Objectives The purpose of this study was to investigate the relationship between angiographic patterns of in-stent restenosis (ISR) after femoropopliteal (FP) stenting and the frequency of refractory ...ISR. Background In-stent restenosis after FP stenting is an unsolved problem. The incidence and predictors of refractory restenosis remain unclear. Methods This study was a multicenter, retrospective observational study. From September 2000 to December 2009, 133 restenotic lesions after FP artery stenting were classified by angiographic pattern: class I included focal lesions (≤50 mm in length), class II included diffuse lesions (>50 mm in length), and class III included totally occluded ISR. All patients were treated by balloon angioplasty for at least 60 s. Recurrent ISR or occlusion was defined as ISR or occlusion after target lesion revascularization. Restenosis was defined as >2.4 of the peak systolic velocity ratio by duplex scan or >50% stenosis by angiography. Results Sixty-four percent of patients were male, 67% had diabetes mellitus, and 24% underwent hemodialysis. Class I pattern was found in 29% of the limbs, class II in 38%, and class III in 33%. Mean follow-up period was 24 ± 17 months. All-cause death occurred in 14 patients; bypass surgery was performed in 11 limbs, and major amputation was performed in 1 limb during the follow-up. Kaplan-Meier survival curves showed that the rate of recurrent ISR at 2 years was 84.8% in class III patients compared with 49.9% in class I patients (p < 0.0001) and 53.3% in class II patients (p = 0.0003), and the rate of recurrent occlusion at 2 years was 64.6% in class III patients compared with 15.9% in class I patients (p < 0.0001) and 18.9% in class II patients (p < 0.0001). Conclusions Restenotic patterns after FP stenting are important predictors of recurrent ISR and occlusion.
Background:The randomized controlled VOLCANO trial demonstrated comparable 1-year rhythm outcomes between patients with and without ablation targeting low-voltage areas (LVAs) in addition to ...pulmonary vein isolation among paroxysmal atrial fibrillation (PAF) patients with LVAsMethods and Results:An extended-follow-up study of 402 patients enrolled in the VOLCANO trial with PAF, divided into 4 groups based on the results of voltage mapping: group A, no LVA (n=336); group B, LVA ablation (n=30); group C, LVA without ablation (n=32); and group D, incomplete voltage map (n=4). At 25 (23, 31) months after the initial ablation, AF/atrial tachycardia (AT) recurrence rates were 19% in group A, 57% in group B, 59% in group C, and 100% in group D. Recurrence rates were higher in patients with LVAs than in those without (group A vs. B+C, P<0.0001), and were comparable between those with and without LVA ablation (group B vs. C, P=0.83). Among patients who underwent repeat ablation, ATs were more frequently observed in patients with LVAs (Group B+C, 50% vs. A, 14%, P<0.0001). In addition, LVA ablation increased the incidence of AT development (group B, 71% vs. C, 32%, P<0.0001).Conclusions:Patients with LVAs demonstrated poor long-term rhythm outcomes irrespective of LVA ablation. ATs were frequently observed in patients with LVAs, and LVA ablation might exacerbate the occurrence of iatrogenic ATs.
Background:The efficacy of ablation targeting low-voltage areas (LVAs) is controversial, although LVA presence is well known to be associated with atrial fibrillation (AF) recurrence after ablation. ...AF substrate may not localize within LVAs.Methods and Results:This observational study enrolled 405 consecutive patients who underwent an initial AF ablation procedure. The left atrial (LA) voltage map was obtained after pulmonary vein isolation. LVAs were defined as areas with voltage <0.5 mV. To estimate whole LA electrophysiological degeneration, mean regional voltage at each of the 6 regions and LA total conduction velocity were measured. LVAs existed in 143 of 405 (35.3%) patients. Patients with LVAs demonstrated lower mean regional voltages throughout all 6 regions compared to those without LVAs (1.3 1.8, 0.8 vs. 0.6 1.0, 0.2 mV for the anterior wall, P<0.001). In contrast, LA conduction velocity was lower in patients with LVAs than in those without (0.89 1.01, 0.74 vs. 0.93 1.03, 0.87 m/s, P<0.001). Multivariate analysis revealed that low LA total conduction velocity and a higher number of regions with mean voltage reduction were independently associated with AF recurrence, although LVA presence was not.Conclusions:Patients with localized LA LVAs were characterized by whole LA electrophysiological degeneration as assessed by mean regional voltage and conduction velocity. In addition, whole LA electrophysiological degeneration parameters were well associated with AF recurrence.
Background: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This ...multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 μm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99).Conclusions: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.
Aim: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). ...Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX.Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year.Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group.Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.
Background:Although patients with poor ability to perform activities of daily living, such as those with high Clinical Frailty Score (CFS), will often receive a cardiac implantable electric device ...(CIED), the indications for implantation in these patients have not been clearly defined. We investigated the association between CFS and prognosis in patients with a CIED.Methods and Results:We retrospectively enrolled 323 consecutive patients who underwent initial device implantation (age, 77 (70–83) years; male, 181 56% patients; high-voltage device, 49 15% patients), and the CFS was retrospectively estimated. Primary outcome was all-cause death, and the secondary outcome was hospitalization due to heart failure (HF). Median CFS was 4 (3–5) points. During 2 years’ follow-up, all-cause death occurred in 32 patients (10%). Freedom from all-cause death was significantly lower in patients with a high CFS than in those with a low score (1–2 points: 100%, 3–4 points: 92.9%, 5–9 points: 77.3%, P<0.01). After adjustment for age and sex, the CFS was an independent predictor of the primary outcome (hazard ratio HR 2.0, 95% confidence interval CI 1.6–2.5, P<0.01), and of the secondary outcome (HR 1.6 95% CI 1.2–2.0, P<0.01).Conclusions:The CFS is an independent predictor of both death and hospitalization due to HF in patients with a CIED.
Background:The purpose of this study was to elucidate the effect of the temporal relationship between atrial fibrillation (AF) and heart failure (HF) on clinical outcomes after catheter ...ablation.Methods and Results:We included 129 consecutive patients with AF and HF who underwent catheter ablation in hospital from December 2014 to September 2017. The patients were divided into 2 groups based on the temporal relationship between AF and HF. Group 1 consisted of 42 patients with AF following HF while Group 2 consisted of 87 patients with AF preceding HF or those who developed both of them simultaneously at the timing of first visit to a doctor. The primary endpoint was a composite of death and hospitalization due to HF during a 2-year follow-up. AF recurrence was more common in Group 1 (45% vs. 23%; hazard ratio HR, 2.49; 95% confidence interval CI, 1.25–4.94; P=0.009). Death and HF hospitalization were more frequent in Group 1 (19 45%, 6 7% patients, respectively, P<0.0001). After adjustment for several covariates, patients in Group 1 were independently associated with poorer outcomes after AF ablation (HR, 8.66; 95% CI, 2.942–5.5; P<0.0001).Conclusions:Adverse clinical outcomes of death, HF hospitalization and AF recurrence were more frequent in patients with AF following HF than in those with AF preceding HF.
Background:The detailed mechanism of early-phase arterial healing after novel fluoropolymer-based paclitaxel-eluting stent (PES) implantation in the femoropopliteal (FP) lesions has not been ...elucidated.Methods and Results:We evaluated the intravascular status of 20 PES implanted in 11 FP lesions of 9 patients using angioscopy at approximately 3 months after implantation. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the extent of uncovered struts; and (3) the presence of intrastent thrombus. NIC was classified into 4 grades: grade 0, stent struts fully visible; grade 1, stent struts bulging into the lumen although covered; grade 2, stent struts embedded in neointima, but translucently visible; grade 3, stent struts fully embedded and invisible. The extent of uncovered struts was scored as follows: score 0, no uncovered struts of the entire stent; score 1, uncovered struts area approximately <30% of the stent; and score 2, uncovered struts area approximately ≥30% of the stent. In total, 90% of stents demonstrated grade 1 dominant NIC and 10% showed grade 2 dominant NIC; 85% of stents showed an uncovered stent score of 0, and the remainder had a score of 1. Thrombus was observed in all stents.Conclusions:Widely uncovered stent struts were not observed by angioscopy at 3 months after PES implantation in these FP lesions, even with the detection of thrombus adhesion.
Background: Vessel preparation for endovascular treatment (EVT) is important but because the contributory factors for favorable outcomes are not yet known, we conducted the present study to elucidate ...the factors associated with sufficient vessel preparation for severely calcified femoropopliteal (FP) lesions.Methods and Results: This was a single-center retrospective observational study of 97 patients (mean age, 75±8 years, 76% male) with 106 de novo severely calcified FP lesions who underwent EVT under intravascular ultrasound (IVUS) evaluation. The lesion definition was 360° of superficial calcification on IVUS. The primary outcome measure was sufficient vessel preparation, which was defined as successful cracking of severely calcified lesions evaluated by IVUS after predilation. The mean lesion length was 200±103 mm, and chronic total occlusion was present in 38% of patients. According to the greater difference between the preballoon size and the lumen diameter of the severely calcified lesion, the frequency of sufficient vessel preparation increased (odds ratio, 4.68; 95% confidence interval, 2.09–10.49; P<0.01). Balloon type (noncompliant, P=0.80; scoring: P=0.25) and pressure (P=0.27) were non-contributory.Conclusions: The difference between the lumen diameter at the severely calcified FP lesion site and the preballoon dilatation diameter was the sole factor contributing to sufficient vessel preparation.
Aim: Although current guidelines recommend surgical revascularization as the first-line therapy for chronic total occlusion of the abdominal aorta (Leriche syndrome), endovascular therapy (EVT) has ...been increasingly utilized because of the development of new technologies and techniques. EVT has demonstrated durable midterm outcomes for aortoiliac occlusive disease (AIOD). Nonetheless, little is known regarding their long-term outcomes and predictors of restenosis.Methods: We retrospectively analyzed a multicenter database of 64 consecutive patients (age, 73±10 years; 64% male; 22% critical limb ischemia) undergoing EVT for aortoiliac occlusive disease between September 2005 and March 2016. The outcome measures were primary and secondary patency, following EVT, calculated using the Kaplan–Meier method. Independent predictors associated with restenosis were assessed using Cox proportional hazard regression model.Results: Technical success was achieved in 61 patients (95%). In total, 214 stents (192 self-expandable stents, 22 balloon-expandable stents) were implanted. During the follow-up of 33±28 months, 11 patients experienced loss of patency. The primary patency rates were 88%, 70%, and 70% at 1, 3, and 5 years, respectively. The secondary patency rates were 98%, 87%, and 77% at 1, 3, and 5 years, respectively. In Cox regression analysis, E-Luminexx stent use (in 29 patients, 48%) was associated with restenosis hazard ratio, 4.41, P=0.038.Conclusion: In this retrospective study, EVT for AIOD demonstrated favorable 5-year patency. E-Luminexx stent implantation was associated with restenosis in this population.
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