Contemporary Outcomes of in Situ Open Surgical Repair of Mid-Portion and Distal Renal Artery Aneurysms.

INTRODUCTION: The best management of renal artery aneurysms (RAAs) remains controversial, especially when they are located from the mid to distal portions of the main renal artery. Our aim is to evaluate our 10-year experience with in situ open surgical repairs from a cohort of non-proximal RAAs at a single vascular surgery center. METHODS: A retrospective review of a prospectively maintained database of all patients who underwent RAA in situ repairs located from the mid to distal portions of the renal artery at our Institution was performed between 2009 and 2020. Data on patient demographics, comorbidities, aneurysm location and morphology, type of in situ technique, and perioperative data were assessed. Postoperative biomarkers and renal function were collected, and mid-term follow-up results were analyzed. RESULTS: A total of 15 RAA located at mid and distal portions of the renal artery repaired with in situ techniques were performed in 15 patients (nine men, mean age 62.4 ± 6.36 years). At diagnosis, 12 patients were asymptomatic; a history of abdominal pain was found in one patient, and two patients had drug-resistant hypertension. Two patients had already undergone previous unsuccessful attempts of endovascular treatment. All patients presented an aneurysm diameter >20 mm (mean diameter 2.75 ± 5 mm). At admission, mean serum creatinine and glomerular filtration rate were 1.10 ± 0.23 mg/dL and 69.8 ± 9.8 mL/min/1.73 m2, respectively. Nine lesions were present in the distal portion of the renal artery, with 4 cases having ≥3 efferent branches and the other 5 with two efferent branches. The other six RAAs were in the mid-portion: in 4 cases, one efferent branch, and in 2 cases, two efferent branches were involved. All patients underwent in situ open repair: an end-to-end anastomosis was performed in 9 cases, aneurysm resection with primary closure in 3 cases, bypass with graft interposition in 2 cases (one iliac-renal reconstruction), and with vein interposition in 1 case. The mean renal ischemia time was 21.8 ± 9.4 min. A significant decrease on renal function was not observed (mean glomerular filtration rate at discharge: 64.8 ± 12.0 mL/min/1.73m2; P > 0.22). During recovery, one patient developed retroperitoneal hematoma treated conservatively. During follow-up (mean 46 months, range 2-135), one patient developed occlusion of a terminal renal artery branch without decreased kidney function. CONCLUSION: In situ techniques for RAA from the mid to distal portions of the renal artery are technically complex; however, based on our results, these procedures were safe and effective, providing satisfactory early and mid-term outcomes.

Endovascular Oriented Classification and Treatment of Celiac Trunk Aneurysms: 10 Years Experience.

OBJECTIVE: To propose an endovascular-oriented classification of celiac trunk aneurysms (CTa) and discuss single center results of this rare pathology. METHODS: Data of all patients admitted to our institution for CTa from 2011 to 2021 were prospectively collected. Of them, those who underwent endovascular treatment were retrospectively analyzed. All preoperative CT scans were reviewed and CTa were classified in 4 different configurations based on progressive distal landing zone. We excluded from the classification all cases with median arcuate ligament syndrome (MALS), patients with coexistent aortic dilation or no endovascular proximal neck. Preoperative demographics, intraoperative data and post-operative complications were recorded. All-cause late mortality and complications were identified through a review of office charts and telephone assessment. RESULTS: During the study period 19 patients were referred to our Institution for CTa. Ten patients underwent endovascular treatment (ET). In 6 cases a watchful waiting strategy was adopted, 2 (10.5 %) patients refused ET and one patient without suitable proximal landing zone (< 10 mm) was not proposed to open surgical repair for surgical contraindication but is followed by strict instrumental and clinical evaluation. Six (60%) patients presented type 2 CTa; all of them underwent ET requiring positioning of covered stent-graft and SA embolization. Three (30%) patients presented type 3 CTa; all of them underwent ET with covered stent-graft deployment over the GDA with preliminary embolization. One (10%) patient presented type 4 CTa that was treated by means of covered stent-graft deployment along the right hepatic artery with left hepatic artery embolization. Overall, no major complications and perioperative mortality was observed. CONCLUSION: Celiac trunk aneurysms are rare, and no classifications have still been presented. Stent-graft exclusion provides excellent short-term outcome with no significant morbidity and mortality rate when technically feasible.

Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the theoretical anatomic feasibility of endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with three off-the-shelf multibranched stent-grafts: t-Branch (Zenith t-Branch; Cook Medical, Bloomington, Ind), Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz), and E-nside (E-nside multibranch stent graft system; Jotec GmbH, Hechingen, Germany). METHODS: Computed tomography scans of patients with degenerative TAAAs treated from 2007 to 2019 were reviewed, and the anatomic feasibility of the multibranched stent-grafts was assessed according to the manufacturer's instructions for use. The anatomic factors determining the overall feasibility were divided into access feasibility, aortic feasibility, and visceral vessel feasibility. RESULTS: Degenerative TAAAs in 268 patients were analyzed. The overall feasibility did not differ significantly (TAMBE, 33%; t-Branch, 39%; E-nside, 43%; P = .271). Access, aortic, and visceral vessel feasibility alone excluded 18% to 22%, 35% to 49% and 21% to 26% of the patients respectively. The only significant difference between the devices was in aortic feasibility (P = .005), which was more frequently limited by the proximal aortic neck diameter in the TAMBE cohort and the inner visceral aortic diameter in the t-Branch cohort. The overall treatment feasibility using any of the three devices would have been 58%. CONCLUSIONS: The new investigational off-the-shelf multibranched stent-grafts did not significantly improve the theoretical applicability in an extensive cohort of patients with TAAAs. Improvements are warranted to increase their overall feasibility.

Doppler Ultrasound Monitoring of Echogenicity in Asymptomatic Subcritical Carotid Stenosis and Assessment of Response to Oral Supplementation of Vitamin K2 (PLAK2 Randomized Controlled Trial).

BACKGROUND: Plaque composition may predict the evolution of carotid artery stenosis rather than its sole extent. The grey scale median (GSM) value is a reproducible and standardized value to report plaque echogenicity as an indirect measure of its composition. We monitored plaque composition in asymptomatic subcritical carotid stenosis and evaluated the effect of an oral modulating calcification factor (vitamin K2). METHODS: Carotid plaque composition was assessed by GSM value. Monitoring the effects of standard therapy (acetylsalicylic acid and low-medium dosage statin) (acetylsalicylic acid (ASA) arm) or standard therapy plus vitamins K2 oral supplementation (ASA + K2 arm) over a 12 months period was conducted using an ultrasound scan in a prospective, open-label, randomized controlled trial (PLAK2). RESULTS: Sixty patients on low-medium dosage statin therapy were enrolled and randomized (30 per arm) to either ASA + K2 or ASA alone. Thirty-seven patients (61.6%) showed at 12 months a stable plaque with a mean increase in the GSM value in respect to the baseline of 2.6% with no differences between the two study arms (p = 0.66). Fifteen patients (25%) showed an 8% GSM value reduction respect the baseline with no differences between the two study arms (p = 0.99). At multivariable analysis, the adjusted mean (95% confidence interval) GSM change per month from baseline was greater in the ASA + K2 arm (-0.55 points, p = 0.048) compared to ASA alone (-0.18 points, p = 0.529). CONCLUSIONS: Carotid plaque composition monitoring through GSM value represents a laborious procedure. Although its use may not be applied to everyday practice, a specific application consists in evaluating the effect of pharmacological therapy on plaque composition. This 12 months randomized trial showed that the majority of subcritical asymptomatic carotid plaque on treatment with low-medium dosage statin presented a stable or increased echogenicity. Although vitamin K2 beyond standard therapy did not determine a significant change in plaque composition, for those who presented with GSM reduction it did enhance a GSM monthly decline.

Endovascular treatment of iliofemoral vein obstruction below the inguinal ligament using a new-dedicated stent: early experience from a single center.

BACKGROUND: The aim of this study was to assess our experience with a new commercially available venous stent as an extension below the inguinal ligament in patients with iliofemoral venous outflow obstruction involving the common femoral vein. METHODS: We treated 16 patients with iliofemoral venous outflow occlusion and post-thrombotic syndrome (PTS) (mean age: 52.5±20.2; female: 87.5%) with the Blueflow Venous Stent (plusmedica GmbH & Co. KG, Düsseldorf, Germany) between 2019 and 2020. All patients had unilateral venous disease with >50% stenosis in the iliofemoral veins. The primary endpoints assessed were technical success, primary and secondary patency rate at 1 year of follow-up, respectively. Clinical improvement was assessed with the Villalta Scale, revised venous clinical severity score (rVCSS) classification and visual analog-scale (VAS) respectively. RESULTS: The technical success rate was 100%. No intraoperative and 30-days postoperative complications were documented. The primary and secondary patency rates were 80.2% and 100% respectively, at 1 year of follow-up. One in-stent occlusion and two in-stent restenosis were detected during follow-up. Stent fracture and/or migration were not observed during follow-up. A significant improvement in the Villalta Scale and rVCSS score was documented with a median score of 3 (IQR: 2-6) and 2.5 (IQR: 1-5) versus baseline at the last follow-up. A pain reduction of 18 mm on the VAS scale was documented at 1-year follow-up. CONCLUSIONS: In this cohort of patients, the Blueflow Venous Stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease, with a high primary patency rate at 1-year of follow-up. However, longer follow-up and larger cohorts are still needed.

Early results of mechanochemical ablation for small saphenous vein incompetency using 2% polidocanol.

OBJECTIVE: The aim of the present study was to investigate the early results of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence. METHODS: We performed a single-center, retrospective analysis of a prospectively collected database of 60 patients treated with MOCA for single-axis SSV incompetence. All procedures were performed with the patient under local anesthesia using the ClariVein catheter (Merit Medical, South Jordan, Utah) combined with 2% polidocanol and, where appropriate, additional microphlebectomy. The primary study endpoint was to assess the SSV occlusion rate at the 1-, 6-, and 12-month follow-up examinations. The secondary endpoints included the Venous Clinical Severity Score, quality of life (QoL) assessment, periprocedural pain, and further complications after the intervention and during the follow-up period. Patient QoL was assessed using the Aberdeen Varicose Vein Questionnaire. Pain was measured using a 100-mm visual analog scale. RESULTS: Technical success was achieved in 100% of the cases. The mean visual analog scale score on the first postoperative day was 15 mm. No major events were recorded. No neurological complications or deep vein thrombosis were observed. Minor complications included ecchymosis in 3.3% of cases (2 of 60), transient phlebitis of the SSV in 5% of cases (3 of 60), and itching in 3.3% of cases (2 of 60). At the 1-, 6-, and 12-month follow-up examinations, the occlusion rate was 100% (60 of 60), 98.3% (57 of 58), and 92.6% (50 of 54). The median Venous Clinical Severity Score had significantly decreased from 5 (interquartile range [IQR], 3-6) at baseline to 2 (IQR, 1-4) at the 1-month follow-up (P < .001), 1 (IQR, 1-2) at the 6-month follow-up (P < .001) and 1 (IQR, 0-1) at the 12-month follow-up (P < .001). The mean Aberdeen Varicose Vein Questionnaire score had improved from the baseline score of 25 ± 14.61 to 15.81 ± 13.76 at the 1-month follow-up (P < .001), to 9.81 ± 7.42 at the 6-month follow-up (P < .001) and 4.73 ± 3.32 at the 12-month follow-up (P < .001). CONCLUSIONS: The results of our study have shown that MOCA is a feasible, safe, and painless procedure for the treatment of SSV incompetence with an occlusion rate of 92.6% at the 12-month examination. No sural nerve injuries or other major complications were observed. The procedure also provided good clinical results and positive effects on patient QoL.

Single-center midterm results with the low-profile Zenith Alpha thoracic endovascular stent graft.

OBJECTIVE: The analysis of endovascular treatment of thoracic aortic diseases using new low-profile stent grafts in large series is crucial to understanding the durability of these devices. The present study reports the midterm outcomes of a single-center experience using the Zenith Alpha thoracic endovascular stent graft. METHODS: The outcomes of 270 procedures performed on 262 patients (197 men; mean age, 70.5 ± 9.5 years) using the Zenith Alpha thoracic endovascular stent graft from November 2013 to December 2019 for different thoracic aortic diseases were analyzed. The primary endpoints were 30-day clinical success and midterm (5-year) clinical success. The secondary endpoints were the adverse event rate at 30 days and midterm and access- and device-related complications. The follow-up of surviving patients was performed using computed tomography angiography and office visits at 1, 6, and 12 months and annually thereafter. Kaplan-Meier analysis was performed for overall survival, and freedom from thoracic aortic endovascular repair-related mortality and related reinterventions. RESULTS: The overall 30-day mortality was 5.2% (2.5% for elective and 30.8% for nonelective cases). Type I endoleaks were identified in six patients. The 30-day primary technical and clinical success rates were 97.8% and 92.6%, respectively. Femoral cutdown was used in 41.1% of cases and percutaneous access in 58.5%. The rate of femoral artery complications after the percutaneous approach was 5.1%, with the need for surgical conversion in 1.9%. The stroke rate was 4.1% (major stroke, 2.2%), and the spinal cord ischemia rate was 3.7% (permanent paraplegia, 0.7%). Of the 248 survivors, 239 complied with the follow-up protocol with adequate computed tomography angiograms available images. Overall follow-up survival was 94.0% at 1 year, 91.6% at 2 years, 88.9% at 3 years, and 88.5% at 5 years. The unplanned secondary endovascular procedure rate was 5.3%. No stent fractures or new-onset type I endoleaks due to stent graft migration were observed in the study cohort. CONCLUSIONS: The midterm outcomes of this new generation of low-profile devices were satisfactory. The reported low incidence of secondary procedures and the absence of migrations are promising for the long-term durability of these devices.

Sex-Related Anatomical Feasibility Differences in Endovascular Repair of Thoracoabdominal Aortic Aneurysms With a Multibranched Stent-Graft.

PURPOSE: To evaluate the potential anatomical feasibility of using the off-the-shelf multibranched Zenith t-Branch for the treatment of thoracoabdominal aortic aneurysms (TAAAs) in female patients. MATERIALS AND METHODS: A total of 268 patients (median age 68 years; 69 women) with degenerative TAAA treated at a single institution by means of open or endovascular repair between 2007 and 2019 were retrospectively analyzed to determine the feasibility of using the Zenith t-Branch based on the manufacturer's instructions for use. The factors determining overall anatomical feasibility were divided into vascular access, aortic anatomy, and visceral vessels. The results were stratified by sex and compared. A logistic regression model was constructed to determine any association between feasibility and clinical factors or potential confounding variables; results are expressed as the odds ratio (OR) with 95% confidence interval (CI). RESULTS: The overall anatomical feasibility was 39% (22% women vs 45% men, p=0.001). The feasibility was negatively influenced by female sex (p<0.001) in multivariable analysis (OR 2.9, 95% CI 1.5 to 5.4, p=0.001). Vascular access feasibility was 82% (61% women vs 89% men, p<0.001). Aorta feasibility was 65% (52% women vs 69% men, p<0.001), and visceral vessel feasibility was 74% (78% women vs 73% men, p=0.260). An access diameter ≤8.5 mm excluded 17% of the patients (39% women vs 9% men, p<0.001). The aortic feasibility was limited by the infrarenal aortic diameter in 16% of patients (45% women vs 6% men, p<0.001) and the aortic lumen at the visceral vessels in 17% patients (19% women vs 17% men, p=0.741). The visceral vessel feasibility was mainly limited by inadequate numbers or diameters of target vessels. Location and orientation of the target vessels were adequate in 96% of patients. CONCLUSION: A little more than a third of an all-comers cohort of patients with degenerative TAAA could have been treated with on-label use of the Zenith t-Branch. However, only 22% of women could have been treated because of sex-related anatomical limitations. New generations of multibranched devices should address these differences.

Anatomical feasibility of a new off-the-shelf inner branch stent graft (E-nside) for endovascular treatment of thoraco-abdominal aneurysms.

OBJECTIVES: The aim of this study was to evaluate the proportion of thoraco-abdominal aortic aneurysms (TAAAs) that could theoretically be treated with the JOTEC® E-nside® Thoracoabdominal Branch Endoprosthesis off-the-shelf multibranched endograft. METHODS: Preoperative computed tomography scans of patients with atherosclerotic TAAA treated between 2007 and 2019 were reviewed, and the anatomical feasibility of the E-nside graft was verified by a retrospective study (clinicaltrials.gov: NCT03959670) based on the investigational manufacturer instructions for use. The anatomical factors determining overall feasibility were divided into vascular access (AC) feasibility, aortic (AO) feasibility and visceral vessels (VV) feasibility. RESULTS: Two hundred sixty-eight patients with thoraco-abdominal aneurysms were analysed: the overall treatment feasibility was 43%. AC feasibility was 78%, AO feasibility 60% and VV feasibility 79%. An iliac diameter <8.5 mm excluded 21% of the patients. Aortic feasibility was limited by infrarenal aortic diameter (16%) and size of aortic lumen at the level of visceral vessels (14%). Visceral vessels feasibility was mainly limited by inadequate number (8%) or diameter (12%) of target vessels. Height and orientation of target vessels were adequate in 97% of the cases. Overall feasibility was negatively influenced by female gender (Odds ratio: 3.89; 95% confidence interval 2.03-7.44; P < 0.001): the limiting factors in this subgroup being iliac diameter, infrarenal aortic diameter and visceral vessels diameter. CONCLUSIONS: The E-nside off-the-shelf stent graft can be theoretically employed in almost half of the cases from an all-comers cohort of patients with TAAA. Improvement of device profile and creation of a dedicated infrarenal component are warranted to increase overall feasibility. Female gender significantly affects the overall feasibility. CLINICALTRIALS.GOV: NCT03959670.

Late Open Conversion Following Failure of EVAR and TEVAR: "State of the Art".

Abdominal endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) have changed the aortic surgery, due to several advantages in terms of reduced morbidity and mortality. However, increasing rate of late complications requiring secondary procedures has been observed over time. Even if the majority of them may be treated by means of endovascular techniques, late open surgical conversion (LOSC) is required in specific situations. This paper aims to provide our single-center experience with LOSCs and an updated review of the literature. From 1995 to 2020, indications and outcomes of patients treated with LOSC for failed EVAR and TEVAR, at our institutions, were analyzed. LOSC was required to treat a broad range of complications that were classified into two main groups: "disease related" and "stent-graft (SG) related." Among the 121 patients treated with LOSC after EVAR, endoleak (75.2%) represented the most common indication. The overall 30-day mortality rate was 3.3%. A higher mortality rate was associated with infection after EVAR (p. 006). Among the 81 patients treated with LOSC after TEVAR, endoleak (32.1%) was the most common indication. The overall 30-day mortality rate was 13.6% with a higher incidence in the SG-related group (p. 02). LOSC is associated with an increased surgical complexity, in both the abdominal and thoracic area, that results in higher morbidity and mortality rates compared with standard open repair. Depending on the indication to LOSC, specific surgical maneuvers are required to improve clinical outcomes.

A Modified Proximal Stent-Graft for Spinal Cord Preconditioning During Staged Endovascular Repair of Thoracoabdominal Aortic Aneurysms.

Purpose: To describe a new custom-made thoracic device able to seal against the aortic wall and occlude intercostal arteries for spinal cord preconditioning during the first thoracic stage of a thoracoabdominal endovascular repair. Technique: The custom-made device, based on the Zenith Alpha stent-graft, combines different features from 2 previously described devices: the outer part is designed with a bell-bottom configuration similar to the "Embo" stent-graft, while the inner part mimics the "2 in 1" design. The outer stent-graft is designed to span the entire length of the thoracic aorta and cover as many intercostal arteries as possible during the first stage to effectively precondition the spinal cord. The sutured inner component is customizable in diameter and 20 to 40 mm shorter than the outer stent-graft. The technique has been used in 5 patients. Conclusion: The use of this new custom-made thoracic stent-graft might represent an additional tool for effectively preconditioning the spinal cord during fenestrated and branched staged procedures whenever a proximal thoracic proximal component is needed.

Staged Fenestrated/Branched Repair of Postdissecting Thoracoabdominal Aneurysm With Candy-Plug False Lumen Occlusion for Spinal Cord Preconditioning.

Purpose: To describe a possible application of thoracic false lumen occlusion techniques with a Candy-Plug occluder to induce false lumen thrombosis for preconditioning the spinal cord during staged fenestrated repair of postdissecting thoracoabdominal aneurysms. Technique: A Candy-Plug occluder is deployed within the thoracic false lumen after proximal entry tear coverage with a standard thoracic stent-graft during staged repair of postdissecting thoracoabdominal aneurysms. The blockade of thoracic false lumen retrograde reperfusion from distal entry tears induces a controlled thrombosis of both the thoracic false lumen and intercostal arteries. Then, when the fenestrated device is delivered 4 to 6 weeks later, the procedure is completed with standard techniques according to the staging protocols of individual centers. Conclusion: A new possible application of a Candy-Plug false lumen occlusion technique might be an intermediate procedure aimed at preconditioning the spinal cord by occluding the thoracic false lumen during complex staged fenestrated thoracoabdominal repairs.

Anterior accessory saphenous vein confluence anatomy at the sapheno-femoral junction as risk factor for varicose veins recurrence after great saphenous vein radiofrequency thermal ablation.

BACKGROUND: Varicose veins recurrence rate remained almost unchanged despite the constant technological advancement in its treatment. The aim of this study is to evaluate the variable accessory saphenous vein (ASV) anatomy at the sapheno-femoral junction (SFJ) as a possible risk factor for recurrent varicose vein (RVV) after great saphenous vein (GSV) radiofrequency thermal ablation (RTA). METHODS: Two-hundred consecutive patients affected by chronic venous disease (mean age 52.4±10.3 years; 187 women; CEAP C2-C6; 25.2±1.4), underwent to RTA from 2014 to 2016, at our Institute. Preoperatively all patients underwent duplex-ultrasound scanning, reporting the anatomical site, extension of reflux and the ASV anatomy at the SFJ. Duplex ultrasound and physical examination was performed postoperatively at 1, 6 and 12 months, and yearly thereafter. RESULTS: Patients were divided in two groups based on the anatomical site of reflux: group A (N.=187) including GSV and SFJ, group B (N.=82) including SFJ reflux. There was no preoperative statistical difference between the two groups. At a mean follow-up of 29.7±2.4 months, a freedom from recurrent varicose vein and GSV recanalization was: 100% and 100% at 1 month, 95.9% and 99.1% at 1 year, 93.7% and 96.7% at 3 years, respectively. A higher rate of RVV was documented for patients in group A at 3-year of follow-up (P=0.042). Cox regression analysis found, among five potential predictors of outcome, that direct confluence of ASV in SFJ (HR=1.561; 95% CI: 1.0-7.04; P=0.032) was a negative predictors of 1-year RVV. CONCLUSIONS: Sapheno-femoral junction morphology may affect recurrent varicose veins formation. In particular, a concomitant incompetence of the accessory saphenous vein or its directly confluence into the SFJ could represent an indication to simultaneous treatment by non-surgical techniques (RTA or laser) and avoid surgical ligation.