Role of intravascular ultrasound for the technical assessment of endovascular reconstruction of the aortic bifurcation.

OBJECTIVE: The aim of this study was to evaluate the role of intravascular ultrasound (IVUS) for the technical assessment of kissing stents (KSs) and covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac obstructive disease involving the aortic bifurcation. METHODS: We conducted a single-center retrospective review of patients undergoing endovascular treatment of severe aorto-iliac obstructive disease (2019-2023). IVUS was performed in patients treated by KSs or CERAB according to preoperative indications, in cases of moderate/severe calcifications, mural thrombus, total occlusions, and lesion extension towards the proximity of renal or hypogastric arteries. Indications for IVUS-guided intraoperative revisions were residual stenosis or compression >30%, incomplete stent-to-wall apposition, or flow-limiting dissection at the landing site. Follow-up assessment was performed at 6 and 12 months, and then yearly. Thirty-day outcomes and 2-year patency rates were evaluated. Logistic regression was used to identify factors associated with significant technical defects detected by IVUS needing intraoperative revision. RESULTS: IVUS was used for the technical assessment of 102 patients treated by KSs (n = 57; 56%) or CERAB (n = 45; 44%) presenting with severe intermittent claudication (39%), rest pain (39%), or ischemic tissue loss (25%). Twenty-nine significant technical defects were identified by IVUS in 25 patients (25%) who then had successful intraoperative correction by additional ballooning (n = 23; 80%) or stenting (n = 6; 20%). Patients with a severely calcified chronic total occlusion (odds ratio, 1.85; 95% confidence interval, 1.01-5.27; P = .044) or severely calcified narrow aortic bifurcation with <12 mm diameter (odds ratio, 2.34; 95% confidence interval, 1.10-8.64; P = .032) were at increased risk for IVUS-guided intraoperative revision. There were no postoperative deaths and no major adverse events. Two-year primary patency was 100%. CONCLUSIONS: IVUS was used for the technical assessment of KSs/CERAB in a selected cohort of patients with severe aorto-iliac obstructive disease. This allowed the identification and intraoperative correction of a significant technical defect not detected by completion angiogram in one-quarter of patients, achieving optimal 2-year results. IVUS assessment of KSs/CERAB may be considered especially in patients with a calcified total occlusion or narrow aortic bifurcation.

The role of multimodal imaging in emergency vascular conditions: The journey from diagnosis to hybrid operating rooms.

Multimodal imaging is the incorporation of two or more imaging modalities during the same examination, and it has both diagnostic and treatment applications. The use of image fusion for intraoperative guidance in endovascular interventions is being extended increasingly to the field of vascular surgery, especially in the context of hybrid operating rooms. The aim of this work was to perform a review and narrative synthesis of the available literature in order to report on current applications of multimodal imaging in diagnosis and treatment of emergent vascular conditions. Of 311 records selected in the initial search, 10 articles were included in the present review: 4 cohort studies and 6 case reports. The authors have presented their experience in treating ruptured abdominal aortic aneurysms; aortic dissections; traumas; standard endovascular aortic aneurysm repair, with or without deterioration of renal function; and complex endovascular aortic aneurysm repair, and reported on the long-term clinical results. Although the current literature about multimodal imaging application in emergency vascular conditions is limited, this review highlights the potential of image fusion in hybrid angio-surgical suites, especially for diagnosing and performing treatment in the same operating room, avoiding patient transfer, and allowing procedures with zero or low-dose contrast mean.

Post-Operative and Mid-Term Renal Function Impairment Following Elective Fenestrated Endovascular Aortic Repair for Complex Aortic Aneurysms: Incidence and Risk Factors Analysis.

Background. The aim of this study was to assess the incidence of two post-operative acute kidney injury (AKI) stages according to the Risk, Injury, Failure, Loss of function, End-stage (RIFLE) criteria in patients undergoing fenestrated endovascular aortic repair (FEVAR) for complex aortic aneurysms. Furthermore, we analyzed predictors of post-operative AKI and mid-term renal function deterioration and mortality. Methods. We included all patients who underwent elective FEVAR for abdominal and thoracoabdominal aortic aneurysms between January 2014 and September 2021, independently from their preoperative renal function. We registered cases of post-operative acute kidney injury (AKI) both at risk (R-AKI) and injury stage (I-AKI) according to the RIFLE criteria. Estimated glomerular filtration rate (eGFR) was noted preoperatively, at the 48th post-operative hour, at the maximum post-operative peak, at discharge, and then during follow-up approximately every six months. Predictors of AKI were analyzed with univariate and multivariate logistic regression models. Predictors of mid-term chronic kidney disease (CKD) (stage ≥ 3) onset and mortality were analyzed using univariate and multivariate Cox proportional hazard models. Results. Forty-five patients were included in the present study. Mean age was 73.9 ± 6.1 years and 91% of patients were males. Thirteen patients (29%) presented with a preoperative CKD (stage ≥ 3). Post-operative I-AKI was detected in five patients (11.1%). The aneurysm diameter, thoracoabdominal aneurysms and chronic obstructive pulmonary disease were identified as predictors of AKI in univariate analysis (OR 1.05, 95% CI [1.005-1.20], p = 0.030; OR 6.25, 95% CI [1.03-43.97], p = 0.046; OR 7.43, 95% CI [1.20-53.36], p = 0.031; respectively), yet none of these factors were significative on multivariate analysis. Predictors of CKD onset (stage ≥3) during follow-up on multivariate analysis were age (HR 1.16, 95% CI [1.02-1.34], p = 0.023), post-operative I-AKI (HR 26.82, 95% CI [4.18-218.10], p < 0.001) and renal artery occlusion (HR 29.87, 95% CI [2.33-309.05], p = 0.013), while aortic-related reinterventions where not significantly associated with this outcome in univariate analysis (HR 0.66, 95% CI [0.07-2.77], p = 0.615). Mortality was influenced by preoperative CKD (stage ≥3) (HR 5.68, 95% CI [1.63-21.80], p = 0.006) and post-operative AKI (HR 11.60, 95% CI [1.70-97.51], p = 0.012). R-AKI did not represent a risk factor for CKD (stage ≥ 3) onset (HR 1.35, 95% CI [0.45-3.84], p = 0.569) or for mortality (HR 1.60, 95% CI [0.59-4.19], p = 0.339) during follow-up. Conclusions. In-hospital post-operative I-AKI represented the main major adverse event in our cohort, influencing CKD (≥ stage 3) onset and mortality during follow-up, which were not influenced by post-operative R-AKI and aortic-related reinterventions.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Applications of Three-Dimensional Printing in the Management of Complex Aortic Diseases.

The use of three-dimensional (3D) printing is gaining considerable success in many medical fields, including surgery; however, the spread of this innovation in cardiac and vascular surgery is still limited. This article reports our pilot experience with this technology, applied as an additional tool for 20 patients treated for complex vascular or cardiac surgical diseases. We have analyzed the feasibility of a "3D printing and aortic diseases project," which helps to obtain a more complete approach to these conditions. 3D models have been used as a resource to improve preoperative planning and simulation, both for open and endovascular procedures; furthermore, real 3D aortic models were used to develop doctor-patients communication, allowing better knowledge and awareness of their disease and of the planned surgical procedure. A 3D printing project seems feasible and applicable as an adjunctive tool in the diagnostic-therapeutic path of complex aortic diseases, with the need for future studies to verify the results.

Clinical and Imaging Predictors of Disease Progression in Type B Aortic Intramural Hematomas and Penetrating Aortic Ulcers: A Systematic Review.

BACKGROUND: This work aims to review recent literature on penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs), in order to identify clinical and imaging factors connected to aortic-related adverse events (AAE). METHODS: We performed a systematic review according to the Preferred Reporting Items for Systematic review and Metanalyses (PRISMA) guidelines. An electronic search was conducted on Medline and Embase databases. We included articles reporting on PAUs and/or IMHs localized in the descending thoracic and/or abdominal aorta and analyzing clinical and/or radiological markers of AAE. RESULTS: Of 964 records identified through database searching, 17 were incorporated in the present review, including 193 and 1298 patients with type B PAUs and IMHs, respectively. The 30-days aortic-related mortality (ARM) was 4.3% and 3.9% for PAUs and IMHs. A total of 21% of patients with IMHs underwent intervention during the follow-up period, and 32% experienced an AAE. PAU markers of AAE were minimum depth (ranging from 9.5 to 15 mm) and diameter (≥12.5 mm). Maximum aortic diameter (MAD) cut-off values ranging from 38 to 44.75 mm were related to AAE for IMHs, together with ulcer-like projection (ULP) of the aortic wall. CONCLUSIONS: Despite data heterogeneity in the literature, this PAU- and IMH-focused review has highlighted the imaging and clinical markers of disease progression, thus identifying patients that could benefit from an early intervention in order to reduce the AAE rate.

Open repair versus EVAR with parallel grafts in patients with juxtarenal abdominal aortic aneurysm excluded from fenestrated endografting.

BACKGROUND: We compared the outcomes of open surgical repair (OSR) versus endovascular aortic repair (EVAR) with parallel graft technique (PG) in patients with juxtarenal abdominal aortic aneurysm (JAAA) excluded from fenestrated endovascular aortic repair (FEVAR) due to clinical, anatomical, technical or manufacturing time reasons. METHODS: A single-center analysis of consecutive patients who underwent elective and urgent (within 24-48 hours) repair of JAAA from January 2010 to January 2019 was performed. Two groups were compared: patients excluded from FEVAR and respectively treated by OSR or by PG for JAAA. Perioperative clinical, anatomic and operative data were collected in a dedicated database. The endpoints were primary technical success, changes in renal function, early and long-term mortality, freedom from aortic related reinterventions (ARRs) and aortic related mortality (ARM). RESULTS: Overall, 118 consecutive patients were treated for JAAA, 32 of whom (27.1%) with FEVAR. Eighty-six patients were enrolled in the study (OSR group, N.=61; PG group, N.=25). The mean age was 77.4±6.5 years for PG group and 71.1±6.7 years for OSR group (P=0.0001); the average comorbidity score of the Society for Vascular Surgery was higher for patients treated by PG (10.2±4.8 vs. 5.5±0.4, P=0.0001), with no differences for hypertension and renal score. After propensity score matching, 42 patients (27 OSR, 15 PG) without differences in the preoperative risk factors were selected. Conical shape and neck mural thrombus were respectively more represented in the OSR group (95.1% vs. 56.0%; 63.9% vs. 36.0%). Aortic clamp site was supraceliac for 12 patients (19.7%), suprarenal for 21 (34.4%) and trans-renal for 28 patients (45.9%). In the PG group, 16 patients (64%) were treated with a single renal chimney. Primary technical success was similar in the two groups (100.0% vs. 92.0%, P=0.08), with a higher rate of procedure achieved by assisted technical success for the PG group after propensity score matching analysis (20.0% vs. 0%, P=0.04). Deterioration of renal function occurred for both groups of patients, with a significant creatinine increasing 12 months after surgery in the PG group compared with OSR group (1.72±0.66 vs. 1.18±0.40, P=0.006). Multiple logistic regression shows no independent predictor of peri-operative medical complication among demographics and pre-operative relevant clinical factors between the two cohorts. No difference in terms of early mortality was observed between the groups (1.6% vs. 0%, P=1.00). At 5 years, overall survival was lower for patients treated by PG (53.5% vs. 70.2%, P=0.007), such as freedom from ARRs (64.6 vs. 90.5%, P=0.03). Freedom from ARM at 5 years did not show significant differences among the two groups (100% vs. 98.4%, P=1.00). CONCLUSIONS: PG represents a feasible procedure for patients excluded from FEVAR due to clinical, anatomical, technical or device manufacturing time reasons, ensuring low rates of ARM. However, ARRs during the follow-up remain the Achilles heel of this technique. OSR is still the most durable procedure in the endovascular era, allowing the treatment of proximal "hostile necks" with low rates of reoperation and a similar impact on the renal function compared to PG.

Improving Outcomes in Carotid Body Tumors Treatment: The Impact of a Multidisciplinary Team Approach.

BACKGROUND: The purpose of this study was to evaluate how a multidisciplinary approach, including patients and familiar genetic counseling, preoperative succinate-dehydrogenase (SDH) gene mutation analysis, preoperative adjunctive endovascular procedures (PAEPs) and postoperative rehabilitative team may affect the outcomes in patients who underwent surgery for carotid body tumors (CBTs). METHODS: Fifty-seven consecutive CBT resections were performed from January 1995 to December 2019 in a single center institution. Two groups of patients were compared: group A (1995-2003; n = 10) and group B (2004-2019; n = 47), treated before and after the establishment of a multidisciplinary approach to CBTs. Group A and group B were evaluated retrospectively and prospectively for SDH mutations, respectively. PAEPs (external carotid artery stenting, percutaneous transfemoral embolization or direct percutaneous puncture of the tumor with simultaneous embolization) were performed only in patients of group B, when the size of the tumor exceeded the 45 mm. Primary endpoints were blood loss (BL) and cranial nerve injuries. Secondary endpoint was the number of new silent masses (NSMs) discovered after genetic evaluation. RESULTS: SDH mutations were found in 2 patients of group A and in 11 patients of group B. There were no significant differences in mass diameter between the groups. A significant difference regarding the surgical procedure time was observed in the 2 groups, with a higher time in the group A (Group A: 180 ± 77.3; Group B: 138 ± 54.5, P= 0.04). BL was significantly lower in group B (203 ± 69.5 mL vs. 356 ± 102 mL; P = 0.0001), as well as for patients underwent PAEPs vs. those underwent direct surgery (n = 15, 149 ± 53 mL vs. n = 42, 273 ± 88 mL; P = 0.0001). No differences between transient and persistent cranial nerve injuries were observed between the 2 groups. Carotid reconstruction was necessary for 2 patients of group A (n = 2 vs. n = 0; P = 0.02). Unilateral tumor recurrence was detected in 7 patients, with a significantly higher rate (P ≤ 0.002) in patients carrying SDH mutations compared to those without SDH mutation (wild-type). SDH mutations detected in the groups lead to discover 7 NSMs (group A n = 1 vs. group B n = 6; P = 1.00). CONCLUSION: The impact of the multidisciplinary team suggests that surgical resection still remains the gold standard for the treatment of CBTs, but the use of PAEPs in selected cases may reduce surgical procedure time, BL and the need for reconstructive carotid surgery. Genetic counseling and SDH gene analysis allow to diagnose NSMs in asymptomatic patients. Larger studies should be considered to evaluate the effectiveness of postoperative rehabilitative program.

Stem cell mobilization with plerixafor and healing of diabetic ischemic wounds: A phase IIa, randomized, double-blind, placebo-controlled trial.

Bone marrow-derived cells contribute to tissue repair, but traffic of hematopoietic stem/progenitor cells (HSPCs) is impaired in diabetes. We therefore tested whether HSPC mobilization with the CXCR4 antagonist plerixafor improved healing of ischemic diabetic wounds. This was a pilot, phase IIa, double-blind, randomized, placebo-controlled trial (NCT02790957). Patients with diabetes with ischemic wounds were randomized to receive a single subcutaneous injection of plerixafor or saline on top of standard medical and surgical therapy. The primary endpoint was complete healing at 6 months. Secondary endpoints were wound size, transcutaneous oxygen tension (TcO2 ), ankle-brachial index (ABI), amputations, and HSPC mobilization. Twenty-six patients were enrolled: 13 received plerixafor and 13 received placebo. Patients were 84.6% males, with a mean age of 69 years. HSPC mobilization was successful in all patients who received plerixafor. The trial was terminated after a preplanned interim analysis of 50% of the target population showed a significantly lower healing rate in the plerixafor vs the placebo group. In the final analysis data set, the rate of complete healing was 38.5% in the plerixafor group vs 69.2% in the placebo group (chi-square P = .115). Wound size tended to be larger in the plerixafor group for the entire duration of observation. No significant difference was noted for the change in TcO2 and ABI or in amputation rates. No other safety concern emerged. In conclusion, successful HSPC mobilization with plerixafor did not improve healing of ischemic diabetic wounds. Contrary to what was expected, outside the context of hematological disorders, mobilization of diabetic HSPCs might exert adverse effects on wound healing.

Hybrid arteriovenous graft for hemodialysis vascular access in a multicenter registry.

OBJECTIVE: The aim of our study was to identify patients' characteristics that predicted a higher chance of arteriovenous graft patency in patients undergoing Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access. The GHVG is a polytetrafluroethylene (PTFE) prosthesis with a nitinol-reinforced section (NRS) at the venous end. METHODS: All consecutive patients undergoing GHVG implantation for hemodialysis access at 10 tertiary referral centers between December 2013 and January 2018 were included in the study and compared with a control group of patients undergoing standard PTFE graft implantation. Selection of patients for hybrid graft implantation was based on the impossibility of autogenous vascular access creation. RESULTS: There were 145 patients included in the GHVG group and 218 in the PTFE group. In the GHVG and the PTFE groups, the mean age was 67 ± 13 years and 65 ± 13 years, and male patients totaled 52% and 46%, respectively. The technical success was 99%. The mean duration of the intervention was 100 minutes (median, 95 minutes; interquartile range, 80-120 minutes). The brachial-axillary configuration was used in the majority of cases (n = 78 [54%]). The 5-cm NRS length was prevalent (n = 108 [75%]). The median NRS oversize was 14% (interquartile range, 0%-21%). Mean follow-up was 13 months (range, 0-55 months). Seventy-one patients (49%) underwent at least one reintervention. Primary, assisted primary, and secondary patency estimates at 12 months were 44% ± 5%, 47% ± 5%, and 65% ± 4% for the GHVG group and 41% ± 4%, 53% ± 4%, and 75% ± 3% for the control group, respectively (P = NS). One-year survival was 90% ± 3%. On multivariable Cox regression analysis, hypotension (P < .001; hazard ratio [HR], 5.8; confidence interval [CI], 2.6-13) and diabetes (P = .024; HR, 1.9; CI, 1.1-3.2) were significant predictors of GHVG loss. A larger graft size was protective against GHVG loss (P = .042; HR, 0.73; CI, 0.54-0.99). The 10-cm-long graft showed a tendency toward improved patency but did not reach statistical significance (P = .074; HR, 0.48; CI, 0.21-1.07). CONCLUSIONS: Diabetes and hypotension were predictors of loss of hybrid arteriovenous access. Smaller diameters of NRS were more prone to thrombosis, whereas the 10-cm length seemed to perform better than the 5-cm one.

Urotensin II Exerts Pressor Effects By Stimulating Renin And Aldosterone Synthase Gene Expression.

We investigated the in vivo pressor effects of the potent vasoconstrictor Urotensin II (UII). We randomized normotensive Sprague-Dawley rats into 4 groups that received a 7-day UII infusion (cases) or vehicle (controls). Group 1 received normal sodium intake; Group 2 underwent unilateral nephrectomy and salt loading; Group 3 received spironolactone, besides unilateral nephrectomy and salt loading; Group 4 only received spironolactone. UII raised BP transiently after a lag phase of 12-36 hours in Group 1, and progressively over the week in Group 2. Spironolactone did not affect blood pressure, but abolished both pressor effects of UII in Group 3, and left blood pressure unaffected in Group 4. UII increased by 7-fold the renal expression of renin in Group 2, increased aldosterone synthase expression in the adrenocortical zona glomerulosa, and prevented the blunting of renin expression induced by high salt. UII raises BP transiently when sodium intake and renal function are normal, but progressively in salt-loaded uninephrectomized rats. Moreover, it increases aldosterone synthase and counteracts the suppression of renin induced by salt loading. This novel action of UII in the regulation of renin and aldosterone synthesis could play a role in several clinical conditions where UII levels are up-regulated.

Definition of Type II Endoleak Risk Based on Preoperative Anatomical Characteristics.

PURPOSE: To define the risk for type II endoleak (EII) after endovascular aneurysm repair (EVAR) based on preoperative anatomical characteristics. METHODS: Between January 2008 and December 2015, 189 patients (mean age 78.4±7.6 years; 165 men) underwent standard EVAR. Mean aneurysm diameter was 5.7±0.7 cm and mean volume 125.2±45.8 cm3. Patients were assigned to the "at-risk" group (n=123, 65%) when at least one of the following criteria was present: patency of a >3-mm inferior mesenteric artery (IMA), patency of at least 3 pairs of lumbar arteries, or patency of 2 pairs of lumbar arteries and a sacral artery or accessory renal artery or any diameter patent IMA; otherwise, patients were entered in the "low-risk" group (n=66, 35%). EII rates and freedom from EII reintervention were compared using Kaplan-Meier curves. Preoperative clinical and anatomical characteristics were evaluated for their association with EII and EII reinterventions using multiple logistic regression analysis; results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: Freedom from endoleak was lower in the at-risk group compared with the low-risk group at 36 months after EVAR (p=0.04). Freedom from EII-related reinterventions was significantly lower in the at-risk group (80% vs 100%, p=0.001) at 48 months. Based on the multiple regression analysis, the at-risk group had a higher likelihood of both EII (OR 9.91, 95% CI 2.92 to 33.72, p<0.001) and EII-related reinterventions (OR 9.11, 95% CI 1.06 to 78.44, p=0.04). These criteria had 89.4% (95% CI 83.9% to 93.2%) sensitivity and 48.0% (95% CI 40.7% to 55.3%) specificity for EII; sensitivity and specificity for EII reintervention were 100% (95% CI 93.8% to 100%) and 38.8% (95% CI 31.9% to 46.2%). Within the at-risk group, a sac thrombus volume <35% was an additional predictor for both EII (OR 5.21, 95% CI 1.75 to 15.47, p=0.003) and EII-related reinterventions (OR 8.33, 95% CI 2.20 to 31.51, p<0.002). CONCLUSION: The selection criteria effectively discriminated between low-risk patients and patients at risk for EII and associated reinterventions. A thrombus volume <35% was an additional predictor for EII and EII-related reintervention among patients at risk. These criteria may be useful for preemptively selecting patients who may benefit from EII prevention procedures or a more aggressive surveillance protocol.

Iliac Artery Stenting Combined with Ipsilateral Open Femoro-Popliteal Revascularization and Its Effect on Bypass Patency.

BACKGROUND: In cases of multilevel obstructive atherosclerotic disease, hybrid procedures of concomitant iliac artery stenting and femoro-popliteal bypass (IS-FPB) may represent a valid approach, but results are still unclear. The aim was to evaluate early and long-term outcomes of concurrent IS-FPB. METHODS: This retrospective study included 75 patients (76 limbs) treated with concomitant IS-FPB between January 2010 and June 2016. All patients were prospectively enrolled in a dedicated database. Long-term patency and limb salvage rates were reported using Kaplan-Meier curves. Clinical presentation, lesion sites and extension, distal runoff, type of stent, and bypass were evaluated for their association with patency using univariate and multivariate analysis. RESULTS: Mean age was 72.2 ± 9.4 years; the Society for Vascular Surgery comorbidity score was 1.14 ± 0.61. A covered stent (CS) was implanted in 41 (54%) iliac arteries and a bare-metal stent in 35 (46%); a polytetrafluoroethylene graft was used for bypass in 44 limbs (58%) while 32 limbs (42%) had great saphenous vein bypass. Technical success was 99%; the 30-day cumulative surgical complications rate was 6%, mortality 2%, and morbidity 1%. At 42 months, primary patency of the entire ilio-femoral axis was 65.2% (95% confidence interval [CI], 53-86%). This finding was primarily related to femoro-popliteal bypass occlusion (primary patency, 69.5%), rather than iliac stent loss of patency (primary patency, 94.6%). Secondary patency was 77.6% and limb salvage 89.9%. Univariate analysis demonstrated that Rutherford category 5/6 was a negative predictor of FPB patency (P = 0.04), whereas common femoral artery endarterectomy (P = 0.03) and the use of a CS (P = 0.02) were positive predictors. Multivariate analysis finally indicated that the use of CS to treat iliac obstructive disease was an independent predictor of patency (hazard ratio, 0.15; 95% CI, 0.03-0.64; P = 0.01). CONCLUSIONS: Concurrent IS-FPB has acceptable early and long-term results. Even if further studies are needed, the use of a CS for the iliac obstruction seem to provide better outcomes in the hybrid treatment of these cases of multilevel disease.

Outcomes of endovascular aneurysm repair with contemporary volume-dependent sac embolization in patients at risk for type II endoleak.

OBJECTIVE: The aim of this study was to evaluate outcomes of intraoperative aneurysm sac embolization during endovascular aneurysm repair (EVAR) in patients considered at risk for type II endoleak (EII), using a sac volume-dependent dose of fibrin glue and coils. METHODS: Between January 2012 and December 2014, 126 patients underwent EVAR. Based on preoperative computed tomography evaluation of anatomic criteria, 107 patients (85%) were defined as at risk for EII and assigned to randomization for standard EVAR (group A; n = 55, 44%) or EVAR with intraoperative sac embolization (group B; n = 52, 42%); the remaining 19 patients (15%) were defined as at low risk for EII and excluded from the randomization (group C). Computed tomography scans were evaluated with OsiriX Pro 4.0 software to obtain aneurysm sac volume. Freedom from EII, freedom from EII-related reintervention, and aneurysm sac volume shrinkage at 6, 12, and 24 months were compared by Kaplan-Meier estimates. Patients in group C underwent the same follow-up protocol as groups A and B. RESULTS: Patient characteristics, Society for Vascular Surgery comorbidity scores (0.99 ± 0.50 vs 0.95 ± 0.55; P = .70), and operative time (149 ± 50 minutes vs 157 ± 39 minutes; P = .63) were similar for groups A and B. Freedom from EII was significantly lower for group A compared with group B at 3 months (58% vs 80%; P = .002), 6 months (68% vs 85%; P = .04), and 12 months (70% vs 87%; P = .04) but not statistically significant at 24 months (85% vs 87%; P = .57). Freedom from EII-related reintervention at 24 months was significantly lower for group A compared with group B (82% vs 96%; P = .04). Patients in group B showed a significantly overall mean difference in aneurysm sac volume shrinkage compared with group A at 6 months (-11 ± 17 cm(3) vs -2 ± 14 cm(3); P < .01), 12 months (-18 ± 26 cm(3) vs -3 ± 32 cm(3); P = .02), and 24 months (-27 ± 25 cm(3) vs -5 ± 26 cm(3); P < .01). Patients in group C had the lowest EII rate compared with groups A and B (6 months, 5%; 12 months, 6%; 24 months, 0%) and no EII-related reintervention. CONCLUSIONS: This randomized study confirms that sac embolization during EVAR, using a sac volume-dependent dose of fibrin glue and coils, is a valid method to significantly reduce EII and its complications during early and midterm follow-up in patients considered at risk. Although further confirmatory studies are needed, the faster aneurysm sac volume shrinkage over time in patients who underwent embolization compared with standard EVAR may be a positive aspect influencing the lower EII rate also during long-term follow-up.

Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions.

OBJECTIVE: This study compared early and midterm outcomes of polytetrafluoroethylene-covered stents (CSs) vs bare-metal stents (BMSs) in the primary treatment of severe TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C and D iliac artery obstructive lesions. METHODS: Between January 2009 and June 2014, 128 patients underwent stenting of 167 iliac arteries; CSs were implanted in 82 iliac arteries (49%) and BMSs in 85 (51%). All patients were prospectively enrolled in a dedicated database. Thirty-day outcomes, mid-term patency, limb salvage, and survival were compared, and follow-up results were analyzed with Kaplan-Meier curves. Clinical presentation, lesion site, extension, and laterality were evaluated for their association with patency in the two groups using multiple logistic regressions. RESULTS: Patients were a mean age of 70 ± 10.3 years, The Society for Vascular Surgery comorbidity score was 0.89 ± 0.57, with no differences after stratification by CS and BMS (P = .17). Iliac lesions were classified by limb as TASC II C in 86 (51%) and D in 81 (49%). Comparing CS and BMS, technical success was 99% in both groups (P = 1.0); the 30-day cumulative surgical complications rate (7.3% vs 4.7%; P = .53), mortality (1.8% vs 0%; P = .45), and morbidity (1.8% vs 1.4%; P = .99) were equivalent. At 24 months (average 22 months; range, 30 days-56 months), primary patency of CS vs BMS was similar (93% vs 80%; P = .14), and this finding was maintained after stratification by TASC II C (97% vs 93%; P = .59) and D (88% vs 61%; P = .07); secondary patency was 98% vs 92% (P = .22), and limb salvage was 99% and 95% (P = .35) respectively. Multivariate analysis indicated that BMS in long-segment stenosis involving the common and external iliac arteries was a negative predictor of patency (odds ratio, 0.16; 95% confidence interval, 0.04-0.62; P = .007); within this subgroup of TASC II D lesions, primary patency at 24 months was significantly higher for CS than for BMS (88% vs 57%; P = .03). CONCLUSIONS: Overall, the use of CSs for severe iliac lesions has similar early and midterm outcomes compared with BMS. In a subcategory of TASC II D lesions with long-segment severe stenosis of both the common and external iliac arteries, CS should be considered as the primary line of treatment.

Diabetes modifies the relationships among carotid plaque calcification, composition and inflammation.

BACKGROUND AND AIMS: Diabetes is traditionally associated with vascular calcification, but the molecular mechanisms are largely unknown. We herein explored the relationships among carotid plaque calcification, composition and gene expression, and how these are modified by diabetes. METHODS: We collected carotid endoarterectomy specimen from 59 patients, of whom 23 had diabetes. We analysed histology with pentachromic staining, calcification with Alizarin red and Von Kossa's staining, chemical calcium extraction and quantification, as well as gene expression by quantitative PCR. RESULTS: We detected no differences in the extent of plaque calcification and in plaque composition between diabetic and non-diabetic patients. In non-diabetic plaques, calcium content was directly correlated with the area occupied by muscle/fibrinoid tissue and inversely correlated with collagen, but such correlations were not seen in plaques from diabetic patients. While consistent correlations were found between calcium content and RUNX2 (direct), as well as Osteopontin (inverse), diabetes modified the association between plaque calcification and inflammatory gene expression. Only in diabetic plaques, calcium content was inversely correlated with MCP1 and IL1b, whereas the direct correlation with TNF-alpha expression seen in non-diabetic plaques was lost in diabetes. CONCLUSIONS: Though plaque composition and calcification were not quantitatively affected, diabetes modified the relationships between plaque calcium, composition and inflammation. These results suggest that the mechanisms and the clinical significance of atherosclerotic calcification in diabetic may be different than in non-diabetic patients.

Outcomes of endovascular repair for blunt thoracic aortic injury.

OBJECTIVE: Consistent long-term follow-up data of thoracic endovascular repair (TEVAR) for acute blunt thoracic aortic injury (BTAI) are largely absent at this time. The late outcomes of TEVAR for BTAI are the focus of this study to evaluate the durability of this type of repair. METHODS: The records of 46 consecutive cases of TEVAR for BTAI from November 2000 to August 2012 were reviewed. Patient demographics, lesion characteristics, procedure details, and outcomes were recorded. We performed a clinical and body computed tomography angiography follow-up at 1, 6, and 12 months after the intervention; thereafter, it was done on a yearly basis if device-related defects were ruled out. RESULTS: There were 35 (76.1%) males. Mean age was 39 ± 18 years (range, 17-92). Indications for intervention were BTAI at the aortic isthmus in 73.9% (n = 34) of the cases, and in the proximal one-half of the descending thoracic aorta in the remaining 26.1% (n = 12). Pseudoaneurysm or free rupture accounted for 44 (95.6%) cases. Primary technical success was obtained in all cases. All patients survived the intervention, open conversion was never required, and no patient required reintervention. In-hospital mortality was 6.5% (n = 3). Mean follow-up was 66 ± 46 months (range, 1-144; median, 72). No patient was lost during this period. All patients who were discharged from the hospital are still alive. Aortic hematoma or hemothorax were completely reabsorbed in 42 (97.7%) cases. Endoleak or modifications of the native aorta were never detected; endograft-related complication was observed in one (2.3%) case only. An asymptomatic collapse was observed at a 36-month follow-up and was managed conservatively. CONCLUSIONS: Midterm follow-up of TEVAR for acute BTAI is feasible with satisfactory late outcomes. In our experience, TEVAR is a durable and definitive treatment for BTAI.

Outcomes of endovascular aneurysm repair on renal function compared with open repair.

OBJECTIVE: Recent studies have shown that progressive renal dysfunction may develop in patients after endovascular aneurysm repair (EVAR). Data are conflicting about the effect of EVAR on renal function compared with open repair (OR). The purpose of this study was to compare the effects of EVAR, both with transrenal fixation (TRF) and infrarenal fixation (IRF), vs OR on renal function detected with renal perfusion scintigraphy (RPS). METHODS: A prospective study was carried out from January 2003 to December 2007. Exclusion criteria included factors that could influence post-procedural renal function as: preoperative creatinine clearance level <65 mL/min for men and 60 mL/min for women, renal artery stenosis >60%, renal accessory artery planned to be covered by the endograft, single functioning kidney, hemodialysis, and kidney transplant. To evaluate renal function, an RPS was performed preoperatively, at 30 days, at 6 and 12 months, and then yearly. The glomerular filtration rate (GFR) was estimated with the Gates method. RESULTS: During the study period, 403 patients were enrolled; 243 (60%) had OR and 160 (40%) EVAR; among these, 83 (51%) had a TRF and 77 (48%) an IRF; 55 patients were excluded from the study. No statistical differences were observed between groups for demographics and risk factors. Statistically significant differences emerged between OR and EVAR for early postoperative death (4% vs 0%; P = .01). Follow-up ranged from 54 to 126 months (mean, 76 months) for OR and from 54 to 124 months (mean, 74 months) for EVAR (P = NS). Kaplan-Meier analysis survival rate at 9 years was 70% for OR and 58% for EVAR with a risk of secondary procedure of 9% and 34%, respectively (P < .0001). A deterioration of the GFR was observed during the follow-up in both groups with a decrease after 9 years of 11% in the EVAR group and 3% in the OR group respective to baseline (P < .001). A remarkable difference emerged on renal function between EVAR patients who required a secondary procedure compared with the other EVAR patients (P < .005). No significant differences emerged between TFR and IRF for GFR decline during the follow-up period. CONCLUSIONS: After EVAR, there is a continuous decline in renal function with respect to OR, regardless of fixation level and independently of pre-existing renal insufficiency. The risk of GFR impairment after EVAR should be taken into consideration in selecting patients with preoperative renal insufficiency.

Intentional coverage of the left subclavian artery during endovascular repair of traumatic descending thoracic aortic transection.

OBJECTIVE: This single-center, prospective study aimed to investigate the technical success and outcome of intentional coverage of the left subclavian artery (LSA) in patients undergoing thoracic endovascular aortic repair (TEVAR) for traumatic rupture of the aortic isthmus at a tertiary care medical center. METHODS: From January 2005 to June 2011, patients who presented with traumatic aortic transection underwent TEVAR with coverage of the LSA when the distance between the artery and the rupture was <2 cm. At 12, 24, and 72 hours postoperatively, clinical and neurologic evaluation including transcranial Doppler insonation of the brachial artery was performed. A decrease in peak systolic velocity (PSV) >60% with respect to the contralateral one was considered relevant. Functional status of the left arm was evaluated using a provocative test. Thoracoabdominal computerized tomographic angiography was performed postoperatively at 3-, 6-, and 12-month follow-up. RESULTS: Thirty-one patients (mean age 35 years) underwent emergency TEVAR for traumatic aortic transection with intentional LSA coverage during the study period. In four cases (12.9%) coverage was partial. Two patients (6.4%) died during the postoperative period due to associated lesions. No signs of vertebrobasilar insufficiency, stroke, or paraplegia were observed in any of the patients. Nine patients (36%) had severe arm claudication (ischemic pain within 60 seconds of beginning arm exercise and decrease of PSV between 50% and 60%). Risk factors for the condition were left vertebral artery diameter <3 mm (P < .0001). A significant correlation was found between the degree of PSV reduction and left arm symptoms (P < .0001). There was an improvement in ischemic arm symptoms (P < .0001) during mean follow-up of 36 months (range, 6-65 months), with only one patient (4.2%) presenting with severe claudication. Freedom from reintervention at 48 months was 93.5%. No signs of endoleaks or graft migrations were detected on computerized tomographic angiography control scans. CONCLUSIONS: Coverage of the LSA during TEVAR for traumatic aortic injuries appears to be a feasible, safe method for extending the endograft landing zone without increasing the risk of paraplegia, stroke, or left arm ischemia. Left vertebral artery diameter can be used to identify patients at risk for postoperative left arm ischemia.

Modification of the Viabahn Padova sutureless technique for challenging anastomosis between a prosthetic graft and a circumferentially calcified target artery.

PURPOSE: To describe modification of the Viabahn Padova Sutureless (ViPS) technique for challenging anastomosis between a prosthetic graft and a circumferentially calcified target artery. TECHNIQUE: The technique is demonstrated in a 75-year-old man with complete superficial femoral artery (SFA) occlusion and reconstitution of a circumferentially calcified above-knee popliteal artery. A 7-mm Viabahn endoprosthesis with its constraining string was withdrawn from its delivery system; the string at the proximal edge of the stent was gently cut with a scalpel, causing the proximal part of the stent to deploy, while the undeployed distal tip with its smooth profile retained its commercial orientation. The proximal end was subsequently sutured to a 7-mm polytetrafluoroethylene (PTFE) graft. After surgical exposure, the popliteal artery was transected, and the undeployed distal portion of the Viabahn was inserted into the distal segment, supported by a stiff guidewire. By pulling the constraining string, the stent was deployed in a "non-reversed" fashion and subsequently dilated to achieve optimal apposition. Finally, the proximal end of the PTFE graft was tunneled under the sartorius muscle and sutured to the common femoral artery. CONCLUSION: This modification to the ViPS technique using a "non-reversed" method of Viabahn stent preparation allows a safer and more accurate deployment of the endoprosthesis in the calcified target artery.