350 results on '"Keisuke, Hirano"'
Search Results
2. Revascularization for controlling hypertension and improving cardiorenal failure in Leriche syndrome
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Sho Takagi, Keisuke Hirano, Akio Nakasu, Junji Yanagisawa, Yoshihiro Goto, and Yasuhide Okawa
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Leriche syndrome ,Renovascular hypertension ,Heart failure ,Renal failure ,Aorto‐bifemoral bypass ,Renal artery stenting ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Leriche syndrome usually occurs when atherosclerotic obstructions result in luminal narrowing of the abdominal aorta or iliac arteries and leads to thrombosis; it rarely causes heart or renal failure. We report the case of a 58‐year‐old Asian man with heart and renal failure as the dominant clinical manifestations of renovascular hypertension caused by Leriche syndrome. We performed an aorto‐bifemoral bypass and unilateral renal artery stenting. Post‐operative echocardiography showed improved cardiac function, with the left ventricular ejection fraction increasing from 30% before surgery to 54.2% after surgery. Moreover, his heart rate and blood pressure became stable, and his serum creatinine and brain natriuretic peptide levels decreased from 3.46 to 1.08 mg/dL and 685 to 4 pg/mL, respectively. Our case report shows that aorto‐bifemoral bypass and unilateral renal artery stenting can effectively treat heart and renal failure resulting from renovascular hypertension caused by Leriche syndrome.
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- 2022
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3. The feasibility of the flower stenting technique for ostial lesions of the common iliac artery
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Toshihiko Kishida, Keisuke Hirano, Shinsuke Mori, Masahiro Yamawaki, Norihiro Kobayashi, Masakazu Tsutsumi, Yohsuke Honda, Kenji Makino, Shigemitsu Shirai, and Yoshiaki Ito
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dissection ,iliac artery ,stenosis ,stent ,Medicine - Abstract
Abstract Background and Aims A balloon‐expandable stent (BES) is generally used for ostial lesions of the common iliac artery (CIA) owing to the positional ease of stent adjustment. However, there are potential risks such as vessel dissection and perforation due to vessel overstretching during. In our hospital, we performed endovascular therapy (EVT) for CIA ostial lesions via a novel method named “the flower stenting method,” using a self‐expandable stent. This study aimed to analyze the efficacy and safety of this method. Methods This study was single‐center, retrospective, and observational. We enrolled 83 patients (91 limbs) who underwent EVT with SMART stent (Cordis, Miami, Florida) for CIA ostial lesions from 2007 to 2014. The primary endpoint was the rate of freedom from target lesion revascularization (TLR) in 5 years, and the secondary endpoint was the success rate of stent placement for the CIA ostium. Results The average patient age was 72.3 ± 9.4 years, 71% of the patients were men, 19% were receiving hemodialysis, and 60% had diabetes. Additionally, 38% of the lesions were Trans‐Atlantic Inter‐Society Consensus C/D lesions, while 37% were chronic total occlusion lesions. The average lesion length was 36 ± 23 mm, and the average vessel diameter was 10.7 ± 1.4 mm. The rate of freedom from TLR was 97.3% at 5 years, and the success rate of only stent placement was 90.1%. Conclusion The flower stenting method leads to acceptable outcomes and is useful for accurate stent deployment.
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- 2021
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4. Feasibility and impact of extra‐vascular ultrasound‐guided endovascular treatment for infrapopliteal artery occlusive disease
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Takahiro Tokuda, Yasuhiro Oba, Ai Kagase, Hiroaki Matsuda, Yoriyasu Suzuki, Akira Murata, Tatsuya Ito, and Keisuke Hirano
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Radiology, Nuclear Medicine and imaging ,General Medicine ,Cardiology and Cardiovascular Medicine - Published
- 2023
5. Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study
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Yohsuke Honda, Keisuke Hirano, Masahiro Yamawaki, Motoharu Araki, Norihiro Kobayashi, Yasunari Sakamoto, Shinsuke Mori, Masakazu Tsutsumi, Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, Takahiro Nakano, and Yoshiaki Ito
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Introduction. The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. Methods. In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. Results. Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p=0.004). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p=0.0001). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR (p=0.71) for ALI (p=0.79). Conclusions. AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.
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- 2021
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6. A Comment on: 'Invidious Comparisons: Ranking and Selection as Compound Decisions' by Jiaying Gu and Roger Koenker
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Keisuke Hirano
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Economics and Econometrics - Published
- 2023
7. Use of the orbital atherectomy system backed up with the guide-extension catheter for a severely tortuous calcified coronary lesion
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Norihiro Kobayashi, Masahiro Yamawaki, Keisuke Hirano, Motoharu Araki, Tsuyoshi Sakai, Yasunari Sakamoto, Shinsuke Mori, Masakazu Tsutsumi, Masahiro Nauchi, Naohiko Sahara, Yohsuke Honda, Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, Yuta Sugizaki, Takahide Nakano, Tomoya Fukagawa, Toshihiko Kishida, Yuki Kozai, Yusuke Setonaga, Shutaro Goda, and Yoshiaki Ito
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Medicine (General) ,R5-920 - Abstract
A 68-year-old man was scheduled to undergo percutaneous coronary intervention for in-stent total occlusion of the severely tortuous right coronary artery. Intravascular ultrasound revealed heavy in-stent calcification. Lesion atherectomy was required; however, severe proximal vessel tortuosity was detected. We introduced a 7-Fr guide-extension catheter beyond the severely tortuous part and performed rotational atherectomy with a 1.5 mm burr. However, the balloon could not expand; therefore, we changed to an orbital atherectomy system. Subsequently, the balloon successfully expanded, and intravascular ultrasound revealed an enlarged lumen. Severe proximal vessel tortuosity limits the use of atherectomy devices; however, a guide-extension catheter delivers the atherectomy device beyond the tortuosity. The delivery of the orbital atherectomy system inside the guide-extension catheter is easy due to its low profile; the debulking effect increases with the number of passes and rotational speed. This strategy is a useful option for treating severe calcified lesions with proximal vessel tortuosity.
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- 2020
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8. Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging
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Norihiro Kobayashi, Keisuke Hirano, Masahiro Yamawaki, Motoharu Araki, Tsuyoshi Sakai, Yasunari Sakamoto, Shinsuke Mori, Masakazu Tsutsumi, Masahiro Nauchi, Naohiko Sahara, Yohsuke Honda, Kenji Makino, Shigemitsu Shirai, Masafumi Mizusawa, Yuta Sugizaki, Takahide Nakano, Tomoya Fukagawa, Toshihiko Kishida, Yuki Kozai, Yusuke Setonaga, Shutaro Goda, and Yoshiaki Ito
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Medicine (General) ,R5-920 - Abstract
A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease.
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- 2020
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9. A Comparative Analysis between Ultrasound-Guided and Conventional Distal Transradial Access for Coronary Angiography and Intervention
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Shinsuke Mori, Keisuke Hirano, Masahiro Yamawaki, Norihiro Kobayashi, Yasunari Sakamoto, Masakazu Tsutsumi, Yohsuke Honda, Kenji Makino, Shigemitsu Shirai, and Yoshiaki Ito
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Objectives. To compare feasibility and safety between ultrasound-guided and conventional distal transradial access (dTRA). Background. Distal transradial access, a new technique for coronary angiography (CAG) and percutaneous coronary interventions (PCI), is safe and feasible and will become popular worldwide. Ultrasound-guided dTRA has been advocated to reduce failure rate and access-site complications. However, to date, the comparison of feasibility and safety between ultrasound-guided and conventional dTRA has not been reported. Method. Overall, 137 patients (144 procedures) who underwent CAG or PCI using dTRA between September 2018 and February 2019 were investigated. These patients were classified into two groups: C (dTRA with conventional punctures; 76 patients, 79 procedures) and U (dTRA with ultrasound-guided punctures; 61 patients, 65 procedures) groups. Successful procedural rate, procedural outcomes, and complication rate during hospital stays were compared between the two groups. Results. The procedural success rate was significantly higher in the U group than in the C group (97% vs. 87%, P=0.0384). However, the rate of PCI, puncture time, total fluoroscopy time, the volume of contrast medium, the rate of access-site ecchymosis, and incidence of nerve disorder were similar between the two groups. Additionally, radial artery occlusion after the procedure did not occur in this study. Conclusion. The ultrasound-guided dTRA for CAG or PCI was associated with a lower failure rate than conventional dTRA. However, there were no significant differences in puncture time and complication rate between the two procedures.
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- 2020
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10. Analyzing cross-validation for forecasting with structural instability
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Keisuke Hirano and Jonathan H. Wright
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Economics and Econometrics ,Mathematical optimization ,Computer science ,Applied Mathematics ,Sampling (statistics) ,Window (computing) ,Point (geometry) ,Local parameter ,Sample (statistics) ,Time series ,Cross-validation ,Selection (genetic algorithm) - Abstract
When forecasting with economic time series data, researchers often use a restricted window of observations or downweight past observations in order to mitigate the potential effects of parameter instability. In this paper, we study the problem of selecting a window for point forecasts made at the end of the sample. We develop asymptotic approximations to the sampling properties of window selection methods, and post-window selection point forecasts, where there is local parameter instability of various sorts. We examine risk properties of point forecasts made after cross-validation to select the window, and compare this approach to some alternative methods of selecting the window. We also propose a quasi-Bayesian form of cross-validation that we find to have good risk properties.
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- 2022
11. The Effect of Aggressive Wire Recanalization in Calcified Atheroma and Dilatation (ARCADIA) Technique in Eccentric Calcified Lesion of No-stenting Zone
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Mitsuyasu Terashima, Kenya Nasu, Yoshihisa Kinoshita, Ryoji Koshida, Tetsuo Matsubara, Keisuke Hirano, Maoto Habara, Hirokazu Konishi, Etsuo Tsuchikane, and Takahiko Suzuki
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Novel technique ,medicine.medical_specialty ,business.industry ,Coronary Artery Disease ,Dilatation ,Plaque, Atherosclerotic ,Calcified lesion ,Treatment Outcome ,Calcified atheroma ,medicine ,Humans ,Eccentric ,Stents ,Radiology, Nuclear Medicine and imaging ,Surgery ,Radiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Purpose: The endovascular approach for eccentric calcified lesions of the no-stenting zone is challenging. This study aimed to investigate the effect of a novel technique for these lesions. Methods: We performed EVT for severe and eccentric calcified lesions using the technique, which is presented previously and named aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA). In brief, a guidewire is passed to the residual lumen firstly. Next, another guidewire is advanced into and cross through the calcified plaque and returned to the distal original lumen with intravascular ultrasound (IVUS) guided. The calcified plaque is dilated by using a scoring-balloon or non-compliant balloon. Results: Consecutive 14 peripheral artery disease patients with isolated and eccentric calcification in a no-stenting zone were treated using ARCADIA technique between January 2018 and March 2020. In IVUS data, lumen cross-section area was significantly increased from 5.2 ± 2.0 mm2 to 18.1 ± 6.9 mm2 (p < 0.01), lumen area was expanded roundly evaluating as symmetry index from 0.45 ± 0.09 to 0.81 ± 0.12 (p < 0.01). There were no distal embolization and perforation after ARCADIA technique. One-year target lesion revascularization occurred in only 2 cases. The primary patency of 1 year was 85.7%. Conclusion: ARCADIA technique is safe and appropriate, and can be 1 option to treat for eccentric calcified lesions of the no-stenting zone as an optimal wire crossing method.
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- 2021
12. Distal embolization of coronary calcified nodule after rotational atherectomy
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Norihiro Kobayashi, Yoshiaki Ito, Masahiro Yamawaki, Motoharu Araki, Tsuyoshi Sakai, Yasunari Sakamoto, Shinsuke Mori, Masakazu Tsutsumi, Masahiro Nauchi, Yohsuke Honda, Kenji Makino, Shigemitsu Shirai, Tomoya Fukagawa, Toshihiko Kishida, and Keisuke Hirano
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Medicine (General) ,R5-920 - Abstract
A 62-year-old man with effort angina underwent percutaneous coronary intervention in our hospital. The target lesion was severely calcified at the mid part of the right coronary artery. Pre-procedural intravascular imaging and optical frequency domain imaging showed a calcified nodule at the lesion. We performed rotational atherectomy with a 2.0 mm burr and observed an increase in the lumen area; however, a large amount of calcified nodule persisted. We decided to perform rotational atherectomy with a burr size of 2.25 mm; however, distal embolization of the calcified nodule occurred. We failed to retrieve the embolus; hence, we performed balloon dilatation with a 2.0-mm balloon, which was successfully performed. Yet, the lesion with the embolus immediately recoiled. Finally, a drug-eluting stent was implanted in both the distal lesion with the embolus and the lesion with the calcified nodule. Final coronary angiography showed good results. We confirmed good stent expansion and that calcified nodule was compressed outside the stent. Atherectomy of a calcified nodule is effective at achieving sufficient stent expansion and reducing the risk of vessel perforation. However, we experienced distal embolization of the calcified nodule at the time of rotational atherectomy and so distal embolization should be considered at the time of treatment of calcified nodule.
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- 2018
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13. THE ET INTERVIEW: PROFESSOR GARY CHAMBERLAIN
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Guido W. Imbens, Bryan S. Graham, and Keisuke Hirano
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Economics and Econometrics ,Art history ,Social Sciences (miscellaneous) ,Mathematics - Published
- 2021
14. Impact of Extravascular Ultrasound-Guided Wiring on Achieving Optimal Vessel Preparation and Patency in Endovascular Therapy for Superficial Femoral Artery Chronic Total Occlusion
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Yasunari, Sakamoto, Keisuke, Hirano, Shinsuke, Mori, Masahiro, Yamawaki, Motoharu, Araki, Norihiro, Kobayashi, Masakazu, Tsutsumi, Yohsuke, Honda, and Yoshiaki, Ito
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Femoral Artery ,Peripheral Arterial Disease ,Treatment Outcome ,Humans ,Stents ,Angioplasty, Balloon ,Ultrasonography, Interventional ,Vascular Patency ,Retrospective Studies - Abstract
The study aim was to evaluate the impact of extravascular ultrasound-guided (EVUSG) wiring on achieving optimal vessel preparation and patency in endovascular therapy (EVT) for superficial femoral artery (SFA) chronic total occlusion (CTO).Between April 2007 and January 2019, a total of 239 SFA-CTO limbs were successfully treated with EVT and bailout implantation of self-expandable nitinol stents at our hospital. The study subjects were divided into 2 groups according to the type of guidance strategy used during CTO wiring, ie, the EVUSG group and the conventional angiography guidance (AG) group. Immediately after the initial balloon angioplasty and successful passage of the wire through the SFA-CTO lesions, the EVUSG (65 limbs) and AG groups (174 limbs) were retrospectively evaluated for angiographic dissection patterns. The primary patency rate was also compared between the 2 groups.No significant difference was observed in the balloon diameter at the initial dilation immediately after successful wire passing (3.7 ± 0.5 mm in the EVUSG group vs 3.8 ± 0.5 mm in the AG group; P=.17). The incidence of severe dissection was significantly lower (Plt;.001) in the EVUSG group (28/65; 43%) than in the AG group (137/174; 79%). The 3-year primary patency rates in the EVUSG and AG groups were 84.5% and 68.4%, respectively (Plt;.001).EVUSG for SFA-CTO may achieve optimal vessel preparation, defined as an initial balloon angioplasty without severe dissection, and subsequent implantation of self-expandable stents may lead to a better patency rate.
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- 2022
15. Impact of Dialysis Vintage and Renal Biomarkers on Mortality in Dialysis-Dependent Patients With Critical Limb Ischemia Undergoing Revascularization
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Akio Kodama, Masatsugu Nakano, Nobuyoshi Azuma, Norihiro Kobayashi, Osamu Iida, Yoshimitsu Soga, Yasutaka Yamauchi, Mitsuyoshi Takahara, Hiroyoshi Komai, and Keisuke Hirano
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Male ,medicine.medical_specialty ,Time Factors ,Critical Illness ,medicine.medical_treatment ,Kaplan-Meier Estimate ,Revascularization ,Endovascular therapy ,Amputation, Surgical ,Ischemia ,Renal Dialysis ,Risk Factors ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Dialysis ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Renal biomarkers ,business.industry ,Endovascular Procedures ,Critical limb ischemia ,Limb Salvage ,Treatment Outcome ,Cardiology ,Surgery ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Biomarkers - Abstract
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 2/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.
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- 2021
16. Introduction to the Annals Issue in Honor of Gary Chamberlain
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Bryan S. Graham and Keisuke Hirano
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Economics and Econometrics ,Annals ,Computer science ,Applied Mathematics ,Honor ,Classics - Published
- 2022
17. Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry
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Takahiro Tokuda, Mitsuyoshi Takahara, Osamu Iida, Shun Kohsaka, Yoshimitsu Soga, Yasuhiro Oba, Keisuke Hirano, Toshiro Shinke, Tetsuya Amano, and Yuji Ikari
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Radiology, Nuclear Medicine and imaging ,Surgery ,Cardiology and Cardiovascular Medicine - Abstract
Purpose: Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear. Materials and Methods: Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect. Results: The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (Conclusion: In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. Clinical Impact EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.
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- 2023
18. A Geometric Arbiter Selection Algorithm on Infrared Wireless Inter-robot Communication.
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Hiroyuki Takai, Hirotoshi Hara, Keisuke Hirano, Gen'ichi Yasuda, and Keihachiro Tachibana
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- 2002
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19. Clinical impact and risk stratification of balloon angioplasty for femoropopliteal disease in nitinol stenting era: Retrospective multicenter study using propensity score matching analysis
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Taketsugu Tsuchiya, Takaaki Takamura, Yoshimitsu Soga, Osamu Iida, Keisuke Hirano, Kenji Suzuki, Terutoshi Yamaoka, Yusuke Miyashita, Michihiko Kitayama, and Koji Kajinami
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Medicine (General) ,R5-920 - Abstract
Objective: Nitinol stenting could bring the better outcome in endovascular therapy for femoropopliteal disease. However, it might be expected that recent marked advances in both device technology and operator technique had led to improved efficacy of balloon angioplasty even in this segment. The aims of this study were to evaluate the clinical impact of balloon angioplasty for femoropopliteal disease and make risk stratification clear by propensity score matching analysis. Methods: Based on the multicenter retrospective data, 2758 patients (balloon angioplasty: 729 patients and nitinol stenting: 2029 patients), those who underwent endovascular therapy for femoropopliteal disease, were analyzed. Results: The propensity score matching procedure extracted a total of 572 cases per group, and the primary patency rate of balloon angioplasty and nitinol stenting groups after matching was significantly the same (77.2% vs 82.7% at 1 year; 62.2% vs 64.3% at 3 years; 47.8% vs 54.3% at 5 years). In multivariate Cox hazard regression analysis, significant predictors for primary patency were diabetes mellitus, regular dialysis, cilostazol use, chronic total occlusion, and intra-vascular ultra-sonography use. The strategy of balloon angioplasty was not evaluated as a significant predictor for the primary patency. After risk stratification using five items ( d iabetes mellitus, regular d ialysis, no use of i ntra-vascular ultra-sonography, c hronic total occlusion, and no use of c ilostazol: the DDICC score), the estimated primary patency rates of each group (low, DDICC score 0–2; moderate, DDICC score 3; high risk, DDICC score 4–5) were 88.6%, 78.3%, and 63.5% at 1 year; 75.2%, 60.7%, and 39.8% at 3 years; and 66.0%, 47.1%, and 26.3% at 5 years (p
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- 2016
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20. Comparison of Long‐Term Clinical Outcomes of Lesions Exhibiting Focal and Segmental Peri‐Stent Contrast Staining
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Takahiro Tokuda, Masahiro Yamawaki, Mitsuyohi Takahara, Shinsuke Mori, Kenji Makino, Yosuke Honda, Hiroya Takafuji, Takuro Takama, Masakazu Tsutsumi, Yasunari Sakamoto, Hideyuki Takimura, Norihiro Kobayashi, Motoharu Araki, Keisuke Hirano, and Yoshiaki Ito
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peri‐stent contrast staining ,segmental peri‐stent contrast staining ,stent thrombosis ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
BackgroundPeri‐stent contrast staining (PSS) after metallic drug‐eluting stent deployment is associated with target lesion revascularization and very late stent thrombosis. However, the type of PSS that influences the clinical outcomes is unknown. Therefore, we aimed to reveal which PSS type was influencing clinical outcomes. Methods and ResultsThis study included 5580 de novo lesions of 4405 patients who were implanted with a first‐ or second‐generation drug‐eluting stent and who were evaluated using follow‐up angiography within 12 months after stent implantation. We compared the clinical outcomes of patients divided into focal PSS and segmental PSS groups for 6 years after stent implantation. Total PSS was observed in 97 lesions (2.2%), of which 42 and 55 lesions were focal and segmental PSS, respectively. Baseline characteristics were similar between groups, except for intraoperative chronic total occlusion (segmental PSS=47.3% versus focal PSS=11.9%, P=0.0001). The incidence of segmental PSS tended to be higher in patients with a first‐generation drug‐eluting stent (83.6% versus 16.4%, P=0.05). The cumulative incidence of stent thrombosis in the 6 years of segmental PSS group was significantly higher than that of the focal PSS group (13.9% versus 0%, P=0.04). The cumulative incidence of overall target lesion revascularization for restenosis, excluding target lesion revascularization procedures for stent thrombosis, was significantly higher in the segmental PSS group (38.0% versus 0%, P=0.01). ConclusionsThe incidence of segmental PSS tended to be higher in patients with a first‐generation drug‐eluting stent and appeared to be significantly associated with target lesion revascularization and stent thrombosis.
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- 2016
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21. Accuracy of quantitative vessel analysis in endovascular treatment for femoropopliteal lesions
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Masahiro Yamawaki, Shinsuke Mori, Kenji Makino, Shigemitsu Shirai, Mitsuyoshi Takahara, Yohsuke Honda, Masakazu Tsutsumi, Keisuke Hirano, Norihiro Kobayashi, and Yoshiaki Ito
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medicine.medical_specialty ,business.industry ,medicine ,Radiology, Nuclear Medicine and imaging ,Vessel analysis ,Original Article ,Radiology ,Endovascular treatment ,business - Abstract
BACKGROUND: Our aim was to evaluate the accuracy of quantitative vessel analysis (QVA) in measuring the reference vessel diameter (RVD) of femoropopliteal lesions. METHODS: Between October 2014 and September 2015, 30 consecutive femoropopliteal lesions in 25 patients who underwent endovascular therapy (EVT) under intravascular ultrasound (IVUS) guidance were analyzed. RVDs measured using QVA(sheath) (calibrated using a 6-Fr sheath in the common femoral artery) and QVA(ruler) (calibrated using a ruler on the angiography table) were compared to those obtained using IVUS as the reference values. RESULTS: The mean QVA(sheath)-measured RVD was significantly larger than the mean IVUS-measured RVD (5.34±1.29 vs. 5.07±1.20 mm, P=0.001). In contrast, mean QVA(ruler)-measured RVD was 4.60±1.04 mm, which was significantly smaller than both the mean IVUS- and mean QVA(sheath)-measured RVD (both P
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- 2022
22. Vessel Diameter Evaluated by Intravascular Ultrasound Versus Angiography
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Keisuke Hirano, Toshiaki Mano, Yoshimitsu Soga, Donghoon Choi, Osamu Iida, Mitsuyoshi Takahara, Masahiko Fujihara, and Daizo Kawasaki
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Angiography ,Endovascular therapy ,Clinical Practice ,Vessel diameter ,Peripheral Arterial Disease ,Treatment Outcome ,Intravascular ultrasound ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Surgery ,Radiology ,Prospective Studies ,Cardiology and Cardiovascular Medicine ,business ,Ultrasonography, Interventional - Abstract
Purpose: Although reference vessel diameter (RVD) is conveniently measured by angiography during femoropopliteal (FP) endovascular therapy (EVT) in clinical practice, angiography will potentially underestimate RVD. On the other hand, intravascular ultrasound (IVUS) can measure RVD precisely. The aim of this study was to reveal the difference between angiography- and IVUS-assessed RVD in patients undergoing FP-EVT for symptomatic peripheral artery disease (PAD). Methods: We analyzed a prospective and multicenter database including 1967 limbs of 1725 patients with symptomatic PAD undergoing IVUS-supported FP-EVT. The study outcome measure was the difference between IVUS- and angiography-assessed distal RVD ( ΔRVD), calculated as angiography-assessed RVD subtracted from IVUS-assessed RVD. The clinically important difference was defined as 1 mm or larger. Results: IVUS-assessed RVD was significantly larger than angiography-assessed RVD (6.0±1.0 mm vs 5.0±1.0 mm; pConclusion: The current study revealed the difference between angiography-assessed reference lumen diameter and IVUS-assessed reference EEM diameter of FP lesions. About half of population had ΔRVD ≥1 mm. IVUS-assessed RVD was more likely to be different by angiography in cases with small vessels, CTO, bilateral calcification, and history of stent implantation.
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- 2021
23. Vascular Pathology and Impact of Stent Eccentricity for Stent Restenosis in Femoropopliteal Endovascular Therapy
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Tomoaki Mochidome, Mitsuyoshi Takahara, Takashi Miura, Yoshimitsu Soga, Masahiko Fujihara, Daizo Kawasaki, Keisuke Hirano, Donghoon Choi, and Osamu Iida
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Endovascular Procedures ,Drug-Eluting Stents ,Constriction, Pathologic ,Prosthesis Design ,Femoral Artery ,Peripheral Arterial Disease ,Cross-Sectional Studies ,Treatment Outcome ,Risk Factors ,Humans ,Radiology, Nuclear Medicine and imaging ,Popliteal Artery ,Stents ,Prospective Studies ,Cardiology and Cardiovascular Medicine ,Vascular Patency ,Retrospective Studies - Abstract
To explore the clinical features associated with stent eccentricity and reveal the impact of stent eccentricity on the risk of 1-year restenosis after femoropopliteal stent implantation for symptomatic atherosclerotic peripheral artery disease (PAD).The clinical database of a multicenter prospective study was used. It registered 2,018 limbs of 1,766 patients in whom intravascular ultrasound (IVUS)-supported femoropopliteal endovascular therapy (EVT) for symptomatic atherosclerotic PAD was planned from November 2015 to June 2017. The study included 1,233 limbs of 1,088 patients implanted with a bare nitinol stent, drug-eluting stent (DES), or stent graft and administered ≥2 antithrombotic drugs. The stent eccentricity was evaluated using IVUS, calculated as [(maximum diameter) / (minimum diameter) - 1] at the cross-sectional segment with the lowest lumen area after stent implantation.Chronic total occlusion and bilateral arterial calcification (peripheral artery calcification scoring system Grades 3 and 4) were positively associated with stent eccentricity, whereas renal failure while receiving dialysis, DES use, and stent graft use were negatively associated with stent eccentricity (all P.05). Stent eccentricity was associated with an increased risk of 1-year restenosis (odds ratio [OR], 1.18; 95% CI, 1.01-1.37; P = .034). However, after adjustment for lesion severity and implanted stent types, the association was no longer significant (OR, 1.07; 95% CI, 0.91-1.24; P = .43).Stent eccentricity was not significantly associated with the risk of 1-year restenosis after femoropopliteal EVT.
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- 2021
24. Clinical characteristics of patients with Rutherford category IV, compared with V and VI
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Taketsugu Tsuchiya, Osamu Iida, Tatsuya Shiraki, Yoshimitsu Soga, Keisuke Hirano, Kenji Suzuki, Terutoshi Yamaoka, Yusuke Miyashita, Michihiko Kitayama, and Koji Kajinami
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Medicine (General) ,R5-920 - Abstract
Objective: Patients categorized Rutherford category IV might have different characteristics compared with Rutherford category V and VI. Our study aims were to estimate the clinical differences between Rutherford category IV and Rutherford category V and VI, for those underwent endovascular therapy for isolated infrapopliteal disease, and also to find risk factors for endovascular therapy in Rutherford category IV. Methods: Based on the Japanese multi-center registry data, 1091 patients with 1332 limbs (Rutherford category IV: 226 patients with 315 limbs, Rutherford category V and VI: 865 patients with 1017 limbs) were analyzed retrospectively. Results: Patients’ backgrounds and lesions’ characteristics had significant differences. Both freedom rate from major adverse limb event with perioperative death and amputation-free survival rate at 1 year were better in Rutherford category IV than Rutherford category V and VI (93.6% vs 78.3%, 87.7% vs 66.7%) and those maintained to 3 years ( p 3.0 mg/dL), chronic obstructive pulmonary disease, and coronary artery disease in Rutherford category IV. Conclusion: From the present results, Rutherford category IV should be recognized to have quite different backgrounds and better outcome from Rutherford category V and VI.
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- 2015
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25. The feasibility of the flower stenting technique for ostial lesions of the common iliac artery
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Norihiro Kobayashi, Yohsuke Honda, Shinsuke Mori, Keisuke Hirano, Kenji Makino, Toshihiko Kishida, Yoshiaki Ito, Masakazu Tsutsumi, Shigemitsu Shirai, and Masahiro Yamawaki
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Perforation (oil well) ,Dissection (medical) ,Lesion ,medicine.artery ,Clinical endpoint ,Medicine ,cardiovascular diseases ,iliac artery ,Research Articles ,business.industry ,stenosis ,Stent ,General Medicine ,medicine.disease ,Common iliac artery ,Surgery ,Stenosis ,Ostium ,dissection ,stent ,medicine.symptom ,business ,Research Article - Abstract
Background and Aims A balloon‐expandable stent (BES) is generally used for ostial lesions of the common iliac artery (CIA) owing to the positional ease of stent adjustment. However, there are potential risks such as vessel dissection and perforation due to vessel overstretching during. In our hospital, we performed endovascular therapy (EVT) for CIA ostial lesions via a novel method named “the flower stenting method,” using a self‐expandable stent. This study aimed to analyze the efficacy and safety of this method. Methods This study was single‐center, retrospective, and observational. We enrolled 83 patients (91 limbs) who underwent EVT with SMART stent (Cordis, Miami, Florida) for CIA ostial lesions from 2007 to 2014. The primary endpoint was the rate of freedom from target lesion revascularization (TLR) in 5 years, and the secondary endpoint was the success rate of stent placement for the CIA ostium. Results The average patient age was 72.3 ± 9.4 years, 71% of the patients were men, 19% were receiving hemodialysis, and 60% had diabetes. Additionally, 38% of the lesions were Trans‐Atlantic Inter‐Society Consensus C/D lesions, while 37% were chronic total occlusion lesions. The average lesion length was 36 ± 23 mm, and the average vessel diameter was 10.7 ± 1.4 mm. The rate of freedom from TLR was 97.3% at 5 years, and the success rate of only stent placement was 90.1%. Conclusion The flower stenting method leads to acceptable outcomes and is useful for accurate stent deployment.
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- 2021
26. Feasibility of Ultrasound-Guided Transoccluded Radial Access for Coronary Angiography or Percutaneous Coronary Intervention
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Yohsuke Honda, Motoharu Araki, Yoshiaki Ito, Keisuke Hirano, Kenji Makino, Masakazu Tsutsumi, Norihiro Kobayashi, Masahiro Yamawaki, Shinsuke Mori, and Yasunari Sakamoto
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Male ,Coronary angiography ,Cardiac Catheterization ,medicine.medical_specialty ,medicine.medical_treatment ,Arterial Occlusive Diseases ,Punctures ,030204 cardiovascular system & hematology ,Coronary Angiography ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Internal medicine ,medicine.artery ,Catheterization, Peripheral ,Occlusion ,medicine ,Humans ,030212 general & internal medicine ,Radial artery ,Ultrasonography, Interventional ,Aged ,Cardiac catheterization ,Aged, 80 and over ,business.industry ,Percutaneous coronary intervention ,Middle Aged ,Ultrasound guided ,Radial Artery ,Conventional PCI ,Cardiology ,Feasibility Studies ,Female ,Ultrasonography ,Cardiology and Cardiovascular Medicine ,business - Abstract
Transradial access for coronary angiography (CAG) or percutaneous coronary intervention (PCI) is progressively used worldwide due to its low bleeding and vascular complications ([1][1]). Despite precautionary measures, radial artery occlusion (RAO) occurs in up to 12.0% of cases following radial
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- 2020
27. Independent predictors of loss of primary patency at 1 year after aortoiliac stent implantation
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Daizo Kawasaki, Yoshito Yamamoto, Osamu Iida, Yoshimitsu Soga, Masahiko Fujihara, Yoshiaki Shintani, Teruyasu Sugano, Omotenashi investigators, Keisuke Hirano, Masato Nakamura, Hiroyoshi Yokoi, Yasutaka Yamauchi, Mitsuyoshi Takahara, and Akira Miyamoto
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Stent ,Subgroup analysis ,030204 cardiovascular system & hematology ,Vascular surgery ,equipment and supplies ,medicine.disease ,Endovascular therapy ,Surgery ,Cardiac surgery ,03 medical and health sciences ,0302 clinical medicine ,Restenosis ,Concomitant ,medicine ,Population study ,cardiovascular diseases ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business - Abstract
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
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- 2019
28. Ultra-Long Inflation in Superficial Femoral Artery Stenosis and Occluded Lesions Using Guide Liner ('Ultra SOUL'): A Case Report
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Yosuke Honda, Masahiro Yamawaki, Shinsuke Mori, Norihiro Kobayashi, Keisuke Hirano, Motoharu Araki, Yoshiaki Ito, Kenji Makino, Yasunari Sakamoto, Shigemitsu Shirai, and Masakazu Tsutsumi
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Constriction, Pathologic ,030204 cardiovascular system & hematology ,030218 nuclear medicine & medical imaging ,Constriction ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Angioplasty ,medicine ,Humans ,Vascular Patency ,Ultrasonography, Interventional ,medicine.diagnostic_test ,business.industry ,Angiography ,Equipment Design ,General Medicine ,Middle Aged ,medicine.disease ,Femoral Artery ,Stenosis ,Catheter ,Treatment Outcome ,Balloon dilation ,Surgery ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Superficial femoral artery stenosis ,Angioplasty, Balloon ,Vascular Access Devices - Abstract
Following an era of the use of several drug-coated balloons in angioplasty, “leave nothing behind” and stentless strategies have been gaining attention. In stentless strategies, it is necessary to avoid major dissections and limit flow. Balloon dilation is an important step in vessel preparation. In this study, we report a novel predilation technique. We performed prolonged balloon inflation for >10 min after normal ballooning in a procedure to treat an occluded lesion in the superficial femoral artery (SFA). We used a guide extension catheter to avoid foot ischemia and obtained better angiographic results than those using short duration balloon inflation. We named this technique “Ultra-Long Inflation in SFA Stenosis and Occluded Lesions Using Guide Liner” or “Ultra SOUL.” The Ultra SOUL technique may be considered a useful option in balloon dilation.
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- 2019
29. Independent Predictors of Major Adverse Cardiovascular Events at 3 Years after Aortoiliac Stent Implantation
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Yasutaka Yamauchi, Mitsuyoshi Takahara, Osamu Iida, Yoshiaki Shintani, Teruyasu Sugano, Yoshito Yamamoto, Daizo Kawasaki, Masahiko Fujihara, Yoshimitsu Soga, Keisuke Hirano, Tetsuo Yamaguchi, Hiroyoshi Yokoi, Akira Miyamoto, Masato Nakamura, Kan Zen, Amane Kozuki, Yoshinori Tsubakimoto, Tatsuki Doijiri, Makoto Utsunomiya, Shinya Sasaki, Hitoshi Anzai, Hiroshi Ando, Hiroshi Ohta, Shuichi Seki, Tetsuo Horimatsu, Akiko Tanaka, Hiroaki Nakamura, Tomofumi Tanaka, Masahide Horiguchi, Kimiaki Nagase, Shin Takiuchi, Atsushi Mizuno, Masashi Nakao, Hideaki Aihara, Makoto Nakahama, Hiroki Takahashi, Nobuhito Kaneko, Sumio Mizuno, Tsuyoshi Miyazawa, Masayuki Doi, Ryo Yoshioka, Tatsuya Nakama, Hiroki Imoto, Kazushi Urasawa, Hiroaki Okabayashi, Hiroshi Suzuki, Minoru Wake, Takeshi Niizeki, Ken Kongoji, Jun Tosaka, Shunsuke Matsuno, Jun Tanabe, Kenji Kawamoto, Takahide Suzuki, You Iwata, Takashi Miura, Yoriyasu Suzuki, Takeshi Tsuchiya, Mitsuru Munemasa, Eiji Karashima, Koji Houzawa, Yoshiro Chiba, and Ryuta Ito
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Adult ,Aged, 80 and over ,Male ,Myocardial Infarction ,Middle Aged ,Femoral Artery ,Stroke ,Peripheral Arterial Disease ,Treatment Outcome ,Risk Factors ,Humans ,Female ,Popliteal Artery ,Stents ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Renal Insufficiency ,Cardiology and Cardiovascular Medicine ,Vascular Patency ,Aged - Abstract
To identify the risk factors for major adverse cardiovascular events (MACEs) in real-world practice for symptomatic peripheral artery disease in Japan.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.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).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.
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- 2022
30. Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup
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Yuta Sugizaki, Yohsuke Honda, Masaru Obokata, Masahiro Yamawaki, Tsuyoshi Sakai, Tomoya Fukagawa, Shinsuke Mori, Masahiro Nauchi, Shigemitsu Shirai, Keisuke Hirano, Masakazu Tsutsumi, Yoshiaki Ito, Kenji Makino, Motoharu Araki, Toshihiko Kishida, Norihiro Kobayashi, and Yasunari Sakamoto
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medicine.medical_specialty ,Peripheral artery disease ,business.industry ,medicine.medical_treatment ,Hazard ratio ,Endovascular therapy ,Original article ,General Medicine ,Femoropopliteal disease ,Critical limb ischemia ,medicine.disease ,Balloon ,Surgery ,Lesion ,Restenosis ,Peripheral Vascular Disease ,Angioplasty ,medicine ,Stent implantation ,medicine.symptom ,Balloon angioplasty ,business - Abstract
Background: Little is known about the superiority of balloon angioplasty vs. stent implantation for femoropopliteal (FP) lesions according to subgroup. Methods and Results: This study involved 1,018 de novo (balloon angioplasty, n=462; stent implantation, n=556) and 114 in-stent restenosis (ISR) FP lesions (balloon angioplasty, n=69; stent implantation, n=45) treated with endovascular therapy. For de novo FP lesions, the 3-year primary patency rate was significantly better with stent implantation than with balloon angioplasty (61% vs. 69%, log-rank P=0.001), but it was similar for ISR FP lesions (40% vs. 43%, log-rank P=0.83). For de novo FP lesions, stent implantation was favorable in all subgroups except for female sex (hazard ratio [HR], 0.92; 95% CI: 0.65-1.31, P=0.66), critical limb ischemia (CLI; HR, 0.70; 95% CI: 0.46-1.06, P=0.10), calcified lesion (HR, 0.81; 95% CI: 0.46-1.39, P=0.44), and poor tibial run-off (HR, 0.86; 95% CI: 0.59-1.25, P=0.42) subgroups. No difference was found between the 2 treatment strategies for ISR FP lesions in the majority of subgroups. Stent implantation, however, was favorable in totally occluded ISR FP lesions (HR, 0.45; 95% CI: 0.21-1.01, P=0.05). Conclusions: The primary patency rate in de novo FP lesions for the 2 treatment strategies was similar in the female, calcified lesion, CLI, and poor tibial run-off subgroups. Stent implantation was superior to balloon angioplasty for totally occluded ISR FP lesions.
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- 2021
31. Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study
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Keisuke Hirano, Masahiro Yamawaki, Masafumi Mizusawa, Masakazu Tsutsumi, Shigemitsu Shirai, Motoharu Araki, Yoshiaki Ito, Takahiro Nakano, Yasunari Sakamoto, Yohsuke Honda, Norihiro Kobayashi, Shinsuke Mori, and Kenji Makino
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Male ,medicine.medical_specialty ,Article Subject ,medicine.drug_class ,Arterial Occlusive Diseases ,030204 cardiovascular system & hematology ,Single Center ,03 medical and health sciences ,0302 clinical medicine ,Restenosis ,Risk Factors ,Internal medicine ,Atrial Fibrillation ,medicine ,Clinical endpoint ,Diseases of the circulatory (Cardiovascular) system ,Humans ,Radiology, Nuclear Medicine and imaging ,Popliteal Artery ,030212 general & internal medicine ,Correlation of Data ,Retrospective Studies ,business.industry ,Incidence (epidemiology) ,Hazard ratio ,Anticoagulant ,Graft Occlusion, Vascular ,Anticoagulants ,Atrial fibrillation ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Femoral Artery ,Treatment Outcome ,RC666-701 ,Cardiology ,Female ,Stents ,Vascular Grafting ,Cardiology and Cardiovascular Medicine ,business ,Research Article - Abstract
Introduction. The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. Methods. In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. Results. Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p = 0.004 ). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p = 0.0001 ). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR ( p = 0.71 ) for ALI ( p = 0.79 ). Conclusions. AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.
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- 2021
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32. Comparison of ultrasound‐guided versus angiography‐guided endovascular treatment for femoropopliteal artery occlusive disease
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Takahiro Tokuda, Shinsuke Mori, Keisuke Hirano, Ryoji Koshida, Hiroaki Matsuda, Yasuhiro Oba, Akira Murata, Ai Kagase, Yoriyasu Suzuki, and Tatsuya Ito
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medicine.medical_specialty ,medicine.medical_treatment ,Occlusive disease ,030204 cardiovascular system & hematology ,Revascularization ,Lesion ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Popliteal Artery ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Endovascular treatment ,Ultrasonography, Interventional ,Vascular Patency ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Endovascular Procedures ,Angiography ,General Medicine ,Ultrasound guided ,Femoral Artery ,Radiation exposure ,Treatment Outcome ,medicine.anatomical_structure ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Artery - Abstract
PURPOSE This study aimed to compare the efficacy of ultrasound-guided and angiography-guided intraluminal approach for femoropopliteal (FP) artery occlusive disease. METHODS A retrospective analysis was performed using the data collected regarding patients that underwent endovascular treatment (EVT) for FP artery occlusive disease between January 2010 and April 2018 at two centers. A total of 221 consecutive de novo lesions were analyzed according to the method of recanalization. Propensity score-matched analysis was performed to compare the clinical outcomes of recanalization methods for FP occlusive lesions. The prognostic value was analyzed based on the number of guidewires, wire cross time, distal puncture rate, radiation exposure, the amount of contrast media, primary patency, and clinically driven-target lesion revascularization (CD-TLR) at 1 year. RESULTS A total of 44 matched pairs of patients were analyzed after propensity score-matched analysis. The number of guidewires, distal puncture rate, wire passage time, radiation exposure, and the amount of contrast media were significantly lower in the ultrasound-guide group, with 3.4 vs. 4.7, 9.1% vs. 54.5%, 47 min vs. 83 min, 207 mGy vs. 821 mGy, 66 ml vs. 109 ml, respectively (p
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- 2020
33. Frequency, predictors, and effect of the slow-flow phenomenon after drug-coated balloon angioplasty for femoropopliteal lesions
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Yasunari Sakamoto, Keisuke Hirano, Yoshiaki Ito, Masakazu Tsutsumi, Shinsuke Mori, Motoharu Araki, Norihiro Kobayashi, Yosuke Honda, Kenji Makino, Shigemitsu Shirai, and Masahiro Yamawaki
- Subjects
Chronic Limb-Threatening Ischemia ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Balloon ,Lesion ,03 medical and health sciences ,Peripheral Arterial Disease ,0302 clinical medicine ,Coated Materials, Biocompatible ,Risk Factors ,Angioplasty ,medicine.artery ,medicine ,Clinical endpoint ,Humans ,Popliteal Artery ,030212 general & internal medicine ,Survival rate ,Vascular Patency ,Retrospective Studies ,business.industry ,Critical limb ischemia ,Popliteal artery ,Surgery ,Cardiac surgery ,Femoral Artery ,Treatment Outcome ,Pharmaceutical Preparations ,No-Reflow Phenomenon ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Angioplasty, Balloon - Abstract
Drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions has been available in Japan since 2018. In daily practice, we encountered cases of the slow-flow phenomenon after DCB angioplasty. However, no data regarding the slow-flow phenomenon after DCB angioplasty for FP lesions are available. This study aimed to investigate the frequency, predictors, and effect of the slow-flow phenomenon following DCB angioplasty for FP lesions. This single-center, retrospective, observational study analyzed 88 FP lesions treated by DCB angioplasty between April 2018 and July 2019. Patients were divided into the slow-flow group (n = 7) and non-slow-flow group (n = 81) and were analyzed. The primary endpoint was primary patency at 6 months. The slow-flow phenomenon was observed in seven cases (8.0%). The slow-flow group had higher incidence rates of critical limb ischemia (CLI) (71% vs. 25%, p
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- 2020
34. Efficacy of the novel technique HIRANODOME in preventing distal embolization during endovascular treatment of femoropopliteal lesions
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Kenji Makino, Masakazu Tsutsumi, Keisuke Hirano, Yoshiaki Ito, Norihiro Kobayashi, Masahiro Yamawaki, Tomoya Fukagawa, Yohsuke Honda, and Shinsuke Mori
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Distal embolization ,030204 cardiovascular system & hematology ,Lesion ,03 medical and health sciences ,Peripheral Arterial Disease ,0302 clinical medicine ,Risk Factors ,medicine.artery ,Occlusion ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Popliteal Artery ,030212 general & internal medicine ,Thrombus ,Vascular Patency ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,General Medicine ,Blood flow ,Critical limb ischemia ,Middle Aged ,medicine.disease ,Limb Salvage ,Popliteal artery ,Surgery ,Femoral Artery ,Treatment Outcome ,Hemodialysis ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objectives The efficacy and clinical outcomes of a novel technique "HIRANODOME" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated. Background Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative. Methods Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate. Results The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%). Conclusions The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions.
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- 2020
35. Occurrence and clinical course of peri-stent contrast staining: comparison between second-generation drug-eluting stents and third generation drug-eluting stents
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M Tsutsumi, Y Honda, Makoto Araki, T Kishida, N Kobayashi, T Fukagawa, Y Sakamoto, Shinichi Shirai, Yoichi M. Ito, M Yamawaki, S Mori, M Mizusawa, Kenji Makino, Keisuke Hirano, and T Nakano
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Drug ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,medicine.medical_treatment ,Peri ,Coronary arteriosclerosis ,Clinical course ,Stent ,Third generation ,Staining ,medicine ,Contrast (vision) ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,media_common - Abstract
Background Peri-stent contrast staining (PSS) has been reported to be associated with very late stent thrombosis. The aims of this study was to compare the occurrence rate of PSS between second generation drug-eluting stents (2nd DES) and third generation drug-eluting stents (3rd DES), and to identify clinical characteristics associated with PSS. Methods and results This study comprised 1899 patients with 2493 de novo lesions treated with 2nd or 3rd DES from October 2015 to September 2018. Follow-up angiography was available for 1883 lesions (75.5%). There were 725 patients with 968 lesions treated with 2nd DES, and 716 patients with 915 lesions treated with 3rd DES. The occurrence of PSS, types of PSS, and VLST related to PSS were compared between 2nd and 3rd DES implantation. Mean follow-up period was 30±12 months. The occurrence rate of PSS and segmental type of PSS were similar between two groups (2nd DES vs. 3rd DES, 1.5% vs. 1.7%, p=0.73, 47% vs. 50%, p=0.85, and respectively). The VLST related to PSS occurred in only one case in 3rd DES group. (0% vs. 6.3%, p=0.33). Conclusion The occurrence rate of PSS and clinical course were similar between 2nd and 3rd DES. Funding Acknowledgement Type of funding source: None
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- 2020
36. Feasibility of the novel proximal superficial femoral artery puncture technique to recanalize chronic total occlusions
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Keisuke Hirano, Shinsuke Mori, and Tomoya Fukagawa
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medicine.medical_specialty ,Punctures ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Occlusion ,medicine ,Deep Femoral Artery ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Endovascular treatment ,medicine.diagnostic_test ,Superficial femoral artery ,business.industry ,General Medicine ,medicine.disease ,Femoral Artery ,Ostium ,Stenosis ,Treatment Outcome ,medicine.anatomical_structure ,Angiography ,Feasibility Studies ,Stents ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Angioplasty, Balloon ,Artery - Abstract
Chronic total occlusion (CTO) of the superficial femoral artery (SFA) with flush occlusion is sometimes difficult to be treated by endovascular treatment (EVT). The guidewire could not pass the proximal cap because the entry of the CTO could not be detected by angiography. Thus, a retrograde approach is considered; however, there was a risk of jeopardizing the adjacent deep femoral artery by subintimal angioplasty. Moreover, the retrograde approach is not feasible when the distal artery could not be punctured because of stenosis, occlusion, or uncomfortable positioning for patients during EVT. Therefore, we considered a novel technique to overcome this problem, called the Proximal superficial femoral Artery Puncture to RecanalIze the Chronic totAl occlusion (PAPRICA) technique. In this technique, to establish wire externalization, a retrograde puncture was performed from the proximal site of the SFA-CTO under ultrasound guidance, and the guidewire was advanced retrogradely from the puncture needle via the CTO site. After wire externalization, the guide catheter could be advanced into the SFA ostium. By pulling up the externalization wire, a strong backup and improved coaxial alignment of the guide catheter were achieved. This report presents two successful cases of flush SFA-CTO using this novel technique.
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- 2020
37. A Novel Angiographic Risk Score for Femoropopliteal Interventions
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Keisuke Hirano, Yoshimitsu Soga, Mitsuyoshi Takahara, Donghoon Choi, Daizo Kawasaki, Osamu Iida, Masahiko Fujihara, and Toshiaki Mano
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Male ,medicine.medical_specialty ,Scoring system ,Psychological intervention ,030204 cardiovascular system & hematology ,Prosthesis Design ,Endovascular therapy ,03 medical and health sciences ,Peripheral Arterial Disease ,0302 clinical medicine ,Restenosis ,Risk Factors ,Occlusion ,medicine ,Alloys ,Humans ,Radiology, Nuclear Medicine and imaging ,Popliteal Artery ,030212 general & internal medicine ,Prospective Studies ,Vascular Patency ,Aged ,Aged, 80 and over ,Framingham Risk Score ,business.industry ,Angioplasty ,Endovascular Procedures ,medicine.disease ,Femoral Artery ,Stenosis ,Treatment Outcome ,Risk stratification ,Surgery ,Female ,Stents ,Radiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
PurposeTo present a novel angiographic scoring system that stratifies the risk of restenosis after endovascular therapy (EVT) to inform the decision to use paclitaxel-eluting devices in the femoropopliteal segment.Materials and MethodsA prospective, multicenter registry including 1799 limbs of 1578 patients (mean age 74±9 years; 1090 men) with symptomatic peripheral artery disease undergoing intravascular ultrasound–supported femoropopliteal EVT was used as the basis for developing the angiographic score. Multivariable analysis identified baseline patient and limb characteristics associated with restenosis at 12 months. These risk factors for 12-month restenosis were explored using a generalized linear mixed model with a logit-link function in which the inter-institutional and inter-subject variability were treated as random effects. The multiple imputation method was adopted to address missing data. Results of the regression analysis are presented as the odds ratio (OR) with 95% confidence interval (CI).ResultsTwelve-month primary patency was estimated to be 65.1% (95% CI 62.7% to 67.5%). After multivariable analysis, distal reference vessel diameter per 1 mm (OR 0.71, 95% CI 0.62 to 0.81, pConclusionThe current study demonstrated a novel angiographic score for 12-month restenosis after femoropopliteal EVT in a real-world clinical practice. The developed score was significantly and independently associated with the 12-month restenosis risk, but the TASC class was not.
- Published
- 2020
38. Usefulness of ultrasound-guided intraluminal approach for long occlusive femoropopliteal lesion
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Norihiro Kobayashi, Yohsuke Honda, Keisuke Hirano, Masahiro Yamawaki, Kenji Makino, Yasunari Sakamoto, Shinsuke Mori, Yoshiaki Ito, Shigemitsu Shirai, and Masakazu Tsutsumi
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Arterial Occlusive Diseases ,030204 cardiovascular system & hematology ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Restenosis ,Intravascular ultrasound ,medicine ,Humans ,Popliteal Artery ,030212 general & internal medicine ,Ultrasonography, Interventional ,Vascular Patency ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Hazard ratio ,Endovascular Procedures ,Vascular surgery ,medicine.disease ,Confidence interval ,Cardiac surgery ,Femoral Artery ,Treatment Outcome ,Surgery, Computer-Assisted ,Female ,Radiology ,Hemodialysis ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67–0.98, p = 0.0339] and lesion length (HR 1.11; CI 1.00–1.22; p = 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.
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- 2020
39. Use of the orbital atherectomy system backed up with the guide-extension catheter for a severely tortuous calcified coronary lesion
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Naohiko Sahara, Takahide Nakano, Masahiro Nauchi, Masahiro Yamawaki, Keisuke Hirano, Masafumi Mizusawa, Yuta Sugizaki, Yuki Kozai, Yasunari Sakamoto, Shinsuke Mori, Tsuyoshi Sakai, Shigemitsu Shirai, Tomoya Fukagawa, Masakazu Tsutsumi, Norihiro Kobayashi, Yoshiaki Ito, Motoharu Araki, Yohsuke Honda, Yusuke Setonaga, Kenji Makino, Shutaro Goda, and Toshihiko Kishida
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Case Report ,030204 cardiovascular system & hematology ,Rotational atherectomy ,Total occlusion ,Orbital atherectomy ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Orbital atherectomy system ,medicine.artery ,Intravascular ultrasound ,medicine ,severe tortuous calcified lesion ,rotational atherectomy ,lcsh:R5-920 ,medicine.diagnostic_test ,business.industry ,Percutaneous coronary intervention ,General Medicine ,guide-extension catheter ,Catheter ,030220 oncology & carcinogenesis ,Right coronary artery ,Radiology ,medicine.symptom ,lcsh:Medicine (General) ,business - Abstract
A 68-year-old man was scheduled to undergo percutaneous coronary intervention for in-stent total occlusion of the severely tortuous right coronary artery. Intravascular ultrasound revealed heavy in-stent calcification. Lesion atherectomy was required; however, severe proximal vessel tortuosity was detected. We introduced a 7-Fr guide-extension catheter beyond the severely tortuous part and performed rotational atherectomy with a 1.5 mm burr. However, the balloon could not expand; therefore, we changed to an orbital atherectomy system. Subsequently, the balloon successfully expanded, and intravascular ultrasound revealed an enlarged lumen. Severe proximal vessel tortuosity limits the use of atherectomy devices; however, a guide-extension catheter delivers the atherectomy device beyond the tortuosity. The delivery of the orbital atherectomy system inside the guide-extension catheter is easy due to its low profile; the debulking effect increases with the number of passes and rotational speed. This strategy is a useful option for treating severe calcified lesions with proximal vessel tortuosity.
- Published
- 2020
40. Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging
- Author
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Yoshiaki Ito, Kenji Makino, Shinsuke Mori, Motoharu Araki, Tomoya Fukagawa, Yusuke Setonaga, Norihiro Kobayashi, Takahide Nakano, Tsuyoshi Sakai, Keisuke Hirano, Yuki Kozai, Yuta Sugizaki, Masakazu Tsutsumi, Masahiro Yamawaki, Naohiko Sahara, Shigemitsu Shirai, Yohsuke Honda, Masafumi Mizusawa, Masahiro Nauchi, Toshihiko Kishida, Shutaro Goda, and Yasunari Sakamoto
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Case Report ,030204 cardiovascular system & hematology ,Balloon ,Endovascular therapy ,03 medical and health sciences ,0302 clinical medicine ,Angioplasty ,Medicine ,Paclitaxel coated balloon ,superficial femoral artery disease ,lcsh:R5-920 ,optical coherence tomography ,optical frequency domain imaging ,business.industry ,Superficial femoral artery ,General Medicine ,medicine.disease ,Stenosis ,Paclitaxel-coated balloon ,030220 oncology & carcinogenesis ,Radiology ,medicine.symptom ,business ,Claudication ,lcsh:Medicine (General) ,Intravascular imaging - Abstract
A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease.
- Published
- 2020
41. Asymptotic analysis of statistical decision rules in econometrics
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Keisuke Hirano and Jack Porter
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Asymptotic analysis ,Point (typography) ,Computer science ,Covariate ,Econometrics ,Common value auction ,Inference ,Estimator ,Decision rule ,Heuristics - Abstract
Statistical decision rules map data into actions. Point estimators, inference procedures, and forecasting methods can be viewed as statistical decision rules. However, other types of rules are possible, such as rules for assigning individuals to treatments based on covariates, and methods for designing auctions. We discuss heuristics for constructing statistical decision rules, and survey results that characterize the properties of various classes of decision rules. Particular attention is paid to developing large-sample approximations to the distributions and associated risk properties of statistical decision rules.
- Published
- 2020
42. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial
- Author
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William A Gray, Koen Keirse, Yoshimitsu Soga, Andrew Benko, Anvar Babaev, Yoshiaki Yokoi, Henrik Schroeder, Jeffery T Prem, Andrew Holden, Jeffrey Popma, Michael R Jaff, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, Thomas Albrecht, Kenji Ando, Michael J Bacharach, William Bachinsky, Danielle Bajakian, Robert Beasley, James Benenati, Mark Burket, Joseph Cardenas, Tony Das, Randall De Martino, Hannes Deutschmann, Daniel Dulas, Robert Feldman, Mark Fugate, Lawrence Garcia, Jaafer Golzar, Rao Gutta, Patrick Hall, Stewart Hawkins, Steve Henao, Benjamin Herdrich, Keisuke Hirano, Safwan Jaalouk, Sean Janzer, Daizo Kawasaki, Yazan Khatib, Kimihiko Kichikawa, Ethan Korngold, Christian Loewe, Louis Lopez, Henry Lui, Toshiaki Mano, Robert Mendes, Akira Miyamoto, Masato Nakamura, David O'Connor, Takao Ohki, James Park, Richard Powell, Antonis Pratsos, Jeffery Prem, Vikram Rao, John Rashid, Robert Rhee, Jason Ricci, Dierk Scheinert, Herman Schroë, Peter O Simon, Gagan Singh, Kongteng Tan, Paul Tolerico, Thodur Vasudevan, Frank Vermassen, Martin Werner, Bret Wiechmann, Hiroyoshi Yokoi, and Thomas Zeller
- Subjects
Target lesion ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Stent ,General Medicine ,030204 cardiovascular system & hematology ,Popliteal artery ,Surgery ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Femoropopliteal Artery Segment ,Randomized controlled trial ,law ,medicine.artery ,medicine ,Vascular Patency ,030212 general & internal medicine ,medicine.symptom ,Adverse effect ,Claudication ,business - Abstract
Summary Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov , number NCT02574481 . Findings Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI −0·66]; p Interpretation The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding Boston Scientific.
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- 2018
43. Optical coherence tomography-guided versus intravascular ultrasound-guided rotational atherectomy in patients with calcified coronary lesions
- Author
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Motoharu Araki, Kenji Makino, Yohsuke Honda, Keisuke Hirano, Norihiro Kobayashi, Yoshiaki Ito, Yasunari Sakamoto, Masahiro Yamawaki, Shinsuke Mori, Masafumi Mizusawa, Masaru Obokata, Shigemitsu Shirai, and Masakazu Tsutsumi
- Subjects
Atherectomy, Coronary ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Rotational atherectomy ,Balloon ,Coronary Angiography ,Atherectomy ,03 medical and health sciences ,0302 clinical medicine ,Optical coherence tomography ,Angioplasty ,Intravascular ultrasound ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Vascular Calcification ,Ultrasonography, Interventional ,medicine.diagnostic_test ,business.industry ,Stent ,Coronary Vessels ,Treatment Outcome ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine ,Tomography, Optical Coherence - Abstract
AIMS We aimed to evaluate whether optical coherence tomography (OCT)-guided rotational atherectomy (RA) improves stent expansion and clinical outcomes compared to intravascular ultrasound (IVUS)-guided RA. METHODS AND RESULTS From our database, we identified 247 de novo calcified coronary lesions that underwent RA between September 2013 and December 2017. Of these, lesions with no intravascular imaging data (n=11), poor image quality (n=7), balloon angioplasty alone (n=16), and complications (two burr entrapments, two perforations) were excluded. Finally, 88 and 121 lesions that underwent OCT-guided and IVUS-guided RA, respectively, were included in the study. The primary endpoint of the present study was percent stent expansion. Burr upsizing was more frequently performed (55% vs 32%, p=0.001) and the final burr size was significantly larger (1.75 [1.50-1.75] vs 1.50 [1.50-1.75] mm, p
- Published
- 2019
44. Additional debulking efficacy of low-speed rotational atherectomy after high-speed rotational atherectomy for calcified coronary lesion
- Author
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Tomoya Fukagawa, Yohsuke Honda, Masahiro Yamawaki, Keisuke Hirano, Naohiko Sahara, Motoharu Araki, Kenji Makino, Tsuyoshi Sakai, Shinsuke Mori, Yoshiaki Ito, Norihiro Kobayashi, Takahide Nakano, Yusuke Setonaga, Masahiro Nauchi, Toshihiko Kishida, Shutaro Goda, Yasunari Sakamoto, Yuki Kozai, Masafumi Mizusawa, Shigemitsu Shirai, Masakazu Tsutsumi, and Yuta Sugizaki
- Subjects
Atherectomy, Coronary ,Male ,Time Factors ,Lumen (anatomy) ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Rotational atherectomy ,Coronary Angiography ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Optical coherence tomography ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Angioplasty, Balloon, Coronary ,High speed rotational atherectomy ,Vascular Calcification ,Cardiac imaging ,Aged ,Retrospective Studies ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Middle Aged ,Low speed rotational atherectomy ,Debulking ,Treatment Outcome ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine ,Tomography, Optical Coherence - Abstract
We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10 years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000 rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000 rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5–1.75) and 1.75 (1.5–2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47 s, and 4000 (3000–5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11 s, and 1000 (0–2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.
- Published
- 2019
45. Utility of indigo carmine angiography in patients with critical limb ischemia: Prospective multi-center intervention study (DIESEL-study)
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Yoshinori Tsubakimoto, Mitsuyoshi Takahara, Akihiro Higashimori, Masashi Fukunaga, Hideyuki Takimura, Daizo Kawasaki, Keisuke Hirano, Shinsuke Mori, Yoshiaki Yokoi, Tatsuya Nakama, and Makoto Utsunomiya
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Critical Illness ,Perfusion Imaging ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Indigo Carmine ,Peripheral Arterial Disease ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Japan ,Ischemia ,Predictive Value of Tests ,Angioplasty ,medicine.artery ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Coloring Agents ,Aged ,Aged, 80 and over ,Wound Healing ,medicine.diagnostic_test ,Foot ,business.industry ,Endovascular Procedures ,Angiography ,General Medicine ,Critical limb ischemia ,Popliteal artery ,Surgery ,Catheter ,Treatment Outcome ,Indigo carmine ,chemistry ,Regional Blood Flow ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Wound healing ,Perfusion - Abstract
Objectives To assess the efficacy of indigo carmine angiography for wound healing after successful below-the-knee intervention in patients with critical limb ischemia (CLI). Methods A multi-center prospective intervention study was conducted. Fifty-four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine. Results The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography-related complications were not seen. Conclusion Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.
- Published
- 2018
46. Impact of infection severity on clinical outcomes in critical limb ischemia with tissue loss after endovascular treatment
- Author
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Norihiro Kobayashi, Kenji Makino, Motoharu Araki, Yasunari Sakamoto, Keisuke Hirano, Mori Shinsuke, Yoshiaki Ito, and Masahiro Yamawaki
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Ischemia ,030204 cardiovascular system & hematology ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Surgical Wound Infection ,030212 general & internal medicine ,Aged ,Retrospective Studies ,Wound Healing ,business.industry ,Endovascular Procedures ,Critical limb ischemia ,Vascular surgery ,Limb Salvage ,Prognosis ,medicine.disease ,Cardiac surgery ,Surgery ,Systemic inflammatory response syndrome ,Log-rank test ,Lower Extremity ,Amputation ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Wound healing ,business ,Follow-Up Studies - Abstract
Critical limb ischemia with infected wounds is known to have a poor prognosis and evaluation of infection severity using the Wound, Ischemia, and foot Infection classification system has been recommended. However, little is known about how infection severity influences the clinical outcomes of critical limb ischemia in patients with tissue loss. We investigated the impact of infection severity on the clinical outcomes in critical limb ischemia with tissue loss after endovascular treatment. In April 2007–August 2014, we enrolled 263 patients (328 limbs) who received endovascular treatment for critical limb ischemia with tissue loss. In the limbs examined, 369 individual wounds existed. We evaluated wound infection using the Infectious Disease Society of America (IDSA) classification. We also investigated wound healing rates at 12 months and limb salvage and major amputation-free survival rates at 2 years after endovascular treatment. Wound healing rates at 12 months for class 0, 1, 2, and 3 were 89, 81, 58, and 33%, respectively (log rank P
- Published
- 2018
47. The Impact of Decline in Activities of Daily Living (ADL) of Patients With Critical Limb Ischemia (CLI) After Endovascular Treatment
- Author
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Motoharu Araki, Yosuke Honda, Yoshiaki Ito, Masahiro Yamawaki, Masakazu Tsutsumi, Norihiro Kobayashi, Keisuke Hirano, Shisuke Mori, Yasunari Sakamoto, and Takahiro Tokuda
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Activities of daily living ,Multivariate analysis ,Critical Illness ,Health Status ,Ischemia ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Amputation, Surgical ,Disease-Free Survival ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Activities of Daily Living ,Odds Ratio ,Humans ,Medicine ,Cumulative incidence ,030212 general & internal medicine ,Endovascular treatment ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Aged, 80 and over ,Peripheral Vascular Diseases ,Wound Healing ,Chi-Square Distribution ,business.industry ,Endovascular Procedures ,General Medicine ,Odds ratio ,Critical limb ischemia ,Middle Aged ,medicine.disease ,Confidence interval ,Hospitalization ,Treatment Outcome ,Lower Extremity ,Multivariate Analysis ,Female ,Surgery ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Certain patients with critical limb ischemia (CLI) experience significant decline in activities of daily living (ADL) during hospitalization. The prognosis of decline in ADL during hospitalization remains unknown. Methods: A retrospective analysis was performed on collected data of patients with CLI treated by endovascular treatment between April 2007 and December 2015. We evaluated CLI in patients ADL at the time of hospitalization and after discharge using the Barthel index. We classified all patients into patients with decline in ADL and stable in ADL and compared clinical outcomes (cumulative incidence of wound healing, amputation-free survival at 1 year) between the 2 groups. Results: Two hundred and fifty-five consecutive patients with CLI (221 limbs), who underwent successful endovascular intervention, were enrolled in this study. Of all patients, 22 patients were classified into the decline group. The prevalence of wound, Ischemia, foot infection (WIfI) classification high grade was higher in the decline group (30.7% vs 63.6%; P < .01). The wound healing rates were worse in the decline group than in the stable group (40% vs 78% at 1 year; P < .01). The same trends were observed in the amputation-free survival (37% vs 78%; P < .01). After multivariate analysis, decline in ADL was an independent predictor of wound healing and amputation-free survival (odds ratio [OR]: 2.85, 95% confidence interval [CI]: 1.61-3.35, P < .01; OR: 2.46, 95% CI: 1.26-4.53, P = .01). Conclusions: Patients with CLI with decline in ADL during hospitalization were found to have a poor prognosis suggesting that a decline in ADL may affect the clinical outcomes.
- Published
- 2018
48. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease
- Author
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Motoharu Araki, Yohsuke Honda, Yoshiaki Ito, Shinsuke Mori, Tsuyoshi Sakai, Norihiro Kobayashi, Yasunari Sakamoto, Masakazu Tsutsumi, Keisuke Hirano, and Masahiro Yamawaki
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Databases, Factual ,medicine.medical_treatment ,Lumen (anatomy) ,Kaplan-Meier Estimate ,Dissection (medical) ,030204 cardiovascular system & hematology ,Balloon ,Severity of Illness Index ,Lesion ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Restenosis ,Predictive Value of Tests ,Recurrence ,Risk Factors ,Angioplasty ,medicine ,Humans ,Popliteal Artery ,030212 general & internal medicine ,Vascular Patency ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Aged, 80 and over ,Chi-Square Distribution ,business.industry ,Hazard ratio ,Angiography ,Middle Aged ,Vascular System Injuries ,medicine.disease ,Confidence interval ,Femoral Artery ,Aortic Dissection ,Treatment Outcome ,Multivariate Analysis ,Female ,Stents ,Surgery ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Angioplasty, Balloon - Abstract
Objective Angiographic dissection is considered to be associated with restenosis. However, little is known about the impact of the severity of angiographic dissection on future restenosis. Methods A total of 319 consecutive de novo femoropopliteal lesions were treated by balloon angioplasty alone. All of these lesions were divided into three groups: group A, no angiographic dissection; group B, mild dissection, the width of the dissection was less than one-third of the lumen; and group C, severe dissection, the width of the dissection was more than one-third of the lumen. Kaplan-Meier analysis estimated the primary patency rate at 3 years between the groups. Results The primary patency rates at 3 years were 66.0% in group A, 63.8% in group B, and 32.5% in group C (log-rank, P 100 mm (hazard ratio, 1.734; 95% confidence interval, 1.099-2.735; P = .018) and severe angiographic dissection (hazard ratio, 1.956; 95% confidence interval, 1.276-2.997; P = .002) were predictors of primary patency loss at 3 years. When the lesions were divided into two groups according to the lesion length >100 mm or not, angiographic dissection had a larger impact on restenosis in a long lesion >100 mm (≤100 mm: 65.5% in group A, 75.6% in group B, and 48.0% in group C [log-rank, P = .015]; >100 mm: 68.8% in group A, 42.5% in group B, and 24.2% in group C [log-rank, P = .017]). Conclusions Severe angiographic dissection was associated with future restenosis after balloon angioplasty for femoropopliteal lesions, but mild angiographic dissection was not. Angiographic dissection had more impact on future restenosis particularly in treated long lesions. Stents might not be necessary in short lesions with mild dissection.
- Published
- 2018
49. Novel Type of Nanoparticle Cross-linked Silicone Polymer Film
- Author
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Hidehiro Kamiya, Motoyuki Iijima, and Keisuke Hirano
- Subjects
Fluid Flow and Transfer Processes ,Materials science ,Chemical engineering ,Process Chemistry and Technology ,Nanoparticle ,Filtration and Separation ,Silicone polymer ,Catalysis - Published
- 2018
50. Identification of time and risk preferences in buy price auctions
- Author
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Daniel A. Ackerberg, Keisuke Hirano, and Quazi Shahriar
- Subjects
TheoryofComputation_MISCELLANEOUS ,Economics and Econometrics ,Risk aversion ,05 social sciences ,TheoryofComputation_GENERAL ,Bidding ,Microeconomics ,symbols.namesake ,Reservation price ,Ask price ,Nash equilibrium ,0502 economics and business ,symbols ,Economics ,Revenue ,Common value auction ,050207 economics ,050205 econometrics ,Valuation (finance) - Abstract
Buy price auctions merge a posted price option with a standard bidding mechanisms, and have been used by various online auction sites including eBay and General Motors Assistance Corporation. A buyer in a buy price auction can accept the buy price to win with certainty and end the auction early. Intuitively, the buy price option may appeal to bidders who are risk averse or impatient to obtain the good, and a number of authors have examined how such mechanisms can increase the seller's expected revenue over standard auctions. We show that data from buy price auctions can be used to identify bidders' risk aversion and time preferences. We develop a private value model of bidder behavior in a buy price auction with a temporary buy price. Bidders arrive stochastically over time, and the auction proceeds as a second‐price sealed bid auction after the buy price disappears. Upon arrival, a bidder in our model is allowed to act immediately (i.e., accept the buy price if it is still available or place a bid) or wait and act later. Allowing for general forms of risk aversion and impatience, we first characterize equilibria in cutoff strategies and describe conditions under which all symmetric pure‐strategy subgame‐perfect Bayesian Nash equilibria are in cutoff strategies. Given sufficient exogenous variation in auction characteristics such as reserve and buy prices and in auction lengths, we then show that the arrival rate, valuation distribution, utility function, and time‐discounting function in our model are all nonparametrically identified. We also develop extensions of the identification results for cases where the variation in auction characteristics is more limited. Nonparametric identification auctions risk aversion time preferences C14 C57 D44 L81
- Published
- 2017
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