The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms.

An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta that progressively grows until it ruptures. Treatment is typically recommended when the diameter is more than 5 cm. The EVAR (Endovascular aneurysm repair) is a minimally invasive procedure that involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. For years, stent grafts' essential design was based on metallic stent frames to support the fabric. More recently, a polymer-based technology has been proposed as an alternative method to seal AAA. This review underlines the two platforms that are based on a polymer technology: (1) the polymer-filled endobags, also known as Endovascular Aneurysm Sealing (EVAS) with Nellix stent graft; and (2) the O-ring EVAR polymer-based proximal neck sealing device, also known as an Ovation stent graft. Polymer characteristics for this particular aim, clinical applications, and durability results are hereby summarized and commented critically. The technique of inflating endobags filled with polymer to exclude the aneurysmal sac was not successful due to the lack of an adequate proximal fixation. The platform that used polymer to create a circumferential sealing of the aneurysmal neck has proven safe and effective.

Mini-Skin Incision for Carotid Endarterectomy: Neurological Morbidity and Health-related Quality of Life.

BACKGROUND: Cranial and cervical nerve (CCN) injury is recognized as a possible complication after carotid endarterectomy (CEA), which may result in minor local neurologic deficiencies and significant discomfort for the patient. The aim of this study is to investigate the effect of a mini-skin incision (<5 cm) on the CCN injury after CEA in comparison to standard longitudinal incision of 12-15 cm in a high volume center, and to evaluate health-related quality of life (HRQOL) outcomes in those patients who had undergone both types of the skin incision. METHODS: From January 2013 to December 2019, 446 CEAs (47.3%) were performed through a standard neck incision of 12-15 cm (group A), while 496 (52.7%) were performed through a mini-skin incision (<5 cm) (group B). Sixty-two patients underwent standard neck incision on one side and mini-skin incision on the other side (subgroup B). The main outcome measures were stroke, death, CCN injuries, cervical hematoma rates, and reinterventions. The HRQOL was assessed at baseline and after 30 days using Medical Outcomes Study Short-Form 36 and 6 disease-specific modified Likert scales. RESULTS: The stroke and death rate at 30 days was 1.12% in group A and 1% in group B (P = 1). The incidence of CCN deficits was significantly lower in group B (5.1%) in comparison to group A (13.4%) (P < 0.001). The cervical hematoma was more common after standard incision (4.9% vs. 1.2%, P = 0.02). HRQOL at 1 month showed that the outcomes after mini-skin incision were significantly better for less difficulty with eating/swallowing and neck pain (P < 0.01). CONCLUSIONS: CEA through a small incision (<5 cm) may reduce CCN complications without additional perioperative neurologic risks. As validated by patients with bilateral disease who experienced both surgical techniques, mini-skin incision is also associated with better HRQOL at 1 month, particularly with regard to eating/swallowing and neck pain.

Midterm outcomes of 71 consecutive abdominal aortic aneurysm patients treated with the TREO stent-graft in a single center.

BACKGROUND: Endovascular repair of abdominal aortic aneurysm (EVAR) presents an increasing role in treatment of abdominal aortic aneurysms in patients at high and mid risk for conventional surgery. Most Vascular Surgery Units need to identify a single device as workhorse in AAA treatment. Objective of this study is to analyze midterm results of consecutive unselected patients treated with the same device in a single center series. METHODS: A retrospective analysis of a prospective database of all consecutive patients treated between January 2016 and June 2019 with the TREO device in our center. Primary outcomes of the study were AAA related mortality rate, migration rate and type 1 endoleak at 1-year follow-up. RESULTS: During the study period 71 consecutive patients (96% male) were treated with TREO device. Technical success was achieved in all patients. Mean follow-up was 19.6 months (range: 1-42 months). Procedure related mortality was 1.4% (N.=1), No AAA related mortality, migration or type 1b endoleak were recorded during follow-up. Two cases of late type 1a endoleak were recorded, both resolved with aortic cuffing. Median shrinkage of the residual sac was 10% and 18.5% at 6 and 18 months, respectively. CONCLUSIONS: EVAR using TREO device seems to be safe and effective treatment for unselected patients suffering AAA. Particularly this device seems to be suitable as workhorse device in a single center with skillness between open and endovascular techniques.

The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft.

OBJECTIVE: In cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft. METHODS: A single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported. RESULTS: Overall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years. CONCLUSIONS: The described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints.

A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft.

OBJECTIVE: The objective of this study was to compare outcomes of patients with favorable neck angulation (FNA) and hostile neck angulation (HNA) treated with the Treovance stent graft (Terumo Aortic [formerly Bolton Medical], Sunrise, Fla). METHODS: Patients with abdominal aortic aneurysms suitable for endovascular repair with Treovance were included in the RATIONALE postmarket surveillance registry. A post hoc subgroup analysis compared patients with infrarenal neck angles <60 degrees (FNA) and ≥60 degrees (HNA). RESULTS: After 1 year, 179 FNA (89.5%) and 21 HNA (10.5%) patients were analyzed. Both groups were similar in terms of sex (male, 92.7% FNA and 95.2% HNA) and age (73.0 years vs 72.6 years), but the HNA group had more Asian or other race representation (7.3% vs 19.0%) and more patients assigned to American Society of Anesthesiologists class 3 and class 4 (57.6% vs 66.7%). Mean suprarenal angles (standard deviation) were 13.1 (±13.5) degrees vs 29.0 (±16.4) degrees; mean infrarenal angles were 23.2 (±16.4) degrees vs 65.4 (±4.6) degrees, respectively. Aneurysm sac size maximum diameter was 58.1 (±9.8) mm vs 62.0 (±14.1) mm. There was a significant difference in unplanned adjunctive procedures (2.2% vs 19.0%; P = .01). Mean procedural duration was also significantly different for HNA patients, who underwent protracted operations (111.3 [±47.3] minutes vs 153.5 [±44.5] minutes; P < .0001). However, there were no significant differences in rates of clinical success (96.1% vs 95.2%). The rate of reintervention was low overall but 0% in the HNA group. Changes in sac size at 1 year were significant in both groups but not as pronounced in HNA patients (relative change of -11.8% [±13.3] vs -6.6% [±11.4]). CONCLUSIONS: Patients with high neck angulation treated with Treovance underwent more complex procedures but showed equally good technical success and 1-year clinical success parameters.

Trends in use of 3D printing in vascular surgery: a survey.

INTRODUCTION: The purpose of the following research was to provide a systematic survey on the use of additive manufacturing in vascular surgery. The survey focuses on applications of 3D printing in endovascular surgery like endovascular aneurysm repair (EVAR), a quite unexplored application domain. 3D printing is an additive production process of three-dimensional objects starting from a three-dimensional digital model. This kind of manufacturing process is getting great attention in the medical field and new applications have emerged in recent years especially thanks to the combination of additive printing with 3D imaging techniques. The purpose of the study is to reflect on additive manufacturing and its potential as an inclusive manufacturing practice which can provide benefits at economic and societal level. EVIDENCE ACQUISITION: The article first introduces the use of 3D printing in surgery by summarizing the results of previous reviews which reveal three main usages of 3D printing: anatomic models, surgical tools, implants and prostheses. These studies point out that vascular surgery is still an unexplored field of application of 3D printing. Starting from this result, a new survey was carried out in databases Pubmed, Elsevier, Research Gate and ACM Digital Library for terms related to 3D printing in vascular surgery using the following keywords: 3D printing, vascular surgery, EVAR, aneurysm. The search screened articles published up to 2019 for relevance and practical application of the technology in vascular surgery, in particular the topic is related to the treatment of complex abdominal aortic aneurysm. EVIDENCE SYNTHESIS: Initially 437 records published up to 2019 were found, but then were narrowed down to 29 full-text articles. The findings reveal that in addition to the applications found in the previous studies, new experiments are ongoing related to the use of 3D printing in the "Off label" practice to manually fenestrate the stent to improve the accuracy of the EVAR. CONCLUSIONS: Different applications of the use of 3D printing and digital imaging in vascular surgery have been experimented with a different maturity level. Whilst the technology has increased its potential in the latest years, the number of studies documented in the literature is still quite narrow. Further research is necessary to fully test the potential of 3D printing, also in combination with other technologies (e.g. 3D imaging and CNC cutting). Early experimentations show that these technologies have the potential to radically change the vascular surgery practice in the near future, in particular in treatment like EVAR, to improve the planning and therefore the success of the surgery.

Influence of earthquakes on the occurrence of aortic aneurysm ruptures.

BACKGROUND: Catastrophic events have been correlated to increased incidence of cardio-vascular events, but no correlation between RAA and seismic activities have ever been investigated. METHODS: Hospital admissions related to RAA between January 2014 and December 2016 were retrospectively assessed in nine vascular centers of central Italy and correlated with date-matched seismic events. Correlation between RAA presentation and seismic event was first evaluated by Linear Regression analysis. Incidence of RAA events, mortality rate, and type of intervention were analyzed during seismic days (SD) and compared to outcomes during non-seismic days (nSD). RESULTS: A total of 376 patients were admitted with a diagnosis of RAA, and a total of 783 seismic events were reviewed. Twenty patients died before intervention (untreated). Open surgery was performed in 72.8%, endovascular treatment in 27.2%. General mortality at 30 days was 26.6% (30.5% for open surgery; 21.6% for endovascular treatment; P=0.24). Linear regression analysis between RAA and seismic periods revealed a significant correlation (slope=0.11±0.04, equation: y = 0.1143 x + 3.034, P=0.02). Incidence of RAA was 0.34 event per day during the entire period, 0.32 during nSD and 0.44 during SD (P=0.006). During seismic days, patients with RAA were older (80.5 years during SD vs. 77 years during nSD, P=0.12), were in poorer general condition at admission and remained untreated more frequently (8% SD vs. 4.7% nSD, P=0.3), and had a higher mortality rate at 30 days (46.2% SD vs. 27.2% nSD, P=0.012). CONCLUSIONS: During seismic days, the incidence of RAA is higher in comparison to non-seismic days. Patients with rupture during seismic days have a higher risk of death.

The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol.

BACKGROUND: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. OBJECTIVE: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. METHODS: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. RESULTS: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints. CONCLUSIONS: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/9972.

Early carotid artery stenting after onset neurologic symptoms.

Multicenter clinical trials level 1 evidence favors the application of carotid endarterectomy in symptomatic patients, especially the in the elderly cohort. Carotid artery stenting has been proposed as a possible early alternative in selected patients after onset of ipsilateral neurologic symptoms. It is well known that treatment of acute stroke is time-dependent in patients with acute ischemic stroke caused by high-grade stenosis of the internal carotid artery, but intensive medical treatment in conjunction with intervention to improve stroke severity and clinical outcomes has not been established. Two major clinical concerns exist: (1) the risk of hemorrhagic infarction after cerebral revascularization in the acute stage and (2) application of carotid stenting in the acute embolic stage, which may be associated with continued embolic risk after carotid artery stenting compared to carotid endarterectomy, which removes the symptomatic plaque. This review summarizes the indications and results of early carotid artery stenting after onset of neurologic symptoms, considering the new carotid stents and cerebral protection systems available for clinical use and enhanced stenting techniques.

History of the diagnosis and treatment of critical limb ischemia and diabetic foot.

The history of the recognition and surgical treatment of lower limb ischemia dates back to the Middle Ages. The twin Saints Comas and Damian were ascribed to have saved a gangrenous limb in the 13th century and became patrons of future surgeons. The physicians that followed developed the theories of blood flow, anatomy of the arterial circulation, and recognition that occlusive disease was the cause of limb ischemia and gangrene. Innovative physicians developed the techniques of arterial surgery and bypass grafting to restore limb blood flow and allow healing of lesions. In the 1960s, the era of endovascular intervention by the pioneering work of Charles Dotter, who developed techniques to image diseased arteries during a recanalization procedure. The development of guide wires, angioplasty balloons, and stents quickly followed. Management of lower limb ischemia and the diabetic foot will continue to evolve, building on the history and passion of preceding physicians and surgeons.

Device selection for carotid stenting: reviewing the evidence.

INTRODUCTION: Carotid artery stenting (CAS) has recently changed the status in the treatment of the extracranial carotid atheromasic disease. In recent years, evolution in both stents and protection devices as well as in carotid stenting techniques, has resulted in an important reduction in the rate of stroke in patients undergoing CAS procedures. Areas covered: The purpose of this article is reviewing the literature and summarizing the current evidence of the new available materials to underline the importance of the correct choice of the devices during the procedure. Expert commentary: Certainly a key issue in order to limit the periprocedural events to the lowest possible, is to select the appropriate device for the appropriate patient anatomy and clinical syndrome, the so called 'tailored approach'.

Incidental extravascular findings in computed tomographic angiography for planning or monitoring endovascular aortic aneurysm repair: Smoker patients, increased lung cancer prevalence?

AIM: To validate the feasibility of high resolution computed tomography (HRCT) of the lung prior to computed tomography angiography (CTA) in assessing incidental thoracic findings during endovascular aortic aneurysm repair (EVAR) planning or follow-up. METHODS: We conducted a retrospective study among 181 patients (143 men, mean age 71 years, range 50-94) referred to our centre for CTA EVAR planning or follow-up. HRCT and CTA were performed before or after 1 or 12 mo respectively to EVAR in all patients. All HRCT examinations were reviewed by two radiologists with 15 and 8 years' experience in thoracic imaging. The results were compared with histology, bronchoscopy or follow-up HRCT in 12, 8 and 82 nodules respectively. RESULTS: There were a total of 102 suspected nodules in 92 HRCT examinations, with a mean of 1.79 nodules per patient and an average diameter of 9.2 mm (range 4-56 mm). Eighty-nine out of 181 HRCTs resulted negative for the presence of suspected nodules with a mean smoking history of 10 pack-years (p-y, range 5-18 p-y). Eighty-two out of 102 (76.4%) of the nodules met criteria for computed tomography follow-up, to exclude the malignant evolution. Of the remaining 20 nodules, 10 out of 20 (50%) nodules, suspected for malignancy, underwent biopsy and then surgical intervention that confirmed the neoplastic nature: 4 (20%) adenocarcinomas, 4 (20%) squamous cell carcinomas, 1 (5%) small cell lung cancer and 1 (5%) breast cancer metastasis); 8 out of 20 (40%) underwent bronchoscopy (8 pneumonia) and 2 out of 20 (10%) underwent biopsy with the diagnosis of sarcoidosis. CONCLUSION: HRCT in EVAR planning and follow-up allows to correctly identify patients requiring additional treatments, especially in case of lung cancer.

Endovascular correction in acute bleeding after femoro-popliteal bypass: a single-center experience.

BACKGROUND: The endovascular correction (EC) has emerged in recent years as a possible alternative to surgical revision (SR) in case of bleeding complications after peripheral bypass (PB). The purpose of this study is to evaluate the efficacy and safety of EC compared to SR in case of bleeding complications of PB. METHODS: From January 2004 to December 2014, we have submitted 32 patients to surgery for acute bleeding in previous PB (25 venous bypass, in situ or reversed, 6 PTFE bypass and 1 composite bypass). The cause of the bleeding was the dehiscence of proximal anastomosis in 14 patients, the dehiscence of distal anastomosis in 11 patients and the rupture of the graft in 7 patients. All patients postoperatively underwent anticoagulation or antiplatelet therapy, antibiotic therapy and close ultrasound follow-up. Patency rate, limb salvage rate and survival rate in the short term were assessed by Kaplan-Meier curves. RESULTS: Of the 32 patients treated for acute bleeding in previous PB, 11 underwent endovascular correction with a technical success of 100% (no need for reintervention), while in 21 patients a surgical revision was performed. Among the latter, in 4 cases (19.1%) an early bleeding occurred, and endovascular correction was promptly performed solving the bleeding in the absence of sequelae (then a total of 15 patients were treated by endovascular correction). The 12-month patency, limb salvage and survival rates were respectively 71.4%, 88.2% and 88.2% in the SR group and 80%, 93.3% and 100% in the EC. CONCLUSIONS: This topic underlines that endovascular correction after peripheral bypass bleeding is an attractive alternative to surgery, but there are still a few data to change the gold standard treatment. Randomized clinical trials comparing the two treatment options are warranted.

Patient Discomfort during Carotid Artery Stenting: A Comparison Study between Iodixanol versus Iopamidol.

BACKGROUND: The aim of this study was to compare the adverse effects of iodixanol and iopamidol in terms of patient's discomfort in subjects undergoing carotid artery stenting (CAS). METHODS: We retrospectively analyzed data of all successful CAS procedures performed in our department during a 15-year period study. All patients judged to be collaborative were included. From December 2000 to December 2005, we adopted iopamidol as contrast media (CM), thereafter iodixanol. Any transient unpleasant sensation of bitter taste or warmth perceived by the patient after intra-arterial injection of CM was recorded. Injection-associated discomfort was assessed by visual analog scale (VAS) score. Comparison between the 2 CMs with regard to the overall discomfort was carried out by using the Mann-Whitney test. Spearman correlation was performed to assess the correlation among discomfort, age, and CM used. A univariate analysis was performed for slightly bitter taste and warmth sensation to compare these clinical outcomes and CM used; subsequently, a logistic multivariate analysis regression was performed with the "backward elimination." RESULTS: Data from 1,633 patients were evaluated. A total of 608 patients underwent CAS procedure using iopamidol, and 1,025 using iodixanol. The total amount of CM used during a single procedure was 85 ± 17 mL/patient (range 60-135). The median VAS value was statistically significantly lower in the iodixanol group than in the iopamidol group (P < 0.001). A significant Spearman correlation coefficient was found between age and discomfort for both CMs used (Spearman rho 0.18 for iodixanol, 0.17 for iopamidol). The univariate analysis showed that patients undergoing CAS with iopamidol had an odds ratio (OR) of 8.48 (P < 0.001) to perceive warmth sensation. When adjusted for age and gender, the multivariate analysis still showed an OR of 8.03. For slightly bitter taste sensation, the crude analysis showed an OR of 1.31 (P = 0.018); adjusting for age and gender, OR became 1.15 and the difference was not statistically significant (P = 0.257). CONCLUSIONS: During CAS, less overall discomfort was reported in patients receiving iodixanol than iopamidol; in terms of warmth sensation, patients undergoing procedure using iopamidol as CM have a higher risk to perceive this clinical symptom than iodixanol. Slightly bitter taste seems to have a statistically significant relation with age and gender, and not with CM used.

Abdominal aortic aneurysm.

Endovascular repair of abdominal aortic aneurysms has become a milestone in the treatment of patients with abdominal aortic aneurysm. Technological improvement allows treatment in more and more complex cases. This review summarizes all grafts available on the market. A complete review of most important trial on this topic is provided to the best of our knowledge, and technical tips and tricks for standard cases are also included.