Publications by authors named "Enrico Gallitto"

85 Publications

MicroRNA profiles of human peripheral arteries and abdominal aorta in normal conditions: MicroRNAs-27a-5p, -139-5p and -155-5p emerge and in atheroma too.

Mech Ageing Dev 2021 Sep 28;198:111547. Epub 2021 Jul 28.

DIMES-Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy; Subcellular Nephro-Vascular Diagnostic Program, Pathology Unit, IRCCS, Policlinico S. Orsola Hospital, Bologna, Italy.

Atherosclerosis may starts early in life and each artery has peculiar characteristics likely affecting atherogenesis. The primary objective of the work was to underpin the microRNA (miR)-profiling differences in human normal femoral, abdominal aortic, and carotid arteries. The secondary aim was to investigate if those identified miRs, differently expressed in normal conditions, may also have a role in atherosclerotic arteries at adult ages. MiR-profiles were performed on normal tissues, revealing that aorta and carotid arteries are more similar than femoral arteries. MiRs emerging from profiling comparisons, i.e., miR-155-5p, -27a-5p, and -139-5p, were subjected to validation by RT-qPCR in normal arteries and also in pathological/atheroma counterparts, considering all the available 20 artery specimens. The three miRs were confirmed to be differentially expressed in normal femoral vs aorta/carotid arteries. Differential expression of those miRs was also observed in atherosclerotic arteries, together with some miR-target proteins, such as vimentin, CD44, E-cadherin and an additional marker SLUG. The different expression of miRs and targets/markers suggests that aorta/carotid and femoral arteries differently activate molecular drivers of pathological condition, thus conditioning the morphology of atheroma in adult life and likely suggesting the future use of artery-specific treatment to counteract atherosclerosis.
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http://dx.doi.org/10.1016/j.mad.2021.111547DOI Listing
September 2021

Intracranial Hemorrhage After Endovascular Repair of Thoracoabdominal Aortic Aneurysm.

J Endovasc Ther 2021 Jun 30:15266028211028226. Epub 2021 Jun 30.

University of Bologna, Hospital of Bologna Sant'Orsola-Malpighi Polyclinic IRCCS, Bologna, Emilia-Romagna, Italy.

Background: Intracranial hemorrhage (ICH) is a rare but devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair with fenestrated/branched endograft (f/bEVAR). The cerebrospinal fluid drainage (CSFD) is considered one of the leading causes; however, other possible concomitant factors have not been individualized yet. The aim of the present work was to evaluate the pattern of ICH events after f/bEVAR for TAAA and to identify possible associated factors.

Materials And Methods: All f/bEVAR procedures for TAAA performed in a single academic center from 2012 to 2020 were evaluated. ICH was assessed by cerebral computed tomography if neurological symptoms arose. Pre-, intra-, and postoperative characteristics were analyzed in order to identify possible factors associated.

Results: A total of 135 f/bEVAR were performed for 72 (53%) type I, II, III and 63 (47%) type IV TAAA; 74 (55%) were staged procedures, 101 (73%) required CSFD, and 24 (18%) were performed urgently. The overall 30-day mortality was 8% (5% in elective cases); spinal-cord ischemia occurred in 11(8%) and ICH in 8 (6%) patients. All ICH occurred in patients with CSFD. ICH occurred intraoperatively in 1 case, inter-stage in 4 and after F/BEVAR completion in 3, after a median of 6 days the completion stage. Three (38%) of 8 patients with ICH died at 30 days and ICH was associated with 30-day mortality: odds ratio (OR) 13.2, 95% confidence interval (CI): 2.3-76, p=0.01. The analysis of the perioperative characteristics identified platelet reduction >60% (OR 11, 95% CI 1.6-77, p=0.03), chronic kidney disease (16% vs 0%, p=0.002), and total volume of liquor drained >50 mL (OR 8.1, 95% CI 1.1-69, p=0.03) as associated with ICH.

Conclusions: Current findings may suggest that ICH is a potential lethal complication of the endovascular treatment for TAAAs and it mainly occurs in patients with CSFD. High-volume liquor drainage, platelet reduction, and chronic kidney disease seems increase significantly the risk of ICH and should be considered during the perioperative period and for further studies.
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http://dx.doi.org/10.1177/15266028211028226DOI Listing
June 2021

Reinterventions after fenestrated and branched endografting for degenerative aortic aneurysms.

J Vasc Surg 2021 Jun 2. Epub 2021 Jun 2.

Division of Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi, Bologna, Italy.

Objective: Fenestrated/branched endovascular abdominal aortic aneurysm repair (F/B-EVAR) is widely accepted technique to treat juxta/pararenal abdominal aortic aneurysms (J/P-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) for patients at high-surgical risk. However, the follow-up results should be carefully evaluated, especially in terms of the reintervention rate. The aim of the present study was, therefore, to evaluate the early and mid-term reinterventions after FB-EVAR for J/P-AAAs and TAAAs and their effects on follow-up survival.

Methods: From 2006 to 2019, all consecutive patients who had undergone F/B-EVAR for J/P-AAAs or TAAAs were prospectively enrolled. Cases requiring reinterventions were retrospectively analyzed. Patients with aortic dissection were excluded from the present analysis. Reinterventions were classified as follows: access related, aortoiliac related, or target visceral vessel (TVV) related. Freedom from reintervention and survival were assessed using the Kaplan-Meier method, and univariate and multivariate analyses were used to determine the risk factors.

Results: Overall, 221 F/B-EVAR procedures were performed for 111 J/P-AAAs (50.3%) and 110 TAAAs (49.7%) in an elective (182; 82%) or urgent (39; 18%) setting. The median follow-up was 27 months (interquartile range, 13 months). Overall, 41 patients had undergone 52 reinterventions (single, 30 [14%]; multiple, 11 [5%]; access related, 17 [33%]; aortoiliac related, 6 [12%]; TVV related, 29 [55%]). Of the 52 reinterventions, 32 (62%) and 20 (38%) had occurred within and after 30 days, respectively. Eight reinterventions (15%) had been were performed in an urgent setting. Endovascular and open reinterventions were performed in 32 (62%) and 20 (38%) cases, respectively. Open reinterventions were frequently access related (access, 16; no access, 4; P ≤ .001). Technical success was 95% (39 patients); failures consisted of one splenic artery rupture and one renal artery loss. Patients undergoing reintervention had more frequently undergone a primary urgent F/B-EVAR (urgent, 12 of 39 [31%]; elective, 29 of 182 [16%]; P < .001) and had had TAAAs (TAAAs, 34 of 41 [83%]; J/P-AAAs, 7 of 41 [17%]; P < .001). The patients with TAAAs had had a greater incidence of TVV-related reintervention (TAAAs, 26 of 28 [93%]; J/P-AAAs, 2 of 28 [7%]; P < .001) and multiple reinterventions (TAAAs, 9 of 11 [82%]; J/P-AAAs, 2 of 11 [18%]; P = .03) compared with those with J/P-AAAs. Survival at 3 years was 75%. Freedom from reintervention was 81% at 3 years. Patients who had undergone reinterventions had lower 3-year survival (reintervention, 61%; no reintervention, 77%; P = .02). Preoperative chronic renal failure (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.1-3.6; P = .02), TAAAs (HR, 2.3; 95% CI, 1.1-4.8; P = .03), and urgent primary F/B-EVAR procedures (HR, 2.5; 95% CI, 1.2-4.9; P = .01) were independent predictors of late mortality.

Conclusions: Reinterventions after F/B-EVAR are not uncommon and were related to TVVs in only one half of cases. Most of them can be performed in an elective setting using endovascular techniques. The technical success rate was excellent. Reinterventions were more frequent after TAAAs and urgent F/B-EVAR procedures and had a significant effect on overall survival in these situations.
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http://dx.doi.org/10.1016/j.jvs.2021.05.027DOI Listing
June 2021

[Endovascular repair of an aortic aneurysm by a custom-made three-inner branched endograft].

G Ital Cardiol (Rome) 2021 03;22(3 Suppl 1):46S-50S

U.O. Chirurgia Vascolare.

We report the case of a total endovascular repair of an aortic arch aneurysm by a custom-made endograft with three inner branches for supra-aortic trunks in a high-risk patient unfit for open surgery. An 82-year-old female at high risk for open repair was treated for an asymptomatic aortic arch aneurysm (97 mm in diameter) by a custom-made three-inner branched endograft. Two anterograde branches were planned for the innominate trunk and the left carotid artery while a retrograde branch with a preloaded catheter was planned for the left subclavian artery. The procedure was successfully completed and postoperative course was uneventful. Computed tomography angiography demonstrated aneurysm exclusion, patency of the three supra-aortic branches and absence of cerebral ischemic lesion at 30 and 90 days. A custom-made endovascular device with three inner branches is a safe and effective option to guarantee a total endovascular repair of aortic arch aneurysm in high-risk patients in the presence of anatomical feasibility.
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http://dx.doi.org/10.1714/3578.35635DOI Listing
March 2021

Tailored Sac Embolization During EVAR for Preventing Persistent Type II Endoleak.

Ann Vasc Surg 2021 Apr 3. Epub 2021 Apr 3.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Background: Persistent type II endoleaks (ELIIp) occur in 8-23% of patients submitted to endovascular aneurysm repair (EVAR) and may lead to aneurysm progression and rupture. Intraoperative embolization of the abdominal aortic aneurysm (AAA) sac is effective to prevent their occurrence, however a method to achieve complete sac thrombosis has not been standardized yet. Aim of our study was to identify factors associated with prevention of ELIIp after intraoperative embolization, in order to optimize technical details.

Methods: Patients at high risk for ELIIp, who underwent EVAR with AAA - sac coil embolization were prospectively collected into a dedicated database from January 2012 to March 2015. The endoluminal residual sac volume (ERV), not occupied by the endograft [ERV= AAA total volume (TV) - (AAA-thrombus volume (THV) + endograft volume (EgV)] was calculated on preoperative computed tomography and the concentration of coils implanted (CCoil= n coils implanted/ERV) for each patient was evaluated. AAA volumetric evaluation was conducted by dedicated vessels analysis software (3Mensio). ELIIp presence was evaluated by contrast-enhanced ultrasound at 6 and 12-month. Patients with ELIIp at 12 months (Group 1) were clustered and compared to patients without ELIIp (Group 2), in order to evaluate the incidence of ELIIp in patients undergone to preventive AAA-sac embolization, and identify the predictors of ELIIp prevention. Morphological potential risk factors for ELIIp such as TV, THV, VR% and EgV were also considered in all patients. Statistical correlation was assessed by Fisher Exact Test.

Results: Among 326 patients undergone to standard EVAR, 61 (19% - M: 96.7%, median age: 72 [IQR: 8] years, median AAA diameter: 57 [IQR: 7] mm) were considered at high risk for ELIIp and were submitted to coil embolization. The median AAA total volume (TV) and median ERV were 156 (IQR: 59) cc and 46 (IQR: 26) cc, respectively. The median number and concentration of coils (IMWCE-38-16-45 Cook M-Ray) positioned in AAA-sac were 5 (IQR: 1) coils and 0.17 coil/cm (range 0.02-1.20). Among this high-risk population, the incidence of ELIIp was 29.5% and 23% at 6 and 12-month, respectively. Fourteen patients (23%) were clustered in Group1 and 47 (77%) in Group 2. Both groups were homogeneous for clinical characteristics and preoperative morphological risk factors. There were no differences in the preoperative median TV, AAA-thrombus volume (THV), %VR, EgV and number of implanted coils between Group1 and Group2. Patients in Group1 had a significantly higher ERV (59 [IQR: 13] cm vs. 42 [IQR: 27] cm, P = 0.002) and lower CCoil (0.09 [IQR: 0.03] vs. 0.18 [IQR: 0.21], P = 0.006) than patients of Group2. ELIIp was significantly related to the presence of ERV > 49 cm (86 % vs. 42 %, Group1 and Group2 respectively, P = 0.006) and CCoil < 0.17coil/ cm (100% vs. 68%, Group1 e Group2 respectively, P = 0.014).

Conclusion: According with our results, Coil concentration and endoluminal residual volume can affect the efficacy of the AAA - sac embolization in the prevention of ELIIp, moreover CCoil ≥0.17coil/ cm maight be considered to determine the tailored number of coils.
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http://dx.doi.org/10.1016/j.avsg.2021.01.118DOI Listing
April 2021

Carotid Endarterectomy is often not Possible after an Unheralded Stroke: Unheralded Stroke in Carotid Artery Stenosis.

J Stroke Cerebrovasc Dis 2021 Mar 8;30(3):105594. Epub 2021 Jan 8.

Division of Vascular Surgery, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy.

Objectives: The ongoing literature recommends carotid endarterectomy (CEA) primarily for patients with neurological symptoms, however CEA can be precluded by the onset of a severe stroke or a total carotid occlusion. The present study aims to evaluate the effect of unheralded strokes in patients with a previously asymptomatic carotid stenosis (ACS) possibly considered for CEA.

Materials And Methods: From 2009 to 2019, patients with an unheralded stroke from an ACS were considered. By neurological examination, patients were divided in unfit-for-CEA (uCEA) - either for the severity of the stroke (according to modified Rankin-Scale - mRS) or the onset of a total carotid occlusion - and patients submitted to CEA. Predictors for uCEA and stroke severity were evaluated.

Results: Over a total of 532 patients with symptomatic carotid stenosis, 277 (52%) with unheralded stroke were included in the study. One hundred and one (36%) were considered uCEA: 64(23%) due to their neurological conditions (mRS:5) and 37 (13%) because of the onset of carotid occlusion. One hundred seventy-six (64%) patients underwent CEA. The preoperative medical therapy was similar in uCEA vs CEA patients. Age≥80 years and female sex were independently associated with uCEA (OR:5.9, 95%CI:3.1-11.4, P<.01; OR:3.9, 95%CI:2.0-7.6, P<.01. respectively). Patients submitted to CEA had mRS: 0-2 in 102(37%) cases and mRS:3-4 in 74 (27%). The contralateral carotid occlusion (CCO) was independently associated with mRS:3-4 (OR:8.4, 95%CI 1.8-79, P=.01). Postoperative stroke rate after CEA was 2.9% (4/167); patients with preoperative mRS:3-4 had a higher risk for postoperative stroke compared to those with mRS:0-2 (5.9% vs. 0%. P=.02).

Conclusions: An unheralded stroke in patients with ACS leads to a severe neurological damage in more than half of cases, either precluding CEA (36%) or increasing the risk of postoperative complications (27%). Female sex, age≥80 and CCO are independent predictors of these occurrences and should be considered in ACS patients.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2020.105594DOI Listing
March 2021

Proximal Aortic Coverage and Clinical Results of the Endovascular Repair of Juxta-/Para-renal and Type IV Thoracoabdominal Aneurysm with Custom-made Fenestrated Endografts.

Ann Vasc Surg 2021 May 4;73:397-406. Epub 2021 Jan 4.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.

Background: Juxta-renal (JAAA)/para-renal (PAAA) and type IV-thoracoabdominal (TAAA) aneurysms can be repaired by custom-made fenestrated endografts (CM-FEVAR). Differently from open repair, a relatively long segment of healthy proximal aorta needs to be covered to achieve a durable sealing, and this may be considered a disadvantage of the endovascular approach. We aimed to quantify the additional proximal aortic coverage in JAAAs, PAAAs, and type-IV TAAAs treated with CM-FEVAR and to evaluate its impact on early/follow-up clinical outcomes.

Methods: Between 2006 and 2018, preoperative, intraoperative, and postoperative data of JAAAs, PAAAs, and type-IV TAAAs submitted to CM-FEVAR were collected. The length of proximal healthy aortic coverage was evaluated on the preoperative endograft planning as the distance between the top of the CM-FEVAR endograft and the hypothetical level of aortic cross-clamping in case of open repair (type-IV TAAA-above the celiac trunk; PAAA-above the superior mesenteric artery; JAAA-above the lowest renal artery). Spinal cord ischemia (SCI), bowel ischemia (BI), renal function worsening (RFW) (estimated glomerular filtration rate reduction > 25% of the baseline level - RFW), and mortality were assessed at 30-day. Survival, target visceral vessel (TVV) patency, and freedom from reinterventions (FFRs) were assessed during follow-up by Kaplan-Meier analysis R2.

Results: One hundred forty-seven cases were submitted to CM-FEVAR, for 72 (49%) JAAAs, 46 (31%) PAAAs, and 29 (20%) type IV-TAAAs, with 1(4-3%), 2 (28-19%), 3 (48-33%), and 4 (67-45%) fenestrations. JAAAs required a fenestration + bridging stent graft for the superior mesenteric artery and celiac trunk, in 46(64%) and 24(33%) cases, respectively. Nineteen (41%) PAAAs required a fenestration + bridging stent graft for the celiac trunk. The mean proximal additional aortic coverage was 48 ± 2 mm with no differences among JAAAs (52 ± 1 mm), PAAAs (42 ± 2 mm), and type IV-TAAAs (50 ± 2 mm) (P.09). Technical success, defined as correct endograft deployment, with TVV patency, absence of type I-III endoleaks, iliac leg stenosis/occlusions, open surgical conversion, and 24-hour mortality, was achieved in 98% of cases. Failures occurred for 1 type-III endoleak (type-IV TAAA) and 2 renal artery losses (PAAA and type IV-TAAA). The only case of SCI (0.7%) occurred in a type-IV TAAA where the proximal healthy aortic coverage was 80 mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24 hours in 1 type IV-TAAA (0.7%). Thirty-five patients (24%) suffered postoperative RFW and required hemodialysis in 1 (0.7%) JAAA with severe preoperative chronic renal failure. There was no difference of proximal additional aortic coverage between patients with (49 ± 29 mm) and without (48 ± 23 mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2 months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5 years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5 years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5 years, respectively.

Conclusions: Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2 mm above the level of hypothetical aortic cross-clamping in case of open repair. This aspect should be considered for CM-FEVAR indication in JAAAs, PAAAs, and type-IV TAAAs; nevertheless, it does not appear to be associated with negative early and follow-up clinical sequelae.
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http://dx.doi.org/10.1016/j.avsg.2020.12.008DOI Listing
May 2021

Impact of cerebral ischemic lesions on the outcome of carotid endarterectomy.

Ann Transl Med 2020 Oct;8(19):1264

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, DIMES, University of Bologna, Bologna, Italy.

Patients with carotid artery stenosis (CAS) are commonly defined as asymptomatic or symptomatic according with their neurological conditions, however, emerging evidences suggest stratifying patients according also with the presence of cerebral ischemic lesions (CIL). In asymptomatic patients, the presence of CIL increases the risk of future neurologic event from 1% to 4% per year, leading to a stronger indication to carotid revascularization. In symptomatic patients, the presence of CIL does not seem to influence the outcome of the carotid revascularization if the volume of the lesion is small (<4,000 mm); the benefit of the revascularization is also more significant if performed within 2 weeks from the index event. However, high volume (>4,000 mm) CIL are associated in some experiences with a higher risk of carotid revascularization suggesting to delay the carotid revascularization for at least 4 weeks. As a matter of fact, the evaluation of CIL dimensions and characteristics in patients with CAS gives to the physician involved in the treatment a valuable adjunctive tool in the choice of the ideal treatment.
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http://dx.doi.org/10.21037/atm-20-1098DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607094PMC
October 2020

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

J Vasc Surg 2021 May 19;73(5):1566-1572. Epub 2020 Oct 19.

Department of Vascular Surgery, University Hospital, LMU Munich, Munich, Germany.

Background: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported.

Methods: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes.

Results: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively.

Conclusions: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.
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http://dx.doi.org/10.1016/j.jvs.2020.09.036DOI Listing
May 2021

Predictors and Consequences of Silent Brain Infarction in Patients with Asymptomatic Carotid Stenosis.

J Stroke Cerebrovasc Dis 2020 Oct 14;29(10):105108. Epub 2020 Jul 14.

Vascular Surgery, University of Bologna "Alma Mater Studiorum", Policlinico S. Orsola Malpighi, 40138 Bologna. Electronic address:

Aim: Silent brain infarction (SBI) is associated with an increased risk of stroke in patients with asymptomatic carotid stenosis (ACS), and is therefore one of the criteria for performing carotid endarterectomy (CEA). Despite an extensive literature, this issue is still a matter of debate. Aim of the present work was to evaluate incidence and predictors of SBI in patients undergoing CEA for ACS, and to investigate its possible impact on CEA outcome.

Methods: All patients submitted to CEA in a single academic center from 2005 to 2019 were prospectively inserted into a specific database. The presence of SBI was evaluated by preoperative computed tomography (CT), considering exclusively infarctions in the carotid territories from an athero-embolic source. Preoperative characteristics were investigated as possible risk factor for SBI at the uni- and multivariate analysis. The impact of SBI on stroke occurrence after CEA was also evaluated.

Results: In the designated period, over a total of 1288 ACS considered and submitted to CEA, 105 (8.2%) were associated with SBI. Male sex, hypertension, dyslipidaemia, smoking, contralateral carotid occlusion and severity of carotid stenosis were associated with SBI at the univariate analysis; preoperative statin therapy showed to be a protective factor. At the multivariate analysis, contralateral carotid occlusion and severity of stenosis were independently associated with SBI (OR: 3.16, 95%CI 1.62-6.18, P=.001; OR: 1.04, 95%CI 1.01-1.07, P=.004, respectively), with statin therapy confirmed as a protective factor (OR: 0.60, 95%CI: 0.40-0.92, P=.002). Overall post-CEA stroke rate was 0.9%, with a higher post-operative risk independently predicted by the presence of SBI (OR:4.23, 95%CI: 1.40-12.73, P=.01).

Conclusion: SBI is present in 8% of patients with ACS, and is significantly associated with contralateral carotid occlusion and severity of the carotid stenosis. Statin therapy reduces the occurrence of this phenomenon. The presence of SBI should be carefully considered in indication to CEA since it significantly increases the surgical risk.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2020.105108DOI Listing
October 2020

Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair.

Eur J Vasc Endovasc Surg 2020 Dec 24;60(6):843-852. Epub 2020 Aug 24.

Vascular Surgery, University of Bologna, DIMES, Policlinico S. Orsola, Bologna, Italy.

Objective: Proximal para-anastomotic aneurysms, or aneurysmal degeneration of the native aorta above a previous open abdominal aortic repair (Pr-AAAs), are challenging scenarios. The aim of this study was to report the early and mid term outcomes of endovascular repair of Pr-AAAs by fenestrated and branched endovascular aneurysm repair (FB-EVAR).

Methods: From 2006 to 2017, pre-operative, intra-operative, and post-operative data from patients undergoing FB-EVAR for Pr-AAAs at two European vascular surgery units were prospectively collected and retrospectively analysed. Early results were considered in terms of technical success (target visceral vessel cannulation and stenting, absence of type I - III endoleak, iliac limb occlusion and 24 h mortality); spinal cord ischaemia (SCI) and 30 day and in hospital mortality. Survival, target visceral vessel (TVV) patency, and freedom from re-interventions were also considered at the mid term follow up.

Results: Five hundred and forty-four patients underwent FB-EVAR to treat juxta/pararenal or thoraco-abdominal aneurysms. Of these patients, 108 (19.8%) cases were Pr-AAAs (94% male; mean ± standard deviation [SD] age 71 ± 4 years; American Society of Anesthesiologists' grade 3-4 in 74% and 26%, respectively). The previous open aortic repair (OR) was performed 10 ± 2 years before FB-EVAR. It was a tubular aorto-aortic repair in 63 (58.3%) cases, a bifurcated aortobi-iliac repair in 37 (34.2%) cases, and an aortobifemoral bypass repair in eight (7.4%) cases. A previous thoracic endovascular aneurysm repair (TEVAR) had been performed in seven patients (6.5%). The aortic lesion at the time of FB-EVAR was, according to the Crawford classification, a type I - III in 69 (63.9%) or a type IV 39 (36.1%) thoraco-abdominal aneurysm. The mean ± SD aneurysm diameter was 64 ± 6 mm. Overall, 390 TVVs (3.6 ± 1 TVV/case) were revascularised by an endograft with fenestrations (n = 63 [58.3%]), with branches (n = 26 [24.1%]), or with both fenestrations and branches (n = 19 [17.6%]). Tubular, trimodular, or aorto-uni-iliac implants were planned in 68 (63.0%), 38 (35.2%), and two (1.8%) patients, respectively. Proximal TEVAR, carotid-subclavian bypass, and iliac branch devices were planned as adjunctive procedures in 41 (38.0%), five (4.6%), and three (2.8%) cases, respectively. Overall technical success was 93%, with technical failures including five TVV losses (coeliac trunk, n = 1; renal arteries, n = 4) and three deaths within 24 h. Post-operative SCI occurred in seven patients (6.5%), four of which (3.7%) were permanent. SCI was more frequent in category I - III TAAAs (p = .042) and in endografts incorporating both fenestrations and branches (p = .023). Cardiac, pulmonary, and renal complications (reduction in glomerular filtration rate of ≥30% compared with baseline) occurred in 9%, 10%, and 20%, respectively. Bowel ischaemia was seen in three (2.8%) patients. Thirty day mortality was 4% and was associated with pre-operative chronic renal failure (p = .034), post-operative cardiac morbidity (p = .041), and bowel ischaemia (p = .003). Overall in hospital mortality was 5.5% (n = 6). Mean ± SD follow up was 38 ± 18 months. Survival was 82%, 64%, and 54% at one, three, and five years, respectively, and target visceral vessel patency was 93%, 91%, and 91%, respectively. Permanent haemodialysis was needed in four patients (3.7%). There was no late aneurysm related mortality. Survival during follow up was statistically significantly affected by pre-operative chronic renal failure (p = .022), post-operative cardiac morbidity (p = .042), SCI (p = .044), and bowel ischaemia (p = .003). Freedom from re-intervention at one, three, and five years was 89%, 77%, and 74%, respectively.

Conclusion: Endovascular treatment of aneurysmal aortic degeneration above a previous open abdominal repair with FB-EVAR is safe and effective. If those promising results are confirmed at later follow up, FB-EVAR should be considered a prominent therapeutic option, especially in high risk patients.
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http://dx.doi.org/10.1016/j.ejvs.2020.07.071DOI Listing
December 2020

The Efficacy of a Protocol of Iliac Artery and Limb Treatment During EVAR in Minimising Early and Late Iliac Occlusion.

Eur J Vasc Endovasc Surg 2020 Nov 25;60(5):663-670. Epub 2020 Aug 25.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Objective: Iliac limb occlusion (ILO) is a complication of endovascular aortic repair (EVAR) and requires re-intervention in most cases. Attention to any intra-operative defect of iliac limbs and arteries may prevent ILO. The study aimed to analyse the long term effect of an intra-operative protocol of iliac limb treatment during EVAR on ILO.

Methods: Patients treated from 2012 to 2017 for abdominal aortic aneurysm (AAA) with standard EVAR were collected prospectively. Pre-operative computed tomography angiography anatomical characteristics were evaluated. The protocol for intra-operative iliac limb management was: a. pre-EVAR angioplasty of common/external iliac artery stenosis; b. precise contralateral iliac limb deployment at the same level of the flow divider; c. iliac limb kissing ballooning with high pressure non-compliant balloons; d. iliac limb stenting for residual tortuosity/kink and adjunctive external iliac stenting for residual stenosis/dissection after EVAR. ILO was evaluated at 30 days and at follow up, which was performed by duplex ultrasonography before discharge, at three, six, and 12 months and yearly thereafter. Kaplan-Meier and Cox linear regression were used.

Results: Four hundred and forty-two patients and 884 iliac limbs were included in the study. Severe iliac tortuosity and calcification were present in 15% (132/884) and 8% (70/884), respectively. External iliac angioplasty and stenting of iliac limb were performed in 2% (18/884) and 9.5% (84/884) of limbs. The thirty day mortality was 1.6%, with no ILO. At a mean follow up of 33 ± 12 months, ILO occurred in 7/884 (0.8%) limbs of six patients. Five ILO were treated by endovascular relining, two surgically: one by femorofemoral bypass and one by surgical explant. On univariable analysis, sac shrinkage was significantly associated with ILO (HR 1, 95% CI 0.8-2.5, p = .043).

Conclusion: A protocol of aggressive iliac limb treatment in EVAR leads to a very low rate of late ILO. The role of sac shrinkage in ILO should be investigated further.
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http://dx.doi.org/10.1016/j.ejvs.2020.07.066DOI Listing
November 2020

"Flaring-Kissing Ballooning" of the Stentgrafts in Fenestrated Endograft Procedures to Ensure Target Visceral Vessels Patency.

Ann Vasc Surg 2021 Jan 12;70:567.e7-567.e11. Epub 2020 Aug 12.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.

Purpose: To describe a dedicated technique used in fenestrated endografting (FEVAR) for juxtarenal aneurysm (JAAA) to avoid intraoperative bridging stentgraft crushing in case of adjacent origin of left renal (LRA) and superior mesenteric (SMA) artery.

Case Report: A 78-year-old male, at high surgical risk, underwent FEVAR for JAAA. SMA and LRA fenestrations were adjacent, at 12:30 and 2:45 o'clock evaluation, respectively. The fenestrated endograft and the bridging stentgrafts for target visceral vessels (TVVs) were deployed without complications. The completion angiography and the cone-beam CT showed patency of TVVs, except for LRA, which showed crushing of its stentgraft. SMA and LRA were re-cannulated, and the renal stentgraft was dilated with a 4 × 40 mm balloon. Finally, "Flaring-Kissing ballooning" of SMA and LRA stentgrafts was performed using two 10 × 20 mm balloon under fluoroscopy rotational guidance, to ensure the patency of both arteries. The completion angiography and the postoperative CT-angiography showed the resolution of the crushing and the patency of TVVs. The postoperative course was uneventful; the patient was discharged home after 5 days. CT-angiography at 12 months showed patency of TVVs and no endoleaks.

Conclusions: The "Flaring-Kissing ballooning" of adjacent stentgrafts is a valid, safe and effective intra-procedural maneuver to preserve the patency of the TVVs.
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http://dx.doi.org/10.1016/j.avsg.2020.08.006DOI Listing
January 2021

Is it Possible to Safely Maintain a Regular Vascular Practice During the COVID-19 Pandemic?

Eur J Vasc Endovasc Surg 2020 07 19;60(1):127-134. Epub 2020 May 19.

Vascular Surgery Metropolitan Unit, University of Bologna, DIMES, Policlinico S. Orsola and Ospedale Maggiore, Bologna, Italy.

Objective: This study aimed to evaluate the protocol adopted during the emergency phase of the COVID-19 pandemic to maintain elective activity in a vascular surgery unit while minimising the risk of contamination to both patients and physicians, and the impact of this activity on the intensive care (IC) resources.

Methods: The activity of a vascular surgery unit was analysed from 8 March to 8 April 2020. Surgical activity was maintained only for acute or elective procedures obeying priority criteria. The preventive screening protocol consisted of nasopharyngeal swabs (NPS) for all patients and physicians with symptoms and for unprotected contact infected cases, and serological physician evaluations every 15 days. Patients treated in the acute setting were considered theoretically infected and the necessary protective devices were used. The number of patients and the possible infection of physicians were evaluated. The number and type of interventions and the need for post-operative IC during this period were compared with those in the same periods in 2018 and 2019.

Results: One hundred and fifty-one interventions were performed, of which 34 (23%) were acute/emergency. The total number of interventions was similar to those performed in the same periods in 2019 and 2018: 150 (33, of which 22% acute/emergency) and 117 (29, 25% acute/emergency), respectively. IC was necessary after 6% (17% in 2019 and 20% in 2018) of elective operations and 33% (11) of acute/emergency interventions. None of the patients treated electively were diagnosed with COVID-19 infection during hospitalisation. Of the 34 patients treated in acute/emergency interventions, five (15%) were diagnosed with COVID-19 infection. It was necessary to screen 14 (47%) vascular surgeons with NPS after contact with infected colleagues, but none for unprotected contact with patients; all were found to be negative on NPS and serological evaluation.

Conclusion: A dedicated protocol allowed maintenance of regular elective vascular surgery activity during the emergency phase of the COVID-19 pandemic, with no contamination of patients or physicians and minimal need for IC resources.
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http://dx.doi.org/10.1016/j.ejvs.2020.05.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236703PMC
July 2020

Commentary: How Old Is Too Old for EVAR?

J Endovasc Ther 2020 10 25;27(5):845-847. Epub 2020 May 25.

Unit of Vascular Surgery, Alma Mater Studiorum - University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

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http://dx.doi.org/10.1177/1526602820924659DOI Listing
October 2020

The benefit of deferred carotid revascularization in patients with moderate-severe disabling cerebral ischemic stroke.

J Vasc Surg 2021 01 26;73(1):117-124. Epub 2020 Apr 26.

Vascular Surgery, University of Bologna "Alma Mater Studiorum", Policlinico S. Orsola-Malpighi, Bologna, Italy.

Objective: Symptomatic carotid artery stenosis needs revascularization within 2 weeks by carotid endarterectomy (CEA) to reduce the risk of symptom recurrence; however, the optimal timing of intervention is yet to be defined in patients with large-volume cerebral ischemic lesion (LVCIL) and modified Rankin scale (mRS) score ≥3. The aim of this study was to determine the most appropriate timing for CEA in patients with a recent stroke and LVCIL.

Methods: Data from patients with symptomatic carotid stenosis with LVCIL and mRS score of 3 or 4 from 2007 to 2017 were considered. Patients were submitted to CEA if they had a stable clinical condition and life expectancy >1 year. LVCIL was defined as a cerebral ischemic lesion of volume >4000 mm. Perioperative stroke and death were evaluated by stratifying for timing of CEA by χ test and multiple logistic regression. Patients with similar characteristics (LVCIL and mRS score of 3 or 4) unfit for CEA served as the control group for recurrence of stroke at 1-year follow-up.

Results: In an 11-year period, of a total 4020 CEAs, 126 (2.9%) were performed in patients with a moderate stroke and LVCIL occurring in the same admission. The patients' median age was 69 years (interquartile range [IQR], 10 years); 72% (91) were male, with mRS score of 3 (IQR, 1) and LVCIL volume of 20,000 mm (IQR, 47,000 mm). The median time elapsed from symptoms to CEA was 7 weeks (IQR, 8 weeks). Overall perioperative stroke/death was 7.3% (eight strokes and one death). By selective timing evaluation of the postoperative events, CEA performed within 4 weeks was associated with a significantly higher rate of stroke/death compared with patients operated on after 4 weeks: 11.9% (8/67) vs 1.7% (1/59; P = .03). By logistic regression, CEA within 4 weeks was an independent (from sex, cerebral ischemic lesion volume, dyslipidemia, and carotid stenosis) predictor of postoperative stroke/death (odds ratio, 8.2; 95% confidence interval, 1.01-73). In the same period, 101 patients were considered unfit for CEA for dementia (n = 22), severe comorbidities (n = 55), or short (<1-year) life expectancy (n = 24), and 43 (43%) survived at 1 year. At 1 year, the perioperative/recurrent stroke after CEA vs patients unfit for CEA was similar (6.2% vs 13.9%; P = .11), but CEA performed after 4 weeks led to significantly lower perioperative/recurrent stroke (1.7% vs 13.9%; P = .02).

Conclusions: The surgical risk of CEA in patients with a recent moderate-severe ischemic stroke and LVCIL is high. However, if the intervention is delayed >4 weeks, its benefit seems significant.
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http://dx.doi.org/10.1016/j.jvs.2020.03.043DOI Listing
January 2021

The Combined Use of a Distal Self-Expandable and Proximal Balloon-Expandable Stent Graft in Bridging Hostile Renal Arteries in Thoracoabdominal Branched Endografting.

Ann Vasc Surg 2020 Oct 23;68:326-337. Epub 2020 Apr 23.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Background: To evaluate early/midterm outcomes of a specific configuration of a bridging stent graft-that is a distal self-expandable (SE) stent graft combined with proximal balloon-expandable (BE) one-in hostile renal artery (RA) anatomy in branched thoracoabdominal aneurysm (TAAA) repair.

Methods: Between 2010 and 2019, all TAAAs undergoing fenestrated and branched endografting (FB-EVAR) were prospectively collected. Preoperative, procedural, and postoperative data of RAs accommodated by branch design and patent at the completion angiography were retrospectively analyzed. Hostile RA anatomy included upward (type B) and downward + upward (type D) orientations. Type B and D RAs treated by the combination of an SE + BE stent graft as a bridging stent (BE + SE group) were compared with RAs treated by a BE stent graft only (BE group). RA occlusion, reinterventions, and branch instability were assessed.

Results: Over a total of 112 TAAAs undergoing FB-EVAR, 189 RAs were treated by fenestrations (113-60%) and branches (76-40%). Among the 66 (86%) RAs accommodated by branch and patent at completion angiography, 55 had a type B/D orientation. BE stent grafts were used in 15/55 (27%) RAs and SE + BE in 40/55 (73%). At a median follow-up of 12 (8) months, 5/55 (9%) RAs occluded: 4/15 (27%) in the BE group and 1/40(2.5%) in the SE + BE group (P: 0.017). RA patency was 83 ± 5% at 24 months. The SE + BE group had higher patency than the BE group (90 ± 5% vs. 68 ± 5% at 12 months; P: 0.039). Overall freedom from RA-related reinterventions was 87 ± 5% at 24 months. Six (9%) RAs required reinterventions: 4/15 (27%) in the BE group and 2/40 (5%) in the BE + SE group (P: 0.041). RAs managed by an SE + BE stent graft had lower reinterventions than RAs treated by a BE stent graft only (93 ± 5% vs. 76 ± 5% at 12 months; P: 0.01). Freedom from branch instability was 78 ± 5% at 24 months, with 8 overall cases (12%) occurring-5/15 (33.3%) in the BE group versus 3/40 (7.5%) in the SE + BE group (P: 0.02). RAs managed by an SE + BE stent graft had lower branch instability than RAs treated only by a BE stent graft (BE: 68 ± 5% vs. SE + BE: 80 ± 5% at 12 months; P: 0.02).

Conclusions: In hostile renal anatomy, the combination of a distal SE and proximal BE stent graft as a bridging stent in branched endografting is safe and effective with lower rates of occlusion, reinterventions, and branch instability at midterm follow-up compared with a BE stent graft alone.
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http://dx.doi.org/10.1016/j.avsg.2020.04.013DOI Listing
October 2020

Long-term Efficacy of EVAR in Patients Aged Less Than 65 Years with an Infrarenal Abdominal Aortic Aneurysm and Favorable Anatomy.

Ann Vasc Surg 2020 Aug 10;67:283-292. Epub 2020 Apr 10.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Background: The aim of this study was to compare early and long-term outcomes of endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) in patients aged ≤ 65 years.

Methods: Data of patients aged ≤65 years undergoing infrarenal abdominal aortic aneurysm repair, between 2005 and 2013, were retrospectively reviewed. All EVAR procedures were performed according to the instruction for use, and only OSR procedures with an infrarenal aortic cross-clamping were included in the study.

Results: In this group of 115 patients (EVAR: 58 patients, 51% and OSR: 57 patients, 49%), EVAR and OSR patients had similar comorbidities, except for obesity (EVAR: 38% vs. OSR: 19%; P = 0.03). A stay in the intensive care unit (ICU) was necessary in 19% of patients with EVAR versus 79% with OSR (P = 0.001), and the amount of blood transfusion was 236 ± 31 mL for EVAR versus 744 ± 98 mL for OSR (P = 0.001). The hospital stay was 4 ± 2 days for EVAR versus 9 ± 6 days for OSR (P = 0.03). The overall 30-day mortality was 1% (EVAR: 0% vs. OSR: 2%; P = 0.30). Five patients (4%) required reinterventions within 30 days (EVAR: 0% vs. OSR: 8%, P = 0.001). The mean follow-up was 86 ± 38 months. Freedom from reintervention at 10 years after EVAR was 81% versus OSR 74%; (P = 0.77). Late reinterventions were reported in 13 patients (23%) with OSR and in 10 patients (17%) with EVAR. Postoperative retrograde ejaculation occurred more often in patients with OSR (31%) versus EVAR (2%) (P = 0.001). During the follow-up, cancer was found in 19 (17%) patients with no difference between EVAR and OSR (P = 0.83). The global survival at 10 years was 72% (EVAR: 79% vs. OSR: 70%; P = 0.94).

Conclusions: In this study, EVAR was associated with a shorter hospital stay, less need for the ICU, and less early reinterventions than OSR. Survival and reinterventions during the follow-up were not significantly different between EVAR and OSR. According to these results, EVAR may be considered for patients aged ≤65 years with a favorable anatomy.
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http://dx.doi.org/10.1016/j.avsg.2020.03.038DOI Listing
August 2020

Endovascular Repair of a Common Carotid Artery Perforation during Pacemaker Insertion.

Ann Vasc Surg 2020 Oct 10;68:568.e11-568.e15. Epub 2020 Apr 10.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, DIMES, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Background: We report the percutaneous endovascular management of an iatrogenic perforation of the left common carotid artery (LCCA) during an attempted trans-subclavian pacemaker (PM) placement.

Methods: An 87-year-old woman was urgently transferred after an attempted left subclavian vein PM implantation. Computed tomography angiography scan showed the accidental cannulation of LCCA in its most proximal segment. Owing to the significant surgical risks, the mortality rate, and the distal position of the vessel from the skin, we opted for an endovascular strategy with a balloon-expandable stent graft. The Advanta 8 × 38 mm V12 was inserted via a 7 French Flexor Introducer sheath through the right common femoral artery.

Results: The patient was discharged on postoperative day 2 without complications. A 6-month follow-up computed tomography angiography demonstrated stent graft and LCCA patency and the patient was in a good stable condition.

Conclusions: This case highlights the effectiveness of a minimal invasive endovascular approach to treat this uncommon but potentially lethal injury.
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http://dx.doi.org/10.1016/j.avsg.2020.04.005DOI Listing
October 2020

The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting.

J Vasc Surg 2020 12 8;72(6):1906-1916. Epub 2020 Apr 8.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi, Bologna, Italy.

Background: Contrast-induced nephropathy is a possible adverse event in fenestrated endovascular aneurysm repair (FEVAR). Automated carbon dioxide (CO) angiography has been proposed as an alternative to iodinated contrast medium (ICM) for standard endovascular aneurysm repair; however, its use in FEVAR has not yet been investigated. The aim of this study was to analyze the possibility of reducing the amount of procedural ICM during FEVAR by combining CO with intraprocedural three-dimensional preoperative computed tomography angiography images overlaid on two-dimensional live fluoroscopy images (fusion imaging [FI]).

Methods: Between January and April 2018, juxtarenal and pararenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms undergoing FEVAR with a CO + FI protocol were prospectively collected and compared with FEVAR cases treated with standard procedural imaging (ICM + FI) between June and December 2017. Preoperative, intraoperative, and postoperative data were analyzed. Amount of ICM, procedure and fluoroscopy time, total radiation dose (dose-area product), endoleaks, and technical success (defined as absence of type I or type III endoleak and target visceral vessel patency at completion angiography) were assessed. The 30-day renal function worsening (estimated glomerular filtration rate reduction >25% of the preoperative value) and 6-month reinterventions were also considered. Analysis was done by Fisher exact and Mann-Whitney tests.

Results: Forty-five patients were enrolled, 15 (33%) managed by CO + FI and 30 (67%) by ICM + FI. The two groups were homogeneous in their clinical, anatomic, and endograft features. Median ICM administration was significantly lower in CO + FI compared with ICM + FI (41 mL [interquartile range (IQR), 26 mL] vs 138.5 mL [IQR, 88 mL]; P = .001). There was no difference in median procedure time, fluoroscopy time, and dose-area product between CO + FI and ICM + FI. Intraoperative type I or type III endoleak detection was similar (P = 1) in CO + FI (7%) and ICM + FI (7%), with immediate repair and technical success achieved in all cases. Early type II endoleak did not differ in the two groups (CO + FI, 27%; ICM + FI, 20%; P = .7). Postoperative renal function deteriorated in two patients (13%) in the CO + FI group vs eight patients (27%) in the ICM + FI group (P = .04). The median increase of postoperative creatinine concentration was smaller in the CO + FI group than in the ICM + FI group (0.09 mg/dL [IQR, 0.03 mg/dL] vs 0.3 mg/dL [IQR, 0.4 mg/dL]; P = .04). The median hospitalization time was shorter in the CO + FI group (5 days [IQR, 1 day] vs 8 days [IQR, 4 days]; P = .002). No reintervention was necessary at 30-day and 6-month follow-up in either group.

Conclusions: CO + FI is safe and effective in FEVAR and allows the amount of ICM to be significantly reduced, leading to shorter hospitalization time and better renal function preservation at 30 days. Technical success, procedure and fluoroscopy time, radiation dose, and 6-month reinterventions are comparable with those of the standard ICM imaging protocol for FEVAR. Based on this preliminary experience, CO + FI may be proposed as an effective tool to reduce the overall amount of procedural ICM, with consequent benefits on perioperative renal function.
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http://dx.doi.org/10.1016/j.jvs.2020.02.051DOI Listing
December 2020

Predictors of Survival in Patients Over 80 Years Old Treated with Fenestrated and Branched Endograft.

Ann Vasc Surg 2020 Aug 28;67:52-58. Epub 2020 Mar 28.

Division of Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Background: Fenestrated and branched endovascular aneurysm repair endograft (f/bEVAR) allows the endovascular repair of thoracoabdominal and juxtarenal and pararenal abdominal aortic aneurysms (T-J-P-AAAs); however, given their high cost and complexity, their use should be limited to patients with life expectancy >2 years. Nevertheless, the number of patients older than 80 years treated by f/bEVAR is growing, with no hard evidence of the real efficacy in this context. The aim of the present study is to analyze the survival of ≥80-year-old patients treated with f/bEVAR, and to identify possible predictors of late mortality.

Methods: An analysis of clinical, anatomical, and technical characteristics of patients treated with f/bEVAR for J-, P-, and T-AAA from 2010 to 2019 in a single academic center was performed. Follow-up data were collected prospectively with clinical visit and computed tomography angiography at discharge, after 6 months, and yearly thereafter. Survival after 2 years was evaluated by Kaplan-Meier analysis. Possible predictors of mortality were evaluated by univariable/multivariable analysis.

Results: In the study period, a total of 243 f/bEVARs were considered: 83 for TAAA (34%) and 160 for J/PAAA (66%). Mean age was 73 ± 6 years, with 35 (14%) patients ≥80 years old; 209 patients (86%) were male and 78 (39%) had an American Society of Anesthesiology score IV. The 30-day and 2-year survival were 96% and 80 ± 3%, respectively. At a mean follow-up of 36 ± 25 months, independent predictors of late mortality by Cox regression analysis were chronic obstructive pulmonary disease (COPD), chronic renal failure (CRF), and ≥80 years old (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.02-3.2, P = 0.05; HR 1.7, 95% CI 1.01-3.4, P = 0.04; HR 3.1, 95% CI 1.5-6.3, P = 0.002, respectively). Preoperative clinical characteristics were similar in ≥80 years old versus younger patients, except for the prevalence of TAAA (14% vs. 38%, P = 0.04). The technical success and 30-day mortality were similar in ≥80 vs. <80-year-old patients (93% vs. 96%, P = 0.31; 7% vs. 3.5%, P = 0.60, respectively). The 2-year survival estimation was significantly lower in ≥80 years old compared with younger patients (62 ± 10% vs. 82 ± 3%, P = 0.003). The association of COPD and CRF significantly affects the 2-year survival in ≥80-year-old patients (no patients survived at 2 years) and was significantly different compared with the survival in ≥80-year-old patients without these risk factors (70 ± 11%, P = 0.001).

Conclusions: The early mortality rate and the 2-year survival after f/bEVAR justify this type of treatment in patients ≥80 years old; however, the presence of comorbidities such as COPD and CRF significantly reduces mid-term survival in this group and should be taken into consideration in the indication to f/bEVAR.
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http://dx.doi.org/10.1016/j.avsg.2020.03.034DOI Listing
August 2020

Different Drugs Effect on Mesenchymal Stem Cells Isolated From Abdominal Aortic Aneurysm.

Ann Vasc Surg 2020 Aug 12;67:490-496. Epub 2020 Mar 12.

Clinical Pathology, Department of Experimental, Diagnostic and Speciality Medicine (DIMES), University of Bologna, Bologna, Italy.

Background: Abdominal aortic aneurysm (AAA) is a progressive dilation of the aortic wall, determined by the unbalanced activity of matrix metalloproteinase (MMPs). In vitro and in vivo studies support the pivotal role of MMP-9 to AAA pathogenesis. In our experience, we elucidated the expression of MMP-9 in an ex vivo model of human mesenchymal stem cells isolated from AAA specimen (AAA-MSCs). Thus, MMP-9 inhibition could be an attractive therapeutic strategy for inhibiting AAA degeneration and rupture. Our study was aimed at testing the effect of 3 different drugs (pioglitazone, doxycycline, simvastatin) on MMP-9 and peroxisome proliferator-activated receptor (PPAR)-γ expression in AAA-MSCs.

Methods: Aneurysmal aortic wall segments were taken from AAA patients after the open surgical treatment. MSCs were isolated from AAA (n = 20) tissues through enzymatic digestion. AAA-MSCs were exposed to different doses of pioglitazone (5-10-25 μM), doxycycline (10-25 μM), and simvastatin (10 μM) for 24 h. The effect of each drug was evaluated in terms of cell survival, by crystal violet stain. MMP-9 and PPAR-γ mRNA were analyzed using real-time PCR.

Results: AAA-MSCs were not affected by the exposure to the selected drugs, as shown by the analysis of cell viability. Interestingly, MMP-9 mRNA resulted significantly decreased after each treatment, recording a downregulation of 50% in presence of pioglitazone, 90% with doxycycline, and 40% with exposed to simvastatin, in comparison to untreated cells. We further analyzed the expression of PPAR-γ, target of pioglitazone, observing an upregulation in exposed AAA-MSCs to controls.

Conclusions: Our data support the potential therapeutic effect of pioglitazone, doxycycline, and simvastatin on AAA by reducing the MMP-9 expression in a patient-specific model (AAA-MSCs). In addition, pioglitazone drives the increase of PPAR-G, another promising target for AAA therapy. Further studies are necessary to elucidate the mechanism driving this inhibitory pathway, which can reduces the mortality risk associated with AAA rupture.
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http://dx.doi.org/10.1016/j.avsg.2020.03.001DOI Listing
August 2020

The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.

J Vasc Surg 2020 07 13;72(1):16-24. Epub 2020 Feb 13.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi, Bologna, Italy.

Objective: The objective of this study was to evaluate adverse events occurring during the lead period of custom-made fenestrated/branched endograft for juxtarenal/pararenal abdominal aortic aneurysm (j/p-AAA) and thoracoabdominal aortic aneurysm (TAAA).

Methods: Between 2008 and 2017, patients enrolled for custom-made fenestrated/branched endograft repair were prospectively collected. Anatomic, procedural, and postoperative data were retrospectively analyzed. Lead period was defined as the time between the endograft order to the manufacturer and implantation. Aneurysm diameter, target visceral vessel (TVV) severe stenosis (>75% of ostial lumen), and number of planned TVVs were evaluated at preoperative computed tomography angiography. Patency of TVVs was evaluated intraoperatively. Aneurysm rupture and TVV occlusion during the lead period were assessed.

Results: There were 141 custom-made fenestrated/branched endograft repairs planned. Of these, 133 patients (male, 87%; age, 73 ± 6 years) with complete available data were considered for the study. There were 75 (56%) j/p-AAAs and 58 (44%) TAAAs. The mean aneurysm diameter was 58 ± 6 mm (j/p-AAA, 56 ± 6 mm; TAAA, 67 ± 8 mm); 15 cases (11%) had >70-mm diameter. Planned TVVs were 431 (mean, 3 ± 1 TVVs/patient). The mean lead period was 89 ± 25 days, with five (3.8%) aneurysm ruptures (j/p-AAA, one; TAAA, four) occurring, two (1.5%) during manufacture and three (2.3%) with endograft available in the hospital (all three procedures were postponed because of cardiac or pulmonary comorbidities). In one TAAA rupture, the endograft was successfully implanted and the patient survived. Four of five ruptures had >70-mm diameter. On univariate analysis, chronic obstructive pulmonary disease (P = .01; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2) and aneurysm diameter >70 mm (P = .001; OR, 42; 95% CI, 4-411) were risk factors for aneurysm rupture during the lead period, with aneurysm diameter >70 mm being confirmed as an independent risk factor on multivariate analysis (P = .005; OR, 29.3; 95% CI, 2.8-308). Overall, eight endografts (6%) were not implanted (refusal, two; aneurysm rupture, four; death not related to aneurysm, two). In the remaining 125 patients (94%), 405 TVVs were planned. Of them, 46 (11%) had severe stenosis at preoperative computed tomography angiography. Twelve (3%) TVVs occluded in the lead period (renal arteries, five; celiac trunks, seven); six were recanalized and six were abandoned. Severe preoperative stenosis was a risk factor for TVV occlusion during the lead period (P = .000; OR, 1.3; 95% CI, 1.1-1.6).

Conclusions: In our series, custom-made design required a mean lead period of 89 days, which was determined by both manufacturing time and clinical reasons. During this delay, there is a high risk of both rupture in aneurysms >70 mm and TVV occlusion in severely stenosed vessels. These factors should be considered in the indication for custom-made fenestrated/branched endograft repair.
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http://dx.doi.org/10.1016/j.jvs.2019.08.273DOI Listing
July 2020

Steerable Sheath for Cannulation and Bridging Stenting of Challenging Target Visceral Vessels in Fenestrated and Branched Endografting.

Ann Vasc Surg 2020 Aug 16;67:26-34. Epub 2019 Dec 16.

Vascular Surgery, Department of Experimental, Diagnostic and Speciality Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Background: To report the use of the Oscor Destino steerable sheath in challenging target visceral vessel (TVV) cannulation/bridging stenting in fenestrated and branched endovascular aneurysm repair (FB-EVAR).

Methods: Between 2016 and 2018, patients undergoing FB-EVAR for juxtarenal/pararenal aneurysms (j/p-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) were recorded. Cases requiring the use of the steerable sheath as planned or unplanned maneuvers were analyzed. Technical success, freedom from reinterventions, and TVV patency were assessed.

Results: Two hundred sixty patients underwent FB-EVAR to treat j/p-AAAs and TAAAs, for an overall of 956 TVVs. Among these, the Oscor Destino steerable sheath was used in 33 (13%) cases to cannulate a total of 62 (7%) TVVs. FB-EVAR was performed for 7 (21%) j-AAAs, 4 (12%) p-AAAs, 11 (61%) TAAAs, and 2 (6%) previously failed EVAR. The TVVs were 37 (60%) renal arteries, 9 (15%) superior mesenteric arteries, and 16 (25%) celiac trunks. The Oscor Destino steerable sheath was used as the primary cannulation approach in 29 (47%) cases and after failure of the standard cannulation technique in 33 (53%) cases. Technical success was achieved in 61/62 (98%) TVVs. There was no 30-day mortality or bowel ischemia. At the discharge, there were no type I/III endoleaks, whereas 4 type II endoleaks were detected. The median follow-up was 12 months (interquartile range: 8). One patient died at 6 months because of aneurysm-unrelated cause. No TVV occlusion or TVV-related reinterventions occurred. There were no type I-III endoleaks.

Conclusions: The use of the steerable sheath could be an effective adjunctive tool and can be used primarily as a planned technique or in case of failure of the standard cannulation technique in challenging TVV anatomy during FB-EVAR.
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http://dx.doi.org/10.1016/j.avsg.2019.11.039DOI Listing
August 2020

Fenestrated endografting is the preferred option for juxta-renal aortic aneurysm reconstruction.

J Cardiovasc Surg (Torino) 2020 Feb 13;61(1):2-9. Epub 2019 Dec 13.

Unit of Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Background: The aim of this study was to report early/mid-term-up outcomes of fenestrated endografting (FEVAR) for juxta-renal aneurysms (j-AAAs).

Methods: Between 2008 and 2019, all consecutive j-AAAs treated by FEVAR were prospectively collected and retrospectively analyzed. Early endpoints were technical success, renal function worsening and 30-day mortality. Follow-up endpoints were survival, freedom from re-interventions (FFRs) and target visceral vessels (TVVs) patency.

Results: Among 240 cases of FB-EVAR, 98(41%) were j-AAAs. Endografts with 1,2,3,4 and 5 fenestrations were planned in 3(3%), 25(26%), 35(36%), 33(34%) and 2(1%) cases, respectively. Overall, 360 TVVs were treated by fenestrations and scallops. Technical success was achieved in 97(99%) cases. The only failure was 1 type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening was reported in 22(22%) and 12(12%) cases at 24-hour and 30-day, respectively. One patient required hemodialysis and died within 30-day (1%). This was the only case of 30-day mortality. The mean follow-up was 36±32months. Aneurysm sac shrinkage or stability was observed in 55(56%) and 41(42%) cases, respectively. Two (2%) patients with persistent type II endoleak had sac enlargement and required re-interventions. Freedom from reinterventions at 5-year was 86%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24-month in a case with a severe preoperative stenosis. No late renal arteries occlusions or type I-III endoleaks occurred. TVVs-patency was 96% at 5-year. Renal function worsening was reported in 10(10%) patients during follow-up. Survival at 5-year was 73%, with no j-AAA related mortality. Chronic obstructive pulmonary disease (COPD) (P=0.007; OR:4.8; 95% CI: 1.5-15.3) and postoperative renal function worsening (P=0.028; OR:1,1; 95% CI: 1.1-1.2) were independent predictor for mortality at the multivariate analysis.

Conclusions: FEVAR for j-AAAs is safe and effective at early and long-term follow-up. According with these results, it could be proposed as the first line treatment in high risk patients if anatomically fit. Long term survival is reduced in the presence of preoperative COPD and postoperative renal function worsening.
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http://dx.doi.org/10.23736/S0021-9509.19.11185-8DOI Listing
February 2020

Endovascular Treatment of a Ruptured Superficial Femoral Artery Aneurysm in Behcet's Disease: Case Report and Literature Review.

Ann Vasc Surg 2020 May 23;65:287.e1-287.e6. Epub 2019 Nov 23.

Vascular Surgery, University of Bologna, DIMES, Policlinico Sant'Orsola, Malpighi, Bologna, Italy.

Purpose: The aim of the study was to report the endovascular repair of a ruptured superficial femoral artery (SFA) aneurysm in a young patient with Behcet's disease and review the literature.

Case Report: A 43-year-old man with a known history of vasculo-Behcet's disease (v-BD) under daily immunosuppressive therapy presented with a ruptured aneurysm of the left SFA. The patient underwent urgent endovascular exclusion of the aneurysm using a self-expanding covered stent. Surgical cut-down followed by direct puncture of the SFA was preferred to percutaneous approach to reduce the risk of postoperative pseudoaneurysm formation. The procedure and postoperative recovery were successful. Doppler ultrasound performed at 3 months and computed tomography angiography performed at 6 months after the procedure confirmed aneurysm exclusion, the endograft patency, and the absence of aneurysm degeneration both at the level of surgical access and endograft landing zone.

Conclusions: The endovascular treatment of ruptured lower limb aneurysms has been scarcely reported in the literature despite representing the less invasive option. A rare case of ruptured aneurysm SFA in a patient with v-BD was successfully treated with endovascular therapy (ET) and led to satisfactory midterm outcomes. ET offers encouraging results in terms of reduced vessel trauma and reduced postoperative complication rates.
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http://dx.doi.org/10.1016/j.avsg.2019.11.023DOI Listing
May 2020

FEVAR: is still the preferred therapeutic option for juxtarenal aortic aneurysms?

J Cardiovasc Surg (Torino) 2020 02 18;61(1). Epub 2019 Nov 18.

Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.

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http://dx.doi.org/10.23736/S0021-9509.19.11198-6DOI Listing
February 2020

Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms.

Ann Vasc Surg 2020 Jul 31;66:132-141. Epub 2019 Oct 31.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi, Bologna, Italy.

Background: The aim of this study was to report early and mid-term outcomes of fenestrated endografting (FEVAR) for juxtarenal aneurysm (J-AAAs).

Methods: Between 2008 and 2017, all consecutive J-AAAs treated by FEVAR were prospectively collected. Early endpoints were technical success, renal function worsening, and 30-day mortality. Follow-up endpoints were survival, freedom from reinterventions (FFRs), target visceral vessels (TVVs) patency, J-AAAs shrinkage, and renal function worsening.

Results: Among 181 cases who underwent FB-EVAR, 66 (36%) were J-AAAs. Endograft with 1, 2, 3, and 4 fenestrations were planned in 2 (3%), 22 (33%), 27 (41%) and 15 (23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations and scallops. Technical success was achieved in 65 (99%) cases. The only failure occurred for a type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening occurred in 7 (10%) cases: 4 returned to baseline within 30-day, 1 required hemodialysis and died within 30 days (1.5%). This was the only case of 30-day mortality. The mean follow-up was 46 ± 32 months. Aneurysm sac shrinkage or stability was observed in 42 (64%) and 22 (33%) cases, respectively. Two patients (3%) with persistent type II endoleak had sac enlargement and required reinterventions. Freedom from reinterventions at 5 years was 88%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24 months in a case with a severe preoperative stenosis. No late renal arteries occlusions or type I-III endoleaks occurred. Overall, renal function worsening was reported in 5 (8%) patients during follow-up. Survival at 5 years was 67%, with no j-AAA-related mortality. COPD was the only independent predictor for mortality at the multivariate analysis (P: 0.021; OR: 5.3; 95% CI, 1.3-21.9).

Conclusions: FEVAR for J-AAAs is safe and effective at early and mid-term follow-up. According to these results, it could be proposed as the first-line treatment in high-risk patients if anatomically fit. Long-term survival is reduced in the presence of preoperative COPD.
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http://dx.doi.org/10.1016/j.avsg.2019.10.077DOI Listing
July 2020
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