Clinical validity of the Japanese below-the-knee chronic total occlusion scoring system for the prediction of successful guidewire crossing.

OBJECTIVE: To validate Japanese below-the-knee (J-BTK) chronic total occlusion (CTO) score for the prediction of successful guidewire crossing in angiographic evaluation. METHODS: A prospective, multicenter, non-randomized study examined 751 consecutive BTK CTOs in 497 patients treated with endovascular therapy (EVT) in 16 Japanese medical centers from April 2021 to March 2022. The cohort was classified into 2 groups: a successful guidewire crossing (S-GC) group and a failed guidewire crossing group. RESULTS: The J-BTK CTO score which assigned one point to "Blunt type at the proximal entry point", one point to "Calcification at the proximal entry point", one point to "Reference vessel diameter < 2.0mm", one point to "CTO length ≥ 200mm", and two points to "No outflow of the target vessel" was utilized to categorize BTK CTOs into 4 grades with varying probabilities of successful guidewire crossing: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of successful guidewire crossing in each grade (grade A, B, C, and D) were 97.5%, 89.1%, 62.5%, and 27.3%, respectively. The area under the receiver-operating characteristic (ROC) curve for successful guidewire crossing was 0.8304. Although the previous J-BTK CTO study enrolled only de novo lesions, both de novo and restenotic lesions were evaluated in this study. De novo lesions have a lower chance of S-GC (odds ratio: 0.24, 95% confidence interval: 0.09-0.67) in the multivariate analysis and the area under the ROC curve of the modified J-BTK CTO score, which additionally assigned two points to "De novo lesion", was 0.846. The modified J-BTK CTO score showed an appropriate calibration (Hosmer-Lemeshow p=0.957). CONCLUSION: The J-BTK CTO score and the modified J-BTK CTO score predict the probability of a S-GC of BTK CTOs and stratify the difficulty of EVT for BTK CTOs in angiographic evaluation.

Chronic Clinical Findings after Rheocarna® Therapy in a Chronic Limb-threatening Ischemia Patient with Inframalleolar Lesions: A Case Report.

An 87-year-old man was referred to our hospital for non-healing ulcers on the right third, fourth, and fifth toes. The patient was diagnosed with chronic limb-threatening ischemia. Pre-treatment angiography of the right lower extremity revealed inframalleolar lesions. We failed to perform endovascular treatment because of severe calcification. Therefore, we treated the patient with a novel low-density lipoprotein apheresis device (Rheocarna®; Kaneka Corporation, Osaka, Japan). Angiography performed four days after therapy revealed significant improvement in microcirculation. One year after therapy, he managed to avoid major amputation and achieve wound healing. In addition, angiography revealed that the microcirculation was maintained.

Chronic Limb-Threatening Ischemia is a Residual Bleeding Risk Factor among Patients with Lower Extremity Artery Disease.

AIM: Lower-extremity artery disease (LEAD) is a high-risk factor for bleeding. However, the specific risk factors for bleeding in patients with LEAD remain unclear. We aimed to identify risk factors for bleeding in patients with LEAD after endovascular treatment (EVT). METHODS: This multicenter, retrospective, observational study included 732 consecutive patients with LEAD who underwent EVT between January 2018 and December 2019. Patient characteristics, laboratory data, target lesions, and medications were compared between patients with and without chronic limb-threatening ischemia (CLTI). Predictive bleeding risk factors were explored using Cox regression analysis with differential models. RESULTS: In model 1, a body mass index (BMI) ＜18.5 kg/m2, prior heart failure, high bleeding risk, use of single antiplatelet therapy (SAPT) plus warfarin, and CLTI were predictive bleeding risk factors (hazard ratio [HR] 2.05; 95% confidence interval [CI] 1.13-3.52; p＜0.01; HR 2.15; 95% CI 1.28-3.55; p＜0.01; HR 3.40; 95% CI 1.28-3.55; p＜0.01; HR 2.05; 95% CI 1.33-5.84; p＜0.01; respectively). In model 2, a BMI ＜18.5 kg/m2, prior heart failure, anemia (＜11 g/dL), low platelet count (＜10*104/µL), chronic kidney disease, use of single antiplatelet therapy (SAPT) plus warfarin, and CLTI were independent risk factors for bleeding (model 2: HR 2.05; 95% CI 1.12-3.56; p=0.02; HR 2.35; 95% CI 1.39-3.90; p＜0.01; HR 2.71; 95% CI 1.64-4.50; p＜0.01; HR 2.66; 95% CI 1.00-5.89; p=0.05; HR 2.47; 95% CI 1.25-5.45; p＜0.01; HR 2.79; 95% CI 1.24-5.63; p=0.01; respectively) Conclusions: CLTI is a residual and predictive risk factor for bleeding in patients with LEAD. We have to pay attention to the bleeding events of patients with CLTI after EVT during follow-up.

Validation of the Usefulness of the Diameter Reduction, Spiral Shape, Flow Impairment, or Adverse Morphology Classification System in Real-World Clinical Practice.

AIM: The accuracy of the DISFORM (diameter reduction, spiral shape, flow impairment, or adverse morphology) classification system has not been validated. METHODS: This retrospective multicenter observational study enrolled 288 consecutive patients with lower extremity artery disease who underwent endovascular therapy with drug-coated balloons for femoropopliteal lesions between January 2018 and December 2021. Patients were classified into DISFORM I-IV groups. Primary patency (PP) and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months, and recurrence predictors at 12 months were investigated. RESULTS: In total, 183, 66, 11, and 28 patients were classified into DISFORM I, II, III, and IV groups, respectively. In the DISFORM I, II, III, and IV groups, the PP rates were 75.3%, 91.1%, 87.5%, and 50.0%, respectively, and freedom from CD-TLR rates were 86.0%, 91.6%, 88.9%, and 76.7%, respectively, at 12 months. In the DISFORM I-III and IV groups, the PP rates were 79.4% and 50.0%, respectively, and freedom from CD-TLR rates were 87.5% and 76.7%, respectively, at 12 months. Multivariate analysis showed that chronic limb-threatening ischemia, DISFORM IV, and Lutonix™ use were independent predictors of PP loss at 12 months. CONCLUSION: DISFORM IV had a lower PP rate than DISFORM I-III in midterm phase.

JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.

Although endovascular treatment (EVT) has developed and still progressing, calcified lesions remain a big challenge to operators in obtaining good results. Whenever, the eccentric and calcified plaques or nodules are present, balloon dilatation may be difficult and vascular complications may frequently occur. We present a 73-year-old woman, with severe, eccentric, calcified lesion in the right superficial femoral artery (SFA). First, we performed the aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA) technique for the eccentric plaques. Then, we used a WingmanⓇ crossing catheter (ReFlow Medical, Inc.) to penetrate and pass through the calcifications and eventually exchanged to a ParachuteⓇ (Good Care, Inc.) filter wire. Finally, we performed rotational atherectomy using the JETSTREAMⓇ (Boston Scientific) rotational atherectomy device for debulking to obtain good lesion expansion and was able to avoid potential complications. Performing ARCADIA technique then using a Wingman catheter for inserting a filter wire before JETSTREAMⓇ atherectomy is safe and effective for heavily calcified, eccentric lesions. Further studies will be needed to validate the safety and efficacy of this approach.

Longitudinal changes in skin perfusion pressure after endovascular therapy in patients with chronic limb-threatening ischemia.

PURPOSE: The skin perfusion pressure (SPP) increases after endovascular treatment (EVT) for up to 1 month, although changes beyond 1 month remain unreported. This study aimed to investigate the changes in the SPP over time after EVT. MATERIALS AND METHODS: This was a single-center, prospective, observational study. We included patients with chronic limb-threatening ischemia who underwent EVT between January 2019 and July 2022. We evaluated the SPP after EVT monthly for up to 3 months and compared the changes in the SPP between patients with different comorbidities. Moreover, we investigated the independent predictors of recurrent foot ischemia using a multivariate analysis. RESULTS: Overall, 87 patients were included in the study. The mean preprocedural dorsal and plantar SPP was 33.9 ± 14.7 and 33.4 ± 13.1 mmHg, respectively. After the procedure, the SPP significantly increased at 1 month but decreased during months 2 and 3 (the dorsal SPP at 1, 2, and 3 months was 59.6 ± 20.3, 48.3 ± 20.9, and 39.7 ± 14.7, respectively, p < 0.01; the plantar SPP at 1, 2, and 3 months was 57.3 ± 18.2, 48.2 ± 15.6, and 40.5 ± 15.3, respectively, p < 0.01). Changes in the SPP did not differ among patients with different comorbidities. The multivariate analysis revealed that severe infrapopliteal calcification was an independent predictor of recurrent foot ischemia (odds ratio, 3.8; 95% confidence interval, 1.1-13.4; p = 0.04). CONCLUSION: The SPP after EVT significantly increased at 1 month and decreased monthly for up to 3 months. Severe infrapopliteal calcification was the sole predictor of foot ischemia recurrence. Meticulous follow-up after EVT and regular hemodynamic examinations are important.

Utility and safety of a novel method using a Wingman catheter for patients with lower extremity arterial disease complicated with severely calcified lesions: Wingman's bevel tip inner catheter removal technique-A prospective cohort study.

Background and Aims: In cases of lower extremity artery disease (LEAD) accompanied by heavily calcified lesions, endovascular treatment becomes necessary at times. To effectively address these challenging calcified lesions, we developed an innovative approach named WINNER (Wingman's bevel tip inner catheter removal) technique. This study investigated the effectiveness and safety of a novel method using the WINNER technique. Methods: This was a two-center, prospective observational study. We analyzed the clinical data of patients with LEAD complicated with severely calcified lesions who underwent the WINNER technique between January 2021 and December 2022. We investigated the patients' characteristics, target lesions, and intervention results in terms of crossing device rates and periprocedural complications. Results: A total of 35 patients were treated using the WINNER technique for LEAD complicated by severely calcified lesions. Key patient characteristics were a mean age of 75 ± 9 years, 83% male, 71% hemodialysis, 60% chronic limb-threatening ischemia, and mean lesion length of 147 ± 88 mm. Using the WINNER technique, a device crossing was achieved in 34 patients (97.1%). Wire perforation occurred in one patient, and WINNER catheter rupture occurred in three patients. Conclusions: The WINNER technique is useful for treating severely calcified lesions, and we should consider using this technique to cross devices for lesions with severe calcifications.

Predictors of recurrence based on intravascular ultrasound findings after Eluvia placement in symptomatic peripheral arterial disease: A retrospective study.

Background and Aims: Polymer-coated drug-eluting stents (Eluvia) have shown favorable clinical outcomes in real-world registries. There are no reports on recurrent predictors after Eluvia placement based on intravascular ultrasound (IVUS) findings. Methods: We analyzed clinical data from the ASIGARU PAD registry, a retrospective, multicenter, observational study that enrolled patients who underwent endovascular therapy for superficial femoral and proximal popliteal arteries lesions using Eluvia or drug-coated balloon. The primary outcome was the identification of recurrent predictors, including IVUS parameters at 12 months. The rate of target lesion recurrence was also assessed. Results: IVUS images were obtained in 54 of 65 cases. Seven recurrent cases (13.0%) were observed within 12 months. The random survival forest method presented eight predictive variables of recurrence: Clinical Frailty Scale (CFS), distal stent edge area, distal plaque burden, age, sex, distal external elastic membrane (EEM) area, minimum stent area (MSA), and distal lumen area. Furthermore, the partial dependence plot showed that frailty (CFS ≥ 6), smaller distal stent edge area, higher and lower distal plaque burden, older and younger age, female sex, smaller distal EEM area, smaller MSA, and smaller and larger distal lumen area predicted recurrence after Eluvia placement within 12 months. Conclusion: CFS, distal stent edge area, distal plaque burden, age, sex, distal EEM area, MSA, and distal lumen area were significant recurrent predictors after Eluvia placement.

Clinical Outcomes Based on High Bleeding Risk in Patients With Lower Extremity Peripheral Artery Disease Who Have Undergone Endovascular Therapy.

PURPOSE: Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. In this study, we investigated the prevalence and severity of HBR, as well as its association with clinical outcomes in the patients with PAD who underwent EVT. MATERIALS AND METHODS: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria were applied to 732 consecutive patients with lower extremity PAD post-EVT to assess the prevalence of HBR, and its association with major bleeding events, all-cause mortality, and ischemic events. The ARC-HBR scores (1 point for each major criterion and 0.5 points for each minor criterion) were obtained and the patients were divided into four groups (score: 0-0.5; low risk, score: 1-1.5; moderate risk, score: 2-2.5; high risk, and score: ≥3; very high risk) according to the score. Major bleeding events were defined as Bleeding Academic Research Consortium type-3 or type-5 bleeding, and ischemic events were defined as the composite of myocardial infarction, ischemic stroke, and acute limb ischemia within 2 years. RESULTS: High bleeding risk occurred in 78.8% of the patients. Major bleeding events, all-cause mortality, and ischemic events occurred in 9.7%, 18.7%, and 6.4% of the study cohort, respectively, within 2 years. During the follow-up period, major bleeding events significantly increased with the ARC-HBR score. The severity of the ARC-HBR score was significantly associated with an increased risk of major bleeding events (high risk: adjusted hazard ratio [HR] 5.62; 95% confidence interval [CI]: [1.28, 24.62]; p=0.022; very high risk: adjusted HR: 10.37; 95% CI: [2.32, 46.30]; p=0.002). All-cause mortality and ischemic events also significantly increased with higher ARC-HBR score. CONCLUSIONS: High bleeding risk patients with lower extremity PAD can be at a high risk of bleeding events, mortality, and ischemic events after EVT. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with lower extremity PAD who undergo EVT. CLINICAL IMPACT: Endovascular therapies (EVTs) for symptomatic lower extremity peripheral artery disease (PAD) are efficient and minimally invasive. However, patients with PAD tend to have high bleeding risk (HBR), and there are limited data regarding the HBR for patients with PAD after EVT. Post EVT, most of the patients with PAD were classified as having HBR using the Academic Research Consortium for HBR (ARC-HBR) criteria and the rate of bleeding events as well as mortality and ischemic events within 2 years increased as the ARC-HBR score increased in this retrospective study of 732 participants. HBR patients with PAD can be at high risk of not only bleeding events but also mortality and ischemic events in the mid-term. The ARC-HBR criteria and its associated scores can successfully stratify HBR patients and assess the bleeding risk in patients with PAD who underwent EVT.

Removal of Migrated Vascular Closure Device Plug Material From the Popliteal Artery Using the Bi-Directional Approach "Push Balloon Into Vessel and Close Embolus From Retrograde Site (PINCER)" Technique: A Case Report.

Vascular closure devices (VCDs) are widely used to achieve rapid hemostasis after percutaneous intervention via the common femoral artery (CFA), with well-established efficacy and safety. Although VCD-related artery occlusion is rare, it can be critical. A 72-year-old female underwent endovascular therapy (EVT) for stent occlusion in the left superficial femoral artery through a 7-Fr guiding sheath from the right CFA. After the procedure, an acute right popliteal artery (POP-A) occlusion, associated with the EXOSEAL VCD plug, occurred. The plug material was successfully removed using a bidirectional approach. The migration plug was blocked to prevent distal vessel migration and pushed gently to close the antegrade system, using an over-the-wire balloon from the retrograde site. We named this the "Push balloon INto vessel and Close Embolus from Retrograde site" (PINCER) technique. Finally, the plug was successfully removed using biopsy forceps. Acute limb ischemia (ALI) caused by EXOSEAL is a rare condition. Removal of the emboli by EVT is clinically significant because it is minimally invasive. However, it is sometimes difficult to remove the embolus using only antegrade approach; thus, the bidirectional approach using the PINCER technique can be effective in these situations.

Feasibility and impact of extra-vascular ultrasound-guided endovascular treatment for infrapopliteal artery occlusive disease.

PURPOSE: This study aimed to examine the feasibility and impact of extra-vascular ultrasound (EVUS)-guided intervention for infrapopliteal (IP) artery occlusive disease. MATERIALS AND METHODS: A retrospective analysis was performed using data collected from patients who underwent endovascular treatment (EVT) for IP artery occlusive disease between January 2018 and December 2020 at our institution. A total of 63 consecutive de novoocclusive lesions were compared according to the recanalization method utilized. Propensity score matching analysis was performed to compare the clinical outcomes of the methods utilized. The prognostic value was analyzed based on the technical success rate, distal puncture rate, radiation exposure, amount of contrast media, postprocedural skin perfusion pressure (SPP), and procedural complication rate. RESULTS: Eighteen matched pairs of patients were analyzed using propensity score-matched analysis. Radiation exposure was significantly lower in the EVUS-guided group than in the angio-guided group, with 135 and 287 mGy (p = 0.04) exposure on average, respectively. There were no significant differences between the two groups in terms of technical success rate, distal puncture rate, the amount of contrast media, postprocedural SPP, and procedural complication rate. CONCLUSION: EVUS-guided EVT for IP occlusive disease achieved a feasible technical success rate and significantly reduced radiation exposure.

Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry.

PURPOSE: Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear. MATERIALS AND METHODS: Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect. RESULTS: The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (<52 cases/year) than in the other quartiles (P < .01, respectively). On the contrary, the adjusted ORs for procedural complications were significantly higher in the first and second quartiles than in the third and fourth quartiles (P < .01, respectively). CONCLUSION: In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. CLINICAL IMPACT: EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

Association between High Bleeding Risk and 2-Year Mortality in Patients with Chronic Limb-Threatening Ischemia.

AIM: Patients with chronic limb-threatening ischemia (CLTI) have a high bleeding risk (HBR) and mortality rate. The 2-year life expectancy is an important factor in deciding the appropriate treatment strategy. This study aimed to assess the influence of HBR on the prognosis of patients with CLTI. METHODS: A total of 259 patients with CLTI who underwent endovascular therapy (EVT) (mean age, 76.2 years; male, 62.9%) between January 2018 and December 2019 were evaluated. The Academic Research Consortium for HBR (ARC-HBR) criteria were applied to each patient, and the ARC-HBR scores were calculated. The cut-off score for predicting all-cause mortality within two years was derived using a survival classification and regression tree (CART) model. Causes of death and the association between ARC-HBR scores and major bleeding events within two years were also investigated. RESULTS: Based on the CART model, patients were divided into three groups (low HBR score 0-1.0, 48 patients; moderate HBR score 1.5-3.0, 176 patients; and high HBR score ≥ 3.5, 35 patients). During the study period, 82 patients (39.6%) died due to cardiac (n=23) and non-cardiac causes (n=59). All-cause mortality increased significantly with increasing ARC-HBR scores. Cox multivariate analysis revealed a significant association between high ARC-HBR scores and the risk of all-cause mortality within two years. Major bleeding events increased significantly with increasing ARC-HBR scores. CONCLUSIONS: The ARC-HBR score could predict 2-year mortality in patients with CLTI who underwent EVT. Thus, this score can help determine the best revascularization strategy for patients with CLTI.

Two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease.

We aimed to assess the clinical performance and risk factors for patency loss within 2 years following the use of polymer-coated paclitaxel-eluting stents (PC-PESs) and drug-coated balloons (DCBs) in patients with lower extremity artery disease. Multi-center registry data from 151 patients (65 and 86 treated with PC-PES and DCB, respectively) were retrospectively investigated. Two-year primary patency (PP) and clinically driven target lesion revascularization (CD-TLR) were evaluated using Kaplan-Meier analysis. Predictors of restenosis within 2 years of the procedures were analyzed using the random survival forest method. The consistent predictors of restenosis within 1 and 2 years were assessed and validated using Kaplan-Meier analysis. Two-year PP was 77.2 and 57.2% (log rank p = 0.047) and freedom from CD-TLR was 84.4 and 84.8% in the PC-PES and DCB groups, respectively (log rank p = 0.89). In the DCB group, most of the patients (n = 77, 89.5%) were treated with high-dose DCB. Consistent predictors of restenosis were lower vessel diameter and severity of Clinical Frailty Scale in the PC-PES group, and severity of peripheral artery calcification scoring system grade, severity of post dissection pattern, and smaller vessel diameter in the DCB group. The validation analysis revealed that patients with consistent predictors had significantly worse PP values than that of those without in the PC-PES (87.9% vs. 55.3%, log rank p = 0.003) and DCB groups (75.9% vs. 35.2%, log rank p = 0.001). The 2-year PP of DCBs was lower than that of PC-PESs. A smaller vessel diameter could predict restenosis in both devices. Vessel calcification and dissection should be considered when using DCB to ensure longer term patency.