Lessons Learned with Enhanced Recovery for Open Abdominal Aortic Aneurysm Surgery: A Long Term Regional Network Experience.

OBJECTIVE: This enhanced recovery programme (ERP) aimed to achieve early recovery for patients undergoing major surgery. Results of a standardised ERP protocol for open infrarenal abdominal aortic aneurysm (AAA) repair within a hub and spoke regional network are presented. METHODS: In this monocentric prospective study (January 2004 - December 2021), consecutive AAAs (≥ 55 mm) were included in the ERP (patient discharge on post-operative day [POD] 4). The four phases of the ERP were pre-admission, pre-operative, intra-operative, and post-operative. Exclusion criteria were BMI > 35 kg/m2, functional capacity < 4 MET, previous aortic or abdominal surgery, and life expectancy < 5 years. Transperitoneal surgery was undertaken with routine AAA resection, graft interposition, and closure. RESULTS: Consecutive patients (n = 778) were enrolled into the study (mean age 72.3 ± 3.2 years; n = 712 men); 160 (20.5%) were treated in spoke hospitals. Median follow up was 78 (IQR 28, 128) months; median length of stay, procedure time, and blood loss were 4 days (IQR 3, 5), 190 min (IQR 170, 225), and 564 mL (IQR 300, 600). Infrarenal clamping and tube graft configuration were used in 96.5% (n = 751) and 72.5% (n = 564) of patients; 30 day mortality and complication rates were 0.4% (n = 3) and 9.2% (n = 72). Discharge after POD 4 occurred in 15.0%, and most significant predictors for discharge after POD 4 were haemotransfusion, re-intervention, and ileus over 3 days. Overall survival was: 98.2% at 1 year, 85.0% at 5 years, and 59.9% at 10 years. Freedom from re-intervention was 97.9% at 1 year, 94.1% at 5 years, and 86.8% at 10 years. Short and long term outcomes were comparable between hub and spoke hospitals. CONCLUSION: The ERP protocol was associated with low short and long term mortality and complication rates. Future studies should apply the ERP protocol to other vascular centres.

The Impact of Revascularization Strategy on Clinical Failure, Hemodynamic Failure and Chronic Limb Threatening Ischemia Symptoms in the BEST-CLI Trial.

OBJECTIVES: Sustained clinical and hemodynamic benefit following revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI following endovascular (ENDO) vs bypass (OPEN) revascularization in the BEST-CLI trial. METHODS: As planned secondary analyses of the BEST-CLI trial, we examined the rates of A) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); B) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to initially increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); C) time to resolution of presenting CLTI symptoms; and D) incidence of recurrent CLTI. Time-to-event analyses were by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N=1434; cohort 2: lacking suitable SSGSV, N= 396) and multivariate stratified Cox regression models were created. RESULTS: In cohort 1, there was a significant difference in time to clinical failure (log-rank p<0.001), hemodynamic failure (log-rank p<0.001), and resolution of presenting symptoms (log-rank p=0.009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank p=0.006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with significantly lower risk of clinical and hemodynamic failure in both cohorts, and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates (end stage renal disease (ESRD), prior revascularization, smoking, diabetes, age>80, WIfI stage, tissue loss, infrapopliteal disease). Factors independently associated with clinical failure included age>80 in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2. CONCLUSIONS: Durable clinical and hemodynamic benefit following revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions and limb loss. When compared with ENDO, initial treatment with OPEN surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM).

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.

Results of iliac branch devices for hypogastric salvage after previous aortic repair.

OBJECTIVE: The aim of this multicentric study was to assess the "REsults of iliac branch deviceS for hypogastriC salvage after previoUs aortic rEpair (RESCUE)." METHODS: All consecutive patients who underwent implantation of iliac branch devices (IBDs) after previous open aortic repair (OAR) or endovascular aortic repair (EVAR) at seven centers were captured. The study cohort was divided into two groups according to the type of repair originally performed. Early outcomes included immediate technical success and perioperative adverse events. Late outcomes included survival, side branch (SB) primary patency, SB instability, and new onset buttock claudication. RESULTS: A total of 94 patients (82 male) were included in the study, 10 of them received bilateral implantation of IBDs. This resulted in a total of 104 devices included in the final analysis. Indication for treatment were endoleak 1b or progressive iliac aneurysmal degeneration or distal para-anastomotic aortic aneurysms; 73 were implanted after previous EVAR and 31 after previous OAR. Technical success was 100% in both groups. The 3-year rate of freedom from SB instability was 90.1% after previous EVAR and 85.4% after previous OAR, respectively (P = .05). The 3-year estimates of SB primary patency were significantly lower in patients who had received OAR as compared with those that had received EVAR (89.8% vs 94.9%; P = .05). CONCLUSIONS: Endovascular treatment with IBDs following previous OAR or EVAR is safe and effective up to 3 years. Freedom from SB instability during follow-up was lower in patients who had previously undergone OAR than EVAR.

The new educational project Televascular Games during the Coronavirus Disease 2019 pandemic.

Objective: To report methodology and first-year results of a new educational project called Televascular Games," which took place during coronavirus disease 2019 pandemic. Methods: Complex aneurysmal aortic disease was discussed during a 2-hour competition webinar, according to three modalities. (1) Planning case competition (PCC): Two to four preoperative computed tomography angiography (CTA) scans of an already performed selected case were submitted for the competition. CTA scans were uploaded anonymously, without any reference to the center or the surgeon who performed the case. The competitor had to prepare a presentation of how he or she would have diagnosed, sized, planned, treated, and followed up the case, of the medical therapy and of the bail-out maneuvers. (2) Challenging case competition (CCC): The competitor elaborates a presentation of an already treated case concerning an aortic topic and discusses sizing, planning, treatment, possible bail-out maneuvers and obtained results. For the CCC and PCC, the competitors with the best score were preselected to present and discuss their plan during the webinars. (3) Quiz competition: Two to six CTA scans of already performed selected aortic cases were submitted for the competition. A quiz with multiple choice questions was answered by the competitors. The top four competitors were selected for the webinars and then they discussed the cases during the webinar. Finally, at the end of the case discussion, the effective case resolution and follow-up were shown. A final winner was voted via televoting, based on six preestablished criteria. The project was endorsed by different national and international societies. Results: Between October 2020 and December 2021, there were 12 Italian and 1 international webinars with 1695 participants overall (mean, 130; range, 86-177). Competitors were 54 years of age (mean, 27 years; range, 22-38 years). Two editions were CCCs, two quiz competitions, and nine PCCs. The reliability of the interobserver sizing of competitors was κ = 0.43 and κ = 0.62 for the proximal and distal sealing measurements respectively and very good (κ = 0.88-0.95) in the evaluation of orientation of the vessels, presence of angulations, calcifications, and thrombus. The sizing discrepancy resulted in a significant variability of the planning (κ = 0.45). The project ranked 9.6 on a 10-point rating scale by all the participants and competitors. Conclusions: The formula of gaming and collegial discussion of aortic cases herein reported has proved valid and attractive during coronavirus disease 2019 pandemic period. The variability of the results on sizing and planning suggested to confer with a second opinion, especially for less experienced surgeons.

Editor's Choice - Peri-Operative Outcomes of Carotid Endarterectomy are Not Improved on Dual Antiplatelet Therapy vs. Aspirin Monotherapy: A Systematic Review and Meta-Analysis.

OBJECTIVE: A systematic review and meta-analysis of the peri-operative outcomes of carotid endarterectomy (CEA) on dual antiplatelet therapy (DAPT) vs. aspirin monotherapy was carried out, to determine optimal peri-operative management with these antiplatelet agents. DATA SOURCES: The Web of Science, Pubmed, and Embase databases were searched from inception to July 2021. The corresponding authors of excluded articles were contacted to obtain additional data for possible inclusion. REVIEW METHODS: The main outcomes included ischaemic complications (stroke, transient ischaemic attack [TIA], and transcranial Doppler [TCD] measured micro-emboli), haemorrhagic complications (haemorrhagic stroke, neck haematoma, and re-operation for bleeding), and composite outcomes. Pooled estimates using odds ratios (ORs) were combined using a random or fixed effects model based on the results of the chi square test and calculation of I2. RESULTS: In total, 47 411 patients were included in 11 studies, with 14 345 (30.2%) receiving DAPT and 33 066 (69.7%) receiving aspirin only. There was no significant difference in the rates of peri-operative stroke (OR 0.87, 95% confidence interval [CI] 0.72 - 1.05) and TIA (OR 0.78, 95% CI 0.52 - 1.17) despite a significant reduction in TCD measured micro-emboli (OR 0.19, 95% CI 0.10 - 0.35) in the DAPT compared with the aspirin monotherapy group. Subgroup analysis did not reveal any significant difference in ischaemic stroke risk between patients with asymptomatic and symptomatic carotid artery stenosis. DAPT was associated with an increased risk of neck haematoma (OR 2.79, 95% CI 1.87 - 4.18) and re-operation for bleeding (OR 1.98, 95% CI 1.77 - 2.23) vs. aspirin. Haemorrhagic stroke was an under reported outcome in the literature. CONCLUSION: This meta-analysis found that CEA while on DAPT increased the risk of haemorrhagic complications, with similar rates of ischaemic complications, vs. aspirin monotherapy. This suggests that the risks of performing CEA on DAPT outweigh the benefits, even in patients with symptomatic carotid stenosis. The overall quality of studies was low, and improved reporting of CEA outcomes in the literature is necessary.

Open vascular surgery training in the endovascular era: 5-year experience with cadaver laboratory.

BACKGROUND: Vascular cadaver laboratory (CAD LAB) courses included vascular exposure techniques and simulations of open procedures. Aim of the study was to demonstrate the benefit of cadaver laboratory (CAD LAB) courses to improve trainees' experience in open surgical vascular procedures. METHODS: Between 2014 and 2020, 162 vascular surgeons or medical trainees (mean age 28 years) participated in vascular CAD LAB courses in Italy and France. Outcomes were measured using the Linkert survey, performed pre- and postcourse to evaluate self-efficacy/confidence, surgical experience, and resident perception of the course with a range score from 0 to 5 for each point. Anatomical knowledge improvement was measured using a questionnaire with multiple answers pre- and postcourse. The course was considered to have yielded a positive result if the postcourse Linkert Survey Score increased by ≥2 points, or in the case of an increase of at least 30% above the baseline value of the multiple questionnaires. RESULTS: Postcourse questionnaires were positive for all outcomes evaluated. Participants' perception of the usefulness of the CAD LAB evaluation was 4.8 out of 5. For the vascular CAD LAB, participant anatomical knowledge improved overall from an average of 55% to 93% (P<0.001), and self-efficacy/confidence improved from 2.3 to 4.5 out of 5 (P<0.001). Regarding the different operative procedures, the greatest self-efficacy/confidence improvement was recorded in carotid endarterectomy and aortic procedures (+50% and +66% respectively; P<0.001). The city location (Italy vs. France) did not affect the results. CONCLUSIONS: CAD LAB courses were shown to be effective in increasing participants' self-efficacy, confidence, and anatomical knowledge in open vascular surgical procedures.

Timing to Carotid Endarterectomy Affects Early and Long Term Outcomes of Symptomatic Carotid Stenosis.

BACKGROUND: The aim of this study is to evaluate early and long-term outcomes according to the timing to carotid endarterectomy (CEA) of symptomatic carotid stenosis. METHODS: Consecutive CEAs with selective shunting for symptomatic carotid stenosis ≥50% performed between 2009 and 2020. Patients had acute neurological impairment on presentation, defined as <5 points on the National Institutes of Health Stroke Scale (NIHSS). We grouped patients according to time between index event and CEA: the first group was operated between 0 and 2 days, the second group between 3 and 7 days, the third group between 8 and 14 days and the last group after 15 days. Thirty-day neurological status improvement was defined as a decrease (≥1) in the 30-day NIHSS score versus NIHSS score immediately before surgery. RESULTS: Five hundred CEAs were performed. The perioperative combined stroke and mortality rate was 3.6% (18/500), representing a perioperative mortality rate of 0.2 (n = 1) and stroke rate of 3.4% (n = 17). Overall freedom from stroke was 95% at 1 year, 89 % at 6 years, and 88% at 10 years. Annual stroke rate was 0.6% after the 30-day period. Thirty-day improvement in neurologic status occurred in 103 patients (20.6%), while in 380 (76%) neurologic status was unchanged, and 17 (3.4%) experienced worsening of their neurologic status. Patients treated within 7 days from the index event had significant benefit (OR = 2.6) in the 30-day neurological improvement versus those treated after 7 days from the index event. Timing to CEA <2 days increased significantly the risk of late stroke (OR = 9.7). CONCLUSIONS: The ideal timing for performing CEA is between 3 and 7 days from the index event if NIHSS <5 as it is associated with the best rates of improvement in neurological status and durability in the long term. Very early CEA (<48 hrs) was associated with increased late stroke occurrence.

Influence of pedal arch quality on 5-year survival and limb salvage in patients with diabetic foot ulcers undergoing peripheral angiography.

INTRODUCTION: The aim of this study was to evaluate the influence of pedal arch quality on 5-year survival and limb salvage in diabetic patients with foot wounds undergoing peripheral angiography. METHODS: Between January 2014 and December 2014, 153 diabetic patients with foot wounds underwent peripheral angiography. Final foot angiograms were used to allocate patients according to pedal arch: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Five-year survival and limb salvage rates were analyzed with Kaplan-Meier curves and compared by means of Gehan-Breslow-Wilcoxon test. Associations of patient and procedure variables with overall survival and limb salvage outcomes were sought with univariate and multivariate analyses. RESULTS: A below-the-knee (BTK) artery was the target vessel in 80 cases (52.3%). Five-year Kaplan-Meier rates of survival were similar in all groups (p = 0.1): CPA 30%, IPA 27.5%, and APA 26.4%. Five-year limb salvage rates were significantly better in patients with CPA/IPA (p < 0.001): CPA 95.1%, IPA 94.3%, and APA 67.3%. In the whole population study, multivariate analysis showed significant association of smoking (p = 0.01), chronic renal failure (p = 0.02), and severity of foot wounds (p < 0.001) with survival. Coronary artery disease (p = 0.03), severity of foot wounds (p = 0.001), and pedal arch status (p = 0.05) showed strong association with limb salvage. CONCLUSIONS: Pedal arch quality significantly affected limb salvage but not survival at 5 years in patients with diabetic foot ulcers. Smoking, chronic renal failure, and severity of foot wounds affected overall survival, whilst coronary artery disease, and severity of foot wounds limb salvage.

Reallocation of Carotid Surgery Activity with the Support of Telemedicine in a COVID-Free Clinic during COVID-19 Pandemic.

The aim of this study is to report the reallocation of carotid surgery activity with the support of telemedicine in a COVID-free clinic during COVID-19 pandemic. Patients with symptomatic carotid stenosis or asymptomatic vulnerable plaques were reallocated to a COVID-free private clinic which began to cooperate with the National Health System during the emergency. Quick training of staff nurses was performed. Surgeons moved to the COVID-19 free clinic. Remote cerebral monitoring was performed with the support of telemedicine. Twenty-four patients underwent standard carotid endarterectomy with eversion technique. Five patients (20.8%) had recently symptomatic stenosis, and the remaining 19 patients (79.2%) had a risky asymptomatic carotid stenosis. No technical issue with remote cerebral monitoring was detected. In the early postoperative period, no neurological/systemic complication was observed. Three patients under dual antiplatelet therapy (12.5%) had neck hematoma. All patients were discharged the day after surgery. In our preliminary experience, reallocation in a COVID-free clinic allowed us to maintain a functioning carotid surgery activity during COVID-19 pandemic. A multidisciplinary approach and support of telemedicine were crucial. Training of unskilled nurse staff was necessary.

Direct percutaneous embolization of aneurysm sac: a safe and effective procedure to treat post-EVAR type II endoleaks.

PURPOSE: To report safety and effectiveness of type II endoleak embolization, with percutaneous direct aneurysm sac puncture. MATERIALS AND METHODS: Fifty patients, 31 male (mean age 55 ± 5), with post-EVAR type-II endoleak underwent direct percutaneous sac puncture for embolization. Procedures were performed, under local anesthesia. Sac puncture was done using a 20G needle under rotational angiography guidance. A coaxial system (4 Fr catheter + 2.7 microcatheter) was used to navigate the sac. During the follow-up period, all patients underwent contrast-enhanced ultrasound (CEUS) at 6 and 12 months. RESULTS: Technical success, with complete exclusion of the aneurysm sac, was achieved in all cases. Time of procedure varied between 36 and 68 min (mean 51.36 min). Mean fluoroscopy time was 16.7 min. A posterior left access was used in 41 cases, posterior right access in 6 cases, and an anterior approach in 3. In 19 cases (38%), one or more feeding vessels were visualized and embolized. Sac embolization was done using Onyx plus micro-coils in 31 cases (62%) and Onyx alone in 19 cases (38%). Mean amount of Onyx was 6 ml. No complications, correlated with the direct percutaneous sac puncture, or to Onyx injection occurred. After 1-year follow-up, sac shrinkage occurred in 34 cases (68%), while in 16 patients (32%) sac size remained stable without evidence of sac perfusion. CONCLUSION: Percutaneous direct sac embolization using Onyx in combination or not with microcoils represents a safe and valid technique to solve post-EVAR type II endoleaks.

Nineteen-year outcomes with the Anaconda stent graft system from two tertiary centers.

OBJECTIVE: The Anaconda stent graft device presents peculiar and unique features in its design and deployment sequence, available on the market for many years with minor modifications, among different generations. The aim of this study was to assess the long-term, real-life, outcomes obtained in two high-volume centers with this endograft for infrarenal aortic aneurysms treatment over a period of 19 years. METHODS: All patients treated with the investigated device between 2000 and 2019, with at least 1 year of follow-up, were entered into a prospective database and data were reviewed retrospectively. The long-term results were assessed according to the Kaplan-Meier method. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes were freedom from late reintervention, freedom from late conversion to open repair, freedom from late limb occlusion, and freedom from late EVAR failure. RESULTS: A total of 260 consecutive patients were treated during the study period. Technical success was achieved in 98.5% (256/260) of the cases. Two perioperative deaths (0.8%) and four major complications (1.5%) were recorded. At a mean follow-up of 54 ± 38 months (summary follow-up index = 0.86), the late survival estimate was 94.8% at 1 year, 75.2% at 5 years, 50.5% at 10 years, and 43.3% at 13 years, with no case of late AAA rupture or late AAA-related death. Late freedom from conversion was 99.2% at 1 year, 96.9% at 5 years, 94.0% at 10 years, and 94.0% at 13 years. Freedom from late limb thrombosis was 96.8% at 1 year and 91.0% at 5, 10, and 13 years. Estimates of freedom from late reintervention was 95.6% at 1 year, 87.0% at 5 years, 77.4% at 10 years, and 77.4% at 13 years. Estimates of limb thrombosis at 11 years were significantly different in patients receiving or not intraoperative iliac kissing balloon maneuver with noncompliant angioplasty catheters (98.0% vs 88.4%; P = .029). CONCLUSIONS: The Anaconda stent graft demonstrated effective and durable outcomes for AAA treatment over a 19-year period, with no case of late AAA rupture or AAA related death in the studied population. Late limb occlusion was the leading cause of reintervention; however, a positive prevention strategy was found in intraoperative kissing balloon, which was associated with significant reduced rate of iliac thrombosis over time.

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

OBJECTIVE: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. RESULTS: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. CONCLUSION: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

The Italian USL Toscana Centro model of a vascular hub responding to the COVID-19 emergency.

BACKGROUND: Spreading of the COVID-19 pandemic in Italy forced health facilities to drastically change their organization to face the overwhelming number of infected patients needing hospitalization. The aim of this paper is to share with all the vascular community the protocol developed by the USL (Unità Sanitaria Locale) Toscana Centro for the reorganization of the Vascular Surgery Unit during the COVID-19 emergency, hoping to help other institutions to face the emergency during the hard weeks coming. METHODS: The USL Toscana Centro is a public Italian health care institution including four districts (Empoli, Florence, Pistoia, Prato) with 13 different hospitals, serving more than 1,500,000 people in a 5000 km2 area. The USL adopted a protocol of reorganization of the Vascular Surgery Unit during the first difficult weeks of the epidemic, consisting in the creation of a Vascular Hub for urgent cases, with a profound reorganization of activities, wards, surgical operators, operating blocks, and intensive care unit (ICU) beds. RESULTS: All 13 hospitals are now COVID-19 as the first days of April passed. The San Giovanni di Dio Hospital (Florence) has more than 80 COVID-19 patients in different settings (ICU, medical and surgical ward), which at the time of writing is almost one-third of the total hospital capacity (80/260 beds). It has been identified as the Surgical Hub for urgent vascular COVID-19 cases. Therefore, the elective surgical and office activities were reduced by 30% and 80%, respectively, and reserved to priority cases. A corner of the whole operating block, well separate from the remaining operating rooms, was rapidly converted into one operating room and six ICU beds dedicated to COVID patients. The COVID-19 surgical path now includes an emergency room for suspected COVID-19 patients directly connected to an elevator for the transfer of COVID patients in the COVID operating block and dedicated COVID-19 ward and ICU beds. CONCLUSIONS: Rapid modification of hospital settings, a certain "flexibility" of the medical personnel, a stepwise shutdown of vascular surgical and office activity, and the necessity of a strong leadership are mandatory to cope with the tsunami of the COVID-19 outbreak.

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.

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.