Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial.

Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (-6.6 mmHg) and sham control (-6.5 mmHg) groups (difference: -0.1, 95% confidence interval -5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: -1.8 mmHg [p = 0.488] and -2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. CLINICAL TRIAL REGISTRATION: NCT02918305 ( http://www.clinicaltrials.gov ).

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions.

PURPOSE: Drug-coated balloons (DCBs) are commonly used for endovascular treatment of femoropopliteal lesions. Here, we employed intravascular ultrasound (IVUS) to investigate the predictors of restenosis after DCB treatment. METHODS: This retrospective and single-center study was performed to examine 1-year primary patency after DCB treatment and to identify the risk factors for restenosis by analyzing clinical characteristics, angiographic findings, and IVUS measurements. We included 111 consecutive patients undergoing DCB treatment for de novo femoropopliteal lesions at our hospital from July 2018 to March 2020. RESULTS: The primary patency rate was found to be 80.0% at 1 year. The Cox proportional hazard multivariate analysis revealed that restenosis was independently associated with chronic total occlusion (CTO; p < 0.001), circumferential calcification (p = 0.023), and smaller postprocedural minimum lumen area (MLA; p = 0.036). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of postprocedural MLA to prevent restenosis was 12.7 mm2, with an area under the curve of 0.774 (p< 0.001). The multivariate analysis indicated that patients with a postprocedural MLA below 12.7 mm2 (n = 44) had a significantly smaller distal reference vessel size (p < 0.001) compared to those with a postprocedural MLA over 12.7 mm2 (n = 67). CONCLUSIONS: Restenosis after DCB treatment was shown to correlate with CTO, circumferential calcification, and postprocedural MLA as evaluated by IVUS. Moreover, smaller vessel sizes might represent a particular challenge to the DCB strategy due to the difficulty of restoring a sufficient postprocedural lumen area by balloon dilatation.

Role of Cardiac Magnetic Resonance (CMR) in Determining Implantable Cardioverter-Defibrillator (ICD) Indication in Acromegalic Cardiomyopathy: A Case Report.

Potentially fatal arrhythmia is one of the causes of premature death in acromegalic cardiomyopathy patients who are not properly treated. Implantable cardioverter-defibrillator (ICD) is one of the most effective and established treatments to prevent sudden cardiac death due to potentially fatal tachyarrhythmia. However, since the indication of ICD changes depending on whether it is ischemic cardiomyopathy or non-ischemic cardiomyopathy, proper diagnosis is important in patients with these diseases. Cardiac magnetic resonance (CMR) is a convenient and useful tool for diagnosing these. Both potentially fatal arrhythmias and coronary artery disease (CAD) are known to be important complications of acromegaly. Herein, we present a case of potentially fatal tachyarrhythmia due to acromegalic cardiomyopathy with the acute coronary syndrome. Furthermore, we mention the usefulness of CMR in the case which is difficult to determine the indication for an ICD.

Ecological, physiological, and biomechanical differences between gametophytes and sporophytes of Chondrus ocellatus (Gigartinales, Rhodophyta)1.

Although variation among habitats in the ratio of gametophytes to sporophytes has been reported in various gigartinacean species, factors controlling the phase ratio remain poorly understood. Over 18 months, we examined the phase ratio of Chondrus ocellatus at three sites: a sheltered intertidal site, Hiruga A; an exposed intertidal site, Hiruga B; and a subtidal site, Shikimi. The mean proportion of gametophytes at Hiruga A (73.1%) was significantly higher than that at Shikimi (51.2%) and Hiruga B (44.7%). Due to a significantly higher water retention ability of the gametophytes, it was expected that the gametophytes would exhibit higher desiccation tolerance. After dehydration treatments, however, neither the photosynthetic rate of vegetative blades nor the survival rate of spores was significantly different between the phases. Measurements of blade strength indicated that the sporophytic blades were less stiff and more flexible, and a culture experiment revealed that the sporophytic germlings showed a significantly higher growth rate. Flexible blades and fast-growing germlings are considered advantageous for colonizing wave-swept intertidal habitats, so these properties may have caused the different fluctuation pattern of phase ratio among the sites. The present data demonstrate that biomechanical and physiological differences between the two phases of C. ocellatus make one phase advantageous in certain environmental conditions, and that these differences likely cause an unequal ratio of isomorphic phases.

Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions.

BACKGROUND: The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. METHODS: After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. RESULTS: The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57-16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21-12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06-0.41; p < 0.001). CONCLUSIONS: At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. EVIDENCE-BASED MEDICINE: Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.

Genetic engineering of eggplant accumulating ß-carotene in fruit.

KEY MESSAGE: Genetic engineering of eggplant using fruit-specific EEF48 promoter-driven bacterial PSY gene, crtB, confers ß-carotene accumulation in fruit. Eggplant (Solanum melongena L.) is globally cultivated especially in Asia and is an important source of nutrients in the diets of low-income consumers in developing countries. Since fruits of eggplant have low provitamin A carotenoid content, it is expected to develop eggplant with high carotenoid content for combatting vitamin A deficiency. To achieve this, the present study implemented a metabolic engineering strategy to modify the carotenoid biosynthetic pathway in eggplant. Expression analysis of carotenogenic genes in eggplant tissues showed that the expression of the endogenous phytoene synthase (PSY) was low in fruit and callus. Orange-colored calluses were generated from ectopic expression of crtB gene, which encodes bacterial PSY, in eggplant cells. The orange calluses accumulated > 20 µg g-1 FW of ß-carotene, which was approximately 150-fold higher than that of the untransformed calluses. These observations suggest that the PSY expression is the rate-limiting step for ß-carotene production in callus and fruit. Since the orange calluses did not regenerate plants, we chose eggplant EEF48 gene, which is presumably expressed in fruit. We amplified its promoter region by TAIL-PCR and showed that the EEF48 promoter is indeed active in eggplant fruit. Subsequently, transgenic eggplant lines having EEF48 promoter-driven crtB were produced. Among the transgenic lines produced, one line set fruit containing 1.50 µg g-1 FW of ß-carotene, which was 30-fold higher than that of the untransformed fruits (0.05 µg g-1 FW). The self-pollinated progenies showed a 3:1 segregation ratio for the presence and absence of the transgene, which was linked to the ß-carotene accumulation in fruit. These results provide a strategy for improvement of carotenoid content in eggplant fruit.

Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions.

Purpose: To investigate the efficacy of scoring balloons for immediate success of percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions. Materials and Methods: Between 2013 and 2019, 398 consecutive patients with de novo femoropopliteal lesions were treated using PTA in our hospital. The procedure success rate was compared among patients undergoing PTA with vs without scoring balloons after 1:1 propensity score matching on hemodialysis, TransAtlantic Inter-Society Consensus II classification, Peripheral Arterial Calcium Scoring System (PACSS) grade, lesion length, and use of intravascular ultrasound. Propensity matching produced 84 patients (mean age 73.4±8.3; 65 men) treated with scoring balloons and 84 patients (mean age 75.6±8.7; 56 men) treated with plain balloons. Kaplan-Meier analysis investigated patency after the procedure in both groups; estimates are given with the 95% confidence interval (CI). Results: Residual stenosis <30% was achieved more often (77.4% vs 57.1%, p=0.005) and severe arterial dissection occurred less frequently (16.7% vs 29.8%, p=0.043) in the scoring balloon group vs the plain balloon group, respectively. The rate of provisional stenting was significantly lower after scoring balloon use (13.3% vs 29.8%, p=0.008). Multivariable analysis revealed that use of scoring balloons (p<0.001) and prolonged inflation time (p<0.001) were independent predictors of successful angioplasty, whereas chronic total occlusion (p=0.005) and longer lesion length (p=0.005) were predictors of an unsuccessful procedure. Among 108 patients with PACSS 0-3 lesions in the matched population, Kaplan-Meier analysis showed better primary patency at 18 months in the scoring balloon group in the intention to treat analysis [68.6% (95% CI 53.5% to 80.6%) vs 43.0% (95% CI 28.7% to 58.5%), p=0.044]. Conclusion: Scoring balloons may be effective in restoring acute lumen gain and preventing severe arterial dissection in femoropopliteal lesions. Moreover, scoring balloons might be associated with better primary patency at 18 months in PACSS 0-3 lesions.

A prospective interventional registry of short-term dual-antiplatelet treatment after implantation of drug-eluting stents in patients with atrial fibrillation requiring oral anticoagulation therapy.

There are limited data regarding the use of antithrombotic therapy in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES). In this prospective interventional study, we evaluated the feasibility of short-term dual-antiplatelet therapy (DAPT) after DES implantation in AF patients treated with oral anticoagulation (OAC). The antithrombotic regimen in the present study was 1-month DAPT, followed by single-antiplatelet therapy with OAC. A total of 285 consecutive patients were enrolled between 2015 and 2017. The mean CHA2DS2-VASc score was 3.91 ± 1.51. The duration of DAPT was 28.5 ± 11.5 days. At 1-year follow-up, serious bleeding complications, defined as Bleeding Academic Research Consortium type ≥ 2, were observed in 27 patients (9.5%). Multivariate analysis showed that previous history of bleeding episodes (P = 0.009) and continuation of aspirin (P = 0.003) were independent predictors for the serious bleeding complications. High ORBIT (P = 0.008) and PRECISE-DAPT (P = 0.002) scores were associated with the bleeding complications, and the cut-off values were 5.00 and 49.0, respectively. No definite stent thrombosis occurred in any of the patients. Short-term DAPT is feasible in AF patients treated with OAC after undergoing PCI with DES. The previous history of bleeding episodes and long-term aspirin use were associated with their 1-year serious bleeding events.

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

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

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.

PURPOSE: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. RESULTS: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. CONCLUSION: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

RenalGuard system to prevent contrast-induced acute kidney injury in Japanese patients with renal dysfunction; RESPECT KIDNEY study.

Increasing the urine flow rate (UFR) reduces the toxic effect of contrast media. Use of the RenalGuard system enables the achievement of a high UFR by maintaining intravascular volume and prevents the development of contrast-induced acute kidney injury (CI-AKI). However, the efficacy and safety of RenalGuard system have not yet been evaluated in Japan. This multicenter prospective study evaluated the efficacy and safety of the RenalGuard therapy in preventing CI-AKI development in 60 Japanese patients with renal dysfunction [estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2] undergoing catheter procedures. Baseline eGFR and Mehran's CIN (contrast-induced nephropathy) risk score were 35.1 ± 8.5 mL/min/1.73 m2 and 11.7 ± 4.3, respectively. Regardless of this high-risk profile, the incidence of CI-AKI was 8.6% (5/58) compared with the 26.1% incidence estimated by the CIN risk score. Moreover, two-sided 95% (Fisher's) exact confidence interval was 2.9-19.0 and its upper limit (i.e., 19.0) was less than the prespecified threshold incidence of 25.0. Univariate logistic regression analysis demonstrated that the UFR during catheter procedure was one of the most important factor associated with CI-AKI (odds ratio 0.99, confidence interval 0.98-1.00, p = 0.03). In conclusion, RenalGuard therapy may prevent CI-AKI development in Japanese patients with renal dysfunction. Further large-scale prospective multicenter studies are necessary to confirm our findings.

Endovascular treatment of ureteroarterial fistula using a covered stent, evaluated by intravascular ultrasound: a case report.

BACKGROUND: Ureteroarterial fistula is a rare life-threatening complication of indwelling ureteral stents. The mechanism has not yet been fully evaluated using intravascular imaging. CASE PRESENTATION: An-84-year-old female was referred to our unit because of large volume pulsatile bleeding from the left ureter during routine stent exchange in the urology department. The hematuria was initially managed by rapidly exchanging for a new stent; however, the patient went into hypovolemic shock due to acute blood loss. The patient underwent implantation of the bilateral ureteral stents due to urinary retention caused by retroperitoneal fibrosis 2 years ago. To prevent ureteral infection, occlusion of the stents and stone formation, the stents were exchanged every 6 months. Computed tomography revealed contact between the left ureter and the common iliac artery. Therefore, ureteroarterial fistula was suspected and endovascular therapy was performed. Although angiography did not show definite blood flow into the ureter, a soft guidewire was advanced from the subintima of the external iliac artery to the left ureter. The diagnosis of ureteroarterial fistula was confirmed. Intravascular ultrasound identified the stent in the ureter and its connection to the subintima of the external iliac artery. The ureter did not contact directly to the inner lumen of the iliac arteries according to the ultrasound findings; therefore, we considered that the risk of stent-graft infection might not be high. After coil embolization of the ipsilateral internal iliac artery, a covered stent was implanted in the external iliac artery to seal the subintimal entry. The patient had no further episodes of any gross hematuria on dual anti-platelet therapy, when the ureteral stent was exchanged three time during 1 year after the endovascular therapy. CONCLUSIONS: We demonstrated a case of ureteroarterial fistula, in which intravascular ultrasound allowed to visualize the communication between the ureter and the subintimal lumen in the external iliac artery.

Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions.

PURPOSE: To investigate if balloon angioplasty with a prolonged inflation time (>3 minutes) can prevent postdilation dissection in femoropopliteal lesions. METHODS: A retrospective single-center analysis examined 294 consecutive patients (mean age 74.1±8.7 years; 215 men) with de novo femoropopliteal lesions treated with balloon angioplasty between 2013 and 2018. The patients were classified into 2 groups to compare angiographic dissection patterns: 175 patients treated with balloon angioplasty for 3 minutes (3-minute group) and 119 treated for >3 minutes (>3-minute group). RESULTS: Mean balloon inflation time was 7.8±2.7 minutes in the >3-minute group. Severe dissections (type C or higher) were observed less frequently after balloon dilation in the >3-minute group (22.7% vs 50.9%, p<0.001); therefore, significantly more patients in the >3-minute group had successful endovascular treatment after initial balloon angioplasty (57.1% vs 38.3%, p=0.001). Additional balloon dilation was attempted more frequently in the 3-minute group (30.9% vs 14.3%, p=0.001); as a result, there were more patients in whom additional balloon dilation repaired severe dissection that occurred after the initial dilation (25.1% vs 10.9%, p=0.001). Multivariate analysis revealed that chronic total occlusion (p<0.001) and longer lesion (p<0.001) were independent predictors of severe dissection, and prolonged dilation time was independently related to preventing severe dissection (p<0.001). Among 171 patients undergoing successful balloon angioplasty without stent implantation, the Kaplan-Meier estimates of primary patency within 1 year did not differ significantly according to inflation time. CONCLUSION: Balloon dilation with prolonged inflation time (>3 minutes) may be effective as an initial strategy to prevent severe dissection in femoropopliteal lesions compared to inflation for 3 minutes.

Transradial Intervention in Patients With Non-ST Elevation Acute Coronary Syndrome Using One 4.0 Fr Sheath and One Sheathless Guide Catheter Via a Single Puncture Site: The 1-1-1 Strategy.

OBJECTIVES: The optimal primary transradial intervention (TRI) technique has not been established in non-ST segment elevation acute coronary syndrome (NSTEACS) patients, because they often, but not always, undergo immediate revascularization after coronary angiography (CAG). Moreover, TRI failure has been reported in 5%-10% of cases. We investigated whether a newly designed strategy of immediate TRI using one sheathless hydrophilic-coated guiding catheter (SH-GC) after diagnostic CAG with one 4.0 Fr sheath via a single access site (the 1-1-1 strategy) could be beneficial for NSTEACS patients. METHODS: We performed immediate TRI prospectively using SH-GC in consecutive NSTEACS patients in our hospital and compared the procedural success rate with that of conventional TRI performed before this study. RESULTS: Between 2015 and 2017, immediate TRI using SH-GC was performed in 330 consecutive NSTEACS patients after CAG using a 4.0 Fr sheath. Compared with the conventional TRI group (n = 330), the procedural success rate was significantly higher in the SH-GC group (P<.01), as SH-GC prevented TRI failure due to radial spasm (P<.01). SH-GC use was also significantly associated with completion of both diagnostic CAG and immediate TRI using only one sheath (P<.001) and one guiding catheter (P=.02). Multivariate analysis revealed that SH-GC use was an independent predictor of successful TRI (P<.01). The rates of major adverse cardiac events were comparable; however, rates of major access-site bleeding (P<.01) and blood transfusion (P=.02) were significantly lower in the SH-GC group. CONCLUSIONS: The 1-1-1 strategy using SH-GC may offer better TRI treatment than conventional systems for NSTEACS patients and simultaneously prevent access-site bleeding.

Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study.

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

A randomised comparison of incidence of radial artery occlusion and symptomatic radial artery spasm associated with elective transradial coronary intervention using 6.5 Fr SheathLess Eaucath Guiding Catheter vs. 6.0 Fr Glidesheath Slender.

AIMS: The aim of this study was to compare incidences of radial artery occlusion (RAO) and spasm (RAS) associated with transradial coronary intervention (TRI) using a 6.5 Fr SheathLess hydrophilic-coated guide catheter (SH-GC) vs. a 6.0 Fr Glidesheath Slender (GSS). METHODS AND RESULTS: We conducted an open-label, single-centre, randomised study to compare radial complications in 600 consecutive patients undergoing elective TRI using 6.5 Fr SH-GC (n=300) or 6.0 Fr GSS (n=300) between 2015 and 2016. The primary endpoint was a composite of RAO evaluated by sonography and symptomatic RAS. The mean diameter of radial arteries was 2.20 mm in both groups; however, the sheath/radial artery diameter (S/RA) ratio was significantly smaller in the SH-GC group (1.03 vs. 1.17, p<0.001). SH-GC was associated with a higher rate of system crossover (1.7% vs. 0.7%, p=0.450) and coronary ostial dissection (1.0% vs. 0.3%, p=0.624), although there were no statistically significant differences. The incidence of major adverse cardiac events was comparable. A lower incidence of RAO and access-site crossover owing to RAS was significantly associated with SH-GC (0.0% vs. 2.0%, p=0.031). Multivariate analysis revealed that a larger S/RA ratio predicted RAO and RAS independently (p=0.007). CONCLUSIONS: The 6.5 Fr SH-GC offers a promising alternative to conventional TRI and is associated with fewer radial complications than the 6.0 Fr GSS.

A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease.

AIM: We investigated the efficacy and safety of using paclitaxel-coated balloon (PCB) to treat small vessel disease. METHODS AND RESULTS: In this multicenter, prospective, randomized controlled trial, one-hundred and thirty-five patients with native coronary lesions in small vessels were randomized into a PCB group and plain balloon angioplasty (POBA) group at a ratio of 2:1. There were no differences in target vessel failure (TVF) that was defined as cardiac death or target vessel-related myocardial infarction or target lesion revascularization (TLR), between the two groups (3.4 vs. 10.3%; P = 0.20), and TLR was slightly lower in the PCB group (2.3%) than that in the POBA group (10.3%) during 24 weeks follow-up. The late lumen loss (LLL) was significantly lower in the PCB group (0.01 ± 0.31 vs. 0.32 ± 0.34 mm; P < 0.01) and late lumen enlargement (LLE) was more frequently observed in the PCB group (48 vs. 15%; P < 0.01) by angiographic follow-up after 24 weeks. There were no cases of death, myocardial infarction, thrombosis and reocclusion in either group. CONCLUSIONS: This study was not able to demonstrate superiority of PCB compared with POBA.

A case of double stent implantation for left main coronary artery occlusion in transcatheter aortic valve implantation using SAPIEN XT device.

Transcatheter aortic valve implantation is an established alternative and less invasive procedure to replace heart valves in symptomatic aortic stenosis patients; however, severe, life-threatening complications still exist. Coronary artery occlusion is a primary complication. We report a case of left main coronary artery occlusion after transcatheter aortic valve replacement, which was ameliorated using a double stent implantation technique.

Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions.

BACKGROUND: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions. METHODS: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups. RESULTS: The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. CONCLUSION: The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.