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.

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.

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.

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.

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.

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.

Correlation of pre-existing radial artery macrocalcifications with late patency of primary radiocephalic fistulas in diabetic hemodialysis patients.

OBJECTIVE: The aim of this study was to evaluate the impact of pre-existing radial artery macrocalcification (Mönckeberg type of arteriosclerosis) on patency rates of radiocephalic fistulas (RCFs) in diabetic end-stage renal disease (ESRD) patients undergoing hemodialysis. METHODS: In this observational prospective study, the long-term patency rates (primary outcome measures) of RCFs in ESRD diabetics who had Mönckeberg radial (±brachial) artery disease (calcified [C] group) were compared with those obtained in ESRD diabetics who had healthy, noncalcified vessels before RCF construction (healthy [H] group). Vessel calcification was assessed by plain two-dimensional radiography. For inclusion in the C-group, uniform linear railroad track-type macrocalcifications of at least 6 cm in length, in the medial wall of the radial artery ipsilateral to RCF creation, were required. Patients were included in the H-group if the radial artery ipsilateral to the RCF creation was free of any macrocalcification, of either intima or media type. Any intimal-like plaque with irregular and patchy distribution was an exclusion criterion for both groups. Patients in both groups also were required to have suitable upper limb vascular anatomy on the basis of ultrasound imaging before RCF creation (cephalic vein of minimum diameter of 1.6 mm, without stenosis or thrombosis in all outflow areas, and radial artery of minimum diameter of 1.5 mm, without proximal hemodynamically significant stenosis). Secondary outcome measures included all-cause mortality. Kaplan-Meier statistics were used for comparison between groups. RESULTS: The arm radiograph at the site of possible fistula construction showed abnormality in 39 patients (C-group, 47 RCFs), whereas 33 patients had noncalcified ("healthy") vascular anatomy (H-group, 40 RCFs). Mean duration of the diabetic disease at the time of RCF creation was 8.9 ± 5.6 years (range, 2-25 years) for the H-group and 14 ± 9.9 years (range, 1-40 years) for the C-group (P = .018). The mean follow-up period for H-group and C-group was 51.9 ± 35.9 months (range, 0.1-126 months) and 26.1 ± 31.6 months (range, 0.1-144 months), respectively (P = .0006). Forty-four patients died during the follow-up period. Primary patency rates at 12, 24, 36, and 48 months for C-group vs H-group were 50.2% vs 80%, 36.5% vs 72.3%, 32.4% vs 67.9%, and 29.1% vs 59.3% (P = .0019). Respective values for secondary patency rates were 52.4% vs 87.5%, 40.9% vs 82.4%, 36.6% vs 78.1%, and 33.2% vs 72.8% (P = .00064). Patient survival rates at 24 and 48 months were 56.1% and 46.4% for C-group and 92.4% and 67.4% for H-group, respectively (P = .05). CONCLUSIONS: ESRD diabetics with radial artery Mönckeberg calcifications receiving RCFs had worse late clinical outcomes compared with ESRD diabetics with healthy distal arm vessels receiving the same access. The long-term benefit of RCFs may be lost in diabetics with extensively calcified vessels, and preferably the brachial artery should be used instead.

Impact of long-term warfarin treatment on EVAR durability: a meta-analysis.

PURPOSE: To evaluate whether postoperative long-term oral anticoagulation affects the durability of endovascular aneurysm repair (EVAR) and whether it is associated with an increased incidence of endoleak and subsequent need for reintervention. METHODS: A literature search was performed to identify studies of abdominal aortic aneurysm patients undergoing EVAR including an arm receiving warfarin postoperatively and reporting the frequency of any endoleaks and/or persistent type II endoleaks and reinterventions. The search identified 81 articles, of which 5 observational cohort studies ultimately met the inclusion criteria. RESULTS: Postoperative anticoagulation was required in 219 (14.6%) of the 1499 patients in the selected studies. The pooled effects analysis found that EVAR patients receiving long-term warfarin postoperatively had significantly more endoleaks of any type (OR 1.77, 95% CI 1.26 to 2.48, p=0.001) as well as persistent type II endoleaks (OR 1.58, 95% CI 1.05 to 2.37, p=0.03) compared with patients not on anticoagulation; however, there was no statistically significant difference in the reintervention rate between the groups. CONCLUSION: Long-term anticoagulation in EVAR patients was associated with a statistically significant increase in any endoleak and persisting type II endoleaks, although it was not linked to an increased risk of reintervention. Close monitoring for EVAR patients who require long-term oral anticoagulation is advised.

Endovascular repair for ruptured abdominal aortic aneurysm confers an early survival benefit over open repair.

BACKGROUND: Despite the intuitive advantages of endovascular repair (EVAR) of ruptured abdominal aortic aneurysms (AAAs), uncertainty remains about the optimal management in the absence of convincing high-quality evidence. Our objective was to undertake a comprehensive literature review and perform a meta-analysis of outcome data of treatment modalities for ruptured AAAs. METHODS: Systematic searches were conducted of electronic information sources to identify studies comparing perioperative outcomes of EVAR and open repair for AAA rupture. Summary estimates of odds ratios (ORs) or standardized mean difference and 95% confidence intervals (CIs) were obtained with a random-effects model. Meta-regression models were formed to explore potential heterogeneity as a result of changes in practice over time. RESULTS: We selected 41 studies for analysis. The entire meta-analysis population comprised 59,941 patients (8201 EVAR patients and 51,740 open repair patients). EVAR was associated with a significantly lower incidence of in-hospital mortality (OR, 0.56; 95% CI, 0.50-0.64; P < .01; meta-analysis of risk-adjusted observational studies and randomized controlled trials: OR, 0.58; 95% CI, 0.46-0.73; P < .01). EVAR patients had a significantly decreased risk of developing respiratory complications (OR, 0.59; 95% CI, 0.49-0.69; P < .01) and acute renal failure (OR, 0.65; 95% CI, 0.55-0.78; P < .01) and a trend toward a reduced incidence of cardiac complications (OR, -0.02; 95% CI, -0.03 to 0.00; P = .05) and mesenteric ischemia (OR, 0.66; 95% CI, 0.44-1.00; P = .05). Patients treated with EVAR had significantly less requirements of intraoperative blood transfusion (standardized mean difference, -0.88; 95% CI, -1.06 to -0.70; P < .01). Random-effects meta-regression revealed no statistical evidence for an association between death and year of publication (P = .19). CONCLUSIONS: Our analysis provides evidence to motivate the adoption of an EVAR-first policy in a nonelective setting and the establishment of standardized protocols for the management ruptured AAAs.

Clinical outcomes after crossed-limb vs. conventional endograft configuration in endovascular AAA repair.

PURPOSE: To report a case controlled analysis of endovascular aneurysm repair (EVAR) outcomes using the crossed-limb (CxL) endovascular configuration vs. the straight-limb configuration (SLC). METHODS: From January 2007 to July 2012, 27 patients (25 men; mean age 73.7±7.2 years, range 53-82) were treated by EVAR with the CxL technique. These patients were matched anatomically with 27 patients (27 men; mean age 72.4±7.4 years, range 52-86) who underwent EVAR using the same endograft and the standard SLC within a ±6-month period. Primary outcome measures included technical and clinical success and freedom from graft limb thrombosis, any type of endoleak, early or late secondary interventions, and aneurysm-related death estimated using the Kaplan-Meier method. RESULTS: The median follow-up periods for the CxL and SLC groups were 29.9 (range 6-54) and 33.5 (range 6-59) months, respectively (p=0.81). The technical success rate was 100% in both groups, but mean procedure times were significantly longer in the CxL group (116.3 vs. 90.7 minutes, p=0.035). Twelve intraoperative endoleaks (3 each for types Ia, Ib, II, and IV) occurred but without any difference between groups (p=0.51). One CxL group patient died in the early postoperative period (aneurysm-related) and another had an early graft limb thrombosis. One late type Ib intraoperative endoleak was recorded in the SLC group (p=0.51). For the CxL vs. SLC groups, the 1-year rates for freedom from endograft limb thrombosis (94% vs. 96%), any type of endoleak (96% vs. 96%), early or late reintervention (94% vs. 96%), and aneurysm-related death (94% vs. 96%) were not significantly different. Respective values at 36 months were 82% vs. 82%, 85% vs. 84%, 81% vs. 78%, and 83% vs. 84% (p>0.05). Clinical success rates at 12 months for the CxL and SLC groups were 91% and 100% (p>0.05), respectively, whereas at 36 months, the rates were 83% and 90% (p>0.05). CONCLUSION: No difference was found between the crossed-limb technique and the conventional endograft position as regards short- or midterm clinical outcomes.

Surgical or endovascular therapy of abdominal penetrating aortic ulcers and their natural history: a systematic review.

Little is known regarding the outcomes of endovascular and surgical treatment of penetrating ulcers in the abdominal aorta. The potential benefit of conservative management of asymptomatic disease is also debatable. A systematic review of the literature was undertaken to investigate these issues.

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).