracic endograft released in the ascending aorta to correct a large anastomotic pseudoaneurysm in a patient who underwent ascending aorta replacement and subsequent LVAD implantation. We used a trans-septal needle device inserted through a direct access to the right carotid artery and performed an ISF to restore the patency of the outflow ostium of the LVAD. Window was then completed and stabilized with a nitinol balloon expandable covered stent graft obtaining an effective exclusion of the anastomotic aortic aneurism and the regular patency of the LVAD outflow graft with no signs of leaks. CONCLUSIONS: Multidisciplinary teamwork approach can be crucial in challenging procedures where an alternative approach may lead to problem solving. The ISF technique may be a valid option to adopt in emergency cases in which no other technical solutions are suitable. CLINICAL IMPACT: The endovascular approach has become more and more frequent for the treatment of vascular pathologies, getting increasingly refined and complex. Thereby the chance of incurring intraprocedural troubles has grown and bailout strategies should always be present. In situ fenestration is a technique to be aware of and that could help you recover from difficult situations. We report a possible rescue maneuver that can be applied also in arduous anatomies such as the ascending aorta. Moreover, we would like to highlight the importance of a multidisciplinary working environment that can enrich our everyday practice accomplishing effective and unexpected solutions.

Thoracic Endovascular Aortic Repair Using the C-TAG® Device with ACTIVE CONTROL System.

OBJECTIVE: To describe our experience with the Gore® C-TAG® endograft with ACTIVE CONTROL System (ACS) (W.L. Gore & Associates, Inc., Flagstaff, AZ, USA) in thoracic aortic repair, focusing on deployment accuracy and aortic wall apposition. METHODS: All patients who underwent thoracic endovascular aortic repair (TEVAR) using the Gore® C-TAG® endograft with ACS from September 2017 to September 2021 were enrolled in a dedicated database and retrospectively analysed. We collected anatomic data on aortic arch angulation and tortuosity, proximal and distal landing zones, and the target for deployment accuracy. Proximal and distal deployment accuracies (PDA and DDA) were measured through intraoperative digital subtraction angiography (DSA), and postoperative computed tomography angiography (CTA) was required to define endograft apposition to the aortic wall. RESULTS: Twenty-eight patients who underwent TEVAR with the Gore® C-TAG® with ACS at our institution were selected for this study: 46% presented with a type 3 aortic arch and a proximal landing zone < 3 was used in 53% of cases. Mean PDA and DDA were 1.89 ± 3.5 mm and 0.6 ± 1.4 mm, and were obtained in 93% and 100% of procedures, respectively. Mean proximal and distal wall apposition were 91 ± 17% and 98 ± 5.9%. Fifteen patients required an associated planned procedure, either to revascularize supra-aortic vessels when PLZ was < 3 or to assure optimal distal fixation with EndoAnchors™ (Medtronic, Minneapolis, MN, USA) delivery in selected cases. Two patients required reintervention during the same hospitalisation because of type 1a endoleak onset. No further reinterventions were needed during follow-up. CONCLUSIONS: Our single-centre analysis found promising results using the Gore® C-TAG® with ACS, with an optimal accuracy in deployment and wall apposition at both proximal and distal landing zones.

Propensity-Matched Comparison for Carotid Artery Stenting in Primary Stenosis Versus after Carotid Endarterectomy Restenosis.

BACKGROUND: Carotid artery stenting (CAS) has been proposed as the treatment of choice in case of restenosis (RES) after carotid endarterectomy (CEA). The aim of this study was to analyze periprocedural results of CAS for the treatment of post-CEA RES compared with those of CAS performed for primary carotid stenosis (PRS). METHODS: Data from consecutive patients submitted to CAS at our institution from 2008 to 2016 were retrospectively reviewed. Patients with in-stent RES were excluded. Initially, preoperative risk factors, demographics, intraoperative variables, and perioperative outcomes were analyzed according to the indication groups (PRS and RES). Then, propensity score matching was performed obtaining 2 homogeneous groups of patients. Covariates included were age, gender, hypertension, hyperlipidemia, cardiac disease, chronic renal disease, symptomatic carotid plaque, and positive ipsilateral brain computed tomography scan. Intraoperative data and perioperative outcomes were then compared between the 2 matched groups. RESULTS: Of 480 included patients, 300 (62.5%) underwent CAS for PRS, and 180 (37.5%) for RES. After propensity score analysis (158 patients/group), no significant difference was observed in terms of technical success, number, and type of stent used, except for need of intraoperative atropine administration that was higher in the PRS group (38.6% vs. 13.3%, respectively; P < 0.001). In the perioperative period, composite neurologic event was significantly higher in the PRS group (7.6% vs. 1.9%; P = 0.017). Moreover, need of ionotropic support was higher in the PRS group (8.9% vs. 1.9%; P = 0.0069). Myocardial infarction rate and 30-day mortality were similar in both groups (P = 0.317; P = 1, respectively). CONCLUSIONS: In a large single-center experience, CAS for post-CEA RES was associated with a significantly lower risk of any neurologic event and hemodynamic instability in the perioperative period compared with CAS performed for primary carotid lesions. Our results confirm that post-CEA RES may represent an elective indication for CAS.

Fracture of a Supera Interwoven Nitinol Stent After Treatment of Popliteal Artery Stenosis.

PURPOSE: To present a Supera stent fracture following treatment of popliteal artery stenosis. CASE REPORT: A 60-year-old man previously treated with angioplasty/stenting of a popliteal artery lesion with a Supera stent presented at 8 months with in-stent occlusion that proved to be secondary to stent fracture. CONCLUSION: Supera interwoven nitinol stents, despite having higher radial force and conformability than classic tube stents, are not free from fracture. Moreover, due to their peculiar structure, a break in these stents results in complete loss of integrity and consequent device collapse, thus jeopardizing endovascular recanalization and relining.

Standardized approach for four-fenestrated physician-modified endograft to treat complex abdominal aortic aneurysms using Valiant Captivia.

We describe the feasibility and safety of a standardized approach for four-fenestrated physician-modified endograft (PMEG) placement to treat complex abdominal aortic aneurysms using the Valiant Captivia platform (Medtronic). The standardization is based on specific selection criteria for anatomical feasibility, measurement method, and modification technique of a single endograft type. Six cases (two juxtarenal, two pararenal, and two type IV thoracoabdominal aneurysms) were treated, with 24 target vessels incorporated with fenestrations. Four cases were treated in an urgent setting and two were elective. The time modification required was 121 ± 18 minutes. Technical success was 100%, with no mortality or complications at 30 days. Postoperative computed tomography at 3 months demonstrated complete aneurysm exclusion, without a type I or III endoleak, no main graft- or fenestration-related loss of integrity, and no target vessel misalignment or stent fracture. The present standardized approach seems safe and feasible and might represent an initial benchmark for comparison with future studies.

Technical tips and clinical experience with the Nexus Endospan arch branch stent-graft.

Aortic arch pathologies are commonly treated by open surgery which is still the gold standard. Patients that are unfit for surgery can be effectively treated mini-invasively with novel endovascular endograft specifically designed for the arch. Endovascular technology has remarkably improved in recent years and is a valid alternative option for the treatment of aortic arch. Available endografts on the market include fenestrated and branched (single, double, or triple). Most endograft designed for the aortic arch are custom-made and production time could be limiting. The aim of this study is to report our experience with the only single branch bi-modular off-the shelf device available on the market specifically designed for aortic arch aneurysms and dissections. We perform endovascular treatment of the arch in a multidisciplinary team together with dedicated anesthesiologist team, interventional cardiologists, and cardiac surgeons. Prior to the implantation of the endograft, a debranching procedure must be made to redirect the blood from brachiocephalic trunk (BCT) to the left common carotid artery and left subclavian artery. A through and through system from the right axillary artery to the femoral artery is required to deploy the main module. The ascending module is delivered over an extra stiff guidewire placed in the left ventricle. Molding of the endografts is performed with kissing balloon in rapid pacing. We performed 8 cases. Six of them came to our attention for residual dissection and has already been treated with ascending aorta replacement. Mean aortic diameter was 63 mm. All patients required complete debranching of the supra-aortic vessel and received a right common carotid -left subclavian artery bypass with reimplantation of the left common carotid artery on the graft. Timing of the debranching was a few days before the endovascular procedure in 76% of cases. Technical success of the endovascular intervention occurred in 100% of cases. In 2 cases the target supra-aortic trunk for the deployment of the main module BCT branch was the left subclavian artery with no adverse event related to this variation. No intraoperative adjunctive maneuvers have been registered, left subclavian artery have been embolized during the procedure in 5 cases. No access complications have been reported. We experienced 1 case of major stroke with permanent neurological impairments that lead to worsening of clinical condition and death at 6 months. No cardiological adverse event have been registered. Two cases of type 2 endoleak have been reported and required reintervention with embolization of the LSA. At 1 year follow-up no aorta-related adverse event has been reported. The use of this off-the-shelf device for the treatment of aortic arch pathologies requiring total debranching of the supra-aortic vessels seems to be safe and effective. Preliminary results are promising despite available data are insufficient and further data collection is mandatory.

Groin Surgical Site Infection in Vascular Surgery: Systemic Review on Peri-Operative Antibiotic Prophylaxis.

OBJECTIVES: Surgical site infections (SSIs) in lower extremity vascular surgeries, post-groin incision, are not only common complications and significant contributors to patient mortality and morbidity, but also major financial burdens on healthcare systems and patients. In spite of recent advances in pre- and post-operative care, SSI rates in the vascular surgery field remain significant. However, compliant antibiotic therapy can successfully reduce the SSI incidence pre- and post-surgery. METHODS: In October 2021, we conducted a systematic literature review using OVID, PubMed, and EMBASE databases, centered on studies published between January 1980 and December 2020. The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta Analyses checklist. Inclusion/exclusion criteria have been carefully selected and reported in the text. For analyses, we calculated 95% confidence intervals (CI) and weighted odds ratios to amalgamate control and study groups in publications. We applied The Cochrane Collaboration tool to assess bias risk in selected studies. RESULTS: In total, 592 articles were identified. After the removal of duplicates and excluded studies, 36 full-texts were included for review. CONCLUSIONS: The review confirmed that antibiotic therapy, administered according to all peri-operative protocols described, is useful in reducing groin SSI rate in vascular surgery.

The Orthopedic-Vascular Multidisciplinary Approach Improves Patient Safety in Surgery for Musculoskeletal Tumors: A Large-Volume Center Experience.

Objective: Wide-margin resection is mandatory for malignant bone and soft tissue tumors. However, this increases the complexity of resections, especially when vessels are involved. Patients in this high-risk clinical setting could be surgically treated using the multidisciplinary orthopedic-vascular approach. This study was carried out in this healthcare organization to evaluate patient safety in term of oncologic outcomes and reduction of the complication rate. Materials and Methods: We retrospectively reviewed 74 patients (37 males, 37 females; mean age 46 years, range 9-88) who underwent surgical excision for bone/soft tissue malignant tumors closely attached to vascular structures from October 2015 to February 2019. Vascular surgery consisted of isolation of at least one vessel (64 patients), bypass reconstruction (9 patients), and end-to-end anastomosis (1 patient). Mean follow-up was 27 months. Patients' demographics, tumor characteristics, adjuvant treatments, type of orthopedic and vascular procedures, and oncologic and functional outcomes and complications were recorded. Results: Overall survival was 85% at 3 years follow-up. In total, 22 patients experienced at least one major complication requiring further surgery and 13 patients experienced at least one minor complication, whereas 17 reported deviations from the normal postoperative course without the need for pharmacological or interventional treatment. Major complications were higher in pelvic resections compared to limb-salvage procedures (p = 0.0564) and when surgical time was more than 4 h (p = 0.0364) at univariate analysis, whereas the most important multivariate independent predictors for major complications were pelvic resection (p = 0.0196) and preoperative radiotherapy (p = 0.0426). Conclusions: A multidisciplinary ortho-vascular approach for resection of malignant bone and soft tissue tumors tightly attached to important vascular structures should be considered a good clinical practice for patient safety.