Background:Outcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, ...observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front AdvanceTM. We evaluated device- and procedure-related complications and clinical outcomes at 6 months.Methods and Results:The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1–91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure.Conclusions:Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation. (Circ J 2016; 80: 1744–1749)
Background: Target anticoagulation levels for warfarin in Japanese patients with non-valvular atrial fibrillation (NVAF) are unclear. Methods and Results: Of 7,527 patients with NVAF, 1,002 did not ...receive warfarin (non-warfarin group), and the remaining patients receiving warfarin were divided into 5 groups based on their baseline international normalized ratio (INR) of prothrombin time (≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0). Patients were followed-up prospectively for 2 years. Primary endpoints were thromboembolic events (cerebral infarction, transient ischemic attack, and systemic embolism), and major hemorrhage requiring hospital admission. During the follow-up period, thromboembolic events occurred in 3.0% of non-warfarin group, but at lower frequencies in the warfarin groups (2.0, 1.3, 1.5, 0.6, and 1.8%/2 years for INR values of ≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0, respectively; P=0.0059). Major hemorrhage occurred more frequently in warfarin groups (1.5, 1.8, 2.4, 3.3, and 4.1% for INR values ≤1.59, 1.6–1.99, 2.0–2.59, 2.6–2.99, and ≥3.0, respectively; P=0.0041) than in non-warfarin group (0.8%/2 years). These trends were maintained when the analyses were confined to patients aged ≥70 years. Conclusions: An INR of 1.6–2.6 is safe and effective at preventing thromboembolic events in patients with NVAF, particularly patients aged ≥70 years. An INR of 2.6–2.99 is also effective, but associated with a slightly increased risk in major hemorrhage. (UMIN Clinical Trials Registry UMIN000001569) (Circ J 2013; 77: 2264–2270)
ABSTRACT Background Few studies (in other countries than the US) have reported on the efficacy and safety of dexmedetomidine for sedation of patients undergoing surgical or medical procedures under ...local anesthesia without intubation outside the intensive care unit. We performed a randomized, double-blind study in Japan. Methods Adult patients were randomly allocated to receive placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min. Then, both dexmedetomidine groups received dexmedetomidine 0.2-0.7 μg/kg/h for maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of <- 4 ; however, propofol was administered to rescue patients whose score exceeded this value. The primary endpoint was the percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of <- 4. Results In total, 162 patients were included in the placebo (n = 53), DEX 0.5 (n = 53), and DEX 1.0 (n = 56) groups. Propofol was not required in significantly more patients in the dexmedetomidine 0.5 and 1.0 μg/kg groups (52.8% and 57.1%, respectively) compared with the placebo group (1.9%) (P < 0.001 for both). Common adverse events were protocol-defined hypotension, respiratory depression and bradycardia. The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) (P = 0.041 and P = 0.008, respectively). Conclusion We concluded that a loading dose of 0.5 or 1.0 μg/kg dexmedetomidine followed by infusion at a rate of 0.2-0.7 μg/kg/h provided effective and well-tolerated sedation in patients undergoing surgical or medical procedures under local anesthesia without intubation.
Background
The local impedance (LI) reflects the electrical catheter‐tissue coupling and correlates with the local tissue temperature. However, there have been few clinical studies showing the ...recommended method for LI monitoring catheters. This study aimed to investigate the optimal ablation setting for this catheter in an in vitro experimental model.
Methods
LI monitoring catheters were used in an excised swine heart experimental model. The tissue contact force (CF) was directly monitored from an external weight scale. Radiofrequency ablation was performed with a combination of various energy power settings (30, 40, and 50 W), and various CFs (10, 30, and 50 g) for 60 s. The correlation between the LI‐related indexes, power, and CF with the lesion formation was statistically analyzed.
Results
A positive correlation between the LI or lesion formation and CF was observed under all powers. Although the LI drop always correlated with the maximum lesion depth, lesion diameter, and lesion volume, the coefficient of the correlation value was lower under a high CF (lesion depth, diameter, and volume; 10 g, r = 0.8064, r = 0.8389, r = 0.8477; 30 g, r = 0.7590, r = 0.8063, r = 0.8060; 50 g r = 0.5555, r = 0.5701, and r = 0.5678, respectively). Steam pops occurred only under a 50 W ablation and the LI drop cutoff value for steam pops was 46 Ω.
Conclusion
The same LI drop did not always lead to the same lesion size when the CF differed. Monitoring the LI and not exceeding 46 Ω would be useful for a safe ablation.
Abstract
Average beat interval (BI) and beat interval variability (BIV) are primarily determined by mutual entrainment between the autonomic-nervous system (ANS) and intrinsic mechanisms that govern ...sinoatrial node (SAN) cell function. While basal heart rate is not affected by age in humans, age-dependent reductions in intrinsic heart rate have been documented even in so-called healthy individuals. The relative contributions of the ANS and intrinsic mechanisms to age-dependent deterioration of SAN function in humans are not clear. We recorded ECG on patients (n = 16 < 21 years and n = 23 41–78 years) in the basal state and after ANS blockade (propranolol and atropine) in the presence of propofol and dexmedetomidine anesthesia. Average BI and BIV were analyzed. A set of BIV features were tested to designated the “signatures” of the ANS and intrinsic mechanisms and also the anesthesia “signature”. In young patients, the intrinsic mechanisms and ANS mainly contributed to long- and short-term BIV, respectively. In adults, both ANS and intrinsic mechanisms contributed to short-term BIV, while the latter also contributed to long-term BIV. Furthermore, anesthesia affected ANS function in young patients and both mechanisms in adult. The work also showed that intrinsic mechanism features can be calculated from BIs, without intervention.
Tourism helps communities sustain the memories of disaster and pass on live lessons. On the other hand, the memories and experiences of disaster and reconstruction thereafter constitute an important ...part of local resources for tourism that contribute to the development of local economies. In Indonesia, such tourism is even associated with sustainable tourism. In a particular type of tourism characterized by locally organized programs that exploits the indigenous resources and contacts with local resident, telling live lessons plays a pivotal role in linking pre- and post-devastation, local resident and visitors, and areas with and without disaster experiences. Here, we examine the significance of tourism as a forum for learning from and connecting with areas hit by disasters from the viewpoint of three “Links.” That is, “linking between pre- and post-devastation,” “linking between local resident and visitors,” and “linking between areas with and without disaster experiences.”
Objective The aim of this study was to clarify the circadian and seasonal variations in addition to identify sex-based differences in Japanese patients with Takotsubo syndrome (TTS). Methods The ...authors conducted a retrospective observational study to analyse the differences between the groups based on sex. Patients The patients were registered out of each institute registry of the acute coronary syndrome (ACS) which contains a total of 10,622 cases in eight academic hospitals in east Japan. Results Data for 344 consecutive TTS (73 male and 271 female) were extracted from each hospital registry. In-hospital mortality was higher in the male group than in the female group (18% vs. 7%; p=0.005). With regard to the circadian variations in all study patients, TTS events occurred most often in the afternoon and least often during the night. Moreover, the patterns of circadian variations in the female and male groups were the same as that of all study patients. TTS events occurred most frequently in the autumn and least often in the spring in the whole study cohort. Moreover, the seasonal variation in the female group showed the same pattern as that of the whole cohort. However, there were no significant seasonal differences in the incidence of TTS in the male group. Conclusion In a multicenter study in Japan, seasonal variation was observed in the female group but not in the male group. Circadian variation was observed in both groups. These results suggested that the pathogenesis and clinical features of TTS might therefore differ according to sex.
Background
The ablation index (AI) is reported to be useful for a durable pulmonary vein isolation (PVI). However, there have been no studies investigating the relationship between the power, contact ...force (CF), AI, and steam pops.
Methods
Using an in vitro model, ablation energy was delivered until a steam pop occurred and the time to the steam pop and AI when the steam pop occurred were measured. The experiment was performed with a combination of various powers (20, 30, 40, and 50 W) and contact forces (CFs) (10, 30, and 50 g) 20 times for each setting. The analysis consisted of two protocols. The first protocol was a comparison between the ablation power and several parameters under the same CF (10, 30, and 50 g). The second protocol was a comparison between the CF and several parameters under the same power (20, 30, 40, and 50 W). The correlation between the lesion formation and ablation parameters was evaluated.
Results
The AI value when steam pops occurred varied depending on the ablation settings. All AI median values were <500 under an ablation power of 50 W. On other hand, the median ablation time up to the steam pop was more than 46 seconds, but all median values of the AI were more than 550 under an ablation with 20 W.
Conclusions
The AI cannot predict steam pops. A low power and long duration ablation could obtain a high AI value. However, high‐power ablation could not obtain a high AI value because of an early occurrence of steam pops.
Background
After the reports of recalled leads, several technological improvements have been introduced and the durability of implantable cardioverter defibrillator (ICD) leads has improved. The ...incidence of lead failures is now less than in the previous studies. However, there are few reports that have shown the long‐term durability of ICD leads as compared to pacemaker (PM) leads. This study analyzed the medium to long‐term performance of transvenous ICD leads as compared to PM leads.
Methods
We retrospectively studied 1227 cases from April 2007 to December 2017 who underwent an initial transvenous ICD or PM implantation. The number of lead failures and patient background characteristics were analyzed.
Results
During a median 3–3.5 years follow up period, 1 (0.3%) ICD lead and 18 (2.4%) PM leads failed. The incidence of lead failures was significantly higher in the PM group than ICD group (p = .019). Males were associated with a higher incidence of lead failures in the PM group.
Conclusion
Since the era of recalled ICD leads, the durability of ICD leads has remarkably improved and the incidence of lead failures with non‐recalled ICD leads has been less than that for PM leads.
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