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Assistance by family members or friends plays important roles in the course of treating patients with chronic limb-threatening ischemia (CLTI), both during hospitalization and after discharge. The aim of this study was to reveal the prevalence of social isolation and to explore relevant clinical backgrounds in patients with CLTI presenting with tissue loss and requiring revascularization. We analyzed 413 patients registered in a multicenter study in whom revascularization were scheduled for CLTI with tissue loss. Social isolation was analyzed by assessing the residence status of the patients and the involvement of a trusted family member or friend in their daily lives and during hospitalization. Patients living alone accounted for 24.5% (95% confidence interval [CI] 20.1–28.8%) of the study population. Patients receiving welfare were more likely to live alone (P

To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1–6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events. Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined. The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

The current study aimed to reveal the clinical impact of plasma homocysteine levels in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization. This was a sub-analysis of a prospective multicenter registry of CLTI patients, named the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study. The current analysis included 192 non-dialysis-dependent CLTI patients who underwent revascularization for CLTI, and whose plasma homocysteine levels at baseline were available. The association of clinical characteristics with homocysteine levels was evaluated with the linear regression model. The association of homocysteine levels with the mortality risk was investigated using the Cox proportional hazards regression model. Cystatin C-based estimated glomerular filtration rate (eGFR) was independently associated with log-transformed homocysteine levels; the adjusted standardized regression coefficient (95% confidence interval) was − 0.432 (− 0.657 to − 0.253; P P = 0.017); the unadjusted hazard ratio was 1.71 (1.13–2.50) per twofold increase. The association was significantly attenuated when adjusted for cystatin C-based eGFR (P P = 0.29). An apparent association of homocysteine levels with an increased risk of mortality could be explained by renal dysfunction. Future studies will be needed to validate the current findings.

Background To evaluate the efficacy of the GLadIus MG drilLINg technique (GLIMGLIN), a novel initial wiring technique using the Gladius MG™ structural features, for crossing the superficial femoral artery (SFA) with chronic total occlusion (CTO). Methods This retrospective, single-center study enrolled 27 symptomatic patients (mean age 77.4 ± 8.5 years; 20 men) with de novo SFA CTO (mean CTO length 16.1 ± 8.9 cm) who underwent GLIMGLIN as the initial wiring between January 2020 and December 2021. The success of GLIMGLIN was defined when the wire crossing was completed using a Gladius MG™ and a microcatheter without any additional devices and techniques. Results The success rate of GLIMGLIN was 48.1%. Intravascular ultrasound findings showed complete true lumen passage in the GLIMGLIN success group. Compared to the failure group, the proximal (6.3 ± 0.8 vs. 5.5 ± 0.9 mm, p = 0.02) and distal (5.9 ± 0.5 vs. 5.4 ± 0.6 mm, p = 0.02) reference vessel diameters were significantly larger, and the rate of calcium angle > 180° was significantly lower (30.8 vs. 71.4%, p = 0.04) in the success group. No significant difference was shown in the CTO length between two groups. Total wiring time, total procedure time, and fluoroscopic time were significantly shorter in the success group. Conclusions GLIMGLIN may enable operators to perform CTO wiring easily and efficiently in selected cases.

To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT). IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30–140 mm, Rutherford category 2–4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow. At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan–Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings. Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events. Clinical trial Registration: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015. Level of evidence: Level 1; randomized controlled trial.

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

Background This study aimed to reveal the association of diabetes mellitus and dialysis-dependent renal failure with the lesion severity and chronic total occlusion (CTO) in patients undergoing femoropopliteal endovascular therapy for intermittent claudication. Methods This multicenter retrospective study analyzed the data of 2056 consecutive patients with moderate to severe intermittent claudication, who underwent endovascular therapy for de novo lesions in the superficial femoral artery to the proximal popliteal artery between 2010 and 2018 at five cardiovascular centers in Japan. The association of the clinical characteristics with severity of the lesions, as assessed by the Trans-Atlantic Inter-Society Consensus (TASC) II classification, was investigated using the ordinal logistic regression model. Their association with CTO, lesion length, and severity of calcifications was additionally analyzed using the binomial logistic regression model. Results The prevalence of diabetes mellitus and dialysis-dependent renal failure was 54.7% and 21.4%, respectively; 12.5% of the patients had lesions corresponding to TASC II class D, and 39.3% of the patients had CTO. Current smoking and severe claudication were associated with more severe lesions assessed according to the TASC II classification; diabetes mellitus and dialysis dependence were inversely associated with disease severity. The adjusted odds ratios of diabetes mellitus and dialysis dependence were 0.82 (95% confidence interval 0.70–0.97; p = 0.018) and 0.76 (0.62–0.94; p = 0.009), respectively. Diabetes mellitus and dialysis dependence were also inversely associated with CTO (both p p p Conclusions Diabetes mellitus and dialysis-dependent renal failure were inversely associated with the lesion severity, as assessed by the TASC II classification, and CTO in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.

To investigate the efficacy of statin treatment after endovascular therapy (EVT) for isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). From March 2004 to June 2011, 812 patients (984 limbs, 69.0 % male, 71.6 ± 10.0 years old) with CLI underwent successful EVT for de novo isolated BTK lesions at 11 cardiovascular centers in Japan. Of these patients, 169 patients were treated with statins. Successful EVT was defined as direct-line flow to the pedal arch with

The safety and patency of endovascular treatment (EVT) in isolated common femoral artery (CFA) and popliteal artery (PA) remain poorly understood. We investigated the efficacy after EVT for isolated CFA and PA disease. This study was performed as a multicenter retrospective registry of a prospectively maintained database. Between January 2001 and December 2010, consecutive 183 patients (214 lesions; CFA 111, PA 103) who received endovascular procedure for de novo isolated CFA and PA disease were enrolled. The main endpoints of this study were primary and secondary patency after EVT. Procedure success was 95.8 %. The 1- and 5-year primary patencies for CFA (PA) lesions after EVT were 73.5 % (75.5 %) and 46.9 % (56.2 %), respectively. There was no significant difference of primary patency rate between CFA and PA (46.9 vs. 56.2 % at 5-year, p = 0.83). However, secondary patency significantly differed between CFA and PA (97.6 vs. 86.2 % at 5-year, p = 0.009). Stent placement was not effective for the reduction of restenosis in both CFA and PA lesion. On multivariate analysis to define the predictors of primary patency for the CFA, renal failure, coronary artery disease, calcified lesion and residual stenosis after EVT were independent predictors. Also, the predictors of primary patency for the PA were BMI, reference vessel diameter, anemia and residual stenosis after EVT. Short-term patency after EVT for isolated CFA and PA lesion seems to be feasible. However, long-term patency was not promising. Furthermore, stent placement does not improve the primary patency.

The optimal diameter of a self-expandable stent for femoropopliteal (FP) artery disease remains unclear. The aim of this study is to investigate the influence of stent diameter on the clinical outcome after FP stenting and to identify optimal stent diameter of self-expandable stent implantation. This study was a prospective observational study. Eighty patients who underwent successful self-expandable stent implantation for FP disease were enrolled in this study. A commercially available self-expandable stent was used. The operator determined the type, diameter and length of the stent based on a visual estimate in angiography. A peak systolic velocity ratio >2.0 was defined as restenosis. Primary patency was defined as treated vessel without restenosis and repeat revascularization. Secondary patency was defined as target vessel which subsequently become totally occluded and is reopened by repeat revascularization. As a result, restenosis was found in 34 patients (42.5%) during the follow-up of 24 months. In-stent restenosis was independently predicted by stent fracture [hazard ratio (HR) 2.6, p = 0.01], chronic total occlusion (HR 2.4, p = 0.02) and stent diameter ×10/vessel diameter (S/V) ratio (HR 1.7, p = 0.04). Using receiver-operator characteristic analysis, S/V ratio >1.30 best separated patients with and without in-stent restenosis. Primary and secondary patency was significantly lower in patients with S/V ratio >1.30 (85 vs. 44%, p = 0.002 and 90 vs. 65%, p = 0.009, respectively). In conclusion, an S/V ratio was an independent predictor of in-stent restenosis after FP stenting, and it was also associated with the clinical outcome.