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

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

Impact of neointimal tissue characterization and heterogeneity of bare-metal stents and drug-eluting stents on the time course after stent implantation evaluated by integrated backscatter intravascular ultrasound.

Pathological studies have suggested the different process of in-stent restenosis (ISR) of bare-metal stents (BMS) and drug-eluting stents (DES). Here, we evaluated the components of neointimal tissue using integrated backscatter intravascular ultrasound (IB-IVUS) and focused on the time course after stent implantation and tissue signal distribution. We evaluated 125 lesions of 125 patients who underwent target lesion revascularization for ISR (BMS: n = 73, DES: n = 52). Volume analysis of a 4-mm length centered on a minimum lumen area in every 1-mm cross-sectional area was performed. For IB-IVUS analysis, color-coded maps were constructed from the default setting based on the integrated backscatter (IB) values (middle-IB value, green: fibrous and low-IB value, blue: lipid pool). For the neointimal tissue volume, we evaluated the ratios of the green (%G) and blue (%B) areas. Tissue signal distribution (TD) was also obtained from the default setting based on IB values in each pixel of IB-IVUS imaging. We compared values of neointimal tissues measured by IB-IVUS between the DES and BMS and time course. The observed period was longer after BMS implantation than after DES implantation (BMS: 2545 days, DES: 1233 days, p < 0.001). Overall, %G and %B were similar between the BMS and DES groups (%G: 55% and 51%, respectively, p = 0.10; %B: 36% and 38%, respectively, p = 0.51); however, TD was significantly higher in the DES group than in the BMS group (1091 vs. 1367, p < 0.001). TD in the DES group remained high during the follow-up periods. However, TD in the BMS group was low in the early phase and significantly increased over time (r = 0.56, p < 0.001). When analyzing the ISR within 2 years after stent implantation, the BMS was distinguished with a sensitivity of 66% and a specificity of 90% (cut-off value: TD = 1135, area under the curve 0.83, 95% confidence interval 0.74-0.92). TD could differentiate neointimal tissue after BMS implantation in the early phase. TD can be a useful index in the observation of neoatherosclerosis.

One-Year Clinical Outcomes following Implantation of InnovaTM Self-Expanding Nitinol Stents in Patients with Peripheral Artery Diseases Presenting Femoropopliteal Artery Lesions.

AIM: Although the InnovaTM self-expanding nitinol stent (Boston Scientific, Marlborough, MA) exhibits acceptable performance in long-term safety and efficacy when used for the treatment of femoropopliteal (FP) lesions, clinical outcomes following its implantation have not been systematically studied in real-world settings. We investigated the one-year clinical outcomes after implantation of InnovaTM self-expanding nitinol stents for the treatment of FP lesions in real-world settings. METHODS: In this multicenter study, 481 lesions in 453 consecutive patients with peripheral artery disease (PAD) (74±9 years; male, 70%; diabetes mellitus, 61%; dialysis, 27%; critical limb ischemia, 37%) who underwent endovascular therapy with the implantation of InnovaTM self-expanding nitinol stents for FP lesions were analyzed from February 2016 to April 2017. The primary endpoint was one-year restenosis, whereas the secondary endpoints included one-year major adverse limb events and predictors for one-year restenosis. RESULTS: The mean lesion length was 18±10 cm. One-year restenosis and major adverse limb event rates were 36% and 18%, respectively. Multivariate analysis revealed that the presence of diabetes mellitus (odds ratio [OR]: 1.83; 95% confidence interval [CI]: 1.07-3.13), distal reference vessel diameter (OR: 1.86; 95% CI: 1.09-3.16), spot stenting (OR: 2.27; 95% CI: 1.27-4.06), and lack of one-year cilostazol treatment (OR: 0.58; 95% CI: 0.33-1.00) were independent risk factors for one-year restenosis. CONCLUSION: The current study demonstrated one-year clinical outcomes after InnovaTM self-expanding nitinol stent placement for the treatment of FP lesions, including challenging cases in real-world settings.

Motion of left atrial appendage as a determinant of thrombus formation in patients with a low CHADS2 score receiving warfarin for persistent nonvalvular atrial fibrillation.

BACKGROUND: The aim of this study was to define the independent determinants of left atrial appendage (LAA) thrombus among various echocardiographic parameters measured by Velocity Vector Imaging (VVI) in patients with nonvalvular atrial fibrillation (AF) receiving warfarin, particularly in patients with a low CHADS2 score. METHODS: LAA emptying fraction (EF) and LAA peak longitudinal strain were measured by VVI using transesophageal echocardiography in 260 consecutive patients with nonvalvular persistent AF receiving warfarin. The patients were divided into two groups according to the presence (n=43) or absence (n=217) of LAA thrombus. Moreover, the patients within each group were further divided into subgroups according to a CHADS2 score ≤1. RESULTS: Multivariate logistic regression analysis showed that LAAEF was an independent determinant of LAA thrombus in the subgroup of 140 with a low CHADS2 score. Receiver operating characteristics curve analysis showed that an LAAEF of 21% was the optimal cutoff value for predicting LAA thrombus. CONCLUSIONS: LAA thrombus formation depended on LAA contractility. AF patients with reduced LAA contractile fraction (LAAEF ≤21%) require strong anticoagulant therapy to avoid thromboembolic events regardless of a low CHADS2 score (≤1).

Effects of pitavastatin on cardiac structure and function and on prevention of atrial fibrillation in elderly hypertensive patients: a prospective study of 2-years' follow-up.

BACKGROUND: The aim of this prospective study was to determine whether statin therapy (pitavastatin) has a beneficial effect on the prevention of new-onset atrial fibrillation (AF) in elderly patients with hypertension (HTN) and to evaluate the relationships among statin treatment, the development of AF, and left atrial (LA) and ventricular (LV) structure and function. METHODS AND RESULTS: We enrolled eligible elderly patients (≥65 years old) with HTN and LV hypertrophy until the number of patients reached 110 in both groups. The 110 patients with HTN who needed statin therapy (HTN with statin group) were started on pitavastatin (1-2 mg/day), and both groups continued with appropriate medication for HTN. LV and LA structure and function were examined by conventional and speckle-tracking echocardiography at baseline and after 1 year. LA volume and function in the HTN with statin group improved more than in the HTN without statin group. There was a significant difference in survival free of new-onset AF in the patients with and without statin therapy during the 2-year follow-up (hazard ratio: 0.32, P=0.027). CONCLUSIONS: Pitavastatin had a beneficial effect on LV diastolic function and LA structure and function in elderly patients with HTN. Pitavastatin treatment may be associated with a lower incidence of new-onset AF.

Left atrial global and regional function in patients with paroxysmal atrial fibrillation has already been impaired before enlargement of left atrium: velocity vector imaging echocardiography study.

AIMS: Left atrial volume (LAV) has been proposed as a predictor of atrial fibrillation (AF) and LA function has been investigated by velocity vector imaging (VVI) echocardiography. The aim of this study was to determine whether LA function was associated with the existence of AF. METHODS AND RESULTS: We examined emptying function (EF) as a global function and strain rate (SR) as a regional function of LA function during three phases of the cardiac cycle (reservoir, conduit, and booster pump phase). The parameters were measured (apical four-chamber view) by VVI in 302 subjects [126 sinus rhythm, 91 paroxysmal AF (PAF), and 85 chronic AF]. Global and regional LA function were significantly lower in PAF patients during sinus rhythm (LA total EF: 35 ± 8%; SR at atrial contraction: -0.8 ± 0.3s(-1)) and much lower in chronic AF patients (LA total EF 22 ± 8%) than in subjects with sinus rhythm (LA total EF: 47 ± 7%; SR at atrial contraction: -1.4 ± 0.4s(-1)). In multivariate logistic regression analysis, LA active EF and SR at atrial contraction were independent features of PAF. CONCLUSION: LA function, particularly LA active relaxation and contraction, was lower in PAF patients than in subjects with sinus rhythm, regardless of LA size and age. LA functional impairment was observed regardless of hypertension before LA enlargement in patients with PAF. Reduced LA function, as assessed by VVI, is an important feature of AF as well as LA structure.

Over 10 years clinical outcomes in patients with mitral stenosis with unilateral commissural calcification treated with catheter balloon commissurotomy: single-center experience.

OBJECTIVES: Treatment of mitral valve stenosis with catheter balloon commissurotomy (CBC) yields acceptable immediate results even when one commissure shows calcification. However, the long-term outcomes in such cases remain unclear. METHODS: We examined the immediate and long-term (mean: 11+/-5 years) outcomes of 57 patients who underwent 58 CBC procedures. Patients were classified into group A (no commissural calcification, n=44) or group B (unilateral commissural calcification, n=13). From the appearance of the mitral valve just after CBC, commissurotomy was judged to be bilateral, incomplete, or excessive. End points were death, recurrence of congestive heart failure necessitating hospitalization, embolism, repeat CBC, or mitral valve replacement. RESULTS: There were significant numbers of unfavorable mitral valve morphologies evaluated according to Sellors classification, estimated by echocardiograms; Sellors class I: 20 patients in group A vs. none in group B (p<0.05). Class II: 24 in group A vs. 10 in group B. and class III: none in group A vs. 3 in group B (p<0.05). CBC increased the mitral valve area (Gorin formula) from 1.3+/-0.3 to 2.1+/-0.5 cm2 in patients in group A and from 1.1+/-0.2 to 1.8+/-0.4 cm2 in those in group B (p=n.s.). Among the latter, there were significantly more excessive commissurotomies than in group A and no bilateral commissurotomy. The overall or event-free survival rate during the follow-up of group B showed a lower tendency than in group A (overall: group A: 86.2% vs. group B: 84.6%, p, n.s. event-free: 56.8% vs. 46.2%, respectively, p=n.s.). Univariate predictors of all events in group B included post-CBC pulmonary arterial pressure, and the pattern of commissurotomy after CBC (p<0.05). Excessive commissurotomy increased clinical events some years later, after the procedure. CONCLUSIONS: In this study, involving a small number of subjects, long-term outcomes of patients with unilateral commissural calcification receiving CBC showed no significant difference as compared to those with commissural calcification absence. However, it is necessary to perform careful follow-up of CBC patients with unilateral commissural calcium.

Association of a polymorphism of ABCB1 with obesity in Japanese individuals.

The aim of the present study was to identify gene polymorphisms that confer susceptibility to obesity. A total of 5448 unrelated Japanese individuals from two independent populations were examined: subject panel A comprised 4252 individuals who visited participating hospitals; subject panel B comprised 1196 community-dwelling elderly individuals. The genotypes for 95 polymorphisms of 67 candidate genes were determined. The chi(2) test revealed that six polymorphisms were related (p<0.05) to the prevalence of obesity in subject panel A; after application of Bonferroni's correction, however, only the 2677G --> A/T polymorphism (rs2032582) of the ATP-binding cassette, subfamily B, member 1 gene (ABCB1) was significantly associated (p=0.0003) with obesity. Subsequent multivariable logistic regression analysis also revealed that the 2677G --> A/T polymorphism of ABCB1 was significantly associated with obesity. For validation of this association, the 2677G --> A/T polymorphism of ABCB1 was examined in subject panel B and again found to be significantly associated with obesity. Body mass index was significantly (p=0.01) greater for individuals with the variant T allele of this polymorphism than for those with the GG genotype in the combined subject panels A and B. Our results suggest that the ABCB1 genotype may prove informative for assessment of genetic risk for obesity in Japanese individuals.

Prospective randomized trial comparing a nitinol self-expanding coronary stent with low-pressure dilatation and a high-pressure balloon expandable bare metal stent.

The recent SCORES trial demonstrated that lower dilatation pressures seen with self-expanding (SE) stents may be associated with lower rates of target lesion revascularization (TLR). To determine whether SE stents with low-pressure dilatation are as safe and effective as balloon expandable (BE) stents. We randomly assigned 254 patients with 279 coronary lesions to groups receiving either SE with low-pressure dilatation <12 atm (n = 143) or conventional BE stents (n = 136). Thereafter, acute results and long-term outcomes were compared. Baseline patient and angiographic characteristics were similar in two groups. The incidence of procedural complications, such as slow flow, side branch occlusion, and edge dissection were significantly lower in the SE group than in the BE group (overall: SE, 17; BE, 35; P < 0.01), and the occurrence of myocardial infarction tended to be lower in SE than in BE (SE, 1; BE, 4; not significant). Although acute gain was significantly smaller with SE than BE (SE, 2.21 +/- 0.65 mm; BE, 2.42 +/- 0.62; P < 0.01), probably due to gradual expansion of the SE stent, nearly identical minimum luminal diameters on follow-up angiography (SE, 2.14 +/- 0.92 mm vs. BE, 2.22 +/- 0.93; not significant) and similar angiographic restenosis (SE, 18.1% vs. BE, 20.5%). and TLR rates (SE, 16.1% vs. BE, 14.0%) were apparent. This prospective randomized trial demonstrates that SE stents with low-pressure dilatation is safe and effective strategy for treating coronary arterial stenosis.

Prevention of no-reflow/slow-flow phenomenon during rotational atherectomy--a prospective randomized study comparing intracoronary continuous infusion of verapamil and nicorandil.

BACKGROUND: The potential exists for microcirculatory impairment during rotational coronary atherectomy (RA) due to embolization of plaque debris, platelet aggregation, or vasospasm. This prospective randomized pilot study aimed to confirm favorable effects of nicorandil during RA compared with verapamil. METHODS: We randomly assigned 200 patients with 219 coronary lesions planned to undergo RA with intracoronary infusion of nicorandil cocktail (100 patients, 109 lesions), which contained nicorandil 24 mg, nitroglycerin 5 mg, and heparin 10,000 U in 1000 mL saline, or verapamil cocktail (100 patients, 110 lesions), which contained verapamil 10 mg instead of nicorandil. Drug cocktails were infused through a 4F Teflon sheath of the rotablator system during RA. The primary end point was incidence of no-reflow/slow-flow phenomenon; secondary end points were those of continuous ST elevation, Q-wave myocardial infarction (MI), and non-Q-wave MI. RESULTS: Group baseline and coronary angiographic characteristics were similar. Rotational atherectomy was performed successfully, and no patients died or required emergency coronary artery bypass grafting. Incidence of no-reflow/slow-flow phenomenon was significantly lower in the nicorandil group (nicorandil 5/109 lesions, verapamil 13/110 lesions, P < .005). Incidences of persistent ST-segment elevation and non-Q-wave MI were significantly lower in the nicorandil group (ST-segment elevation: nicorandil 3/100 patients, verapamil 10/100 patients, P < .05; non-Q-wave MI: nicorandil 2/100, verapamil 9/100 patients, P < .05). One patient each in the 2 groups experienced Q-wave MI. CONCLUSION: Our findings suggest that continuous intracoronary infusion of nicorandil during RA prevents acute periprocedural complications. Nicorandil should be used as adjunctive treatment during RA.