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This study aimed to investigate the long-term impact of guideline-directed medical therapy (GDMT) on 10-year mortality in patients with chronic limb-threatening ischaemia (CLTI) after revascularization.We performed a retrospective multicentre study enrolle 459 patients with CLTI who underwent revascularization (396 endovascular therapy [EVT] and 63 bypass surgery [BSX] cases) between January 2007 and December 2011. The primary outcome measure was all-cause mortality. We additionally explored the predictors for all-cause mortality using Cox regression hazard models; the influence of GDMT, defined as prescription of antiplatelet agents, statins, and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in aggregate, on all-cause mortality, and the association between baseline characteristics using interaction effects.During the 10-year follow-up after revascularization, 234 patients died. In Kaplan-Meier analysis, 10-year mortality was significantly lower in patients who received statins (p＜.001) and ACE inhibitors or ARBs (p=.010) than those who did not. However, there were no differences in 10-year mortality between patients who received anti-platelet agents and those who did not (p=.62). Interaction analysis revealed that GDMT had a significantly different hazard ratio in patients who were and were not on hemodialysis and in those treated with EVT or BSX (p for interaction =.002 and .044, respectively). In the multivariate analysis, age ＞75 years, non-ambulatory status, hemodialysis, congestive heart failure, left ventricular ejection fraction ＜50%, and GDMT were significantly associated with all-cause mortality.Appropriate GDMT use was independently associated with 10-year mortality in patients with CLTI after revascularization.

Very late recurrence of atrial fibrillation (VLRAF) occurring1 year after catheter ablation may influence long-term follow-up strategies, including oral anticoagulant therapy. However, little is known about the predictors of this condition. Given that the prevalence of left atrial low-voltage areas (LVAs) is strongly associated with the recurrence of atrial tachyarrhythmias following catheter ablation, we hypothesized that VLRAF might occur more frequently in patients with LVAs at the time of initial ablation. The purpose of this study was to investigate the impact of LVAs on VLRAF.This study included 1001 consecutive patients undergoing initial ablation procedures for AF. LVAs were defined as regions with bipolar peak-to-peak voltages of0.50 mV on the voltage map obtained during sinus rhythm after pulmonary vein isolation. During a 1-year follow-up period, 248 patients had a late recurrence of AF (LRAF), defined as recurrence within 3-12 months after ablation. The occurrence of VLRAF was examined in 711 patients without LRAF who were followed for more than 1 year.A total of 711 patients who did not develop AF recurrence within 1 year and for whom clinical data were available after 1 year were analyzed. During a median follow-up of 25 (19, 37) months, VLRAF more than 1 year after the initial ablation was detected in 123 patients. On multivariate analysis, independent predictors of VLRAF were the existence of LVAs, female, left atrial diameter and early recurrence of AF. A Kaplan-Meier analysis showed that the AF-free survival rate was significantly lower in patients with LVAs than in those without LVAs within 1 year and on more than 1-year follow-up (p .001). An additional Kaplan-Meier analysis of the incidence of VLRAF in propensity score-matched patients with and without LVAs showed that VLRAF occurred significantly more frequently in patients with LVAs (p = .003).LVAs during the initial AF ablation procedures have an impact on VLRAF occurrence.

The global vascular guideline proposed a novel anatomical classification of infra-malleolar (IM) arterial lesions. We aimed to investigate the association of IM classification with clinical outcomes in patients with chronic limb-threatening ischemia (CLTI) due to isolated infrapopliteal (IP) lesions. We retrospectively analyzed 509 limbs with tissue loss in 357 patients due to isolated IP lesions who underwent endovascular therapy (EVT) between April 2010 and December 2018. The primary outcome was 1-year wound healing rate. The association of patient and anatomic characteristics with non-healing was evaluated using Cox proportional hazards regression analysis. The 1-year cumulative wound healing rate was 59.7%. Multivariable analysis demonstrated that IM grade 2 (hazard ratio [HR], 1.41; P = .044), non-ambulatory status (HR, 1.49; P = .008), hemodialysis (HR, 1.37; P = .020), left ventricular ejection fraction < 50% (HR, 1.72; P = .030), and wound, ischemia, and foot infection (WIfI) classification 4 (HR, 1.33; P = .032) were significantly associated with non-healing, whereas no below-the-ankle (BTA), below-the-knee (BTK) runoff, and Global Limb Anatomic Staging System (GLASS) IP grade had no statistically significant association with non-healing. Global Limb Anatomic Staging System IM grade 2 was an independent risk factor for wound healing in patients who underwent EVT with CLTI due to isolated IP disease.

Aims Hemodialysis vintage and serum phosphorus levels adversely affect outcomes in patients on hemodialysis. Whether these factors have a similar prognostic impact on patients who are on hemodialysis and have chronic limb-threatening ischemia (CLTI) has not been systematically studied. We aimed to explore the risk factors, including hemodialysis vintage and serum phosphorus levels, on clinical outcomes after endovascular therapy (EVT) in hemodialysis patients with CLTI. Methods The current study rerospectively analyzed 374 hemodialysis patients with CLTI presenting with ischemic tissue loss (age: 72.3±9.0 years, male: 73.3%, diabetes mellitus: 68.2%, Rutherford 5: 75.9%, 6: 24.1%, WIfI stage 4: 50.0%) primarily treated with EVT between April 2007 and December 2016. The primary outcome measure was 1-year amputation-free survival (AFS), while the secondary outcome measure was 1-year wound healing. Predictors for each outcome were evaluated by Cox proportional hazards model. Results Multivariate analysis significantly associated longer hemodialysis vintages with higher serum phosphorus levels (hazard ratio [HR], 0.599; 95% confidence interval [CI], 0.394-0.910; p=0.016) with 1-year AFS. Longer vintages for hemodialysis with higher serum phosphorus levels were marginally, but not significantly, associated with 1-year wound healing. (HR, 0.684; 95% CI, 0.467-1.000; p=0.050). Conclusion Longer hemodialysis vintages with higher serum phosphorus levels adversely affect outcomes after EVT for hemodialysis patients with CLTI presenting with ischemic tissue loss.

BackgroundAtrial myocardial degeneration predisposes to atrial fibrillation (AF), ischemic stroke, and heart failure. Studies suggest the presence of sex differences in atrial myocardial degeneration. This study aimed to delineate sex differences in the prevalence, predictors, and prognostic impact of left atrial low-voltage areas (LVAs).MethodsThis observational study included 1,488 consecutive patients undergoing initial ablation for AF. Voltage mapping was performed after pulmonary vein isolation during sinus rhythm. LVAs were defined as regions where bipolar peak-to-peak voltage was < 0.50 mV. Results: LVA prevalence was higher in women (37.6%) than in men (16.0%). High age, persistent form of AF, diabetes mellitus, and a large left atrium were shown to be common predictors in both sex categories. Heart failure and history of stroke/thromboembolic events were men-specific predictors of LVA existence. Women experienced more AF recurrence than men (31.1% vs. 25.7%, p = 0.027). LVA existence was significantly associated with increased AF recurrence in each sex category, with a respective hazard ratio, 95% confidence interval and p value of 2.45, 1.87-3.22, and < 0.0001 in men and 1.82, 1.33-2.49, and < 0.0001 in women.ConclusionsLVA was more frequent in women than men, and predicted frequent AF recurrence irrespective of sex category.

Background: The efficacy of ablation targeting low-voltage areas (LVAs) is controversial, although LVA presence is well known to be associated with AF recurrence after ablation. Atrial fibrillation (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 voltage map was obtained after pulmonary vein isolation. LVAs were defined as areas with voltage < 0.5 mV. To estimate whole atrial electrophysiological degeneration, mean regional voltage at each of 6 regions and left atrial 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 than those without LVAs (1.3 [1.8, 0.8] vs. 0.6 [1.0, 0.2] for anterior wall, p

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; P0.01). Balloon type (noncompliant, P=0.80; scoring: P=0.25) and pressure (P=0.27) were non-contributory.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.

Purpose: This study investigated the incidence of acute thrombotic occlusion (ATO) and its predictors after contemporary femoropopliteal (FP) endovascular therapy (EVT) for peripheral artery disease. Materials and Methods: We retrospectively examined 763 limbs (chronic limb-threatening ischemia [CLTI]: 44%, involving popliteal lesion: 44%) in 644 patients (mean age: 75±9 years, male: 71%, hemodialysis: 34%) who successfully underwent EVT with contemporary FP devices (drug-coated stent: n=220, stent graft: n=158, drug-eluting stent: n=150, drug-coated balloon [DCB]: n=235) from June 2012 to July 2020. The outcome measure was ATO defined as acute onset of claudication and/or signs of CLTI in combination with angiographic evidence of occlusive thrombus formation within the treated segment. Cox proportional hazards regression models were used to identify baseline characteristics associated with the incidence of ATO after EVT treated with scaffold. To determine the impact of ATO occurrence and creatine phosphokinase (CPK) elevation on the subsequent composite outcome of mortality or major amputation, we developed the Cox model in which the trichotomous variable (free from ATO, ATO without CPK elevation, and ATO with CPK elevation) was a time-dependent covariate. Results: The 24-month incidence of ATO in the overall population was 4.3%±0.8% (DCB: 1.0%±0.7% vs scaffold: 5.8%±1.1%, pConclusion: We found a substantial incidence of ATO after contemporary FP-EVT, particularly with scaffold. Hemodialysis and involving popliteal lesion were significantly associated with ATO risk in patients treated with scaffold. The occurrence of ATO, particularly with CPK elevation, was associated with an increased risk of a subsequent composite outcome of mortality or major amputation. The scaffold was safely used in patients without those risk factors of ATO, but a non-scaffolding strategy should be considered for patients with more risk factors. Clinical Impact The scaffold was safely used in patients without hemodialysis and involving popliteal lesion, but a non-scaffolding strategy should be considered for patients with those risk factors. The occurrence of ATO, particulary with CPK elevation, was of high risk of mortality or amputation.

Although the superiority of DCBs to uncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions has been demonstrated, the association of clinical factors, including anatomical features evaluated by intravascular ultrasound (IVUS) and platelet reactivity, with the loss of patency has not been systematically studied. The current prospective, observational study enrolled 160 consecutive patients (male 67.5%, mean age 74.7 ± 9.7 years) with 213 FP lesions treated with DCBs under IVUS evaluation. The platelet reactivity was measured in P2Y12 reaction units for all of the patients at the DCB treatment. The primary end point was primary patency at 12 months, while the secondary end points were freedom from target lesion revascularization (TLR), all-cause death, major target limb amputation and bleeding events at 12 months. Mean lesion length was 11.9 ± 9.4 cm and 34 (16.0%) were chronic total occlusions (CTOs). Thirty-four (16.0%) were severely calcified lesions. Primary patency by Kaplan-Meier estimate was 79.2% at 12 months, while the 12-month freedom from TLR, all-cause death and bleeding events were observed in 89.1%, 93.4% and 97.4%, respectively. There were no major target limb amputations through 12 months. Multivariate analysis showed that subintimal angioplasty for CTO lesions was a sole risk factor for loss of 12-month primary patency, while other IVUS parameters and platelet reactivity were not.

Purpose: Although the size of drug-coated balloons (DCBs) is determined according to the vessel diameter during femoropopliteal (FP)-endovascular therapy (EVT), the measurements of the vessel diameter vary among modalities and its definitions. The aim of this study was to reveal whether the DCB size fitting (1) angiographically-measured lumen diameter (Angio-lumen size), (2) intravascular ultrasound (IVUS)-measured lumen diameter (IVUS-lumen size), or (3) IVUS-measured external elastic membrane (EEM) diameter (IVUS-EEM size) would be beneficial in restenosis occurrence. Materials and Methods: This retrospective, single-center study included 231 de novo FP lesions in 165 patients with peripheral artery disease treated with IN.PACT Admiral DCB under IVUS evaluation. The reference vessel diameter was evaluated as the lumen or EEM diameter at the healthy site distal to the lesion. We retrospectively determined whether the DCB size was close to (ie, equal to or different by Results: The mean lesion length was 13 ± 9 cm and the prevalence of chronic total occlusion was 18%. During a mean follow-up period of 17 ± 9 months, restenosis occurred in 26% of lesions. Lesions treated with a DCB of IVUS-EEM size had a lower 2 year restenosis rate than those treated with a DCB over/under IVUS-EEM size (19.7 ± 5.7% vs 34.5 ± 4.7%, p=0.02 by the log-rank test), while the restenosis rate was not significantly different between DCBs of Angio-lumen size or IVUS-lumen size and those over/under the size (both p>0.05). The multivariate Cox regression analysis revealed that DCBs of IVUS-EEM size were independently associated with a reduced risk of restenosis (adjusted hazard ratio 0.50; 95% confidence interval 0.27–0.95; p=0.03). Conclusion: The DCBs of IVUS-EEM size, but not of Angio-lumen size or IVUS-lumen size, were associated with a reduced risk of restenosis after FP-EVT. Determining the DCB size according to IVUS-evaluated EEM diameter would be potentially beneficial in restenosis occurrence.

Although the global vascular guidelines recently proposed the Global Limb Anatomic Staging System (GLASS) as an anatomical classification for chronic limb-threatening ischaemia (CLTI), prediction of perioperative outcomes using the GLASS classification in patients with CLTI due to isolated below-the-knee (BTK) lesions has not been well studied.This retrospective study included 585 patients with CLTI due to isolated BTK lesions who underwent endovascular therapy (EVT). The severity of arterial lesions was graded using the GLASS infrapopliteal (IP) and inframalleolar (IM) classifications and defined as follows: non-severe IP, 0-3; severe IP, 4; non-severe IM, P0-1; and severe IM, P2. The outcome measures were technical failure, defined as recanalisation failure of the target artery path, and perioperative failure, defined as a composite of all-cause death, major amputation, or repeat revascularisation within 30 days.Technical and perioperative failures occurred in 9.4% (n = 55) and 9.9% (n = 58) patients, respectively. Compared to patients with non-severe IP and IM, those with both severe IP and IM were significantly associated with technical and perioperative failures (odds ratio [OR]: 13.87 [95% confidence interval (CI) 4.69-41.02, P 0.001] and OR: 2.18 [95% CI 1.08-4.38, P = 0.041], respectively).The GLASS classification may have predictive value for technical and perioperative failure in patients with CLTI due to isolated BTK lesions after EVT.

Purpose: The current study sought to investigate the impact of cardiac condition on loss of patency after endovascular therapy (EVT) using new-generation devices for femoropopliteal (FP) lesions. Materials and Methods: We retrospectively studied 547 lesions (chronic limb-threatening ischemia: 44%, TASC II C/D lesion: 61%, chronic total occlusion: 37%, in-stent restenosis: 13%, involving popliteal arterial lesion: 45%) belonging to 416 patients (average age: 75±9 years, male: 69%, diabetes mellitus: 62%, hemodialysis: 33%) who underwent EVT with new-generation FP-specific devices (polymer-free paclitaxel-eluting stent, n=186; stent graft, n=119; fluoropolymer-based paclitaxel-eluting stent, n=29; interwoven stent, n=17; drug-coated balloon, n=196) from June 2012 to May 2019. Cardiac function was evaluated using echocardiography. The primary outcome measure was primary patency, which was defined as free from peak systolic velocity ratio (PSVR) >2.5 assessed by duplex ultrasound. Predictors for loss of patency were evaluated using Cox proportional hazards regression analysis. Results: Overall 12 primary patency were 80.0±1.8%. After the multivariate analysis, reduced stroke volume evaluated by echocardiography (hazard ratio [HR]=0.99, 95% confidence interval [CI]=0.97-0.99, p=0.03), chronic heart failure (HR=1.76, 95% CI=1.05-2.97, p=0.03), and a smaller distal reference vessel diameter (HR=0.73, 95% CI=0.55-0.97, p=0.03) were significantly associated with loss of 12-month primary patency, whereas lesion length (HR=1.01, 95% CI=0.99–1.03, p=0.33) and presence of chronic total occlusion (CTO; HR=0.92, 95% CI=0.61-1.40, p=0.70) were not statistically significant. Conclusion: The current study revealed that cardiac function represented by reduced stroke volume and presence of chronic heart failure as well as a smaller distal reference vessel diameter were significantly associated with loss of 12-month primary patency in patients with peripheral artery disease (PAD) presenting FP lesions endovascularly treated with new-generation devices.