Geometric Analysis of the Gore Excluder Conformable Endoprosthesis in the Infrarenal Aortic Neck: One Year Results of the EXCeL Registry.

OBJECTIVE: The Gore Excluder Conformable Endoprosthesis (CEXC) is designed to treat challenging infrarenal anatomy because of its active angulation control, repositionability, and enhanced conformability. This study evaluated 30 day and one year position and apposition of the CEXC in the infrarenal neck. METHODS: Patients treated with the CEXC between 2018 and 2022 with an available 30 day computed tomography angiography (CTA) were selected from four hospitals in a prospective registry. Endograft apposition (shortest apposition length [SAL]) and position (shortest fabric distance [SFD]) were assessed on the 30 day and one year CTAs. Maximum infrarenal aortic curvature was compared between the pre-operative and post-operative CTAs to evaluate conformability of the CEXC. RESULTS: There were 87 patients with a 30 day CTA, and for 56 of these patients the one year CTA was available. Median (interquartile range [IQR]) pre-operative neck length was 22 mm (IQR 15, 32) and infrarenal angulation was 52° (IQR 31, 72). Median SAL was 21.2 mm (IQR 14.0, 29.3) at 30 days for all included patients. The SAL in 13 patients (15%) was < 10 mm at 30 days, and one patient had a SAL of 0 mm and a type Ia endoleak. There was no significant difference in SAL between patients within and outside instructions for use. The SAL significantly increased by 1.1 mm (IQR -2.3, 4.7; p = .042) at 1 year. The SAL decreased in seven patients (13%), increased in 13 patients (23%), and remained stable in 36 patients (64%). Median SFD was 2.0 mm (IQR 0.5, 3.6) at 30 days, which slightly increased by 0.3 mm (IQR -0.5, 1.8; p = .019) at 1 year. One patient showed migration (SFD increase ≥ 5 mm). Median endograft tilt was 15.8° (IQR 9.7, 21.4). Pre-operative maximum infrarenal curvature was 36 m-1 (IQR 26, 56) and did not significantly change thereafter. CONCLUSION: In most patients, the CEXC was implanted close to the renal arteries, and sufficient (≥ 10 mm) post-operative apposition was acquired at 30 days, which slightly increased at one year. Post-operative endograft tilt was relatively low, and aortic geometry remained unchanged after implantation of the CEXC, probably due to its high conformability.

Long Term Outcomes of the Gore Excluder Low Permeability Endoprosthesis for the Treatment of Infrarenal Aortic Aneurysms.

OBJECTIVE: This study evaluated the long term outcomes of endovascular aneurysm repair using the Gore Excluder Low Permeability (LP) endoprosthesis across high volume Dutch hospitals. METHODS: A retrospective analysis was conducted of patients treated with the Excluder LP for infrarenal abdominal aortic aneurysm (AAA) in four hospitals between 2004 and 2017. Primary outcomes were overall survival, freedom from re-interventions (overall, inside and outside instructions for use, IFU), and AAA sac dynamics: growth (> 5 mm), stabilisation, and regression (< 5 mm). Secondary outcomes were technical success (device deployment), procedural parameters, and re-interventions. Follow up visits were extracted from patient files, with imaging assessed for complications and AAA diameter. RESULTS: Five hundred and fourteen patients were enrolled, with a median (IQR) follow up of 5.0 (2.9, 6.9) years. Survival rates were 94.0% at one year, 73.0% at five years, and 37.0% at 10 years, with freedom from re-interventions of 89.0%, 79.0%, and 71.0%, respectively. 37.9% were treated outside IFU, leading to significantly more re-interventions over 10 years compared with those treated inside IFU (36.0% vs. 25.0%, respectively; p = .044). The aneurysm sac regressed by 53.5% at one year, 65.8% at five years, and 77.8% at 10 years, and grew by 9.8%, 14.3%, and 22.2%, respectively. Patients with one year sac growth had significantly worse survival (p = .047). Seven patients (1.4%) had a ruptured aneurysm during follow up. Over 15 years, type 1a endoleak occurred in 5.3%, type 1b in 3.1%, type 3 in 1.9%, type 4 in 0.2%, and type 2 in 35.6% of patients. CONCLUSION: This multicentre study of real world endovascular aneurysm repair data using the Gore Excluder LP endoprosthesis demonstrated robust long term survival and re-intervention rates, despite 37.9% of patients being treated outside IFU, with type 4 endoleak being rare. Treatment outside IFU significantly increased re-intervention rates and one year sac growth was associated with statistically significantly worse survival.

Five-year outcomes for bell bottom, iliac branch endoprosthesis, and coil and cover approaches from the GREAT registry.

OBJECTIVE: There are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia. METHODS: Subjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ2 test and the Kruskal-Wallis rank-sum test. RESULTS: We found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006). CONCLUSIONS: Overall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair.

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

Active aortic aneurysm sac treatment with shape memory polymer during endovascular aneurysm repair.

Preprocedural image analysis and intraprocedural techniques to fully treat infrarenal abdominal aortic aneurysm sacs outside of the endograft with shape memory polymer (SMP) devices during endovascular aneurysm repair were developed. Prospective, multicenter, single-arm studies were performed. SMP is a porous, self-expanding polyurethane polymer material. Target lumen volumes (aortic flow lumen volume minus endograft volume) were estimated from the preprocedural imaging studies and endograft dimensions. SMP was delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. Technical success was achieved in all cases, defined as implanting enough fully expanded SMP volume to treat the actual target lumen volume.

Brown-Séquard Syndrome after Thoracic Endovascular Aortic Repair for a Stanford Type B Aortic Dissection.

We present a case of Brown-Séquard syndrome (BSS) after thoracic endovascular aortic repair (TEVAR) to treat Stanford type B aortic dissection. A 49-year-old male presented to the emergency department with acute tearing pain between the scapulae, connected to respiratory movements. Computed tomography showed Stanford type B aortic dissection from the left subclavian artery to the level of the 11th thoracic vertebra. Conservative treatment was initiated with intravenous antihypertensives. However, due to persistent pain and an increase in the aortic diameter with an intramural hematoma, TEVAR was performed. The patient developed symptoms suspicious of spinal cord ischemia postoperatively. A lesion limited to the left-sided spinal cord was observed on magnetic resonance imaging at the level of the 4th to 5th thoracic vertebra. BSS after TEVAR is a rare phenomenon with a fairly good prognosis, depending on the initial injury severity.

Nationwide Experience with EVAS Relining of Previous Open or Endovascular AAA Treatment in The Netherlands.

OBJECTIVE: Relining of a previously placed surgical graft or endograft for an abdominal aortic aneurysm (AAA) is a reintervention to treat progression of disease or failure of the primary (endo)graft. Endovascular Aneurysm Sealing (EVAS) relining is a technique with potential advantages due to the absence of a bifurcation, the possibility for a unilateral approach, and sealing concept of the endobags. The purpose of this study was to describe the nationwide experience with EVAS relining of previous AAA repair in the Netherlands. METHODS: A retrospective analysis of all patients who underwent EVAS relining in 7 high volume vascular centres in the Netherlands between 2014 and 2019 was performed. Primary outcomes were technical and clinical success. Secondary outcomes were perioperative outcomes, complications and survival. RESULTS: Thirty-three patients underwent EVAS relining of open (n = 10) or endovascular (n = 23) repair. 26 were elective cases, 5 were urgent and 2 were acute (ruptured). Mean time between primary treatment and EVAS relining was 99 ± 74 months. Indications after open repair were proximal progression of disease (n = 7) and graft defect (n = 3). Indications after EVAR were type IA (n = 10), type IB (n = 3), type IIIA (n = 4), type IIIB (n = 3) endoleak, and endotension (n = 3). 18 patients underwent regular EVAS, 4 unilateral EVAS and 11 chimney-EVAS. In-hospital mortality was 6% (both patients with rAAA). Technical success was achieved in 97%. Median follow-up after EVAS relining was 20 months (range 0-43). Freedom from reintervention at 1-year and 2-year were 83% and 61% and the estimated survival 79% and 71%, respectively. EVAS relining after open repair had a clinical success of 90% at 1-year and of 70% at latest follow-up, while after EVAR clinical success rates were 70% and 52%, respectively. CONCLUSION: EVAS relining of previous AAA repair is associated with high technical success, however with limited clinical success at median follow-up of 20 months. Clinical success was higher in patients with EVAS relining after open repair than after EVAR. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated.

Solitary iliac branch endoprosthesis placement for iliac artery aneurysms.

BACKGROUND: Isolated iliac artery aneurysms (IAAs), accounting for 2% to 7% of all abdominal aneurysms, are often treated with the use of iliac branched endografts. Although outside the manufacturer's instructions for use, iliac branched devices can be used solely, without the adjunctive placement of an endovascular aneurysm repair device, for the treatment of an isolated IAA. In the present study, we have described the outcomes of the use of the Gore iliac branched endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz), without the support of an infrarenal endovascular aneurysm repair device, for the exclusion of an isolated IAA. The present study was an international multicenter retrospective cohort analysis. METHODS: All the patients who had undergone treatment with a solitary IBE for IAA exclusion from January 11, 2013 to December 31, 2018 were retrospectively reviewed. The primary outcome was technical success. The secondary outcomes included mortality, intraoperative and postoperative complications, and reintervention. RESULTS: A total of 18 European and American centers participated, with a total of 51 patients in whom 54 IAAs were excluded. The technical success rate was 94.1%, with an assisted technical success rate of 96.1%. No 30-day mortality occurred, with 98.1% patency of the internal and external iliac artery found at 24 months of follow-up. At 24 months of follow-up, 81.5% of the patients were free of complications and 90% were free of a secondary intervention. CONCLUSIONS: Treatment with a solitary IBE is a safe and, at midterm, an effective treatment strategy for selected patients with a solitary IAA.

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.

BACKGROUND: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200-220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. METHODS: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200-220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. DISCUSSION: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. TRIAL REGISTRATION {2A}: NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27 TRIAL REGISTRATION: DATA SET {2B}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

OBJECTIVE: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. METHODS: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. RESULTS: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. CONCLUSION: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

Physical Activity in Patients with Symptomatic Peripheral Artery Disease: Insights from the PORTRAIT Registry.

OBJECTIVE: A physically active lifestyle reduces the risk of cardiovascular events and functional impairment in patients with peripheral artery disease (PAD). There are limited data on the patterns of physical activity in patients with PAD compared between countries. METHODS: Self reported physical activity (sedentary vs. not) was obtained at enrolment, 3, 6, and 12 months in the US and Netherlands' cohorts of the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry of patients with new or worsening claudication. Multivariable repeated measures using modified Poisson regression analysis compared the proportion of sedentary participants over time between countries to identify factors that attenuate intercountry differences. RESULTS: Of 1 098 participants, 743 (67.7%) and 355 (32.3%) were recruited from the USA and the Netherlands respectively. Compared with the Netherlands, participants from the US were older (mean age 68.6 vs. 65.3 years; p < .001), more obese (41.3% vs. 20.5%; p < .001), and more likely to be female (41.3% vs. 31.4%; p = .002). There were fewer current smokers (30.1% vs. 52.8%; p < .001) and supervised exercise referrals (1.6% vs. 63.9%; p < .001) in the US compared with the Netherlands. US participants were more sedentary at baseline (43.7% vs. 34.1%; p < .001). Sedentary behaviour decreased after three months in both countries, then diverged with an increase in sedentary participants in the USA. Risk of sedentary behaviour was significantly greater in the USA compared with the Netherlands at 12 months, after adjustment of sociodemographic, lifestyle factors, and comorbidities (relative risk [RR] 1.56, 95% confidence interval [CI] 1.08-2.25; p = .020) but was attenuated after accounting for referral to supervised exercise (RR 1.20, 95% CI 0.67-2.16; p = .54). CONCLUSION: Referral to supervised exercise was key in explaining the observed difference in the physical activity levels between patients with PAD in the USA and the Netherlands. Further promotion of supervised exercise for PAD may improve physical activity in patients with PAD and modify cultural norms of inactivity in the US.

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.

Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.

BACKGROUND: We report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: From 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years. RESULTS: GREAT patients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREAT patients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREAT patients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREAT patients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression. CONCLUSIONS: Midterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.

Patient-specific Rehearsal Before EVAR: Influence on Technical and Nontechnical Operative Performance. A Randomized Controlled Trial.

OBJECTIVE: To assess the effect of patient-specific virtual reality rehearsal (PsR) before endovascular infrarenal aneurysm repair (EVAR) on technical performance and procedural errors. BACKGROUND: Endovascular procedures, including EVAR, are executed in a complex multidisciplinary environment, often treating high-risk patients. Consequently, this may lead to patient harm and procedural inefficiency. PsR enables the endovascular team to evaluate and practice the case in a virtual environment before treating the real patient. METHODS: A multicenter, prospective, randomized controlled trial recruited 100 patients with a nonruptured infrarenal aortic or iliac aneurysm between September 2012 and June 2014. Cases were randomized to preoperative PsR or standard care (no PsR). Primary outcome measures were errors during the real procedure and technical operative metrics (total endovascular and fluoroscopy time, contrast volume, number of angiograms, and radiation dose). RESULTS: There was a 26% [95% confidence interval (CI) 9%-40%, P = 0.004) reduction in minor errors, a 76% (95% CI 30%-92%, P = 0.009) reduction in major errors, and a 27% (95% CI 8.2%-42%, P = 0.007) reduction in errors causing procedural delay in the PsR group. The number of angiograms performed to visualize proximal and distal landing zones was 23% (95% CI 8%-36%, P = 0.005) and 21% (95% CI 7%-32%, P = 0.004) lower in the PsR group. CONCLUSIONS: PsR before EVAR can be used in different hospital settings by teams with various EVAR experience. It reduces perioperative errors and the number of angiograms required to deploy the stent graft, thereby reducing delays. Ultimately, it may improve patient safety and procedural efficiency.

Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.

OBJECTIVE: In this study, we analyzed the procedural success and early outcome of endovascular treatment of a multicenter cohort of patients with common iliac artery (CIA) aneurysms treated with the new GORE EXCLUDER (W. L. Gore & Associates, Flagstaff, Ariz) iliac branch endoprosthesis (IBE). METHODS: A retrospective cohort analysis was performed in 13 sites in The Netherlands. Anatomic, demographic, procedural, and follow-up data were assessed from hospital records. RESULTS: From November 2013 to December 2014, 51 CIA aneurysms were treated with an IBE in 46 patients. The median diameter of the treated aneurysm was 40.5 (range, 25.0-90.0) mm. The mean procedural time was 198 ± 56 minutes. All but one implantation were successful; two type Ib endoleaks were noticed, resulting in a procedural success rate of 93.5%. The two type Ib endoleaks spontaneously disappeared at 30 days. There was no 30-day mortality. Ipsilateral buttock claudication was present in only two cases at 30 days and disappeared during follow-up. The incidence of reported erectile dysfunction was low and severe ischemic complications were absent. After a mean follow-up of 6 months, data on 17 treated aneurysms were available. Two showed a stable diameter, whereas 15 showed a mean decrease of 3.9 ± 2.2 mm (P < .001). Reinterventions were performed in two patients (7.1%). The 6-month primary patency of the internal component of the IBE device was 94%. CONCLUSIONS: The use of the GORE EXCLUDER IBE device for CIA aneurysms is related to high procedural success, high patency rates, and low reintervention rates at short-term follow-up. Prospective data with longer follow-up are awaited to establish the role of the device in the treatment algorithm of CIA aneurysms.

Vascular access outcome in the elderly dialysis patient in combination with the quality of life.

PURPOSE: We performed a retrospective study on hemodialysis fistulae in patients aged 75 years and older. METHODS: Dialysis records of 2 hospitals were searched for patients of 75 years and older who had primary autologous radiocephalic arteriovenous fistulae (RCAVFs) and brachiocephalic arteriovenous fistulae (BCAVFs). Outcome measures were primary, primary-assisted, and secondary patency rates. Also, quality of life (QOL) was measured. RESULTS: A total of 107 fistulae were placed in 90 patients; 65 (61%) RCAVFs and 42 (39%) BCAVFs were created. The primary patency rate (P = .026) and the primary-assisted patency rate (P = .016) of BCAVFs were significantly higher than that of RCAVFs. Secondary patency rates at 1 year (P = .01) and 2 years (P = .035) were higher in BCAVFs than in RCAVFs. CONCLUSIONS: The BCAVFs give significantly higher primary and primary-assisted patency rates and also significantly higher secondary patency rates at 1 and 2 years. Therefore, we suggest the placement of elbow fistulae in the elderly patients. The QOL was surprisingly high in this population despite a high mortality rate.

Report of two in situ reconstructions with a saphenous spiral vein graft of Coxiella burnetii-infected aneurysms of the abdominal aorta.

Coxiella burnetii is a rare cause of vascular infections. Yet, Q fever is endemic in the southern part of The Netherlands. This report describes two patients--from the southern part of The Netherlands--with infected aneurysms of the abdominal aorta caused by Coxiella burnetii. Both patients underwent surgical debridement, in situ reconstruction with a great saphenous vein spiral graft, and a transmesenteric omentumplasty. One patient fully recovered, while the other died due to ischemic complications. A multidisciplinary work-up approach to treat infected abdominal aneurysms is proposed, including adequate surgical treatment and long-term antibiotic administration.

Infected abdominal aneurysm due to Salmonella sepsis: report of a unique case treated using the superficial femoral vein.

We describe a 61-year-old patient with an infected aneurysm of the abdominal aorta due to Salmonella sepsis. Treatment was successful and included aneurysm resection, extensive debridement, and reconstruction of the abdominal aorta using the superficial femoral vein, combined with long-term antibiotic therapy.

The upside down Gore Excluder contralateral leg without extracorporeal predeployment for aortic or iliac aneurysm exclusion.

Endovascular techniques, including branched devices to preserve the internal iliac artery are evolving rapidly, but in cases in which the diameter of the proximal sealing zone is larger than that of the distal sealing zone, a reversed tapered device is needed. We describe the off label use of the Gore Excluder contralateral leg endoprosthesis in an upside down configuration to accommodate this diameter mismatch. The preinsertion technical steps of stent graft preparation, which do not require extracorporeal predeployment, are described in detail. As such, an aneurysm of the internal iliac artery and a saccular abdominal aortic aneurysm were successfully excluded.