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Background: In patients with persistent atrial fibrillation (AF), extensive ablation for substrate modification, such as linear ablation or complex fractionated atrial electrogram ablation in addition to pulmonary vein isolation (PVI) remains controversial. Previous studies investigating extensive ablation have demonstrated its varying efficacy, suggesting the possible heterogeneity of its efficacy. Aging is a major risk factor for AF and is associated with atrial remodeling. We aimed to compare the efficacy and safety of the extensive ablation strategy compared with PVI alone strategy between young and elderly patients., Methods: This study is a post-hoc analysis of the multicenter, randomized controlled, noninferiority trial investigating the efficacy and safety of PVI-only (PVI-alone arm) compared with extensive ablation (PVI-plus arm) in patients with persistent AF (EARNEST-PVI trial). We divided the overall population into 2 groups based on age and assessed treatment effects., Results: In the young group (age <65 years, N = 206), there was no significant difference in the recurrence rate between the PVI-alone group and PVI-plus group [hazard ratio (HR): 1.00, 95 % CI: 0.57-1.73, p = 0.987], whereas the recurrence rate was significantly lower in the PVI-plus group compared to the PVI-alone group in the elderly group (age ≥65 years, N = 291) (HR: 0.47, 95 % CI: 0.29-0.76, p = 0.0021) (p for interaction = 0.0446). There were no fatal procedural complications., Conclusion: In patients with persistent AF, the extensive ablation strategy was more effective than the PVI-alone strategy in elderly patients, while the effectiveness of both approaches was comparable in young patients., Trial Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT03514693. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr&#95;e/ctr&#95;view.cgi?recptno=R000022454 Unique ID issued by UMIN: UMIN000019449., Competing Interests: Declaration of competing interest Y. Sotomi has received grants from Roche Diagnostics, FUJIFILM Toyama Chemical, TOA EIYO, Bristol-Myers Squibb, Biosense Webster, Abbott Medical Japan, and NIPRO, and personal fees from Abiomed, Abbott Medical Japan, AstraZeneca, Amgen Astellas BioPharma, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Boston Scientific Japan, Bayer, Daiichi Sankyo, Eli Lilly, Novartis, TERUMO, Medtronic, and Pfizer Pharmaceuticals. S. Hikoso has received grants from Roche Diagnostics, FUJIFILM Toyama Chemical, Actelion Pharmaceuticals; and personal fees from AstraZeneca, Daiichi Sankyo, Astellas Pharma, Bayer, Pfizer Pharmaceuticals, Boehringer Ingelheim Japan, Kowa Company, and Ono Pharmaceutical. D. Nakatani has received personal fees from Roche Diagnostics. T. Dohi has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study. A. Sunaga has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study and personal fees from Bayer, Daiichi Sankyo, and Medtronic, outside the submitted work. M. Masuda has received personal fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, Boston Scientific, Abbott, Nihon Kohden, Otsuka Pharmaceutical, AstraZeneca, and Medtronic, outside the submitted work. T. Watanabe has received personal fees from Biosense Webster, Abbott, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Daiichi Sankyo, Nihon Kohden, and Fukuda Denshi, outside the submitted work. H. Minamiguchi has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study, and personal fees from Medtronic, Abbott, Johnson & Johnson, Nihon Kohden, Biotronik, Japan Lifeline, Daiichi Sankyo, Bayer, Pfizer, Squibb, Boehringer Ingelheim, Kowa, Ono Pharmaceutical, and Otsuka Pharmaceutical, outside the submitted work. Y. Egami has received personal fees from Japan Lifeline and Medtronic, and non-financial support from Johnson & Johnson, Abbott, and Medtronic, outside the submitted work; T. Oka has received personal fees from Medtronic, Biotronik, Abbott, Daiichi Sankyo, Beyer, Bristol-Myers Squibb, Boehringer Ingelheim, MSD, and AstraZeneca, outside the submitted work. Y. Matsuda has received personal fees from Daiichi Sankyo, Boehringer Ingelheim, Bayer, Medtronic, and Biotronik, outside the submitted work. M. Kawasaki has received personal fees from Medtronic, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Bristol-Myers Squibb, and Abbott, and grants from Osaka Heart Club, outside the submitted work. K. Inoue has received personal fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, and Medtronic, outside the submitted work. Y. Sakata has received personal fees from Otsuka Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, AstraZeneca K.K. and Actelion Pharmaceuticals, and grants from Roche Diagnostic, FUJIFILM Toyama Chemical, Bristol-Myers Squibb, Co, Biosense Webster, Inc., Abbott Medical Japan, Otsuka Pharmaceutical, Daiichi Sankyo Company, Mitsubishi Tanabe Pharma Corporation, Astellas Pharma, Kowa Company, Boehringer Ingelheim Japan, and Biotronik. Other authors have nothing to disclose., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Extensive ablation in addition to pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) has not yielded consistent results, indicating diversity in their efficacy. Mitral regurgitation (MR) associated with AF may indicate a higher prevalence of arrhythmogenic substrate, suggesting potential benefits of extensive ablation for these patients., Methods: This post-hoc analysis of the EARNEST-PVI trial compared PVI alone versus an extensive ablation strategy (PVI-plus) in persistent AF patients, stratified by MR presence. The primary endpoint of the study was the recurrence of AF. The secondary endpoints included death, cerebral infarction, and procedure-related complications., Results: The trial included 495 eligible patients divided into MR and non-MR groups. The MR group consisted of 192 patients (89 in the PVI-alone arm and 103 in the PVI-plus arm), while the non-MR group had 303 patients (158 in the PVI-alone arm and 145 in the PVI-plus arm). In the non-MR group, recurrence rates were similar between PVI-alone and PVI-plus arms (Log-rank P = 0.47, Hazard ratio = 0.85 [95%CI: 0.54-1.33], P = 0.472). However, in the MR group, PVI-plus was significantly more effective in preventing AF recurrence (Log-rank P = 0.0014, Hazard ratio = 0.40 [95%CI: 0.22-0.72], P = 0.0021). No significant differences were observed in secondary endpoints between the two arms., Conclusions: For persistent AF patients with mild or greater MR, receiving PVI-plus was superior to PVI-alone in preventing AF recurrence. Conversely, for patients without MR, the effectiveness of extensive ablation was not demonstrated. These findings suggest tailoring ablation strategies based on MR presence can lead to better outcomes in AF management., Competing Interests: Declaration of competing interest Y. Sotomi has received grants from Roche Diagnostics, FUJIFILM Toyama Chemical, TOA EIYO, Bristol-Myers Squibb, Biosense Webster, Abbott Medical Japan, and NIPRO, and personal fees from Abiomed, Abbott Medical Japan, AstraZeneca, Amgen Astellas BioPharma, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Boston Scientific Japan, Bayer, Daiichi Sankyo, Eli Lilly, Novartis, TERUMO, Medtronic, and Pfizer Pharmaceuticals. S. Hikoso has received grants from Roche Diagnostics, FUJIFILM Toyama Chemical, Actelion Pharmaceuticals; and personal fees from AstraZeneca, Daiichi Sankyo, Astellas Pharma, Bayer, Pfizer Pharmaceuticals, Boehringer Ingelheim Japan, Kowa Company, and Ono Pharmaceutical. D. Nakatani has received personal fees from Roche Diagnostics. T. Dohi has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study. A. Sunaga has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study and personal fees from Bayer, Daiichi Sankyo, and Medtronic, outside the submitted work. M. Masuda has received personal fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, Boston Scientific, Abbott, Nihon Kohden, Otsuka Pharmaceutical, AstraZeneca, and Medtronic, outside the submitted work. T. Watanabe has received personal fees from Biosense Webster, Abbott, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Daiichi Sankyo, Nihon Kohden, and Fukuda Denshi, outside the submitted work. H. Minamiguchi has received grants from Medtronic, Johnson & Johnson, and Abbott, during the conduct of the study, and personal fees from Medtronic, Abbott, Johnson & Johnson, Nihon Kohden, Biotronik, Japan Lifeline, Daiichi Sankyo, Bayer, Pfizer, Squibb, Boehringer Ingelheim, Kowa, Ono Pharmaceutical, and Otsuka Pharmaceutical, outside the submitted work. Y. Egami has received personal fees from Japan Lifeline and Medtronic, and non-financial support from Johnson & Johnson, Abbott, and Medtronic, outside the submitted work; T. Oka has received personal fees from Medtronic, Biotronik, Abbott, Daiichi Sankyo, Beyer, Bristol-Myers Squibb, Boehringer Ingelheim, MSD, and AstraZeneca, outside the submitted work. Y. Matsuda has received personal fees from Daiichi Sankyo, Boehringer Ingelheim, Bayer, Medtronic, Boston Scientific Japan, Japan Lifeline, Asahi Kasei ZOLL Medical, Synaptic Medical Japan and Biotronik, outside the submitted work. M. Kawasaki has received personal fees from Medtronic, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Bristol-Myers Squibb, and Abbott, and grants from Osaka Heart Club, outside the submitted work. K. Inoue has received personal fees from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, and Medtronic, outside the submitted work. Y. Sakata has received personal fees from Otsuka Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, AstraZeneca K.K. and Actelion Pharmaceuticals, and grants from Roche Diagnostic, FUJIFILM Toyama Chemical, Bristol-Myers Squibb, Co, Biosense Webster, Inc., Abbott Medical Japan, Otsuka Pharmaceutical, Daiichi Sankyo Company, Mitsubishi Tanabe Pharma Corporation, Astellas Pharma, Kowa Company, Boehringer Ingelheim Japan, and Biotronik. Other authors have nothing to disclose., (Copyright © 2023. Published by Elsevier B.V.)

Background: The optimal duration of atrial fibrillation (AF) persistence for predicting poor outcomes after catheter ablation of long-standing AF (LsAF) and the best ablation strategy for these patients remain unclear., Objective: We aimed to assess the impact of the duration of AF persistence on outcomes after catheter ablation of AF., Methods: We analyzed the Efficacy of Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation (EARNEST-PVI) trial data comparing pulmonary vein isolation (PVI) alone (PVI-alone) with additional linear ablation or defragmentation (PVI-plus) in persistent AF (PerAF). Patients who received catheter ablation by contact force-sensing catheter were enrolled in the study. In patients with LsAF, the optimal cutoff duration of AF persistence was evaluated. With use of the threshold, patients with LsAF were divided into 2 groups and compared with PerAF <1 year for arrhythmia-free survival after a 3-month blanking period., Results: The optimal cutoff duration was 2.4 years. Of 458 patients, arrhythmia-free survival rates for LsAF 1-2.4 years were comparable to those of PerAF (hazard ratio [HR], 1.01; 95% CI, 0.67-1.52). However, LsAF >2.4 years had a higher recurrence risk than PerAF (HR, 2.22; 95% CI, 1.42-3.47). In LsAF >2.4 years, the PVI-plus strategy showed advantages over the PVI-alone strategy (HR, 0.36; 95% CI, 0.14-0.89). However, the interaction effect between LsAF 1-2.4 years and LsAF >2.4 years did not reach statistical significance (P = .116)., Conclusion: Whereas LsAF 1-2.4 years has similar outcomes to those of PerAF, LsAF >2.4 years was linked to higher arrhythmia recurrence risks. For LsAF >2.4 years, the PVI-plus strategy showed a potential to be superior to the PVI-alone strategy., Competing Interests: Disclosures Drs Minamiguchi, Dohi, Nakatani, Hikoso, and Sakata have received grants from Medtronic, Johnson & Johnson, and Abbott during the conduct of the study. Other authors have nothing to disclose related to the submitted work. Conflict of interest outside the submitted work is found in a supplemental file., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Backgrounds: Drug treatments of heart failure with preserved ejection fraction (HFpEF) have a little clinical benefit, but cardiovascular polypharmacy (CP) trend is observed in elderly HFpEF. We investigated the impact of CP on octogenarian with HFpEF., Methods: We examined 783 consecutive octogenarians (≥80 years) enrolled in the PURSUIT-HFpEF registry. We defined medications for hypertension, dyslipidemia, heart failure (HF), coronary artery disease, stroke, peripheral artery disease, and atrial fibrillation as cardiovascular medications (CM). In this study, we defined CP as ≥5 CM. We investigated whether CP was correlated with the composite end point (CE) of all-cause mortality and HF rehospitalization., Results: The proportion with CP was 51.9% (n = 406). Background characteristics correlated with CP were frailty, history of coronary artery disease, atrial fibrillation and left atrial dimension. Multivariable Cox proportional hazards analysis showed CP was significantly and independently correlated with CE (hazard ratio (HR): 1.31; 95% confidence Interval (CI): 1.01-1.70) in addition to age, clinical frailty scale, history of HF admission and N-terminal pro brain natriuretic peptide. Kaplan-Meier curve analysis showed that, compared with the non-CP group, the CP group had significantly higher risk of CE and HF (HR: 1.27; 95%CI: 1.04-1.56; P = 0.02 and HR: 1.46; 95%CI: 1.13-1.88; P < 0.01, respectively), but not any-cause death. In addition, diuretics were correlated with CE (HR: 1.61; 95%CI: 1.17-2.22; P < 0.01), but antithrombotic drugs and HFpEF medications were not., Conclusions: CP at discharge is a prognostic factor driven by HF rehospitalization in octogenarians with HFpEF. In these patients, diuretics may be correlated with the prognosis., Competing Interests: Declaration of Competing Interest Daisaku Nakatani has received honoraria from Roche Diagnostics. Shungo Hikoso has received personal fees from Daiichi Sankyo Company, Bayer, Astellas Pharma, Pfizer Pharmaceuticals and Boehringer Ingelheim Japan, and grants from Roche Diagnostics, FUJIFILM Toyama Chemical and Actelion Pharmaceuticals. Yasushi Sakata has received personal fees from Otsuka Pharmaceutical, Ono Pharmaceutical, Daiichi Sankyo Company, Mitsubishi Tanabe Pharma Corporation and Actelion Pharmaceuticals, and grants from Roche Diagnostic, FUJIFILM Toyama Chemical, Abbott Medical Japan, Otsuka Pharmaceutical, Daiichi Sankyo Company, Mitsubishi Tanabe Pharma Corporation and Biotronik. The other authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Individualized treatment approach based on pre-procedural precise risk balance assessment between bleeding and thrombosis would be desirable for patients with myocardial infarction (MI) undergoing emergent percutaneous coronary intervention (PCI) in this ultra-short dual antiplatelet therapy era. We aimed to develop and validate a quick thrombosis/bleeding risk-balance assessment tool., Methods: We developed and validated a novel thrombosis/bleeding risk-balance assessment tool using individual patient data from the prospective multicenter MI registry. Individual risks of thrombosis and bleeding within 7 days of the index PCI were estimated using a multinomial logistic regression model. The model was developed in the derivation cohort (4554 patients enrolled during 2003-2009) and validated in the validation cohort (2215 patients during 2010-2014)., Results: A total of 6769 patients (66 ± 12 years, 5175 men) were eligible in this analysis. Predictive performance of the multinomial logistic regression models for bleeding and thrombosis assessed by calibration plots was good both in the derivation and validation cohorts. The net predicted probability (NPP) was defined as predicted probability of bleeding event (%) - predicted probability of thrombotic event (%). The NPP successfully stratified patients into those with a higher risk of bleeding than thrombosis and those with a higher risk of thrombosis than bleeding. This finding was consistent between the derivation and validation cohorts., Conclusions: We have established the risk balance assessment model for bleeding and thrombosis. Pre-procedural quick and precise assessment of the risk balance may help a decision making of procedural strategy and antithrombotic regimens in STEMI/non-STEMI patients undergoing PCI., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Y. Sotomi received research grants from Abbott Medical Japan and TOA EIYO, and speaker honoraria from Abbott Medical Japan, Boston Scientific Japan, TERUMO, Japan Lifeline, Biosensors, Medtronic, Daiichi-Sankyo, Bayer, Boehringer Ingelheim, and Bristol Myers Squibb, and is an endowed chair funded by TOA EIYO. H. Mizuno is an endowed chair funded by TERUMO, Asahi Intecc, NIPRO, and Shimadzu Corporation, and received personal fees from Medtronic Japan, Japan Lifeline, and Abbott Medical Japan. Y. Sakata received grants form Abbott Medical Japan and Biotronik. The other authors have nothing to disclose., (© 2023 The Authors.)

To investigate the difference in the prognostic impact of loop diuretics in patients with acute myocardial infarction (AMI) based on plasma volume status, a total of 3,364 survivors of AMI who were registered in the large database of the Osaka Acute Coronary Insufficiency Study (OACIS) were studied. Plasma volume status was assessed by the estimated plasma volume status (ePVS) that was calculated based on a weight- and hematocrit-based formula at discharge. The endpoint was a composite endpoint of all-cause death and rehospitalization due to heart failure for 5 years. During a median follow-up period of 1.9 years, 90 and 223 patients had events in the groups with low ePVS (

Background: Blood urea nitrogen (BUN) reflects decreased glomerular filtration rate (GFR). The effect of BUN on clinical outcomes, excluding the impact of GFR, in heart failure with preserved ejection fraction (HFpEF) patients remains unknown., Methods: We enrolled HFpEF (left ventricular ejection fraction ≥50%) patients hospitalized due to acute decompensated heart failure (HF) from PURSUIT-HFpEF registry which was prospective, multicenter and observational study. For excluding the effect of renal function on BUN value, propensity score-matching was performed using the variables which were associated with GFR. The incidence of composite of all-cause death and HF readmission among the patients stratified by BUN and the association between BUN and echocardiographic parameters in HFpEF patients were evaluated., Results: We finally analyzed 1029 patients. In the present study, BUN cut-off value was defined as 24.4 mg/dL, which was the median value in overall population. The high and low BUN groups consisted of 193 patients after 1:1 propensity score-matching, respectively. The median follow-up duration was 401 days and the composite endpoint occurred in 129 patients (33.4%). Kaplan-Meier analysis showed the high BUN group had a significantly greater risk of the composite endpoint than the low group in the propensity score-matched pairs (p = 0.032). BUN value significantly correlated with left atrial volume index by multiple regression analysis using echocardiographic parameters (standardized beta-coefficient = 0.139, p = 0.043)., Conclusion: BUN was a useful marker for the composite of all-cause death and HF readmission, regardless of the baseline renal function and correlated with left atrial function in HFpEF patients., Clinical Trial Registration: UMIN000021831 ; PURSUIT-HFpEF., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Aims: Direct oral anticoagulant (DOAC) is widely used for the prevention of embolic stroke in non-valvular atrial fibrillation (NVAF) patients. However, the gastrointestinal bleeding risk in several DOAC regimens was higher than warfarin, especially in once-daily regimens., Methods and Results: We conducted a single-center prospective registry of patients with NVAF treated with DOACs: the DIRECT registry (N = 2216; follow-up duration 650 [IQR 103-1574] days, UMIN000033283). All patients were divided into 2 groups: the twice-daily (BID) regimen group (dabigatran and apixaban) versus the once-daily (QD) regimen group (rivaroxaban and edoxaban). Out of 2216 patients, we successfully matched 904 patients in the QD group and 904 patients in the BID group using propensity score. The primary endpoint was gastrointestinal bleeding defined as any bleeding in the gastrointestinal tract that was identified through medical records regardless of bleeding site or severity. The BID group showed a significantly lower gastrointestinal bleeding rate than the QD group (3.5/100 person-year vs. 6.2/100 person-year, log-rank P < 0.0001). The secondary endpoints were all death, stroke, major bleeding, and any bleeding. The rate of major bleeding was significantly lower in patients with BID regimen group (log-rank P = 0.040). In contrast, all death, stroke, and any bleeding did not differ between both groups (log-rank P = 0.280, 0.520 and 0.066, respectively)., Conclusions: The BID regimen as compared with the QD regimen was associated with reduced risk of gastrointestinal bleeding., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Y. Sotomi, A. Hirata, Y. Sakata, A. Hirayama, and Y. Higuchi received grants, travel expenses, and speaker honorarium from Daiichi-Sankyo, Bayer, Boehringer Ingelheim, and Bristol-Myers Squibb. The other authors have nothing to disclose., (© 2022 The Author(s).)

Background: The prognostic significance of combining intra-aortic balloon pumping (IABP) with extracorporeal membrane oxygenation (ECMO) for acute myocardial infarction (AMI) patients is still unclear. We investigated whether combining IABP with veno-arterial (VA)-ECMO is associated with a lower risk of short-term mortality., Methods: Among 12,093 AMI cases enrolled in the Osaka Acute Coronary Insufficiency Study (OACIS), we identified 519 who were administered VA-ECMO during hospitalization. Among these, 459 received IABP support (IABP group) and 60 cases did not (no-IABP group). The primary endpoint was 30-day all-cause death; the secondary endpoint was major bleeding. Logistic regression analysis using original data was conducted. We also established weighted logistic regression models with inverse probability of treatment weighting (IPTW)., Results: Logistic regression analysis revealed that IABP use was significantly associated with a reduced risk of 30-day death in the original data [odds ratio (OR) 0.504, 95% confidence interval (CI) 0.282-0.901, p = 0.021]. After IPTW-adjustment for clinically relevant covariates with the use of IABP, patients receiving VA-ECMO with IABP had a lower risk of 30-day death (OR 0.816, 95% CI 0.746-0.892, p < 0.001) compared to those without IABP. The incidence of major bleeding was comparable between the groups (IABP 29.0% vs. non-IABP 21.7%, p=0.302). However, the risk of major bleeding was higher in the IABP group after IPTW-adjustment (OR 1.092, 95% CI 1.008-1.184, p=0.032)., Conclusions: IABP support for AMI patients with VA-ECMO was significantly associated with reduced risk of short-term mortality, suggesting that the addition of IABP support might contribute to improved survival in AMI patients requiring VA-ECMO., Competing Interests: Conflicts of interest All authors declare no conflicts of interest associated with this manuscript., (Copyright © 2021. Published by Elsevier Ltd.)

Background and Aims: Whether coronary calcification is correlated with plaque/media shrinkage (PS) remains unclear. The aim of this study was to assess the relationship between the calcification process and PS, combining serial optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in vessels treated with bioresorbable vascular scaffolds (BVS)., Methods: In 15 patients (16 vessels), OCT and IVUS images were matched using anatomic landmarks at post-procedure and five years. PS was defined as relative decrease in plaque/media area >5%. The association between the calcification process and PS was investigated. Mixed effect models were used to assess correlations and changes over time., Results: Seventy-two OCT and IVUS paired cross sections in- and out-scaffolded segments were matched at baseline and follow-up (432 images). In total, 35 out of the 72 cross sections showed PS, and 37 cross sections showed no PS (non-PS) at 5-year follow-up. Delta (Δ) plaque/media area showed negative correlation with Δ OCT calcium area (r = -0.29, p = 0.004), Δ OCT calcium arc (r = -0.42, p < 0.001), Δ OCT calcium length (r = -0.5, p < 0.001), and Δ IVUS calcium arc (r = -0.31, p = 0.024), respectively. On echogenicity analysis, Δ plaque/media area was positively associated with Δ hypoechogenic area (r = 0.47, p = 0.002). An increase in calcium area was negatively correlated to Δ hypoechogenicity (r = -0.29, p < 0.016). The increase in calcium area was positively correlated with Δ lumen area (r = 0.24, p = 0.044)., Conclusions: In segments treated with BVS, the calcification process was associated with PS, decrease in the hypoechogenic tissue and late luminal enlargement. Combining IVUS and OCT provides a unique method to assess the correlation between the calcification process and plaque/media shrinkage., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to assess calcium growth with fused grayscale intravascular ultrasound (IVUS), IVUS-virtual histology, and optical coherence tomography (OCT) from baseline to 5-year follow-up in patients treated with bioresorbable vascular scaffolds., Background: IVUS and OCT have individual strengths in assessing plaque composition and volume. Fusion of images obtained using these methods could potentially aid in coronary plaque assessment., Methods: Anatomic landmarks and endoluminal radiopaque markers were used to fuse OCT and IVUS images and match baseline and follow-up., Results: Seventy-two IVUS-virtual histology and OCT paired matched cross-sectional in- and out-scaffold segments were fused at baseline and follow-up. In total, 46 calcified plaques at follow-up were detected using the fusion method (33 in-scaffold, 13 out-scaffold), showing either calcium progression (52.2%) or de novo calcifications (47.8%). On OCT, calcification volume increased from baseline to follow-up by 2.3 ± 2.4 mm 3 (p = 0.001). The baseline virtual histologic tissue precursors of dense calcium at follow-up were necrotic core in 73.9% and fibrous or fibrofatty plaque in 10.9%. In 15.2%, calcium was already present at baseline. Precursors on OCT were lipid pool in 71.2%, fibrous plaque in 4.3%, and fibrocalcific plaque in 23.9%., Conclusions: The use of OCT and IVUS fusion imaging shows similar calcium growth in- and out-scaffold segments. Necrotic core is the most frequent precursor of calcification. The scaffold resorption process creates a tissue layer that re-caps the calcified plaques. (Absorb Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES)., Background: Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes., Methods: In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status., Results: Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm 2 vs. 5.72 ± 1.77 mm 2 ; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm 2 vs. 5.55 ± 1.77 mm 2 ; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72)., Conclusions: In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare long-term survival between patients with severe coronary artery disease undergoing coronary artery bypass grafting (CABG) and those undergoing percutaneous coronary intervention (PCI) achieving complete revascularization (CR) or incomplete revascularization., Background: The importance of CR in decision making regarding revascularization strategy in patients with severe coronary artery disease is unknown., Methods: Data were pooled from the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trials. The primary outcome was death from any cause and was compared in an as-treated analysis., Results: The rate of CR was 61.7% (57.2% with PCI and 66.8% with CABG). During a median 4.9-year follow-up period (interquartile range: 4.5 to 5.0 years), compared with patients undergoing CABG with CR, those undergoing PCI with incomplete revascularization had a higher risk for death from any cause (adjusted hazard ratio [aHR]: 1.43; 95% confidence interval [CI]: 1.03 to 2.00; p = 0.036) and the composite of death, myocardial infarction, and stroke (aHR: 1.48; 95% CI: 1.14 to 1.92; p = 0.003). However, there was no significant difference between patients undergoing CABG with CR and those undergoing PCI with CR regarding the risk for death from any cause (aHR: 1.16; 95% CI: 0.83 to 1.63; p = 0.39) and the composite of death, myocardial infarction, and stroke (aHR: 1.14; 95% CI: 0.87 to 1.48; p = 0.35). Subgroup analysis of multivessel coronary disease, high SYNTAX score (>32), and diabetes showed consistent findings., Conclusions: For the treatment of left main or multivessel coronary artery disease, PCI resulting in CR was associated with a similar long-term survival rate to CABG resulting in CR. Therefore, the ability to achieve CR should enter into the decision algorithm for choice of revascularization strategy., (Copyright © 2017. Published by Elsevier Inc.)

Objectives: The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device., Background: The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns., Methods: In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months., Results: Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: d post-procedure  = 0.41, d 6 months  = 1.00, d 12 months  = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups., Conclusions: At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated the vasomotor response to nitroglycerine (NTG) up to 5 years after ABSORB implantation., Background: There are no data regarding long-term vasomotor response after everolimus-eluting bioresorbable vascular scaffold ABSORB implantation., Methods: We performed quantitative coronary angiography of the scaffolded and proximal and distal adjacent segments of patients from ABSORB Cohort B study before and after 200 μg of intracoronary NTG at 2, 3, and 5 years of follow-up. The mean changes of maximal and mean lumen diameters in the scaffolded and adjacent segments were calculated., Results: The mean in-scaffold lumen diameter change in response to NTG showed a trend to increase over time with absolute values of 0.03 ± 0.09 mm, 0.05 ± 0.12 mm, and 0.07 ± 0.08 mm at 2, 3, and 5 years, respectively (p = 0.40). The maximal in-scaffold lumen diameter change significantly increased with values of 0.03 ± 0.14 mm, 0.06 ± 0.16 mm, and 0.11 ± 0.1 mm at 2, 3, and 5 years, respectively (p = 0.03). The normalized mean lumen diameter change after NTG in the scaffold relative to the adjacent segments was 51.9 ± 54.8% at 5 years of follow-up (p = 0.60)., Conclusions: Although there was a numerical increase of the vasomotor response to NTG after ABSORB implantation measured by quantitative coronary angiography with mean lumen diameter, the change was not statistically significant. However, the maximal lumen diameter changes increased over time from 2 to 5 years and attained statistical significance. The vasomotor response to NTG after ABSORB implantation moderately trended to increase, which is consistent with the progressive degradation and bioresorption of the scaffold, but the degree of vasomotor response remained lower in comparison with adjacent segments., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and Aim: Local hemodynamic changes are one of the main factors that determine the vessel wall biological response after stent/scaffold implantation. Computational fluid dynamic studies provide an opportunity to investigate the rheological effects of implanted stent/scaffold. The aim of this study was to assess the local hemodynamic microenvironment in scaffolded segments in porcine coronary models., Methods: In six epicardial coronary arteries of healthy mini-pigs, six Absorb bioresorbable vascular scaffolds (Absorb BVS) were implanted. Optical coherence tomography(OCT) was performed after scaffold implantation and the images were fused with the angiographic data to reconstruct the three-dimensional coronary artery anatomy. Blood flow simulations were performed, and endothelial shear stress(ESS) distribution was estimated for each scaffolded segment. In a linear mixed-effect model, the contributing factors for low (<1.0Pa) ESS levels were assessed. At 30-day post-implantation, histopathological assessment was performed at 2 scaffolds., Results: In scaffolded segments, the median ESS was 0.57 (IQR: 0.29-0.99) Pa. In linear mixed-effect analysis, cross-section area was associated with low shear stress levels. In scaffolded segments, the percentage of the recirculation zone per scaffolded luminal surface was 3.26±2.07%. At 30-day histopathological assessment of implanted vessel segments revealed minimal injury score, minimal neointimal inflammation and minimal adventitial inflammation scores with moderate endothelial coverage. Fibrin accumulation was seen at 95.69±2.47% of the struts., Conclusion: The thick rectangular strut design of the Absorb BVS incited flow disruptions with low shear stress inducing fibrin accumulation. CFD assessment can be used to guide improvements in the scaffold design for a more "hemo-compatible" geometry., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objectives: The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD)., Background: The relative efficacy and safety of CABG versus PCI with DES for left main or multivessel CAD remain controversial., Methods: Data were pooled from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trials. The primary outcome was a composite of all-cause death, myocardial infarction, or stroke., Results: The median follow-up was 60 months, and follow-up was completed for 96.2% of patients. The rate of primary outcome was significantly lower with CABG than with PCI (13.0% vs. 16.0%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.69 to 1.00; p = 0.046). The difference was mainly driven by reduction in myocardial infarction (HR: 0.46; 95% CI: 0.33 to 0.64; p < 0.001). There was significant interaction between treatment effect and types of CAD, showing CABG to be superior compared with PCI with DES in patients with multivessel CAD (p = 0.001), but no between-group difference in those with left main CAD (p = 0.427). The rates for all-cause death and stroke were similar between the 2 groups. By contrast, the need for repeat revascularization was significantly lower in the CABG group compared with the PCI group., Conclusions: CABG, as compared with PCI with DES, reduced long-term rates of the composite of all-cause death, myocardial infarction, or stroke in patients with left main or multivessel CAD. The advantage of CABG over PCI with DES was particularly pronounced in those with multivessel CAD., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel., Methods: The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281., Findings: Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; p superiority =0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; p non-inferiority =0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm 2 [SD 1·48] vs 5·38 mm 2 [1·51]; p<0·0001). The secondary endpoints of patient-oriented composite endpoint, Seattle Angina Questionnaire score, and exercise testing were not statistically different in both groups. However, a device-oriented composite endpoint was significantly different between the Absorb group and the Xience group (10% vs 5%, hazard ratio 2·17 [95% CI 1·01-4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16)., Interpretation: The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research., Funding: Abbott Vascular., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: The purpose of this study is to analyze the impact of average contact force (CF) and its regional variability during pulmonary vein isolation (PVI) for atrial fibrillation (AF) on periprocedural parameters and midterm outcome., Methods: This retrospective cohort study enrolled 57 drug-refractory AF patients who underwent initial PVI for AF using an open-irrigated CF catheter (SmartTouch Thermocool, Biosense Webster, Diamond Bar, CA, USA). Thirty patients were assigned to a lower CF (LCF) group (average CF≤10g) and 27 patients to a higher CF (HCF) group (average CF>10g). The relationship between CF and clinical outcome was analyzed., Results: Patients were followed-up for 317±57 days after PVI. The CF was 8.1±1.3g in the LCF group and 12.4±1.5g in the HCF group. Higher average CF was associated with shorter ablation time (28±6min vs. 36±9min, p=0.0002) and lower radiofrequency energy delivery (79±18 vs. 99±26, p=0.0016) for PVI. The rate of acute PV reconnection (APVR) was similar in both groups (LCF group 60% vs. HCF group 44%, p=0.36). Four patients (13%) in the LCF group and nine patients (33%) in the HCF group experienced AF-recurrence. Average CF did not impact on AF-recurrence during midterm clinical outcome (p=0.09 by log-rank test). In the non-recurrence group (n=44), average CF was higher at left posterosuperior PV and right anteroinferior PV than that in the recurrence group (n=13) (p=0.012 and p=0.004, respectively)., Conclusions: Higher average CF decreased ablation time and radiofrequency energy delivery for PVI, but did not decrease APVR rate or improve midterm clinical outcome., (Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Objectives: The study sought to validate the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score II mortality prediction model after percutaneous coronary intervention (PCI) or coronary artery bypass grafting in a large pooled population of patients with multivessel coronary disease (MVD) and/or unprotected left main disease (UPLMD) enrolled in the PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) and BEST (Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) randomized controlled trials., Background: For patients with MVD and/or UPLMD, the choice of the best revascularization strategy remains challenging., Methods: Pooled individual patient-level data from PRECOMBAT and BEST were used to assess calibration and discrimination of the SYNTAX score II prediction model for all-cause mortality after PCI and coronary artery bypass grafting at 4-year follow-up. The study population comprised 1,480 patients (600 with UPLMD, 880 with MVD)., Results: The overall incidence of all-cause mortality was 6.1% after a median follow-up period of 4.9 years. Validation plots showed good model calibration overall and across treatment groups but tended to overestimate all-cause mortality in the highest risk quintiles of patients in the whole population and the PCI arm. The SYNTAX score II showed moderate discrimination ability for the whole population (C index = 0.685) but better for patients receiving PCI than CABG (C index = 0.718 vs. 0.662 in patients with UPLMD, C index = 0.700 vs. 0.661 in those with MVD). Observed all-cause mortality was higher when the treatment received was at variance with that recommended by the model and similar when it was concordant., Conclusions: The SYNTAX score II has good calibration but only moderate discrimination ability for long-term mortality prediction in this randomized population. This score provides an important tool to help guide the heart team's decision-making process regarding the selection of the best revascularization strategy for patients with MVD and/or UPLMD. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease, NCT00422968; Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease, NCT00997828)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices., Background: It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb., Methods: Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks., Results: Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm(2) vs. 4.27 mm(2), respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation., Conclusions: At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up., Background: Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent., Methods: The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected., Results: Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037)., Conclusions: BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the present study was to investigate the relationship between the integration process and luminal enlargement with the support of light intensity (LI) analysis on optical coherence tomography (OCT), echogenicity analysis on intravascular ultrasound, and histology up to 4 years in a porcine model., Background: In pre-clinical and clinical studies, late luminal enlargement has been demonstrated at long-term follow-up after everolimus-eluting poly-l-lactic acid coronary scaffold implantation. However, the time relationship and the mechanistic association with the integration process are still unclear., Methods: Seventy-three nonatherosclerotic swine that received 112 Absorb scaffolds were evaluated in vivo by OCT, intravascular ultrasound, and post-mortem histomorphometry at 3, 6, 12, 18, 24, 30, 36, 42, and 48 months., Results: The normalized LI, which is the signal densitometry on OCT of a polymeric strut core normalized by the vicinal neointima, was able to differentiate the degree of connective tissue infiltration inside the strut cores. Luminal enlargement was a biphasic process at 6 to 18 months and at 30 to 42 months. The latter phase occurred with vessel wall thinning and coincided with the advance integration process demonstrated by the steep change in normalized LI (0.26 [interquartile range (IQR): 0.20 to 0.32] at 30 months versus 0.68 [IQR: 0.58 to 0.83] at 42 months, p < 0.001)., Conclusions: In this pre-clinical model, late luminal enlargement relates to strut integration into the arterial wall. Quantitative LI analysis on OCT could be used as a surrogate method for monitoring the integration process of poly-l-lactic acid scaffolds, which could provide insight and understanding on the imaging-related characteristics of the bioresorption process of polylactide scaffolds in human., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax)., Background: Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies., Methods: A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group., Results: Of 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI]: 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01)., Conclusions: Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: This study aimed to evaluate the association between left atrial (LA) structural remodeling and very late recurrence [VLR; initial recurrence >12 months after catheter ablation (CA)] after successful CA for non-paroxysmal atrial fibrillation (AF)., Methods: We retrospectively evaluated 63 patients who underwent initial, single ablation for drug-refractory persistent or long-standing persistent AF and those who had no recurrence in the first year after CA. We followed patients for a mean of 3.2±1.5 years and divided them into VLR and no-recurrence (NR) groups. Before and 3 months after ablation, all patients were subjected to 64-slice multidetector computed tomography scanning to estimate LA volume, including maximum and minimum volume during the cardiac cycle (LAMaxV and LAMinV, respectively), and the LA emptying fraction., Results: VLR occurred in 21 patients. The reduction rate of LAMaxV after CA was significantly larger in the NR group than in the VLR group (25±19% vs. 5±18%, p=0.0002). Receiver operating characteristic analysis was performed to determine the best cut-off values in the prediction of VLR. The highest area-under curve was obtained with post-CA LAMinV [0.828 (95% confidence interval, 0.712-0.912), p<0.0001], with a best cut-off value of 44mL (sensitivity 81.0%, specificity 81.0%)., Conclusions: Persistent LA structural remodeling after initially successful CA for non-paroxysmal AF may be an important risk factor for VLR., (Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Objectives: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation., Background: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury., Methods: In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise., Results: Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002)., Conclusions: There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Randomized controlled trials concerning pulmonary artery catheters (PACs) use have yielded little evidence of their beneficial effects on survival. This study aimed to evaluate the association between PACs and in-hospital mortality in patients with acute heart failure syndromes (AHFS)., Methods: The Acute Decompensated Heart Failure Syndromes (ATTEND) Registry is a prospective, observational, multicenter cohort study performed in Japan, since April 2007. We analyzed data from the ATTEND Registry and evaluated the effectiveness of PAC in AHFS treatment using propensity score-matching and the Cox proportional hazards model., Results: Final follow-up examinations of the 4842 patients were conducted in December 2012. During the study period, 813 patients (16.8%) were managed with PACs, of which 502 patients (PAC group) were propensity score-matched with 502 controls (Control group). Of the 1004 score-matched patients, 22 (4.4%) patients from the Control group and 7 (1.4%) from the PAC group died. The risk of all-cause death was lower in the PAC group than that in the Control group [hazard ratio (HR), 0.3; 95% confidence interval (CI), 0.13-0.70; p=0.006]. PAC-guided therapy decreased all-cause mortality in patients with lower systolic blood pressure (SBP ≤ 100 mm Hg; HR, 0.09; 95% CI, 0.01-0.70; p=0.021) or inotropic therapy (HR, 0.22; 95% CI, 0.08-0.57; p=0.002)., Conclusions: This study revealed that appropriate PAC use effectively decreases in-hospital mortality in AHFS patients, particularly those with lower SBP or receiving inotropic therapy, suggesting that real-world PAC use could improve AHFS management., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)