Five Year Post-Endovascular Aneurysm Repair Aneurysm Sac Evolution in the GREAT Registry: an Insight in Diabetics Using Propensity Matched Controls.

OBJECTIVE: To assess differences in the five year abdominal aortic aneurysm (AAA) sac regression rate after endovascular aneurysm repair (EVAR) in patients with and without diabetes mellitus (DM). METHODS: An international prospective registry (Europe, USA, Brazil, Australia, and New Zealand) of patients treated with the GORE EXCLUDER endograft. All scheduled EVARs for infrarenal AAA between 2014 and 2016 with complete five year imaging follow up were included. Emergency procedures, ancillary proximal procedures, and inflammatory and infectious aetiologies were excluded. Descriptive and inferential statistics, and Cox proportional hazards survival models were used. A control group of patients without DM with similar age and comorbidities was selected using propensity scores, matched in a 1:2 scheme. RESULTS: A total of 2 888 patients (86.1% male; mean age 73.5 ± 8 years) was included, of whom 545 (18.9%) had DM. Patients with DM had higher rates of hypertension (89.2% vs. 78.4%), dyslipidaemia (76.0% vs. 60.7%), coronary artery disease (52.3% vs. 37.9%), and chronic renal impairment (20.9% vs. 14.0%) (all p < .001). The mean pre-procedural AAA diameter was 58.1 ± 10 mm. Five years post-EVAR, the type 1A endoleak rate was 1.1% (0.6% DM vs. 1.2% non-DM), the endograft related re-intervention rate was 7.3% (6.2% vs. 7.6%), the major adverse cardiovascular event (MACE) rate was 1.4% (1.1% vs. 1.5%), and aortic related mortality rate was 1.0% (0.6% vs. 1.2%), without statistically significant differences between groups. The overall five year mortality rate was higher in diabetics (36.3% vs. 30.5%; hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.07 - 1.58; p = .001). No statistically significant differences were found in sac regression rate (≥ 5 mm) between diabetics and non-diabetics 70.0% vs. 73.1%; HR 0.88, 95% CI 0.75-1.04; p = .131. These differences remained statistically non-significant after excluding patients performed out of instructions for use (p = .61) and patients with types 1, 2 or 3 endoleaks (p = .39). CONCLUSION: The paradoxical relationship between DM and AAA does not appear to result in differences in post-EVAR sac regression rates. However, even when controlling for other comorbidities, patients with DM undergoing EVAR may have a higher five year mortality rate.

Self-Made Bovine Pericardial Tube Grafts for the Treatment of Abdominal Aortic Infections.

BACKGROUND: Aortic infections are uncommon but life-threatening diseases. The material of choice for aortic reconstruction is still a matter of debate. The aim of this study is to examine the short- and mid-term outcomes in the treatment of abdominal aortic infections using self-made bovine pericardium tube grafts. METHODS: This retrospective, single-center study collected all patients who underwent in situ abdominal aortic reconstruction using self-made bovine pericardial tube grafts between February 2020 and December 2021 in a tertiary care center. Patient comorbidities, symptoms, radiological, bacteriological, and perioperative findings, as well as postoperative outcomes, were analyzed. RESULTS: Bovine pericardial aortic tube grafts were used in 11 patients (10 males, median age 68.7 years). Two patients presented with a native aortic infection, and 9 had graft infections (4 bypass grafts, 4 endografts, and a plurioperated patient who had undergone both endovascular and open procedures). There were 2 emergent surgeries due to infectious aneurysm ruptures. All patients were symptomatic, and the most frequent clinical finding was lumbar or abdominal pain (36%), followed by wound infection (27%), and fever (18%). Seven bifurcated and 4 straight pericardial tube grafts were needed. Purulent drainage was obtained around the previous graft or in the aneurysmal sac in 7 cases; intraoperative cultures were positive in 6 cases (gram + bacteria). Two patients died in the immediate postoperative period (perioperative mortality 18%; urgent procedures 50%; scheduled procedures 11%). One patient had a major complication due to bilateral severe acute respiratory syndrome coronavirus 2 pneumonia. There was 1 single reintervention to control hemostasis due to bleeding nongraft-related. The median follow-up was 14.1 months (3-24 months). CONCLUSIONS: Our preliminary experience in the treatment of abdominal aortic infections by in situ reconstruction with self-made bovine pericardial tube grafts shows promising results. These should be confirmed in the long term.

Midterm Outcomes of Antegrade In Situ Laser Fenestration of Polyester Endografts for Urgent Treatment of Aortic Pathologies Involving the Visceral and Renal Arteries.

OBJECTIVE: Aortic endografting and antegrade in situ laser fenestration of visceral arteries (LFEVAR) may be considered as an alternative to open surgery for the emergency repair of complex abdominal aortic aneurysms (AAA) in fragile patients. The aim of this article was to evaluate the midterm results of LFEVAR performed with polyester endografts. METHODS: From August 2015 to December 2020, all consecutive LFEVAR performed for non-deferrable treatment of complex AAA were analysed. Polyester endografts were deployed and subsequently fenestrated using an atherectomy laser probe; the fenestrations were enlarged using cutting and semicompliant balloons before implantation of balloon expandable bridging stents into the target vessels. Prospectively collected midterm survival, patency, and re-intervention rates were analysed. RESULTS: Forty four procedures were performed for 11 type 1a endoleaks, five thoraco-abdominal aneurysms, 20 pararenal aneurysms, four segmental renal artery (RA) preservations, three anastomotic aneurysms, and one aortic dissection. One hundred and eight laser fenestrations were performed (26 for the superior mesenteric artery [SMA], 13 for the coeliac trunk, 33 and 31 for the right and left RA, respectively). The median ischaemia duration was 7, 48, 48, and 45 minutes, respectively. The technical success rate was 97%, with no open surgical conversions. The 30 day mortality was 4.5% (n = 2). No spinal cord ischaemia events were observed nor early stent related complications. Kaplan-Meier overall survival at two years was 73%, the aortic related re-intervention free survival was 70%, and the stent related re-intervention free survival was 90.6%. Four target vessel thromboses were detected, of which three were rescued. Three type IIIc endoleaks, one RA false aneurysm, and one SMA stenosis, required re-intervention during a median follow up of 24.7 months. CONCLUSION: Antegrade LFEVAR is feasible, safe, and provides satisfactory early and midterm outcomes for non-deferrable treatment of aortic pathologies involving the visceral segment. Long term data are mandatory to confirm the usefulness of this promising off label technique.

An early single-center experience with the Relay double inner-branch arch endograft.

Background: Open surgery remains the gold standard technique for the treatment of aortic arch pathologies, although endovascular techniques offer a new opportunity for patients deemed unfit for open repair. This paper assesses the early outcomes of patients treated with a double inner-branched arch endograft in a single, tertiary-care institution. Methods: All consecutive cases of elective endovascular arch repair from 2016 to 2022 were included in a prospective database. All procedures were performed using the custom-made Relay® (Terumo Aortic-Bolton Medical Inc., Sunrise, FL, USA) double inner-branched endograft; an extra-anatomical bypass was associated in all cases to preserve the patency of supra-aortic trunks. Comorbidities, periprocedural data, immediate results and follow-up complications were analyzed. Results: Twelve patients were treated during the study period [mean age 74±7 years, 100% male, 58% American Society of Anesthesiologists (ASA) risk ≥3]. Treated conditions included aneurysms (n=9), one pseudoaneurysm, one aortic ulcer and a type IA endoleak. The technical success rate was 100%. Early complications included respiratory insufficiency (n=3; 25%), stroke (n=1; 8.3%), acute coronary syndrome needing coronary stenting (n=1; 8.3%), and one perioperative death (n=1; 8.3%) secondary to an intracranial bleeding after coronary stenting. One patient required early reintervention due to retroperitoneal iliac access bleeding (n=1; 8.3%). During a median follow-up of 15.5 (range, 0-44) months, four patients suffered neurological events (two of them of cardioembolic origin), one reintervention was needed (subclavian anastomosis pseudoaneurysm), and a type IB endoleak was diagnosed. Overall mortality was of 17% (n=2), with an 83% overall survival at 2 years. The aortic-related death-free survival was 100%. Conclusions: Endovascular treatment of aortic arch pathology is feasible and shows promising early mortality and stroke rates in high-risk candidates. The main short and midterm goal should be minimizing neurological complications. A longer follow-up is mandatory to determine the effectiveness of the technique and to detect device related complications.

Midterm results of endovascular versus open surgical repair for infrarenal abdominal aortic aneurysms in low surgical risk patients.

OBJECTIVE: The objective of this study was to analyze midterm outcomes of endovascular repair (EVAR) versus open repair (OR) for treatment of infrarenal abdominal aortic aneurysms (AAAs) in low surgical risk patients. METHODS: Elective patients with AAAs undergoing treatment from 2003 to 2017 in a single, tertiary-care institution were evaluated. All patients with a low preoperative risk of complications and perioperative mortality (Medicare Aneurysm Scoring System <3) were included, and rates of perioperative and long-term mortality, adverse events, and reintervention were evaluated for EVAR and OR. A propensity score-matched cohort, leveling age, risk factors, and comorbidities was additionally performed. RESULTS: A total of 227 patients were included (EVAR 59.9% and OR 40.1%) and followed for a mean of 80 ± 48 months. Patients undergoing EVAR were older (66.6 ± 5 vs. 64.1 ± 6 years; P <.001), had a higher body mass index (29.6 ± 4 vs 28.1 ± 3 kg/m2; P = .005), a higher prevalence of chronic obstructive pulmonary disease (27.3% vs 9.9%; P = .001), and lower prevalence of dyslipidaemia (46.3% vs 65.9%; P = .004). Patients undergoing OR had a higher rate of major adverse events (19.7% vs 2.6%; P = .001) and 30-day reinterventions (8.8% vs. 1.5%; P = .016), with 30-day mortality being 0% in both groups. The propensity-score matched cohort included 76 matched pairs (1:1), with differences in hospital stay and major complications remaining significant, without affecting mortality. At 5-year follow-up, there were no significant differences in the reintervention rate (EVAR 18.5% vs OR 17.6%; P = .67) or survival (EVAR 85% vs OR 91%; P = .195). CONCLUSIONS: In low surgical risk patients with AAAs, EVAR may offer comparable midterm results to OR, with a lower rate of major adverse events and a shorter in-hospital stay. With the current OR-first paradigm in low-risk patients, several factors should be taken into account for decision-making (anatomic suitability, risk of sexual dysfunction, risk of type 2 endoleaks, and need for follow-up).

Endovascular Treatment of a Traumatic Axillary Artery Rupture Using the Dual Bull's-Eye Technique.

BACKGROUND: Our purpose is to report a case of an axillary artery rupture treated by endovascular means using the dual bull's-eye technique. An 83-year-old woman with multiple comorbidities was diagnosed with axillary artery rupture after the reduction of a shoulder dislocation. METHODS: An endovascular repair attempt was made, but, despite the use of a double approach (antegrade and retrograde), reconnecting both ends of the severed artery was deemed not possible. 5-mm Amplatz GooseNeck snares were advanced from each access and superposed in a perpendicular plane. A percutaneous infraclavicular puncture with a lumbar needle was made through both snares, and a V14 guidewire was subsequently introduced. The guidewire was recovered through femoral and brachial accesses, and a 7 × 100 mm covered self-expandable stent was deployed. RESULTS: The final angiographic control did not show further hemorrhage, and the patient recovered radial pulse. Follow-up showed complete patency and no complications at 9 months after the procedure. CONCLUSIONS: The dual bull's-eye technique can be used as a resource tool in cases of arterial rupture, when the arterial continuity cannot be re-established by conventional approaches.

Predictive Factors of Aneurysm Sac Growth in Patients with a Type II Endoleak in the First Post-EVAR Control.

BACKGROUND: The objective of this study was to identify predictive factors associated with aneurysm sac growth over time in patients diagnosed with a type II endoleak (TII-EL) in the first postoperative control after endovascular aneurysm repair (EVAR). METHODS: A retrospective analysis of all patients undergoing an elective EVAR procedure from January 2003 to December 2011 (9 years) in a single center was performed. Patients with a TII-EL detected in the first post-EVAR imaging control and with over twelve months of follow-up were included. The primary end point was aneurysm sac growth > 5 mm from the first month computed tomography angiography (CTA) to the last available CTA. Demographic variables, cardiovascular risk factors, comorbidities, aneurysm-related data, and procedural information were collected. Three-dimensional volume rendering with the Mimics ® software (Materialise NV, Leuven, Belgium) was used to measure the endoleak nidus. Descriptive, univariate, and multivariate analyses (Cox proportional hazards model) were performed. RESULTS: In this period, 220 EVAR procedures were performed. 63 TII-ELs (28.7%) were detected in the first CTA control (90.5% male, mean age: 75.7 ± 8 years). After a median follow-up of 54 months (interquartile range [IQR], 56.5), aneurysm sac growth > 5 mm was detected in 19 patients (30.1%). Age (P = 0.02) and dyslipidemia (P = 0.03) were associated with sac growth > 5 mm, whereas the presence of chronic obstructive pulmonary disease (COPD) behaved as a protective factor (P = 0.02). The craniocaudal length of the endoleak nidus (P < 0.01) and the nidus volume (P < 0.001) were the only aneurysm-related variables associated with sac growth. Age (HR: 14.1, 95% CI: 2.1-92.3, P = 0.006) and the presence of COPD (HR: 9.6, 95% CI: 1.4-63.7, P = 0.019) were the only independent predictors in the multivariate analysis. CONCLUSIONS: Reliable predictors of long-term aneurysmal sac growth are lacking, although some variables such as age or nidus volume appear to be associated. Strict surveillance remains mandatory.

Immunological Aspects Involved in the Degeneration of Cryopreserved Arterial Allografts.

Introduction: Cryopreserved arterial allografts have remained an option in patients requiring distal revascularization or associated with vascular infection, in the absence of a valid autogenous saphenous vein. The objective of this study is to describe the different clinical, anatomopathological, and immunological findings related to vascular transplant rejection. Methods: In a prospective trial, 35 patients who underwent cryopreserved allogeneic arterial bypass were studied, including demographics and conduit patency. Anti-HLA antibody production was stablished prior to the surgery, 7 days, 1, 3 months, and every 3 months since. Clinical and ultrasound evaluation was added after the first month. Donor HLA-typing was retrieved whenever available, allowing for the characterization and quantification of donor specific antibodies. Cytotoxic crossmatch test was also performed. A second group of patients with allograft degenerations registered during the follow up period was studied. In this group, exclusively for aneurysm description and histopathological analysis, they were included those degenerated vascular transplants from the original series, but also those implanted prior to the beginning of the study and degraded during follow up. Results: All patients studied displayed an increase in anti-HLA antibodies one month after the intervention, regarding bypass patency. In total, 14 patients fulfilled requirements for the study of donor specific antibodies, equally showing IgG production detectable one month after surgery. The presence of complement-fixing antibodies was also confirmed. Antibody levels were not related to graft degeneration. No specific immune markers able to predict aneurysmal development and evolution were found. From the original group, 3 patients suffered aneurysmal degeneration during follow up, together with 9 bypasses previously implanted. Average time until the first degeneration was 33 ± 19.7 months, with 30.6 ± 17.7 and 54.5 ± 2.5 months for a second and third degeneration, when occurring. Therefore, subsequent vascular transplants frequently augmented the time for new degenerations, despite increasing sensibilization. Samples from eight degenerated allografts were available for analysis, unexpectedly showing inflammatory infiltrate in only four cases and immune complex deposition in 7. Conclusions: Immune response against vascular transplants was confirmed in all cases, but chronic rejection did not necessarily provoke bypass degradation or reduced the time for new aneurysms to develop in subsequent allografts.

Midterm Results of Endovascular Treatment for Complete Iliac Axis Occlusions Using Covered Stents.

BACKGROUND: Endovascular treatment of complex aortoiliac disease is seeing a growing popularity despite the Trans-Atlantic Inter-Society Consensus (TASC) II recommendations for open surgery in this cases. However, the available evidence does not focus particularly on patients with complete unilateral iliac axis obstruction (CIAO) (TASC II D4 group). This study reports mid-term results of endovascular therapy with covered stents for CIAO. METHODS: This is single-center retrospective review of patients with CIAO endovascular treatment from January 2015 to December 2017 (3 years). Two types of covered stents were used, alone or combined: the Viabahn self-expandable stent (W. L. Gore, Flagstaff, AZ) and the Advanta V12 balloon-expandable stent (Atrium-Maquet, Hudson, NH). Thirty-day outcomes, long-term patency (assessed with Kaplan-Meier estimates), in-hospital stay, and limb salvage were analyzed. RESULTS: Thirty-nine patients with CIAO were treated in the period (87.2% male, mean age 64.3 ± 9 years). A majority presented with critical limb ischemia (56.4%, n = 22). Recanalization could be accomplished from an ipsilateral or contralateral femoral access in 82.1% of patients (1 case needed the use of a re-entry device), and from a left brachial access in 17.9%. Technical success was 100%. About 66.7% of cases received an aortic kissing stent technique. Common femoral artery/profundoplasty with prosthetic or bovine patch was associated with 74.3% of cases. Thirty-day mortality was 2.6% (1/39). Primary, assisted, and secondary patency rates at 24 months were all 96.8%. Mean in-hospital stay was 5 days; no limb loss was registered during follow-up. CONCLUSIONS: Endovascular treatment of complete iliac axis occlusions can offer comparable midterm patency rates to open surgery aortoiliac femoral bypass, when an adequate combination of balloon and self-expandable covered stents is used and an appropriate outflow through the common femoral artery is warranted.

Multicenter Registry about the Use of EndoAnchors in the Endovascular Repair of Abdominal Aortic Aneurysms with Hostile Neck Showed Successful but Delayed Endograft Sealing within Intraoperative Type Ia Endoleak Cases.

BACKGROUND: The durability of endovascular aortic aneurysms repair (EVAR) is highly related to several anatomical constraints. The term "hostile neck" describes several anatomical features that usually make EVAR treatment technically demanding despite having higher risk of failure. The aim of the study was to describe a multicenter experience with EVAR and an adjunctive use of EndoAnchors in hostile neck anatomies. METHODS: Data were prospectively collected from 4 academic vascular centers including 46 patients with a hostile neck treated by standard EVAR with the adjunctive use of EndoAnchors. Twenty-two of them (47.8%, group A) had an intraoperative type Ia endoleak, and 24 (52.2%) patients were treated in a preventive manner (group B). Primary endpoints were technical and procedural success. Secondary endpoints were regression of the aneurysm sac, freedom from type Ia endoleak, and reinterventions. RESULTS: Neck length and diameter showed no statistical difference in preoperative measures, 9.1 ± 6.9 mm and 8.6 ± 2.8 mm and 25.4 ± 4.7 mm and 27.3 ± 4.7 mm, in group A and B, respectively. Aneurysm sac diameter decreased from 58.2 ± 8 mm and 57.9 ± 9.8 mm to 55.7 ± 8.5 mm and 53.8 ± 10.4 mm in group A and B; respectively, at the last computed tomography scan. Technical and procedural success was 97.8% and 100%, respectively, for group B. Group A showed persistence of type Ia endoleak at completion angiogram in 9 (40.9%) patients. Five of them showed early spontaneous sealing at the first (30 days) computed tomography angiography (CTA), and in the remaining 4, a delayed spontaneous sealing was diagnosed at 12-month CTA. No neck-related secondary procedures were performed. Overall survival was 91%. CONCLUSIONS: Our study shows that additional use of EndoAnchors can successfully improve the sealing of abdominal endografts in case of intraoperative type Ia endoleaks in hostile neck anatomies, representing a safe and effective endovascular alternative in our armamentarium. However, meticulous radiological follow-up is necessary because complete resolution of all observed intraoperative type Ia endoleaks was not observed until the 12-month CTA follow-up.

Failed Minimally Invasive Staged Treatment of a Giant Symptomatic Aortic Perigraft Hygroma after Open Aortic Repair.

BACKGROUND: Perigraft hygromas or seromas are an unusual finding and/or complication after open aortic repair. METHODS AND RESULTS: We present a case of an 82-year-old man with a previous urgent aortic bifurcated graft for abdominal aortic aneurysm rupture. He received several treatments due to abdominal compartment syndrome, requiring a Bogota Bag and colostomy derivation. He was finally discharged home and lost on follow-up. Eight years after this procedure, he presented to the urgency department with an abdominal mass and pain. Urgent computed tomography (CT) scan revealed a giant bilobed aortic sac, corresponding with a huge hygroma. A 3-stage minimally invasive procedure was scheduled due to hostile abdomen. Six months after successful treatment, patient came with fever and abdominal pain. He was diagnosed with graft infection and aortoenteric fistula and was treated with explantation and silver in situ repair. CONCLUSIONS: Aortic hygroma or seromas after open repair should be treated by open means whenever possible. Endovascular techniques could be a valid option in selected patients; however, further evidence is needed.