One-Year Analysis of Autologous Peripheral Blood Mononuclear Cells as Adjuvant Therapy in Treatment of Diabetic Revascularizable Patients Affected by Chronic Limb-Threatening Ischemia: Real-World Data from Italian Registry ROTARI.

Wounds in diabetic patients with peripheral arterial disease (PAD) may be poorly responsive to revascularization and conventional therapies. Background/Objective: This study's objective is to analyze the results of regenerative cell therapy with peripheral blood mononuclear cells (PBMNCs) as an adjuvant to revascularization. Methods: This study is based on 168 patients treated with endovascular revascularization below the knee plus three PBMNC implants. The follow-up included clinical outcomes at 1-2-3-6 and 12 months based on amputations, wound healing, pain, and TcPO2. Results: The results at 1 year for 122 cases showed a limb rescue rate of 94.26%, a complete wound healing in 65.59% of patients, and an improvement in the wound area, significant pain relief, and increased peripheral oxygenation. In total, 64.51% of patients completely healed at 6 months, compared to the longer wound healing time reported in the literature in the same cohort of patients, suggesting that PBMNCs have an adjuvant effect in wound healing after revascularization. Conclusions: PBMNC regenerative therapy is a safe and promising treatment for diabetic PAD. In line with previous experiences, this registry shows improved healing in diabetic patients with below-the-knee arteriopathy. The findings support the use of this cell therapy and advocate for further research.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

A novel risk assessment tool for postoperative delirium in vascular surgery: The stress model (Siena posTopeRative dElirium in vaScular Surgery).

OBJECTIVE: Postoperative delirium (POD) is a common complication with a high health-related impact. The creation of a model (Siena posTopeRative dElirium in vaScular Surgery) to identify high-risk patients with consecutive prompt diagnosis and correct management. METHODS: This is an observational retrospective study to evaluate POD incidence in patients who underwent elective vascular surgery procedures between 2018 and 2020. POD was detected using CAM and defined as the onset of an acute confusional state, clinically manifesting as a disturbed state of consciousness, cognitive dysfunction, or alteration in perception and behavior. The total population was divided in the development and validation subsamples. Multivariable logistic regression analysis was performed, identifying variables related to the occurrence of POD. An additive score was created and the STRESS score was internally validated using the Validation subgroup. RESULTS: A total of 1067 patients were enrolled. POD occurred in 111 cases (10.4%). Multivariable logistic regression analysis for POD occurrence revealed as significant predictors: age>75 years, CKD, dyslipidaemia, psychiatric disease, CAD, hospitalization in the previous month, preoperative NLR >3.59, preoperative Hb < 12 g/dl, preoperative Barthel score <75, major amputation, CLTI revascularization, general anesthesia, and postoperative urinary catheter. These variables were used to create the STRESS score. The model was applied to both development and validation subgroups; AUC was respectively 0.7079 (p < .0001) and 0.7270 (p < .0001). CONCLUSION: The STRESS score has a good predictive potentiality for POD occurrence in elective vascular surgery procedures. However, implementation and external validation are needed to be correctly used in everyday clinical practice.

Residual Aneurysmal Sac Shrinkage Post-Endovascular Aneurysm Repair: The Role of Preoperative Inflammatory Markers.

INTRODUCTION: In this study, we evaluated the role of preoperative inflammatory markers as Neutrophil-to-Lymphocyte (NLR) and Platelet-to-Lymphocyte (PLR) ratios in relation to post-endovascular aneurysm repair (EVAR) sac shrinkage, which is known to be an important factor for abdominal aortic aneurysm (AAA) healing. METHODS: This was a single-center retrospective observational study. All patients who underwent the EVAR procedure from January 2017 to December 2020 were eligible for this study. Pre-operative blood samples of all patients admitted were used to calculate NLR and PLR. Sac shrinkage was defined as a decrease of ≥5 mm in the maximal sac diameter. The optimal NLR and PLR cut-offs for aneurysmal sac shrinkage were obtained from ROC curves. Stepwise multivariate analysis was performed in order to identify independent risk and protective factors for the absence of AAA shrinkage. Kaplan-Meier curves were used to evaluate survival rates with respect to the AAA shrinkage. RESULTS: A total of 184 patients were finally enrolled. The mean age was 75.8 ± 8.3 years, and 85.9% were male (158/184). At a mean follow-up of 43 ± 18 months, sac shrinkage was registered in 107 patients (58.1%). No-shrinking AAA patients were more likely to be older, to have a higher level of NLR and PLR, and be an active smoker. Kaplan-Meier curves highlighted a higher rate of survival for shrinking AAA patients with respect to their counterparts (p < 0.03). Multivariate analysis outlined active smoking and NLR as independent risk factors for no-shrinking AAA. CONCLUSIONS: Inflammation emerged as a possible causative factor for no-shrinking AAA, playing a role in aneurysmal sac remodeling. This study revealed that inflammatory biomarkers, such as NLR and PLR, can be used as a preoperative index of AAA sac behavior after EVAR procedures.

Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.

BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI. METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up. RESULTS: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered. CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.

Outcomes of Self-Expanding Covered Stents for the Treatment of External ILIAC Artery Obstructive Disease.

PURPOSE: To describe the early results and mid-term patency rates of external iliac artery (EIA) stenting using self-expanding covered stents. METHODS: We conducted a multicenter retrospective study (2015-2021), including patients receiving primary endovascular treatment of external iliac artery occlusive disease with self-expanding covered stents. All patients were treated with the Viabahn (W.L Gore & Associates, Inc., Flagstaff, AZ-USA) stent. Patency and limb salvage rates were estimated with Kaplan-Meier curves. RESULTS: Ninety-three patients (mean age, 69 ± 9 years; 81% males) were treated for disabling claudication in 44%, rest pain in 28%, and tissue loss in 28%. TASC C/D lesions were present in 72% and iliac complete occlusion in 30%. Mean lesion length was 6.9 ± 2.4 cm; 30% had moderate/severe EIA calcifications; and the mean iliac tortuosity index was 1.17 ± 0.13. Technical success was 100%. There was one perioperative death (1.4%) and procedural complication rate was 6.5%. At 42 months (mean, 25 months), primary patency was 89.8% (95%CI 83-98); the presence of EIA tortuosity (tortuosity index > 1.25, 87.7 ± 11% vs 89.9 ± 8%; P = .6) or severe calcifications (87.6 ± 9% vs 96.0 ± 8%; P = .400) had no significant impact. After univariate analysis, the use of a stent with diameter < 8 mm (HR 8.5, 95%CI 3.24-14.22; P < .001) was negatively associated with primary patency. CONCLUSIONS: The use of self-expanding covered stents provided excellent early and mid-term results in the treatment of obstructive disease of the EIA, also in cases of high EIA tortuosity and high grade of calcifications. The use of a < 8 mm-diameter stent was associated with a reduced primary patency.

The Combination of Vacuum-Assisted Thromboaspiration and Covered Stent Graft for Acute Limb Ischemia due to Thromboembolic Complications of Popliteal Aneurysm.

BACKGROUND: We present a standardized protocol of endovascular revascularization for patients with acute limb ischemia due to popliteal artery aneurysm (PAA) thromboembolic complication, based on the combination of vacuum-assisted thromboaspiration to improve tibiopedal outflow and covered stent graft to exclude the PAA. METHODS: All patients with a diagnosis of PAA complicated by thromboembolic events undergoing total endovascular rescue were prospectively enrolled in a dedicated database from November 2018 to November 2021. To assess vessel patency, the TIPI (Thromboaspiration In Peripheral Ischemia) classification was used. The primary end point was the primary technical success (at least one tibial vessel with a TIPI flow of 2 or 3). The 30-day overall mortality and amputation rates were considered as secondary end points. Patients' overall survival, limb salvage, freedom from reocclusion and reinterventions were reported as secondary late outcomes using Kaplan-Meier method. RESULTS: Seventeen male patients were enrolled with a mean age of 75.7 ± 9 years. Rutherford grading score was IIa in 52.9% (9/17) and IIb in 47.1% (8/17). PAA mean diameter was 37.4 ± 11.2 mm. All patients had tibial arteries involvement, and in 9 cases (52.9%) there was also the occlusion of the PAA. Mechanical thrombectomy with Indigo/Penumbra thromboaspiration system was used in all patients. PAAs were excluded using one or more VIABAHN covered endografts (range 1-3 pieces). Technical success was achieved in 94.1%. Fasciotomy was performed in 1 case (5.9%). Mortality and amputation rates at 30-day follow-up were respectively 0% and 5.9%. Survival rates at 6, 12, and 24 months were respectively 94.1%, 86.3%, and 67.9%. Secondary patency was achieved in all cases (100%). Freedom from reintervention was 80.4%, 65.8%, and 54.8% at 6-, 12-, and 24-month follow-up. Limb salvage was 88.2% at 6-, 12-, and 24-month follow-up, respectively. CONCLUSIONS: Although preliminary, our experience of total endovascular rescue for complicated PAA with thromboembolic events highlighted promising rates of limb salvage at 30 days after intervention. The total endovascular approach seems able to maximize tibiopedal outflow offering an interesting strategy in limb salvage.

High Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Associated with a Higher Risk of Hemodialysis Vascular Access Failure.

Our aim was to determine the predictive role of the preoperative neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in vascular access malfunctioning in patients who had undergone their first native arterio-venous fistula (AVF) for hemodialysis. Methods: This was a single-center retrospective observational study. All patients who underwent the procedure of the creation of a first native AVF for hemodialysis from January 2019 to December 2020 were considered eligible to be part of this study. Reinterventions for AVF malfunctioning were registered and the population was subdivided into two groups with respect to AVF malfunctioning. ROC curves were obtained to find the appropriate cut-off values for the NLR and PLR. A multivariate analysis was used to identify the independent predictors for an AVF malfunction. Kaplan−Meier curves were used to evaluate the AVF patency rates. A total of 178 patients were enrolled in the study, of them 70% (n = 121) were male. The mean age was 67.5 ± 12 years. Reinterventions for AVF malfunctioning were performed on 102 patients (57.3%). An NLR > 4.21 and a PLR > 208.8 was selected as the cut-off for AVF malfunctioning. The study population was divided into two groups depending on the NLR and PLR values of the individual. For the NLR < 4.21 group, the AVF patency rates were 90.7%, 85.3%, and 84% at the 3-, 6-, and 12-month follow-up, respectively, and 77.5%, 65.8%, and 39.3% at 3, 6, and 12 months for the NLR > 4.21 group, respectively (p < 0.0001). For the PLR < 208.8 group, the patency rates were 85.6%, 76.7%, and 67.7% at the 3-, 6-, and 12-month follow-up. For the PLR > 208.28 group, the patency rates were 80.8%, 71.2%, and 50.7% for the 3-, 6-, and 12-month follow-up, respectively (p = 0.014). The multivariate analysis highlighted that diabetes mellitus, the neutrophil count, the lymphocyte count, and the NLR were independent risk factors for an AVF failure. In our experience, the NLR and PLR are useful markers for the stratification of vascular access failure in hemodialysis patients. The inexpensive nature and ready availability of the values of these biomarkers are two points of strength for everyday clinical practice.

The Predictive Role of Inflammatory Biochemical Markers in Post-Operative Delirium After Vascular Surgery Procedures.

Background: Post-operative delirium (POD) is a common complication, especially in elderly patients who underwent vascular surgery procedures. The aim of this study was to evaluate the relation of inflammatory biochemical markers as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and systemic inflammation index (SII) with POD occurrence. Methods: This was a single-center, retrospective, observational study. We analyzed the perioperative data of patients who had undergone elective vascular surgery procedures. The occurrence of delirium after procedure was used to divide the population in two groups: POD-pos and POD-neg group. ROC curves were performed to find the appropriate cut-off values of NLR, PLR and SII. Multivariate analysis was used to identify the independent predictors for POD. Results: A total of 646 patients were enrolled. Mean age was 76.2±9.8 years, 68.4% were male. Seventy-three patients (11.3%) developed POD. Mean hospital stay was significantly increased in the POD-pos group (6.1±5.4 vs 3.2±2.8 days, p=0.0001). In-hospital reinterventions were more frequent in the POD-pos group (8.2% vs 3.8%). Blood values analysis reported significant differences: Hb, NLR, PLR, SII, creatinine and RCP were strongly increased (p<0.05) in the POD-pos group. ROC curves identified cut-off values for NLR>3.57, PLR>139.2 and SII>676.4. Multivariate analysis revealed that age, Renal Failure, peripheral revascularization procedures, major amputation, general anesthesia, hospitalization in the previous month, NLR>3.57 and SII>676.4 were independent risk factors for POD. Conclusion: POD represents a common complication of vascular surgery patients. Our study demonstrated that NLR, PLR and SII are reliable and readily available laboratory predictors of POD in vascular surgery that could help in POD risk-stratification.

Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study.

BACKGROUND: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. OBJECTIVE: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. METHODS: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. RESULTS: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. CONCLUSIONS: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label. TRIAL REGISTRATION: ClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36995.

Case Report: Inferior Vena Cava Agenesia in a Young Male Patient Presenting With Bilateral Iliac Veins Thrombosis.

Introduction: Anomalies in inferior vena cava represent an uncommon finding with a prevalence of 0. 3 to 0.5% among healthy patients. Specifically, the condition characterized by the agenesis of the inferior vena cava (IVC; AIVC) has been observed among the 0.0005 to 1% of the general population. AIVC is strongly related to deep vein thrombosis (DVT) of the lower limb and pelvic district, especially in young patients. The rarity of the presented condition could relate to an underestimation of its impact on a particular clinical setting leading to a delayed diagnosis and inaccurate early- and long-term management. Report: We presented a case of this anomaly regarding a 31-year-old man presenting with bilateral symptomatic proximal DVT. Duplex vascular ultrasound and subsequent CT-angiography revealed the complete occlusion of the right external and common iliac vein, as well as partial occlusion of the contralateral external iliac vein, in the patient. The exam also revealed the interruption of IVC in its infrarenal part. At the level of renal veins coalescence, IVC appeared again in its usual position. A dilatated portal system, hepatic veins, and azygos and hemiazygos systems were also highlighted. Anticoagulation was promptly started with the administration of Fondaparinux (7.5 mg/die). In addition, compression stocking was initiated within 24 h from diagnosis. After 3 weeks, the anticoagulation regimen was shifted toward the administration of a direct oral anticoagulant (Apixaban; 5 mg two times a day). At 1-month follow-up, a vascular duplex ultrasound revealed a complete resolution of the iliac veins' thrombosis. Conclusion: It is important to consider the eventuality of IVC anomalies in a young adult presenting with unexplained, extensive, or bilateral DVT. Accurate diagnostic evaluation is necessary to fully identify this condition that could represent a real challenge.

Prevalence of Erectile Dysfunction in Patients With Abdominal Aortic Aneurysm: An Exploratory Study.

Introduction: Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain a satisfactory erection for sexual intercourse. Many studies have highlighted that ED shares common cardiovascular risk factors with cardiovascular disease. No data are reported about the prevalence of ED in patients with the abdominal aortic aneurysm (AAA). The aim of our study was to investigate the preoperative information given about sexual functions of patients undergoing endovascular aneurysm repair (EVAR) and to compare it with the presence and severity of steno-occlusive atherosclerotic lesions of the pelvic arterial tree at pre-operative Computed Tomography Angiography (CTA). Methods: We prospectively enrolled all men patients who underwent elective EVAR from September to November 2021. Preoperative ED was evaluated using the International Index of Erectile Function (IIEF-5) questionnaire. Preoperative imaging was routinely performed with CTA scan of the abdominal aorta and iliac-pelvic district. An innovative score of pelvic arterial disease associated to AAA was defined, dividing the iliac district in 4 zones attributing a grading of severity for each zone bilaterally (score ranges 0-24). Linear regression analysis was used to correlate IIEF-5 score to anatomical score of pelvic arterial steno-occlusive disease. Results: A total of 25 patients were enrolled. Median age was 74 ± 5.3 years. IIEF-5 average score was 14.8 ± 7.1. Eight cases (32%) had severe ED; one case (4%) had moderate, five patients (20%) had mild to moderate ED; five patients (20%) had mild ED, and 6 (24%) patients had no ED. CTA evaluation revealed an average anatomical score of 7.9 ± 4.5. Pelvic disease was considered moderate-severe in 20 cases (80%) and not significant in 20% (five cases). Linear regression analysis confirmed the hypothesis that a more diseased pelvic arterial tree was correlated to a more severe ED (Y = -1.531* × + 26.35 [slope CI: -1.946 to -1.117, p < 0.0001]). Conclusion: Although typically unreported, the prevalence of ED associated to AAA was found to be high. A vasculogenic origin of ED in patients with AAA is plausible and may be easily confirmed by the evaluation of pelvic arterial distribution at angio-CT performed for EVAR planning. Our proposed "MAPPING AND SCORING SHEET" may help to identify the vasculogenic origin of ED in AAA patients.

Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair.

INTRODUCTION: Since 2010, the Ovation Abdominal Stent Graft System has offered a new sealing concept, achieved by a sealing ring filled with polymer 13 mm from the renal arteries. In the latest version, called Ovation Alto, the sealing ring is relocated 6 mm closer to the top of the fabric. This study describes the early clinical outcomes, after CE Mark approval in August 2020, of endovascular aneurysm repair with the Alto endograft. REPORT: Eleven patients underwent endovascular aneurysm repair with implantation of Ovation Alto endografts. All patients were male, and the median age was 75 (IQR 5.5) years. Hostile proximal aortic neck (<10 mm) was identified in six cases (54.5%). All procedures were performed using bilateral percutaneous approaches with no groin complications. The median procedure time was 58 (IQR 7.2) minutes, the median contrast volume used was 65 (IQR 4.2) mL, and the median blood loss 40 (IQR 12.4) mL. Technical success was achieved in all cases. The median stent graft landing distance between the top of the fabric and the lowest renal artery was 1.4 (IQR 0.8) mm. No intra-operative high flow endoleaks were registered. At one and six month follow up, there was 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, abdominal aortic aneurysm related mortality, or secondary intervention). DISCUSSION: Initial experience confirms the early technical and clinical success of the new Ovation Alto stent graft. Technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on label. Further studies are needed to evaluate long term durability outcomes.

The relation between neutrophil/lymphocyte and platelet/lymphocyte ratios with mortality and limb amputation after acute limb ischaemia.

OBJECTIVE: Acute limb ischaemia is still considered a significant event, with considerable early- and long-term amputation and mortality risk. Our study aims to investigate the predictive role of pre-operative neutrophil/lymphocyte and platelet/lymphocyte ratios in terms of mortality and amputation risk in patients with acute limb ischaemia. METHODS: Pre-operative blood samples of all patients admitted with acute limb ischaemia were used to calculate neutrophil/lymphocyte and platelet/lymphocyte ratios. Population was subdivided into quartiles by platelet/lymphocyte ratio and neutrophil/lymphocyte ratio values, and Kaplan-Meier life tables were obtained for overall survival and limb salvage. The optimal neutrophil/lymphocyte ratio and platelet/lymphocyte ratio cut-offs were obtained from receiver operating characteristic curves with all-cause mortality and all kinds of amputation. Stepwise multivariate analysis was performed in order to identify independent risk and protective factors for mortality and amputations. RESULTS: A total of 168 patients were included in the analysis. Receiver operating characteristic curves identified cut-off values for neutrophil/lymphocyte ratio and platelet/lymphocyte ratio: neutrophil/lymphocyte ratio ≥5.57 for mortality; neutrophil/lymphocyte ratio ≥6.66 and platelet/lymphocyte ratio ≥269.9 for all amputations. Kaplan-Meier analysis revealed that survival rate in group neutrophil/lymphocyte ratio <5.57 was 83.4%, 78.9%, 73.7%, and 59.8%, respectively, at 12, 24, 36, and 48 months; in neutrophil/lymphocyte ratio ≥5.57 group was 62.4%, 51.3%, 47.8, and 43.7%, respectively (p < 0.0001). Freedom from all amputations was significantly higher in case of neutrophil/lymphocyte ratio and platelet/lymphocyte ratio below the identified cut-off values (p < 0.0001). Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio were found as independent risk factors. CONCLUSION: Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio are reliable markers for stratification of mortality and limb amputations in patients with acute limb ischaemia. The inexpensive nature and ready availability of these biomarkers' values reinforced their usefulness in everyday clinical practice.

Case Report: An Unusual Case of Acute Lower Limb Ischemia as Precursor of the Asherson's Syndrome.

Introduction: Asherson's Syndrome, also defined as Catastrophic Antiphospholipid Syndrome (CAPS), represents the most severe manifestation of Antiphospholipid Antibody Syndrome. Rarely, the first CAPS diagnosis is based on macro-thrombotic event as acute limb ischemia. Case Presentation: We present a case of a 65-year-old woman admitted with an acute lower limb arterial ischemia with a complete occlusion of all the three tibial vessels. Three endovascular recanalization procedures were performed contemporary to 48 h intraarterial thrombolysis administration. The patency of tibial arteries was restored with a near-complete absence of digital arteries and microvessel perfusion of the foot. In the following days, an aggressive foot gangrene was established, leading to a major lower-limb amputation. Due to the general clinical status worsening and aggressiveness of ischemic condition, further investigations were performed leading to the diagnosis of an aggressive Asherson's Syndrome that was also complicated by a severe heparin-induced thrombocytopenia. Medical management with a high dose of intravenous steroids and nine sessions of plasma exchange led to a clinical condition stabilization. Conclusion: In our case, the presence of a "sine causa" acute arterial occlusion of a large vessel represented the first manifestation of an aggressive form of Asherson's Syndrome that could represent a fatal disease. Due to the extreme variety of manifestations, early clinical suspicion, diagnosis, and multidisciplinary management are essential to limit the life-threatening consequences of patients.

Multiple cavernous malformation syndrome: a casual diagnosis during carotid revascularization procedure.

INTODUCTION: Familial cerebral cavernous malformations (FCCM) are a rare condition characterized by the multiple presences of cavernous malformations located in the central nervous system. CASE DESCRIPTION: We present a case of FCCM incidental diagnosis in a 71-year-old male patient who underwent carotid artery stenting for high-grade carotid artery disease and subsequent reintervention for severe stent restenosis, determining neurological deficit. FCCM diagnosis was made due to the presence of hundreds of cavernous malformations located both in supra- and sub-tentorial regions highlighted by magnetic resonance and confirmed by genetic test for the mutation of the gene KRIT1, inherited also by his son.

Misdiagnosed Acute Limb Ischemia in Three Nonhospitalized Patients Recovering From a Nonsevere COVID-19 Infection.

The incidence of venous and arterial thromboembolic complications in COVID-19 patients is significant. The vast majority of COVID-19 patients spend their quarantine at home in a self-isolation condition. The occurrence of Acute limb ischemia (ALI) is a dangerous event that needs prompt diagnosis and management with time-dependent recanalization outcomes. We present a case series of three COVID-19 patients who suffered from ALI that occurred during home self-isolation, and that were diagnosed and treated with a significant time-delay due to COVID-19 social implications.

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

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

A Simple Rescue Maneuver to Retrieve Intravascular Foreign Body: The Triple Wire Twisting Technique.

INTRODUCTION: Device fracture causing intravascular foreign body (IFB) is a rare event during endovascular procedures, with potential catastrophic outcome if not promptly removed. We present two cases of retrieval of fractured devices during peripheral lower limb procedures using three guidewires tangled around the IFB. TECHNIQUES: Case 1 was a patient with critical limb ischemia. During balloon angioplasty of a high calcified peroneal artery, the balloon catheter Amphirion Deep 2.5/150 mm (Medtronic) fractured in two pieces, leaving a 20 cm distal part into the artery. Three 0.014" guides were advanced distally the IFB and twisted all together using a single torque-device. It was possible to pull back the long balloon fragment into the popliteal and to reline it inside a 5 French sheath. Case 2 was a patient with acute limb ischemia. During the mechanical thrombo-aspiration using the Indigo System (Penumbra inc.), the distal wire of the olive-shaped separator cracked in the posterior tibial artery. By crossing the IFB with three 0.014" wires and twisting them around it, this 15mm fragment was successfully recaptured. CONCLUSIONS: We named this procedure Triple Wire Twisting Technique and, in our experience, this technique is safe and effective to recapture IFB during complex peripheral procedures. This poorly known rescue technique is not complex and requires materials that are available in all cath-lab. We truly believe that physicians can take advantage of knowing it when facing with IFB in any vessel.