Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy.

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.

Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.

BACKGROUND: The utilisation rate of endovascular aortic aneurysm repair has increased continuously over the past 2 decades. Endovascular aortic aneurysm repair is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. PURPOSE: We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). METHODS: A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A "challenging neck" was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. FINDINGS: Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p≤0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs. 56.4 mm, P< 0.0001), shorter proximal neck length (18 mm vs. 30 mm, P< 0.0001) and larger infrarenal neck angle (60.8° vs. 25.8°, P< 0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, P< 0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, P= 0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, P= 0.002) and aorta-related mortality (3.8% vs. 1.1%, P= 0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (P= 0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, P< 0.001) and requirement for reintervention (13.3% vs. 9.7%, P< 0.001) were higher in those treated outside the IFU (challenging neck group). CONCLUSIONS: Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry.

PURPOSE: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups. RESULTS: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07). CONCLUSION: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.

The Relationship Between Operative Volume and Peri-operative Mortality After Non-elective Aortic Aneurysm Repair in Australia.

OBJECTIVE: Hospital and surgeon operative caseload is thought to be associated with peri-operative mortality following the non-elective repair of aortic aneurysms; however, whether such an association exists within the Australian healthcare setting is unknown. METHODS: The Australasian Vascular Audit was interrogated to identify patients undergoing non-elective (emergency [EMG] or semi-urgent [URG]) aortic aneurysm repair between 2010 and 2016, as well as their treating surgeon and hospital. Hierarchal logistic regression modelling was used to assess the impact of caseload on outcomes after both endovascular (EVAR) and open surgical repair (OSR). RESULTS: Volume counts were determined from 14 262 patients (4 121 OSR and 10 141 EVAR). After exclusion of elective procedures and duplicates, 1 153 EVAR (570 EMG and 583 URG) and 1 245 OSR (946 EMG and 299 URG) non-elective cases remained for the analysis. Crude mortality was 24.0% following OSR (EMG 29.2%; URG 7.7%) and 7.5% following EVAR (EMG 12.6%; URG 2.4%). Univariable analysis demonstrated an association between OSR mortality and hospital volume (quintile [Q] 1: 25.3%, Q2: 27.8%, Q3: 23.9%, Q4: 27.0%, Q5: 16.2%; p = .030), but not surgeon (Q1: 25.2%, Q2: 27.4%, Q3: 26.0%, Q4: 21.4%, Q5: 19.5%, p = .32). Multivariable analysis confirmed this association (odds ratio (OR) [95% CI]; Q1 vs 5: 1.91 [1.13-3.21], Q2 vs. 5: 2.01[1.24-3.25], Q3 vs. 5: 1.41 [0.86-2.29], Q4 vs. 5: 1.92 [1.17-3.15]; p = .020). The difference was most pronounced in the EMG OSR group [Q1 - 3 vs. 4-5] (OR 1.63 [1.07-2.48]; p = .020). Mortality after EVAR was not associated with either hospital (Q1: 6.3%, Q2: 10%, Q3: 6.8%, Q4: 4.5%, Q5: 10%; p = .14) or surgeon volume (Q1: 9.3%, Q2: 5.7%, Q3: 8.1%, Q4: 7.0%, Q5: 7.3%; p = .67). CONCLUSION: There is an inverse correlation between hospital volume and peri-operative mortality following EMG open repair of aortic aneurysm. These data support restructuring Australian pathways of care to direct suspected ruptured aneurysm to institutions that reach a minimum volume threshold.

Sex-Related Outcomes After Endovascular Aneurysm Repair Within the Global Registry for Endovascular Aortic Treatment.

BACKGROUND: Abdominal aortic aneurysms (AAAs) are more common in men. However, women have been shown to have more short- and long-term adverse outcomes after endovascular aneurysm repair. This disparity is thought to be multifactorial, including anatomical differences, hormonal differences, older age of presentation, and a greater degree of preoperative comorbidities. METHODS: A retrospective analysis that included data for 3,758 patients from the Global Registry for Endovascular Aortic Treatment (GREAT) was conducted. Patients were recruited into GREAT between August 2010 and October 2016 and received the Gore Excluder stent graft for infrarenal AAAs repair. Cox multivariate regression analyses were performed to analyze any reintervention and device-related intervention rates. RESULTS: Of the 3,758 patients, 3,220 were male (mean age 73 years) and 538 were female (mean age 75 years). Women had higher prevalence rates of chronic obstructive pulmonary disease (P < 0.0001) and renal insufficiency (P = 0.03), whereas men had higher rates of cardiovascular comorbidities. The AAAs in women were smaller in diameter with shorter and more angulated necks. Women did not experience a significantly higher rate of endoleaks but did exhibit higher reintervention rates, including reintervention for device-related issues. In terms of mortality, aorta-related mortality was most prevalent within the first 30 days after procedure in both sexes. CONCLUSIONS: Women were treated at an older age and had a more hostile aneurysmal anatomy. Although the mortality rates were lower in women, they had significantly higher rates of reintervention, and thus higher morbidity rates after endovascular aneurysm repair.

Multivariable Analysis of Patients With Severe Persistent Postprocedural Hypotension After Carotid Artery Stenting.

Purpose: To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). Materials and Methods: A total of 146 patients (mean age 72.8 years; 104 men) who underwent 160 CAS procedures using a standardized protocol at 3 vascular centers were retrospectively analyzed. The primary endpoint was postprocedural hypotension, defined as a reduction in systolic blood pressure (SBP) >40 mm Hg from baseline or an SBP of <90 mm Hg sustained for >1 hour after CAS. Potential prognostic factors for postprocedural hypotension were identified and subjected to logistic regression analyses; outcomes are presented as the odds ratios (ORs) with 95% confidence intervals (CIs). Results: PPH developed in 36 (24.7%) patients after 37 (23.1%) CAS procedures. These patients had significantly longer intensive care unit and hospital stays than those who did not develop hypotension (p<0.001). PPH was associated with severe lesion calcification (OR 6.28, 95% CI 1.81 to 21.98, p=0.004) and contrast volume (OR 1.02, 95% CI 1.01 to 1.02, p<0.001). A 4-fold increase in the risk of PPH (OR 4.22, 95% CI 1.38 to 13.33, p=0.012) was found between the embolic protection device most associated with PPH (Angioguard) and the device least associated with PPH (Emboshield NAV6). A similar trend was also observed for the Precise vs Xact stents (OR 6, 95% CI 2.08 to 17.6, p=0.001). Bootstrapped multivariable modeling identified the Precise stent and contrast volume as significant predictors of persistent postprocedural hypotension. Further investigation of the contrast volume revealed associations with sex, severe calcification, arch type, previous coronary artery bypass surgery, and primary stenting, suggesting that the contrast volume reflects the complexity of the procedure. Conclusion: The complexity of the procedure and type of stent may play a role in the development of postprocedural hypotension after CAS.

The Relationship Between Aortic Aneurysm Surgery Volume and Peri-Operative Mortality in Australia.

OBJECTIVES: Operative caseload is thought to be associated with peri-operative mortality following intact aortic aneurysm repair. The aim was to study that association in the Australian setting, which has a unique healthcare provision system and geographical population distribution. METHODS: The Australasian Vascular Audit database was used to capture volume measurements for both individual surgeon and hospital and to separate it into quintiles (1, lowest, to 5, highest) for endovascular (EVAR), open surgical repair (OSR), and subgroups of repair types between 2010 and 2016. Multivariable logistic regression modelling was used to assess the impact of caseload volumes on in hospital mortality after adjustment for confounders. RESULTS: Volume counts were determined from 14,262 aneurysm repair procedures (4121 OSR, 10,106 EVAR). After exclusions, 2181 OSR (161 complex, 2020 standard) and 7547 EVAR (6198 standard, 1135 complex, 214 thoracic (TEVAR)) elective cases were available for volume analysis. Unadjusted mortality after EVAR was unaffected by either surgeon (Quintile 1, 1.0%; Quintile 5, 0.9%; p = .28) or hospital volume (Quintile 1, 0.8%; Quintile 5, 1.3%; p = .47). However, univariable analysis of the TEVAR subgroup revealed a significant correlation with hospital volume (Quintiles 1-2 vs. Quintiles 3-5; p = .02). Univariable analysis for OSR demonstrated a marginal, non-significant value for surgeon (Quintile 1, 4.0%; Quintile 5, 3.6%; p = .06), but not hospital volume (Quintile 1, 4.7%; Quintile 5, 4.0%; p = .67). After adjustment for confounders hospital volume remained a significant predictor of peri-operative TEVAR mortality (Quintile 1-2 vs. 3-5; OR 5.62, 95% CI 1.27-24.83; p = .02) and surgeon volume a predictor following standard OSR (Quintile 1-2 vs. Quintile 3-5; OR 2.15, 95% CI 1.21-3.83; p = .01). CONCLUSIONS: There is an inverse correlation between both surgeon volume of open aortic aneurysm repair, hospital volume of thoracic endovascular aneurysm repair and in hospital mortality. These findings suggest that in Australia TEVAR should be performed by high volume hospitals and OSR by high volume surgeons.

Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.

OBJECTIVE: The Covered vs Balloon Expandable Stent Trial (COBEST) is the first multicenter trial to investigate the patency of covered stents (CSs) and bare-metal stents (BMSs) in the treatment of aortoiliac arterial disease. The short-term results demonstrated that CSs were superior to BMSs in maintaining patency for TransAtlantic Inter-Society Consensus (TASC) C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. The current study was conducted to determine if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up. METHODS: A retrospective post hoc analysis of COBEST was performed. Originally, 125 patients with 168 iliac arteries were prospectively enrolled and randomly assigned to receive a CS or BMS. In this study, 77 of the 125 patients (61.6%; 119 limbs) were assessed at 60 months for the primary and secondary end points, with particular attention paid to the outcomes stratified according to TASC lesion severity. The primary end point was the rate of binary stenosis or freedom from stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography. RESULTS: The 5-year results of the COBEST showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1%, 82.1%, 79.9%, 74.7% for CS vs 73.9%, 70.9%, 63% and 62.5% for BMS; log-rank test, P = .01). On multivariate analysis, the type of stent used (hazard ratio [HR], 2.797; 95% confidence interval [CI], 1.471-5.318; P = .002) and the Rutherford classification (HR, 2.019; 95% CI, 1.278-3.191; P = .026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95% CI, 54.253-75.753; P = .003). Moreover, fewer patients received target limb revascularization in the CS group than in the BMS group (odds ratio, 2.32; 95% CI, 1.47-3.36; P = .02); however, there was no statistically significant difference in the rate of amputations between the groups. CONCLUSIONS: The 5-year results of the COBEST demonstrated that the CS has an enduring patency advantage over the BMS in both the short and long terms. Furthermore, the CS showed acceptable patency rates for the treatment of more severe TASC C and D lesions, and patients who received a CS required fewer revascularization procedures. However, the choice of stent did not affect the rate of major limb amputations.

Transradial approach for challenging vascular access interventions.

BACKGROUND: Percutaneous interventional procedures for vascular access are usually performed using the draining cephalic or basilic vein. The transradial approach, which has been extensively investigated for coronary angiography and intervention, could be an attractive new technique for peri-anastomotic arteriovenous fistula stenosis. METHOD: From June 2012 to February 2013, 30 patients with end-stage renal failure were evaluated for transradial vascular access intervention. A 4-French (Fr) micropuncture kit was used to access the radial artery and then subsequently upgraded to a 5-Fr sheath. Fourteen patients required an upgrade to a 6-Fr sheath for the final intervention. RESULTS: Primary technical success (residual stenosis <30%) was achieved in all cases where angioplasty was performed. Technical success regarding access was achieved in all patients. There were no peri-procedural complications. The post-interventional primary patency was calculated as 100%, 100%, 88.4% and 32.8% at 1, 6, 9 and 12 months, respectively. The post-interventional primary assisted patency was calculated as 100%, 100%, 100% and 63.3% at 1, 6, 9 and 12 months, respectively. Based on colour-coded Duplex scan and/or photoelectric plethysmography, all access-site arteries showed normal perfusion; however, the freedom from significant radial artery restenosis was 92.4% at 12-month follow-up. CONCLUSION: The transradial approach for vascular access endovascular interventions is technically feasible and safe. It allows simultaneous treatment of peri-anastomotic lesions in fistulas with complex venous anatomy as well as lesions in the arterial inflow and central outflow.

Incidence and prognosis of vascular complications after transcatheter aortic valve implantation.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has gained increasing global popularity as a minimally invasive option for high-risk cardiac patients. However, this operation is not without risk, particularly of significant vascular complications that increase the morbidity, mortality, and overall cost of the procedure. We aim to present our experience of TAVI-related vascular complications, including the morbidity and cost impacts of these events. METHODS: A case-series study was performed for all patients undergoing TAVI at our center. Vascular complications were defined according to the 2011 Valve Academic Research Consortium standardized end points. The data were prospectively collected from February 2009 to April 2012, and the outcomes were entered into a database and cross-checked with the hospital notes. RESULTS: TAVI was performed on 100 patients in our center during the study period, and the 30-day mortality was 6%. Access approaches included 81 transfemoral, 18 transapical, and one trans-subclavian access. The average patient age was 84.9 years, and 65% of the patients were male. Among the transfemoral procedures, there were 16 vascular access-related complications (VAC), including nine major and seven minor complications. The major complications included aortic dissection, iliac arterial rupture, femoral dissection, false aneurysms, and distal embolization, all of which required surgical or endovascular repair. An apical false aneurysm and an apical tear were major VAC of the transapical group, with the latter resulting in death. Patients with VAC had higher blood transfusion requirements (4.1 ± 4.5 units vs 0.9 ± 2.2 units; P = .004), greater length of hospital stay (16.4 ± 10.7 days vs 6.5 ± 5.1 days; P = .001), and increased cost (A$93,448 ± 21,435 vs A$69,932 ± 15,007; P = .002) compared with the non-VAC group. The predictors of vascular complications using multivariate analysis included European System for Cardiac Operative Risk Evaluation (odds ratio, 1.06; 95% confidence interval, 1.02-1.10; P = .001) and diabetes mellitus (odds ratio, 5.07; 95% confidence interval, 1.17-21.88; P = .03). Occurrence of major VAC did not affect in-hospital or 30-day mortality rates and was not associated with poorer survival. CONCLUSIONS: Vascular complications affect perioperative management and outcomes following TAVI. Our findings show that these complications often require urgent surgical or endovascular repair and result in increased blood transfusions, greater length of hospital stay, and significantly increased costs. Diabetes mellitus and logistic European System for Cardiac Operative Risk Evaluation may be predictive of VAC and should be considered during TAVI patient selection.

Endovascular repair of abdominal aortic aneurysms with reverse taper neck anatomy using the Endurant stent-graft: analysis of stent-graft oversizing.

PURPOSE: To evaluate endovascular repair of infrarenal abdominal aortic aneurysms (AAA) using the Endurant stent-graft and compare the outcomes of patients with different neck anatomies, particularly as pertains to stent-graft oversizing. METHODS: A retrospective review was conducted of 75 consecutive patients (69 men; mean age 75 years) undergoing endovascular AAA repair using the Endurant Stent Graft System from December 2008 to September 2011. The mean AAA size was 57±10 mm (range 51-92), with a mean proximal neck length of 33±10 mm (9-127) and a mean infrarenal neck angulation of 25°±15° (0°-91°). Patients were stratified according to neck anatomy [reverse taper (n=22) vs. inside (n=44) and outside (n=9) the Instructions for Use (IFU) criteria]. Standard safety and efficacy outcome measures were augmented by measurements of the percent oversizing at the proximal and distal neck and volumes of the proximal neck and stent-graft. RESULTS: Technical success was 100% in all groups, with no early or late type Ia endoleak detected in any group. Procedure time, contrast volumes, and radiation dosages were comparable in all groups. The reverse taper neck group had stent-graft diameters and volumes that were significantly larger (p=0.007) than the other groups. The proximal neck oversizing of the endograft was significantly greater (p=0.008) in the reverse taper neck group (42.9%±17.5%) compared to the within the IFU group (30.1%±11.7%). Over a mean follow-up of 20 months (range 14-46), there were no aneurysm-related deaths and 9 type II endoleaks (5 in the reverse taper neck group; overall, 3 were treated and 6 resolved spontaneously). The outside the IFU group suffered no endoleak of any type and had no secondary interventions. CONCLUSION: The Endurant stent-graft can be utilized with acceptable results in more challenging neck anatomies, such as those with a reverse taper, as long as there is adequate oversizing of the stent-graft.

Results from the First-in-Human Study of the Caterpillar™ Arterial Embolization System.

PURPOSE: To assess occlusion success and adverse events associated with the use of a self-expanding device for peripheral artery embolization. METHODS: This prospective, single-arm, feasibility study was conducted using the Caterpillar™ Arterial Embolization Device composed of opposing nitinol fibers and a flow-occluding membrane. Twenty patients (24 embolization sites) were treated at four investigational centers in New Zealand and Australia and followed for 30 days. Embolization sites included mesenteric, accessory renal, and iliac arteries and their branches. Primary outcome measures were peri-procedural occlusion confirmed by angiography and freedom from device-related serious adverse events (SAEs) at 30 days. Secondary observations included time to occlusion and assessment of adverse events. RESULTS: Peri-procedural occlusion was 100%, and freedom from a device-related SAE was 94.7% at 30 days. One patient had abdominal bloating that required hospitalization deemed possibly related to the device or procedure. Twenty-two of 24 embolization sites were occluded with one device (91.7%). Mean procedure duration was 11.7 ± 8.6 min (device deployment time: 1.8 ± 1.0 min), and mean fluoroscopy time was 241 ± 290.7 s. All embolization sites occluded during the procedure with 62.5% occluded within three minutes and 91.6% occluded within ten minutes. No devices migrated or required re-embolization. Freedom from device- and procedure-related adverse events was 84.2%. One patient died from aortic rupture during a subsequent adjunctive abdominal aortic endovascular procedure deemed unrelated to the embolization device or procedure. CONCLUSIONS: This first-in-human study of the Caterpillar embolization device achieved peri-procedural occlusion in all patients with a 94.7% freedom from device-related SAE at 30 days. LEVEL OF EVIDENCE: Level 2b-prospective, multicenter, single-arm, first-in-human clinical study. Pre-specified endpoints were analyzed using descriptive statistics.

A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease.

OBJECTIVE: This trial was conducted to determine if covered stents offer a patency advantage over bare-metal stents in the treatment of aortoiliac arterial occlusive disease. METHODS: The Covered Versus Balloon Expandable Stent Trial (COBEST), a prospective, multicenter, randomized controlled trial, was performed involving 168 iliac arteries in 125 patients with severe aortoiliac occlusive disease who were randomly assigned to receive a covered balloon-expandable stent or bare-metal stent. Patient demographic data, clinical signs and symptoms, TransAtlantic Inter-Society Consensus (TASC) classification, and preprocedure and postprocedure ankle-brachial index measurements were recorded. The primary end points included freedom from binary restenosis and stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography, or both. Postprocedural follow-up was at 1, 6, 12, and 18 months. RESULTS: Aortoiliac lesions treated with a covered stent were significantly more likely to remain free from binary restenosis than those that were treated with a bare-metal stent (hazard ratio [HR], 0.35; 95% confidence interval (CI), 0.15-0.82; P = .02). Freedom from occlusion was also higher in lesions treated with covered stents than in those treated with a bare-metal stent (HR, 0.28; 95% CI, 0.07-1.09); however, this did not reach statistical significance (P = .07). Subgroup analyses demonstrated a significant difference in freedom from binary restenosis for covered stents in TASC C and D lesions compared with a bare stent (HR, 0.136; 95% CI, 0.042-0.442). This difference was not demonstrated for TASC B lesions (HR, 0.748; 95% CI, 0.235-2.386). CONCLUSIONS: COBEST demonstrates covered and bare-metal stents produce similar and acceptable results for TASC B lesions. However, covered stents perform better for TASC C and D lesions than bare stents in longer-term patency and clinical outcome.

The Impact of Endograft Selection on Mid-Term Outcomes in Female Patients Following Endovascular Aortic Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA).

Background Abdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort. Purpose To identify whether graft selection influences outcomes following AAA endoluminal repair in female patients. Methodology A retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts. Results Of the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT. Conclusion The newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction.

PURPOSE: To assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction. MATERIALS AND METHODS: Twenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months. RESULTS: Freedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan-Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related. CONCLUSION: The Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures. LEVEL OF EVIDENCE: Level 2-prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. REGISTRATION CLINICALTRIALS.GOV: Unique Identifier NCT02655887.

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

Background Endovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU. Purpose To identify whether graft selection influences outcomes following EVAR outside of IFU. Methodology A retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts. Results Of the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder. Conclusion Treatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial.

PURPOSE: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. MATERIALS AND METHODS: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. RESULTS: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. CONCLUSIONS: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.

Homocysteine predicts vascular target organ damage in hypertension and may serve as guidance for first-line antihypertensive therapy.

Homocysteine is an independent risk factor for cardiovascular and cerebrovascular disease and has been proposed to contribute to vascular dysfunction. We sought to determine in a real-world clinical setting whether homocysteine levels were associated with hypertension mediated organ damage (HMOD) and could guide treatment choices in hypertension. We performed a cross-sectional analysis of prospectively collected data in 145 hypertensive patients referred to our tertiary hypertension clinic at Royal Perth Hospital and analyzed the association of homocysteine with HMOD, renin-angiotensin-aldosterone system (RAAS), and RAAS blockade. The average age of participants was 56 ± 17 years, and there was a greater proportion of males than females (89 vs. 56). Regression analysis showed that homocysteine was significantly associated with PWV (ß = 1.99; 95% CI 0.99-3.0; p < .001), albumin-creatinine ratio (lnACR: ß = 1.14; 95% CI 0.47, 1.8; p < .001), 24 h urinary protein excretion (ß = 0.7; 95% CI 0.48, 0.92; p < .001), and estimated glomerular filtration rate (ß = -29.4; 95% CI -36.35, -22.4; p < .001), which persisted after adjusting for potential confounders such as age, sex, 24 h BP, inflammation, smoking, diabetes mellitus (DM), and dyslipidemia. A positive predictive relationship was observed between plasma homocysteine levels and PWV, with every 1.0 µmol/L increase in homocysteine associated with a 0.1 m/s increase in PWV. Homocysteine was significantly associated with elevated aldosterone concentration (ß = 0.26; p < .001), and with attenuation of ACEi mediated systolic BP lowering and regression of HMOD compared to angiotensin receptor blockers in higher physiological ranges of homocysteine. Our results indicate that homocysteine is associated with hypertension mediated vascular damage and could potentially serve to guide first-line antihypertensive therapy.

Multicentre Covariate Adjustment Analysis of Short-Term and 5-Year Outcomes after Endovascular Repair according to Sex.

BACKGROUND: Several studies have reported worse outcomes in women compared to men after endovascular aneurysm repair (EVAR). This study aimed to evaluate sex-specific short-term and 5-year outcomes after EVAR. METHODS: A total of 409 consecutive patients underwent elective EVAR from 2004 to 2017 at two tertiary hospitals in Western Australia. Baseline, intraoperative, and postoperative variables were examined retrospectively according to sex. The primary outcome was 30-day mortality (death within 30 days after EVAR). Secondary outcomes were 30-day composite endpoint, length of stay after EVAR, 5-year survival, freedom from reintervention, residual aneurysm size after EVAR, and major adverse event rate at 5-year follow-up. RESULTS: A cohort of 409 patients, comprising 57 women (14%) and 352 men (86%), was analysed. Female patients were older (median age, 76.8 versus 73.5 years, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%. CONCLUSION: This study found no significant differences in 30-day and 5-year outcomes between female and male patients treated with EVAR, implying that EVAR remains a safe treatment choice for female patients.