Results of a prospective observational study of autologous peripheral blood mononuclear cell therapy for no-option critical limb-threatening ischemia and severe diabetic foot ulcers.

BACKGROUND: Cell therapy with autologous peripheral blood mononuclear cells (PB-MNCs) may help restore limb perfusion in patients with diabetes mellitus and critical limb-threatening ischemia (CLTI) deemed not eligible for revascularization procedures and consequently at risk for major amputation (no-option). Fundamental is to establish its clinical value and to identify candidates with a greater benefit over time. Assessing the frequency of PB circulating angiogenic cells and extracellular vesicles (EVs) may help in guiding candidate selection. METHODS: We conducted a prospective, non-controlled, observational study on no-option CLTI diabetic patients that underwent intramuscular PB-MNCs therapy, which consisted of more cell treatments repeated a maximum of three times. The primary endpoint was amputation rate at 1 year following the first treatment with PB-MNCs. We evaluated ulcer healing, walking capability, and mortality during the follow-up period. We assessed angiogenic cells and EVs at baseline and after each cell treatment, according to primary outcome and tissue perfusion at the last treatment [measured as transcutaneous oxygen pressure (TcPO2)]. RESULTS: 50 patients were consecutively enrolled and the primary endpoint was 16%. TcPO2 increased after PB-MNCs therapy (17.2 ± 11.6 vs 39.1 ± 21.8 mmHg, p < .0001), and ulcers healed with back-to-walk were observed in 60% of the study population (88% of survivors) during follow-up (median 1.5 years). Patients with a high level of TcPO2 (≥ 40 mmHg) after the last treatment showed a high frequency of small EVs at enrollment. CONCLUSIONS: In no-option CLTI diabetic patients, PB-MNCs therapy led to an improvement in tissue perfusion, a high rate of healing, and back-to-walk. Coupling circulating cellular markers of angiogenesis could help in the identification of patients with a better clinical benefit over time.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

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.

Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use.

PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). RESULTS: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. CONCLUSION: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Restenosis after Coronary and Peripheral Intervention: Efficacy and Clinical Impact of Cilostazol.

Restenosis is one of the main complications in patients undergoing coronary or peripheral revascularization procedures and is the leading cause for their long-term failures. Cilostazol is the only pharmacotherapy that showed an adequate efficacy for preventing restenosis in randomized, controlled studies after coronary or peripheral revascularization procedures. The present review sums up the main clinical evidence supporting the use of cilostazol after revascularization interventions, focusing on all its benefits, warnings, and administration schedules.

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.

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft.

OBJECTIVE: Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. METHODS: This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. RESULTS: Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). CONCLUSIONS: No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

The Gore Hybrid Vascular Graft in renovisceral debranching for complex aortic aneurysm repair.

OBJECTIVE: This study reports our initial experience with the Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) for staged hybrid open renovisceral debranching and endovascular aneurysm repair in patients affected by thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms (PAAAs). METHODS: Between December 2012 and December 2013, we analyzed outcomes of 13 patients who underwent open surgical debranching of renovisceral vessels for thoracoabdominal aortic aneurysm and PAAAs. All patients were considered at high risk for conventional surgery. Inclusion criterion was treatment by open surgical debranching of at least one visceral artery (renal artery, superior mesenteric artery [SMA], or celiac trunk [CT]) using the GHVG. In a second step, the aortic stent graft was implanted to exclude the aneurysm. If required, parallel grafts to the remaining visceral arteries were deployed in the same procedure. One patient had a symptomatic descending thoracic aortic aneurysm and another had a ruptured PAAA. Perioperative measured outcomes were immediate technical success rate, mortality, and morbidity. Median follow-up was 24.8 months (range, 0-15; mean, 8.2; standard deviation, 4 months). RESULTS: All open surgical debranching of renovisceral vessels were completed as intended. GHVG was used to revascularize 20 visceral vessels in 13 patients with a mean of 1.54 vessels per patient. Six renal arteries (30%; 2 right and 4 left), 9 SMAs (45%), and 5 CTs (25%) were debranched. In nine of 13 (66%) patients, other renovisceral arteries were addressed with chimney/periscope, Viabahn Open Revascularization Technique, and end-to-side anastomosis. Two of 13 patients (15%) died of bowel ischemia. Neither patient had GHVG revascularization to the SMA or CT. Perioperative complications occurred in three patients (23%; 1 renal hematoma, 1 respiratory insufficiency, and 1 small-bowel ischemia related to a SMA GHVG thrombosis). At 24 months, estimated survival was 85%, and estimated primary and secondary patency were 94% and 100%, respectively. CONCLUSIONS: This limited series extracted from a more consistent hybrid procedure experience showed a mortality rate similar to most recent reports. Technical feasibility and the short-term patency rate of the GHVG for renovisceral debranching during staged hybrid open and endovascular procedures were satisfactory. Use of GHVGs may represent a useful revascularization adjunct to minimize visceral ischemia in these challenging patients.

24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions.

BACKGROUND: To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting. METHODS: The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed. RESULTS: Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis. CONCLUSION: The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category.

Fistula first, graft on arterialized vein second.

OBJECTIVES: Arterovenous grafts (AVGs) present a feasible solution for creating a vascular access in patients who are unsuitable for autogenous fistula (AVF). The aim of this study is to assess the prevention rate of vein stenosis, placing a graft on an arterialized vein (GAV) instead of an anastomized AVG in a native vein (GNV). METHODS: This was a cohort study conducted from January 2009 to November 2012. All consecutive patients who underwent AVG in our institution were included. All patients requiring a secondary intervention were also referred to our centre. Patients underwent ultrasound follow up at first and the every month. A Kaplan-Meier method was used; a Log-rank test was used to identify whether significant difference existed between GAV and GNV (p < 0.05). RESULTS: Forty-six grafts were placed. Twenty patients had arterialized receiving veins (group A), while 26 patients received an AVG immediately because they lacked autogenous veins suitable for fistula (group B).The average follow-up period was 16.1 months (range 0-41). The group A 41 months-patency rate was 84.3%, while group B was 43.7% (p = 0.06). Secondary patency was similar in the two groups. CONCLUSIONS: Vein arterialization seems to prevent venous stenosis improving AVG-patency rate. More data are needed; however, the borderline p value encourages new studies.

The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia.

OBJECTIVE: Surgical arterial thromboembolectomy (TE) is an efficient treatment for acute arterial thromboemboli of lower limbs, especially if a single large artery is involved. Unfortunately, residual thrombus, propagation of thrombi, chronic atherosclerotic disease, and vessel injuries secondary to balloon catheter passage may limit the clinical success rate. Intraoperative angiography can identify any arterial imperfection after TE, which may be corrected simultaneously by endovascular techniques (so-called "hybrid procedures," HP). The aim of this study is to compare outcomes of surgical TE vs HP in patients with acute lower limb ischemia (ALLI). METHODS: From 2006 to 2012, 322 patients with ALLI were admitted to our department. Patients received urgent surgical treatment using only a Fogarty balloon catheter (TE group = 112) or in conjunction with endovascular completion (HP group = 210). In-hospital complications, 30-day mortality, primary and secondary patency, reintervention rate, limb salvage, and overall survival rates were calculated using the Kaplan-Meier method and compared by log-rank test. RESULTS: HPs (n = 210) following surgical TE consisted of angioplasty (PTA) ± stenting in 90 cases, catheter-directed intra-arterial thrombolysis + PTA ± stenting in 24, thrombus fragmentation and aspiration by large guiding catheter + PTA ± stenting in 67, vacuum-based accelerated thromboaspiration by mechanical devices in 9, and primary covered stenting in 12. Estimated primary patency was 90.4% vs 70.4% at 2-year and 87.1% vs 66.3% at 5-year follow-up, respectively, for HP and TE patients (hazard ratio, 3.1; 95% confidence interval, 1.78-5.41; P < .01). A hazard ratio of 2.1 for limb salvage was noted for the HP group (95% confidence interval, 1.01-4.34; P = .03). Estimated freedom from reintervention at 1 year was 94.4% for HP vs 82.1% for TE patients, and 89% vs 73.7% at 5 years, respectively (P = .04). CONCLUSIONS: HPs for ALLI may represent the tools that, when applied to specific clinical scenarios, hold the potential to reduce the morbidity previously associated with acute arterial occlusion.

Immediate and two-year outcomes after EVAR in "on-label" and "off-label" neck anatomies using different commercially available devices. analysis of the experience of two Italian vascular centers.

BACKGROUND: Endovascular aneurysm repair (EVAR) has fast become the therapeutic strategy of choice for abdominal aortic aneurysms (AAAs). Nowadays, the most important limit to the effectiveness of this technique is represented by complex anatomical situations, especially regarding the morphology of the proximal sealing zone. The aim of this study was to evaluate the 2-year outcome of unselected, real-world patients with "off-label" (off-L) proximal necks treated in 2 high-volume Italian vascular centers. METHODS: A double-center study was conducted on a prospectively compiled computerized database between January 2010 and December 2011. One hundred and ninety-six consecutive elective surgery patients were analyzed and divided into 2 groups ("on-label" [on-L] and "off-L" necks) on the basis of their aortic neck anatomy. The neck was classified as an "off-L neck" in the presence of: (1) a noncylindrical neck, (2) an angulated neck, (3) a short neck, and (4) an enlarged neck. The end points were 30-day and 2-year technical and clinical success, evaluated in terms of freedom from reintervention and death. RESULTS: One hundred and thirty-three elective patients were treated by standard EVAR in the presence of an "off-L" proximal neck anatomy. Technical success was achieved in all cases in both groups. Six (9.5%) unplanned adjunctive procedures were necessary in the on-L group and 16 (12%) in the off-L group (P = ns). Perioperative endoleaks, reinterventions, stent-graft migration rates, and AAA-related deaths were null. A multivariate analysis was performed to evaluate the subgroups of patients with 2 or > 2 anatomic factors that indicate a challenging neck. In patients with 2 such factors, a significant difference was observed in terms of intraoperative adjunctive procedures, intraoperative endoleaks, and all-cause mortality: 26.7% vs. 9.9% (P = 0.048), 6.7% vs. 0.5% (P = 0.023), and 13.3% vs. 1.1% (P = 0.0012), respectively. The same differences became increasingly evident when analyzing patients with > 2 criteria: 50% vs. 10% (P = 0.0022), 16.7% vs. 0.5% (P < 0.001), and 16.7% vs. 1.0% (P = 0.01). No AAA-related deaths or AAA ruptures were reported in either group at the end of the 2-year follow-up. High-flow endoleaks, stent-graft migration, and, consequently, reintervention were more frequent in the off-L group, but none of these parameters reached statistical significance. CONCLUSIONS: Our experience seems to show that the off-L use of EVAR could be considered effective for the treatment of patients unfit for open surgery. In patients with more than one anatomical proximal neck feature contraindicating open surgery, the rate of immediate complications and reinterventions was higher, but this did not affect the clinical benefit and success at 2-year follow-up.

Rescue EVAR for ruptured AAA: Clinical success does not mean technical success.

We report a clinical evolution of a 85-years old male admitted to our Emergency Department for ruptured abdominal aortic aneurysm (rAAA). One month later a huge type I proximal endoleak was detected and corrected by proximal aortic extension. We decided to fix the stent-graft to the aortic wall using EndoAnchors. However, an asymptomatic type III endoleak due to controlateral limb disconnection was detected at the followed schedulated CT angio and corrected by a relining of the endograft. The patient is now in good clinical condition with no evidence of endoleaks at 1-year follow-up.

Living-Donor Uterus Transplantation: A Clinical Review.

Uterus transplantation (UTx) is currently the only available treatment for absolute uterine factor infertility. More than 90 uterus transplantations have been performed worldwide, mostly from living donors. Living-donor (LD) UTx is a challenging surgical procedure since it poses ethical issues, and it is a high-risk and invasive surgery with higher hysterectomy-related risks compared to conventional hysterectomy. A total of 59 living-donor hysterectomies have been reported in the literature, including 35 performed with a laparotomic approach, 20 with a robotic approach and 4 with a laparoscopic approach. The mean donor age was 45.6 ± 9.1 years, and 22 were unrelated with the recipients, 34 were emotionally related (27 mothers, 5 sisters, 2 mother's sisters). The mean recipient age was 28.8 ± 4.5 years. Mayer-Rokitansky-Küster-Hauser syndrome was the most common indication for uterus transplant. Robotic living-donor hysterectomy had the longest operative time but resulted in a lower blood loss and postoperative stay compared to laparotomic and laparoscopic approaches. Twenty-nine births from LD-UTx have been reported, four after robotic living-donor hysterectomy and twenty-five after a laparotomic procedure. UTx is now an effective treatment for women with UFI. While living-donor UTx in some cases may be considered an experimental procedure, it offers the extraordinary possibility to give women the opportunity to have a pregnancy. Many efforts should be made to reduce the potential risks for donors, including the use of mini-invasive techniques, and the efficacy of UTx in the recipients, giving the potential harm of immunosuppression in a recipient of a non-life-saving organ.

Inguinal field block for femoral artery exposure during endovascular aneurysm repair.

PURPOSE: To analyze the feasibility and outcomes of an inguinal field block (IFB) for femoral artery exposure in patients undergoing elective endovascular aneurysm repair (EVAR). METHODS: Between January 2004 and June 2012, 784 patients (597 men; mean age 76 years) underwent elective EVAR via surgical cutdown to the common femoral arteries. The data from these procedures were retrospectively analyzed to determine the technical feasibility of IFB, need for conversion to general anesthesia, mortality, and complication rate. RESULTS: IFB was successfully performed in 768 (97.9%) patients. Conversion from IFB to general anesthesia was necessary in 11 (1.4%) patients owing to patient discomfort (n=3, 0.4%), anxiety (n=5, 0.6%), and persistent patient movement (n=3, 0.4%). The remaining 5 (0.7%) patients underwent EVAR under general anesthesia because they refused IFB. Technical success of EVAR was 99.7%; the mean operation time was 84 minutes and the radiation time was 13 minutes. The mean hospital stay was 3.7 days; no patient required intensive care. At 6 months, there were no reports of local/systemic complications related to IFB, such as infection, seroma, hematoma, nerve injury, or allergic/toxic reactions. CONCLUSION: Our study demonstrated that performing EVAR with femoral cutdown under IFB is a feasible, safe, and effective surgical and anesthetic combination, with very little need for conversion to general anesthesia.

Carotid restenosis after endarterectomy and stenting: a critical issue?

BACKGROUND: Carotid artery stenting (CAS) is currently considered a valid alternative to carotid endarterectomy (CEA) for the prevention of stroke in high-risk patients. One of the most important issues for both of these techniques is carotid restenosis. The aim of our study was to evaluate the incidence of post-CEA and post-CAS restenosis in a large cohort of patients in a single high-volume center. METHODS: Between December 2000 and December 2010, 2453 CEA and 2628 CAS procedures were performed in the Vascular and Endovascular Surgery Unit at our institution. The mean age of patients was 73.8 years (range 55‒89 years), 78% of whom were men. Indications for carotid revascularization were: presence of symptomatic carotid artery stenosis of >70%, or asymptomatic stenosis of at least 80%, especially in patients with vulnerable plaques. RESULTS: Mild and long-term results after CEA and CAS were similar. The overall perioperative neurologic complication rate (minor and major stroke) was similar in the 2 groups. At 1-year follow-up the restenosis rate after CEA was 1.58%. In-stent restenosis after CAS occurred in 1.67% of the procedures. All but 3 arteries had been treated for postsurgical restenosis. All lesions were approached secondarily with endovascular procedures. Statistical analysis demonstrated that post-CEA restenosis was the most important predictive factor for the development of in-stent restenosis after CAS. CONCLUSIONS: This review of our 10-year experience confirms that patients who develop restenosis after CEA are also prone to developing in-stent restenosis after CAS.

Outcome Analysis of Speed Gate Cannulation during Standard Infrarenal Endovascular Aneurysm Repair.

BACKGROUND: Endovascular aortic repair (EVAR) is generally performed with bi/trimodular stent-grafts requiring retrograde contralateral gate cannulation (CGC). In the case of tricky CGC, an increased EVAR procedural time and radiation exposure have been reported. Herein, we compare the outcomes of conventional CGC and CGC using the speed gate cannulation (SGC) technique in standard EVAR for a propensity-matched cohort. METHODS: A total of 371 patients were retrospectively analyzed. Inclusion criteria were fulfilled in 172 patients who underwent propensity score matching. Primary outcomes included operative time, CGC time, mean contrast medium, fluoroscopy time, and CGC fluoroscopy time. RESULTS: After matching, 78 patients were included in each group (SGC vs. standard). Primary outcomes registered a significant reduction in CGC time (4 [1-6] vs. 8 [6-14] min; p = 0.001) and fluoroscopy time (12 [9-16] vs. 17 [12-25] min). CONCLUSIONS: In this preliminary experiment, the use of SGC was feasible with no significant registered postoperative complications. A significant reduction in contrast medium usage, radiation exposure, and CGC time was observed with the use of SGC. SGC is a simple adjunctive technique, and its use should be considered in standard EVAR, especially in emergency scenarios, where time is of the essence.

Safety and feasibility of intravascular optical coherence tomography using a nonocclusive technique to evaluate carotid plaques before and after stent deployment.

PURPOSE: To evaluate the safety and feasibility of optical coherence tomography (OCT) in patients with carotid stenosis undergoing carotid artery stenting (CAS). METHODS: In a prospective study, 25 consecutive patients (15 men; mean age 74±4 years) undergoing protected CAS were enrolled and underwent high-definition (homoaxial resolution 10 µm) OCT image acquisition before stent deployment, immediately after stent placement, and following postdilation of the stent (3 scans/patient). Pullbacks were started during a nonocclusive flush, mechanically injecting 24 mL of 50% diluted contrast at 6 mL/s to displace blood from the artery. Two independent physicians judged the quality of images on a predefined 1-10 scale. The proportions of specific agreement and kappa values (κ) were calculated. RESULTS: No procedural or in-hospital neurological complications occurred (any stroke/death 0%). The technical success of OCT pullbacks was 97.3% (73/75). The total amount of contrast was 86±18 mL/patient. No significant alteration in glomerular filtration rate or any other significant adverse event occurred. The images obtained were of high quality (mean value 8.1 out of 10), with good inter- and intraobserver agreement (κ = 0.81-0.87 and κ = 0.95, respectively). OCT images revealed innovative features such as rupture of the fibrous cap, plaque prolapse, and stent malapposition in a high percentage of the patients (range 24%-100%). CONCLUSION: Intravascular OCT during a nonocclusive flush appears to be feasible and safe in carotid arteries. Since some original and unexpected information after CAS has been made available for the first time at such a high definition, future studies with OCT should focus on the interaction between carotid plaque and stent design, which might revolutionize our understanding of the mechanisms of carotid stenting, as well as influence our clinical policies.

A case of contrast-induced encephalopathy using iodixanol.

PURPOSE: To document a heretofore unreported complication of the contrast agent iodixanol during an endovascular procedure. CASE REPORT: A 76-year-old woman with a history of coronary artery disease was admitted to the emergency department for recurrent transient ischemic attacks. Before combined percutaneous transluminal coronary angioplasty and carotid artery stenting (CAS) using iodixanol, the patient suffered from concomitant unstable angina and recurrent transient ischemic attacks. The total amount of iodixanol used during the CAS procedure was 300 mL. Contrast-induced encephalopathy, which manifested as aphasia, stupor, and full hemiparesis immediately after the combined procedure, was diagnosed by urgent computed tomography. Treatment was based on anti-edema drugs, and the patient made a complete recovery within 48 hours, without any neurological sequelae. CONCLUSION: Although previously reported in relation to other types of contrast media, contrast-induced encephalopathy has never been described as a complication of an endovascular procedure using iodixanol.

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.