Left atrial low voltage areas and heart failure in patients with atrial fibrillation: Implication of the atrial myopathy.

AIMS: Atrial fibrillation (AF) and heart failure (HF) affect each other and are often co-morbid. The fact that HF development is not uncommon even after ablation suggests that we need a deeper understanding of the pathology of these conditions. Atrial myocardial degeneration is an underlying factor in AF patients and may be associated with HF development after ablation. This study aimed to investigate the impact of low-voltage areas (LVAs) on HF prognosis after AF ablation. METHODS AND RESULTS: This observational study included 1481 consecutive patients undergoing initial ablation for AF. Left atrial LVAs were defined as regions with a bipolar peak-to-peak voltage of <0.50 mV. Patients were divided into three groups: no LVA (LVA size indexed to body surface area <3 cm2/m2, n = 1129), small LVA (3-10 cm2/m2, n = 217), and extensive LVA (≥10 cm2/m2, n = 135). A composite endpoint of HF hospitalization or death occurred more frequently in patients with larger LVAs (3.3% vs. 6.5% vs. 13.3%, P < 0.0001) during the 3-year follow up period. The extent of LVAs was independently related to the risk of the composite endpoint with an adjusted hazard ratio of 1.55 (95% confidence interval, 1.16-2.10) for each additional step of LVA classification (P = 0.003). CONCLUSIONS: LVA presence and its extent were associated with frequent HF hospitalization and death. Underlying atrial myopathy appears to define a poor HF prognosis after AF ablation.

Impact of Immunosuppressive Therapy on Lead Dislodgement After Cardiac Implantable Electronic Device Implantation.

BACKGROUNDS: Lead dislodgement is a severe complication in cardiac implantable electronic device (CIED) implantation. Inflammation after CIED implantation results in the development of adhesions between lead and tissues, resulting in the lead becoming fixed in the body. In patients with immunosuppressive therapy, however, adhesion is inhibited by anti-inflammatory effects. However, the association between lead dislodgement and immunosuppressive therapy has not been clarified. The purpose of this study was to investigate the association between lead dislodgement and immunosuppressive therapy. HYPOTHESIS: We hypothesized that lead dislodgement more frequently occur in patients with immunosuppressive therapy than those without. METHODS: In total, 651 consecutive patients who underwent CIED implantation or lead addition (age, 76 ± 11 years; and males, 374 [58%], high voltage device, 121 [19%], lead addition 23 [4%]) were retrospectively enrolled. Immunosuppressive therapy was with regular steroids or immunosuppressants. Lead placement was guided by fluoroscopy, and active fixation leads were used. Restraint of the upper limb by chest tape was performed for 1 week after the procedure. Lead dislodgement was defined as a change in lead position and/or lead failure requiring reoperation. RESULTS: Twenty (3.1%) patients received immunosuppressive therapy. Among these, 15 (2.3%) patients regularly took steroids and 8 (1.2%) took immunosuppressants. Lead dislodgement occurred in 10 (1.5%) patients. Lead dislodgement was more frequent in patients with immunosuppressive therapy than in those without (3 [15%] vs. 7 [1%], p = 0.003). CONCLUSION: In patients with CIED implantation or lead addition, lead dislodgement is more frequent in patients with immunosuppressive therapy than in those without.

Atrial Functional Substrates for the Prediction of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation.

Low-voltage areas have been used as atrial structural substrates in estimating fibrotic degeneration in patients with atrial fibrillation (AF). The high-resolution maps obtained by recently developed mapping catheters allow the visualization of several functional abnormalities. We investigated the association between left atrial (LA) functional abnormal findings on a high-resolution substrate map and AF recurrence in patients who underwent pulmonary vein isolation without any additional LA substrate ablation. This observational study included 100 consecutive patients who underwent second ablation for AF (paroxysmal, 48%; persistent, 52%). Patients with extra-pulmonary-vein LA substrate ablation during the initial and second ablation were excluded. LA mapping was performed using a 64-pole mini-basket catheter on the RHYTHMIA mapping system (Boston Scientific, Marlborough [Cambridge] Massachusetts). Patients were followed for 2 years. AF recurrence developed in 39 (39%) patients. On the high-resolution substrate map, AF recurrence was associated with the presence of the following findings: low-voltage areas (<1.0 mV, >5 cm2; hazard ratio [HR] = 2.53; 95% confidence interval [CI] = 1.30 to 4.93; p <0.006), fractionated-electrogram areas (≥5 peaks, >5 cm2; HR = 2.15, 95% CI = 1.10 to 4.19; p = 0.025), LA conduction time of >130 ms (HR = 3.11, 95% CI = 1.65 to 5.88, p <0.0001), deceleration zone (≥5 isochrones/cm2; HR = 1.97, 95% CI = 1.04 to 3.37, p = 0.039), and multiple septal break-out points (HR = 3.27, 95% CI = 1.50 to 7.16, p = 0.003). Accumulation of these risk factors increased AF recurrence in a stepwise manner, with an HR = 1.90, 95% CI = 1.44 to 2.52, p <0.00001 for each additional risk factor. In conclusion, a high-resolution map revealed new LA functional substrates associated with AF recurrence. Implementation of functional substrates may improve the prediction of AF recurrence after ablation, and possibly aid the development of tailored AF ablation strategies.

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 Procedural Techniques on Midterm Patency of Fluoropolymer-Based Drug-Eluting Stent Placed in the Femoropopliteal Artery.

PURPOSE: To investigate the impact of compliance with recommended procedural techniques on the midterm patency of a fluoropolymer-based drug-eluting stent (FP-DES) in the femoropopliteal artery. MATERIALS AND METHODS: This retrospective study included 200 femoropopliteal lesions (chronic limb-threatening ischemia, 59%; chronic total occlusion, 41%) in 173 patients (male, 66%; diabetes mellitus, 62%; hemodialysis, 40%) with lower extremity arterial disease who underwent intravascular ultrasound (IVUS)-guided endovascular therapy with FP-DES between January 2016 and July 2021. The primary outcome measure was restenosis, defined as a peak systolic velocity ratio of >2.4 based on the duplex US findings. The association between procedural techniques and incidence of restenosis was investigated using Cox proportional hazards regression models. RESULTS: The 2-year cumulative incidence of restenosis was 19.5% (SD ± 3.3). Multivariate analysis revealed that noncompliance with recommended procedural techniques, such as plaque burden at the stent edge of <50%, a minimum stent area (MSA) of >12 mm2, and stent placement within the P1 segment, was independently associated with an increased risk of restenosis (hazard ratios [HRs], 3.22, 4.71, and 4.67 and P = .004, P < .001, and P < .001, respectively). The 2-year restenosis risk for procedures performed in compliance with all 3-technical criteria was 8.4% (SD ± 3.4), whereas the risks for those in compliance with 2-technical criteria or 0- or 1-technical criteria were 25.0% (SD ± 6.2) and 48.6% (SD ± 10.4), respectively. HRs relative to 3-technical criteria compliance were 3.79 (P = .007) and 11.85 (P < .001), respectively. CONCLUSIONS: Noncompliance with recommended procedural techniques, including plaque burden at the stent edge of <50%, MSA of >12 mm2, and stent placement within the P1 segment, was significantly associated with an increased risk of 2-year restenosis after FP-DES implantation in the femoropopliteal artery.

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.

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.

Prognostic impact of atrial cardiomyopathy: Long-term follow-up of patients with and without low-voltage areas following atrial fibrillation ablation.

BACKGROUND: Atrial cardiomyopathy is known as an underlying pathophysiological factor in the majority of patients with atrial fibrillation (AF). Left atrial low-voltage areas (LVAs) are reported to coincide with fibrosis and likely represent atrial cardiomyopathy. OBJECTIVE: The purpose of this study was to delineate differences in the long-term prognosis of patients stratified by the size of LVAs. METHODS: This observational study included 1488 consecutive patients undergoing initial ablation for AF. LVAs were defined as regions with a bipolar peak-to-peak voltage <0.50 mV. The total study population was divided into 3 groups stratified by LVA size: patients with no LVAs (n = 1136); those with small (<20 cm2) LVAs (n = 250) LVAs; and those with extensive (≥20 cm2) LVAs (n = 102). Composite endpoints of death, heart failure, and stroke were followed for up to 5 years. RESULTS: Composite endpoints developed in 105 of 1488 patients (7.1%), and AF recurrence occurred in 410 (27.6%). Composite endpoints developed more frequently in the order of patients with extensive LVAs (19.1%), small LVAs (10.8%), and no LVAs (5.1%) (P for trend <.0001). Multivariable analysis revealed that LVA presence was independently associated with higher incidence of composite endpoints, irrespective of AF recurrence (modified hazard ratio 1.73; 95% confidence interval 1.13-2.64; P = .011) CONCLUSION: LVA presence and its extent both were associated with poor long-term composite endpoints of death, heart failure, and stroke, irrespective of AF recurrence or other confounders. Underlying atrial cardiomyopathy seems to define a poor prognosis after AF ablation.

Two-year real world clinical outcomes after intravascular imaging device guided percutaneous coronary intervention with ultrathin-strut biodegradable-polymer sirolimus-eluting stent.

BACKGROUND: There are little clinical data on imaging-guided percutaneous coronary intervention (PCI) 1 year after the biodegradable-polymer sirolimus-eluting stents (BP-SES) implantation, when the polymer disappears. METHODS: We retrospectively analyzed 2455 patients who underwent successful PCI with BP-SES or durable-polymer everolimus-eluting stents (DP-EES) between September 2011 and March 2021, and compared 2-year clinical outcomes of BP-SES (n = 459) with DP-EES (n = 1996). The outcome measures were target lesion revascularization (TLR) and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. Multivariate analysis using the Cox proportional hazard model and inverse probability weighting (IPW) analysis based on the propensity score were used to evaluate the clinical outcomes. RESULTS: The 2-year cumulative incidences of TLR (BP-SES: 4.9% vs. DP-SES: 6.1%, p = 0.304) and MACE (10.3% vs. 12.5%, p = 0.159) were similar between the two groups. Multivariable and IPW analysis revealed the risks of TLR (p = 0.388 and p = 0.500) and MACE (p = 0.139 and p = 0.083) also had no significant difference. There was a significant interaction between none/mild and moderate/severe calcification with respect to MACE and TLR (adjusted p for interaction = 0.036 and 0.047, respectively). The risk of MACE was significantly lower in BP-SES than in DP-EES in lesions with none/mild calcification (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.30-0.91), while it was similar in those with moderate/severe calcification (aHR: 0.95; 95% CI: 0.58-1.55). CONCLUSIONS: Compared with DP-EES, BP-SES demonstrated durable 2-year clinical outcomes. However, BP-SES showed better clinical performance than DP-EES for lesions with none/mild calcification.

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.

Clinical Outcomes of Patients With Cholesterol Crystal Embolism Accompanied by Lower Extremity Wound.

Cholesterol crystal embolism (CCE) accompanied by a lower extremity wound is occasionally difficult to differentiate from chronic limb-threatening ischemia (CLTI) and treat. The present multi-center retrospective observational study investigated the clinical characteristics and prognosis of CCE with lower extremity wounds. Consecutive patients (n = 58) clinically diagnosed as CCE with lower extremity wounds between April 2010 and December 2019 were studied. CCE was diagnosed using histological findings, foot condition, renal impairment, and eosinophilia. The primary outcome was 1-year wound healing rate. Patients with CCE were compared with 1309 patients diagnosed with CLTI with tissue loss during the same study period. The CCE group had a significantly more severe Wound, Ischemia, and foot Infection (WIfI) classification compared with the CLTI group. After Kaplan-Meier analysis, the CCE group had a similar 1-year wound healing (55.1 vs 58.3%, P = .096) as the CLTI group. In multivariate stratified Cox regression analysis by WIfI stages, CCE was significantly associated with poor wound healing compared with CLTI [hazard ratio .36 (95% confidence interval .21-.62)]. In conclusion, among the similar WIfI clinical stages, wound healing was significantly worse in the CCE group than in the CLTI group.

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.

Gender Differences in Atrial Fibrosis and Cardiomyopathy Assessed by Left Atrial Low-Voltage Areas During Catheter Ablation of Atrial Fibrillation.

Atrial myocardial degeneration predisposes to atrial fibrillation (AF), ischemic stroke, and heart failure. Studies suggest the presence of gender differences in atrial myocardial degeneration. This study aimed to delineate gender differences in the prevalence, predictors, and prognostic impact of left atrial low-voltage areas (LVAs). This observational study included 1,488 consecutive patients who underwent 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. LVA prevalence was higher in women (38.7%) 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 gender 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 gender category, with a respective hazard ratio, 95% confidence interval, and p value of 2.45, 1.87 to 3.22, and <0.0001 in men and 1.82, 1.33 to 2.49, and <0.0001 in women. In conclusion, LVA was more frequent in women than men, and predicted frequent AF recurrence irrespective of gender category.

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 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.

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.

Identification of post-procedural optical coherence tomography findings associated with the 1-year vascular response evaluated by coronary angioscopy.

Optical coherence tomography (OCT) provides higher resolution intravascular imaging and allows detailed evaluations of stent implantation sites post-percutaneous coronary intervention (PCI). Coronary angioscopy (CAS) can evaluate the vascular response after drug-eluting stent (DES) implantation. The post-PCI OCT findings that are associated with the CAS 1-year vascular response have not been known. We enrolled 168 lesions from 119 patients who underwent OCT-guided PCI using DES and follow-up CAS observation at 1 ± 0.5 year from August 2012 to December 2019. Outcome measures were sufficient neointimal coverage (NIC) defined as stent struts embedded in the neointima, subclinical intrastent thrombus, and vulnerable stented segments defined as those with angioscopic yellow or intensive yellow color 1 year after PCI. We identified the post-PCI OCT findings associated with these CAS findings. Sufficient NIC, subclinical intrastent thrombus, and vulnerable stented segment were detected in 85 lesions (51%), 47 lesions (28%), and 54 lesions (32%), respectively. A multivariate analysis demonstrated that malapposed struts were negatively associated with sufficient NIC (odds ratio 0.87; 95% CI 0.76-0.99; p = 0.029). However, no specific OCT findings immediately after PCI were associated with subclinical intrastent thrombus or vulnerable stented segment. Malapposition immediately after PCI was negatively associated with sufficient NIC at 1 year even without associations between post-PCI OCT findings and subclinical intrastent thrombus or vulnerable stented segment.

Very Early Progression of an In-Stent Calcified Nodule 2 Weeks After Drug-Eluting Stent Implantation in the Calcified Lesion.

In-stent calcified nodules (CNs) are one of the mechanisms of in-stent restenosis, but their underlying cause has not been elucidated. We report a case of a patient with early stent thrombosis due to an in-stent CN only 2 weeks after drug-eluting stent implantation. The fact that the in-stent CN was detected only 2 weeks after the initial percutaneous coronary intervention means that the underlying mechanism was the progression of the CN, indicating that in-stent CNs can occur even in the subacute phase. After percutaneous coronary intervention for a severe calcified lesion, very early progression of CNs can occur, and they require close follow-up and intensive antiplatelet therapy.

La présence d'un nodule calcifié (NC) est l'un des facteurs pouvant donner lieu à une resténose intra-endoprothèse, mais la cause sous-jacente n'est pas encore bien comprise. Nous décrivons ici le cas d'une patiente qui a subi une thrombose précoce due à un NC à l'intérieur de la prothèse à peine deux semaines après la mise en place d'une endoprothèse médicamentée. La détection du NC dans la prothèse seulement deux semaines après l'intervention percutanée initiale signifie que la progression du NC constitue la cause sous-jacente et indique que des NC peuvent survenir même au cours de la phase subaiguë. Après une intervention coronarienne percutanée pour traiter une lésion calcifiée grave, une progression très précoce des NC peut avoir lieu, d'où l'importance d'un suivi rigoureux et d'un traitement antiplaquettaire intensif.