Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study.

BACKGROUND: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. MATERIALS AND METHODS: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. RESULTS: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). CONCLUSIONS: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.

Developing a Novel Pediatric Eye Chart Assessing Visual Acuity by Minimum Separable Threshold.

The purpose of this study was to develop a new pediatric acuity chart that can assess the minimum separation threshold by incorporating the minimum separation threshold into the picture. To overcome the design limitations of the Landolt ring, two designs of highly versatile minimum separable thresholds that can be easily incorporated into a picture were created: a black, filled circle (the "Circle") and a segment (the "Square"), both with the same break as in the Landolt ring. The three designs-the Landolt ring, Circle, and Square-were used to evaluate and compare the differences in the visual acuity of 21 healthy adults. No significant differences were observed between the results of the visual acuity tested with the Landolt ring, Circle, and Square (Landolt ring vs. Circle: p = 0.92, Landolt ring vs. Square: p = 0.31, Circle vs. Square: p = 0.40). The Bland-Altman analysis revealed no fixed errors between the Landolt ring and Circle and between the Landolt ring and Square (95% CI: -0.09-0.08, -0.09-0.12). Proportional errors were also not observed (p = 0.68, p = 0.41). The Landolt ring, Circle, and Square designs obtained equal results in visual acuity, thus achieving the successful development of a novel pediatric visual acuity chart using these designs.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

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.

Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease: The PROSPECT MONSTER Study Outcomes.

BACKGROUND: Randomized trials have shown comparable outcomes between second-generation low-dose drug-coated balloons (LD-DCBs) and first-generation high-dose drug-coated balloons (HD-DCBs); but the trial patients had low clinical complexity, and there were no comparisons in medically complex populations. OBJECTIVES: The aim of this study was to compare outcomes between an LD-DCB (Ranger; 2.0 µg/mm2) and an HD-DCB (IN.PACT; 3.5 µg/mm2) in patients with symptomatic femoropopliteal artery disease. METHODS: PROSPECT MONSTER (Prospective Comparison of Second-Generation Low-Dose Drug-Coated Balloon With High-Dose Drug-Coated Balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the LD-DCB (n = 370) or the HD-DCB (n = 211) for symptomatic femoropopliteal artery disease (Rutherford classes 2-5). The primary outcome was the 1-year primary patency of the LD-DCB in comparison with that of the HD-DCB, as evaluated using propensity score matching. The incidence of impaired flow after drug-coated balloon application was also evaluated. RESULTS: Propensity score matching extracted 163 pairs (358 and 163 patients in the LD-DCB and HD-DCB groups, respectively), with no significant intergroup difference in baseline characteristics. The 1-year primary patency rates in the matched population were similar between the LD-DCB and HD-DCB groups (87.0% [95% CI: 82.5%-91.7%] vs 81.3% [95% CI: 74.8%-88.5%]; HR: 0.93; 95% CI: 0.55-1.59; P = 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; OR: 1.46; 95% CI: 0.78-2.73; P = 0.24). No baseline characteristics had any significant interaction effects on the association of the LD-DCB vs the HD-DCB and 1-year restenosis risk. CONCLUSIONS: LD-DCBs demonstrate efficacy and safety comparable with HD-DCBs in patients with complex clinical backgrounds, suggesting that drug-coated balloon treatment using a lower dose may be possible.

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.

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.

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.

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.

Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound.

AIM: This study aimed to reveal whether a larger postprocedural minimum lumen area (MLA) would reduce restenosis risk after endovascular therapy (EVT) using drug-coated balloons (DCBs) in femoropopliteal (FP) lesions. METHODS: This retrospective, nonrandomized, single-arm, and multicenter registry analyzed patients with FP lesions undergoing intravascular ultrasound (IVUS)-guided EVT with DCB between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. The association between IVUS-based MLA and restenosis risk was investigated using a generalized propensity score (GPS) method to address imbalance of baseline covariates. The dose-response function of IVUS-measured MLA for restenosis risk was developed using the GPS-adjusted Cox proportional hazards regression model. RESULTS: This study enrolled consecutive 489 patients with 595 lesions undergoing DCB treatment. The median MLA (interquartile range) was 13.20 (9.90-16.91) mm2. Kaplan-Meier estimates showed that freedom from restenosis was 84.4% at 1 year. The GPS-adjusted dose-response function showed that MLA was inversely associated with restenosis risk. The upper limit of 95% confidence interval (CI) of the slope was lower than 0 between 10.6 and 17.0 mm2 of MLAs. The 1-year cumulative incidence of restenosis was estimated to be 9.8% (95% CI, 5.8%-13.7%) for the 3rd quartile of MLA (16.91 mm2) versus 18.5% (12.3%-24.1%) for the 1st quartile (9.90 mm2), with a hazard ratio of 0.51 (95% CI, 0.39-0.67; p＜0.001). CONCLUSIONS: The present GPS analysis suggested that larger IVUS-measured MLA might be associated with lower risk of 1-year restenosis after DCB treatment for FP lesions.

Retrospective multicenter registry for endovascular treatment with newer devices in over 25-cm femoropopliteal artery disease: A retrospective observational study.

Background and Aims: Endovascular therapy (EVT) is recommended in femoropopliteal (FP) lesions shorter than 25 cm by current guidelines; however, diffuse FP lesions remains challenging for EVT. The aim of this study was to investigate the efficacy of EVT with the latest devices for FP lesions longer than 25 cm. Methods: This retrospective multicenter registry analyzed patients presented peripheral artery disease (PAD) having FP lesions longer than 25 cm who underwent EVT using the latest devices between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. Results: The present study enrolled a total of 504 PAD patients with 614 lesions undergoing EVT for diffuse FP lesions. The Kaplan-Meier analysis showed that the rates of freedom from restenosis and clinically-driven target lesion revascularization were 79.3% and 82.4% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that clinical features associated independently with restenosis risk were cilostazol use (adjusted hazard ratio, 0.49 [0.32-0.74]; p = 0.001), reference vessel diameter (RVD) (0.72 [0.58-0.89] per 1-mm increase; p = 0.002), and P3 segment involvement (2.08 [1.33-3.26]; p = 0.001). The Kaplan-Meier analysis was conducted to compare the primary patency between cases with and without a small RVD, P3 involvement, and/or lack of cilostazol; any risk factors were related to a worse primary patency rate, compared with cases without risk factors. Conclusion: In the current EVT era, the primary patency at 1 year was acceptable at 79.3% in patients with FP lesions longer than 25 cm. A small vessel and P3 segment involvement might be associated with a poor 1-year patency rate after EVT, whereas cilostazol administration might contribute to reducing restenosis.

Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study.

BACKGROUND: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO. MATERIALS AND METHODS: We retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model. RESULTS: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003). CONCLUSIONS: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.

Comparison of Amblyopia Treatment Effect with Dichoptic Method Using Polarizing Film and Occlusion Therapy Using an Eye Patch.

We developed a novel, low-cost, easily administered method that uses a polarizing film to enable dichoptic treatment for amblyopia. In this study, we compared its effects with occlusion therapy using an eye patch. Fifty-eight patients (aged 4.7 ± 1.0 years) diagnosed with anisometric amblyopia were included and instructed to wear complete refractive correction glasses with either occlusion therapy using an eye patch (eye patch group) or dichoptic treatment using polarizing film (polarizing film group) for 2 h per day. We examined the improvement in the visual acuity and compliance rate of the patients 2 months after treatment initiation. After treatment, the polarizing film group showed significant improvement in visual acuity compared with the eye patch group. Moreover, the compliance rate was significantly better in the polarizing film group than in the eye patch group. In both groups, there was a significant correlation between the improvement in visual acuity and compliance rate. This new dichoptic treatment using a polarizing film was shown to be effective for anisometropic amblyopia.

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.

1-Year Outcomes of Thromboendarterectomy vs Endovascular Therapy for Common Femoral Artery Lesions: CAULIFLOWER Study Results.

BACKGROUND: Thromboendarterectomy (TEA) is the gold-standard treatment for common femoral artery (CFA). However, because of its low invasiveness and short hospitalization duration, CFA endovascular therapy (EVT) is performed in real-world practice. However, the clinical benefits and appropriate target population for CFA EVT remain unclear. OBJECTIVES: The aims of this study were to compare the clinical outcomes of TEA with those of EVT in patients with symptomatic CFA diseases and to identify the adequate target population for CFA EVT. METHODS: A total of 1,193 consecutive patients who underwent EVT (n = 761) or TEA (n = 432) for CFA were identified and retrospectively reviewed from a registry of 66 institutions. The primary outcome was 1-year primary patency compared between EVT and TEA using propensity score matching. An interaction analysis was performed to explore the appropriate target population for CFA EVT. RESULTS: After propensity score matching, the 1-year primary patency rate was significantly higher in the TEA group (82.3% vs 96.6%; P < 0.001), whereas perioperative complications were more frequently observed in the TEA group (P = 0.047). Nonambulatory status attenuated the HR of EVT vs TEA for restenosis risk (P = 0.021), whereas the presence of nodular calcification significantly increased the HR (P = 0.040). In the EVT subgroup analysis for restenosis risk, stent use showed the lowest HR compared with plain balloon angioplasty and drug-coated balloon angioplasty (P < 0.001). CONCLUSIONS: TEA showed superior 1-year patency compared with EVT in a nationwide multicenter study. Nonambulatory status attenuated the superiority, whereas the presence of nodular calcification enhanced it.

Differences in Intravascular Ultrasound Measurement Values Between Treatment Modalities for Restenosis in Femoropopliteal Lesions.

BACKGROUND: The risk of restenosis after intervention is higher in femoropopliteal than in aortoiliac lesions. However, the appropriate endovascular therapy (EVT) for preventing restenosis after intervention for femoropopliteal lesions remains unknown. This study aimed to elucidate the relationship between lesion characteristics and patency after EVT using intravascular ultrasound (IVUS) measurement and to determine the predictors of restenosis on IVUS.Methods and Results:This prospective observational study was performed at 18 Japanese centers. We evaluated the lesion characteristics before and after EVT for femoropopliteal lesion using IVUS. Angiographic or duplex ultrasound follow-up was performed at 1 year after EVT. A total of 263 lesions underwent EVT between December 2016 and December 2017. In total, 20 lesions (8 cases of isolated common femoral artery lesion and 12 cases of restenosis lesion) were excluded, and 243 lesions were enrolled in this study. A total of 181 lesions were treated with stent placement, and 62 lesions were treated only with balloon angioplasty. In the case of stent use, a larger distal plaque burden was associated with restenosis, while a lower calcification angle was associated with higher patency in the case of balloon angioplasty alone. CONCLUSIONS: The factors related to patency differed depending on the treating modality. The findings suggest that IVUS is a useful tool for predicting patency because it can provide a more accurate evaluation after EVT for femoropopliteal lesions.

Objective measurement of nine gaze-directions using an eye-tracking device.

PURPOSE: To investigate the usefulness and efficacy of a novel eye-tracking device that can objectively measure nine gaze-directions. METHODS: We measured each of the nine gaze-directions subjectively, using a conventional Hess screen test, and objectively, using the nine gaze-direction measuring device, and de-termined the correlation, addition error, and proportional error. We obtained two consecu-tive measurements of the nine gaze-directions using the newly developed device in healthy young people with exophoria and investigated the reproducibility of the measurements. We further measured the nine gaze-directions using a Hess screen test and the newly developed device in three subjects with cover test-based strabismus and compared the results. RESULTS: We observed that the objective measurements obtained with the newly developed gaze-direction measuring device had significant correlation and addition error compared to the conventional subjective method, and we found no proportional error. These measure-ments had good reproducibility. CONCLUSION: The novel device can be used to observe delayed eye movement associated with limited eye movement in the affected eye, as well as the associated excessive movement of the healthy eye in patients with strabismus, similar to the Hess screen test. This is a useful device that can provide objective measurements of nine gaze-directions.

Positive Myocardial Uptake of Bone Scintigraphic Agents Associated with Cardiac Amyloidosis: Frequency of Positive Uptake Data Based on Daily Clinical Practice.

Objective: The bone scan plays an important role for detecting number of conditions relating to bones, including: bone cancer or bone metastasis, bone inflammation. Extraosseous uptake, in particular, myocardial uptake, was observed in some patients examined with the bone scans. Positive uptake of 99mTc-labeled bone radiotracers is associated with cardiac amyloidosis. However, the frequency and cause of positive cardiac 99mTc-MDP uptake have not been fully studied. In this regard, the aim of this study was to assess the frequency and characteristics of patients with high myocardi-al uptake of bone scintigraphy in daily clinical practice setting. Methods: We retrospectively analyzed 4180 bone scintigraphies performed in daily clinical practice during 7-years period. The intensity of the myocardial uptake was graded based on a visual scale ranging from 0 to 3 points. Score 0 indicates the absence of uptake. Score 1 defined uptake less than that of bone (referred to as the adjacent rib). Uptake similar to that of bone was classified score 2. Score 3 was defined as uptake greater than that of reference bone. Positive myocardial uptake included a visual score 2 or 3. Result: Positive 99mTc-MDP myocardial uptake occurred in 12 patients among 4180 patients (0.3%). 7 of 12 positive scan patients were consistent with amyloidosis confirmed by biopsy. In these patients, the mean age was 75.6 ± 5.2 years old. Ten cases showed biventricular uptake and 2 showed LV uptake only. Conclusion: Positive cardiac uptake of bone scintigraphic agents was present in 0.3% of bone scintigraphies in a clinical practice setting. This may be a sign of cardiac amyloidosis involvement which may give the presence of extraosseous bone tracer uptake its own importance and a new role.

Peak systolic velocity ratio derived from quantitative vessel analysis for restenosis after femoropopliteal intervention: a multidisciplinary review from Endovascular Asia.

With technological improvements in the endovascular armamentarium, there have been tremendous advances in catheter-based femoropopliteal artery intervention during the last decade. However, standardization of the methodology for assessing outcomes has been underappreciated, and unvalidated peak systolic velocity ratios (PSVRs) of 2.0, 2.4, and 2.5 on duplex ultrasonography have been arbitrarily but routinely used for assessing restenosis. Quantitative vessel analysis (QVA) is a widely accepted method to identify restenosis in a broad spectrum of cardiovascular interventions, and PSVR needs to be validated by QVA. This multidisciplinary review is intended to disseminate the importance of QVA and a validated PSVR based on QVA for binary restenosis in contemporary femoropopliteal intervention.