EXTENT study: Medium-term outcomes of EXTra-design engineering inner-branch ENdografts for the treatment of complex aortic aneurysms from a multicenter collaboration.

OBJECTIVE: This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results. METHODS: A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events. RESULTS: Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches. CONCLUSIONS: EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions.

Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Intraoperative Transit-Time Flow as a Predictor of Failure after Infrainguinal Revascularization with Heparin-Bonded Expanded Polytetrafluoroethylene Graft.

BACKGROUND: The heparin-bonded expanded polytetrafluoroethylene (He-ePTFE) conduit is an option for patients requiring infrainguinal revascularization (iIR), but the risk of failure may be unpredictable, especially in cases with poor run-off. Intraoperative transit-time flow (TTF) provides an automated and quantitative analysis of flow and may serve as an adjunct evaluation during surgical revascularization. The aim of this study was to assess TTF in patients undergoing iIR with He-PTFE at 3 referral hospitals and to establish a predictive flow threshold for graft occlusion. METHODS: A prospective registry initiated in 2020 enrolled patients undergoing iIR using He-PTFE for critical limb ischemia or severe claudication, and TTF measurement was analyzed. Preoperative assessments of anatomical and clinical characteristics were available for all patients. The HT353 Optima Meter (Transonic Systems Inc., Ithaca, NY, USA) was used in all procedures according to a standardized protocol. The institutional ethics committee approved the study. A predictive model using receiver operating characteristic curve analysis was utilized to establish the threshold of flow, and variables were compared. Anatomical and clinical evaluation were reported according to Rutherford grade, Global Limb Anatomic System and Wound, Ischemia, and foot Infection classification. The main outcome considered was the correlation between TTF and graft occlusion. Secondary outcomes included survival, other predictors of graft occlusion, freedom from major adverse cardiovascular events, and freedom from major amputation. RESULTS: Among 68 patients, 55.8% had Rutherford 5-6, 45.6% had Global Limb Anatomic System 3 and 73.5% had Wound, Ischemia, and foot Infection 3-4. Distal anastomosis was at tibial level in 23.5% and mean diameter of conduit was 6.4 mm. Basal and postoperative TTF were 27.8 ± 15.6 ml/min and 109.0 ± 53.0 ml/min, respectively. After a mean follow-up of 18 ± 13 months, 7 (10.9%) patients presented graft occlusion and 5 (7.8%) required major amputation. TTF threshold = 80 ml/min revealed a sensitivity and specificity of 81.8% (95% confidence interval 48.2-97.7) and 80.7% (95% confidence interval 68.1-90.0) respectively, and it was selected as cut-off for graft occlusion. Freedom from graft occlusion in patients with TTF >80 ml/min vs. TTF ≤80 ml/min at 6, 12, and 24 months was 95.7% (standard error (SE) = 0.030) vs. 65.5% (SE = 0.115), 95.7% (SE = 0.030) vs. 58.9% (SE = 0.120) and 90.9% (SE = 0.054) vs. 51.6% (SE = 0.126), P = 0.0003. No statistical difference in primary patency, secondary patency and limb salvage was observed. At multivariate analysis, distal anastomosis at tibial vessel (odds ratio 8.50) and TTF ≤80 ml/min (odds ratio 9.39) were independent predictors of graft occlusion. CONCLUSIONS: These results suggest that TTF may serve as a valuable tool in the management of iIR. A TTF measurement of ≤80 ml/min should be regarded as a predictor of graft occlusion, prompting consideration of additional intraoperative maneuvers to enhance arterial flow. Caution should be exercised in patients requiring direct tibial artery revascularization, as it represents a predictor of failure independent of TTF levels. Larger cohorts of patients and longer follow-up periods are necessary to confirm these findings.

Early outcomes of the Conformable endograft in severe neck angulation from the Triveneto Conformable Registry.

OBJECTIVE: The study reports retrospective evaluation of early outcomes from a multicentric experience with the Excluder conformable endograft with active control system (CEXC Device) in the treatment of abdominal aortic aneurysms. Its design allows more flexibility, given by proximal unconnected stent rows and a bending wire within the delivery catheter enables control of proximal angulation. This study specifically focuses on the severe neck angulation (SNA) subgroup (≥60°). METHODS: All patients treated with CEXC Device in nine vascular surgery centers of Triveneto area (Northeast Italy) between January 2019 and July 2022 were enrolled prospectively and analyzed retrospectively. Demographic and aortic anatomical characteristics were evaluated. Endovascular aneurysm repair in SNA were selected for analysis. Major investigated outcomes were technical success, endoleaks, morbidity, mortality, and reinterventions at 30 days and during follow-up. Endograft migration and postoperative aortic neck angulation changes were also analyzed. RESULTS: A total of 129 patients were enrolled. An infrarenal angle of ≥60° was observed in 56 patients (43%) (SNA group) and their data analyzed. The mean patient age was 78.9 ± 5.9 years and median abdominal aortic aneurysm diameter 59 mm (range, 45-94 mm). Median aortic infrarenal neck length, angulation and diameter were 22 mm (range, 13-58 mm), 77° (range, 60°-150°), and 22.0 ± 3.5 mm respectively. Analysis revealed a technical success rate of 100% and perioperative major complication rate of 1.7%. Intraoperative and perioperative morbidity and mortality rates were 3.5% (one buttock claudication and one inguinal surgical cutdown) and 0%, respectively. No perioperative type I endoleaks were observed. The median follow-up was 13 months (range, 1-40 months). Five patients died during follow-up from aneurysm-unrelated causes. Two reinterventions occurred (3.5%): one conversion for a type IA endoleak and one sac embolization for a type II endoleak. Aneurysm sac shrinkage was observed in 15 patients (26%) and aneurysm stability in 35 patients (62%), respectively. Estimated freedom from reinterventions at 24 months was 92%. Aortic neck median postoperative angulation was 75° (range, 45°-139°). CONCLUSIONS: The Triveneto Conformable Registry shows good early results of the CEXC device in severely angulated aortic infrarenal necks. These data need confirmation on longer follow-up and a wider cohort of patients to further increase endovascular aneurysm repair eligibility in SNA.

Two-Year Outcomes With Bentley BeGraft as Bridging Stent-Grafts for Reno-Visceral Target Vessels During Fenestrated Endovascular Aortic Repair.

INTRODUCTION: The aim of this study was to present the short-term and 2-year outcomes after use of the Bentley BeGraft as bridging stent-graft (BSG) for reno-visceral target vessel (TV) during fenestrated endovascular aortic repair (FEVAR) from a contemporary multicentric experience. METHODS: A retrospective review of all consecutive patients who underwent elective FEVAR at 7 institutions located in Italy from 2015 to 2021 was performed. The main outcomes of interest for this study were technical success and TV instability, defined in accordance with current reporting standards. Patients' survival was also assessed. RESULTS: Overall, 81 patients received elective FEVAR during the study period. Mean age of patients was 78 years, and 89% were men. Most patients were treated for a juxta-pararenal abdominal aortic aneurysm (AAA) (68%), and 23% had already received an infrarenal aortic reconstruction. Most endografts had 3-vessel or 4-vessel design (27% and 55%, respectively), and a Cook endograft was used in 73% of cases. Overall, 266 Bentley BeGraft were implanted, of which 44 (16.5%) in the celiac trunk, 69 (26%) in the superior mesenteric artery, 79 (29.5%) in the right renal artery, and 74 (28%) in the left renal artery. Technical success was 94%, with 5 instances of technical failure that were recorded and required an additional intraoperative procedure. The early mortality rate was 4%, and acute kidney injury occurred in 14 cases with 1 requiring definitive hemodialysis. Survival at 6, 12, and 24 months in the overall cohort was 98.8%, 95.3%, and 83.4%, respectively. Freedom from TV instability at 6, 12, and 24 months in the overall cohort was 98.4%, 97.9%, and 97.2%, respectively. Events of TV instability included 3 cases of type 1C endoleak and 3 cases of type 3C endoleak, while no events of BSG fracture or thrombosis were noted. Five out of 6 cases of TV instability occurred in renal arteries, and they were all successfully treated by endovascular means. CONCLUSIONS: The data from this multicentric study show favorable short-term and 2-year outcomes of the Bentley BeGraft as BSG for reno-visceral TV during FEVAR, with low rates of TV-related endoleak and no stent occlusion up to 2 years. CLINICAL IMPACT: The data from this multicentric study show satsfactory outcomes up to two years of follow-up for the Bentley BeGraft when used for brdiging reno-visceral vessels during fenestrated endovascular aortic repair. Further research will be needed to identify predictors of stent-related reinterventions and ascertain the long-term durability.

Editor's Choice - Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED).

OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

Early and midterm outcomes following open surgical conversion after failed endovascular aneurysm repair from the "Italian North-easT RegIstry of surgical Conversion AfTer Evar" (INTRICATE).

OBJECTIVE: To report the early and mid-term outcomes following open surgical conversion (OSC) after failed endovascular aortic repair (EVAR) using data from a multicentric registry. METHODS: A retrospective study was carried out on consecutive patients undergoing OSC after failed EVAR at eight tertiary vascular units from the same geographic area in the North-East of Italy, from April 2005 to November 2019. Study endpoints included early and follow-up outcomes. RESULTS: A total of 144 consecutive patients were included in the study. Endoleaks were the most common indication for OSC (50.7%), with endograft infection (24.6%) and occlusion (21.9%) being the second most prevalent causes. The overall rate of 30-day all-cause mortality was 13.9% (n = 20); 32 patients (22.2%) experienced at least one major complication. Mean length of stay was 13 ± 12.7 days. On multivariate logistic regression, age (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.01-1-19; P = .02), renal clamping time (OR, 1.07; 95% CI, 1.02-1.13; P = .01), and suprarenal/celiac clamping (OR, 6.66; 95% CI, 1.81-27.1; P = .005) were identified as independent predictors of perioperative major complications. Age was the only factor associated with perioperative mortality at 30 days. Renal clamping time >25 minutes had sensitivity of 65% and specificity of 70% in predicting the occurring of major adverse events (area under the curve, 0.72; 95% CI, 0.61-0.82). At 5 years, estimated survival was significantly lower for patients treated due to aortic rupture/dissection (28%; 95% CI, 13%-61%), compared with patients in whom the indication for treatment was endoleak (54%; 95% CI, 40%-73%), infection (53%; 95% CI, 30%-94%), or thrombosis (82%; 95% CI, 62%-100%; P = .0019). Five-year survival rates were significantly lower in patients who received emergent treatment (28%; 95% CI, 14%-55%) as compared with those who were treated in an urgent (67%; 95% CI, 48%-93%) or elective setting (57%; 95% CI, 43%-76%; P = .00026). Subjects who received suprarenal/celiac (54%; 95% CI, 36%-82%) or suprarenal (46%; 95% CI, 34%-62%) aortic cross-clamping had lower survival rates at 5 years than those whose aortic-cross clamp site was infrarenal (76%; 95% CI, 59%-97%; P = .041). Using multivariate Cox proportional hazard, older age and emergency setting were independently associated with higher risk for overall 5-year mortality. CONCLUSIONS: OSC after failed EVAR was associated with relatively high rates of early morbidity and mortality, particularly for emergency setting surgery. Endoleaks with secondary sac expansion were the main indication for OSC, and suprarenal aortic cross-clamping was frequently required. Endograft infection and emergent treatment remained associated with poorer short- and long-term survival.

Left subclavian artery as an alternative site for left ventricular assist device outflow graft in challenging situations.

Left ventricular assist device (LVAD) has emerged as an effective surgical therapy for end-stage heart failure. In an attempt to reduce invasiveness and avoid difficult sternal re-entries, alternative surgical approaches have been adopted. In particular, when the thoracic aorta is severely diseased or difficult to expose, subclavian arteries could serve as site for outflow graft anastomosis. However, major concerns regarding the utilization of subclavian arteries are the small caliber of these vessels that could lead to inadequate LVAD flow, arm complications related to excessive blood flow, and possible outflow graft compression. In the present case series, we describe an innovative technique for LVAD implantation, in which the left subclavian artery was employed as an outflow graft anastomosis site, and the left ventricular apex was approached through a mini-thoracotomy. Technical issues were considered to prevent possible complications: the adequacy of left subclavian artery diameter, the banding of the artery distal to the anastomosis site to limit left arm overflow, and the outflow graft covering with a reinforced vascular graft to avoid any external compression. During follow-up, the technique reported was found to be effective in ensuring good LVAD function and flow, and no complications related to the procedure were reported.

Arterial Thrombotic Sequalae After Covid-19: Mind the Gap.

Investigations have shown that infection from the severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is responsible also for initiating severe inflammatory responses that can lead macrovascular and microvascular thrombosis. Several studies have already described acute limb ischemia and peripheral arterial disease in critically ill patients with Coronavirus disease 2019 (Covid-19), as well as coronary artery disease and ischemic stroke as a manifestation usually associated with respiratory distress. However, what still remains unclear is how long inflammation and thrombotic derangements can last after recovery from the symptoms of Covid-19. Hence, in this article we report 3 cases of arterial thrombotic sequalae after this viral infection. To the best of our knowledge, this is the first cases' series that had described different delayed vascular arterial complications, which occurred after the index infection, with a negative nasopharyngeal swab and Covid-19 systemic symptoms resumption. A better understanding of the coagulopathy in Covid-19 could have an essential role to guide prevention and treatment of arterial thromboembolic events, both during and after the viral infection. Further investigations are required to confirm these data and to estabilish the type, dose and duration of anticoagulant/antiplatelet therapy not just during but also after Covid-19 infection.

Hybrid Approach to Popliteal Artery Aneurysm with Thromboembolic Symptoms. A Pilot Study.

BACKGROUND: The treatment of patients with thromboembolic symptoms due to a popliteal artery aneurysm (PAA) is still controversial with poor results in terms of primary patency. The aim of our pilot study was to evaluate whether improving the outflow with an endovascular pretreatment consisting in thromboaspiration and angioplasty could positively ameliorate the primary patency of the subsequent femoropopliteal (FP) bypass in symptomatic patients with at least one below the knee (BTK) patent vessel. METHODS: This is a single-center pilot case-control study that involves patients treated at the Vascular and Endovascular Surgery Unit of Udine, Italy, from January 2015 to November 2019. The inclusion criteria were the presence of thromboembolic symptoms due to PAA distal embolization, associated with the presence of a patent PAA >20 mm and a poor runoff (no more than one patent BTK artery). The case group was treated in a two-step approach: the first step consisted in thromboaspiration followed by BTK angioplasty, when appropriate, and the second one consisted in performing the surgical FP bypass. The control group moved on directly to the open surgical intervention. RESULTS: The case group was composed of 11 patients, 10 males and 1 female, with a mean age of 69.3 ± 10.8 years. The mean PAA dimension was 32.6 ± 9.9 mm. Particularly, 9 patients were operated on through the medial vascular approach and 2 through the posterior one. The grafts used were 10 polytetrafluoroethylene (PTFE) and 1 great saphenous vein (GSV) in situ. The control group was composed of 11 male patients with a mean age of 75.5 ± 8.7 years, and the mean PAA dimension was 29.8 ± 13.4 mm. All the FP bypasses were approached medially, and the materials used were 10 PTFE and 1 reversed GSV. The median follow-up was 31.5 ± 12.6 months. Primary patency in the case group was 72.7% within one year; on the contrary, it was 27.3% in the control group. The amputation rate was 0% in the case group, 27.3% in the controls. By comparing the 2 groups, we found a higher and significant risk (P = 0.0261) of early FP bypass occlusion and major limb amputation in the control group. CONCLUSIONS: This pilot study shows encouraging results; the endovascular approach is a safe and repeatable procedure which, improving the runoff in thromboembolic symptomatic PAA, seems to guarantee a better FP graft primary patency.

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

OBJECTIVE: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. RESULTS: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. CONCLUSION: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

Extra-anatomical splanchnic revascularization for hybrid treatment of thoracoabdominal aortic aneurysms.

Treatment of thoracoabdominal aortic aneurysms with endovascular or conventional surgical techniques is burdened by high risk in older patients. Furthermore, the standard hybrid approach might be not feasible in case of severe atherosclerotic disease of the peripheral vessels. This report describes an alternative hybrid procedure which consists of an innovative mini-invasive thoracic approach combined with laparotomy to perform antegrade revascularization of the visceral arteries from the ascending aorta, followed by endovascular treatment.

Aortic arch aneurysm and Kommerell's diverticulum: Repair with a single-stage hybrid approach.

Kommerell's diverticulum is a rare congenital anomaly, consisting in aneurysmal dilatation at the origin of an aberrant subclavian artery. Depending on concomitant anatomical characteristics, different endovascular and open surgical procedures have been proposed. The following report describes the first single-stage hybrid repair of a type I Kommerell's diverticulum associated with an aortic arch aneurysm and anomalous origin of the brachiocephalic vessels by total aortic arch replacement with a composite frozen elephant trunk prosthesis and endovascular treatment of the right subclavian artery. This hybrid procedure may represent an alternative to more challenging open repairs when totally endovascular approach is unfeasible.

Drug-coated balloon dilation before carotid artery stenting of post-carotid endarterectomy restenosis.

PURPOSE: To investigate if drug-coated balloon (DCB) predilation may improve the efficacy of carotid artery stenting (CAS) for restenosis after carotid endarterectomy (CEA). METHODS: Eighteen consecutive patients (11 men; median age 75 years) with significant restenosis within 24 months of CEA were treated with a paclitaxel-coated DCB prior to CAS. Clinical outcomes and stent patency were systematically appraised. RESULTS: All patients were successfully treated according to this clinical protocol. The only complication occurred in a patient who had a transient ischemic attack during prolonged DCB inflation. At a median follow-up of 18 months, no >50% restenosis was observed on duplex ultrasound scans; however, moderate hyperplasia at the proximal stent edge was found in 4 patients. One patient died at 9 months from a myocardial infarction. CONCLUSION: Despite the small sample size and in keeping with the historically high risk of recurrent restenosis after CAS for CEA restenosis, this case series suggests that DCB dilation followed by CAS for postsurgical restenosis is feasible, safe, and may be associated with favorable clinical outcomes at midterm follow-up.

Omniflow® II biosynthetic graft offers acceptable early and mid-term outcomes in redo surgery in patients with critical limb-threatening ischemia with no available autologous vein material.

BACKGROUND: In this study, the early and mid-term outcomes of Omniflow® II (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic graft in redo surgery in patients with critical limb-threatening ischemia (CLTI) with no available autologous vein material were investigated with the aim to compare the outcomes obtained in "de novo" surgery versus redo surgery. METHODS: From January 2018 until December 2022, data of CLTI patients from 18 centers in Italy with no autologous vein material underwent infrainguinal bypass with Omniflow® II biosynthetic graft were collected. Thirty-day outcome measures including intraoperative technical success, major morbidity, mortality, and graft patency were assessed and compared. At two-year follow-up, estimated outcomes of survival, primary patency, primary assisted patency, secondary patency, freedom from reintervention, and amputation-free survival were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: In the study period 119 CLTI patients had an infrainguinal bypass with Omniflow® II biosynthetic graft. Seventy-seven patients (64.7%) underwent bypass as "de novo" treatment (group de novo), whilst in the remaining 42 patients (35.3%) the procedure was performed as redo surgery due to occlusion and/or infection of a previous bypass graft (group redo). Two groups were homogeneous in terms of demographic, clinical, and morphological data. In group redo explantation of an infected prosthetic graft was needed in 4 cases (9.5%). Intraoperative technical success was achieved in all cases in both groups. At 30 days, the overall patency rate did not differ between the two groups (69/77, 89.6%, group de novo vs. 35/42, 83.3%, group redo; P=0.24), whilst in group redo limb loss was higher with a statistically significant different 30-day major amputation rate between the two groups (11.9% group redo vs. 1.3% group de novo; P<0.001). Overall median duration of follow-up was eight months (IQR 6-13). At two-year follow-up there were no differences between the two groups in terms of survival (67.7% group de novo vs. 55.8% group redo, P=0.53), primary patency (34.4% group de novo vs. 26.8% group redo, P=0.25), primary assisted patency (43.6% group de novo vs. 28.8% group redo, P=0.12), freedom from reintervention (64.1% group de novo vs. 68.8% group redo, P=0.98), and amputation-free survival (67.8% group de novo vs. 60% group redo, P=0.12). Secondary patency was significantly higher in group de novo (53.7% vs. 32.3%, P=0.05). During the follow-up, the overall rates of graft infection and aneurysmal degeneration were 3.4%, and 0.8%, respectively. CONCLUSIONS: Nevertheless, poorer early outcomes in terms of limb salvage, Omniflow® II biosynthetic graft offers acceptable ywo-year outcomes in redo surgery in CLTI patients with no available autologous vein material. Further studies with larger population sizes are needed to validate these outcomes.

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.

Role of aneurysm sac embolization during endovascular aneurysm repair in the prevention of type II endoleak-related complications.

OBJECTIVE: The goal of this study was to evaluate the role of intraoperative aneurysm sac embolization during endovascular aneurysm repair (EVAR) using a standard dose of coils and fibrin glue in the prevention of type II endoleak (EII). METHODS: Two groups were compared: 83 patients underwent standard EVAR during the period 2008-2009 (group A) and 79 patients underwent EVAR during the period 2010-2011 (group B). Computed tomography scans were evaluated with Osirix Pro 4.0 software to obtain aneurysm sac volume. EII rates at the first computed tomography scan follow-up, as well as midterm freedom from EII and freedom from related reintervention, were compared. Preoperative number of patent aortic side branches (inferior mesenteric artery, lumbar arteries, accessory renal arteries), sac thrombus, and sac volume were evaluated for their association with EII in the two groups using multiple logistic regressions. RESULTS: Patient characteristics, Society for Vascular Surgery comorbidity scores (0.85 ± 0.44 vs 0.82 ± 0.46; P = .96), and operative time (185 ± 52 vs 179 ± 49; P = .92) were similar for groups A and B. The first computed tomography scan (≤3 months) revealed a significantly larger number of EIIs in group A than in group B (23% vs 10%; P = .02). Spontaneous EII resolution occurred in 65% of patients in group A and in 79% in group B (P = 1.0), whereas sac volume increased in 25% and 10% (P = .63) of cases, respectively. At 18 months (range, 6 months to 4.4 years), overall mean differences in sac volume shrinkage (27 ± 12 cm(3) vs 25 ± 12 cm(3); P = .19) and freedom from EII (92% vs 96%; P = .33) were similar, whereas freedom from reintervention was significantly lower in group A (93% vs 99%; P = .03) than in group B. Multivariate analysis showed preoperative aneurysm sac volume >125 cm(3) to be the only independent significant predictor of EII (odds ratio, 4.0; 95% confidence interval, 1.5-10.5; P = .005). CONCLUSIONS: Although further confirmatory studies are needed, sac embolization during EVAR may be a valid approach to preventing EII and its complications during short- and midterm follow-up. More aggressive intraoperative embolization should be considered for patients with a preoperative aneurysm sac volume >125 cm(3).

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.

When Heart Team Really Counts: Radical Excision of Intracardiac Leiomyomatosis.

Intravenous leiomyomatosis (IVL) are rare and complex tumors, characterized by high rates of recurrences after surgical removal and the capability of multi-organ involvement including pulmonary embolization. Regarding the surgical treatment of Intracardiac Leiomiomatosis (ICL), only few articles have been published and no controlled data are available. A combined approach that involves a Team of Cardiologists, Heart Surgeons, Vascular surgeons and Radiologists seems to be successful in treating ICL.

Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry.

BACKGROUND: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). METHODS: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. FOLLOW-UP: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. RESULTS: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively (p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. CONCLUSION: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes.