scholarly journals First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease

2016 ◽  
Vol 24 (1) ◽  
pp. 11-18 ◽  
Author(s):  
Andrew Holden ◽  
Stephen Merrilees ◽  
Brendan Buckley ◽  
Brigid Connor ◽  
Frances Colgan ◽  
...  

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.

2013 ◽  
Vol 12 (2) ◽  
pp. 91-101
Author(s):  
Leonardo Ghizoni Bez

BACKGROUND: Endovascular treatment of peripheral arterial occlusive disease has become increasingly frequent in the past few years. Because it is a less invasive procedure, lower morbidity and mortality rates are associated with this form of treatment. OBJECTIVES: To describe the endovascular procedures performed in iliac arteries for the treatment of peripheral arterial occlusive disease. METHODS: This retrospective study assesses 59 cases of iliac artery angioplasty performed according to a specific protocol from January 2004 to February 2010. RESULTS: Mean age of patients was 62 years (minimum: 42, maximum: 89). Thirty seven were male (62.72%) and 22 female (37.28%). The main indications for treatment were moderate to severe intermittent claudication in 30 cases (50.84%) and rest pain or trophic lesions (critical ischemia) in 29 cases (49.15%). Postoperative follow-up included ankle-brachial index measurements and a duplex ultrasound at 30 days, 3 months, 6 months, 12 months, and every 6 months thereafter. Minimum follow-up time was 3 months, and maximum, 72 months (6 years), with primary and secondary patency rates of 91.37 and 94.82%, respectively. CONCLUSIONS: The results of this case series, combined with literature review results, allow to conclude that the endovascular approach is an effective and safe option to treat peripheral arterial occlusive disease in iliac arteries.


2018 ◽  
Vol 26 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Erik Groot Jebbink ◽  
Suzanne Holewijn ◽  
Michel Versluis ◽  
Frederike Grimme ◽  
Jan Willem Hinnen ◽  
...  

Purpose: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. Materials and Methods: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. Results: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. Conclusion: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.


Medicina ◽  
2013 ◽  
Vol 48 (12) ◽  
pp. 96
Author(s):  
Žana Kavaliauskienė ◽  
Aleksandras Antuševas ◽  
Rytis Kaupas ◽  
Nerijus Aleksynas

The rate of endovascular interventions for iliac occlusive lesions is continuously growing. The evolution of the technology supporting these therapeutic measures improves the results of these interventions. We performed a review of the literature to report and appreciate short- and long-term results of endovascular stenting of iliac artery occlusive lesions. The Medline database was searched to identify all the studies reporting iliac artery stenting for aortoiliac occlusive disease (Trans Atlantic Inter-Society Consensus [TASC] type A, B, C, and D) from January 2006 to July 2012. The outcomes were technical success, long-term primary and secondary patency rates, early mortality, and complications. Technical success was achieved in 91% to 99% of patients as reported in all the analyzed articles. Early mortality was described in 5 studies and ranged from 0.7% to 3.6%. The most common complications were access site hematomas, distal embolization, pseudoaneurysms, and iliac artery ruptures. The complications were most often treated conservatively or using percutaneous techniques. The 5-year primary and secondary patency rates ranged from 63% to 88% and 86% to 93%, respectively; and the 10-year primary patency rates ranged from 68% to 83%. In this article, combined percutaneous endovascular iliac stenting and infrainguinal surgical reconstructions and new techniques in the treatment of iliac stent restenosis are discussed. Iliac stenting is a feasible, safe, and effective method for the treatment of iliac occlusive disease. Initial technical and clinical success rates are high; early mortality and complication rates are low. Longterm patency is comparable with that after bypass surgery.


Vascular ◽  
2021 ◽  
pp. 170853812110183
Author(s):  
Ottavia Borghese ◽  
Ciro Ferrer ◽  
Carlo Coscarella ◽  
Claudio Spataro ◽  
Nicolò Diotallevi ◽  
...  

Objective To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. Methods A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients’ clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate. Results During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1–9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6–48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) ( P < 0.001) and target lesion revascularization rate was 12.5%. At two years, the limb salvage rate was 100%, and primary and secondary patency rates were 87.5% and 100%, respectively. Conclusion CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.


2020 ◽  
Vol 27 (5) ◽  
pp. 728-736 ◽  
Author(s):  
Jean M. Panneton ◽  
Jean Bismuth ◽  
Bruce H. Gray ◽  
Andrew Holden

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.


Angiology ◽  
2021 ◽  
pp. 000331972199137
Author(s):  
Ender Özgün Çakmak ◽  
Emrah Bayam ◽  
Fatih Yilmaz ◽  
Muzaffer Kahyaoğlu ◽  
Mehmet Çelik ◽  
...  

We report the results of endovascular treatment of Trans-Atlantic Inter-Society Consensus II (TASC) A&B, TASC C, and TASC D aortoiliac lesions in a single vascular center. In this retrospective, observational cohort study, we analyzed 395 patients (mean age 61.2 ± 9.0; 359 men) between January 2015 and December 2017. Technical success was achieved in 96.5%; in-hospital mortality was 1.2% (n = 5). Median follow-up was 36 months (range 24-49 months). After 1 and 5 years, the primary patency rates were 99% and 85% for TASC A&B, 90%, and 78% for TASC C, and 90% and 74% for TASC D. Secondary patency rates were 99% and 90% for TASC A&B, 98% and 65% for TASC C, and 97% and 65% for TASC D. Previous peripheral revascularization (hazard ratio: 1.76, 95% CI: 1.01-3.08, P = .04) was associated with decreased primary patency along with lower age, TASC C, and TASC D class. This analysis reported the acceptable effectiveness and safety of stenting for all types of aortoiliac occlusive disease in a modern setting, with few complications and excellent long-term primary and secondary patency rates.


2021 ◽  
pp. 152660282110250
Author(s):  
Athanasios Saratzis ◽  
Murtaza Salem ◽  
Cezar Sabbagh ◽  
Said Abisi ◽  
Bella Huasen ◽  
...  

Objective This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). Materials and Methods Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. Results A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4–6) and 52% with IC (Rutherford 1–3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42–90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1–91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). Conclusion Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.


Vascular ◽  
2012 ◽  
Vol 20 (5) ◽  
pp. 262-267 ◽  
Author(s):  
Dimitrios Papadimitriou ◽  
Dieter Mayer ◽  
Mario Lachat ◽  
Felice Pecoraro ◽  
Thomas Frauenfelder ◽  
...  

Bypass surgery in aortoiliac or aortofemoral occlusive disease can be technically demanding and hazardous due to huge calcifications and/or patient co-morbidities. We report about mid-term results of a telescoping sutureless aortic anastomosis technique using endografts as connectors to address such challenging situations. This is a single-center experience (2004–2011) in seven patients (63 ± 6 years) requiring aortoiliac (three) or aortofemoral (four) bypass surgery. In six cases, an aortic stent graft was telescoped into the infrarenal aorta and partly deployed within the aorta and partly outside the aorta. In the first case, a bifurcated stent graft was deployed and the iliac legs were prolonged extra-anatomically with surgical grafts to reach the femoral bifurcation. In the following five cases, a tapered tubular stent graft was deployed through the aortic wall, landing inside a bifurcated surgical graft that was extra-anatomically connected to the iliac or femoral arteries. In the last case, which presented a hostile abdomen and high-risk for extensive surgery, a similar technique was used, but on the iliac artery level. In that case, an iliac stent graft re-loaded ‘upside down’ was deployed through the left common iliac wall, landing distally inside a hand-made 10 × 10 mm bifurcated surgical graft that was extra-anatomically connected to the left external iliac artery and to the right femoral artery. The distal anastomoses on the seven cases were performed either with running sutures (ten) or with VORTEC (four). Telescoping aortic and/or iliac anastomosis was successful in all patients. There was no perioperative mortality. One patient developed postoperative hyperperfusion of the left leg and necessitated fasciotomy. During a mean follow-up of 1.8 ± 2 years (minimum: 270 days, maximum: 7.1 years), all of the grafts remained patent and there was neither stent-graft migration nor stenosis on the level of the aortic or iliofemoral connection. One patient showed disease progression and required percutaneous transluminal angioplasty on the external iliac artery during follow-up. The uneventful perioperative course in these seven patients, with a follow-up of up to six years, underscores that this new technique can be considered in patients with aortoiliac or aortofemoral occlusive disease and in whom clamping and/or anastomosis is expected to be cumbersome or impossible.


Vascular ◽  
2021 ◽  
pp. 170853812110232
Author(s):  
Peixian Gao ◽  
Changliang Li ◽  
Xuejun Wu ◽  
Gang Li ◽  
Dianning Dong ◽  
...  

Purpose To evaluate the safety and efficacy of transbrachial and transfemoral approaches combined with visceral protection for the endovascular treatment of juxtarenal aortoiliac occlusive disease (AIOD) over an average 19-month follow-up period. Methods In this retrospective analysis, all patients with juxtarenal AIOD at a single institution were reviewed from June 2015 to January 2020. Patient characteristics, angiographic results, and follow-up outcomes were retrospectively recorded. The indications for treatment were critical limb threatening ischemia in 12 patients and bilateral claudication in five patients. Percutaneous access via the left brachial artery was first obtained to recanalize the infrarenal occluded lesions. After that, femoral accesses were achieved. A 4-Fr catheter, a 4 mm balloon, or a 6-Fr 90-cm-long sheath was used to complete visceral artery protection. Results A total of 17 juxtarenal AIOD patients (14 males; mean age, 63.4 ± 8.1 years) underwent endovascular treatment. The technical success rate was 100%. Complete reconstruction was achieved in 15 (88.2%) patients. The infrarenal aorta was reconstructed with kissing covered stent grafts ( n = 7), kissing bare-metal stents ( n = 2), covered stent grafts ( n = 2), bare-metal stents ( n = 1), or the off-label use of iliac limb stent grafts ( n = 5). Renal embolization was found in 3 (17.6%) patients during intraoperative angiography. There was 1 (5.9%) case of distal runoff embolization after CDT and 1 (5.9%) case of left iliac artery rupture. One (5.9%) death occurred due to acute myocardial infarction 20 days after the operation. The average follow-up period was 19.3 ± 16.7 months (range, 1–54 months) in the remaining 16 cases. The renal artery patency rate was 100%. The estimated cumulative primary patency rates were 92.3% at 12 months and 59.3% at 36 months according to the Kaplan–Meier method. Conclusions Transbrachial and transfemoral approaches combined with visceral protection offer a safe and effective alternative to open revascularization for the endovascular treatment of juxtarenal AIOD.


Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Jeffrey Lorne Grenville ◽  
Kong Teng Tan ◽  
Hadas Moshonov ◽  
Dheeraj Kumar Rajan

Purpose: Describe outcomes after endovascular intervention of TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease. Materials and methods: Retrospective cohort study. Patient demographics, ankle-brachial indices, and lesion details were analyzed from a prospectively maintained database. In all, 980 limbs treated with percutaneous transluminal angioplasty ± stenting of the femoro-popliteal segment between 2005 and 2012 were reviewed. Seventy-six patients representing 83 limbs with de novo TransAtlantic Inter-Society Consensus C and D lesions measuring ≥15 cm continuously were identified (mean age 71.3 ± 12.1 years, 62% male). Results: Twenty-five (30.1%) limbs were treated for severe claudication and 58 (69.9%) for critical limb ischemia. The mean pre-procedural ankle-brachial index was 0.47 ± 0.19. The mean lesion length was 22.9 ± 4.82 cm. Seventy patients representing 77 limbs were available for a mean follow-up length of 19.5 months (range 0–79). The mean post-procedural ankle-brachial index was 0.71 ± 0.28. Primary, assisted-primary, and secondary patency rates were 68.1%, 72.7%, and 83.3% at 6 months, 55.3%, 63.6%, and 58.3% at 12 months, and 38.2%, unavailable, and 10.4% at 24 months, respectively. Conclusions: Angioplasty-first strategy for TransAtlantic Inter-Society Consensus C and D lesions of the femoro-popliteal artery can be safely performed. However, patency drastically decreases after 12 months suggesting further improvements are required to achieve longer-term clinical benefit.


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