Reintervention rate after infrarenal aortic aneurysm repair is lower for open than endovascular repair with aneurysm sac shrinkage: a fifteen-year study.

BACKGROUND: The aim of this study was to report long-term results of infrarenal abdominal aortic aneurysm (AAA) in a single tertiary Hospital. METHODS: One thousand seven hundred seventy-seven consecutive AAA repairs (2003-2018) were included. Primary outcomes were all-cause mortality, AAA-related mortality, reinterventions rate. Open repair (OSR) was offered in case the patient had a functional capacity ≥4 metabolic equivalents (MET), and a predicted >10 year life expectancy. Endovascular repair (EVAR) was offered in case of hostile abdomen, presence of anatomic feasibility for standard endovascular graft, and <4 MET. Sac shrinkage was defined as a reduction of both anterior-posterior and latero-lateral diameter of the sac of at least 5 mm at the last follow-up vs. the first post- operative follow-up imaging. RESULTS: Eight hundred twenty-eight (47%) OSRs and 949 (53%) EVARs were performed 90.6% (N.=1610) were male, mean age was 73.8 years. Mean follow-up was 79 (SD: 51) months. 30-day mortality was 0.7% (N.=6) and 0.6% (N.=6) for OSR and EVAR respectively (P=1). Long-term survival was better for OSR as expected by the selection criteria used (P<0.001), while AAA-related death was similar in the OSR vs. EVAR group (P=0.37); 664 (70%) sac shrinkages occurred at the last follow-up in the EVAR group. Freedom from reintervention was 97% and 96% at 1 year, 96.5% and 88.4% at 5 years, 95.8% vs. 81.7% at 10 years, and 94.6% vs.72.3% at 15 years for OSR and EVAR, respectively (P<0.001). The reintervention rate was significantly lower in the sac shrinkage vs. no-sac shrinkage subgroup and but higher than the OSR (P≤0.001). Any statistical difference was found for the survival outcome in case of sac shrinkage (P=0.1). CONCLUSIONS: Open repair of an infrarenal AAA had a lower reintervention rate than EVAR even in case of a shrinked sac at a long-term follow-up. Further studies with greater sample size are needed.

Mills valvulotome reduces distal vein injuries and improves follow-up freedom from restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

BACKGROUND: In this study, the early and mid-term outcomes of the use of the Mills valvulotome in patients with chronic limb-threatening ischemia (CLTI) undergoing infrainguinal in-situ saphenous vein bypass were investigated. METHODS: From January 2018 until December 2019, 153 consecutive CLTI patients from 7 centers have been treated with infrainguinal in-situ saphenous vein bypass. In all patients the devalvulation of the great saphenous vein (GSV) was obtained with the use of the HYDRO LeMaitre® valvulotome (LeMaitre Vascular, Burlington, MA, USA). Eighty-six patients (56.2%) received the additional treatment of the LeMills valvulotome (LeMaitre Vascular) to disrupt the distal valves of the GSV (Group MV), whilst in the remaining 67 patients (43.8%) this adjunctive device was not used (Group no-MV). Initial outcome measures including intraoperative vein injuries were assessed and compared. At 2-year follow-up, estimated outcomes of primary patency, primary assisted patency, secondary patency, freedom from distal vein restenosis, and limb salvage were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: Intraoperatively, the overall rate of vein injuries related to the devalvulation was 5.2% (8 cases) with four cases in both groups (4/86, 4.6%, Group MV vs. 4/67, 6%, Group no-MV; P=0.49). Overall, 4 lesions occurred in the distal portion of the GSV and were all reported in Group no-MV (0/86, 0%, Group MV vs. 4/67, 6%, Group no-MV; P=0.03). Median duration of follow-up was 12 months (IQR: 6-24). At 2-year follow-up there were no differences between the two groups in terms of primary patency (69.9% Group MV vs. 79.8% Group no-MV, P=0.08), primary assisted patency (85.4% Group MV vs. 90.5% Group no-MV, P=0.37), secondary patency (94.2% Group MV vs. 92.1% Group no-MV, P=0.61), and limb salvage (97.4% Group MV vs. 98.2% Group no-MV, P=0.74). Patients in Group MV had a higher rate of freedom from distal vein restenosis (92.2% Group MV vs. 76% Group no-MV, P=0.03). CONCLUSIONS: Adjunctive use of the Mills valvulotome (LeMaitre Vascular) reduces intraoperative distal vein injuries and improves the 2-year freedom from distal vein restenosis in patients undergoing infrainguinal in-situ saphenous vein bypass.

Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia.

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan-Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.

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.

Intra-arterial injection of iloprost reduces the risk of early recoil after balloon angioplasty of below-the-knee vessels in patients with critical limb ischemia.

BACKGROUND: Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). METHODS: Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). RESULTS: Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. CONCLUSIONS: In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

Long-term analysis of standard abdominal aortic endovascular repair using different grafts focusing on endoleak onset and its evolution.

OBJECTIVE: To report long-term results of standard EVAR focusing on endoleak onset (ELo) and its evolution. METHODS: 880 EVARs using different stentgrafts (1999-2015) were included. Primary outcomes were all-cause mortality and AAA-related mortality. Timing of ELo after EVAR was categorized as follows: ELo1 = 0-2 years, ELo2 = 2-4 years, ELo3 = 4-6 years, ELo4 = 6-8 years, and ELo5 ≥ 8 years. The rate of sac shrinkage/sac expansion and the need to re-intervene were the variables considered to determine EL evolution. RESULTS: Median follow-up was 60 months (IQR: 36-84). Summary follow-up index was 0.99. Survival rate was 94.5% at 2 years, 57.7% at 10 years, 33.3% at 14 years. Freedom from AAA-related-death rate was 99.3% at 14 years. Freedom from endoleak was 86.4% at 2 years, 68.3% at 10 years, and 48.6% at 14 years. EL rate was 1.9% (n = 19),16.6% (n = 146), 0.8% (n = 7), and 0.4% (n = 4) for type I, II, III and IV, respectively. Only type II EL showed a significant difference in the ELo (Elo1 = 31%; ELo2 = 12.8%; ELo3 = 9.4%; Elo4 = 10.2%; Elo5 = 11.4%; P < .001). Sac shrinkage occurred in 791 (90%) patients while 89 (10%) had a persistent sac expansion at the last follow-up. Freedom from reintervention was 95.6% at 2 years, 86.4% at 10 years, and 80% at 14 years. 48 out of 176 (27.2%) patients with EL underwent reintervention. The re-intervention rate was significantly higher within the first two years of follow-up if compared to the following years (17.6% vs. <10%; P < .001). CONCLUSIONS: An active lifelong surveillance follow-up can guarantee good long-term EVAR outcomes. Reinterventions and type II EL were more frequent in the first two-year of follow-up.

Endovascular Aortic Repair Follow up Protocol Based on Contrast Enhanced Ultrasound Is Safe and Effective.

OBJECTIVES: The aim of this study was to define the safety and effectiveness of a contrast enhanced ultrasound (CEUS) based follow up for endovascular aortic repair (EVAR) surveillance at a mid-term period (4 years). METHODS: At the tertiary referral centre EVAR surveillance was based on plain abdominal radiograph and duplex ultrasound (CDU), with computed tomography angiography (CTA) reserved for any non-diagnostic imaging during the period 1999-2011 (Group A). From 2012, CEUS was performed when (a) any endoleak was detected at CDU, (b) sac growth > 5 mm within 6 months, and routinely for (c) patients with renal insufficiency (above Stage 3 chronic kidney disease), or (d) iodine contrast allergy (Group B). RESULTS: A total of 880 patients (mean age 75.6 ± 8.4 years; 824 male) who underwent EVAR between 1999 and 2015 and with a minimum of 1 year follow up were included. Six hundred and nineteen patients were in Group A (70%) and the remaining 261 in Group B (30%). Median follow up was 48 months (interquartile range 24-84). During the study period 318 CEUS scans were performed with no related complications. Indications for CEUS were the following: (a) 160 (50%) endoleak presence, (b) 34 (11%) significant sac expansions, (c) 91 (29%) renal insufficiency (Stage 3 or above CKD), and 33 (10%) iodine contrast allergies. CEUS was compared with CTA, with additional confirmation by angiographic and operative findings in the case of repair in the first 100 patients. CEUS had 100% sensitivity and 100% specificity in classifying endoleaks. No differences in endoleak, re-interventions and sac shrinkage percentage were seen between the two groups at 4 years. A 4 year analysis of CTA use found a 90% reduction with the introduction of CEUS. CONCLUSIONS: The introduction of a CEUS based protocol for EVAR follow up was safe and effective and it was similar to the previous CTA based follow up protocol with regard to identification of endoleaks in a mid-term period. Moreover, CEUS allowed for 90% reduction of CTA, thereby decreasing radiation exposure for patients.

Impact of Pedal Arch Patency on Tissue Loss and Time to Healing in Diabetic Patients with Foot Wounds Undergoing Infrainguinal Endovascular Revascularization.

Objective: To retrospectively evaluate the impact of pedal arch quality on tissue loss and time to healing in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization. Materials and Methods: Between January 2014 and June 2015, 137 consecutive diabetic patients with foot wounds underwent infrainguinal endovascular revascularization (femoro-popliteal or below-the-knee, arteries). Postprocedural angiography of the foot was used to divide the patients into the following three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Time to healing and estimated 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated and compared among the three groups. Results: Postprocedural angiography showed the presence of a CPA in 42 patients (30.7%), IPA in 60 patients (43.8%), and APA in 35 patients (25.5%). Healing within 3 months from the procedure was achieved in 21 patients with CPA (50%), 17 patients with IPA (28.3%), and in 7 patients with APA (20%) (p = 0.01). There was a significant difference in terms of 1-year freedom from minor amputation among the three groups (CPA 84.1% vs. IPA 82.4% vs. APA 48.9%, p = 0.001). Estimated 1-year limb salvage was significantly better in patients with CPA (CPA 100% vs. IPA 93.8% vs. APA 70.1%, p < 0.001). Estimated 1-year survival was significantly better in patients with CPA (CPA 90% vs. IPA 80.8% vs. APA 62.7%, p = 0.004). Conclusion: Pedal arch status has a positive impact on time to healing, limb salvage, and survival in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization.

One-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease.

OBJECTIVE: The objective of this study was to report the methodology and 1-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease (TAAD). METHODS: Complex TAADs without a feasible conventional surgical repair were prospectively evaluated by vascular surgeons of the same public health service (National Health System) located in a huge area of 22,994 km2 with 3.7 million inhabitants and 11 tertiary hospitals. Surgeons evaluated computed tomography scans and clinical details that were placed on a web platform (Google Drive; Google, Mountain View, Calif) and shared by all surgeons. Patients gave informed consent for the teleconsultation. The surgeon who submits a case discusses in detail his or her case and proposes a possible therapeutic strategy. The other surgeons suggest other solutions and options in terms of grafts, techniques, or access to be used. Computed tomography angiography, angiography, and clinical outcomes of cases are then presented at the following telemeetings, and a final agreement of the operative strategy is evaluated. Teleconsultation is performed using a web conference service (WebConference.com; Avaya Inc, Basking Ridge, NJ) every month. An inter-rater agreement statistic was calculated, and the κ value was interpreted according to Altman's criteria for computed tomography angiography measurements. RESULTS: The rate of participation was constant (mean number of surgeons, 11; range, 9-15). Twenty-four complex TAAD cases were discussed for planning and operation during the study period. The interobserver reliability recorded was moderate (κ = 0.41-0.60) to good (κ = 0.61-0.80) for measurements of proximal and distal sealing and very good (κ = 0.81-1) for detection of any target vessel angulation >60 degrees, significant calcification (circumferential), and thrombus presence (>50%). The concordance for planning and therapeutic strategy among all participants was complete in 16 cases. In one case, the consultation was decisive for creating an innovative therapeutic strategy; in the remaining seven cases, the strategy proposed by the patient's surgeon was changed completely after the discussion. Technical success was the same (100%) if concordance in planning was present initially or not. Overall 6-month mortality was 4%, 0% for those patients with initial concordance in planning vs 12% for those without initial concordance (P = .33). Surgery was always performed in a tertiary hospital by local surgeons, and in two cases (8%) external surgeons joined the local surgical team. CONCLUSIONS: Such a regional service of teleconsultation may be of value in standardizing the treatment and derived costs of complex TAADs in a huge region under the same health provider. The shared decision-making strategy may be of medical-legal value as well.

Carbon-coated self-expandable stents in patients with atherosclerotic iliac artery disease.

BACKGROUND: The aim of this study was to evaluate the safety and effectiveness of carbon-coated self-expandable stents in the revascularization of atherosclerotic iliac artery lesions. METHODS: Between January 2012 and June 2016 54 carbon-coated self-expandable stents (Easy HiFlype and Easy Flype; manufactured by CID S.p.A., a member of Alvimedica Group, Istanbul, Turkey) in 40 patients were implanted in our Center. Early and 2-year outcomes have been evaluated in terms of major morbidity, mortality, primary patency, primary assisted patency, secondary patency, absence of target lesion restenosis (TLR), healing of the lesions/relief of symptoms, and limb salvage. RESULTS: The patients were predominantly males (32/40, 80%) with a mean age of 71 years (range 46-94). One patient (2.5%) had a documented nickel allergy. Mean duration of follow-up was 13.9 months (range 1-48). At 30 days no patient died and 1 patient underwent surgical revision of percutaneous femoral access. The estimated 2-year primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage were 92.8%, 93.1%, 95.7%, 79.5%, and 100%, respectively. At univariate analysis none of the pre- or intra-operative factors significantly affected the primary and primary assisted patency rates. Secondary patency was significantly affected by absence of post-stent balloon dilatation (P=0.003). Absence of TLR was significantly affected by age more than 80 years (P=0.01) and common iliac artery lesions (P=0.02). These significances were confirmed at Cox regression analysis. CONCLUSIONS: Use of carbon-coated self-expandable stents in atherosclerotic iliac lesions was safe and effective. At 2 years, the patency rates and the absence of TLR were encouraging. Post-stent balloon dilatation should be recommended in all cases. Older patients and common iliac artery lesions were risk factors for restenosis in the mid-term period.

Outcomes of three types of native arteriovenous fistula in a single center.

OBJECTIVE: To study the outcomes of three different types of native arteriovenous fistula (AVF), the distal (D: radial-cephalic), middle-arm (MA: radial-cephalic) and proximal (P: brachial-cephalic) AVF access creation for hemodialysis patients in a single center. METHODS: An 8-year retrospective review, from 2006 to 2014, was conducted at a single institution in which the surgical outcomes for three different types of native AVF creation were reviewed. Preoperative duplex vein mapping was obtained in all patients to choose the best vein and site for access. RESULTS: There were 317 patients identified with 41 D-AVFs, 120 MA-AVFs and 156 P-AVFs. Younger patients with a lower Charlson's Index were more frequent in the D-AVF group (p = 0.02). Mean operating room time was 15 minutes longer for the MA-AVF group than the two others (p = 0.018). Early failure (thrombosis at 30-day), one-year patency, one-year primary AVF functional patency for the D-AVF, MA-AVF, and P-AVF groups were 2.4% (n = 1), 8% (n = 1), 3.8% (n = 6), (p = 0.14); 97.6% (n = 39), 99% (n = 117), 89% (n = 129), (p<0.001); 80.5% (n = 33), 75.8% (n = 91), and 61.5% (n = 96) (p<0.001), respectively. Reintervention for fistula maturation was required in 17% (n = 7), 23% (n = 28), and 24% (n = 38) (p<0.01). The one-year venipuncture hematoma and steal syndrome occurrences were 9.7% (n = 4), 6.7% (n = 8), 3.8% (n = 6) (p = 0.06); and 0%, 0% and 3.8% (n = 6) (p = 0.04), respectively. In case of failure of either MA-AVF or D-AVF, a P-AVF was always feasible as a second native AVF hemodialysis access. CONCLUSIONS: D-AVF is still the gold-standard access for hemodialysis. If D-AVF is not possible, MA-AVF should be always investigated before committing to a P-AVF.

Midterm Results of Low-Profile Stents to Treat Atherosclerotic Iliac Artery Disease.

PURPOSE: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. METHODS: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. RESULTS: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1-72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). CONCLUSION: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.

Pedal arch patency and not direct-angiosome revascularization predicts outcomes of endovascular interventions in diabetic patients with critical limb ischemia.

BACKGROUND: The aim of this study was to evaluate the impact of pedal arch status and direct-angiosome revascularization (DAR) on clinical outcomes in diabetic patients with foot wounds undergoing endovascular revascularization. METHODS: Between January 2014 and June 2015, 93 diabetic patients with foot wounds underwent endovascular revascularization of at least one below-the-knee vessel. Patients were divided into three groups according to the pedal arch status: complete pedal arch (CPA), incomplete pedal arch (IPA) and absent pedal arch (APA). Healing within 3 months and 1-year outcomes in terms of freedom from minor amputation, limb salvage, and survival were evaluated on the basis of DAR and pedal arch status. RESULTS: DAR did not affect healing within 3 months from the procedure (DAR, 13/55 cases, 23.6% vs. n-DAR, 9/38 cases, 23.7%; P=1), estimated 1-year freedom from minor amputation (DAR 74.4% vs. n-DAR 76.8%, P=0.80), limb salvage (DAR 88.2% vs. n-DAR 89.5%, P=0.44), and survival (DAR 83.3% vs. n-DAR 66.6%, P=0.15). Pedal arch had positive impact on wound healing within 3 months from the procedure (CPA 45.8% vs. IPA 12.5% vs. APA 20.7%, P=0.009), estimated 1-year limb salvage (CPA 100% vs. IPA 90.9% vs. APA 76.1%, P=0.02), and 1-year survival (CPA 100% vs. IPA 87.2% vs. APA 60.3%, P=0.02). CONCLUSIONS: DAR is not a predictor of good outcomes in diabetic patients undergoing endovascular procedure. Pedal arch patency seems to be a key factor to obtain good outcomes in terms of wound healing, and limb salvage.

Technical Notes for Treatment of a Pluri-Relapsing Iliac and Femoral Pseudoaneurysm.

BACKGROUND: To describe a technique that connects an Anaconda stent graft (Vascutek, Terumo, Inchinnan, Scotland) to a target artery in a hybrid method. CASE REPORT: The patient was a 65-year-old man with a huge pluri-relapsing iliac and femoral pseudoaneurysm of a previous aortobifemoral bypass. An Anaconda stent graft was used to repair the lesion. After partial dissection of the femoral bifurcation, the Anaconda stent graft was partially introduced via a direct puncture in the anterior wall of the femoral artery over a guidewire. The end of the stent graft outside that artery was cut and adjusted to the exact length to be sutured in an end-to-end fashion to the profunda femoral artery. The proximal sutureless telescoping anastomosis avoided a challenging and risky iliac surgical access. The distal surgical anastomosis guaranteed a stable suture in such a dynamic region. CONCLUSIONS: The hybrid technique using the Anaconda stent graft herein described is a safe alternative for challenging iliofemoral aneurysmatic disease treatment. Longer follow-up and more patients are needed before this technique could be recommended for use.

Cranial nerve injury is associated with dual antiplatelet therapy use and cervical hematoma after carotid endarterectomy.

OBJECTIVE: To determine predictors of cranial nerve injury (CNI) after carotid endarterectomy (CEA). METHODS: Consecutive CEAs performed over a 5-year period were enrolled in this study. Outcomes analyzed included 30-day major adverse event rate (composite of stroke, death, and myocardial infarction), death, stroke, disabling stroke, myocardial infarction, cervical hematoma and CNI rate, reoperation, and hospital readmission at 30 days. RESULTS: There were 1258 CEAs were included in the study, 1168 (93%) were performed using an eversion technique. Patients with symptoms comprised 27% of the cohort (n = 340). At 30 days, there were no deaths, 23 major adverse events (1.8%), 11 strokes (0.9%: nine minor, two major), 12 myocardial infarctions (0.9%), 41 cervical hematomas (3.3%), 9 reoperations (0.7%) and 10 hospital readmissions (0.8%). Median duration of stay was 1 day (interquartile range, 1-2 days). CNI rate at discharge was 2.3% (n = 29). Two patients (9%) had more than one cranial nerve affected. The marginal mandibular branch of the facial nerve was most frequently involved (n = 16; 52%), followed by the hypoglossal (n = 9; 29%), the vagus (n = 4; 13%), and the spinal accessory nerve (n = 2; 6%). Horner's syndrome, consistent with an injury to the cervical sympathetic chain, occurred in 13 patients (1%) who had a true cranial nerve affected as well. The vast majority (94%) of these CNIs and all Horner's syndrome neurapraxias were transient; only the two accessory lesions persisted at their follow-up visit (median, 32 months; range, 8-72 months). Significant predictors for CNI included diabetes (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.0-6.2; P = .048), cervical hematoma (OR, 41.7; 95% CI, 13.8-125.4; P < .001), and dual antiplatelet therapy (OR, 4.4; 95% CI, 1.7-11.4; P = .002). CONCLUSIONS: CNI is predominantly a transient complication, but is associated significantly with dual antiplatelet therapy use and the occurrence of a postoperative cervical hematoma. Scrupulous attention to hemostasis might reduce the incidence of CNI.

Diabetic Foot Infection: Preliminary Results of a Fast-Track Program with Early Endovascular Revascularization and Local Surgical Treatment.

BACKGROUND: To demonstrate that a fast-track program consisting in early endovascular revascularization and local surgical treatment saves tissue in patients with diabetic foot infection (DFI). METHODS: Between January and December 2014, 48 patients with DFI underwent early endovascular revascularization and local surgical treatment at our Diabetic Foot Center. In all cases, endovascular revascularization and local surgical treatment were performed within 1 week from the diagnosis of infection and during the same hospital stay. One-year outcomes were evaluated in terms of survival, primary patency, primary-assisted patency, secondary patency, absence of target lesion restenosis (TLR), and limb salvage. RESULTS: The patients were predominantly males (34 of 48, 70.8%) with a mean age of 72.4 years (range, 51-91). The target vessel was a tibial artery in 34 cases (70.8%). Surgical treatment consisted of debridement without bone resection in 27 cases (56.2%), toe and/or ray amputation in 15 cases (31.2%), Lisfranc amputation in 2 cases (4.2%), transmetatarsal amputation in 2 cases (4.2%). In the remaining 2 cases, a leg amputation was necessary with an overall 30-day major amputation rate of 4.2%. During the follow-up (mean duration 6.9 months, range 1-12) healing of the lesions was obtained in 30 cases (62.5%). Estimated 12-month survival, primary patency, primary-assisted patency, secondary patency, absence of TLR, and limb salvage rates were 83.5%, 53.4%, 65%, 65%, 60.7%, and 86.6%, respectively. CONCLUSIONS: A fast-track program consisting in early endovascular revascularization and local surgical treatment contributes to our experience in limiting amputation levels in patients with DFI. A multidisciplinary approach and adoption of diabetic foot triage are essential to achieve these outcomes.

Use of Tapered Balloons to Recanalize Occluded Below-the-Knee Arteries in Diabetic Patients with Critical Limb Ischemia.

BACKGROUND: The aim of this study was to evaluate the outcome of tapered balloon use in recanalization of long occlusions of below-the-knee (BTK) arteries in diabetic patients with critical limb ischemia (CLI). METHODS: Forty-nine occluded BTK arteries in 35 diabetic patients with CLI were revascularized in our Diabetic Foot Center between January and September 2014 using tapered balloons. Twelve-month outcomes were evaluated in terms of healing of the lesions, survival, limb salvage, primary patency, primary assisted patency, and secondary patency. RESULTS: The patients were predominantly male (27/35, 77.1%) with a mean age of 70.9 years (±10.3 standard deviation [SD]). During the follow-up (mean duration 12.4 months ± 4 SD), healing of the lesions was obtained in 27 of the 35 cases (77.1%). Estimated 12-month survival and limb salvage were 85.7% and 91.1%, respectively. Estimated 12-month primary patency, primary assisted patency, and secondary patency were 78.3%, 79%, and 88.9%, respectively. Univariate analysis demonstrated that the presence of chronic renal failure affected survival (P = 0.005), and assignment to Rutherford class 6 affected limb salvage (P = 0.005), primary patency (P < 0.001), and primary assisted patency (P < 0.001). Furthermore, the presence of coronary artery disease affected primary patency (P = 0.001) and primary assisted patency (P = 0.05). CONCLUSIONS: Tapered balloons are a safe and effective means to recanalize long occlusions of BTK arteries in diabetic patients with CLI. Outcomes are poorer in patients with major tissue loss and with a history of coronary artery disease. Further experience with larger groups is needed to validate these outcomes.

Urgent endovascular revascularization in acute on chronic critical limb ischemia.

BACKGROUND: The aim of this study was to evaluate early and one-year outcomes of urgent endovascular treatment in patients with acute on chronic critical limb ischemia (CLI). METHODS: Between January 2012 and December 2013 104 patients with acute on chronic CLI (Rutherford class 4-6) were referred to two tertiary hospitals. In all cases the urgent endovascular revascularization was considered the first therapeutic option. Twenty-seven patients (26%) were excluded from this approach (long occlusion >30 cm of the femoro-popliteal tract and/or massive gangrene with abscess/osteomyelitis/necrotizing fasciitis). RESULTS: Seventy-seven out of 104 patients received an urgent endovascular treatment. They were predominantly male (43, 55.8%) with a mean age of 76.5 years (range 47-94). In 67 cases (87%) the patients had leg/foot lesions (54, 70.1%, Rutherford class 5, and 13, 16.9%, Rutherford class 6). During the follow-up (mean duration 6.2 months, range 1-24 months) the healing of the lesions and the relief of rest pain were obtained in 46 cases (59.7%). Estimated one-year primary patency, primary assisted patency, secondary patency, and limb salvage rates were 63.6%, 68.3, 69%, and 84.1%, respectively. At uni- and multivariate analysis patients in Rutherford class 6 showed poor results in terms of primary patency, primary assisted patency, secondary patency, and limb salvage (P<0.001). CONCLUSIONS: Urgent endovascular treatment in selected patients with acute on chronic CLI represents a safe and effective option with good results in terms of healing of the ischemic lesions, relief of rest pain, and limb salvage. Patients in Rutherford class 6 showed fewer benefits with this approach.

Drug-eluting balloons to treat iliac in-stent restenosis.

BACKGROUND: To report our experience in the use of drug-eluting balloons (DEBs) for the treatment of symptomatic iliac in-stent restenosis (ISR). CASE REPORTS: Six patients underwent treatment using DEBs for iliac ISRs in our centers between September 2011 and May 2014. The patients were predominantly women (4 of 6, 66.7%) with a mean age of 67.2 years (range, 46-75 years). Technical success was achieved in all cases. During the follow-up (mean duration, 15.5 months; range, 3-30 months), healing of the lesions/relief of symptoms was obtained in 5 of 6 cases (83.3%). Estimated 2-year rates of overall patency and limb salvage were 100%. CONCLUSIONS: The use of DEBs in the treatment of iliac ISR is safe and effective. The early and 2-year outcomes are promising. However, further experience with larger patient groups is needed.

"Thirty-day neurologic improvement associated with early versus delayed carotid endarterectomy in symptomatic patients".

BACKGROUND: Neurologic outcome after early or delayed carotid endarterectomy (CEA) has yet to be fully elucidated. The aim of this study was to determine 30-day neurologic improvement with respect to the timing of CEA in symptomatic patients. METHODS: Single-institution review of consecutive patients who underwent CEA for symptomatic carotid stenosis ≥60% in the period between January 2009 and November 2013. Patients recruited had acute neurologic impairment on presentation, defined as <5 points on the National Institutes of Health Stroke Scale (NIHSS). Patients were grouped according to time between the qualifying event and surgery (0-14 days, early CEA and 15-30 days, delayed CEA). Thirty-day neurologic status improvement was defined as a decrease (≥1) in the 30-day NIHSS score versus NIHSS score immediately before surgery. RESULTS: There were 100 and 222 patients in the early and delayed CEA groups, respectively. The type of qualifying symptoms (stroke versus transient ischemic attack rate) was similar and there were no significant differences in 30-day adverse outcome rates between the 2 cohorts. There were no deaths, 4 strokes (1.2%, 3 vs. 1; P = 0.091), and 4 myocardial infarcts (1.2%, 0 vs. 4; P = 0.315). Thirty-day improvement in neurologic status was associated with early CEA, very early CEA (48 hours), and NIHSS >2 before surgery, with an odds ratio of 4.9 (confidence interval [CI], 0.9-25.7; P = 0.03), 12.9 (CI, 1.4-115.7; P = 0.02), and 2.6 (CI, 1.7-4.1; P < 0.001), respectively. CONCLUSIONS: Our results suggest that reducing the time to intervention in selected (NIHSS <5) symptomatic patients is safe and associated with improved neurologic status.