Peripheral artery disease (PAD) is a systemic disease associated with impaired limb function, poor quality of life, and increased cardiovascular morbidity. Its incidence has been dramatically ...increasing over years because of the emergence of an aging society and the increase in the number of patients with atherosclerotic risk factors. The clustering of these risk factors promotes disease development, reportedly leading to the differential location of atherosclerotic lesions in lower extremity arteries. The clinical presentations of PAD include intermittent claudication and chronic limb-threatening ischemia (CLTI). PAD is associated with a high risk of mortality and morbidity from both cardiovascular and limb events. The therapeutic goals for patients with PAD include 1) relief from PAD-related limb symptoms, 2) the prevention of new-onset and the development and recurrence of PAD, and 3) the prevention of concomitant adverse events due to coronary artery disease (CAD) and cerebrovascular disease (CVD). There are several types of antithrombotic agents, and their main role in patients with PAD is to reduce systemic events mainly including cardiovascular and lower extremity-related events. Currently, the efficacy of direct oral anticoagulant (DOAC) is also suggested by recent clinical trials. Although endovascular therapy (EVT) has been a first-line revascularization strategy for symptomatic PAD, whether clinical outcomes after EVT are comparable to those after surgical bypass therapy remains inconclusive.
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.
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.
Aim: The aim of the current study was to describe the clinical profile, frequency of in-hospital complications, and predictors of adverse events in patients undergoing endovascular therapy (EVT) for ...acute limb ischemia (ALI), and to compare them with those of patients undergoing EVT for chronic symptomatic peripheral artery disease (PAD). Methods: The current study compared 2,398 cases of EVT for ALI with 74,171 cases of EVT for chronic symptomatic PAD performed between January 2015 and December 2018 in Japan. We first compared the clinical profiles of ALI patients with those of PAD patients. We then evaluated the proportion of in-hospital complications and investigated their risk factors in the ALI patients. The association of clinical characteristics with the risk of in-hospital complications was analyzed via logistic regression modeling. Results: Patients with ALI were older and had a higher prevalence of female sex, impaired mobility, and history of cerebrovascular disease, but a lower prevalence of cardiovascular risk factors and history of coronary artery disease. The proportion of in-hospital EVT-related complications in ALI was 6.1% and was significantly higher compared with those in chronic symptomatic PAD patients (2.0%, P＜0.001). Bedridden status (adjusted odds ratio aOR, 1.74 1.14 to 2.66; P=0.010), history of coronary artery disease (aOR, 1.80 1.21 to 2.68; P=0.004), and a suprapopliteal lesion (aOR, 1.70 1.05 to 2.74; P=0.030) were identified as independent risk factors for in-hospital complications. Conclusion: The current study demonstrated that ALI patients with significant comorbidities show a higher proportion of in-hospital complications after EVT.
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.
PDF
