Clinical outcomes of thoracic endovascular aneurysm repair using commercially available fenestrated stent graft (Najuta endograft).

OBJECTIVE: Thoracic endovascular aneurysm repair (TEVAR) for the aortic arch aneurysm is challenging because of its curved anatomic configuration and the presence of the supra-aortic branches. The Najuta fenestrated endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) was developed to treat aortic arch diseases, offering maximal proximal landing length while preserving the blood flow to the supra-aortic branches. We evaluated the perioperative and midterm outcomes of this fenestrated endograft. METHODS: Between July 2007 and July 2013, 32 patients were treated with the Najuta endograft at three vascular centers. The mean age of the patients was 74.5 ± 9.8 years (23 patients were men). Technical success, complication, overall survival rate, freedom from aneurysm-related death, secondary intervention, aneurysm enlargement, device migration, and patency of supra-aortic branches were investigated retrospectively. RESULTS: The median follow-up period was 2.5 years (range, 0.2-6.2 years). Seventy-one supra-aortic vessels (30 brachiocephalic arteries, 31 left common carotid arteries, 10 left subclavian arteries) were planned to be preserved with fenestrations. Technical success rate was 91% (29 of 32; three type I endoleaks were seen), and five perioperative complications (two Stanford A dissections, one cerebral infarction, one celiac artery obstruction, one spinal cord ischemia) were recognized. Perioperative death was not observed. Overall survival rate and rate of freedom from aneurysm-related death at 3 years were 67% and 97%, respectively. The rate of freedom from secondary intervention and the rate of freedom from aneurysm enlargement at 3 years were 84% and 85%, respectively. Device migration was not observed. There were two branch (left carotid artery and left subclavian artery) occlusions at 2 weeks after TEVAR due to the endograft's infolding. No other branch occlusion was seen in this follow-up period. As a result, the patency rate of the supra-aortic branch was 97% at 3 years. CONCLUSIONS: The perioperative and 3-year outcomes of TEVAR using the Najuta precurved, fenestrated endograft demonstrated high freedom from aneurysm enlargement and patency rates of the supra-aortic branches.

Technique of percutaneous direct needle puncture of calcified plaque in the superficial femoral artery or tibial artery to facilitate balloon catheter passage and balloon dilation of calcified lesions.

Heavy calcified arterial lesions are challenging to endovascular treatment. Even if a guide wire passes the lesion, calcified plaque can inhibit passage or dilation of the balloon catheter. We developed a novel technique of percutaneous direct needle puncture of calcified plaque (PIERCE) to allow subsequent passage and dilation of the balloon. PIERCE was performed in three patients with superficial femoral artery (SFA) lesions and one patient with a tibial artery lesion. In all four cases, balloon passage and lesion dilatation were achieved. Minor hemorrhage from the punctured site occurred in two patients with SFA lesions, which resolved with stent placement.

A decade of outcomes and predictors of sac enlargement after endovascular abdominal aortic aneurysm repair using zenith endografts in a Japanese population.

PURPOSE: To present 10-year outcomes and risk factors for sac enlargement after endovascular aneurysm repair (EVAR) using the Zenith AAA Endovascular Graft (Cook, Inc, Bloomington, Indiana) in a Japanese population. MATERIAL AND METHODS: During the period 1999-2011, 127 patients underwent elective EVAR using Zenith endografts at a single institution. A retrospective investigation looked at initial rates of technical success and complications, 10-year rate of freedom from all-cause and aneurysm-related mortality, freedom from secondary intervention and sac enlargement, and risk factors for second intervention and sac enlargement. RESULTS: The median age of the patients was 78 years, and the median follow-up time was 43 months. The initial technical success rate was 98.4% (125 of 127 patients). Major adverse events occurred in 7 of 127 (5.5%) patients. Rates of freedom from all-cause and aneurysm-related mortality at 1, 3, 5, and 10 years were 95%, 87%, 77%, and 39% (all-cause mortality) and 100%, 100%, 99%, and 93% (aneurysm-related mortality). Rates of freedom from secondary intervention at 1, 3, 5, and 10 years were 97%, 91%, 88%, and 70%. Rates of primary freedom from sac enlargement at 1, 3, 5, and 10 years were 99%, 87%, 75%, and 67%. Multivariate analysis revealed aneurysm sac diameter as an independent risk factor for a secondary intervention. Preoperative sac diameter combined with an angulated short (AS) proximal neck was a risk factor for sac enlargement. CONCLUSIONS: The 10-year results of EVAR using Zenith endografts in a Japanese population were comparable to results from Western countries. Larger aneurysms and AS neck were predictors of sac enlargement after EVAR.

Intravascular ultrasound assessment of acute expansion of the balloon-expandable stent in heavy calcified iliac artery lesions or in lesions resistant to dilation by a self-expanding stent.

BACKGROUND: To evaluate the acute stent expansion of a balloon-expandable stent (BES) by intravascular ultrasound (IVUS) in lesions with heavy calcification or in lesions resistant to dilation by a self-expanding stent (SES). METHODS: Primary stent placement using the Express LD was performed for 72 limbs in 56 patients. The BES was deployed both for ostial lesions of the common iliac artery (CIA) in 63 limbs and for additional dilation of an SES using a stent-in-stent maneuver in 9 limbs. Of the CIA ostial lesions, 71% (45 of 63) had heavy calcification. The primary endpoint was an acute stent expansion as assessed by IVUS. The ratio of the IVUS-measured minimal stent diameter (MSD) to the diameter predicted by the manufacturer's compliance chart was used as a measure of the acute stent expansion. The ratio was compared between noncalcified and calcified CIA lesions and between before and after additional placement of the BES in the case of insufficient expansion of an SES. RESULTS: The BES achieved 81 ± 10% of the predicted MSD in noncalcified CIA lesions and 78 ± 12% of the predicted MSD in heavy calcified CIA lesions (P = 0.346). In the 9 limbs with insufficient expansion of an SES, deployment of the BES resulted in an improvement in MSD from 39 ± 16% to 77 ± 8% of the predicted MSD (P < 0.001). CONCLUSIONS: Sufficient acute expansion of the BES was demonstrated in heavy calcified lesions or in lesions with insufficient expansion of an SES.

Technical tips and procedural steps in endovascular aortic aneurysm repair with concomitant recanalization of iliac artery occlusions.

PURPOSE: The goal of this paper is to describe our technical strategy and procedural steps for endovascular aneurysm repair (EVAR) when performed with concomitant recanalization of the iliac artery occlusion. MATERIALS AND METHODS: Three octogenarians having abdominal aortic aneurysm (AAA)/common iliac artery aneurysms (CIAA) with unilateral external iliac artery (EIA) occlusion underwent EVAR with recanalization of the occluded iliac arteries. Crossing the iliac artery occlusions was attempted in a retrograde approach using a 0.035 inch-hydrophilic guidewire. After passage of a guidewire, predilation was performed using 6mm balloon. Then a 12-Fr sheath was advanced via the occluded EIA for contralateral iliac limb delivery. Internal iliac artery embolization was subsequently performed as needed. A self-expanding stent was then placed in the occluded EIA after EVAR. RESULTS: Recanalization of the EIA occlusion, followed by stentgraft delivery through the occlusion and EVAR, was successfully performed in all three patients. Penetration of the occluded EIA was successfully achieved only by retrograde approach in two patients, and by bidirectional approach in the other patient. No perioperative complication or death occurred. Postoperative CT showed no type I or III endoleaks in the aneurysms and patent iliac arteries in all patients. CONCLUSIONS: Total endovascular repairs were successfully performed for three patients with AAA and concomitant unilateral EIA occlusions. The proposed steps described in this report might reduce the complication rate and enhance the technical success rate associated with this procedure.

Catheter-based bailout techniques for an interrupted deployment of the excluder endograft due to broken deployment string.

In this report we describe catheter-based bailout techniques for when the distal end of the ipsilateral leg of an Excluder endograft has remained undeployed due to a broken deployment string. We attempted to advance a percutaneous transluminal angioplasty (PTA) balloon into an undeployed leg via the brachial artery, but were unable to do so. The delivery catheter was then pulled out through the undeployed leg while the main body was supported by a dilated touch-up balloon to prevent stent graft migration, which subsequently enabled insertion of the balloon via the ipsilateral femoral artery. Complete deployment was accomplished by balloon dilation. Although this is situation is extremely rare, it should be recognized and catheter-based strategies should be known for dealing with this complication.

Iliac artery stent placement relieves claudication in patients with iliac and superficial femoral artery lesions.

PURPOSE: To evaluate the efficacy of iliac artery stent placement for relief of claudication in patients with both iliac and superficial femoral artery (SFA) lesions. METHODS: Stent placement for only iliac artery occlusive disease was performed in 94 limbs (74 patients) with both iliac and SFA occlusive disease on the same limb. All procedures were performed because intermittent claudication did not improve after continuation of antiplatelet medication therapy and home-based exercise for 3 months. Rutherford classification was 2 in 20 limbs and 3 in 74 limbs. Patients with critical limb ischemia were excluded. Median duration of follow-up was 40 months. Primary patency rates of the iliac stent, clinical improvement rates, and risk factors for requiring additional SFA procedures were evaluated. RESULTS: Primary patency rates of the iliac stent at 1, 3, 5, and 7 years were 97, 93, 79, and 79 %, respectively. The initial clinical improvement rate was 87 %. Continued clinical improvement rates at 1, 3, 5, and 7 years were 87, 81, 69, and 66 %, respectively. SFA Trans-Atlantic Inter-Society Consensus (TASC) II C/D lesion was a significant risk factor for requiring additional SFA procedures. CONCLUSION: Intermittent claudication was relieved by iliac stent placement in most patients with both iliac and SFA lesions. Thus, the indications for treatment of the SFA intended for claudicants should be evaluated after treatment of the iliac lesion.

Fracture and collapse of balloon-expandable stents in the bilateral common iliac arteries due to shiatsu massage.

We report a case of stent fracture and collapse of balloon-expandable stents caused by shiatsu massage. A 76-year-old man presented with complaints of intermittent claudication of the right lower extremity. Stenoses of the bilateral common iliac arteries (CIAs) were detected. Balloon-expandable stents were deployed in both CIAs, resulting in resolution of symptoms. Five months later, pelvis x-ray showed collapse of both stents. Despite the stent collapse, the patient was asymptomatic, and his ankle brachial index values were within the normal range. Further history showed that the patient underwent daily shiatsu therapy in the umbilical region, which may have triggered collapse of the stent. Physicians should advise patients to avoid compression of the abdominal wall after implantation of a stent in the iliac artery.

[Endovascular therapy for aortic aneurysm].

Recently minimally invasive endovascular therapy using a stent graft has made significant advances in the treatment of aortic aneurysm. Eventually, five kinds of stent grafts were commercial available in Japan for the thoracic and abdominal aortic aneurysm with acceptable outcomes. Initial results of stent graft are superior than those of open surgery in many cases, but further investigation for endoleak and sac behavior should attempt to determine its efficacy over a longer follow-up period.

Long-term outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)-II.

PURPOSE: To compare long-term outcomes of systematic primary stent placement between Trans-Atlantic Inter-Society Consensus (TASC)-II C/D disease and TASC-II A/B disease. METHODS: Between 1997 and 2009, endovascular treatments with primary stent placement were performed for 533 lesions in 413 consecutive patients with iliac artery occlusive disease. Median follow-up term was 72 months (range, 1-144 months). Lesion severity in this retrospective study was classified according to TASC-II as type A in 134 patients (32%), type B in 154 patients (37%), type C in 64 patients (16%), and type D in 61 patients (15%). Technical success rates, procedure time, complication rates, and cumulative primary patency rates were compared between the complex lesion group (TASC-II type C/D) and the simple lesion group (TASC-II type A/B). Risk factors for in-stent restenosis were also analyzed. RESULTS: Technical success rates in TASC-II C/D and A/B were both 99%. Procedure times for TASC-II type A, B, C, and D lesions were 98 ± 40, 124 ± 50, 152 ± 55, and 183 ± 68 minutes, respectively. Procedure time was significantly longer in TASC-II C/D (167 ± 63 minutes) than in TASC-II A/B (112 ± 47 minutes; P < .001). The complication rate was significantly higher in TASC-II C/D (9%) than in TASC-II A/B (3%; P = .014). Cumulative primary patency rates at 1, 3, 5, and 10 years were 90%, 88%, 83%, and 71% in TASC-II C/D and 95%, 91%, 88%, and 83% in TASC-II A/B, respectively. No significant differences were apparent between groups (P = .17; Kaplan-Meier method, log-rank test). In multivariate analysis, lesion length was an independent risk factor for in-stent restenosis (hazard ratio, 1.12, P = .03; 95% confidence interval, 1.01-1.24). CONCLUSIONS: Primary stent placement for complex iliac artery occlusive disease provides acceptable long-term outcomes, although the procedure takes relatively longer and is associated with a higher frequency of complications than for simple disease.

Elevated serum levels of interleukin-18 in patients with overt diabetic nephropathy: effects of miglitol.

BACKGROUND: Interleukin-18 (IL-18), a pro-inflammatory cytokine, is a predictor of cardiovascular and renal disease in diabetic patients. Postprandial hyperglycemia is one of the important factors contributing to an increase in the circulating pro-inflammatory cytokine levels. This study investigated the effect of miglitol, an α-glucosidase inhibitor, on postprandial hyperglycemia and IL-18 levels in diabetic patients with nephropathy. METHODS: Fifteen Japanese diabetic patients with persistent proteinuria and preserved renal function were recruited. The patients received 50 mg miglitol thrice daily after the baseline examinations and were followed up for 12 weeks. A meal tolerance test was performed on eight patients at baseline and week 12. The fasting miglitol concentration was measured in seven patients just before the meal tolerance test. RESULTS: There were no changes in the body weight, blood pressure, liver and renal function, and proteinuria from baseline to week 12. However, the levels of glycated hemoglobin and interleukin 18 significantly decreased from baseline to week 12. During the meal tolerance test, plasma glucose was significantly decreased 60 min after treatment with miglitol, whereas the serum concentration of insulin was not changed. Fasting and postprandial levels of IL-18 were significantly decreased from baseline to week 12. Serum miglitol concentrations showed a significantly negative correlation with eGFR (r = -0.82, p = 0.02). However, the serum miglitol concentrations did not changed during the course of this study. CONCLUSION: Miglitol improved postprandial hyperglycemia and reduced serum IL-18 levels in patients with stage 3 diabetic nephropathy. Miglitol may therefore prevent atherosclerotic diseases and diabetic micro-vascular complications through decreasing glucose swings and/or the circulating IL-18 level.

Initial experience of branched endovascular graft for abdominal aortic aneurysm with complex anatomy of proximal neck: planning and technical considerations.

The purpose of this report was to demonstrate initial Japanese cases of abdominal aortic aneurysm (AAA) with complex anatomy of proximal neck treated using a Zenith fenestrated endograft with branched endovascular technique and to describe the device's design and technical considerations. Planning and sizing of endografts were performed using high-resolution computed tomography on a three-dimensional workstation. Branched endograft technique combined with reinforced fenestrated device and balloon-expandable stent graft was used in two patients because of challenging morphology for the fenestrated device with a bare stent. Successful exclusion of the aneurysm sac was achieved in both patients with antegrade perfusion in incorporated visceral vessels. Endovascular repair using a fenestrated device with graft material incorporating the visceral arteries is feasible. The combination of the reinforced fenestration and the balloon-expandable stent graft can provide an adequate sealing effect for the compromised anatomy. Initial and midterm results are reported with further follow-up and patient accrual.

[Current status and future of TEVAR for descending thoracic aortic aneurysm].

As a new option for treatment of thoracic aortic aneurysm, thoracic endovascular aneurysm repair (TEVAR) has become more popular recently in Japan, because TEVAR is less invasive and TAG and Tallent are approved as a commercially available device for descending thoracic aorta The results of TEVAR showed more favorable compared to open surgery. Incidence of paraplegia after TEVAR is lower than that of open surgery. However we performed spinal cord drainage to avoid paraplegia in patients with history of the aortic aneurysm repair or long segmental coverage with stent graft. It has higher risk of injury to the iliac artery compared to EVAR, and in patients with small iliac artery and/or severe calcified artery, iliac conduit should be made before TEVAR. To expand the indication of TEAVR and to obtain better outcome, team approach with borderless and improvement of devices should be required. TEAVR will become more predominant and safer treatment in the future.