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.

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.

Impact of Guideline-Directed Medical Therapy on 10-Year Mortality after Revascularization for Patients with Chronic Limb-Threatening Ischemia.

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

Influence of catheter ablation for atrial fibrillation on atrial and ventricular functional mitral regurgitation.

AIMS: The purpose of this study was to compare the impact of catheter ablation on cardiac structural reverse remodelling and atrial (AFMR) and ventricular (VFMR) functional mitral regurgitation (MR), and the long-term prognosis of patients with AFMR and VFMR. METHODS AND RESULTS: The retrospective study included persistent AF patients who had AFMR (n = 136, left atrial (LA) volume index >30 mL/m2 and left ventricular (LV) ejection fraction ≥40%) or VFMR (n = 31, LV ejection fraction <40% or LV regional asynergy) and had undergone the initial AF ablation from April 2015 to December 2019. Baseline and 6 month follow-up echocardiography were performed to assess MR, LA, and LV sizes. MR improvement after ablation was comparable in the AFMR (64%) and VFMR groups (52%, P = 0.20). Patients with AFMR improvement showed a greater decrease in left atrial volume after ablation than those without (amount of change: -11.4 ± 15.1 vs. -2.3 ± 21.1 mL/m2 , P = 0.01). Patients with VFMR improvement showed a greater increase in LV ejection fraction than those without (amount of change: 28.5 ± 13.6% vs. 9.0 ± 14.8%, P = 0.001). The composite endpoint of all-cause death and heart failure hospitalization during the 2 year follow-up period was more frequently observed in the VFMR than in the AFMR group (22.6% vs. 3.7%, P < 0.0001). Patients with MR improvement after catheter ablation less frequently demonstrated the composite endpoint than those without (1.9% vs. 15.6%, P < 0.0001). CONCLUSIONS: Atrial functional mitral regurgitation and VFMR improvement after ablation were associated with atrial and ventricular reverse remodelling, respectively. It is possible that long-term prognosis is better in patients with AFMR than with VFMR, and in those with MR improvement than in those without.

Safety, efficacy, and cost-performance of a simplified cryoballoon ablation procedure for paroxysmal atrial fibrillation.

BACKGROUND: The search for a less invasive and lower cost cryoballoon-based strategy for atrial fibrillation (AF) ablation has resulted in a simplified procedure that may be suitable for cryoballoon ablation (CBA). Here, we compared procedural characteristics and outcomes between conventional CBA and simple CBA. METHODS: We enrolled 628 consecutive patients who underwent initial CBA for AF (age, 69 ± 12 years; female, 263 (42%); paroxysmal AF, 576 (92%); CHA2DS2-VASc score, 2.7 ± 1.6 points). Simple CBA was characterized by the minimal procedure required to isolate pulmonary veins, including the following: (1) CBA was performed without guidance from a 3-D mapping system; (2) a coronary sinus electrode and esophageal temperature probe were not used; (3) a waiting period after pulmonary vein isolation was not set; and AF induction by isoproterenol and atrial burst stimuli were not performed. RESULTS: Simple CBA was performed in 240 (38%) patients. Procedural time (49 ± 18 versus 85 ± 27 min, p < 0.01) was shorter, and total procedural costs (20,699 ± 8,091 versus 30,350 ± 11,647 US dollars, p < 0.01) were lower with simple CBA than conventional CBA. Freedom from AF recurrence during the 12-month study period (79.8% versus 78.4%, p = 0.52) and complication rate (8.8% versus 13.1%, p = 0.09) were similar between the two groups. CONCLUSION: Compared with conventional CBA, simple CBA reduced procedural time and procedural costs while providing comparable outcomes.

Consensus document on the standard of coronary angioscopy examination and assessment from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Coronary angioscopy (CAS) is a unique diagnostic device that allows direct visualization of the vascular luminal surface in living patients. CAS contributes to elucidate the pathology of coronary artery disease. This consensus document provides a standard for CAS examination and assessment.

Saphenous vein size as a surrogate marker for mortality of patients with chronic limb-threatening ischemia undergoing endovascular therapy.

BACKGROUND: The size of the autologous vein graft is an important determinant of prognosis in patients with chronic limb-threatening ischemia (CLTI) undergoing bypass surgery. However, it is unclear whether reconstruction using a small vein graft would directly affect prognosis, or a subgroup having small veins would be subject to a poor prognosis. If the latter is true, having small veins would work as a marker for a poor prognosis even in patients with CLTI undergoing endovascular therapy (EVT). Therefore, we investigated the association between the size of saphenous veins and prognosis in patients with CLTI undergoing EVT. METHODS: This study included 209 consecutive patients with CLTI who primarily underwent EVT between January 2017 and December 2018. The diameter of the saphenous vein was measured at three locations (saphenous-femoral junction, knee, and ankle joint) per limb before EVT by ultrasonography. A small saphenous vein was defined as the mean diameter <3.0 mm. RESULTS: All-cause mortality rate was significantly higher in patients with a small saphenous vein than in those with non-small one (46.3% versus 10.7% at 2 years, p<0.001). The multivariate Cox regression analysis revealed that a small saphenous vein was independently associated with an increased risk of all-cause mortality. CONCLUSIONS: Having a small saphenous vein was an independent marker for all-cause mortality in patients with CLTI undergoing EVT.

Improved crossability with novel cutting balloon versus scoring balloon in the treatment of calcified lesion.

Cutting balloons and scoring balloons are commonly used for the preparation of calcified lesion. However, problems with crossability occasionally limit the use of cutting balloons. We prospectively selected 173 calcified lesions treated using a novel cutting balloon (Wolverine™, C group). As control, we retrospectively analyzed 146 calcified lesions treated using a scoring balloon (Lacrosse NSE ALPHA™, S group). Either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was used by the operator's discretion. The primary outcome was delivery success, which was defined as successful passage to the target lesion immediately after IVUS or OCT evaluation. The secondary outcome was acute cross-sectional area (CSA) gain, which was defined as post-interventional minimum stent area minus pre-procedural minimum lumen area. A multivariate analysis evaluated the independent predictors for delivery success. The delivery success rate was significantly higher in the C group versus the S group (90.8% versus 79.5%, P = 0.006). However, the acute CSA gain was similar between the two groups (IVUS: 3.2 ± 1.8 mm2 versus 3.4 ± 1.9 mm2, P = 0.53; OCT: 3.6 ± 1.4 mm2 versus 4.1 ± 1.9 mm2, P = 0.11). Usage of cutting balloon was an independent predictor for delivery success even after the adjustment for the patient and lesion characteristics [odds ratio (OR): 2.72 (95% confidence interval 1.38-5.33), P = 0.004] as well as the procedural characteristics [OR: 2.34 (1.15-4.86), P = 0.018]. Novel cutting balloons demonstrated better crossability and similar acute CSA gain compared with scoring balloons in calcified lesion.

Angioscopic assessments and clinical outcomes one year after polymer-free biolimus A9-coated coronary stent implantation.

BACKGROUND: Polymer-free biolimus A9-coated coronary stent (DCS) has novel features which lead to the expectation of better arterial healing. However, comparisons of intravascular status between DCS and drug-eluting stents (DES), and robust real-word clinical assessments of DCS have been lacking to date. METHODS: From September 2017 to September 2018, we evaluated the intra-vascular status of 74 DCS implanted in 55 lesions from 43 patients using coronary angioscopy (CAS) approximately one year after implantation from a cohort of 219 lesions in 158 patients. We set 239 second-generation durable-polymer DES (DP-DES) implanted in 211 lesions from 180 patients from a cohort of 2652 lesions in 1914 patients as the control. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the heterogeneity of NIC; (3) yellow color grade of the stented segment; and (4) the presence of intra-stent thrombus. The primary outcome was the incidence of thrombus and secondary outcomes were the other CAS findings, and the 1-year clinical outcomes which included target lesion revascularization (TLR) and major adverse cardiac events (MACE). To minimize inter-group differences in baseline characteristics, propensity score matching was performed for clinical outcomes. RESULTS: Incidence of thrombus adhesion was similar in DCS and DP-DES groups (28.4% versus 22.6%, p=0.31). However, the dominant NIC grade was significantly higher in DCS (p<0.001), while NIC was more heterogeneous in DCS than in DP-DES (p=0.001). Maximum yellow color grade was similar (p=0.22). After propensity score matching, 202 lesion pairs from 146 patient pairs were retained for analysis. The cumulative incidence of TLR (4.6% versus 3.8%, p=0.38) and MACE (11.6% versus 11.7%, p=0.84) was similar for DCS and DP-DES. CONCLUSIONS: DCS showed thrombus adhesion and clinical outcomes at 1 year similar to DP-DES. DCS can thus be used with similar safety and efficacy as DP-DES.

Impact of diabetes mellitus on the early-phase arterial healing after drug-eluting stent implantation.

BACKGROUND: Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation. METHODS: This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3-5 months after DES implantation. We divided the lesion into two groups: DM (n = 149) and non-DM (n = 188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. RESULTS: Minimum NIC grade was significantly lower in DM than in non-DM groups (p = 0.002), whereas dominant and maximum NIC grades were similar between them (p = 0.59 and p = 0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p = 0.32) and maximum yellow color grade (p = 0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19-3.86, p = 0.011). CONCLUSIONS: DM patients showed more uncovered struts than non-DM patients 3-5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

Angioscopic Assessments at 3 Months After Fluoropolymer-Based Paclitaxel-Eluting Stent Implantation for Femoropopliteal Endovascular Intervention.

BACKGROUND: The detailed mechanism of early-phase arterial healing after novel fluoropolymer-based paclitaxel-eluting stent (PES) implantation in the femoropopliteal (FP) lesions has not been elucidated.Methods and Results:We evaluated the intravascular status of 20 PES implanted in 11 FP lesions of 9 patients using angioscopy at approximately 3 months after implantation. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the extent of uncovered struts; and (3) the presence of intrastent thrombus. NIC was classified into 4 grades: grade 0, stent struts fully visible; grade 1, stent struts bulging into the lumen although covered; grade 2, stent struts embedded in neointima, but translucently visible; grade 3, stent struts fully embedded and invisible. The extent of uncovered struts was scored as follows: score 0, no uncovered struts of the entire stent; score 1, uncovered struts area approximately <30% of the stent; and score 2, uncovered struts area approximately ≥30% of the stent. In total, 90% of stents demonstrated grade 1 dominant NIC and 10% showed grade 2 dominant NIC; 85% of stents showed an uncovered stent score of 0, and the remainder had a score of 1. Thrombus was observed in all stents. CONCLUSIONS: Widely uncovered stent struts were not observed by angioscopy at 3 months after PES implantation in these FP lesions, even with the detection of thrombus adhesion.

Additional Low-Voltage-Area Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the Randomized Controlled VOLCANO Trial.

Background The efficacy of low-voltage-area (LVA) ablation has not been well determined. This study aimed to investigate the efficacy of LVA ablation in addition to pulmonary vein isolation on rhythm outcomes in patients with paroxysmal atrial fibrillation (AF). Methods and Results VOLCANO (Catheter Ablation Targeting Low-Voltage Areas After Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation. Of 398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A). The remaining 62 (15%) patients with LVAs were randomly allocated to undergo LVA ablation (group B, n=30) or not (group C, n=32) in a 1:1 fashion. Primary end point was 1-year AF-recurrence-free survival rate. No adverse events related to LVA ablation occurred. Procedural (124±40 versus 95±33 minutes, P=0.003) and fluoroscopic times (29±11 versus 24±8 minutes, P=0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%, P<0.0001; C, 53%, P<0.0001). However, LVA ablation in addition to pulmonary vein isolation did not impact AF-recurrence-free survival rate (group B versus C, P=0.67). Conclusions The presence of LVA was a strong predictor of AF recurrence after pulmonary vein isolation in patients with paroxysmal AF. However, LVA ablation had no beneficial impact on 1-year rhythm outcomes. Registration URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000023403.

A Global Vascular Guidelines-Based Bypass-Preferred Population and Their Surgical Risk Among CLTI Patients Treated With Endovascular Therapy in a Real-World Practice.

PURPOSE: To determine in a chronic limb-threatening ischemia (CLTI) population who underwent endovascular therapy (EVT) how many patients would have been categorized as preferred for bypass surgery according to the Global Vascular Guidelines (GVG) and ascertain their surgical risk. MATERIALS AND METHODS: The current study analyzed 1043 CLTI patients who presented WIfI (wound, ischemia, and foot infection) stage ≥2 and underwent EVT between April 2010 and December 2017. Of these, 176 were excluded for lack of angiographic or other data, leaving 867 CLTI patients (mean age 74±10 years; 523 men) for stratification according to the GVG into bypass-preferred, indeterminate, or EVT-preferred groups. The GVG recommend bypass as the first-line treatment when the wound is severe (WIfI stage ≥3) and lesions are complex (GLASS stage III). Surgical risk was estimated using the modified PREVENT III risk score. To further stratify the bypass-preferred population according to mortality risk, a survival decision tree was constructed using recursive partitioning. RESULTS: The bypass-preferred group accounted for 55% [95% confidence interval (CI) 51% to 58%] of the overall population. The decision tree analysis extracted a low-mortality risk subgroup with a survival rate of 99% (95% CI 98% to 100%) at 1 month and 80% (95% CI 73% to 87%) at 2 years. According to the PREVENT III score, 34% (95% CI 27% to 42%) of the low mortality risk subgroup were classified as high surgical risk. CONCLUSION: A high proportion of patients undergoing EVT were considered bypass preferred based on the GVG, and the survival of these patients was not significantly different whether they were high or low surgical risk.

A saline contrast-enhanced echocardiography-guided approach to cryoballoon ablation.

BACKGROUND: Pulmonary vein isolation (PVI) with a cryoballoon usually uses iodinated contrast medium for confirmation of venous occlusion. We hypothesized that an alternative to angiography with iodinated contrast, saline bolus-enhanced echocardiography with the microbubbles formed in situ, could be used to assess venous occlusion. We sought to assess the efficacy and safety of the contrast-enhanced intracardiac echocardiographic (ICE) approach. METHODS: Thirty-four consecutive patients without iodine sensitivity or renal insufficiency were studied to assess the accuracy of ICE-guided PV occlusion underwent both angiographic guidance and ICE guidance (validation group). Twenty consecutive patients with paroxysmal atrial fibrillation (AF) and contraindications to iodinated contrast medium (ICE-guided group) underwent PV occlusion and ablation with ICE guidance alone. Procedural results and clinical outcomes were compared with those of 245 control patients undergoing PVI by the conventional angiographic method (control group). RESULTS: In the validation group, ICE-guided PV occlusion was as effective as angiography-guided PV occlusion. In the ICE-guided group, two patients required touch-up ablation using a radiofrequency ablation catheter with fluoroscopic guidance. Procedure time, radiation exposure, and requirements for touch-up ablation were similar between the ICE-guided group and the control group. In patients requiring only PVI, the ICE-guided approach involved significantly less radiation exposure than the conventional approach. There was no significant difference in atrial fibrillation (AF)-free survival rate between the two groups during a follow-up period of 14 ± 6 months. CONCLUSIONS: An echo-guided approach using saline infusion was effective in terms of avoidance of iodinated contrast use and radiation exposure.

One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease.

AIM: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX. METHODS: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year. RESULTS: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group. CONCLUSION: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Efficacy and safety of the cryoballoon-based atrial fibrillation ablation in patients aged ≥80 years.

INTRODUCTION: The prevalence of atrial fibrillation (AF) increases with age. Although the efficacy of cryoballoon ablation (CB-A) in patients with AF has been demonstrated, data on the efficacy of this CB-A in elderly patients are limited. The aim of this study was to evaluate the 1-year efficacy and safety of CB-A in patients aged ≥80 years compared with those less than 80 years. METHODS: A total of 49 consecutive patients ≥80 years with paroxysmal AF (PAF) who underwent CB-A were compared with 241 patients aged <80 years. AF-free survival rate at 1 year and procedural data were compared between the groups. RESULTS: Median (25th, 75th quartile) age was 83 (82, 85) years in the older group and 68 (61, 73) years in the younger group. At 1-year follow-up, the success rate did not significantly differ between the groups. In Cox regression analysis, age ≥80 years was not significantly related to AF recurrence. Low-voltage areas were more frequently observed in the elderly group than the control group (39% vs 17%; P = .01). Fluoroscopy time and procedure time did not differ significantly. There was no significant difference in the occurrence rate of transient phrenic nerve palsy. No severe complications occurred in either group, including procedure-related deaths, atrioesophageal fistula, cardiac tamponade, and cerebrovascular embolic events. CONCLUSION: The results of our study showed that CB-A for PAF is a feasible and safe procedure even in elderly patients, with similar success and complication rates when compared with a younger population.

Additional Risk Stratification Using Local and Systemic Factors for Patients with Critical Limb Ischaemia Undergoing Endovascular Therapy in the WIfI Era.

OBJECTIVES: While current guidelines describe the importance of assessing limb characteristics for predicting limb prognosis in patients with critical limb ischaemia (CLI), several reports have also suggested that systemic factors are associated with limb prognosis. The aim of this study was to evaluate whether systemic factors have the same impact on wound healing as limb characteristics in CLI patients undergoing endovascular therapy. METHODS: A total of 735 patients who were treated for the first time for CLI with tissue loss between April 2010 and December 2015 were extracted from a prospective registry and data for the Wound, Ischaemia, and foot Infection (WIfI) classification were searched retrospectively. The predictors of wound healing were explored with Cox proportional hazards regression. RESULTS: The one year wound healing rate was 60.2% in WIfI stage 1-3 patients and 53.6% in WIfI stage 4 (p = .01). In WIfI stage 1-3, no systemic factors were significantly associated with wound healing, whereas, in WIfI stage 4 patients, non-ambulatory status [hazard ratio (HR) 1.98; 95% confidence interval (CI) 1.37-2.84], haemodialysis (HR 1.90; 95% CI 1.33-2.72) and an albumin level under 3.0 g/dL (HR 1.53; 95% CI 1.02-2.31), were identified as independent risk factors for failure to achieve wound healing. If none or one of these risk factors were present, wound healing was comparable with WIfI 4 and WIfI 1-3 patients (67.7% vs. 63.6%, p = .89), whereas in patients with two or more risk factors wound healing was worse in WIfI 4 than in WIfI 1-3 patients (35.7% vs. 49.5%, p = .01). CONCLUSION: Non-ambulatory status, haemodialysis, and a low albumin level were additional systemic risk factors for impaired wound healing in patients with WIfI stage 4. The wound healing rate in WIfI stage 4 patients with one or fewer of these risk factors was comparable to that in WIfI stage 1-3.

Comparison of ablation outcomes of the second ablation procedure for recurrent atrial fibrillation using an ultra-high-resolution mapping system and conventional mappings system.

BACKGROUND: The utility of an ultra-high-resolution electroanatomical mapping system (UHR-EAM, Rhythmia) for repeat atrial fibrillation (AF) ablation has not been evaluated. HYPOTHESIS: A second AF ablation procedure performed using UHR-EAM may demonstrate different outcomes compared with that using a conventional electroanatomical mapping system (C-EAM, CARTO3). METHOD: This observational study enrolled consecutive patients who underwent a second AF ablation procedure using UHR-EAM (n = 103) and C-EAM (n = 153). The second ablation procedure included re-isolation of reconnected pulmonary veins (PVs) and elimination of clinical or induced non-PV AF triggers and atrial tachycardia (AT). Other empirical ablations were additionally conducted at the discretion of the operators. RESULTS: Re-isolation of PVs was achieved in 196 patients who had ≥1 left atrial-PV reconnection. The elimination rate of AT was higher in the UHR-EAM group than the C-EAM group (87% vs 65%, P = .040), while that of non-PV AF triggers was similar (63% vs 63%, P = 1.00). The UHR-EAM demonstrated shorter radiofrequency application time (21.8 ± 16.8 vs 28.0 ± 21.3 minutes, P = .017), but longer fluoroscopic time (26.2 ± 12.6 vs 21.4 ± 9.3 minutes, P = .0001). No severe complication developed. The total 1-year AF/AT-free survival rates were similar between the two groups (off AADs, 59.2% vs 56.2%, P = .62; on AADs, 65.0% vs 69.3%, P = .49). CONCLUSION: The efficacy and safety outcomes of repeat AF ablation using UHR-EAM was comparable to those using C-EAM.

Vascular response to paclitaxel-eluting nitinol self-expanding stent in superficial femoral artery lesions: post-implantation angioscopic findings from the SHIMEJI trial (Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation).

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Early- and middle-phase arterial repair following bioresorbable- and durable-polymer drug-eluting stent implantation: An angioscopic study.

BACKGROUND: Bioresorbable-polymer drug-eluting stent (BP-DES) demonstrates comparable clinical outcomes compared to durable-polymer drug-eluting stent (DP-DES). However, early- and middle-phase arterial repair following deployment of BP-DES and DP-DES has not been elucidated to date. METHODS: We extracted coronary angioscopy (CAS) findings covering early phase (4 ±â€¯1 months) or middle phase (10 ±â€¯2 months) between January 2010 and February 2018 from the database of Kansai Rosai Hospital. Neointimal coverage (NIC), yellow color intensity of the stented segment and incidence of thrombus adhesion were compared between BP-DES (Synergy or Ultimaster) and DP-DES (Promus or Resolute or Xience) in early (39 BP-DES of 33 lesions from 24 patients and 83 DP-DES of 74 lesions from 56 patients) and middle (198 BP-DES of 175 lesions from 135 patients and 204 DP-DES of 184 lesions from 149 patients) phases. RESULTS: In early phase, while NIC was similar in both groups (P = 0.84), the incidence of thrombus adhesion was significantly higher in BP-DES than in DP-DES (67% versus 34%, P = 0.001) even though maximum yellow color was less intense in BP-DES (P = 0.004). In middle phase, while NIC was better in BP-DES (P < 0.001), thrombus adhesion (23% versus 22%, P = 0.81) and maximum yellow color (P = 0.72) were similar in both groups. CONCLUSIONS: Although NIC was similar in the early phase, the incidence of thrombus adhesion was significantly higher in BP-DES than in DP-DES. The incidence of thrombus adhesion reached similar values and NIC improved in BP-DES over that in DP-DES in the middle phase.