Early outcomes of the Conformable endograft in severe neck angulation from the Triveneto Conformable Registry.

OBJECTIVE: The study reports retrospective evaluation of early outcomes from a multicentric experience with the Excluder conformable endograft with active control system (CEXC Device) in the treatment of abdominal aortic aneurysms. Its design allows more flexibility, given by proximal unconnected stent rows and a bending wire within the delivery catheter enables control of proximal angulation. This study specifically focuses on the severe neck angulation (SNA) subgroup (≥60°). METHODS: All patients treated with CEXC Device in nine vascular surgery centers of Triveneto area (Northeast Italy) between January 2019 and July 2022 were enrolled prospectively and analyzed retrospectively. Demographic and aortic anatomical characteristics were evaluated. Endovascular aneurysm repair in SNA were selected for analysis. Major investigated outcomes were technical success, endoleaks, morbidity, mortality, and reinterventions at 30 days and during follow-up. Endograft migration and postoperative aortic neck angulation changes were also analyzed. RESULTS: A total of 129 patients were enrolled. An infrarenal angle of ≥60° was observed in 56 patients (43%) (SNA group) and their data analyzed. The mean patient age was 78.9 ± 5.9 years and median abdominal aortic aneurysm diameter 59 mm (range, 45-94 mm). Median aortic infrarenal neck length, angulation and diameter were 22 mm (range, 13-58 mm), 77° (range, 60°-150°), and 22.0 ± 3.5 mm respectively. Analysis revealed a technical success rate of 100% and perioperative major complication rate of 1.7%. Intraoperative and perioperative morbidity and mortality rates were 3.5% (one buttock claudication and one inguinal surgical cutdown) and 0%, respectively. No perioperative type I endoleaks were observed. The median follow-up was 13 months (range, 1-40 months). Five patients died during follow-up from aneurysm-unrelated causes. Two reinterventions occurred (3.5%): one conversion for a type IA endoleak and one sac embolization for a type II endoleak. Aneurysm sac shrinkage was observed in 15 patients (26%) and aneurysm stability in 35 patients (62%), respectively. Estimated freedom from reinterventions at 24 months was 92%. Aortic neck median postoperative angulation was 75° (range, 45°-139°). CONCLUSIONS: The Triveneto Conformable Registry shows good early results of the CEXC device in severely angulated aortic infrarenal necks. These data need confirmation on longer follow-up and a wider cohort of patients to further increase endovascular aneurysm repair eligibility in SNA.

Peri-Operative Management of Patients Undergoing Fenestrated-Branched Endovascular Repair for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms: Preventing, Recognizing and Treating Complications to Improve Clinical Outcomes.

The advent and refinement of complex endovascular techniques in the last two decades has revolutionized the field of vascular surgery. This has allowed an effective minimally invasive treatment of extensive disease involving the pararenal and the thoracoabdominal aorta. Fenestrated-branched EVAR (F/BEVAR) now represents a feasible technical solution to address these complex diseases, moving the proximal sealing zone above the renal-visceral vessels take-off and preserving their patency. The aim of this paper was to provide a narrative review on the peri-operative management of patients undergoing F/BEVAR procedures for juxtarenal abdominal aortic aneurysm (JAAA), pararenal abdominal aortic aneurysm (PRAA) or thoracoabdominal aortic aneurism (TAAA). It will focus on how to prevent, diagnose, and manage the complications ensuing from these complex interventions, in order to improve clinical outcomes. Indeed, F/BEVAR remains a technically, physiologically, and mentally demanding procedure. Intraoperative adverse events often require prolonged or additional procedures and complications may significantly impact a patient's quality of life, health status, and overall cost of care. The presence of standardized preoperative, perioperative, and postoperative pathways of care, together with surgeons and teams with significant experience in aortic surgery, should be considered as crucial points to improve clinical outcomes. Aggressive prevention, prompt diagnosis and timely rescue of any major adverse events following the procedure remain paramount clinical needs.

Early and midterm outcomes following open surgical conversion after failed endovascular aneurysm repair from the "Italian North-easT RegIstry of surgical Conversion AfTer Evar" (INTRICATE).

OBJECTIVE: To report the early and mid-term outcomes following open surgical conversion (OSC) after failed endovascular aortic repair (EVAR) using data from a multicentric registry. METHODS: A retrospective study was carried out on consecutive patients undergoing OSC after failed EVAR at eight tertiary vascular units from the same geographic area in the North-East of Italy, from April 2005 to November 2019. Study endpoints included early and follow-up outcomes. RESULTS: A total of 144 consecutive patients were included in the study. Endoleaks were the most common indication for OSC (50.7%), with endograft infection (24.6%) and occlusion (21.9%) being the second most prevalent causes. The overall rate of 30-day all-cause mortality was 13.9% (n = 20); 32 patients (22.2%) experienced at least one major complication. Mean length of stay was 13 ± 12.7 days. On multivariate logistic regression, age (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.01-1-19; P = .02), renal clamping time (OR, 1.07; 95% CI, 1.02-1.13; P = .01), and suprarenal/celiac clamping (OR, 6.66; 95% CI, 1.81-27.1; P = .005) were identified as independent predictors of perioperative major complications. Age was the only factor associated with perioperative mortality at 30 days. Renal clamping time >25 minutes had sensitivity of 65% and specificity of 70% in predicting the occurring of major adverse events (area under the curve, 0.72; 95% CI, 0.61-0.82). At 5 years, estimated survival was significantly lower for patients treated due to aortic rupture/dissection (28%; 95% CI, 13%-61%), compared with patients in whom the indication for treatment was endoleak (54%; 95% CI, 40%-73%), infection (53%; 95% CI, 30%-94%), or thrombosis (82%; 95% CI, 62%-100%; P = .0019). Five-year survival rates were significantly lower in patients who received emergent treatment (28%; 95% CI, 14%-55%) as compared with those who were treated in an urgent (67%; 95% CI, 48%-93%) or elective setting (57%; 95% CI, 43%-76%; P = .00026). Subjects who received suprarenal/celiac (54%; 95% CI, 36%-82%) or suprarenal (46%; 95% CI, 34%-62%) aortic cross-clamping had lower survival rates at 5 years than those whose aortic-cross clamp site was infrarenal (76%; 95% CI, 59%-97%; P = .041). Using multivariate Cox proportional hazard, older age and emergency setting were independently associated with higher risk for overall 5-year mortality. CONCLUSIONS: OSC after failed EVAR was associated with relatively high rates of early morbidity and mortality, particularly for emergency setting surgery. Endoleaks with secondary sac expansion were the main indication for OSC, and suprarenal aortic cross-clamping was frequently required. Endograft infection and emergent treatment remained associated with poorer short- and long-term survival.

Early and midterm outcomes of endovascular aneurysm repair with an ultra-low-profile endograft from the Triveneto Incraft Registry.

OBJECTIVE: We evaluated the early and midterm outcomes of the Incraft (Cordis Corp, Bridgewater, NJ) ultra-low-profile endograft by analyzing data from the Triveneto Incraft Registry (TIR). METHODS: TIR is an independent multicenter cohort registry of 10 vascular surgery units in the Triveneto area (Northeast Italy). A prospective analysis of patients electively treated with Incraft from September 2014 to June 2019 was performed. The main outcomes were technical success, major 30-day complications, 30-day aneurysm-related death, freedom from reintervention, and mortality rate during follow-up and were analyzed using Kaplan-Meier curves. Univariable Cox regression was used to evaluate the associations between anatomic complexity factors and reintervention. RESULTS: During the study period, 209 patients were included in the registry. Their mean age was 76.9 ± 7.7 years and the Society for Vascular Surgery comorbidity score was 0.97 ± 0.52. Most patients (n = 181; 86.6%) had presented with at least one complex anatomic factor: aortic neck angle α <135° in 31 patients (14.8%), conic neck in 17 patients (8.2%), iliac tortuosity index τ >1.5 in 102 (48.8%), iliac artery calcification >50% in 106 (50.7%), and external iliac artery <6 mm in 45 (21.5%). The concurrent presence of two or more complex iliac anatomic factors was present in 67 patients (32.1%). The technical success rate was 99.5%, and the early major complication rate was 1.5% (one limb occlusion, one iliac branch stenosis, one type III endoleak [EL]). No 30-day mortality was recorded. The mean follow-up period was 18.5 ± 13.2 months. The overall mortality was 9.5% (n = 18), none related to the aneurysm. The freedom from reintervention rate was 92.1%. Of these patients, six (3.2%) had been treated for type II EL embolization, one (0.5%) for type IA EL, four (2.1%) for iliac branch occlusion, and one (0.5%) for flow-limiting external iliac artery dissection. None of the single anatomic factors analyzed were predictive of reintervention. However, the association of two or more complex iliac anatomic factors was predictive of related reintervention (hazard ratio, 7.25; P = .014). The crude reintervention rate in this complex subgroup of patients was low (4 of 67; 6%). CONCLUSIONS: Data from the TIR have demonstrated excellent early and midterm outcomes of endovascular aneurysm repair using the Incraft stent graft in patients with complex anatomy. The concurrent presence of two or more complex iliac anatomic factors still represent an issue for endovascular aneurysm repair success. However, the technical characteristics of this device resulted in low intervention rates, even for patients with these challenging issues.

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.

Open Repair for Juxtarenal Aortic Aneurysm: Short and Long-term Results.

BACKGROUND: The recent technological evolution has also allowed for the treatment of juxtarenal aortic aneurysm (JAA) with an endovascular technique, but short- and long-term results must be compared with the results of open treatment, which is the gold standard. In this study, we analyzed the short- and long-term results of open surgical treatment (open repair) in patients with JAA in our series. METHODS: From January 2006 to December 2016, 155 patients were treated for JAA with open repair; the data were analyzed retrospectively. The mean age was 71.17 years (standard deviation [SD] 7.1), and mean size of aneurysm was 6.15 cm (SD 1.1). The ASA classes 2, 3, and 4 were 20%, 74% and 6%, respectively. Follow-up included clinical visit and abdominal aorta Duplex scan after 1 and 6 months and annually. The mean follow-up interval was 48.6 (SD 32.4) months. RESULTS: The mean surgical time was 256 min (SD 69), the mean stay in the intensive care unit was 1.6 days (SD 1.2), and the mean total hospital stay was 10.2 days (SD 4.3). Aortic cross-clamping was usually suprarenal (110, 71%); in 39 (25%), the aortic clamping was between the renal arteries, and 6 patients (4%) required a supraceliac cross-clamping. The mean renal ischemia time due to aortic clamping was 17 min (SD 3.5). In 32 patients (21%), the left renal vein was sectioned for performing proximal aortic anastomosis and then reconstructed. Twelve patients (8%) required a renal revascularization, and in 49 patients (32%), an hypogastric bypass was performed. The 30-day mortality rate was 0.6%, and only 1 patient died in the postoperative due to intestinal infarction. The postoperative morbidities occurred in 15 cases (10%). Six patients had dehiscence of the laparotomy without the involvement of the muscle, 4 patients had an asymptomatic small increase of the troponin, and in 3 patients, there was an increase in creatinine >1.8 mg/dL. No dialysis was performed. Two patients had peripheral embolism in the lower limbs. Twenty-six patients (15%) died in the follow-up, but causes have never been related to aortic disease. CONCLUSIONS: Open repair of JAA is still safe, effective, and durable also in the long-term period and even in patients with multiple cardiovascular risk factors.

Aortic Epithelioid Angiosarcoma after Endovascular Aneurysm Repair.

We report a case of epithelioid angiosarcoma of the abdominal aortic wall after endovascular treatment for abdominal aortic aneurysm (EVAR). A 60-year-old male, treated 7 years before with EVAR, presented with abdominal back pain, general fatigue, and fever. It was assumed to be a graft infection with periaortic tissue compatible with an inflammatory reaction. The endograft was therefore completely removed and a Dacron silver aorto-bisiliac graft was implanted. After a few days the patient worsened, the angio-computed tomography scan showed a progressive increase of the periaortic mass and numerous small nodules in the abdomen were also detected. The patient was again brought to surgery, an axillo-bifemoral bypass was performed, and the aorto-bisiliac graft was removed but the patient died after surgery. The histological examination showed an aortic epithelioid angiosarcoma with peritoneal metastasis.

Surgical treatment for pseudo-occlusion of the internal carotid artery.

OBJECTIVES: Carotid artery pseudo-occlusion is a rare condition and its natural history and clinicopathological characteristics are not well defined. We reported our 7-year experience in the surgical treatment of carotid artery pseudo-occlusion to determine the real benefit of the surgical option. METHODS: From January 2006 to December 2013, 1414 patients were treated for high-grade stenosis of the internal carotid artery, 33 (2.3%) presented with a carotid pseudo-occlusion (26 males and 7 females, mean age: 70 ± 10). Nineteen patients were symptomatic, and 14 asymptomatic. Carotid artery pseudo-occlusion was identified by duplex scan (segmental occlusion at the origin of internal carotid artery with very thin distal flow) and the diagnostic confirmation was obtained by angio-computed-tomography (CT) scan. The operation was performed under general anaesthesia and constant Electroencephalography (EEG) monitoring. The follow-up was performed by duplex scan at discharge, 30 days, 6 months and yearly. RESULTS: Politetrafluoroetilene (PTFE) patch endarterectomy, eversion endarterectomy and carotid bypass were performed in 20 (61%), 10 (30%) and 3 patients (9%), respectively. No mortality or stroke was observed in postoperative period. Four patients presented with an asymptomatic postoperative thrombosis of the internal carotid artery. No restenosis was observed. CONCLUSIONS: Surgical treatment for carotid artery pseudo-occlusion is safe and effective.

Surgery for acute lower limb ischemia in the elderly population: results of a comparative study.

BACKGROUND: To evaluate the outcome of surgical treatment of acute lower limb ischemia in elderly patients. The primary endpoints were early and midterm rates of survival and limb salvage. METHODS: A retrospective analysis involving 76 consecutive patients observed for acute lower limb ischemia between March 2005 and December 2008 who underwent revascularization was conducted. A total of 44 patients (group A) of age >80 years (average age: 86.9 ± 4.5 years; 13 men and 31 women) had a site of obstruction at the level of abdominal aorta in one case (2.3%), common-external iliac artery/common femoral artery in 15 (34.1%), superficial femoral artery/popliteal artery in 26 (59.1%), and infrapopliteal arteries in two (4.5%), and embolectomy, thrombectomy, bypass, and angioplasty was performed in 24 (54.5%), 11 (25.0%), eight (18.2%), and one (2.3%) case(s), respectively. A total of 32 patients (group B) of age <80 years (average age: 67.2 ± 12.2 years; 19 men and 13 women) with an analogous site of obstruction at the level of abdominal aorta in one case (3.1%), common/external iliac artery/common femoral artery in 12 (37.5%), superficial femoral artery/popliteal artery in three (9.4%), and infrapopliteal arteries in 16 (50.0%) underwent the same aforementioned procedures in 10 (31.3%), 12 (37.5%), nine (28.1%), and one (3.1%) case(s), respectively. RESULTS: At 30 days after surgery, survival and limb salvage were both 93.2% in group A versus 96.9% and 87.5%, respectively, in group B, whereas they were 93.2% and 65.8%, respectively, in group A versus 85.7% and 96.9%, respectively, in group B (p = 0.22 and p = 0.19, respectively) at the midterm control. The univariate and multivariate analyses showed that category 2b of acute ischemia (immediately-threatening) has a negative statistically significant influence on the survival rate (p = 0.01). CONCLUSIONS: Limb salvage rates after surgical intervention for acute lower limb ischemia in the elderly population are comparable with those of the younger population, whereas survival rates are lower, but without statistical significance. The only factor that negatively influences the survival rate is the 2b clinical category of acute ischemia, regardless of the age of the patient.

Intrasac fibrin glue injection after platinum coils placement: the efficacy of a simple intraoperative procedure in preventing type II endoleak after endovascular aneurysm repair.

OBJECTIVES: To verify in our experience if fibrin glue injection into the aneurysm sac, made at the end of endovascular aneurysm repair (EVAR), can reduce type II endoleak rates. METHODS: Between January 2005 and February 2008, 38 patients underwent EVAR for an unruptured abdominal aortic aneurysm. The first 20 consecutive patients (Group A) had standard EVAR while the last 18 patients (Group B) had EVAR with fibrin glue injection into the sac, regardless of type II endoleak's presence. RESULTS: There was no statistically significant difference between the two groups concerning the surgical time and the time of X-ray exposure (P=0.30 and 0.54, respectively). Type II endoleak rate was significantly higher in Group A compared to Group B (6 cases, 30% vs. 1 case, 5.5%, respectively, P=0.05). Primary short-term clinical success was 95% and 100%, respectively. At 12 months, selective lumbar embolization was performed in two patients in Group A and in one patient in Group B. Patients in Group A had less computed tomography (CT) studies than patients in Group B (2.0 vs. 1.2, respectively, P=0.024). CONCLUSIONS: Fibrin glue injection is a safe procedure and seems to reduce type II endoleak rates. Patients who received this procedure had fewer CT examinations, with reduced health-care costs.

Hypogastric artery bypass in open repair of abdominal aortoiliac aneurysm: a safe procedure.

OBJECTIVES: The aim of this study is to assess the immediate and mid-term results of hypogastric artery bypass (HAB) in open repair of abdominal aortic aneurysm (AAA). METHODS: The clinical data of 24 patients with an average age of 70.4 years [standard deviation (S.D.)+/-8.1 years] with AAA treated between January 2005 and December 2008 with HAB during open repair of aortoiliac aneurysm were reviewed. Eighteen patients received unilateral and six bilateral hypogastric bypasses, using a segment of Dacron graft prosthesis. Concomitant hypogastric eversion endarterectomy was associated in six cases (25%). Follow-up was complete in all the 24 patients and averaged 16.2 months (range 1-35). Postoperative imaging protocol involved a conventional Echocolordoppler and CT-scan. With respect to the operating time, the blood loss, the intensive care unit (ICU) and the length of ward admission (LWA) stay, we compared the 24 patients who underwent hypogastric bypass (group A) with the 50 patients who had bifurcated graft without hypogastric bypass (group B). RESULTS: Between the two groups, statistically different results were demonstrated only with respect to the duration of operation (h) (group A 5.19+/-1.38 vs. group B 4.39+/-1.32, P=0.0195). No statistical differences were noted for ICU stay (h) (group A median 21.50 vs. group B median 21.3, range 1 degrees -3 degrees quartile 19.75-23.50) and LWA stay (days) (group A median 8.50, range 1 degrees -3 degrees quartile 7.00-11.50 vs. group B median 8.0, range 1 degrees -3 degrees quartile 7.00-9.00). There were no operative deaths, bowel or intestinal ischemia in the early postoperative period between the two groups. In group A, one patient had transient renal failure and one patient had an acute coronary syndrome. In group B, one patient had a peripheral ischemia who required tibioperoneal embolectomy. The patency of the hypogastric grafts was demonstrated in all cases. CONCLUSIONS: In our experience, direct revascularization of the hypogastric artery to ensure pelvic vascularization in aortoiliac surgery appears a safe procedure.