Dual- vs single-layer stents for endovascular treatment of symptomatic and asymptomatic internal carotid artery stenosis.

BACKGROUNDS: Plaque protrusion is a common event among carotid artery stenting (CAS) patients and increases ischemic complication risk. Dual-layer stents (DLS) with micromesh technology may offer greater plaque protection compared to single-layer stents (SLS), but few data are available. The aim of the study is to compare clinical outcomes at 12 months for asymptomatic and symptomatic patients treated for primary CAS with DLS or SLS in a high-volume center. METHODS: A retrospective analysis of consecutive symptomatic and asymptomatic patients treated with primary CAS for internal carotid artery (ICA) stenosis, with either DLS or SLS between 2015 and 2019, was performed. Primary endpoints included rates of ipsilateral transient ischemic attacks (TIA)/stroke and death within 1-year from CAS. Secondary endpoints included patency rates and survival according to stent type. RESULTS: Of the 301 patients who met inclusion criteria (74.8 % male; 73.6 mean age ± 8.7 years), most patients were asymptomatic (77.4 %). Among all patients DLS was most frequently deployed (66 %); also, among asymptomatic (62 %) and symptomatic patients (81 %), p < 0.01. Symptomatic patients had less comorbidities and severe disease than asymptomatic patients. Six peri-operative strokes were recorded and, within 1 year, 2 additional strokes were registered among symptomatic patients treated with SLS. No post-operative strokes were encountered in the DLS group (p = 0.04) among symptomatic patients. Higher rates of TIA were observed among asymptomatic patients treated with DLS compared to SLS while rates of TIA were reduced among symptomatic patients treated with DLS. There were no differences in patency rates for DLS and SLS in symptomatic and asymptomatic patients. Primary patency was similar among DLS stent types but differed among SLS stent types (p = 0.01). At a mean follow-up of 27 months ±17.6, survival was comparable between DLS and SLS groups (p = 0.98). CONCLUSION: CAS with DLS seems to reduce the risk of post-procedural stroke for symptomatic patients compared to SLS whilst the choice of stent did not influence ipsilateral TIA, survival or patency rates. These data require confirmation from larger, randomized, prospective studies.

Real-world outcomes of Cook Zilver PTX in femoro-popliteal district from multicenter experience.

BACKGROUND: The purpose is to evaluate the follow-up outcomes after femoro-popliteal stenting with Cook Zilver PTX in a multicenter experience. METHODS: Collected data from four Units were retrospectively joined and analyzed considering Zilver PTX deployed from August 2009 according to the instruction for use. Patient demographics, preoperative comorbidities, Rutherford classification, arterial characteristics and stent data were considered. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms. Primary outcome was the freedom from TLR (ffTLR) and its risk factors. Secondary outcomes were primary patency (PP) of the stent, amputation-free survival (AFS) and their risk factors. RESULTS: Considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (CLTI) affected 154 patients (75.9%). The length of the treated lesion was <120 mm in 99 (48.8%), ≥120 mm and <200 mm in 65 (32%) and ≥200 mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7 mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases. Two or more crural run-off vessels were patent in 124 (61.1%). Mean follow-up was 23.2 months ±21.3. At 1, 2 and 3 years, the ffTLR was 90.6±4.2%, 86.4±6.1% and 80.4±8.3%, respectively, and the PP was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively. Negative prognostic factor for ffTLR and PP was the reference vessel diameter (P=0.001 and P<0.001, respectively). At 1, 2 and 3 years, the AFS was 81.8±6.0%, 75.5±7.1% and 74.2±7.5% respectively; coronary artery disease (P=0.041) and CLTI (P=0.011) resulted negative prognostic factors. CONCLUSIONS: In the real-world practice, around 3/4 of patients were treated for CLTI. The rate of ffTLR is high, and PP is substantially lower. A small vessel diameter (<5 mm) is a negative factor for both ffTLR and PP. The rate of AFS is about 75% at 2 years and CLTI and coronary artery disease are negative prognostic factors.

Chimney Stenting Versus Surgical Debranching for the Treatment of Aortic Arch Pathologies-A Propensity-Matched Analysis.

BACKGROUND: Endovascular repair of aortic arch lesions requires revascularization of epiaortic vessels in case of coverage. The objective of this study was to compare the outcomes of surgical bypass versus endovascular reconstruction with a chimney graft. METHODS: A retrospective analysis of a multicenter register between January 2005 and December 2019 was performed. A total of 127 patients were included and divided into 2 groups: thoracic endovascular aortic repair + surgical debranching (n = 72) and thoracic endovascular aortic repair + chimney stenting (n = 55). The main end points were major neurologic sequelae and type IA endoleak. Propensity score matching was performed to analyse baseline variables related to these outcomes. RESULTS: The mean follow-up was 35.6 months for the debranching group and 34.1 for the chimney group (P = 0.65). The incidence of stroke was higher in the chimney group although not statistically significant (7.3% vs. 4.1%; P = 0.46); for both groups, a wide angle between the ostium of the target vessel and the aorta and landing in Ishimaru Zone 0 was found to be the main predictors for major neurologic sequelae (P = 0.002 and P = 0.003, respectively). During follow-up, 9 (12.5%) type IA endoleaks occurred in the debranching group and 12 (21.8%) in the chimney group (P = 0.14). Aortic diameter larger than 66 mm and arch angle >46° had a strong association with proximal endoleak incidence (P = 0.001 and P = 0.011, respectively) CONCLUSIONS: Surgical debranching showed better results than chimney stenting in terms of major neurologic events incidence and type IA endoleak, although the difference between the groups was not statistically significant. Further research with larger cohorts is needed to establish the indications for these procedures.

Multicenter comparison between open conversions and semi-conversions for late endoleaks after endovascular aneurysm repair.

OBJECTIVE: The aim of this study is to compare early and follow-up outcomes of late open conversions (LOC, with complete or partial endograft explantation) and semi-conversions (SC, with endograft preservation) after endovascular aneurysm repair in a multicenter experience. METHODS: All LOC and SC performed from 1997 to 2020 in 11 vascular centers were compared. Endograft infections or thrombosis were excluded. Primary endpoints were early mortality and long-term survival estimates. Secondary endpoints were differences in postoperative complication rates and conversion-related complications during follow-up. RESULTS: In the considered period, 347 patients underwent surgery for endovascular aneurysm repair complications. Among these, 270 were operated on for endoleaks (222 LOC, 48 SC). The two groups were homogeneous in terms of American Society of Anesthesiologists score (LOC, 3.2 ± 0.7; SC, 3 ± 0.5; P = .128) and main endograft characteristics (suprarenal fixation, bifurcated/aorto-uni-iliac configuration). The mean age was 75 ± 8 years for LOC and 79 ± 7 years for SC (P = .009). Reasons for LOC were: 62.2% (138/222) type I endoleak, 21.6% (48/222) type II endoleak, 7.7% (17/222) type III endoleak, and 8.5% (19/222) endotension. Indications for SC were: 64.6% (31/48) type II endoleak, 33.3% (16/48) type I endoleak, and 2.1% (1/48) type III endoleak. Thirty-day mortality was 12.2% (27/222) in the LOC group, and 10.4% (5/48) in the SC group (P = .73). Postoperative complication rate was higher in the LOC group (45.5% vs 29.2%; P = .04). The estimated survival rate after LOC was 80% at 1 year and 64% at 5 years; after SC, it was 72% at 1 year and 37% at 5 years (log-rank P = .01). During the median follow-up of 21.5 months (interquartile range, 2.4-61 months), an endoleak after SC was found in the 38.3% of the cases; sac growth was recorded in the 27.7% of SC patients. CONCLUSIONS: SC has an early benefit over LOC in terms of reduced postoperative complications but has a significantly inferior mid-term survival. The high rates of persistent and/or recurrent endoleaks reduce SC durability.

Successful Endovascular and Endoscopic Treatment of a Symptomatic Celiac Artery Aneurysm for Obstructive Jaundice: A Clinical Case Report.

BACKGROUND: Celiac artery aneurysm (CAA) is an infrequent aneurysm of the celiac visceral branch and is potentially life-threatening, mainly due to the risk of rupture. CAA is often diagnosed following rupture and rarely diagnosed secondary to a primary manifestation; obstructive jaundice is extremely rare and poorly described. This clinical case report reports a combined endovascular and endoscopic noninvasive treatment. METHODS: A 51-year old male was admitted to the emergency department at the Arcispedale Santa Maria Nuova in Reggio Emilia following several days of jaundice. The patient did not have any history of abdominal trauma, chronic pancreatitis, bile duct calculus or alcohol abuse. Cholestatic impairment was demonstrated by blood analyses and abdominal ultrasound revealed a large cephalo-pancreatic mass. Contrast-enhanced computed tomography (CT) showed a 40 mm CAA, causing a common bile duct (CBD) compression and dilatation of the hepatic bile ducts. After a multidisciplinary team consultation, a noninvasive, combined endovascular and endoscopic approach was programmed in a hybrid room. RESULTS: Immediate results confirmed successful exclusion of the CAA, stent graft patency and the absence of endoleak with correct positioning of a plastic stent in the CBD. At 1 month, an abdominal CT-angiography (CTA) evidenced a type II endoleak, successfully treated with an endovascular secondary procedure and an asymptomatic, partial downward dislodgement of the plastic stent in the CBD was correct with the positioning of 2 plastic stents. At 3-months cholangiography showed no dilation of intraepatic biliary ducts. CONCLUSIONS: Symptomatic CAA with common bile duct compression could be amenable to a combined endovascular and endoscopic noninvasive treatment.

Twenty-two Year Multicentre Experience of Late Open Conversions after Endovascular Abdominal Aneurysm Repair.

OBJECTIVE: The aim was to report indications, technical aspects, and outcomes of a multicentre experience of late open conversions (LOCs) after endovascular abdominal aneurysm repair (EVAR), in order to identify risk factors which may influence early morbidity and mortality rates, and long term survival. METHODS: Ten vascular centres retrospectively reviewed all patients requiring LOC (≥30 days from initial EVAR, undergoing total or partial endograft explantation) from 1996 to 2017. Baseline characteristics, endograft data, indications, procedural details, post-operative outcomes, and follow up data were reviewed and analysed. RESULTS: Included patients totalled 232 (90.1% males, mean age 74.3 ± 7.9 years). The number of LOC per year significantly increased during the study period, reaching 22 in 2017 (correlation r = 0.867, p < .0001). Reasons for LOC were 80.2% endoleak (186/232), 15.5% endograft infection (36/232), and 9.9% endograft thrombosis (23/232). Sixty-nine patients (29.7%) were operated on urgently; rupture was present in 18.5% (43/232). Eighty-nine patients (38.4%) underwent endovascular re-interventions prior to LOC. The proximal aortic cross clamp site was infrarenal in 40.5% (94/232), suprarenal in 25.4% (59/232), supracoeliac in 32.8% (76/232), and thoracic in 1.3% (3/232). Endograft explantation was total in 164/232 patients (70.7%), and partial in the remaining 68/232 (29.3%). The overall 30 day mortality was 11.2% (26/232). Early mortality was significantly higher for patients operated on urgently (26.1% vs. 4.9%, p < .001). Suprarenal clamping (odds ratio (OR) 2.34, 95% CI 1.12-4.88) and pre-existing renal insufficiency (OR 2.11, 95% CI 1.03-4.31) were independent risk factors for post-operative renal failure on multivariable analysis. Median follow up was 24.1 months (IQR 4.4-60.6). The estimated overall one and five year survival rates were 79.7% and 58.6%, respectively. Survival estimates were significantly lower for patients with endograft infection (83.8% vs. 59% at one year, 65.2% vs. 28.9% at five years; log rank p = .005), as well as for urgent patients (87.2% vs. 62.1% at one year, 65.1% vs. 43.7% at five years; log rank p < .0001). CONCLUSION: The annual number of LOC increased over time. LOCs performed urgently or for endograft infection are associated with poor survival. Infrarenal aortic clamping has lower post-operative complication rates.

Influence of Thoracic Endovascular Repair on Aortic Morphology in Patients Treated for Blunt Traumatic Aortic Injuries: Long Term Outcomes in a Multicentre Study.

OBJECTIVE: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). METHODS: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. RESULTS: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20-80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%-35%). Following a median follow up of 67.4 ± 56.1 months (range 14-153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p < .001), age (p < .001 and p = .002, respectively) and sealing in zone 2 (p = .027 and p = .042, respectively). For every 10% increase in oversizing, proximal neck diameter remodelling was 3.4% (p = .05). The distal axis decreased over time (p < .001; significant between three and six years). CONCLUSION: TEVAR is safe for BTAI in the mid to long term. This study reports a correlation between time, oversizing, and remodelling, but the level of adverse events was low.

Late open conversions after endovascular abdominal aneurysm repair in an urgent setting.

OBJECTIVES: We report a multicenter experience of urgent late open conversion (LOC), with the goal of identifying the mode of presentation, technical aspects, and outcomes of this cohort of patients. METHODS: A retrospective analysis of endovascular aneurysm repair (EVAR) requiring LOC (>30 days after implantation) from 1996 to 2016 in six vascular centers was performed. Patients with aneurysm rupture or other conditions requiring urgent surgery (<24 hours) were included. Patient demographics, time interval between EVAR and LOC, endograft characteristics, previous attempts at endovascular correction, indications, operative technique, 30-day mortality and morbidity, and long-term survival were analyzed. RESULTS: There were 42 patients (88.1% men; mean age, 75.8 ± 9.0 years) included. Among the 42 explanted grafts, 33 were bifurcated, 1 tube, 6 aortouni-iliac, and 2 side-branch devices. Suprarenal fixation was present in 78.6%. Twelve patients (28.6%) underwent endovascular reintervention before LOC. Indications for urgent LOC were aneurysm rupture in 24 of the 42 cases (57.1%), endograft infection in 11 (26.2%), endoleak associated with aneurysm growth and pain in 6 (14.3%), and recurrent endograft thrombosis in 2 (4.8%). The proximal aortic cross-clamping site was infrarenal in 38.1% of cases, suprarenal in 19.1%, and supraceliac in 42.9%. Complete removal of the endograft was performed in 32 patients (76.2%) and partial removal in 10 (proximal preservation in 7 of 10). Reconstructions were performed with Dacron grafts in 33 of the 42 cases, cryopreserved arterial allografts in 5, and endograft removal associated with prosthetic axillobifemoral bypass in 4. The 30-day mortality was 23.8%; hemorrhagic shock was an independent risk factor of early mortality (odds ratio, 10.5; 95% confidence interval, 1.5-73.7; P = .018). During a mean follow-up of 23.9 ± 36.0 months, two late aneurysm-related deaths occurred. The estimated 1- and 5-year survival rates were 62.1% and 46.1%, respectively. CONCLUSIONS: Urgent LOC after EVAR are associated with high postoperative mortality rates and poor long-term survival. Further studies are necessary to define the timing and the best treatment option for failing EVAR.

Standard "off-the-shelf" multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience.

OBJECTIVE: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. METHODS: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. RESULTS: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. CONCLUSIONS: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.

Successful Conservative Treatment of a Kommerell Aneurysm Associated With Right-Sided Aortic Arch.

Right-side aortic arch is a rare congenital aortic anomaly occurring in 0.05% to 0.1% of the general population. Approximately, half of these cases may be associated with an aberrant left subclavian artery and occasionally with aneurysmatic change at its origin known as Kommerell diverticulum or aneurysm (KA). Herein we report a challenging case of a right-side aortic arch associated with KA incidentally observed in a 73-year-old male with metastatic lung cancer. After careful multidisciplinary discussion, a conservative strategy of care was successfully adopted.