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Aim: To investigate the impact of institutional volume on clinical outcomes after aortoiliac (AI) stenting in patients with symptomatic peripheral artery disease (PAD). Methods: We analyzed the clinical database from the Observational prospective Multicenter registry study on the Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in the aortoIliac artery (OMOTENASHI) registry. The volume of each institution was evaluated as the number of endovascular therapy (EVT) procedures performed in 2 years (2014–2015). High-volume centers were defined as being in the highest tertile of the procedural volume (≥ 611 EVT procedures in 2 years). Clinical outcomes, treatment strategies, and endovascular procedures were compared between high- and low-volume centers using a propensity score matching. Results: The propensity score matching extracted 236 pairs of patients (as many patients treated at high-volume centers and 519 patients treated at low-volume centers), with no remarkable intergroup differences in the baseline characteristics. Patients treated at high-volume hospitals had a significantly lower 12-month restenosis rate than that of patients treated at low-volume hospitals (6.5% vs. 15.8%, P = 0.032), although comparable outcomes between the two groups included the technical success rate (99.6% vs. 99.8%, P = 0.58) and the rate of 30-day major adverse events (0.4% vs. 0.8%, P = 0.59). Conclusion: Institutional volume was associated with the 12-month restenosis rate after AI stenting for PAD, although comparable perioperative outcomes were also observed between high-volume and low-volume hospitals.

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25 cm, and distal reference vessel diameter (RVD)

To identify the risk factors for restenosis at 1 year after aortoiliac stenting for symptomatic peripheral artery disease in real-world practice. We performed subgroup analysis of a large-scale prospective multicenter registry study enrolling Japanese patients with peripheral arterial disease who underwent aortoiliac endovascular therapy from April 2014 to April 2016. The subgroup comprised 880 patients (1108 limbs) who received iliac stenting. The Rutherford class was 2, 3, and 4 in 42%, 51%, and 7% of the patients, respectively. TASC II class D disease was noted in 18% of the patients and 35% had chronic total occlusion. Mean total stent length was 82.1 ± 48.5 mm and minimum stent diameter was 9.0 ± 1.3 mm. Balloon-expandable stents were used in 8% of the limbs. Concomitant femoropopliteal lesions were present in 36% of the limbs with aortoiliac lesions. In the overall patient population, the risk of restenosis at 1 year after stenting was 11.4%. Femoropopliteal lesions and the minimum stent diameter were identified as independent risk factors for restenosis at 1 year. When the study population was stratified according to these two risk factors, the restenosis rate at 1 year was 27.1% in the patients with a minimum stent diameter

Purpose: To assess calcium patterns in superficial femoral artery (SFA) disease before and after balloon angioplasty ± stent implantation using fluoroscopy, angiography, and intravascular ultrasound (IVUS) imaging and then correlate calcification severity and midterm clinical outcomes. Materials and Methods: A multicenter investigation was carried out to retrospectively review 130 symptomatic patients (mean age 73.2±8.4 years; 86 men) with de novo SFA lesions who had successfully undergone endovascular therapy (EVT) at 7 centers between January and October 2015. The primary outcome was lumen gain measured as minimum lumen area (MLA) in post-EVT IVUS images according to calcification severity. The secondary outcomes included rates of stent malapposition, restenosis, and clinically-driven target lesion revascularization (TLR). Results: A total of 102 (78.5%) cases had calcification in the lesions over a mean length of 64.3±72.8 mm. Of these, 70 cases were classified as having bilateral calcification according to fluoroscopy and angiography; 50 (49%) lesions had ≥180° calcification according to IVUS. The lumen gain in calcified lesions was significantly smaller than in the 28 noncalcified lesions (14.1±4.4 vs 17.8±5.2 mm2, p

To identify the risk factors for major adverse cardiovascular events (MACEs) in real-world practice for symptomatic peripheral artery disease in Japan.Data on Japanese patients (N = 880) from the Observational Prospective Multicenter Registry Study on Outcomes of Peripheral Arterial Disease Patients Treated by Angioplasty Therapy for Aortoiliac Artery who underwent de novo aortoiliac stent placement. The 3-year risk of incident MACEs was investigated.The median age of the patients was 72.6 years (range, 34-97 years), and 83.1% of the patients were men. The patients had the following conditions: smoking (35.6%), hypertension (94.1%), dyslipidemia (81.7%), diabetes (48.0%), renal failure on dialysis (12.6%), myocardial infarction (12.7%), stroke (15.8%), and chronic limb-threatening ischemia (7.1%). Femoropopliteal lesions were present in 38.8% of the limbs with aortoiliac lesions. The 3-year rate of freedom from MACEs was 89.1%. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, were independently associated with the risk of incident MACEs. When the study population was stratified according to these risk factors, the rate of MACEs was highest in patients with at least 3 risk factors (32.9% at 3 years).The 3-year rate of freedom from MACEs was reported. Baseline characteristics, such as age, renal failure on dialysis, myocardial infarction, stroke, and femoropopliteal lesions, are independent risk factors for MACEs after aortoiliac stent placement.

Aim: The post-endovascular treatment outcomes of thrombotic lesions remain unclear. This study aimed to investigate the effects of thrombotic lesions on post-endovascular treatment outcomes in patients with non-acute aortoiliac total occlusions. Methods: This subanalysis of a multicenter prospective observational registry study included patients from 64 institutions in Japan between April 2014 and April 2016. A total of 346 patients (394 limbs; median age, 72 years), including 186 men, underwent endovascular treatment for non-acute aortoiliac total occlusions and were included. The patients were classified as having thrombotic or non-thrombotic lesions. The primary (1-year primary patency rate) and secondary (1-year overall survival rate) endpoints were evaluated. Results: Thrombotic lesions were identified in 18.5% (64/346) of the patients. The 1-year primary patency (85.9% versus 95.4%, log-rank p ＜.001) and overall survival (90.6% versus 97.9%, log-rank p =.003) rates were significantly lower in the thrombotic group than in the non-thrombotic group. Thrombotic lesions had significant effects on the post-endovascular treatment outcomes, with adjusted hazard ratios of 3.91 (95% confidence interval, 1.64–9.34, p =.002) for primary patency and 4.93 (95% confidence interval, 1.59–15.3, p =.006) for all-cause mortality. Conclusions: Thrombotic lesions were associated with 1-year restenosis and all-cause mortality after endovascular treatment for non-acute aortoiliac total occlusions. Endovascular treatment strategies should be carefully planned for patients with thrombotic lesions.

Purpose To investigate the effect of intravascular ultrasound (IVUS) imaging use on clinical outcomes after aortoiliac stenting in patients with peripheral artery disease (PAD). Materials and Methods Subjects for this retrospective analysis were derived from the OMOTENASHI registry database, which contained 803 symptomatic PAD patients (Rutherford categories 2–4) who were treated with self-expanding stent implantation for aortoiliac atherosclerotic lesions at 61 centers in Japan between January 2014 and April 2016. Of the 803 patients, 545 (67.9%) patients (mean age 73±9 years; 453 men) underwent IVUS-supported stent implantation and were compared with the 258 patients (mean age 73±8 years; 217 men) treated without IVUS. A propensity score analysis of 138 matched pairs was conducted to compare treatment strategies and clinical outcomes between patients having IVUS-supported endovascular therapy and those treated without IVUS. Results Endovascular strategies and postoperative medications were not significantly different between the IVUS and no-IVUS groups. A procedure time under 1 hour was less frequent in the IVUS group, which had a longer fluoroscopy time. The 12-month restenosis rate was not significantly different between the 2 groups [10.2% (95% CI 6.9 to 14.9%) vs 10.3% (95% CI 5.4 to 18.6%), p=0.99]. There was no interaction between baseline characteristics and the association of IVUS use with restenosis risk. Conclusion Propensity score matching analysis revealed that duration and fluoroscopy time during IVUS-supported procedures were significantly longer than in cases without IVUS use, whereas the 12-month restenosis rate was not significantly different between the groups. IVUS use in aortoiliac lesions may be unnecessary.

The aim of this study was to assess the impact of baseline and updated nutritional status on prognosis in patients with chronic limb threatening ischaemia (CLTI) undergoing revascularisation.The clinical database of the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study, a prospective, multicentre, observational study, was used. The current analysis included 499 patients who underwent endovascular therapy or surgical reconstruction for CLTI. Nutritional status at baseline was evaluated using the Geriatric Nutritional Risk Index (GNRI; baseline GNRI). A GNRI82 points indicates major nutrition related risk. GNRI was also calculated at 1, 3, 6, 12, 24, and 36 months after revascularisation (updated GNRI). The association between baseline and updated GNRIs and the mortality risk was analysed with the Cox regression model.Mean ± standard deviation (SD) GNRI at baseline was 89.9 ± 9.8 points. The proportion of patients alive with a GNRI ≥82 points was 78% (95% confidence interval [CI] 74-81) at baseline but gradually decreased during follow up, finally reaching 19% (95% CI 0-42) at 36 months. In patients with a GNRI82 points at baseline, a GNRI of ≥82 points was increased to 37% (95% CI 6-68) 12 months after revascularisation. In the multivariable analysis, baseline and updated GNRIs were associated with a reduced mortality risk independently of each other; the adjusted hazard ratios per 1 SD were 0.80 (95% CI 0.65-0.98; p = .031) and 0.66 (95% CI 0.49-0.91; p = .015), respectively. Similar findings were observed when nutritional status was evaluated using the Controlling Nutritional Stats (CONUT) score, except for the association between its updated value and mortality risk, which marginally lost significance.There was still room for improvement in nutritional status after revascularisation for patients with CLTI. Updated GNRI was associated with death independently of baseline GNRI.

Background The clinical usefulness of peripheral blood (PB) mononuclear cell (MNC) transplantation in patients with peripheral arterial disease (PAD), especially in those with mild-to-moderate severity, has not been fully clarified.Methods and Results:A randomized clinical trial was conducted to evaluate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF)-mobilized PBMNC transplantation in patients with PAD (Fontaine stage II-IV and Rutherford category 1-5) caused by arteriosclerosis obliterans or Buerger's disease. The primary endpoint was progression-free survival (PFS). In total, 107 subjects were enrolled. At baseline, Fontaine stage was II/III in 82 patients and IV in 21, and 54 patients were on hemodialysis. A total of 50 patients had intramuscular transplantation of PBMNC combined with standard of care (SOC) (cell therapy group), and 53 received SOC only (control group). PFS tended to be improved in the cell therapy group than in the control group (P=0.07). PFS in Fontaine stage II/III subgroup was significantly better in the cell therapy group than in the control group. Cell therapy-related adverse events were transient and not serious. Conclusions In this first randomized, large-scale clinical trial of G-CSF-mobilized PBMNC transplantation, the cell therapy was tolerated by a variety of PAD patients. The PBMNC therapy was significantly effective for inhibiting disease progression in mild-to-moderate PAD.

Purpose: To evaluate the short- and long-term efficacy of intravascular ultrasound (IVUS) guidance during endovascular treatment (EVT) of subclavian artery disease. Methods: The multicenter SCALLOP registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry) was interrogated to identify 542 patients who underwent successful EVT for SCAD between January 2003 and December 2012. Lesions were classified according to the use of IVUS guidance: 177 patients (mean age 68.9±8.6 years; 149 men) with and 373 patients (mean age 69.9±8.7 years; 275 men) without. The main outcome was the difference in primary patency; secondary outcomes were differences in assisted primary patency, secondary patency, overall survival, freedom from major adverse cardiovascular events [MACE; all-cause mortality, myocardial infarction (MI), and stroke], and freedom from major adverse events (MAE). Multivariate analysis of the IVUS+ group was performed to identify predictors of failure; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: In total, 538 (97.8%) lesions were treated with stents and 12 lesions by balloon angioplasty alone. Periprocedural and in-hospital overall complication rates did not differ significantly between IVUS+ (10.2%) and IVUS– (8.8%, p=0.617). Long-term follow-up demonstrated no significant difference between IVUS+ and IVUS– groups in 5-year all-cause mortality (p=0.37), MI (p=0.07), stroke (p=0.31), or MACE (p=0.07). However, 5-year primary patency was significantly higher in the IVUS+ group (88.5% vs 77.7%, p=0.03). There were no group differences in 5-year assisted primary patency (90.4% vs 89.9%, p=0.81) or secondary patency (99.4% vs 97.1%, p=0.25). Multivariate analysis of the IVUS+ group identified in-hospital stroke (HR 16.92, 95% CI 3.60 to 79.42, p

Background The real‐world safety and efficacy of uninterrupted anticoagulation treatment with edoxaban (EDX) or warfarin (WFR) during the peri‐procedural period of catheter ablation (CA) for atrial fibrillation (AF) are yet to be investigated. Methods We conducted a two‐center experience, observational study to retrospectively investigate consecutive patients who underwent CA for AF and received EDX or WFR. We examined the incidence of thromboembolic and bleeding complications during the peri‐procedural period. Results The EDX and WFR groups included 153 and 103 patients, respectively (total: 256 patients). Demise or thromboembolic events did not occur in either of the groups. The incidence of major bleeding in the EDX and WFR groups was 0.7% and 2.9%, respectively. The total incidence of major/minor bleeding in the EDX and WFR groups was 7.8% and 8.7%, respectively. Of note, the incidence of bleeding complications in the uninterrupted WFR strategy group was markedly high in patients with an estimated glomerular filtration rate (eGFR), Patients with severely impaired renal function and/or a higher bleeding risk during uninterrupted therapy with Warfarin were at a prominent risk of bleeding complications. Therefore, utmost attention should be paid in the treatment of these patients to prevent bleeding complications.

Background The use of intravascular ultrasound (IVUS) promotes better clinical outcomes for intervention in complex lesions. However, the data demonstrating whether use of IVUS improves primary patency following stenting for aorto-iliac lesions in patients with peripheral artery disease (PAD) are limited. Purpose The purpose of the current study was to investigate the impact of IVUS use on primary patency 12 months after stent implantation for aorto-iliac lesions. Methods We analyzed a clinical database of the OMOTENASHI registry (Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery), registering symptomatic PAD patients (Rutherford category 2, 3, or 4) undergoing endovascular therapy for aorto-iliac lesions between January 2014 and April 2016 in Japan. The current study analyzed 803 patients who underwent self-expandable stent implantation at 61 centers with the institutional volume known. The primary endpoint was 12-month restenosis, defined as ≥50% stenosis on computed tomography or angiography, or a peak systolic velocity ratio ≥2.5 on duplex ultrasound. When treatment strategies, endovascular procedures and clinical outcomes were compared between the patients treated with IVUS use and those treated without IVUS use, the propensity score matching was performed to minimize the inter-group difference in baseline characteristics. Results A total of 545 patients (67.9%) underwent IVUS-supported stent implantation. Patients treated with IVUS use had a lower prevalence of regular dialysis, whereas they had a higher prevalence of TASC II class D and chronic total occlusion. In patients treated with IVUS use, carbon dioxide contrast agent were more often used, and 0.035-inch guidewire was less frequently selected. Implanted stents in these patients were longer and smaller in diameter. The propensity score matching extracted 138 pairs, with no remarkable intergroup difference in baseline characteristics. Procedure time ≤1 hour was less frequent in patients treated with IVUS use; their radiation time was longer. Endovascular strategies, as well as postoperative medication were not significantly different between patients with and without IVUS use. The 12-month restenosis risk was not significantly different between patients with and without IVUS use (10.2% [6.9 to 14.9%] versus 10.3% [5.4 to 18.6%], P=0.99). Conclusion IVUS use in aorto-iliac stenting for patients with PAD was not associated with primary patency at 12 months. Acknowledgement/Funding None

To identify the risk factors for restenosis at 1 year after aortoiliac stenting for symptomatic peripheral artery disease in real-world practice. We performed subgroup analysis of a large-scale prospective multicenter registry study enrolling Japanese patients with peripheral arterial disease who underwent aortoiliac endovascular therapy from April 2014 to April 2016. The subgroup comprised 880 patients (1108 limbs) who received iliac stenting. The Rutherford class was 2, 3, and 4 in 42%, 51%, and 7% of the patients, respectively. TASC II class D disease was noted in 18% of the patients and 35% had chronic total occlusion. Mean total stent length was 82.1 ± 48.5 mm and minimum stent diameter was 9.0 ± 1.3 mm. Balloon-expandable stents were used in 8% of the limbs. Concomitant femoropopliteal lesions were present in 36% of the limbs with aortoiliac lesions. In the overall patient population, the risk of restenosis at 1 year after stenting was 11.4%. Femoropopliteal lesions and the minimum stent diameter were identified as independent risk factors for restenosis at 1 year. When the study population was stratified according to these two risk factors, the restenosis rate at 1 year was 27.1% in the patients with a minimum stent diameter 8 mm and femoropopliteal lesions, whereas it was only 5.3% in those with a minimum stent diameter ≥ 10 mm and no femoropopliteal lesions. Femoropopliteal lesions and a smaller stent diameter were independent risk factors for restenosis at 1 year after aortoiliac stenting.

Aim: The treatment strategy for hemodialysis (HD) patients with critical limb ischemia (CLI) has been clinically debatable. Here we compared clinical outcomes after bypass surgery (BSX) and after endovascular therapy (EVT) using propensity score matching. Methods: A retrospective multicenter database of 246 (68 BSX and 178 EVT) consecutive HD patients with CLI (79% with tissue loss) who underwent infrainguinal revascularization from 2007 to 2009 was used to compare clinical outcomes, including overall survival (OS), major amputation (MA), major adverse limb event (MALE: repeat EVT, surgical reconstruction, or MA), and MALE-free survival after BSX vs. EVT using propensity score matching. Results: The median (interquartile range) follow-up duration after revascularization was 21 (8–33) months. The analysis of the 63 propensity score-matched pairs revealed no significant difference in OS (53% vs. 52%, P = 0.96), MA (25% vs. 14%, P = 0.71), MALE (42% vs. 58%, P = 0.63), and MALE-free survival (33% vs. 11%, P = 0.37) at 3 year after BSX vs. EVT. Conclusions: In HD patients with CLI who underwent infrainguinal revascularization, OS, MA, MALE, and MALE-free survival rates were not significantly different after EVT vs. BSX. The less invasive EVT should be considered as the first-choice therapeutic strategy for HD patients with CLI.

Purpose To compare primary patency between MISAGO (Terumo Corporation, Tokyo, Japan) and S.M.A.R.T. CONTROL (Cordis Corporation, Miami Lakes, Florida), second-generation and first-generation nitinol stents, in femoropopliteal lesions. Materials and Methods This multicenter, retrospective study included 240 cases with MISAGO stent implantation and 1,265 cases with S.M.A.R.T. stent implantation. The S.M.A.R.T. group had more Trans-Atlantic Inter-Society of Consensus (TASC) II class C/D lesions (53% vs 41%, P = .001) and smaller reference vessel diameter (RVD) (5.3 mm ± 0.9 vs 5.5 mm ± 0.9, P Results Kaplan-Meier estimates of 2-year primary patency after S.M.A.R.T. and MISAGO stent implantation were 67% and 55% ( P = .007). Interaction analysis revealed that TASC II classification and RVD had a significant influence on the association of MISAGO versus S.M.A.R.T. stents with the outcome. The study population was stratified according to TASC II classification and RVD, and MISAGO and S.M.A.R.T. stents were compared after propensity score matching. There was no significant difference in 2-year patency between the 2 stents in the subgroup with TASC II class A/B and RVD ≥ 5 mm (S.M.A.R.T. 82% ± 4 vs MISAGO 74% ± 5, P = .480). MISAGO stents had lower primary patency than S.M.A.R.T. stents in cases with TASC II class C/D or RVD P = .015). Conclusions S.M.A.R.T. and MISAGO stents had similar patency in simple lesions, but MISAGO stents had lower patency than S.M.A.R.T. stents in more complex lesions.

Background: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions. Methods: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups. Results: The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. Conclusion: The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

Objectives This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR. Background The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined. Methods This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study. The current study included 210 cases with loss of patency confirmed 1 year after DES implantation. Morphology of DES-ISR was classified into the following subgroups: class I, focal lesions (≤50 mm in length), class II, diffuse lesions (>50 mm in length), and class III, totally occluded ISR. One-year prognosis after re-EVT for DES-ISR was assessed by restenosis and major adverse limb events (MALE). Results Classes I, II, and III accounted for 50%, 25%, and 25% of DES-ISR, respectively. Factors associated with the morphology of DES-ISR were the presence of chronic total occlusion and the size of the external elastic membrane area before DES implantation (p = 0.009 and 0.017). Compared with the class I restenotic lesion, the class II and III lesions had a significantly higher risk of restenosis (74% and 78% vs. 53%: p = 0.048 and 0.019, respectively) and MALE (56% and 56% versus 32%: p = 0.025 and 0.022, respectively) 1 year after re-EVT. Conclusions We evaluated the characteristics of ISR after DES implantation for FP lesions and 1-year prognosis of re-EVT for DES-ISR. The morphology of DES-ISR had a significant association with 1-year prognosis after re-EVT.

Objectives This study sought to investigate the 3-year follow-up results of OLIVE registry patients. Background Although favorable 12-month clinical outcomes after endovascular therapy (EVT) in OLIVE registry patients with critical limb ischemia (CLI) from infrainguinal disease have been reported, long-term results after EVT remain unknown. Methods This was a prospective multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI. The primary outcome was 3-year amputation-free survival (AFS), whereas secondary outcome measures were 3-year freedom from major adverse limb events (MALE), wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test. Results The completion rate of 3-year follow-up was 95%. Three-year AFS, freedom from MALE, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index ≤18.5 (HR: 2.17, p = 0.001), dialysis (HR: 2.91, p Conclusions In CLI patients with infrainguinal lesions, 3-year clinical results of EVT were reasonable despite high reintervention and moderate ulcer recurrence rate. (A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [OLIVE 3-Year Follow-Up Study]; UMIN000014759 )

Purpose: To examine the 2-year mortality in hemodialysis (HD) patients with critical limb ischemia (CLI) and determine predictors that may aid in the selection of a revascularization strategy [bypass surgery or endovascular therapy (EVT)] according to current guidelines. Methods: From 2007 to 2009, 246 consecutive CLI patients (mean age 69±10 years; 170 men) on HD underwent revascularization for de novo infrainguinal lesions (178 EVT and 68 bypass grafting). The majority of the patients had diabetes (170, 69%) and tissue loss (194, 79%); nearly half (111, 45%) were nonambulatory. Overall survival after revascularization was estimated by Kaplan-Meier analysis. Predictors for 2-year mortality after revascularization were determined using a Cox proportional hazards model; results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: Overall survival rate was 77% at 1 year and 66% at 2 years. Predictors of 2-year mortality after revascularization were age >75 years (HR 1.82, 95% CI 1.14 to 2.91, p=0.012), albumin

Background: Although skin perfusion pressure (SPP) is widely used clinically to predict probability of wound healing, correlation between clinical outcomes and SPP has not been systematically studied. Methods: This subanalysis of the prospective multicenter OLIVE registry of patients who received infrainguinal endovascular therapy (EVT) for critical limb ischemia (CLI) assessed the association between clinical outcomes and postoperative SPP in 211 consecutive patients. Logistic regression analysis was performed, with amputation-free survival (AFS), modified major adverse limb events (MALEs), and complete wound healing as dependent variables and postprocedural SPP as independent variable. Result: Pre- and postprocedural SPP was 28 ± 11 and 46 ± 18 mm Hg, respectively. In logistic regression analysis, postprocedural SPP correlated with 1-year AFS ( P = .018), modified MALEs ( P < .001), and wound healing ( P = .022). Conclusion: Postprocedural SPP correlates with clinical outcomes after EVT for patients with CLI.

Objectives There have been limited data regarding the prediction of cardiac benefits after renal artery stenting for patients with atherosclerotic renal artery disease (ARAD). The aim of this multicentre retrospective study was to identify clinical or echocardiographic factors associated with improvements of cardiac symptoms after renal artery stenting. Methods We enrolled 58 patients with de novo ARAD undergoing successful renal artery stenting for heart failure, angina or both between January 2000 and August 2015 at 13 hospitals. Results Improvement of cardiac symptoms was observed in 86.2% of patients during a mean follow-up of 6.0±2.7 months. Responders demonstrated significantly lower New York Heart Association functional class, higher estimated glomerular filtration rate, lower serum creatinine and lower interventricular septal wall thickness (IVS), lower left ventricular mass index, lower left atrial dimension and lower E-velocity than non-responders. Backward stepwise multivariate analysis identified IVS as an independent predictor of improvement of cardiac symptoms (OR 0.451, 95% CI 0.209 to 0.976; p=0.043). According to receiver operating characteristic curve analysis, an IVS cut-off of 11.9 mm provided the best predictive value, with sensitivity of 71.4%, specificity of 75.5% and accuracy of 73.5%. The positive predictive value was 74.5% and the negative predictive value was 72.5%. Conclusions This multicentre retrospective study shows that the echocardiographic index of IVS is an independent predictor for improvement of cardiac symptoms after renal artery stenting.

Objectives To assess the safety and efficacy of carbon dioxide (CO2) angiography-guided endovascular therapy (EVT) for renal, iliofemoral artery disease. Background Patients with peripheral vascular disease (PVD) often have chronic kidney disease (CKD) and the use of iodinated contrast media may enhance the risk of contrast-induced nephropathy (CIN). Contrast volume reduction is an effective CIN preventive strategy. Methods A prospective multicenter registry was developed and six clinical centers participated in the study. Patients with an estimated glomerular filtration rate (eGFR) of

Efficacy of endovascular therapy (EVT) with nitinol stents for femoropopliteal (FP) lesions is limited by restenosis. Oral cilostazol reduces angiographic restenosis rate; however, treatment duration remains unclear. In a retrospective analysis of a multicenter database of 3471 consecutive limbs in 2737 patients (mean age: 72 ± 9 years; 61% diabetic; and 26% on regular dialysis) undergoing EVT for FP lesions between January 2004 and December 2011, we compared Kaplan-Meier estimated primary patency after EVT followed or not by cilostazol treatment. We used Cox hazard regression analysis to assess temporal association between cilostazol treatment and post-EVT restenosis. Five-year primary patency was higher in the cilostazol group than in the noncilostazol group (57% vs 47%, P < .0001). Cilostazol treatment was inversely associated with restenosis for the first 2 years following EVT ( P < .05); however, no significant association was observed thereafter. Cilostazol use therefore appears efficacious in preventing restenosis up to 2 years after EVT for FP lesions.

To investigate whether use of intravascular ultrasound (IVUS) improves primary patency following nitinol stenting for TASC II (TransAtlantic Inter-Society Consensus) A-C femoropopliteal lesions.Using a retrospective multicenter database of 1198 limbs from 965 patients (695 men; mean age 72±9 years) with TASC II A-C lesions (28% critical limb ischemia) treated by provisional stenting from April 2004 to December 2011, primary patency rate was compared between 234 propensity score-matched pairs with vs. without IVUS use.IVUS was used in 22% (n=268) of the overall population. It was more likely to be used in cases with generally more complicated femoropopliteal lesions (e.g., more severe TASC II class, longer lesion length, and narrower reference diameter). Analysis of the 234 propensity score-matched pairs (mean follow-up 1.9±1.5 years; 142 events) revealed higher 5-year primary patency with than without IVUS use (65%±6% vs. 35%±6%, p0.001). IVUS resulted in significantly better assisted primary patency (p0.001), secondary patency (p=0.004), freedom from any reintervention (p0.001), freedom from any adverse limb event (p0.001), and event-free survival (p0.001).IVUS use in femoropopliteal stenting for TASC II A-C lesions appears to be associated with higher primary patency rate.

Objectives To investigate factors associated with 30-day perioperative complications (POC) after aorto-iliac (AI) stenting, and to compare follow-up cardiovascular prognosis between patients with and without POC. Materials and methods This was a retrospective multicenter study. We used a multicenter database of 2012 consecutive patients who successfully underwent AI stenting for peripheral arterial disease in 18 centers in Japan from January 2005 to December 2009 to analyze independent predictors of POC and impact of POC on prognosis by logistic regression and a Cox proportional hazard regression model, respectively. Results Mean age was 71 ± 9 years (median: 72 years; range: 37–98 years), and 1,636 patients (81%) were men. POC occurred in 126 patients (6.3%). In multivariate logistic regression analysis, old age (≥80 years), critical limb ischemia (CLI), and Trans Atlantic Inter-Societal Consensus (TASC) II class C/D were independently associated with POC with adjusted odds ratios and 95% confidence intervals (CI) of 1.9 (1.3–2.9), 2.3 (1.5–3.4), and 2.4 (1.6–3.4), respectively. Out of 2012 patients, 1995 were followed up for more than 30 days (mean: 2.6 ± 1.5 years; range: 2–2,393 days). In a Cox hazard regression model adjusted for baseline clinical characteristics, POC was positively and independently associated with follow-up major adverse cardiac events (adjusted hazard ratio [HR]: 1.9; 95% CI: 1.3–2.8; p = .002), but not with major adverse limb events and target lesion revascularization (adjusted HR: 1.4; 95% CI: 0.7–2.7; p = .25; and adjusted HR: 1.2; 95% CI 0.6–2.6; p = .568), respectively. Conclusions Age >80 years, CLI, and TASC C/D lesion were positively associated with POC after AI stenting. Occurrence of POC appears to adversely affect follow-up cardiovascular, but not limb and vessel prognosis.

To report long-term outcomes of endovascular therapy (EVT) for aortoiliac bifurcation lesions.Patients enrolled in the multicenter REtrospective AnaLysis of Aorto-Iliac stenting (REAL-AI) registry in Japan were pooled. Of 2096 patients who underwent EVT for de novo aortoiliac disease between January 2005 and December 2009, 190 patients (148 men; mean age 70±9 years) had aortoiliac bifurcation lesions that were treated with stents, whose configuration (single, V, or kissing) and type (balloon-expandable or self-expanding) were subjected to regression analysis to determine any impact on primary patency along with other demographic, clinical, and lesion characteristics, including Trans-Atlantic Inter-Society Consensus II C/D classification. The primary endpoints were restenosis and target lesion revascularization (TLR). Secondary endpoints were all-cause death, major cardiovascular events, and major cardiovascular + limb events.The overall complication rate was 6.3%, and 1- and 5-year primary patency rates were 87% and 73%, respectively. Over a mean follow-up of 31±15 months, there were 36 (19.0%) restenoses, 22 (11.6%) TLRs, and 4 (2.1%) reocclusions; stent fracture (2, 1.1%) and major amputation (2, 1.1%) were rare. Only female gender [adjusted hazard ratio (AHR) 4.26, 95% CI 1.89 to 9.71, p0.001] and residual diameter stenosis (AHR 1.04, 96% CI 1.01 to 1.06, p=0.01) were independent predictors of primary patency.Stenting for aortoiliac bifurcation lesions was found to be safe and effective. Neither stent configuration nor type appeared to affect vessel patency in true bifurcation lesions.

Platypnea-orthodeoxia syndrome (POS) is a rare clinical condition defined by the presence of dyspnea and deoxygenation accompanying changing from a supine to an upright position. We experienced the case of a 75-year-old woman who developed severe acute dyspnea after a car accident. Detailed history taking and a physical examination offered important clues that helped to make an accurate diagnosis of POS. The mechanism of onset is unique and rare; however, it is important for clinical cardiologists to keep this possibility in mind when making a differential diagnosis.

Background: Although endovascular therapy (EVT) has advanced, few reports have compared EVT and bypass surgery in claudication patients with femoropopliteal disease. The present study used data from a multicenter registry in Japan to analyze outcomes of EVT and bypass surgery for claudication patients with Trans-Atlantic Inter-Society Consensus (TASC)-II C and D femoropopliteal lesions. Methods and Results: Of 1,156 patients who underwent revascularization, 696 patients were treated for intermittent claudication. A total of 263 patients with femoropopliteal lesion were classified into TASC-II C and D. The primary and secondary patency rates of the EVT and bypass surgery groups were analyzed. The overall complication rate was 14.4% in the bypass surgery group and 3.5% in the EVT group (P

Background Intraluminal femoropopliteal stenting enables favorable dilation and good immediate results; however, whether this contributes to long-term patency is unclear. We compared patency after femoropopliteal stenting for a long occlusion using either an intraluminal or subintimal approach. Methods Between January 2004 and December 2011, 902 endovascular procedures using either an intraluminal approach (651 procedures) or a subintimal approach (251 procedures) for long femoropopliteal occlusion were analyzed retrospectively. The outcomes of this study were periprocedural complication; primary, assisted-primary, and secondary patency; and overall survival. Results The mean follow-up period of survivors was 29 ± 16 months. Between the intraluminal and subintimal approach, technical success (91% vs 90%; P = .71) and periprocedural complications (11% vs 13%; P = .34) were similar. However, procedure time was significantly longer for the intraluminal approach (126 ± 63 minutes vs 98 ± 49 minutes; P = .003). The improvement of ankle-brachial index was also similar. A quarter of cases started with the intraluminal approach were switched to a subintimal approach. There was no significant difference in primary, assisted-primary and secondary patency at 3 years between the two groups (55% vs 53%; P = .30; 65% vs 74%; P = .11; and 80% vs 85%; P = .37). The 3-year overall survival also did not differ significantly between groups (84% vs 86%; P = .55). After adjusting for baseline differences, the subintimal approach was found to be similar to the intraluminal approach for primary patency (hazard ratio, 1.21; 95% confidence interval, 0.94-1.56; adjusted P = .14). Conclusions Initial result and 3-year patency was similar in both approaches. Given the longer procedure time and high crossover rate, we suggest that a subintimal approach may be preferred in the treatment of long femoropopliteal occlusions with stenting.

Objectives To investigate factors in patients with critical limb ischemia (CLI) and isolated infrapopliteal lesions that adversely affect outcomes of endovascular therapy (EVT) with or without angiosome-oriented revascularization. Methods This was a retrospective multicenter study. We used a database of 718 consecutive CLI patients (70 ± 11 years, 75% diabetics, 68% on hemodialysis, 24% Rutherford class 6) with ischemic tissue loss due to isolated infrapopliteal lesions undergoing primary EVT. Primary outcome was MALE (major adverse limb event). Association between indirect EVT (recanalization of a non-angiosome-based artery) and outcome was assessed by Cox proportional hazard regression model. Results C-reactive protein (CRP) level was >3 mg/dL in 32% of cases. Indirect EVT (in 307 CLI patients, 43%), was associated with MALE ( p = .04, hazard ratio [95% confidence interval] 1.25 [1.01, 1.55]), and interacted with CRP >3 mg/dL ( p .004) but not with other baseline characteristics. Indirect EVT with CRP >3 mg/dL had higher MALE risk (HR 2.08), and interacted with diabetes mellitus (DM) presence. Indirect EVT with CRP >3 mg/dL and DM had higher MALE risk (HR 2.17). Conclusion Limb prognosis was equivalent for direct and indirect endovascular revascularization except in the presence of both diabetes and wound infection, when indirect revascularization has a poorer outcome.

To compare the safety and efficacy of the S.M.A.R.T. Control stent vs. other stents in patients with symptomatic aortoiliac occlusive disease (AIOD) followed for up to 4 years.A subgroup analysis of data from a retrospective multicenter registry examined 2036 symptomatic patients (1659 men; mean age 71±8 years) who received stent-supported endovascular therapy for 2541 AIOD lesions between April 2005 and December 2009. The cohort was divided into the S.M.A.R.T. stent group (955 patients/1196 lesions) and the "other" stent group (1081 patients/1345 lesions). The main study outcomes of primary patency and event-free survival at 4 years were compared before and after propensity matching analysis. The rates for freedom from major amputation, surgical conversion, target lesion revascularization (TLR), and major adverse limb events were also assessed.The S.M.A.R.T. Control stent group had greater frequency of critical limb ischemia (CLI), TASC C/D lesions, and chronic total occlusions. The mean follow-up was 25±17 months in the S.M.A.R.T. group vs. 29±19 months in the other stent group. After propensity matching, 4-year primary patency (86% vs. 76%, p0.001) and freedom from adverse limb events (93% vs. 90%, p=0.04) were greater in the S.M.A.R.T. Control stent group, while event-free survival rates (75% vs. 77%, p=0.50) were similar between groups. Univariate subgroup analysis showed that use of the S.M.A.R.T. stent was associated with greater primary patency in patients with renal insufficiency (serum creatinine1.5 mg/dL) and CLI.After propensity matching analysis, the durability of the S.M.A.R.T. stent was superior to that of other stents, which might reflect differing design characteristics.

We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation.The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear.We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length.Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P0.001).Lesions in small (4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.

We investigated the relationship between the outcomes of endovascular therapy (EVT) for femoropopliteal (FP) lesions and vessel diameter. Several studies have reported a relationship between the outcome of EVT for FP lesions and lesion characteristics. However, the relationship with vessel diameter has not been explored.We retrospectively analyzed 2656 patients with 3340 de novo FP lesions (mean age, 73.9 ± 9 years; 70% male) who underwent EVT from January 2004 to December 2011. We classified the lesions into four groups according to the vessel diameter: group 1, ≤4 mm; group 2, 4 to 5 mm; group 3, 5 to 6 mm; and group 4,6 mm. We investigated the relationship between the outcomes of EVT and vessel diameter. The primary outcome measure was restenosis, and the secondary outcome measures were target lesion revascularization and major adverse limb events.The restenosis rate at 3 years in group 1 was significantly higher compared with the other groups (62.2%, 35.7%, 37.1%, and 41.0% for groups 1, 2, 3, and 4, respectively; log-rank, P .0001). The outcome among small vessels was significantly worse in the stent group, and the outcomes for target lesion revascularization and major adverse limb events were similar. After adjustment, a small vessel ≤4 mm remained an independent predictor of restenosis (hazard ratio, 1.69; 95% confidence interval, 1.44-1.98; P .0001).This study suggested that vessel diameter, especially a small vessel ≤4 mm, was associated with poor EVT outcomes. The tendency was particularly evident in the stent group, which suggested that primary stenting should not necessarily be recommended for small vessels.

Background Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients. Methods This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events. Results A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol + aspirin group and 81% in the aspirin group, with no significant difference ( P = 0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group ( P = 0.73). In addition, no significant difference was observed in any secondary points. Conclusions Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.

Purpose: To investigate the clinical outcomes of endovascular therapy (EVT) for upper extremity peripheral artery disease (PAD) with critical hand ischemia (CHI). Methods: A subanalysis was performed of multicenter registry data on 36 consecutive patients (mean age 65.7±10.3 years; 19 men) who underwent EVT from January 2003 to December 2013 for angiographically diagnosed de novo upper limb PAD with CHI in 40 limbs. Fifty percent of patients had diabetes, and two-thirds were on hemodialysis. Technical success of EVT was straight-line flow to the hand and final residual diameter stenosis ≤50% for balloon angioplasty alone and ≤30% without flow-limiting dissection for subclavian artery stenting. The primary outcome was 12-month amputation-free survival [AFS; freedom from a composite of major (above-the-wrist) amputation and death]. The 12-month secondary outcomes were overall survival, limb salvage, freedom from major adverse limb events (MALE; major amputation or any repeat revascularization of the limb), and wound healing (complete epithelialization without death or major amputation). Results: Initial success was achieved in 87% (35 of 40 limbs); 1 patient experienced puncture site problems, and 3 (8%) of 36 patients (4 treated limbs) died within 30 days. Hand symptoms were alleviated in 37 (92%) limbs. The mean follow-up was 26.8±27.8 months. Seven fingers (5 limbs) underwent phalanx amputations and 2 limbs had an amputation above the wrist. Complete wound healing was achieved in only 5 (19%) of 26 surviving patients at 12 months. At 1 year, the Kaplan-Meier estimates for AFS, overall survival, limb salvage, and freedom from MALE were 56.4%, 59.4%, 93.1%, and 78.5%, respectively. Univariate analysis revealed that the predictors of AFS at 1 year were diabetes (p=0.03), hemodialysis (p

Optimal medical therapy following endovascular therapy (EVT) for femoropopliteal (FP) lesions remains unclear. Therefore, we investigated whether sarpogrelate improves primary patency after EVT for FP lesions. This study was performed as a multicenter, randomized, open-label clinical trial. 186 patients (mean age 75 ± 9 years, 78 % men) with Rutherford class 2–5 due to an FP lesion were randomly assigned to receive or not receive sarpogrelate in addition to aspirin. Primary endpoint was 1-year primary patency and the secondary endpoints were target lesion revascularization (TLR) and secondary patency. Primary patency was defined as a treated vessel without restenosis or repeat revascularization. Restenosis was defined as >2.5 of peak systolic velocity ratio. Patient, lesion, and procedural characteristics did not differ significantly between two groups (mean lesion length 156 ± 94 mm, total occlusion 35 %). Stenting was performed in 133 patients (76 %). Eighty-four (94 %) could ingest sarpogrelate during follow-up period. Primary patency was 66 % in sarpogrelate group and 56 % in non-sarpogrelate group, showing no significant difference between the groups (p = 0.33). The incidence of TLR did not differ in both groups (sarpogrelate 24 % vs non-sarpogrelate 32 %, p = 0.12). Secondary patency also did not differ (sarpogrelate 90 % vs non-sarpogrelate 92 %, p = 0.43). When the interaction of sarpogrelate with the primary patency was analyzed in previously established subgroups, no interactions were noted for any subset. Sarpogrelate did not improve primary patency after EVT for FP disease in this study.

We experienced a rapidly growing huge coronary pseudoaneurysm with symptomatic restenosis after rotational atherectomy. A BMS had successfully obliterated the huge coronary pseudoaneurysm at 3 months follow-up on CTA. The OCT at 9 months follow-up showed that the most of stent strut was covered with neo-intima. This case suggests that BMS deployment is recommended as a useful method for treating coronary pseudoaneurysms. © 2011 Wiley Periodicals, Inc.

Objective:To examine the long-term outcome of the stent fracture (SF) and the potential predictive factors contributing to in-stent restenosis (ISR) in the fractured stent. Background:The SF is thought to be a higher risk of ISR in drug-eluting stent, although SF does not always develop ISR. Methods:The consecutive 1,228 de novo lesions in 1,079 patients who underwent sirolimus-eluting stents implantation and assessed by 8 months follow-up coronary angiography were retrospectively analyzed. Results:One hundred and seventeen SFs (9.5%) were identified in 100 patients and 22 (18.8%) SFs revealed ISR at the first follow-up. In addition, 16 (13.7%) developed new ISRs from 95 residual SFs without ISR prior to the second follow-up. Overall, 38 (32.5%) of all 117 SFs developed ISR, and 16 (42.1%) of 38 SFs occurred in a late phase beyond the first 8 months follow-up. A higher risk of ISR in the SF site was associated with the chronic total occlusion (ISR vs. no ISR: 34.2% vs. 16.5%, P = 0.0304), calcified lesions (55.3% vs. 34.2%, P = 0.0299), and correspondence 89.5% versus 43.0%, P < 0.0001 (SF site occurring at the original target lesion site) in the univariate analysis. The correspondence was identified as the only strong predictive factor for ISR at the SF site according to a multivariate logistic regression analysis (odds ratio 12.6, 95% confidence interval 3.82–53.5, P < 0.0001). Conclusions:SF occurring at the site of the original target lesion was a strong independent predictor of ISR. This indicates the need for a careful, long-term follow-up in those situations, even when no significant ISR is initially detected. (J Interven Cardiol 2011;24:165–171)

A 64-year-old female with chronic hemodialysis complained of a worsening of bilateral intermittent claudication. Computed tomographic angiography (CTA) demonstrated severe calcified bilateral aortoiliac occlusions. The kissing stent placement was therefore attempted: A 10 × 60 mm SMART stent was placed into the right aortoiliac lesion at the 1st session, and a 10 × 60 mm SMART stent was placed into the left aortoiliac lesion parallel with the previous SMART stent at the 2nd session, thus completing the "staged" kissing stent placement. CTA indicated the penetrating point in the calcified plaque clearly, and this case suggested the usefulness of CTA guided percutaneous peripheral intervention.

Objectives This study sought to characterize coronary hyperintense plaques (HIP) using noncontrast T1-weighted imaging (T1WI) in cardiac magnetic resonance, which was then compared with multislice computed tomography and intravascular ultrasound. Background Carotid plaque components such as intraplaque hemorrhages and/or lipid-rich necrotic cores can be detected as HIP by noncontrast T1WI. Although coronary HIPs have been successfully detected using this technique, the properties of hyperintense signals in coronary plaques have not yet been systematically evaluated. Methods Thirty-eight lesions from 37 patients with angina pectoris who demonstrated >70% coronary stenosis on multislice computed tomography were evaluated by noncontrast T1WI using a 1.5-T magnetic resonance imager, and 25 lesions were evaluated by intravascular ultrasound. Signal intensity of coronary plaque to cardiac muscle ratio >1.0 was defined as HIP. We divided 25 lesions into the 2 groups, according to the presence or absence of HIP: HIP (n = 18) and non-HIP (n = 7) groups. Results In comparison with the non-HIP group, the HIP group demonstrated significantly higher coronary plaque to cardiac muscle ratio (1.7 ± 0.7 vs. 0.9 ± 0.1, p Conclusions The typical HIP case was associated with ultrasound attenuation, positive remodeling, remarkably low computed tomography density, and a high incidence of slow-flow phenomena. Noncontrast T1WI in cardiac magnetic resonance imaging may be useful for the assessment of coronary plaque characterization in patients with coronary artery disease.

Purpose: To evaluate the relationship between 1-year primary patency and lesion length in patients with femoropopliteal disease treated with bare nitinol stents. Methods: The study was a retrospective analysis of a prospectively maintained multicenter database. Between January 2004 and December 2011, 1047 consecutive patients (mean age 72 years; 765 men) underwent femoropopliteal stenting with nitinol stents in 1373 limbs. The mean vessel diameter was 5.3±0.7 mm and the mean lesion length was 142±75 mm. One-year follow-up data were collected and analyzed to ascertain which lesion length would be expected to demonstrate a 1-year primary patency above the established 66% objective performance goal (OPG). Results: The lower limit of the 95% confidence interval (CI) for the unadjusted 1-year primary patency was >66% when the lesion length was ≤243 mm. After adjustment of the covariates to match those of the OPG-derived population, the 1-year primary patency decreased linearly with longer lesion length. The 1-year primary patency was 83.2% (95% CI 79.8% to 86.1%) for a 100-mm lesion length, 76.4% (95% CI 71.7% to 80.5%) for a 200-mm lesion length, and 70.7% (95% CI 62.4% to 77.7%) for a 300-mm lesion length. The maximum lesion length providing a 1-year primary patency significantly greater than 66% was calculated to be 263 mm. Conclusion: The 1-year primary patency of femoropopliteal lesions treated with bare nitinol stents decreased linearly with longer lesion length. The maximum lesion length providing a higher patency rate than the OPG of 66% was ~25 cm.

Purpose: To investigate the perioperative and long-term outcomes of endovascular therapy (EVT) for subclavian artery disease in a large-scale multicenter study. Methods: The study analyzed the outcomes from a multicenter retrospective registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry: SCALLOP) of 718 consecutive patients with upper extremity artery disease who underwent EVT between January 2003 and December 2012 at 37 Japanese cardiovascular centers. Of the 718 patients enrolled in the registry, 162 patients were excluded, leaving 553 patients (mean 70±7 years, range 41–91; 405 men) who underwent primary EVT for de novo subclavian artery disease (560 arms). Results: Procedure success was achieved in 96.8% (100% for stenoses, 91% for total occlusions). The perioperative complication rate was 9.2%. Stroke was found in 1.8%, with ipsilateral posterior infarction accounting for 0.9%. The 30-day mortality was 0.7%. The mean follow-up was 39±24 months. Primary patency estimates were 90.6%±1.3%, 83.4%±1.8%, and 80.5%±2.2% at 1, 3, and 5 years, respectively. There was no significant difference in primary patency between stenotic and occlusive lesions. Secondary patency estimates were 99.2%±0.4%, 98.2%±0.6%, and 97.7%±0.8% at 1, 3, and 5 years, respectively. The respective overall survival rates were 94.6%±1.0%, 86.8%±1.7%, and 79.0%±2.4%. There were 86 deaths during follow-up, of which half were due to cardiovascular causes. On multivariate analysis, critical hand ischemia (hazard ratio [HR] 4.6, 95% CI 2.06 to 10.2, p

The recent studies reported that the utility of invasive fractional flow reserve (iFFR) to assess hemodynamic significance of coronary artery disease (CAD) was superior to anatomic stenosis of coronary artery by coronary computed tomographic angiography (CCTA). Then, iFFR guided treatment was

Background: Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions. Methods: This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes. Results: After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm ( P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm ( P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821). Conclusion: The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used.

Aim To investigate the prognosis and to clarify the predictors of both patient and limb survival among hemodialysis (HD) patients with critical limb ischemia (CLI) due to isolated below-the-knee (BK) disease. Methods An observational cohort study, analyzing a total of 546 HD patients with 681 limbs who underwent endovascular treatment (EVT) for CLI with isolated BK disease at 11 hospitals in Japan between March 2004 and June 2011, was performed. Results The mean patient age was 69.0±9.5 years, and 420 (76.9%) of the subjects were men. The number of patients classified with Rutherford stage 4, 5 and 6 disease was 103 (18.9%), 332 (60.8%) and 111 (20.3%), respectively. The mean HbA1c level was 6.48±1.20%, and 195 (35.7%) of the subjects were active smokers. During the follow-up period (mean: 557.5 days), 191 (35.0%) patients died and 82 (12.0%) limbs underwent major amputation. The freedom from all-cause death was 75.5%, 53.4% and 36.9% and freedom from major amputation was 86.7%, 83.9% and 83.9% at one, three and five years after EVT, respectively. Cox proportional hazard regression analyses revealed that a non-ambulatory status, low serum albumin level and ＜2 runoff vessels after EVT were significant predictors for both all-cause death and major amputation. Conclusions Although patient survival remains poor, the limb salvage rate after EVT is favorable among those on HD with CLI due to isolated BK disease. The present results allow for the risk stratification of HD patients with CLI undergoing EVT for isolated BK disease.