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Current guidelines equally recommend direct oral anticoagulants (DOACs) and warfarin for atrial fibrillation (AF) patients with a bioprosthetic valve (BPV); however, there are limited data comparing DOACs and warfarin in AF patients with an aortic BPV.Methods and Results: This post-hoc subgroup analysis of a multicenter, prospective, observational registry (BPV-AF Registry) aimed to compare DOACs and warfarin in AF patients with an aortic BPV. The primary outcome was a composite of stroke, systemic embolism, major bleeding, heart failure requiring hospitalization, all-cause death, or BPV reoperation. The analysis included 479 patients (warfarin group, n=258; DOAC group, n=221). Surgical aortic valve replacement was performed in 74.4% and 36.7% of patients in the warfarin and DOAC groups, respectively. During a mean follow up of 15.5 months, the primary outcome occurred in 45 (17.4%) and 32 (14.5%) patients in the warfarin and DOAC groups, respectively. No significant difference was found in the primary outcome between the 2 groups (adjusted hazard ratio: 0.88, 95% confidence interval: 0.51-1.50). No significant multiplicative interaction was observed between the anticoagulant effects and type of aortic valve procedure (P=0.577).Among AF patients with an aortic BPV, no significant difference was observed in the composite outcome of adverse clinical events between patients treated with warfarin and those treated with DOACs, suggesting that DOACs can be used as alternatives to warfarin in these patients.

Women experience more severe arrhythmogenic substrates. This study hypothesized that an extensive ablation strategy, such as linear ablation and/or complex fractionated atrial electrogram (CFAE) ablation in addition to pulmonary vein isolation (PVI-plus), might be effective for women, whereas the PVI alone strategy (PVI-alone) might be sufficient for men to maintain sinus rhythm. The aim of this study was to test this hypothesis.Methods and Results: This study is a post-hoc subanalysis of the EARNEST-PVI trial focusing on sex differences in the efficacies of different ablation strategies. The EARNEST-PVI trial was a prospective, multicenter, randomized, and open-label non-inferiority trial in patients with persistent AF. The primary endpoint was recurrence of AF, atrial flutter, or atrial tachycardia. The EARNEST-PVI trial randomized 376 (76%) men (PVI-alone 186, PVI-plus 190) and 121 (24%) women (PVI-alone 63, PVI-plus 58). The event rate was significantly lower for men and numerically lower for women in the PVI-plus than the PVI-alone group, and there was no interaction between men and women (hazard ratio, 0.641; 95% confidence interval, 0.417-0.985; P value, 0.043 for men vs. hazard ratio, 0.661; 95% confidence interval, 0.352-1.240; P value, 0.197 for women; P value for interaction, 0.989).The superiority of the extensive ablation strategy vs. the PVI-alone strategy for persistent AF was consistent across both sexes.

BACKGROUND Although bioprosthetic valve (BPV) replacements are becoming more common within our aging society, there are limited prospective data on the appropriate antithrombotic therapy for East Asian patients with atrial fibrillation (AF) and BPV replacement. Antithrombotic therapy and thrombotic and hemorrhagic event rates in Japanese patients with AF and BPV replacement are investigated.Methods and Results:This multicenter, prospective, observational study enrolled patients with BPV replacement and AF. The primary efficacy outcome was stroke or systemic embolism, and the primary safety outcome was major bleeding. Of the 894 patients analyzed, 54.7%, 29.4%, and 9.6%, were treated with warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, or antiplatelet therapy without anticoagulants, respectively; 6.3% did not receive any antithrombotic drugs. The mean observation period was 15.3±4.0 months. The event rates for stroke or systemic embolism and major bleeding were 1.95%/year and 1.86%/year, respectively. The multivariate adjusted hazard ratios for DOAC vs. warfarin were 1.02 (95% confidence intervals [CI], 0.30-3.41 [P=0.979]) for systemic embolic events and 0.96 (95% CI, 0.29-3.16 [P=0.945]) for major bleeding. CONCLUSIONS Approximately 30% of patients with AF and BPV replacement were treated with DOAC. The risks of major bleeding and stroke or systemic embolism were similar between warfarin- and DOAC-treated patients with AF who had BPV replacement. Treatment with DOACs could be an alternative to warfarin in this population.

BACKGROUND Although diastolic dysfunction is important pathophysiology in heart failure with preserved ejection fraction (HFpEF), its prognostic impact in HFpEF patients, including those with atrial fibrillation (AF), remains to be elucidated.Methods and Results:We included the data for 863 patients (321 patients with AF) registered in a prospective multicenter observational study of patients with HFpEF. Patients were divided into 3 groups according to the 2016 ASE/EACVI recommendations. The primary endpoint was a composite of all-cause death or HF rehospitalization. Median age was 83 years, and 55.5% were female. 196 (22.7%) were classified with normal diastolic function (ND), 253 (29.3%) with indeterminate (ID) and 414 (48.0%) with diastolic dysfunction (DD). The primary endpoint occurred more frequently in patients with DD than in those with ND or ID (log-rank P

Background It is unclear whether balloon size can influence lesion formation. The aim of this study was to evaluate the impact of balloon size on lesion formation during laser balloon procedures in an in vitro model.Methods and Results:Laser energy was applied to chicken muscle using a first generation laser balloon. Laser ablation was performed with 2 different balloon sizes (18 mm and 32 mm) using 2 different power settings (12 W/20 s and 8.5 W/20 s) on the chicken muscle. The lesion characteristics, including maximum lesion depth, maximum lesion diameter, surface diameter and depth at maximum diameter, were compared between the 18-mm and 32-mm balloon groups at 12 W/20 s and 8.5 W/20 s, respectively. We created 40 lesions using laser energy at 12 W/20 s and 80 lesions at 8.5 W/20 s. At both power settings, the maximum lesion depth and the depth at the maximum diameter were larger in the 18-mm than in the 32-mm balloon group. At both power settings, the maximum lesion diameter and the surface diameter were smaller in the 18-mm than in the 32-mm balloon group. Conclusions The balloon size could affect the lesion formation during laser balloon ablation. The lesion with the larger balloon size was wider and shallower than the lesion with the smaller balloon size.

BACKGROUND We describe our original left ventricular assist device (LVAD) speed ramp and volume loading test designed to evaluate native heart function under continuous-flow LVAD support.Methods and Results:LVAD speed was decreased in 4 stages from the patient's optimal speed to the minimum setting for each device. Under minimal LVAD support, patients were subjected to saline loading (body weight [kg]×10 mL in 15 min). Echocardiographic and hemodynamic data were obtained at each stage of the LVAD speed ramp and every 3 min during saline loading. Patients were divided into Recovery (with successful LVAD removal; n=8) and Non-recovery (others; n=31) groups. During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P

BACKGROUND Associations between characteristics of premature atrial contraction (PAC) 6 months after catheter ablation (CA) and later recurrence are not known. We investigated the effects of PAC characteristics on long-term outcomes of initially successful atrial fibrillation (AF) ablation.Methods and Results:In all, 378 patients (mean age 61 years, 21% female, 67% paroxysmal AF) who underwent initial radiofrequency CA for AF without recurrence up to 24-h Holter monitoring 6 months after the procedure were reviewed retrospectively. The calculated number of PAC/24 h and the length of the longest PAC run during Holter recording were analyzed. After 4.3±1.2 years (mean±SD) follow-up, 123 (32.5%) patients experienced late recurrence. Patients with recurrence had significantly more PAC/24 h (median [interquartile range] 110 [33-228] vs. 42 [16-210]; P

This study investigated the impact of systemic inflammation on bleeding risk in non-valvular atrial fibrillation (NVAF) patients treated with direct oral anticoagulants (DOAC).Methods and Results:We conducted a single-center prospective registry of 2,216 NVAF patients treated with DOAC: the DIRECT registry (UMIN000033283). High-sensitivity C-reactive protein (hsCRP) was measured ≤3 months before (pre-DOAC hsCRP) and 6±3 months after initiation of DOAC (post-DOAC hsCRP). Multivariate logistic regression model was used to assess the influence of systemic inflammation and conventional bleeding risk factors on major bleeding according to International Society on Thrombosis and Haemostasis criteria. Based on the findings, we created a new bleeding risk assessment score: the ORBIT-i score, which included post-DOAC hsCRP0.100 mg/dL and all components of the ORBIT score. A total of 1,848 patients had both pre- and post-DOAC hsCRP data (follow-up duration, 460±388 days). Post-DOAC hsCRP was associated with major bleeding (OR, 2.770; 95% CI: 1.687-4.548, P0.001). Patients with post-DOAC hsCRP0.100 mg/dL more frequently had major bleeding than those without (log-rank test, P0.001). ORBIT-i score had the highest C-index of 0.711 (95% CI, 0.654-0.769) compared with the ORBIT and HAS-BLED scores.Persistent systemic inflammation was associated with major bleeding risk. ORBIT-i score had a higher discriminative performance compared with the conventional bleeding risk scores.

BACKGROUND This study evaluated the safety and efficacy of venous figure-of-eight (FoE) suture to achieve femoral venous hemostasis after radiofrequency (RF) catheter ablation (CA) for atrial fibrillation (AF).Methods and Results:We retrospectively examined 517 consecutive patients undergoing RFCA for AF. The control group (n=247) underwent manual compression for femoral venous hemostasis after sheath removal with 6 h of bed rest. The FoE group (n=270) underwent FoE suture technique with 4 h of bed rest. All patients achieved successful hemostasis within 24 h after CA. Although the incidence of hematoma was similar between the groups, the incidence of rebleeding was lower in the FoE group than in the control group (FoE vs. control, 3.7% vs. 18.6%, P

Background Blood stream infection is thought to increase the risk of hemorrhagic stroke, a major adverse event with devastating outcome, in patients with continuous-flow left ventricular assist devices (LVADs). We analyzed the risk factors of hemorrhagic stroke in LVAD patients, as well as the time relationship between systemic bacteremia and hemorrhagic stroke.Methods and Results:We evaluated the incidence of systemic bacteremia and stroke in 164 patients who underwent continuous-flow LVAD implantation between 2005 and 2016. At 1 and 2 years after implantation, the incidence of bacteremia was 29% and 36%, and the incidence of hemorrhagic stroke was 22% and 22% in patients without bacteremia, and 32% and 44% in those with bacteremia, respectively (P=0.035). This higher prevalence of hemorrhagic stroke in patients with bacteremia was notable particularly in the chronic phase (>90 days after implantation). Multivariate analysis revealed that bacteremia was an independent risk factor of hemorrhagic stroke in the chronic phase [hazard ratio, 2.36 (1.02-5.62); P=0.044]. The hazard rate was the highest immediately after the onset of bacteremia, and the risk steadily declined by 90 days after the last episode of bacteremia and flattened thereafter. Conclusions Bacteremia was an independent risk factor of hemorrhagic stroke in patients in the chronic phase, with the highest risk seen in the early phase following an episode of bacteremia.

Background TY-0201 (TY) is a transdermal formulation of bisoprolol that is the free base of bisoprolol fumarate (BO), a drug widely used to treat chronic heart failure (CHF). The objectives of this phase II study were to evaluate the efficacy and safety of TY when switching from oral BO to TY in patients with CHF whose drug therapy was optimized, and to determine the dose conversion rate of BO to TY.Methods and Results:The efficacy and safety of once daily TY patch use for 16 weeks was investigated in 40 patients with CHF who were stabilized with an optimized drug treatment, including BO, after switching from BO to TY at the dose conversion rate of 5:8. The pre-switch left ventricular ejection fraction was 50.13±11.09% (mean±SD). The post-switch value was 50.87±10.79% after 16 weeks, which was not significantly different, with similar results for other efficacy and safety parameters. The 16-week study was continued for all patients without changing doses after switching to TY. No cardiovascular deaths, hospitalizations for worsening HF, or significant safety concerns were observed. Conclusions Efficacy was maintained without significant safety concerns in patients with CHF who were stabilized with BO treatment after switching to TY, suggesting the appropriateness of the dose conversion rate.

BACKGROUND Durable pulmonary vein isolation (PVI) is critical in reducing recurrence after radiofrequency catheter ablation for atrial fibrillation (AF). The VISITAG Module, an automatic annotation system that takes account of catheter stability and contact force (CF), might be useful in accomplishing this.Methods and Results:In 49 patients undergoing VISITAG-guided AF ablation (group A), we set the following automatic annotation criteria: catheter stability range of motion ≤1.5 mm, duration ≥5 s, CF ≥5 g, time ≥25% and tag diameter at 6 mm. We used ablation >20 s and force-time integral >150 gs at each site, then moved to the next site where a new tag appeared that overlapped with the former tag. Results and outcome were retrospectively compared for 42 consecutive patients undergoing CF-guided AF ablation without this algorithm (group B). Successful PVI at completion of the initial anatomical line was more frequent in group A than B (66.3% vs. 36.9%, P=0.0006) while spontaneous PV reconnection was less frequent (14.2% vs. 30.9%, P=0.0014) and procedure time was shorter (138±35 min vs. 180±44 min, P

From August 27th to 31st, the 2016 Annual Congress of the European Society of Cardiology (ESC 2016) was held in Fiera di Roma, Italy. Despite the socially unstable situation, more than 32,000 attendees, including clinical physicians, basic researchers, medical students, and paramedical personnel, as well as 5,000 exhibitors from 106 countries gathered in this historical city to share the latest findings and to discuss the present issues in cardiovascular medicine. There were scientific sessions, including 28 Hot Lines, 26 clinical trial updates, 24 registry studies, and 5 clinical practice guideline sessions. Japan had 1,170 attendees, with 1,743 submitted and 670 accepted abstracts, including the NIPPON trial presented in the hotline session. From 2011 to 2016, Japan has been the first abstract submitter and has had the most abstracts accepted, which indicates the great contribution of Japanese cardiologists and the Japanese Circulation Society. This report briefly introduces the key presentations and highlights from the ESC 2016 Scientific Sessions. (Circ J 2016; 80: 2282-2286).

BACKGROUND Although transcatheter aortic valve implantation (TAVI) is a new alternative treatment with acceptable midterm results for high surgical risk patients, at present performing the procedure in dialysis patients is not reimbursed in Japan. METHODS AND RESULTS The study group of 17 dialysis patients (mean age, 76.7±5.0 years) underwent TAVI with the SAPIEN/SAPIEN XT. EuroSCORE and STS score were 25.0±19.0% and 15.4±12.3%, respectively. Transiliofemoral and transapical approaches were performed in 7 (41.2%) and 10 patients (58.8%), respectively. ICU and hospital stays after TAVI were 1.8±1.6 and 12.9±12.7 days, respectively. Mean transvalvular gradients at discharge significantly decreased from 45.9±13.3 mmHg to 10.7±4.3 mmHg (P

Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported.The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm(2)(P0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively.A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.

BACKGROUND Warfarin reduces the risk of stroke in patients with atrial fibrillation, but requires a moderate-to-high time in therapeutic range (TTR). We hypothesized that point-of-care (POC) testing for prothrombin time-internationalized normalized ratio (PT-INR) could improve the TTR in patients receiving warfarin. METHODS AND RESULTS Eight outpatient clinics that introduced POC testing for PT-INR participated in this study. We identified 148 consecutive patients who received warfarin for at least 12 months before and after the introduction of POC testing. We compared the TTR before and after the introduction of POC testing for each patient. TTR after the introduction of POC testing was significantly higher than that beforehand (51.9%±33.0% vs. 69.3%±26.3%; P

Background: Hospitalized heart failure (HHF) is a critical issue in Japan. To improve its management and outcomes, the clinical features, in-hospital management, and outcomes should be analyzed to improve the guidelines for HHF. Methods and Results: The acute decompensated heart failure syndromes (ATTEND) registry is the largest study of HHF in Japan. The present report covers the clinical features and in-hospital management of HHF patients. The data from 4,842 enrolled patients have demonstrated that most Japanese HHF patients are elderly, with new onset, and a history of hypertension and orthopnea on admission. During hospitalization, furosemide and carperitide were commonly used and the length of stay was extremely long (mean 30 days), with 6.4% in-hospital mortality. Conclusions: The findings of the present study suggest the following: (1) the focus for hypertensive elderly and diabetic patients should be on primary prevention of HHF,(2) more intensive management with noninvasive positive pressure ventilation should be performed at the urgent stage, (3) it is necessary to clarify the clinical benefit of carperitide and angiotensin-receptor blockers, because they are commonly used in Japan, and (4) it is necessary to clarify the relationship between in-hospital mortality and length of stay from the viewpoint of both outcome and cost of patient care. (Circ J 2013; 77: 944–951)

Systolic abnormality, as well as diastolic dysfunction, is observed in patients with heart failure with preserved ejection fraction (HFPEF). However, the role of these 2 conditions in the transition from asymptomatic diastolic dysfunction to symptomatic heart failure remains unclear. We recently demonstrated that diastolic wall strain (DWS) inversely correlates to the myocardial stiffness constant.This study consisted of 127 subjects: 52 consecutive HFPEF patients (HFPEF group), 50 asymptomatic hypertensive patients with ejection fraction ≥50% whose age, gender and left ventricular (LV) mass index matched those of the HFPEF group (HT group) and 25 normal volunteers (Normal group). The tissue Doppler-derived peak systolic and early diastolic velocities of the mitral annulus were significantly decreased in groups HFPEF and HT than in group Normal, but were not significantly different between groups HFPEF and HT. DWS was significantly lower in group HFPEF than in group HT.The transition from asymptomatic diastolic dysfunction stage to HFPEF stage is not attributed to progression of systolic abnormality, and exacerbation of LV distensibility rather than relaxation plays a crucial role in the development of HFPEF.

It has been generally believed that advanced congestive heart failure (HF) is progressive, but there is increasing evidence that mechanical unloading with the use of left ventricular assist system (LVAS) occasionally reverses the progress of HF and permits device explantation. This "bridge to recovery" strategy is attracting interest, not only for the treatment of severe HF, but also in the study of the pathophysiological mechanisms involved in remodeling and its regression, with the hope of establishing reliable indicators of sustained recovery and strategies to enhance this process. Tissue samples obtained at the time of LVAS implantation and at explantation enabled study of the effects of LV unloading at the cellular and gene levels. However, the problem with these analyses is the lack of correlation between clinical improvement and cellular or molecular changes. Clinically, there are still many questions about the application of this strategy. The evaluation of LV function while on LVAS and the prediction of sustained recovery after explantation of the device have been the major concerns. Pharmacological regimens to promote recovery have been proposed, but require validation by multicenter study. Further investigation of the underlying mechanisms may help to establish strategies to enhance the recovery process.

There is an emerging interest in heart failure with preserved ejection fraction (HFPEF) because of its high prevalence in the community and several specific characteristics compared with "classic" heart failure with reduced ejection fraction. HFPEF patients are older and more often female, and lack left ventricular dilatation. A likely principal cause of HFPEF is diastolic dysfunction, particularly ventricular stiffening; however, the clinical phenotype of HFPEF is also modulated by dysfunction of other organs such as kidney, vasculature, etc. Despite its social burden, the diagnostic criteria and therapeutic strategies remain to be established. In particular, the lack of established diagnostic criteria has resulted in conceptual confusions about HFPEF in clinical practice. In this review, what is known and unknown about HFPEF is discussed, and several challenging proposals about its diagnosis and therapy are raised.

BACKGROUND An effect of aldosterone on ventricular fibrosis has been demonstrated in animals, but remains unclear in human patients. This study aimed to investigate (1) the relationship between left ventricular (LV) fibrosis and myocardial ultrasonic texture as assessed with myocardial radio-frequency (RF) signals analyzed from the viewpoint of their waveform with chaos theory in animals and (2) serial changes in myocardial ultrasonic texture following long-term aldosterone blockade in patients with LV hypertrophy. METHODS AND RESULTS In an animal study, Sprague-Dawley rats were divided into 2 groups with and without adriamycin administration, and the relationship between the RF signals and LV fibrosis was assessed. In a clinical study, effects of 12-month-administration of spironolactone were assessed in patients with LV hypertrophy. The animal study revealed that the correlation dimension (CD) calculated from the RF signals inversely correlated with the area of fibrosis. The clinical study demonstrated an increase in CD following 6-month administration of spironolactone. The changes in CD positively correlated with those in the serum carboxy-terminal telopeptide of collagen type I. CONCLUSION Myocardial RF signals analyzed with chaos theory reflect the severity of LV fibrosis. Aldosterone blockade may alter myocardial ultrasonic texture with regression of LV fibrosis, at least partly through enhanced collagen degradation.