Multicentric experience of antegrade thoracic endovascular aortic repair for the treatment of thoracic aortic diseases.

OBJECTIVES: Aim of this multicentre retrospective cohort study is to evaluate technical success, early and late outcomes of thoracic endovascular repair (TEVAR) with grafts deployed upside-down through antegrade access, to treat thoracic aortic diseases. METHODS: Antegrade TEVAR performed between January 2010 and December 2021 have been collected and analyzed. Both elective and urgent procedures were included. Exclusion criteria were endografts deployed into previous or concomitant surgical or endovascular repairs. RESULTS: Fourteen patients were enrolled; 13 males (94%) with mean age of 71 years (IQR 62; 78). Five patients underwent urgent procedures (2 ruptured aortas and 3 symptomatic patients). Indication to treatment were 8 (57%) aneurysms/pseudoaneurysms, 3 (21%) dissections and 3 (21%) penetrating aortic ulcers. Technical success was achieved in all procedures. Early mortality occurred in 4 (28%) cases, all urgent procedures. Median follow-up was 13 months (IQR 1; 44). Late death occurred in 2 (20%) patients, both operated in elective setting. The first died at 19 months due to aortic-related reintervention, the second died at 34 months for a not aortic-related cause. Two patients (14%) underwent aortic-related reintervention for late type I endoleak. Survival rate in elective procedures was 100%, 84% and 67% at 12, 24 and 36 months respectively. Freedom from reintervention was 92%, 56% and 56% at 12, 24 and 36 months respectively. CONCLUSIONS: Antegrade TEVAR can seldomly be considered an alternative when traditional retrograde approach is not feasible. Despite good technical success and low access-site complications, this study demonstrates high rates of late type I endoleak and aortic-related reinterventions.

Endovascular revascularization of critical limb ischemia: the role of ultrasound-guided popliteal sciatic nerve block for the procedural pain management.

OBJECTIVES: To evaluate the impact of the ultrasound-guided popliteal sciatic nerve block (PSNB) for pain management during endovascular treatment of chronic limb-threatening ischemia (CLTI). MATERIAL AND METHODS: From November 2020 to January 2022, 111 CLTI patients that underwent endovascular procedures were prospectively enrolled in this prospective single-arm interventional study. Ultrasound-guided PSNB was used for procedural pain control. Pain intensity was evaluated throughout the procedure (baseline, 10 min after the block, pain peak, and at the end of the procedure) with the visual analog scale (VAS). RESULTS: Forty-six patients underwent above-the-knee revascularization (ATK), 20/111 below-the-knee (BTK) revascularization, 20/111 to both ATK and BTK revascularization. In 25 cases, no endovascular option was feasible at diagnostic angiography. The PSNB was effective in 96% of patients, with no need for further pain management with a statistically significant reduction (p < 0.0001) in the mean value of the VAS from 7.86 ± 1.81 (pre-procedural) to 2.04 ± 2.20 after 10 min from the block and up to 0.74 ± 1.43 at the end of the procedure (mean time 43 min). Only 1 complication related to the popliteal sciatic nerve block was registered (a temporary foot drop, completely resolved within 48 h). The time necessary to perform the block ranged between 4 and 10 min. CONCLUSION: Ultrasound-guided PSNB is a feasible and effective method to manage patients with rest pain and increase comfort and compliance during endovascular procedures. CLINICAL RELEVANCE STATEMENT: An ultrasound-guided popliteal sciatic nerve block is a safe, feasible, and effective technique to manage pain during endovascular treatment of chronic limb-threatening ischemia, especially in frail patients with multiple comorbidities who are poor candidates for deep sedoanalgesia or general anesthesia. KEY POINTS: Endovascular treatment of CTLI may require long revascularization sessions in patients with high levels of pain at rest, which could be exacerbated during the revascularization procedure. The PSNB is routinely used for anesthesia and analgesia during foot and ankle surgery, but the experience with lower limb revascularization procedures is very limited and not included in any international guideline. Ultrasound-guided PSNB is a feasible and effective regional anesthesia technique to relieve procedural and resting pain. Because of its safety and availability, every interventional radiologist should know how to perform this type of loco-regional anesthesia.

First pilot case-control interventional study using autologous extracellular vesicles to treat chronic venous ulcers unresponsive to conventional treatments.

Current therapeutic approaches for chronic venous ulcers (CVUs) still require evidence of effectiveness. Diverse sources of extracellular vesicles (EVs) have been proposed for tissue regeneration, however the lack of potency tests, to predict in-vivo effectiveness, and a reliable scalability have delayed their clinical application. This study aimed to investigate whether autologous serum-derived EVs (s-EVs), recovered from patients with CVUs, may be a proper therapeutic approach to improve the healing process. A pilot case-control interventional study (CS2/1095/0090491) has been designed and s-EVs recovered from patients. Patient eligibility included two or more distinct chronic lesions in the same limb with 11 months as median persistence of active ulcer before enrollment. Patients were treated three times a week, for 2 weeks. Qualitative CVU analysis demonstrated that s-EVs-treated lesions displayed a higher percentage of granulation tissue compared to the control group (Sham) (s-EVs 3 out of 5: 75-100 % vs Sham: none), further confirmed at day 30. s-EVs-treated lesions also displayed higher sloughy tissue reduction at the end of treatment even increased at day 30. Additionally, s-EV treatment led to a median surface reduction of 151 mm2 compared to 84 mm2 in the Sham group, difference even more evident at day 30 (s-EVs 385 mm2vs Sham 106 mm2p = 0.004). Consistent with the enrichment of transforming growth factor-ß1 in s-EVs, histological analyses showed a regenerative tissue with an increase in microvascular proliferation areas. This study first demonstrates the clinical effectiveness of autologous s-EVs in promoting the healing process of CVUs unresponsive to conventional treatments.

Stent-Assisted Coil Embolization of a Saccular Visceral Aortic Aneurysm: Case Report and Review of the Literature.

PURPOSE: We present the results of unconventional endovascular treatment of a voluminous (65 mm) saccular visceral aortic aneurysm in a 78-year-old woman. Patient was deemed unfit for open surgery due to comorbidities. Fenestrated or branched endografting was also excluded due to the small diameter of the aorta, the severe stenosis at the origin of celiac trunk, and the anomalous origin of superior mesenteric artery arising infrarenally. CASE REPORT: After a preliminary selective angiography of the superior mesenteric artery showing valid anastomotic network with celiac trunk branches, an aortic self-expandable bare stent (Jotec E-XL) was deployed in the visceral aorta. Aneurysm sac embolization (Penumbra detachable Ruby Coils) in a coil-jailing technique was performed. Finally, an aortic cuff endograft (Gore) was deployed immediately above the origin of the left renal artery to cover the wide neck of the saccular aneurysm and improve sac exclusion. Hospital stay was uneventful, computed tomography (CT) at 12-month demonstrated aneurysm shrinkage to 62 mm without images of endoleak. Literature review showed how this technique has successfully been applied to manage similar cases of postsurgical and posttraumatic saccular aortic aneurysms in high-risk patients; however, long-term results are still unknown. CONCLUSION: Coil-jail technique for the treatment of saccular aortic aneurysms can be considered an alternative when open surgery or conventional endovascular treatment is not feasible. Technical success and mid-term outcomes are promising but strict follow-up is recommended. CLINICAL IMPACT: This study aims to share the unconventional endovascular treatment of a visceral aortic aneurysm in a patient unfit both for open and traditional endovascular surgery. To the best of our knowledge this is one of the first cases published in Literature, for this reason, a step-by-step video has been created to describe the procedure. Literature review was then performed to analyze midterm results of this technique. Despite being a treatment that is not recommended for conventional cases, the knowledge of endovascular devices and techniques may help to manage or simplify complex aortic diseases.

Percutaneous closure of accidentally subclavian artery catheterization: time to change first line approach?

PURPOSE: To present our experience and provide a literature review dissertation about the use of a suture-mediated percutaneous closure device (Perclose Proglide -PP- Abbott Vascular Inc., Santa Clara, CA, USA) to achieve hemostasis for unintended subclavian arterial catheterization during central venous line placement. MATERIALS & METHODS: Since October 2020, we have successfully treated four consecutive patients with a central venous catheter (8 to 12 French) in the subclavian artery. In each patient, we released a PP, monitoring its efficacy by performing a subclavian angiogram and placing, as a rescue strategy, an 8 mm balloon catheter near the entry point of the misplaced catheter. Primary outcome is technical and clinical success. Technical success is defined as absence of bleeding signs at completion angiography, while clinical success is a composite endpoint defined as absence of hematoma, hemoglobin loss at 12 and 24 h, and absence of procedure-related reintervention (due to vessel stenosis, pseudoaneurysm or distal embolization). RESULTS: Technical success was obtained in 75% of cases. In one patient a mild extravasation was resolved after 3 min of balloon catheter inflation. No early complications were observed for all patients. CONCLUSIONS: PP showed a safe and effective therapeutic option in case of unintentional arterial cannulation. It can be considered as first-line strategy, as it does not preclude the possibility to use other endovascular approaches in case of vascular closure device failure.

Carotid Ultrasound Boundary Study (CUBS): Technical considerations on an open multi-center analysis of computerized measurement systems for intima-media thickness measurement on common carotid artery longitudinal B-mode ultrasound scans.

After publishing an in-depth study that analyzed the ability of computerized methods to assist or replace human experts in obtaining carotid intima-media thickness (CIMT) measurements leading to correct therapeutic decisions, here the same consortium joined to present technical outlooks on computerized CIMT measurement systems and provide considerations for the community regarding the development and comparison of these methods, including considerations to encourage the standardization of computerized CIMT measurements and results presentation. A multi-center database of 500 images was collected, upon which three manual segmentations and seven computerized methods were employed to measure the CIMT, including traditional methods based on dynamic programming, deformable models, the first order absolute moment, anisotropic Gaussian derivative filters and deep learning-based image processing approaches based on U-Net convolutional neural networks. An inter- and intra-analyst variability analysis was conducted and segmentation results were analyzed by dividing the database based on carotid morphology, image signal-to-noise ratio, and research center. The computerized methods obtained CIMT absolute bias results that were comparable with studies in literature and they generally were similar and often better than the observed inter- and intra-analyst variability. Several computerized methods showed promising segmentation results, including one deep learning method (CIMT absolute bias = 106 ± 89 µm vs. 160 ± 140 µm intra-analyst variability) and three other traditional image processing methods (CIMT absolute bias = 139 ± 119 µm, 143 ± 118 µm and 139 ± 136 µm). The entire database used has been made publicly available for the community to facilitate future studies and to encourage an open comparison and technical analysis (https://doi.org/10.17632/m7ndn58sv6.1).

Long-Term Outcomes of Open and Endovascular Abdominal Aortic Repair in Younger Patients.

BACKGROUND: Aim of this study is to evaluate long-term results in abdominal aortic aneurysm (AAA) surgery by either open aortic repair (OAR) or endovascular aortic repair (EVAR) in patients under 70 years of age. METHODS: A retrospective analysis of a prospectively collected database of patients with age under 70 years old undergoing elective infrarenal AAA surgery between 2010 and 2018 was performed. The study population was divided into 2 groups: OAR and EVAR. Primary end points were overall survival and aneurysm-related death, while secondary outcomes were need for reintervention and development of minor and major complications. RESULTS: One hundred ninety-one patients younger than 70 years old treated with elective AAA surgery were enrolled: 157 OAR (98% males, mean age 65 ± 4 years) and 34 EVAR (94% males, mean age 66 ± 4 years). Hospital stay, 30-day mortality, and need for reintervention were similar; OAR population presented higher incidence of postoperative major complications (18% vs. 2.9%; P = 0.01) while minor complications were 32% in the OAR versus 21% in the EVAR group (P = 0.08). Median follow-up was 69 months for OAR (interquartile range [IQR] 53 months) vs. 79 months (IQR 51 months) for EVAR (P = 0.9): long-term AAA-related reinterventions were more frequent after EVAR (1.9% OAR vs. 17% EVAR; P = 0.01) while AAA-related long-term mortality was similar in both subgroups (1.3% OAR and 3% EVAR; P = 0.8). At univariate analysis higher risk of reintervention was reported for conical necks in the EVAR group (P = 0.03) and for the concomitant presence of iliac aneurysms in both groups (P = 0.01). CONCLUSIONS: According to our data, EVAR in young patients is presenting an excessive rate of reintervention compared to OAR. The presence of conical neck is an independent predictor of EVAR failure and late reintervention, while it does not play a significant role in the OAR group. Open surgery should be considered the first option in younger patients with a long-life expectancy.

Long-term outcomes of endovascular aortic repair with flared iliac limb endografts in patients with abdominal aortic aneurysm and aneurysmal common iliac arteries.

BACKGROUND: The aim of this study was to evaluate the long-term outcomes of endovascular aneurysm repair with flared iliac limb grafts in patients with abdominal aortic aneurysm (AAA) and aneurysmal common iliac arteries (CIAs). METHODS: This is a multicenter, retrospective, observational cohort study that involves four tertiary referral hospitals between May 1, 2005, and April 30, 2019. Primary outcomes were freedom from aneurysm-related mortality (ARM), and freedom from iliac-related reintervention. RESULTS: We studied 995 aneurysmal iliac limbs in 795 (85.2%) patients who met the inclusion criteria. Median AAA diameter was 55mm (IQR: 51-60). Early mortality occurred in 3 (0.4%) patients. The median of follow-up time was 52 months (IQR: 26-88). Estimated freedom from ARM was 99±0.002% (95% CI: 99-99.9) at 1 year, and 99±0.004% (95% CI: 97.9-99.6) at 5-years. Chronic obstructive pulmonary disease (HR=6.4, 95% CI: 1.7-24.0, P=0.006), chronic kidney disease (HR=5.5, 95% CI: 1.4-21.9, P=0.016), and the presence of an aneurysmal left CIA (HR=5.3, 95% CI: 1.0.5-27.4, P=0.044) was associated with ARM. There were 42 (7.3%) late iliac-related events (limb occlusion, N.=5; iliac-related endoleaks, N.=37). Estimated freedom from iliac-related reintervention was 98±0.003% (95% CI: 97-99) at 1 year, and 95±0.01% (95% CI: 92.7-96.7) at 5-years, which was associated with an aneurysmal right CIA (HR=2.2, 95% CI: 1.3-3.9; P=0.005), and age ≥78 years (HR=1.9, 95% CI: 1.01-1.3; P=0.039). CONCLUSIONS: EVAR flared iliac limb grafts showed a high rate of freedom from ARM and a low reintervention rate. Owing to these results, it can be a durable and stable alternative for patients aged >78 years.

Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

PURPOSE: To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS: Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS: The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS: The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

Physician-modified fenestrated Navion endograft for the treatment of a symptomatic postdissection thoracoabdominal aneurysm.

We report the case of a physician-modified four-fenestration endograft for the emergent treatment of a 65-year-old patient with postdissection thoracoabdominal aneurysm deemed unfit for open surgery. The patient, after elective thoracic endovascular aneurysm repair as the first stage of a preplanned two-stage total thoracoabdominal endovascular repair, presented acute onset of dyspnea and thoracic pain. Computed tomography angiography (CTA) showed signs of contained rupture. The Valiant Navion thoracic endograft was used for the creation of a physician-modified four-fenestration stent graft. A diameter-reducing wire technique was used to constrain posteriorly the prosthetic graft and to allow intraprocedural partial deployment. The modified stent graft was finally folded into its original sheath and implanted; four balloon-expandable stent grafts were used as bridging components. Postoperative CTA showed a residual type IIIc endoleak that was treated with a relining procedure 4 months later. At the 20-month follow-up, the patient is alive and well and CTA shows complete seal of the thoracic aneurysm with persisting small type IIIc endoleak in the abdominal aneurysm. A physician-modified endograft can be considered a valuable option in case of urgent treatment of TAAA in patients deemed unfit for open surgery when off-the-shelf devices are not available or contraindicated.

Proportional meta-analysis of open surgery or fenestrated endograft repair for postdissection thoracoabdominal aneurysms.

OBJECTIVE: To determine outcomes of postdissection thoracoabdominal aneurysms by either open or endovascular repair with fenestrated or branched endografts. METHODS: A systematic review was conducted for open or endovascular repair of postdissection thoracoabdominal aneurysms, between January 2009 and February 2020. A meta-analysis was performed for postoperative complications and both early and late mortality and reinterventions. RESULTS: Fifteen noncomparative studies (eight endovascular repair and seven open repair) were suitable for meta-analysis. Overall, 1337 patients were included, 1068 in the open repair group (73% male; mean age 58 years) and 269 in the endovascular repair group (79% male; mean age 65 years). The 30-day mortality was 6% for open repair vs 3% for endovascular repair (P = .35), whereas the 30-day reintervention rate was 3% for open repair vs 1% for endovascular repair (P = .66). The only significant difference was reported for 30-day respiratory complication rate (30% open repair vs 2% endovascular repair; P < .01). The incidence of spinal cord ischemia was 9% for open repair vs 8% for endovascular repair (P = .95). The mean follow-up was 44 months: 48 months (range, 10-72 months) after open repair and 17 months (range, 12-25 months) after endovascular repair (P < .01). Late aortic reinterventions were more frequent after endovascular repair (11% vs 32%; P < .001). The late overall mortality rate was 19% for open repair vs 7% for endovascular repair (P = .08), whereas aortic-related mortality was 7% for open repair vs 3% for endovascular repair (P = .22). CONCLUSIONS: In the absence of comparative studies, this meta-analysis showed that endovascular repair seems to be a viable alternative for patients unfit for open repair.

Carotid Ultrasound Boundary Study (CUBS): An Open Multicenter Analysis of Computerized Intima-Media Thickness Measurement Systems and Their Clinical Impact.

Common carotid intima-media thickness (CIMT) is a commonly used marker for atherosclerosis and is often computed in carotid ultrasound images. An analysis of different computerized techniques for CIMT measurement and their clinical impacts on the same patient data set is lacking. Here we compared and assessed five computerized CIMT algorithms against three expert analysts' manual measurements on a data set of 1088 patients from two centers. Inter- and intra-observer variability was assessed, and the computerized CIMT values were compared with those manually obtained. The CIMT measurements were used to assess the correlation with clinical parameters, cardiovascular event prediction through a generalized linear model and the Kaplan-Meier hazard ratio. CIMT measurements obtained with a skilled analyst's segmentation and the computerized segmentation were comparable in statistical analyses, suggesting they can be used interchangeably for CIMT quantification and clinical outcome investigation. To facilitate future studies, the entire data set used is made publicly available for the community at http://dx.doi.org/10.17632/fpv535fss7.1.

Long Term Outcomes of Endovascular Aortic Repair in Patients With Abdominal Aortic Aneurysm and Ectatic Common Iliac Arteries.

OBJECTIVE: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs). METHODS: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention. RESULTS: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2). CONCLUSION: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures.

Mid-Term Outcomes of Complex Endografting for Chronic Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: To report early and mid-term results of post-aortic dissection thoracoabdominal aneurysms (pD-TAAA) treated by complex endografting in three tertiary referral hospitals. MATERIALS AND METHODS: 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. RESULTS: 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%). CONCLUSION: 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.

Current results of balloon expandable visceral stent-grafts in fenestrated endografting.

Endovascular repair of thoracoabdominal and juxtarenal aortic aneurysm has recently become a valuable alternative to open surgery especially in high-risk patients. Progressive improvements in graft materials and low-profile devices allow treatment of complex aneurysms even in adverse anatomical settings. However, all published experiences report risks of occlusion and reinterventions due to visceral stent-graft failures in the long term. The purpose of this systematic review is to analyze the results of currently used balloon expandable bridging stent-grafts and to evaluate the newest developments for fenestrated endovascular aortic repair (FEVAR) in juxtarenal endovascular repair. Data were retrieved from retrospective analyses, case series and case reports conducted from 2000 to September 2019. The literature analysis provided a list of the most commonly used balloon-expandable bridging stent-grafts for FEVAR. For each stent-graft a brief summary of structural characteristics and performances have been described. No randomized controlled trials (RCTs) or comparative data between the stent-grafts are available for this specific topic. Several balloon-expandable stent-grafts have been used as bridging stents during FEVAR but the ideal bridging stent-graft is far to be designed. The better understanding of the system FEVAR-native aorta and the strict collaboration and exchange of expertise between physicians and engineers are mandatory in order to increase the performances of these important components and to reduce re-interventions and complications in FEVAR.

Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry.

OBJECTIVE: 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). METHODS: 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). RESULTS: 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 increased >5 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. CONCLUSIONS: 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.

Oxygen Delivery Therapy with EPIFLO Reduces Wound Hyperperfusion in Patients with Chronic Leg Ulcers: A Laser Speckle Contrast Analysis.

BACKGROUND: Today transdermal continuous oxygen therapy (TCOT) is used in wound care to promote healing by improving local hypoxia and preventing infection, and it has been described to reduce local inflammation over 1 month of administration. The present study aims to investigate the effects of this treatment on wound microcirculation through laser speckle contrast analysis (LASCA). METHODS: 20 adult patients (mean age: 76 ± 11.5 years) were prospectively enrolled. Inclusion criteria were presence of venous or mixed lower limb ulcers from three or more months without dimension reduction and without indication to surgery and weekly treatment by our outpatient clinic with silver dressings. Subjects underwent 1 month of TCOT (EPIFLO®) in addition to foam dressing. The primary endpoint was the comparison of ulcer and healthy skin perfusion through LASCA, performed before and after the treatment period. Secondary considered endpoints were wound area, wound area severity index and PUSH Tools 3.0 ulcer severity scales, and pain assessment (Numerical Rating Scale [NRS]). RESULTS: Before treatment, the wound area was significantly more perfused than healthy skin (+45%; P = 0.005). At the end of the study, this difference was not significant anymore (+20.5%; P = 0.11). Ulcer perfusion decreased (-12.5%, P = 0.047), whereas healthy skin perfusion did not vary significantly. A reduction of the wound dimension (median difference: 2 cm; P = 0.009) and pain (median difference: 2 NRS point; P < 0.001) after therapy were assessed. CONCLUSIONS: LASCA shows that 1 month of TCOT can help reduce hyperperfusion of ulcer bed in patients with chronic lower limb ulcers, strengthening the hypothesis that this treatment effectively contrasts inflammation. This could correlate with the area and pain reduction assessed; however, the absence of a control group in this study does not allow a generalization of this hypothesis. Larger, controlled trials are needed to properly assess the relationship between TCOT effects on wound microenvironment and effective healing process.