Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform.

BACKGROUND: Complex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. METHODS: All patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. RESULTS: From 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft's main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. CONCLUSIONS: Inner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Balloon Endoclamping for Postdissection Infrarenal Aorto-Iliac Aneurysm Repair.

BACKGROUND: Isolated post dissection infrarenal and iliac aneurysm is a rare condition that often requires surgical treatment. Surgical repair should involve the replacement of the aneurysmal segments and a wide fenestration in the residual proximal untreated abdominal aorta. However, in these patients proximal aortic clamping may be challenging. Indeed, infrarenal clamping may hamper an appropriate fenestration in the proximal dissecting lamella, and suprarenal or supraceliac clamping can be dangerous and highly demanding, especially in acute and subacute patients. Here we report our initial experience with a balloon endoclamping technique. MATERIAL AND METHODS: Our technique includes 1) direct aortic true lumen catheterization, 2) balloon endoclamping of the proximal thoracic aorta, 3) wide fenestration of the infrarenal aorta followed by external clamp positioning, 4) infrarenal aorta and iliac artery reconstruction. RESULTS: Between October 2018 and November 2019, 4 patients (male n = 4, median age 57 years) underwent postdissection iliac aneurysm repair in our institution. All patients had previously undergone emergent thoracic aorta repair. Postoperative courses were uneventful in all cases. At a median FU of 13 months, all patients remain well, with stable diameters in visceral aorta. CONCLUSIONS: In our initial experience, proximal aortic endoclamping appeared to be a safe technique associated with promising results. This approach may facilitate proximal aortic clamping and allow for a wide aortic fenestration. Further larger clinical trials are needed to validate our preliminary observations.

Emergency Endovascular Treatment of Coral Reef Aorta with an Unconventional Technique.

Coral reef aorta (CRA) is a rare condition featured by rock-hard calcifications that grow into the lumen of the thoracoabdominal aorta. Patients suffering from CRA may present severe downstream ischemic and embolic events involving the viscera and the lower limbs. In these patients, open surgical repair is the first choice of treatment. We present a case of a 70-year-old woman with acute presentation of bilateral limb ischemia and abdominal pain. An angio-computed tomography (CT) scan showed the subocclusion of the distal thoracic aorta due to a severe calcified coarctation with intraluminal thrombosis, a chronic occlusion of the superior mesenteric and celiac trunk arteries, a hypertrophic inferior mesenteric artery associated with signs of partial left kidney ischemia. The patient underwent urgent endovascular repair. A soft dilatation of the coarctation using a 7-mm noncompliant balloon was initially performed; a 21-mm conformable thoracic stent graft was subsequently deployed and increasingly dilated using progressively larger angioplasty balloons. The procedure was uneventful and the aortic gradient was reduced to zero. A postoperative CT scan revealed the proper deployment of the graft with no residual stenosis. Endovascular approach with the covered thoracic stent graft could be an accurate technique to treat CRA in the emergency setting. It allows for a primary protected balloon angioplasty and, in case of aortic-graft recoiling, a subsequent placement of covered or uncovered balloon-expandable stent graft can be safely and easily performed.

Treatment of a Proximal Giant Thoracic Aortic Aneurysm in Preview Open Repair of Thoracoabdominal Aortic Aneurysm, Sandwich Technique with Valiant Navion Evo Thoracic Endograft®.

We treated a 73-year-old female patient with a giant thoracic proximal aortic aneurysm above a previous multibranched thoracoabdominal graft without a distal neck for a standard endovascular approach. A procedure with sandwich technique was performed using the new Valiant Navion Evo Thoracic Endograft® to preserve visceral graft. Postoperative angio-computed tomography scan demonstrated the correct position of the endoprosthesis without any leakage with patency of visceral graft.

Endovascular Treatment of Blunt Thoracic Aortic Injury by Fractured Rib.

We treated an 89-year-old patient affected by a descending thoracic aorta lesion due to a rib fracture with a penetrating costal stump. An urgent combined thoracic and endovascular surgical approach was performed, removing the rib fragment and positioning an aortic endoprosthesis simultaneously. Postoperative angio-computed tomography scan demonstrated the correct position of the endoprosthesis without any leakage or periaortic hemorrhage.

Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study.

BACKGROUND: In vascular surgery with aortic cross-clamping, ischemia/reperfusion injury induces systemic haemodynamic and microcirculatory disturbances. Different anaesthetic regimens may have a varying impact on tissue perfusion. The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anaesthesia. METHODS: Prospective observational study. Patients undergoing elective open infrarenal abdominal aortic aneurysm repair received balanced (desflurane + remifentanil, n = 20) or total intravenous anaesthesia (TIVA, propofol + remifentanil using target-controlled infusion, n = 20) according to the clinician's decision. A goal-directed haemodynamic management was applied in all patients. Measurements were obtained before anaesthesia induction (baseline) and at end-surgery and included haemodynamics, arterial/venous blood gases, sublingual microvascular flow and density (incident dark field illumination imaging), peripheral muscle tissue oxygenation and microcirculatory reactivity (thenar near infrared spectroscopy with a vascular occlusion test). RESULTS: The two groups did not differ for baseline characteristics, mean aortic-clamping time and requirement of vasoactive agents during surgery. Changes in mean arterial pressure, systemic vascular resistance index, haemoglobin and blood lactate levels were similar between the two groups, while the cardiac index increased at end-surgery in patients undergoing balanced anaesthesia. The sublingual microcirculation was globally unaltered in the TIVA group at end-surgery, while patients undergoing balanced anaesthesia showed an increase in the total and perfused small vessel densities (from 16.6 ± 4.2 to 19.1 ± 5.4 mm/mm2, p < 0.05). Changes in microvascular density were negatively correlated with changes in the systemic vascular resistance index. The area of reactive hyperaemia during the VOT increased in the balanced anaesthesia group (from 14.8 ± 8.1 to 25.6 ± 14.8%*min, p < 0.05). At end-surgery, the tissue haemoglobin index in the TIVA group was lower than that in the balanced anaesthesia group. CONCLUSIONS: In patients undergoing elective open abdominal aortic aneurysm repair with a goal-directed hemodynamic management, indices of sublingual or peripheral microvascular perfusion/oxygenation were globally preserved with both balanced anaesthesia and TIVA. Patients undergoing balanced anaesthesia showed microvascular recruitment at end-surgery. TRIAL REGISTRATION: NCT03510793 , https://www.clinicaltrials.gov, date of registration April 27th 2018, retrospectively registered.

Use of the Gore Hybrid Vascular Graft in a challenging high-lying extracranial carotid artery aneurysm.

Extracranial carotid artery aneurysm is a rare condition with relatively significant morbidity and mortality. When surgery is not indicated, endovascular techniques are emerging as the preferred treatment. However, even this approach may be contraindicated due to anatomic factors. We present a case of a high-lying extracranial carotid artery aneurysm with challenging anatomy unsuitable for conventional or endovascular repair. After resecting the aneurysm, the carotid artery was revascularized using the new Gore Hybrid Vascular Graft (W. L. Gore & Associates, Flagstaff, Ariz). This straightforward procedure turned out to be safe and further reduced the cerebral ischemic time.

Inflammatory abdominal aortic aneurysm presenting as bilateral hydroureteronephrosis: a case report and review of literature.

We report a case of Inflammatory Abdominal Aortic Aneurysm (IAAA) producing bilateral hydro-ureteronephrosis. A 74-year-old patient presented to urologist office for bilateral hydronephrosis detected by kidney and bladder ultrasound (US). Patient reported lower urinary tract symptoms and inconstant and slight low back pain irradiated to inguinal region dating 3 weeks. Renal function, urine analysis and abdominal examination were normal. However the repeated ultrasound in the urologist office revealed abdominal aortic aneurism extended to iliac vessels. The patient was sent directly to vascular surgery unit where contrast computerized tomography (CT) and successful surgical repair were done. Final diagnosis was IAAA. The post-operative course was uneventful. Renal function was regular and the hydronephrosis reduced spontaneously under monitoring by CT and US. We review diagnosis and management of hydronephrosis that is sometimes linked to IAAA rather than standard AAA. Abdominal ultrasound is mandatory in any bilateral hydronephrosis and it could save lives.

Multicentre experience of antegrade thoracic endovascular aortic repair for the treatment of thoracic aortic diseases.

OBJECTIVES: The goal of this multicentre retrospective cohort study was to evaluate technical success and early and late outcomes of thoracic endovascular repair (TEVAR) with grafts deployed upside down through antegrade access, to treat thoracic aortic diseases. METHODS: Antegrade TEVAR operations performed between January 2010 and December 2021 were collected and analysed. Both elective and urgent procedures were included. Exclusion criteria were endografts deployed in previous or concomitant surgical or endovascular repairs. RESULTS: Fourteen patients were enrolled; 13 were males (94%) with a mean age of 71 years (interquartile range 62; 78). Five patients underwent urgent procedures (2 ruptured aortas and 3 symptomatic patients). Indications for treatment were 8 (57%) aneurysms/pseudoaneurysms, 3 (21%) dissections and 3 (21%) penetrating aortic ulcers. Technical success was achieved in all procedures. Early mortality occurred in 4 (28%) cases, all urgent procedures. Median follow-up was 13 months (interquartile range 1; 44). Late deaths occurred in 2 (20%) patients, both operated on in elective settings. The first died at 19 months of aortic-related reintervention; the second died at 34 months of a non-aortic-related cause. Two patients (14%) underwent aortic-related reinterventions for late type I endoleak. The survival rate of those having the elective procedures was 100%, 84% and 67% at 12, 24 and 36 months, respectively. Freedom from reintervention was 92%, 56% and 56% at 12, 24 and 36 months, respectively. CONCLUSIONS: Antegrade TEVAR can seldom be considered an alternative when traditional retrograde approach is not feasible. Despite good technical success and few access-site complications, this study demonstrates high rates of late type I endoleak and aortic-related reinterventions.

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.

Long-term outcomes of endovascular aortic repair with flared iliac limb endografts in patients with abdominal aortic aneurysm and aneurysmal common iliac arteries.

BACKGROUND: The aim of this study was to evaluate the long-term outcomes of endovascular aneurysm repair with flared iliac limb grafts in patients with abdominal aortic aneurysm (AAA) and aneurysmal common iliac arteries (CIAs). METHODS: This is a multicenter, retrospective, observational cohort study that involves four tertiary referral hospitals between May 1, 2005, and April 30, 2019. Primary outcomes were freedom from aneurysm-related mortality (ARM), and freedom from iliac-related reintervention. RESULTS: We studied 995 aneurysmal iliac limbs in 795 (85.2%) patients who met the inclusion criteria. Median AAA diameter was 55mm (IQR: 51-60). Early mortality occurred in 3 (0.4%) patients. The median of follow-up time was 52 months (IQR: 26-88). Estimated freedom from ARM was 99±0.002% (95% CI: 99-99.9) at 1 year, and 99±0.004% (95% CI: 97.9-99.6) at 5-years. Chronic obstructive pulmonary disease (HR=6.4, 95% CI: 1.7-24.0, P=0.006), chronic kidney disease (HR=5.5, 95% CI: 1.4-21.9, P=0.016), and the presence of an aneurysmal left CIA (HR=5.3, 95% CI: 1.0.5-27.4, P=0.044) was associated with ARM. There were 42 (7.3%) late iliac-related events (limb occlusion, N.=5; iliac-related endoleaks, N.=37). Estimated freedom from iliac-related reintervention was 98±0.003% (95% CI: 97-99) at 1 year, and 95±0.01% (95% CI: 92.7-96.7) at 5-years, which was associated with an aneurysmal right CIA (HR=2.2, 95% CI: 1.3-3.9; P=0.005), and age ≥78 years (HR=1.9, 95% CI: 1.01-1.3; P=0.039). CONCLUSIONS: EVAR flared iliac limb grafts showed a high rate of freedom from ARM and a low reintervention rate. Owing to these results, it can be a durable and stable alternative for patients aged >78 years.

Graft endoclamping with brachio-femoral wire conduit for elephant trunk retrieval in open thoraco-abdominal aortic repair.

Staged repair involving aortic arch replacement with elephant trunk (ET) technique and thoraco-abdominal aorta (TAA) replacement is the treatment of choice for patients with extensive aortic disease. The ET graft serves as a proximal platform for subsequent distal aortic repair as it allows one to avoid hazardous dissection of the distal arch and facilitate proximal anastomosis. However, in patients with large proximal descending aorta aneurysm, identifying and retrieving the ET during the second-stage TAA intervention can be challenging because of an unclampable aorta. Here, we present our brachio-femoral wire conduit technique for a safe ET clamping and retrieval during second-stage TAA procedures.

[Indications for vascular grafts as dialysis access; consensus from the Italian experience]. / Indicazioni all'uso delle protesi vascolari per l'accesso emodialitico: un'esperienza Italiana basata sul consenso.

In Italy, the use of arteriovenous grafts (AVGs) is limited (1-4%) due to different approaches to vascular access management compared to other countries, where guidelines that may not apply to the Italian setting have been produced. Therefore, the Vascular Access Study Group of the Italian Society of Nephrology produced this position paper, providing a list of 8 recommendations built upon current guidelines. The most controversial and innovative issues of the existing guidelines have been summed up in 12 different topics. We selected 60 Italian dialysis graft experts, nephrologists and vascular surgeons (PP1SIN Study Investigators). They were asked to express their approval or disapproval on each issue, thus creating a new method to share and exchange information. Almost all agreed on specific criteria for the choice of AVG over native arteriovenous fistulas (AVF) and tunneled venous catheters (tVC) and on the necessary conditions to implant them. They did not fully agree on the use of AVG in obese patients and patients at risk of developing ischemia, as an alternative to brachiobasilic fistula with vein transposition, and in case of a poorly organized setting. When AVF is feasible, it should be preferred. AVGs are indicated when superficial veins are unavailable or to repair an AVF (bridge graft). An AVG is an alternative to tVC if the expected patient survival is long enough to allow clinical benefits. The ultimate choice of the graft type is made by the physician in charge of the surgical intervention. Antithrombotic prophylaxis may be justified in some cases.

[Vascular access for hemodialysis: recommendations of the Vascular Access Study Group of the Italian Society of Nephrology]. / Gli accessi vascolari per emodialisi: le raccomandazioni del Gruppo di Studio della Società Italiana di Nefrologia.

The Vascular Access Study Group of the Italian Society of Nephrology has scheduled four national studies regarding the choice, implantation and use of vascular access. Study topics will include 1) utilization of vascular grafts for hemodialysis; 2) indications and use of venous catheters; 3) tunneled central venous catheter infection; 4) organization of the implantation and repair of vascular access. After examining the difficulties in implementing international guidelines on vascular access in Italy and the differences in practice patterns between our and other countries (where the most important studies were published), the Study Group set out to prepare four position papers based on discussion of controversial aspects of the international guidelines by nephrologists and surgeons experienced in the Italian practice. An innovative operative method for verifying the consensus on vascular access practice patterns was used. The final aim was to write a document addressed to vascular access operators (surgeons and nephrologists) based on the consensus of experts on controversial vascular-access- related issues. The project will include yearly updates of the documents.

Pararenal aortic aneurysm in situs inversus totalis: open repair with right retroperitoneal approach.

Situs inversus totalis (SIT) refers to a mirror-image reversal of the internal organ position. The coexistence of abdominal aortic aneurysm and SIT is extremely rare; very short series have been reported; therefore its prevalence has never been estimated. The presence of anatomical anomalies could increase operative risk. The authors describe a case of successfully repaired pararenal abdominal aortic aneurysm with a right retroperitoneal approach in situs inversus totalis.

Chimney technique with endoanchors in treatment of late type 1a endoleak after endovascular aortic repair.

The late type Ia endoleak after endovascular aortic repair could be a challenging issue. Over the last years, in case of short or enlarged neck, fenestrated and branched stent grafts have been increasingly employed with improving results. However, these devices have limited use in urgent/emergent cases as custom graft manufacturing takes long time, and may not be fit in patients with particular anatomic features. In this setting, chimney and relining remain an alternative but sometimes may not be adequate. According to literature, the use of the endoanchors associated to chimney technique can improve the procedure results in primary endovascular aortic repair. We treated two patients with a late type Ia endoleak after endovascular aortic repair with a simultaneous relining, single renal chimney, and endoanchors implant. These patients were valuated unfit for open repair with neck configuration unadapt for a simple relining, ballooning, or stenting. The patient conditions were unfavorable for an endovascular repair with branched endovascular aortic repair-fenestrated endovascular aortic repair. The same procedure was performed in both patients. Postoperative angio-computed tomographic scan demonstrated the resolution of the endoleak with patency of renal graft. Our preliminary experience, in these selected cases, demonstrate the feasibility of the technique in late type Ia endoleak.