Gore Viabahn Research Articles

Outcomes of Gore Iliac Branch Endoprosthesis With Internal Iliac Component Versus Gore Viabahn VBX

The Gore Excluder iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz) is the only iliac branch device approved in the United States to preserve blood flow to the external and internal iliac arteries (IIAs). In some cases, surgeons have used the Gore Viabahn VBX balloon expandable endoprosthesis (VBX; W.L. Gore & Associates) in the IIA rather than the self-expanding endograft designed for use with the IBE, the internal iliac component (IIC). The objective of the present study was to examine the outcomes in a cohort of patients treated for iliac artery aneurysms with the IBE using either the IIC or VBX.

Alternative Endograft Aortoiliac Reconstruction for Iliac Branch Endoprostheses

Endovascular treatment of complex common iliac artery (CIA) and internal iliac artery (IIA) aneurysms using iliac branch endoprostheses (IBE) has proven safe and effective. Instructions for use (IFU) require deployment of current IBE technology with the corresponding manufacturer's modular bifurcated aortic endograft. Concomitant aortoiliac occlusive disease, inadequate renal artery-iliac bifurcation length, and unfavorable aortic anatomy preclude on-label IBE deployment. This study aimed to evaluate the technical feasibility and safety of Alternative Endograft Aortoiliac Reconstruction (AEGAR) for branched endovascular treatment of complex iliac artery aneurysms. In 7 consecutive patients with CIA or IIA aneurysms, computed tomography angiography (CTA) and center-line reconstruction revealed aortoiliac anatomy incompatible with the current IBE IFU due to inadequate proximal CIA landing zone (n=7), inadequate renal artery to iliac bifurcation length (n=2), compromised aortic anatomy (n=3), or short infrarenal neck <15 mm (n=1), either alone or in combination. To overcome these restrictions and facilitate IBE deployment, aortoiliac reconstruction was performed using the Endologix AFX, Endologix Ovation limbs or the Medtronic Endurant II platforms (AEGAR technique). All internal iliac artery reconstructions and external iliac artery extensions were performed using the Gore VBX or Viabahn stent grafts. Technical success was defined as successful delivery of all endograft components without migration or endoleak. The mean patient age was 69 years (range 52-82 years; 6 male). Four patients had bilateral CIA aneurysms and 3 patients had unilateral CIA aneurysms (mean diameter 4.3cm; range 2.2-7 cm). There were 13 IIA VBX stent grafts used for a total of 9 IIAs treated with IBE (bilateral IBE=2 patients). The mean fluoroscopy time was 38.8 min (range 21.3-64.3 min) and the mean contrast volume was 168.5 mL (range 122-226 mL). Technical success was achieved in all patients and there were no perioperative complications. Mean hospital-stay was 2.2 days (range 1-3 days). Follow-up ranged from 82-957 days (mean=487 days). At last follow-up, all patients were alive without cardiovascular morbidity; and CTA revealed stable or decreased aneurysm size, patent endografts, and no evidence of endoleak or migration. The AEGAR technique can be used to safely and effectively overcome certain aortoiliac anatomic constraints that preclude use of current IBE technology. We encourage broader use of these alternative endografts in pertinent anatomic configurations.

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm.

Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. The two groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing >20% was the most frequent deviation against IFU (n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference >1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17-2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018-2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference >1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.

Thoracic aortic parallel stent-graft behaviour when subjected to radial loading

To manage complex aortic arch disease using minimally invasive techniques, interventionalists have reported the use of multiple stent-graft devices deployed in a parallel configuration. The structural device-device and device-artery interactions arising during aortic arch parallel endografting, also known as chimney thoracic endovascular aortic repair (ch-TEVAR), is not well understood. Through the use of a radial force testing system we sought to characterise both the loading and deformation behaviour of parallel endografts in representative ch-TEVAR configurations. Four commercially available devices (Bentley BeGraft, Gore TAG, Gore Viabahn, and Medtronic Valiant) were subjected to uniform radial load individually, and in six combinations, to quantify loading profiles. Image data collected during testing were analysed to evaluate mechanical deformations in terms of gutters, chimney and main endograft compression, as well as graft infolding. Parallel endografting was found to increase radial loads when compared to standard TEVAR. Chronic outward force during ch-TEVAR was dependent on main endograft manufacturer, with TAG combinations leading to consistently higher loads than Valiant, but independent of chimney graft type. Endograft deformations were dependent on chimney graft type, with Viabahn combinations presenting with lower gutter areas and increased lumen compression than BeGraft. Chimney graft deformations were also influenced by deployment arrangement in the case of double ch-TEVAR. This study emphasizes the significant variability in both radial loads and mechanical deformations between clinically relevant ch-TEVAR configurations.

GORE VIABAHN stent placement for hemostasis of bleeding by pancreatic fistula in four cases

Introduction: Due to recent advances in surgical techniques, and in perioperative management, the mortality rate after pancreaticoduodenectomy (PD) has significantly decreased. However, the morbidity rate remains significantly high after PD. In perioperative management of pancreatic surgery, postoperative abdominal hemorrhaging from the pseudoaneurysm is often fatal and as yet a treatment method has not been established. In the recent years, transcatheter arterial embolization (TAE) has been used for the treatment of this fatal complication, but it may lead to other organs ischemia.

Outcomes of chimney and fenestrated endografting using Viabahn VBX and atrium iCAST stents.

The Atrium iCAST balloon expandable stent is the traditional choice of stent for chimney and fenestrated endovascular aneurysm repair (ChEVAR and FEVAR respectively). Due to the iCAST's lack of flexibility, the Gore Viabahn balloon-expandable stent (VBX; W. L. Gore & Associates, Inc., Newark, DE, USA) has arisen as a flexible alternative for parallel or branch graft placement during complex EVAR. Our purpose was to analyze patients' outcomes after undergoing ChEVAR or FEVAR using VBX or iCAST stents with the major outcome of assessing stent graft patency. The secondary outcome was residual aneurysm sac behavior. We retrospectively reviewed patients who were treated by ChEVAR or FEVAR with placement of iCAST or VBX stents from July 2012 to August 2018. Patients received follow-up CT scan and/or aortic duplex imaging. We examined 53 cases (70% ChEVAR and 30% FEVAR) with 15.6 months (0-76.5 months) mean follow-up period. Placement of stents included renal (65 iCAST and 38 VBX), superior mesenteric (12 iCAST and 13 VBX), celiac (4 iCAST and 5 VBX), and iliac arteries (1 iCAST and 5 VBX). A total of 143 stents (57% iCAST and 43% VBX) were successfully deployed with 100% initial patency. Follow-up patency was similar for both stent types (100% VBX vs 98.7% iCAST). VBX and iCAST had the same follow-up Type 1a endoleak occurrence (9%). Average aneurysm sac sizes for iCAST decreased more than VBX (9% iCAST and 4% VBX, P=0.21), however, the iCAST group had longer follow-up. Our experience demonstrates that the use of VBX stents for ChEVAR and FEVAR is a safe and effective alternative to iCAST stents with excellent mid-term patency without a negative impact on endoleak frequency.

Preliminary Results of Gore Viabahn Balloon-Expandable Endoprosthesis in Visceral and Renal Arteries of Patients Treated With Branched or Fenestrated Endografts for Complex Aortic Aneurysmal Disease

The objective was to retrospectively evaluate perioperative and midterm results of Gore Viabahn balloon-expandable endoprosthesis (VBX; W. L. Gore & Associates, Flagstaff, Ariz) as a visceral bridging stent in fenestrated and branched procedures. From January 2007 to December 2019, 127 fenestrated and branched endovascular aneurysm repairs for complex aortic disease were performed and 460 visceral vessels were included in the repair (3.6 vessels per patient). Data concerning such interventions were prospectively recorded in a certified institutional registry. A retrospective analysis of the registry was performed, and 103 visceral vessels treated with Gore VBX in 28 patients between July 2018 and December 2019 were found. Perioperative results were analyzed in terms of technical success, VBX-related adjunctive procedures, 30-day patency, and reinterventions. The follow-up program consisted of a computed tomography angiography scan at 1 month and yearly thereafter and duplex ultrasound examination at 3 months and every 6 months thereafter. Follow-up results were analyzed in terms of bridging stent-related patency, complications, and reinterventions. The indication for intervention was a thoracoabdominal aneurysm in 18 cases, a juxtarenal dilation in 5 patients, a pararenal aneurysm in 3 patients, a proximal para-anastomotic aneurysm after open aortic reconstruction in 1 case, and a short-neck (<5 mm) aneurysm in another patient. All patients underwent an elective intervention. In 19 cases, a fenestrated graft was placed, and in 4, a branched graft; in the remaining 5 cases, a combination of both fenestrations and branches was the configuration of choice. Overall, 55 renal arteries, 25 superior mesenteric arteries, and 23 celiac trunks were treated with Gore VBX. Technical success was 100%. Additional stent placement into a target visceral vessel to extend the distal landing zone was required in five vessels (4.9%). The asymptomatic occlusion (1/103 [0.9%]) of the VBX for a celiac trunk affected by subocclusive stenosis preoperatively was recorded 20 days after the procedure and was left untreated. No perioperative reinterventions were performed. Median duration of follow-up was 4.4 months (range, 1-14 months); no occlusion was documented. Reintervention rate was 0.9% (1/103); a type IC endoleak from a celiac trunk was diagnosed 3 months after the procedure and was treated with distal placement of another VBX stent graft into the celiac trunk, with complete resolution of the endoleak. In our experience of 103 target visceral vessels, the Gore VBX stent graft guaranteed satisfying perioperative results, providing optimal delivery and adaptability into target vessels. Further investigation is needed to evaluate follow-up results, especially in terms of resistance to the continuous aortic remodeling and the pinching load related to vessel pulsatility.

Initial Results of Selected Use of Covered Stents in Transcarotid Artery Revascularization

Transcarotid artery revascularization (TCAR) is a novel, hybrid approach to treating carotid disease in the treatment of stroke and stroke prevention. Early results of this hybrid approach to carotid stenting using flow reversal have been promising, with reported stroke rates around 1-2.8%.1,2 Currently, carotid stenting, regardless of approach, is performed with uncovered stents, which incurs the risk of plaque protrusion through the stent and in-stent restenosis. Overall, plaque protrusion is a rare event, with a reported incidence of 2.8% on angiography, but it is associated a high rate of ischemic complications (up to 66.7%).3 The use of covered stents could eliminate the risk of plaque protrusion and therefore short to midterm embolic phenomenon during the remodeling process. It also may improve rates of in-stent restenosis as it is a fully covered stent. Adoption of this technique has the potential to further improve the safety, efficacy, and durability of TCAR. We performed a retrospective review of a prospectively maintained database of patients undergoing TCAR with covered stents between September 2018 and December 2019. Procedures were performed by the same operator at 2 separate institutions. Indications included severe asymptomatic or symptomatic carotid stenosis with high-risk lesions defined as lesions 2cm lesions or longer and/or >50% of the lesion containing soft plaque or bleeding carotid pseudoaneurysm. Our primary outcomes included periprocedural and 30-day stroke rates. Secondary outcomes included stent patency and other procedure-related complications. All patients were maintained on clopidogrel postprocedure for 3months and then transitioned to aspirin, unless otherwise indicated. A total of 6 patients underwent TCAR with covered stent angioplasty during this time period. Patient demographics included 5 males and 1 female, with an average age of 70.8±4.6years. Indications for stenting included 4 patients with asymptomatic >70% carotid stenosis and 1 patient with transient ischemic attack-like symptoms and >70% stenosis, and 1 patient with bleeding carotid pseudoaneurysm. Gore Viabahn covered stents were used in all patients. There were no periprocedural or postprocedural ischemic events at 30days. All 6 stents remained patent at follow-up on duplex ultrasound, and all patients remained asymptomatic on clinical follow-up (average 3.4 [1.4-6.9] months). The use of covered stents for TCAR appears to be a safe and effective in select patients requiring carotid intervention. It holds the potential to decrease ischemic events from plaque protrusion and in-stent restenosis in the long-term. Further investigation in device design or clinical evaluation is warranted.

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. Conclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Hybrid Treatment of a True Right Subclavian Artery Aneurysm (SAA) involving the Vertebral Artery (VA) Using the Gore Viabahn Endoprosthesis.

Hybrid Treatment of a True Right Subclavian Artery Aneurysm (SAA) involving the Vertebral Artery (VA) Using the Gore Viabahn Endoprosthesis.

Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms

ObjectiveThe objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms. MethodsPatients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention. ResultsThere were 126 patients (61% male; mean age, 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (−7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months vs 8±8 months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% vs 96% ± 2%; P = .004), freedom from TAI (96% ± 2% vs 88% ± 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% ± 1% vs 92% ± 3%; P = .0004), and freedom from target artery reinterventions (98% ± 1% vs 88% ± 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% vs 99% ± 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001). ConclusionsDirectional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.

1271 Arteriobiliary Fistula Repair With Biliary Endoprosthesis: When Trans Arterial Embolization Is Not an Option

INTRODUCTION: Arteriobiliary fistula is an uncommon complication manifesting as hemobilia or an upper gastrointestinal (GI) bleed. Etiologies include intra-hepatic artery chemo-embolization, trauma or previous invasive biliary instrumentation. We describe a case report of using two fully covered metal biliary stents for closure of an acquired arteriobiliary fistula. CASE DESCRIPTION/METHODS: 20-year-old male with history of neuroblastoma s/p resection and chemoradiation underwent placement of percutaneous transhepatic biliary drain (PTBD) for common bile duct (CBD) strictures. He was admitted to the hospital with acute blood loss anemia, transaminitis and sanguineous output from the biliary drain. Upper endoscopy revealed one clean based gastric ulcer which was injected with epinephrine. Patient was scheduled to undergo replacement of external/internal biliary drain. Intraoperative cholangiogram revealed extensive thrombus within central biliary ducts. It also demonstrated a fistulous connection between the common hepatic duct and the right hepatic artery. Angiogram showed replaced right hepatic artery, originating from superior mesenteric artery with occluded 4 cm proximal end, distal reconstitution was seen via fine collaterals; which made endovascular repair impossible (Figure 1 left). As a temporizing measure, a COOK 16 Fr × 40 cm biliary drain was replaced and advanced beyond the arterial-biliary fistulous connection, serving as a tamponade (Figure 1 right). Over the subsequent days, patient continued to have intermittent sanguineous biliary output. After surgical options were ruled out, two GORE VIABAHN 11 mm × 29 mm balloon expandable fully covered metal stents were deployed within the common bile duct to exclude the biliary-right hepatic artery fistula (Figure 2 left, right). A similar sized biliary drain was replaced subsequently (Figure 3). Hemobilia resolved and hemoglobin remained stable. Patient was discharged successfully to a center of excellence for multivisceral transplant. DISCUSSION: The management of hematobilia often includes an initial cholangiogram, if an arterial source is identified, hepatic artery embolization is the treatment of choice. This unique case demonstrates the utility of an endobiliary prosthesis for exclusion of arteriobiliary fistula where endovascular repair was not an option. The shortest possible endoprosthesis should be used to avoid obliteration of other large vessels or bile duct branches. Complications include bacteremia and liver infarction adjacent to stent-grafts.

Preliminary study of the Gore Viabahn stentgraft as a bridge between branched or fenestrated stentgrafts and target arteries

To evaluate the clinical results of the Gore Viabahn Balloon Expandable (VBX) stentgraft used as a bridge between a fenestrated or branched aortic stentgraft and the target arteries.

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair

The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft. Between April and June 2018, patients undergoing fenestrated and branched-endovascular aortic repair were prospectively collected. Anatomical, procedural, and postoperative data of patients treated with VBX as bridging stents to connect fenestrations/branches to target visceral vessels (TVVs) were analyzed. Technical success and any TVV-related adverse event were assessed before discharge, at 30 days, and after 6months of follow-up. Fifteen patients undergoing fenestrated and branched-endovascular aortic repair for juxta/pararenal aneurysms (11), proximal type I endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study. Overall, 60 TVVs-celiac trunk (n=14), superior mesenteric artery (n=13), renal arteries (n=30), hypogastric artery (n=3)-were accommodated by fenestrations (n=51), branches (n=7), and scallops (n=2). The bridging stent graft was a VBX in 40 (67%) TVVs. A renal artery dissection was successfully managed by a self-expandable bare metal stent. Overall, relining of a bridging stent graft was required in 2 TVVs revascularized by fenestrations (superior mesenteric artery: n=1, renal artery: n=1). One intraoperative type III endoleak from renal fenestration was detected and successfully sealed by an adjunctive flaring maneuver. Technical success was achieved in all cases. At 5-day, 1 VBX (1/40: 2.5%) lost its sealing in a renal artery revascularized by a branch (type II thoracoabdominal aortic aneurysm) and required reintervention and relining with a self-expandable stent graft. No TVV occlusion or reintervention occurred <30 days or after 6months of follow-up. According to these preliminary results, the Gore Viabahn VBX balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts. A longer follow-up with a larger case load is necessary in order to validate this preliminary experience.

Use of the Gore Viabahn VBX balloon‐expandable endoprosthesis in the congenital heart disease population

The Gore Viabahn VBX balloon-expandable endoprosthesis (W. L. Gore & Associates, Flagstaff, AZ) is a flexible covered stent that is FDA-approved for the treatment of iliac artery stenosis, including lesions at the aortic bifurcation. In this case series, we report the first use of the VBX covered stent in congenital heart disease, highlighting several of its unique advantages.

PC042. Performance of Gore Viabahn VBX Compared With Atrium iCast as Bridging Stents During Fenestrated Endovascular Aortic Repairs

Fenestrated endovascular aneurysm repair (FEVAR) is a well-established, effective technique for complex abdominal and thoracoabdominal aneurysm repair. Among various bridging stents, Atrium iCast (Maquet, Rastatt, Germany) covered stents have been adopted by many as the device of choice, with excellent outcomes. Recently, Gore Viabahn VBX stents (W. L. Gore & Associates, Flagstaff, Ariz) became commercially available in the United States. The aim of our study was to compare our experience with VBX and iCast as bridging stents during FEVAR. A retrospective review was performed of FEVARs for complex abdominal and thoracoabdominal aneurysms at a single institution from 2015 to 2018. All patients were at high risk for open repairs. Custom-manufactured or physician-modified devices were implanted. Bridging stents across reinforced fenestrations were included in the study. VBX and iCast stents were compared for technical success, branch patency, branch-related endoleak, and reinterventions. There were 75 patients who underwent FEVAR during the study period; 10 patients had juxtarenal, 23 had pararenal, and 41 had thoracoabdominal aortic aneurysms, and 1 had a pseudoaneurysm. Twenty-four patients were symptomatic, and three patients presented with rupture. A total of 197 branch vessels were targeted with fenestrations. Of 197 targeted branch vessels, 193 (34 celiac, 55 superior mesenteric artery [SMA], 104 renals) were bridged successfully (98%). Four target vessels (three renals and one dominant intercostal) could not be bridged because of severe aortic tortuosity causing fenestration misalignment. A total of 87 vessels were incorporated with iCast and 106 vessels with VBX. The mean follow-up was 5.5 months (6.7 months for iCast and 3.8 months for VBX). Secondary relining stents were used in 14 (16.1%) iCast branches (1 celiac, 3 SMA, and 10 renals) and 8 (7.5%) VBX stents (4 SMA, and 4 renals; P = .072). The 6-month branch patency for iCast was 96.2%, with one celiac and one renal in-stent stenosis; the 6-month patency for VBX was 97.4%, with one celiac branch occlusion (P = .661). At 6 months, there were no branch-related endoleaks for iCast, whereas six VBX branch (5.7%) vessels had type IC endoleak due to branch stent undersizing (P = .033). There were no type III endoleaks across the fenestration seal in either group. Overall short-term branch-related reintervention rate was 0% for iCast and 2.8% (3/106) for VBX (P = .253). One celiac and two SMA endoleaks were intervened on in the VBX group. Gore Viabahn VBX and Atrium iCast show high short-term patency and low endoleak rates as bridging stents during fenestrated endovascular repair of complex abdominal and thoracoabdominal aneurysms. Longer follow-up is needed to assess late device-related complications.

Combined surgical and endovascular treatment with arch preservation of acute DeBakey type I aortic dissection.

DeBakey type I aortic dissection is a catastrophic event that presents a formidable challenge to cardiovascular surgeon. Here, we evaluate a new combined surgical and endovascular technique for acute condition. Between December 2011 and December 2015, 12 patients with type I aortic dissection concomitant involving supra-aortic vessels underwent ascending aortic replacement and simultaneous stent grafts inserted into the descending aorta, left subclavian, and left carotid arteries, and into the innominate artery when possible, without arch replacement. The stent grafts, Gore TAG thoracic endoprosthesis and Viabahn, were deployed under visual guidance through opened aortic arch into the true lumen, with the techniques of circulatory arrest, moderate hypothermia, and bilateral antegrade cerebral perfusion. Operation was performed smoothly in all patients. There was one death, and the other 11 recovered without any neurological deficits. Follow-up computed tomography scans showed that the true lumen expanded and false lumen regressed in both arch and descending aortic segments in 1 year. The diameter did not increase in either arch or descending aortic segments. Ascending aortic replacement and stent graft for supra-aortic arteries and the descending aorta without arch replacement are feasible options for type I aortic dissection with satisfactory short-term aortic remodeling.

Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms

ObjectiveThis study reports the technical aspects and 30-day outcomes of the prospective, multicenter early feasibility study designed to evaluate the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz). MethodsThirteen patients with pararenal or extent IV thoracoabdominal aortic aneurysms were prospectively enrolled at five U.S sites and one non-U.S. site from 2014 to 2016. The TAMBE included four portals with either retrograde or antegrade renal portal configuration and used GORE VIABAHN Balloon-Expandable Endoprosthesis (W. L. Gore & Associates) for stenting of the renal and mesenteric arteries. The primary end point was procedural safety at 30 days, defined by absence of major adverse events, including any-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, severe acute kidney injury (>50% decline in estimated glomerular filtration rate), dialysis, and procedural blood loss >1000 mL. ResultsThere were 11 male and two female patients with a mean age of 69 ± 8 years. Mean aneurysm diameter was 61 ± 13 mm. A total of 52 renal and mesenteric arteries were incorporated (4 vessels/patient). Technical success was achieved in 12 patients (92%). One patient had inadvertent occlusion of a right renal artery due to dissection. There was no mortality, aneurysm rupture, conversion to open repair, dialysis, or spinal cord injury. Mean length of hospital stay was 5 ± 3 days. At 30 days, four patients (31%) had major adverse events, all due to procedural blood loss >1000 mL. One patient had a type I endoleak at the distal renal branch, which was successfully treated by placement of an additional renal stent before dismissal. Computed tomography angiography at 30 days showed patent target vessels and no type I or type III endoleak. ConclusionsThis study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms. The high technical success, no mortality, and low morbidity rate support continuation of clinical investigation in a larger population of patients.

A novel unembalmed human cadaveric limb model for assessing conformational changes in self-expanding nitinol stents in the popliteal artery.

To develop an unembalmed human cadaveric lower limb model as a more realistic environment for testing self-expanding nitinol stents. We studied conformational changes and strain induced by knee flexion in nitinol stents deployed in the popliteal artery (PA). One Lifestent® each was deployed into one limb of four cadavers (control group), while the contralateral leg received a different stent (Absolute®, Protégé Everflex®, Supera®, and Gore Viabahn®). The limbs were mounted on a quasi-static knee rig (QKR) and X-ray imaging was performed at pre-defined knee flexion angles. A least-squares solution to the equation of a circle was used to assess radius of curvature at flexion points (FP), and nominal strain was calculated for each stented artery. There were differences but also some similarities in conformational changes seen in the various stents. Knee flexion produced at least two FP in all stents. The mean radius of curvature decreased with increasing degrees of flexion but more so in distal (main) than proximal (accessory) FP (22 mm vs. 11 mm) in all stents. Supera® stent had the greatest relative radii of curvatures, and Absolute® stent had the highest strain value in comparison to the contralateral PA as the control group. This study describes a novel human cadaveric limb model for testing self-expanding nitinol stents implanted in the PA. Several parameters of conformational change in the stented PA such as FP formation, FP translocation and strain induced by axial compression were described. These may be useful for developing new stents for the PA location.

PC010. Use of a Novel Flexible Covered Stent (GORE VIABAHN VBX) in Fenestrated and Parallel Grafts During Endovascular Treatment of Complex Perivisceral Aortic Aneurysms: Acute Results

PC010. Use of a Novel Flexible Covered Stent (GORE VIABAHN VBX) in Fenestrated and Parallel Grafts During Endovascular Treatment of Complex Perivisceral Aortic Aneurysms: Acute Results