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

BACKGROUND AND 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: A left atrial-PV model was constructed using a 3-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 5 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. RESULTS: Tissue cooling effects were in the order of the 2-mm, 4-mm, and 6-mm thicknesses (Figure), with an average temperature of -41.4 ± 4.2 for 2 mm, -33.0 ± 4.0 for 4 mm, and 8.0 ± 8.7 °C for 6 mm at 180 sec (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, 3.9 ± 0.7, 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.

Impact of baseline yellow plaque assessed by coronary angioscopy on vascular response after stent implantation.

BACKGROUND: The relationship between baseline yellow plaque (YP) and vascular response after stent implantation has not been fully investigated. METHODS: This was a sub-analysis of the Collaboration-1 study (multicenter, retrospective, observational study). A total of 88 lesions from 80 patients with chronic coronary syndrome who underwent percutaneous coronary intervention were analyzed. Optical coherence tomography (OCT) and coronary angioscopy (CAS) were serially performed immediately and 11 months after stent implantation. YP was defined as the stented segment with yellow or intensive yellow color assessed by CAS. Neoatherosclerosis was defined as a lipid or calcified neointima assessed by OCT. OCT and CAS findings at 11 months were compared between lesions with baseline YP (YP group) and lesions without baseline YP (Non-YP group). RESULTS: Baseline YP was detected in 37 lesions (42 %). OCT findings at 11 months showed that the incidence of neoatherosclerosis was significantly higher in the YP group (11 % versus 0 %, p = 0.028) and mean neointimal thickness tended to be lower (104 ±â€¯43 µm versus 120 ±â€¯48 µm, p = 0.098). CAS findings at 11 months demonstrated that the dominant and minimum neointimal coverage grades were significantly lower (p = 0.049 and P = 0.026) and maximum yellow color grade was significantly higher (p < 0.001) in the YP group. CONCLUSIONS: Baseline YP affected the incidence of neoatherosclerosis as well as poor neointimal coverage at 11 months after stent implantation.

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.

Sex Differences in 5-Year Outcomes After Deferral of Revascularization Following Physiological Coronary Assessment.

Background: The relationship between sex differences and long-term outcomes after fractional flow reserve (FFR)- and instantaneous wave-free ratio (iFR)-guided deferral of revascularization has yet to be elucidated. Methods and Results: From the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on FFR in a multicenter registry), this study included 432 lesions from 385 patients (men, 323 lesions in 286 patients; women, 109 lesions in 99 patients) with paired data of FFR and iFR. The primary endpoint was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. The median FFR value was lower in men than in women (0.85 [0.81, 0.88] vs. 0.87 [0.83, 0.91], P=0.002), but the iFR value was comparable between men and women (0.94 [0.90, 0.98] vs. 0.93 [0.89, 0.98], P=0.26). The frequency of discordance between FFR and iFR was comparable between men and women (19.5% vs. 23.9%, P=0.34), although with different discordance patterns (P=0.036). The cumulative incidence of 5-year TVF did not differ between men and women after adjustment for baseline characteristics (13.9% vs. 6.9%, adjusted hazard ratio 1.82 [95% confidence interval: 0.44-7.56]; P=0.41). Conclusions: Despite sex differences in the results for physiological indexes, the 5-year TVF in deferred lesions did not differ between men and women after adjustment for baseline characteristics.

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.

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.

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.

Prognostic Impact of Renal Function on 5-Year Outcomes After Fractional Flow Reserve-Guided Deferral of Revascularization.

Background Chronic kidney disease (CKD) might influence fractional flow reserve (FFR) value, potentially attenuating its prognostic utility. However, few large-scale data are available regarding clinical outcomes after FFR-guided deferral of revascularization in patients with CKD. Methods and Results From the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1218 patients were divided into 3 groups according to renal function: (1) non-CKD (estimated glomerular filtration rate ≥60 mL/min per 1.73 m2), n=385; (2) CKD (estimated glomerular filtration rate 15-59 mL/min per 1.73 m2, n=763); and (3) end-stage renal disease (ESRD) (eGFR <15 mL/min per 1.73 m2, n=70). The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinical driven target vessel revascularization. Cumulative 5-year incidence of TVF was significantly higher in the ESRD group than in the CKD and non-CKD group, whereas it did not differ between the CKD and non-CKD groups (26.3% versus 11.9% versus 9.5%, P<0.001). Although the 5-year TVF risk increased as the FFR value decreased regardless of renal function, patients with ESRD had a remarkably higher risk of TVF at every FFR value than those with CKD and non-CKD. Conclusions At 5 years, patients with ESRD showed a higher incidence of TVF than patients with CKD and non-CKD, although with similar outcomes between patients with CKD and non-CKD. Patients with ESRD had an excess risk of 5-year TVF at every FFR value compared with those with CKD and non-CKD. Registration URL: https://www.umin.ac.jp; Unique identifier: UMIN000014473.

Angiographic patterns of restenosis after drug-coated balloon angioplasty for femoropopliteal lesions and 1-year prognosis after repeat endovascular therapy.

AIM: The aim of the current study sought to investigate the angiographic patterns of restenosis after drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions and which repeat endovascular therapy (EVT) for DCB restenosis would provide more freedom from recurrent restenosis. METHODS: This retrospective multicenter study included 119 limbs (chronic limb-threatening ischemia [CLTI]: 55%, lesion length: 136.9 ± 89.6 mm, chronic total occlusion: 25%) of 95 patients (diabetes mellitus: 70%, hemodialysis: 56%) who were diagnosed with DCB restenosis between January 2018 and December 2019. The cases were classified into three groups based on angiographic patterns of restenosis: Class I: focal lesions ≤50 mm, Class II: diffuse lesions >50 mm, and Class III: totally occluded lesions. The DCB restenosis patterns and frequency and predictors of recurrent restenosis after repeated EVT (re-EVT) were investigated. RESULTS: The mean follow-up duration was 29.8 ± 9.5 months. Groups I, II, and III comprised of 30 (25.2%), 55 (46.2%), and 34 (29.0%) cases, respectively. The overall rate of 1-year freedom from recurrent restenosis was 58.2%. One-year rate of freedom from recurrent restenosis after repeat DCB was not statistically different from that after scaffolding (71.1% vs. 74.6%, respectively, p = 0.911); however, it was significantly better than that after noncoated balloon angioplasty (repeat DCB vs. noncoated balloon angioplasty: 71.1% vs. 25.7%, respectively, p < 0.001). Multivariate analysis demonstrated that CLTI (hazard ratio [HR]: 5.15, p < 0.001) and re-EVT with noncoated balloon (HR: 3.16, p < 0.001) were significantly associated with recurrent restenosis; however, Class III pattern of DCB restenosis was not associated with recurrent restenosis (HR: 1.04, p = 0.918). CONCLUSIONS: This study revealed the angiographic patterns of restenosis after DCB therapy for FP lesions and the 1-year rate of recurrent restenosis after repeat revascularization. Repeat DCB therapy demonstrated acceptable 1-year recurrent restenosis rates.

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.

Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

BACKGROUND: There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years. AIMS: We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. METHODS: The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES. RESULTS: From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. CONCLUSIONS: The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.

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.

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.