The Absorb GT1 Bioresorbable Vascular Scaffold System　- 5-Year Post-Market Surveillance Study in Japan.

BACKGROUND: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

Drug-Coated Balloon for the Treatment of Small Vessel Coronary Artery Disease　- A Randomized Non-Inferiority Trial.

BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the treatment of in-stent restenosis (ISR) and small vessel disease (SVD). However, data comparing the treatment efficacy of different DCBs are limited.Methods and Results: AGENT Japan is a prospective randomized controlled trial that compares the Agent balloon coated with a low-dose formulation of paclitaxel (2 µg/mm2) to the SeQuent Please paclitaxel-coated balloon (3 µg/mm2) for the treatment of SVD. Patients with target lesion length ≤28 mm and reference diameter between ≥2.00 and <3.00 mm were randomized 2 : 1 for treatment with Agent (n=101) or SeQuent Please (n=49). This trial also includes a separate single-arm substudy evaluating the clinical safety and effectiveness of Agent in patients with ISR. The primary endpoint of 6-month target lesion failure (TLF) was observed in 3.0% of Agent and 0.0% of SeQuent Please patients (difference=3.0%; 97.5% upper confidence bound [UCB]=9.57%, which is less than the prespecified margin of 13.2%; Pnon-inferiority=0.0012). There were no deaths or thrombosis, and angiographic and quality-of-life outcomes were comparable between groups. The AGENT Japan ISR substudy (n=30) primary endpoint was met because the one-sided 97.5% UCB for 6-month TLF (3.3%) was significantly less than the study success criterion of 15.1% (97.5% UCB=9.8%; P<0.0001). CONCLUSIONS: Data from this study demonstrate good clinical outcomes with the Agent DCB when used to treat patients with SVD or ISR.

Post-ablation left atrial function impacts long-term recurrence of atrial fibrillation after ablation.

Left atrial (LA) function can help predict various cardiovascular events. Catheter ablation for atrial fibrillation (AF) modifies baseline LA function through the maintenance of sinus rhythm and myocardial injury. We investigated the impact of post-ablation LA function on recurrence of AF after ablation and identified the predictors of reduced post-ablation LA function. A total of 616 patients who underwent AF ablation (paroxysmal, N = 310; non-paroxysmal, N = 306) were retrospectively examined with cardiac computed tomography at baseline and 3 months after the final ablation procedure. Post-ablation LA emptying fraction (LAEFpost) was calculated. We evaluated the association between LAEFpost and recurrence of AF after the final ablation procedure. Further, we assessed the predictors of reduced LAEFpost. The recurrence rate of AF was 72.7% after the final ablation procedure [median follow-up 48 months (48.0, 48.0), total number of ablation sessions: 1.4 ± 0.7]. Multivariate analysis revealed that LAEFpost was associated with the recurrence of AF (hazard ratio/10% increase: 0.62, 95% confidence interval: 0.51-0.75, P < 0.0001). LAEFpost had a mild predictive power for recurrence of AF (c-statistics: 0.670, optimal cutoff: 26.36%, P < 0.0001). The recurrence-free proportion among patients with reduced LAEFpost (< 26.36%, N = 100) and those with preserved LAEFpost (≥ 26.36%, N = 516) was 40% and 79%, respectively (P < 0.0001). The predictors of reduced LAEFpost were low pre-ablation LAEF, high pre-ablation LA volume, low body mass index (BMI), and female sex. Further, reduced LAEFpost was associated with the total number of ablation sessions and extra-pulmonary vein LA ablation. In conclusion, reduced LAEFpost was associated with recurrence of AF after ablation. Advanced LA remodeling, low BMI, and female sex could predict reduced LAEFpost. Although additional ablation was associated with reduced LAEFpost, it remains unclear whether reduced LAEFpost resulted from the additional ablation. Reduced LAEFpost might help stratify patients with ablation-refractory AF.

Decrease in red cell distribution width as a useful predictor of success after catheter ablation for atrial fibrillation: a retrospective multi-center study.

Red cell distribution width (RDW) is reportedly associated with cardiovascular events, including atrial fibrillation (AF). We investigated whether the RDW values were associated with the outcomes of catheter ablation for AF. This retrospective multicenter study included 501 patients with AF (239 paroxysmal AF cases, 196 persistent AF cases, and 66 long-standing persistent AF cases) who underwent initial AF ablation between March 2017 and May 2018. The RDW values were evaluated before and at 1-3 months after the procedure. The patients were stratified based on the recurrence of AF within 1 year after the index procedure with a blanking period of 3 months into recurrence group (107 patients, 21.4%) and no-recurrence group (394 patients, 78.6%). There were no significant differences in preoperative RDW values between the groups (p = 0.37). The RDW value did not change significantly after the ablation in the recurrence group (13.55-13.60%, p = 0.37), although it decreased significantly in the no-recurrence group (13.64-13.37%, p < 0.001). Multivariate Cox proportional hazards regression analyses revealed that a postoperative change in RDW (ΔRDW) was independently associated with AF recurrence (hazard ratio 2.00, 95% confidence interval 1.42-2.76, p < 0.001). Receiver operating characteristic curve analysis revealed that a ΔRDW cut-off value of - 0.1% provided a c-statistic of 0.65 for predicting AF recurrence. Decrease in RDW during the blanking period after ablation independently predicted the 1-year success of AF ablation.

Home Sleep Apnea Test to Screen Patients With Atrial Fibrillation for Sleep Apnea Prior to Catheter Ablation.

BACKGROUND: Whether all atrial fibrillation (AF) patients should be evaluated for sleep apnea before catheter ablation (CA) remains controversial. Watch-type peripheral arterial tonometry (W-PAT) is a home sleep testing device and an easier tool for diagnosing sleep apnea than polysomnography. We investigated the prevalence and predictors of sleep apnea using W-PAT in unscreened sleep apnea patients with AF before CA.Methods and Results:The study was conducted under a retrospective, single-center, observational design. We included 776 consecutive patients who underwent both W-PAT and AF ablation. Sleep apnea assessments were successfully performed in 774 patients (99.7%; age 65±11 years, 73.3% male; body mass index [BMI] 24.1±3.5, 56.8% paroxysmal AF). The mean apnea-hypopnea index (AHI) was 20.1±15.6. Although 81.7% of the patients had normal Epworth sleepiness scores (mean 6.5), only 88 (11.4%) had a normal AHI (AHI <5) and 412 (53.2%) had moderate-severe sleep apnea (AHI ≥15). Obesity, male sex, nonparoxysmal AF, hypertension, and a left atrial diameter (LAd) ≥40 mm were predictors of moderate-severe sleep apnea. However, the prevalence of moderate-severe sleep apnea in patients without those predictors (i.e., non-obesity (44.2%), female sex (43.0%), paroxysmal AF (43.9%), no hypertension (45.5%)), and LAd <40 mm (41.0%) was considerably high. CONCLUSIONS: Almost all patients successfully underwent W-PAT to diagnose sleep apnea. Patients undergoing AF ablation had a high prevalence of sleep apnea, and screening for sleep apnea was important in those patients even if they did not have sleepiness or risk factors.

Sex differences in atrial fibrillation ablation outcomes: insights from a large-scale multicentre registry.

AIM: The impact of sex differences on the clinical outcomes of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) is controversial. We investigated the sex differences regarding the efficacy and clinical outcomes of RFCA of AF. METHODS AND RESULTS: We conducted a large-scale, prospective, multicentre, observational study (Kansai Plus Atrial Fibrillation Registry). We enrolled 5010 consecutive patients who underwent an initial RFCA of AF at 26 centres (64 ± 10 years; non-paroxysmal AF, 35.7%). The median follow-up duration was 2.9 years. Female patients (n = 1369, 27.3%) were older (female vs. male, 68 ± 9 vs. 63 ± 11 years, P < 0.0001) with a lower prevalence of non-paroxysmal AF (27.1% vs. 38.9%, P < 0.0001). Fewer females experienced time-dependent pulmonary vein (PV) reconnections and more females received a non-PV foci ablation than males in the index RFCA. The 3-year cumulative incidence of AF recurrences in the multivariate analysis after single procedures was significantly higher in females than males (43.3% vs. 39.0%, log rank P = 0.0046). Females remained an independent predictor of AF recurrence (hazard ratio 1.24; 95% confidence interval 1.12-1.38, P < 0.0001). The AF recurrence rates after multiple procedures were also higher in females, but fewer females experienced PV reconnections during second sessions. More females experienced de novo pacemaker implantations during the long-term follow-up. Females were associated with a higher risk of heart failure hospitalizations and major bleeding after RFCA in the multivariate analysis. CONCLUSIONS: Females experienced more frequent AF recurrences probably due to non-PV arrhythmogenicity and de novo pacemaker implantations than males during the long-term follow-up after RFCA of AF.

Burden and Long Firing of Premature Atrial Contraction Early After Catheter Ablation Predict Late Recurrence of Atrial Fibrillation.

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<0.01) and a longer longest PAC run (5 [2-8] vs. 3 [1-5]; P<0.01) than those without. Receiver operating characteristic curve analysis indicated 58 PAC/24 h and a longest PAC run of 5 were optimal cut-off values for predicting recurrence. After adjusting for previously reported predictors of late recurrence, frequent PAC (≥58/24 h) and longest PAC run ≥5 were found to be independent predictors of late recurrence (hazard ratios [95% confidence intervals] 1.93 [1.24-3.02; P<0.01] and 1.81 [1.20-2.76; P<0.01], respectively). CONCLUSIONS: Six months after successful AF ablation, both frequent PAC and long PAC run are independent predictors of late recurrence.

Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque　- 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

BACKGROUND: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32). CONCLUSIONS: In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.

Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients　- Results From the SCAN-HF Study.

BACKGROUND: Integrated device diagnostics, Triage-HF, is useful in risk stratifying patients with heart failure (HF), but its performance for Japanese patients remains unknown. This is a prospective study of Japanese patients treated with a cardiac resynchronization therapy defibrillator (CRT-D), with a Medtronic OptiVol 2.0 feature.Methods and Results:A total of 320 CRT-D patients were enrolled from 2013 to 2017. All received HF treatment in the prior 12 months. Following enrollment, they were followed every 6 months for 48 months (mean, 22 months). Triage-HF-stratified patients at low, medium and high risk statuses at every 30-day period, and HF-related hospitalization occurring for the subsequent 30 days, were evaluated and repeated. The primary endpoint was to assess Triage-HF performance in predicting HF-related hospitalization risk. All device data were available for 279 of 320 patients (NYHA class II or III in 93%; mean left ventricular ejection fraction, 31%). During a total of 5,977 patient-month follow-ups, 89 HF-related hospitalization occurred in 72 patients. The unadjusted event numbers for Low, Medium and High statuses were 19 (0.7%), 42 (1.6%) and 28 (4.1%), respectively. Relative risk of Medium to Low status was 2.18 (95% CI 1.23-3.85) and 5.78 (95% CI 3.34-10.01) for High to Low status. Common contributing factors among the diagnostics included low activity, OptiVol threshold crossing, and elevated night heart rate. CONCLUSIONS: Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization.

Absorb GT1 Bioresorbable Vascular Scaffold System　- 1-Year Post-Marketing Surveillance in Japan.

BACKGROUND: The Japan post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) mandated an intracoronary imaging-guided implantation technique.Methods and Results:We enrolled 135 patients who were planned to undergo PCI with THE Absorb GT1. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a noncompliant balloon to minimize final diameter stenosis were recommended. The primary endpoint was the scaffold thrombosis rate at 3 months. All patients successfully received at least 1 Absorb GT1 at the index procedure and completed 1-year follow-up. All 139 lesions were predilatated: cutting/scoring balloon and noncompliant balloon were used in 48 (34.5%) and 58 (41.7%) lesions, respectively. Post-dilatation was performed in 137 (98.5%) lesions with mean high pressure of 18.8 atm. Optical coherence tomography (OCT) was used in 127 of 139 (91.4%) lesions, and revealed 56.7% of lesions had incomplete scaffold apposition (ISA) but only in 1.89% in the per strut analysis. All patients received adenosine diphosphate receptor antagonist at discharge, and 132 (97.8%) patients continued therapy through the year. No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year follow-up. CONCLUSIONS: Appropriate OCT-guided BVS implantation may prevent incomplete strut apposition, thereby reducing the risk of target lesion failure and scaffold thrombosis.

Comparison of the Safety and Efficacy of Automated Annotation-Guided Radiofrequency Ablation and 2nd-Generation Cryoballoon Ablation in Paroxysmal Atrial Fibrillation.

BACKGROUND: Automated ablation lesion annotation with optimal settings for parameters including contact force (CF) and catheter stability may be effective for achieving durable pulmonary vein isolation. Methods and Results: We retrospectively examined 131 consecutive patients who underwent initial catheter ablation (CA) for paroxysmal atrial fibrillation (PAF) by automatic annotation system (VISITAG module)-guided radiofrequency CA (RFCA) (n=61) and 2nd-generation cryoballoon ablation (CBA) (n=70) in terms of safety and long-term efficacy. The automatic annotation criteria for the RFCA group were as follows: catheter stability range of motion ≤1.5 mm, duration ≥5 s, and CF ≥5 g. We ablated for >20 s with a force-time integral >150 gs at each site, before moving to the next site. Each interlesion distance was <6 mm. Procedural complications were more frequent in the CBA group (1.6% vs. 10.0%, P=0.034). Across a median follow-up of 2.98 years, 88.5% and 70.0% of patients in the RFCA and CBA groups, respectively, were free from recurrence (log-rank test, P=0.0039). There was also a significant difference in favor of RFCA with respect to repeat ablations (3.3% vs. 24.3%, log-rank test, P=0.0003). CONCLUSIONS: RF ablation guided by an automated algorithm that includes CF and catheter stability parameters showed better long-term outcomes than CBA in the treatment of patients with PAF without increasing complications.

Multiple Shifts of the Earliest Retrograde Atrial Activation Site Along the Tricuspid Annulus During the Fast-Slow Form of Atrioventricular Nodal Reentrant Tachycardia by Radiofrequency Modification.

A 70-year-old woman was admitted for treatment of supraventricular tachycardia. Ventriculoatrial conduction was revealed through programmed ventricular stimulation; the coronary sinus ostium (CSos) was the earliest atrial activation site. The fast-slow forms of atrioventricular nodal reentrant tachycardia (AVNRT) were induced by ventricular extra-stimuli. During tachycardia, the earliest atrial activation site was located at the bottom of CSos. Radiofrequency (RF) energy application to this site resulted in the delay of local electrical potential, prolongation of tachycardia cycle length, and a shift of the earliest retrograde activation site to the roof of CSos. Subsequent ablation induced a similar shift to the inferior tricuspid annulus and to the right posterior septum. Finally, RF energy application to the right posterior septum resulted in the termination of tachycardia, which was not induced afterward. Multiple shifts in the earliest retrograde atrial activation site along the tricuspid annulus after each slow pathway ablation suggested that annular tissue plays a substantial role as a substrate for AVNRT.

Efficacy and Safety of Figure-of-Eight Suture for Hemostasis After Radiofrequency Catheter Ablation for Atrial Fibrillation.

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<0.001). The post-procedural use of analgesic and/or anti-emetic agents was less frequent in the FoE group (19.3% vs. 32.0%, P<0.001). On multiple logistic regression analysis after adjustment for age and sex, the use of a vitamin K antagonist (OR, 2.42; 95% CI: 1.18-4.99, P=0.02) and the FoE suture technique (OR, 0.17; 95% CI: 0.08-0.35, P<0.001) were independent predictors of rebleeding after CA. CONCLUSIONS: FoE suture technique effectively achieved femoral venous hemostasis after RFCA for AF. It reduced the risk of rebleeding, shortened bed rest duration, and relieved patient discomfort.

Effect of QRS Morphology and Duration on Clinical Outcomes After Cardiac Resynchronization Therapy　- Analysis of Japanese Multicenter Registry.

BACKGROUND: QRS duration (QRSd) and morphology are established response predictors of cardiac resynchronization therapy (CRT). However, evidence in Japanese populations is lacking.Methods and Results:We retrospectively analyzed the Japanese multicenter CRT database. We divided patients according to their intrinsic QRSd and morphology, and assessed echocardiographic responses and clinical outcomes. The primary endpoint was a composite of all-cause death or hospitalization because of heart failure. A total of 510 patients were enrolled: 200 (39%) had left bundle branch block (LBBB) and QRSd ≥150 ms; 80 (16%) had LBBB (QRSd: 120-149 ms); 61 (12%) had non-LBBB (NLBBB) (QRSd: ≥150 ms); 54 (11%) had NLBBB (QRSd: 120-149 ms); 115 (23%), narrow (<120 ms). The proportion of echocardiographic responders was higher in LBBB (QRSd ≥150 ms) [74% vs. 51% vs. 38% vs. 52% vs. 50%, LBBB (QRSd ≥150 ms) vs. LBBB (QRSd 120-149 ms) vs. NLBBB (QRSd ≥150 ms) vs. NLBBB (QRSd 120-149 ms) vs. narrow, respectively, P<0.001]. During follow-up (3.2±1.5 years), the incidence of the primary endpoint was lowest in the LBBB group (QRSd ≥150) (28.6% vs. 42.3% vs. 45.9% vs. 55.6% vs. 55.3%, respectively, P<0.001). This difference was still significant after adjusting for other baseline characteristics. CONCLUSIONS: In this Japanese patient population, LBBB intrinsic QRS morphology and prolonged QRSd (≥150 ms) exhibited the best response to CRT.

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　- Pooled Analysis From the RESET and NEXT Trials.

BACKGROUND: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55). CONCLUSIONS: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

One-Year Outcome of Fractional Flow Reserve-Based Coronary Intervention in Japanese Daily Practice　- CVIT-DEFER Registry.

BACKGROUND: Clinical use of fractional flow reserve (FFR) has been rapidly increasing, but outcomes after FFR-based coronary intervention in Japanese daily clinical practice have not been well investigated.Methods and Results:The prospective multicenter cardiovascular intervention therapeutics registry (CVIT)-DEFER enrolled consecutive patients for whom FFR measurement was clinically indicated. This study comprised 3,857 vessels in 3,272 patients. Lesions were categorized into 4 groups according to FFR result and revascularization strategy: group 1: FFR >0.8, and deferral of PCI (n=1992); group 2: FFR >0.8, then PCI (n=230); group 3: FFR ≤0.8, and deferral of PCI (n=506); and group 4: FFR ≤0.8, then PCI (n=1,129). The event rate for deferred lesions was significantly low compared with that for PCI lesions (3.5% vs. 6.6%; P<0.05). Vessel-related events occurred in 62 (3.1%), 11 (4.8%), 25 (4.9%), and 79 (7.0%) patients in groups 1, 2, 3, and 4, respectively. PCI for lesions in which FFR was >0.8 (group 2) showed no improvement in the event rate compared with a defer-strategy. On the other hand, deferred lesions with lower FFR values had a higher risk of vessel-related events. CONCLUSIONS: A FFR-based revascularization strategy in daily clinical practice was safe with regard to vessel-related events.

Automated Ablation Annotation Algorithm Reduces Re-conduction of Isolated Pulmonary Vein and Improves Outcome After Catheter Ablation for Atrial Fibrillation.

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<0.001). One-year success rate off anti-arrhythmic drugs was higher in group A (91.8% vs. 69.1%, log rank P=0.0058). CONCLUSIONS: An automated annotation algorithm with an optimal setting reduced acute resumption of left atrium-PV conduction, shortened procedure time, and improved AF ablation outcome.

Regional difference of optimal contact force to prevent acute pulmonary vein reconnection during radiofrequency catheter ablation for atrial fibrillation.

BACKGROUND: Regional differences in optimal contact force (CF) to prevent acute pulmonary vein reconnection (APVR) during catheter ablation for atrial fibrillation (AF) remain unclear. OBJECTIVE: The purpose of this study was to evaluate regional difference in optimal CF during AF ablation. METHODS: This single-center observational study evaluated data from 57 consecutive drug-refractory AF patients (mean age, 62 ± 11 years; 43 males) who underwent initial pulmonary vein isolation (PVI) using the THERMOCOOL® SMARTTOUCH™ (Biosense Webster, Diamond Bar, CA, USA) catheter from June to August 2013. APVR was defined as the time-dependent reconnection >20 minutes after initial PVI and/or reconnection evoked by intravenous adenosine administration (20 mg). Point-by-point relationships between the reconnected points and their CF values were evaluated. RESULTS: Total 72 gaps causing APVR were observed. Of a total of 4,421 ablation points, 285 (6.4%) were associated with APVR. The average CF value of the points with APVR was significantly lower than that of those without (APVR vs. no APVR; 7.5 ± 6.7 g vs. 9.9 ± 8.4 g; P < 0.0001). The areas under the curve and optimal CF values differed between segments (range 0.593-0.761 and 10-22 g, respectively). The optimal CF value was highest in bottom of the right PV and posterosuperior right PV segments (22 g) and lowest in posteroinferior right PV segment (10 g). CONCLUSIONS: There was a regional difference in optimal CF values to prevent APVR, and the optimal CF value to prevent APVR with >95% probability was 10-22 g, depending on the individual peri-PV segments.