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.
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.
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.
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.
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.
Abstract Effects of daily fluctuation of ambient temperature and concentrations of air pollutants on acute cardiovascular events have not been well studied. Between January 2011 and December 2012, a ...total of 56,863 consecutive ST-segment elevation myocardial infarction (STEMI) patients who underwent primary percutaneous coronary intervention were registered from 929 institutes with median inter-institutional distance of 2.6 km. We constructed generalized linear mixed models in which presence or absence of STEMI patients per day per institute was included as a binomial response variable, with daily meteorological and environmental data obtained from their respective observatories nearest to the institutes (median distance of 9.7 km and 5.6 km) as the explanatory variables. Both lower mean temperature, and increase in maximum temperature from the previous day were independently associated with the STEMI occurrence throughout the year (OR 0.92595%CI 0.915-0.935, per10°C, P<0.001, and OR 1.01295%CI 1.009-1.015, per°C, P<0.001, respectively). Decrement in minimum temperature from -4 day to -3 day before the event date was marginally associated with the STEMI occurrence, only during the wintertime (OR 0.99195%CI 0.982-0.999, per°C, P=0.03). As for the air pollutants, nitrogen oxides and suspended particle matter were not correlated with the occurrence of STEMI after adjusting for the meteorological and livelihood variables. Both the absolute value and relative change in the ambient temperature were associated with the occurrence of STEMI; the associations with the air pollutant levels were less clear after adjustment for these meteorological variables in Japan.
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.
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.
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.
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 (LAEF
post
) was calculated. We evaluated the association between LAEF
post
and recurrence of AF after the final ablation procedure. Further, we assessed the predictors of reduced LAEF
post
. 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 LAEF
post
was associated with the recurrence of AF (hazard ratio/10% increase: 0.62, 95% confidence interval: 0.51–0.75,
P
< 0.0001). LAEF
post
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 LAEF
post
(< 26.36%,
N
= 100) and those with preserved LAEF
post
(≥ 26.36%,
N
= 516) was 40% and 79%, respectively (
P
< 0.0001). The predictors of reduced LAEF
post
were low pre-ablation LAEF, high pre-ablation LA volume, low body mass index (BMI), and female sex. Further, reduced LAEF
post
was associated with the total number of ablation sessions and extra-pulmonary vein LA ablation. In conclusion, reduced LAEF
post
was associated with recurrence of AF after ablation. Advanced LA remodeling, low BMI, and female sex could predict reduced LAEF
post
. Although additional ablation was associated with reduced LAEF
post
, it remains unclear whether reduced LAEF
post
resulted from the additional ablation. Reduced LAEF
post
might help stratify patients with ablation-refractory AF.
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