Long-term outcomes of the Endurant endograft in patients undergoing endovascular abdominal aortic aneurysm repair.

OBJECTIVE/BACKGROUND: To investigate the long-term outcomes after endovascular aneurysm repair (EVAR) in a real-world setting using the Endurant endograft (EG). METHODS: 184 EVAR candidates treated with the Endurant family EGs in a single vascular center were prospectively enrolled from January 2009 to December 2016. Kaplan-Meir estimates of long-term standardized primary and secondary outcome measures were performed. Per protocol, subgroup comparison analysis was performed in three groups: patients treated within instructions for use (in-IFU) vs patients treated outside IFU (outside-IFU), EVAR in patients receiving the Endurant proximal diameter 32 or 36 mm EG vs those receiving the <32 mm diameter EG and EVAR with various Endurant EG versions. RESULTS: The mean follow-up was 75.09 ± 37.9 months (range: 4.1-172 months). The median age of the patients was 72.96 ± 7.03 years (range: 55-88 years). A total of 177 patients were male (96.2%). Compliance with IFU was followed in 107 patients (58.2%). Overall survival was 69.5% and 48% at 5 and 8 years, respectively. Of the 102 all-cause deaths, 7 (6.9%) were aneurysm related. Six of these postimplant deaths occurred in patients presented with aneurysm rupture from type Ia or/and type Ib endoleak. At 5, 8, and 10 years of observation, freedom from aneurysm rupture, open surgical conversion, type I/III endoleak, any type of endoleak, aneurysm-related secondary intervention probabilities, and neck-related events were as follows: 98.1%, 95%, and 89.4%; 95.1%, 91.2%, and 85.7%; 93.6%, 87.3%, and 83.9%; 83.4%, 74%, and 70.9%; 89.8%, 76.7%, and 72%; and 96.3%, 90%, and 87.6%, respectively. Corresponding clinical success was 90%, 77.4%, and 68.4%, respectively. Patients treated outside-IFU had significantly higher risk of aneurysm rupture, open surgical conversion probability, occurrence of type I/III endoleak, and chance of reinterventions and lower clinical success probabilities compared with the in-IFU counterparts at 5 and 8 years. This statistical difference remained when type Ia endoleak or endoleak of any type was considered independently. In addition, it was stronger in patients having extreme anatomic boundaries (>1 hostile anatomic condition), when aneurysm-related death, aneurysm rupture, and clinical success at 5 years were considered. Overall proximal migration and limb occlusion were recorded in 1.1% and 4.9% of the patients, respectively. Overall reintervention rate was 17.4%. An increase in aneurysm sac diameter was observed in 12.5% of patients and was not related to IFU status. The Endurant version or the proximal EG diameter had no significant association with the chance of any complication or adverse event. CONCLUSIONS: The data confirmed the durability of the Endurant EG, achieving promising long-term outcomes in a real-world setting. However, its positive performance must be interpreted with caution in patients treated off-label especially those with extreme anatomic boundaries. In this cohort, some of EVAR advantages might be lost in the late future. Further similar studies are warranted.

Superficialization Methods of Arteriovenous Fistula in Obese Patients: A Review of the Literature.

BACKGROUND: The creation of an arteriovenous fistula in obese patients with end-stage-renal-disease, might not lead to a successful hemodialysis session, partly due to excess adipose tissue overlapping the enlarged vein. This review summarizes the available evidence on superficialization methods in studies dealing with obese patients. METHODS: An English-language literature search was undertaken in the MEDLINE/SCOPUS databases looking for publications that described procedures of salvaging autologous arteriovenous access in upper extremities of obese patients. Perioperative outcomes including technical and clinical success, mean vein depth reduction, wound complications and patency rates were compared within all identified techniques. RESULTS: We identified 12 prospective and 8 retrospective studies. A total of 1149 patients with a mean age 57.2 (range: 49-68) years and a mean BMI 35.8 (range: 28.2-40.8) kg/m2 underwent mainly radial-cephalic and brachial-cephalic arteriovenous fistula superficialization procedures [transposition, 54%; elevation, 11.1%; lipectomy, 26.1%; liposuction, 2.4%; implantation of a venous window needle guide device, 6.4%]. Technical success was similar between all methods (≥96%). However, successful cannulation was lower after liposuction and elevation (81.5% and 78.1% respectively). Transposition achieved lower mean vein depth reduction and clinical success when compared with lipectomy (4.9 mm vs. 8.8 mm and 90% vs. 92.7% respectively). Transposition and liposuction had the lowest and highest complication rate respectively (1.6% vs. 40.8%). Primary and secondary patency rates were lower with liposuction (51.8% and 76.6% respectively), while lipectomy and elevation achieved the highest primary patency rates (68.3% and 71.6% respectively) at 12 months. CONCLUSIONS: In obese patients, all superficialisation techniques report high technical success rates. Although limited by the design of individual published studies and lack of a standard for reporting outcomes, these results lead to satisfactory postoperative and early outcomes. In aggregate, lipectomy and transposition are more clinically effective and more durable procedures.

Late Basilic Vein Superficialization Combined with Revision Using Distal Inflow (RUDI) Operation to Treat a Symptomatic High Flow Fistula.

BACKGROUND: Vascular access (VA)-related high flows (HF) are common with brachial artery based fistulas. Flow-reduction procedures are indicated in symptomatic patients or asymptomatic ones with flows >2 L/min. However concomitant issues increase their complexity. We describe a case of a patient suffering congestive heart failure as a result of HF brachial-basilic fistula >3 L/min. A simultaneous late basilic vein transposition and revision using distal inflow (RUDI) was performed. METHODS: A large diameter untransposed arterialized basilic vein was carefully and completely mobilized up to the proximal upper arm. After harvesting an autologous great saphenous vein (GSV) segment, a new inflow anastomosis was performed in the proximal ulnar artery. At the final stage, and after tunneling the mobilizing basilic vein in a subcutaneous semicircular configuration, an end-to-end anastomosis joining the two stumps (basilic vein outflow portion and GSV inflow arterial portion) was performed. A decision-making process in order to reach this complex option is discussed. Results Access flow and cardiac output were greatly attenuated following our approach. After a mean follow-up of 9 months no VA complications were observed, with flow still detected below 2 L/min. All cardiac symptoms and ultrasound investigations improved. CONCLUSION: Multiple VA issues including HF pose a risk for abandonment and a challenge for the vascular surgeon. An effort toward increasing the "upper extremity life span" is advised.

Lessons Learned from Open Surgical Conversion after Failed Previous EVAR.

BACKGROUND: Delayed open conversion (OpC) after endovascular aortic aneurysm repair (EVAR) is becoming increasingly common worldwide. We reviewed our experience to characterize the perioperative spectrum of OpC repairs. MATERIALS AND METHODS: A retrospective analysis of a prospectively maintained institutional database to identify patients who underwent late OpC after failed EVAR was performed. Patient and aneurysm baseline characteristics, mechanism of failure, perioperative details, including type of repair/complications/survival, and late outcomes were examined. RESULTS: From January 2003 to January 2020, 38 male patients (mean age, 75 ± 7 years; range, 60-90) required late OpC. Interval time from initial EVAR to OpC was 63.6 ± 33.8 months (range, 17-120). Mean diameter of the aneurysms was 82.2 ± 22.1 mm before OpC compared with 62.9 ± 13 mm before endograft implantation. Mechanisms of failure were type Ia, Ib, II, and III endoleaks in 14 (36.8%), 9 (23.7%), 4 (10.5%), and 1 (2.6%) patient(s), respectively; infection in 3 (7.9%), leg ischemia in 2 (5.3%), and multiple causes in 5 (13.2%) patients. We observed 4 (10.5%) asymptomatic, 16 (42.1%) symptomatic, and 18 (47.3%) ruptured aneurysms. Four patients (10.5%) had stable contained ruptures, whereas the remaining 13 (34.2%) and 1 additional patient (2.6%) with aortoenteric fistula presented with hemorrhagic shock (class ≥II). Total endograft explantation, endograft preservation, or proximal/distal partial graft removal was performed in 16 (42.1%), 10 (26.3%), and 2 (5.2%)/9 (23.7%) of patients, respectively. Technical success was 100%, excluding an early postaortic clamping death. Overall, 30-day mortality was 21.1% (8 of 38) and significantly higher in patients with hemorrhagic shock or hemodynamic instability at presentation (P = 0.04 and P = 0.009, respectively) and in patients who had endografts with hooks/barbs or experiencing higher postoperative complication rate (P = 0.02 and P = 0.006, respectively). By definition, procedure success was 81.1%. Mean follow-up was 37.6 ± 39.8 months. By the end of the study, we recorded 11 deaths (2 were aneurysm related). CONCLUSIONS: Despite high technical success, OpC has a significant mortality in patients presenting with hemorrhagic shock and had active fixation endografts or experiencing high complication rate. Many other confounding factors may play a role.

Multicenter Mid-term Results After Endovascular Aortic Aneurysm Repair with the Incraft® Device.

OBJECTIVES: Durability after endovascular aortic aneurysm repair (EVAR) is considered an ongoing topic of investigation and was always a point of concern with smaller profile devices. Recently released five-year clinical trial results using the Incraft® ultralow profile device are encouraging. However, additional real-life experience will need to assist these initial findings. Herein, we investigated the outcomes after EVAR, in real world practice using the Incraft® endograft (EG). MATERIAL AND METHODS: Seventy-seven patients with infrarenal abdominal aortic aneurysms (AAA) ≥50 mm in diameter treated with the Incraft® device in three vascular centers were enrolled from November 2015 to July 2018. Follow-up was completed in August 2020. Selection of EVAR using the Incraft® device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient. At the early phase of the study, we specifically opted for preferential use of this low profile EG mainly in cases of small and tortuous iliac vessels (more challenging access routes). At later stages, it was used according to surgeon preference and not specifically in complex anatomies (real-world conditions). End-points included technical success, perioperative complications, 30-day survival, endoleg patency, presence of endoleaks, sac enlargement >5 mm and clinical success. RESULTS: The primary technical success rate was 97.4% before the addition of an aortic cuff and iliac extension for a type Ia and type Ib endoleak respectively, and the repair of a maldeployment iliac component (primary-assisted and secondary technical success, 100%). Intraoperative small type II endoleaks (visible in final angiogram) were noted in 19 patients (24.7%). There were no intraoperative deaths from AAA rupture, primary conversions or conversions to aortounilateral grafts. Two complications occurred, necessitating hybrid techniques for repair (replaced of a dislodged endoleg and distal external iliac artery hemostasis). No deaths were reported within 30 days. Occlusion of an endoleg, was observed in two patients, 6 and 14 months respectively after implantation (2.6%), and were treated by femoral-femoral PTFE bypass after unsuccessful endovascular recanalization. The latter required open conversion, 3 mo later, to repair compromised flow to the inflow iliac axis. Three patients (3.9%) experienced sac enlargement >5 mm in diameter compared with the 1-month CT scan. All of these had type II endoleaks and two received embolization procedures. Eleven patients died from causes unrelated to AAA repair. Clinical success was 97.3%, 92.8% and 89.4% through 1, 2 and 3 years respectively. CONCLUSIONS: EVAR with the Incraft® device might be considered a reliable option in real-world conditions and not specifically only in complex iliac anatomies.

Composite Contralateral Axillobifemoral Bypass for Ipsilateral Axillobifemoral Bypass Infection.

We report an innovative technique in an 82-year-old patient with a patent but infected right axillobifemoral (AxBF) bypass performed 7 years ago owingto critical limb ischemia who underwent a semielective de novo left-sided composite AxBF bypass consisting of a central prosthetic polytetrafluoroethylene segment and distal autologous limbs to the femoral regions (femoral crossover bypass vein to the right limb using the femoral vein and jump graft to the left femoral limb using the great saphenous vein.) Although AxBF bypass is not considered the "gold standard" surgical composite revascularization procedure in the suprainguinal region, it can constitute an acceptable intervention in selected cases.

Thigh arteriovenous grafts. Quantitative comparison with alternative options: A meta-analysis.

Thigh arteriovenous grafts are required in a number of patients with exhausted upper extremity veins and comprise 1%-5% of the total access procedures performed. Alternative autogenous lower extremity options are the rarely used sapheno-tibial arteriovenous fistulae, the saphenous vein transpositions, and the femoral vein transpositions. The latter have proven to be the most durable lower limb access procedures, with low infection rates and their primary patency rates ranged from 74% up to 87% at 2 years. Synthetic thigh grafts are suitable for patients who are not good candidates for any upper limb or any autogenous lower limb access and their secondary patency rates ranged from 54% up to 83% at 2 years. Thigh grafts often get infected and their average weighed infection rate in 920 such grafts included in eight large series was 22.9%. A literature search was performed to evaluate thigh grafts compared with alternative options using meta-analysis. Lower limb accesses were found superior compared to HeRO® device regarding 1-year primary failure rate (odds ratio = 0.28, confidence interval = 0.09-0.88, p = 0.03) and additionally autogenous lower limb accesses were found superior compared to thigh grafts regarding the 1-year primary failure rate (odds ratio = 6.54, confidence interval = 2.29-18.72, p = 0.0005).

Positional Changes of an Endurant Endograft Leading to Simultaneous Ipsilateral Iliac Limb Obstruction and Contralateral Type IIIa Endoleak.

We report the case of a 79-year-old man who was admitted to our department with acute limb ischemia due to the occlusion of the left iliac limb of an Endurant endograft. The admission computed tomography angiography revealed also a type IIIa endoleak due to modular disconnection of the iliac extensions from the right iliac limb of the endograft main body. Interestingly, during the 4-year post-endovascular aneurysm repair period, an increased kinking of the right limb has been observed leading to an almost cross-limb configuration of the limbs at the time of complications. To our knowledge, this is the first case in the literature of the simultaneous presence of limb thrombosis and late type IIIa endoleak with this particular device. The ischemia was treated with a femoro-femoral cross-over bypass, and the endoleak was corrected with the position of 2 Endurant iliac limb extensions bridging the dislocated endograft pieces.

Endovascular treatment of complex abdominal and thoracoabdominal type IV aortic aneurysms with fenestrated technology.

The establishment use of fenestrated and branched devices to treat complex aortic aneurysms as a first-line management option has been previously reported. This article reviews the current literature of the use of fenestrated devices to treat complex abdominal and thoracoabdominal type IV aortic aneurysms as a first-line management option. A literature search was performed. This review particularly focuses on all the aspects of the use and results of fenestrated stent-grafts (SGs) in patients with complex abdominal and type IV thoracoabdominal aortic aneurysms and summarizes the available evidence. The use of fenestrated SGs for complex aortic aneurysm disease has grown enormously the last years. SGs with fenestrations, scallops and occasionally branches have to be customized to each patient's anatomy and precisely deployed in vivo. Bridging covered stents between the main graft and the target vessels eventually exclude the aneurysm preserving blood flow to vital organs. Multiple device morphologies have been used incorporating the visceral arteries in various combinations. High technical success rates and satisfactory perioperative outcomes are described as well as mid- and long-term success and durability including target vessel and branch stent perfusion, data emerging mainly from high volume specialized centers. Percentage of target vessel successfully perfused was reported between 90.5 and 100%. 30-day mortality is reported between 0% and 4.1% while the lowest type 1 or type 3 endoleak rates were 2.5% and 1.3% respectively. Migration rates are kept below 3%. Renal failure was the most frequent complication reported. Advances in SG technology have reduced but not eliminated secondary interventions. Outcomes depend mostly on proximal extension of the disease which increases also the complexity of the repair. High level of expertise and organizational facilities are required for better mid- and long-term outcomes. Fenestrated EVAR (fEVAR) has been shown to be safe and effective in the short and mid-term follow-up. Remaining issues including secondary interventions and the need for follow-up are still within the range of those reported for EVAR. These, continue to plague fEVAR for complex abdominal or type IV thoracoabdominal aortic aneurysms.

Comparison of standard forearm prosthetic loop grafts to composite semiloop forearm grafts ("semi-grafts") in hemodialysis patients: A prospective study.

INTRODUCTION: To prospectively assess the performance of composite semiloop antebrachial grafts ("semi-grafts," SGs) in hemodialysis patients. METHODS: Eighty-five patients who received 67 loop antebrachial grafts (LG-group) and 25 antebrachial semigrafts (SG-group) were enrolled. SGs were defined as those originating from the brachial artery and anastomosed with the proximal mature mid-antebrachial cephalic vein. Cephalic vein length should be at least 10 cm in length and of ≥5 mm in diameter for inclusion in the SG-group. LG-group included all possible outflow vein options of minimum diameter 3 mm. Kaplan-Meier statistics was used for comparison of groups. FINDINGS: Main indication for a SG was a failing radiocephalic fistula with extensive distal cephalic vein stenosis not amenable to correction or failed after endovascular repair or requiring long interposition grafting. The mean follow-up period was 20.16 ± 22.6 and 29.6 ± 36.7 months for the LG- and SG-group, respectively (P = 0.14). Forty-two patients died during the follow-up. Primary patency (up to first intervention or failure) at 6 and 12 months for LG- vs. SG-group was 93.9% vs. 83.7% and 47% vs. 55.8% (P = 0.08). Secondary patency (up to abandonment) was 58.2% vs. 61.1% and 36% vs. 45.8% at 12 and 24 months (P = 0.18). Mortality at 48 months was 22.4% (LG-group) and 24% (SG-group) (P = 0.9). DISCUSSION: There was a trend toward better primary and secondary patency rates for the SGs especially in the long-term. This is a valuable option in selected patients that access surgeons and nephrologists should be aware of.

Preemptive open surgical vs. endovascular repair for juxta-anastomotic stenoses of autogenous AV fistulae: a meta-analysis.

PURPOSE: There is controversy about the best mode of preemptive repair of juxta-anastomotic stenoses in radial-cephalic arteriovenous fistula (AVFs). The aim of the present review was to compare the outcome of surgical vs. endovascular repair of those AVF stenoses. METHODS: A systematic review and meta-analysis was performed for studies comparing the outcome of open surgical vs. endovascular preemptive repair of AVF stenoses located in the juxta-anastomotic region. A search was carried out in April 2015. The analyzed outcome measures were the primary patency at 12 and 18 months and the assisted primary patency at 24 months. In addition, assessment of the methodological quality of the included studies was carried out. RESULTS: Four non-randomized cohort studies (297 patients) were analyzed. A random effects model was used to pool the data. The pooled odds ratio (OR and 95% confidence intervals) for the primary patency at 12 and at 18 months was 0.42 (0.25-0.72) and 0.33 (0.2-0.56), respectively, showing statistically significant higher patency of the surgically repaired group. The pooled OR for the assisted primary patency at 24 months was 0.53 (0.28-0.98) also in favor of the surgically repaired group (p<0.04). CONCLUSIONS: The available evidence, based on non-randomized cohort studies, suggests that surgery is the best way to treat 'juxta-anastomotic' stenotic lesions in distal radial-cephalic AVFs, although angioplasty remains a valuable but less durable option in this location of the stenosis.

What is the best training for vascular access surgery?

Questions have been raised whether there is a lack of appropriate training in access creation and maintenance, and if training juniors in arteriovenous (AV) fistulas may affect the outcome. A survey was undertaken to study "experts" opinion in access training using a closed questionnaire. The majority of "experts" consented that there is a lack of appropriate training in access creation and maintenance in a great extent, although they located the main deficit regarding access training in the preoperative planning and decision making. Regarding the second question, a literature search revealed only four studies, comparing the outcomes of AV fistulas created either by consultant surgeons or trainees. A meta-analysis performed revealed that 1-year patency rate was not statistically significant different among access procedures created either by consultants or trainees. Access surgery shares the same basic principles with vascular surgery and provides a valuable workload for the trainees and is a necessity to become a building component in all "core" vascular curricula; the required skills can be acquired with the trainees operating independently simple cases, as the latter is not leading to suboptimal outcomes.

Valve-Like and Protruding Calcified Intimal Flap Complicating Common Iliac Arteries Kissing Stenting.

Endovascular therapy for iliac artery chronic total occlusions is nowadays associated with low rates of procedure-related complications and improved clinical outcomes, and it is predominantly used as first-line therapy prior to aortobifemoral bypass grafting. Herein, we describe the case of a patient presenting with an ischemic left foot digit ulcer and suffering complex aortoiliac lesions, who received common iliac arteries kissing stents, illustrating at final antegrade and retrograde angiograms the early recognition of a blood flow obstructing valve-like calcified intimal flap protruding through the stent struts, which was obstructing antegrade but not retrograde unilateral iliac arterial axis blood flow. The problem was resolved by reconstructing the aortic bifurcation at a more proximal level. Completion angiogram verified normal patency of aorta and iliac vessels. Additionally, a severe left femoral bifurcation stenosis was also corrected by endarterectomy-arterioplasty with a bovine patch. Postintervention ankle brachial pressure indices were significantly improved. At the 6-month and 2-year follow-up, normal peripheral pulses were still reported without intermittent claudication suggesting the durability of the procedure. Through stent-protruding calcified intimal flap, is a very rare, but existing source of antegrade blood flow obstruction after common iliac arteries kissing stents.

Bibliometric analysis of factors predicting increased citations in the vascular and endovascular literature.

BACKGROUND: Dissemination of research findings in the scientific community is reflected by the citation count. Our objective was to investigate the relative citation impact of vascular research studies and identify potential predictors of increased citation rates. METHODS: Articles published in leading journals of vascular and general surgery (Journal of Vascular Surgery, European Journal of Vascular and Endovascular Surgery, Journal of Endovascular Therapy, Annals of Vascular Surgery and Annals of Surgery, British Journal of Surgery, Journal of the American College of Surgeons, and JAMA Surgery) during a 4-month period were identified through electronic databases. Variables potentially associated with increased citation rates, including subject, design, title characteristics, article length, bibliographic references, authorship, geographic distribution, interdisciplinary collaboration, article access, and funding, were assessed in univariate and multiple linear regression models through December 2012. RESULTS: A total of 226 articles with a total number of 4,605 citations were identified. Univariate analysis revealed that endovascular-related studies, study design, studies reporting design in the title, long articles, and studies with high number of references were associated with higher citation rates. On multivariate analysis, 3 variables were found to independently predict the number of citations: study subject (endovascular-related studies; regression coefficient [95% confidence interval], 0.474 [0.240-0.708]; P < 0.001); study design (randomized controlled trial; regression coefficient [95% confidence interval], 0.575 [0.145-1.005]; P = 0.009); and article length (number of pages; regression coefficient [95% confidence interval], 0.069 [0.016-0.123]; P = 0.011). CONCLUSIONS: Authors involved in vascular research may enhance the impact of their work by embarking on research strategies of high methodologic quality and pursuing work related with new technologies and evolving endovascular therapies.