The mid-term effect of intravascular ultrasound on endovascular interventions for lower extremity peripheral arterial disease: A systematic review and meta-analysis.

OBJECTIVE: Intravascular ultrasound (IVUS) is an important adjunctive tool for patients with lower extremity peripheral arterial disease (PAD) undergoing endovascular therapy (EVT). The evidence regarding the advantages of IVUS use is evolving, and recent studies have reported conflicting results. We aimed to perform a meta-analysis to evaluate the efficacy of IVUS during angiography-guided EVT for patients with PAD. METHODS: MEDLINE and EMBASE were searched through April 2023 to identify studies that investigated the outcomes of IVUS with angiography-guided EVT vs angiography-alone-guided EVT. The primary outcome was restenosis/occlusion rate; secondary outcomes were target lesion revascularization, major amputation, and mortality. RESULTS: One randomized controlled trial and 14 observational studies, largely of moderate quality, were included, yielding a total of 708,808 patients with 709,189 lesions that were treated with IVUS-guided EVT (n = 101,405) vs angiography-alone (n = 607,784). Compared with angiography alone, IVUS-guided EVT was associated with a non-significant trend towards decreased restenosis/occlusion (relative risk [RR], 0.74; 95% confidence interval [CI], 0.54-1.00; I2 = 60%). Although the risk of target lesion revascularization and mortality were comparable (RR, 0.85; 95% CI, 0.65-1.10; I2 = 70%; RR, 1.01; 95% CI, 0.79-1.28; I2 = 43%, respectively), the use of IVUS was also associated with significantly lower risk of major amputation (RR, 0.74; 95% CI, 0.67-0.82; I2 = 47%). Subgroup analysis focusing on femoropopliteal disease demonstrated significantly higher patency (RR, 0.72; 95% CI, 0.52-0.98; I2 = 73%). However, superiority with major amputation was not observed. CONCLUSIONS: IVUS-guided EVT for PAD may possibly be associated with a lower major amputation rate compared with angiography alone-guided EVT, although the difference in patency remained an insignificant trend in favor of IVUS-guided EVT. Adjunctive use of IVUS during EVT may be beneficial, and further prospective studies are warranted to delineate this relationship and the applicability of this technology in routine practice.

Impact of intravascular ultrasound-guided endovascular therapy on periprocedural outcomes in patients with lower-extremity artery disease.

BACKGROUND: Although technological improvements in intravascular ultrasound (IVUS) may reduce technical failures in endovascular therapy (EVT), perioperative complications (POCs) associated with IVUS use may increase. AIMS: This study investigated the impact of IVUS on periprocedural outcomes in symptomatic lower-extremity artery disease (LEAD) patients undergoing EVT. METHODS: This study evaluated 28,088 symptomatic LEAD patients who underwent EVT between January 2021 and December 2021 using a prospective nationwide registry in Japan. Outcome measures included periprocedural outcomes, including technical failure and POCs. To compare outcomes with and without IVUS use, propensity score matching analysis was performed for overall and for each arterial region (aortoiliac [AI], femoropopliteal [FP], and infrapopliteal [IP] arteries) using a binary logistic regression model. RESULTS: IVUS was used in 75%, 72%, and 37% of AI, FP, and IP lesions, respectively. After propensity matching extraction, the IVUS group had a tendency of lower technical failure rate than the non-IVUS group, although not statistically different (3.9% vs. 5.4%, p = 0.054), without an increase in the POC rate (1.8% vs. 1.6%, p = 0.54). Regarding the per-regional analysis, the technical failure rate of FP-EVT was significantly lower in the IVUS group (3.1% vs. 4.2%, p = 0.006), whereas those of AI-EVT (2.2% vs. 3.1%, p = 0.12) and IP-EVT (6.8% vs. 6.1%, p = 0.37) were not significantly different between the two groups. Furthermore, IVUS did not increase the POC rate for any region (AI-EVT: 1.3% vs. 1.3%, p = 1.00; FP-EVT: 1.8% vs. 1.7%, p = 0.75; and IP-EVT: 2.0% vs. 1.7%, p = 0.56). CONCLUSION: The current study revealed that IVUS did not increase the POCs and technical failure for overall lesions but reduced the incidence of FP-EVT technical failure.

Multicenter Registry of Common Femoral Artery Disease Treated With Endovascular Revascularization Using Interwoven Nitinol Stents: An Observational Retrospective Study.

PURPOSE: Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice. MATERIALS AND METHODS: This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT. RESULTS: This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08-0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56-10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00-9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73-0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04-30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02-6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion. CONCLUSIONS: Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization. CLINICAL IMPACT: This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.

Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study.

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods: A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion: The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. (ClinicalTrials.gov Identifier: NCT04706273).

Delayed rupture of peroneal artery pseudoaneurysm following endovascular treatment in a patient with chronic limb-threatening ischemia: A case report.

Below-the-knee (BTK) pseudoaneurysms that occur after endovascular therapy (EVT) and result in delayed rupture have rarely been reported. In this report, we present a rare case of an 86-year-old man with chronic limb-threatening ischemia who developed delayed rupture of an idiopathic pseudoaneurysm of the peroneal artery (PA) following EVT. The PA chronic total occlusion (CTO) was successfully crossed using a guidewire via an antegrade approach, however, subintimal crossing was confirmed by intravascular ultrasound. Balloon angioplasty was then performed using an appropriately sized balloon, resulting in successful recanalization of the PA CTO with minor dissection and no complications. Postoperatively, the patient's condition was stable until he suddenly complained of right calf pain 10 days after EVT. Computed tomography revealed a rupture of the PA pseudoaneurysm. Urgent angiography revealed two pseudoaneurysms, one saccular and the other spindle-shaped. The ruptured saccular aneurysm was successfully excluded through coil embolization and stent graft placement. To the best of our knowledge, this is the first reported case of delayed rupture of a BTK pseudoaneurysm following EVT. Balloon angioplasty in the subintimal space can lead to the formation of a pseudoaneurysm and its delayed rupture.

Impact of calcification on clinical outcomes after drug-coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system.

PURPOSE: To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. MATERIALS AND METHODS: We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at seven cardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. RESULTS: The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. CONCLUSION: The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.

Stent Implantation and Thromboendarterectomy for the Common Femoral Artery in Real-World Practice.

PURPOSE: To compare the outcomes of thromboendarterectomy (TEA) and endovascular therapy (EVT) with stenting for patients with atherosclerotic common femoral artery (CFA) occlusive disease. MATERIALS AND METHODS: From a retrospective registry of 1193 consecutive patients with CFA treatment performed between 2018 and 2020 at 66 institutions in Japan, we identified patients who underwent TEA (n=432) or stent implantation (n=157). The primary outcome measures were the 1-year primary patency of TEA versus stenting with propensity score matching. The secondary outcome measures were perioperative complications, length of hospital stay, any reintervention, limb salvage, and overall survival. Interaction analysis for primary patency was performed with propensity score stratification to determine the appropriate target population for CFA stenting. RESULTS: Propensity score matching extracted 101 pairs (101 patients in the EVT group and 253 patients in the TEA group). The 1-year primary patency rate was significantly higher in the TEA cohort (92.8% vs 84.6%, p=0.006). The freedom from reintervention rate was also significantly higher in the TEA cohort (94.0% vs 89.9%, p=0.030). However, the 1-year limb salvage (98.7% vs 100.0%, p=0.32), 1-year overall survival (90.8% vs 85.0%, p=0.14), and frequency of perioperative complications were not significantly different between the cohorts (6.9% vs 14.2%, p=0.10). Based on interaction analysis, the superiority of TEA over EVT in terms of patency was less apparent in patients with advanced age and chronic heart failure. CONCLUSIONS: Thromboendarterectomy was superior to stenting in terms of primary patency and freedom from revascularization at 1 year. There was no significant difference in the incidence of perioperative complications between both groups. Thromboendarterectomy may be recommended as the standard treatment strategy for patients with atherosclerotic CFA disease, whereas stenting may be considered for patients with advanced age and chronic heart failure. CLINICAL IMPACT: Thromboendarterectomy compared to stenting was the preferred revascularization strategy for patients with CFA disease in terms of primary patency and freedom from target lesion revascularization during the 1st year. The difference was attenuated in subgroups with advanced age (85 years or older) or chronic heart failure, thus stenting may be considered in patients with these backgrounds.

Comparing the Safety and Feasibility of Endovascular Therapy via Transradial and Transfemoral Approaches in Patients with Aortoiliac Occlusive Disease: A Propensity Score-Matched Analysis of the Nationwide Registry.

PURPOSE: Our objective was to evaluate the feasibility of performing endovascular therapy (EVT) for aortoiliac artery disease using transradial approach (TRA) as compared to transfemoral approach (TFA). METHODS: We analyzed 9671 cases with symptomatic lower extremity artery disease due to aortoiliac occlusive disease (AIOD) treated using EVT from a Japanese Nationwide EVT Registry between January and December 2021. We compared the baseline characteristics, procedural information, and 30-day outcomes of patients who received EVT only via TRA (n=863 [16.9%]) and those only via TFA (n=4255 [83.1%]) by using propensity score (PS) matching, after excluding those who required regular dialysis, those who underwent hybrid surgeries, and those who received EVT through 2 or more approach sites. RESULTS: After matching, the final study population consisted of 862 matched patients with similar baseline characteristics in each group. Technical success rate was comparable between the 2 groups (99.3% vs. 99.3%, p>0.99). No significant differences were observed with respect to the composite of all-cause death within 48 hours after EVT and post-procedural complications within 30 days, including severe bleeding that required transfusion, revascularization procedures, urgent surgeries, cerebral infarction, and major limb amputation (0.2% vs. 0.7%, p=0.29). Transradial approach was associated with shorter operation time (85 vs. 90 minutes, p=0.016), but longer fluoroscopy time (26 vs. 20 minutes, p<0.001) and higher contrast agent volume (80 vs. 75 mL, p<0.001). CONCLUSION: After PS matching, TRA showed the comparable rates of successful EVT and 30-day complications in patients with AIOD compared to TFA. Transradial approach was found to be safe and be a viable alternative of TFA for the treatment of AIOD. CLINICAL IMPACT: The efficacy of transradial approach (TRA) is established in percutaneous coronary intervention; however, its safety and feasibility are unclear in endovascular therapy (EVT). We analyzed 9,671 cases with symptomatic aortoiliac occlusive disease treated using EVT from a Nationwide Registry to compare the 30-day outcomes of those who received EVT only via TRA (n = 863 [16.9%]and those only via TFA (n=4,255 [83.1%]) by using propensity score matching. Technical success rate (99.3% vs. 99.3%, p > 0.99) and 30-day complications (0.2% vs. 0.7%, p = 0.29) were comparable between the two groups. EVT via TRA could be performed safely.

Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study.

PURPOSE: To investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification. MATERIAL AND METHODS: This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored. RESULTS: Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%-92.1%) at 1 year and 80.8% (95% CI, 76.1%-85.8%) at 2 years. The CD-TLR-free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002). CONCLUSIONS: The implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency.

Comparison of Clinical Outcomes in Patients Undergoing Common Femoral Thromboendarterectomy With or Without Patch Angioplasty.

OBJECTIVE: Surgical thromboendarterectomy (TEA) is the standard treatment for an occlusive lesion of the common femoral artery (CFA). However, there is limited knowledge on the need for patch angioplasty in CFA TEA. The objective of this study was to compare the peri-operative and two year results of CFA TEA with or without patch angioplasty. METHODS: A multicentre retrospective observational study was performed at 34 Japanese centres. Comparisons were made between patients undergoing CFA TEA with or without patch angioplasty after propensity score matching (PSM). The primary endpoints were primary patency and freedom from target lesion revascularisation (TLR) of the TEA lesion. The secondary endpoints were hospital outcomes, limb salvage, and overall survival. RESULTS: Between 2018 and 2020, 428 TEA procedures (237 with patch angioplasty and 191 with primary closure) were performed. PSM extracted 151 pairs with no significant intergroup differences in baseline characteristics. Peri-operative death and complications occurred in 0.7% vs. 1.3% (p = 1.0) and 6.0% vs. 6.6% (p = 1.0), respectively. The follow up rate was 96% over a median follow up of 14.9 months (interquartile range 8.3, 24.3). Loss of primary patency occurred in 18 patients. The two year primary patency of patch angioplasty cases was statistically significantly higher than that of primary closure cases (97.0% vs. 89.9%; p = .021). TLR was performed in 14 patients. The two year freedom from TLR in patch angioplasty cases was also statistically significantly higher than in primary closure cases (98.6% vs. 92.9%; p = .003). During follow up, seven limbs required major amputation and 40 patients died. There was no statistically significant difference in limb salvage and survival between the two groups after PSM. CONCLUSIONS: This is the first report to show that patch angioplasty may decrease re-stenosis and target lesion revascularisation of CFA TEA lesions.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Multicenter, retrospective registry of isolated atherosclerotic popliteal arteries treated with endovascular revascularization.

Isolated atherosclerotic popliteal lesions (IAPLs) have been considered challenging. This study aimed to investigate the efficacy of endovascular therapy (EVT) using the newer devices for IAPLs. This retrospective multicenter registry analyzed patients with lower extremity artery disease having IAPLs who underwent EVT using the newer devices between 2018 and 2021. The primary outcome was primary patency 1 year after EVT. A total of 392 consecutive patients undergoing EVT for IAPLs were enrolled. The Kaplan-Meier analysis showed that the primary patency and the freedom from target lesion revascularization were 80.9% and 87.8% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that the clinical features that were independently associated with restenosis risk were drug-coated balloon (DCB) use for younger age (< 75 years old; adjusted hazard ratio, 3.08 [95% confidence interval 1.08-8.74]; P = 0.035), non-ambulatory status (2.74 [95% confidence interval 1.56-4.81]; P < 0.001), cilostazol use (0.51 [95% confidence interval 0.29-0.88]; P = 0.015), severe calcification (1.86 [95% confidence interval 1.18-2.94]; P = 0.007), and small external elastic membrane (EEM) area measured by intravascular ultrasound (IVUS) (< 30 mm2) (2.07 [95% confidence interval 1.19-3.60]; P = 0.010). From the univariate analysis, among patients treated with DCB, younger patients (n = 141) were associated with more comorbidities including smoking (P < 0.001), diabetes mellitus (P < 0.001), end-stage renal disease (P < 0.001), history of revascularization (P = 0.046) and small EEM area (P = 0.036), compared to older patients (n = 140). Moreover, smaller post-procedural minimum lumen area measured by IVUS after DCB dilatation was observed in younger patients (12 ± 4 vs. 14 ± 4 mm2, P = 0.033). This retrospective study demonstrated that the current EVT provided an acceptable 1-year primary patency rate in patients with IAPLs. The primary patency was lower following DCB in younger patients, likely due to the higher rates of comorbidities in this patient population.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Technical Aspects of Percutaneous Deep Venous Arterialization Using Off-the-Shelf Devices.

PURPOSE: Chronic limb-threatening ischemia (CLTI) represents the clinical end stage of lower extremity peripheral arterial disease (PAD). Although conventional open and endovascular revascularization options are available, some CLTI patients do not respond to these treatments, generally due to small vessel occlusive disease, with only limited or no clinical improvement achieved. This article aims to provide insights related to pertinent venous anatomy of the leg and below the ankle and a technical review of percutaneous deep venous arterialization (pDVA) creation using commonly-available devices. TECHNIQUE: For patients with "no-option" CLTI, the risk of major amputation and mortality remains high. Although arterial revascularization remains the optimal treatment of CLTI, some patients with severely-diseased or gracile distal arteries have poor outcome. Deep venous arterialization (DVA), in a subset of patients with tibial anatomy amenable to DVA creation, represents the last-ditch attempt before these patients are deemed to have "no-hope" at limb salvage, and major amputation becomes necessary. Refinement in technique and advancement in device development have been shown to allow pDVA to be created with respectable outcomes for the "no-option" CLTI patient population. CONCLUSION: The pDVA has garnered increasing interest among endovascular specialists to further understand the anatomical and technical key points of this procedure, and it may yet prove to be a useful addition in the armamentarium in our battle against CLTI. CLINICAL IMPACT: Percutaneous deep venous arterialisation provides another option in the treatment of challenging "no-option" CLTI patients, and off-the-shelf devices will allow this procedure to be performed in centers where dedicated devices are not available.

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries.

PURPOSE: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). MATERIALS AND METHODS: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. RESULTS: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. CONCLUSION: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials.

PURPOSE: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. RESULTS: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. CONCLUSION: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT: Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

Clinical outcomes of endovascular procedure using VIABAHN® VBX covered stent in complex aortoiliac artery disease: Result from AVOCADO study.

OBJECTIVE: To investigate the safety and efficacy of a balloon-expandable covered stent in the treatment of complex aortoiliac artery disease. BACKGROUND: Peripheral intervention in complex aortoiliac disease still remains a challenge. METHODS: We retrospectively analyzed symptomatic patients with aortoiliac disease who were treated with GORE® VIABAHN® VBX covered stent (W.L. Gore & Associates, Flagstaff, AZ). The primary study outcome was a 1-year primary patency without the necessity of any subsequent clinically-driven target revascularization (CD-TLR) based intervention. The proportion of technical success, defined in terms of the absence of residual stenosis, stent edge dissection, and procedure-related severe complications, was also reported. RESULTS: VBX covered stent was used in 231 patients. Key patient characteristics include mean age of 73.4 ± 9 years, 77% male, 45% diabetes, and 18% suffering from end-stage renal dysfunction on dialysis. TASC II CD lesions were observed in 51% patients, which included 81% calcified lesions. Combined therapy with standard self-expandable stent was performed in 40% patients. The technical success rate was 92.6%. During median follow-up after 13.1 months, the primary patency rate was estimated to be 93.4% (95% confidence interval, 90.0%-96.8%) at 12 months, whereas the rate of freedom from TLR was 95.3% (92.5%-98.2%). As per the univariate analysis, the TASC II classification, number of diseased regions, and chronic total occlusion were significantly associated with risk of restenosis. CONCLUSIONS: The results of the year-long AVOCADO study demonstrated that usage of the novel VBX covered stent has a patency-based advantage with reduced chances for subsequent revascularization procedures.

Efficacy of the novel inner PIERCE technique for severely calcified below-the-knee occlusions in a patient with chronic limb-threatening ischemia.

A severely calcified lesion is the most challenging entity in endovascular therapy (EVT) for below-the-knee (BTK) arteries. In this report, we introduce a challenging plaque modification technique known as the inner PIERCE technique. A 65-year-old man on hemodialysis with multiple toe ulcerations underwent an EVT for his BTK artery diseases. During EVT, the guidewire passed through the severely calcified posterior tibial and plantar arteries; however, the other devices could not pass through the lesion. Therefore, a novel inner PIERCE technique was performed. After guidewire externalization, an 18G 20 cm needle was advanced from the retrograde approach site, following the guidewire, for percutaneous transhepatic cholangiodrainage (PTCD). The PTCD needle was advanced into the severely calcified plaque using a rotational motion. Finally, the needle could pass through the lesion. After the inner PIERCE technique, an angioplasty was performed with a 2.5 mm balloon. The final angiography showed sufficient blood flow. After the EVT, complete wound healing was achieved in 4 months. This challenging technique may be an additional option for EVT to treat severely calcified BTK arteries.

Percutaneous endoluminal anatomical bypass for patients with external iliac artery occlusion after failed conventional endovascular recanalization.

Endovascular therapy, an established first-line treatment for isolated iliac artery (IA) occlusion (IAO), may be of limited use in challenging lesions. We describe a novel percutaneous endoluminal anatomical bypass (PEApass) technique for uncrossable external IA (EIA) occlusion. A 70-year-old man on hemodialysis with a history of colostomy presented with chronic limb-threatening ischemia due to a left EIA with below-the-knee occlusions. During a previous colostomy, the left EIA was accidentally ligated. Conventional endovascular recanalization for the ligated EIA failed, and a femoral-femoral bypass and below-knee angioplasty were performed as alternative therapy. Two weeks later, surgical site infection developed at both anastomosis sites. PEApass was performed prior to removing the infected graft. An arteriovenous fistula (AVF) in the distal location was created using a re-entry device, and its proximal location was created using a 0.014-in. penetration guidewire, which was snared on the inside of the iliac vein (IV) using a retrograde snare. The proximal and distal sections of the IA were connected using an 8.0-mm × 100-mm stent graft implanted through the IV. A final angiogram indicated that flow to the occluded IA was completely restored without complications. Following the PEApass, the infected graft was removed. Complete wound healing was achieved within approximately 1 month. This innovative PEApass procedure is feasible and could be an alternative procedure for patients with uncrossable IAO.