Viabahn Stent Graft Research Articles

Endovascular treatment with Viabahn stent-grafts for arterial injury and bleeding at the visceral arteries: initial and midterm results

PurposeThe purpose of the study is to evaluate the initial and midterm efficacy and safety of endovascular treatment (EVT) using Viabahn stent-graft (SG) for arterial injury and bleeding (AIB) at the visceral arteries.Materials and methodsConsecutive patients with visceral AIB who underwent EVT using Viabahn between January 2017 and February 2021 were retrospectively reviewed. Technical success, clinical success, peripheral organ ischemia, peri-procedural complications, bleeding-related mortality, 30-day mortality, neck length, re-bleeding, endoleaks, and patency of the SGs at 1, 3, 6, and 12 months were evaluated.ResultsEVT using Viabahn was performed in 14 patients (mean age: 68.6 years; 12 males) and 15 arteries. The technical and clinical success rates were 100%. The rates of peripheral organ ischemia, peri-procedural complications, bleeding-related mortality, and 30-day mortality were all 0%. The mean neck length was 9.9 mm. No endoleaks or re-bleeding occurred during the follow-up (mean: 732 days). The SG patency was confirmed after 1, 3, 6, and 12 months in 78.6%, 78.6%, 78.6%, and 56.1% of the patients, respectively.ConclusionEVT using Viabahn for AIB at the visceral arteries was safe and effective. SG occlusions without ischemia often occurred after 12 months.

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.

Viabahn stent graft in the treatment of traumatic axillary artery pseudoaneurysm.

Viabahn stent graft in the treatment of traumatic axillary artery pseudoaneurysm.

Popliteal artery aneurysms treatments: early midterm results of the use of endovascular stent grafts

Background/aimPopliteal artery aneurysms (PAAs) are abnormal bulgings, which account for 70% of all peripheral artery aneurysms. They are usually asymptomatic. In this study, we present our long-term results of endovascular stent grafts in the treatment of PAA in the light of literature data.Material and methodsA total of 63 legs of 63 patients with PAA, who were treated with endovascular techniques in our clinic between July 2010 and July 2019, were retrospectively analyzed. All patients underwent color Doppler ultrasound (DUS), magnetic resonance angiography (MRA), or computed tomography angiography (CTA) to identify the diameter and length of PAAs, vessel tortuosity, the presence and degree of thrombus, and diameter in the healthy landing zone and to visualize tibioperoneal vascular structures. A Viabahn stent graft was inserted in all patients.Results57 patients (90.5%) were males with a mean age of 76.35 ± 7 years. 24 patients (38.1%) were symptomatic, while 11 patients (17.5%) had a concomitant abdominal aortic aneurysm (AAA). The mean follow-up period was 46.05 ± 25.01 months. The primary patency rate was 79.3%. A graft thrombosis was observed in 13 patients (20.6%) during a mean follow-up period of 8.31 ± 5.91 months. The number of distal arteries was significantly lower in the patients with thrombosis than those without.ConclusionsEndovascular treatment of PAA using stentgrafts is safe in selected cases. However, it is reasonable to avoid endovascular treatment due to an increased risk for thrombosis in patients with a low number of patent distal arteries or impaired distal flow.

Late Vascular Injury at Both Edges of the VIABAHN Stent Graft after Endovascular Repair for Idiopathic Superficial Femoral Artery Rupture.

The VIABAHN stent graft is often used for traumatic and iatrogenic vascular injuries. In this case, vascular injury at both edges of the VIABAHN stent graft was noted 4 months after endovascular repair for idiopathic superficial femoral artery (SFA) rupture. The longitudinal compression of the SFA with a decrease in hematoma size was assumed to exceed the flexibility of the stent graft. Thus, the use of stent grafts for vascular injuries with giant pseudoaneurysms may result in late vascular injuries at both edges of the stent graft. Therefore, cautious assessment of its indications and strict surveillance are required.

Did You Say “Flexible”?

A 48 year old patient was referred with a 45 mm post-anastomotic dilation of a retrograde venous aortohepatic bypass (A) performed four years ago for hepatic ischaemia. Endovascular treatment was preferred because of a persistent thrombocytopenia. An “endo-bypass” using 7 and 6 mm Viabahn stent grafts (W.L. Gore & Associates, Flagstaff, AZ, USA) and common hepatic artery embolisation (6 mm Amplatzer Vascular Plug 4; Abbott Vascular, Santa Clara, CA, USA) were performed to exclude the aneurysm with an adequate sealing zone. One year computed tomography angiography showed thrombosis of the venous bypass aneurysm, satisfactory stent patency, and a collateral arterial network to the spleen (B).

Remote endarterectomy to remove infected Viabahn stent-graft

Infection of peripheral arterial vascular grafts and stent-grafts represents a complex surgical scenario, with a number of proposed management strategies. Surgical removal of infected material with adjunctive arterial reconstruction is often required. However, surgical removal is often difficult and complex. This case study demonstrates an infected Viabahn stent-graft between the external iliac artery and the superficial femoral artery, with arterial autolysis of the common femoral artery and proximal superficial femoral artery, in which a hybrid technique combining remote endarterectomy and surgical debridement was used to remove the infected stent-graft.

Covered Endovascular Reconstruction of the Popliteal Artery Bifurcation in a Patient with a Popliteal Aneurysm

Popliteal artery aneurysms (PAAs) can present as extensive disease entities that predispose to distal ischaemic complications. Endovascular repair has become a common intervention but is typically limited to a single tube exclusion of the PAA that necessitates a distal landing zone. Presented is a technique of covered endovascular reconstruction of the popliteal artery bifurcation (CERPAB) using Viabahn Endoprosthesis (Gore & Associates, Flagstaff, AZ, USA) covered stent grafts delivered via a percutaneous femoral approach in a patient with extensive PAA with anterior tibial artery (ATA) and tibioperoneal trunk (TPT) involvement. A 79 year old patient presented with a PAA (20 mm diameter) with irregular luminal narrowing extending into the proximal ATA (5 mm diameter) and TPT (6 mm diameter), which was regarded as aneurysmal (normal diameter 3 mm). The patient was asymptomatic but showed growth under surveillance. Under general anaesthesia and through a percutaneous antegrade left femoral approach a 9 × 150 mm standard profile Viabahn stent graft was placed in the popliteal artery as a main body through a 10 F sheath using a 0.035 inch wire. The ATA and TPT were cannulated separately with subsequent placement, simultaneous deployment and kissing balloon dilatation of 6 × 50 mm and 7 × 50 mm low profile stent grafts in the respective arteries using a 0.018 inch platform through a single sheath, overlapping the popliteal stent graft by 3 cm. Procedural angiography (Fig. 1) showed successful exclusion of the PAA with adequate run off distally. Post-operatively, dual antiplatelet therapy with clopidogrel and aspirin was started and the patient was discharged home the next day. Follow up computed tomography at three months showed adequate patency (Fig. 2) with no complications during this period.Figure 2(A) Computed tomography angiography at the three month follow up showing a patent covered reconstruction of the popliteal artery bifurcation by Viabahn stent grafts with 3 cm of overlap. (B) Volume rendered computed tomography scan reconstruction of the covered endovascular reconstruction at the three month follow up.View Large Image Figure ViewerDownload Hi-res image Download (PPT) CERPAB seems to be a possible modality for treatment of patients with PAAs and involvement of the ATA and TPT by reconstructing the popliteal bifurcation and successfully excluding the aneurysmal tract from the peripheral circulation. This procedure is reminiscent of covered endovascular repair of the aortic or femoral bifurcation and allowed exclusion of the PAA without a distal landing zone. To the best of the authors’ knowledge, this is the first time such a procedure has been reported.

Clinical Impact of Stent Graft Thrombosis in Femoropopliteal Arterial Lesions.

This study sought to elucidate the clinical impact and prognosis of stent graft (SG) thrombosis. The VIABAHN SG offers a favorable outcome in long peripheral artery occlusive disease (PAOD) lesions in the femoropopliteal artery. One concern after SG deployment is the incidence of stent thrombosis and consequent acute limb ischemia (ALI). In this retrospective multicenter study, we collected the clinical data of PAOD patients treated with VIABAHN SG who subsequently experienced SG thrombosis. The clinical symptoms of SG thrombosis, patency after reintervention, and predictors of loss of patency after reintervention were examined. VIABAHN SGs were used for 1,215 patients; SG thrombosis occurred in 159 (13%) patients at a median of 6.4 months (interquartile range: 2.8 to 13.5 months) after SG implantation; 21 (13%) patients presented with ALI. A total of 131 (82%) patients underwent reintervention for SG thrombosis, whereas 2 (1%) underwent primary major amputation and the remaining 26 (16%) were treated conservatively. The patency rate 1 year after reintervention, freedom from major adverse limb events, and limb salvage after reintervention were 54.9%, 73.6%, and 92.5%, respectively. Critical limb-threatening ischemia at SG implantation and ALI presentation at SG thrombosis were positively associated with an increased risk of rethrombosis, whereas distal stent diameter was negatively associated with the risk of rethrombosis. SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal.

Endovascular Relining of Chronically Occluded Infrainguinal Venous Bypass Grafts

Treatment of chronically occluded infrainguinal venous bypass grafts in patients presenting with recurrent chronic limb threatening limb ischemia (CLTI) represent a clinical challenge. Recent case reports have suggested the use of endovascular recanalization techniques without preceding thrombolysis. This study assesses feasibility and mid-term outcomes of this technique. A retrospective review of 5 consecutive patients (3 men, 2 women, mean age 70 ± 5 years) presenting with chronic venous bypass graft occlusion and recurrence of CLTI during 1 year was performed. Patients were treated with relining of the bypass grafts. Patients were followed up at median 26 (6-36) months. All patients were treated successfully with restoration of flow in the grafts using recanalization and relining technique without thrombolysis. In 4 patients, a Viabahn stentgraft (SG) was used with the addition of interwoven nitinol stents (INS) in 3. In 1 patient, the graft was treated with INS without the addition of a stentgraft. No peripheral embolization was encountered during the procedures. One patient occluded the relined grafts after 6 months. The remaining 4 grafts were all patent at 24-month follow-up. A total of 6 reinterventions (in 3 patients) were performed to reach 80% secondary patency. This case series demonstrate feasibility and promising mid-term results, from relining of chronically occluded infra-inguinal venous bypass grafts using stent grafts, interwoven and bare-metal stents without preceding thrombolysis. The technique could be an alternative treatment option in the treatment of these challenging cases.

Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions

Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings. This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10cm or longer with reference vessel diameters of 4.0 to 7.5mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis. In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P= .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P= .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction= .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction= .034). Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Endovascular Treatment with VIABAHN Stent Graft for a Popliteal Pseudoaneurysm after Total Knee Replacement: Report of a Case

Endovascular Treatment with VIABAHN Stent Graft for a Popliteal Pseudoaneurysm after Total Knee Replacement: Report of a Case

Three Cases of Hybrid Treatment Using Viabahn Stentgraft for Superficial Femoral Artery Occlusion with Common Femoral Artery Lesion

Three Cases of Hybrid Treatment Using Viabahn Stentgraft for Superficial Femoral Artery Occlusion with Common Femoral Artery Lesion

Coronary artery perforation treated with Viabahn stent graft: A case report

Coronary artery perforation is a rare but serious complication of percutaneous coronary intervention. This case report describes a patient with Grade III perforation of the left anterior descending coronary artery who underwent placement of a peripheral arterial stent graft due to persistent contrast extravasation refractory to conventional coronary stent graft placement and balloon tamponade.

One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

Purpose: To evaluate the real-world primary patency of heparin-bonded stent-graft therapy for femoropopliteal (FP) occlusive disease and identify any clinical factors, including the prothrombotic state, associated with the loss of patency. Materials and Methods: This multicenter study prospectively enrolled 424 limbs of 371 patients (mean age 75±8 years; 247 men) scheduled for Viabahn stent-graft placement in the FP segment. A full-coverage strategy using only a Viabahn stent-graft was preferred, but “spot stenting” with the Viabahn was also allowed. The prothrombotic state was assessed by measuring platelet reactivity. Vascular morphology was evaluated using intravascular ultrasound (IVUS). Primary patency was estimated using the Kaplan-Meier method in the subgroup of patients having full lesion stent-graft coverage (n=343 limbs, 81.1%). The secondary outcomes were major amputation, surgical reconstruction, target lesion revascularization (TLR), and thrombotic occlusion. Regression analyses were used to explore associations of baseline and clinical variables with loss of patency; the results are given as the odds ratio (OR) and 95% confidence interval (CI). Results: The 1-year primary patency estimate was 80.3% (95% CI 75.5% to 85.1%) in the full-coverage group. There were 7 surgical reconstructions, 46 TLRs, 21 acute thrombotic occlusions, and 1 major amputation during the 1-year follow-up in the full-coverage group. Only angiography- and IVUS-determined vessel diameters were significantly associated with loss of patency, with crude ORs of 0.64 (95% CI 0.45 to 0.89, p=0.009) and 0.67 (95% CI 0.51 to 0.90, p=0.009), respectively, per 1-mm increase, whereas other variables, including the prothrombotic state (p=0.74), were not. Multivariable analysis demonstrated that only IVUS-determined vessel diameter was independently associated with loss of patency (adjusted OR per 1-mm increase 0.72, 95% CI 0.52 to 1.00, p=0.049). Conclusion: FP stent-graft placement achieved acceptable patency at 1 year in a real-world setting. A smaller vessel size was significantly associated with loss of patency, whereas the prothrombotic state was not.

A case report of a perigraft inflammatory reaction to a Viabahn stent-graft: diagnosis with MRI and treatment with steroids

BackgroundPerigraft inflammatory reactions to prosthetic graft materials in vascular surgery have been reported; however, to our knowledge, this is the first report of a perigraft inflammatory reaction to a Viabahn stent-graft used in a superficial femoral artery occlusion lesion.Case presentationA 76-year-old man with right leg claudication was diagnosed with a right superficial femoral artery occlusion via contrast-enhanced computed tomography. Endovascular treatment included intravascular ultrasound for passing through the true lumen. A 25-cm Viabahn stent-graft (diameter 5 mm) was implanted. The patient developed pain and local swelling of the right thigh 5 days after endovascular treatment. Blood analysis revealed elevated inflammatory marker levels. Magnetic resonance imaging revealed extensive soft-tissue edema and a high perivascular T2 signal around the right superficial femoral artery. Clinical symptoms resolved within 7 days after initiating steroid therapy, which was gradually decreased and halted after 3 weeks. Follow-up magnetic resonance imaging demonstrated substantially reduced inflammation over the following months.ConclusionsPerigraft inflammatory reaction to a Viabahn stent-graft implant can be immediately diagnosed via magnetic resonance imaging and treated with steroids to reduce the possibility of stent-graft occlusion.

Efficacy of stent-graft placement to salvage central vein stents with recalcitrant restenosis in patients with arteriovenous fistulas.

The purpose of this study was to determine the effectiveness and permanency of stent-graft placement to salvage stents with recalcitrant restenosis due to central vein stenosis (CVS). Between May 2014 and February 2016, VIABAHN stent-grafts were deployed in patients with functioning arteriovenous (AV) fistulas who underwent previous bare metal stent (BMS) placement and had recalcitrant stent restenosis that did not respond to percutaneous transluminal angioplasty (PTA). Surveillance was carried out at 3, 6, 12, 18, and 24months with diagnostic fistulography. Fourteen patients initially underwent 15 BMS placements. In the follow-up period (range, 118-976days), patients presented with symptomatic venous hypertension; subsequently, a total of 52 unsuccessful repeat PTAs for BMS restenosis were undertaken, and the median primary access survival of PTAs was 66±43days. For salvage, 14 stent-grafts were placed in segments with recalcitrant restenosis of a CVS stent. Within 1.25±0.72days after stent-graft placement, patients who initially presented with symptomatic venous hypertension reported complete resolution. The median primary access survival (mean, 1183±312days) was longer than PTAs alone (P<.01). No major or minor complications were associated with stent-graft deployment or any of the subsequent interventions in the study period. The primary patency rate at 6, 12, and 18months was 100%, and it was 85.7% at 24months. The secondary access patency rate was 92.9% at 24months. In conclusion, stent-graft placement to salvage CVS stents with recalcitrant restenosis in patients with AV fistulas is safe and effective if PTAs fails to maintain luminal patency.

Floating Stent-Graft as a Support to Bridge an Unfavorable Renal Artery During Postdissection TAAA Repair Using a Multibranched Thoracoabdominal Endograft

Purpose: To report an unusual endovascular technique to manage unfavorable renal artery anatomy encountered in an urgent case of symptomatic postdissection thoracoabdominal aortic aneurysm (TAAA) treated with an off-the-shelf multibranched device. Technique: The technique is demonstrated in a 77-year-old woman who had a history of previous open abdominal aortic aneurysm repair and an emergent procedure to implant a thoracic endograft and an aortic bare Z-stent (PETTICOAT) for acute Stanford type B dissection 7 years prior. The patient presented with a symptomatic, rapidly growing, postdissection TAAA. Endovascular treatment with a Zenith t-Branch was planned. After standard catheterization techniques failed in the left renal artery, a bailout maneuver was utilized to place a “floating” Viabahn stent-graft in the aneurysm sac to create sufficient support to deliver the bridging stent-grafts through the bare stent to the target left renal artery. The procedure was successful in excluding the TAAA and preserving perfusion to all target vessels. No neurological complications occurred. Six-month imaging follow-up confirmed the patency of the bridging stents. Conclusion: Remodeling changes after complex endovascular TAAA procedures often require the use of innovative techniques and materials during secondary procedures. In this case, the presence of a post-PETTICOAT bare aortic stent and hostile target artery anatomy increased the technical difficulty of t-Branch implantation. A “floating” stent-graft could be useful to reach challenging target vessels by providing additional support to bridging stent advancement and deployment.

Eligibility of Endovascular Repair for Popliteal Artery Aneurysms According the Instructions for Use

Popliteal artery aneurysms (PAAs) are the most common peripheral aneurysms. Although rare and often asymptomatic, there is a significant risk of thrombosis, embolism, and limb loss. The aim of this study was to evaluate the eligibility for endovascular repair of patients treated for symptomatic and asymptomatic PAAs in accordance with the instructions for use (IFU). All patients treated for PAA with open surgical repair between the years 2010 and 2017 were analyzed if suitable for endovascular treatment. Preoperative imaging was reviewed for applicability with an interventional radiologist and 2 vascular surgeons. Evaluation was performed in accordance with the following criteria adopted from the IFU of the Gore ® Viabahn stent graft: at least a single-vessel tibial runoff, proximal and distal landing zone more than 2cm, no large difference in vessel diameter proximal and distal to the aneurysm, no overstenting of significant collaterals necessary, and no inadequate kinking of the artery. The patients were classified in 3 categories: the patient was eligible, endovascular treatment was feasible, and endovascular treatment was not appropriate. 51 patients with 61 symptomatic and asymptomatic PAAs were identified. Forty-five cases were asymptomatic, 11 cases showed clinical symptoms such as claudication, and in 5 cases, the patients presented with acute ischemia. Twenty-four patients were eligible for endovascular intervention, 14 cases were feasible, and in 23 cases, it was not appropriate in accordance with the IFU. In this study, more than one-third of the patients with PAA were not eligible for endovascular treatment in accordance with the IFU and another 23 % showed substantial reasons against endovascular treatment. These data suggest that endovascular repair remains a treatment option for selected patients only. Cross-sectional imaging is mandatory for procedure selection.

Use of VIABAHN Stent Graft for Subclavian Artery Injury due to Inadvertent Catheter Placement

Use of VIABAHN Stent Graft for Subclavian Artery Injury due to Inadvertent Catheter Placement