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Purpose: To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9±2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1–127) and 29.3 months (range 1–127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%). Conclusion: IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation.

To report early and mid-term results of post-aortic dissection thoracoabdominal aneurysms (pD-TAAA) treated by complex endografting in three tertiary referral hospitals. A review of all patients with pD-TAAA unfit for open surgery treated with complex endovascular repair from 2012 to 2018 was performed. Simple thoracic endografts (TEVAR) were excluded. Staged procedures in case of extensive aortic coverage were always planned. In total, 21 patients (16 males, mean age 63 ± 10 years) with pD-TAAA underwent aortic repair by fenestrated or branched thoracoabdominal endografts for visceral vessels. Mean TAAA diameter was 61 ± 6.2 mm. Spinal cord drainage was performed in all patients. A staged approach was used in 12 (57%) cases. Technical success was achieved in 18 (86%) patients. No in-hospital deaths occurred. Two patients experienced transient post-procedural spinal cord ischemia. At 30 days, six type II endoleaks (29%), two type Ic endoleak (9.5%) and one type IIIc endoleak (5%) were reported. At a mean follow-up of 23 ± 13 months, no late aortic-related deaths occurred. Three patients underwent reintervention for type Ic and IIIc endoleaks. No visceral vessel occlusion was observed. Estimated freedom from reintervention at 12 and 24 months was 85.7 ± 0.7%. In 13 cases, TAAA diameter decreased at least 5 mm, while increased > 5 mm in only one case. Complete false lumen thrombosis was achieved in 18 patients (86%). Complex endografting for pD-TAAA showed favorable mid-term results. Staged and carefully planned endovascular procedures may represent a safe and effective therapeutic option in patients deemed at high risk of open repair.

To assess the outcomes of Cook t-Branch off-the-shelf multibranched stent graft in the treatment of complex aortic aneurysms with narrow internal aortic lumen.Between 2016 and 2020, 48 patients (mean age, 73 years) underwent elective or urgent or emergent Cook t-Branch implantation for thoracoabdominal or para/juxtarenal aortic aneurysms in two Italian vascular centers. Among these, 20 patients presented a paravisceral or pararenal luminal diameter of less than 25 mm. Major clinical and radiologic outcomes of patients with narrow aortic lumen were compared with patients with a larger lumen in a multicenter, nonrandomized, retrospective fashion.The in-hospital mortality was 10% (5% in the elective setting). Spinal cord ischemia occurred in 6% of the cases. During a mean follow-up of 18 months (range, 1-63 months), late t-Branch procedure-related mortality and the need for reintervention was 0% and 12%, respectively. Comparing the outcomes of patients with large internal aortic lumen (group 1) with patients with small lumen (group 2), no significant difference was found regarding fluoroscopy time (P = .3); technical success (P = 1); early (P = .4) and late (P = 1) mortality; spinal cord ischemia (P = .2); bowel ischemia (P = .5); renal (P = .7), cardiac (P = 1), and respiratory complications (P = 1); reintervention rate (P = 1); and primary patency rate of stented target vessels (P = 1).The use of the Cook t-Branch in our experience was safe and effective in the treatment of complex aortic aneurysms regardless the caliber of the aortic lumen. With all the limitations of a small sample size, this approach has demonstrated to be feasible when maneuverability is decreased, with low mortality and morbidity, and acceptable reintervention rates. Perioperative mortality remains closely related to clinical presentation. Large-scale studies are needed to confirm these results.

Objective To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. Methods A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients’ clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate. Results During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1–9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6–48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) ( P Conclusion CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.

Background The aim of this study was to report the results of a multicenter experience on the use of adjunctive stents deployed inside abdominal aortic endografts with the purpose to prevent or treat limb occlusion after endovascular aneurysm repair (EVAR). Methods Between 2010 and 2018, there were 35 patients with aorto-iliac aneurysm presenting one or more risk factors for endograft limb occlusion (narrow aortic bifurcation and/or stenotic, highly angulated or occluded iliac arteries), who were treated with standard bifurcated stent graft reinforced by the means of a single model of balloon-expandable platinum/iridium bare stent (CP Stent; NuMED, Inc., Hopkinton, NY, USA). Technical success, mortality, limb patency and reintervention rate during follow-up were the main endpoints assessed. Results Technical success was 100%. No patients died perioperatively and no major complication was registered. During a mean follow-up of 48 months (range 1-87), neither aortic-related death nor secondary intervention was registered. At a mean follow-up imaging of 39.4 months (range 1-81) no endograft limb lost its patency. Conclusions The use of high-radial force balloon-expandable stents deployed inside bifurcated endografts to prevent or treat limb occlusion is a safe and effective adjunctive procedure, with outstanding long-term outcomes in terms of patency and reinterventions.

Purpose: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation. Methods: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies. Results: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (

Purpose: To compare the outcomes of iliac branch devices (IBD) used in combination with standard endovascular aneurysm repair (EVAR) vs with fenestrated/branched EVAR (f/bEVAR) to treat complex aortoiliac aneurysms. Materials and Methods: The pELVIS Registry database containing the outcomes of IBD use at 8 European centers was interrogated to identify all IBD procedures that were combined with either standard EVAR or f/bEVAR. Among 669 patients extracted from the database, 629 (mean age 72.1±8.8 years; 597 men) had received an IBD combined with standard EVAR vs 40 (mean age 71.1±8.0 years; 40 men) who underwent f/bEVAR with an IBD. The mean aortic aneurysm diameters were 46.4±13.3 mm in the f/bEVAR patients vs 45.0±15.5 mm in the standard EVAR cases. The groups were similar in terms of baseline clinical characteristics and aneurysm morphology. The Kaplan-Meier method was used to compare patient survival, IBD occlusion, type III endoleak, and aneurysm-related reinterventions in follow-up. The estimates are presented with the 95% confidence interval (CI). Results: Technical success was 100% in the f/bEVAR+IBD group and 99% in the EVAR+IBD group (p=0.85). The 30-day mortality was 0% vs 0.5%, respectively (p=0.66), while the 30-day reintervention rates were 7.5% vs 4.1% (p=0.31). The mean follow-up was 32.1±21.3 months for f/bEVAR+IBD patients (n=30) and 35.5±26.8 months for EVAR+IBD patients (n=571; p=0.41). The 12-month survival estimates were 93.4% (95% CI 93.2% to 93.6%) in the EVAR+IBD group vs 93.6% (95% CI 93.3% to 93.9%) for the f/bEVAR+IBD group (p=0.93). There were no occlusions or type III endoleaks in the f/bEVAR+IBD group at 12 months, while the estimates for freedom from occlusion and from type III endoleak in the EVAR+IBD group were 97% (95% CI 96.8% to 97.2%) and 98.5% (95% CI 98.4% to 98.6%), respectively. The 12-month estimates for freedom for aneurysm-related reintervention were 93% (95% CI 92.7% to 93.3%) in the EVAR+IBD group vs 86.4% (95% CI 85.9% to 86.9%) in the f/bEVAR+IBD patients (p=0.046). Conclusion: Treatment of complex aortoiliac disease with f/bEVAR+IBD can achieve equally good early and 1-year outcomes compared to treatment with IBDs and standard bifurcated stent-grafts, except for a somewhat higher reintervention rate in f/bEVAR patients.

Prodromal signs of a non-healing wound after revascularisation, which might be strictly linked with impending failure of vascular reconstructions, are associated with an inflammatory response mediated by several circulating adhesion molecules, extracellular endopeptidases, and cytokines. The aim of our study was to investigate the role of selected plasma biomarkers in the prediction of both wound healing and failure of infrapopliteal vein graft or percutaneous trans-luminal angioplasty (PTA) with selective stent positioning of the superficial femoral artery (SFA) in a population affected with critical limb ischaemia. A total of 68 patients who underwent either surgical or endovascular revascularisation of the inferior limb with autologous saphenous vein infrapopliteal bypass or PTA and selective stenting of the SFA were enrolled in our study. Patients were divided into two groups according to treatment: 41 patients were included in Group 1 (open surgery) and 27 in Group 2 (endovascular procedure). Plasma and blood samples were collected on the morning of surgery and every 6 months thereafter for up to 2 years of follow-up or until an occlusion occurred of either the vein bypass graft or the vessel treated endovascularly. Fifteen age-matched healthy male volunteers were considered a reference for biological parameters. Vascular cell adhesion molecule 1 [VCAM-1]/CD106, inter-cellular adhesion molecule-1 [ICAM-1]/CD54), interleukin-1 (IL-1), interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-α), and metalloproteinases (MMP)-2 and -9 plasma levels were measured with enzyme-linked immunosorbent assay (ELISA) kits. The mean observed time to heal of 54 wounds was 13 ± 4 months, with no statistically significant differences among the groups. The healing failure of the remaining wounds was strictly related to an unsuccessful open (n = 12) or endovascular (n = 8) treatment. The 2-year primary patency rate was 65% (SE = .09) in Group 1 and 52% (SE = .1) in Group 2. When compared with mean concentration values of Group 1, VCAM-1 and ICAM-1 were always significantly higher during follow-up in patients of Group 2 (P < .05). Furthermore, in the same group, IL-6 and tumour necrosis factor alpha (TNF-α) were found to be significantly higher at 6- and 12-month (P < .05) when compared with surgically treated patients. Cox regression analysis showed that elevated plasma levels of VCAM-1, ICAM-1, IL-6, and TNF-α during follow up were strongly related to impaired wound healing and/or revascularisation failure (P < .05). Elevated plasma levels of inflammatory markers VCAM-1, ICAM-1, IL-6, and TNF-α may be related to the failure of wound healing and revascularisation procedures. Interestingly, we have observed that endovascular treatments cause a higher level of these inflammation biomarkers when compared with a vein graft, although wound-healing and patency and limb salvage rates are not influenced.

The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry).All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg).Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure.In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining.

Objective The objective of this study was to assess early and midterm results after endovascular aortic arch repair using a double inner branch stent graft (DIBSG) in patients with aortic arch aneurysm or dissection unfit for open surgery. Methods Between 2012 and 2018, there were 24 patients with aortic arch disease who were treated with a single model of a DIBSG (Terumo Aortic, Glasgow, United Kingdom) in nine Italian cardiovascular centers. We investigated technical success, mortality, occurrence of major complications, and need for reintervention in a multicenter, nonrandomized, retrospective fashion. Results The in-hospital mortality rate was 16.7%. Cerebrovascular events occurred in 25% of patients and major strokes in 12.5%. Two patients experienced a retrograde dissection (8.3%), whereas none reported any type I or type III endoleak. During a mean follow-up of 18 months (range, 1-60 months), one patient died of a nonaortic cause and one reported a nonarch-related major stroke. No late secondary intervention was needed during the follow-up. Excluding from the analysis the first six patients treated until 2014 as part of the learning curve, in-hospital mortality, major stroke, and retrograde dissection rates were 11.1%, 11.1%, and 5.6%, respectively. Conclusions Endovascular aortic arch repair using this model of DIBSG is feasible, and results are acceptable for a new technique in a high-risk subset of patients. Operative mortality suffers the effect of a learning curve, whereas midterm aorta-related survival is promising. Endovascular repair of aortic arch disease with a DIBSG should always be considered to give high-risk patients a chance of repair. Large-scale studies are needed to assess the long-term durability of this technique.

Background In the light of current evidence, endovascular repair of aortic arch pathologies with custom-made devices should be considered a valid alternative to decrease operative mortality and morbidity associated with open or hybrid repair. Today, two double inner branch devices are available on market. We report our single-center experience with Bolton double branch stent graft in the treatment of aortic arch disease. Methods Between 2013 and 2016, 15 high-risk patients with arch pathology were treated in our center with a custom-made branched device. Six of these received a Cook arch branched stent graft. Nine were treated with Bolton device. Among these, 2 with single branch model were excluded leaving a subgroup of 7 patients object of this study. Results Out of the 7 male patients (mean age 76, range 70-85) included in the study, 2 died in-hospital after stroke and retrograde dissection, respectively. No other death, major complication or secondary intervention was recorded at a mean follow-up of 24 (min-max 6-53) months, neither any aneurysmal diameter evolution nor branch related complications. Conclusions Despite the small sample size, our results are in line with the early-published experiences about this technique. Endovascular repair of aortic arch disease with custom-made branched devices should always be considered to give high-risk patients a chance of repair.

Objective Hypogastric aneurysms (HAs) frequently coexist with aortoiliac aneurysms (AIAs). However, the presence of an HA is a contraindication to endovascular aneurysm treatment by iliac branch devices (IBDs) because of the risk of distal sealing-related endoleaks. No robust evidence exists in the published literature, and therefore we sought to evaluate the performance of IBDs in the presence of HAs within a multicenter registry of nine vascular centers. Methods Clinical and radiographic information of 804 patients with AIAs treated by IBDs was retrospectively reviewed and analyzed using prearranged, defined, and documented protocols. The treatment period was between January 2005 and April 2017. Results HA was present in 315 (32.6%) of the overall 910 deployed IBDs. Mean radiologic follow-up was 32 months. The incidence of incomplete aneurysm exclusion and type I endoleak was 3% in the HA group vs 0.7% in the non-HA group (P = .019). The 5-year freedom from IBD-related type I endoleak was 93% vs 98% in the HA group vs the non-HA group, respectively (P = .006). Subgroup analysis of the HA group revealed that use of a single distal bridging stent graft vs multiple bridging devices led to higher rate of type I endoleak (9.6% vs 2.8%; P = .031), branch occlusions (8.3% vs 0.9%; P = .009), and buttock claudication (7.6% vs 1.9%; P = .038). Conclusions This series of AIAs with HAs is the largest reported. It shows that HAs coexisting with AIAs, when treated with IBDs, have significantly worse outcomes. Lengthening the distal landing zone with more than one bridging stent graft into the distal healthy hypogastric artery or one of its main branches improves outcomes.

Background: Off-the-shelf devices for branched endovascular aortic repair of thoracoabdominal aortic aneurysm (TAAA) have been developed to overcome the manufacturing- and logistics-related delays characteristic of device customization. Nonetheless, the structural requirements of branched endovascular aortic repair, together with the need for additional thoracic components to suit different anatomies, might lead to a large sacrifice of healthy aorta. Methods: We enrolled 18 consecutive TAAA patients treated between 2010 and 2016 in two centers employing the off-the-shelf t-Branch (Cook Medical, Bloomington, Ind) device (TB group). We matched these 18 patients one-to-one with another 18 patients of the 464 consecutive TAAAs treated in the same period by means of open repair (O group) in one of the two centers. The patients were matched on the basis of t-Branch feasibility, distance from the left subclavian artery to the beginning of the aneurysm, and diameter of proximal landing zone evaluated at preoperative computed tomography angiography. We compared the overall length of sacrificed healthy native aorta (the sealing zone in the TB group) in the two groups according to postoperative computed tomography angiography, and we investigated the number of intercostal arteries lost from that healthy aortic segment. We calculated also the real unnecessary sacrificed aorta by subtracting the compulsory minimum neck coverage requested to obtain the proximal sealing (25 mm). Results: We matched one-to-one six extent II, seven extent III, and five extent IV TAAAs. Overall, the length of sacrificed healthy aorta was longer (P < .001) in the TB group (median length: TB group, 49 mm [interquartile range (IQR), 31-60 mm]; O group, 14 mm [IQR, 10-20 mm]), and consequently the number of intercostal arteries lost (median number of pairs lost: TB group, four [IQR, three-four]; O group, two [IQR, one-three]) was higher (P = .004). Stratifying the results according to TAAA extent and after having subtracted from the TB group the length of aorta required for proximal sealing (25 mm), the length of sacrificed healthy aorta was longer (P = .008) only in the extent IV TAAA, 125 mm (IQR, 56-155 mm). The number of intercostal artery pairs sacrificed was significantly higher only in extent III TAAA (P = .043) and extent IV TAAA (P = .024). No significant 30-day clinical outcomes difference was observed between the matched groups. Conclusions: The use of the t-Branch device compared with open repair is associated with a greater sacrifice of healthy aorta in extent IV TAAA and with an increased loss of intercostal arteries arising from healthy aortic proximal neck. The theoretical possible increased risk of spinal cord ischemia secondary to the routine use of this off-the-shelf device should thus be analyzed further.

Objective We evaluated the short- and long-term results of off-label use of iliac branch devices (IBDs) in isolated common iliac artery aneurysms compared with the manufacturer-recommended configuration with additional extension in the infrarenal aorta based on the pELVIS Registry (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation). Methods Between January 2005 and April 2017, 804 patients underwent endovascular aneurysm repair with 910 IBDs owing to aneurysmal involvement of the iliac bifurcation in nine high-volume European vascular centers. Among this cohort, 231 IBDs were implanted in 207 patients to treat an isolated common iliac aneurysm; 91 IBDs (group 1) were implanted without proximal aortic extension in the infrarenal aorta, and in the remaining cases (n = 140; group 2) an aortic bifurcated stent graft was deployed proximally as stated in the instructions for use. Primary outcomes were IBD and target hypogastric artery occlusions, type I and III endoleaks, procedure-related reinterventions, and aneurysm-related deaths. Results Technical success was achieved in 90 cases (98.9%) in group 1 versus 137 cases (97.8%) in group 2 (P = .55). The overall aneurysm-related early reintervention rate for the two groups was 4.4% (4 of 91) and 2.1% (3 of 140), respectively (P = .33). The 30-day mortality was 1.1% in group 1 (n = 1), and 0% in group 2 (P = .21). The median postoperative follow-up in groups 1 and 2 were 34.1 months (range, 1-108 months) and 17.5 months (range, 1-90 months), respectively. The estimated rates of freedom from IBD occlusion at 60 months were 86% in group 1 and 83% in group 2 (P = .69). The estimated rates of freedom from target hypogastric artery occlusion at 60 months were 98.3% in group 1 and 91.3% in group 2 (P = .45). The estimated freedom from reintervention rates at 60 months for types I, types III, and IBD stenosis-occlusion were 78.2% in group 1 and 79.9% in group 2 (P = .79). The estimated freedom from all cause reintervention at 60 months was 64.5% in group 1 and 66.1% in group 2 (P = .44). The estimated freedom from aneurysm-related death at 60 months was 97.9% in group 1 and 100% in group 2 (P = .83). Conclusions Single IBD placement for isolated common iliac artery aneurysms seems to be a safe and effective treatment option, when a proper anatomic patient selection is provided. Major benefits are represented by the decrease in X ray exposure, overall procedural time, and use of contrast medium, without affecting perioperative and long-term results in comparison with more extensive procedures.

To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA).From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Mean CIAA diameter was 39.1±10.5 mm (range 25-65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed.Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2±33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage ≥5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up.The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results.

The purpose of this report was to describe the exclusion of the false lumen in a residual type A aortic dissection (TAAD) by the deployment of 2 covered stents: one in the right common carotid artery (RCCA) and one in the left subclavian artery (LSA). A 77-year-old female, already treated with ascending aorta replacement for acute TAAD, was referred to our center for a 97-mm post-dissection arch aneurysm. A computed tomography angiography (CTA) showed false lumen patency by reperfusion from secondary tears located at the level of RCCA and LSA. No primary aortic tear was noted. Under local anesthesia and by transfemoral percutaneous approach, the tears at the level of RCCA and LSA were covered by a 9-mm Viabahn stent graft (Gore, Flagstaff, AZ), and a 10-mm V-12 stent graft (Maquet, Rastatt, Germany), respectively. The false lumen was finally occluded by the deployment of a 6-mm vascular plug at the level of LSA re-entry tear, by left transbrachial puncture. The procedure was completed uneventfully. Twelve-month CTA showed exclusion of the false lumen, patency of all supra aortic trunks, and initial shrinkage of the aneurysm. Spot stenting of secondary re-entry tears, already described for visceral branches, seems to be safe and effective also for supra-aortic trunks in selected patients.

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.

Background Iliac branch device (IBD) technique has been introduced as an appealing and effective solution to avoid complications occurring during repair of aorto-iliac aneurysm with extensive iliac involvement. Nevertheless, no large series with long-term follow-up of IBD are available. The aim of this study was to analyse safety and long-term efficacy of IBD in a consecutive series of patients. Methods Between 2006 and 2011, 100 consecutive patients were enrolled in a prospective database on IBD. Indications included unilateral or bilateral common iliac artery aneurysms combined or not with abdominal aneurysms. Patients were routinely followed up with computed tomography. Data were reported according to the Kaplan–Meier method. Results There were 96 males, mean age 74.1 years. Preoperative median common iliac aneurysm diameter was 40 mm (interquartile range (IQR): 35–44 mm). Sixty-seven patients had abdominal aortic aneurysm >35 mm (IQR: 40–57 mm) associated with iliac aneurysm. Eleven patients presented hypogastric aneurysm. Twelve patients underwent isolated iliac repair with IBD and 88 patients received associated endovascular aortic repair. Periprocedural technical success rate was 95%, with no mortality. Two patients experienced external iliac occlusion in the first month. At a median follow-up of 21 months (range 1–60) aneurysm growth >3 mm was detected in four iliac (4%) arteries. Iliac endoleak (one type III and two distal type I) developed in three patients and buttock claudication in four patients. Estimated patency rate of internal iliac branch was 91.4% at 1 and 5 years. Freedom from any reintervention rate was 90% at 1 year and 81.4% at 5 years. No late ruptures occurred. Conclusions Long-term results show that IBD use can ensure persistent iliac aneurysm exclusion at 5 years, with low risk of reintervention. This technique can be considered as a first endovascular option in patients with extensive iliac aneurysm disease and favourable anatomy.

Objective The aim of this study was to investigate outcomes of patients treated with endovascular repair (ER) with the use of fenestrated and branched stent grafts or open surgery (OS) for thoracoabdominal aortic aneurysm (TAAA) in a current series of patients. Methods All TAAA patients undergoing repair at three centers between January 2007 and December 2014 were included in a prospective database. Patients were stratified according to treatment by ER or OS, and outcomes were compared using propensity score matching (1:1). Covariates included age, sex, aneurysm extent, hypertension, coronary disease, chronic pulmonary disease, diabetes, and renal function. The primary end points were mortality and paraplegia. Secondary end points included any spinal cord ischemia (SCI), renal and respiratory insufficiency, and a composite of these complications or death at 30 days. All-cause survival and freedom from reintervention were compared in the two groups. Results Of 341 patients, 84 (25%) underwent ER and 257 underwent OS (75%). After propensity score matching (65 patients per group), no significant differences were observed in rates of 30-day mortality (7.7% in ER and 6.2% in OS; P = 1) and paraplegia (9.2% and 10.8%; P = 1). Any SCI, renal insufficiency, and respiratory insufficiency were 12.3% and 20% ( P = .34), 9.2% and 12.3% ( P = .78), and 0% and 12.3% ( P = .006) in ER and OS, respectively. The incidence of the composite end point was significantly lower in ER patients (18.5% in ER vs 36.0% in OS; P =.03). According to Kaplan-Meier estimates, all-cause survival at 24 months was 82.8% in ER and 84.9% in OS, with rates unchanged at 42 months ( P = .9). Rates of freedom from reintervention were 91.0% vs 89.7% at 24 months and 80.0% vs 79.9% at 42 months in ER vs OS, respectively ( P = .3). Conclusions A propensity score analysis in patients with TAAA undergoing repair suggests an early benefit from ER compared with OS with regard to the composite end point because of reduced 30-day respiratory complications. No significant differences were found in SCI and renal insufficiency at 30 days and in survival and reintervention rates at midterm.

Objective The objective of this multicenter registry was to review current treatments and late results of repair of aneurysm of aberrant right subclavian artery (AARSA). Methods All consecutive AARSA repairs from 2006 to 2013 in seven centers were reviewed. End points were 30-day and late mortality, reintervention rate, and AARSA-related death. Results Twenty-one AARSA repairs were included (57% men; mean age, 67 years); 3 ruptures (14%) required emergent treatment; 12 (57%) were symptomatic for dysphagia (33%), dysphonia (24%), or pain (19%). Eight cases (38%) presented with thoracic aortic aneurysm, two with intramural hematoma, and one with acute type B aortic dissection. Mean AARSA diameter was 4.2 cm; a single bicarotid common trunk was present in 38% of cases. The majority of patients underwent hybrid intervention (n = 15; 71%) consisting of single (n = 2) or bilateral (n = 12) subclavian to carotid transposition or bypass or ascending aorta to subclavian bypass (n = 1) plus thoracic endovascular aortic repair (TEVAR); 19% of cases underwent open repair and 9% simple TEVAR with AARSA overstenting. Perioperative death occurred in two patients (9%): in one case after TEVAR in ruptured AARSA, requiring secondary sternotomy and aortic banding; and in an elective case due to multiorgan failure after a hybrid procedure. Median follow-up was 30 (interquartile range, 15-46) months. The Kaplan-Meier estimate of survival at 36 months was 90% (standard error, 0.64). Late AARSA-related death in one case was due to AARSA-esophageal fistula presenting with continuing backflow from distal AARSA and previous TEVAR. At computed tomography controls, one type I endoleak and one type II endoleak were detected; the latter required reintervention by aneurysm wrapping and ligature of collaterals. AARSA-related death was more frequent after TEVAR, a procedure reserved for ruptures, compared with elective open or hybrid repair. Conclusions Hybrid repair is the preferred therapeutic option for patients presenting with AARSA. Midterm results show high rates of clinical success with low risk of reintervention. Simple endografting presents high risk of related death; these findings underline the importance of achieving complete sealing to avoid treatment failures.

ObjectiveThis study analyzed total aortic arch reconstruction in a contemporary comparison of current open and endovascular repair.MethodsEndovascular (group 1) and open arch procedures (group 2) performed during 2007 to 2013 were entered in a prospective database and retrospectively analyzed. Endovascular repair (proximal landing zones 0-1), with or without a hybrid adjunct, was selected for patients with a high comorbidity profile and fit anatomy. Operations involving coverage of left subclavian artery only (zone 2 proximal landing: n = 41) and open hemiarch replacement (n = 434) were excluded. Early and midterm mortality and major complications were assessed.ResultsOverall, 100 (78 men; mean age, 68 years) consecutive procedures were analyzed: 29 patients in group 2 and 71 in group 1. Seven group 1 patients were treated with branched or chimney stent graft, and 64 with partial or total debranching and straight stent graft. The 29 patients in group 2 were younger (mean age, 61.9 vs 70.3; P = .005), more frequently females (48.2% vs 11.3; P < .001) with less cardiac (6.9% vs 38.2%; P = .001), hypertensive (58.5% vs 88.4%; P = .002), and peripheral artery (0% vs 16.2%; P = .031) disease. At 30 days, there were six deaths in group 1 and four in group 2 (8.5% vs 13.8%; odds ratio, 1.7; 95% confidence interval, 0.45-6.66; P = .47), and four strokes in group 1 and one in group 2 (odds ratio, 0.59; 95% confidence interval, 0.06-5.59; P = 1). Spinal cord ischemia occurred in two group 1 patients and in no group 2 patients. Three retrograde dissections (1 fatal) were detected in group 1. During a mean follow-up of 26.2 months, two type I endoleaks and three reinterventions were recorded in group 1 (all for persistent endoleak), and one reintervention was performed in group 2. According to Kaplan Meier estimates, survival at 4 years was 79.8% in group 1 and 69.8% in group 2 (P = .62), and freedom from late reintervention was 94.6% and 95.5%, respectively (P = .82).ConclusionsDespite the older age and a higher comorbidity profile in patients with challenging aortic arch disease suitable and selected for endovascular arch repair, no significant differences were detected in perioperative and 4-year outcomes compared with the younger patients undergoing open arch total repair. An endovascular approach might also be a valid alternative to open surgery in average-risk patients with aortic arch diseases requiring 0 to 1 landing zones, when morphologically feasible. However, larger concurrent comparison and longer follow-up are needed to confirm this hypothesis.

Objective Currently, the best approach to the aortic arch remains unsupported by robust evidence. Most of the available data rely on small sample numbers, heterogeneous settings, and limited follow-up. The objective of this study was to evaluate early and midterm results of arch debranching and endovascular procedures. Methods From 2005 through 2013, 104 consecutive patients underwent elective arch treatment with debranching and thoracic endovascular aortic repair. Rates of perioperative (30-day) mortality and neurological complications, and mortality, endoleak, supra-aortic vessel patency, and arch diameter changes at 5 years were analyzed. Results Patients' mean age was 69.8 years, and 90 were males. Twenty arches were repaired for dissection. Nineteen patients required total debranching for diseases extended to zone 0. In 59, debranching and thoracic endovascular aortic repair procedures were staged. At 30 days, death, stroke, and spinal cord ischemia occurred in six, four, and three patients, respectively. Extension to ascending aorta (zone 0 landing) was the only multivariate independent predictor for perioperative mortality (odds ratio, 9.6; 95% confidence interval, 1.54-59.90; P = .015), but not for stroke. Four retrograde dissections, two fatal, occurred during the perioperative period. At 1, 3, and 5 years, Kaplan-Meier survival rates were 89.0%, 82.8%, and 70.9%, and freedom from persistent endoleak rates were 96.1%, 92.5%, and 88.3%, respectively. Over 5-year follow-up, 34 aneurysms shrank ≥ 5 mm, and four grew. Five reinterventions were required. Two supra-aortic vessel occlusions and no late aorta-related mortalities were recorded. Conclusions Despite the perioperative mortality risk, the late outcome of endovascular arch repair presents a low rate of aorta-related deaths and reinterventions and acceptable midterm survival. Furthermore, more than one-third of the aneurysms' diameters decrease over 5 years as a measure of the long-term efficacy of treatment. Retrograde type A dissection remains a major concern in the perioperative period and careful arch approach is required.

Dilation of one or both common iliac arteries (CIAs) is a major concern in endovascular aneurysm repair (EVAR). One option for CIA aneurysm repair is hypogastric embolization followed by endograft extension into the external iliac artery. However, hypogastric occlusion does not always go unpunished and it may lead to ischemic complications. Aim of the paper was to evaluate early results with the Gore® Excluder® Iliac Branch Endoprosthesis (IBE) in the treatment of iliac aneurysms associated or not with abdominal aortic aneurysms.Between November 2013 and April 2014, in our Institution 7 Gore IBE were implanted in 5 patients. Technical success, 30-day mortality and complications were investigated.Technical success and branch patency was 100%. There was no 30-day mortality. In 1 of the 2 bilateral cases an endovascular relining with bare stents was required due to a compression of iliac legs at level of aortic bifurcation.Use of Gore IBE device in the treatment of aorto-iliac disease is feasible and safe. Late results are necessary to evaluate the performance of this endograft in the long term.