Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry.

BACKGROUND: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). METHODS: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. FOLLOW-UP: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. RESULTS: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively (p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. CONCLUSION: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes.

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry).

PURPOSE: This study reports the outcomes from a Multicenter Registry on unibody stent-graft system for the treatment of spontaneous infrarenal acute aortic syndrome (MURUSSIAS registry). MATERIALS AND METHODS: The retrospective MURUSSIAS registry included spontaneous infrarenal acute aortic dissection (IAAS) managed with the unibody stent-graft system (AFX endovascular AAA system; Endologix Inc., Irvine, California) outside the current instruction for use. IAAS considered aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Indications to IAAS treatment were symptoms, associated dilated abdominal aorta (>3 cm), rapidly-growing (>0.5 cm/6 months) aorta, IAAS disease progression. Measured results were technical success, early (within 30 days) and midterm outcomes (after 30 days), including mortality, complications, symptoms recurrence, type I/III endoleak occurrence, stent-graft patency, survival, and freedom from reintervention. The mean follow-up was 22.12 ± 17 months. RESULTS: The MURUSSIAS registry included 83 patients from 7 participating centers. IAAS indication to treatment were symptoms in 42 (51%). In 14 (17%) patients, the infrarenal aortic length was <80 mm, and in 28 (34%), the aortic bifurcation diameter was <16 mm. Technical success was 100%. Mortality occurred early in 1 (1%) and at the midterm in 3 (4%) patients. Complications occurred early in 10 (12%) patients (1 severe, 3 moderates, and 6 mild) and at midterm in 2 (2%) (2 moderate). No symptoms' recurrence or type I/III endoleaks were registered. The 36-month estimated survival and freedom from reinterventions were 89% and 92%, respectively. CONCLUSIONS: The MURUSSIAS registry is the largest collection of spontaneous IAAS managed endovascularly using the AFX endovascular AAA system. The IAAS peculiar anatomic features were fitted with the used technique with excellent results. This treatment strategy might be considered in IAAS unless specifically-designed endovascular solutions will be available also in the emergent setting. Further studies are required to assess the longer-term performances and the stability of the reported technique. CLINICAL IMPACT: The lack of specifically designed devices for infrarenal acute aortic syndrome (IAAS) disease remains an issue principally for its specific anatomic features. The MURUSSIAS registry retrospectively examined the outcomes of spontaneous IAAS treated using the unibody stent-graft system in a spontaneous national study; and reports the largest available data on this topic. The use of the unibody stent-graft system showed to fit the anatomic peculiarities of IAAS with excellent outcomes. This IAAS treatment strategy should be considered unless specifically designed endovascular solutions will be available.

How the First Year of the COVID-19 Pandemic Impacted Patients' Hospital Admission and Care in the Vascular Surgery Divisions of the Southern Regions of the Italian Peninsula.

Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study. Each received a 13-point questionnaire investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs. 2019 (9161 patients): post-EVAR surveillance, hospitalization for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased (1484 (16.2%) vs. 1014 (14.3%), p = 0.0009; 1401 (15.29%) vs. 959 (13.52%), p = 0.0006; and 1558 (17.01%) vs. 934 (13.17%), p < 0.0001, respectively), while admissions for revascularization or major amputations for chronic limb-threatening ischemia and urgent revascularization for symptomatic carotid stenosis significantly increased (1204 (16.98%) vs. 1245 (13.59%), p < 0.0001; 355 (5.01%) vs. 358 (3.91%), p = 0.0007; and 153 (2.16%) vs. 140 (1.53%), p = 0.0009, respectively). Conclusions: The suspension of elective procedures during the COVID-19 pandemic caused a significant reduction in post-EVAR surveillance, and in the hospitalization of asymptomatic carotid stenosis revascularization and Rutherford 3 peripheral arterial disease. Consequentially, we observed a significant increase in admissions for urgent revascularization for symptomatic carotid stenosis, as well as for revascularization or major amputations for chronic limb-threatening ischemia.

A Case of Multilevel Aortic Disease Treated Using Cardiatis Multilayer Flow Modulator.

A recent systematic review and meta-analysis shows that synchronous and metachronous thoracic and abdominal aortic aneurysms are present in 19.2% of cases. The management remains controversial: elective simultaneous TEVAR and EVAR could increase morbidity due to increased aortic coverage during a single procedure, longer operative times, increased blood loss, and greater contrast exposure. Conversely, simultaneous thoracic endovascular aortic repair (TEVAR) and endovascular aneurysms repair (EVAR) prevent the need for two interventions, reduces future access site complications, and obviates interval aortic complications. We present a case of a multilevel aortic disease treated in three stages: EVAR, TEVAR, and exclusion of an increasing aortic visceral penetrating aortic ulcer through a multilayer flow modulator endograft with an optimal result.

The role of cord blood platelet gel in the management of a diabetic foot with tendon exposure.

Diabetic foot infection is frequent in diabetic patients and is due to neuropathy, trauma or peripheral arterial disease. The presence of an abscess requires urgent drainage and specific antibiotic therapy. Patients with critical limb ischemia need revascularization and, subsequently the intervention of a plastic surgeon is often required in cases of exposure of tendons and ligaments. During the COVID-19 pandemic, a patient was refered to our department with an abscess on the dorsum of the left foot. After urgent drainage with tendon exposure, he started specific antibiotic therapy and underwent tibial vessels angioplasty. After infection healing cord blood platelet gel was applied, accelerating the healing process, with injection of its liquid part into the exposed tendons, thus retaining the vital functions of the tendons.

Stent-Graft Relining Using the Altura Endograft for Type Ia and IIIb Endoleaks after Kissing Iliac Arteries Stent.

A 79 years old man, affected by serious comorbidities, occurred to the Emergency Room of our Hospital complaining abdominal pain. He was previously submitted to kissing iliac arteries stent for iliac aneurysms. An urgent CT scan showed a type Ia and a type IIIb endoleaks with left common iliac artery enlargement, occlusion of both hypogastric arteries and inferior mesenteric artery, and a severe stenosis of the right iliac external artery. We opted for a relining with a two-piece D-shaped Altura endograft for the aorta, with bilateral iliac components, landing at the level of the external iliac arteries. Postoperative course was uneventful with no endoleak or endograft migration on CT scan control at 6 months.

A Case of Late Type Ia Endoleak After Endovascular Aneurysm Sealing Using the Nellix System: Proximal Extension with Triple Chimney and Gutter Endoleak Embolization.

An 87-year-old man, who submitted to endovascular aneurysm sealing (EVAS) on 2017, presented a type Ia endoleak 2 years later, with enlargement of the aneurysmal sac. We planned an endovascular procedure of correction consisting of a proximal extension through two covered stent grafts deployed into the previous Nellix stent grafts, with associated triple chimney. However, 3 months later, he had a further 5 mm aneurysmal sac enlargement. He was submitted to angiography with coil embolization of gutters, obtaining a successfully result. At 1 and 3 months, he is free from endoleak, with a stable aneurysmal diameter.

Use of cord blood platelet gel to enhance healing of deep surgical site dehiscences after peripheral bypass.

Surgical site dehiscence after lower limb revascularization through bypass represents a serious postoperative complication, especially in diabetic and obese patients, with subsequent risk of early graft failure, infection, sepsis, hemorrhage, major amputation and sometimes death. To prevent bypass exposure and subsequent complications, physicians recur to reoperation, antibiotic therapy, advanced dressing and vacuum-assisted closure therapy. To improve the process of wound healing, cord blood platelet gel can be used to fill deep and large wounds. Growth factors released from platelets in the cord blood platelet gel stimulate the process of healing and allow patients to be followed up in Outpatient Surgery, thus reducing hospital stay and costs, while providing excellent results.

Early and mid-term results of endovascular treatment of thoracic aorta diseases: a single-center experience.

We conducted an analysis to assess early and mid-term outcomes of patients after thoracic endovascular aortic repair (TEVAR) for type B thoracic aorta dissection, descending thoracic aneurysm, or traumatic aortic transection. From January 2016 through December 2018, twenty-seven patients (23 male, 4 female, mean age of 57 years) affected by type B dissection (n = 13 [48.2%]), thoracic aneurysm (n = 9 [33.3%]), and post-traumatic aortic isthmus rupture (n = 5 [18.5%]) were treated using TEVAR with and without left subclavian artery revascularization. All procedures were performed in a hybrid operating room using general (n = 12) or regional (n = 15) anesthesia. A combined brachial artery and bilateral femoral artery access was used in all patients. To achieve adequate proximal thoracic aorta landing zone length, coverage of the left subclavian artery with proximal endovascular plug occlusion was performed in 17 patients (62.9%); including 4 patients undergoing carotid-subclavian artery bypass before TEVAR stent-graft deployment. Primary procedural success rate was 96.3%; 1 patient had a Type Ib endoleak that was treated by distal stent graft extension. Four adverse outcomes occurred in the immediate postoperative period, including 2 cases of left upper arm acute ischemia (7.4%), ischemic stroke (3.7%), and asymptomatic iliac artery dissection (3.7%). During a mean follow-up of 18 months, no graft-related deaths or endoleak occurred. One patient developed symptomatic subclavian steal syndrome 1 month after operation and underwent a left carotid-subclavian artery bypass with symptom resolution. One patient died 6 months after TEVAR due to neoplasm. Our experience indicates TEVAR is a safe and less invasive alternative to open surgery for a spectrum of thoracic aorta diseases, especially for urgent conditions and in patients with high-risk surgical comorbidities.

Endovascular Treatment of Juxtarenal Abdominal Aortic Aneurysms Recurring to the "Vent Technique".

BACKGROUND: Juxtarenal abdominal aortic aneurysms represent 15-20% of all abdominal aortic aneurysms (AAAs). The gold standard of treatment is represented by open surgical repair (OSR). Patients judged unfit for OSR could be submitted to fenestrated endovascular aortic repair (FEVAR) or the chimney technique. FEVAR requires 3-4 weeks for endograft production, a minimal length of 4 mm for proximal aortic neck and a large access vessels diameter, with high costs. The traditional chimney technique, feasible also in urgent cases, has a risk of type IA endoleak due to the space created between covered stents introduced into visceral arteries and the endograft. METHODS: In the present article, we report our experience about juxtarenal AAA (jAAA) treatment in 5 patients, recurring to uncovered bare metal stents associated with the ultralow profile Ovation endograft. RESULTS: No intraoperative complications or type IA endoleaks were recorded. Primary clinical success at 1 month was also 100%. During a mean follow-up period of 12.1 ± 3.6 months (range, 9-15 months), no complications related to aneurysm were recorded. CONCLUSIONS: The technique reported represents a valid endovascular option for jAAA treatment in patients at high risk for OSR. With respect to FEVAR, urgent patients should also be treated. With respect to traditional Ch-EVAR, the risk of type IA endoleak is reduced, with a lower rate of reoperation during follow-up. Preliminary clinical results are promising.

Successfully Kissing Stent of Innominate Artery and Left Common Carotid Artery Subsequent to Blunt Injury, in the Setting of a Bovine Aortic Arch.

Blunt injuries of the great vessels arising from the aortic arch are usually fatal. The innominate artery lesions represent the most common site of injury after the aortic isthmus distal to the left subclavian artery. Injuries are usually located at the origin of the vessel from the aortic arch, especially in patients with bovine aortic arch. Open traditional repair is a successful but invasive treatment, with long hospital stay and different possible complications. Although a bovine aortic arch presents an increased technical challenge, it is possible to achieve a complete and safe repair of the innominate artery injuries through a total endovascular treatment, with important reduction of risks and complications related to operation, compared to traditional open repair. We report the case of a 62-year-old man in our hospital with a posttraumatic pseudoaneurysm of the innominate artery in the setting of a bovine aortic arch, associated with a transection of the descending thoracic aorta. In the urgent setting, the patient was submitted to a kissing stent of innominate artery-left common carotid artery and deployment of thoracic endoprosthesis to exclude the aortic transection, with good final result.

Percutaneous drug-eluting balloon angioplasty to treat dialysis access stenosis.

A common complication of arteriovenous fistula for hemodialysis is development of conduit stenosis, which compromises function and can result in access thrombosis. Possible treatment options include open repair and endovascular therapy, with the latter preferred due to lower morbidity and similar outcomes. Recurrence of conduit stenosis is common and, based on the pathophysiology of this lesion, the application of drug-coated balloon angioplasty is attractive. In this report, the application of drug-eluting balloon angioplasty for dialysis access stenosis in 18 consecutive patients is detailed and primary patency rates of 82% at 1 year and 68% at 2 years were calculated.

Preliminary Results of Aorfix™ Stent Graft to Treat Infrarenal Abdominal Aortic Aneurysms with Severe Proximal Aortic Neck Angulation.

BACKGROUND: We report a preliminary experience about endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysm (iAAA) with severe proximal aortic neck angulation (NA) using the Aorfix™ stent graft. METHODS: Data of consecutive patients with iAAA with severe proximal NA submitted to endovascular repair between September 2012 and December 2014 in 2 Italian centers of Vascular and Endovascular Surgery were retrospectively reviewed, and outcomes were analyzed using the software JMP 5.1.2. RESULTS: A total of 26 patients were treated. Median proximal NA was 87.5° (range 68-108°), and 3 patients were treated outside the instruction for use of Aorfix because of a proximal NA > 90°. Eleven patients (42.3%) had severe iliac tortuosity. The primary success rate was 92.3%, as 2 patients required intraoperative correction of a type Ia endoleak. Within 30 days, a right limb occlusion was successfully resolved with endovascular recanalization. The median follow-up period was 14 months (range 1-48 months): 1 patient died for neoplasm and 1 patient presented a type II endoleak from lumbar arteries at 3 months, which is still under surveillance. No other complications were reported during the follow-up period. CONCLUSIONS: Preliminary results with the Aorfix stent graft seemed to be promising in the aim of reducing endoleak and migration rates in presence of iAAA with severe proximal aortic NA.

Efficacy of cord blood platelet gel application for enhancing diabetic foot ulcer healing after lower limb revascularization.

The efficacy of umbilical cord blood platelet gel (CBPG) application on healing foot ulcers was analyzed in 10 diabetic patients treated for critical lower limb ischemia by surgical or endovascular arterial revascularization. During a 9-month period, 20 diabetic patients affected by critical lower limb ischemia with tissue loss were enrolled in this nonblinded, consecutive series, randomized clinical trial. After clinical evaluation, patients underwent endovascular or surgical revascularization of the affected limb, followed by minor amputations or surgical debridement of ischemic lesions. Patients were then randomly divided into two groups: 10 patients in Group A treated with standard wound care and 10 patients in Group B treated with topic application of CBPG. The CBPG protocol consisted of platelet gel application twice a week for 4 weeks and then once a week for an additional 4 weeks. Healing was assessed by direct ulcer dimension tracing onto clear plastic sheet and subsequent computerized planimetry. The mean pretreatment and post-treatment ulcer areas at 30 days for Group A were 15.1 cm2 and 8.1 cm2, respectively, and for Group B were 15.7 cm2 and 3.25 cm2, respectively; resulting in a mean ulcer area reduction of 46% for Group A and 79% for Group B patients (P < .01). These observations suggest CBPG application can promote more rapid wound healing than standard care, and indicate the need for a randomized, multicenter trial to confirm clinical efficacy.

The role of procalcitonin as a marker of diabetic foot ulcer infection.

Foot ulcers are frequent in diabetic patients and are responsible for 85% of amputations, especially in the presence of infection. The diagnosis of diabetic foot ulcer infection is essentially based on clinical evaluation, but laboratory parameters such as erythrocyte sedimentation rate (ESR), white blood count (WBC), C-reactive protein (CRP) and, more recently, procalcitonin (PCT) could aid the diagnosis, especially when clinical signs are misleading. Fifteen diabetic patients with infected foot ulcers were admitted to our department and were compared with an additional group of patients with non-infected diabetic foot ulcers (NIDFUs). Blood samples were collected from all patients in order to evaluate laboratory markers. In the current study, the diagnostic accuracy of PCT serum levels was evaluated in comparison with other inflammatory markers such as CRP, ESR and WBC as an indicator to make the distinction between infected diabetic foot ulcers (IDFUs) and NIDFUs. CRP, WBC, ESR and especially PCT measurements represent effective biomarkers in the diagnosis of foot infections in diabetic patients particularly when clinical signs are misleading.

An Hybrid 2-Stage Technique to Treat a Post-Traumatic Internal Carotid-Jugular Fistula.

Penetrating wounds of the neck involving the carotid arteries can lead to 2 possible and important late sequelae: pseudoaneurysm formation and arteriovenous fistula (AVF), if an artery and the adjacent jugular vein are simultaneously lacerated. Traumatic AVF of the neck are rare complications and if untreated may cause congestive heart failure, cerebral ischemia, thromboembolism, or even rupture complications. Current treatment options for carotid-jugular AVF include operative repair, detachable balloon, coiling, or stenting. We present a hybrid 2-stage technique to treat an internal carotid-jugular vein fistula in a young woman, based first on carotid stenting to reduce the bleeding and reestablish an adequate cerebral perfusion, followed by stent removal and safe vessels surgical reconstruction through carotid-to-carotid bypass and vein repair.

An Uncommon Case of Type III Endoleak Treated with a Custom-made Thoracic Stent Graft.

Endovascular aortic repair (EVAR) has been shown to be a valid and minimally invasive alternative to open abdominal aortic aneurysm repair. A major shortcoming for EVAR is the need to submit patients to regular follow-up to detect potential complications such as endoleak, limb occlusion, aneurysm expansion, aneurysm rupture, infection, structural failure, and migration. In this case report, we describe an uncommon case of late type III endoleak due to complete detachment of the stent-graft main body segment from its suprarenal uncovered fixation stent. It was treated with a custom-made Relay(®) NBS Plus (Bolton Medical, Barcelona, Spain) thoracic stent graft which also provided extra suprarenal fixation of the thoracic stent graft in the proximal neck. The postoperative period was uneventful and a computed tomography scan 1 year later revealed proper positioning of the stent graft and no signs of endoleak. The successful strategy chosen to correct this complication was at the same time original and infrequent, and also avoided potential complications related to open surgical repair and general anesthesia.

Spinal Cord Stimulation Therapy for the Treatment of Concomitant Phantom Limb Pain and Critical Limb Ischemia.

Phantom limb pain (PLP) is a chronic condition experienced by about 80% of patients who have undergone amputation. In most patients, both the frequency and the intensity of pain attacks diminish with time, but severe pain persists in about 5-10%. Probably, factors in both the peripheral and central nervous system play a role in the occurrence and persistence of pain in the amputated lower limb. The classical treatment of PLP can be divided into pharmacologic, surgical, anesthetic, and psychological modalities. Spinal cord stimulation (SCS) does not represent a new method of treatment for this condition. However, the concomitant treatment of PLP and critical lower limb ischemia by using SCS therapy has not yet been described in the current literature. The aim of the present article is to highlight the possibility of apply SCS for the simultaneous treatment of PLP and critical lower limb ischemia on the contralateral lower limb after failure of medical therapy in a group of 3 patients, obtaining pain relief in both lower limbs, delaying an endovascular or surgical revascularization. After SCS implantation and test stimulation, the pain was reduced by 50% on both the right and the left side in all our patients. The main indications for permanent SCS therapy after 1 week of test stimulation were represented by transcutaneous oxygen (TcPO2) increase >75%, decrease of opioids analgesics use of at least 50% and a pain maintained to within 20-30/100 mm on visual analog scale.

Old and New Techniques as a Safe Hybrid Approach for Carotid Tandem Lesions.

BACKGROUND: Carotid revascularization is performed to prevent stroke. Carotid tandem lesions represent a challenge for treatment, and a hybrid approach may result effective. CASE REPORT: A high-risk 65-year-old woman presented with a "tandem lesion" of left common and internal carotid artery. She was deemed unfit for "simple" standard carotid endarterectomy (CEA). A "single-step" safe hybrid procedure was scheduled for the patient. A "Cormier" carotid vein graft bypass with a retrograde stenting was performed under local anesthesia. CONCLUSIONS: The "safe hybrid procedure" for tandem lesions of the common and internal carotid artery is effective and suitable in high-risk patients in a high-volume centers.

Symptomatic superior vena cava syndrome in hemodialysis patients: mid-term results of primary stenting.

This clinical report details the results of endovascular treatment of symptomatic superior vena cava syndrome due to central vein stenosis or obstruction (CVSO) by stent angioplasty in patients with dialysis-dependent end-stage renal disease. A 3-year retrospective review of two institutional registries identified 25 chronic hemodialysis patients (17 men, 8 women) affected by CVSO who received endovascular treatment. The majority of the patients (n = 19) presented with symptomatic arm, breast, and facial swelling; and 6 patients presented with dialysis-access dysfunction and venous-line hypertension. The etiology of CVSO was before central venous catheter in all but 2 patients. Venography showed 19 cases of stenosis (4 stenoses of superior vena cava, 3 brachiocephalic, 10 subclavian, and 2 axillary veins) and 6 occlusions of the superior vena cava. After percutaneous transluminal angioplasty and primary stent angioplasty, there was an immediate regression of symptoms and arteriovenous fistula preservation in 21 cases; 4 patients received a new arteriovenous fistula after interventional treatment. No procedural major complications or patient deaths occurred. During the follow-up period, we recorded a primary patency rate of 95%, 80%, and 70%, respectively, at 6, 12, and 18 months; and a secondary patency rate of 100%, 95%, and 90%, respectively, at 6, 12, and 18 months. In conclusion, endovascular treatment with primary stenting has proven to be a durable treatment option for hemodialysis patients with CVSO, and this treatment should be considered before dialysis access placement in patients with catheter-induced central vein obstruction.