Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.

Comparison of the Pre-Established and Finally Selected Treatment Strategies for Endovascular Treatment in Femoropopliteal Artery Lesions.

This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.

Percutaneous deep venous arterialization with balloon angioplasty salvaged a life-threatening critical limb in a hemodialysis patient after repeated pedal angioplasty failed: A case report.

Chronic limb-threatening ischemia (CLTI) with severe below-the-ankle (BTA) lesions is often difficult to revascularize with endovascular treatment (EVT) and surgical treatment. We present a case of successful limb salvage using percutaneous deep venous arterialization (pDVA) in a patient with CLTI whose BTA lesion reconstruction failed. A 57-year-old man with diabetes mellitus and end-stage renal failure on maintenance hemodialysis was referred to our hospital because of gangrene in the second and third toes of his left foot. EVT was repeated for the anterior tibial artery, posterior tibial artery (PTA), dorsal foot artery, and plantar artery lesions; however, revascularization below the ankle was unsuccessful. As the infection had spread to the sole of the foot, below-the-knee amputation was indicated, but the patient refused. Therefore, we performed pDVA on the left PTA simultaneously with a Lisfranc amputation. An arteriovenous fistula was created at the ankle joint using a Venous Arterialization Simplified Technique and a guidewire was inserted into the plantar vein. Balloon dilatation from PTA to the plantar vein was performed to complete the pDVA. Although repeated EVT was required to maintain blood flow in the pDVA, skin grafting was performed 3 months after the pDVA, the wound completely healed, and he was discharged 6 months after the DVA. The pDVA can be an option for limb salvage in patients with no-option CLTI who are confronted by imminent amputation.

Lesion Characteristics Associated with Loss of Primary Patency After Endovascular Therapy for Common Femoral Artery Lesions.

PURPOSE: To identify lesion characteristics associated with restenosis after endovascular therapy (EVT) for common femoral artery (CFA) lesions in patients with peripheral artery disease (PAD) in real-world practice. MATERIALS AND METHODS: We included 751 Japanese patients with PAD who underwent CFA EVT. Data were from a large-scale retrospective multicenter registry study. The association of lesion characteristics with the risk of restenosis was investigated with the Cox proportional hazards regression model. RESULTS: Lesions extended to the external iliac artery in 10.0% of patients, were isolated in the CFA in 59.9%, and involved the bifurcation in 30.1%. Chronic total occlusion was noted in 21.1%, and 99% stenosis, in 19.9%. Among the limbs with CFA lesions, 16.4% had a history of CFA EVT. Mean total lesion length was 32 ± 15 mm, and reference vessel diameter, 7.3 ± 1.4 mm. Plain old balloon angioplasty, drug-coated balloon angioplasty, and stent implantation were performed in 56.3, 23.2, and 20.5% of patients, respectively. The mean follow-up period was 10.4 ± 9.5 months. Rates of freedom from restenosis and reintervention at 1 year were 78.2 and 86.6%, respectively. Lesion characteristics independently associated with restenosis were history of CFA EVT, reference vessel diameter less than 6 mm, and lesion length greater than or equal to 50 mm; adjusted hazard ratios were 1.63 (P = 0.007), 1.93 (P = 0.006), and 1.71 (P = 0.018), respectively. CONCLUSION: History of CFA EVT, smaller reference vessel diameter, and longer lesion length are independent risk factors for restenosis after CFA EVT. LEVEL OF EVIDENCE: Level 3.

Vessel Patency and Associated Factors of Drug-Coated Balloon for Femoropopliteal Lesion.

Background Although clinical trials have reported favorable outcomes after drug-coated balloon (DCB) therapy for femoropopliteal lesions, their real-world performance and predictors have not been well evaluated. This study aimed to elucidate 1-year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1-year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow-up of 14.2 months, 811 patients experienced restenosis. The Kaplan-Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1-year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low-dose DCB, and residual stenosis. Conclusions The 1-year clinical outcomes after DCB use for femoropopliteal lesions in real-world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.

Comparison Between Clinical Outcomes of Low- and High-Dose Paclitaxel Drug-Coated Balloon in Endovascular Therapy for Femoropopliteal Lesion.

PURPOSE: There is a little datum about the impact of paclitaxel dosage in patients undergoing drug-coated balloons (DCB) in endovascular therapy (EVT) for femoropopliteal lesions. In the current study, the authors sought to compare the clinical outcomes of low-dose (LD) and high-dose (HD) paclitaxel DCBs for patients undergoing EVT for femoropopliteal lesions in a real-world setting. MATERIALS AND METHODS: The study population was derived from a multicenter registry named "Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa" (LANDMARK registry). This registry consists of patients from 5 hospitals in Kanagawa, Japan. Overall, 1,378 patients with 1,777 lesions received treatment between July 2017 and June 2020. Among these, DCB angioplasty was performed in 477 patients (516 lesions). Propensity score matching analysis was performed to compare the clinical outcomes of LD-DCB (Lutonix; Becton Dickinson and Company, Franklin Lakes, New Jersey) and HD-DCB (IN.PACT Admiral; Medtronic Vascular, Santa Clara, CA, USA). RESULTS: A total of 160 matched pairs of lesions were analyzed. Primary patency and freedom from target lesion revascularization at 2 years were similar between the two groups (LD-DCB vs. HD-DCB: 72% vs. 70%, p = 0.53; and 75% vs. 73%, p = 0.59, respectively). CONCLUSION: No significant differences were found in the clinical outcomes between LD-DCB and HD-DCB angioplasty for femoropopliteal lesions. LEVEL OF EVIDENCE: Level 3.

Two-year results of endovascular therapy for femoropopliteal artery disease in Japan during the introduction of drug-eluting devices.

Although various devices and strategies were introduced into endovascular therapy, factors associated with chronic outcomes remain unclear. Therefore, this study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology. This research was a multicenter, prospective, and observational study. A total of 1003 consecutive patients with a mean age of 73.6 ± 8.3 years from 67 institutes were registered from February 2017 to June 2018 in Japan. In addition to the baseline data, angiographic findings affecting primary patency were studied. Lesion length was 16.4 ± 9.6 cm, and chronic total occlusion was found in 42%. Calcified lesions were found in 75% of patients. The 1-year and 2-year freedom from target lesion revascularization were 81% and 75%, respectively, and maximum walking distance showed improvement over the two years (pre; 234 m ± 211 m, 1-year; 402 m ± 241 m, 2-year; 428 m ± 231 m). The independent predictors for primary patency were pre-procedure ankle-brachial index, history of minor amputation, ostium lesion, and drug-coated balloon use. Angiographic analysis revealed that only lesion length and full cover stent were related to primary patency. Two-year freedom from target vessel revascularization was 75% in the Japanese transitional period of drug-eluting devices. Maximum walking distance was improved and well maintained for up to 2-year.

Independent Predictors of Major Adverse Cardiovascular Events at 3 Years after Aortoiliac Stent Implantation.

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

Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions.

PURPOSE: To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Impact of Dialysis Vintage and Renal Biomarkers on Mortality in Dialysis-Dependent Patients With Critical Limb Ischemia Undergoing Revascularization.

PURPOSE: Revascularization of both endovascular therapy (EVT) and surgical reconstruction improve clinical outcomes of patients with critical limb ischemia (CLI); however, treatment of dialysis-dependent patients with CLI is still challenging. This study aimed to investigate the impact of dialysis-related parameters on the risk of mortality in dialysis-dependent patients undergoing revascularization for CLI. MATERIALS AND METHODS: We retrospectively identified 274 dialysis-dependent patients with CLI (196 males; mean age 71 years), who underwent revascularization, from the clinical database of the surgical reconstruction vs peripheral intervention in patients with critical limb ischemia (SPINACH) study, which was a prospective, multicenter, observational study. Of these patients, 175 patients underwent EVT and 99 patients received surgical reconstruction. The current study evaluated the impact of dialysis vintage and renal biomarkers on the mortality rate of dialysis-dependent patients with CLI undergoing revascularization. RESULTS: During a mean follow-up period of 1.7 ± 1.1 years, 147 deaths were observed. The 3-year overall survival rate and its standard error were estimated to be 40.5% ± 8.1% using the Kaplan-Meier method. A Cox proportional hazard analysis revealed that dialysis vintage ≥4 years, serum creatinine levels <4.7 mg/dL, serum urea nitrogen ≥88 mg/dL, and calcium-phosphate product ≥62.6 mg2/dL2 were independent risk factors for mortality after adjustment for the detailed mortality risk score developed in the SPINACH study. Adding these parameters to the original mortality risk score slightly, but not significantly, increased the area under the time-dependent receiver operating characteristics curve from 0.74 (95% CI, 0.67 to 0.81) to 0.77 (0.71 to 0.84) (p=0.084), whereas continuous net reclassification improvement reached 0.75 (0.12 to 0.90) (p=0.027). CONCLUSION: We found that long dialysis vintage, low serum creatinine, high serum urea nitrogen, and high calcium-phosphate product were independently associated with the increased risk of mortality in dialysis-dependent patients with CLI undergoing revascularization.

A novel technique of percutaneous intraluminal cracking using a puncture needle for severe calcified lesions of below-the-knee and below-the-ankle arteries.

PURPOSE: Endovascular therapy has recently become acceptable for the reconstruction of below-the-knee (BTK) and below-the-ankle (BTA) arterial lesions. However, we have sometimes experienced BTK or BTA lesions with calcifications that are too severe for balloon catheters to cross or expand despite successful guidewire passage. In this study, we assessed the feasibility and safety of the novel inner PIERCE technique for breaking down the calcium burden of BTK and BTA arterial lesions. METHODS: We retrospectively reviewed the records of patients who had undergone endovascular therapy between August 2018 and December 2019. The inner PIERCE technique was performed in those cases where low-profile balloon catheters were unable to pass through the target lesions or balloon indentation did not disappear beyond the rated burst pressure. An externalized guidewire system was established in 8 cases via bidirectional approaches, and a 20-gauge needle was directly inserted through the guidewires from the distal puncture site. In 10 cases of successful antegrade wiring, the tibial or pedal arteries distal to the lesion site were punctured for a retrograde guidewire approach to the lesion. The needle was slowly rotated and advanced across the lesion. RESULTS: We found that all lesions were severely calcified and 83.3% had chronic total occlusion. The inner PIERCE procedure allowed successful passage of the needle and subsequent low-profile balloon catheters in all cases. Optimal balloon dilatation was achieved in 94.4% of the cases using this technique. No procedure-related adverse events were observed. CONCLUSION: The novel inner PIERCE technique is a safe and feasible method for disrupting calcified BTK and BTA lesions.

Thrombotic Lesions are Associated with Poor Outcomes after Endovascular Treatment in Patients with Non-Acute Aortoiliac Total Occlusions.

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

Intravascular Ultrasound Imaging During Aortoiliac Stenting: No Impact on Outcomes at 1 Year.

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

Impact of Diabetes Mellitus on Critical Limb Ischemia With Below the Knee Disease: Japan Below-the-Knee Artery Treatment Subanalysis.

BACKGROUND: A strong association exists between diabetes mellitus and critical limb ischemia. METHODS AND RESULTS: We performed endovascular therapy on 1060 limbs in 884 patients with below knee lesions only. The patients were divided into diabetes (DG) and nondiabetes groups (NDG). Limb salvage was poorer in the DG (79% vs 89%, P = .0061). No significant difference was observed in mortality, amputation-free survival (AFS), and target vessel revascularization (TVR). Multivariate analysis revealed diabetes status, infection, poor activity of daily living (ADL), younger age, and procedure failure as independent predictors of major amputation in DG. In the NDG, procedure failure was the predictor, and younger age and poor ADL showed tendency of major amputation. CONCLUSIONS: Mortality, AFS, and TVR showed no significant difference between the 2 groups, but major amputation was more frequent in DG. Not only revascularization but also infection and diabetes control were very important for limb salvage in DG.

Independent predictors of loss of primary patency at 1 year after aortoiliac stent implantation.

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

Impact of Hospital Volume on Clinical Outcomes after Aortoiliac Stenting in Patients with Peripheral Artery Disease.

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

Comparison of 3-year clinical outcomes after endovascular therapy for aortoiliac artery occlusive disease between patients with and without hemodialysis: Subanalysis of the REAL-AI registry.

PURPOSE: The impact of hemodialysis (HD) on aortoiliac (AI) occlusive lesions remains unknown. Here, we report the 3-year clinical outcomes of endovascular treatment (EVT) for AI occlusive lesions in propensity-matched populations of patients who did and did not undergo HD. METHODS: The cohort of this large-scale, multicenter, retrospective registry study included 574 consecutive patients with AI occlusive disease. Propensity score-matched analysis was performed to compare AI occlusive lesions between patients who did and did not undergo HD. The endpoints were primary patency, assisted primary patency, and secondary patency as well as overall survival and major adverse limb events (MALEs). RESULTS: A total of 57 matched pairs of patients who did and did not undergo HD were analyzed after propensity score-matched analysis. No significant difference was observed in primary patency, assisted primary patency, secondary patency, and MALEs at 3 years. The survival rate was significantly lower in the HD group than in the without-HD group (68% vs. 93%, P = 0.03). CONCLUSIONS: Although the survival rate of HD patients was poor, the results of EVT for AI occlusive lesions were reasonable in these patients.

Clinical Impact of Intravascular Ultrasound Guidance During Endovascular Treatment of Subclavian Artery Disease.

PURPOSE: To evaluate the short- and long-term efficacy of intravascular ultrasound (IVUS) guidance during endovascular treatment (EVT) of subclavian artery disease. METHODS: The multicenter SCALLOP registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry) was interrogated to identify 542 patients who underwent successful EVT for SCAD between January 2003 and December 2012. Lesions were classified according to the use of IVUS guidance: 177 patients (mean age 68.9±8.6 years; 149 men) with and 373 patients (mean age 69.9±8.7 years; 275 men) without. The main outcome was the difference in primary patency; secondary outcomes were differences in assisted primary patency, secondary patency, overall survival, freedom from major adverse cardiovascular events [MACE; all-cause mortality, myocardial infarction (MI), and stroke], and freedom from major adverse events (MAE). Multivariate analysis of the IVUS+ group was performed to identify predictors of failure; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: In total, 538 (97.8%) lesions were treated with stents and 12 lesions by balloon angioplasty alone. Periprocedural and in-hospital overall complication rates did not differ significantly between IVUS+ (10.2%) and IVUS- (8.8%, p=0.617). Long-term follow-up demonstrated no significant difference between IVUS+ and IVUS- groups in 5-year all-cause mortality (p=0.37), MI (p=0.07), stroke (p=0.31), or MACE (p=0.07). However, 5-year primary patency was significantly higher in the IVUS+ group (88.5% vs 77.7%, p=0.03). There were no group differences in 5-year assisted primary patency (90.4% vs 89.9%, p=0.81) or secondary patency (99.4% vs 97.1%, p=0.25). Multivariate analysis of the IVUS+ group identified in-hospital stroke (HR 16.92, 95% CI 3.60 to 79.42, p<0.01) and combined use of balloon-expandable and self-expanding stents (HR 5.59, 95% CI 1.22 to 25.65, p=0.02) as independent negative predictors of primary patency. CONCLUSION: These results suggest that IVUS guidance can significantly improve long-term primary patency following endovascular treatment of subclavian artery disease.