Midterm outcomes of the Viabahn VBX balloon-expandable covered stent for fenestrations during complex endovascular aortic aneurysm repair.

OBJECTIVES: The optimal bridging stent for fenestrations during complex endovascular aortic aneurysm repair (EVAR) has not been defined. At our institution, the Viabahn VBX is frequently used given its availability and mechanical and heparin-bonding characteristics. This study aimed to assess the performance of the Viabahn VBX vs the iCast balloon-expandable covered stents as bridging stents for fenestrations during complex EVAR. METHODS: A retrospective study of consecutive patients undergoing complex EVAR between 2015 and 2021 was performed. Celiac arteries (CAs), superior mesenteric arteries (SMAs), left renal arteries, and right renal arteries stented with fenestrations were grouped according to the type of bridging stent, VBX vs iCast. Target vessels (TV) stented with a branch or scallop were excluded. The primary end points included primary patency and freedom from TV instability. RESULTS: A total of 292 patients undergoing complex EVAR were treated using VBX or iCast with a mean follow-up of 190 days (interquartile range, 36-384 days) for the VBX cohort and 804 days (interquartile range, 384-1507 days) for the iCast cohort. A total of 677 TVs were stented, including 134 CAs (20%), 175 SMAs (26%), 182 left RAs (27%), 186 right RAs (27%), and 12 additional vessels (2%). Proximal reinforcement was more frequent with VBX than with iCast stent (23% vs 2.4%; P < .0001). There was no difference in primary patency rates at 2 years between VBX and iCast stent for CA (100% vs 96.4%; P = .32), SMA (97.8% vs 100%; P = .14), and the RAs (96.7% vs 99.4%; P = .11). There was no difference between VBX and iCast in the cumulative incidence of type Ic and type IIIc endoleaks (3.2% vs 5.6%; P = .69) or freedom from TV instability at 2 years. CONCLUSIONS: Viabahn VBX stents are a safe and effective option as bridging stents in fenestrations during complex EVAR with comparable midterm outcomes to iCast stents. However, proximal stent reinforcement may be required with VBX stent to ensure adequate sealing at the fenestrations. Longer follow-ups and larger series are required to assess long-term outcomes and durability.

Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass.

OBJECTIVE: To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. DESIGN: A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. SETTING: Six centers in the Netherlands. PARTICIPANTS: A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. PRIMARY AND SECONDARY OUTCOMES MEASURES: Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. RESULTS: Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). CONCLUSIONS: Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. REGISTRATION: The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. CLINICAL IMPACT: Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

OBJECTIVE: This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. BACKGROUND: The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. METHODS: Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. RESULTS: At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. CONCLUSION: Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. CLINICAL IMPACT: This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.

Is the Mid-Term Patency Rate of Small-Diameter Viabahn Stent-Grafts in Peripheral Artery Disease Related to Their Length? A Systematic Review.

OBJECTIVE: Small-diameter endografts can be used for the treatment of the peripheral vascular disease, but the patency rate during the follow-up is still under debate. With this review, we aimed at analyzing the mid-term patency of small-diameter Viabahn stent-grafts and investigating the relationship between patency and the length of the graft. METHODS: We performed a review of articles published until September 2020 and reporting use of ≤7-mm-diameter Viabahn stent-grafts in diseased peripheral arteries. Data on study type, demographic, lesion length, stent-graft diameter, length, and patency (1-year, 3-year, 5-year primary patency, primary-assisted patency, and secondary patency), follow-up, endoleak, and re-intervention rates were extracted and analyzed. A statistical test was applied to identify a correlation between stent-graft length and patency. RESULTS: 16 retrospective and 7 prospective studies reported the outcome of 1613 patients (mean age: 69.6±33.7 years). There was considerable heterogeneity in reporting standards among studies. The diameter of Viabahn stent-grafts ranged 5 to 7mm and the average length was 23.6±12.4cm. Heparin-bonded grafts were used in 46.4% of cases. Mean follow-up time was 26.4±17.6 months. The 1- and 5-year primary patency rate was 75.7% (95% CI, 73.6%-77.8%) and 46.8% (95% CI, 41.0%-52.6%), respectively. The 1- and 5-year primary-assisted patency rate was 80.9% (95% CI, 73.9%-87.8%) and 60.9% (95% CI, 46.4-75.5%), respectively. The 1- and 5-year second-assisted patency was 90.4% (95% CI, 87.4%-93.3%) and 73.7% (95% CI, 64.7%-82.8%), respectively. No correlation between the stent-graft length and patency was found. CONCLUSIONS: Small-diameter Viabahn stent-graft implantation represents a safe treatment for patients with peripheral artery disease, and the mid-term patency rate seems not be affected by the length of the graft. CLINICAL IMPACT: The use of small diameter stent-grafts for peripheral vascular disease is an established technique but the patency rate is still under debate. With this review we have investigated the relationship between the mid-term patency and the diameter of the stent-grafts. Afterv having analysed data from 23 published studies including 1613 patients we can conclude that the treatment of the peripheral artery disease with small diameter stent-grafts is safe and the mid-term patency rate seems not be affected by the lenght of the grafts.

Endovascular treatment of postoperative hemorrhage after pancreatectomy: a retrospective study.

BACKGROUND: Ruptured aneurysm is a serious complication of distal pancreatectomy (DP) or pancreatoduodenectomy (PD) that can be life-threatening if not treated promptly. This study aimed to examine the efficacy of a Viabahn stent graft for stopping bleeding after pancreatectomy. METHODS: Between April 2016 and June 2022, we performed 245 pancreatectomies in our institution. Six patients experienced postoperative bleeding and underwent endovascular treatment. RESULTS: All six cases of bleeding occurred post-PD (3.7%). The bleeding was from gastroduodenal artery (GDA) pseudoaneurysms in three patients, and Viabahn stent grafts were inserted. All three patients did not show liver function abnormalities or hepatic blood flow disorders. One patient with a Viabahn stent graft experienced rebleeding, which required further management to obtain hemostasis. Of the six cases in which there was hemorrhage, one case of bleeding from the native hepatic artery could not be managed. CONCLUSIONS: Using the Viabahn stent graft is an effective treatment option for postoperative bleeding from GDA pseudoaneurysms following PD. In most cases, using this device resulted in successful hemostasis, without observed abnormalities in hepatic function or blood flow.

Simultaneous aortoiliac kissing Endovascular stenting for management of isolated monolateral common iliac artery aneurysm with no proximal landing zone.

BACKGROUND: Isolated iliac artery aneurysm (IIAA) is an uncommon finding. It, accounts for 0.03% of all patients and 2% of all abdominal aneurysm. Endovascular approach represents the treatment of choice for most patients with IIAA. We reported our experience on iliac aneurysm with no proximal landing zone by simultaneous aortoiliac kissing endovascular (S.A.K.E.) covered stenting. METHODS: This is a retrospective analysis of nine consecutive patients with IIAA with no proximal landing zone, who underwent endovascular kissing covered stenting (Gore®Viabahn®VBX) The median aneurysm diameter was 4.1 cm, with a median 3-mm proximal neck length. In 3/9 aneurysms involving the internal iliac arteries the origin of the internal iliac artery was covered after its embolization and a stent graft extending to the external iliac artery (EIA) was placed. All stents were flared with semi-compliant balloon. RESULTS: Iliac aneurysm exclusion was obtained in all cases (100%), no graft migration or endo-leak were recorded. The median operative time was 28 min; the median fluoroscopy time was 9 min and a median 70 mL of contrast was used. At a median 24-month follow-up, all patients are alive, and no endo-leak or migration, infection, distal embolization, limb loss were observed. Moderate buttock claudication was experienced in 1/9 patients with internal iliac artery embolization. In 6/9 patients a shrinkage of the aneurysmal sac was recorded after 1 year. DISCUSSION: Endovascular management of IIAAs cases has been reported in literature and it was confirmed to be safe and successful. The IAA usually progresses into expansion which eventually leads into rupture. Adequate long proximal and distal landing zones were the most important feature related to better outcomes. Short proximal neck (˂10 mm) represents a real challenge for iliac aneurysm treatment and, nowadays, a classical bifurcated aortoiliac endograft deployment represents the treatment of choice. Endovascular repair of isolated CIA aneurysms with no proximal neck is safe and successful using the SAKE stenting technique with VBX adequately flared and it represents effective and minimally invasive alternative to aortobiliac endograft implantation in the treatment of these aneurysms. To the best of our knowledge, this is the first report which describes this approach in the treatment of IIAA with no adequate proximal landing zone. Our approach overcomes the need to aortic bifurcation graft implantation and reduces procedure time, contrast dose and radiation exposure. It also preserves relevant collaterals vessels thanks to inferior mesenteric artery and lumbar arteries sparing. A proximal aortic bifurcation endograft allows proximal sealing to be regained. Large population study with longer follow-up are needed to establish this approach as a new standard.

Stent-Graft Placement for Radiation-Induced Abdominal Aortic Stenosis after Renal Autotransplantation.

Renovascular hypertension (RVH) is a common cause of secondary hypertension. However, there have been no reports on RVH due to radiation-induced abdominal aorta stenosis after renal autotransplantation. A 27-year-old woman with a history of neuroblastoma treated by radiation therapy and RVH treated with renal autotransplantation presented with hypertension and dyspnea. At age 19, she had experienced hypertensive heart failure due to RVH from radiation-induced left renal artery stenosis and had undergone renal autotransplantation involving the extraction of her left kidney. Her systolic blood pressure (BP) was well-controlled but had increased progressively. She was diagnosed with hypertensive heart failure and admitted to hospital. Although her dyspnea soon subsided after treatment, her BP remained high. Renal artery ultrasound revealed no obvious stenosis. The ankle brachial pressure index (ABI) showed a significant bilateral decrease to 0.71/0.71 (right/left) from 0.94/0.95 eight years before. Magnetic resonance angiography and aortic angiography revealed severe stenosis in the abdominal aorta, and the systolic pressure gradient of intra-aortic blood flow, distal and proximal to a stenotic lesion, was 58 mmHg. These arterial stenoses in the irradiated area were highly suggestive of radiation-induced vasculopathy. She finally underwent an endovascular VIABAHN VBX balloon-expandable stent-graft placement for this radiation-induced abdominal aorta stenosis, which resolved the pressure gradient. After the procedure, her ABI improved to 0.91/0.88 and her BP was well-controlled. This is the first case of successful stent-graft placement for RVH after renal autotransplantation due to radiation-induced abdominal aorta stenosis as a consequence of neuroblastoma.

Outcomes of Gore iliac branch endoprosthesis with internal iliac component versus Gore Viabahn VBX.

OBJECTIVE: The Gore Excluder iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) is the only iliac branch device approved in the United States to preserve blood flow to the external and internal iliac arteries (IIAs). Some 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 the IBE, the internal iliac component (IIC). The objective of the present study was to examine the outcomes for patients treated for aortoiliac artery aneurysms using the IBE with either the IIC or VBX stent. METHODS: We performed a retrospective, single-center review of patients treated for aortoiliac artery aneurysms using the Gore IBE device, with either the IIC or VBX stent into the IIA, from February 2016 to March 2021. The patient demographics, procedure details, 30-day morbidity and mortality, and 6-month and 1-year outcomes and mortality were analyzed. The categorical factors are summarized using frequencies and proportions. Continuous measures are summarized as the mean ± standard deviation. A significance level of P = .05 was assumed for all test results. The analyses were performed using SAS software, version 9.4 (SAS Institute, Cary, NC). RESULTS: A total of 62 patients (64 arteries) had undergone elective aortoiliac artery aneurysm repair with the IBE. The IIC was used exclusively in 35 cases (55%) and the VBX in 29 (45%). The patients who had received the VBX had had a higher American Society of Anesthesiologists class (P = .006). Upper extremity access was used for VBX delivery in 24.1% of the procedures. No return to the operating room was required in either group. No differences were found in technical success (IIC, 97.1%; VBX, 93.1%; P = .59), the presence of endoleak on completion (20.0% vs 6.9%; P = .17), readmission (97.1% vs 93.1%; P = .59), or mortality (1.6% vs 0%; P = .45) at 30 days. No differences were found in the requirement for any IBE reintervention after 30 days. No type Ia, Ib, or III endoleaks had occurred in either group at any follow-up point. No significant difference was found in internal iliac limb primary patency (IIC, 100%; VBX, 96.3%) between groups. A nonstatistically significant trend was found toward fewer trunk-ipsilateral leg type II endoleaks in the VBX group during follow-up. CONCLUSIONS: These data suggest that the VBX is a reasonable substitute for the IIC, with a comparable safety and efficacy profile. Given its inherent conformability, greater range of diameters, and longer working length, the VBX stent offers expanded IIA branch options with the IBE.

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

OBJECTIVES: The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis. BACKGROUND: The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome. METHODS: After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates. RESULTS: Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up. CONCLUSIONS: Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries.

PURPOSE: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). MATERIALS AND METHODS: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. RESULTS: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. CONCLUSION: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

Viabahn-Assisted Extra-Arterial Bypass Combined With Surgical Arterial Endarterectomy as a Salvage Technique to Treat Critical Limb Ischemia.

BACKGROUND: Revascularization of patients with critical limb ischemia (CLI) is always challenging because of long occlusive arterial lesions with severe calcification and poor general condition. Here we describe a novel hybrid technique to treat a CLI patient. METHODS: The patient was a 60-year-old male with left foot ulcer. Preoperative scan showed long calcific and occlusive lesions running from the left proximal common femoral artery to P1 of the popliteal artery (PA). Surgical endarterectomy was performed on the proximal femoral artery. Then, retrograde PA access was achieved to protect the vital collateral artery at the proximal PA. When the retrograde V18 guidewire failed to advance because of severe occlusion in the middle one-third of the SFA, we punctured the artery with the V18 guidewire, and manually introduced it into the lumen of the proximal SFA. Three Viabahn stent grafts were successively implanted, parts of which were situated outside the SFA. RESULTS: Computed tomography 1 week after surgery showed patent blood flow to the left toes. Good recovery was observed during a 1-year follow up, the toe wound healed after amputation, and no rest pain recurred. Ultrasound showed 60% stenosis in the PA stent, while the other stents were patent. The anklebrachial index of the left limb was 0.48. CONCLUSIONS: This case illustrates successful use of Viabahn-assisted extra-arterial bypass combined with surgical arterial endarterectomy to salvage the limb after CLI. This novel technique might be an alternative in carefully selected patients.

Portomesenteric and portosystemic venous reconstructions in children using balloon-expandable endoprostheses.

BACKGROUND: Portomesenteric and portosystemic venous occlusive disease may lead to portomesenteric hypertension, variceal bleeding, ascites and hypersplenism. Data regarding endovascular reconstructive strategies in children, however, are limited. OBJECTIVE: To report technical success, outcome and patency of portomesenteric and portosystemic venous reconstruction using VIABAHN VBX balloon-expandable endoprostheses in pediatric patients. MATERIALS AND METHODS: Five pediatric patients (median age: 15 years, range: 4-18 years), including 3 (60%) boys and 2 (40%) girls, with portomesenteric or portosystemic venous occlusion or recurrent stenosis, underwent balloon-expandable stent graft reconstruction. Presenting symptoms included acute variceal bleeding, without (n = 2, 40%) or with (n = 1, 20%) splenomegaly, and transfusion-dependent chronic melena (n = 1, 20%). One patient was asymptomatic (n = 1, 20%). Preprocedural imaging included Doppler ultrasound and contrast-enhanced computed tomography (CT) in all patients. Initial imaging showed 4 (80%) occlusions and 1 (20%) recurrent stenosis greater than 50%. Technical aspects of the reconstructions, technical successes, clinical outcomes and adverse events were recorded. Technical success was defined as completion of stent graft reconstruction. Adverse events were categorized according to Society of Interventional Radiology criteria. Clinical success was defined as resolution of the presenting symptoms and/or prevention of portal hypertensive sequela. RESULTS: Venous reconstruction was technically successful in all five patients. Stent graft locations included the main portal vein in 2 (40%), the superior mesenteric vein in 1 (20%), autologous Meso-Rex shunt in 1 (20%) and splenocaval shunt in 1 (20%). Six stent grafts were placed (two stent grafts placed in a single patient). Stent grafts had a median diameter of 7 mm (range: 6-10 mm) and a median length of 59 mm (range: 19-79 mm). Median fluoroscopy time was 36.6 min (range: 13.4-95.8 min) and median air kerma was 301.0 mGy (range: 218.0-1,148.2 mGy). No adverse events occurred. Median clinical follow-up was 18 months (range: 6-29 months). Median imaging follow-up was 17 months (range: 2-29 months). Clinical success was achieved in all patients and maintained during the follow-up period. One patient required follow-up intervention with superior mesenteric vein side extension with a self-expanding bare metal stent due to perigraft stenosis detected on CT 3 months after stent placement. There were no stent graft occlusions. CONCLUSION: Portomesenteric and portosystemic venous reconstruction using balloon-expandable stent grafts in pediatric patients was feasible and clinically successful in this preliminary experience. Additional studies are warranted.

Application of covered stent graft in the treatment of complex carotid artery lesions: A single center experience.

PURPOSE: To assess the clinical efficiency and imaging outcome of applying covered stent grafts for the treatment of complex carotid artery lesions. METHOD: A total of 39 consecutive patients with carotid artery lesions treated with covered stent grafts at our institution from December 2016 to December 2019 were reviewed. Two kinds of stent including self-expandable covered stent (Viabahn; W. L. Gore & Associates) and balloon-expandable covered stent (Willis; Microport) were applied. The angiograms immediately after the procedure, perioperative complications, and follow-up outcomes were recorded. RESULT: Based on imaging features, 11 patients exhibited pseudoaneurysms, 23 patients had blood blister-like aneurysms (BBAs), and five patients were carotid cavernous fistulas. A total of 40 stent implantations were performed, including nine Viabahn stents and 31 Willis stents. Two patients received double implants of Willis stents. Stent failed to perform for one patient due to tortuous parent artery. The angiography reports immediately after the procedure showed that the lesions in 36 patients were completely occluded, whereas two patients had minimal endoleaks. With respect to the occurrence of procedural complications, an aneurysm ruptured during the procedure in one case, which resulted in CCF, and acute in-stent thrombosis occurred in another case. Clinical and angiographic follow-up (11.2±2.4 months) sessions were conducted for 38 patients and a complete lesion exclusion was achieved in 36 patients. The minimal endoleak persisted in one patient and another patient experienced recurrence with stent migration, leading to ipsilateral blepharoptosis. However, none of the patients developed hemorrhage or ischemia and in-stent stenosis was not observed. CONCLUSION: Covered stent grafts appear to be a safe and feasible for the treatment of complex carotid artery lesions. Despite the potential for stent delivery failure as well as endoleak and procedure-related complications, covered stent grafts should be considered when selecting the optimal treatment strategy.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery.

OBJECTIVE: We assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). METHODS: The present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. RESULTS: Of the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. CONCLUSIONS: Stent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

Drug-coated balloon angioplasty for the treatment of edge stenosis after self-expanding covered stent placement for superficial femoral artery occlusive disease.

BACKGROUND: Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. PURPOSE: The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. METHOD: We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). RESULTS: A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). CONCLUSION: The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

[Analysis of curative efficacy of transjugular intrahepatic portosystemic shunt using viabahn stent in the treatment of Budd-Chiari syndrome with extensive hepatic vein occlusion].

Objective: To investigate the efficacy of transjugular intrahepatic portosystemic shunt (TIPS) using viabahn stent in patients with Budd-Chiari syndrome (BCS) with extensive hepatic vein occlusion. Methods: Technical success rates, portal pressure gradient (PPG), complications and shunt patency rate of 25 cases with BCS with extensive hepatic vein occlusion treated by TIPS using viabahn stent were retrospectively analyzed. Color Doppler ultrasound was used for postoperative follow-up. Patency rates were evaluated by Kaplan-Meier curve. Results: The technical success rate of TIPS was 100%. Mean PPG decreased from (22.7 ± 6.2) mmHg preoperatively to (9.7 ± 2.6) mmHg postoperatively (t = 9.58, P < 0.05). Hepatic encephalopathy incidence was 8.0% (2/25), and there were no complications such as intra-abdominal hemorrhage. Twenty-five cases were followed up for 1 to 39 ( mean 19.0 ± 11.9) months, and one patient died of liver failure three months after interventional treatment. The primary patency rates at 1, 2, and 3 years after interventional treatment were 91.3%, 91.3%, and 78.2%, respectively, while the repatency rates were 100%, 92.9%, and 92.9%, respectively. Conclusion: TIPS using viabahn stent can bring better short-term and mid-term curative efficacy in treatment of BCS with extensive hepatic vein occlusion.

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease.

OBJECTIVE: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. METHODS: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. RESULTS: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. CONCLUSIONS: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.

Hybrid Viabahn-Assisted Bypass for Long Femoro-Popliteal Occlusive Disease　- Midterm Results.

BACKGROUND: Endovascular therapy has become the first-line treatment for most peripheral artery diseases, but re-entry into the true lumen is not always possible, particularly in some cases of chronic total occlusion (CTO). We previously reported a novel hybrid Viabahn-assisted bypass (VAB) technique to facilitate revascularization of the femoro-popliteal CTO. This study assessed the midterm results of VAB technique.Methods and Results:Between January 2013 and April 2017, 440 patients received femoro-popliteal intervention and 17 of them (mean age, 76.2 years; 11 male patients) were treated using the VAB technique. The technical success was 100%. The mean follow-up period was 27.4±14.4 months (range, 6-50 months). Two patients underwent major amputation at 6 and 11 months postoperatively, but they died of acute myocardial infarction and of sepsis, respectively. Another 3 patients received re-intervention because of edge stenosis of the Viabahn stent graft. Another patient had acute Viabahn thrombosis and was treated using open thrombectomy. The primary and secondary patency rates at 12 months were both 88.2%, and at 24 months they were 69.2% and 84.6%, respectively. CONCLUSIONS: The VAB technique could be a safe and feasible alternative treatment for long femoro-popliteal CTO when conventional treatments fail. The technical success is high, and the midterm patency rates are acceptable.

Clinical Outcome of Isolated Popliteal Artery Aneurysms Treated with a Heparin-bonded Stent Graft.

OBJECTIVE: The use of self-expanding stent grafts for treatment of popliteal artery aneurysms (PAA) is a matter of debate, although several studies have shown similar results compared with open surgery. In recent years, a new generation stent graft, with heparin-bonding technology, became available. The aim of this study is to present the results of endovascular PAA repair with heparin-bonded stent grafts. METHODS: Data on all patients with PAA treated with a heparin-bonded polytetrafluoroethylene (ePTFE) stent graft between April 2009 and March 2014 were gathered in a database and retrospectively analyzed. Data were collected from four participating hospitals. Standard follow-up consisted of clinical assessment, and duplex ultrasound at 6 weeks, 6 months, 12 months, and annually thereafter. The primary endpoint of the study was primary patency. Secondary endpoints were primary-assisted and secondary patency and limb salvage rate. RESULTS: A total of 72 PAA was treated in 70 patients. Mean age was 71.2 ± 8.5 years and 93% were male (n = 65). The majority of PAA were asymptomatic (78%). Sixteen cases (22%) had a symptomatic PAA, of which seven (44%) presented with acute ischemia. Early postoperative complications occurred in two patients (3%). Median follow-up was 13 months (range 0-63 months). Primary patency rate at 1 year was 83% and after 3 years 69%; primary assisted patency rate was 87% at 1 year and 74% after 3 years. Secondary patency rate was 88% and 76% at 1 and 3 years, respectively. There were no amputations during follow-up. CONCLUSION: Endovascular treatment of PAA with heparin-bonded stent grafts is a safe treatment option with good early and mid-term patency rates comparable with open repair using the great saphenous vein.