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Background: Despite the widespread use of drug-coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions., Methods: This multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled., Results: The Kaplan-Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79-0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36-7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15-6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001)., Conclusion: Repeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis., (© 2024 Wiley Periodicals LLC.)

Background: Balloon pulmonary angioplasty (BPA) is used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and residual pulmonary hypertension after pulmonary endarterectomy (PEA) to improve hemodynamics, right ventricular function, and exercise capacity. However, the effectiveness and safety of guide extension catheters for BPA treatment in patients with CTEPH have not been demonstrated., Methods: We retrospectively analyzed 91 lesions in 55 sessions of 28 patients with CTEPH who underwent BPA using a guide extension catheter. The purpose (backup, coaxial, and extension), efficacy, and safety of the guide extension catheters were explored. The efficacy of the guide extension catheter was assessed based on the success of the procedures and safety was evaluated based on procedure-related complications., Results: Regarding the intended use, a guide extension catheter was used to strengthen the backup force of the guiding catheter in 52% of cases, extend the tip of the catheter in 38% of cases, and maintain the coaxiality of the guiding catheter in 10% of cases. Procedural success was achieved in 92.7% of 55 sessions and in 95.6% of 91 lesions. Complex lesions had a lower success rate than simple lesions (p = 0.04). Regarding safety concerns, complications were observed in 5 of 55 sessions (9.1%) and 6 of 91 lesions (6.6%). Only one case of pulmonary artery dissection using a guide extension catheter was reported. Except for this one case, extension catheter-related complications were not observed., Conclusions: A guide extension catheter can be used safely in BPA procedures with anatomically complex pulmonary artery branches and complex lesions by increasing backup support., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Takigami et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Vasculopathy of systemic sclerosis (SSc) is known to lead to severe limb ischemia and is often associated with macrovascular diseases. Revascularization of proximal macrovascular lesions that cause limb ischemia in patients with SSc has been recommended; however, it has rarely been reported for lesions below-the-elbow (BTE) involving the palmar artery. A 66-year-old female patient with SSc experienced critical hand ischemia (CHI) with gangrene of the left third finger that failed to respond to conventional pharmacological treatment. Angiography revealed total occlusion of the distal radial and ulnar arteries with a palmar artery lesion. Balloon angioplasty was performed for bilateral occlusive lesions around the wrist, which improved antegrade flow to the digital artery. Endovascular therapy may be a feasible option for BTE lesions involving palmar artery disease, presenting with CHI in SSc, when conventional conservative treatments fail.

Background: Balloon pulmonary angioplasty (BPA) is an effective treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH). The purpose of this study is to evaluate the therapeutic effect and safety of the non-slip element percutaneous transluminal angioplasty (NSE PTA) scoring balloons in BPA., Methods: 108 pulmonary artery branches in 14 CTEPH patients who underwent BPA using NSE PTA scoring balloon (the NSE PTA group) or plain balloon (the POBA group) and pressure gradient evaluation were analyzed. We compared the improvement of the pressure ratios after BPA (Δ Pressure ratio) of both groups., Results: There was no significant difference in the Δ Pressure ratios of the two groups (0.241 ± 0.196 POBA, 0.259 ± 0.177 NSE PTA, p = 0.63). No complications occurred in the NSE PTA group, while 3 episodes of hemoptysis were seen in the POBA group. This, however, was not found to be significant (p = 0.27). In the cases where balloon-to-vessel ratio exceeded 1.0 (n = 35), multivariate analysis showed that the use of NSE PTA scoring balloon and pressure ratio before BPA were significantly correlated with Δ Pressure ratio (β coefficient: 0.047, 95% CI: 0.0016 to 0.093, p = 0.043 and β coefficient: -0.60, 95% CI: -0.78 to -0.42, p < 0.01, respectively)., Conclusions: Although NSE PTA scoring balloon was safe, there was no significant pressure gradient improvement with NSE PTA scoring balloon compared to conventional BPA. Nevertheless, the NSE PTA scoring balloon showed effective blood-flow improvement in the case of large balloon-to-vessel ratio., Competing Interests: The authors have declared that no competing interests exist.

The objective of this study is to develop a model for predicting the time of early symptomatic (delayed or nonhealing wound) restenosis after infrapopliteal angioplasty in patients with critical limb ischemia (CLI). This is a single-center retrospective cohort study evaluating 60 de novo infrapopliteal lesions of 38 limbs in 35 patients with CLI, who underwent successful endovascular treatment (EVT) from October 2016 to December 2018 and follow-up angiography within 3 months from the procedure. Outcome measures were binary restenosis at follow-up angiography and clinical outcome at 3 months. Patient/limb/lesion characteristics were compared between the restenosis and non-restenosis groups. Angiographic restenosis predictors were assessed to develop a model for predicting the time of restenosis using multinomial logistic regression. The restenosis rate at follow-up angiography (median time, 41 days [IQR 27-58 days]) was 38% (23/60). After adjustment for covariables, longer period between EVT and follow-up angiography and lower C-reactive protein (CRP) were the predictors of angiographic restenosis. We developed a model for predicting the time of early symptomatic restenosis with a probability of 70%: "Days = 200 - 2.1 age - 13 CTO + 3.3 CRP" (R 2 = 0.81, RMSE = 0.27), e.g., 80 years old, CTO (+), CRP 4.4 mg/dl: 32.2 days. The predictive model including age, CTO, and CRP might allow estimation of the period for the angiographic restenosis development.

Purpose: To report the endovascular treatment for acute progressive and very-late-onset multiple segmental small-artery stenoses in transplanted kidney parenchyma presenting with rapidly deteriorating renal function and refractory hypertension in a 65-year-old man., Case Report: Nineteen years ago, the patient received a living renal transplant via end-to-end anastomosis of the right internal iliac artery for kidney failure caused by chronic glomerulonephritis. His transplant renal function (creatinine: 0.9 mg/dL) and blood pressure were stable for 18 years. Then rapid worsening of renal function (creatinine: 2.5 mg/dL) and refractory hypertension occurred. Magnetic resonance angiography and renal angiography showed multiple small segmental artery stenoses in the transplanted kidney. At the 1-month follow-up consultation, total occlusion of 2 branches traversing the inferior pole of the kidney was observed, revealing acute progression of artery stenosis. Balloon angioplasty was successfully performed on those branches; renal function improved (creatinine: 1.3 mg/dL), and blood pressure was sufficiently controlled., Conclusions: This is a rare case that revealed very-late-onset multiple segmental renal artery stenoses with acute progression in the transplant kidney. Even multiple small segmental artery stenoses can reduce transplant renal function in the chronic phase and progress rapidly. Early percutaneous transluminal angioplasty may thus be feasible and important for preventing graft loss., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The combination of a bioresorbable scaffold and antiproliferative drugs is a promising treatment for peripheral artery disease. The novel paclitaxel-eluting peripheral Igaki-Tamai stent (PTX-ITS) has the same backbone design as the drug-free peripheral Igaki-Tamai stent and a paclitaxel coating. Arterial responses to the PTX-ITS and ITS using optical coherence tomography (OCT) and histological analysis in a porcine iliac artery model were compared., Methods and results: In total, 6 PTX-ITSs and 6 ITSs implanted in porcine iliac arteries were evaluated. Quantitative measurements of the scaffold, lumen, neointimal areas, and percent area stenosis were performed using OCT at 1 and 3 months. Histological evaluations (PTX-ITS [n=5], ITS [n=4]) were performed following euthanasia at 3 months. Injury, inflammation, endothelialization, and fibrin scores were measured. Baseline angiographic characteristics were similar in both groups. The ITS group showed significantly smaller scaffold areas than the PTX-ITS group at 1 month (18.50±3.62 mm 2 vs. 23.54±3.64 mm 2 ; P=0.037) and 3 months (15.82±2.57 mm 2 vs. 21.67±3.57 mm 2 ; P=0.009). Percent area stenosis was significantly lower in the PTX-ITS group at 3 months (28.70±7.24% vs. 40.36±7.07%; P=0.018). Histological evaluations revealed similar low-grade inflammatory reactions for both scaffolds., Conclusions: PTX-ITSs showed significantly better suppression of late scaffold shrinkage and lower in-scaffold stenosis for up to 3 months. Additionally, PTX-ITSs exhibited high biocompatibility, which is comparable to ITSs.

Background: Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive disorder with a poor prognosis. Recently, balloon pulmonary angioplasty (BPA) has been reported to be an effective treatment for inoperable patients with CTEPH. However, this catheter-based treatment has potentially life-threatening vascular complications. To improve the efficacy and safety of BPA, we assessed the morphological evaluation of organised thrombus and the vascular injury by BPA procedure., Methods: In this study, we assessed the morphology of organised thrombi and the vascular injury observed by angioscopy during BPA in 28 lesions from nine CTEPH patients., Results: Angioscopy visualised various forms of organised thrombi such as 'Mesh', 'Slit', 'Flap' and 'Mass' and allowed for a detailed evaluation of organised thrombus that was difficult to do by conventional contrast angiography. In addition, after balloon dilation for BPA, angioscopy revealed a haemorrhage due to a vessel wall injury caused by wiring and/or ballooning., Conclusions: Assessment of organised thrombus and vascular injury by angioscopy might contribute to improving the treatment of the patients with CTEPH., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

A 60-year-old man with a history of Raynaud's phenomenon presented with bilateral intermittent claudication and an ulcer on his right toe. The ankle-brachial index of the right and left legs was 0.77 and 0.75, respectively. Laboratory data showed prolongation of the activated partial thromboplastin time and a positive result on the lupus anticoagulant test. Computed tomography angiography revealed isolated infrarenal aortic stenosis with irregular surface and noncalcified plaques. Intravascular ultrasonography examination demonstrated a noncalcified, irregular, and mobile plaque, suggestive of abdominal aortic thrombosis. In addition to anticoagulant and dual antiplatelet therapy, endovascular treatment was performed. A total of three 40-mm-long balloon-expandable stents were successfully implanted on a 15-mm balloon. The final angiography showed good results except for minimal plaque shifting in the terminal aorta. Three months later, the ulcer resolved and a final diagnosis of primary antiphospholipid syndrome (APS) was made. Clinicians should recognize that APS can affect the abdominal aorta, leading to aortic thrombosis. Endovascular treatment may be the one good treatment option for this rare condition.

Purpose: To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy., Methods: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test., Results: The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95)., Conclusion: These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR)., Methods: A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion. The primary outcome measure was the 1-year incidence of recurrent restenosis; the secondary outcome was major adverse limb events (MALE). Multivariate logistic regression analysis was performed to look for any independent association of DES implantation with 1-year recurrent restenosis in the respective subgroups; results are presented as the odds ratio (OR) and 95% confidence interval (CI)., Results: In the subgroup without in-stent occlusion, there was no significant difference between DES and PTA in the 1-year incidence of recurrent restenosis (40.5% vs 45.7%, p=0.583, respectively) or MALE (27.8% vs 20.7%, p=0.322, respectively). However, in the subgroup with in-stent occlusion, DES implantation was associated with significantly lower incidences of recurrent restenosis (44.1% vs 90.3% for PTA, p<0.001) and MALE (25.5% vs 53.6% for PTA, p<0.001). Multivariate analysis confirmed that DES implantation had a significant independent negative association with the risk of recurrent restenosis in the subgroup with occlusion (OR 0.2, 95% CI 0.1 to 0.6, p=0.006)., Conclusion: DES implantation may be more effective than PTA in the management of femoropopliteal ISR with occlusion, but equally effective to PTA in nonocclusive ISR lesions. These results require confirmation in prospective randomized studies., (© The Author(s) 2016.)

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., (© The Author(s) 2015.)