Endovascular Repair of One-hundred Urgent and Emergent free or Contained Thoraco-abdominal Aortic Aneurysms Ruptures. An International Multi-Center Trans-Atlantic experience.

OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.

Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02921230.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry.

PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.

Role of historical and procedural staging during elective fenestrated and branched endovascular treatment of extensive thoracoabdominal aortic aneurysms.

OBJECTIVE: Procedural staging is often performed to reduce the incidence of spinal cord ischemia (SCI) during endovascular treatment of extensive thoracoabdominal aortic aneurysms (TAAAs). However, its role in the case of previous thoracic or infrarenal aortic repair (historical staging) has been controversial. In the present study, we evaluated the SCI rates when procedural staging was routinely used and studied its potential benefits when previous aortic repairs had already been performed. METHODS: The data from patients treated electively with fenestrated/branched endovascular aortic repair for extent I, II, III, and V TAAAs were retrieved from a multicenter registry (four high-volume national teaching hospitals) and analyzed. The primary endpoint was the rate of SCI and its association with preoperative and postoperative variables, including historical staging, procedural staging, and an impaired collateral network (subclavian or hypogastric stenosis >75% per occlusion). Variables were defined in accordance with the Society for Vascular Surgery reporting standards. A logistic regression model with stepwise selection was used to identify the predictors of SCI. RESULTS: A total of 240 patients (76% male; median age, 73 years) were analyzed. Of the 240 patients, 43 (18%) had presented with an impaired collateral network, 136 (57%) had had historical staging, and 157 (65%) had received procedural staging. Preoperative spinal fluid cerebrospinal drainage was performed in 130 patients (54%). Permanent grade 3 SCI was observed in 13 patients (5%) and was negatively affected by both an impaired collateral network (odds ratio [OR], 17.3; 95% confidence interval [CI], 1.7-176; P = .016) and the presence of bilateral iliac occlusive disease (OR, 10.1; 95% CI, 1.1-98.3; P = .046). Both historical (OR, 0.02; 95% CI, 0.001-0.46; P = .014) and procedural (OR, 0.01; 95% CI, 0.02-0.7; P = .019) staging mitigated the permanent SCI rates. The need for postoperative transfusions (OR, 1.4; 95% CI, 1.1-1.8; P = .014) and the occurrence of postoperative renal complications (OR, 6.5; 95% CI, 1.2-35.0; P < .001) were associated with the development of SCI. Among the patients with historical staging, no further benefit from procedural staging was observed (SCI with procedural staging, 1%; vs no staging, 2%; P = NS). CONCLUSIONS: For patients with extensive TAAAs treated with fenestrated/branched endovascular aortic repair, both historical and planned procedural staging were associated with reduced permanent SCI rates. However, no additional benefit was observed when procedural staging was performed in patients with historical staging and an intact collateral network. The protective role of preoperative cerebrospinal fluid drainage placement requires further investigation.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Endovascular Oriented Classification and Treatment of Celiac Trunk Aneurysms: 10 Years Experience.

OBJECTIVE: To propose an endovascular-oriented classification of celiac trunk aneurysms (CTa) and discuss single center results of this rare pathology. METHODS: Data of all patients admitted to our institution for CTa from 2011 to 2021 were prospectively collected. Of them, those who underwent endovascular treatment were retrospectively analyzed. All preoperative CT scans were reviewed and CTa were classified in 4 different configurations based on progressive distal landing zone. We excluded from the classification all cases with median arcuate ligament syndrome (MALS), patients with coexistent aortic dilation or no endovascular proximal neck. Preoperative demographics, intraoperative data and post-operative complications were recorded. All-cause late mortality and complications were identified through a review of office charts and telephone assessment. RESULTS: During the study period 19 patients were referred to our Institution for CTa. Ten patients underwent endovascular treatment (ET). In 6 cases a watchful waiting strategy was adopted, 2 (10.5 %) patients refused ET and one patient without suitable proximal landing zone (< 10 mm) was not proposed to open surgical repair for surgical contraindication but is followed by strict instrumental and clinical evaluation. Six (60%) patients presented type 2 CTa; all of them underwent ET requiring positioning of covered stent-graft and SA embolization. Three (30%) patients presented type 3 CTa; all of them underwent ET with covered stent-graft deployment over the GDA with preliminary embolization. One (10%) patient presented type 4 CTa that was treated by means of covered stent-graft deployment along the right hepatic artery with left hepatic artery embolization. Overall, no major complications and perioperative mortality was observed. CONCLUSION: Celiac trunk aneurysms are rare, and no classifications have still been presented. Stent-graft exclusion provides excellent short-term outcome with no significant morbidity and mortality rate when technically feasible.

A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms.

OBJECTIVE: Patients in the Valiant Evo U.S. and international clinical trials had positive short-term outcomes; however, late structural failures, including type IIIb endoleaks have been recently discovered. Type IIIb endoleaks are serious adverse events because the repressurization of the aneurysm sac increases the risk of rupture. The purpose of the present study was to detail the imaging patterns associated with the structural failures with the aim of increasing awareness of failing graft presentation, early recognition, and prompt treatment. METHODS: The Valiant Evo clinical trial was a prospective, single-arm investigation of a thoracic stent graft system. With the recent late structural failures, sites were requested to submit all available imaging studies to date to allow the core laboratory to assess for structural failures such as type IIIb endoleaks, stent ring fractures, and stent ring enlargement. Of the 100 patients originally enrolled in the trial from 2016 to 2018, the core laboratory assessed the imaging studies performed at ≥1 year for 83 patients. RESULTS: No structural failures of the graft were reported through 1 year of follow-up. At 1 to 4 years, graft structural failures were detected in 11 patients with descending thoracic aortic aneurysms. Of the 11 patients, 5 had a type IIIb endoleak. Four of the five had imaging findings showing stent fractures consistent with the location of the graft seam and one had a type IIIb endoleak attributed to calcium erosion with no stent fracture or ring enlargement. Of the four patients with stent fracture in line with the graft seam, three underwent a relining procedure that successfully excluded the type IIIb endoleak. One of these three patients died 4 days later of suspected thoracic aortic rupture because the distal thoracic endovascular aortic repair extension had been landed in a previously dissected and fragile section of the aorta. The remaining six patients had had stent ring enlargement. One of the six patients had had persistent aneurysm expansion from the time of implantation onward and had died of unknown causes. The remaining five patients have continued to be monitored. CONCLUSIONS: In the present preliminary analysis, the imaging patterns associated with type IIIb endoleaks, stent fractures, and stent ring enlargement appear to be related to the loss of seam integrity or detachment of the stent rings from the surface of the graft material. The imaging patterns we have detailed should be closely monitored using computed tomography angiography surveillance to allow structural failures to be promptly identified and treated.

Single-center midterm results with the low-profile Zenith Alpha thoracic endovascular stent graft.

OBJECTIVE: The analysis of endovascular treatment of thoracic aortic diseases using new low-profile stent grafts in large series is crucial to understanding the durability of these devices. The present study reports the midterm outcomes of a single-center experience using the Zenith Alpha thoracic endovascular stent graft. METHODS: The outcomes of 270 procedures performed on 262 patients (197 men; mean age, 70.5 ± 9.5 years) using the Zenith Alpha thoracic endovascular stent graft from November 2013 to December 2019 for different thoracic aortic diseases were analyzed. The primary endpoints were 30-day clinical success and midterm (5-year) clinical success. The secondary endpoints were the adverse event rate at 30 days and midterm and access- and device-related complications. The follow-up of surviving patients was performed using computed tomography angiography and office visits at 1, 6, and 12 months and annually thereafter. Kaplan-Meier analysis was performed for overall survival, and freedom from thoracic aortic endovascular repair-related mortality and related reinterventions. RESULTS: The overall 30-day mortality was 5.2% (2.5% for elective and 30.8% for nonelective cases). Type I endoleaks were identified in six patients. The 30-day primary technical and clinical success rates were 97.8% and 92.6%, respectively. Femoral cutdown was used in 41.1% of cases and percutaneous access in 58.5%. The rate of femoral artery complications after the percutaneous approach was 5.1%, with the need for surgical conversion in 1.9%. The stroke rate was 4.1% (major stroke, 2.2%), and the spinal cord ischemia rate was 3.7% (permanent paraplegia, 0.7%). Of the 248 survivors, 239 complied with the follow-up protocol with adequate computed tomography angiograms available images. Overall follow-up survival was 94.0% at 1 year, 91.6% at 2 years, 88.9% at 3 years, and 88.5% at 5 years. The unplanned secondary endovascular procedure rate was 5.3%. No stent fractures or new-onset type I endoleaks due to stent graft migration were observed in the study cohort. CONCLUSIONS: The midterm outcomes of this new generation of low-profile devices were satisfactory. The reported low incidence of secondary procedures and the absence of migrations are promising for the long-term durability of these devices.

Contemporary Results of Carotid Artery Stenting Using Low-Profile Dual-Metal Layer Nitinol Micromesh Stents in Relation to Single-Layer Carotid Stents.

PURPOSE: To evaluate patients characteristics, procedural details, perioperative outcomes, and midterm results of carotid artery stenting (CAS) performed with the Roadsaver/Casper stent (Terumo Corp, Tokyo, Japan) as compared to concurrent patients treated with other commercially available carotid stents. MATERIALS AND METHODS: This is a single-center, retrospective, nonrandomized study including 200 consecutive patients who underwent a total of 205 elective CAS procedures due to severe internal carotid artery stenosis between April 2015 and December 2018. Procedural data and outcomes for patients treated with the Roadsaver/Casper stent implantation (100 procedures, in 97 patients) vs first-generation carotid stents implantations (90 procedures, in 88 patients) were compared. Fifteen patients were treated with CGuard carotid stent (InspireMD, Tel Aviv, Israel), and outcomes were reported separately. Primary endpoints were the occurrence of major adverse cerebrovascular events (MACE), including death, ipsilateral stroke, and transitory ischemic attack (TIA). Secondary endpoints were the rate of intrastent stenosis, the need for reintervention, and the occurrence of adverse cardiovascular events, including myocardial infarction, arrhythmias, and need for inotropic support. RESULTS: No difference in demographics and preoperative risk factors were observed between patients treated with and without the Roadsaver/Casper stent. The mean procedure time was shorter in the Roadsaver/Casper group (40.7±16.9 vs 49.4±27.3 minutes; p=0.008), while radial percutaneous access was more frequent (24% vs 5%; p<0.001). The rate of stroke/TIA/death at 30 days was 3% in the Roadsaver group vs 1% in the first-generation stent group (p=0.623). The primary patencyrate was 100% and 93.4% at 1- and 3-year of follow-up in the Roadsaver/Casper groupand 99% and 94.3% in the other stent group, respectively (p=0.95). CONCLUSIONS: In this real-world cohort of patients undergoing CAS, the Roadsaver/Casper stent was used to treat more symptomatic and vulnerable carotid plaques as compared to other carotid stents. Nevertheless, patients treated with this low-profile dual-layer micromesh stent showed low events rates at both 30 days and follow-up, similar to that observed for other stents.

Thoracic Endovascular Aortic Repair With Additional Distal Bare Stents in Type B Aortic Dissection Does Not Prevent Long-Term Aneurysmal Degeneration.

PURPOSE: TEVAR (thoracic endovascular aortic repair) + PETTICOAT (Provisional ExTension to Induce COmplete ATtachment) technique has been selectively employed since 2005 at our institution during endovascular treatment of type B aortic dissection (TBD). The aim of this study is to evaluate the long-term (>5 years) clinical results and the evolution of aortic volume. MATERIALS AND METHODS: All the patients receiving an endovascular treatment for TBD with the PETTICOAT technique were collected in a prospectively maintained database and follow-up computed tomography scan were retrospectively analyzed. Study endpoints included short- and long-term clinical success (absence of need for reintervention) and any major adverse event. The volumes of thoracic and abdominal aorta at long-term follow-up were also analyzed. RESULTS: Twenty-eight patients received a TEVAR + PETTICOAT and were followed up (median follow-up 85 months). Primary 30-day clinical success rate was 82% with an adverse event rate of 31%; 4 type I endoleak and 1 retrograde dissection were recorded. Secondary mid-term clinical success was 96% while the long-term clinical success rate was 79%. Six cases (21%) received either an open repair or an endovascular repair for a significant distal aortic enlargement at follow-up. With regards to volumetric analysis, an increase of overall (thoracic and abdominal) aortic volume was observed in 8 cases mainly related to an increase (mean: +31%) of the abdominal volume that was observed in 11 cases. CONCLUSIONS: PETTICOAT technique does not protect from long-term significant aneurysmal degeneration that may require aortic open or endovascular reinterventions. Aortic growth occurs mainly in the bare-stented aorta and thus, life-long surveillance is advisable in these patients.

Vascular Surgery During COVID-19 Emergency in Hub Hospitals of Lombardy: Experience on 305 Patients.

OBJECTIVE: During the most aggressive phase of the COVID-19 outbreak in Italy, the Regional Authority of Lombardy identified a number of hospitals, named Hubs, chosen to serve the whole region for highly specialised cases, including vascular surgery. This study reports the experience of the four Hubs for Vascular Surgery in Lombardy and provides a comparison of in hospital mortality and major adverse events (MAEs) according to COVID-19 testing. METHODS: Data from all patients who were referred to the Vascular Surgery Department of Hubs from 9 March to 28 April 2020 were collected prospectively and analysed. A positive COVID-19 polymerase chain reaction swab test, or symptoms (fever > 37.5 °C, upper respiratory tract symptoms, chest pain, and contact/travel history) associated with interstitial pneumonia on chest computed tomography scan were considered diagnostic of COVID-19 disease. Patient characteristics, operative variables, and in hospital outcomes were compared according to COVID-19 testing. A multivariable model was used to identify independent predictors of in hospital death and MAEs. RESULTS: Among 305 included patients, 64 (21%) tested positive for COVID-19 (COVID group) and 241 (79%) did not (non-COVID group). COVID patients presented more frequently with acute limb ischaemia than non-COVID patients (64% vs. 23%; p < .001) and had a significantly higher in hospital mortality (25% vs. 6%; p < .001). Clinical success, MAEs, re-interventions, and pulmonary and renal complications were significantly worse in COVID patients. Independent risk factors for in hospital death were COVID (OR 4.1), medical treatment (OR 7.2), and emergency setting (OR 13.6). COVID (OR 3.4), obesity class V (OR 13.5), and emergency setting (OR 4.0) were independent risk factors for development of MAEs. CONCLUSION: During the COVID-19 pandemic in Lombardy, acute limb ischaemia was the most frequent vascular disease requiring surgical treatment. COVID-19 was associated with a fourfold increased risk of death and a threefold increased risk of major adverse events.

Propensity-Matched Comparison for Carotid Artery Stenting in Primary Stenosis Versus after Carotid Endarterectomy Restenosis.

BACKGROUND: Carotid artery stenting (CAS) has been proposed as the treatment of choice in case of restenosis (RES) after carotid endarterectomy (CEA). The aim of this study was to analyze periprocedural results of CAS for the treatment of post-CEA RES compared with those of CAS performed for primary carotid stenosis (PRS). METHODS: Data from consecutive patients submitted to CAS at our institution from 2008 to 2016 were retrospectively reviewed. Patients with in-stent RES were excluded. Initially, preoperative risk factors, demographics, intraoperative variables, and perioperative outcomes were analyzed according to the indication groups (PRS and RES). Then, propensity score matching was performed obtaining 2 homogeneous groups of patients. Covariates included were age, gender, hypertension, hyperlipidemia, cardiac disease, chronic renal disease, symptomatic carotid plaque, and positive ipsilateral brain computed tomography scan. Intraoperative data and perioperative outcomes were then compared between the 2 matched groups. RESULTS: Of 480 included patients, 300 (62.5%) underwent CAS for PRS, and 180 (37.5%) for RES. After propensity score analysis (158 patients/group), no significant difference was observed in terms of technical success, number, and type of stent used, except for need of intraoperative atropine administration that was higher in the PRS group (38.6% vs. 13.3%, respectively; P < 0.001). In the perioperative period, composite neurologic event was significantly higher in the PRS group (7.6% vs. 1.9%; P = 0.017). Moreover, need of ionotropic support was higher in the PRS group (8.9% vs. 1.9%; P = 0.0069). Myocardial infarction rate and 30-day mortality were similar in both groups (P = 0.317; P = 1, respectively). CONCLUSIONS: In a large single-center experience, CAS for post-CEA RES was associated with a significantly lower risk of any neurologic event and hemodynamic instability in the perioperative period compared with CAS performed for primary carotid lesions. Our results confirm that post-CEA RES may represent an elective indication for CAS.

Emergency management of the COVID-19 pandemic in a vascular surgery department of a large metropolitan hospital in Italy. Preparation, escalation, de-escalation, and normal activity.

BACKGROUND: During the first phase of coronavirus disease-2019 (COVID-19) pandemic in Italy, several strategies have been taken to deal with the pandemic outbreak. AIM OF THE STUDY: To report the remodeling of the Vascular Surgery Department of San Raffaele Hospital as regards the strategies of preparation, escalation, and return to normal activities during the COVID-19 pandemic. PREPARATION, ESCALATION, DE-ESCALATION: The Regional Authority of Lombardy remodeled the hospitalization system to allocate appropriate resources to treat patients with COVID-19 and to identify "Hub/Spoke" hospitals for highly specialized medical activities. The Hubs hospitals were required to guarantee full-time evaluation of all patients presenting with cardiovascular diseases with an independent pathway for patients with suspect or confirmed COVID-19 infection. San Raffaele Hospital was identified as Hub for cardiovascular emergencies and the Vascular Surgery Department was remodeled to face this epidemic situation. Surgical treatment was reserved only to symptomatic, urgent, or emergent cases. Large areas of the hospital were simultaneously reorganized to assist patients with COVID-19. RESULTS: During this period, 135 patients were referred to San Raffaele Vascular Surgery Department. COVID-19 was diagnosed in 24 patients and, among them, acute limb ischemia was the most common cause of admission. At this time, the COVID-19 trend is in decline in Italy, and the local authorities reorganized the healthcare system to return to normal activities avoiding new escalations of COVID-19 cases. The COVID-19 pandemic will be remembered in Lombardy as a cataclysm. Nevertheless, the HUB/spoke system has proven to be a valid model in the management of ischemic emergencies. Continuous surveillance, cooperation, coordination, and communication to effectively respond to COVID-19 pandemic is crucial because COVID-19 reference centers could face similar issues in the near future.

Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair.

OBJECTIVE: The aim of this study was to evaluate the safety and effectiveness of endovascular occlusion of the prevertebral subclavian artery (SA) using an Amplatzer vascular plug after prophylactic revascularization with carotid-subclavian bypass (CSB) in the setting of endovascular thoracic stent grafting or open arch repair with frozen elephant trunk. METHODS: All patients who underwent SA plug embolization (SAPE) and CSB from September 2009 to December 2018 were enrolled in a registered study (SAPE study: clinicaltrials.govNCT03620006). The primary end point was technical success, defined as complete occlusion of the origin of the SA, and how it was influenced by SA anatomy. The secondary end points were access vessel complications, cerebrovascular events, and CSB patency. RESULTS: The 101 SAPE procedures were performed using a type I (35 patients) or a type II (66 patients) Amplatzer vascular plug. A percutaneous ipsilateral upper extremity access was used in 66% of patients and a radial artery access was used in 50% of procedures. The 30-day primary technical success rate was 95% (five patients received an additional plug during the index); five type IC endoleaks were observed and successfully treated either with surgical ligation (in open arch repair procedures) or secondary embolization procedure (thoracic endovascular aneurysm repair group). Three access vessel complications (3%) were recorded with percutaneous brachial approach. At a median follow-up time of 11 months (range, 2-19 months), no new-onset type IC endoleak was observed, and the CSB patency rate was 97%. CONCLUSIONS: SAPE after CSB is feasible and safe, and has low incidence of type IC endoleaks. Further device developments are needed to better adapt to the subclavian anatomy.

Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures.

OBJECTIVE: The aim of this study was to assess the feasibility and safety of percutaneous axillary access with vessel closure device closure after puncturing the first segment during endovascular treatment of complex aneurysms with fenestrated and branched endografts (F/BEVAR). METHODS: The PAXA (Percutaneous AXillary Access) study is a physician initiated, single centre, ambispective, non-randomised study (clinicaltrials.gov: NCT03223311). The primary endpoint was the closure success rate defined as the absence of any vascular injury to achieve haemostasis at the puncture site, requiring any treatment other than manual compression or adjunctive endovascular ballooning. The secondary endpoints were minor access complications, cerebrovascular complication rate, short term access vessel patency, and study cohort anatomical evaluation of the axillary artery. RESULTS: Sixty-four patients required an upper extremity access during F/BEVAR procedure during study period (November 2016 to July 2019) and were screened for the PAXA study: 59 patients (47 males; median age: 75 years, IQR 69-78) met the study inclusion criteria and were enrolled (one patient had bilateral access). Closure success was obtained in 54 cases (90%) with no open conversion required: five patients received a bare or covered stenting to the AXA and in one patient mechanical failure of the delivery system was recorded. No 30 day permanent peripheral nerve injuries and two non-ipsilateral ischaemic strokes (3.4%) were recorded. Seven patients (12%) had access haematomas managed conservatively associated with closure failure (p = .002), oral anticoagulants therapy (p = .005) and procedure length (p = .028). At short term follow up (6 months), no late complications were observed, and all access vessels were patent. CONCLUSION: PAXA on the first segment using a large sheath (10-16F) is technically feasible, relatively safe with no need for open conversion but it may require access related secondary endovascular procedures. Further prospective studies are needed to modify the device instruction for use and to put the procedure on label.

Elective Multistaged Endovascular Repair of Thoraco-abdominal Aneurysms with Fenestrated and Branched Endografts to Mitigate Spinal Cord Ischaemia.

OBJECTIVE: To evaluate the safety and effectiveness of a multistaged approach for elective thoraco-abdominal aneurysm (TAAAs) repair by means of endovascular fenestrated and/or branched (F/B-EVAR) grafts. METHODS: Between 2013 and 2018, 80 high risk surgical patients received elective F/B-EVAR for TAAAs with a protocolled multistaged approach (thoracic, visceral, and limb steps) and were enrolled in an ambispective single centre study called STEAR (STaged Endovascular Aortic Repair - NCT03342755). Data regarding all study participants, single step mortality and morbidity (systemic complications) rates were recorded and the overall results were considered for statistical analysis. RESULTS: Previous aortic interventions (61/80 cases, 76.3%) combined with the TAAA extents resulted in different staging strategies: 58 patients (73%) had a thoracic step and 33 (41%) a limb step. The median TAAA treatment time was 77 days (50-107). The overall mortality was six cases (8%) and 30 day clinical success rate 64 cases (80%). The overall rate of grade 2 or 3 (including death) systemic complications was 19 cases (24%) and 20 patients (25%) experienced grade 1 complications. Three patients with type II or III TAAAs (4%) had permanent and fatal spinal cord (SC) impairment. On multivariable analysis, SC ischaemia was associated with an aortic coverage ≥350 mm (OR: 9.15, p = .03, 95% CI: 1.3-66.4) and bovine arch (OR: 10.6, p = .01, 95% CI: 1.6-68.6). The overall short term (six month) clinical success was 72 cases (90%) and none experienced SC ischaemia after late endoleak resolution or treatment. At mid term (mean follow up: 13.3 ± 15.4 months), the overall freedom from conversions, re-interventions, late rupture, or type I and III endoleaks was 57 of 72 survivors (79%). CONCLUSION: A multistaged approach with a third limb step in case of TAAAs is safe and technically feasible, with an acceptable rate of permanent spinal cord ischaemia. Different staging methods and protocols have been proposed and standardisation is required, especially for type I-II-III aneurysms.

Single-Center Vascular Hub Experience after 7 weeks of COVID-19 Pandemic in Lombardy (Italy).

BACKGROUND: The aim of this study was to report the experience of one of the major "hubs" for vascular surgery in Lombardy, Italy, during the first 7 weeks after total lockdown due to COVID-19 pandemic. METHODS: Data from all patients treated at our Department since the decision of the regional healthcare authorities of Lombardy to centralize surgical specialties creating a hub/spoke system (March 9, 2020) were prospectively collected and compared with a retrospectively collected cohort from the same period of year 2019. Primary study end point was defined as primary clinical success. Secondary end points were defined as in-hospital mortality and/or any in hospital major adverse event or lower limb amputation. RESULTS: One hundred sixteen patients were treated (81 men, 70%; median age: 71 years, IQR 65-81). Thirty-two patients (28%) were addressed from spoke hospitals directly referring to our hub, 19 (16%) from hospitals belonging to other hub/spoke nets, 48 (41%) came directly from our emergency department, and 17 (15%) were already hospitalized for COVID-19 pneumonia. Acute limb ischemia was the most observed disease, occurring in 31 (26.7%), 12 (38.7%) of whom were found positive for COVID-19 pneumonia on admission, whereas 3 (9.7%) became positive during hospitalization. Chronic limb ischemia was the indication to treatment in 24 (20.7%) patients. Six (5.2%) patients underwent primary amputation for irreversible ischemia. Aortic emergencies included 21 cases (18.1%), including 13 (61.9%) symptomatic abdominal aortic or iliac aneurysms, 4 (19.0%) thoracoabdominal aortic aneurysms, 2 (9.5%) cases of acute type B aortic dissection (one post-traumatic). Seventeen (14.7%) patients were admitted for symptomatic carotid stenosis (no COVID-19 patients); all of them underwent carotid endarterectomy. Seventeen (14.7%) cases were treated for other vascular emergencies. Overall, at a median follow-up of 23 ± 13 days, primary clinical success was 87.1% and secondary clinical success was 95.9%. We recorded 3 in-hospital deaths for an overall mortality rate of 2.6%. Compared with the 2019 cohort, "COVID era" patients were older (72 vs. 63 years, P = 0.002), more frequently transferred from other hospitals (44% vs. 21%, P = 0.014) and more frequently with decompensated chronic limb threatening ischemia (21% vs. 3%, P = 0.015); surgical outcomes were similar between the 2 cohorts. CONCLUSIONS: Since its appearance, SARS-CoV-2 has been testing all national healthcare systems which founds themselves facing an unprecedented emergency. Late referral in the pandemic period could seriously worsen limb prognosis; this aspect should be known and addressed by health care providers. Vascular surgical outcomes in pre-COVID and COVID era were comparable in our experience.

Open Repair of Proximal Abdominal Aneurysms Analyzed According to the Anatomy, Clamping Site, and Theoretical Fenestrated Endovascular Design.

BACKGROUND: To report our experience with the open repair (OR) of hostile-necked, juxtarenal, pararenal, and suprarenal (SR) aortic aneurysms (proximal abdominal aortic aneurysms) and stratify the results according to the equivalent endovascular repair. METHODS: Data from all patients treated between 2010 and 2015 were prospectively collected and retrospectively reviewed. Preoperative computed tomographic (CT) scans were analyzed to plan a hypothetical equivalent endovascular approach (2, 3, and 4 fenestrations [FENs]). Postoperative results were recorded based on the cross-clamping level: supraceliac (SC), SR, and infrarenal (IR). Major adverse events (MAEs) were defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke, and renal insufficiency. RESULTS: One hundred fifty-seven patients were treated; 93 met the CT scan criteria (slice thickness, <1.5 mm) and were included in the study. Thirty-day mortality was 2.2% (SC, 7.4%; SR, 0%; IR, 0%) and MAE was 31.2% (SC, 51.9%; SR, 27.3%; IR, 13.6%) in the entire cohort. After endovascular planning, 11 (11.8%) patients would have been treated with a 2-FEN device, 20 3-FEN (21.5%), and 62 4-FEN (66.7%). Only 35.5% of the 4-FEN patients received an SC aortic cross-clamping, whereas 43% SR and 21% IR. Renal/visceral perfusion was performed in 45 (72.5%) 4-FEN patients, and in 20 (64%) 2/3-FEN patients (P < 0.001); renal/visceral revascularization was needed in 23 (37.1%) 4-FEN and 5 (19.2%) 2/3-FEN patients (P = 0.054). CONCLUSIONS: Implementing a fenestrated endovascular aortic repair (FEVAR) endovascular program could reduce MAEs, but it must be clear that FEVAR for juxtarenal disease may overcomplicate treatment and include manipulation of visceral vessels that would not need to be affected if IR clamping is possible in OR, when it gives excellent results.