Search

The objective of this study was to investigate the mid-term outcomes of embolization procedures for type II endoleak after endovascular abdominal aortic repair, and clarify the risk factors for aneurysm enlargement after embolization procedures.This was a retrospective multicenter registry study enrolling patients who underwent embolization procedures for type II endoleaks after EVAR from January 2012 to December 2018 at 19 Japanese centers. The primary end point was the rate of freedom from aneurysm enlargement, more than 5 mm in the aortic maximum diameter, after an embolization procedure. Demographic, procedural, follow-up, and laboratory data were collected. Continuous variables were summarized descriptively, and Kaplan-Meier analyses and a Cox regression model were used for statistical analyses.A total of 315 patients (248 men and 67 women) were enrolled. The average duration from the initial embolization procedure to the last follow-up was 31.6 ± 24.6 months. The rates of freedom from aneurysm enlargement at 3 and 5 years were 55.4 ± 3.8% and 37.0 ± 5.2%, respectively. A multivariate analysis revealed that a larger aortic diameter at the initial embolization procedure and the presence of a Moyamoya endoleak, defined as heterogeneous contrast opacity with an indistinct faint border, were associated with aneurysm enlargement after embolization management.The embolization procedures were generally ineffective in preventing further expansion of abdominal aortic aneurysms in patients with type II endoleaks after EVAR, especially in patients with a large abdominal aortic aneurysm and/or a presence of a Moyamoya endoleak.

The objective of this study was to assess the accuracy of predicting stent graft position for thoracic endovascular aortic repair by measuring three lengths of the virtual stent graft: smaller curvature (SC), center lumen line (CL), and greater curvature (GC).From January 2012 to December 2016, patients treated at our institution were analyzed retrospectively. Patients who were treated with more than two devices, patients treated for aortic dissection, and cases without complete preoperative or postoperative computed tomography (CT) data were excluded. From the preoperative CT data, the virtual stent graft image based on the SC (SCVS) was created so that its SC length matched that of the stent graft actually used. In the same manner, virtual stent graft images based on the CL (CLVS) and GC (GCVS) were created. These virtual stent graft images were created using SYNAPSE VINCENT software (Fujifilm Co, Tokyo, Japan) and superimposed on the postoperative CT image to measure the misalignment between these virtual stent graft images and the actual stent graft. These misalignments were compared using Wilcoxon signed rank sum test. In addition, the actual length (AL) of the stent graft was measured on the basis of the CL from postoperative CT data and compared with its original length (OL).A total of 35 cases were analyzed. Twenty-six patients were men. The average age of the patients was 72.4 ± 13.0 years. The proximal landing zone were located at the descending aorta (n = 11) and the aortic arch (n = 24). The misalignment between SCVS, CLVS, and GCVS and actual stent graft position was -47.8 ± 18.1 mm, -21.5 ± 9.4 mm, and 5.3 ± 7.4 mm, respectively. The difference in means between the three groups was significant (P .001). The relationship between the AL based on CL and OL was represented by the formula AL = OL * 0.92 - 0.05 (in the descending aorta) and AL = OL * 0.77 + 9.85 (in the aortic arch).Compared with CLVS and SCVS, GCVS was the most accurate predictor of stent graft position for thoracic endovascular aortic repair.

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.

The present study used data from the Japanese Committee for Stentgraft Management's national registry, which contains unique surgical data, including surgical timing, anatomic factors, and pathologic factors, to determine the generalized community experience with thoracic endovascular abdominal aortic repair (TEVAR).The medical background and short-term outcomes were reviewed for patients who had undergone TEVAR for a thoracic aortic aneurysm (TAA; 14,235 cases) or aortic dissection (AD; 990 type A and 4259 type B) from 2008 to 2015. TEVAR for AD was separated from that for TAAs; only the background and short-term outcomes were evaluated. The technical outcomes of TEVAR for TAA were also evaluated. All the cases were categorized as follows: elective, urgent (within 24 hours after admission), or emergent (immediately after admission). The outcomes included in-hospital mortality and persistent stroke and paraplegia diagnosed at discharge. The number of debranching bypasses, proximal landing zone (0, 1, 2, ≥3), and zone length were included in the logistic regression analysis.The mortality, stroke, and paraplegia rates in the TAA and AD groups were 4.4%, 4.6%, and 3.7% and 4.0%, 2.9%, and 2.8%, respectively. After analyzing the TAA cohort, we found that urgent and emergent cases were associated with all adverse outcomes. The rate of paraplegia increased drastically in the patients with stent graft coverage that extended for six or more zones. Massive atheroma was associated with stroke and paraplegia. The cumulative survival rate of the TAA group was stratified by the urgency (ie, elective, urgent, emergent; P .001). We found that the more proximal (0, 1, and 2) the landing zone, the greater the risk of stroke. Likewise, the longer (six or more zones) the coverage, the greater the risk of paraplegia.Urgency was strongly associated with mortality, stroke, and paraplegia, and the classification of urgent and emergent, according to the surgical timing after admission, successfully stratified the population in the long-term overall survival analysis. A proximal landing zone involving the aortic arch and debranching bypasses were associated with the occurrence of stroke, and the length of stent graft coverage for six or more zones was associated with paraplegia. Identifying these risk factors will help operators of TEVAR develop appropriate operative strategies to mitigate patient risk.

Objective We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms. Methods This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture. Results One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years. Conclusions This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.

Objective Carotid artery stenting (CAS) is a less invasive alternative to carotid endarterectomy, but it is essential to prevent thromboembolic complications during CAS and to suppress in-stent restenosis (ISR) after CAS because of the relatively high risk of periprocedural and follow-up stroke events. Clinical trials have demonstrated the strong relationship of carotid plaque vulnerability with the subsequent risk of ipsilateral ischemic stroke and thromboembolic complications during CAS. Recent studies demonstrated that both low eicosapentaenoic acid (EPA) and low docosahexaenoic acid (DHA) levels were significantly associated with lipid-rich coronary and carotid plaques, but little is known about the effect of administration of omega-3 fatty acids (O-3FAs) containing EPA and DHA before and after CAS for stabilizing carotid plaque, preventing thromboembolic complications, and suppressing ISR. In this study, the efficacy of pretreatment with and ongoing daily use of O-3FA in addition to statin treatment was evaluated in patients undergoing CAS. Methods This study was a nonrandomized prospective trial with retrospective analysis of historical control data. From 2012 to 2015, there were 100 consecutive patients with hyperlipidemia undergoing CAS for carotid artery stenosis who were divided into two groups. Between 2012 and 2013 (control period), 47 patients were treated with standard statin therapy. Between 2014 and 2015 (O-3FA period), patients were treated with statin therapy and add-on oral O-3FA ethyl esters containing 750 mg/d DHA and 1860 mg/d EPA from 4 weeks before CAS, followed by ongoing daily use for at least 12 months. In all patients, the plaque morphology by virtual histology intravascular ultrasound, the incidence of new ipsilateral ischemic lesions on the day after CAS, the slow-flow phenomenon during CAS, and ISR within 12 months after CAS were compared between the periods. Results The slow-flow phenomenon during CAS with filter-type embolic protection devices decreased in the O-3FA period (1 of 53 patients [2%]) compared with the control period (7 of 47 patients [15%]; P = .02). Furthermore, ISR for 12 months after CAS was significantly decreased in the O-3FA period (1 of 53 patients [2%]) compared with the control period (10 of 47 patients [21%]; P = .01). On virtual histology intravascular ultrasound analysis, the fibrofatty area was significantly smaller and the fibrous area was significantly greater in the O-3FA period. On multivariate logistic regression analysis, a low EPA/arachidonic acid ratio and a symptomatic lesion were the factors related to vulnerable plaque ( P = .01 [odds ratio, 5.24; 95% confidence interval, 1.65-16.63] and P = .01 [odds ratio, 11.72; 95% confidence interval, 2.93-46.86], respectively). Conclusions Pretreatment with O-3FA reduces the slow-flow phenomenon generated by plaque vulnerability during CAS, and on-going daily use of O-3FA suppresses ISR after CAS.

The objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery.This prospective, multicenter (15 hospitals) study assessed heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease. Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ankle-brachial index ≤0.9, and color flow duplex ultrasound-assessed SFA lesions with cumulative length ≥10 cm and ≥50% stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events, respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio 2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria.Of 103 enrollees (74.2 ± 7.0 years old; 17.5% female; 97.1% claudicants), 100 subjects were evaluated through postoperative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7% were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1% (95% confidence interval [CI], 87.3%-97.3%) at 12 months. The primary patency-surgical rate was 92.1% (95% CI, 84.8%-96.0%), the primary patency-interventional rate was 88.1% (95% CI, 80.0%-93.1%), and freedom from TLR was 93.1% (95% CI, 86.1%-96.7%). Mean ankle-brachial index increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (P .0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through postoperative 30 days. No life- or limb-threatening intraoperative or perioperative adverse events and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6% ± 15.7% to 72.9% ± 18.6% at 12 months (P .0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median postoperative hospital stay was 2.0 days (mean, 3.4 ± 2.9 days) in the Viabahn (W. L. GoreAssociates, Flagstaff, Ariz) claudicant subgroup, values that were significantly lower than the 76.5% general anesthesia rate (P .0001) and 11.0 days median hospitalization stay (mean, 12.7 ± 5.3 days; P .0001) in the 51 open bypass claudicant subjects.Stent grafting appears to be a safe and less invasive alternative to above-knee bypass surgery, providing 88% to 92% primary patency at 12 months in long, complex lesions.

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.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.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).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.

Purpose To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting. Materials and Methods A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 and 2007. While clinical data and images were retrospectively reviewed for all patients, 165 patients who underwent self-expanding stenting and plain radiograph with ≥6-months follow-up were analyzed. Mean follow-up was 43 months for 305 stents (elgiloy, n=83; nitinol, n=222) implanted in 216 iliac arteries. The mean duration until the last imaging study was 38 months. Items concerning prevalence of stent fracture, factors associated with fracture, and outcomes for patients with stent fracture were analyzed. Results Stent fracture was detected in 11 of 216 iliac arteries (5.1%). In stent-based analysis, 11 of 305 stents (3.6%) showed stent fracture, classified as type I in 2 stents, type II in 3 stents, type III in 4 stents, type IV in 1 stent, and type V in 1 stent. Stent fracture was detected in 11 of 222 nitinol stents (5.0%), but no Elgiloy stents. Cox proportional hazards regression model indicated stenting for chronic occlusion as a risk factor associated with nitinol stent fracture (hazard ratio [HR] = 6.09, P = 0.008, 95% confidence interval [CI] 1.59-23.3). Cumulative primary patency rates in iliac arteries with and without fractured stents were 90% and 91% at 8 years ( P = .80), respectively. Conclusion Fracture of self-expanding stents is rare in iliac arteries, but stenting for chronic occlusion represents a risk factor for fracture. Fractures of stents placed in iliac arteries rarely affect patency.

Objective The purpose of this study was to assess the safety and efficacy of the Misago stent (Terumo Corp, Tokyo, Japan) in occlusive and stenotic superficial femoral artery (SFA) disease. Methods The safety and efficacy of the Misago SFA stent were evaluated prospectively in this initial collaboration trial between Japan and the United States. Because this trial enrolled patients mainly from Japan and the United States and because there is a question as to whether a race difference exists in SFA stent performance, the race difference on outcome was also analyzed. In addition, results were compared with a prior SFA stent trial. Results The Misago stent was implanted in 261subjects with TransAtlantic Inter-Society Consensus (TASC) type A and type B SFA lesions (201 subjects in the United States, 50 in Japan, 9 in Taiwan, 1 in South Korea). The mean age of the patients was 69.3 ± 10.0 years, and the mean lesion length was 83.8 ± 41.3 mm. The overall 12-month primary patency rate and clinically driven target lesion revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) and outcomes between U.S. and Asian patients were similar, including primary patency (82.9% vs 83.0%; P = .889), clinically driven target lesion revascularization (13.4% vs 11.7%; P = .829), stent fracture rate (1.3% vs 0.0%; P = 1.000), and stent thrombosis rate (0.5% vs 0.0%; P = 1.000). Conclusions OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials.

Objective Contrast-enhanced computed tomography (CE-CT) has been commonly used for follow-up imaging after endovascular aneurysm repair (EVAR), but it is difficult to use on patients with renal insufficiency. Superparamagnetic iron oxide (SPIO) particles, contrast medium for magnetic resonance imaging (MRI) that has been widely used for detection of the liver tumor, rarely affects renal function. The present study examined SPIO-enhanced dynamic MRI as a potential alternative to CE-CT for detection of endoleaks after EVAR. Methods Institutional review board approval was obtained for this prospective study. Twenty-three consecutive patients with normal renal function were evaluated using both CE-CT and SPIO-enhanced MRI within 2 weeks after EVAR. The median interval between the two modalities was 2 days. SPIO-enhanced MRI was performed at 1.5 T with T1-weighted, SPIO-enhanced dynamic, and postcontrast T1-weighted gradient echo sequences. The CE-CT protocol consisted of triple scans. Two experienced, blinded observers evaluated all images. Consensus reading of CE-CT and SPIO-MRI was defined as the reference standard. Interobserver, intraobserver, and intermodality agreement for endoleak detection was assessed by κ statistics. Results A total of 11 type II endoleaks originating from either the lumbar or inferior mesenteric artery were detected. Eight were able to be detected by CE-CT (8/11:73%) and 10 (10/11:91%) by SPIO-enhanced MRI. Interobserver (κ = 0.91; 95% CI, 0.74-1.00) and intraobserver agreement for MRI (κ = 1.00) were excellent. Intermodality agreement for endoleak detection was moderate (κ = 0.63; 95% CI, 0.32-0.94; and κ = 0.62; 95% CI, 0.29-0.95 for observers A and B, respectively). Conclusions SPIO-enhanced MRI could represent a useful alternative to CE-CT, as it offers excellent interobserver, intraobserver agreement, and could detect more endoleaks than CE-CT.

Objective Optimal platelet inhibition is an important therapeutic adjunct in patients with carotid artery stenosis undergoing carotid artery stenting (CAS). Clopidogrel resistance is associated with increased periprocedural thromboembolic complications from neurovascular stent placement procedures. The addition of cilostazol to dual antiplatelet therapy (DAT) has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention. This study was undertaken to evaluate the impact of adjunctive cilostazol in patients with CAS. Methods Platelet function was assessed by light transmittance aggregometry using the VerifyNow assay. Sixty-four consecutive patients who underwent CAS received standard DAT, clopidogrel (75 mg daily), and aspirin (100 mg daily) more than 4 weeks before the procedure. From 2010 to 2011 (period I), 28 patients underwent CAS under standard DAT. From 2011 to 2013 (period II), 36 patients prospectively had preoperative assessment of platelet function, and 13 patients with clopidogrel resistance received adjunctive cilostazol (200 mg daily) in addition to standard DAT. The incidence of new ipsilateral ischemic lesions on diffusion-weighted imaging a day after CAS and ischemic or hemorrhagic events within 30 days was assessed. Results Clopidogrel resistance was indentified in 12 patients (43%) in period I and 13 patients (36%) in period II ( P = .615). In period II, the addition of cilostazol significantly decreased P2Y12 reaction units and % inhibition ( P = .006 and P = .005, respectively), and there was a significant difference in P2Y12 reaction units between the two periods. New ipsilateral ischemic lesions were significantly decreased in period II (2/36 patients) compared with period I (7/28 patients; P = .034); however, there was no significant difference in hemorrhagic and thromboembolic events between the two periods. Conclusions Adjunctive cilostazol (triple antiplatelet therapy) in clopidogrel-resistant patients reduces the rate of clopidogrel resistance and suppresses new ischemic lesions without hemorrhagic complications, as compared with standard DAT. Antiplatelet management based on the evaluation of antiplatelet resistance would be required for prevention of perioperative thromboembolic complications in CAS.