Clinical impact of left atrial remodeling pattern in patients with atrial fibrillation: Comparison of volumetric, electrical, and combined remodeling.

INTRODUCTION: Atrial fibrillation (AF) is accompanied by various types of remodeling, including volumetric enlargement and histological degeneration. Electrical remodeling reportedly reflects histological degeneration. PURPOSE: To clarify the differences in determinants and clinical impacts among types of remodeling. METHODS: This observational study included 1118 consecutive patients undergoing initial ablation for AF. Patients were divided into four groups: minimal remodeling (left atrial volume index [LAVI] < mean value and no low-voltage area [LVA], n = 477); volumetric remodeling (LAVI ≥ mean value and no LVA, n = 361); electrical remodeling (LAVI < mean value and LVA presence, n = 96); and combined remodeling (LAVI ≥ mean value and LVA presence, n = 184). AF recurrence and other clinical outcomes were followed up for 2 and 5 years, respectively. RESULTS: Major determinants of each remodeling pattern were high age for electrical (odds ratio = 2.32, 95% confidence interval = 1.68-3.25) and combined remodeling (2.57, 1.88-3.49); female for electrical (3.85, 2.21-6.71) and combined remodeling (4.92, 2.90-8.25); persistent AF for combined remodeling (7.09, 3.75-13.4); and heart failure for volumetric (1.71, 1.51-2.53) and combined remodeling (2.21, 1.30-3.75). Recurrence rate after initial ablation increased in the order of minimal remodeling (20.1%), volumetric (27.4%) or electrical remodeling (36.5%), and combined remodeling (50.0%, p < .0001). A composite endpoint of heart failure, stroke, and death occurred in the order of minimal (3.4%), volumetric (7.5%) or electrical (8.3%), and combined remodeling (15.2%, p < .0001). CONCLUSION: Volumetric, electrical, and combined remodeling were each associated with a unique patient background, and defined rhythm and other clinical outcomes.

Impact of diabetes mellitus and poor glycemic control on the prevalence of left atrial low-voltage areas and rhythm outcome in patients with atrial fibrillation ablation.

INTRODUCTION: Left atrial low-voltage areas (LVAs) are known to be correlated with atrial scarring and atrial fibrillation (AF) recurrence after ablation. However, the association between LVAs and glycemic status before ablation has not been fully clarified. The purpose of this study was to investigate associations among the prevalence of diabetes mellitus (DM), glycemic control, and the prevalence of LVAs in patients with AF ablation. METHODS: In total, 912 (age, 68 ± 10 years; female, 299 [33%]; persistent AF, 513 [56%]) consecutive patients who underwent initial AF ablation were included. A preprocedure glycated hemoglobin A1c (HbA1c) ≥7% was set as the cutoff for poor glycemic control in patients with DM. LVAs were defined as areas with a bipolar voltage of <0.5 mV covering ≥5 cm2 of left atrium. RESULTS: LVAs existed in 208 (23%) patients, and 168 (18%) patients had DM. LVAs were found more frequently in patients with DM and poor glycemic control. On multivariate analysis, DM with HbA1c ≥7% was an independent predictor of LVAs (odds ratio, 3.3; 95% confidence interval: 1.6-6.7; p = .001). In patients with LVAs, freedom from AF recurrence during the 24-month study period was significantly lower in patients who had DM with HbA1c ≥7% than in those without DM (37.9% vs. 54.7%, p = .02). CONCLUSION: In patients with AF ablation, LVAs were found more frequently in patients with DM and poor glycemic control. DM with HbA1c ≥7% was an independent predictor of LVAs.

Impact of wall thickness on the tissue cooling effect of cryoballoon ablation.

AIMS: Understanding of the tissue cooling properties of cryoballoon ablation during pulmonary vein (PV) isolation is lacking. The purpose of this study was to delineate the depth of the tissue cooling effect during cryoballoon freezing at the pulmonary venous ostium. METHODS AND RESULTS: A left atrial-PV model was constructed using a three-dimensional printer with data from a patient to which porcine thigh muscle of various thicknesses could be affixed. The model was placed in a 37°C water tank with a PV water flow at a rate that mimicked biological blood flow. Cryofreezing at the PV ostium was performed five times each for sliced porcine thigh muscle of 2, 4, and 6 mm thickness, and sliced muscle cooling on the side opposite the balloon was monitored. The cooling effect was assessed using the average temperature of 12 evenly distributed thermocouples covering the roof region of the left superior PV. Tissue cooling effects were in the order of the 2, 4, and 6 mm thicknesses, with an average temperature of -41.4 ± 4.2°C for 2 mm, -33.0 ± 4.0°C for 4 mm, and 8.0 ± 8.7°C for 6 mm at 180 s (P for trend <0.0001). In addition, tissue temperature drops were steeper in thin muscle (maximum temperature drop per 5 s: 5.2 ± 0.9°C, 3.9 ± 0.7°C, and 1.3 ± 0.7°C, P for trend <0.0001). CONCLUSION: The cooling effect of cryoballoon freezing is weaker in the deeper layers. Cryoballoon ablation should be performed with consideration to myocardial thickness.

Comparison of voltage maps using OCTARAY catheter and PENTARAY catheter.

BACKGROUND: Recently, a new OCTARAY® mapping catheter was commercially launched. The catheter is designed to enable high-density mapping and precise signal recording via 48 small electrodes arranged on eight radiating splines. The purpose of this study was to compare bipolar voltage and low-voltage-area size, and mapping efficacy between the OCTARAY catheter and the PENTARAY® catheter METHODS: Twelve consecutive patients who underwent initial and second ablations for persistent atrial fibrillation within 2 years were considered for enrollment. Voltage mapping was performed twice, first during the initial ablation using the PENTARY catheter and second during the second ablation using the OCTARAY Long 3-3-3-3-3 (L3) catheter. RESULTS: Mean voltage with the OCTARAY-L3 catheter (1.64 ± 0.57 mV) was 32.3% greater than that with the PENTARAY catheter (1.24 ± 0.46 mV, p < .0001) in total left atrium. Low-voltage-area (<0.50 mV) size with the OCTARAY-L3 catheter was smaller than that with the PENTARAY catheter (6.9 ± 9.7 vs. 11.4 ± 13.0 cm2 , p < .0001). The OCTARAY-L3 catheter demonstrated greater efficacy than the PENTARAY catheter in terms of shorter mapping time (606 ± 99 vs. 782 ± 211 s, p = .008) and more mapping points (3,026 ± 838 vs. 781 ± 342 points, p < .0001). CONCLUSION: The OCTARAY catheter demonstrated higher voltage recordings, narrower low-voltage areas, and a more efficacious mapping procedure than the PENTARAY catheter.

Impact of Cardiac Function on Loss of Patency in Patients With Peripheral Artery Disease Presenting the Femoropopliteal Lesions Endovascularly Treated With New-Generation Devices.

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.

Clinical Impact of the Size of Drug-Coated Balloon Therapy on Restenosis Rate in Femoropopliteal Lesions.

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 <0.5 mm from) Angio-lumen size, IVUS-lumen size, and IVUS-EEM size. The association of the size of DCB with restenosis risk was investigated. 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.

Factors Associated With Early and Late Restenosis Following Drug-Coated Balloon Treatment for Patients With Femoropopliteal Lesions.

PURPOSE: Clinical trials have demonstrated the superiority of drug-coated balloon (DCB) to noncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions. In those trials, the difference of primary patency between DCB and noncoated angioplasty widens especially after 6 months, speculating that the antirestenosis effect of paclitaxel is manifested after 6 months. Factors associated with restenosis after 6 months differ from those associated with restenosis within 6 months. This study aimed to elucidate the prognostic factors associated with early (within 6 months) and late (after 6 months) restenosis following DCB treatment in real-world FP practice. MATERIALS AND METHODS: This multicenter, retrospective study analyzed 486 FP lesions (mean lesion length, 11.9±10.1 cm; chronic total occlusion, 21.0%) in 423 patients (diabetes mellitus, 59.3%; hemodialysis, 37.1%; chronic limb-threatening ischemia, 41.6%) who underwent successful DCB treatment between January 2018 and December 2019. The outcome measure was restenosis which is defined as a peak systolic velocity ratio >2.4 based on duplex ultrasound findings. Early and late restenosis were classified by the cutoff period of 6 months after the procedure. The associations of baseline and procedural characteristics with early and late restenosis were explored using Cox proportional hazards regression analysis. RESULTS: The mean follow-up period was 25.3±12.1 months. The 6, 12, 18, and 24 month cumulative incidences of restenosis were 7.4%±2.4%, 20.9%±3.9%, 29.9%±4.5%, and 38.4%±5.1%, respectively. During the follow-up period, early and late restenosis was evident in a total of 31 lesions and 138 lesions, respectively. Multivariate analysis revealed that chronic total occlusion (hazard ratio [HR], 2.29; 95% confidence interval [CI], 1.07-4.92; p=0.033) and superficial femoral artery ostial lesion (HR, 2.73; 95% CI, 1.28-5.80; p=0.009) were significantly associated with early restenosis. On the other hand, calcification circumference over 270° (HR, 1.67; 95% CI, 1.17-2.37; p=0.004), distal external elastic membrane diameter under 5 mm assessed by intravascular ultrasound (HR, 1.90; 95% CI, 1.29-2.79; p=0.001), and involving popliteal arterial lesion (HR, 1.54; 95% CI, 1.08-2.21; p=0.017) were significantly associated with late restenosis. CONCLUSION: The prognostic factors associated with late restenosis differed from those associated with early restenosis in the real-world FP-DCB practice. CLINICAL IMPACT: The current multicenter, retrospective study revealed that factors associated with early restenosis differed from those with late restenosis in the real-world FP-DCB practice. CTO and SFA ostial lesion were associated with early restenosis, while severe calcification, smaller vessel, and involving popliteal arterial lesions were associated with late restenosis.Early restenosis indicates "balloon failure" and would potentially result from recoil, which primary stent implantation might be required. On the other hand, late restenosis after 6 months would be attributed to "DCB failure", with inadequate drug uptake into the arterial wall, which might be minimized by the use of atherectomy devices.

Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions.

PURPOSE: Despite widespread use of anti-restenosis devices, drug-coated balloons (DCBs) and drug-eluting stents (DESs), their appropriate use for femoropopliteal (FP) lesions has not been well investigated and the risk factors for restenosis have not been compared. To investigate risk factors associated with restenosis after endovascular therapy using DCB and DES for contemporary FP lesions. MATERIALS AND METHODS: This single-center, retrospective, observational study evaluated 378 FP lesions in 273 patients treated with DCB (278 lesions in 193 patients) or DES (120 lesions in 106 patients). The DCB used was high-dose DCB (IN.PACT, Admiral. Medtronic, Inc.) and DES was fluoropolymer-based DES (ELUVIA, Boston Scientific). Vessel preparation failure was defined as a residual stenosis of ≥50% and a dissection grade of D or greater on pre-dilatation angiography. The outcome measure was restenosis, and factors associated with restenosis in the DCB and DES groups were assessed using a Cox proportional hazards model. RESULTS: The 2-year restenosis rate was not significantly different between the DCB and DES groups (29%±4% vs. 24%±5%, p=0.42). Interaction analysis demonstrated that popliteal lesions and plaque burden of ≥50% were restenosis-related factors for DES but not for DCB, whereas vessel preparation failure was a factor for DCB but not for DES (p<0.05). Vessel diameter of <6 mm and nodular calcification were risk factors in both groups (p<0.05). CONCLUSION: In contemporary FP lesions, smaller vessels and nodular calcification were shared restenosis-related factors for high-dose DCB and fluoropolymer-based DES. Popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB. CLINICAL IMPACT: Shared and differential restenosis-related factors after endovascular therapy using high-dose drug-coated balloons (DCBs) and fluoropolymer-based drug-eluting stents (DESs) in contemporary femoropopliteal (FP) lesions are unclear. This single-center retrospective study included 378 FP lesions in 273 patients with lower-extremity arterial disease (high-dose DCB, 278 lesions in 193 patients; fluoropolymer-based DES, 120 lesions in 106 patients). Smaller vessels and calcified nodules were shared restenosis-related factors for both high-dose DCB and fluoropolymer-based DES, whereas popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.

Factors in Sufficient Endovascular Vessel Preparation for Severely Calcified Femoropopliteal Lesions.

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.

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions.

BACKGROUND: Although favorable clinical outcomes have been demonstrated for fluoropolymer-based paclitaxel-eluting stents (FP-DES) in the treatment of femoropopliteal lesions, the vascular response after implantation has not been systematically studied through intravascular imaging.Methods and Results: We angioscopically compared FP-DES: 24 in the early phase (mean [±SD] 3±1 months), 26 in the middle phase (12±3 months), and 20 in the late phase (≥18 months) after implantation. The dominant neointimal coverage grade, heterogeneity of neointimal coverage grade, and thrombus adhesion in the stent segment were evaluated. Neointimal coverage was graded as follows: Grade 0, stent struts exposed; Grade 1, struts bulging into the lumen, although covered; Grade 2, struts embedded in the neointima, but visible; Grade 3, struts fully embedded and invisible. Dominant neointimal coverage and heterogeneity grades were significantly higher in the middle and late phases than in the early phase (all P<0.05), but did not differ significantly between the middle and late phases. The incidence of thrombus adhesion was recorded for all stents in each of the 3 different phases. CONCLUSIONS: The middle and late phases after FP-DES implantation were associated with significantly higher dominant neointimal coverage and heterogeneity grades than the early phase. However, thrombus adhesion was observed in all phases after FP-DES implantation. Arterial healing may not be completed even in the late phase after FP-DES implantation.

Impact of intravascular ultrasound parameters and platelet reactivity on primary patency after drug-coated balloon angioplasty for femoropopliteal artery disease.

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.

Impact of left atrial low-voltage areas during initial ablation procedures on very late recurrence of atrial fibrillation.

BACKGROUND: Very late recurrence of atrial fibrillation (VLRAF) occurring >1 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. METHODS: This study included 1001 consecutive patients undergoing initial ablation procedures for AF. LVAs were defined as regions with bipolar peak-to-peak voltages of <0.50 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. RESULTS: 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). CONCLUSIONS: LVAs during the initial AF ablation procedures have an impact on VLRAF occurrence.

Low-Voltage-Area Ablation in Paroxysmal Atrial Fibrillation　- Extended Follow-up Results of the VOLCANO Trial.

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.

Left Atrial Localized Low-Voltage Areas Indicate Whole Left Atrial Electrophysiological Degeneration in Atrial Fibrillation Patients.

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.

Clinical features and prognosis of patients with and without diabetes mellitus undergoing endovascular aortic aneurysm repair.

BACKGROUND: This study aimed to compare the clinical features and prognoses of patients with and without diabetes mellitus (DM) who underwent endovascular repair for aortic aneurysm (AA). METHODS: We analyzed the clinical database of a prospective multicenter study, registering 929 patients who underwent their first endovascular AA repair in Japan between January 2016 and June 2018. The baseline characteristics and prognoses (including all-cause mortality and cardiovascular events) after repair were compared between the DM and non-DM groups. Prognoses were also compared between the groups after propensity score matching. RESULTS: In total, 226 patients (24.3%) had DM. Compared with non-DM patients, DM patients had higher pack-years of smoking (P = 0.011), higher body mass index (P = 0.009), lower high-density lipoprotein cholesterol levels (P = 0.038), higher triglyceride levels (P = 0.025), and lower left ventricular ejection fraction (P = 0.005). Meanwhile, the low-density lipoprotein cholesterol and blood pressure levels showed no significant intergroup difference (all P > 0.05). DM patients had a higher prevalence of myocardial infarction (P = 0.016), history of coronary revascularization (P = 0.015), and lower extremity artery disease (P = 0.019). Lesion characteristics and procedures were similar between the groups (all P > 0.05). DM patients had a higher risk of all-cause mortality and cardiovascular events than non-DM patients (both P < 0.001). Subsequent propensity score matching also demonstrated that DM patients had a significantly lower rate of overall survival (P = 0.001) and freedom from cardiovascular events (P = 0.010). The Kaplan-Meier estimates at 1 year for the overall survival were 85.6% (95% confidence interval [CI], 80.9% to 90.5%) and 94.3% (95% CI, 91.7% to 97.0%) for patients with and without DM, respectively. The corresponding estimates for freedom from cardiovascular events were 79.8% (95% CI, 74.5% to 85.5%) and 87.7% (95% CI, 84.2% to 91.3%), respectively. CONCLUSIONS: Among patients undergoing endovascular AA repair, those with DM had more cardiovascular risk factors. DM patients had a higher incidence rate of all-cause mortality and cardiovascular events. Matching analysis indicated that DM per se would be a risk factor for poor prognoses after AA repair.

Predictive impact of the Global Limb Anatomic Staging System (GLASS) on perioperative outcomes in patients with chronic limb-threatening ischaemia with isolated below-the-knee lesions.

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.

Predictive Factors for Restenosis Following Stent-Supported Endovascular Therapy with Intravascular Ultrasound Evaluation for Femoropopliteal Chronic Total Occlusion.

PURPOSE: To determine the predictive factors for in-stent restenosis (ISR) following stent-supported endovascular therapy (EVT) with intravascular ultrasound (US) evaluation for femoropopliteal chronic total occlusion. MATERIALS AND METHODS: This was a single-center, retrospective, observational study. The study included 276 lesions in 251 patients who underwent stent-supported EVT with intravascular ultrasound evaluation for femoropopliteal chronic total occlusion from July 2012 to June 2019. The wire passage route was assessed using intravascular US, and lesions were classified accordingly into 2 groups: intraluminal and subintimal passage. In this study, the intraluminal group was further divided into 3 subgroups by severity of calcification: none, <180°, and ≥180° circumferential. The subintimal group was further divided into 2 subgroups: subintimal passage without or with calcification. The primary outcome measure was ISR. Cox proportional hazards regression was used to determine the association of clinical characteristics with ISR rates. RESULTS: The mean follow-up period was 19 months ±16, during which time ISR was observed in 31% of lesions. After multivariate analysis, an increased degree of plaque burden (hazard ratio [HR] = 1.101) and subintimal passage with calcification (HR = 3.408) were associated with an increased risk of ISR; a larger distal external elastic membrane area (HR = 0.898) and use of a stent graft (HR = 0.130) were significantly associated with a reduced risk of ISR. CONCLUSIONS: This study revealed that factors associated with ISR after stent-supported EVT with intravascular US evaluation were distal external elastic membrane area, plaque burden, subintimal passage with calcification, and use of a stent graft.

Clinical Frailty Score Predicts Long-Term Mortality and Hospitalization Due to Heart Failure After Implantation of Cardiac Implantable Electric Device.

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.

A new clinical risk score for predicting the prevalence of low-voltage areas in patients undergoing atrial fibrillation ablation.

INTRODUCTION: Although the presence of left atrial low-voltage areas (LVAs) is strongly associated with the recurrence of atrial fibrillation (AF) after ablation, few methods are available to classify the prevalence of LVAs. The purpose of this study was to establish a risk score for predicting the prevalence of LVAs in patients undergoing ablation for AF. METHODS: We enrolled 1004 consecutive patients who underwent initial ablation for AF (age, 68 ± 10 years old; female, 346 (34%); persistent AF, 513 (51%)). LVAs were deemed present when the voltage map after pulmonary vein isolation demonstrated low-voltage areas with a peak-to-peak bipolar voltage of <0.5 mV covering ≥5 cm2 of the left atrium. RESULTS: LVAs were present in 206 (21%) patients. The SPEED score was obtained as the total number of independent predictors as identified on multivariate analysis, namely female sex (odds ratio [OR], 3.4 [95% confidence interval {CI} 2.2-5.2], p < .01), persistent AF (OR, 1.8 [95% CI, 1.1-3.0], p = .02), age ≥ 70 years (OR, 2.3 [95% CI, 1.5-3.4], p < .01), elevated brain natriuretic peptide ≥100 pg/ml or N-terminal probrain natriuretic peptide ≥400 pg/ml (OR, 1.7 [95% CI, 1.02-2.8], p = .04), and diabetes mellitus (OR, 1.8 [95% CI, 1.1-2.8], p = .02). LVAs were more frequent in patients with a higher SPEED score, and prevalence increased with each additional SPEED score point (OR, 2.4 [95% CI, 2.0-2.8], p < .01). CONCLUSION: The SPEED score accurately predicts the prevalence of LVAs in patients undergoing ablation for AF.

Clinical utility of local impedance monitoring during pulmonary vein isolation.

INTRODUCTION: Local impedance (LI) at the tip of ablation catheter can be measured using a recently available technology. We aimed to explore target LI measurements at each radiofrequency application (RFA) for creating sufficient ablation lesions during pulmonary vein (PV) isolation. METHODS: This prospective study included 15 consecutive patients scheduled to undergo an initial ablation of paroxysmal atrial fibrillation (AF). Circumferential ablation around both ipsilateral PVs was performed using a 4-mm irrigated ablation catheter with an LI sensor. Point-by-point ablation was used with a 4-mm inter-ablation-point distance. Operators were blinded to LI measurements during the procedure. Creation of sufficient ablation lesions was assessed by the absence of a conduction gap. RESULTS: After first-pass encircling PV antrum ablation, left atrium to PV conduction remained in 12 of 30 (40%) ipsilateral PVs. Mapping using the minibasket catheter identified 48 ablation points through which the propagation wave entered the PV. At ablation points with a gap, the LI drop during RFA was half that at points without a gap (12 ± 7 vs. 23 ± 12 Ω; p < .001). The generator impedance drop did not differ between ablation points with and without a gap (12 ± 7 vs. 14 ± 10 Ω; p = .10). An LI drop of 13.4 Ω predicted sufficient lesion formation without a gap with a sensitivity of 0.78, specificity of 0.75, and predictive accuracy of 0.75. CONCLUSION: An LI drop of 13.4 Ω at each RFA under the conditions of a 4-mm inter-ablation-point distance and RFA duration ≥20 s may facilitate creation of sufficient lesions during PV isolation.